The U.S. Food and Drug Administration (FDA) has approved two supplemental new drug indications (sNDAs) for doravirine (Pifeltro) and doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo). This approval allows treatment-experienced adults living with HIV who are undetectable and have no history of treatment failure to switch to either treatment option. The approval was granted to Merck.
Doravirine is a 100 mg, once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI), and doravirine/lamivudine/tenofovir disoproxil fumarate is a once-daily fixed-dose combination tablet of 100 mg doravirine, 3TC/300 mg lamivudine, and TDF/300 mg tenofovir disoproxil fumarate. Both were first approved by the FDA in August 2018 for adult patients with no documented past antiretroviral therapy.
The FDA's decision was based on the results of the DRIVE-SHIFT study. The phase 3 trial evaluated switching to doravirine/lamivudine/tenofovir disoproxil fumarate compared with continuing a standard regimen of two nucleoside reverse transcriptase inhibitors plus a boosted protease inhibitor, either boosted elvitegravir or an NNRTI.
El estudio alcanzó su objetivo primario, demostrando una eficacia no inferior. Esto se midió por la proporción de participantes que cambiaron la terapia y tenían niveles plasmáticos de ARN del VIH-1 <50 copias / ml hasta la semana 48, en comparación con los participantes que continuaron su régimen inicial y tenían niveles de ARN del VIH-1 <50 copias / ml en la semana 24 .
The most common adverse reactions observed with doravirine/lamivudine/tenofovir disoproxil fumarate in clinical studies were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with doravirine were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (5%), abdominal pain (5%), and abnormal dreams (5%).
“Today’s approvals provide doravirine treatment options for people living with HIV-1 who are virus-suppressed, reflecting Merck’s ongoing commitment to HIV treatment research and development,” said George Hanna, MD, vice president and head of the Infectious Diseases Therapeutic Area, Global Clinical Development, Merck Research Laboratories, in the announcement. “We thank the researchers and the HIV community for their collaboration that made this possible.”
From: https://www.contagionlive.com/news/fda-approves-expanded-indications-for-2-hiv-therapies
September 20, 2019 | EDITORIAL STAFF CONTAGION ®