Efficacy and Safety of Peginterferon-Alpha 2b and Ribavirin Combination Therapy in Children With Chronic Hepatitis C Infection

Pediatric Liver Service, La Paz University Hospital, Madrid, Spain.
The Pediatric Infectious Disease Journal (Impact Factor: 2.72). 02/2008; 27(2):142-8. DOI: 10.1097/INF.0b013e318159836c
Source: PubMed


Interferon (IFN)-alpha2b plus ribavirin is approved for treatment of hepatitis C in children; however, little is known about efficacy and tolerability of pegylated IFN (PEG-IFN)-alpha2b in this population. The objective of this study was to test the efficacy and safety of PEG-IFN-alpha2b plus ribavirin in children with chronic hepatitis C.
Thirty children 3-16 years of age who had detectable hepatitis C virus (HCV) RNA for >or=3 years after exposure and elevated alanine aminotransferase values received PEG-IFN-alpha2b 1.0 microg/kg/wk plus ribavirin 15 mg/kg/d for 24 weeks (genotype 2/3) or 48 weeks (genotype 1/4). The primary endpoint was sustained virologic response (SVR), defined as undetectable HCV RNA (<50 IU/mL) at week 24 of follow-up.
SVR was achieved in 50% of patients (3/3 genotype 3; 12/27 genotype 1/4). At week 12, 52% of patients were HCV RNA negative and 72% had a >2 log10 decrease in viral load, compared with baseline; 87% and 71% of these patients, respectively, attained an SVR. Therapy was discontinued in 3 patients as a result of adverse events. No patient required ribavirin dose reduction; PEG-IFN-alpha2b dose was reduced in 23% of patients to manage neutropenia.
Combination therapy with PEG-IFN-alpha2b and ribavirin treatment was effective in children with chronic hepatitis C. Virologic status at week 12 identified future responders and nonresponders. PEG-IFN-alpha2b and ribavirin were reasonably well tolerated, with no unexpected or permanent adverse effects. Further studies are needed to identify the optimum treatment regimen for this patient population.

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    • "This retrospective study was performed in a large unique monocentric cohort of 82 pediatric patients infected with difficult-to-treat HCV genotypes 1 and 4, who were treated with peg-IFN and RBV. Up to now, the results of several trials in children and adolescents with chronic hepatitis C using peg-IFNα-2a or 2b in combination with RBV have been reported [13–17]. As expected, based on adult studies, the rates of virological response were significantly lower in patients infected with HCV genotypes 1 and 4 than in patients infected with other genotypes. "
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    ABSTRACT: IL-28B polymorphisms are predictors of response to therapy in adults infected with hepatitis C. We do not know whether they are markers of response to therapy in children and adolescents. The aim of this study was to determine whether single-nucleotide polymorphisms (SNPs) in the IL-28B gene could influence the probability of response to therapy compared with other known baseline prognostic factors and correlate with clinical findings in pediatric patients infected with hepatitis C virus (HCV) genotypes 1 or 4. We determined three SNPs of IL-28B (rs12979860, rs12980275, and rs8099917) in 82 patients with chronic HCV infection treated with pegylated interferon alpha and ribavirin (peg-IFNα/RBV). Treatment response and clinical data were analyzed. Overall, sustained virological response (SVR) was achieved by 45 % of patients infected with difficult-to-treat HCV genotypes 1 and 4. Except for IL-28B polymorphisms, there was no association of SVR with any other clinical data. IL-28B rs12979860 CC [odds ratio (OR), 6.81; p = 0.001] and rs8099917 TT (OR, 3.14; p = 0.013) genotypes were associated with higher SVR rates. IL-28B rs12980275 was not significantly associated with SVR (p = 0.058). Only the distribution between CC and CT-TT genotypes of rs12979860 significantly differentiated patients achieving early virological response (EVR) (OR, 10.0; p = 0.011). Children with the rs12979860 CC genotype had significantly higher baseline viral load compared with CT-TT patients (p = 0.010). In children and adolescents chronically infected with HCV genotypes 1 and 4, IL-28B rs12979860 and rs8099917 polymorphisms were the only predictors of response to peg-IFN/RBV.
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    • "We were unable to bring out an accurate conclusion about the impact of INF on the impairment of growth velocity, because we had a limited number of children involved in this study. Today there are serious studies that assess the growth of children during the treatment with INF and 5 years later without treatment [29,30]. "
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    • "The authors do not mention how the infection was acquired. Based on previous experiences [14] [15], patients with genotype 2 or 3 with a low viral load (HCV-RNA less than 600,000 IU/ml) were treated for 24 weeks, whereas children infected with genotype 1 or 4, and genotype 3 with a high viral load (HCV-RNA greater than 600,000 IU/ml) received 48 weeks of therapy. The primary endpoint was a sustained virological response (SVR), defined as the absence of serum HCV-RNA after 24 weeks from therapy; secondary end-points were rapid virological response (RVR), defined as undetectable HCV-RNA at week 4 of treatment, and early virological response (EVR), defined as complete absence of serum HCV-RNA at week 12 of therapy. "

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