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In a subset analysis of the blinded phase of HPTN 083

Bone mineral density changes with APRETUDE vs TRUVADA

(SECONDARY ENDPOINT)

Consider how bone mineral density data may inform your prescribing decisions

  • A statistically significant difference* in bone mineral density that favored APRETUDE was seen between the 2 treatment arms at Weeks 57 and 1052
  • A loss in bone mineral density by DXA scans was observed in the TRUVADA arm, consistent with previous findings with other TDF-containing regimens2,3
  • The long-term clinical significance of these changes is not known (eg, fracture risk).2

*Adjusted for age and race.

BMD=bone mineral density; DXA=dual-energy X-ray absorptiometry; TDF=tenofovir disoproxil fumarate.

SAFETY ESTABLISHED IN 2 CLINICAL TRIALS

HPTN 083 Safety

Cisgender men and transgender women

SAFETY PROFILE ESTABLISHED IN >4500 PARTICIPANTS

Adverse drug reactions*: All grades reported in ≥1% in APRETUDE arm

6% of participants receiving APRETUDE and 4% of participants receiving TRUVADA 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 TRUVADA (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.

HPTN=HIV Prevention Trials Network.

ISR breakdown

Most ISRs were mild to moderate and frequency and severity of reported ISRs decreased over time**

  • The majority (97%) were Grade 1 or 2; 3% were Grade 3; none were Grade 4
  • The median duration was 4 days
  • 3% of participants discontinued APRETUDE due to ISRs

See data on bone mineral density

#Participants in the TRUVADA arm received placebo injections (matching vehicle, identical volume) during the double-blind phase of the study.1

**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; Grade 4=a potentially life-threatening event.

ISR=injection-site reaction.

HPTN 084 Safety

Cisgender women

SAFETY PROFILE ESTABLISHED IN >3200 PARTICIPANTS

Adverse drug reactions††: All grades reported in ≥1% in APRETUDE arm

1% of participants receiving APRETUDE and 1% of participants receiving TRUVADA 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=1519) and TRUVADA (n=1516).

§§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.

ISR breakdown

  • Most ISRs were mild to moderate and frequency and severity of reported ISRs decreased over timeb
    • The majority (>99%) were Grade 1 or 2; <1% were Grade 3; none were Grade 4
    • The median duration was 8 days
    • No participants receiving APRETUDE discontinued due to ISRs

aParticipants in the TRUVADA arm received placebo injections [matching vehicle, identical volume] during the double-blind phase of the study.4

bSelf-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; Grade 4=a potentially life-threatening event.

ISR=injection-site reaction.

View expert discussion from colleagues

See Dr Kevin Hatfield discuss the efficacy and safety of APRETUDE.

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Real HCP compensated by ViiV Healthcare.

Video still of Dr Hodge, an African American male physician

PMUS-CBTWCNT240014

References:

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

  2. Brown TT, Arao RF, Phanuphak N, et al. Bone density changes with CAB-LA or TDF/FTC PrEP in MSM and TGW in HPTN 083. Poster presented at: 30th Conference on Retroviruses and Opportunistic Infections; February 19-22, 2023; Seattle, WA. Accessed January 29, 2024. https://www.croiconference.org/abstract/bone-density-changes-with-cab-la-or-tdf-ftc-prep-in-msm-and-tgw-in-hptn-083

  3. Baranek B, Wang S, Cheung AM, Mishra S, Tan DHS. The effect of tenofovir disoproxil fumarate on bone mineral density: a systemic review and meta-analysis. Antivir Ther. 2020;25(1):21-32. doi:10.3851/IMP334633-1

  4. Delany-Moretlwe S, Hughes JP, Bock P, et al. 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