Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy

Oliver Lenz; Joep De Bruijne; Leen Vijgen; Thierry Verbinnen; Christine Weegink; Herwig Van Marck; Ina Vandenbroucke; Monika Peeters; Kenneth Simmen; Greg Fanning; Rene Verloes; Gaston Picchio; Hendrik Reesink

doi:10.1053/j.gastro.2012.07.117

Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy

Oliver Lenz^*, Joep De Bruijne, Leen Vijgen, Thierry Verbinnen, Christine Weegink, Herwig Van Marck, Ina Vandenbroucke, Monika Peeters, Kenneth Simmen, Greg Fanning, Rene Verloes, Gaston Picchio, Hendrik Reesink

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

In the TMC435-C101 study, 6 patients infected with hepatitis C virus genotype 1 were treated with the protease inhibitor TMC435 (200 mg once daily) as monotherapy for 5 days. Approximately 1.5 years later, 5 of these patients were re-treated with TMC435 (200 mg once daily) plus pegylated interferon alfa-2a and ribavirin (PegIFNα-2a and RBV) for 4 weeks, followed by PegIFNα-2a and RBV until week 48 (in the Optimal Protease inhibitor Enhancement of Response to therApy [OPERA-1] study). TMC435-resistant variants, which emerged in all 5 patients during the TMC435-C101 study, were no longer detected at the beginning of the OPERA-1 study based on virus population sequencing. During the OPERA-1 study, 3 patients had a sustained virologic response; deep sequencing indicated low-level persistence of resistant variants in the remaining 2 patients, which might have affected their response to re-treatment. Clinical trials.gov Number, NCT00561353.

Original language	English
Pages (from-to)	1176-1178.e6
Journal	Gastroenterology
Volume	143
Issue number	5
DOIs	https://doi.org/10.1053/j.gastro.2012.07.117
Publication status	Published - Nov 2012
Externally published	Yes

Keywords

Clinical Trial
HCV NS3/4A
Sustained Virologic Response
TMC435-C101

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10.1053/j.gastro.2012.07.117

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Lenz, O., De Bruijne, J., Vijgen, L., Verbinnen, T., Weegink, C., Van Marck, H., Vandenbroucke, I., Peeters, M., Simmen, K., Fanning, G., Verloes, R., Picchio, G., & Reesink, H. (2012). Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy. Gastroenterology, 143(5), 1176-1178.e6. https://doi.org/10.1053/j.gastro.2012.07.117

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title = "Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy",

abstract = "In the TMC435-C101 study, 6 patients infected with hepatitis C virus genotype 1 were treated with the protease inhibitor TMC435 (200 mg once daily) as monotherapy for 5 days. Approximately 1.5 years later, 5 of these patients were re-treated with TMC435 (200 mg once daily) plus pegylated interferon alfa-2a and ribavirin (PegIFNα-2a and RBV) for 4 weeks, followed by PegIFNα-2a and RBV until week 48 (in the Optimal Protease inhibitor Enhancement of Response to therApy [OPERA-1] study). TMC435-resistant variants, which emerged in all 5 patients during the TMC435-C101 study, were no longer detected at the beginning of the OPERA-1 study based on virus population sequencing. During the OPERA-1 study, 3 patients had a sustained virologic response; deep sequencing indicated low-level persistence of resistant variants in the remaining 2 patients, which might have affected their response to re-treatment. Clinical trials.gov Number, NCT00561353.",

keywords = "Clinical Trial, HCV NS3/4A, Sustained Virologic Response, TMC435-C101",

author = "Oliver Lenz and {De Bruijne}, Joep and Leen Vijgen and Thierry Verbinnen and Christine Weegink and {Van Marck}, Herwig and Ina Vandenbroucke and Monika Peeters and Kenneth Simmen and Greg Fanning and Rene Verloes and Gaston Picchio and Hendrik Reesink",

year = "2012",

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doi = "10.1053/j.gastro.2012.07.117",

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Lenz, O, De Bruijne, J, Vijgen, L, Verbinnen, T, Weegink, C, Van Marck, H, Vandenbroucke, I, Peeters, M, Simmen, K, Fanning, G, Verloes, R, Picchio, G & Reesink, H 2012, 'Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy', Gastroenterology, vol. 143, no. 5, pp. 1176-1178.e6. https://doi.org/10.1053/j.gastro.2012.07.117

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AU - Lenz, Oliver

AU - De Bruijne, Joep

AU - Vijgen, Leen

AU - Verbinnen, Thierry

AU - Weegink, Christine

AU - Van Marck, Herwig

AU - Vandenbroucke, Ina

AU - Peeters, Monika

AU - Simmen, Kenneth

AU - Fanning, Greg

AU - Verloes, Rene

AU - Picchio, Gaston

AU - Reesink, Hendrik

PY - 2012/11

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N2 - In the TMC435-C101 study, 6 patients infected with hepatitis C virus genotype 1 were treated with the protease inhibitor TMC435 (200 mg once daily) as monotherapy for 5 days. Approximately 1.5 years later, 5 of these patients were re-treated with TMC435 (200 mg once daily) plus pegylated interferon alfa-2a and ribavirin (PegIFNα-2a and RBV) for 4 weeks, followed by PegIFNα-2a and RBV until week 48 (in the Optimal Protease inhibitor Enhancement of Response to therApy [OPERA-1] study). TMC435-resistant variants, which emerged in all 5 patients during the TMC435-C101 study, were no longer detected at the beginning of the OPERA-1 study based on virus population sequencing. During the OPERA-1 study, 3 patients had a sustained virologic response; deep sequencing indicated low-level persistence of resistant variants in the remaining 2 patients, which might have affected their response to re-treatment. Clinical trials.gov Number, NCT00561353.

AB - In the TMC435-C101 study, 6 patients infected with hepatitis C virus genotype 1 were treated with the protease inhibitor TMC435 (200 mg once daily) as monotherapy for 5 days. Approximately 1.5 years later, 5 of these patients were re-treated with TMC435 (200 mg once daily) plus pegylated interferon alfa-2a and ribavirin (PegIFNα-2a and RBV) for 4 weeks, followed by PegIFNα-2a and RBV until week 48 (in the Optimal Protease inhibitor Enhancement of Response to therApy [OPERA-1] study). TMC435-resistant variants, which emerged in all 5 patients during the TMC435-C101 study, were no longer detected at the beginning of the OPERA-1 study based on virus population sequencing. During the OPERA-1 study, 3 patients had a sustained virologic response; deep sequencing indicated low-level persistence of resistant variants in the remaining 2 patients, which might have affected their response to re-treatment. Clinical trials.gov Number, NCT00561353.

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Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy

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Keywords

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