Treatment of Chronic Hepatitis C Virus Infection in Children

Indolfi, Giuseppe; Hierro, Loreto; Dezsőfi, Antal; Jahnel, Jörg; Debray, Dominique; Hadžić, Nedim; Czubowski, Piotr; Gupte, Girish; Mozer‐Glassberg, Yael; Woerd, Wendy Van der; Smets, Françoise; Verkade, Henkjan J.; Fischler, Björn

doi:10.1097/mpg.0000000000001872

Cited by 105 publications

(87 citation statements)

References 65 publications

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“…In children infected with GT2 and GT3, the SVR rate was approximately 90%; with GT1 and GT4, the SVR rate was approximately 48% 13, 25. Treatment is associated with a high incidence of undesirable AEs, such as anemia, neutropenia, leukopenia, and depression 11, 25…”

Section: Discussionmentioning

confidence: 99%

“…The European Medicines Agency and the FDA have approved the use of sofosbuvir with RBV for adolescents with chronic GT2 or GT3 infection and the fixed‐dose combination of sofosbuvir plus ledipasvir for adolescents with chronic GT1, GT4, GT5, or GT6 infection 1, 2, 13. In clinical trials,26, 27 adult formulations of both sofosbuvir‐based regimens had plasma exposures in adolescent patients that were comparable to those in adults, with no severe AEs or laboratory abnormalities.…”

Section: Discussionmentioning

confidence: 99%

“…Current guidance from the joint American Association for the Study of Liver Diseases and Infectious Diseases Society of America, the European Association for the Study of the Liver, and the Hepatology Committee of European Society of Pediatric Gastroenterology, Hepatology, and Nutrition no longer recommends pegylated IFN and RBV for the treatment of adolescents. For children 3 to 12 years of age, the guidance is to defer treatment until IFN‐free regimens are approved for this age group,1, 2, 13 whereas adolescents older than 12 years should receive sofosbuvir‐based regimens based on the recent approvals 1, 2, 13…”

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confidence: 99%

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Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir and With or Without Ribavirin for Adolescents With HCV Genotype 1 or 4

Leung

Wirth

Yao

et al. 2018

Hepatology Communications

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In adults, treatment of hepatitis C virus (HCV) infection with ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with or without dasabuvir (DSV) and ±ribavirin (RBV) results in high rates of sustained virologic response (SVR). However, these regimens have not been investigated in adolescents. This ongoing, open‐label, phase 2/3 study evaluated the pharmacokinetics, safety, and efficacy of OBV/PTV/r+DSV±RBV treatment for 12 weeks in adolescents infected with HCV genotype (GT) 1 without cirrhosis (part 1) and the safety and efficacy of OBV/PTV/r±DSV±RBV treatment for 12 or 24 weeks in adolescents infected with GT1 or GT4 without cirrhosis or with compensated cirrhosis (parts 1 and 2). Patients were 12‐17 years of age and treatment naive or interferon experienced. Treatment regimens were based on HCV GT and cirrhosis status. Endpoints were SVR at posttreatment week 12 (SVR12), adverse events (AEs), and pharmacokinetic parameters. Thirty‐eight adolescents were enrolled, 66% were female patients, and 76% were White; 42%, 40%, and 18% of patients had HCV GT1a, GT1b, and GT4 infections, respectively. Median age was 15 years (range, 12‐17 years), and 1 patient had cirrhosis. The SVR12 rate was 100% (38/38; 95% confidence interval [CI], 90.8%‐100%). No treatment‐emergent grade 3 or 4 laboratory abnormalities were reported. No serious AEs occurred on treatment, and no AEs led to study drug discontinuation. The most common AEs were headache (21%), fatigue (18%), nasopharyngitis (13%), pruritus (13%), and upper respiratory tract infection (11%). Intensive pharmacokinetic results showed OBV, PTV, DSV, and ritonavir drug exposures were comparable to those seen in adults. Conclusion: Treatment with OBV/PTV/r±DSV±RBV was well tolerated and highly efficacious in adolescents with HCV GT1 or GT4 infection.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir and With or Without Ribavirin for Adolescents With HCV Genotype 1 or 4

Leung

Wirth

Yao

et al. 2018

Hepatology Communications

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“…Approximately 7,500 new cases of CHC occur annually in the US from vertical transmission 9. There is increasing concern for horizontal transmission through injection drug use, especially among adolescents 10. HCV infection rates are rising among adolescents and young adults in the US, especially in eastern rural regions of the country.…”

Section: Clinical Course Of Hcv Infection In Pediatric Patientsmentioning

confidence: 99%

“…For patients with genotype 3, doses are the same but duration is 24 weeks (Table 1). 10 There are ongoing trials for treatment with these agents for younger children. The current recommendation from the Hepatology Committee of the European Society of Pediatric Gastroenterology, Hepatology, and Nutrition (ESP-GHAN) is to consider waiting until younger children are old enough to receive approved therapy, or use these medications off-label in young children with severe disease (Table 2).…”

Section: Medical Therapy For Pediatric Patients With Chcmentioning

confidence: 99%

Clinical utility of ledipasvir/sofosbuvir in the treatment of adolescents and children with hepatitis C

Yang

Goel

Ahmed

2018

AHMT

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Chronic infection with hepatitis C virus (HCV) affects an estimated 0.1%–2% of the pediatric population in the United States. While the clinical course in young children is indolent, adolescents who contract HCV have a disease course similar to adults, with a 26-fold increased risk of chronic liver disease-associated mortality, hepatocellular carcinoma, and need for curative liver transplantation. Furthermore, adolescent patients are entering childbearing age and carry a risk of passing HCV to their offspring via vertical transmission. Pegylated-interferon (PEG-IFN) with ribavirin was previously the only treatment option for pediatric patients with chronic hepatitis C (CHC), but the high likelihood of adverse reactions and subcutaneous route of administration limited its use and efficacy. Recently, the direct-acting antivirals (DAAs) ledipasvir (LDV) and sofosbuvir (SOF) were approved for adolescents with CHC. This review discusses the natural history of CHC in pediatric patients, data supporting LDV/SOF in adolescents, and ongoing studies evaluating DAAs in pediatric patients.

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Adolescents with chronic hepatitis C might be good candidates for direct‐acting antiviral therapy

Sato

Yamazaki

Kanayama

et al. 2022

Clinical Case Reports

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Treatment of Chronic Hepatitis C Virus Infection in Children

Abstract: This position paper addresses therapeutic management issues including goals, endpoints, indications, contraindications, and the optimal treatment regimen in children with chronic HCV infection.

Cited by 105 publications

References 65 publications

Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir and With or Without Ribavirin for Adolescents With HCV Genotype 1 or 4

Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir and With or Without Ribavirin for Adolescents With HCV Genotype 1 or 4

Clinical utility of ledipasvir/sofosbuvir in the treatment of adolescents and children with hepatitis C

Adolescents with chronic hepatitis C might be good candidates for direct‐acting antiviral therapy

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