Merck announced that the Food and Drug Administration (FDA) has approved Delstrigo (doravirine, lamivudine, tenofovir disoproxil fumarate) fixed-dose tablets and Pifeltro (doravirine) tablets for the treatment of HIV-1 infection in appropriate patients.
Specifically, both Delstrigo and Pifeltro are indicated to treat HIV-1 infection in adults with no prior antiretroviral treatment experience. Delstrigo is approved as a complete regimen whereas Pifeltro is to be administered in combination with other antiretrovirals. Both medications are given once daily with or without food.
Delstrigo combines doravirine, a new non-nucleoside reverse transcriptase inhibitor (NNRTI), with lamivudine and tenofovir disoproxil fumarate, 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs). It carries a Boxed Warning regarding post-treatment acute exacerbation of hepatitis B (HBV) infection.
The FDA approval was supported by data from the Phase 3, randomized, multicenter, double-blind, active-controlled trials, DRIVE-AHEAD (N=728) and DRIVE-FORWARD (N=766), which evaluated the safety and efficacy of Delstrigo and Pifeltro, respectively.
In DRIVE-AHEAD, treatment with Delstrigo demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy vs efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF). Viral suppression (HIV-1 RNA <50 copies/mL) was achieved in 84% of patients in the Delstrigo group vs 81% in the EFV/FTC/TDF group (treatment difference 3.5%, 95% CI, -2.0%, 9.0%). At week 48, Delstrigo-treated patients had statistically significant superior lipid profiles (changes in LDL and non-HDL cholesterol) compared with EFV/FTC/TDF.
In DRIVE-FORWARD, treatment with Pifeltro demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy vs darunavir + ritaonvir (DRV+r), each in combination with FTC/TDF or abacavir (ABC)/3TC. Viral suppression was achieved in 84% of patients in the Pifeltro group vs 80% in the DRV+r group (treatment difference 3.9%, 95% CI, -1.6%, 9.4%). At week 48, Pifeltro-treated patients had statistically significant superior lipid profiles (changes in LDL and non-HDL cholesterol) compared with DRV+r.
Delstrigo will be available as 100mg/300mg/300mg strength tablets in 30-count bottles. Pifeltro will be available as 100mg strength tablets in 30-count bottles. The Company anticipates both products to be available within 1 month.
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