مورد إلكتروني
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: | Beckthold B., Kaye S., Land S., Walker S., Haubrich R., DeJesus E., Berthon-Jones N., Espinosa N., Courtney-Vega K., Absar N., Haskelberg H., Robson R., Donaldson A., Guelman D., 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 J.R., Allendes G., Hocqueloux F.L., Stephan C., Ebeling F., Spath B., Jensen B.-E.O., 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., Simelane S., Assmann J., Ghavami-Kia B., Imahashi M., Tanabe K., Yokomaku Y., Imamura J., de Oca M.M., Gonzalez L., Ponce D., Mendoza A., Sierra-Madero J., Hernandez J.E.S., Ballesteros E.J.R., del Moral Ponce S., Ignatowska A., Bakowska E., Pulik P., Sanz-Moreno J., Paredes R., Puig J., Domingo P., Gutierrez M., Gonzalez-Cordon A., Callau P., Aldeguer J.L., Tovar S.C., Noval M.L., Rivas I., Delgado-Fernandez M., Arribas J.R., Castro J.M., 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., Pett S., 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.J., 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., Fisher M., Rockstroh J., Stellbrink J., Merlin K., Yeung J., Fsadni B., Marks K., Suzuki K., Rismanto N., Salomon H., Rubio A.E., Chibo D., Birch C., Swenson L., Chan D., Berg T., Obermeier M., Schuelter E., Aragon S.S., Luebke N., Coughlan S., Dean J., Iwatani Y., Teran G.R., Avila S., Sirivichayakul S., Naphassanant M., Ubolyam S., Gambardella L., Valdovinos M., Arnaiz J., Beleta H., Ramos N., Targa M., Boesecke C., Engelhardt A., Perry N., 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. |
| بيانات النشر: | Blackwell Publishing Ltd (E-mail: customerservices@oxonblackwellpublishing.com) United Kingdom 2017-12-19 |
| نوع الوثيقة: | Electronic Resource |
| 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. Method(s): 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. Result(s): 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. Conclusion(s): MVC as a switch for a PI/r is safe and effective at maintaining virological suppression while having significant lipid benefits over 96 weeks.Copyright © 2017 British H |
| مصطلحات الفهرس: | priority journal, randomized controlled trial, treatment duration, unspecified side effect/si [Side Effect], virology, virus load, abacavir/ct [Clinical Trial], abacavir/cb [Drug Combination], abacavir/cm [Drug Comparison], abacavir/dt [Drug Therapy], atazanavir/ct [Clinical Trial], atazanavir/cb [Drug Combination], cholesterol/ec [Endogenous Compound], lamivudine/ct [Clinical Trial], lamivudine/cb [Drug Combination], lamivudine/cm [Drug Comparison], lamivudine/dt [Drug Therapy], lopinavir/ct [Clinical Trial], lopinavir/cb [Drug Combination], lopinavir/dt [Drug Therapy], low density lipoprotein cholesterol/ec [Endogenous Compound], maraviroc/ae [Adverse Drug Reaction], maraviroc/ct [Clinical Trial], maraviroc/cb [Drug Combination], maraviroc/cm [Drug Comparison], maraviroc/dt [Drug Therapy], ritonavir/ct [Clinical Trial], ritonavir/cb [Drug Combination], ritonavir/cm [Drug Comparison], ritonavir/dt [Drug Therapy], triacylglycerol/ec [Endogenous Compound], virus RNA/ec [Endogenous Compound], atazanavir/dt [Drug Therapy], drug withdrawal, follow up, human, Human immunodeficiency virus 1, Human immunodeficiency virus 1 infection/dt [Drug Therapy], intention to treat analysis, kidney function, longitudinal study, major clinical study, multicenter study, outcome assessment, population, adult, adverse drug reaction, antiretroviral therapy, article, CD4 lymphocyte count, cholesterol blood level, clinical effectiveness, controlled study, drug efficacy, drug safety, drug substitution, Article |
| URL: | HIV Medicine Click here for full text options LibKey Link |
| الإتاحة: | Open access content. Open access content Copyright 2019 Elsevier B.V., All rights reserved. |
| أرقام أخرى: | AUSHL oai:repository.monashhealth.org:1/37141 HIV Medicine. 19 (1) (pp 65-71), 2018. Date of Publication: January 2018. 1464-2662 https://repository.monashhealth.org/monashhealthjspui/handle/1/37141 28703491 [http://www.ncbi.nlm.nih.gov/pubmed/?term=28703491] 617328463 (Pett, Amin, Tu, Silk, Kelleher, Cooper, Emery) The Kirby Institute, UNSW Australia, Sydney, NSW, Australia (Pett) Institutes of Clinical Trials and Methodology, University College London, London, United Kingdom (Pett) Clinical Research Group, Infection and Population Health, Institute for Global Health, University College London, London, United Kingdom (Horban) Wojewodzki Szpital Zakazny Centre for AIDS therapy and Diagnosis, Warsaw, Poland (Andrade-Villanueva) Hospital Civil de Guadalajara "Fray Antonio Alcalde", Jalisco, Mexico (Losso) Hospital General de Agudos J M Ramos Mejia, Buenos Aires, Argentina (Losso, Belloso) Fundacion IBIS CICAL, Buenos Aires, Argentina (Porteiro) Fundacion IDEAA, Buenos Aires, Argentina (Madero) Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Tlalpan, Mexico (Belloso) Hospital Italiano de Buenos Aires, Buenos Aires, Argentina (Kelleher, Cooper) St Vincent's Hospital, Sydney, NSW, Australia (Harrigan) BC Centre for Excellence in HIV/AIDS, Vancouver, BC, Canada (Clark) ViiV Healthcare Ltd, London, United Kingdom (Sugiura) Nagoya Medical Centre, Nagoya, Japan (Wolff) Fundacion Arriaran, Santiago, Chile (Gill) Southern Alberta Clinic, Calgary, AB, Canada (Gatell) Hospital Clinic de Barcelona, Barcelona, Spain (Clarke) Brighton & Sussex University Hospitals NHS Trust, Brighton, United Kingdom (Ruxrungtham) HIV-NAT, Thai Red Cross AIDS Research Center, Australia (Ruxrungtham) Chulalongkorn University, Bangkok, Thailand (Prazuck) Orleans Hospital (CHR Orleans La Source), Orleans, France (Kaiser) Institut fur Virologie, Cologne, Germany (Woolley) Monash Medical Centre and Monash University, Melbourne, Vic, Australia (Alberto Arnaiz) Fundacion Clinic Spain CTU, Barcelona, Spain (Rockstroh) Department of Medicine I, University Hospital Bonn, Bonn, Germany (Mallon) School of Medicine, University College Dublin, Dublin, Ireland (Emery) Faculty of Medicine, The University of Queensland, Brisbane, Qld, Australia Pett S.L.; spett@kirby.unsw.edu.au 1305133435 |
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