Treatment of Chronic Hepatitis C Virus Infection in Children. A Position Paper by the Hepatology Committee of European Society of Paediatric Gastroenterology, Hepatology and Nutrition
Indolfi Giuseppe; Hierro, Loreto; Dezsofi, Antal; Jahnel, Jörg; Debray, Dominique; Hadzic, Nedim; Czubowski, Piotr; Gupte, Girish; Mozer-Glassberg, Yael; van der Woerd, Wendy; Smets, Françoise; Verkade, Henkjan J; Fischler, Bjorn
Journal of Pediatric Gastroenterology and Nutrition: Post Acceptance: December 28, 2017
doi: 10.1097/MPG.0000000000001872
What is known
Direct-acting antiviral drugs active against hepatitis C virus (HCV) infection are highly effective and safe for treatment of adults with chronic HCV infection.
Pegylated interferon (PEG IFN) and ribavirin are no more recommended for treatment of adults.
What is new
The fixed-dose combination of sofosbuvir/ledipasvir and the combination of sofosbuvir and ribavirin have been recently approved for treatment of children ≥12 years or weighing >35 Kg with chronic HCV genotype 1, 4, 5 and 6 and 2 and 3 infection, respectively.
PEG IFN and ribavirin are no more recommended for treatment of children older than 12 years of age.
ABSTRACT
Objectives:
In 2017, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) approved the use of the fixed-dose combination of ledipasvir/sofosbuvir and of the combination of sofosbuvir and ribavirin for treatment of adolescents (12–17 years, weighing more than 35 kg) with chronic hepatitis C virus (HCV) genotype 1, 4, 5 and 6 and genotype 2 and 3 infections, respectively. Although trials with direct acting antivirals (DAAs) are ongoing for younger children, the only available treatment in US and Europe for those < 12 years is still the dual therapy of pegylated interferon (PEG IFN) and ribavirin. There is currently a lack of a systematic approach to the care of these patients. The Hepatology Committee of the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) developed an evidence-based position paper for the management of chronic HCV infection in children.Methods:A systematic literature search and meta-analysis were performed using MEDLINE and Embase from June 1, 2007 to June 1, 2017. The approach of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) was applied to evaluate outcomes. ESPGHAN Hepatology Committee members voted on each recommendation, using the nominal voting technique.Results:The efficacy of the different DAAs combinations tested was higher, the relapse and the treatment discontinuation rates lower when compared to PEG IFN and ribavirin.Conclusions:This position paper addresses therapeutic management issues including goals, endpoints, indications, contra-indications and the optimal treatment regimen in children with chronic HCV infection.
Objectives:
In 2017, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) approved the use of the fixed-dose combination of ledipasvir/sofosbuvir and of the combination of sofosbuvir and ribavirin for treatment of adolescents (12–17 years, weighing more than 35 kg) with chronic hepatitis C virus (HCV) genotype 1, 4, 5 and 6 and genotype 2 and 3 infections, respectively. Although trials with direct acting antivirals (DAAs) are ongoing for younger children, the only available treatment in US and Europe for those < 12 years is still the dual therapy of pegylated interferon (PEG IFN) and ribavirin. There is currently a lack of a systematic approach to the care of these patients. The Hepatology Committee of the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) developed an evidence-based position paper for the management of chronic HCV infection in children.
Methods:
A systematic literature search and meta-analysis were performed using MEDLINE and Embase from June 1, 2007 to June 1, 2017. The approach of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) was applied to evaluate outcomes. ESPGHAN Hepatology Committee members voted on each recommendation, using the nominal voting technique.
Results:
The efficacy of the different DAAs combinations tested was higher, the relapse and the treatment discontinuation rates lower when compared to PEG IFN and ribavirin.
Conclusions:
This position paper addresses therapeutic management issues including goals, endpoints, indications, contra-indications and the optimal treatment regimen in children with chronic HCV infection.
Objectives:
In 2017, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) approved the use of the fixed-dose combination of ledipasvir/sofosbuvir and of the combination of sofosbuvir and ribavirin for treatment of adolescents (12–17 years, weighing more than 35 kg) with chronic hepatitis C virus (HCV) genotype 1, 4, 5 and 6 and genotype 2 and 3 infections, respectively. Although trials with direct acting antivirals (DAAs) are ongoing for younger children, the only available treatment in US and Europe for those < 12 years is still the dual therapy of pegylated interferon (PEG IFN) and ribavirin. There is currently a lack of a systematic approach to the care of these patients. The Hepatology Committee of the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) developed an evidence-based position paper for the management of chronic HCV infection in children.
Methods:
A systematic literature search and meta-analysis were performed using MEDLINE and Embase from June 1, 2007 to June 1, 2017. The approach of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) was applied to evaluate outcomes. ESPGHAN Hepatology Committee members voted on each recommendation, using the nominal voting technique.
Results:
The efficacy of the different DAAs combinations tested was higher, the relapse and the treatment discontinuation rates lower when compared to PEG IFN and ribavirin.
Conclusions:
This position paper addresses therapeutic management issues including goals, endpoints, indications, contra-indications and the optimal treatment regimen in children with chronic HCV infection.
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