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.
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=HIV Prevention Trials Network.
HPTN 084: Safety profile established in >1600 participants1
The most common adverse reactions regardless of severity reported in ≥1% of participants in HPTN 084 are presented below.
Adverse Drug Reactions* of All Grades Reported in at Least 1% of Participants Receiving APRETUDE
*Adverse reactions defined as “treatment-related” as assessed by the investigator, with exception of injection-site reactions, where all injection-site reactions were reported regardless of causality. †Participants who received injection: HPTN 084, APRETUDE (n = 1519) and TDF/FTC (n = 1516). ‡Fatigue includes fatigue, malaise. §Abdominal pain includes abdominal pain, upper abdominal pain. ‖Rash includes rash, erythema, pruritus, macular, papular, maculopapular. ¶Sleep disorders include insomnia, abnormal dreams.
1% of participants receiving APRETUDE and 1% of participants receiving TDF/FTC discontinued due to adverse reactions (all causality).
- 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 most common ISRs (all grades) reported in at least 10% of participants who experienced at least 1 ISR (all causality) with APRETUDE in HPTN 084 included pain/tenderness (90%), swelling (18%), nodules (14%), and induration (12%)
- The median duration was 8 days
- No participants receiving APRETUDE discontinued due to ISRs
- The proportion of ISRs reported at each visit and the severity decreased over time
- Self-reported ISRs could potentially underestimate the true rate of ISRs over time. ISRs may still be present but not reported during the course of the study
Grade 1=mild; Grade 2=moderate; Grade 3=severe.
Continue the Safety Story
1. APRETUDE [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021