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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 : March 17, 2020
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 last Week 96 study visit for the primary endpoint occurred on 31 January 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 0 0
Not Completed 2700 2699
Reason Not Completed
Randomized but Never Treated             6             6
Still on Study             2295             2328
Adverse Event             15             20
Death             1             2
Investigator's Discretion             6             10
Non-Compliance with Study Drug             6             7
Protocol Violation             4             2
Withdrew Consent             157             146
Lost to Follow-up             206             172
HIV-1 Infection             4             6
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 190 participants 185 participants 375 participants
1.029  (0.1542) 1.021  (0.1322) 1.025  (0.1436)
[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 190 participants 188 participants 378 participants
1.131  (0.1615) 1.131  (0.1380) 1.131  (0.1501)
[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.
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 29 months)
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% 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 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 158 158
Mean (Standard Deviation)
Unit of Measure: Percent Change
0.183  (2.3841) -0.988  (2.4351)
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 <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares mean (LSM)
Estimated Value 1.123
Confidence Interval (2-Sided) 95%
0.608 to 1.638
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 159 160
Mean (Standard Deviation)
Unit of Measure: Percent Change
0.496  (2.9883) -1.123  (2.9446)
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 <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 1.609
Confidence Interval (2-Sided) 95%
0.955 to 2.264
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 2347 2338
Median (Inter-Quartile Range)
Unit of Measure: Percent Change
-10.7
(-42.0 to 25.9)
15.3
(-23.0 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 <0.001
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 2361 2355
Median (Inter-Quartile Range)
Unit of Measure: Percent Change
0.2
(-24.9 to 35.4)
19.9
(-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 <0.001
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 2356 2349
Measure Type: Count of Participants
Unit of Measure: Participants
≤ 200 mg/g at Baseline; ≤ 200 mg/g at Week 48 2319 2296
≤ 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 0.005
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 2371 2369
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 <0.001
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 31 months)
Outcome Measure Data Not Reported
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 100 105
Mean (Standard Deviation)
Unit of Measure: Percent Change
0.424  (2.6122) -1.202  (2.8970)
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 <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 1.602
Confidence Interval (2-Sided) 95%
0.848 to 2.357
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 100 112
Mean (Standard Deviation)
Unit of Measure: Percent Change
0.877  (3.1427) -1.248  (3.9178)
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 <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 2.115
Confidence Interval (2-Sided) 95%
1.152 to 3.078
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 1181 1232
Median (Inter-Quartile Range)
Unit of Measure: Percent Change
-17.2
(-47.6 to 19.2)
11.0
(-26.8 to 88.6)
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 <0.001
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 1204 1259
Median (Inter-Quartile Range)
Unit of Measure: Percent Change
-2.1
(-31.0 to 33.3)
19.9
(-16.1 to 73.2)
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 <0.001
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 1186 1239
Measure Type: Count of Participants
Unit of Measure: Participants
≤ 200 mg/g at Baseline; ≤ 200 mg/g at Week 96 1157 1213
≤ 200 mg/g at Baseline; > 200 mg/g at Week 96 15 15
> 200 mg/g at Baseline; ≤ 200 mg/g at Week 96 10 4
> 200 mg/g at Baseline; > 200 mg/g at Week 96 4 7
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 0.56
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 1210 1264
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.01  (0.116) 0.02  (0.116)
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 <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.01
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 primary endpoint assessment plus 30 days (maximum: 125 weeks + 30 days)
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
92.7 92.6
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 primary endpoint assessment plus 30 days (maximum: 125 weeks + 30 days)
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
72.1 75.0
Time Frame First dose date up to the data cut for primary endpoint assessment plus 30 days (maximum: 125 weeks + 30 days)
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   1/2694 (0.04%)   2/2693 (0.07%) 
Hide Serious Adverse Events
Descovy (DVY) Truvada (TVD)
Affected / at Risk (%) Affected / at Risk (%)
Total   169/2694 (6.27%)   138/2693 (5.12%) 
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  2/2694 (0.07%)  1/2693 (0.04%) 
Angina pectoris  1  1/2694 (0.04%)  0/2693 (0.00%) 
Atrial fibrillation  1  2/2694 (0.07%)  4/2693 (0.15%) 
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%) 
Myocardial infarction  1  1/2694 (0.04%)  2/2693 (0.07%) 
Palpitations  1  0/2694 (0.00%)  1/2693 (0.04%) 
Supraventricular tachycardia  1  2/2694 (0.07%)  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%) 
Gastrointestinal disorders     
Abdominal pain  1  1/2694 (0.04%)  1/2693 (0.04%) 
Anal fistula  1  0/2694 (0.00%)  2/2693 (0.07%) 
Colitis  1  2/2694 (0.07%)  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%)  2/2693 (0.07%) 
Diverticular perforation  1  0/2694 (0.00%)  1/2693 (0.04%) 
Diverticulum  1  1/2694 (0.04%)  0/2693 (0.00%) 
Duodenitis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Enteritis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Gastrooesophageal reflux disease  1  0/2694 (0.00%)  1/2693 (0.04%) 
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  1/2694 (0.04%)  0/2693 (0.00%) 
Intestinal obstruction  1  1/2694 (0.04%)  0/2693 (0.00%) 
Mesenteric vein thrombosis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Mesenteritis  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%) 
Reactive gastropathy  1  1/2694 (0.04%)  0/2693 (0.00%) 
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%) 
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  1/2694 (0.04%)  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%) 
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%) 
Cholelithiasis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Hepatitis acute  1  0/2694 (0.00%)  1/2693 (0.04%) 
Immune system disorders     
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 oral  1  0/2694 (0.00%)  1/2693 (0.04%) 
Anal abscess  1  1/2694 (0.04%)  3/2693 (0.11%) 
Appendicitis  1  8/2694 (0.30%)  9/2693 (0.33%) 
Breast abscess  1  0/2694 (0.00%)  1/2693 (0.04%) 
Campylobacter gastroenteritis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Cellulitis  1  4/2694 (0.15%)  4/2693 (0.15%) 
Cellulitis orbital  1  0/2694 (0.00%)  1/2693 (0.04%) 
Cholecystitis infective  1  1/2694 (0.04%)  1/2693 (0.04%) 
Device related infection  1  0/2694 (0.00%)  1/2693 (0.04%) 
Diverticulitis  1  1/2694 (0.04%)  3/2693 (0.11%) 
Epididymitis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Eye infection gonococcal  1  0/2694 (0.00%)  1/2693 (0.04%) 
Gastroenteritis  1  2/2694 (0.07%)  2/2693 (0.07%) 
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%)  1/2693 (0.04%) 
Hepatitis A  1  5/2694 (0.19%)  1/2693 (0.04%) 
Infected bite  1  1/2694 (0.04%)  0/2693 (0.00%) 
Infective tenosynovitis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Influenza  1  2/2694 (0.07%)  1/2693 (0.04%) 
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%) 
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  0/2694 (0.00%)  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%) 
Perirectal abscess  1  1/2694 (0.04%)  0/2693 (0.00%) 
Peritonsillar abscess  1  1/2694 (0.04%)  0/2693 (0.00%) 
Pharyngeal abscess  1  1/2694 (0.04%)  0/2693 (0.00%) 
Pneumonia  1  4/2694 (0.15%)  4/2693 (0.15%) 
Pneumonia pneumococcal  1  1/2694 (0.04%)  0/2693 (0.00%) 
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  2/2694 (0.07%)  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  0/2694 (0.00%)  2/2693 (0.07%) 
Tooth infection  1  0/2694 (0.00%)  1/2693 (0.04%) 
Urinary tract infection  1  0/2694 (0.00%)  2/2693 (0.07%) 
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%)  2/2693 (0.07%) 
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  0/2694 (0.00%)  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%) 
Intentional overdose  1  0/2694 (0.00%)  1/2693 (0.04%) 
Joint dislocation  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%) 
Overdose  1  2/2694 (0.07%)  1/2693 (0.04%) 
Post procedural haemorrhage  1  2/2694 (0.07%)  1/2693 (0.04%) 
Radius fracture  1  0/2694 (0.00%)  2/2693 (0.07%) 
Road traffic accident  1  4/2694 (0.15%)  0/2693 (0.00%) 
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%) 
Subdural haematoma  1  1/2694 (0.04%)  1/2693 (0.04%) 
Tendon rupture  1  2/2694 (0.07%)  0/2693 (0.00%) 
Toxicity to various agents  1  1/2694 (0.04%)  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  0/2694 (0.00%)  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%) 
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  1/2694 (0.04%)  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%) 
Scoliosis  1  1/2694 (0.04%)  0/2693 (0.00%) 
Spinal column stenosis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Spinal osteoarthritis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
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%) 
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%) 
Pituitary tumour  1  0/2694 (0.00%)  1/2693 (0.04%) 
Prostate cancer  1  2/2694 (0.07%)  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%) 
Cerebrovascular accident  1  1/2694 (0.04%)  0/2693 (0.00%) 
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%) 
Intracranial venous sinus thrombosis  1  1/2694 (0.04%)  0/2693 (0.00%) 
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%) 
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%) 
Radiculopathy  1  1/2694 (0.04%)  0/2693 (0.00%) 
Sciatica  1  1/2694 (0.04%)  0/2693 (0.00%) 
Seizure  1  1/2694 (0.04%)  0/2693 (0.00%) 
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%) 
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%) 
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  4/2694 (0.15%)  1/2693 (0.04%) 
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%) 
Psychotic disorder  1  2/2694 (0.07%)  2/2693 (0.07%) 
Schizoaffective disorder  1  0/2694 (0.00%)  1/2693 (0.04%) 
Substance abuse  1  1/2694 (0.04%)  1/2693 (0.04%) 
Substance-induced psychotic disorder  1  1/2694 (0.04%)  1/2693 (0.04%) 
Suicidal ideation  1  7/2694 (0.26%)  5/2693 (0.19%) 
Suicide attempt  1  4/2694 (0.15%)  1/2693 (0.04%) 
Renal and urinary disorders     
Acute kidney injury  1  5/2694 (0.19%)  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 tubular necrosis  1  0/2694 (0.00%)  1/2693 (0.04%) 
Ureterolithiasis  1  0/2694 (0.00%)  1/2693 (0.04%) 
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  1/2694 (0.04%)  1/2693 (0.04%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/2694 (0.04%)  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 oedema  1  0/2694 (0.00%)  1/2693 (0.04%) 
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     
Cardiac ablation  1  0/2694 (0.00%)  1/2693 (0.04%) 
Ligament operation  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%) 
1
Term from vocabulary, MedDRA 21.1
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   2498/2694 (92.72%)   2494/2693 (92.61%) 
Gastrointestinal disorders     
Diarrhoea  1  429/2694 (15.92%)  421/2693 (15.63%) 
Nausea  1  196/2694 (7.28%)  187/2693 (6.94%) 
General disorders     
Fatigue  1  147/2694 (5.46%)  163/2693 (6.05%) 
Infections and infestations     
Anal chlamydia infection  1  770/2694 (28.58%)  792/2693 (29.41%) 
Gastroenteritis  1  143/2694 (5.31%)  113/2693 (4.20%) 
Nasopharyngitis  1  350/2694 (12.99%)  355/2693 (13.18%) 
Oropharyngeal gonococcal infection  1  740/2694 (27.47%)  722/2693 (26.81%) 
Pharyngeal chlamydia infection  1  175/2694 (6.50%)  149/2693 (5.53%) 
Pharyngitis  1  140/2694 (5.20%)  82/2693 (3.04%) 
Proctitis gonococcal  1  693/2694 (25.72%)  671/2693 (24.92%) 
Syphilis  1  342/2694 (12.69%)  321/2693 (11.92%) 
Upper respiratory tract infection  1  356/2694 (13.21%)  310/2693 (11.51%) 
Urethritis  1  160/2694 (5.94%)  154/2693 (5.72%) 
Urethritis chlamydial  1  280/2694 (10.39%)  259/2693 (9.62%) 
Urethritis gonococcal  1  216/2694 (8.02%)  210/2693 (7.80%) 
Injury, poisoning and procedural complications     
Exposure to communicable disease  1  465/2694 (17.26%)  441/2693 (16.38%) 
Nervous system disorders     
Headache  1  186/2694 (6.90%)  180/2693 (6.68%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  153/2694 (5.68%)  140/2693 (5.20%) 
1
Term from vocabulary, MedDRA 21.1
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 of Results:
Hare B. The Phase 3 DISCOVER Study: Daily F/TAF or F/TDF for HIV Preexposure Prophylaxis [Presentation]. Conference on Retroviruses and Opportunistic Infections (CROI); 2019 04-07 March; Seattle, WA.
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: March 17, 2020