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Aliment Pharmacol Ther. 2018 Feb;47(3):421-431. doi: 10.1111/apt.14428. Epub 2017 Nov 29.

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

Author information

1
Faculty of Medicine, Cairo University, Cairo, Egypt.
2
Faculty of Medicine, Helwan University, Cairo, Egypt.
3
Faculty of Medicine, Ain Shams University, Cairo, Egypt.
4
National Liver Institute, Menoufiya University, Shebeen EL Kom, Egypt.
5
Faculty of Medicine, Zagazig University, Zagazig, Egypt.
6
Faculty of Medicine, Fayoum University, Fayoum, Egypt.
7
Faculty of Medicine, Assiut University, Assiut, Egypt.
8
National Research Center, Cairo, Egypt.
9
National Committee for Control of Viral Hepatitis, Cairo, Egypt.
10
National Hepatology and Tropical Medicine Research Institute, Cairo, 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.

PMID:
29193226
DOI:
10.1111/apt.14428
[Indexed for MEDLINE]
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