HPTN 083 Safety
The safety profile of APRETUDE was established in >2000 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 >2000 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.
Grade 1=mild; Grade 2=moderate; Grade 3=severe.
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