H Omar1, W El Akel1, T Elbaz1, M El Kassas2, K Elsaeed3, H El Shazly4, M Said1, M Yousif5, A A Gomaa6, A Nasr7, M AbdAllah8, M Korany9, S A Ismail10, M K Shaker3, W Doss1, G Esmat1, I Waked4, Y El Shazly3. 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.
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: Hala Rady Ahmed; Nancy G F M Waly; Rehab Mahmoud Abd El-Baky; Ramadan Yahia; Helal F Hetta; Amr M Elsayed; Reham Ali Ibrahem Journal: PLoS One Date: 2021-04-15 Impact factor: 3.240
Authors: Ossama A Ahmed; Mohamed A Elsebaey; Mohamed Hassan A Fouad; Heba Elashry; Ahmed I Elshafie; Ahmed A Elhadidy; Noha E Esheba; Mohammed H Elnaggar; Shaimaa Soliman; Sherief Abd-Elsalam Journal: Infect Drug Resist Date: 2018-03-28 Impact factor: 4.003