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Open Access 01-12-2018 | Research article

The efficacy of paritaprevir/ritonavir/ombitasvir+dasabuvir and ledipasvir/sofosbuvir is comparable in patients who failed interferon-based treatment with first generation protease inhibitors - a multicenter cohort study

Authors: Ewa Janczewska, Dorota Zarębska-Michaluk, Hanna Berak, Anna Piekarska, Andrzej Gietka, Dorota Dybowska, Włodzimierz Mazur, Teresa Belica-Wdowik, Witold Dobracki, Magdalena Tudrujek-Zdunek, Zbigniew Deroń, Iwona Buczyńska, Marek Sitko, Agnieszka Czauż-Andrzejuk, Beata Lorenc, Jolanta Białkowska-Warzecha, Jolanta Citko, Łukasz Laurans, Jerzy Jaroszewicz, Łukasz Socha, Olga Tronina, Brygida Adamek, Andrzej Horban, Waldemar Halota, Barbara Baka-Ćwierz, Krzysztof Tomasiewicz, Krzysztof Simon, Aleksander Garlicki, Marta Wawrzynowicz-Syczewska, Robert Flisiak

Published in: BMC Infectious Diseases | Issue 1/2018

Abstract

Background

According to the EASL and AASLD guidelines, the recommended treatment for patients who failed to achieve a sustained virologic response (SVR) on prior interferon-based triple therapy with protease inhibitors (PI), is a combination of sofosbuvir and NS5A inhibitors. Polish national recommendations also allow the use of paritaprevir/ritonavir/ombitasvir+dasasbuvir±ribavirin (PrODR) in this group of patients. The aim of the study was to evaluate the efficacy and safety of PrODR vs. ledipasvir/sofosbuvir±RBV (LSR) in PI-experienced patients in real-life setting.

Methods

Our analysis included patients registered in the nationwide, investigators initiated, multicentre EpiTer-2 database.

Among 4530 patients registered, 335 with genotype 1 (93% 1b) were previously treated with IFN-based regimens with PIs: 127 with boceprevir (BOC), 208 with telaprevir (TVR).

Patients with advanced fibrosis (F3/F4) were significantly predominant (BOC 28.4%/61.4%, TVR 18.8%/64.4%, respectively).

Subjects were assigned to IFN-free retreatment as follows: BOC - 64 (50.4%) PrODR and 63 (49.6%) LSR; TVR- 103 (49.5%) PrODR and 105 (50.5%) LSR.

Results

SVR rates were comparable for particular groups: BOC → PrODR- 100%; BOC → LSR - 98%; TVR → PrODR - 97%; TVR → LSR - 96% (intent-to treat analysis-ITT) and BOC → PrODR→100%; BOC → LSR - 99%; TVR → PrODR - 99%; TVR → LSR - 98% (modified intent-to treat analysis-mITT).

Both treatment regimens had a favourable safety profile. Adverse events (AEs) were generally mild or moderate in severity. Three deaths were reported. The treatment was stopped due to AEs in five patients (three treated with PrODR and two with LSR).

Conclusion

Efficacy and safety of treatment with PrODR and LSR is comparable in BOC or TVR-experienced patients.

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Title: The efficacy of paritaprevir/ritonavir/ombitasvir+dasabuvir and ledipasvir/sofosbuvir is comparable in patients who failed interferon-based treatment with first generation protease inhibitors - a multicenter cohort study
Authors: Ewa Janczewska
Dorota Zarębska-Michaluk
Hanna Berak
Anna Piekarska
Andrzej Gietka
Dorota Dybowska
Włodzimierz Mazur
Teresa Belica-Wdowik
Witold Dobracki
Magdalena Tudrujek-Zdunek
Zbigniew Deroń
Iwona Buczyńska
Marek Sitko
Agnieszka Czauż-Andrzejuk
Beata Lorenc
Jolanta Białkowska-Warzecha
Jolanta Citko
Łukasz Laurans
Jerzy Jaroszewicz
Łukasz Socha
Olga Tronina
Brygida Adamek
Andrzej Horban
Waldemar Halota
Barbara Baka-Ćwierz
Krzysztof Tomasiewicz
Krzysztof Simon
Aleksander Garlicki
Marta Wawrzynowicz-Syczewska
Robert Flisiak
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: BMC Infectious Diseases / Issue 1/2018
Electronic ISSN: 1471-2334
DOI: https://doi.org/10.1186/s12879-018-3465-2

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The efficacy of paritaprevir/ritonavir/ombitasvir+dasabuvir and ledipasvir/sofosbuvir is comparable in patients who failed interferon-based treatment with first generation protease inhibitors - a multicenter cohort study

Abstract

Background

Methods

Results

Conclusion

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Abstract

Background

Methods

Results

Conclusion

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