Merck: Doravirine (MK-1439) is safe and effective, Phase 3 trials show

Merck & Co. (MRK) has announced positive results following Phase 3 clinical trials of its anti-HIV drug, doravirine (MK-1439). According to company officials, a 48-week test on previously untreated adults showed that the drug is safe and just as effective as a ritonavir-boosted Prezista regimen (also known as darunavir) when given in addition to standard two-drug antiretroviral regimens.

The trial compared the efficacy of two drug regimens, the first consisting of doravine and tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) and the second made up of ritonavir-boosted darunavir with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in previously untreated and treatment-naïve adults with HIV-1 infection.

Researchers said that, in comparison to some other antiretroviral drugs, doravirine is less likely to cause elevations in blood low-density lipoprotein cholesterol (LDL-c) levels, and that doravirine, which is similar to efavirenz, has a significantly better safety profile. Based on this information, there is potential for doravirine to become one of the leading antiretroviral medications used to treat HIV/AIDS in treatment-naïve HIV-1 patients. While HIV can typically be managed with existing antiretroviral therapies (ART), some have argued for the importance of developing new treatments with improved potency, dosing, tolerability, and effectiveness against drug-resistant HIV strains.