@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}
}
@article{SchlevogtBoekerMaussetal.2021,
  author    = {Schlevogt, Bernhard and Boeker, Klaus H. W. and Mauss, Stefan and Klinker, Hartwig and Heyne, Renate and Link, Ralph and Simon, Karl-Georg and Sarrazin, Christoph and Serfert, Yvonne and Manns, Michael P. and Wedemeyer, Heiner},
  title     = {Weight gain after interferon-free treatment of chronic hepatitis C — results from the German Hepatitis C-Registry (DHC-R)},
  series = {Biomedicines},
  volume    = {9},
  journal   = {Biomedicines},
  number    = {10},
  issn      = {2227-9059},
  doi       = {10.3390/biomedicines9101495},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-248476},
  year      = {2021},
  abstract  = {Chronic hepatitis C can be treated very effectively with direct-acting antivirals (DAA) with only minor side effects compared to an interferon-containing treatment regimen. The significance of metabolic comorbidities after HCV cure is not well defined. This study aims to investigate short- and long-term weight change of patients receiving interferon-free antiviral treatment for chronic hepatitis C. The German Hepatitis C-registry (DHC-R) is a national multicenter real-world cohort. A total of 5111 patients were followed prospectively after DAA treatment for up to 3 years. Weight change compared to baseline was analyzed at end of treatment and at years 1, 2, and 3 after completion of antiviral therapy. Regression analysis was performed to identify baseline predictors for weight change. While there was no relevant mean weight change (-0.2 kg, SD 4.3 kg) at the end of antiviral treatment, weight started to increase during long-term follow-up reaching +1.7 kg (SD 8.0 kg, p < 0.001) compared to baseline at 3 years (follow-up year 3, FU3) after completion of antiviral therapy. 48\%, 31\%, and 22\% of patients had a weight gain greater than 1, 3, and 5 kg at FU3, respectively. During follow-up, a body mass index (BMI) <30 proved to be the only consistent predictor for weight gain. DAA treatment is followed by a substantial weight gain (+3 kg or more) in one-third of the patients during long-term follow-up. Non-obese patients seemed to be most vulnerable to weight gain. The body compartment involved in weight gain as well as the mechanism of weight gain remain to be elucidated.},
  language  = {en}
}