BOSTON, MA—For patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection with advanced fibrosis or cirrhosis, the 3-DAA regimen is well-tolerated and associated with a high 12-week sustained virological response (SVR12) rate, according to findings from a phase 3 study presented at The Liver Meeting® 2016 have shown.
3-DAA is an all-oral, direct-acting antiviral regimen of ombitasvir, paritaprevir, and ritonavir co-administered with dasabuvir, with or without ribavirin.
“Treatment with 3-DAA ± ribavirin in treatment-naive and -experienced individuals resulted in 96.4% SVR12 rates in HCV GT1-infected Brazilian patients with bridging fibrosis (METAVIR F3) or compensated cirrhosis (METAVIR F4),” reported lead author Mario G. Pessôa, MD, PhD, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, Brazil.
In 2014, the estimated number of Brazilians with HCV was 1.45 million. The 3-DAA regimen, with or without ribavirin, was approved in Brazil in 2015 for patients with HCV GT1 infections.
Dr. Pessôa reported efficacy and safety results from the open-label, multicenter TOPAZ-III trial conducted in Brazil to assess the efficacy of the regimen in treatment-naive or interferon-experienced patients with advanced fibrosis or compensated cirrhosis (METAVIR F3-F4).
A total of 222 patients from 16 centers were enrolled and all but 1 patient completed treatment. Most were white (82.4%) and male (55.4%), and had body mass indices (BMI) <30 kg/m2 (76%). Fifty-four percent of patients had previously received IFN-based treatment.
There were four study groups: (1) included GT1a-infected patients (METAVIR F4) who received 3-DAA plus ribavirin for 12 or 27 weeks (n=64; 3-DAA plus ribavirin for 12 weeks; those who were non-responders to pegylated interferon/ribavirin with cirrhosis were treated for 24 weeks); (2) GT1a (METAVIR F3), 3-DAA+RBV for 12 weeks (n=46); (3) GT1b (METAVIR F4), 3-DAA+RBV for 12 weeks (n=69); and (4) GT1b (METAVIR F3), 3-DAA for 12 weeks.
A total of 78.4% of patients experienced at least one treatment-associated adverse event (TEAE). Six serious adverse events (SAEs) occurred but only one of these was deemed to be possibly treatment-related, involving hepatic decompensation after the end of treatment (post-treatment Day 141).
“Two deaths occurred during the post-treatment period: 1 due to hepatocellular carcinoma (post-treatment Day 155) and 1 due to septicemia and hepatic decompensation (post-treatment Day 141) after complications from total hip arthroplasty,” concluded Dr Pessôa.