Efficacy and safety of Efavirenz 400 mg-based regimens switching from 600 mg-based regimens in people living with HIV with virological suppression in China: a randomized, open-label, non-inferiority study

Abstract

BackgroundEfavirenz (EFV) 400 mg has been recommended to replace EFV 600 mg. There are only 200 mg and 600 mg dosage forms of EFV in China. Whether switching from one-tablet EFV 600 mg to two-tablet EFV 200 mg would weaken adherence or further affect efficacy or safety is unknown. MethodsVirologically suppressed people living with HIV with a regimen composed of one-tablet tenofovir (TDF), one-tablet lamivudine (3TC), and one-tablet EFV (600 mg) were randomized to continue original regimen or switch to two-tablet EFV (200 mg). Self-reported adherence questionnaires, 12-Item Short-Form Health Survey (SF-12), Hospital Anxiety and Depression Scale (HADS), and Pittsburgh Sleep Quality Index (PSQI) were used. Primary end point was the difference in proportions of participants with plasma HIV-RNA ≥ 50 copies/mL at week 48 with noninferiority margin of 4%. ResultsA total of 209 participants were randomized to the EFV 400 mg group and 211 to the EFV 600 mg. Primary end point result was −3.3% (95% CI −8.1–1.6). Further decrease of GGT (−3.1 vs. −0.3 U/L) and TC (−0.26 vs. 0.12 U/L) was observed in EFV 400 mg participants through 48 weeks. No significant changes in adherence, quality of life, and neuropsychologic condition were reported. ConclusionsEFV 400 mg was noninferior to EFV 600 mg and showed mild improvement of safety profile. Adherence was not weakened in patients taking EFV 400 mg. For patients taking EFV 600 mg with neuropsychologic symptoms, it would be better to switch to other drugs instead of EFV 400 mg.