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

Prior treatment

• Self-reported history of previous positive results on an HIV test.
• Coenrollment in any other interventional research study or other concurrent studies that may interfere with this study (as provided by self-report or other available documentation) without prior approval from the Medical Monitor/Joint Clinical Management Committee while participating in this study.
• Prior use of long-acting systemic pre-exposure prophylaxis (PrEP) (including cabotegravir (CAB) or islatravir studies).

Other illness

• Any reactive or positive HIV test result at screening or enrollment, even if HIV infection is not confirmed.
• Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless individual provides documentation of receipt of placebo (ie, not active product).
• 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 clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding). In individuals with active hepatitis C, Fibrosis-4 (FIB-4) score \> 3.25 (formula provided below).
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

• Urine drug screen positive for any drug of misuse including, but not limited to, opioids (eg, fentanyl, heroin), stimulants (eg, cocaine, amphetamines), psychoactive drugs (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 according to the Cockcroft-Gault formula for creatinine clearance (CLcr).