BMC Infectious Diseases (Nov 2018)

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

  • 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

DOI
https://doi.org/10.1186/s12879-018-3465-2
Journal volume & issue
Vol. 18, no. 1
pp. 1 – 9

Abstract

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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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