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

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 table...

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Bibliographic Details
Published in:Scientific reports 2019-09, Vol.9 (1), p.13593-8, Article 13593
Main Authors: Shiha, Gamal, Soliman, Reham, Elbasiony, Mohamed, Darwish, Noureldien H. E., Mousa, Shaker A.
Format: Article
Language:English
Subjects:
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Adult
Antiviral drugs
Catechin - administration & dosage
Catechin - adverse effects
Catechin - analogs & derivatives
Daclizumab - administration & dosage
Daclizumab - adverse effects
Drug Administration Schedule
Drug Therapy, Combination - adverse effects
Epigallocatechin gallate
Female
Genotypes
Hemoglobin
Hepacivirus - drug effects
Hepacivirus - genetics
Hepatitis C
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - virology
Humanities and Social Sciences
Humans
Interferon
Load distribution
Male
Middle Aged
multidisciplinary
Pilot Projects
Random Allocation
Ribavirin
Ribavirin - administration & dosage
Ribavirin - adverse effects
Science
Science (multidisciplinary)
Sofosbuvir - administration & dosage
Sofosbuvir - adverse effects
Standard of Care
Statistical analysis
Sustained Virologic Response
Tablets
Treatment Outcome
Viral Load - drug effects
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Summary: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  
ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-019-49973-6