@article{CornbergStoehrNaumannetal.2022, author = {Cornberg, Markus and Stoehr, Albrecht and Naumann, Uwe and Teuber, Gerlinde and Klinker, Hartwig and Lutz, Thomas and M{\"o}ller, Hj{\"o}rdis and Hidde, Dennis and Lohmann, Kristina and Simon, Karl-Georg}, title = {Real-world safety, effectiveness, and patient-reported outcomes in patients with chronic hepatitis C virus infection treated with glecaprevir/pibrentasvir: updated data from the German Hepatitis C-Registry (DHC-R)}, series = {Viruses}, volume = {14}, journal = {Viruses}, number = {7}, issn = {1999-4915}, doi = {10.3390/v14071541}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-281939}, year = {2022}, abstract = {Using data from the German Hepatitis C-Registry (Deutsche Hepatitis C-Register, DHC-R), we report the real-world safety and effectiveness of glecaprevir/pibrentasvir (GLE/PIB) treatment and its impact on patient-reported outcomes (PROs) in underserved populations who are not typically included in clinical trials, yet who will be crucial for achieving hepatitis C virus (HCV) elimination. The DHC-R is an ongoing, non-interventional, multicenter, prospective, observational cohort study on patients treated for chronic HCV infection in Germany. The data cutoff was 17 January 2021. The primary effectiveness endpoint was sustained virologic response at post-treatment Week 12 (SVR12). Safety outcomes were assessed in all patients receiving GLE/PIB. PROs were assessed using the SF-36 survey. Of 2354 patients, 1964 had valid SVR12 data (intention-to-treat analysis). Of these, 1905 (97.0\%) achieved SVR12 with rates similar across the comorbidities analyzed, except for people who actively use drugs (PWUD (active)) (86.4\%). Excluding those who discontinued treatment and did not achieve SVR12, or were reinfected with HCV, the rate was 99.3\%, with similar results regardless of comorbidity. PWUD (active) and those with psychiatric disorders had the most meaningful improvements in PROs. Adverse events (AEs) occurred in 631/2354 patients (26.8\%), and serious AEs in 44 patients (1.9\%). GLE/PIB was highly effective and well tolerated in this real-world study of patient groups key to HCV elimination.}, language = {en} }