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FDA approves supplemental NDAs for Pifeltro, Delstrigo for treating HIV in adults
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The FDA approved a supplemental new drug application to expand the use of Pifeltro and Delstrigo to include the treatment of patients who are virologically suppressed on a stable ART regimen with no history of treatment failure, Merck announced.
“Thanks to developments in HIV science, more treatment options are becoming available to address the medical needs of people living with HIV,” Princy Kumar, MD, chief of the Division of Infectious Diseases and Tropical Medicine at MedStar Georgetown University Hospital and professor of medicine and microbiology at Georgetown University School of Medicine, said in the news release. “The expanded indications offer certain people with HIV-1 infection and their doctors the choice to switch their current antiretroviral therapy to Delstrigo or Pifeltro in combination with other antiretroviral agents.”
Pifeltro (100 mg), a non-nucleoside reverse-transcriptase inhibitor to be used in combination with other ART medications, and Delstrigo, a once-daily, fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg) and tenofovir disoproxil fumarate (300 mg), were approved by the FDA in August 2018 for the treatment of HIV-1 infection in adults with no prior ART experience. Both drugs are produced by Merck. Following the phase 3 DRIVE-SHAFT trial, which demonstrated noninferior efficacy of switching to Delstrigo compared with continuing a baseline regimen of two nucleoside reverse-transcriptase inhibitors plus a boosted protease inhibitor, an FDA submission for the supplemental NDAs was submitted and accepted.
“Today’s approvals provide doravirine treatment options for people living with HIV-1 who are virally suppressed, reflecting Merck’s continued commitment to research and development of HIV treatments,” George Hanna, MD, vice president and therapeutic area head of infectious diseases, Global Clinical Development at Merck Research Laboratories, said in the news release. “We are thankful to the researchers and HIV community for their collaboration that made this possible.” – by Caitlyn Stulpin
Disclosures: Hanna is an employee of Merck. Infectious Disease News could not confirm any relevant financial disclosures for Kumar at the time of publication.