Safety and Efficacy of Sofosbuvir with Ribavirin® in Hepatitis C, Genotype 3 Patients with Cirrhosis: A Real-world Experience.

Introduction Hepatitis C virus (HCV) is the leading cause of cirrhosis. The advent of Directly Acting Antivirals (DAAs) like Sofosbuvir (SOF) has dramatized the treatment and is the cornerstone for the treatment of HCV. Most trials have been conducted in HCV genotype 1 (GT-1) and data for Interferon-free regimen in genotype 3 (GT-3) is limited especially in cirrhotic patients. Aim To evaluate the safety and efficacy of SOF plus Ribavirin® (RIB) in patients with compensated and decompensated cirrhosis. Methods This was a quasi-experimental study in HCV patients with compensated and decompensated cirrhosis. Each group (compensated and decompensated) was further subdivided into the treatment-naïve and treatment-experienced groups. Efficacy was assessed by end treatment response (ETR) and sustained viral response (SVR) in the treatment-naïve and experienced groups. Adverse events were recorded on designed proforma on serial follow-up visits. Results The study consisted of 110 consecutive patients. Among 110 patients, 51 had compensated cirrhosis and 59 had decompensated cirrhosis. The mean age was 53.8 ± 11 years. Males were n=56 (50.9%) and females were n=54 (49.1%). All the patients in Child-Turcotte-Pugh class A were in the compensated group. CTP B class was found to be 10.5% and 89.5% in the compensated and decompensated groups, respectively, whereas all the patients in CTP class C were in the decompensated group. In the compensated cirrhosis group, ETR was achieved in 36 (87.8%) treatment-naïve and 8 (88.9%) experienced patients. In decompensated cirrhosis, treatment-naïve and experienced patients achieved ETR in 28 (82.4%) and 18 (85.7%) patients, respectively. Whereas in compensated cirrhosis treatment-naïve and experienced patients, SVR was achieved in 25 (83.3%) and five (71.4%), respectively. In decompensated cirrhosis, 21 (77.8%) treatment-naïve and 12 (75%) experienced patients achieved SVR. The most common adverse events experienced by the patients were fatigue followed by myalgia, nausea, and diarrhea. The new onset of complications found due to cirrhosis were ascites, followed by hepatoma, upper gastrointestinal bleed, portosystemic encephalopathy, acute on chronic liver failure, and death. Conclusion Sofosbuvir in combination with Ribavirin® is safe but suboptimal in treatment outcomes, particularly in treatment-experienced patients with decompensated cirrhosis than in treatment-naive patients with compensated cirrhosis due to HCV GT-3.