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
| Original language | English |
|---|---|
| Article number | dks130 |
| Pages (from-to) | 2020-2028 |
| Number of pages | 9 |
| Journal | Journal of Antimicrobial Chemotherapy |
| Volume | 67 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - Aug 2012 |
Keywords
- Efavirenz
- HBV
- HCV
- Hepatic safety
- Hepatitis
- Non-nucleoside reverse transcriptase inhibitors
- TMC278
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)
- Infectious Diseases
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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. / 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, 08.2012, p. 2020-2028.Research output: Contribution to journal › Article › peer-review
}
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
Y1 - 2012/8
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
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
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 -