Merck’s Delstrigo and Pifeltro HIV Treatments Receive Expanded Indications

The FDA granted Merck’s Delstrigo and Pifeltro expanded indications to include adult patients with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure.

Delstrigo (doravirine, lamivudine, tenofovir disoproxil fumarate) was approved last year as a complete regimen to treat HIV-1 infection in adult patients with no antiretroviral treatment history, and Pifeltro (doravirine) was approved to treat the condition in combination with other antiretroviral agents.

The agency expanded the indications based on the results of a phase 3 clinical trial that evaluated a switch to Delstrigo in virologically suppressed participants with no history of virologic failure, which met its primary endpoints.