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The safety of APRETUDE was studied
in 2 international, multicenter, double-blind trials: HPTN 083 and HPTN 084

HPTN=HIV Prevention Trials Network.

Cisgender men and transgender women who have sex with men and are at risk of acquiring HIV infection through sex

View HPTN 083 safety data

Cisgender women at risk of acquiring HIV-1 through sex

View HPTN 084 safety data

HPTN 083 Adverse Reactions

Safety profile established in >2,200 participants in HPTN 083

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

Table depicting APRETUDE safety

*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=2,117) and TDF/FTC (n=2,081).

‡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.

6% of participants receiving APRETUDE and 4% of participants receiving TDF/FTC discontinued due to adverse events (all causality).

Injection-site Reactions

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

Table depicting APRETUDE safety
  • 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; no Grade 4 reactions were reported
    • The median duration was 4 days
  • 3% of participants who experienced an ISR discontinued APRETUDE as a result of it

#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.

HPTN 084 Adverse Reactions

Safety profile established in >1,600 participants in HPTN 084

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

Table depicting APRETUDE safety

**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=1,519) and TDF/FTC (n=1,516).

‡‡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.

1% of participants receiving APRETUDE and 1% of participants receiving TDF/FTC discontinued due to adverse events (all causality).

Injection-site Reactions

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

Table depicting APRETUDE safety
  • 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.2

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References:

  1. Landovitz RJ, Donnell D, Clement ME, et al; HPTN 083 Study Team. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385(7):595-608. doi:10.1056/NEJMoa2101016

  2. 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