Trial Outcomes & Findings for 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 (NCT NCT02842086)

NCT ID: NCT02842086

Last Updated: 2025-11-13

Results Overview

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)

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

5399 participants

Primary outcome timeframe

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)

Results posted on

2025-11-13

Participant Flow

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.

5857 participants were screened.

Participant milestones

Participant milestones
Measure	Descovy (DVY) 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.	Truvada (TVD) 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 Study STARTED	2700	2699
Overall Study COMPLETED	2156	2206
Overall Study NOT COMPLETED	544	493

Reasons for withdrawal

Reasons for withdrawal
Measure	Descovy (DVY) 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.	Truvada (TVD) 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 Study Randomized but Never Treated	6	6
Overall Study Still in Double-Blind Phase	7	3
Overall Study Adverse Event	18	20
Overall Study Death	3	3
Overall Study Investigator's Discretion	9	13
Overall Study Non-Compliance with Study Drug	9	8
Overall Study Protocol Violation	8	4
Overall Study Withdrew Consent	205	194
Overall Study Lost to Follow-up	274	236
Overall Study HIV-1 Infection	5	6

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Descovy (DVY) n=2694 Participants 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.	Truvada (TVD) n=2693 Participants 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 n=5387 Participants Total of all reporting groups
Race/Ethnicity, Customized Ethnicity · Not Permitted	1 Participants n=2694 Participants	2 Participants n=2693 Participants	3 Participants n=5387 Participants
Region of Enrollment Canada	191 Participants n=2694 Participants	162 Participants n=2693 Participants	353 Participants n=5387 Participants
Region of Enrollment Austria	35 Participants n=2694 Participants	42 Participants n=2693 Participants	77 Participants n=5387 Participants
Region of Enrollment Denmark	98 Participants n=2694 Participants	104 Participants n=2693 Participants	202 Participants n=5387 Participants
Age, Continuous	36 years STANDARD_DEVIATION 10.6 • n=2694 Participants	36 years STANDARD_DEVIATION 10.7 • n=2693 Participants	36 years STANDARD_DEVIATION 10.6 • n=5387 Participants
Sex/Gender, Customized Transgender Women	45 Participants n=2694 Participants	29 Participants n=2693 Participants	74 Participants n=5387 Participants
Sex: Female, Male Female	0 Participants n=2694 Participants	0 Participants n=2693 Participants	0 Participants n=5387 Participants
Sex: Female, Male Male	2694 Participants n=2694 Participants	2693 Participants n=2693 Participants	5387 Participants n=5387 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	12 Participants n=2694 Participants	14 Participants n=2693 Participants	26 Participants n=5387 Participants
Race/Ethnicity, Customized Race · Asian	113 Participants n=2694 Participants	120 Participants n=2693 Participants	233 Participants n=5387 Participants
Race/Ethnicity, Customized Race · Black/Mixed Black	240 Participants n=2694 Participants	234 Participants n=2693 Participants	474 Participants n=5387 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	17 Participants n=2694 Participants	23 Participants n=2693 Participants	40 Participants n=5387 Participants
Race/Ethnicity, Customized Race · White	2264 Participants n=2694 Participants	2247 Participants n=2693 Participants	4511 Participants n=5387 Participants
Race/Ethnicity, Customized Race · Other (Nonblack)	45 Participants n=2694 Participants	50 Participants n=2693 Participants	95 Participants n=5387 Participants
Race/Ethnicity, Customized Race · Not Permitted	3 Participants n=2694 Participants	5 Participants n=2693 Participants	8 Participants n=5387 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	635 Participants n=2694 Participants	683 Participants n=2693 Participants	1318 Participants n=5387 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	2058 Participants n=2694 Participants	2008 Participants n=2693 Participants	4066 Participants n=5387 Participants
Region of Enrollment France	18 Participants n=2694 Participants	14 Participants n=2693 Participants	32 Participants n=5387 Participants
Region of Enrollment Germany	187 Participants n=2694 Participants	183 Participants n=2693 Participants	370 Participants n=5387 Participants
Region of Enrollment Ireland	40 Participants n=2694 Participants	38 Participants n=2693 Participants	78 Participants n=5387 Participants
Region of Enrollment Italy	37 Participants n=2694 Participants	21 Participants n=2693 Participants	58 Participants n=5387 Participants
Region of Enrollment Netherlands	31 Participants n=2694 Participants	40 Participants n=2693 Participants	71 Participants n=5387 Participants
Region of Enrollment Spain	219 Participants n=2694 Participants	195 Participants n=2693 Participants	414 Participants n=5387 Participants
Region of Enrollment United Kingdom	247 Participants n=2694 Participants	265 Participants n=2693 Participants	512 Participants n=5387 Participants
Region of Enrollment United States	1591 Participants n=2694 Participants	1629 Participants n=2693 Participants	3220 Participants n=5387 Participants
Hip Bone Mineral Density (BMD)	1.030 g/cm^2 STANDARD_DEVIATION 0.1553 • n=191 Participants • 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.	1.021 g/cm^2 STANDARD_DEVIATION 0.1322 • n=185 Participants • 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.	1.025 g/cm^2 STANDARD_DEVIATION 0.1443 • n=376 Participants • 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	1.134 g/cm^2 STANDARD_DEVIATION 0.1646 • n=191 Participants • 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.	1.131 g/cm^2 STANDARD_DEVIATION 0.1381 • n=188 Participants • 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.	1.132 g/cm^2 STANDARD_DEVIATION 0.1518 • n=379 Participants • 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	204.3 µg/g STANDARD_DEVIATION 951.77 • n=2677 Participants • Participants in Safety Analysis Set with available data were analyzed.	188.5 µg/g STANDARD_DEVIATION 1010.19 • n=2676 Participants • Participants in Safety Analysis Set with available data were analyzed.	196.4 µg/g STANDARD_DEVIATION 981.35 • n=5353 Participants • Participants in Safety Analysis Set with available data were analyzed.
Urine Retinol Binding Protein (RBP) to Creatinine Ratio	148.8 µg/g STANDARD_DEVIATION 553.54 • n=2686 Participants • Participants in Safety Analysis Set with available data were analyzed.	142.8 µg/g STANDARD_DEVIATION 256.64 • n=2686 Participants • Participants in Safety Analysis Set with available data were analyzed.	145.8 µg/g STANDARD_DEVIATION 431.41 • n=5372 Participants • Participants in Safety Analysis Set with available data were analyzed.
Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories ≤ 200 mg/g	2662 Participants n=2687 Participants • Participants in Safety Analysis Set with available data were analyzed.	2657 Participants n=2682 Participants • Participants in Safety Analysis Set with available data were analyzed.	5319 Participants n=5369 Participants • Participants in Safety Analysis Set with available data were analyzed.
Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories > 200 mg/g	25 Participants n=2687 Participants • Participants in Safety Analysis Set with available data were analyzed.	25 Participants n=2682 Participants • Participants in Safety Analysis Set with available data were analyzed.	50 Participants n=5369 Participants • Participants in Safety Analysis Set with available data were analyzed.
Serum Creatinine	0.96 mg/dL STANDARD_DEVIATION 0.146 • n=2694 Participants	0.96 mg/dL STANDARD_DEVIATION 0.148 • n=2693 Participants	0.96 mg/dL STANDARD_DEVIATION 0.147 • n=5387 Participants

PRIMARY outcome

Timeframe: 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)

Population: 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.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2670 Participants 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.	Truvada (TVD) n=2665 Participants 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.
Incidence of HIV-1 Infection Per 100 Person Years (PY)	0.160 HIV-1 infections per 100 PY Interval 0.064 to 0.33	0.342 HIV-1 infections per 100 PY Interval 0.191 to 0.564

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: 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.

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

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=159 Participants 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.	Truvada (TVD) n=157 Participants 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.
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase	0.218 Percent Change Standard Deviation 2.3668	-0.968 Percent Change Standard Deviation 2.4343

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: 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.

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

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=160 Participants 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.	Truvada (TVD) n=159 Participants 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.
Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase	0.512 Percent Change Standard Deviation 2.9854	-1.061 Percent Change Standard Deviation 2.9382

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2346 Participants 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.	Truvada (TVD) n=2337 Participants 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.
Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase	-10.6 Percent Change Interval -42.0 to 25.9	15.4 Percent Change Interval -22.9 to 97.2

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in Safety Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2360 Participants 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.	Truvada (TVD) n=2354 Participants 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.
Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase	0.1 Percent Change Interval -24.9 to 35.3	20.0 Percent Change Interval -13.0 to 68.2

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in Safety Analysis Set with available data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2355 Participants 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.	Truvada (TVD) n=2348 Participants 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.
Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase ≤ 200 mg/g at Baseline; ≤ 200 mg/g at Week 48	2318 Participants	2295 Participants
Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase ≤ 200 mg/g at Baseline; > 200 mg/g at Week 48	16 Participants	35 Participants
Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase > 200 mg/g at Baseline; ≤ 200 mg/g at Week 48	12 Participants	8 Participants
Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase > 200 mg/g at Baseline; > 200 mg/g at Week 48	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in Safety Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2370 Participants 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.	Truvada (TVD) n=2368 Participants 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.
Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase	-0.01 mg/dL Standard Deviation 0.107	0.01 mg/dL Standard Deviation 0.111

SECONDARY outcome

Timeframe: When all participants have 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 157 weeks)

Population: Participants in Full Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2670 Participants 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.	Truvada (TVD) n=2665 Participants 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.
Incidence of HIV-1 Infection Per 100 PY	0.159 HIV-1 infections per 100 PY Interval 0.069 to 0.313	0.297 HIV-1 infections per 100 PY Interval 0.166 to 0.49

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in Hip DXA Analysis Set with available data were analyzed.

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

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=144 Participants 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.	Truvada (TVD) n=138 Participants 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.
Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase	0.565 Percent Change Standard Deviation 2.9379	-1.048 Percent Change Standard Deviation 2.9277

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in Spine DXA Analysis Set with available data were analyzed.

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

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=145 Participants 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.	Truvada (TVD) n=142 Participants 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.
Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase	0.831 Percent Change Standard Deviation 3.4608	-1.426 Percent Change Standard Deviation 3.5508

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in Safety Analysis Set with available data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2169 Participants 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.	Truvada (TVD) n=2195 Participants 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.
Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase	-14.5 Percent Change Interval -45.4 to 23.9	14.1 Percent Change Interval -26.2 to 99.5

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in Safety Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2188 Participants 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.	Truvada (TVD) n=2211 Participants 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.
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase	0.3 Percent Change Interval -27.1 to 35.7	21.4 Percent Change Interval -13.8 to 73.9

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in Safety Analysis Set with available data were analyzed.

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.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2175 Participants 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.	Truvada (TVD) n=2199 Participants 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.
Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase ≤ 200 mg/g at Baseline; ≤ 200 mg/g at Week 96	2134 Participants	2153 Participants
Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase ≤ 200 mg/g at Baseline; > 200 mg/g at Week 96	21 Participants	28 Participants
Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase > 200 mg/g at Baseline; ≤ 200 mg/g at Week 96	14 Participants	10 Participants
Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase > 200 mg/g at Baseline; > 200 mg/g at Week 96	6 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in Safety Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2194 Participants 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.	Truvada (TVD) n=2218 Participants 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.
Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase	0.01 mg/dL Standard Deviation 0.114	0.03 mg/dL Standard Deviation 0.117

SECONDARY outcome

Timeframe: First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)

Population: Participants in Safety Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2694 Participants 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.	Truvada (TVD) n=2693 Participants 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.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events	93.7 percentage of participants	93.6 percentage of participants

SECONDARY outcome

Timeframe: First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)

Population: Participants in Safety Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Descovy (DVY) n=2672 Participants 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.	Truvada (TVD) n=2665 Participants 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.
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality	76.1 percentage of participants	79.1 percentage of participants

Adverse Events

Descovy (DVY)

Serious events: 202 serious events

Other events: 2258 other events

Deaths: 3 deaths

Truvada (TVD)

Serious events: 186 serious events

Other events: 2229 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER

Measure	Descovy (DVY) n=2694 participants at risk 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.	Truvada (TVD) n=2693 participants at risk 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.
Gastrointestinal disorders Diarrhoea	17.8% 479/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	16.7% 451/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Gastrointestinal disorders Nausea	7.8% 209/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	7.6% 204/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
General disorders Fatigue	6.7% 180/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	6.7% 181/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Anal chlamydia infection	33.0% 890/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	33.5% 902/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Gastroenteritis	6.3% 171/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	5.2% 141/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Influenza	5.4% 145/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	5.3% 143/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Nasopharyngitis	14.8% 399/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	14.9% 402/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Oropharyngeal gonococcal infection	32.3% 871/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	31.1% 838/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Pharyngeal chlamydia infection	8.0% 215/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	6.9% 186/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Pharyngitis	6.2% 166/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	4.0% 108/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Proctitis gonococcal	29.9% 805/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	29.6% 797/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Syphilis	15.3% 413/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	14.6% 392/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Upper respiratory tract infection	14.9% 402/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	12.8% 346/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Urethritis	7.2% 193/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	7.0% 189/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Urethritis chlamydial	12.8% 346/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	11.7% 314/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Infections and infestations Urethritis gonococcal	9.6% 259/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	9.5% 255/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Injury, poisoning and procedural complications Exposure to communicable disease	20.6% 554/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	20.3% 548/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Nervous system disorders Headache	7.6% 206/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	7.8% 209/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 152/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	5.1% 136/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.4% 172/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	6.1% 165/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.
Skin and subcutaneous tissue disorders Rash	5.0% 136/2694 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.	4.5% 122/2693 • First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) 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.