FDA Approves 2 New HIV Drugs

Officials with the FDA today approved Merck’s doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo) tablet and doravirine (Pifeltro) for the treatment of HIV-1, the company announced in a press release.

Both drugs are indicated for oral, once-daily treatment in adult patients with HIV-1 infection who have had no prior antiretroviral treatment experience.

Delstrigo is a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg). Pifeltro, a new non-nuceloside reverse transcriptase inhibitor, is to be administered in combination with other antiretroviral medications.

The approvals are based on phase 3 trials DRIVE-AHEAD and DRIVE-FORWARD, which evaluated the efficacy and safety of the 2 treatments, respectively, in adults with HIV-1 who had no antiretroviral treatment history.

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