| Autor: |
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, Vinay, Kulkarni |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
Medicine. 101:e31982 |
| ISSN: |
1536-5964 |
| DOI: |
10.1097/md.0000000000031982 |
| Popis: |
To 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.An 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.A 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.The 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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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