1043 Effect of Dose Modification of Ribavirin on SVR 12 in Difficult to Treat Patients on Sofosbuvir, Daclatasvir Based DAA Therapy for Chronic HCV

Abstract

INTRODUCTION: DAAs are recommended as the first line treatment for chronic HCV with SVR rates >95%. Certain groups of patients, cirrhotics and treatment failures, continue to pose challenges for health care providers. In spite of a relatively poor tolerability, weight based Ribavirin has been recommended in these difficult to treat patients. We conducted a study to determine the effect of Ribavirin dose modification on SVR in these patients. METHODS: This was a retrospective chart review of cirrhotic (treatment experienced and naïve) and non-cirrhotic (treatment experienced) HCV patients on Sofosbuvir, Daclatasivir and Ribavirin. Patients aged 18 to 80 were included while those with HCV/ HBV or HCV/ HIV co-infection were excluded. Data was collected using a structured questionnaire and frequencies and percentages were calculated to examine the responses. RESULTS: A total of 100 patients (54 M, 46 F) receiving triple combination of Sofosbuvir, Daclatasvir and Ribavirin for HCV were included. There were 65 non-cirrhotic (all treatment experienced) and 35 cirrhotic patients (22 treatment naïve, 6 relapsers and 7 non-responders). In the cirrhotic group 81.6% of patients achieved SVR 12 (84% treatment naïve, 81% treatment experienced and 80% non-responders). .Amongst the treatment naïve cirrhotics, SVR was 100% and 71% respectively in the moderate (600-1000 mg) and low dose groups respectively. All 9 treatment experienced, 4 relapsers and 5 non-responder, received low dose Ribavirin with an SVR of 80% and 62.5% respectively. Amongst the 65 non-cirrhotic patients, SVR 12 was 91% with no patients on low dose Ribavirin. In the relapser group SVR was 100 % in the high dose Ribavirin group that dropped to 50% in the 2 patients having received moderate dose of ribavirin. In the non-responder group (total of 41 patients) 38 patients received high dose (SVR 95%) and 3 patients received moderate dose of ribavirin (SVR 43%) CONCLUSION: Ribavirin continues to play an important role in resource constrained countries due to its efficacy as part of the most cost-effective Sofosbuvir/ Daclatasvir based DAA therapy for HCV. Our study reemphasizes the need for treating difficult to treat HCV patients with the maximum possible dose of Ribavirin that can be tolerated by these patients. Dose reduction in these difficult to treat patients compromises the outcome and should be discouraged. Various measures to improve the tolerability of Ribavirin should be instituted in order to achieve higher SVRs.