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# FDA Approves 2 Merck HIV-1 Drugs
- URL: https://www.fdaweb.com/fda-approves-2-merck-hiv-1-drugs/
- Published: 2018-08-30T12:00:00.000Z
- Updated: 2026-09-15T00:28:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142241

FDA has approved two Merck NDAs for human immunodeficiency virus (HIV)-1 drugs — Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg) and tenofovir disoproxil fumarate (300 mg); and Pifeltro (doravirine) 100 mg, a new non-nucleoside reverse transcriptase inhibitor to be administered in combination with other antiretroviral medicines. Both drugs are indicated for treating HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food. Approvals for both are based on data from the Phase 3 trials, DRIVE-AHEAD and DRIVE-FORWARD.