Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt.

Abstract

BACKGROUND:

Treatment of chronic hepatitis C using combination of sofosbuvir (SOF) and daclatasvir (DCV) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1-3. The national program in Egypt is using SOF-DCV combination for large scale treatment.

AIM:

To assess the efficacy and safety of combined SOF-DCV in treating patients with HCV-G4 in a real-world setting.

METHODS:

Data and outcome of chronic HCV patients who were treated for 12 weeks with generic medications: DCV 60 mg plus SOF 400 mg ± ribavirin (RBV) within the national hepatitis C treatment program in Egypt are presented. Treatment-naïve patients without cirrhosis were treated without RBV, and those who had cirrhosis or were treatment-experienced (interferon experienced or SOF experienced) received RBV. Efficacy and safety were assessed, and baseline factors associated with sustained virological response at post-treatment week 12 (SVR12) were explored.

RESULTS:

During the first 2 months of the programme, 18 378 patients with HCV-G4 started treatment with SOF-DCV with or without RBV. Overall, 95.1% achieved SVR12 (95.4% among patients treated without RBV and 94.7% for patients treated with RBV, P = .32). Treatment was prematurely discontinued in only 1.5% of patients. The most common events leading to discontinuation were patient withdrawal (n = 76) and pregnancy (n = 5). Five deaths occurred within this group.

CONCLUSIONS:

Real-world experience of generic SOF-DCV in patients with chronic HCV-G4 proved to be safe and associated with a high SVR12 rate, in patients with different stages of fibrosis.

• Authors: H Omar, W El Akel, T Elbaz, M El Kassas, K Elsaeed, H El Shazly, M Said, M Yousif, A A Gomaa, A Nasr, M AbdAllah, M Korany, S A Ismail, M K Shaker, W Doss, G Esmat, I Waked, Y El Shazly
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 47 Issue 3 Pg. 421-431 (02 2018) ISSN: 1365-2036 [Electronic] England
• PMID: 29193226 (Publication Type: Journal Article)
• Copyright: © 2017 John Wiley & Sons Ltd.

Chemical References

• Antiviral Agents
• Carbamates
• Drugs, Generic
• Imidazoles
• Pyrrolidines
• Ribavirin
• Valine
• daclatasvir
• Sofosbuvir

Topics

• Adult
• Antiviral Agents (administration & dosage, adverse effects)
• Carbamates
• Drug Therapy, Combination (adverse effects)
• Drugs, Generic (administration & dosage, adverse effects)
• Egypt (epidemiology)
• Female
• Hepatitis C, Chronic (drug therapy, epidemiology)
• Humans
• Imidazoles (administration & dosage, adverse effects)
• Liver Cirrhosis (drug therapy, epidemiology, virology)
• Male
• Middle Aged
• Pyrrolidines
• Retrospective Studies
• Ribavirin (administration & dosage, adverse effects)
• Sofosbuvir (administration & dosage, adverse effects)
• Sustained Virologic Response
• Treatment Outcome
• Valine (analogs & derivatives)