Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Mar 3:2019:4029541.
doi: 10.1155/2019/4029541. eCollection 2019.

Real World Experience of Chronic Hepatitis C Retreatment with Genotype Specific Regimens in Nonresponders to Previous Interferon-Free Therapy

Dorota Zarębska-Michaluk  1 , Iwona Buczyńska  2 , Krzysztof Simon  2 , Magdalena Tudrujek-Zdunek  3 , Ewa Janczewska  4 , Dorota Dybowska  5 , Marek Sitko  6 , Beata Dobracka  7 , Jerzy Jaroszewicz  8 , Paweł Pabjan  1 , Jakub Klapaczyński  9 , Łukasz Laurans  10   11 , Włodzimierz Mazur  12 , Łukasz Socha  11 , Olga Tronina  13 , Miłosz Parczewski  14 , Robert Flisiak  15
Affiliations

Real World Experience of Chronic Hepatitis C Retreatment with Genotype Specific Regimens in Nonresponders to Previous Interferon-Free Therapy

Dorota Zarębska-Michaluk et al. Can J Gastroenterol Hepatol. .

Abstract

Background and aim: The development of interferon- (IFN-) free regimens substantially improved efficacy of treatment for HCV, but despite excellent effectiveness the failures still occur. The aim of our study was to evaluate the efficacy of retreatment with genotype specific direct acting antivirals- (DAA-) based regimens in nonresponders to previous IFN-free therapy.

Materials and methods: Analysed population consisted of 31 nonresponders to IFN-free regimen, which received second IFN-free rescue therapy, selected from 6228 patients included in a national database EpiTer-2.

Results: Age and gender distribution were similar, whereas proportion of genotype 1b was slightly higher and genotype 4 lower in the whole population compared to studied one. Patients included in the study demonstrated much more advanced fibrosis. Primary therapy was discontinued in 12 patients, which were recognized as failures due to nonvirologic reason, whereas virologic reason of therapeutic failure was recognized in 19 patients which completed therapy. Overall sustained virologic response (SVR) rate was 81% and 86% in intent-to-treat (ITT) and modified ITT analysis, respectively (74% and 78% in virologic failures, 92% and 100% in nonvirologic failures). Resistance-associated substitutions (RAS) testing was carried out in 8 patients from the group of completed primary therapy and three of them had potential risk for failure of rescue therapy due to NS5A association, while two of them achieved SVR.

Conclusions: We demonstrated moderate effectiveness of genotype specific rescue therapy in failures due to virologic reason and high in those who discontinued primary therapy. Therefore rescue therapy with genotype specific regimens should be considered always if more potent regimens are not available.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Efficacy of retreatment according to intent-to-treat (ITT) or modified ITT (mITT) analysis in all retreated and based on completed or discontinued primary therapy; mITT analysis was carried out without lost to follow-up patients.
See this image and copyright information in PMC

References

    1. Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. The Lancet Gastroenterology & Hepatology. 2017;2:161–176. - PubMed
    1. Flisiak R., Pogorzelska J., Berak H., et al. Efficacy of HCV treatment in Poland at the turn of the interferon era - the EpiTer study. Clinical and Experimental Hepatology. 2016;2(4):138–143. doi: 10.5114/ceh.2016.63870. - DOI - PMC - PubMed
    1. European Association for the Study of the Liver. EASL recommendations on treatment of Hepatitis C 2015. Journal of Hepatology. 2015;63(1):199–236. doi: 10.1016/j.jhep.2015.03.025. - DOI - PubMed
    1. Afdhal N., Reddy K. R., Nelson D. R., et al. Ledipasvir and Sofosbuvir for Previously treated HCV genotype 1 infection. The New England Journal of Medicine. 2014;371(6):584–584. doi: 10.1056/NEJMx140042. - DOI - PubMed
    1. Pawlotsky J.-M., Negro F., Aghemo A., et al. EASL recommendations on treatment of hepatitis C 2018. Journal of Hepatology. 2018;69(2):461–511. doi: 10.1016/j.jhep.2018.03.026. - DOI - PubMed

MeSH terms

Substances