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 virus that attacks the body's immune system, and without lifelong treatment, it can progress to AIDS. Idvynso is a once-daily pill containing two drugs: doravirine blocks a key viral enzyme, while islatravir stops the virus from copying its genetic material. This two-drug combination offers a complete maintenance regimen that may help people keep the virus suppressed with a different mechanism than other common treatments.
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