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      Drug Design, Development and Therapy (submit here)

      This international, peer-reviewed Open Access journal by Dove Medical Press focuses on the design and development of drugs, as well as the clinical outcomes, patient safety, and programs targeted at the effective and safe use of medicines. Sign up for email alerts here.

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      Comparison of peginterferon alfa-2a and alfa-2b for treatment of patients with chronic hepatitis C: a retrospective study using the Japanese Interferon Database

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          Abstract

          Purpose

          We aimed to compare the rates of sustained virologic response (SVR) achieved with peginterferon (PEG-IFN) alfa-2a and alfa-2b in combination with ribavinin (RBV) for chronic hepatitis C, using a large database of hepatitis cases to improve the generalizability of these results.

          Methods

          We identified patients with chronic hepatitis C who were treated with PEG-IFN alfa-2a or alfa-2b and RBV, from the Japanese Interferon Database, between December 2009 and April 2013. This database contains the medical records of IFN treatment collected from 36 prefectures in Japan. Multivariable logistic regression analysis was used to compare SVR rates obtained with PEG-IFN alfa-2a and alfa-2b, in combination with RBV.

          Results

          A total of 16,349 patients were recorded in the Japanese Interferon Database. After application of the exclusion criteria, 12,706 patients (3,578 [1,710 males, 1,868 females] on PEG-IFN alfa-2a; and 9,128 [4,652 males, 4,476 females] on PEG-IFN alfa-2b) were included in this analysis. The SVR rate in the PEG-IFN alfa-2b group was 62.0%, as compared with a rate of 55.1% in the PEG-IFN alfa-2a group (crude odds ratio =1.31; 95% confidence interval [CI]: 1.23 to 1.44). There was no significant difference in the adjusted SVR rates between the two groups (adjusted odds ratio =0.96; 95% CI: 0.88 to 1.05). Similar proportions of adverse events were observed in the two groups, with the exception of thrombocytopenia, retinopathy, and anemia.

          Conclusion

          There was no significant difference in the SVR rates and safety profile between chronic hepatitis C patients treated with the PEG-IFN alfa-2a and alfa-2b.

          Most cited references20

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          Randomized study of peginterferon-alpha2a plus ribavirin vs peginterferon-alpha2b plus ribavirin in chronic hepatitis C.

          Alessio Aghemo, Roberta D'Ambrosio, Roberta Soffredini … (2009)
          Ribavirin (RBV) combined with either pegylated interferon (PegIFN) alpha2a or PegIFNalpha2b is the standard of care for chronic hepatitis C virus (HCV) infection. Due to the lack of head-to-head studies, the 2 PegIFNs have not been directly compared. The endpoints of our study were safety and antiviral efficacy of the 2 regimens. Treatment-naïve patients with chronic hepatitis C were randomly (1:1) assigned after stratification for HCV genotype to receive either 1.5 mcg/Kg/week PegIFNalpha2b plus RBV 800-1200 mg/day or 180 mcg/week PegIFNalpha2a plus RBV 800-1200 mg/day for 24 or 48 weeks according to HCV genotype. The study was powered to detect a difference of at least 10% in safety and efficacy of the 2 regimens. The 212 patients on PegIFNalpha2a and the 219 patients on PegIFNalpha2b had similar baseline characteristics, including cirrhosis (20% vs 18%, respectively). By intention to treat, the 2 groups showed similar rates of treatment-related serious adverse events (1% vs 1%, respectively) and drop out rates for adverse effects (7% vs 6%, respectively). Overall, sustained virologic response (SVR) rate was higher in PegIFNalpha2a than in PegIFNalpha2b patients (66% vs 54%, respectively, P = .02), being 48% vs 32% in the 222 HCV-1 and -4 patients (P = .04), and 96% vs 82%, respectively, in the 143 HCV-2 patients (P = .01). PegIFNalpha2a independently predicted SVR in the logistic regression analysis (odds ratio, 1.88; 95% confidence interval: 1.20-2.96). Although the 2 regimens showed a similar safety profile, the PegIFNalpha2a-based treatment yielded significantly more SVR than PegIFNalpha2b. Copyright 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
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            Simeprevir with peginterferon/ribavirin for treatment-naïve hepatitis C genotype 1 patients in Japan: CONCERTO-1, a phase III trial.

            Norio Hayashi, Namiki Izumi, Hiromitsu Kumada … (2014)
            In a Japanese Phase II study, the hepatitis C virus NS3/4A protease inhibitor simeprevir demonstrated potent antiviral activity and significantly improved sustained virologic response rates when added to peginterferon α-2a/ribavirin in treatment-naïve patients infected with hepatitis C virus genotype 1.
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              Peginterferon alpha-2a is associated with higher sustained virological response than peginterferon alfa-2b in chronic hepatitis C: systematic review of randomized trials.

              Tahany Awad, Mahasen Mabrouk, Christian Gluud … (2010)
              A combination of weekly pegylated interferon (peginterferon) alpha and daily ribavirin represents the standard of care for the treatment of chronic hepatitis C according to current guidelines. It is not established which of the two licensed products (peginterferon alpha-2a or peginterferon alfa-2b) is most effective. We performed a systematic review of head-to-head randomized trials to assess the benefits and harms of the two treatments. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and LILACS through July 2009. Using standardized forms, two reviewers independently extracted data from each eligible trial report. We statistically combined data using a random effects meta-analysis according to the intention-to-treat principle. We identified 12 randomized clinical trials, including 5,008 patients, that compared peginterferon alpha-2a plus ribavirin versus peginterferon alfa-2b plus ribavirin. Overall, peginterferon alpha-2a significantly increased the number of patients who achieved a sustained virological response (SVR) versus peginterferon alfa-2b (47% versus 41%; risk ratio 1.11, 95% confidence interval 1.04-1.19; P = 0.004 [eight trials]). Subgroup analyses of risk of bias, viral genotype, and treatment history yielded similar results. The meta-analysis of adverse events leading to treatment discontinuation included 11 trials and revealed no significant differences between the two peginterferons. Current evidence suggests that peginterferon alpha-2a is associated with higher SVR than peginterferon alfa-2b. However, the paucity of evidence on adverse events curbs the decision to definitively recommend one peginterferon over the other, because any potential benefit must outweigh the risk of harm.
              Article 0 comments Cited 35 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Drug Des Devel Ther
                Journal ID (iso-abbrev): Drug Des Devel Ther
                Journal ID (publisher-id): Drug Design, Development and Therapy
                Title: Drug Design, Development and Therapy
                Publisher: Dove Medical Press
                ISSN (Electronic): 1177-8881
                Publication date Collection: 2015
                Publication date (Electronic): 30 December 2014
                Volume: 9
                Pages: 283-290
                Affiliations
                [1 ]Department of Clinical Study and Informatics, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan
                [2 ]Ohta Nishinouchi Hospital, Fukushima, Japan
                [3 ]Department of Mathematics, Tokyo University of Science, Tokyo, Japan
                [4 ]The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Chiba, Japan
                Author notes
                Correspondence: Izumi Sato, 1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan, Tel +81 3 3202 7181 ext 2823, Fax +81 3 3202 7818, Email isato@ 123456hosp.ncgm.go.jp
                Article
                Publisher ID: dddt-9-283
                DOI: 10.2147/DDDT.S72245
                PMC ID: 4283988
                SO-VID: 311d98c8-f5bb-4830-a089-9799d0c61056
                Copyright © © 2015 Sato et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License
                License:

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Subject: Original Research

                ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine
                Keywords: sustained virologic response,hcv genotype,adverse events
                Data availability:
                ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine
                Keywords: sustained virologic response, hcv genotype, adverse events

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