Idvynso Approved for HIV Infection

On April 20, 2026, the US Food and Drug Administration (FDA) approved Merck’s Idvynso^™ (doravirine/islatravir – Merck) for the treatment of Human Immunodeficiency Virus-1 (HIV) infection in adults who are virologically suppressed. Idvynso is a once‑daily, oral, two‑drug single‑tablet regimen combining doravirine, a non‑nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir, a first-in-class nucleoside analog reverse transcriptase inhibitor (NRTI) with translocation inhibition activity that acts through multiple mechanisms to disrupt HIV replication. It is approved as a complete regimen to replace the current antiretroviral regimen in adults with HIV RNA below 50 copies/mL on a stable regimen, with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. The recommended dose is one tablet taken orally once daily, with or without food. Idvynso is contraindicated with strong cytochrome P450 (CYP)3A inducers and with lamivudine or emtricitabine, as co‑administration may reduce drug exposure and decrease treatment effectiveness. It is expected to be available in pharmacies after May 11, 2026. Pricing has not yet been announced. Full prescribing information can be found here.

At a Glance

• Brand Drug: Idvynso^™ (doravirine/islatravir)
• Manufacturer: Merck
• Date Approved: April 20, 2026
• Indication: For adults with virologically suppressed HIV-1, HIV-1 RNA less than 50 copies per mL, with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine
• Dosage Forms Available: Oral tablet containing 100mg doravirine and 0.25mg islatravir
• Launch Date: Will be available in pharmacies after May 11
• Estimated Annual Cost: Not yet known.
• FDA Designation: N/A
• HIV is a chronic viral infection that attacks the immune system but, with effective treatment, can be managed as a lifelong condition with the goal of durable virologic suppression and reduced transmission risk.
• About 1.3 million Americans are living with HIV, with roughly 39,000 new diagnoses each year. Of individuals that have been diagnosed (87%), 67% have achieved virologic suppression.
• Numerous effective drugs from several drug classes are available to treat HIV. To reduce the risk of viral resistance, drugs from more than one class are used together.
• In phase III trials, Idvynso was as effective as a three‑drug integrase strand transfer inhibitor (INSTI)-based regimen in maintaining virologic suppression in adults with HIV who switched therapy, with a comparable safety profile.
• Current oral maintenance regimens for virologically suppressed HIV include INSTIs, such as bictegravir‑ or dolutegravir‑based combinations.  Idvynso is the first two‑drug regimen that does not include an INSTI.
• Two other single tablet regimens are in the pipeline. Gilead’s bictegravir/lenacapavir combines an integrase inhibitor (bictegravir) and HIV capsid inhibitor (lenacapavir) for a unique combination with approval expected by the end of 2026. Merck and Gilead’s islatravir/lenacapavir is in development as an oral once-weekly treatment and may be approved in 2027.
• In an ongoing phase III trial, Idvynso demonstrated noninferiority to a three‑drug INSTI-based regimen in treatment‑naïve adults with HIV. The regimen is not currently approved for this population.