The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of two new oral treatments for adults with HIV-1 infection, Pifeltro and Delstrigo, both from Merck Sharp & Dohme BV.
The US Food and Drug Administration (FDA) approved Pifeltro and Delstrigo in August.
Pifeltro contains doravirine (100 mg), a new 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.
The benefits of Pifeltro and Delstrigo are the ability to achieve a potent antiretroviral response in a once-daily, single-pill regimen, the EMA said in a statement. The most common side effects are nausea and headache.
In a news release, Merck said the CHMP’s positive opinion was based on 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 to efavirenz (EFV)/emtricitabine (FTC)/TDF.
Similarly, in DRIVE-FORWARD, Pifeltro demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy compared to darunavir plus ritonavir, each in combination with FTC/TDF or abacavir (ABC)/3TC.
Both drugs should be prescribed by physicians experienced in the management of HIV infection, the EMA said.
The summary of product characteristics will include detailed recommendations for use of these products and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.
By Megan Brooks