The European Commission (EC) has approved two new oral treatments for adults with HIV-1 infection, Pifeltro and Delstrigo, both from Merck Sharp & Dohme, following a thumbs-up by the European Medicines Agency's Committee for Medicinal Products for Human Use back in September, as reported by Medscape Medical News.
The US Food and Drug Administration approved Pifeltro and Delstrigo in August.
Pifeltro contains doravirine (100 mg), a new, once-daily nonnucleoside reverse transcriptase inhibitor (NNRTI), which inhibits HIV-1 replication by noncompetitive inhibition of HIV-1 reverse transcriptase. Pifeltro is indicated, in combination with other antiretroviral agents, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class.
Delstrigo is a once-daily, fixed-dose combination of doravirine (100 mg), lamivudine (3TC; 300 mg), and tenofovir disoproxil fumarate (TDF; 245 mg). Delstrigo is indicated for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir.
Approval of these agents was based on positive findings from two randomized, multicenter, double-blind, active-controlled phase 3 trials, DRIVE-AHEAD and DRIVE-FORWARD, which evaluated the efficacy and safety of Delstrigo and Pifeltro, respectively, in adults with HIV-1 infection with no prior antiretroviral treatment history.
In DRIVE-AHEAD, Delstrigo demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy compared with efavirenz (EFV)/emtricitabine (FTC)/TDF.
At 48 weeks, 84% of the Delstrigo group achieved viral suppression of HIV-1 RNA <40 copies/mL, as did 80% of the EFV/FTC/TDF group (treatment difference, 4.1%; 95% confidence interval [CI], −1.5 to 9.7). Results through 96 weeks supported the week-48 findings.
Similarly, in DRIVE-FORWARD, Pifeltro demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy compared with darunavir plus ritonavir, each in combination with FTC/TDF or abacavir/3TC.
At 48 weeks, 83% of the Pifeltro group achieved viral suppression versus 79% in the darunavir plus ritonavir group (treatment difference, 4.2%; 95% CI, −1.4 to 9.7). Again, the results were similar at week 96.
In both trials, clinical adverse reactions of all grades occurring in ≥ 5% of participants treated with Delstrigo and Pifeltro included nausea (6%) and headache (5%).
Cite this: EC Clears Two New HIV Drugs (Pifeltro and Delstrigo) - Medscape - Nov 30, 2018.
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