Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4

Abstract

Summary Direct‐acting antivirals have become available for treating chronic HCV (hepatitis C virus) infection in adults and, recently, in children at least 12 years old. Our aim was to investigate the safety and efficacy of combined sofosbuvir (SOF)/daclatasvir (DCV) for HCV Genotype 4 in children aged 8 to 18 years or weighing 17 kg or more. A total of 40 chronic HCV‐infected, treatment‐naïve children with well compensated livers were recruited from two sites. Patients received combined therapy of SOF (400 mg/d for patients weighing greater than 45 kg; 200 mg/d for patients weighing 17 to 45 kg) and DCV (60 mg/d for patients weighing greater than 45 kg; 30 mg/d for patients weighing 17 to 45 kg) for 12 weeks. They were followed up regularly by clinical examination and laboratory tests during treatment (weekly in the first month then monthly to the end of treatment), every 3 months for 6 months post‐treatment, and at 48 weeks post‐treatment. In our cohort, which included 45% of children below the age of 12 years (72.5% genotype 4 and 27.5% mixed genotype 4 and 1), end of treatment response (ETR) was 97.5%. Sustained virologic response for weeks 12 and 24 post‐treatment (SVR12 and SVR24) were 97.5% and 95%, respectively, on an intention to treat basis, and 100% and 100% for those who completed the study protocol. Observed side effects were mild and none required drug cessation. Combined SOF/DCV was found to be effective and safe for treating HCV Genotype 4‐infected children, 8 years of age and above.

Systematic review with meta‐analysis: the efficacy and safety of direct‐acting antivirals in children and adolescents with chronic hepatitis C virus infection

“…In total, 39 references met the inclusion criteria. Twenty‐eight papers were published as full‐text articles 3‐8,11‐32 and 11 as abstracts 33‐43 . Two studies were randomised clinical trials, 27,33 whereas all the other studies were nonrandomised studies.…”

Hepatitis C Virus Infection in Children and Pregnant Women: An Updated Review of the Literature on Screening and Treatments

“…The safety and efficacy term of the sofosbuvir plus daclatasvir combination has been demonstrated in 8 to 18-year-olds with genotype 4 HCV infection. 55 On April 30, 2019, the FDA approved the combination of glecaprevir and pibrentasvir for the treatment of 12 to 17year-olds who are infected with any of the six identified HCV genotypes, either without cirrhosis or with compensated cirrhosis. The safety and efficacy of glecaprevir-pibrentasvir in pediatric patients was evaluated in clinical trials of 47 patients with genotype 1, 2, 3, or 4 HCV infection without cirrhosis or with mild cirrhosis.…”

<p>Successful Treatment of Hepatitis C Virus Infection Using Direct-Acting Antiviral Agents (DAAs) in Adolescents with Kidney Transplantation: A Case Series</p>

“…17 Minor adverse events such as mild fever, fatigue, musculoskeletal pain, decreased appetite, itching and nasal congestion were reported in cases of previous use of DAAs in adolescents. 18 Other adverse events in adults were tinnitus, diarrhea, elevation in serum creatinine, abdominal pain, and unstable blood pressure. No such events were noted in our cases.…”