• Ameet Dravid, Anant S Pilawan, Anuradha S, Dnyanesh N Morkar, John T Ramapuram, Kulkarni Milind Madhukarrao, K Sunil Naik, Milind Bhrusundi, Raveendra K R, Siddabathuni Nageswaramma, and Vinay Kulkarni.
• Department of Medicine, Poona Hospital and Research Centre, Maharashtra, India.
• Medicine (Baltimore). 2022 Dec 2; 101 (48): e31982e31982.

BackgroundTo evaluate the non-inferiority of low dose efavirenz (400 mg) to standard dose efavirenz (600 mg), when taken in combination with tenofovir and lamivudine in Indian patients with HIV-1 infection.MethodsAn open-label, interventional phase IV study with blinded assessment was conducted across 17 sites in India. HIV-1-infected antiretroviral therapy-naive adult patients (≥18 years of age) with a plasma HIV-1 viral load of at least 1000 copies per mL were randomized to receive either tenofovir/lamivudine/efavirenz (TLE) 400 or TLE 600. The primary endpoint was the difference in the proportion of patients achieving < 200 copies per mL at the end of 24 weeks.ResultsA total of 265 patients were enrolled and were randomized in 1:1 ratio to TLE 400 group (130 patients) and TLE 600 group (135 patients). At week 24, the proportion of patients with a viral load of less than 200 copies per mL was 80.70% for TLE 400 and 78.95% for TLE 600 (difference 1.75%, 90% confidence interval: -7.01, 10.49) which was within the predefined margin of -10% (90% confidence interval). Significantly lower study drug-related adverse events were observed in TLE 400 group compared to TLE 600 group (52.30%, n = 68 vs 64.92%, n = 87; P = .037). The treatment discontinuation percentage was marginally higher by 2.08% in TLE 600 group.ConclusionThe fixed-dose combination of TLE 400 is non-inferior to TLE 600 in terms of viral suppression and has an improved safety profile over 24 weeks in adult Indian patients with HIV-1 infection.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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