Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)

Key Inclusion Criteria:

• Urine drug screen positive for any drug of misuse including, but not limited to,opioids (eg, fentanyl, heroin), stimulants (eg, cocaine, amphetamines), psychoactivedrugs (eg, benzodiazepines), or a combination of these drugs.

• Evidence of recent injection (eg, track marks).

• Self-report of injection paraphernalia sharing in the prior 30 days.

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

• 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.

• Any reactive or positive HIV test result at screening or enrollment, even if HIVinfection is not confirmed.

• Coenrollment in any other interventional research study or other concurrent studiesthat may interfere with this study (as provided by self-report or other availabledocumentation) without prior approval from the Medical Monitor/Joint ClinicalManagement Committee while participating in this study.

• 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.

• Have a suspected or known active, serious infection(s) (eg, active tuberculosis,etc).

• Evidence of moderate or severe liver fibrosis or a history of or current clinicaldecompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding). Inindividuals with active hepatitis C, Fibrosis-4 (FIB-4) score > 3.25 (formulaprovided below).

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