Clinical Trial

. 2012 Aug;67(8):2020-8.

doi: 10.1093/jac/dks130. Epub 2012 Apr 24.

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 Nelson¹, Gerardo Amaya, Nathan Clumeck, Clovis Arns da Cunha, Dushyantha Jayaweera, Patrice Junod, Taisheng Li, Pablo Tebas, Marita Stevens, Annemie Buelens, Simon Vanveggel, Katia Boven; ECHO and THRIVE Study Groups

Collaborators, Affiliations

Collaborators

ECHO and THRIVE Study Groups:
L Abusamra, P Cahn, H E Laplume, I Cassetti, M Ceriotto, M D Martins, A Krolewiecki, M Bloch, J Gold, J Hoy, P Martinez, A Rieger, N Vetter, R Zangerle, C A Da Cunha, B Grinsztejn, J V Madruga, J H Pilotto, D Sampaio, P Junod, D Kilby, A Rachlis, S Walmsley, J Gerstoft, L Mathiesen, C Pedersen, L Cotte, P M Girard, J M Molina, F Raffi, D Vittecoq, Y Yazdanpanah, P Yeni, M Fisher, M Nelson, C Orkin, S Taylor, A Lazzarin, P Narciso, A Orani, S Rusconi, G Amaya, G Reyes-Teran, B Rijnders, J Santana, F Antunes, T Branco, R Sarmento, E Castro, T Eugenio, K Mansinho, D Duiculescu, L Negrutiu, L Prisacariu, V Kulagin, E Voronin, A Yakovlev, E Baraldi, N David, O Ebrahim, E Krantz, G H Latiff, D Spencer, R Wood, J R Arribas, J Portilla Sogorb, E Ribera, I Santos Gil, K Westling, P Chetchotisakd, T Sirisanthana, S Sungkanuparph, A Vibhagool, 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, D Baker, R Finlayson, N Roth, R Colebunders, N Clumeck, J-C Goffard, F Van Wanzeele, E Van Wijngaerden, C R Gonsalez, M P Lima, F Rangel, A Timerman, M Boissonnault, J Brunetta, J De Wet, J Gill, K Kasper, J Macleod, J Ballesteros, R Northland, C Perez, L Hongzhou, T Li, W Cai, H Wu, X Li, G Herrera, F Boue, C Katlama, J Reynes, K Arastéh, S Esser, G Fätkenheuer, T Lutz, R Schmidt, D Schuster, H-J Stellbrink, M Johnson, E Wilkins, I G Williams, A Winston, N Kumarasamy, P Patil, A Antinori, G Carosi, F Mazzotta, J Andrade-Villanueva, J G Sierra Madero, A Canton Martinez, A Rodriguez-French, N Sosa, R Marques, C Zorrilla, N Dushkina, A Pronin, O Tsibakova, E Vinogradova, M Botes, F Conradie, J Fourie, L Mohapi, D Petit, D Steyn, B Clotet, F Gutierrez, D Podzamczer, V Soriano, K Ruxrungtham, W Techasathit, L Amarilis Lugo, R 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

Affiliation

¹ Chelsea and Westminster Hospital, St Stephen's Centre, London, UK. mark.nelson@chelwest.nhs.uk

PMID: 22532465
PMCID: PMC4643643
DOI: 10.1093/jac/dks130

Clinical Trial

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 et al. J Antimicrob Chemother. 2012 Aug.

. 2012 Aug;67(8):2020-8.

doi: 10.1093/jac/dks130. Epub 2012 Apr 24.

Authors

Collaborators

ECHO and THRIVE Study Groups:
L Abusamra, P Cahn, H E Laplume, I Cassetti, M Ceriotto, M D Martins, A Krolewiecki, M Bloch, J Gold, J Hoy, P Martinez, A Rieger, N Vetter, R Zangerle, C A Da Cunha, B Grinsztejn, J V Madruga, J H Pilotto, D Sampaio, P Junod, D Kilby, A Rachlis, S Walmsley, J Gerstoft, L Mathiesen, C Pedersen, L Cotte, P M Girard, J M Molina, F Raffi, D Vittecoq, Y Yazdanpanah, P Yeni, M Fisher, M Nelson, C Orkin, S Taylor, A Lazzarin, P Narciso, A Orani, S Rusconi, G Amaya, G Reyes-Teran, B Rijnders, J Santana, F Antunes, T Branco, R Sarmento, E Castro, T Eugenio, K Mansinho, D Duiculescu, L Negrutiu, L Prisacariu, V Kulagin, E Voronin, A Yakovlev, E Baraldi, N David, O Ebrahim, E Krantz, G H Latiff, D Spencer, R Wood, J R Arribas, J Portilla Sogorb, E Ribera, I Santos Gil, K Westling, P Chetchotisakd, T Sirisanthana, S Sungkanuparph, A Vibhagool, 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, D Baker, R Finlayson, N Roth, R Colebunders, N Clumeck, J-C Goffard, F Van Wanzeele, E Van Wijngaerden, C R Gonsalez, M P Lima, F Rangel, A Timerman, M Boissonnault, J Brunetta, J De Wet, J Gill, K Kasper, J Macleod, J Ballesteros, R Northland, C Perez, L Hongzhou, T Li, W Cai, H Wu, X Li, G Herrera, F Boue, C Katlama, J Reynes, K Arastéh, S Esser, G Fätkenheuer, T Lutz, R Schmidt, D Schuster, H-J Stellbrink, M Johnson, E Wilkins, I G Williams, A Winston, N Kumarasamy, P Patil, A Antinori, G Carosi, F Mazzotta, J Andrade-Villanueva, J G Sierra Madero, A Canton Martinez, A Rodriguez-French, N Sosa, R Marques, C Zorrilla, N Dushkina, A Pronin, O Tsibakova, E Vinogradova, M Botes, F Conradie, J Fourie, L Mohapi, D Petit, D Steyn, B Clotet, F Gutierrez, D Podzamczer, V Soriano, K Ruxrungtham, W Techasathit, L Amarilis Lugo, R 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

Affiliation

¹ Chelsea and Westminster Hospital, St Stephen's Centre, London, UK. mark.nelson@chelwest.nhs.uk

PMID: 22532465
PMCID: PMC4643643
DOI: 10.1093/jac/dks130

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.

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Figures

**Figure 1.**
CONSORT diagram showing patient disposition for the pooled primary analysis of ECHO and THRIVE. RPV, rilpivirine; EFV, efavirenz.

See this image and copyright information in PMC

References

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1. Konopnicki D, Mocroft A, de Wit S, et al. Hepatitis B and HIV: prevalence, AIDS progression, response to highly active antiretroviral therapy and increased mortality in the EuroSIDA cohort. AIDS. 2005;19:593–601. - PubMed
1. Thio CL, Seaberg EC, Skolasky R, Jr, et al. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS) Lancet. 2002;360:1921–6. - PubMed
1. Sulkowski MS. Management of hepatic complications in HIV-infected persons. J Infect Dis. 2008;197(Suppl 3):S279–93. - PubMed
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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

Collaborators

Affiliation

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

Authors

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Abstract

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