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Real‐world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C infection: data from the German Hepatitis C‐Registry
Author(s) -
Berg Thomas,
Naumann Uwe,
Stoehr Albrecht,
Sick Christoph,
John Christine,
Teuber Gerlinde,
Schiffelholz Willibold,
Mauss Stefan,
Lohmann Kristina,
König Bettina,
Pangerl Andreas,
Niederau Claus
Publication year - 2019
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.15222
Subject(s) - medicine , german , chronic hepatitis , hepatitis , hepatitis c , intensive care medicine , virology , immunology , virus , archaeology , history
Summary Background Glecaprevir/pibrentasvir is a pangenotypic direct‐acting antiviral regimen approved for treating adults chronically infected with hepatitis C virus (HCV). There are limited real‐world data on glecaprevir/pibrentasvir to date. Aim To evaluate the effectiveness and safety of glecaprevir/pibrentasvir under real‐world conditions in the German Hepatitis C‐Registry (DHC‐R). Methods The DHC‐R is an ongoing, non‐interventional, multicentre, prospective, observational cohort study that monitors patients with chronic HCV infection. Data were collected from patients who initiated glecaprevir/pibrentasvir and completed a screening visit on or after 2 August 2017. The primary effectiveness endpoint was sustained virological response at post‐treatment Week 12 (SVR12). Safety and tolerability were also assessed. Results As of 15 July 2018, 586 patients received glecaprevir/pibrentasvir and had documented SVR12 data, treatment discontinuation, loss to follow‐up or HCV reinfection. Five hundred and fifty‐two patients (94%) received on‐label treatment. At baseline, most on‐label patients were infected with HCV genotype 1 (53%) or 3 (33%), HCV treatment‐naïve (90%), without cirrhosis (94%), and treated for 8 weeks (93%). Five hundred and thirty‐four patients (96.7%) achieved SVR12 (intention‐to‐treat [ITT] analysis). By modified ITT analysis (excluding patients who discontinued and did not achieve SVR12 or patients lost to follow‐up), the SVR12 rate was 99.4% (n/N = 534/537). There was one documented virological failure (relapse) and two documented HCV reinfections. One hundred and forty‐two (26%) adverse events (AEs) and 9 (2%) serious AEs occurred; 2 (<1%) AEs led to treatment discontinuation. All patients treated off‐label (N = 34) achieved SVR12. Conclusion Glecaprevir/pibrentasvir was highly effective and well tolerated under real‐world conditions. Clinical trial number: DRKS00009717 (German Clinical Trials Register, DRKS).