Comparative effectiveness of 8 versus 12 weeks of Ombitasvir/Paritaprevir/ritonavir and Dasabuvir in treatment-naïve patients infected with HCV genotype 1b with non-advanced hepatic fibrosis.

Abstract

PURPOSE:

Since 2017 treatment-naïve patients infected with genotype 1b of hepatitis C virus and minimal or moderate fibrosis can be treated with Ombitasvir/Paritaprevir/ritonavir + Dasabuvir (OPrD) for 8 weeks according to updated Summary of Product Characteristics. The aim of our study was to assess the comparative efficacy of 8 and 12-weeks therapy with OPrD in large cohort of patients eligible for 8 weeks regimen treated in real-world setting.

MATERIALS AND METHODS:

We analysed data of 3067 HCV genotype 1b infected patients treated with OPrD between 2015 and 2017. Final analysis included patients with none, minimal or moderate fibrosis (F0-F2).

RESULTS:

A total of 771 patients were enrolled in the study, including 197 (26%) treated for 8-weeks and 574 patients fulfilling criteria for 8-weeks but assigned to 12-weeks regimen. Majority of patients had no or minimal fibrosis (F0-F1). Longer treatment duration was more often administered in patients with moderate fibrosis, comorbidities, concomitant medications. SVR was achieved in 186 (94%) patients treated for 8 weeks and 558 (97%) for 12 weeks (p = 0.07). After exclusion of lost to follow-up patients, sustained virological response (SVR) rate reached 95% and 99%, respectively (p = 0.01). We were not able to identify factors associated with non-response.

CONCLUSIONS:

This real-word experience study confirmed similar, high effectiveness of 8 and 12-weeks regimens of OPrD in genotype 1b HCV infected patients with non-advanced fibrosis. Despite of reduced SVR rate after 8-weeks regimen, there is no need to extend therapy to 12-weeks in vast majority of such patients and no need to add ribavirin.

• Authors: Dorota Zarębska-Michaluk, Anna Piekarska, Jerzy Jaroszewicz, Jakub Klapaczyński, Włodzimierz Mazur, Rafał Krygier, Teresa Belica-Wdowik, Barbara Baka-Ćwierz, Ewa Janczewska, Paweł Pabjan, Beata Dobracka, Beata Lorenc, Magdalena Tudrujek-Zdunek, Krzysztof Tomasiewicz, Marek Sitko, Aleksander Garlicki, Agnieszka Czauż-Andrzejuk, Jolanta Citko, Dorota Dybowska, Waldemar Halota, Małgorzata Pawłowska, Łukasz Laurans, Zbigniew Deroń, Iwona Buczyńska, Krzysztof Simon, Jolanta Białkowska, Olga Tronina, Robert Flisiak
• Journal: Advances in medical sciences (Adv Med Sci) Vol. 65 Issue 1 Pg. 12-17 (Mar 2020) ISSN: 1898-4002 [Electronic] Netherlands
• PMID: 31841821 (Publication Type: Journal Article)
• Copyright: Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.

Chemical References

• Anilides
• Antiviral Agents
• Carbamates
• Cyclopropanes
• Lactams, Macrocyclic
• Sulfonamides
• ombitasvir
• Uracil
• Proline
• 2-Naphthylamine
• dasabuvir
• Valine
• Ritonavir
• paritaprevir

Topics

• 2-Naphthylamine
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anilides (therapeutic use)
• Antiviral Agents (therapeutic use)
• Carbamates (therapeutic use)
• Cyclopropanes (therapeutic use)
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Genotype
• Hepacivirus (genetics)
• Hepatitis C (complications, virology)
• Humans
• Lactams, Macrocyclic (therapeutic use)
• Liver Cirrhosis (drug therapy, epidemiology, virology)
• Male
• Middle Aged
• Prognosis
• Proline (analogs & derivatives, therapeutic use)
• Retrospective Studies
• Ritonavir (therapeutic use)
• Sulfonamides (therapeutic use)
• Sustained Virologic Response
• Uracil (analogs & derivatives, therapeutic use)
• Valine
• Young Adult