1 The Texas Liver Institute, University of Texas Health, San Antonio, TX, USA.
2 Hospital Centre of Porto (Portugal) and Biomedical School of Medicine, (University of Porto).
3 Former employee of AbbVie; currently with AveXis, a Novartis company, Bannockburn, IL, USA.
4 Louisiana Research Center, Shreveport, LA, USA.
5 AP HP, Department of Internal Medicine and Clinical Immunology, Groupe hospitalier La Pitié-Salpêtrière, Paris, France.
6 Sorbonne Universités, UPMC Univ Paris 06, France.
7 Mount Sinai School of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
8 Gastroenterology and Hepatology Department, Centro Hospitalar de Universitário Lisboa Norte and Medical School of Lisbon, University of Lisbon, Portugal.
9 Internal Medicine Department, Hospitais da Universidade de Coimbra (Centro Hospitalar e Universitário de Coimbra).
10 Virginia Mason Hospital and Seattle Medical Center, Seattle, Washington, United States.
11 AbbVie Inc, North Chicago, Illinois, United States.
12 Former employee of AbbVie, holds AbbVie Stocks, currently with Vaccitech UK.
13 Private Practice, Bakersfield, California, USA.
The 3-DAA regimen consisting of ombitasvir/paritaprevir/ritonavir plus dasabuvir (OBV/PTV/r + DSV) ± ribavirin (RBV) has shown high sustained virologic response rates (~95%) in phase 3 clinical trials including>2300 HCV genotype 1-infected patients. Real-world evidence studies have confirmed the effectiveness of OBV/PTV/r ± DSV ± RBV in patients with chronic HCV genotype 1 infection and are consistent with clinical trial results. TOPAZ-I and TOPAZ-II are ongoing phase 3b trials, assessing safety, efficacy and long-term progression of liver disease and clinical outcomes for up to 5 years post-treatment in patients treated with OBV/PTV/r + DSV ± RBV. High rates of sustained virologic response (SVR) wereachieved regardless of presence or absence of cirrhosis. In this report, we assessed the long-term progression of liver disease and incidence of clinical outcomes up to 3 years of post-treatment follow-up in patients with chronic HCV GT1 infection who were treated with (OBV/PTV/r + DSV) ± RBV in the TOPAZ-I and TOPAZ-II studies. Improvements were observed in liver disease markers including FIB-4, METAVIR, and Child-Pugh scores as well as platelet counts. Clinical outcomes related to long-term progression of liver disease such as liver decompensation were infrequent (<1%).Hepatocellular carcinoma (HCC) occurred in 1.4%of cirrhotic patients.