1 Medical University of Vienna, Vienna, Austria.
2 Department of Gastroenterology and Hepatology, ZNA Stuivenberg, Antwerp, Belgium.
3 IFI Institut für Interdisziplinäre Medizin, Hamburg, Germany.
4 School of Medicine, Trinity College Dublin, Dublin, Ireland.
5 Clinic of Infectious Diseases, University of Medicine and Pharmacy Timisoara, Timisoara, Romania.
6 Hépato-Gastroentérologie, Hôpital Saint-Eloi, Montpellier, France.
7 Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.
8 AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany.
9 AbbVie Inc., North Chicago, Illinois, United States.
10 Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.
Ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin (OBV/PTV/r±DSV±RBV) regimens show high efficacy and good tolerability in clinical trials for chronic hepatitis C virus (HCV) genotypes (GT) 1 or 4. To evaluate whether these results translate to clinical practice, data were pooled from observational studies across 13 countries. Treatment-naïve or -experienced patients, with or without cirrhosis, received OBV/PTV/r±DSV±RBV according to approved local labels and clinical practice. Sustained virologic response at post-treatment Week 12 (SVR12), adverse events (AEs) and comedication management were assessed for patients initiating treatment before June 1, 2017. The safety population included 3850 patients who received ≥1 dose of study drug. The core population (N=3808) further excluded patients with unknown GT or cirrhosis status, or who received off-label treatment. Patients had HCV GT1a (n=732; 19%), GT1b (n=2619; 69%), or GT4 (n=457; 12%). In 3546 patients with sufficient follow-up data at post-treatment Week 12, the SVR12 rate was 96% (n/N=3401/3546 [95% CI 95.2-96.5]). In patients with or without cirrhosis, SVR12 was comparable (96%). In patients with HCV GT1a, GT1b, or GT4, SVR12 rates were 93%, 97%, and 94%. In GT1b-infected patients with planned treatment for 8 weeks, SVR12 was 96%. In patients with ≥1 comorbidity (67%), SVR12 was 95%. 58% of patients received ≥1 comedication and there was minimal impact on SVR12 rates using comedications for peptic ulcers and gastro-esophageal reflux disease, statins, antipsychotics, or antiepileptics. Most comedications were maintained during treatment although 58% of patients changed their statin medication. AEs and serious AEs occurred in 26% and 3% of patients. Post-baseline Grade 3-4 laboratory abnormalities were rare (<3%) and discontinuation rates were low (<4%). Real-world evidence confirms the effectiveness of OBV/PTV/r±DSV±RBV in patients with HCV GT1 or GT4, regardless of common comorbidities or comedications, and is consistent with clinical trial results. Adverse safety outcomes may be limited by underreporting in the real-world setting.