Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has approved two new HIV-1 medicines, DELSTRIGO and PIFELTRO.
They 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.
The FDA approvals of DELSTRIGO, the once-daily fixed-dose combination tablet as a complete regimen, and PIFELTRO, a new NNRTI, are based on findings from the pivotal, randomised, multicenter, double-blind, active controlled Phase 3 trials, DRIVE-AHEAD and DRIVE-FORWARD, evaluating the efficacy and safety of DELSTRIGO and PIFELTRO, respectively, in participants infected with HIV-1 with no antiretroviral treatment history.
DELSTRIGO demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy. Of the 21 percent of study participants with a high viral load at baseline, 77 percent in the DELSTRIGO group and 72 percent in the EFV/FTC/TDF group achieved HIV-1 RNA <50 copies/mL at Week 48.
PIFELTRO demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy compared to DRV+r, each in combination with FTC/TDF or ABC/3TC. Of the 20 percent of study participants with a high viral load at baseline, 77 percent in the PIFELTRO group and 74 percent in the DRV+r group achieved HIV-1 RNA <50 copies/mL at Week 48.
Dr. George Hanna, vice president and therapeutic area head of infectious diseases, Global Clinical Development, Merck Research Laboratories said, “As part of Merck’s 30-year commitment to the care of people with HIV, we are pleased to now bring forward these two new antiretroviral treatment options, DELSTRIGO and PIFELTRO, which we believe offer a compelling clinical profile for clinicians and people living with HIV. We are thankful to the researchers as well as their patients and their communities for the collaboration that made today’s approval possible.”