Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy

B. Hunyady, Margit Abonyi, Zsuzsanna Gerlei, Judit Gervain, Gábor Horváth, Viktor Jancsik, G. Lengyel, Erzsébet Makkai, A. Pár, Zoltán Péter, Margit Pusztay, Pál Ribiczey, László Rókusz, Christoph Sarrazin, Ferenc Schneider, Simone Susser, F. Szalay, István Tornai, Anna Tusnádi, E. ÚjhelyiKlára Werling, Mihály Makara

Research output: Article

Abstract

Aim of the study: Combination of ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3DDA±RBV) therapy is shown to be effective in HCV genotype 1 (GT1) infected patients. However, sparse data exist in patients who failed previous boceprevir or telaprevir based therapies. Real life efficacy and safety of this combination were evaluated in HCV GT1b infected patients (mostly cirrhotics) with compensated liver disease who failed previous boceprevir or telaprevir based therapies more than a year before. Material and methods: Data of previous protease inhibitor failure patients, treated with 3DAA+RBV for 12 weeks (GT1b and/or non-cirrhotics) or 24 weeks (non-GT1b cirrhotics), were retrospectively collected. Results: Population characteristics: boceprevir/telaprevir-failure: 82/45, GT1b: 117, cirrhotic: 111 (87.4%). SVR12/24 was observed in 103/105 patients (98.1%) of those who reached either time point. Four SAEs reported: one death due to myocardial infarction, another due to recurrent hepatocellular carcinoma after achieving SVR12, two hospitalizations (elevation of transaminases, pneumonia). Grade = 3 AEs or laboratory abnormalities were reported in < 10% of patients; they were transient in all patients. No early discontinuation of drugs due to SAE has been reported. Conclusions: One year after previous failure of boceprevir or telaprevir based therapy, 12 weeks of 3DAA+RBV combination in HCV GT1b infected patients is similarly effective and safe as in those with no previous HCV ther stanapy, even in the presence of cirrhosis. These findings might be of particular interest in settings where alternative therapies for such patients are not available or not affordable.

Original languageEnglish
Pages (from-to)83-90
Number of pages8
JournalClinical and Experimental Hepatology
Volume4
Issue number2
DOIs
Publication statusPublished - jan. 1 2018

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Ritonavir
Ribavirin
Protease Inhibitors
Genotype
Therapeutics
ABT-450
ABT-267
ABT-333
Population Characteristics
Complementary Therapies
Transaminases
Liver Diseases
Hepatocellular Carcinoma
Pneumonia
Hospitalization
Fibrosis
Myocardial Infarction
Safety
telaprevir
N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide

ASJC Scopus subject areas

  • Hepatology

Cite this

Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy. / Hunyady, B.; Abonyi, Margit; Gerlei, Zsuzsanna; Gervain, Judit; Horváth, Gábor; Jancsik, Viktor; Lengyel, G.; Makkai, Erzsébet; Pár, A.; Péter, Zoltán; Pusztay, Margit; Ribiczey, Pál; Rókusz, László; Sarrazin, Christoph; Schneider, Ferenc; Susser, Simone; Szalay, F.; Tornai, István; Tusnádi, Anna; Újhelyi, E.; Werling, Klára; Makara, Mihály.

In: Clinical and Experimental Hepatology, Vol. 4, No. 2, 01.01.2018, p. 83-90.

Research output: Article

Hunyady, B, Abonyi, M, Gerlei, Z, Gervain, J, Horváth, G, Jancsik, V, Lengyel, G, Makkai, E, Pár, A, Péter, Z, Pusztay, M, Ribiczey, P, Rókusz, L, Sarrazin, C, Schneider, F, Susser, S, Szalay, F, Tornai, I, Tusnádi, A, Újhelyi, E, Werling, K & Makara, M 2018, 'Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy', Clinical and Experimental Hepatology, vol. 4, no. 2, pp. 83-90. https://doi.org/10.5114/ceh.2018.75957
Hunyady, B. ; Abonyi, Margit ; Gerlei, Zsuzsanna ; Gervain, Judit ; Horváth, Gábor ; Jancsik, Viktor ; Lengyel, G. ; Makkai, Erzsébet ; Pár, A. ; Péter, Zoltán ; Pusztay, Margit ; Ribiczey, Pál ; Rókusz, László ; Sarrazin, Christoph ; Schneider, Ferenc ; Susser, Simone ; Szalay, F. ; Tornai, István ; Tusnádi, Anna ; Újhelyi, E. ; Werling, Klára ; Makara, Mihály. / Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy. In: Clinical and Experimental Hepatology. 2018 ; Vol. 4, No. 2. pp. 83-90.
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abstract = "Aim of the study: Combination of ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3DDA±RBV) therapy is shown to be effective in HCV genotype 1 (GT1) infected patients. However, sparse data exist in patients who failed previous boceprevir or telaprevir based therapies. Real life efficacy and safety of this combination were evaluated in HCV GT1b infected patients (mostly cirrhotics) with compensated liver disease who failed previous boceprevir or telaprevir based therapies more than a year before. Material and methods: Data of previous protease inhibitor failure patients, treated with 3DAA+RBV for 12 weeks (GT1b and/or non-cirrhotics) or 24 weeks (non-GT1b cirrhotics), were retrospectively collected. Results: Population characteristics: boceprevir/telaprevir-failure: 82/45, GT1b: 117, cirrhotic: 111 (87.4{\%}). SVR12/24 was observed in 103/105 patients (98.1{\%}) of those who reached either time point. Four SAEs reported: one death due to myocardial infarction, another due to recurrent hepatocellular carcinoma after achieving SVR12, two hospitalizations (elevation of transaminases, pneumonia). Grade = 3 AEs or laboratory abnormalities were reported in < 10{\%} of patients; they were transient in all patients. No early discontinuation of drugs due to SAE has been reported. Conclusions: One year after previous failure of boceprevir or telaprevir based therapy, 12 weeks of 3DAA+RBV combination in HCV GT1b infected patients is similarly effective and safe as in those with no previous HCV ther stanapy, even in the presence of cirrhosis. These findings might be of particular interest in settings where alternative therapies for such patients are not available or not affordable.",
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T1 - Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy

AU - Hunyady, B.

AU - Abonyi, Margit

AU - Gerlei, Zsuzsanna

AU - Gervain, Judit

AU - Horváth, Gábor

AU - Jancsik, Viktor

AU - Lengyel, G.

AU - Makkai, Erzsébet

AU - Pár, A.

AU - Péter, Zoltán

AU - Pusztay, Margit

AU - Ribiczey, Pál

AU - Rókusz, László

AU - Sarrazin, Christoph

AU - Schneider, Ferenc

AU - Susser, Simone

AU - Szalay, F.

AU - Tornai, István

AU - Tusnádi, Anna

AU - Újhelyi, E.

AU - Werling, Klára

AU - Makara, Mihály

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Aim of the study: Combination of ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3DDA±RBV) therapy is shown to be effective in HCV genotype 1 (GT1) infected patients. However, sparse data exist in patients who failed previous boceprevir or telaprevir based therapies. Real life efficacy and safety of this combination were evaluated in HCV GT1b infected patients (mostly cirrhotics) with compensated liver disease who failed previous boceprevir or telaprevir based therapies more than a year before. Material and methods: Data of previous protease inhibitor failure patients, treated with 3DAA+RBV for 12 weeks (GT1b and/or non-cirrhotics) or 24 weeks (non-GT1b cirrhotics), were retrospectively collected. Results: Population characteristics: boceprevir/telaprevir-failure: 82/45, GT1b: 117, cirrhotic: 111 (87.4%). SVR12/24 was observed in 103/105 patients (98.1%) of those who reached either time point. Four SAEs reported: one death due to myocardial infarction, another due to recurrent hepatocellular carcinoma after achieving SVR12, two hospitalizations (elevation of transaminases, pneumonia). Grade = 3 AEs or laboratory abnormalities were reported in < 10% of patients; they were transient in all patients. No early discontinuation of drugs due to SAE has been reported. Conclusions: One year after previous failure of boceprevir or telaprevir based therapy, 12 weeks of 3DAA+RBV combination in HCV GT1b infected patients is similarly effective and safe as in those with no previous HCV ther stanapy, even in the presence of cirrhosis. These findings might be of particular interest in settings where alternative therapies for such patients are not available or not affordable.

AB - Aim of the study: Combination of ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3DDA±RBV) therapy is shown to be effective in HCV genotype 1 (GT1) infected patients. However, sparse data exist in patients who failed previous boceprevir or telaprevir based therapies. Real life efficacy and safety of this combination were evaluated in HCV GT1b infected patients (mostly cirrhotics) with compensated liver disease who failed previous boceprevir or telaprevir based therapies more than a year before. Material and methods: Data of previous protease inhibitor failure patients, treated with 3DAA+RBV for 12 weeks (GT1b and/or non-cirrhotics) or 24 weeks (non-GT1b cirrhotics), were retrospectively collected. Results: Population characteristics: boceprevir/telaprevir-failure: 82/45, GT1b: 117, cirrhotic: 111 (87.4%). SVR12/24 was observed in 103/105 patients (98.1%) of those who reached either time point. Four SAEs reported: one death due to myocardial infarction, another due to recurrent hepatocellular carcinoma after achieving SVR12, two hospitalizations (elevation of transaminases, pneumonia). Grade = 3 AEs or laboratory abnormalities were reported in < 10% of patients; they were transient in all patients. No early discontinuation of drugs due to SAE has been reported. Conclusions: One year after previous failure of boceprevir or telaprevir based therapy, 12 weeks of 3DAA+RBV combination in HCV GT1b infected patients is similarly effective and safe as in those with no previous HCV ther stanapy, even in the presence of cirrhosis. These findings might be of particular interest in settings where alternative therapies for such patients are not available or not affordable.

KW - Cirrhosis

KW - Direct acting antiviral drugs

KW - Hepatitis C virus

KW - Protease inhibitor

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