Side effects of alpha-interferon therapy and impact on health-related quality of life in children with chronic viral hepatitis

Iorio, Raffaele; Pensati, Pasqualina; Botta, S.; Moschella, Sabino; Impagliazzo, Nicola; Vajro, Pietro; Vegnente, Angela

doi:10.1097/00006454-199710000-00016

Cited by 84 publications

(57 citation statements)

References 24 publications

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“…Most events, such as insomnia, irritability, and somnolence, were mild to moderate in severity. In addition, depression, a side effect not previously reported in children with chronic HCV infection given interferon alone 23 or with ribavirin, [18][19][20][21] occurred in 13% of subjects. This may reflect the fact that the protocols were designed to identify and monitor depressive symptoms.…”

Section: Discussionmentioning

confidence: 94%

Interferon Alfa-2b in Combination With Ribavirin for the Treatment of Chronic Hepatitis C in Children: Efficacy, Safety, and Pharmacokinetics *

et al. 2005

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Chronic hepatitis C virus (HCV) infection is usually asymptomatic in children, but significant liver disease may occur. We evaluated the efficacy, safety, and pharmacokinetics of interferon alfa-2b and ribavirin in children with chronic HCV. We determined the optimal ribavirin dose in an initial cohort of a phase 1 study and then subsequently used it, in combination with interferon alfa-2b, in a second cohort of this study and a phase 3 trial. The primary efficacy endpoint in all studies was sustained virological response, defined by undetectable serum HCV RNA 24 weeks after completion of therapy. All efficacy and safety analyses were performed on the intent-to-treat population. Children receiving interferon alfa-2b plus ribavirin 15 mg/kg/d in the phase 1 study had the maximum reduction in serum HCV RNA at treatment weeks 4 and 12 with an acceptable safety profile. This ribavirin dose was selected as optimal and used in all subsequent studies. In all, 46% (54/118) of optimally treated children achieved sustained virological response. Sustained virological response was significantly higher in children with HCV genotype 2/3 (84%) than in those with HCV genotype 1 (36%). Adverse events led to dose modification in 37 (31%) and discontinuation in 8 (7%). Multiple-dose interferon alfa-2b and ribavirin peak and trough concentrations and area-under-the-curve were similar between children and adults. In conclusion, interferon alfa-2b in combination with ribavirin is effective and safe in children with chronic hepatitis C virus. (HEPATOLOGY 2005;42:1010-1018.) H epatitis C virus (HCV) infection is a global health problem affecting an estimated 170 million individuals worldwide. Although our understanding about the natural history and pathobiology of HCV infection in children is incomplete, it has been associated with significant liver disease, including chronic hepatitis, cirrhosis, and hepatocellular carcinoma in this population. 1-4 Approximately 10% to 20% of adults 5 and 36% of children 6 treated with interferon alone achieve long-term virological remission. The addition of ribavirin to interferon-based regimens markedly improves virological responses in adults. 7,8 Limited data are available regarding the use of interferon alfa with ribavirin in children. Therefore, the aim of our studies was to evaluate the efficacy, safety, and pharmacokinetics of interferon alfa-2b in combination with ribavirin for the treatment of chronic HCV infection in children. Patients and Methods Study DesignA clinical program consisting of two studies was initiated to evaluate the efficacy, safety, and pharmacokinetics of interferon alfa-2b (Intron A, Schering-Plough, KenAbbreviations: HCV, hepatitis C virus; MIU, million international units; PCR, polymerase chain reaction; TSH, thyroid-stimulating hormone; ALT, alanine aminotransferase; SVR, sustained virological response. From the

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Section: Discussionmentioning

confidence: 94%

Interferon Alfa-2b in Combination With Ribavirin for the Treatment of Chronic Hepatitis C in Children: Efficacy, Safety, and Pharmacokinetics *

et al. 2005

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“…Up till now IFN-α is the therapy of first choice for children with chronic hepatitis B in Poland. However the treatment with IFN-α is uncomfortable (especially in children) and has many different side effects [8] . Lamivudine is the first oral antiviral therapy for chronic hepatitis B.…”

Section: Discussionmentioning

confidence: 99%

501 Lamivudine therapy in children with chronic hepatitis B

Liberek¹,

Szaflarska-Popławska²,

Korzon³

et al. 2006

Journal of Hepatology

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“…Less common, but of concern, is the risk for de novo autoimmune disease. These side effects are mostly limited to the treatment period [3,4].…”

Section: Interferonmentioning

confidence: 99%

Update on the Management of Pediatric Chronic Hepatitis B

Erlichman

Haber

2011

Curr Hepatitis Rep

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A primary challenge in the management of pediatric chronic hepatitis B (CHB) is the lack of established child-specific guidelines. Treatment decisions for children with CHB are extrapolated from the robust adult-focused treatment and management guidelines. However, the rationale for treating children differs from adults, and appropriate patient selection for treatment is imperative to avoid mutant virus development and an indefinite treatment course. Few approved therapies exist for children less than 10 years of age, a group who may benefit greatly from novel and effective therapeutics. It is hoped this gap will be met in the near future, as the field of CHB is rapidly evolving and new therapeutics come to market. This review focuses on the currently available pediatric data regarding treatment for CHB, and draws comparisons with adult-focused data where applicable.

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Side effects of alpha-interferon therapy and impact on health-related quality of life in children with chronic viral hepatitis

Abstract: Children have a low risk of developing severe IFN-induced side effects. Adverse reactions and worsening of health-related quality of life were tolerable and did not seem to be a limiting factor for IFN therapy in young candidates.

Cited by 84 publications

References 24 publications

Interferon Alfa-2b in Combination With Ribavirin for the Treatment of Chronic Hepatitis C in Children: Efficacy, Safety, and Pharmacokinetics *

Interferon Alfa-2b in Combination With Ribavirin for the Treatment of Chronic Hepatitis C in Children: Efficacy, Safety, and Pharmacokinetics *

501 Lamivudine therapy in children with chronic hepatitis B

Update on the Management of Pediatric Chronic Hepatitis B

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