Merck announced new clinical data from the Phase 3 DRIVE-AHEAD study that evaluated the investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), doravirine, for the treatment of HIV-1 infection at the 9th International Conference on HIV Science, in Paris, France.
In this study, the once-daily single tablet, fixed-dose combination of doravirine, lamivudine, and tenofovir disoproxil fumarate (TDF) met its primary efficacy endpoint of non-inferiority compared to the fixed-dose combination of efavirenz, emtricitabine, and TDF, in treatment-naive adults with HIV-1 infection (84% vs. 81%, respectively). Non-inferiority was assessed by the proportion of patients achieving HIV-1 RNA levels <50 copies/mL at Week 48.
Increases in mean CD4+ T-cell counts from baseline were 198 cells/mm3 for the doravirine group vs. 188 cells/mm3 for the efavirenz group. Efficacy was comparable between both treatment groups for patients with high viral load (HIV-1 RNA >100,000 copies/mL) at baseline. Of these patients, 81% in both treatment arms met the primary endpoint of <50 copies/mL of HIV-1 RNA.
There were statistically significantly fewer patients in the doravirine group who experienced pre-specified categories of neuropsychiatric events vs. patients in the comparator efavirenz arm through 48 weeks: dizziness (8.8% vs. 37.1%), sleep disorders/disturbances (12.1% vs. 25.5%), inability to think clearly or concentrate (4.4% vs. 8.2%). Patients in the doravirine arm also had a statistically significantly lower change from baseline in fasting LDL-C and non-HDL-C vs. the efavirenz arm at Week 48 (P<0.0001 for both cholesterol types).
The rate of drug-related adverse events was lower in the doravirine group vs. efavirenz group (31% vs. 63%). The incidence of treatment discontinuation due to adverse events was also lower in the doravirine group vs. efavirenz group (3% vs. 7%).
Doravirine is being investigated in other Phase 3 trials including DRIVE-AHEAD, DRIVE-FORWARD, and DRIVE-SHIFT.
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