US-based pharmaceutical company MSD has reported positive results from two Phase III trials of doravirine/islatravir (DOR/ISL), an oral treatment regimen being assessed in adults with virologically suppressed human immunodeficiency virus-1 (HIV-1).
The trials assessed the percentage of participants with HIV-1 RNA levels of 50 copies/mL or higher at week 48.
DOR/ISL proved to be non-inferior to the baseline antiretroviral therapy (bART) in the open-label MK-8591A-051 trial and to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in the double-blind MK-8591A-052 study.
The drug met the primary efficacy hypothesis in the adult populations of both trials, which also both met their primary safety objectives.
Despite this, it did not meet the MK-8591A-052 trial's superiority criteria.
MSD Research Laboratories global clinical development head, chief medical officer and senior vice-president Dr Eliav Barr said: “We are encouraged by the results from these Phase III trials evaluating a once-daily, oral, two-drug, single-tablet regimen of doravirine and islatravir.
“We are committed to advancing our clinical programmes for islatravir in combination with other antiretrovirals as potential options to help address the needs of people living with HIV.”
MSD is planning to submit the data from the trials to regulatory authorities for review in the future. Doravirine has already received approval in the US for the treatment of HIV-1 in the adult population in conjunction with other antiretrovirals.
Islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) that provides both transcriptase and translocation inhibition and delayed chain termination.
It is currently being evaluated in various clinical trials for the treatment of HIV-1, in combination with other antiretroviral therapies.
Additional ongoing Phase III trials for this two-drug, single-tablet regimen include MK-8591A-053, focusing on treatment-naïve individuals, and MK-8591A-054, which assesses DOR/ISL in subjects from earlier Phase III studies.
Earlier this month, MSD published outcomes from a Phase III trial of a potential combination therapy for ovarian cancer.
