Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the phase III randomized, double-blind ECHO and THRIVE trials

Mark Nelson, Gerardo Amaya, Nathan Clumeck, Clovis Arns da cunha, Dushyantha Jayaweera, Patrice Junod, Taisheng Li, Pablo Tebas, Marita Stevens, Annemie Buelens, Simon Vanveggel, Katia Boven, L. Abusamra, P. Cahn, H. E. Laplume, I. Cassetti, M. Ceriotto, M. D. Martins, A. Krolewiecki, L. Amarilis LugoR. Bolan, L. Bush, R. Corales, L. Crane, J. De Vente, M. Fischl, J. Gathe, R. Greenberg, K. Henry, D. Jayaweera, P. Kumar, J. Lalezari, J. Leider, R. Lubelchek, C. Martorell, K. Mounzer, C. Cohen, H. Olivet, R. Ortiz, F. Rhame, A. Roberts, P. Ruane, A. Scribner, S. Segal-Maurer, W. Short, L. Sloan, T. Wilkin, M. Wohlfeiler, B. Yangco, M. Bloch, J. Gold, J. Hoy, P. Martinez, D. Baker, R. Finlayson, N. Roth, A. Rieger, N. Vetter, R. Zangerle, C. A. Da Cunha, B. Grinsztejn, J. V. Madruga, J. H. Pilotto, D. Sampaio, C. R. Gonsalez, M. P. Lima, F. Rangel, A. Timerman, P. Junod, D. Kilby, A. Rachlis, S. Walmsley, M. Boissonnault, J. Brunetta, J. De Wet, J. Gill, K. Kasper, J. Macleod, J. Gerstoft, L. Mathiesen, C. Pedersen, L. Cotte, P. M. Girard, J. M. Molina, F. Raffi, D. Vittecoq, Y. Yazdanpanah, P. Yeni, F. Boue, C. Katlama, J. Reynes, M. Fisher, M. Nelson, C. Orkin, S. Taylor, M. Johnson, E. Wilkins, I. G. Williams, A. Winston, A. Lazzarin, P. Narciso, A. Orani, S. Rusconi, A. Antinori, G. Carosi, F. Mazzotta, G. Amaya, G. Reyes-Teran, J. Andrade-Villanueva, J. G. Sierra Madero, B. Rijnders, J. Santana, C. Zorrilla, F. Antunes, T. Branco, R. Sarmento, E. Castro, T. Eugenio, K. Mansinho, R. Marques, D. Duiculescu, L. Negrutiu, L. Prisacariu, V. Kulagin, E. Voronin, A. Yakovlev, N. Dushkina, A. Pronin, O. Tsibakova, E. Vinogradova, E. Baraldi, N. David, O. Ebrahim, E. Krantz, G. H. Latiff, D. Spencer, R. Wood, M. Botes, F. Conradie, J. Fourie, L. Mohapi, D. Petit, D. Steyn, J. R. Arribas, J. Portilla Sogorb, E. Ribera, I. Santos Gil, B. Clotet, F. Gutierrez, D. Podzamczer, V. Soriano, K. Westling, P. Chetchotisakd, T. Sirisanthana, S. Sungkanuparph, A. Vibhagool, K. Ruxrungtham, W. Techasathit, C. C. Hung, H. C. Lee, H. H. Lin, W. W. Wong, H. Albrecht, N. Bellos, D. Berger, C. Brinson, B. Casanas, R. Elion, J. Feinberg, T. File, J. Flamm, C. Hicks, S. Hodder, C. B. Hsiao, P. Kadlecik, H. Khanlou, C. Kinder, R. Liporace, C. Mayer, D. Mildvan, A. Mills, R. A. Myers, I. Nadeem, O. Osiyemi, M. Para, G. Pierone, B. Rashbaum, J. Rodriguez, M. Saag, J. Sampson, R. Samuel, M. Sension, P. Shalit, P. Tebas, W. Towner, A. Wilkin, J. Eron, D. Wohl, R. Colebunders, N. Clumeck, J. C. Goffard, F. Van Wanzeele, E. Van Wijngaerden, J. Ballesteros, R. Northland, C. Perez, L. Hongzhou, T. Li, W. Cai, H. Wu, X. Li, G. Herrera, K. Arastéh, S. Esser, G. Fätkenheuer, T. Lutz, R. Schmidt, D. Schuster, H. J. Stellbrink, N. Kumarasamy, P. Patil, A. Canton Martinez, A. Rodriguez-French, N. Sosa

Research output: Contribution to journalArticle

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Abstract

Objectives: The efficacy and hepatic safety of the non-nucleoside reverse transcriptase inhibitors rilpivirine (TMC278) and efavirenz were compared in treatment-naive, HIV-infected adults with concurrent hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in the pooled week 48 analysis of the Phase III, double-blind, randomized ECHO (NCT00540449) and THRIVE (NCT00543725) trials. Methods: Patients received 25 mg of rilpivirine once daily or 600 mg of efavirenz once daily, plus two nucleoside/nucleotide reverse transcriptase inhibitors. At screening, patients had alanine aminotransferase/aspartate aminotransferase levels ≤5× the upper limit of normal. HBV and HCV status was determined at baseline by HBV surface antigen, HCV antibody and HCV RNA testing. Results: HBV/HCV coinfection status was known for 670 patients in the rilpivirine group and 665 in the efavirenz group. At baseline, 49 rilpivirine and 63 efavirenz patients [112/1335 (8.4%)] were coinfected with either HBV [55/1357 (4.1%)] or HCV [57/1333 (4.3%)]. The safety analysis included all available data, including beyond week 48. Eight patients seroconverted during the study (rilpivirine: five; efavirenz: three). A higher proportion of patients achieved viral load <50 copies/mL (intent to treat, time to loss of virological response) in the subgroup without HBV/HCV coinfection (rilpivirine: 85.0%; efavirenz: 82.6%) than in the coinfected subgroup (rilpivirine: 73.5%; efavirenz: 79.4%) (rilpivirine, P = 0.04 and efavirenz, P = 0.49, Fisher's exact test). The incidence of hepatic adverse events (AEs) was low in both groups in the overall population (rilpivirine: 5.5% versus efavirenz: 6.6%) and was higher in HBV/HCV-coinfected patients than in those not coinfected (26.7% versus 4.1%, respectively). Conclusions: Hepatic AEs were more common and response rates lower in HBV/HCV-coinfected patients treated with rilpivirine or efavirenz than in those who were not coinfected.

Original languageEnglish
Article numberdks130
Pages (from-to)2020-2028
Number of pages9
JournalJournal of Antimicrobial Chemotherapy
Volume67
Issue number8
DOIs
StatePublished - Aug 1 2012

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Rilpivirine
efavirenz
Coinfection
Hepatitis B virus
Hepacivirus
HIV-1
Safety
Therapeutics
Reverse Transcriptase Inhibitors
Liver

Keywords

  • Efavirenz
  • HBV
  • HCV
  • Hepatic safety
  • Hepatitis
  • Non-nucleoside reverse transcriptase inhibitors
  • TMC278

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the phase III randomized, double-blind ECHO and THRIVE trials. / Nelson, Mark; Amaya, Gerardo; Clumeck, Nathan; Arns da cunha, Clovis; Jayaweera, Dushyantha; Junod, Patrice; Li, Taisheng; Tebas, Pablo; Stevens, Marita; Buelens, Annemie; Vanveggel, Simon; Boven, Katia; Abusamra, L.; Cahn, P.; Laplume, H. E.; Cassetti, I.; Ceriotto, M.; Martins, M. D.; Krolewiecki, A.; Amarilis Lugo, L.; Bolan, R.; Bush, L.; Corales, R.; Crane, L.; De Vente, J.; Fischl, M.; Gathe, J.; Greenberg, R.; Henry, K.; Jayaweera, D.; Kumar, P.; Lalezari, J.; Leider, J.; Lubelchek, R.; Martorell, C.; Mounzer, K.; Cohen, C.; Olivet, H.; Ortiz, R.; Rhame, F.; Roberts, A.; Ruane, P.; Scribner, A.; Segal-Maurer, S.; Short, W.; Sloan, L.; Wilkin, T.; Wohlfeiler, M.; Yangco, B.; Bloch, M.; Gold, J.; Hoy, J.; Martinez, P.; Baker, D.; Finlayson, R.; Roth, N.; Rieger, A.; Vetter, N.; Zangerle, R.; Da Cunha, C. A.; Grinsztejn, B.; Madruga, J. V.; Pilotto, J. H.; Sampaio, D.; Gonsalez, C. R.; Lima, M. P.; Rangel, F.; Timerman, A.; Junod, P.; Kilby, D.; Rachlis, A.; Walmsley, S.; Boissonnault, M.; Brunetta, J.; De Wet, J.; Gill, J.; Kasper, K.; Macleod, J.; Gerstoft, J.; Mathiesen, L.; Pedersen, C.; Cotte, L.; Girard, P. M.; Molina, J. M.; Raffi, F.; Vittecoq, D.; Yazdanpanah, Y.; Yeni, P.; Boue, F.; Katlama, C.; Reynes, J.; Fisher, M.; Nelson, M.; Orkin, C.; Taylor, S.; Johnson, M.; Wilkins, E.; Williams, I. G.; Winston, A.; Lazzarin, A.; Narciso, P.; Orani, A.; Rusconi, S.; Antinori, A.; Carosi, G.; Mazzotta, F.; Amaya, G.; Reyes-Teran, G.; Andrade-Villanueva, J.; Sierra Madero, J. G.; Rijnders, B.; Santana, J.; Zorrilla, C.; Antunes, F.; Branco, T.; Sarmento, R.; Castro, E.; Eugenio, T.; Mansinho, K.; Marques, R.; Duiculescu, D.; Negrutiu, L.; Prisacariu, L.; Kulagin, V.; Voronin, E.; Yakovlev, A.; Dushkina, N.; Pronin, A.; Tsibakova, O.; Vinogradova, E.; Baraldi, E.; David, N.; Ebrahim, O.; Krantz, E.; Latiff, G. H.; Spencer, D.; Wood, R.; Botes, M.; Conradie, F.; Fourie, J.; Mohapi, L.; Petit, D.; Steyn, D.; Arribas, J. R.; Portilla Sogorb, J.; Ribera, E.; Santos Gil, I.; Clotet, B.; Gutierrez, F.; Podzamczer, D.; Soriano, V.; Westling, K.; Chetchotisakd, P.; Sirisanthana, T.; Sungkanuparph, S.; Vibhagool, A.; Ruxrungtham, K.; Techasathit, W.; Hung, C. C.; Lee, H. C.; Lin, H. H.; Wong, W. W.; Albrecht, H.; Bellos, N.; Berger, D.; Brinson, C.; Casanas, B.; Elion, R.; Feinberg, J.; File, T.; Flamm, J.; Hicks, C.; Hodder, S.; Hsiao, C. B.; Kadlecik, P.; Khanlou, H.; Kinder, C.; Liporace, R.; Mayer, C.; Mildvan, D.; Mills, A.; Myers, R. A.; Nadeem, I.; Osiyemi, O.; Para, M.; Pierone, G.; Rashbaum, B.; Rodriguez, J.; Saag, M.; Sampson, J.; Samuel, R.; Sension, M.; Shalit, P.; Tebas, P.; Towner, W.; Wilkin, A.; Eron, J.; Wohl, D.; Colebunders, R.; Clumeck, N.; Goffard, J. C.; Van Wanzeele, F.; Van Wijngaerden, E.; Ballesteros, J.; Northland, R.; Perez, C.; Hongzhou, L.; Li, T.; Cai, W.; Wu, H.; Li, X.; Herrera, G.; Arastéh, K.; Esser, S.; Fätkenheuer, G.; Lutz, T.; Schmidt, R.; Schuster, D.; Stellbrink, H. J.; Kumarasamy, N.; Patil, P.; Canton Martinez, A.; Rodriguez-French, A.; Sosa, N.

In: Journal of Antimicrobial Chemotherapy, Vol. 67, No. 8, dks130, 01.08.2012, p. 2020-2028.

Research output: Contribution to journalArticle

Nelson, M, Amaya, G, Clumeck, N, Arns da cunha, C, Jayaweera, D, Junod, P, Li, T, Tebas, P, Stevens, M, Buelens, A, Vanveggel, S, Boven, K, Abusamra, L, Cahn, P, Laplume, HE, Cassetti, I, Ceriotto, M, Martins, MD, Krolewiecki, A, Amarilis Lugo, L, Bolan, R, Bush, L, Corales, R, Crane, L, De Vente, J, Fischl, M, Gathe, J, Greenberg, R, Henry, K, Jayaweera, D, Kumar, P, Lalezari, J, Leider, J, Lubelchek, R, Martorell, C, Mounzer, K, Cohen, C, Olivet, H, Ortiz, R, Rhame, F, Roberts, A, Ruane, P, Scribner, A, Segal-Maurer, S, Short, W, Sloan, L, Wilkin, T, Wohlfeiler, M, Yangco, B, Bloch, M, Gold, J, Hoy, J, Martinez, P, Baker, D, Finlayson, R, Roth, N, Rieger, A, Vetter, N, Zangerle, R, Da Cunha, CA, Grinsztejn, B, Madruga, JV, Pilotto, JH, Sampaio, D, Gonsalez, CR, Lima, MP, Rangel, F, Timerman, A, Junod, P, Kilby, D, Rachlis, A, Walmsley, S, Boissonnault, M, Brunetta, J, De Wet, J, Gill, J, Kasper, K, Macleod, J, Gerstoft, J, Mathiesen, L, Pedersen, C, Cotte, L, Girard, PM, Molina, JM, Raffi, F, Vittecoq, D, Yazdanpanah, Y, Yeni, P, Boue, F, Katlama, C, Reynes, J, Fisher, M, Nelson, M, Orkin, C, Taylor, S, Johnson, M, Wilkins, E, Williams, IG, Winston, A, Lazzarin, A, Narciso, P, Orani, A, Rusconi, S, Antinori, A, Carosi, G, Mazzotta, F, Amaya, G, Reyes-Teran, G, Andrade-Villanueva, J, Sierra Madero, JG, Rijnders, B, Santana, J, Zorrilla, C, Antunes, F, Branco, T, Sarmento, R, Castro, E, Eugenio, T, Mansinho, K, Marques, R, Duiculescu, D, Negrutiu, L, Prisacariu, L, Kulagin, V, Voronin, E, Yakovlev, A, Dushkina, N, Pronin, A, Tsibakova, O, Vinogradova, E, Baraldi, E, David, N, Ebrahim, O, Krantz, E, Latiff, GH, Spencer, D, Wood, R, Botes, M, Conradie, F, Fourie, J, Mohapi, L, Petit, D, Steyn, D, Arribas, JR, Portilla Sogorb, J, Ribera, E, Santos Gil, I, Clotet, B, Gutierrez, F, Podzamczer, D, Soriano, V, Westling, K, Chetchotisakd, P, Sirisanthana, T, Sungkanuparph, S, Vibhagool, A, Ruxrungtham, K, Techasathit, W, Hung, CC, Lee, HC, Lin, HH, Wong, WW, Albrecht, H, Bellos, N, Berger, D, Brinson, C, Casanas, B, Elion, R, Feinberg, J, File, T, Flamm, J, Hicks, C, Hodder, S, Hsiao, CB, Kadlecik, P, Khanlou, H, Kinder, C, Liporace, R, Mayer, C, Mildvan, D, Mills, A, Myers, RA, Nadeem, I, Osiyemi, O, Para, M, Pierone, G, Rashbaum, B, Rodriguez, J, Saag, M, Sampson, J, Samuel, R, Sension, M, Shalit, P, Tebas, P, Towner, W, Wilkin, A, Eron, J, Wohl, D, Colebunders, R, Clumeck, N, Goffard, JC, Van Wanzeele, F, Van Wijngaerden, E, Ballesteros, J, Northland, R, Perez, C, Hongzhou, L, Li, T, Cai, W, Wu, H, Li, X, Herrera, G, Arastéh, K, Esser, S, Fätkenheuer, G, Lutz, T, Schmidt, R, Schuster, D, Stellbrink, HJ, Kumarasamy, N, Patil, P, Canton Martinez, A, Rodriguez-French, A & Sosa, N 2012, 'Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the phase III randomized, double-blind ECHO and THRIVE trials', Journal of Antimicrobial Chemotherapy, vol. 67, no. 8, dks130, pp. 2020-2028. https://doi.org/10.1093/jac/dks130
Nelson, Mark ; Amaya, Gerardo ; Clumeck, Nathan ; Arns da cunha, Clovis ; Jayaweera, Dushyantha ; Junod, Patrice ; Li, Taisheng ; Tebas, Pablo ; Stevens, Marita ; Buelens, Annemie ; Vanveggel, Simon ; Boven, Katia ; Abusamra, L. ; Cahn, P. ; Laplume, H. E. ; Cassetti, I. ; Ceriotto, M. ; Martins, M. D. ; Krolewiecki, A. ; Amarilis Lugo, L. ; Bolan, R. ; Bush, L. ; Corales, R. ; Crane, L. ; De Vente, J. ; Fischl, M. ; Gathe, J. ; Greenberg, R. ; Henry, K. ; Jayaweera, D. ; Kumar, P. ; Lalezari, J. ; Leider, J. ; Lubelchek, R. ; Martorell, C. ; Mounzer, K. ; Cohen, C. ; Olivet, H. ; Ortiz, R. ; Rhame, F. ; Roberts, A. ; Ruane, P. ; Scribner, A. ; Segal-Maurer, S. ; Short, W. ; Sloan, L. ; Wilkin, T. ; Wohlfeiler, M. ; Yangco, B. ; Bloch, M. ; Gold, J. ; Hoy, J. ; Martinez, P. ; Baker, D. ; Finlayson, R. ; Roth, N. ; Rieger, A. ; Vetter, N. ; Zangerle, R. ; Da Cunha, C. A. ; Grinsztejn, B. ; Madruga, J. V. ; Pilotto, J. H. ; Sampaio, D. ; Gonsalez, C. R. ; Lima, M. P. ; Rangel, F. ; Timerman, A. ; Junod, P. ; Kilby, D. ; Rachlis, A. ; Walmsley, S. ; Boissonnault, M. ; Brunetta, J. ; De Wet, J. ; Gill, J. ; Kasper, K. ; Macleod, J. ; Gerstoft, J. ; Mathiesen, L. ; Pedersen, C. ; Cotte, L. ; Girard, P. M. ; Molina, J. M. ; Raffi, F. ; Vittecoq, D. ; Yazdanpanah, Y. ; Yeni, P. ; Boue, F. ; Katlama, C. ; Reynes, J. ; Fisher, M. ; Nelson, M. ; Orkin, C. ; Taylor, S. ; Johnson, M. ; Wilkins, E. ; Williams, I. G. ; Winston, A. ; Lazzarin, A. ; Narciso, P. ; Orani, A. ; Rusconi, S. ; Antinori, A. ; Carosi, G. ; Mazzotta, F. ; Amaya, G. ; Reyes-Teran, G. ; Andrade-Villanueva, J. ; Sierra Madero, J. G. ; Rijnders, B. ; Santana, J. ; Zorrilla, C. ; Antunes, F. ; Branco, T. ; Sarmento, R. ; Castro, E. ; Eugenio, T. ; Mansinho, K. ; Marques, R. ; Duiculescu, D. ; Negrutiu, L. ; Prisacariu, L. ; Kulagin, V. ; Voronin, E. ; Yakovlev, A. ; Dushkina, N. ; Pronin, A. ; Tsibakova, O. ; Vinogradova, E. ; Baraldi, E. ; David, N. ; Ebrahim, O. ; Krantz, E. ; Latiff, G. H. ; Spencer, D. ; Wood, R. ; Botes, M. ; Conradie, F. ; Fourie, J. ; Mohapi, L. ; Petit, D. ; Steyn, D. ; Arribas, J. R. ; Portilla Sogorb, J. ; Ribera, E. ; Santos Gil, I. ; Clotet, B. ; Gutierrez, F. ; Podzamczer, D. ; Soriano, V. ; Westling, K. ; Chetchotisakd, P. ; Sirisanthana, T. ; Sungkanuparph, S. ; Vibhagool, A. ; Ruxrungtham, K. ; Techasathit, W. ; Hung, C. C. ; Lee, H. C. ; Lin, H. H. ; Wong, W. W. ; Albrecht, H. ; Bellos, N. ; Berger, D. ; Brinson, C. ; Casanas, B. ; Elion, R. ; Feinberg, J. ; File, T. ; Flamm, J. ; Hicks, C. ; Hodder, S. ; Hsiao, C. B. ; Kadlecik, P. ; Khanlou, H. ; Kinder, C. ; Liporace, R. ; Mayer, C. ; Mildvan, D. ; Mills, A. ; Myers, R. A. ; Nadeem, I. ; Osiyemi, O. ; Para, M. ; Pierone, G. ; Rashbaum, B. ; Rodriguez, J. ; Saag, M. ; Sampson, J. ; Samuel, R. ; Sension, M. ; Shalit, P. ; Tebas, P. ; Towner, W. ; Wilkin, A. ; Eron, J. ; Wohl, D. ; Colebunders, R. ; Clumeck, N. ; Goffard, J. C. ; Van Wanzeele, F. ; Van Wijngaerden, E. ; Ballesteros, J. ; Northland, R. ; Perez, C. ; Hongzhou, L. ; Li, T. ; Cai, W. ; Wu, H. ; Li, X. ; Herrera, G. ; Arastéh, K. ; Esser, S. ; Fätkenheuer, G. ; Lutz, T. ; Schmidt, R. ; Schuster, D. ; Stellbrink, H. J. ; Kumarasamy, N. ; Patil, P. ; Canton Martinez, A. ; Rodriguez-French, A. ; Sosa, N. / Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the phase III randomized, double-blind ECHO and THRIVE trials. In: Journal of Antimicrobial Chemotherapy. 2012 ; Vol. 67, No. 8. pp. 2020-2028.
@article{03224fa191f5405eb29be263a0faf95f,
title = "Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the phase III randomized, double-blind ECHO and THRIVE trials",
abstract = "Objectives: The efficacy and hepatic safety of the non-nucleoside reverse transcriptase inhibitors rilpivirine (TMC278) and efavirenz were compared in treatment-naive, HIV-infected adults with concurrent hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in the pooled week 48 analysis of the Phase III, double-blind, randomized ECHO (NCT00540449) and THRIVE (NCT00543725) trials. Methods: Patients received 25 mg of rilpivirine once daily or 600 mg of efavirenz once daily, plus two nucleoside/nucleotide reverse transcriptase inhibitors. At screening, patients had alanine aminotransferase/aspartate aminotransferase levels ≤5× the upper limit of normal. HBV and HCV status was determined at baseline by HBV surface antigen, HCV antibody and HCV RNA testing. Results: HBV/HCV coinfection status was known for 670 patients in the rilpivirine group and 665 in the efavirenz group. At baseline, 49 rilpivirine and 63 efavirenz patients [112/1335 (8.4{\%})] were coinfected with either HBV [55/1357 (4.1{\%})] or HCV [57/1333 (4.3{\%})]. The safety analysis included all available data, including beyond week 48. Eight patients seroconverted during the study (rilpivirine: five; efavirenz: three). A higher proportion of patients achieved viral load <50 copies/mL (intent to treat, time to loss of virological response) in the subgroup without HBV/HCV coinfection (rilpivirine: 85.0{\%}; efavirenz: 82.6{\%}) than in the coinfected subgroup (rilpivirine: 73.5{\%}; efavirenz: 79.4{\%}) (rilpivirine, P = 0.04 and efavirenz, P = 0.49, Fisher's exact test). The incidence of hepatic adverse events (AEs) was low in both groups in the overall population (rilpivirine: 5.5{\%} versus efavirenz: 6.6{\%}) and was higher in HBV/HCV-coinfected patients than in those not coinfected (26.7{\%} versus 4.1{\%}, respectively). Conclusions: Hepatic AEs were more common and response rates lower in HBV/HCV-coinfected patients treated with rilpivirine or efavirenz than in those who were not coinfected.",
keywords = "Efavirenz, HBV, HCV, Hepatic safety, Hepatitis, Non-nucleoside reverse transcriptase inhibitors, TMC278",
author = "Mark Nelson and Gerardo Amaya and Nathan Clumeck and {Arns da cunha}, Clovis and Dushyantha Jayaweera and Patrice Junod and Taisheng Li and Pablo Tebas and Marita Stevens and Annemie Buelens and Simon Vanveggel and Katia Boven and L. Abusamra and P. Cahn and Laplume, {H. E.} and I. Cassetti and M. Ceriotto and Martins, {M. D.} and A. Krolewiecki and {Amarilis Lugo}, L. and R. Bolan and L. Bush and R. Corales and L. Crane and {De Vente}, J. and M. Fischl and J. Gathe and R. Greenberg and K. Henry and D. Jayaweera and P. Kumar and J. Lalezari and J. Leider and R. Lubelchek and C. Martorell and K. Mounzer and C. Cohen and H. Olivet and R. Ortiz and F. Rhame and A. Roberts and P. Ruane and A. Scribner and S. Segal-Maurer and W. Short and L. Sloan and T. Wilkin and M. Wohlfeiler and B. Yangco and M. Bloch and J. Gold and J. Hoy and P. Martinez and D. Baker and R. Finlayson and N. Roth and A. Rieger and N. Vetter and R. Zangerle and {Da Cunha}, {C. A.} and B. Grinsztejn and Madruga, {J. V.} and Pilotto, {J. H.} and D. Sampaio and Gonsalez, {C. R.} and Lima, {M. P.} and F. Rangel and A. Timerman and P. Junod and D. Kilby and A. Rachlis and S. Walmsley and M. Boissonnault and J. Brunetta and {De Wet}, J. and J. Gill and K. Kasper and J. Macleod and J. Gerstoft and L. Mathiesen and C. Pedersen and L. Cotte and Girard, {P. M.} and Molina, {J. M.} and F. Raffi and D. Vittecoq and Y. Yazdanpanah and P. Yeni and F. Boue and C. Katlama and J. Reynes and M. Fisher and M. Nelson and C. Orkin and S. Taylor and M. Johnson and E. Wilkins and Williams, {I. G.} and A. Winston and A. Lazzarin and P. Narciso and A. Orani and S. Rusconi and A. Antinori and G. Carosi and F. Mazzotta and G. Amaya and G. Reyes-Teran and J. Andrade-Villanueva and {Sierra Madero}, {J. G.} and B. Rijnders and J. Santana and C. Zorrilla and F. Antunes and T. Branco and R. Sarmento and E. Castro and T. Eugenio and K. Mansinho and R. Marques and D. Duiculescu and L. Negrutiu and L. Prisacariu and V. Kulagin and E. Voronin and A. Yakovlev and N. Dushkina and A. Pronin and O. Tsibakova and E. Vinogradova and E. Baraldi and N. David and O. Ebrahim and E. Krantz and Latiff, {G. H.} and D. Spencer and R. Wood and M. Botes and F. Conradie and J. Fourie and L. Mohapi and D. Petit and D. Steyn and Arribas, {J. R.} and {Portilla Sogorb}, J. and E. Ribera and {Santos Gil}, I. and B. Clotet and F. Gutierrez and D. Podzamczer and V. Soriano and K. Westling and P. Chetchotisakd and T. Sirisanthana and S. Sungkanuparph and A. Vibhagool and K. Ruxrungtham and W. Techasathit and Hung, {C. C.} and Lee, {H. C.} and Lin, {H. H.} and Wong, {W. W.} and H. Albrecht and N. Bellos and D. Berger and C. Brinson and B. Casanas and R. Elion and J. Feinberg and T. File and J. Flamm and C. Hicks and S. Hodder and Hsiao, {C. B.} and P. Kadlecik and H. Khanlou and C. Kinder and R. Liporace and C. Mayer and D. Mildvan and A. Mills and Myers, {R. A.} and I. Nadeem and O. Osiyemi and M. Para and G. Pierone and B. Rashbaum and J. Rodriguez and M. Saag and J. Sampson and R. Samuel and M. Sension and P. Shalit and P. Tebas and W. Towner and A. Wilkin and J. Eron and D. Wohl and R. Colebunders and N. Clumeck and Goffard, {J. C.} and {Van Wanzeele}, F. and {Van Wijngaerden}, E. and J. Ballesteros and R. Northland and C. Perez and L. Hongzhou and T. Li and W. Cai and H. Wu and X. Li and G. Herrera and K. Arast{\'e}h and S. Esser and G. F{\"a}tkenheuer and T. Lutz and R. Schmidt and D. Schuster and Stellbrink, {H. J.} and N. Kumarasamy and P. Patil and {Canton Martinez}, A. and A. Rodriguez-French and N. Sosa",
year = "2012",
month = "8",
day = "1",
doi = "10.1093/jac/dks130",
language = "English",
volume = "67",
pages = "2020--2028",
journal = "Journal of Antimicrobial Chemotherapy",
issn = "0305-7453",
publisher = "Oxford University Press",
number = "8",

}

TY - JOUR

T1 - Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the phase III randomized, double-blind ECHO and THRIVE trials

AU - Nelson, Mark

AU - Amaya, Gerardo

AU - Clumeck, Nathan

AU - Arns da cunha, Clovis

AU - Jayaweera, Dushyantha

AU - Junod, Patrice

AU - Li, Taisheng

AU - Tebas, Pablo

AU - Stevens, Marita

AU - Buelens, Annemie

AU - Vanveggel, Simon

AU - Boven, Katia

AU - Abusamra, L.

AU - Cahn, P.

AU - Laplume, H. E.

AU - Cassetti, I.

AU - Ceriotto, M.

AU - Martins, M. D.

AU - Krolewiecki, A.

AU - Amarilis Lugo, L.

AU - Bolan, R.

AU - Bush, L.

AU - Corales, R.

AU - Crane, L.

AU - De Vente, J.

AU - Fischl, M.

AU - Gathe, J.

AU - Greenberg, R.

AU - Henry, K.

AU - Jayaweera, D.

AU - Kumar, P.

AU - Lalezari, J.

AU - Leider, J.

AU - Lubelchek, R.

AU - Martorell, C.

AU - Mounzer, K.

AU - Cohen, C.

AU - Olivet, H.

AU - Ortiz, R.

AU - Rhame, F.

AU - Roberts, A.

AU - Ruane, P.

AU - Scribner, A.

AU - Segal-Maurer, S.

AU - Short, W.

AU - Sloan, L.

AU - Wilkin, T.

AU - Wohlfeiler, M.

AU - Yangco, B.

AU - Bloch, M.

AU - Gold, J.

AU - Hoy, J.

AU - Martinez, P.

AU - Baker, D.

AU - Finlayson, R.

AU - Roth, N.

AU - Rieger, A.

AU - Vetter, N.

AU - Zangerle, R.

AU - Da Cunha, C. A.

AU - Grinsztejn, B.

AU - Madruga, J. V.

AU - Pilotto, J. H.

AU - Sampaio, D.

AU - Gonsalez, C. R.

AU - Lima, M. P.

AU - Rangel, F.

AU - Timerman, A.

AU - Junod, P.

AU - Kilby, D.

AU - Rachlis, A.

AU - Walmsley, S.

AU - Boissonnault, M.

AU - Brunetta, J.

AU - De Wet, J.

AU - Gill, J.

AU - Kasper, K.

AU - Macleod, J.

AU - Gerstoft, J.

AU - Mathiesen, L.

AU - Pedersen, C.

AU - Cotte, L.

AU - Girard, P. M.

AU - Molina, J. M.

AU - Raffi, F.

AU - Vittecoq, D.

AU - Yazdanpanah, Y.

AU - Yeni, P.

AU - Boue, F.

AU - Katlama, C.

AU - Reynes, J.

AU - Fisher, M.

AU - Nelson, M.

AU - Orkin, C.

AU - Taylor, S.

AU - Johnson, M.

AU - Wilkins, E.

AU - Williams, I. G.

AU - Winston, A.

AU - Lazzarin, A.

AU - Narciso, P.

AU - Orani, A.

AU - Rusconi, S.

AU - Antinori, A.

AU - Carosi, G.

AU - Mazzotta, F.

AU - Amaya, G.

AU - Reyes-Teran, G.

AU - Andrade-Villanueva, J.

AU - Sierra Madero, J. G.

AU - Rijnders, B.

AU - Santana, J.

AU - Zorrilla, C.

AU - Antunes, F.

AU - Branco, T.

AU - Sarmento, R.

AU - Castro, E.

AU - Eugenio, T.

AU - Mansinho, K.

AU - Marques, R.

AU - Duiculescu, D.

AU - Negrutiu, L.

AU - Prisacariu, L.

AU - Kulagin, V.

AU - Voronin, E.

AU - Yakovlev, A.

AU - Dushkina, N.

AU - Pronin, A.

AU - Tsibakova, O.

AU - Vinogradova, E.

AU - Baraldi, E.

AU - David, N.

AU - Ebrahim, O.

AU - Krantz, E.

AU - Latiff, G. H.

AU - Spencer, D.

AU - Wood, R.

AU - Botes, M.

AU - Conradie, F.

AU - Fourie, J.

AU - Mohapi, L.

AU - Petit, D.

AU - Steyn, D.

AU - Arribas, J. R.

AU - Portilla Sogorb, J.

AU - Ribera, E.

AU - Santos Gil, I.

AU - Clotet, B.

AU - Gutierrez, F.

AU - Podzamczer, D.

AU - Soriano, V.

AU - Westling, K.

AU - Chetchotisakd, P.

AU - Sirisanthana, T.

AU - Sungkanuparph, S.

AU - Vibhagool, A.

AU - Ruxrungtham, K.

AU - Techasathit, W.

AU - Hung, C. C.

AU - Lee, H. C.

AU - Lin, H. H.

AU - Wong, W. W.

AU - Albrecht, H.

AU - Bellos, N.

AU - Berger, D.

AU - Brinson, C.

AU - Casanas, B.

AU - Elion, R.

AU - Feinberg, J.

AU - File, T.

AU - Flamm, J.

AU - Hicks, C.

AU - Hodder, S.

AU - Hsiao, C. B.

AU - Kadlecik, P.

AU - Khanlou, H.

AU - Kinder, C.

AU - Liporace, R.

AU - Mayer, C.

AU - Mildvan, D.

AU - Mills, A.

AU - Myers, R. A.

AU - Nadeem, I.

AU - Osiyemi, O.

AU - Para, M.

AU - Pierone, G.

AU - Rashbaum, B.

AU - Rodriguez, J.

AU - Saag, M.

AU - Sampson, J.

AU - Samuel, R.

AU - Sension, M.

AU - Shalit, P.

AU - Tebas, P.

AU - Towner, W.

AU - Wilkin, A.

AU - Eron, J.

AU - Wohl, D.

AU - Colebunders, R.

AU - Clumeck, N.

AU - Goffard, J. C.

AU - Van Wanzeele, F.

AU - Van Wijngaerden, E.

AU - Ballesteros, J.

AU - Northland, R.

AU - Perez, C.

AU - Hongzhou, L.

AU - Li, T.

AU - Cai, W.

AU - Wu, H.

AU - Li, X.

AU - Herrera, G.

AU - Arastéh, K.

AU - Esser, S.

AU - Fätkenheuer, G.

AU - Lutz, T.

AU - Schmidt, R.

AU - Schuster, D.

AU - Stellbrink, H. J.

AU - Kumarasamy, N.

AU - Patil, P.

AU - Canton Martinez, A.

AU - Rodriguez-French, A.

AU - Sosa, N.

PY - 2012/8/1

Y1 - 2012/8/1

N2 - Objectives: The efficacy and hepatic safety of the non-nucleoside reverse transcriptase inhibitors rilpivirine (TMC278) and efavirenz were compared in treatment-naive, HIV-infected adults with concurrent hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in the pooled week 48 analysis of the Phase III, double-blind, randomized ECHO (NCT00540449) and THRIVE (NCT00543725) trials. Methods: Patients received 25 mg of rilpivirine once daily or 600 mg of efavirenz once daily, plus two nucleoside/nucleotide reverse transcriptase inhibitors. At screening, patients had alanine aminotransferase/aspartate aminotransferase levels ≤5× the upper limit of normal. HBV and HCV status was determined at baseline by HBV surface antigen, HCV antibody and HCV RNA testing. Results: HBV/HCV coinfection status was known for 670 patients in the rilpivirine group and 665 in the efavirenz group. At baseline, 49 rilpivirine and 63 efavirenz patients [112/1335 (8.4%)] were coinfected with either HBV [55/1357 (4.1%)] or HCV [57/1333 (4.3%)]. The safety analysis included all available data, including beyond week 48. Eight patients seroconverted during the study (rilpivirine: five; efavirenz: three). A higher proportion of patients achieved viral load <50 copies/mL (intent to treat, time to loss of virological response) in the subgroup without HBV/HCV coinfection (rilpivirine: 85.0%; efavirenz: 82.6%) than in the coinfected subgroup (rilpivirine: 73.5%; efavirenz: 79.4%) (rilpivirine, P = 0.04 and efavirenz, P = 0.49, Fisher's exact test). The incidence of hepatic adverse events (AEs) was low in both groups in the overall population (rilpivirine: 5.5% versus efavirenz: 6.6%) and was higher in HBV/HCV-coinfected patients than in those not coinfected (26.7% versus 4.1%, respectively). Conclusions: Hepatic AEs were more common and response rates lower in HBV/HCV-coinfected patients treated with rilpivirine or efavirenz than in those who were not coinfected.

AB - Objectives: The efficacy and hepatic safety of the non-nucleoside reverse transcriptase inhibitors rilpivirine (TMC278) and efavirenz were compared in treatment-naive, HIV-infected adults with concurrent hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in the pooled week 48 analysis of the Phase III, double-blind, randomized ECHO (NCT00540449) and THRIVE (NCT00543725) trials. Methods: Patients received 25 mg of rilpivirine once daily or 600 mg of efavirenz once daily, plus two nucleoside/nucleotide reverse transcriptase inhibitors. At screening, patients had alanine aminotransferase/aspartate aminotransferase levels ≤5× the upper limit of normal. HBV and HCV status was determined at baseline by HBV surface antigen, HCV antibody and HCV RNA testing. Results: HBV/HCV coinfection status was known for 670 patients in the rilpivirine group and 665 in the efavirenz group. At baseline, 49 rilpivirine and 63 efavirenz patients [112/1335 (8.4%)] were coinfected with either HBV [55/1357 (4.1%)] or HCV [57/1333 (4.3%)]. The safety analysis included all available data, including beyond week 48. Eight patients seroconverted during the study (rilpivirine: five; efavirenz: three). A higher proportion of patients achieved viral load <50 copies/mL (intent to treat, time to loss of virological response) in the subgroup without HBV/HCV coinfection (rilpivirine: 85.0%; efavirenz: 82.6%) than in the coinfected subgroup (rilpivirine: 73.5%; efavirenz: 79.4%) (rilpivirine, P = 0.04 and efavirenz, P = 0.49, Fisher's exact test). The incidence of hepatic adverse events (AEs) was low in both groups in the overall population (rilpivirine: 5.5% versus efavirenz: 6.6%) and was higher in HBV/HCV-coinfected patients than in those not coinfected (26.7% versus 4.1%, respectively). Conclusions: Hepatic AEs were more common and response rates lower in HBV/HCV-coinfected patients treated with rilpivirine or efavirenz than in those who were not coinfected.

KW - Efavirenz

KW - HBV

KW - HCV

KW - Hepatic safety

KW - Hepatitis

KW - Non-nucleoside reverse transcriptase inhibitors

KW - TMC278

UR - http://www.scopus.com/inward/record.url?scp=84864505008&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84864505008&partnerID=8YFLogxK

U2 - 10.1093/jac/dks130

DO - 10.1093/jac/dks130

M3 - Article

C2 - 22532465

AN - SCOPUS:84864505008

VL - 67

SP - 2020

EP - 2028

JO - Journal of Antimicrobial Chemotherapy

JF - Journal of Antimicrobial Chemotherapy

SN - 0305-7453

IS - 8

M1 - dks130

ER -