Phase 3 data find doravirine safe, effective for HIV-1 treatment
Merck recently announced the results of a phase 3 clinical trial that found doravirine, an investigational non-nucleoside reverse transcriptase inhibitor, was noninferior to ritonavir-based darunavir for the treatment of HIV-1 infection.
Kathleen Squires, MD, professor and director of infectious disease at Thomas Jefferson University, presented the findings of this ongoing double blind, randomized trial, known as DRIVE-FORWARD, at the annual Conference on Retroviruses and Opportunistic Infections (CROI).
Following 48 weeks of treatment, the study met its primary efficacy and safety endpoint of the proportion of participants achieving levels of HIV-1RNA less than 50 copies/mL. These results confirmed the noninferiority of once-daily doravirine (DOR) to once-daily ritonavir-boosted darunavir (DRV+r), each in combination with either tenofovir disoproxil fumarate/emtricitable (TDF/FTC) or abacavir/lamivudine (ABC/3TC) in previously untreated adults with HIV-1 infection.
When taken in combination with TDF/FTC, DVR+r (800 mg) was 83.3% (321 of 383 participants), whereas DRV+r (100 mg) taken in combination with ABC/3TC was 79.9% (306 of 383 participants) with a treatment difference of 3.9 (95% CI; –1.6 to 9.4). Researchers observed 81.0% efficacy for DOR participants with baseline levels of HIV-1 RNA greater than 100,000 copies/mL compared with 76.4% for DRV+r (3.0; CI 95% –11.2 to 17.1).
The results showed that the DOR–treated group had statistically lower levels of fasting low-density lipoprotein cholesterol (LDL-C) compared with the DRV+r group. When investigators assessed the fasting serum blood lipids for the DOR and DRV+r treated groups, they found a significant difference in mean changes from baseline in the levels of LDL-C (–4.5 mg/dL compared with 9.9 mg/dL) and non–high–density lipoprotein cholesterol (–5.3 mg/dL compared with 13.8 mg/dL). Rates of adverse drug reactions, including diarrhea, headache, nausea and nasopharyngitis, were 31% for DOR and 32% for DRV+r.
“Improved understanding of the biology of HIV and growing clinical evidence from current therapies are advancing the management of HIV infection,” Squires said in the press release. “The results of this study provide solid evidence of the efficacy and safety profile of doravirine as a potential treatment option for treatment-naive HIV patients.” – by Savannah Demko
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