99.7% Sustained Virologic Response Rate in 369 HCV Genotype 1b-Infected Patients Treated With Label-Recommended Regimen of Ombitasvir/Paritaprevir/r and Dasabuvir With or Without Ribavirin

Abstract

Introduction: The 3 direct-acting antiviral (3D) regimen of ombitasvir (an NS5A inhibitor), paritaprevir (an HCV NS3/4A protease inhibitor identified by AbbVie and Enanta, boosted with ritonavir) and dasabuvir (a non-nucleoside NS5B RNA polymerase inhibitor) is approved to treat patients infected with HCV genotype (GT) 1. We report the safety and efficacy of the label-recommended 3D regimen with or without ribavirin (RBV) in treatment-naïve and prior pegIFN/RBV-experienced patients with GT1b infection, with or without cirrhosis, using pooled data from three phase 3 studies. Methods: Genotype 1b-infected patients from the PEARL-II, PEARL-III, and TURQUOISE-II studies were included in this post-hoc analysis. Efficacy was assessed by the proportion of patients achieving sustained virologic response (HCV RNA < 25 IU/mL) 12 weeks after completion of treatment (SVR12). Per the US Prescribing Information and European SmPC, the label-recommended regimen for GT1b infection is 3D for 12 weeks in non-cirrhotic patients, and 3D+RBV for 12 weeks in patients with cirrhosis. Adverse events (AEs) and laboratory measures are reported for all patients receiving the labelrecommended regimen.Table 1Results: Among 369 HCV GT1b-infected patients treated with the label-recommended 3D±RBV regimen, 50% were male, 37% were treatment-experienced, 18% had cirrhosis, 83% had an IL28B non-CC genotype, and 78% had baseline viral loads ≥800,000 IU/mL. Sustained virologic response was achieved in 368/369 (99.7%; 95% CI, 98.2-99.9%) patients (Table). One patient experienced post-treatment relapse, a 56 year-old white male with cirrhosis who received 3D + RBV. The majority of AEs were mild to moderate in severity, and most common AEs were headache (24%), fatigue (22%), and asthenia (9%). Grade 3 laboratory abnormalities were infrequent for ALT (0.3%), AST (0.3%), and total bilirubin (2.2%). No patient experienced a grade 3 hemoglobin decline and no patient discontinued treatment prematurely due to an AE. Conclusion: Patients with HCV GT1b infection treated with the label-recommended 3D regimen, with or without RBV, achieve very high SVR12 rates, including those with historically difficult-to-cure disease characteristics such as prior pegIFN/RBV null response and cirrhosis.