Efficacy and safety of lower-dose tenofovir disoproxil fumarate and efavirenz versus standard dose in HIV-infected, antiretroviral-naive adults: a multicenter, randomized, noninferiority trial.
2020
Introduction: Reduced doses of antiretroviral (ARV) drugs may lower toxicity while preserving efficacy. We aimed to evaluate the efficacy of reduced doses of both tenofovir disoproxil fumarate (TDF) and efavirenz compared with standard doses for the treatment of HIV-1 infection in antiretroviral-naive adults.Methods: In this open-label, non-inferiority trial, HIV-1-infected antiretroviral-naive adults from 3 centers in China were randomly assigned to receive either a lower dose anti-retroviral regimen comprised of TDF (200 mg), efavirenz (400 mg), and standard dose lamivudine (300 mg) or the standard dose regimen. The primary endpoint was the proportion of participants with HIV-1 RNA= 50 copies/mL at week 48 using a non-inferiority margin of -10%.Results: At week 48, 79 of 92 (85.9%) participants in the lower dose regimen group and 78 of 92 (84.8%) in the standard dose regimen group achieved HIV-1 RNA= 50 copies/mL (treatment difference 1.1%, 95% CI -9.1 to 11.3) in the intention-to-treat analysis. In the per-protocol population analysis, the treatment difference between the two groups was 0.1% (95%CI -7.1 to 7.3). Drug-related adverse events occurred more frequently in the participants receiving the standard dose regimen compared with the lower dose one (63.0% vs 80.4%). Changes in estimated glomerular filtration rate and bone mineral density at week 48 compared to baseline were comparable between the two groups.Conclusions: The non-inferior efficacy and better safety profile of the lower dose ARV regimen support its use as part of alternative initial therapy for patients with HIV-1 infection, especially when considering cost-saving.Clinical trial number: NCT02945163Trial registration: ClinicalTrials.gov identifier: NCT02945163..
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