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 084 Safety

The safety profile of APRETUDE was established in >1600 cisgender women at risk of acquiring HIV-1 in HPTN 084. The information below gives an overview of the adverse reactions of APRETUDE as observed in HPTN 084, including treatment-related adverse reactions, discontinuation rates due to adverse reactions, and injection-site reactions (ISRs).

HPTN 084 Adverse Reactions

Safety profile established in >1600 participants in HPTN 084

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

Pooled analysis of incidence of injection site reactions from  Week 4 to Week 48
Adverse Reactions Table


1% of participants receiving APRETUDE and 1% 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=1519) and TDF/FTC (n=1516).

Fatigue includes fatigue and malaise.

§Abdominal pain includes abdominal pain and upper abdominal pain.

||Rash includes rash, erythema, pruritus, macular, papular, and maculopapular. 

Sleep disorders include insomnia and abnormal dreams.


TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.

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

  • 38% of participants in the APRETUDE arm experienced at least 1 ISR, most of which were characterized as mild to moderate
    • The majority (>99%) were Grade 1 or 2 with <1% of participants experiencing Grade 3 and no Grade 4 reactions reported
    • The median duration was 8 days
  • No participants receiving APRETUDE discontinued due to ISRs

#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.


Continue the Safety Story



1. Delany-Moretlwe S, Hughes JP, Bock P, et al; HPTN 084 study group, Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022;399(10337):1779-1789. doi:10.1016/S0140-6736(22)00538-4