We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV (CALIBRATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04143594
Recruitment Status : Active, not recruiting
First Posted : October 29, 2019
Results First Posted : December 19, 2022
Last Update Posted : December 19, 2022
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1-infection
Interventions Drug: Oral Lenacapavir
Drug: F/TAF
Drug: Subcutaneous Lenacapavir
Drug: TAF
Drug: BIC
Drug: B/F/TAF
Enrollment 183
Recruitment Details Participants were enrolled at study sites in Dominican Republic, and the United States.
Pre-assignment Details 249 participants were screened.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description

Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Period Title: Overall Study
Started 52 53 52 26
Completed 1 0 0 6
Not Completed 51 53 52 20
Reason Not Completed
Still on study             48             42             48             18
Withdrew consent             0             6             1             1
Lost to Follow-up             2             2             3             0
Investigator's discretion             1             2             0             0
Lack of Efficacy             0             1             0             0
Protocol Violation             0             0             0             1
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF Total
Hide Arm/Group Description

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study. Total of all reporting groups
Overall Number of Baseline Participants 52 53 52 25 182
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 53 participants 52 participants 25 participants 182 participants
33  (9.5) 30  (8.8) 32  (12.3) 33  (11.1) 32  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 53 participants 52 participants 25 participants 182 participants
Female
5
   9.6%
1
   1.9%
6
  11.5%
0
   0.0%
12
   6.6%
Male
47
  90.4%
52
  98.1%
46
  88.5%
25
 100.0%
170
  93.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 52 participants 53 participants 52 participants 25 participants 182 participants
American Indian or Alaska Native
1
   1.9%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
Asian
1
   1.9%
0
   0.0%
1
   1.9%
0
   0.0%
2
   1.1%
Black
24
  46.2%
24
  45.3%
31
  59.6%
16
  64.0%
95
  52.2%
Native Hawaiian or Pacific Islander
1
   1.9%
1
   1.9%
0
   0.0%
0
   0.0%
2
   1.1%
White
23
  44.2%
28
  52.8%
19
  36.5%
8
  32.0%
78
  42.9%
Other
2
   3.8%
0
   0.0%
1
   1.9%
1
   4.0%
4
   2.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 52 participants 53 participants 52 participants 25 participants 182 participants
Hispanic or Latino
25
  48.1%
21
  39.6%
24
  46.2%
12
  48.0%
82
  45.1%
Not Hispanic or Latino
27
  51.9%
32
  60.4%
28
  53.8%
13
  52.0%
100
  54.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 53 participants 52 participants 25 participants 182 participants
Puerto Rico
1
   1.9%
1
   1.9%
5
   9.6%
1
   4.0%
8
   4.4%
United States
37
  71.2%
42
  79.2%
37
  71.2%
21
  84.0%
137
  75.3%
Dominican Republic
14
  26.9%
10
  18.9%
10
  19.2%
3
  12.0%
37
  20.3%
Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA)  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 52 participants 53 participants 52 participants 25 participants 182 participants
4.18  (0.672) 4.35  (0.670) 4.33  (0.722) 4.35  (0.780) 4.30  (0.700)
HIV-1 RNA Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 53 participants 52 participants 25 participants 182 participants
<= 100,000 copies/mL
47
  90.4%
44
  83.0%
43
  82.7%
21
  84.0%
155
  85.2%
> 100,000 copies/mL
5
   9.6%
9
  17.0%
9
  17.3%
4
  16.0%
27
  14.8%
Cluster Determinant 4+ (CD4) Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/μL
Number Analyzed 52 participants 53 participants 52 participants 25 participants 182 participants
506  (297.0) 490  (209.9) 470  (221.7) 534  (260.0) 495  (246.5)
CD4 Cell Count Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 53 participants 52 participants 25 participants 182 participants
< 50 cells/μL
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>= 50 to < 200 cells/μL
0
   0.0%
1
   1.9%
3
   5.8%
0
   0.0%
4
   2.2%
>= 200 to < 350 cells/μL
17
  32.7%
15
  28.3%
16
  30.8%
4
  16.0%
52
  28.6%
>= 350 to < 500 cells/μL
17
  32.7%
15
  28.3%
15
  28.8%
11
  44.0%
58
  31.9%
>= 500 cells/μL
18
  34.6%
22
  41.5%
18
  34.6%
10
  40.0%
68
  37.4%
CD4 Percentage (%)  
Mean (Standard Deviation)
Unit of measure:  Percentage of CD4 cells
Number Analyzed 52 participants 53 participants 52 participants 25 participants 182 participants
24.2  (9.92) 24.1  (8.04) 22.7  (8.28) 26.2  (8.18) 24.0  (8.70)
1.Primary Outcome
Title Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 54 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 54 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 54 window was between Day 323 and 413 (inclusive).
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 52 53 52 25
Measure Type: Number
Unit of Measure: percentage of participants
90.4 84.9 84.6 92.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7178
Comments P-value was from the Cochran-Mantel-Haenszel (CMH) tests stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-18.4 to 13.2
Estimation Comments The difference in percentage of participants between LEN-containing and the B/F/TAF groups, and its 95% confidence interval (CI) were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3900
Comments P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -7.1
Confidence Interval (2-Sided) 95%
-23.4 to 9.3
Estimation Comments The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 3: LEN + F/TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3797
Comments P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -7.2
Confidence Interval (2-Sided) 95%
-23.5 to 9.1
Estimation Comments The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 28 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 28 window was between Days 176 and 231 (inclusive).
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 52 53 52 25
Measure Type: Number
Unit of Measure: percentage of participants
94.2 92.5 94.2 100.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2398
Comments P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -5.5
Confidence Interval (2-Sided) 95%
-15.9 to 4.8
Estimation Comments The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1639
Comments P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -7.4
Confidence Interval (2-Sided) 95%
-18.3 to 3.4
Estimation Comments The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 3: LEN + F/TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2307
Comments P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -5.7
Confidence Interval (2-Sided) 95%
-16.3 to 4.9
Estimation Comments The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 38 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Days 232 and 322 (inclusive).
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 52 53 52 25
Measure Type: Number
Unit of Measure: percentage of participants
90.4 88.7 88.5 96.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3142
Comments P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -6.7
Confidence Interval (2-Sided) 95%
-20.7 to 7.3
Estimation Comments The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3009
Comments P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -7.2
Confidence Interval (2-Sided) 95%
-21.3 to 6.8
Estimation Comments The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 3: LEN + F/TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2859
Comments P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -7.6
Confidence Interval (2-Sided) 95%
-21.8 to 6.7
Estimation Comments The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
4.Secondary Outcome
Title Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot Algorithm
Hide Description [Not Specified]
Time Frame Week 80
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change From Baseline in Log10 HIV-1 RNA at Week 28
Hide Description [Not Specified]
Time Frame Baseline; Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 49 51 50 25
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-2.92  (0.649) -3.04  (0.638) -3.01  (0.716) -3.07  (0.774)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5755
Comments P-value was from analysis of variance (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.20 to 0.37
Estimation Comments Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8697
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.25 to 0.29
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 3: LEN + F/TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7052
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.23 to 0.35
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
6.Secondary Outcome
Title Change From Baseline in Log10 HIV-1 RNA at Week 38
Hide Description [Not Specified]
Time Frame Baseline; Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 49 51 47 25
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-2.96  (0.639) -3.06  (0.641) -3.02  (0.771) -3.04  (0.760)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8942
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.26 to 0.30
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9058
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.28 to 0.25
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 3: LEN + F/TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8129
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.27 to 0.35
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
7.Secondary Outcome
Title Change From Baseline in Log10 HIV-1 RNA at Week 54
Hide Description [Not Specified]
Time Frame Baseline; Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 49 47 47 23
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-2.95  (0.636) -3.12  (0.589) -2.85  (0.840) -3.08  (0.787)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7864
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.25 to 0.33
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7013
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.31 to 0.21
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 3: LEN + F/TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2753
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-0.18 to 0.62
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
8.Secondary Outcome
Title Change From Baseline in Log10 HIV-1 RNA at Week 80
Hide Description [Not Specified]
Time Frame Baseline; Week 80
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 28
Hide Description [Not Specified]
Time Frame Baseline; Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 49 50 50 25
Mean (Standard Deviation)
Unit of Measure: cells/µL
172  (178.2) 158  (164.1) 206  (154.6) 163  (157.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7751
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 12
Confidence Interval (2-Sided) 95%
-73 to 97
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9549
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -2
Confidence Interval (2-Sided) 95%
-79 to 75
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 3: LEN + F/TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2603
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 44
Confidence Interval (2-Sided) 95%
-33 to 120
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
10.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 38
Hide Description [Not Specified]
Time Frame Baseline; Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 49 51 46 25
Mean (Standard Deviation)
Unit of Measure: cells/µL
195  (164.6) 219  (187.4) 210  (167.1) 232  (209.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4827
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -31
Confidence Interval (2-Sided) 95%
-119 to 57
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7844
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -13
Confidence Interval (2-Sided) 95%
-106 to 81
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 3: LEN + F/TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6082
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -23
Confidence Interval (2-Sided) 95%
-112 to 66
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
11.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 54
Hide Description [Not Specified]
Time Frame Baseline; Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 49 47 47 23
Mean (Standard Deviation)
Unit of Measure: cells/µL
206  (187.0) 212  (187.1) 220  (175.5) 193  (191.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6614
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 21
Confidence Interval (2-Sided) 95%
-73 to 115
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6791
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 20
Confidence Interval (2-Sided) 95%
-75 to 115
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 3: LEN + F/TAF, Group 4: B/F/TAF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5563
Comments P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 27
Confidence Interval (2-Sided) 95%
-65 to 120
Estimation Comments Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
12.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 80
Hide Description [Not Specified]
Time Frame Baseline; Week 80
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Hide Description TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug.
Time Frame First dose date up to 54 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 52 53 52 25
Measure Type: Number
Unit of Measure: percentage of participants
96.2 84.9 82.7 84.0
14.Secondary Outcome
Title Percentage of Participants Who Experienced Laboratory Abnormalities
Hide Description Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline visit, up to last exposure date for participants who permanently discontinued study drug, or the last available date in the database snapshot for participants who were still on treatment at the time of an interim analysis. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening.
Time Frame First dose date up to 54 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed 52 53 52 25
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 15.4 3.8 19.2 0
Grade 2 57.7 62.3 51.9 76.0
Grade 3 11.5 20.8 17.3 24.0
Grade 4 9.6 7.5 7.7 0
15.Secondary Outcome
Title Pharmacokinetics (PK) of TAF (Tenofovir Alafenamide)and TFV (Tenofovir): Area Under the Concentration Versus Time Curve (AUClast) on Day 1
Hide Description AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2) and at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK Substudy Analysis Set included participants who were randomized into the study, were enrolled into the PK Substudy, had received at least 1 dose of active study drug, and had at least 1 nonmissing intensive PK substudy concentration value for any analyte of interest reported by the PK lab.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 10 14
Mean (Standard Deviation)
Unit of Measure: hours*nanogram/mL (h*ng/mL)
TAF Number Analyzed 10 participants 14 participants
298.0  (88.0) 260.0  (63.5)
TFV Number Analyzed 4 participants 9 participants
27.1  (27.9) 40.5  (59.7)
16.Secondary Outcome
Title PK of TAF and TFV (Tenofovir): Maximum Observed Concentration of Drug (Cmax) on Day 1
Hide Description Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 10 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
TAF Number Analyzed 10 participants 14 participants
278.8  (87.7) 318.4  (57.7)
TFV Number Analyzed 4 participants 9 participants
5.4  (26.5) 13.8  (160.2)
17.Secondary Outcome
Title PK of TAF and TFV: Time (Observed Time Point) of Cmax (Tmax) on Day 1
Hide Description Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 10 14
Median (Inter-Quartile Range)
Unit of Measure: hours
TAF Number Analyzed 10 participants 14 participants
0.50
(0.50 to 1.00)
0.50
(0.50 to 0.50)
TFV Number Analyzed 4 participants 9 participants
1.50
(1.00 to 2.02)
1.00
(0.50 to 1.17)
18.Secondary Outcome
Title PK of TFV: Last Observed Quantifiable Concentration of the Drug (Clast) on Day 1
Hide Description Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK sub study analysis was conducted for Group 1 and 2 on Day 1.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 4 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.7  (23.1) 3.9  (38.0)
19.Secondary Outcome
Title PK of TAF and TFV: AUClast at Weeks 16, 22, or 28
Hide Description AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 3: LEN + F/TAF
Hide Arm/Group Description:

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
TAF 231.2  (60.0)
TFV 173.1  (52.5)
20.Secondary Outcome
Title PK of TAF and TFV: Cmax at Weeks 16, 22, or 28
Hide Description Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 3: LEN + F/TAF
Hide Arm/Group Description:

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
TAF 308.7  (74.7)
TFV 31.2  (51.7)
21.Secondary Outcome
Title PK of TAF and TFV: Tmax at Weeks 16, 22, or 28
Hide Description Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 3: LEN + F/TAF
Hide Arm/Group Description:

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: hours
TAF
0.53
(0.50 to 1.04)
TFV
1.00
(1.00 to 2.00)
22.Secondary Outcome
Title PK of TFV: Clast at Weeks 16, 22, or 28
Hide Description Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TFV was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 3: LEN + F/TAF
Hide Arm/Group Description:

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
22.2  (62.6)
23.Secondary Outcome
Title PK of TAF: AUClast at Week 38
Hide Description AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
211.5  (74.1)
24.Secondary Outcome
Title PK of TAF: Cmax at Week 38
Hide Description Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
279.0  (67.8)
25.Secondary Outcome
Title PK of TAF: Tmax at Week 38
Hide Description Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 11
Median (Inter-Quartile Range)
Unit of Measure: hours
0.50
(0.50 to 0.50)
26.Secondary Outcome
Title PK of Tenofovir Diphosphate (TFV-DP): AUClast at Weeks 4, 10, 16, or 22
Hide Description AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A peripheral blood mononuclear cell (PBMC) substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame 0 hours (Predose) and at 1, 2, and 6 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
The PBMC PK Substudy Analysis Set included all randomized participants who took at least 1 dose of study drug, participated in the PBMC substudy, and have at least 1 nonmissing postdose concentration value for tenofovir diphosphate (TFV-DP). The PBMC PK Substudy Analysis Set was used for PK analyses of TFV-DP.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: hours*micrometer (h*μM)
16.2  (68.3) 21.6  (71.9)
27.Secondary Outcome
Title PK of TFV-DP: Cmax at Weeks 4, 10, 16, or 22
Hide Description Cmax is defined as the maximum observed concentration of drug. A PBMC substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame 0 hours (Predose) and at 1, 2, and 6 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PBMC PK Substudy Analysis Set with the available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: micrometer (μM)
3.3  (37.5) 4.3  (71.8)
28.Secondary Outcome
Title PK of TFV-DP: Tmax at Weeks 4, 10, 16, or 22
Hide Description Tmax is defined as the time (observed time point) of Cmax. A PBMC substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame 0 hours (Predose) and at 1, 2, and 6 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PBMC PK Substudy Analysis Set with the available data were analyzed.
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 13 13
Median (Inter-Quartile Range)
Unit of Measure: hours
2.00
(1.00 to 6.00)
6.00
(1.00 to 6.00)
29.Secondary Outcome
Title PK of Bictegravir (BIC): AUClast at Week 38
Hide Description AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
72865.9  (31.0)
30.Secondary Outcome
Title PK of BIC: Cmax at Week 38
Hide Description Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
10180.0  (42.8)
31.Secondary Outcome
Title PK of BIC: Tmax at Week 38
Hide Description Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: hours
2.00
(1.00 to 3.00)
32.Secondary Outcome
Title PK of BIC: Clast at Week 38
Hide Description Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.
Time Frame 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Group 2: LEN + F/TAF + BIC
Hide Arm/Group Description:

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
8474.5  (33.3)
Time Frame Adverse Events: First dose date up to 54 weeks; All-Cause Mortality: Enrollment up to 54 weeks
Adverse Event Reporting Description

All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study.

Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.

 
Arm/Group Title Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Hide Arm/Group Description

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.

Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15.

Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.

Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.

Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
All-Cause Mortality
Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/53 (0.00%)   0/52 (0.00%)   0/26 (0.00%) 
Hide Serious Adverse Events
Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/52 (5.77%)   3/53 (5.66%)   4/52 (7.69%)   0/25 (0.00%) 
Blood and lymphatic system disorders         
Lymphadenopathy mediastinal  1  1/52 (1.92%)  0/53 (0.00%)  0/52 (0.00%)  0/25 (0.00%) 
Gastrointestinal disorders         
Vomiting  1  1/52 (1.92%)  0/53 (0.00%)  0/52 (0.00%)  0/25 (0.00%) 
Infections and infestations         
Escherichia infection  1  0/52 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/25 (0.00%) 
Hepatitis A  1  0/52 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/25 (0.00%) 
Perirectal abscess  1  0/52 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/25 (0.00%) 
Pneumocystis jirovecii pneumonia  1  0/52 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/25 (0.00%) 
Pneumonia  1  1/52 (1.92%)  0/53 (0.00%)  0/52 (0.00%)  0/25 (0.00%) 
Staphylococcal infection  1  1/52 (1.92%)  0/53 (0.00%)  0/52 (0.00%)  0/25 (0.00%) 
Injury, poisoning and procedural complications         
Poisoning  1  0/52 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/25 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Metastases to central nervous system  1  1/52 (1.92%)  0/53 (0.00%)  0/52 (0.00%)  0/25 (0.00%) 
Non-small cell lung cancer  1  1/52 (1.92%)  0/53 (0.00%)  0/52 (0.00%)  0/25 (0.00%) 
Uterine leiomyoma  1  1/52 (1.92%)  0/53 (0.00%)  0/52 (0.00%)  0/25 (0.00%) 
Psychiatric disorders         
Bipolar disorder  1  0/52 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/25 (0.00%) 
Major depression  1  0/52 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/25 (0.00%) 
Mental disorder  1  0/52 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/25 (0.00%) 
Psychotic disorder  1  0/52 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/25 (0.00%) 
Substance-induced psychotic disorder  1  0/52 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  1/52 (1.92%)  0/53 (0.00%)  0/52 (0.00%)  0/25 (0.00%) 
Pleural effusion  1  1/52 (1.92%)  0/53 (0.00%)  0/52 (0.00%)  0/25 (0.00%) 
Pneumothorax  1  0/52 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/25 (0.00%) 
1
Term from vocabulary, MedDRA (23.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: LEN + F/TAF + TAF Group 2: LEN + F/TAF + BIC Group 3: LEN + F/TAF Group 4: B/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45/52 (86.54%)   40/53 (75.47%)   36/52 (69.23%)   19/25 (76.00%) 
Blood and lymphatic system disorders         
Lymphadenopathy  1  4/52 (7.69%)  4/53 (7.55%)  6/52 (11.54%)  1/25 (4.00%) 
Gastrointestinal disorders         
Abdominal pain  1  4/52 (7.69%)  1/53 (1.89%)  1/52 (1.92%)  1/25 (4.00%) 
Abdominal pain upper  1  2/52 (3.85%)  0/53 (0.00%)  0/52 (0.00%)  2/25 (8.00%) 
Constipation  1  0/52 (0.00%)  0/53 (0.00%)  3/52 (5.77%)  0/25 (0.00%) 
Diarrhoea  1  3/52 (5.77%)  4/53 (7.55%)  5/52 (9.62%)  1/25 (4.00%) 
Nausea  1  10/52 (19.23%)  5/53 (9.43%)  6/52 (11.54%)  1/25 (4.00%) 
Vomiting  1  2/52 (3.85%)  1/53 (1.89%)  4/52 (7.69%)  0/25 (0.00%) 
General disorders         
Fatigue  1  0/52 (0.00%)  6/53 (11.32%)  2/52 (3.85%)  1/25 (4.00%) 
Injection site erythema  1  21/52 (40.38%)  12/53 (22.64%)  0/52 (0.00%)  0/25 (0.00%) 
Injection site induration  1  8/52 (15.38%)  5/53 (9.43%)  0/52 (0.00%)  0/25 (0.00%) 
Injection site inflammation  1  10/52 (19.23%)  4/53 (7.55%)  0/52 (0.00%)  0/25 (0.00%) 
Injection site nodule  1  9/52 (17.31%)  8/53 (15.09%)  0/52 (0.00%)  0/25 (0.00%) 
Injection site pain  1  15/52 (28.85%)  10/53 (18.87%)  0/52 (0.00%)  0/25 (0.00%) 
Injection site swelling  1  16/52 (30.77%)  13/53 (24.53%)  0/52 (0.00%)  0/25 (0.00%) 
Pyrexia  1  3/52 (5.77%)  2/53 (3.77%)  2/52 (3.85%)  2/25 (8.00%) 
Infections and infestations         
Acarodermatitis  1  3/52 (5.77%)  0/53 (0.00%)  1/52 (1.92%)  1/25 (4.00%) 
Anal chlamydia infection  1  0/52 (0.00%)  1/53 (1.89%)  3/52 (5.77%)  0/25 (0.00%) 
Covid-19  1  5/52 (9.62%)  5/53 (9.43%)  5/52 (9.62%)  3/25 (12.00%) 
Gonorrhoea  1  2/52 (3.85%)  2/53 (3.77%)  3/52 (5.77%)  1/25 (4.00%) 
Influenza  1  4/52 (7.69%)  2/53 (3.77%)  5/52 (9.62%)  0/25 (0.00%) 
Nasopharyngitis  1  4/52 (7.69%)  4/53 (7.55%)  3/52 (5.77%)  0/25 (0.00%) 
Onychomycosis  1  3/52 (5.77%)  1/53 (1.89%)  2/52 (3.85%)  0/25 (0.00%) 
Oropharyngeal gonococcal infection  1  1/52 (1.92%)  1/53 (1.89%)  3/52 (5.77%)  1/25 (4.00%) 
Otitis media  1  0/52 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  2/25 (8.00%) 
Proctitis gonococcal  1  0/52 (0.00%)  1/53 (1.89%)  3/52 (5.77%)  0/25 (0.00%) 
Syphilis  1  5/52 (9.62%)  4/53 (7.55%)  5/52 (9.62%)  4/25 (16.00%) 
Upper respiratory tract infection  1  2/52 (3.85%)  0/53 (0.00%)  2/52 (3.85%)  3/25 (12.00%) 
Urinary tract infection  1  1/52 (1.92%)  1/53 (1.89%)  4/52 (7.69%)  1/25 (4.00%) 
Injury, poisoning and procedural complications         
Ligament sprain  1  0/52 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  2/25 (8.00%) 
Investigations         
Weight increased  1  2/52 (3.85%)  1/53 (1.89%)  2/52 (3.85%)  3/25 (12.00%) 
Metabolism and nutrition disorders         
Hypertriglyceridaemia  1  0/52 (0.00%)  3/53 (5.66%)  0/52 (0.00%)  0/25 (0.00%) 
Vitamin D deficiency  1  0/52 (0.00%)  4/53 (7.55%)  3/52 (5.77%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/52 (3.85%)  4/53 (7.55%)  2/52 (3.85%)  4/25 (16.00%) 
Back pain  1  1/52 (1.92%)  4/53 (7.55%)  4/52 (7.69%)  3/25 (12.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anogenital warts  1  0/52 (0.00%)  1/53 (1.89%)  3/52 (5.77%)  1/25 (4.00%) 
Nervous system disorders         
Dizziness  1  3/52 (5.77%)  2/53 (3.77%)  2/52 (3.85%)  1/25 (4.00%) 
Headache  1  9/52 (17.31%)  5/53 (9.43%)  7/52 (13.46%)  3/25 (12.00%) 
Psychiatric disorders         
Anxiety  1  2/52 (3.85%)  2/53 (3.77%)  3/52 (5.77%)  2/25 (8.00%) 
Depression  1  1/52 (1.92%)  6/53 (11.32%)  3/52 (5.77%)  1/25 (4.00%) 
Insomnia  1  1/52 (1.92%)  0/53 (0.00%)  2/52 (3.85%)  3/25 (12.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/52 (5.77%)  1/53 (1.89%)  1/52 (1.92%)  1/25 (4.00%) 
Oropharyngeal pain  1  2/52 (3.85%)  4/53 (7.55%)  3/52 (5.77%)  0/25 (0.00%) 
Rhinitis allergic  1  0/52 (0.00%)  1/53 (1.89%)  3/52 (5.77%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash  1  1/52 (1.92%)  0/53 (0.00%)  3/52 (5.77%)  2/25 (8.00%) 
Vascular disorders         
Hypertension  1  3/52 (5.77%)  3/53 (5.66%)  1/52 (1.92%)  1/25 (4.00%) 
1
Term from vocabulary, MedDRA (23.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications:
Gupta SK, Berhe M, Crofoot G, et al. Long-Acting Subcutaneous Lenacapavir Dosed Every 6 Months as part of a Combination Regimen in Treatment-Naïve People with HIV: Interim 16-week Results of a Randomized, Open-label, Phase 2 Induction-Maintenance Study (CALIBRATE)
VanderVeen, L, Margot N, Naik V, et al. Interim Resistance Analysis of Long-Acting Lenacapavir in Treatment-Naïve People with HIV at 28 Weeks (CALIBRATE)
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04143594    
Other Study ID Numbers: GS-US-200-4334
First Submitted: October 28, 2019
First Posted: October 29, 2019
Results First Submitted: September 29, 2022
Results First Posted: December 19, 2022
Last Update Posted: December 19, 2022