RPV+DRV/Cobi Dual Therapy in Subjects With HIV Controlled Infection

Summary

This study evaluates efficacy and safety of rilpivirine as substitutive agent for the nucleosidic backbone of HAART in virologic suppressed patients when combined with cobicistat-boosted darunavir.

Timeline

Start

2017-02-01

Primary completion

2019-06-13

Completion

2019-11-30

Outcome

Met primary endpoint

paper At Week 24, 72 (90.0%) of participants with 2DR and 75 (93.8%) with CAR maintained HIV-RNA <50 copies/mL [difference -3.75% (95% CI = -11.63 to 5.63)], confirming non-inferiority. PMID 32129855 ↗

Publications

• Maggiolo F, Gianotti N, Comi L, Di Filippo E, Fumagalli L, Nozza S, Galli L, Valenti D, Rizzi M, Castagna A. Rilpivirine plus cobicistat-boosted darunavir as alternative to standard three-drug therapy in HIV-infected, virologically suppressed subjects: Final results of the PROBE 2 trial. Antivir Ther. 2021 May;26(3-5):51-57. doi: 10.1177/13596535211042226. Epub 2021 Oct 27.
• Maggiolo F, Gianotti N, Comi L, Di Filippo E, Fumagalli L, Nozza S, Galli L, Valenti D, Rizzi M, Castagna A. Rilpivirine plus cobicistat-boosted darunavir as a two-drug switch regimen in HIV-infected, virologically suppressed subjects on steady standard three-drug therapy: a randomized, controlled, non-inferiority trial (PROBE 2). J Antimicrob Chemother. 2020 May 1;75(5):1332-1337. doi: 10.1093/jac/dkaa018.

Drugs

Indications