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

Béla Hunyady; Margit Abonyi; Zsuzsanna Gerlei; Judit Gervain; Gábor Horváth; Viktor Jancsik; Gabriella Lengyel; Erzsébet Makkai; Alajos Pár; Zoltán Péter; Margit Pusztay; Pál Ribiczey; László Rókusz; Christoph Sarrazin; Ferenc Schneider; Simone Susser; Ferenc Szalay; István Tornai; Anna Tusnádi; Eszter Újhelyi; Klára Werling; Mihály Makara

doi:10.5114/ceh.2018.75957

eISSN: 2449-8238
ISSN: 2392-1099

Clinical and Experimental Hepatology

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Original paper

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

Béla Hunyady

,

Margit Abonyi

,

Zsuzsanna Gerlei

,

Judit Gervain

,

Gábor Horváth

,

Viktor Jancsik

,

Gabriella Lengyel

,

Erzsébet Makkai

,

Alajos Pár

,

Zoltán Péter

,

Margit Pusztay

,

Pál Ribiczey

,

László Rókusz

,

Christoph Sarrazin

,

Ferenc Schneider

,

Simone Susser

,

Ferenc Szalay

,

István Tornai

,

Anna Tusnádi

,

Eszter Újhelyi

,

Klára Werling

,

Mihály Makara

Clin Exp HEPATOL 2018; 4, 2: 83-90

DOI: https://doi.org/10.5114/ceh.2018.75957

Online publish date: 2018/05/25

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AMA

Hunyady B, Abonyi M, Gerlei Z, et al. Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy. Clinical and Experimental Hepatology. 2018;4(2):83-90. doi:10.5114/ceh.2018.75957.

APA

Hunyady, B., Abonyi, M., Gerlei, Z., Gervain, J., Horváth, G.,  & Jancsik, V. et al. (2018). Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy. Clinical and Experimental Hepatology, 4(2), 83-90. https://doi.org/10.5114/ceh.2018.75957

Chicago

Hunyady, Béla, Margit Abonyi, Zsuzsanna Gerlei, Judit Gervain, Gábor Horváth, Viktor Jancsik,  and Gabriella Lengyel et al. 2018. "Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy". Clinical and Experimental Hepatology 4 (2): 83-90. doi:10.5114/ceh.2018.75957.

Harvard

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.,  and Makara, M. (2018). Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy. Clinical and Experimental Hepatology, 4(2), pp.83-90. https://doi.org/10.5114/ceh.2018.75957

MLA

Hunyady, Béla et al. "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, 2018, pp. 83-90. doi:10.5114/ceh.2018.75957.

Vancouver

Hunyady B, Abonyi M, Gerlei Z, Gervain J, Horváth G, Jancsik V et al. Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy. Clinical and Experimental Hepatology. 2018;4(2):83-90. doi:10.5114/ceh.2018.75957.

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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 therapy, 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.

keywords:

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

cirrhosis, direct acting antiviral drugs, hepatitis C virus, protease inhibitor