Safety and efficacy of glecaprevir/pibrentasvir in patients with chronic hepatitis C – data from an Austrian “real-life”-cohort

Introduction:

The combination of the two pangenotypic direct-acting antivirals glecaprevir and pibrentasvir has recently been approved for treatment of all HCV genotypes. In phase-2 and phase-3 trials sustained virological response rates (SVR) exceeding 95% have been reported with this regimen. However, only limited “real-life”-data with glecaprevir/pibrentasvir have been presented so far.

Patients and Methods:

90 patients (male/female: 58/32; mean age: 39.2 ± 7.6 years; genotype 1/2/3/4: 46/0/43/1; HIV-coinfection: 4 patients; liver cirrhosis: 7 patients) with chronic hepatitis C were treated with glecaprevir (300 mg)/pibrentasvir (120 mg) once daily at a Viennese center, consisting of the outpatient clinic of a hepatologic center and a low-threshold drug treatment facility. Treatment duration was 8 – 16 weeks according to genotype, fibrosis stage and pretreatment. Patients on opioid substitution (OST) therapy with a high risk of non-adherence to direct-acting antivirals (n = 34) – most of them reporting ongoing intravenous drug use – received antiviral therapy together with OST under direct observation of a pharmacist, physician or nurse at a pharmacy or a low-threshold facility.

Results:

Treatment was well tolerated and there were no treatment related serious adverse events. No patient stopped treatment ahead of schedule. Till now, 25 patients have achieved SVR4, and SVR12 was documented in 10 patients. So far no relapses have been observed. SVR12 data of the majority of patients will be presented at the meeting.

Conclusion:

These preliminary data indicate, that glecaprevir/pibrentasvir is highly efficious and well tolerated in Austrian patients with chronic hepatitis C, including patients receiving OST and patients with ongoing intravenous drug use.