Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)

Key Inclusion Criteria:

• At least 16 years of age at screening.

• Receptive anal or vaginal sex in the past 6 months and at least 1 of the following:

1. Condomless receptive sex (vaginal or anal) with 1 or more sex partners ofunknown HIV status during the past 6 months

2. For a person who has engaged in anal sex in the past 6 months: diagnosis ofsyphilis, gonorrhea, or chlamydia in the past 6 months

3. For a person who has engaged in vaginal sex in the past 6 months: diagnosis ofsyphilis or gonorrhea in the past 6 months

4. Sex with partner known to be living with HIV with an unknown or detectableviral load in the past 6 months

• Negative local rapid fourth generation HIV-1/2 antibody (Ab)/antigen (Ag) test,central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acidamplification testing (NAAT) at screening.

Key Exclusion Criteria:

• Current signs or symptoms suggesting HIV infection

• 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 (eg, ascites, encephalopathy, variceal bleeding)

• Past or current participation in HIV vaccine or HIV broadly neutralizing antibodystudy unless participant provides documentation of receipt of placebo (ie, notactive product)

• Prior use of oral LEN in the past 90 days or subcutaneous LEN in the past 18 months

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