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      Peginterferon plus ribavirin and sustained virological response rate in HCV-related advanced fibrosis: a real life study

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          Abstract

          Background

          Tolerance and response to antiviral HCV treatment is poor in advanced fibrosis. The aim of this study was to assess SVR rate and its predictive factors in HCV advanced fibrosis patients treated in real life with full dose PEG-IFN plus RBV and to evaluate the adverse events related to treatment.

          Methods

          A multicentric, retrospective study was conducted at six university hospitals. METAVIR F3 and F4 HCV monoinfected patients who were treated with PEG-IFN and RBV had their data analyzed. A stepwise logistic regression analysis was performed to identify the variables independently related to SVR. Adverse events were recorded during treatment.

          Results

          308 patients were included, 75% genotype 1 and 23% genotype 3. METAVIR F3 was present in 39% and F4 in 61% of patients. The median Child Pugh score for F4 patients was 5 (5–9). The global SVR rate was 34%, 11% were relapsers and 55% were nonresponders. SVR rates were similar between patients treated with PEG-IFN alfa 2a or alfa 2b ( p = 0.24). SVR rates according to Child–Pugh score were 26% (Child A) and 18% (Child B). The independent factors related to SVR in F4 patients were genotype 3, RVR and fewer Child Pugh score points. Treatment interruption occurred in 31% patients and death occurred in 1.9%, all with liver cirrhosis.

          Conclusion

          Treatment of HCV in patients with advanced fibrosis should not be postponed. However, a very careful evaluation of cirrhotic patients must be performed before treatment is indicated and careful monitoring is required during treatment.

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          Most cited references47

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          Boceprevir for untreated chronic HCV genotype 1 infection.

          Fred Poordad, Jonathan McCone, Bruce Bacon … (2011)
          Peginterferon-ribavirin therapy is the current standard of care for chronic infection with hepatitis C virus (HCV). The rate of sustained virologic response has been below 50% in cases of HCV genotype 1 infection. Boceprevir, a potent oral HCV-protease inhibitor, has been evaluated as an additional treatment in phase 1 and phase 2 studies. We conducted a double-blind study in which previously untreated adults with HCV genotype 1 infection were randomly assigned to one of three groups. In all three groups, peginterferon alfa-2b and ribavirin were administered for 4 weeks (the lead-in period). Subsequently, group 1 (the control group) received placebo plus peginterferon-ribavirin for 44 weeks; group 2 received boceprevir plus peginterferon-ribavirin for 24 weeks, and those with a detectable HCV RNA level between weeks 8 and 24 received placebo plus peginterferon-ribavirin for an additional 20 weeks; and group 3 received boceprevir plus peginterferon-ribavirin for 44 weeks. Nonblack patients and black patients were enrolled and analyzed separately. A total of 938 nonblack and 159 black patients were treated. In the nonblack cohort, a sustained virologic response was achieved in 125 of the 311 patients (40%) in group 1, in 211 of the 316 patients (67%) in group 2 (P<0.001), and in 213 of the 311 patients (68%) in group 3 (P<0.001). In the black cohort, a sustained virologic response was achieved in 12 of the 52 patients (23%) in group 1, in 22 of the 52 patients (42%) in group 2 (P=0.04), and in 29 of the 55 patients (53%) in group 3 (P=0.004). In group 2, a total of 44% of patients received peginterferon-ribavirin for 28 weeks. Anemia led to dose reductions in 13% of controls and 21% of boceprevir recipients, with discontinuations in 1% and 2%, respectively. The addition of boceprevir to standard therapy with peginterferon-ribavirin, as compared with standard therapy alone, significantly increased the rates of sustained virologic response in previously untreated adults with chronic HCV genotype 1 infection. The rates were similar with 24 weeks and 44 weeks of boceprevir. (Funded by Schering-Plough [now Merck]; SPRINT-2 ClinicalTrials.gov number, NCT00705432.).
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            Telaprevir for previously untreated chronic hepatitis C virus infection.

            Ira M Jacobson, John G McHutchison, Geoffrey Dusheiko … (2011)
            In phase 2 trials, telaprevir, a hepatitis C virus (HCV) genotype 1 protease inhibitor, in combination with peginterferon-ribavirin, as compared with peginterferon-ribavirin alone, has shown improved efficacy, with potential for shortening the duration of treatment in a majority of patients. In this international, phase 3, randomized, double-blind, placebo-controlled trial, we assigned 1088 patients with HCV genotype 1 infection who had not received previous treatment for the infection to one of three groups: a group receiving telaprevir combined with peginterferon alfa-2a and ribavirin for 12 weeks (T12PR group), followed by peginterferon-ribavirin alone for 12 weeks if HCV RNA was undetectable at weeks 4 and 12 or for 36 weeks if HCV RNA was detectable at either time point; a group receiving telaprevir with peginterferon-ribavirin for 8 weeks and placebo with peginterferon-ribavirin for 4 weeks (T8PR group), followed by 12 or 36 weeks of peginterferon-ribavirin on the basis of the same HCV RNA criteria; or a group receiving placebo with peginterferon-ribavirin for 12 weeks, followed by 36 weeks of peginterferon-ribavirin (PR group). The primary end point was the proportion of patients who had undetectable plasma HCV RNA 24 weeks after the last planned dose of study treatment (sustained virologic response). Significantly more patients in the T12PR or T8PR group than in the PR group had a sustained virologic response (75% and 69%, respectively, vs. 44%; P<0.001 for the comparison of the T12PR or T8PR group with the PR group). A total of 58% of the patients treated with telaprevir were eligible to receive 24 weeks of total treatment. Anemia, gastrointestinal side effects, and skin rashes occurred at a higher incidence among patients receiving telaprevir than among those receiving peginterferon-ribavirin alone. The overall rate of discontinuation of the treatment regimen owing to adverse events was 10% in the T12PR and T8PR groups and 7% in the PR group. Telaprevir with peginterferon-ribavirin, as compared with peginterferon-ribavirin alone, was associated with significantly improved rates of sustained virologic response in patients with HCV genotype 1 infection who had not received previous treatment, with only 24 weeks of therapy administered in the majority of patients. (Funded by Vertex Pharmaceuticals and Tibotec; ADVANCE ClinicalTrials.gov number, NCT00627926.).
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              Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies.

              Gennaro D'Amico, Guadalupe Garcia-Tsao, Luigi Pagliaro (2006)
              Article 0 comments Cited 430 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Giovanni Faria Silva
                Journal
                Journal ID (nlm-ta): Braz J Infect Dis
                Journal ID (iso-abbrev): Braz J Infect Dis
                Title: The Brazilian Journal of Infectious Diseases
                Publisher: Elsevier
                ISSN (Print): 1413-8670
                ISSN (Electronic): 1678-4391
                Publication date PMC-release: 20 September 2013
                Publication date Collection: Jan-Feb 2014
                Publication date (Electronic): 20 September 2013
                Volume: 18
                Issue: 1
                Pages: 48-52
                Affiliations
                [a ]Botucatu School of Medicine, Universidade Estadual Paulista (UNESP), Botucatu, SP, Brazil
                [b ]Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil
                [c ]Universidade Estadual de Campinas (UNICAMP), Campinas, SP, Brazil
                [d ]Universidade Federal de São Paulo, São Paulo, SP, Brazil
                [e ]Pontifícia Universidade Católica de São Paulo, Sorocaba, SP, Brazil
                Author notes
                [* ] Corresponding author at: Departamento de Clínica Médica, Faculdade de Medicina de Botucatu, Distrito de Rubião Junior, s/n., Botucatu, SP 18618-970, Brazil. giovanni@ 123456fmb.unesp.br giovannifariasilva@ 123456gmail.com
                Article
                Publisher Item ID: S1413-8670(13)00202-X
                DOI: 10.1016/j.bjid.2013.05.007
                PMC ID: 9425191
                PubMed ID: 24055310
                SO-VID: 5dd34941-b370-47cb-8209-42bda5283a93
                Copyright © © 2013 Published by Elsevier Editora Ltda.
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 5 January 2013
                Date accepted : 8 May 2013
                Categories
                Subject: Original Article

                Keywords: hepatitis c,advanced fibrosis,peginterferon,ribavirin
                Data availability:
                Keywords: hepatitis c, advanced fibrosis, peginterferon, ribavirin

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