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HIV Med. 2018 Jan;19(1):65-71. doi: 10.1111/hiv.12532. Epub 2017 Jul 13.

Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study.

Collaborators (213)

Amin J, Belloso W, Clark A, Clarke A, Cooper D, Emery S, Fisher M, Gatell J, Gill J, Horban A, Kaiser R, Kelleher A, Losso M, Madero JS, Pett S, Prazuck T, Rockstroh J, Ruxrungtham K, Stellbrink J, Sugiura W, Wolff MJ, Woolley I, Merlin K, Yeung J, Fsadni B, Marks K, Suzuki K, Rismanto N, Salomon H, Rubio AE, Chibo D, Birch C, Harrigan R, Swenson L, Chan D, Berg T, Obermeier M, Schuelter E, Aragon SS, Luebke N, Coughlan S, Dean J, Iwatani Y, Teran GR, Avila S, Sirivichayakul S, Naphassanant M, Ubolyam S, Kaye S, Land S, Walker S, Haubrich R, DeJesus E, Silk D, Berthon-Jones N, Espinosa N, Courtney-Vega K, Absar N, Haskelberg H, Robson R, Donaldson A, Guelman D, Gambardella L, Valdovinos M, Arnaiz J, Beleta H, Ramos N, Targa M, Späth B, Boesecke C, Engelhardt A, Perry N, Beckthold B, Drummond F, Lefevre E, Corr S, Grant C, Lupo S, Peroni L, Sanchez M, De Paz Sierra M, Viloria G, Parlante A, Bissio E, Luchetti P, Confalonieri V, Warley E, Vieni I, Vilas C, Zarate A, Mayer G, Elliot J, Hagenauer M, Kelley M, Rowling D, Gibson A, Latch N, Tabrett C, Warzywoda E, MacRae K, Sinclair B, Sinn K, Bloch M, Franic T, Vincent T, Stewart N, Jayewardene A, Dwyer D, Kok J, Assam D, Taylor J, King P, Orth D, Youds D, Sowden D, Johnston C, Murray S, Hehir J, Wadham S, Donohue W, Thompson J, Garsia R, Turnham G, Madden T, Nvene J, Gillies A, Bryant M, Walmsley S, Chan W, LeBlanc R, Lanteigne F, Mouawad R, Rahal I, Guber S, Ozturk S, Smith G, Halpenny R, Reko T, Hills JR, Wolff M, Allendes G, Hocqueloux FL, Stephan C, Ebeling F, Spath B, Jensen BO, Feind C, Meyer-Olson D, Stoll M, Hoeper K, Beider R, Faetkenheur G, Thomas E, Baumgarten A, Ingiliz P, Wienbreyer A, Behrendt D, Nienkarken T, Jessen H, Zedlack C, Mallon P, Simelane S, Assmann J, Ghavami-Kia B, Imahashi M, Tanabe K, Yokomaku Y, Imamura J, de Oca MM, Gonzalez L, Ponce D, Mendoza A, Sierra-Madero J, Hernandez JES, Ballesteros EJR, Del Moral Ponce S, Horban A, Ignatowska A, Bakowska E, Pulik P, Sanz-Moreno J, Paredes R, Puig J, Domingo P, Gutierrez M, González-Cordón A, Callau P, Aldeguer JL, Tovar SC, Noval ML, Rivas I, Delgado-Fernandez M, Arribas JR, Castro JM, Avihingsanon A, Maek-A-Nantawat W, Intasan J, Charoenporn W, Cuprasitrut T, Jaisomkom P, Pruksakaew K, Winston A, Mullaney S, Barbour L, Richardson C, Fox J, Murray T, Teague A, Leen C, Morris S, Satyajit D, Sandhu R, Tucker J.

Author information

1
The Kirby Institute, UNSW Australia, Sydney, NSW, Australia.
2
Institutes of Clinical Trials and Methodology, University College London, London, UK.
3
Clinical Research Group, Infection and Population Health, Institute for Global Health, University College London, London, UK.
4
Wojewodzki Szpital Zakazny Centre for AIDS therapy and Diagnosis, Warsaw, Poland.
5
Hospital Civil de Guadalajara "Fray Antonio Alcalde", Jalisco, Mexico.
6
Hospital General de Agudos J M Ramos Mejia, Buenos Aires, Argentina.
7
Fundación IBIS CICAL, Buenos Aires, Argentina.
8
Fundación IDEAA, Buenos Aires, Argentina.
9
Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran, Tlalpan, Mexico.
10
Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
11
St Vincent's Hospital, Sydney, NSW, Australia.
12
BC Centre for Excellence in HIV/AIDS, Vancouver, BC, Canada.
13
ViiV Healthcare Ltd, London, UK.
14
Nagoya Medical Centre, Nagoya, Japan.
15
Fundacion Arriaran, Santiago, Chile.
16
Southern Alberta Clinic, Calgary, AB, Canada.
17
Hospital Clinic de Barcelona, Barcelona, Spain.
18
Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.
19
HIV-NAT, Thai Red Cross AIDS Research Center.
20
Chulalongkorn University, Bangkok, Thailand.
21
Orleans Hospital (CHR Orleans La Source), Orleans, France.
22
Institut für Virologie, Cologne, Germany.
23
Monash Medical Centre and Monash University, Melbourne, Vic, Australia.
24
Fundacion Clinic Spain CTU, Barcelona, Spain.
25
Department of Medicine I, University Hospital Bonn, Bonn, Germany.
26
School of Medicine, University College Dublin, Dublin, Ireland.
27
Faculty of Medicine, The University of Queensland, Brisbane, Qld, Australia.

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.

KEYWORDS:

HIV-1; maraviroc; protease inhibitor; switch

PMID:
28703491
DOI:
10.1111/hiv.12532
[Indexed for MEDLINE]

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