FDA Approves New HIV Treatments

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The U.S. Food and Drug Administration (FDA) has approved pharmaceutical giant Merck’s Delstrigo and Pifeltro for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history.

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 (doravirine, 100 mg) is a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines. Both Delstrigo and Pifeltro are indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience and are administered orally once daily with or without food. Delstrigo contains a boxed warning regarding post-treatment acute exacerbation of hepatitis B (HBV) infection among other possible side effects.

The FDA’s approvals of Delstrigo and Pifeltro are based on findings from the pivotal, randomized, multicenter, double-blind, active controlled Phase 3 trials, DRIVE-AHEAD and DRIVE-FORWARD. In DRIVE-AHEAD, 728 participants with no antiretroviral treatment history received either Delstrigo or a different combination of antivirals. Delstrigo demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint. In the Delstrigo group, 84 percent achieved viral suppression of HIV-1. Of the 21 percent of study participants with a high viral load at baseline (HIV-1 RNA >100,000 copies/mL), 77 percent achieved HIV-1 RNA In DRIVE-FORWARD, 766 participants with no antiretroviral treatment history were randomized and received at least one dose of either Pifeltro once daily or another combination of antrivirals, each in combination with emtricitabine (FTC)/TDF or abacavir (ABC)/3TC. Some eighty-four percent of patients who took Pifeltro achieved viral suppression of HIV-1 RNA of

—Reporting by Hank Trout


Hank Trout, Editor at Large, edited Drummer, Malebox, and Folsom magazines in the early 1980s. A long-term survivor of HIV/AIDS (diagnosed in 1989), he is a thirty-eight-year resident of San Francisco, where he lives with his fiancé Rick. Follow him on Twitter @HankTroutWriter.