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

Key Inclusion Criteria:

Incidence Phase

• CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assignedmale at birth and are at risk for HIV infection.

• HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3months.

• Sexually active with ≥ 1 partner assigned male at birth (condomless receptive analsex) in the last 12 months and 1 of the following:

• Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks.

• History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24weeks.

• Self-reported use of stimulants with sex in the last 12 weeks.

Randomized Phase

• Negative local rapid fourth generation HIV-1/2 Ab/Ag, central fourth generationHIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT).

• Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at screening according tothe Cockcroft-Gault formula for creatinine clearance (CLcr).

Key Exclusion Criteria:

Incidence Phase

• Prior use of HIV PrEP (including F/TDF or F/TAF) or HIV postexposure prophylaxis (PEP) in the past 12 weeks or any prior use of long-acting systemic PrEP (includingcabotegravir or islatravir).

• Prior recipient of an HIV vaccine or HIV broadly neutralizing antibody formulation.

Randomized Phase

• Acute viral hepatitis A, B or C or evidence of chronic hepatitis B or C infection.

• Severe hepatic impairment or a history of or current clinical decompensated livercirrhosis.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.