FDA Expands Indication For HIV Drugs Desltrigo and Pifeltro

The U.S. Food and Drug Administration has expanded the indications for Merck’s Pifeltro (doravirine) and Delstrigo (doraviring/lamivudine/tenofovir disoproxil fumarate) for adults living with HIV whose viral loads are suppressed and have no history of treatment failure or any known resistance to the drugs.

Specifically, the indications were expanded for Pifeltro (a non-nucleoside reverse transcriptase inhibitor) to be used in combination with other antiretroviral drugs, and for Delstrigo (once-daily fixed-dose combination tablet) to be used as a complete regimen.

Both Pifeltro and Delstrigo were approved last year for the treatment of HIV in adults with no prior antiretroviral treatment history.

The FDA approval comes after a successful phase 3 DRIVE-SHIFT trial, which evaluated people’s viral responses upon switching to Delstrigo. All 670 of the participants were previously on a baseline antiretroviral regimen for at least six months before starting treatment with the three-drug combo (doraviring/lamivudine/tenofovir disoproxil fumarate).

Overall, participants who were already undetectable and switched to Delstrigo showed similar safety profiles to those newly diagnosed who had not been on ARTs previously.

“Thanks to developments in HIV science, more treatment options are becoming available to address the medical needs of people living with HIV,” said Dr. Princy Kumar, chief of Division of Infectious Diseases and Tropical Medicine at MedStar Georgetown University Hospital and Professor of Medicine and Microbiology, Georgetown University School of Medicine, Washington, D.C. “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.”

As stated by Merck, Pifeltro and Delstrigo can be co-administered with a wide range of non-antiretroviral agents, while Pifeltro can be co-administered with a wide range of antiretroviral agents.