Safety and efficacy of treatment with pegylated interferon alpha-2a with ribavirin in chronic hepatitis C genotype 4
Consorcio Hospital General Universitario de Valencia, Spain.Annals of hepatology: official journal of the Mexican Association of Hepatology (Impact Factor: 2.07). 01/2013; 12(1):30-5.
The hepatitis C virus (HCV) genotype is an important predictive outcome parameter for pegylated interferon plus ribavirin therapy. Most published therapeutic trials to date have enrolled mainly patients with HCV genotypes 1, 2 and 3. Limited studies have focused on genotype 4 patients, who have had a poor representation in pivotal trials. Our aim was to evaluate the efficacy and safety of treatment with standard dose pegylated interferon alfa-2a in combination with weight-based ribavirin in patients with chronic hepatitis C genotype 4. In this prospective observational study, 198 patients with HCV-4 were included in this study from February 2004 to August 2005,188 patients who received at least 1 dose of drugs were included in the ITT analysis and they were treated with pegylated interferon alfa-2a and ribavirin for 48 weeks. Baseline and demographic characteristics, response to treatment at weeks 12, 48 and 72, and the nature and frequency of adverse effects were analyzed. Virological response at week 12 was achieved in 144 patients (76.6%). Virological response at the end of treatment was present in 110 patients (58.5%). At week 72, 99 patients presented SVR (52.7%). The reported adverse events were similar to those found in the literature for treatments of similar dose and duration. In conclusion, combined treatment with pegylated interferon alfa-2a and ribavirin was well tolerated and effective in chronic hepatitis C genotype 4, yielding response rates between those reported for genotype 1 and those of genotypes 2-3.
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ABSTRACT: Due to advances in interferon (IFN) therapy for chronic hepatitis C, most elderly patients, and even many of those with advanced hepatic fibrosis, now achieve a sustained virological response (SVR). However, carcinogenesis remains problematic in these patients. Hence, we aimed to elucidate risk factors for hepatocarcinogenesis in SVR patients and to present an appropriate follow-up protocol for improving outcomes. We retrospectively studied 562 consecutive SVR patients for a median observation period of 4.8 years. Hepatocellular carcinoma was diagnosed in 31 patients (5.5 %). Respective cumulative incidences were 3.1, 10.1, and 15.9 % at 5, 10, and 15 years after completion of IFN therapy. The proportional hazards model identified moderate or advanced fibrosis stage, advanced age, habitual alcohol consumption, and alpha-fetoprotein elevation as determinants of carcinogenesis, with hazard ratios of 10.7 (p < 0.001), 4.1 (p < 0.01), 3.9 (p < 0.01), and 2.6 (p < 0.05), respectively. Carcinoma was diagnosed in 26 % of patients more than 10 years after completion of IFN therapy. Unexpectedly, F2 fibrosis was detected in 42 % of these patients. The 5-year survival rate was 93 % in the patients who had received periodic cancer screening but only 60 % in those who had not. We recommend that SVR patients be observed at 6-month intervals, at a minimum, to facilitate diagnosis at an early stage, for as long as possible after completion of therapy even if not at an advanced stage of fibrosis.Journal of Gastroenterology 12/2013; 49(11). DOI:10.1007/s00535-013-0921-z · 4.52 Impact Factor
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ABSTRACT: Hepatitis C virus (HCV) remains one of the leading causes of morbidity and mortality worldwide. Combined therapy with pegylated interferon (PEG-IFN) and ribavirin is the current standard of care treatment for HCV genotype 4. Two types of PEG-IFN are commercially available. The limited number of trials that were conducted for HCV genotype 4 and the few head to head comparisons make it impossible to know which is the best option? In this article we review all available PEG-IFN trials performed worldwide for HCV genotype 4 since 2004. Unless another molecule is developed as a standalone for the treatment of HCV, PEG-IFN will continue to be a source of debate.Liver international: official journal of the International Association for the Study of the Liver 02/2014; 34 Suppl 1(s1):24-8. DOI:10.1111/liv.12397 · 4.85 Impact Factor
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ABSTRACT: Pending the emergence and approval of an effective interferon-free regimen, pegylated interferon will remain an integral part of the treatment of genotype 4 hepatitis C virus (HCV). A new 20 kDa pegylated interferon has been developed in a cost-saving fungal-based system and is commercialized in Egypt at a quarter to a third of the price of conventional pegylated interferon. We hereby test the efficacy and safety of this novel cost-saving interferon. One hundred ninety-three consecutive treatment-naive patients with genotype 4 HCV were treated using the following regimen: subcutaneous 20 kDa pegylated interferon 160 μg once weekly plus oral ribavirin 1,000 or 1,200 mg daily (based on body weight <75 kg or ≥75 kg, respectively) for 48 weeks. A sustained virological response (SVR) of 51% was achieved. Interim responses included rapid virological response (RVR): 54%, early virological response (EVR): 78% (complete EVR: 71%, partial EVR: 7%), and end of treatment response: 63%. The most common adverse events were flu-like symptoms, dyspepsia, anorexia, and pruritus. Treatment-related serious adverse events were encountered in only 2 patients (1%). Discontinuation of treatment due to adverse events occurred in only 13 patients (7%). Multiple logistic regression analyses revealed the following factors as predictors of SVR: RVR (P<0.001), alpha-fetoprotein<upper limit of normal (ULN) (P=0.007), and early biochemical response (alanine aminotransferase <ULN at week 12, P=0.018). Hansenula-derived 20 kDa pegylated interferon alpha-2a is an effective and safe treatment for genotype 4 chronic HCV. These results highlight the presence of a less costly treatment for chronic HCV, pending the emergence of an effective inexpensive interferon-free regimen. A direct comparison with 40 kDa interferon remains essential to adequately compare the efficacy and safety.Journal of interferon & cytokine research: the official journal of the International Society for Interferon and Cytokine Research 04/2014; 34(9). DOI:10.1089/jir.2013.0127 · 2.00 Impact Factor
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