for HIV-1 infection in virologically suppressed adults (maintenance regimen)
FDA approved Idvynso (doravirine/islatravir) on April 20, 2026 — ahead of the May 10 2026 PDUFA target. Once-daily oral two-drug single-tablet regimen for adults with virologically-suppressed HIV-1. First NRTTI-containing complete regimen; positioned as a maintenance alternative to integrase-inhibitor backbones (Biktarvy, Dovato).
HIV-1 is a chronic viral infection that attacks the immune system and can progress to life-threatening AIDS if left untreated. Idvynso is a once-daily pill combining doravirine, which blocks the virus from copying its genetic code, and islatravir, which stops that copying process by causing the viral machinery to jam. This two-drug regimen offers a long-term maintenance therapy for those with controlled HIV, potentially reducing the amount of medication needed to keep the virus suppressed.
The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.
Source: ClinicalTrials.gov