Trial Outcomes & Findings for Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection (NCT NCT04925752)

Last Updated: 2025-12-23

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

3292 participants

Primary outcome timeframe

Incidence Phase Screening Visit (Day 1)

Results posted on

2025-12-23

Participant Flow

4807 participants were screened. Out of 4807, 4634 participants had at least 1 non-missing HIV-1 diagnosis based on HIV test results from a central laboratory. Therefore, 4634 participants were considered for screening in the Incidence Phase and were included in the All Screened Set. Out of 4634, 3292 were enrolled and randomized in Randomized Blinded Phase. Incidence Phase refers to the Screening Phase.

Participants were enrolled in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, Puerto Rico and United States. Data submitted represent primary analysis from data collected by Primary Completion Date (PCD) (Per pre-specified analysis, PCD is 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: LEN + Placebo-to-match (PTM) F/TDF Participants received lenacapavir (LEN) 927 mg subcutaneous (SC) injection, every 26 weeks, starting on Day 1 for 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 orally, once daily, up to approximately 52 weeks.	Randomized Blinded Phase: Placebo LEN + F/TDF Participants received F/TDF tablet on Day 1 orally, once daily for 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	2195	1097
Overall Study COMPLETED	123	32
Overall Study NOT COMPLETED	2072	1065

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF Participants received lenacapavir (LEN) 927 mg subcutaneous (SC) injection, every 26 weeks, starting on Day 1 for 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 orally, once daily, up to approximately 52 weeks.	Randomized Blinded Phase: Placebo LEN + F/TDF Participants received F/TDF tablet on Day 1 orally, once daily for 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	1826	926
Overall Study Withdrew Consent	128	59
Overall Study Lost to Follow-up	73	47
Overall Study Randomized but Never Treated	12	9
Overall Study Hiv-1 Infection	6	7
Overall Study Investigator's discretion	8	5
Overall Study Non-compliance with Study Drug	8	5
Overall Study Adverse Event	5	2
Overall Study Death	4	2
Overall Study Protocol Violation	1	3
Overall Study Withdrew Assent	1	0

Baseline Characteristics

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF n=2183 Participants Participants received lenacapavir (LEN) 927 mg subcutaneous (SC) injection, every 26 weeks, starting on Day 1 for 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 orally, once daily, up to approximately 52 weeks.	Randomized Blinded Phase: Placebo LEN + F/TDF n=1088 Participants Participants received F/TDF tablet on Day 1 orally, once daily for 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.	Total n=3271 Participants Total of all reporting groups
Age, Continuous	30 years STANDARD_DEVIATION 8.7 • n=68 Participants	31 years STANDARD_DEVIATION 9.5 • n=4 Participants	30 years STANDARD_DEVIATION 9.0 • n=219 Participants
Age, Customized 16 to <18 years	3 Participants n=68 Participants	1 Participants n=4 Participants	4 Participants n=219 Participants
Age, Customized 18 to ≤ 25 years	749 Participants n=68 Participants	343 Participants n=4 Participants	1092 Participants n=219 Participants
Age, Customized > 25 to < 35 years	912 Participants n=68 Participants	423 Participants n=4 Participants	1335 Participants n=219 Participants
Age, Customized 35 to < 50 years	454 Participants n=68 Participants	267 Participants n=4 Participants	721 Participants n=219 Participants
Age, Customized ≥ 50 years	65 Participants n=68 Participants	54 Participants n=4 Participants	119 Participants n=219 Participants
Sex: Female, Male Female	43 Participants n=68 Participants	24 Participants n=4 Participants	67 Participants n=219 Participants
Sex: Female, Male Male	2140 Participants n=68 Participants	1064 Participants n=4 Participants	3204 Participants n=219 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1378 Participants n=68 Participants	675 Participants n=4 Participants	2053 Participants n=219 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	804 Participants n=68 Participants	413 Participants n=4 Participants	1217 Participants n=219 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=68 Participants	0 Participants n=4 Participants	1 Participants n=219 Participants
Race/Ethnicity, Customized White	722 Participants n=68 Participants	344 Participants n=4 Participants	1066 Participants n=219 Participants
Race/Ethnicity, Customized Black or African American	584 Participants n=68 Participants	301 Participants n=4 Participants	885 Participants n=219 Participants
Race/Ethnicity, Customized Other or More Than One Race	577 Participants n=68 Participants	284 Participants n=4 Participants	861 Participants n=219 Participants
Race/Ethnicity, Customized Asian	269 Participants n=68 Participants	144 Participants n=4 Participants	413 Participants n=219 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	20 Participants n=68 Participants	13 Participants n=4 Participants	33 Participants n=219 Participants
Race/Ethnicity, Customized Not Collected	8 Participants n=68 Participants	2 Participants n=4 Participants	10 Participants n=219 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	3 Participants n=68 Participants	0 Participants n=4 Participants	3 Participants n=219 Participants
Region of Enrollment Puerto Rico	9 Participants n=68 Participants	2 Participants n=4 Participants	11 Participants n=219 Participants
Region of Enrollment Argentina	161 Participants n=68 Participants	64 Participants n=4 Participants	225 Participants n=219 Participants
Region of Enrollment United States	431 Participants n=68 Participants	233 Participants n=4 Participants	664 Participants n=219 Participants
Region of Enrollment Brazil	769 Participants n=68 Participants	396 Participants n=4 Participants	1165 Participants n=219 Participants
Region of Enrollment South Africa	246 Participants n=68 Participants	112 Participants n=4 Participants	358 Participants n=219 Participants
Region of Enrollment Mexico	8 Participants n=68 Participants	4 Participants n=4 Participants	12 Participants n=219 Participants
Region of Enrollment Thailand	250 Participants n=68 Participants	139 Participants n=4 Participants	389 Participants n=219 Participants
Region of Enrollment Peru	309 Participants n=68 Participants	138 Participants n=4 Participants	447 Participants n=219 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	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis n=4634 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.	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 results of HIV testing conducted 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)	2.374 HIV-1 events per 100 person-years Interval 1.649 to 3.417	—

PRIMARY outcome

Timeframe: Up to 149 weeks

Population: Participants in the LEN group 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. The HIV-1 incidence was compared with participants in the All Screened Set.

HIV-1 incidence per 100 PY for LEN 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	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis n=2179 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.	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis n=4634 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: HIV-1 Incidence Reported Per 100 PY for LEN Compared to Background HIV (bHIV, Participants in All Screened Set)	0.103 HIV-1 events per 100 person-years Interval 0.012 to 0.373	2.374 HIV-1 events per 100 person-years Interval 1.649 to 3.417

SECONDARY outcome

Timeframe: Up to 149 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	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis n=2179 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.	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis n=1086 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: HIV-1 Incidence Reported Per 100 PY for LEN Compared to F/TDF	0.103 HIV-1 events per 100 person-years Interval 0.012 to 0.373	0.931 HIV-1 events per 100 person-years Interval 0.426 to 1.768

SECONDARY outcome

Timeframe: Up to 149 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	Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis n=1948 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.	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 results of HIV testing conducted at Incidence Phase screening.
Randomized Blinded Phase: HIV-1 Incidence Among Participants Adherent to LEN	0.125 HIV-1 events per 100 person-years Interval 0.015 to 0.452	—

SECONDARY outcome

Timeframe: Up to 4 years

TEAEs were 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 have a causal relationship with the treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 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: LEN + Placebo-to-match (PTM) F/TDF

Serious events: 71 serious events

Other events: 1912 other events

Deaths: 4 deaths

Randomized Blinded Phase: Placebo LEN + F/TDF

Serious events: 43 serious events

Other events: 882 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Randomized Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF n=2183 participants at risk Participants received lenacapavir (LEN) 927 mg subcutaneous (SC) injection, every 26 weeks, starting on Day 1 up to for 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 orally, once daily, up to approximately 52 weeks.	Randomized Blinded Phase: Placebo LEN + F/TDF n=1088 participants at risk Participants received F/TDF tablet on Day 1 orally, once daily up to for 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.
General disorders Injection site nodule	63.4% 1383/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	39.2% 427/1088 • All-Cause Mortality and Adverse Events: Up to 149 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 Diarrhoea	6.7% 146/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	6.9% 75/1088 • All-Cause Mortality and Adverse Events: Up to 149 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	4.1% 89/2183 • All-Cause Mortality and Adverse Events: Up to 149 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% 67/1088 • All-Cause Mortality and Adverse Events: Up to 149 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 erythema	17.3% 377/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	19.4% 211/1088 • All-Cause Mortality and Adverse Events: Up to 149 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 induration	15.7% 342/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	10.1% 110/1088 • All-Cause Mortality and Adverse Events: Up to 149 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	56.4% 1231/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	53.4% 581/1088 • All-Cause Mortality and Adverse Events: Up to 149 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	6.8% 149/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	9.6% 104/1088 • All-Cause Mortality and Adverse Events: Up to 149 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 Anal chlamydia infection	13.2% 289/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	11.8% 128/1088 • All-Cause Mortality and Adverse Events: Up to 149 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 Anal gonococcal infection	10.7% 233/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	9.1% 99/1088 • All-Cause Mortality and Adverse Events: Up to 149 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 Influenza	5.5% 120/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	6.1% 66/1088 • All-Cause Mortality and Adverse Events: Up to 149 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 Latent syphilis	5.2% 114/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	4.0% 44/1088 • All-Cause Mortality and Adverse Events: Up to 149 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 Oropharyngeal gonococcal infection	13.0% 283/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	10.9% 119/1088 • All-Cause Mortality and Adverse Events: Up to 149 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	6.8% 148/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	7.1% 77/1088 • All-Cause Mortality and Adverse Events: Up to 149 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	5.5% 119/2183 • All-Cause Mortality and Adverse Events: Up to 149 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.	7.0% 76/1088 • All-Cause Mortality and Adverse Events: Up to 149 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