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SAN FRANCISCO—A combination single tablet once-a-day regimen of doravirine/lamivudine/tenofovir disoproxil fumarate demonstrated non-inferiority and no significant adverse events when compared with continuation of established antiretroviral therapy in adults infected with HIV-1, according to results of the DRIVE-SHIFT trial presented at IDWeek 2018, held October 3 to 7, 2018, in San Francisco, California.
Two prior phase 3 trials have shown doravirine, a new non-nucleoside reverse transcriptase inhibitor, to be efficacious in the treatment of adults with HIV-1. Researchers conducted an open-label, active/controlled, non-inferiority trial in adults with and virologic suppression of HIV-1 infection to evaluate the efficacy of a single-pill combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg vs continued established therapy. In addition, inclusion criteria were >6-month history of virologic suppression, HIV-1 viral load of <40 copies/mL, and no history of virologic failure or resistance to any of the aforementioned antiretroviral medications. Participants (n=670) were randomly assigned to start doravirine/lamivudine/tenofovir disoproxil on either day 1 (immediate switch group [ISG]; n=447) or after 24 weeks (delayed switch group [DSG]; n=223). The primary end point was the percentage of participants with HIV-1 viral load <50 copies/mL, the primary comparison between the ISG at 48 weeks, and DSG at 24 weeks.
At 24 weeks, 93.7% of individuals in the ISG and 94.6% of those in the DSG demonstrated a viral load of <50 copies/mL. Of note, 1.8% of each group had >50 viral copies/mL. At 48 weeks, 90.8% of the ISG, vs 94.6% of the DSG at 24 weeks maintained viral load of <50 copies/mL, demonstrating a difference of -3.8% (95% CI, -7.9% to .3%). A secondary outcome was that at 24 weeks, individuals in the ISG had significantly lower fasting low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol levels compared to individuals in the DSG (P<.0001). In addition, adverse events at 24 weeks were higher in the ISG vs the DSG, and most were mild in severity.
The study authors concluded that “a once daily single-tablet regimen of [doravirine/lamivudine/tenofovir disoproxil fumarate] demonstrated non-inferior efficacy and acceptable safety compared to continuing therapy, and is an option for maintaining viral suppression in patients considering a change in therapy.”
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Kumar P, Johnson M, Molina JM, et al. Switch to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) maintains virologic suppression through 48 weeks: results of the DRIVE-SHIFT trial. Poster presented at: IDWeek 2018; October 3-7, 2018; San Francisco, CA. Poster LB2.