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SAN FRANCISCO — The week 96 results of the DRIVE-AHEAD phase 3 noninferiority trial (Clinical Trials identifier: NCT02403674) support noninferiority of doravirine to efavirenz in treatment naïve adults with HIV-1, according to data presented at IDWeek 2018, held October 3 to 7, 2018, in San Francisco, California.
DRIVE-AHEAD is a phase 3, multicenter, double-blind noninferiority trial in which 728 patients were randomly assigned to receive a fixed-dose regimen of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg daily or efavirenz 600 mg, emtricitabine 200 mg, and tenofovir disoproxil fumarate 300 mg daily for up to 96 weeks. Eligible participants were treatment-naive adults with HIV-1 and a pretreatment HIV-1 viral load ≥1000 copies/mL.
Doravirine demonstrated noninferior efficacy to efavirenz and favorable profiles for neuropsychiatric tolerability and lipid level at 48 weeks of treatment. At 96 weeks the efficacy end point of HIV-1 viral load <50 copies/mL was achieved by 77.5% of those treated with doravirine/lamivudine/tenofovir disoproxil fumarate and 73.6% of those treated with efavirenz/emtricitabine/tenofovir disoproxil fumarate (difference 3.8%, 95% CI -2.4, 10.0). Additional phenotypic resistance to doravirine between weeks 48 and 96 was not observed; however, 2 additional cases of resistance to efavirenz occurred in this time period. Symptoms such as dizziness, sleep disorders or disturbances, altered sensorium, and rash were less frequent in the doravirine group. Fasting low-density lipoprotein C cholesterol and non-high-density lipoprotein C cholesterol levels increased in the efavirenz group but not in the doravirine group. The change in total cholesterol/high-density lipoprotein C cholesterol ratio was similar.
Results at week 96 indicated that doravirine/lamivudine/tenofovir disoproxil fumarate was safe and well tolerated. The doravirine group also demonstrated fewer neuropsychiatric events and rash and a favorable lipid profile compared with those treated with efavirenz/emtricitabine/tenofovir disoproxil fumarate.
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Orkin C, Squires K, Molina JM, et al. Doravirine/lamivudine/tenofovir DF continues to be non-inferior to efavirenz/emtricitabine/tenofovir DF in treatment-naïve adults with HIV-1 infection: week 96 results of the DRIVE-AHEAD trial. Presented at: IDWeek 2018; October 3-7, 2018; San Francisco CA. Abstract LB1.