Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection (DISCOVER)

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: NCT02842086
Recruitment Status : Active, not recruiting
First Posted : July 22, 2016
Results First Posted : March 17, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pre-Exposure Prophylaxis of HIV-1 Infection
Interventions Drug: F/TAF
Drug: F/TDF
Drug: F/TAF Placebo
Drug: F/TDF Placebo
Enrollment 5399
Recruitment Details Participants were enrolled at study sites in the United States, Canada, and the European Union. The first participant was screened on 02 September 2016. The data cut date for the end of blinded treatment phase was 12 December 2019.
Pre-assignment Details 5857 participants were screened.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description Blinded Phase: Descovy (DVY; emtricitabine/tenofovir alafenamide [F/TAF] 200/25 mg) fixed-dose combination (FDC) tablet plus placebo-to-match Truvada (TVD) (emtricitabine/tenofovir disoproxil fumarate [F/TDF] 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks. Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Period Title: Overall Study
Started 2700 2699
Completed [1] 2156 2206
Not Completed 544 493
Reason Not Completed
Randomized but Never Treated             6             6
Still in Double-Blind Phase             7             3
Adverse Event             18             20
Death             3             3
Investigator's Discretion             9             13
Non-Compliance with Study Drug             9             8
Protocol Violation             8             4
Withdrew Consent             205             194
Lost to Follow-up             274             236
HIV-1 Infection             5             6
[1]
Completed the Double Blind Phase
Arm/Group Title Descovy (DVY) Truvada (TVD) Total
Hide Arm/Group Description Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks. Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks. Total of all reporting groups
Overall Number of Baseline Participants 2694 2693 5387
Hide Baseline Analysis Population Description
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2694 participants 2693 participants 5387 participants
36  (10.6) 36  (10.7) 36  (10.6)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Transgender Women Number Analyzed 2694 participants 2693 participants 5387 participants
45
   1.7%
29
   1.1%
74
   1.4%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2694 participants 2693 participants 5387 participants
Female 0 0 0
Male 2694 2693 5387
[1]
Measure Description: Reported data indicates sex at birth.
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 2694 participants 2693 participants 5387 participants
American Indian or Alaska Native 12 14 26
Asian 113 120 233
Black/Mixed Black 240 234 474
Native Hawaiian or Pacific Islander 17 23 40
White 2264 2247 4511
Other (Nonblack) 45 50 95
Not Permitted 3 5 8
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 2694 participants 2693 participants 5387 participants
Hispanic or Latino 635 683 1318
Not Hispanic or Latino 2058 2008 4066
Not Permitted 1 2 3
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 2694 participants 2693 participants 5387 participants
191 162 353
Austria Number Analyzed 2694 participants 2693 participants 5387 participants
35 42 77
Denmark Number Analyzed 2694 participants 2693 participants 5387 participants
98 104 202
France Number Analyzed 2694 participants 2693 participants 5387 participants
18 14 32
Germany Number Analyzed 2694 participants 2693 participants 5387 participants
187 183 370
Ireland Number Analyzed 2694 participants 2693 participants 5387 participants
40 38 78
Italy Number Analyzed 2694 participants 2693 participants 5387 participants
37 21 58
Netherlands Number Analyzed 2694 participants 2693 participants 5387 participants
31 40 71
Spain Number Analyzed 2694 participants 2693 participants 5387 participants
219 195 414
United Kingdom Number Analyzed 2694 participants 2693 participants 5387 participants
247 265 512
United States Number Analyzed 2694 participants 2693 participants 5387 participants
1591 1629 3220
Hip Bone Mineral Density (BMD)   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm^2
Number Analyzed 191 participants 185 participants 376 participants
1.030  (0.1553) 1.021  (0.1322) 1.025  (0.1443)
[1]
Measure Analysis Population Description: Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set included all DXA substudy participants who were randomized and received at least one dose of study drug, and had nonmissing hip BMD value for the baseline visit. Participants were grouped according to the treatment they actually received.
Spine BMD   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm^2
Number Analyzed 191 participants 188 participants 379 participants
1.134  (0.1646) 1.131  (0.1381) 1.132  (0.1518)
[1]
Measure Analysis Population Description: Spine DXA Analysis Set included all DXA substudy participants who were randomized and received at least one dose of study drug, and had nonmissing spine BMD value for the baseline visit. Participants were grouped according to the treatment they actually received.
Urine Beta-2 Microglobulin to Creatinine Ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  µg/g
Number Analyzed 2677 participants 2676 participants 5353 participants
204.3  (951.77) 188.5  (1010.19) 196.4  (981.35)
[1]
Measure Analysis Population Description: Participants in Safety Analysis Set with available data were analyzed.
Urine Retinol Binding Protein (RBP) to Creatinine Ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  µg/g
Number Analyzed 2686 participants 2686 participants 5372 participants
148.8  (553.54) 142.8  (256.64) 145.8  (431.41)
[1]
Measure Analysis Population Description: Participants in Safety Analysis Set with available data were analyzed.
Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2687 participants 2682 participants 5369 participants
≤ 200 mg/g 2662 2657 5319
> 200 mg/g 25 25 50
[1]
Measure Description: The UPCR was only calculated when corresponding urine protein (UP) ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g.
[2]
Measure Analysis Population Description: Participants in Safety Analysis Set with available data were analyzed.
Serum Creatinine  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 2694 participants 2693 participants 5387 participants
0.96  (0.146) 0.96  (0.148) 0.96  (0.147)
1.Primary Outcome
Title Incidence of HIV-1 Infection Per 100 Person Years (PY)
Hide Description

The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.

HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:

  • Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or
  • Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or
  • Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)
Time Frame When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, were not HIV positive on Day 1, and had at least 1 postbaseline HIV laboratory assessment.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2670 2665
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: HIV-1 infections per 100 PY
0.160
(0.064 to 0.330)
0.342
(0.191 to 0.564)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments Noninferiority was assessed using a 95.003% confidence interval (CI) constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.
Type of Statistical Test Non-Inferiority
Comments Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.468
Confidence Interval (2-Sided) 95.003%
0.191 to 1.149
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase
Hide Description Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set included all DXA substudy participants who were randomized and received at least one dose of study drug, and had nonmissing hip BMD value for the baseline visit. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 159 157
Mean (Standard Deviation)
Unit of Measure: Percent Change
0.218  (2.3668) -0.968  (2.4343)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments Hip BMD results were compared between the 2 treatment groups using analysis of variance (ANOVA), which included baseline TVD for pre-exposure prophylaxis (PrEP) and treatment as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares mean (LSM)
Estimated Value 1.142
Confidence Interval (2-Sided) 95%
0.628 to 1.655
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase
Hide Description Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Spine DXA Analysis Set included all DXA substudy participants who were randomized and received at least one dose of study drug, and had nonmissing spine BMD value for the baseline visit. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 160 159
Mean (Standard Deviation)
Unit of Measure: Percent Change
0.512  (2.9854) -1.061  (2.9382)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 1.567
Confidence Interval (2-Sided) 95%
0.913 to 2.220
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase
Hide Description

Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.

For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.

Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2346 2337
Median (Inter-Quartile Range)
Unit of Measure: Percent Change
-10.6
(-42.0 to 25.9)
15.4
(-22.9 to 97.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values were from the Van Elteren test stratified by baseline TVD for PrEP.
Method Van Elteren test
Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase
Hide Description

Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.

For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.

Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2360 2354
Median (Inter-Quartile Range)
Unit of Measure: Percent Change
0.1
(-24.9 to 35.3)
20.0
(-13.0 to 68.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values were from the Van Elteren test stratified by baseline TVD for PrEP.
Method Van Elteren test
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase
Hide Description The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2355 2348
Measure Type: Count of Participants
Unit of Measure: Participants
≤ 200 mg/g at Baseline; ≤ 200 mg/g at Week 48 2318 2295
≤ 200 mg/g at Baseline; > 200 mg/g at Week 48 16 35
> 200 mg/g at Baseline; ≤ 200 mg/g at Week 48 12 8
> 200 mg/g at Baseline; > 200 mg/g at Week 48 9 10
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus > 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.
Method Rank analysis of covariance
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2370 2368
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.01  (0.107) 0.01  (0.111)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments Results were compared between the 2 treatment groups using the analysis of covariance (ANCOVA) model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.02 to -0.01
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Incidence of HIV-1 Infection Per 100 PY
Hide Description

The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.

HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:

  • Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or
  • Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or
  • Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)
Time Frame When all participants have 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 157 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Full Analysis Set were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2670 2665
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: HIV-1 infections per 100 PY
0.159
(0.069 to 0.313)
0.297
(0.166 to 0.490)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments Noninferiority was assessed using a 95.003% CI constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.
Type of Statistical Test Non-Inferiority
Comments Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.536
Confidence Interval (2-Sided) 95.003%
0.227 to 1.264
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase
Hide Description Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.
Time Frame Baseline, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Hip DXA Analysis Set with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 144 138
Mean (Standard Deviation)
Unit of Measure: Percent Change
0.565  (2.9379) -1.048  (2.9277)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments Hip BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 1.567
Confidence Interval (2-Sided) 95%
0.896 to 2.237
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase
Hide Description Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.
Time Frame Baseline, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Spine DXA Analysis Set with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 145 142
Mean (Standard Deviation)
Unit of Measure: Percent Change
0.831  (3.4608) -1.426  (3.5508)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 2.253
Confidence Interval (2-Sided) 95%
1.437 to 3.069
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase
Hide Description

Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.

For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.

Time Frame Baseline, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2169 2195
Median (Inter-Quartile Range)
Unit of Measure: Percent Change
-14.5
(-45.4 to 23.9)
14.1
(-26.2 to 99.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values were from the Van Elteren test stratified by baseline TVD for PrEP.
Method Van Elteren test
Comments [Not Specified]
12.Secondary Outcome
Title Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase
Hide Description

Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.

For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.

Time Frame Baseline, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2188 2211
Median (Inter-Quartile Range)
Unit of Measure: Percent Change
0.3
(-27.1 to 35.7)
21.4
(-13.8 to 73.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values were from the Van Elteren test stratified by baseline TVD for PrEP.
Method Van Elteren test
Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase
Hide Description The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g.
Time Frame Baseline, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2175 2199
Measure Type: Count of Participants
Unit of Measure: Participants
≤ 200 mg/g at Baseline; ≤ 200 mg/g at Week 96 2134 2153
≤ 200 mg/g at Baseline; > 200 mg/g at Week 96 21 28
> 200 mg/g at Baseline; ≤ 200 mg/g at Week 96 14 10
> 200 mg/g at Baseline; > 200 mg/g at Week 96 6 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2163
Comments P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus > 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.
Method Rank analysis of covariance
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2194 2218
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.01  (0.114) 0.03  (0.117)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Descovy (DVY), Truvada (TVD)
Comments Results were compared between the 2 treatment groups using the ANCOVA model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.02 to -0.01
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Hide Description [Not Specified]
Time Frame First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2694 2693
Measure Type: Number
Unit of Measure: percentage of participants
93.7 93.6
16.Secondary Outcome
Title Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Hide Description [Not Specified]
Time Frame First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set with available data were analyzed.
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description:
Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
Overall Number of Participants Analyzed 2672 2665
Measure Type: Number
Unit of Measure: percentage of participants
76.1 79.1
Time Frame First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)
Adverse Event Reporting Description The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.
 
Arm/Group Title Descovy (DVY) Truvada (TVD)
Hide Arm/Group Description DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks. TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
All-Cause Mortality
Descovy (DVY) Truvada (TVD)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/2694 (0.11%)   3/2693 (0.11%) 
Hide Serious Adverse Events
Descovy (DVY) Truvada (TVD)
Affected / at Risk (%) Affected / at Risk (%)
Total   202/2694 (7.50%)   186/2693 (6.91%) 
Blood and lymphatic system disorders     
Agranulocytosis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Anaemia  1  1/2694 (0.04%)  1/2693 (0.04%) 
Lymphadenitis  1  0/2694 (0.00%)  2/2693 (0.07%) 
Lymphadenopathy  1  0/2694 (0.00%)  1/2693 (0.04%) 
Pancytopenia  1  1/2694 (0.04%)  0/2693 (0.00%) 
Sickle cell anaemia with crisis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Splenomegaly  1  1/2694 (0.04%)  0/2693 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  1/2694 (0.04%)  1/2693 (0.04%) 
Angina pectoris  1  1/2694 (0.04%)  0/2693 (0.00%) 
Atrial fibrillation  1  2/2694 (0.07%)  7/2693 (0.26%) 
Cardiac failure  1  1/2694 (0.04%)  0/2693 (0.00%) 
Cardiac failure acute  1  0/2694 (0.00%)  1/2693 (0.04%) 
Cardiac flutter  1  0/2694 (0.00%)  1/2693 (0.04%) 
Left ventricular failure  1  0/2694 (0.00%)  1/2693 (0.04%) 
Mitral valve incompetence  1  1/2694 (0.04%)  0/2693 (0.00%) 
Myocardial infarction  1  1/2694 (0.04%)  3/2693 (0.11%) 
Myocarditis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Palpitations  1  0/2694 (0.00%)  1/2693 (0.04%) 
Supraventricular tachycardia  1  2/2694 (0.07%)  0/2693 (0.00%) 
Congenital, familial and genetic disorders     
Pectus excavatum  1  0/2694 (0.00%)  1/2693 (0.04%) 
Sickle cell disease  1  1/2694 (0.04%)  0/2693 (0.00%) 
Ear and labyrinth disorders     
Sudden hearing loss  1  2/2694 (0.07%)  0/2693 (0.00%) 
Endocrine disorders     
Hyperparathyroidism primary  1  1/2694 (0.04%)  0/2693 (0.00%) 
Eye disorders     
Ocular myasthenia  1  1/2694 (0.04%)  0/2693 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/2694 (0.04%)  2/2693 (0.07%) 
Abdominal pain upper  1  1/2694 (0.04%)  0/2693 (0.00%) 
Anal fissure  1  0/2694 (0.00%)  1/2693 (0.04%) 
Anal fistula  1  0/2694 (0.00%)  2/2693 (0.07%) 
Colitis  1  1/2694 (0.04%)  1/2693 (0.04%) 
Constipation  1  2/2694 (0.07%)  0/2693 (0.00%) 
Cyclic vomiting syndrome  1  1/2694 (0.04%)  0/2693 (0.00%) 
Diarrhoea  1  1/2694 (0.04%)  3/2693 (0.11%) 
Diverticular perforation  1  0/2694 (0.00%)  1/2693 (0.04%) 
Duodenitis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Enlarged uvula  1  0/2694 (0.00%)  1/2693 (0.04%) 
Enteritis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Gastrointestinal haemorrhage  1  0/2694 (0.00%)  1/2693 (0.04%) 
Gastrooesophageal reflux disease  1  0/2694 (0.00%)  1/2693 (0.04%) 
Haemorrhoids  1  1/2694 (0.04%)  0/2693 (0.00%) 
Hiatus hernia  1  0/2694 (0.00%)  1/2693 (0.04%) 
Inguinal hernia  1  1/2694 (0.04%)  0/2693 (0.00%) 
Intestinal fistula  1  2/2694 (0.07%)  0/2693 (0.00%) 
Intestinal obstruction  1  1/2694 (0.04%)  0/2693 (0.00%) 
Mesenteric vein thrombosis  1  0/2694 (0.00%)  2/2693 (0.07%) 
Mesenteritis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Nausea  1  1/2694 (0.04%)  0/2693 (0.00%) 
Obstructive pancreatitis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Oesophageal perforation  1  1/2694 (0.04%)  0/2693 (0.00%) 
Oesophageal rupture  1  1/2694 (0.04%)  0/2693 (0.00%) 
Pancreatitis  1  0/2694 (0.00%)  2/2693 (0.07%) 
Proctitis  1  1/2694 (0.04%)  1/2693 (0.04%) 
Rectal lesion  1  1/2694 (0.04%)  0/2693 (0.00%) 
Small intestinal obstruction  1  1/2694 (0.04%)  0/2693 (0.00%) 
Volvulus  1  1/2694 (0.04%)  0/2693 (0.00%) 
Vomiting  1  1/2694 (0.04%)  1/2693 (0.04%) 
General disorders     
Chest pain  1  2/2694 (0.07%)  4/2693 (0.15%) 
Death  1  0/2694 (0.00%)  1/2693 (0.04%) 
Non-cardiac chest pain  1  2/2694 (0.07%)  1/2693 (0.04%) 
Oedema peripheral  1  0/2694 (0.00%)  1/2693 (0.04%) 
Pyrexia  1  2/2694 (0.07%)  0/2693 (0.00%) 
Sudden death  1  0/2694 (0.00%)  1/2693 (0.04%) 
Systemic inflammatory response syndrome  1  1/2694 (0.04%)  0/2693 (0.00%) 
Treatment failure  1  1/2694 (0.04%)  0/2693 (0.00%) 
Hepatobiliary disorders     
Biliary colic  1  0/2694 (0.00%)  1/2693 (0.04%) 
Cholecystitis  1  2/2694 (0.07%)  2/2693 (0.07%) 
Cholecystitis acute  1  0/2694 (0.00%)  1/2693 (0.04%) 
Cholelithiasis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Hepatitis acute  1  0/2694 (0.00%)  1/2693 (0.04%) 
Immune system disorders     
Amyloidosis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Anaphylactic reaction  1  0/2694 (0.00%)  1/2693 (0.04%) 
Infections and infestations     
Abdominal abscess  1  1/2694 (0.04%)  0/2693 (0.00%) 
Abscess limb  1  2/2694 (0.07%)  0/2693 (0.00%) 
Abscess oral  1  0/2694 (0.00%)  1/2693 (0.04%) 
Anal abscess  1  2/2694 (0.07%)  3/2693 (0.11%) 
Appendicitis  1  9/2694 (0.33%)  10/2693 (0.37%) 
Appendicitis perforated  1  0/2694 (0.00%)  1/2693 (0.04%) 
Brain abscess  1  0/2694 (0.00%)  1/2693 (0.04%) 
Breast abscess  1  0/2694 (0.00%)  1/2693 (0.04%) 
Campylobacter gastroenteritis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Cellulitis  1  7/2694 (0.26%)  5/2693 (0.19%) 
Cellulitis of male external genital organ  1  1/2694 (0.04%)  0/2693 (0.00%) 
Cholecystitis infective  1  1/2694 (0.04%)  1/2693 (0.04%) 
Chronic tonsillitis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Device related infection  1  0/2694 (0.00%)  1/2693 (0.04%) 
Diverticulitis  1  3/2694 (0.11%)  3/2693 (0.11%) 
Endocarditis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Epididymitis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Erysipelas  1  0/2694 (0.00%)  1/2693 (0.04%) 
Eye infection gonococcal  1  0/2694 (0.00%)  1/2693 (0.04%) 
Gastroenteritis  1  2/2694 (0.07%)  4/2693 (0.15%) 
Gastroenteritis Escherichia coli  1  1/2694 (0.04%)  0/2693 (0.00%) 
Gastroenteritis bacterial  1  1/2694 (0.04%)  0/2693 (0.00%) 
Gastroenteritis shigella  1  2/2694 (0.07%)  0/2693 (0.00%) 
Gastrointestinal viral infection  1  0/2694 (0.00%)  1/2693 (0.04%) 
Giardiasis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Gonorrhoea  1  0/2694 (0.00%)  1/2693 (0.04%) 
Groin abscess  1  0/2694 (0.00%)  2/2693 (0.07%) 
Hepatitis A  1  6/2694 (0.22%)  2/2693 (0.07%) 
Infected bite  1  1/2694 (0.04%)  1/2693 (0.04%) 
Infective tenosynovitis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Influenza  1  2/2694 (0.07%)  1/2693 (0.04%) 
Large intestine infection  1  1/2694 (0.04%)  0/2693 (0.00%) 
Localised infection  1  0/2694 (0.00%)  1/2693 (0.04%) 
Lower respiratory tract infection  1  1/2694 (0.04%)  1/2693 (0.04%) 
Lymphogranuloma venereum  1  1/2694 (0.04%)  1/2693 (0.04%) 
Malaria  1  0/2694 (0.00%)  1/2693 (0.04%) 
Measles  1  0/2694 (0.00%)  1/2693 (0.04%) 
Meningitis streptococcal  1  1/2694 (0.04%)  0/2693 (0.00%) 
Neurosyphilis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Orchitis  1  2/2694 (0.07%)  0/2693 (0.00%) 
Osteomyelitis  1  1/2694 (0.04%)  1/2693 (0.04%) 
Parotid abscess  1  1/2694 (0.04%)  0/2693 (0.00%) 
Perineal abscess  1  1/2694 (0.04%)  1/2693 (0.04%) 
Periorbital cellulitis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Perirectal abscess  1  1/2694 (0.04%)  0/2693 (0.00%) 
Peritonitis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Peritonsillar abscess  1  1/2694 (0.04%)  0/2693 (0.00%) 
Pharyngeal abscess  1  1/2694 (0.04%)  0/2693 (0.00%) 
Plasmodium falciparum infection  1  0/2694 (0.00%)  1/2693 (0.04%) 
Pneumonia  1  5/2694 (0.19%)  4/2693 (0.15%) 
Pneumonia pneumococcal  1  1/2694 (0.04%)  0/2693 (0.00%) 
Pneumonia staphylococcal  1  0/2694 (0.00%)  1/2693 (0.04%) 
Postoperative wound infection  1  0/2694 (0.00%)  1/2693 (0.04%) 
Proctitis chlamydial  1  1/2694 (0.04%)  0/2693 (0.00%) 
Pyelonephritis  1  1/2694 (0.04%)  1/2693 (0.04%) 
Rectal abscess  1  1/2694 (0.04%)  0/2693 (0.00%) 
Scrotal abscess  1  2/2694 (0.07%)  0/2693 (0.00%) 
Sepsis  1  3/2694 (0.11%)  1/2693 (0.04%) 
Septic shock  1  1/2694 (0.04%)  1/2693 (0.04%) 
Shigella infection  1  0/2694 (0.00%)  1/2693 (0.04%) 
Staphylococcal sepsis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Streptococcal sepsis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Tonsillitis  1  1/2694 (0.04%)  2/2693 (0.07%) 
Tooth infection  1  0/2694 (0.00%)  1/2693 (0.04%) 
Urinary tract infection  1  0/2694 (0.00%)  3/2693 (0.11%) 
Viral pericarditis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Viral rash  1  1/2694 (0.04%)  0/2693 (0.00%) 
Wound infection  1  1/2694 (0.04%)  0/2693 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  0/2694 (0.00%)  1/2693 (0.04%) 
Alcohol poisoning  1  1/2694 (0.04%)  0/2693 (0.00%) 
Ankle fracture  1  2/2694 (0.07%)  0/2693 (0.00%) 
Cervical vertebral fracture  1  0/2694 (0.00%)  1/2693 (0.04%) 
Concussion  1  0/2694 (0.00%)  3/2693 (0.11%) 
Contusion  1  1/2694 (0.04%)  0/2693 (0.00%) 
Craniocerebral injury  1  1/2694 (0.04%)  0/2693 (0.00%) 
Deep vein thrombosis postoperative  1  1/2694 (0.04%)  0/2693 (0.00%) 
Facial bones fracture  1  0/2694 (0.00%)  1/2693 (0.04%) 
Fall  1  1/2694 (0.04%)  1/2693 (0.04%) 
Femur fracture  1  1/2694 (0.04%)  0/2693 (0.00%) 
Foot fracture  1  1/2694 (0.04%)  2/2693 (0.07%) 
Gun shot wound  1  0/2694 (0.00%)  1/2693 (0.04%) 
Head injury  1  1/2694 (0.04%)  0/2693 (0.00%) 
Heat stroke  1  0/2694 (0.00%)  1/2693 (0.04%) 
Intentional overdose  1  0/2694 (0.00%)  1/2693 (0.04%) 
Joint dislocation  1  1/2694 (0.04%)  0/2693 (0.00%) 
Ligament injury  1  1/2694 (0.04%)  0/2693 (0.00%) 
Ligament rupture  1  1/2694 (0.04%)  0/2693 (0.00%) 
Limb injury  1  1/2694 (0.04%)  0/2693 (0.00%) 
Lower limb fracture  1  1/2694 (0.04%)  0/2693 (0.00%) 
Neck injury  1  1/2694 (0.04%)  0/2693 (0.00%) 
Overdose  1  4/2694 (0.15%)  1/2693 (0.04%) 
Pelvic fracture  1  0/2694 (0.00%)  1/2693 (0.04%) 
Post procedural complication  1  0/2694 (0.00%)  1/2693 (0.04%) 
Post procedural haemorrhage  1  3/2694 (0.11%)  1/2693 (0.04%) 
Radius fracture  1  0/2694 (0.00%)  2/2693 (0.07%) 
Reactive gastropathy  1  1/2694 (0.04%)  0/2693 (0.00%) 
Rib fracture  1  0/2694 (0.00%)  1/2693 (0.04%) 
Road traffic accident  1  4/2694 (0.15%)  1/2693 (0.04%) 
Scrotal haematoma  1  0/2694 (0.00%)  1/2693 (0.04%) 
Seroma  1  1/2694 (0.04%)  0/2693 (0.00%) 
Skull fracture  1  0/2694 (0.00%)  1/2693 (0.04%) 
Splenic rupture  1  0/2694 (0.00%)  1/2693 (0.04%) 
Subdural haematoma  1  1/2694 (0.04%)  1/2693 (0.04%) 
Tendon injury  1  0/2694 (0.00%)  1/2693 (0.04%) 
Tendon rupture  1  2/2694 (0.07%)  0/2693 (0.00%) 
Thoracic vertebral fracture  1  0/2694 (0.00%)  1/2693 (0.04%) 
Toxicity to various agents  1  2/2694 (0.07%)  2/2693 (0.07%) 
Traumatic intracranial haemorrhage  1  1/2694 (0.04%)  0/2693 (0.00%) 
Ulna fracture  1  0/2694 (0.00%)  1/2693 (0.04%) 
Upper limb fracture  1  1/2694 (0.04%)  0/2693 (0.00%) 
Investigations     
Aspartate aminotransferase increased  1  0/2694 (0.00%)  1/2693 (0.04%) 
Scan myocardial perfusion abnormal  1  0/2694 (0.00%)  1/2693 (0.04%) 
Metabolism and nutrition disorders     
Dehydration  1  1/2694 (0.04%)  0/2693 (0.00%) 
Diabetic ketoacidosis  1  1/2694 (0.04%)  1/2693 (0.04%) 
Hyperglycaemia  1  1/2694 (0.04%)  0/2693 (0.00%) 
Hypoglycaemia  1  1/2694 (0.04%)  0/2693 (0.00%) 
Metabolic acidosis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Obesity  1  0/2694 (0.00%)  1/2693 (0.04%) 
Type 1 diabetes mellitus  1  0/2694 (0.00%)  1/2693 (0.04%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/2694 (0.04%)  0/2693 (0.00%) 
Bursitis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Cervical spinal stenosis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Intervertebral disc degeneration  1  1/2694 (0.04%)  1/2693 (0.04%) 
Intervertebral disc protrusion  1  2/2694 (0.07%)  0/2693 (0.00%) 
Limb mass  1  0/2694 (0.00%)  1/2693 (0.04%) 
Osteoarthritis  1  0/2694 (0.00%)  2/2693 (0.07%) 
Rhabdomyolysis  1  2/2694 (0.07%)  0/2693 (0.00%) 
Rotator cuff syndrome  1  1/2694 (0.04%)  0/2693 (0.00%) 
Scoliosis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Spinal osteoarthritis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Spinal stenosis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Synovial cyst  1  0/2694 (0.00%)  1/2693 (0.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts  1  0/2694 (0.00%)  1/2693 (0.04%) 
Astrocytoma  1  1/2694 (0.04%)  0/2693 (0.00%) 
Carcinoid tumour  1  0/2694 (0.00%)  1/2693 (0.04%) 
Gastrointestinal carcinoma  1  1/2694 (0.04%)  0/2693 (0.00%) 
Gastrointestinal stromal tumour  1  0/2694 (0.00%)  1/2693 (0.04%) 
Hodgkin's disease  1  1/2694 (0.04%)  0/2693 (0.00%) 
Melanocytic naevus  1  1/2694 (0.04%)  0/2693 (0.00%) 
Metastases to lymph nodes  1  1/2694 (0.04%)  0/2693 (0.00%) 
Metastatic squamous cell carcinoma  1  0/2694 (0.00%)  1/2693 (0.04%) 
Oesophageal cancer metastatic  1  1/2694 (0.04%)  0/2693 (0.00%) 
Pituitary tumour  1  0/2694 (0.00%)  1/2693 (0.04%) 
Prostate cancer  1  3/2694 (0.11%)  0/2693 (0.00%) 
Renal cell carcinoma  1  1/2694 (0.04%)  0/2693 (0.00%) 
Testicular seminoma (pure)  1  1/2694 (0.04%)  0/2693 (0.00%) 
Thyroid cancer  1  1/2694 (0.04%)  0/2693 (0.00%) 
Nervous system disorders     
Amyotrophic lateral sclerosis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Cerebral venous sinus thrombosis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Cerebrovascular accident  1  1/2694 (0.04%)  1/2693 (0.04%) 
Facial paralysis  1  1/2694 (0.04%)  1/2693 (0.04%) 
Generalised tonic-clonic seizure  1  1/2694 (0.04%)  0/2693 (0.00%) 
Guillain-Barre syndrome  1  0/2694 (0.00%)  1/2693 (0.04%) 
Haemorrhage intracranial  1  1/2694 (0.04%)  0/2693 (0.00%) 
Headache  1  0/2694 (0.00%)  1/2693 (0.04%) 
Loss of consciousness  1  1/2694 (0.04%)  1/2693 (0.04%) 
Migraine  1  1/2694 (0.04%)  1/2693 (0.04%) 
Myelitis transverse  1  1/2694 (0.04%)  0/2693 (0.00%) 
Nerve compression  1  1/2694 (0.04%)  0/2693 (0.00%) 
Paraesthesia  1  1/2694 (0.04%)  0/2693 (0.00%) 
Partial seizures  1  0/2694 (0.00%)  1/2693 (0.04%) 
Polyneuropathy  1  0/2694 (0.00%)  1/2693 (0.04%) 
Presyncope  1  0/2694 (0.00%)  1/2693 (0.04%) 
Radiculopathy  1  1/2694 (0.04%)  1/2693 (0.04%) 
Sciatica  1  1/2694 (0.04%)  0/2693 (0.00%) 
Seizure  1  1/2694 (0.04%)  1/2693 (0.04%) 
Speech disorder  1  0/2694 (0.00%)  1/2693 (0.04%) 
Syncope  1  2/2694 (0.07%)  2/2693 (0.07%) 
Transient ischaemic attack  1  1/2694 (0.04%)  0/2693 (0.00%) 
Product Issues     
Device dislocation  1  1/2694 (0.04%)  0/2693 (0.00%) 
Psychiatric disorders     
Acute psychosis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Alcohol use disorder  1  1/2694 (0.04%)  0/2693 (0.00%) 
Alcohol withdrawal syndrome  1  1/2694 (0.04%)  0/2693 (0.00%) 
Alcoholism  1  0/2694 (0.00%)  1/2693 (0.04%) 
Anxiety  1  1/2694 (0.04%)  1/2693 (0.04%) 
Bipolar I disorder  1  0/2694 (0.00%)  1/2693 (0.04%) 
Bipolar disorder  1  0/2694 (0.00%)  1/2693 (0.04%) 
Delirium  1  1/2694 (0.04%)  0/2693 (0.00%) 
Delusion  1  1/2694 (0.04%)  1/2693 (0.04%) 
Depression  1  5/2694 (0.19%)  3/2693 (0.11%) 
Intentional self-injury  1  0/2694 (0.00%)  1/2693 (0.04%) 
Major depression  1  0/2694 (0.00%)  1/2693 (0.04%) 
Panic attack  1  2/2694 (0.07%)  0/2693 (0.00%) 
Personality disorder  1  0/2694 (0.00%)  1/2693 (0.04%) 
Psychotic disorder  1  2/2694 (0.07%)  3/2693 (0.11%) 
Schizoaffective disorder  1  0/2694 (0.00%)  1/2693 (0.04%) 
Substance abuse  1  2/2694 (0.07%)  1/2693 (0.04%) 
Substance-induced psychotic disorder  1  1/2694 (0.04%)  1/2693 (0.04%) 
Suicidal ideation  1  8/2694 (0.30%)  5/2693 (0.19%) 
Suicide attempt  1  5/2694 (0.19%)  1/2693 (0.04%) 
Renal and urinary disorders     
Acute kidney injury  1  7/2694 (0.26%)  2/2693 (0.07%) 
Calculus urinary  1  0/2694 (0.00%)  1/2693 (0.04%) 
Nephrolithiasis  1  2/2694 (0.07%)  2/2693 (0.07%) 
Nephrotic syndrome  1  1/2694 (0.04%)  0/2693 (0.00%) 
Renal colic  1  0/2694 (0.00%)  1/2693 (0.04%) 
Renal infarct  1  0/2694 (0.00%)  1/2693 (0.04%) 
Renal tubular necrosis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Ureterolithiasis  1  0/2694 (0.00%)  2/2693 (0.07%) 
Urethral stenosis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Reproductive system and breast disorders     
Priapism  1  1/2694 (0.04%)  1/2693 (0.04%) 
Prostatitis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Testicular torsion  1  2/2694 (0.07%)  1/2693 (0.04%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/2694 (0.04%)  0/2693 (0.00%) 
Asthma  1  1/2694 (0.04%)  0/2693 (0.00%) 
Dyspnoea  1  2/2694 (0.07%)  0/2693 (0.00%) 
Nasal septum deviation  1  2/2694 (0.07%)  0/2693 (0.00%) 
Pneumonia aspiration  1  1/2694 (0.04%)  0/2693 (0.00%) 
Pneumothorax  1  0/2694 (0.00%)  1/2693 (0.04%) 
Pulmonary embolism  1  1/2694 (0.04%)  2/2693 (0.07%) 
Pulmonary oedema  1  0/2694 (0.00%)  1/2693 (0.04%) 
Respiratory failure  1  1/2694 (0.04%)  0/2693 (0.00%) 
Vocal cord thickening  1  0/2694 (0.00%)  1/2693 (0.04%) 
Skin and subcutaneous tissue disorders     
Stevens-Johnson syndrome  1  0/2694 (0.00%)  1/2693 (0.04%) 
Social circumstances     
Alcohol use  1  1/2694 (0.04%)  0/2693 (0.00%) 
Surgical and medical procedures     
Ligament operation  1  0/2694 (0.00%)  1/2693 (0.04%) 
Medical device removal  1  0/2694 (0.00%)  1/2693 (0.04%) 
Spinal fusion surgery  1  0/2694 (0.00%)  1/2693 (0.04%) 
Vascular disorders     
Deep vein thrombosis  1  2/2694 (0.07%)  0/2693 (0.00%) 
Haematoma  1  1/2694 (0.04%)  0/2693 (0.00%) 
Hypertension  1  0/2694 (0.00%)  1/2693 (0.04%) 
Hypotension  1  1/2694 (0.04%)  0/2693 (0.00%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Descovy (DVY) Truvada (TVD)
Affected / at Risk (%) Affected / at Risk (%)
Total   2258/2694 (83.82%)   2229/2693 (82.77%) 
Gastrointestinal disorders     
Diarrhoea  1  479/2694 (17.78%)  451/2693 (16.75%) 
Nausea  1  209/2694 (7.76%)  204/2693 (7.58%) 
General disorders     
Fatigue  1  180/2694 (6.68%)  181/2693 (6.72%) 
Infections and infestations     
Anal chlamydia infection  1  890/2694 (33.04%)  902/2693 (33.49%) 
Gastroenteritis  1  171/2694 (6.35%)  141/2693 (5.24%) 
Influenza  1  145/2694 (5.38%)  143/2693 (5.31%) 
Nasopharyngitis  1  399/2694 (14.81%)  402/2693 (14.93%) 
Oropharyngeal gonococcal infection  1  871/2694 (32.33%)  838/2693 (31.12%) 
Pharyngeal chlamydia infection  1  215/2694 (7.98%)  186/2693 (6.91%) 
Pharyngitis  1  166/2694 (6.16%)  108/2693 (4.01%) 
Proctitis gonococcal  1  805/2694 (29.88%)  797/2693 (29.60%) 
Syphilis  1  413/2694 (15.33%)  392/2693 (14.56%) 
Upper respiratory tract infection  1  402/2694 (14.92%)  346/2693 (12.85%) 
Urethritis  1  193/2694 (7.16%)  189/2693 (7.02%) 
Urethritis chlamydial  1  346/2694 (12.84%)  314/2693 (11.66%) 
Urethritis gonococcal  1  259/2694 (9.61%)  255/2693 (9.47%) 
Injury, poisoning and procedural complications     
Exposure to communicable disease  1  554/2694 (20.56%)  548/2693 (20.35%) 
Nervous system disorders     
Headache  1  206/2694 (7.65%)  209/2693 (7.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  152/2694 (5.64%)  136/2693 (5.05%) 
Oropharyngeal pain  1  172/2694 (6.38%)  165/2693 (6.13%) 
Skin and subcutaneous tissue disorders     
Rash  1  136/2694 (5.05%)  122/2693 (4.53%) 
1
Term from vocabulary, MedDRA 22.1
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
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02842086    
Other Study ID Numbers: GS-US-412-2055
2016-001399-31 ( EudraCT Number )
First Submitted: July 20, 2016
First Posted: July 22, 2016
Results First Submitted: January 29, 2020
Results First Posted: March 17, 2020
Last Update Posted: January 12, 2021