Merck Announces Positive Top-Line Results from Two Pivotal Phase 3 Trials of Doravirine/Islatravir, Demonstrating Non-Inferior Efficacy to Gilead's Biktarvy in HIV-1 Treatment
Oct 26, 2021 01:10
CST Updated
01:10
MSD
Pharmaceutical R&D and Manufacturer
October 25, 2021 /BioonBIOON/ -- Merck & Co. recently announced positive topline results from two pivotal Phase 3 trials. Conducted in adults living with HIV-1 who had achieved virologic suppression on various antiretroviral therapy (ART) regimens (ILLUMINATE SWITCH A trial) or Gilead’s triple-combination drug Biktarvy (BIC/FTC/TAF; ILLUMINATE SWITCH B trial), these two Phase 3 studies evaluated the efficacy and safety of a once-daily oral fixed-dose combination tablet of doravirine/islatravir (DOR/ISL).
The results showed that,At Week 48 of treatment, both trials met the primary efficacy endpoint (proportion of patients with HIV-1 RNA ≥50 copies/mL): demonstrating comparable antiviral efficacy between DOR/ISL and ART, and between DOR/ISL and Biktarvy.To date, the safety and tolerability profile of DOR/ISL during the trial has been consistent with that previously reported in the Phase 2 study.
Chemical structure of islatravir (MK-8591) (Image source: medchemexpress.cn)
Doravirine has been approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults: as a single agent (Pifeltro) and as a component of a single-tablet regimen (Delstrigo; DOR/3TC/TDF).
Islatravir is a novel oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) under development by MSD., for use in combination with other antiretroviral agents for the treatment of individuals living with HIV-1. Detailed results from these studies will be presented at future scientific congresses and will form the basis for global regulatory submissions.
Dr. Joan Butterton, Vice President of Global Clinical Development for Infectious Diseases at MSD Research Laboratories, stated: "MSD is committed to researching potential treatment options to help meet the changing needs of people living with HIV. We are encouraged by the results from the Phase 3 ILLUMINATE SWITCH A and B trials, which demonstrated that the efficacy of the DOR/ISL fixed-dose tablet is comparable to that of certain commonly used three-drug regimens. We will continue to investigate DOR/ISL in different populations of people living with HIV and look forward to sharing data from these trials." (Bioon.com)