For HIV-1–negative, at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1. See full Indication.

HPTN 083 Safety

The safety profile of APRETUDE was established in >2200 cisgender men and transgender women who have sex with men and have evidence of high-risk behavior for HIV-1 infection in HPTN 083. The information below gives an overview of the adverse reactions of APRETUDE as observed in HPTN 083, including treatment-related adverse reactions, discontinuation rates due to adverse reactions, and injection-site reactions (ISRs).

HPTN 083 Adverse Reactions

Safety profile established in >2200 participants in HPTN 083

Adverse drug reactions* of all grades reported in at least 1% of participants receiving APRETUDE


6% of participants receiving APRETUDE and 4% of participants receiving TDF/FTC discontinued due to adverse events (all causality).


*Adverse reactions defined as “treatment related” as assessed by the investigator, with the exception of ISRs, where all ISRs were reported regardless of causality.

Participants who received injection: APRETUDE (n=2117) and TDF/FTC (n=2081).

Pyrexia includes pyrexia, feeling hot, chills, and influenza-like illness. 

§Fatigue includes fatigue and malaise.

||Sleep disorders include insomnia and abnormal dreams. 

Abdominal pain includes abdominal pain and upper abdominal pain.


TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.

The most common local injection-site reaction was pain/tenderness


  • 82% of participants in the APRETUDE arm experienced at least 1 ISR, most of which were characterized as mild to moderate
    • The majority (97%) were Grade 1 or 2, with 3% of participants experiencing Grade 3; no Grade 4 reactions were reported
    • The median duration was 4 days
  • 3% of participants who experienced an ISR discontinued APRETUDE as a result of it

#Participants in the TDF/FTC arm received placebo injections (matching vehicle, identical volume) during the double-blind phase of the study.1

Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=a potentially life-threatening event; ISR=injection-site reaction; TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.

Continue the Safety Story



1. Landovitz RJ, Donnell D, Clement ME, et al; HPTN 083 Study Team. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385(7):595-608. doi:10.1056/NEJMoa2101016