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

Author

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, Fisher, M, Rockstroh, J, Stellbrink, J, Merlin, K, Yeung, J, Fsadni, B, Marks, K, Suzuki, K, Rismanto, N, Salomon, H, Rubio, AE, Chibo, D, Birch, C, 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, 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, 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, Fisher, M, Rockstroh, J, Stellbrink, J, Merlin, K, Yeung, J, Fsadni, B, Marks, K, Suzuki, K, Rismanto, N, Salomon, H, Rubio, AE, Chibo, D, Birch, C, 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, 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, and Kelley, M

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.

Published
2018

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

Author

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., 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., and Latch N.

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. 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

Published
2017

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

Author

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., 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., and Latch N.

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. 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

Published
2017

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