Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
Summary
This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.
Timeline
- Start
- 2017-11-07
- Primary completion
- 2020-11-05
- Completion
- 2026-10-17
Outcome
Met primary endpoint
paper cabotegravir was superior to TDF-FTC in preventing HIV infection in women. PMID 35378077 ↗
release “Interim analysis from HPTN 084 study shows long-acting injectable cabotegravir administered every two months is 89% more effective than daily pills” viivhealthcare.com ↗
release “90% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084” viivhealthcare.com ↗
release “a 90% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084” viivhealthcare.com ↗
release “HPTN 084 reported that cabotegravir LA for PrEP showed superior efficacy to daily oral” viivhealthcare.com ↗
Publications
- Marzinke MA, Han K, Hanscom B, Guo X, Piwowar-Manning E, Hendrix CW, Rose S, Spooner E, Mathew C, Innes S, Sekabira R, Mutambanengwe M, Rooney JF, Rinehart AR, Adeyeye A, Cohen MS, Hosseinipour M, Ford SL, Delany-Moretlwe S. Pharmacologic evaluation of delayed long-acting cabotegravir administration among cisgender women in HPTN 084. Antimicrob Agents Chemother. 2024 Nov 6;68(11):e0099424. doi: 10.1128/aac.00994-24. Epub 2024 Sep 23.
- Delany-Moretlwe S, Hughes JP, Bock P, Ouma SG, Hunidzarira P, Kalonji D, Kayange N, Makhema J, Mandima P, Mathew C, Spooner E, Mpendo J, Mukwekwerere P, Mgodi N, Ntege PN, Nair G, Nakabiito C, Nuwagaba-Biribonwoha H, Panchia R, Singh N, Siziba B, Farrior J, Rose S, Anderson PL, Eshleman SH, Marzinke MA, Hendrix CW, Beigel-Orme S, Hosek S, Tolley E, Sista N, Adeyeye A, Rooney JF, Rinehart A, Spreen WR, Smith K, Hanscom B, Cohen MS, Hosseinipour MC; 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 May 7;399(10337):1779-1789. doi: 10.1016/S0140-6736(22)00538-4. Epub 2022 Apr 1.
- Scarsi KK. Chasing the cabotegravir tail: implications for prevention. Lancet HIV. 2020 Jul;7(7):e451-e453. doi: 10.1016/S2352-3018(20)30165-X. Epub 2020 Jun 1. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabotegravir | Small molecule | 600 mg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |