To assess the drug safety and efficacy of sofosbuvir plus velpatasvir in hepatitis C patients

Abstract

Hepatitis is an inflammation of the liver. The condition can be self-limiting or can progress to fibrosis (scarring), cirrhosis or liver cancer. Hepatitis viruses are the most common cause of hepatitis in the world, but other infections, toxic substances (e.g. alcohol, certain drugs), and auto-immune diseases can also cause hepatitis. To assess the treatment efficacy of sofosbuvir and velpatasvir to chronic hepatitis C virus-infected patients and to assess the treatment efficacy among the various subgroups of the treated patients. The primary end- point will be to assess sustained virologic response at 12 weeks (sofosbuvir + velpatasvir) after the end of therapy. The objective of the study is that hepatitis C virus is a rare viral disease occurring in the society with prevalence rate to be around 0.5% to 1.5%. So this study helps to assess the safety and efficacy of sofosbuvir and velpatasvir in hepatitis C virus-infected patients. The study was carried in Gandhi Hospital, Secunderabad, Telangana, India, which is a multispecialty hospital with a bed capacity of 1200. The study is conducted in the Gastroenterology and Hepatology department (both inpatients and OP patients). The present study shows that sofosbuvir and velpatasvir provides a significant effect by decreasing HCV RNA levels, decreasing the duration of therapy and fewer adverse events compared to other existing therapies. Low incidence of side effects in the present study established the safety profile of the drug in 6 months period. In this study, most adverse events noticed were headache and fatigue. Sofosbuvir and velpatasvir yield the most favourable future health economic outcomes, compared with other currently available regimens across a broad spectrum of patients, including those with different treatments. Further elucidation of the side effects, a more extended period of sofosbuvir and velpatasvir and, more number of patients need to be studied.