FDA Approves Merck's Idvynso, New Once-Daily Two-Drug HIV Treatment Tablet

The U.S. Food and Drug Administration has approved Merck's Idvynso, a once-daily single tablet combining doravirine and islatravir, for treating HIV-1 infection in adults. The two-drug regimen is designed to replace current antiretroviral treatments in patients who are virologically suppressed with HIV-1 RNA levels below 50 copies per milliliter. This approval represents a notable development in HIV treatment, as most existing therapies require three or more drugs in combination. The simplified two-drug approach may offer benefits in terms of reduced pill burden and potentially fewer side effects for patients maintaining viral suppression.

FDA Approval and Drug Specifications

• ▪Idvynso is composed of doravirine and islatravir
• ▪Idvynso is approved to replace the current antiretroviral regimen in adults who are virologically suppressed
• ▪The U.S. Food and Drug Administration approved Merck's Idvynso for treatment of HIV-1 infection in adults
• ▪Idvynso is a once-daily, two-drug single tablet
• ▪Idvynso is approved for patients with HIV-1 RNA less than 50 copies per milliliter

Perspective of Merck

• ▪Merck's Idvynso provides a new option for virologically suppressed HIV-1 patients seeking treatment alternatives
• ▪Idvynso represents an important advancement in HIV treatment by offering a simplified two-drug regimen