Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

Summary

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.

Timeline

Start

2020-02-18

Primary completion

2021-09-08

Completion

2024-08-26

Outcome

Met primary endpoint

registry p <.001; Estimated Difference -1.49 (95% CI -3.44 to -0.34) NCT04223778 ↗

paper maintained viral suppression up to week 48 and was non-inferior to antiretroviral combinations used in clinical practice for adults with HIV-1 PMID 38734015 ↗

release “both trials met their primary efficacy endpoint” merck.com ↗

release “ART; ILLUMINATE SWITCH A) or bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF; ILLUMINATE SWITCH B). At 48 weeks, both trials met their primary efficacy endpoint” merck.com ↗

Publications

• Results Molina JM, Rizzardini G, Orrell C, Afani A, Calmy A, Oka S, Hinestrosa F, Kumar P, Tebas P, Walmsley S, Grandhi A, Klopfer S, Gendrano I, Eves K, Correll TA, Fox MC, Kim J. Switch to fixed-dose doravirine (100 mg) with islatravir (0.75 mg) once daily in virologically suppressed adults with HIV-1 on antiretroviral therapy: 48-week results of a phase 3, randomised, open-label, non-inferiority trial. Lancet HIV. 2024 Jun;11(6):e369-e379. doi: 10.1016/S2352-3018(24)00031-6. Epub 2024 May 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doravirine	Small molecule	100 mg	Oral
Subject	Islatravir	Other / unclassified	0.75 mg	Oral

Indications