دورية أكاديمية
Week 96 results of the randomized, multicentre Maraviroc Switch ( MARCH) study.
| 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] |
| Copyright of HIV Medicine is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| قاعدة البيانات: | Complementary Index |
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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. 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