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.”
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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.