التفاصيل البيبلوغرافية
| العنوان: |
Efficacy of Sofosbuvir/Daclatasvir in a Single Tablet for Treating Chronic Viral Hepatitis C. |
| المؤلفون: |
Debzi, Nabil, Berkane, Saadi, Manouni, Chafika, Amani, Nassima, Hemmam, Sonia, Yousfi, Mohamed, Taleb, Ayoub, Guessab, Nawal, Moulay Brahim, Ahlem Sarah, Helal, Sarah, Benbitour, Ismahane, Noual, Lynda, Kerbouche, Rafik, Cheikh, Ibtissem Ouled, Drir, Othmane, Belimi, Hibat Allah, Gourari, Samir, Frigga, Issam, Kassah-laouar, Ahmed, Khaberi, Mouna |
| المصدر: |
Journal of Clinical Pharmacy & Therapeutics; 9/1/2023, p1-9, 9p |
| مصطلحات موضوعية: |
DRUG tablets, DRUG efficacy, RESEARCH, CHRONIC hepatitis C, COMBINATION drug therapy, CLINICAL trials, CONFIDENCE intervals, VIRAL load, ANTIVIRAL agents, CIRRHOSIS of the liver, SEVERITY of illness index, GENERIC drugs, GENOTYPES, DESCRIPTIVE statistics, LONGITUDINAL method, THERAPEUTICS, EVALUATION |
| مصطلحات جغرافية: |
ALGERIA |
| مستخلص: |
Background. Published data regarding the real-life application of the combination sofosbuvir/daclatasvir in Algeria are lacking. Therefore, we conducted an observational study to assess the efficacy and safety of this regimen in Algerian patients with chronic hepatitis C. Methods. We carried out a multicentric, observational, open-label study to assess the efficacy and safety of the generic fixed-dose combination (FDC) sofosbuvir/daclatasvir in patients with chronic hepatitis C. We included 100 patients with all genotypes for 12 or 24 weeks of treatment without ribavirin. The primary outcome was the proportion of patients with a sustained virologic response (SVR) 12 weeks after treatment cessation. The secondary outcome assessed the safety and occurrence of adverse events. This study is registered with ClinicalTrials.gov identifier: NCT05138523. Results. The full analysis set included 99 patients with a mean age of 51.4 ± 14.4 years and a sex ratio of M/F = 0.86. Our patients were infected with HCV genotype 1b (n = 47), 2 (n = 17), 1a (n = 3), 2a/2c (n = 2), 3 (n = 2), and 4 (n = 1). A total of 27 patients had missing genotype data. Most patients were naive noncirrhotic (n = 70) and took 12 weeks of treatment, 19 patients had cirrhosis, of which 68.42% (n = 13) were classified as Child–Pugh A, and 5 patients were treatment-experienced. Both cirrhotic and treatment-experienced patients took 24 weeks of treatment. Efficacy analysis was conducted on 95 patients, and the results showed that 91 patients achieved SVR12 with a response rate of 95.8% (95% CI: 92–100%). Six adverse events occurred and were minor and manageable. Conclusion. Our results demonstrate the efficacy and safety of sofosbuvir/daclatasvir in single tablets in treating Algerian HCV patients without ribavirin for 12 or 24 weeks. The promising results of this study warrant further trials to assess the efficacy and safety of this combination in treating special populations. [ABSTRACT FROM AUTHOR] |
|
Copyright of Journal of Clinical Pharmacy & Therapeutics is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
Full Text Finder