التفاصيل البيبلوغرافية
| العنوان: |
Week 96 results of the randomized, multicentre Maraviroc Switch ( MARCH) study. |
| المؤلفون: |
Pett, S. L., Amin, J., Horban, A., Andrade‐Villanueva, J., Losso, M., Porteiro, N., Madero, J. S., Belloso, W., Tu, E., Silk, D., Kelleher, A., Harrigan, R., Clark, A., Sugiura, W., Wolff, M., Gill, J., Gatell, J., Clarke, A., Ruxrungtham, K., Prazuck, T. |
| المصدر: |
HIV Medicine; Jan2018, Vol. 19 Issue 1, p65-71, 7p |
| مصطلحات موضوعية: |
CHOLESTEROL, CONFIDENCE intervals, HIV-positive persons, STATISTICAL sampling, TRIGLYCERIDES, RANDOMIZED controlled trials, MARAVIROC (Drug), DESCRIPTIVE statistics |
| مستخلص: |
Objectives The Maraviroc Switch ( MARCH) study week 48 data demonstrated that maraviroc, a chemokine receptor-5 (CCR5) inhibitor, was a safe and effective switch for the ritonavir-boosted protease inhibitor ( PI/r) component of a two nucleos(t)ide reverse transcriptase inhibitor [N(t) RTI] plus PI/r-based antiretroviral regimen in patients with R5-tropic virus. Here we report the durability of this finding. Methods MARCH, an international, multicentre, randomized, 96-week open-label switch study, enrolled HIV-1-infected adults with R5-tropic virus who were stable (> 24 weeks) and virologically suppressed [plasma viral load ( pVL) < 50 HIV-1 RNA copies/ mL]. Participants were randomized to continue their current PI/r-based regimen ( PI/r) or to switch to MVC plus two N(t) RTIs ( MVC) (1:2 randomization). The primary endpoint was the difference in the proportion with pVL < 200 copies/ mL at 96 weeks. The switch arm was defined as noninferior if the lower limit of the 95% confidence interval ( CI) for the difference was < −12% in the intention-to-treat ( ITT) population. Safety endpoints (the difference in the mean change from baseline or a comparison of proportions) were analysed as key secondary endpoints. Results Eighty-two ( PI/r) and 156 ( MVC) participants were randomized and included in the ITT analysis; 71 (87%) and 130 (83%) were in follow-up and on therapy at week 96. At week 96, 89.0% and 90.4% in the PI/r and MVC arms, respectively, had pVL < 50 copies/ mL (95% CI -6.6, 10.2). Moreover, in those switching away from PI/r, there were significant reductions in mean total cholesterol (differences 0.31 mmol/L; P = 0.02) and triglycerides (difference 0.44 mmol/L; P < 0.001). Changes in CD4 T-cell count, renal function, and serious and nonserious adverse events were similar in the two arms. Conclusions MVC as a switch for a PI/r is safe and effective at maintaining virological suppression while having significant lipid benefits over 96 weeks. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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