Efavirenz 400 vs 600 mg combined with lamivudine and tenofovir in treatment-naïve HIV-infected patients in China: A randomized, multi-centered, controlled trial.

In 30 seconds

This randomized controlled trial evaluated the efficacy and safety of efavirenz (EFV) 400 mg versus 600 mg, each combined with lamivudine and tenofovir, in treatment-naïve HIV-infected adults in China. At week 72, virological suppression was achieved in 86.5% of the 400 mg group compared to 84.1% in the 600 mg group, demonstrating noninferiority.

Key findings

• Virological suppression at week 72 was 86.5% for EFV 400 mg vs 84.1% for EFV 600 mg.
• The difference in virological suppression was +2.5 percentage points, meeting noninferiority criteria.
• The EFV 600 mg group had a significantly higher incidence of serious nonrash adverse events (P = 0.042).
• Drug discontinuation due to adverse events was 4.8% in the 600 mg group vs 1.9% in the 400 mg group.

Why it matters

Optimizing antiretroviral therapy dosing is crucial for minimizing adverse events while maintaining efficacy. This study supports the use of a lower efavirenz dose, which may enhance patient tolerability without compromising treatment outcomes.