Trial Outcomes & Findings for Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (NCT NCT04994509)

Last Updated: 2025-07-17

Results Overview

bHIV per 100 PY in the Incidence Phase was calculated using RITA. The RITA incorporated HIV-1 testing results and recency assay testing results to estimate the bHIV. Recency assay testing was performed for participants in the All Screened Set found to have HIV-1 infection at the Incidence Phase Screening Visit as defined below. Participants were considered to have recent HIV-1 infection if the normalized optical density (ODn) was below 1.5 threshold using the Sedia limiting antigen avidity enzyme immunoassay (LAg-EIA) and the HIV-1 RNA (viral load) was \> 75 copies/mL of blood. HIV-1 infection was defined as participants having at least one of the following central lab results at the Incidence Phase screening visit: * Positive HIV-1/2 differentiation Ab, OR * Positive HIV-1 ribonucleic acid (RNA) qualitative test, OR * HIV-1 RNA quantitative test ≥200 copies/mL.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

5368 participants

Primary outcome timeframe

Incidence Phase Screening Visit (Day 1)

Results posted on

2025-07-17

Participant Flow

8402 participants were screened. Out of 8402, 8094 participants had at least 1 non-missing HIV-1 diagnosis based on HIV test results from a central laboratory. Therefore, 8094 participants were considered for screening in the Incidence Phase and were included in the All Screened Set.

Participants were enrolled at study sites in South Africa and Uganda. Data submitted represent primary analysis performed on data collected by the Primary Analysis Completion Date (Per pre-specified analysis, this is the date by when at least 50% of the planned randomized participants were followed up for at least 52 weeks in the study or prematurely discontinued from the study). Complete data will be submitted within 1 year of actual study completion date.

Participant milestones

Participant milestones
Measure	Randomized Blinded Phase: Lenacapavir Participants received lenacapavir (LEN) 927 mg subcutaneous (SC) injection, every 26 weeks, starting on Day 1 up to approximately 52 weeks. Participants also received loading dose of LEN 600 mg tablet orally, once daily on Day 1 and Day 2. Participants received placebo to match (PTM) emtricitabine/tenofovir disoproxil fumarate (F/TDF) tablet or PTM emtricitabine/tenofovir alafenamide (F/TAF) tablet orally, once daily, up to approximately 52 weeks.	Randomized Blinded Phase: F/TAF Participants received F/TAF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet, orally, once daily on Day 1 and Day 2.	Randomized Blinded Phase: F/TDF Participants received F/TDF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection, every 26 weeks, starting on Day 1 up to approximately 52 weeks and PTM LEN tablet, orally, once daily on Day 1 and Day 2.
Overall Study STARTED	2150	2145	1073
Overall Study COMPLETED	94	77	37
Overall Study NOT COMPLETED	2056	2068	1036

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized Blinded Phase: Lenacapavir Participants received lenacapavir (LEN) 927 mg subcutaneous (SC) injection, every 26 weeks, starting on Day 1 up to approximately 52 weeks. Participants also received loading dose of LEN 600 mg tablet orally, once daily on Day 1 and Day 2. Participants received placebo to match (PTM) emtricitabine/tenofovir disoproxil fumarate (F/TDF) tablet or PTM emtricitabine/tenofovir alafenamide (F/TAF) tablet orally, once daily, up to approximately 52 weeks.	Randomized Blinded Phase: F/TAF Participants received F/TAF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet, orally, once daily on Day 1 and Day 2.	Randomized Blinded Phase: F/TDF Participants received F/TDF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection, every 26 weeks, starting on Day 1 up to approximately 52 weeks and PTM LEN tablet, orally, once daily on Day 1 and Day 2.
Overall Study Still on Study (Participants Continuing in Randomized Blinded Phase)	1909	1910	937
Overall Study Withdrew Consent	73	72	46
Overall Study Lost to Follow-up	39	36	26
Overall Study HIV-1 Infection	4	20	12
Overall Study Investigator's Discretion	9	8	11
Overall Study Randomized but Never Treated	10	10	3
Overall Study Pregnancy	5	5	0
Overall Study Death	0	5	0
Overall Study Adverse Event	2	1	0
Overall Study Non-compliance With Study Drug	1	1	1
Overall Study Withdrew Assent	3	0	0
Overall Study Protocol Violation	1	0	0

Baseline Characteristics

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Blinded Phase: Lenacapavir n=2140 Participants Participants received LEN 927 mg SC injection, every 26 weeks starting on Day 1 up to approximately 52 weeks. Participants also received loading dose of LEN 600 mg tablet orally, once daily on Day 1 and Day 2. Participants received PTM F/TDF tablet or PTM F/TAF tablet orally, once daily, up to approximately 52 weeks.	Randomized Blinded Phase: F/TAF n=2135 Participants Participants received F/TAF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet orally once daily on Day 1 and Day 2.	Randomized Blinded Phase: F/TDF n=1070 Participants Participants received F/TDF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants received PTM LEN SC injection, every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet orally once daily on Day 1 and Day 2.	Total n=5345 Participants Total of all reporting groups
Age, Categorical <=18 years	287 Participants n=5 Participants	256 Participants n=7 Participants	125 Participants n=5 Participants	668 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1853 Participants n=5 Participants	1879 Participants n=7 Participants	945 Participants n=5 Participants	4677 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	21 years STANDARD_DEVIATION 2.2 • n=5 Participants	21 years STANDARD_DEVIATION 2.1 • n=7 Participants	21 years STANDARD_DEVIATION 2.1 • n=5 Participants	21 years STANDARD_DEVIATION 2.1 • n=4 Participants
Sex: Female, Male Female	2140 Participants n=5 Participants	2135 Participants n=7 Participants	1070 Participants n=5 Participants	5345 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2140 Participants n=5 Participants	2135 Participants n=7 Participants	1070 Participants n=5 Participants	5345 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2137 Participants n=5 Participants	2134 Participants n=7 Participants	1068 Participants n=5 Participants	5339 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment South Africa	1811 Participants n=5 Participants	1788 Participants n=7 Participants	909 Participants n=5 Participants	4508 Participants n=4 Participants
Region of Enrollment Uganda	329 Participants n=5 Participants	347 Participants n=7 Participants	161 Participants n=5 Participants	837 Participants n=4 Participants

PRIMARY outcome

Timeframe: Incidence Phase Screening Visit (Day 1)

Population: Participants in the All Screened Set were analyzed. The All Screened Set included all participants who were screened for HIV-1 in the Incidence Phase and had a non-missing HIV-1 diagnosis based on HIV test results at Incidence Phase screening. As the outcome measure was assessed prior to Randomized Blinded Phase, the data is reported in one arm consisting of all participants screened in Incidence Phase.

Outcome measures

Outcome measures
Measure	Participants Screened for HIV-1 in Incidence Phase n=8094 Participants Participants screened for HIV-1 infection and having a non-missing HIV-1 diagnosis based on results of HIV testing conducted at Incidence Phase screening.	Randomized Blinded Phase: F/TAF Participants received F/TAF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet orally once daily on Day 1 and Day 2.	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis Participants screened for HIV-1 infection and having a non-missing HIV-1 diagnosis based on HIV test results at Incidence Phase screening.
Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY)	2.407 HIV-1 events per 100 person-years Interval 1.815 to 3.191	—	—

PRIMARY outcome

Timeframe: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks)

Population: Participants in the LEN and F/TAF groups in the Full Analysis Set (FAS) were analyzed. The FAS included all randomized participants who received at least 1 dose of any study drug and had not been diagnosed with HIV-1 on or prior to the first dose date. Per prespecified analysis, HIV-1 incidence for this outcome measure was reported only for participants who received LEN and F/TAF. The HIV-1 incidence was compared with participants in All Screened Set.

HIV-1 incidence per 100 PY for LEN and F/TAF was calculated as the number of participants who acquired HIV-1 divided by the total of a) for participants not diagnosed with HIV-1, sum of all duration of follow-up time in years, while at risk of HIV-1 infection (where a year is 365.25 days) and b) for participants diagnosed with HIV-1, sum of all duration of follow-up time up to confirmed HIV-1 diagnoses. HIV-1 diagnosis was determined by an HIV adjudication committee who reviewed potential HIV-1 infection events in the randomized participants. The committee, in a blinded, consistent, and unbiased manner, determined whether HIV test results confirmed HIV-1 infection and determined the date of diagnosis for each case, defined as the date of the earliest study visit with evidence of HIV infection considering both prospective HIV testing and back-testing of archived samples. bHIV incidence per 100 PY in All Screened Set was estimated as described in outcome measure#1.

Outcome measures

Outcome measures
Measure	Participants Screened for HIV-1 in Incidence Phase n=2134 Participants Participants screened for HIV-1 infection and having a non-missing HIV-1 diagnosis based on results of HIV testing conducted at Incidence Phase screening.	Randomized Blinded Phase: F/TAF n=2136 Participants Participants received F/TAF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet orally once daily on Day 1 and Day 2.	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis n=8094 Participants Participants screened for HIV-1 infection and having a non-missing HIV-1 diagnosis based on HIV test results at Incidence Phase screening.
Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN and F/TAF Compared to Participants in All Screened Set	0.000 HIV-1 events per 100 person-years Interval 0.0 to 0.19	2.018 HIV-1 events per 100 person-years Interval 1.435 to 2.759	2.407 HIV-1 events per 100 person-years Interval 1.815 to 3.191

SECONDARY outcome

Timeframe: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks)

Population: Participants in the Full Analysis Set were analyzed.

HIV-1 incidence per 100 PY was calculated as the number of participants who acquired HIV-1 divided by the total of a) for participants not diagnosed with HIV-1, sum of all duration of follow-up time in years, while at risk of HIV-1 infection (where a year is 365.25 days) and b) for participants diagnosed with HIV-1, sum of all duration of follow-up time up to confirmed HIV-1 diagnoses. HIV-1 diagnosis was determined by an HIV adjudication committee who reviewed potential HIV-1 infection events in the randomized participants. The committee, in a blinded, consistent, and unbiased manner, determined whether HIV test results confirmed HIV-1 infection and determined the date of diagnosis for each case, defined as the date of the earliest study visit with evidence of HIV infection considering both prospective HIV testing and back-testing of archived samples.

Outcome measures

Outcome measures
Measure	Participants Screened for HIV-1 in Incidence Phase n=2134 Participants Participants screened for HIV-1 infection and having a non-missing HIV-1 diagnosis based on results of HIV testing conducted at Incidence Phase screening.	Randomized Blinded Phase: F/TAF n=2136 Participants Participants received F/TAF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet orally once daily on Day 1 and Day 2.	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis n=1068 Participants Participants screened for HIV-1 infection and having a non-missing HIV-1 diagnosis based on HIV test results at Incidence Phase screening.
Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN, F/TAF and F/TDF	0.000 HIV-1 events per 100 person-years Interval 0.0 to 0.19	2.018 HIV-1 events per 100 person-years Interval 1.435 to 2.759	1.685 HIV-1 events per 100 person-years Interval 0.963 to 2.737

SECONDARY outcome

Timeframe: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks)

Population: Participants in the Full Analysis Set who were adherent to LEN were analyzed.

A participant was defined as adherent to LEN if they have received all per-protocol administrations of LEN within 28 weeks since the previous administration. The incidence of HIV-1 infection per 100 PY calculation is defined in outcome measure #2.

Outcome measures

Outcome measures
Measure	Participants Screened for HIV-1 in Incidence Phase n=1973 Participants Participants screened for HIV-1 infection and having a non-missing HIV-1 diagnosis based on results of HIV testing conducted at Incidence Phase screening.	Randomized Blinded Phase: F/TAF Participants received F/TAF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet orally once daily on Day 1 and Day 2.	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis Participants screened for HIV-1 infection and having a non-missing HIV-1 diagnosis based on HIV test results at Incidence Phase screening.
Randomized Blinded Phase: HIV-1 Incidence Among Participants Adherent to LEN	0.000 HIV-1 events per 100 person-years Interval 0.0 to 0.214	—	—

SECONDARY outcome

Timeframe: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks)

Population: The dried blood spot (DBS) Case-Control Analysis Set included all randomized participants who took at least 1 dose of study drug, were diagnosed with HIV-1 or were selected as a matched control (with no diagnosis of HIV-1) for a participant with HIV-1 and have at least 1 non-missing DBS concentration value reported by the DBS laboratory. Per pre-specified analysis, the data is reported in a subset of participants in the F/TAF arm with and without HIV-1 diagnosis.

A participant's adherence to F/TAF was measured by tenofovir diphosphate (TFV-DP) in dried blood spot (DBS) samples, where \<450 fmol/punch associates with an adherence of \<2 days per week. The data is reported in two categories: low adherence (\<2 days per week) and not low adherence (\>= 2 days per week).

Outcome measures

Outcome measures
Measure	Participants Screened for HIV-1 in Incidence Phase n=37 Participants Participants screened for HIV-1 infection and having a non-missing HIV-1 diagnosis based on results of HIV testing conducted at Incidence Phase screening.	Randomized Blinded Phase: F/TAF n=159 Participants Participants received F/TAF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet orally once daily on Day 1 and Day 2.	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis Participants screened for HIV-1 infection and having a non-missing HIV-1 diagnosis based on HIV test results at Incidence Phase screening.
Randomized Blinded Phase: Percentage of Participants Adherent to F/TAF in HIV-1 Diagnosed Participants and Their Matched Controls Low (< 2 days/Week)	91.9 percentage of participants	65.9 percentage of participants	—
Randomized Blinded Phase: Percentage of Participants Adherent to F/TAF in HIV-1 Diagnosed Participants and Their Matched Controls Not Low (>= 2 days/Week)	8.1 percentage of participants	34.1 percentage of participants	—

SECONDARY outcome

Timeframe: When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)

TEAEs are defined as 1 or both of the following: * Any adverse events (AEs) leading to premature discontinuation of study drug, or * Any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years)

Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post-baseline visit, up to and including the last exposure date for participants who permanently discontinued study drug, or the last available date in the database snapshot for participants who were still on treatment at the time of an analysis.

Outcome measures

Outcome data not reported

Adverse Events

Randomized Blinded Phase: Lenacapavir

Serious events: 59 serious events

Other events: 1757 other events

Deaths: 0 deaths

Randomized Blinded Phase: F/TAF

Serious events: 85 serious events

Other events: 1550 other events

Deaths: 6 deaths

Randomized Blinded Phase: F/TDF

Serious events: 35 serious events

Other events: 756 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Randomized Blinded Phase: Lenacapavir n=2140 participants at risk Participants received LEN 927 mg SC injection, every 26 weeks starting on Day 1 up to approximately 52 weeks. Participants also received loading dose of LEN 600 mg tablet orally, once daily on Day 1 and Day 2. Participants also received PTM F/TDF tablet or PTM F/TAF tablet orally, once daily, up to approximately 52 weeks.	Randomized Blinded Phase: F/TAF n=2135 participants at risk Participants received F/TAF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet orally once daily on Day 1 and Day 2.	Randomized Blinded Phase: F/TDF n=1070 participants at risk Participants received F/TDF tablet on Day 1 orally, once daily up to approximately 52 weeks. Participants also received PTM LEN SC injection, every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet orally once daily on Day 1 and Day 2.
Gastrointestinal disorders Diarrhoea	6.2% 133/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	7.5% 161/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	6.3% 67/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	6.7% 144/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	11.0% 234/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	13.3% 142/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Vomiting	5.8% 125/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	11.0% 235/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	10.0% 107/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
General disorders Injection site nodule	63.8% 1365/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	16.3% 347/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	17.1% 183/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
General disorders Injection site pain	31.3% 669/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	24.4% 521/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	22.1% 237/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
General disorders Injection site swelling	4.5% 96/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	5.7% 121/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	4.7% 50/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
Infections and infestations Genitourinary chlamydia infection	14.0% 300/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	14.8% 317/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	12.1% 129/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
Infections and infestations Genitourinary tract gonococcal infection	6.6% 141/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	7.4% 157/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	6.2% 66/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
Infections and infestations Upper respiratory tract infection	12.7% 271/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	12.8% 274/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	11.3% 121/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
Infections and infestations Urinary tract infection	14.3% 307/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	14.2% 304/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	15.2% 163/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
Infections and infestations Vulvovaginal candidiasis	6.8% 146/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	8.1% 172/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	6.3% 67/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness	5.6% 120/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	6.6% 141/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	7.4% 79/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Headache	13.3% 285/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	16.4% 351/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	14.5% 155/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.
Reproductive system and breast disorders Vaginal discharge	7.8% 166/2140 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	8.9% 191/2135 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.	8.1% 87/1070 • All-Cause Mortality and Adverse Events: When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) All-cause Mortality: The All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Randomized Blinded Phase Safety Analysis Set included all participants who received at least 1 dose of any study drug.

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