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
#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.
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