Addition of Epigallocatechin Gallate 400?mg to Sofosbuvir 400?mg?+?Daclatisvir 60?mg With or Without Ribavirin in Treatment of Patients with Chronic Hepatitis C Improves the Safety Profile: A Pilot Study.

ABSTRACT: Emergence of new molecules acting directly on the hepatitic C virus (HCV) has improved treatment outcomes. However, there is a risk of selecting viral escape mutants, so a new combination is needed using different inhibitors that target different steps of the HCV infectious cycle. Novel single tablet formulations were developed: Dactavira, composed of sofosbuvir (SOF) 400?mg/daclatisvir (DCV) 60?mg/epigallocatechin gallate (EGCG) 400?mg without ribavirin (RBV); and Dactavira plus, which includes RBV 800?mg. A randomized, open-label study was carried out on treatment-naïve non-cirrhotic (Group A, n?=?50) and treatment-naïve cirrhotic (Group B, n?=?22) patients with genotype 4 HCV infection. Group A was randomly assigned to receive a single daily fixed-dose (Dactavira, n?=?25) or the standard of care [SOF 400?mg/DCV 60?mg] (n?=?25) daily for 12 weeks. Group B was randomly assigned to receive a single daily fixed-dose (Dactavira plus, n?=?11) or the standard of care?+?RBV 800?mg (n?=?11) daily for 12 weeks. Patients receiving Dactavira or Dactavira plus had a significantly more rapid rate of viral load decline as compared to patients receiving the standard of care therapy. Sustained virological response for 12 weeks for Dactavira or Dactavira plus showed no statistically significant difference when compared to the standard of care. Also, they did not affect normal hemoglobin levels (p?

SUBMITTER: Shiha G 

PROVIDER: S-EPMC6753069 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature