FDA Approves Two New HIV Treatments

The FDA has approved two new drugs, both from Merck Research Laboratories, for the treatment of HIV: Pifeltro (doravirine), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be used in combination with other drugs in a treatment regimen, and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate), a three-drug, single-tablet regimen.

George Hanna, vice president and therapeutic area head of infectious diseases at Merck said in a press release: “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.”

Plus spoke to Dr. Carey Hwang, executive director of infectious diseases at Merck, who said of once-a-day HIV regimens like Delstrigo, "There are some studies which suggest better adherence with once-daily antiretroviral regimens compared to older regimens or multiple pill regimens."

Hwang also noted that “tolerability of a treatment plays an important role in adherence, as missed doses may lead to the development of viral drug resistance.”

One of the studies that served as the basis for the approval is known as DRIVE-AHEAD, which showed a statistically significant lower proportion of Delstrigo-treated participants compared to EFV-treated participants reported neuropsychiatric adverse events in the three pre-specified categories of dizziness (9 percent vs. 37 percent, treatment difference: -28.3 percent), sleep disorders and disturbances (12 percent versus 26 percent, treatment difference: -13.5 percent), and altered sensorium (4 percent versus 8 percent, treatment difference: -3.8 percent). Through 48 weeks of treatment, fewer Delstrigo-treated participants developed viral drug resistance compared to the EFV-treatment group.

Delstrigo and Pifeltro are indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience (TE). At this time, there are no data to support the use of Delstrigo and Pifeltro in TE patients. Pifeltro is being evaluated in a Phase 3 trial called DRIVE-SHIFT, a trial evaluating a switch to DOR/3TC/TDF in HIV-1 infected adults who are currently virologically suppressed on another antiretroviral regimen.