Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study. Issue 1 (13th July 2017)

• Record Type: Journal Article
• Authors: Pett, SL; Amin, J; Horban, A; Andrade‐Villanueva, J; Losso, M; Porteiro, N; Madero, JS; 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, JK; Mallon, P; Emery, S
• Other Names: Amin Janaki investigator.; Belloso Waldo investigator.; Clark Andrew investigator.; Clarke Amanda investigator.; Cooper David investigator.; Emery Sean investigator.; Fisher Martin investigator.; Gatell Jose investigator.; Gill John investigator.; Horban Andrejz investigator.; Kaiser Rolf investigator.; Kelleher Anthony investigator.; Losso Marcelo investigator.; Madero Juan Sierra investigator.; Pett Sarah investigator.; Prazuck Thierry investigator.; Rockstroh Juergen investigator.; Ruxrungtham Kiat investigator.; Stellbrink Jurgen investigator.; Sugiura Wataru investigator.; Wolff Marcelo J investigator.; Woolley Ian investigator.; Merlin Kate investigator.; Yeung Julie investigator.; Fsadni Bertha investigator.; Marks Kat investigator.; Suzuki Kazuo investigator.; Rismanto Nick investigator.; Salomon Horacio investigator.; Rubio Andrea E investigator.; Chibo Doris investigator.; Birch Chris investigator.; Harrigan Richard investigator.; Swenson Luke investigator.; Chan Dennison investigator.; Berg Thomas investigator.; Obermeier Martin investigator.; Schuelter Eugen investigator.; Aragon Saleta Sierra investigator.; Luebke Nadine investigator.; Coughlan Suzie investigator.; Dean Jonathan investigator.; Iwatani Yasumasa investigator.; Teran Gustavo Reyes investigator.; Avila Santiago investigator.; Sirivichayakul Sunee investigator.; Naphassanant May investigator.; Ubolyam Sasiwimol investigator.; Kaye Steve investigator.; Land Sally investigator.; Walker Sarah investigator.; Haubrich Richard investigator.; DeJesus Edwin investigator.; Silk David investigator.; Berthon‐Jones Nisha investigator.; Espinosa Natalie investigator.; Courtney‐Vega Kymme investigator.; Absar Noorul investigator.; Haskelberg Hila investigator.; Robson Rose investigator.; Donaldson Anna investigator.; Guelman Daniel investigator.; Gambardella Luciana investigator.; Valdovinos Mariana investigator.; Arnaiz Juan investigator.; Beleta Helena investigator.; Ramos Nuria investigator.; Targa Marta investigator.; Späth Brigitta investigator.; Boesecke Christoph investigator.; Engelhardt Angelika investigator.; Perry Nicky investigator.; Beckthold Brenda investigator.; Drummond Fraser investigator.; Lefevre Eric investigator.; Corr Sharon investigator.; Grant Carol investigator.; Lupo Sergio investigator.; Peroni Luciana investigator.; Sanchez Marisa investigator.; De Paz Sierra Mariana investigator.; Viloria Guillermo investigator.; Parlante Angel investigator.; Bissio Emiliano investigator.; Luchetti Pablo investigator.; Confalonieri Valeria investigator.; Warley Eduardo investigator.; Vieni Ines investigator.; Vilas Cecilia investigator.; Zarate Abel investigator.; Mayer Gabriela investigator.; Elliot Julian investigator.; Hagenauer Michelle investigator.; Kelley Mark investigator.; Rowling Diane investigator.; Gibson Abby investigator.; Latch Ngaire investigator.; Tabrett Chantal investigator.; Warzywoda Elizabeth investigator.; MacRae Karen investigator.; Sinclair Brett investigator.; Sinn Kate investigator.; Bloch Mark investigator.; Franic Teo investigator.; Vincent Trina investigator.; Stewart Natasha investigator.; Jayewardene Avindra investigator.; Dwyer Dominic investigator.; Kok Jennifer investigator.; Assam Delene investigator.; Taylor Janette investigator.; King Patricia investigator.; Orth David investigator.; Youds David investigator.; Sowden David investigator.; Johnston Colleen investigator.; Murray Suzanne investigator.; Hehir Jennifer investigator.; Wadham Samantha investigator.; Donohue William investigator.; Thompson Jill investigator.; Garsia Roger investigator.; Turnham Geoffrey investigator.; Madden Tracey investigator.; Nvene June investigator.; Gillies Ainsley investigator.; Bryant Mellissa investigator.; Walmsley Sharon investigator.; Chan Warmond investigator.; LeBlanc Roger investigator.; Lanteigne Francois investigator.; Mouawad Rima investigator.; Rahal Ines investigator.; Guber Sergio investigator.; Ozturk Sefika investigator.; Smith Graham investigator.; Halpenny Roberta investigator.; Reko Tatjana investigator.; Hills Jennifer Robinette investigator.; Wolff Marcelo investigator.; Allendes Gladys investigator.; Hocqueloux Francois Laurent investigator.; Stephan Christoph investigator.; Ebeling Franziska investigator.; Spath Brigitta investigator.; Jensen Bjorn‐Erik Ole investigator.; Feind Cecilie investigator.; Meyer‐Olson Dirk investigator.; Stoll Matthias investigator.; Hoeper Kirsten investigator.; Beider Renata investigator.; Faetkenheur Gerd investigator.; Thomas Ellen investigator.; Baumgarten Axel investigator.; Ingiliz Patrick investigator.; Wienbreyer Andreas investigator.; Behrendt Daniela investigator.; Nienkarken Tanja investigator.; Jessen Heiko investigator.; Zedlack Carmen investigator.; Mallon Paddy investigator.; Simelane Sibongile investigator.; Assmann Jennifer investigator.; Ghavami‐Kia Bijan investigator.; Imahashi Mayumi investigator.; Tanabe Kazue investigator.; Yokomaku Yoshiyuki investigator.; Imamura Junji investigator.; de Oca Melva Montes investigator.; Gonzalez Lucero investigator.; Ponce David investigator.; Mendoza Andrea investigator.; Sierra‐Madero Juan investigator.; Hernandez Jesus Eduardo Sanchez investigator.; Ballesteros Eduardo Jaime Ruiz investigator.; del Moral Ponce Sergio investigator.; Horban Andrzej investigator.; Ignatowska Anna investigator.; Bakowska Elzbieta investigator.; Pulik Piotr investigator.; Sanz‐Moreno Jose investigator.; Paredes Roger investigator.; Puig Jordi investigator.; Domingo Pere investigator.; Gutierrez Mar investigator.; González‐Cordón Ana investigator.; Callau Pili investigator.; Aldeguer Jose Lopez investigator.; Tovar Sandra Cuellar investigator.; Noval Manuel Leal investigator.; Rivas Inmaculada investigator.; Delgado‐Fernandez Marcial investigator.; Arribas Jose Ramon investigator.; Castro Juan Miguel investigator.; Avihingsanon Anchalee investigator.; Maek‐a‐nantawat Wirach investigator.; Intasan Jintana investigator.; Charoenporn Walairat investigator.; Cuprasitrut Thidarat investigator.; Jaisomkom Pachuen investigator.; Pruksakaew Kanchana investigator.; Winston Alan investigator.; Mullaney Scott investigator.; Barbour Lisa investigator.; Richardson Celia investigator.; Fox Julie investigator.; Murray Tammy investigator.; Teague Al investigator.; Leen Clifford investigator.; Morris Shelia investigator.; Satyajit Das investigator.; Sandhu Rumun investigator.; Tucker James investigator.;
• Is Part Of: HIV medicine. Volume 19:Issue 1(2018)
• Page Start: 65
• Page End: 71
• Publication Date: 2017-07-13
• Subjects: HIV‐1 -- maraviroc -- protease inhibitor -- switch; HIV infections -- Treatment -- Periodicals; HIV-positive persons -- Periodicals; HIV infections -- Treatment -- Decision making -- Periodicals; 616.9792
• DOI: 10.1111/hiv.12532
• Languages: English
• ISSNs: 1464-2662

Abstract

Abstract : 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.