Adding epigallocatechin gallate to sofosbuvir plus daclatisvir with or without ribavirin can improve safety in the treatment of patients with chronic hepatitis C virus (HCV), according to results from a pilot study published in Scientific Reports.

Although new molecules acting directly on HCV have improved treatment outcomes in patients with HCV, 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. Two novel single-tablet formulations have been developed: composed of sofosbuvir 400 mg/daclatisvir 60 mg/epigallocatechin gallate 400 mg without ribavirin, and another novel drug combination that includes ribavirin 800 mg.

Researchers conducted a phase 3, open-label, 12-week study (ClinicalTrials.gov Identifier NCT03186313) in patients with cirrhosis who had never received treatment (group A; n=50) and people without cirrhosis who had never received treatment (group B; n=22) with genotype 4 HCV infection. They found that the new drug combinations resulted in high rates of sustained virologic response at 12 weeks in both groups of patients and that both treatment regimens showed no statistically significant difference when compared with the standard of care (sofosbuvir 400 mg/daclatisvir 60 mg ± ribavirin 800 mg). Both drug combinations were well tolerated, with mostly mild adverse events.

“In summary, 12 weeks’ therapy with the novel formulation[s] is safe and effective in both [those with and without cirrhosis who have not been treated and have] genotype 4 HCV,” concluded the authors.

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They added, “Incorporation of epigallocatechin gallate in [novel formulations] interferes with the viral entry mechanisms and may also play a role in enhancing efficacy and preventing relapse compared to the standard of care.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Shiha G, Soliman R, Elbasiony M, Darwish NHE, Mousa SA. 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. Sci Rep. 2019;9(1):13593.