The US Food and Drug Administration (USFDA) has granted approval to United States-based Merck for its two new HIV-1 treatments, Delstrigo and Pifeltro, it was announced Friday.

Delstrigo is a once-daily fixed-dose combination tablet of doravirine (100mg), lamivudine (3TC, 300mg) and tenofovir disoproxil fumarate (TDF, 300mg). Pifeltro (doravirine, 100mg) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) for use in combination with other antiretroviral medicines.

The new medicines have been approved to treat HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food.

Approval was based on data from pivotal, randomized, multicenter, double-blind and active controlled phase three trials such as Drive-Ahead and Drive-Forward.