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Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults

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ClinicalTrials.gov Identifier: NCT02071082
Recruitment Status : Completed
First Posted : February 25, 2014
Results First Posted : April 4, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV
HBV
Intervention Drug: E/C/F/TAF
Enrollment 79
Recruitment Details Participants were enrolled at study sites in North America and Japan. The first participant was screened on 25 February 2014. The last study visit occurred on 26 October 2016.
Pre-assignment Details 113 participants were screened.
Arm/Group Title HIV/HBV Treatment-Naive (Cohort 1) HIV-Suppressed (Cohort 2)
Hide Arm/Group Description HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks. HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Period Title: Overall Study
Started 4 75
Completed 2 68
Not Completed 2 7
Reason Not Completed
Enrolled and Never Treated             1             1
Adverse Event             0             1
Withdrew Consent             0             4
Lost to Follow-up             1             1
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed Total
Hide Arm/Group Description HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks. HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 3 74 77
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 74 participants 77 participants
27  (4.0) 49  (7.8) 49  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 74 participants 77 participants
Female
0
   0.0%
6
   8.1%
6
   7.8%
Male
3
 100.0%
68
  91.9%
71
  92.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 3 participants 74 participants 77 participants
American Indian or Alaska Native 0 1 1
Asian 2 7 9
Black 0 14 14
White 1 50 51
Other 0 2 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 3 participants 74 participants 77 participants
Hispanic or Latino 0 12 12
Not Hispanic or Latino 3 62 65
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 3 participants 74 participants 77 participants
Canada 0 10 10
United States 1 62 63
Japan 2 2 4
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 3 participants 74 participants 77 participants
4.20  (1.242) 1.29  (0.068) 1.41  (0.606)
HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 3 participants 74 participants 77 participants
< 50 copies/mL 0 73 73
≥ 50 copies/mL 3 1 4
HBV DNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 3 participants 74 participants 77 participants
8.31  (0.416) 1.49  (0.883) 1.75  (1.588)
HBV DNA Category  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 3 participants 74 participants 77 participants
< 29 IU/mL 0 64 64
≥ 29 IU/mL 3 10 13
Alanine Aminotransferase (ALT)  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 3 participants 74 participants 77 participants
84  (38.9) 31  (21.1) 33  (23.9)
Hepatitis B Surface Antigen Status  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 3 participants 74 participants 77 participants
Positive 3 71 74
Negative 0 3 3
Hepatitis B e-Antibody Status  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 3 participants 74 participants 77 participants
Positive 0 26 26
Negative 3 43 46
Borderline 0 5 5
Fibrotest® Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 3 participants 74 participants 77 participants
0.27
(0.16 to 0.28)
0.35
(0.21 to 0.54)
0.34
(0.21 to 0.53)
[1]
Measure Description: The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
1.Primary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient'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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, had at least 1 post-Day 1 plasma HBV DNA or HIV-1 RNA result while on study, and had no major protocol violations from the eligibility criteria.
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 72
Measure Type: Number
Unit of Measure: percentage of participants
100.0 94.4
2.Primary Outcome
Title Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
Hide Description The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 72
Measure Type: Number
Unit of Measure: percentage of participants
33.3 86.1
3.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 72
Measure Type: Number
Unit of Measure: percentage of participants
66.7 91.7
4.Secondary Outcome
Title Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
Hide Description The percentage of participants with HBV DNA < 29 IU/mL at Week 48 was calculated using the missing = failure method.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 72
Measure Type: Number
Unit of Measure: percentage of participants
66.7 91.7
5.Secondary Outcome
Title Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24
Hide Description ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 10
Measure Type: Number
Unit of Measure: percentage of participants
100.0 50.0
6.Secondary Outcome
Title Percentage of Participants With Normalized ALT at Week 48
Hide Description ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 10
Measure Type: Number
Unit of Measure: percentage of participants
66.7 40.0
7.Secondary Outcome
Title Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24
Hide Description Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 70
Measure Type: Number
Unit of Measure: percentage of participants
0 1.4
8.Secondary Outcome
Title Percentage of Participants With Seroconversion to Anti-HBs at Week 48
Hide Description Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 70
Measure Type: Number
Unit of Measure: percentage of participants
0 1.4
9.Secondary Outcome
Title Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24
Hide Description Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 30
Measure Type: Number
Unit of Measure: percentage of participants
33.3 3.3
10.Secondary Outcome
Title Percentage of Participants With Seroconversion to Anti-HBe at Week 48
Hide Description Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 30
Measure Type: Number
Unit of Measure: percentage of participants
33.3 0
11.Secondary Outcome
Title Change From Baseline in FibroTest® Score at Week 24
Hide Description The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 3 67
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-0.19
(-0.24 to -0.10)
-0.02
(-0.12 to 0.04)
12.Secondary Outcome
Title Change From Baseline in FibroTest® Score at Week 48
Hide Description The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description:
HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
Overall Number of Participants Analyzed 2 67
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-0.15
(-0.21 to -0.08)
-0.07
(-0.12 to 0.02)
Time Frame Up to 126 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
 
Arm/Group Title HIV/HBV Treatment-Naive HIV-Suppressed
Hide Arm/Group Description E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV treatment-naive and HBV treatment-naive) E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV-suppressed)
All-Cause Mortality
HIV/HBV Treatment-Naive HIV-Suppressed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/74 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
HIV/HBV Treatment-Naive HIV-Suppressed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   12/74 (16.22%) 
Cardiac disorders     
Acute myocardial infarction † 1  0/3 (0.00%)  1/74 (1.35%) 
Gastrointestinal disorders     
Gastritis † 1  0/3 (0.00%)  1/74 (1.35%) 
Small intestinal obstruction † 1  0/3 (0.00%)  1/74 (1.35%) 
General disorders     
Chest pain † 1  0/3 (0.00%)  1/74 (1.35%) 
Infections and infestations     
Abscess limb † 1  0/3 (0.00%)  1/74 (1.35%) 
Appendicitis † 1  0/3 (0.00%)  1/74 (1.35%) 
Meningitis pneumococcal † 1  0/3 (0.00%)  1/74 (1.35%) 
Pneumococcal bacteraemia † 1  0/3 (0.00%)  1/74 (1.35%) 
Pneumonia † 1  0/3 (0.00%)  1/74 (1.35%) 
Pneumonia pneumococcal † 1  0/3 (0.00%)  1/74 (1.35%) 
Injury, poisoning and procedural complications     
Injury † 1  0/3 (0.00%)  1/74 (1.35%) 
Rib fracture † 1  0/3 (0.00%)  1/74 (1.35%) 
Metabolism and nutrition disorders     
Diabetes mellitus † 1  0/3 (0.00%)  1/74 (1.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Renal cell carcinoma † 1  0/3 (0.00%)  1/74 (1.35%) 
Nervous system disorders     
Cerebrovascular accident † 1  0/3 (0.00%)  1/74 (1.35%) 
Renal and urinary disorders     
Calculus urethral † 1  0/3 (0.00%)  1/74 (1.35%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1  0/3 (0.00%)  1/74 (1.35%) 
Prostatitis † 1  0/3 (0.00%)  1/74 (1.35%) 
1
Term from vocabulary, MedDRA 19.1
†
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HIV/HBV Treatment-Naive HIV-Suppressed
Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   51/74 (68.92%) 
Gastrointestinal disorders     
Dental caries † 1  1/3 (33.33%)  0/74 (0.00%) 
Diarrhoea † 1  1/3 (33.33%)  8/74 (10.81%) 
Gastrooesophageal reflux disease † 1  0/3 (0.00%)  7/74 (9.46%) 
Vomiting † 1  1/3 (33.33%)  2/74 (2.70%) 
General disorders     
Pyrexia † 1  0/3 (0.00%)  4/74 (5.41%) 
Infections and infestations     
Bronchitis † 1  0/3 (0.00%)  6/74 (8.11%) 
Chlamydial infection † 1  0/3 (0.00%)  4/74 (5.41%) 
Gonorrhoea † 1  0/3 (0.00%)  4/74 (5.41%) 
Herpes zoster † 1  1/3 (33.33%)  1/74 (1.35%) 
Influenza † 1  0/3 (0.00%)  4/74 (5.41%) 
Nasopharyngitis † 1  1/3 (33.33%)  9/74 (12.16%) 
Sinusitis † 1  0/3 (0.00%)  5/74 (6.76%) 
Syphilis † 1  1/3 (33.33%)  3/74 (4.05%) 
Upper respiratory tract infection † 1  1/3 (33.33%)  17/74 (22.97%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  0/3 (0.00%)  6/74 (8.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma † 1  0/3 (0.00%)  4/74 (5.41%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1  0/3 (0.00%)  4/74 (5.41%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  0/3 (0.00%)  4/74 (5.41%) 
Rhinitis allergic † 1  0/3 (0.00%)  5/74 (6.76%) 
1
Term from vocabulary, MedDRA 19.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02071082     History of Changes
Other Study ID Numbers: GS-US-292-1249
First Submitted: February 21, 2014
First Posted: February 25, 2014
Results First Submitted: January 21, 2016
Results First Posted: April 4, 2016
Last Update Posted: November 16, 2018