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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

Box plot chart showing bone mineral density changes with APRETUDE vs. TRUVADA.
  • A statistically significant difference* in bone mineral density that favored APRETUDE was seen between the 2 treatment arms at Weeks 57 and 1052
  • Overall, no bone mineral density loss was observed in the APRETUDE treatment group 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.

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Number at risk (HPTN 083)1

Table showing HPTN 083 number at risk after each injection.

The decreasing number at risk reflects the staggered enrollment of the study, the removal of participants when they experienced the event/outcome of interest, and when the blinded phase of the trial ended early.

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Number at risk (HPTN 084)5

Table showing HPTN 084 number at risk after each injection.

The decreasing number at risk reflects the staggered enrollment of the study, the removal of participants when they experienced the event/outcome of interest, and when the blinded phase of the trial ended early.

Banner image of a Caucasian man and a Latina woman on a green background.

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

APRETUDE HPTN 083 safety profile and adverse reactions.

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

See data on bone mineral density

*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=injection-site reaction.

ISR breakdown

APRETUDE HPTN 083 injection site reactions table.

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

*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.

Frequency of reported ISRs decreased over time
Line graph showing HPTN 083 frequency of reported ISRs.

The decreasing number at risk reflects the staggered enrollment of the study, the removal of participants when they experienced the event/outcome of interest, and when the blinded phase of the trial ended early.

Number at risk

Graphic showing 4 days median duration of ISRs in HPTN 083. Graphic showing 4 days median duration of ISRs in HPTN 083.

Median duration of ISRs was 4 days with APRETUDE

Graphic showing 3 percent of participants discontinued APRETUDE in HTPN 083. Graphic showing 3 percent of participants discontinued APRETUDE in HTPN 083.

of participants discontinued APRETUDE as a result of ISRs

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.

HPTN 084 Safety

Cisgender women

SAFETY PROFILE ESTABLISHED IN >3200 PARTICIPANTS

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

APRETUDE HPTN 084 safety profile and adverse reactions table.

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=injection-site reaction.

ISR breakdown

APRETUDE HPTN 084 injection site reactions table.
  • Most ISRs were mild to moderate and frequency and severity of reported ISRs decreased over time†
    • 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

*Participants in the TRUVADA arm received placebo injections (matching vehicle, identical volume) during the double-blind phase of the study.4

†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.

Frequency of reported ISRs decreased over time
Line graph showing HPTN 084 frequency of reported ISRs.

The decreasing number at risk reflects the staggered enrollment of the study, the removal of participants when they experienced the event/outcome of interest, and when the blinded phase of the trial ended early.

Number at risk

Graphic showing 8 days median duration of ISRs in HPTN 084. Graphic showing 8 days median duration of ISRs in HPTN 084.

Median duration of ISRs was 8 days with APRETUDE

Graphic showing zero discontinuations on APRETUDE as a result of ISRs in HPTN 084. Graphic showing zero discontinuations on APRETUDE as a result of ISRs in HPTN 084.

discontinuations on APRETUDE as a result of ISRs

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.

Banner image of a Caucasian man, a Black man, and a Latina woman on a green background.

2 months of continuous HIV protection with each injection (after initiation injections)

View dosing information

PMUS-CBTWCNT250021

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

  5. Data on file, ViiV Healthcare.