963 Treatment Failure With Daclatasvir Plus Sofosbuvir With or Without Ribavirin in Treatment Naïve Patients With Chronic Hepatitis C Without Cirrhosis

Abstract

INTRODUCTION: Chronic hepatitis C treatment has been transformed by advent of DAAs. Pakistan is one of worst affected country with hepatitis C with recent suggested prevalence of 4.9%. Current AASLD guidelines recommend treatment with daily sofosbuvir plus daclatasvir with or without addition of weight based ribavirin. However this regimen is not first line recommendation. These drugs are available free of cost in government run setups. However it has raised questions about treatment failure with them and need for other DAAs. METHODS: This cross-sectional study is being conducted at ABSTH Gujrat from Oct. 2018 after approval of IRB and informed consent of patients using non-probability consecutive sampling. No genotyping is being done. Cirrhosis is considered when abdominal ultrasound shows coarse echotexture of liver as either Shear Wave Elastography or Fibroscan are not available. Treatment naive chronic hepatitis C patients without cirrhosis are being included. Patients on PCR testing having viral load of <400000 IU/L are being considered to have low viral load and are being given 12 weeks regimen of daclatasvir plus sofosbuvir. Patients with having viral load of >400000 IU/L are being considered to have high viral load and are being prescribed 24 weeks regimen of daclatasvir plus sofosbuvir with weight based ribavirin. ETR and SVR24 at 24 weeks are being noted. Patients who fail to achieve SVR24 after achieving ETR are being declared as treatment failure. Data analysis is being done using SPSS 20.0. RESULTS: 1073 patients have been included this study till now. Mean age is 46.01 + 11.50 years. 712(66.4%) are female and 361(33.6%) are male. 729(67.9%) patients with low viral load received daclatasvir plus sofosbuvir for 12 weeks while 344(32.1%) patients with high viral load received daclatasvir, sofosbuvir and weight based ribavirin for 24 weeks. ETR and SVR24 have been reported of 163(15.2%) patients till now. All these patients achieved ETR however only 161 patients achieved SVR24. One patients had high viral load while other had low. Treatment failure rate is 1.23% till now but exact figure can only be predicted after completion of study as more results are awaited. CONCLUSION: Treatment failure rate in treatment naive chronic hepatitis C patients without cirrhosis with daclatasvir plus sofosbuvir with or without ribavirin is low. Similar results have been reported previously. However these preliminary results show that there is need to investigate the factors leading to treatment failures.