Merck & Co’s HIV drug meets Phase III trial endpoint
US pharma major Merck & Co (NYSE: MRK) has announced results from a pivotal Phase III trial evaluating the safety and efficacy of doravirine (MK-1439), its investigational non-nucleoside reverse transcriptase inhibitor, to treat the HIV-1 infection.
The study 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.
"The results of this study provide solid evidence of the efficacy and safety profile of doravirine as a potential treatment option for treatment-naïve HIV-1 patients"
This showed the non-inferiority of once-daily doravirine (DOR) to once-daily ritonavir-boosted darunavir (DRV+r), each administered with tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudine, in previously untreated adults with HIV-1 infection.
In addition, a secondary endpoint showed that the DOR-treated group had statistically significant lower levels of fasting low density lipoprotein cholesterol (LDL-C), versus the DRV+r group.
Findings from the ongoing DRIVE-FORWARD Phase III trial following 48 weeks of treatment were presented as a late-breaking abstract at this week’s Conference on Retroviruses and Opportunistic Infections in Seattle, USA.
Kathleen Squires, professor and director of infectious diseases at the USA’s Thomas Jefferson University, said: “Improved understanding of the biology of HIV and growing clinical evidence from current therapies are advancing the management of HIV infection.
“The results of this study provide solid evidence of the efficacy and safety profile of doravirine as a potential treatment option for treatment-naïve HIV-1 patients.”