Peg-Interferon Alpha-2a versus Peg-Interferon Alpha-2b in Nonresponders with HCV Active Chronic Hepatitis: A Pilot Study

Clinic of Infectious Diseases, University of Foggia, Foggia, Italy.
Journal of interferon & cytokine research: the official journal of the International Society for Interferon and Cytokine Research (Impact Factor: 2). 09/2008; 28(10):623-9. DOI: 10.1089/jir.2007.0116
Source: PubMed


The efficacy and tolerability of Peg-Interferon alpha-2a (Peg-IFNalpha-2a) versus Peg-Interferon alpha-2b (Peg-IFNalpha-2b) were compared in a patient cohort with hepatitis C virus (HCV)-related active chronic hepatitis, unresponsive to previous antiviral treatment with standard IFN (6 MU three times/week) plus ribavirin (10.6 mg/kg/day) for a period of at least 3 months.
A total of 143 patients were enrolled and randomized into two treatment groups (A-B). Group A (71 patients) received one vial of Peg-IFNalpha-2a weekly (180 microg) subcutaneously whereas Group B (72 patients) received 1.5 microg/kg of Peg-IFNalpha-2b weekly subcutaneously. Interferon was combined with ribavirin (15 mg/kg/day) in both groups and all patients who demonstrated nondetectable HCV-RNA or a >or=2(log) reduction in viral load at week 12, were treated for 48 weeks, with a 24-week follow up.
Group A (10/71) and Group B (8/72) patients discontinued treatment due to severe side effects. At the end of therapy, HCV-RNA was undetectable in 17/71 (23.9%) Group A and in 19/72 (26.4%) of Group B patients. When terminating follow up, a sustained virological response was observed in 14/71 in Group A (19.7%) and 13/72 in Group B (18.0%).
Within the limits of the relatively small sample size, Peg-IFNalpha-2a and Peg-IFNalpha-2b demonstrated nonstatistically significant differences in effectiveness in patients nonresponsive to previous antiviral treatment.

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Available from: Gaetano Scotto, Jun 16, 2015
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    • "We identified seven papers out of 623 found (databases citation without duplicates plus manual searches) which met our inclusion criteria described above: 1) Ascione, 2009 [41] 2) Rumi, 2009 [42] 3) McHutchison, 2009 [43] 4) Yenice, 2006b [44] 5) Scotto, 2008 [45] 6) Berak, 2007 [46] and 7) Kolakowska, 2008 [47]. Not all papers evaluated all patients’ genotypes, therefore, for genotype 2/3, four papers were included in the meta-analysis and for genotype 1, six papers were evaluated. "
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    ABSTRACT: Chronic hepatitis C affects approximately 170 million people worldwide, and thus being one of the main causes of chronic liver disease. About 20% of patients with chronic hepatitis C will develop cirrhosis over 20 years, and present an increased risk of developing hepatic complications. Sustained virological response (SVR) is associated with a better prognosis compared to untreated patients and treatment failures.The objective of this analysis was to compare treatment costs and outcomes of pegylated interferon-alfa-2a versus pegylated interferon-alfa-2b, both associated with ribavirin, in the therapeutic scheme of 24 weeks and 48 week for hepatitis C genotypes 2/3 and genotype 1, respectively, under the Brazilian Public Health System (SUS) scenario. To project disease progression, a Markov model was built based on clinical stages of chronic disease. A Delphi panel was conducted to evaluate medical resources related to each stage, followed by costing of related materials, services, procedures and pharmaceutical products. The evaluation was made from a public payer perspective. The source used for costing was government reimbursement procedures list (SAI/SIH--SUS). Drug acquisition costs were obtained from the Brazilian Official Gazette and "Banco de Precos em Saude" (government official source). It was assumed a mean patient weight of 70 kg. Costs were reported in 2011 Brazilian Reais (US$1 [almost equal to] $Brz1.80). A systematic review followed by a meta-analysis of the 7 identified randomized controlled trials (RCTs) which compared pegylated interferons, was conducted for obtaining relative efficacy of both drugs: for genotype 2/3, mean rate of SVR was 79.2% for peginterferon-alfa-2a and 73.8% for peginterferon-alfa-2b. For genotype 1, SVR mean rate was 42.09% versus 33.44% (peginterferon-alfa-2a and peginterferon-alfa-2b respectively). Time horizon considered was lifetime. Discount rate for costs and outcomes was 5%, according to Brazilian guidelines for Health Technology Assessment (HTA). Analysis showed that peginterferon-alfa-2a is a dominant therapy compared to peginterferon-alfa-2b for genotype 1 ($Brz 4,345 savings and 0.10 LY/0.25 QALY gains) as well for genotype 2/3 ($Brz 8,001 savings and 0.16 LY/0.39 QALY gains). Projections indicated that for each 1000 patients treated with peginterferon-alfa-2a instead of peginterferon-alfa-2b, the amount of resources saved would be of $Brz 4.3 million for genotypes 2/3 and up to $Brz 8 million for genotype 1. These findings suggest that treatment with peginterferon-alfa-2a is more effective and less costly when compared to peginterferon-alfa-2b under SUS perspective in Brazil.
    Full-text · Article · Oct 2013 · Cost Effectiveness and Resource Allocation
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    • "Of these 1166 abstracts, 45 were retrieved, 6 [18] [19] [20] [21] [22] [23] were excluded because they were published as abstract proceedings, 1 [24] was excluded because patients received monotherapy of peginterferon í µí»¼-2a/2b at the first 4 weeks, 1 [25] was excluded because it was not designed randomly, 1 [26] was excluded because patients received 1.0 í µí¼‡g/kg peginterferon í µí»¼-2b, 1 [27] was excluded because it included patients with HCV/HIV coinfection, and 1 [28] was excluded because duplicate data from the same medical center were published. Finally, 7 trials [5] [6] [7] [8] [9] [10] [11] met our inclusion criteria (Table 1). Totally 1845 and 1823 patients were randomly treated with peginterferon í µí»¼-2a and peginterferon í µí»¼-2b, respectively, both plus ribavirin. "
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    ABSTRACT: Background. The efficacy and tolerability of peginterferon α -2a and peginterferon α -2b in chronic hepatitis C (CHC) patients remain controversial. Methods. PubMed, Ovid, and Cochrane libraries were electronically searched until August 30, 2012. Studies that met the inclusion criteria were systematically evaluated by two reviewers independently. Results. The overall sustained virologic response (SVR) rate of the peginterferon α -2a group was significantly higher than that of the peginterferon α -2b group (46.7% versus 42.4%, P value = 0.01). The same tendency was observed for naïve, genotype 1/4, and genotype 2/3 patients. The early virologic response (EVR) and end-of-treatment response (ETR) rates were significantly higher in the peginterferon α -2a group than in the peginterferon α -2b group (56.1% versus 49.8%, P < 0.0001; 67.9% versus 56.6%, P < 0.00001, resp.). Peginterferon α -2a had a significantly lower discontinuation rate than peginterferon α -2b (27.9% versus 33.9%, P < 0.0001) in naïve patients. In both naïve CHC and hepatitis C virus genotype 1 patients, peginterferon α -2a had a higher relapse rate than peginterferon α -2b. Conclusions. Peginterferon α -2a has superior efficacy with higher EVR, ETR, and SVR than peginterferon α -2b for CHC patients, both plus ribavirin. Peginterferon α -2a might obtain a similar or even lower discontinuation rate than peginterferon α -2b. However, peginterferon α -2a had a higher relapse rate than peginterferon α -2b.
    Full-text · Article · Apr 2013 · Gastroenterology Research and Practice
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    • "All eight trials assessing peginterferon alpha-2a plus ribavirin among treatment-experienced patients provided data on SVR;4–9,24,25 two also provided data on the rate of relapse,7,9 and three also provided data on treatment discontinuations.7–9 All six trials assessing peginterferon alpha-2b plus ribavirin among treatment-experienced patients provided data on SVR;24,25,28–31 one also provided data on the rate of relapse,28 and one provided data on treatment discontinuations.28 "
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    ABSTRACT: With the development of new direct acting antiviral (DAA) therapy for hepatitis C, the backbone peginterferon alpha used may be of importance in maximizing treatment outcomes. To this end, the rates of sustained virologic response (SVR), relapse, and treatment discontinuation among hepatitis C genotype 1-infected patients given peginterferon alpha-2a plus ribavirin or peginterferon alpha-2b plus ribavirin were determined using a meta-analysis. Randomized trials examining peginterferon alpha-2a or peginterferon alpha-2b co-administered with ribavirin for 48 weeks were included. Data were extracted on SVR, relapse, and treatment discontinuations for treatment-naïve and treatment-experienced patients. Pooled proportions using fixed and random effects meta-analysis were calculated. Twenty-six trials provided data on patients treated with peginterferon alpha-2a plus ribavirin, and 19 trials provided data on patients treated with peginterferon alpha-2b plus ribavirin. Five trials were direct head-to-head evaluations. In the subset of trials that included head-to-head evaluations, no significant differences were observed between the two treatments for treatment-naïve (relative risk [RR]: 1.07, 95% confidence intervals [CI]: 0.97-1.18) and treatment-experienced patients (RR: 1.27, 95% CI: 0.58-2.77). Using only active trial arms, a larger proportion of the treatment- naïve patients who were provided peginterferon alpha-2a plus ribavirin achieved a SVR (47%), which is greater than that of treatment-naïve patients who were provided peginterferon alpha- 2b plus ribavirin (40% SVR achievement); however, a larger proportion of treatment- experienced patients who were provided peginterferon alpha-2b plus ribavirin achieved a SVR (16%) when compared with treatment-experienced patients given peginterferon alpha-2a plus ribavirin (12% SVR achievement). A larger proportion of relapses occurred among both treatment-naïve and treatment-experienced patients given peginterferon alpha-2a plus ribavirin, when compared with treatment-naïve and treatment-experienced patients taking peginterferon alpha-2b plus ribavirin. The proportion of patients discontinuing treatment was greater among treatment-naïve patients taking peginterferon alpha-2a plus ribavirin, but smaller among treatment-experienced patients. There are small differences in treatment outcomes for different types of peginterferon- alpha. Patient status and complexity of administration may differentiate clinical outcomes.
    Full-text · Article · Feb 2012 · Clinical and Experimental Gastroenterology
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