Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study
作者： SL Pett , J Amin , A Horban , J Andrade‐Villanueva , M Losso
DOI: 10.1111/HIV.12532
关键词:
摘要: Objectives The Maraviroc Switch (MARCH) study week 48 data demonstrated that maraviroc, a chemokine receptor-5 (CCR5) inhibitor, was safe and effective switch for the ritonavir-boosted protease inhibitor (PI/r) component of two nucleos(t)ide reverse transcriptase [N(t)RTI] plus PI/r-based antiretroviral regimen in patients with R5-tropic virus. Here we report durability this finding. Methods MARCH, an international, multicentre, randomized, 96-week open-label study, enrolled HIV-1-infected adults virus who were stable (> 24 weeks) virologically suppressed [plasma viral load (pVL) < 50 HIV-1 RNA copies/mL]. Participants randomized to continue their current or MVC N(t)RTIs (MVC) (1:2 randomization). The primary endpoint difference proportion pVL 200 copies/mL at 96 weeks. arm defined as noninferior if lower limit 95% confidence interval (CI) −12% intention-to-treat (ITT) population. Safety endpoints (the mean change from baseline comparison proportions) analysed key secondary endpoints. Results Eighty-two 156 participants included ITT analysis; 71 (87%) 130 (83%) follow-up on therapy 96. At 96, 89.0% 90.4% PI/r arms, respectively, had (95% CI -6.6, 10.2). Moreover, those switching away PI/r, there significant reductions total cholesterol (differences 0.31 mmol/L; P = 0.02) triglycerides (difference 0.44 0.001). Changes CD4 T-cell count, renal function, serious nonserious adverse events similar arms. Conclusions MVC is maintaining virological suppression while having lipid benefits over
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