Merck has reported positive results from a pivotal Phase III clinical trial of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine (MK-1439) for the treatment of patients with HIV-1 infection.
The trial met its primary efficacy endpoint of the proportion of participants achieving levels of HIV-1RNA less than 50 copies/mL after 48 weeks of treatment, indicating the non-inferiority of once-daily doravirine (DOR) to once-daily ritonavir-boosted darunavir (DRV+r), each administered with tenofovir disoproxil fumarate / emtricitabine (TDF / FTC) or abacavir / lamivudine (ABC / 3TC), in previously untreated (treatment-naïve) adults with HIV-1 infection.
The determination of the secondary endpoint indicated that the doravirine-treated group had comparitively statistically lower levels of fasting low-density lipoprotein cholesterol (LDL-C) against the DRV+r group.
Merck Research Laboratories clinical research associate vice-president George Hanna said: “Merck has been at the forefront of research into HIV for three decades.
“We are encouraged by these results, which provide additional insights into the efficacy and safety of doravirine.”
The multicentre, double-blind, randomised non-inferiority Phase III trial was conducted in 769 treatment-naïve adults with HIV-1 infection.
The trial also established secondary outcomes such as the effect of the drugs on fasting serum lipids and change from baseline in CD4+ T-cell count, and also evaluated the safety and tolerability.
The drug is being investigated further in Phase II studies as once-daily doravirine (DOR) with 3TC / TDF in treatment-naïve subjects with transmitted resistance to NNRTIs and in patients changing from efavirenz due to intolerability.
A Phase III trial will compare DOR / 3TC / TDF to efavirenz / FTC / TDF in treatment-naïve participants, while another study will evaluate a switch to DOR / 3TC / TDF in subjects who are currently virologically suppressed on another anti-retroviral regimen.
Image: HIV-1 virus. Photo: courtesy of J Roberto Trujillo/Wikipedia.