Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

Key Inclusion Criteria:

• Report at least 1 episode of condomless vaginal or anal sex with a cisgender man inthe 12 months before enrollment.

• Hepatitis B virus (HBV) surface antigen (HBsAg) negative.

• Self-report one or more of the following in the past 12 months (except forincarceration, which could have occurred in the past 5 years):

1. Noninjection recreational drug use (ecstasy, cocaine, crack cocaine,methamphetamine, ketamine, 3,4-methylenedioxy-methamphetamine, or prescription drugsapart from those prescribed by a licensed provider); 2) Alcohol dependence (definedas Cut Down, Annoyed, Guilty, and Eye Opener score of 2); binge-drinking, defined as 4 or more drinks at a time; 3) History of STIs, such as gonorrhea, chlamydia, orsyphilis; 4) Exchange of sex for commodities, such as drugs, money, or shelter; 5)Incarceration (jail or prison > 24 hours within the past 5 years); 6) Two or moresexual partners who were assigned male at birth; 7) Sexual partner assigned male atbirth with history of either injection or noninjection recreational drug use,sexually transmitted infections (STIs), human immunodeficiency virus (HIV) diagnosisor unknown HIV status, additional sex partners during the course of his sexualrelationship with the individual, or incarceration (jail or prison > 24 hours withinthe past 5 years)

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

• Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening accordingto the Cockcroft-Gault formula for creatinine clearance (CLcr).

Key Exclusion Criteria:

• Self-reported history of previous positive results on an HIV test.

• One or more reactive or positive HIV test result at screening or enrollment, even ifHIV infection is not confirmed.

• Past or current participation in HIV vaccine or HIV broadly neutralizing antibodystudy unless individual provides documentation of receipt of placebo (ie, not activeproduct).

• Prior use of long-acting systemic pre-exposure prophylaxis (PrEP) (includingcabotegravir (CAB) or islatravir studies).

• Acute viral hepatitis A or acute or chronic hepatitis B or C infection.

• Severe hepatic impairment or a history of or current clinical decompensated livercirrhosis (eg, ascites, encephalopathy, variceal bleeding, etc).

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