The FDA has approved new drug applications (sNDAs) for Pifeltro in combination with other antiretroviral agents and Delstrigo as a complete regimen for adult patients with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known substitutions linked with resistance to Pifeltro or the individual components of Delstrigo.
Pifeltro (doravirine 100mg) is a non-nucleoside reverse transcriptase inhibitor (NNRTI), which will be administered in combination with other antiretroviral agents.
Delstrigo is a once-daily fixed-dose combination tablet of doravirine (100mg), lamivudine (3TC, 300mg) and tenofovir disoproxil fumarate (TDF 300mg).
The approval of Pifeltro and Delstrigo were based on data from DRIVE-SHIFT phase 3 randomised, international, multicentre and open-label trial that assessed switch to Delstrigo in virologically suppressed participants on a baseline regimen for at least six months prior to trial entry with no history of virologic failure.
The baseline regimen is composed of two nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a protease inhibitor plus either ritonavir or cobicistat, or elvitegravir plus cobicistat or an NNRTI.
Merck randomised 670 participants to start treatment with Delstrigo immediately on day one or after 24 weeks.
The primary efficacy comparison was between the Delstrigo at week 48 and the baseline regimen DSG at week 24.
In August 2018, Pifeltro and Delstrigo have been approved to treat HIV-1 infection in adults with no prior antiretroviral treatment history.
Merck Research Laboratories global clinical development infectious diseases therapeutic area head and vice president Dr George Hanna said: “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.
“We are thankful to the researchers and HIV community for their collaboration that made this possible.”
In July this year, Merck secured FDA approval for its Recarbrio (imipenem, cilastatin and relebactam) to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).