Glecaprevir/pibrentasvir in patients aged 3-17 years with chronic hepatitis C: Real-life data from the POLAC project.

OBJECTIVES

In this noncommercial, nonrandomized, open-label therapeutic program POLAC project, we aimed to analyze the efficacy and safety of the pangenotypic regimen glecaprevir/pibrentasvir (GLE/PIB) in children aged 3-17 years with chronic hepatitis C.

METHODS

Eligible patients for 8-week therapy with GLE/PIB were divided into two age groups. Patients above 12 years of age received tablets containing a fixed dose of 300/120 mg GLE/PIB, and patients below 12 years weighing 12-45 kg were treated with granule formula adjusted to patients' weight. The primary endpoint of the study was treatment efficacy, defined as sustained virologic response at 12 weeks posttreatment (SVR12, undetectable hepatitis C virus (HCV) RNA using a real-time polymerase chain reaction).

RESULTS

We included 63 patients, 21 received tablets, and 42 received the granules formula. Median age of the patients was 8 years (interquartile range, IQR 6-12). There were 37 (59%) males. Fifty-nine children (94%) were infected vertically. Most patients (43, 68%) had genotype 1 HCV. Four patients presented with significant fibrosis (F2-F3 METAVIR) at baseline, but there were no cases of cirrhosis. Sixty-two patients (98%) achieved SVR12. One patient was lost to follow-up before SVR12 evaluation; however, at the end of therapy, his HCV RNA levels were undetectable. Thirty-two patients (51%) had adverse events (AEs). There were 49 AEs possibly related to the treatment, all mild. The most frequent AEs included abdominal pain (14%), fatigue (11%), and pruritus (11%).

CONCLUSIONS

Our study confirms that 8 weeks of therapy with GLE/PIB in children with chronic hepatitis C is highly effective and safe.