Glecaprevir and pibrentasvir (G/P) administered in combination is a short-duration pangenotypic regimen that has been shown to be efficacious and have a favorable safety profile in adolescents with chronic hepatitis C virus (HCV) infection regardless of genotype, according to a study published in Hepatology.1
Worldwide, approximately 13.2 million children aged 1 to 15 years are chronically infected with HCV.2 HCV treatment options for these children are limited, and a pangenotypic, ribavirin-free regimen with shorter durations for pediatric patients is currently unavailable for this age group. However, a pangenotypic short regimen of G/P is approved to treat adults with chronic HCV infection and has demonstrated high cure rates in adults in clinical trials.4 Therefore, researchers conducted an ongoing phase 2/3, nonrandomized, open-label study evaluating the treatment combination in pediatric patients with chronic HCV infection (A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection [DORA]; ClinicalTrials.gov Identifier: NCT030671239).1
In the first part of this study, 47 adolescent patients aged 12 to 17 years old infected with HCV genotypes 1, 2, 3, or 4 were given an adult regimen of G/P (300 mg/120 mg) once daily for 8 to 16 weeks. The investigators found that all 47 (100%) patients achieved a sustained virologic response at 12 weeks following treatment (SVR12), and that no virologic failures or relapses occurred while on treatment. There were also no adverse events that led to treatment discontinuation, and no serious adverse events occurred.
The authors concluded that, “adolescent patients with chronic HCV infection treated with G/P achieved a comparable exposure to adults, 100% SVR12 rate, and safety profile consistent with that in adults.”1 They added, “this is the first pangenotypic regimen to demonstrate 100% efficacy within the adolescent population in as little as 8 weeks of treatment.”
Disclosure: This clinical trial was supported by AbbVie. Please see the original reference for a full list of authors’ disclosures.
1. Jonas MM, Squires RH, Rhee Sm, et al. Pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir in adolescents with chronic HCV: part 1 of the DORA study [published online June 29, 2019]. Hepatology. doi: 10.1002/hep.30840
2. Indolfi G, Hierro L, Dezsofi A, et al. 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. J Pediatr Gastroenterol Nutr. 2018;66:505-15.
3. AbbVie, Inc. Mavyret (glecaprevir/pibrentasvir) prescribing information. North Chicago, IL; 2017.