Ledipasvir/sofosbuvir ± ribavirin for 12 or 24 weeks is safe and effective in children 6–11 years old with chronic hepatitis C infection

Murray, Karen F.; Balistreri, William F.; Bansal, Sanjay; Whitworth, Suzanne; Evans, Helen; González‐Peralta, Regino P.; Wen, Jessica; Massetto, Benedetta; Kersey, Kathryn; Zhu, Yu; Garrison, K.D.; Svarovskaia, Evguenia; Brainard, Diana M.; Arnon, Ronen; Gillis, Lynette A.; Jonas, M.; Lin, Chung-Chi; Narkewicz, Michael R.; Schwarz, K. B.; Rosenthal, P

doi:10.1016/s0168-8278(17)30377-x

Cited by 12 publications

(14 citation statements)

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“…The mean age of patients was 12.5 years. Male outnumbered female, the ration was about 2:1, same as in other study conducted in USA, UK, Canada 6…”

Section: Discussionsupporting

confidence: 75%

“…All patients were started on Sofosbuvir 400 mg/ledipasvir 90mg once daily. If patients were less than 12 years, half the dose was given 6. Ribavirin 10-15 mg/kg/day was added if patient was INF-experienced or had established cirrhosis 7…”

Section: Methodsmentioning

confidence: 99%

“…In April 2017, the FDA had finally approved the use of Sofosbuvir/Ledipasvir in adolescence, more than 12 years,5 further studies evaluated its use for children 6-11ys with high efficacy, and safety 6…”

Section: Introductionmentioning

confidence: 99%

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The effectiveness of oral antiviral (Sofosbuvir/Ledipasvir) in treating children with HCV infection

Al-Kaaby¹,

Al-Ethawi²

2018

Pak J Med Sci

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Objectives:To determine the efficacy of (Sofosbuvir/ledipasvir) in treating children with HCV infection.Methods:This study was conducted at Gastroenterology, Hepatology Center /Pediatrics department and the Central Child Teaching Hospital, Baghdad / Iraq from April 2017 to January 2018. Patients with positive HCV PCR, aged 7 to 18 years were enrolled. History, clinical examinations and investigations were conducted. HCV genotyping was done (if affordable). Sofosbuvir/Ledipasvir was given to all patients once daily. Ribavirin was added for INF-experienced patients or with established cirrhosis. Follow up with liver function and renal function and PCR was done at 12 weeks (end of treatment); then after 12 weeks post treatment (SVR12). Total duration of therapy was 12 weeks, extended to 24 in cases with established cirrhosis. Computer program SPSS version 20 was used for data analysis.Results:The number of patients was 22, with mean age of 12.5 years, 14 boys (63.6%), and 8 girls (36.4%). Genotype 1 was the dominant type (75%). SVR 12 was achieved in 20 patients (90.9%), the remaining two (9.1%) had partial virological response. HBV co-infection was found in five cases; they were kept on Entecavir during the course of treatment. All achieved SVR12 for HCV with decrease in titer of HBV. Even INF-experienced patients (7 patients 31.8%) were responsive with SVR12. The treatment was well tolerated.Conclusion:Sofosbuvir/ledipasvir is effective in treating HCV in children, and is well tolerated.

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“…The mean age of patients was 12.5 years. Male outnumbered female, the ration was about 2:1, same as in other study conducted in USA, UK, Canada 6…”

Section: Discussionsupporting

confidence: 75%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

The effectiveness of oral antiviral (Sofosbuvir/Ledipasvir) in treating children with HCV infection

Al-Kaaby¹,

Al-Ethawi²

2018

Pak J Med Sci

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“…The preliminary results of the fixed-dose combination of ledipasvir/sofosbuvir in children aged 6 to 11 years old was presented at the International Liver Congress in 2017[ 47 ]. This prospective, open-label, uncontrolled trial enrolled 90 patients, all of whom received ledipasvir (45 mg) and sofosbuvir (200 mg) once daily for 12 wk.…”

Section: Direct-acting Antiviral Therapymentioning

confidence: 99%

Hepatitis C virus infection in children in the era of direct-acting antiviral

Pawłowska

Sobolewska-Pilarczyk

Domagalski

2018

WJG

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Hepatitis C virus (HCV) infection remains an important global health problem with chronic infection affecting approximately 11 million children worldwide. The emergence of direct-acting antiviral (DAA) therapies and the development of non-invasive methods for the determination of liver fibrosis will significantly improve the management of paediatric patients with chronic HCV infection in subsequent years. For paediatric patients, a new era of highly effective DAA agents is beginning, and the first results of available clinical trials are very promising. In this era, the identification and monitoring of patients continues to be an important issue. The availability of non-invasive serological and imaging methods to measure hepatic fibrosis enables the identification of patients with significant or advanced liver fibrosis stages. This article summarizes the current data on the epidemiology and progress of research aimed to evaluate the new therapies and non-invasive methods for liver injury in paediatric patients with chronic hepatitis C.

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“…In einer weiteren Studie wurden 6-bis 11-jährige mit HCV-Genotyp 1, 3 und 4 infizierte Kinder für 12 Wochen mit Sofosbuvir/Ledipasvir ± Ribavirin in halber Dosierung behandelt (200 mg Sofosbuvir, 45 mg Ledipasvir und Ribavirin gewichtsadaptiert). Die Ansprechraten waren exzellent und die Therapie wurde ohne schwerwiegende Nebenwirkungen sehr gut vertragen [17]. Weitere Kohorten mit Kindern im Alter von 3-5 Jahren (< 17 kg) werden aktuell evaluiert.…”

Section: Hcv-infizierte Kinderunclassified

Aktuelle Therapie der Hepatitis C: Wo stehen wir 2018?

Peiffer¹,

Zeuzem²

2018

Gastroenterologie up2date

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Ledipasvir/sofosbuvir ± ribavirin for 12 or 24 weeks is safe and effective in children 6–11 years old with chronic hepatitis C infection

Cited by 12 publications

References 0 publications

The effectiveness of oral antiviral (Sofosbuvir/Ledipasvir) in treating children with HCV infection

The effectiveness of oral antiviral (Sofosbuvir/Ledipasvir) in treating children with HCV infection

Hepatitis C virus infection in children in the era of direct-acting antiviral

Aktuelle Therapie der Hepatitis C: Wo stehen wir 2018?

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