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 >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=HIV Prevention Trials Network.
HPTN 083: Safety profile established in >2200 participants1
The most common adverse reactions regardless of severity reported in ≥1% of participants in HPTN 083 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 083, APRETUDE (n = 2117) and TDF/FTC (n = 2081). ‡Pyrexia includes pyrexia, feeling hot, chills, influenza-like illness. §Fatigue includes fatigue, malaise. ||Sleep disorders include insomnia, abnormal dreams. ¶Abdominal pain includes abdominal pain, upper abdominal pain.
FTC=emtricitabine; TDF=tenofovir disoproxil fumarate.
Discontinuation of therapy due to adverse reactions (all causality) was seen in 6% of participants receiving APRETUDE and 4% of participants receiving TDF/FTC.
- 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 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 083 included pain/tenderness (98%), nodules (15%), induration (15%), and swelling (12%)
- The median duration was 4 days
- The proportion of participants reporting ISRs 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
- 3% of participants who experienced an ISR discontinued APRETUDE as a result of these reactions†
Grade 1=mild; Grade 2=moderate; Grade 3=severe.
Continue the Safety Story
1. APRETUDE [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021.