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 |
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| 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., Kaiser, R., Woolley, I., Alberto Arnaiz, J., Cooper, D., Rockstroh, J. K., Mallon, P., Emery, S., Amin, Janaki, Belloso, Waldo, Clark, Andrew, Clarke, Amanda |
| بيانات النشر: | Wiley-Blackwell Publishing |
| سنة النشر: | 2018 |
| المجموعة: | The University of Queensland: UQ eSpace |
| مصطلحات موضوعية: | HIV-1, Maraviroc, Protease inhibitor, Switch, 2719 Health Policy, 2725 Infectious Diseases, 2736 Pharmacology (medical) |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1468-1293 1464-2662 |
| الإتاحة: | https://doi.org/10.1111/hiv.12532Test https://espace.library.uq.edu.au/view/UQ:705380Test |
| رقم الانضمام: | edsbas.AFA7DBDB |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 14681293 14642662 |
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