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

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, Cooper, David, Emery, Sean, Fisher, Martin, Gatell, Jose, Gill, John, Horban, Andrejz, Kaiser, Rolf, Kelleher, Anthony, Losso, Marcelo, Madero, Juan Sierra, Pett, Sarah, Prazuck, Thierry, Rockstroh, Juergen, Ruxrungtham, Kiat, Stellbrink, Jurgen, Sugiura, Wataru, Wolff, Marcelo J, Woolley, Ian, Merlin, Kate, Yeung, Julie, Fsadni, Bertha, Marks, Kat, Suzuki, Kazuo, Rismanto, Nick, Salomon, Horacio, Rubio, Andrea E, Chibo, Doris, Birch, Chris, Harrigan, Richard, Swenson, Luke, Chan, Dennison, Berg, Thomas, Obermeier, Martin, Schuelter, Eugen, Aragon, Saleta Sierra, Luebke, Nadine, Coughlan, Suzie, Dean, Jonathan, Iwatani, Yasumasa, Teran, Gustavo Reyes, Avila, Santiago, Sirivichayakul, Sunee, Naphassanant, May, Ubolyam, Sasiwimol, Kaye, Steve, Land, Sally, Walker, Sarah, Haubrich, Richard, DeJesus, Edwin, Silk, David, Berthon-Jones, Nisha, Espinosa, Natalie, Courtney-Vega, Kymme, Absar, Noorul, Haskelberg, Hila, Robson, Rose, Donaldson, Anna, Guelman, Daniel, Gambardella, Luciana, Valdovinos, Mariana, Arnaiz, Juan, Beleta, Helena, Ramos, Nuria, Targa, Marta, Späth, Brigitta, Boesecke, Christoph, Engelhardt, Angelika, Perry, Nicky, Beckthold, Brenda, Drummond, Fraser, Lefevre, Eric, Corr, Sharon, Grant, Carol, Lupo, Sergio, Peroni, Luciana, Sanchez, Marisa, De Paz Sierra, Mariana, Viloria, Guillermo, Parlante, Angel, Bissio, Emiliano, Luchetti, Pablo, Confalonieri, Valeria, Warley, Eduardo, Vieni, Ines, Vilas, Cecilia, Zarate, Abel, Mayer, Gabriela, Elliot, Julian, Hagenauer, Michelle, Kelley, Mark, Rowling, Diane, Gibson, Abby, Latch, Ngaire, Tabrett, Chantal, Warzywoda, Elizabeth, MacRae, Karen, Sinclair, Brett, Sinn, Kate, Bloch, Mark, Franic, Teo, Vincent, Trina, Stewart, Natasha, Jayewardene, Avindra, Dwyer, Dominic, Kok, Jennifer, Assam, Delene, Taylor, Janette, King, Patricia, Orth, David, Youds, David, Sowden, David, Johnston, Colleen, Murray, Suzanne, Hehir, Jennifer, Wadham, Samantha, Donohue, William, Thompson, Jill, Garsia, Roger, Turnham, Geoffrey, Madden, Tracey, Nvene, June, Gillies, Ainsley, Bryant, Mellissa, Walmsley, Sharon, Chan, Warmond, LeBlanc, Roger, Lanteigne, Francois, Mouawad, Rima, Rahal, Ines, Guber, Sergio, Ozturk, Sefika, Smith, Graham, Halpenny, Roberta, Reko, Tatjana, Hills, Jennifer Robinette, Wolff, Marcelo, Allendes, Gladys, Hocqueloux, Francois Laurent, Stephan, Christoph, Ebeling, Franziska, Spath, Brigitta, Jensen, Bjorn-Erik Ole, Feind, Cecilie, Meyer-Olson, Dirk, Stoll, Matthias, Hoeper, Kirsten, Beider, Renata, Faetkenheur, Gerd, Thomas, Ellen, Baumgarten, Axel, Ingiliz, Patrick, Wienbreyer, Andreas, Behrendt, Daniela, Nienkarken, Tanja, Jessen, Heiko, Zedlack, Carmen, Mallon, Paddy, Simelane, Sibongile, Assmann, Jennifer, Ghavami-Kia, Bijan, Imahashi, Mayumi, Tanabe, Kazue, Yokomaku, Yoshiyuki, Imamura, Junji, de Oca, Melva Montes, Gonzalez, Lucero, Ponce, David, Mendoza, Andrea, Sierra-Madero, Juan, Hernandez, Jesus Eduardo Sanchez, Ballesteros, Eduardo Jaime Ruiz, del Moral Ponce, Sergio, Horban, Andrzej, Ignatowska, Anna, Bakowska, Elzbieta, Pulik, Piotr, Sanz-Moreno, Jose, Paredes, Roger, Puig, Jordi, Domingo, Pere, Gutierrez, Mar, González-Cordón, Ana, Callau, Pili, Aldeguer, Jose Lopez, Tovar, Sandra Cuellar, Noval, Manuel Leal, Rivas, Inmaculada, Delgado-Fernandez, Marcial, Arribas, Jose Ramon, Castro, Juan Miguel, Avihingsanon, Anchalee, Maek-a-nantawat, Wirach, Intasan, Jintana, Charoenporn, Walairat, Cuprasitrut, Thidarat, Jaisomkom, Pachuen, Pruksakaew, Kanchana, Winston, Alan, Mullaney, Scott, Barbour, Lisa, Richardson, Celia, Fox, Julie, Murray, Tammy, Teague, Al, Leen, Clifford, Morris, Shelia, Satyajit, Das, Sandhu, Rumun and Tucker, James (2018) Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study. HIV Medicine, 19 1: 65-71. doi:10.1111/hiv.12532


Author 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
Cooper, David
Emery, Sean
Fisher, Martin
Gatell, Jose
Gill, John
Horban, Andrejz
Kaiser, Rolf
Kelleher, Anthony
Losso, Marcelo
Madero, Juan Sierra
Pett, Sarah
Prazuck, Thierry
Rockstroh, Juergen
Ruxrungtham, Kiat
Stellbrink, Jurgen
Sugiura, Wataru
Wolff, Marcelo J
Woolley, Ian
Merlin, Kate
Yeung, Julie
Fsadni, Bertha
Marks, Kat
Suzuki, Kazuo
Rismanto, Nick
Salomon, Horacio
Rubio, Andrea E
Chibo, Doris
Birch, Chris
Harrigan, Richard
Swenson, Luke
Chan, Dennison
Berg, Thomas
Obermeier, Martin
Schuelter, Eugen
Aragon, Saleta Sierra
Luebke, Nadine
Coughlan, Suzie
Dean, Jonathan
Iwatani, Yasumasa
Teran, Gustavo Reyes
Avila, Santiago
Sirivichayakul, Sunee
Naphassanant, May
Ubolyam, Sasiwimol
Kaye, Steve
Land, Sally
Walker, Sarah
Haubrich, Richard
DeJesus, Edwin
Silk, David
Berthon-Jones, Nisha
Espinosa, Natalie
Courtney-Vega, Kymme
Absar, Noorul
Haskelberg, Hila
Robson, Rose
Donaldson, Anna
Guelman, Daniel
Gambardella, Luciana
Valdovinos, Mariana
Arnaiz, Juan
Beleta, Helena
Ramos, Nuria
Targa, Marta
Späth, Brigitta
Boesecke, Christoph
Engelhardt, Angelika
Perry, Nicky
Beckthold, Brenda
Drummond, Fraser
Lefevre, Eric
Corr, Sharon
Grant, Carol
Lupo, Sergio
Peroni, Luciana
Sanchez, Marisa
De Paz Sierra, Mariana
Viloria, Guillermo
Parlante, Angel
Bissio, Emiliano
Luchetti, Pablo
Confalonieri, Valeria
Warley, Eduardo
Vieni, Ines
Vilas, Cecilia
Zarate, Abel
Mayer, Gabriela
Elliot, Julian
Hagenauer, Michelle
Kelley, Mark
Rowling, Diane
Gibson, Abby
Latch, Ngaire
Tabrett, Chantal
Warzywoda, Elizabeth
MacRae, Karen
Sinclair, Brett
Sinn, Kate
Bloch, Mark
Franic, Teo
Vincent, Trina
Stewart, Natasha
Jayewardene, Avindra
Dwyer, Dominic
Kok, Jennifer
Assam, Delene
Taylor, Janette
King, Patricia
Orth, David
Youds, David
Sowden, David
Johnston, Colleen
Murray, Suzanne
Hehir, Jennifer
Wadham, Samantha
Donohue, William
Thompson, Jill
Garsia, Roger
Turnham, Geoffrey
Madden, Tracey
Nvene, June
Gillies, Ainsley
Bryant, Mellissa
Walmsley, Sharon
Chan, Warmond
LeBlanc, Roger
Lanteigne, Francois
Mouawad, Rima
Rahal, Ines
Guber, Sergio
Ozturk, Sefika
Smith, Graham
Halpenny, Roberta
Reko, Tatjana
Hills, Jennifer Robinette
Wolff, Marcelo
Allendes, Gladys
Hocqueloux, Francois Laurent
Stephan, Christoph
Ebeling, Franziska
Spath, Brigitta
Jensen, Bjorn-Erik Ole
Feind, Cecilie
Meyer-Olson, Dirk
Stoll, Matthias
Hoeper, Kirsten
Beider, Renata
Faetkenheur, Gerd
Thomas, Ellen
Baumgarten, Axel
Ingiliz, Patrick
Wienbreyer, Andreas
Behrendt, Daniela
Nienkarken, Tanja
Jessen, Heiko
Zedlack, Carmen
Mallon, Paddy
Simelane, Sibongile
Assmann, Jennifer
Ghavami-Kia, Bijan
Imahashi, Mayumi
Tanabe, Kazue
Yokomaku, Yoshiyuki
Imamura, Junji
de Oca, Melva Montes
Gonzalez, Lucero
Ponce, David
Mendoza, Andrea
Sierra-Madero, Juan
Hernandez, Jesus Eduardo Sanchez
Ballesteros, Eduardo Jaime Ruiz
del Moral Ponce, Sergio
Horban, Andrzej
Ignatowska, Anna
Bakowska, Elzbieta
Pulik, Piotr
Sanz-Moreno, Jose
Paredes, Roger
Puig, Jordi
Domingo, Pere
Gutierrez, Mar
González-Cordón, Ana
Callau, Pili
Aldeguer, Jose Lopez
Tovar, Sandra Cuellar
Noval, Manuel Leal
Rivas, Inmaculada
Delgado-Fernandez, Marcial
Arribas, Jose Ramon
Castro, Juan Miguel
Avihingsanon, Anchalee
Maek-a-nantawat, Wirach
Intasan, Jintana
Charoenporn, Walairat
Cuprasitrut, Thidarat
Jaisomkom, Pachuen
Pruksakaew, Kanchana
Winston, Alan
Mullaney, Scott
Barbour, Lisa
Richardson, Celia
Fox, Julie
Murray, Tammy
Teague, Al
Leen, Clifford
Morris, Shelia
Satyajit, Das
Sandhu, Rumun
Tucker, James
Title Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study
Journal name HIV Medicine   Check publisher's open access policy
ISSN 1468-1293
1464-2662
Publication date 2018-01-01
Year available 2018
Sub-type Article (original research)
DOI 10.1111/hiv.12532
Open Access Status Not yet assessed
Volume 19
Issue 1
Start page 65
End page 71
Total pages 7
Place of publication Chichester, West Sussex, United Kingdom
Publisher Wiley-Blackwell Publishing
Language eng
Subject 2719 Health Policy
2725 Infectious Diseases
2736 Pharmacology (medical)
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.
Keyword HIV-1
Maraviroc
Protease inhibitor
Switch
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
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Created: Sun, 17 Dec 2017, 01:13:21 EST