ABSTRACT FINAL ID: 1989
TITLE: High efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin for 12 weeks in treatment of genotype 1b HCV infected cirrhotic patients: a large real world cohort
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Background and Aim: Patients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin (3D + R), for 12 weeks in patients with HCV genotype 1b infection and compensated cirrhosis.
Methods: Treatment-naive and peginterferon/ribavirin treatment-experienced patients prospectively received 12 weeks of 3D + R in seven tertiary centers in Romania. All fullfield the mandatory conditions imposed by National Insurance Company (CNSAS) for reimbursement : stage 4 fibrosis evaluated by Fibromax, compensated cirrhosis (maximum Child A 6), with or without previous decompensations of their disease, no evidence of hepatocellular carcinoma, sober for more than 6 months, with no age limit. The undetectable HCV RNA at the end of treatment (EOT) and sustained virological response at 12 weeks after therapy (SVR12) were assessed based on intention-to-treat analysis (ITT) and per protocol.
Results: Three hundred nineteen patients with HCV genotype 1b infection and compensated cirrhosis were included in the study. The study population comprised 181 (56.7% ) women, 54% treatment-experienced, most of the patients were Child-Pugh A5 class (71.7%), 26.6% with esophageal varices, and 5.9 % with albumin <3.5g/dl. Three hundred eleven patients completed treatment. The overall rates of EOT was 97.5% for ITT and 100% per protocol. Interim ITT analysis showed negative PCR at the SVR12 in 38/38 patients. The rest of SVR12 results for all the patients included in the study will be presented at the meeting. The overall treatment discontinuation rate was 2.5% (8 patients), 2 patients for depression, 2 with cardiac failure, 1 patient with cardiac arrhythmia, 1 with intestinal obstruction, 1 with sepsis-induced multi-organ failure, 1 with hepatic encephalopathy. Decompensation occurred in 4 patients: 2 developed variceal bleeding (both continued the treatment), one developed ascites and one hepatic encephalopathy (both discontinued the treatment in the first 2 weeks). The most common adverse events were anemia (33.2%), asthenia (21.3%), prurit (16.6%), insomnia (16.3%), jaundice (10%) and headache (10%). Two patients died from cardiovascular disease (malignant arrhythmia) and multi-organ failure.
Conclusions: The HCV regimen of 3D + R for 12 weeks had a high efficacy and was well tolerated with low discontinuation rate in HCV genotype 1b-infected patients with compensated cirrhosis in a real world setting.