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Abstract：
OBJECTIVE: To assess the effectiveness of generic sofosbuvir (SOF) and branded daclatasvir (DCV) for the treatment of chronic hepatitis C virus (HCV)infected patients.
METHODS: This retrospective study, performed in a single center in Saudi Arabia between August 2017 and July 2022, we enrolled 140 consecutive patients with HCV who received generic SOF and branded DCV. The primary outcome was sustained virologic response at week 12 (SVR12).
RESULTS: The majority of the patients were female (62.1%), infected with genotype 4 (57.9%), and treatment-naïve in 120 (85.7%) patients with baseline cirrhosis in 55 (39.3%). The mean patient age was 61±13.6 years. In the intention-to-treat analysis, 131 (93.6%) patients achieved SVR12. Moreover, 85.7%, 100%, 100%, 88.9%, and 96.3% of genotypes 1a, 1b, 2, 3, and 4, respectively, achieved SVR12. In the per-protocol analysis, 131 (96.3%) patients achieved an SVR of 12. Additionally, 92.3%, 100%, 100%, 88.9%, and 98.7% of the patients with genotypes 1a, 1b, 2, 3, and 4, respectively, achieved SVR12. No HCV virologic breakthroughs occurred. In the subgroup analysis, SVR12 rates were comparable regardless of baseline characteristics, such as treatment history, cirrhosis, and hepatocellular carcinoma. Patients achieving SVR12 showed a significant improvement in post-treatment serum liver enzyme and total bilirubin levels.
CONCLUSIONS: The findings of our study confirm the effectiveness of generic sofosbuvir as a treatment option for HCV infection.
METHODS: This retrospective study, performed in a single center in Saudi Arabia between August 2017 and July 2022, we enrolled 140 consecutive patients with HCV who received generic SOF and branded DCV. The primary outcome was sustained virologic response at week 12 (SVR12).
RESULTS: The majority of the patients were female (62.1%), infected with genotype 4 (57.9%), and treatment-naïve in 120 (85.7%) patients with baseline cirrhosis in 55 (39.3%). The mean patient age was 61±13.6 years. In the intention-to-treat analysis, 131 (93.6%) patients achieved SVR12. Moreover, 85.7%, 100%, 100%, 88.9%, and 96.3% of genotypes 1a, 1b, 2, 3, and 4, respectively, achieved SVR12. In the per-protocol analysis, 131 (96.3%) patients achieved an SVR of 12. Additionally, 92.3%, 100%, 100%, 88.9%, and 98.7% of the patients with genotypes 1a, 1b, 2, 3, and 4, respectively, achieved SVR12. No HCV virologic breakthroughs occurred. In the subgroup analysis, SVR12 rates were comparable regardless of baseline characteristics, such as treatment history, cirrhosis, and hepatocellular carcinoma. Patients achieving SVR12 showed a significant improvement in post-treatment serum liver enzyme and total bilirubin levels.
CONCLUSIONS: The findings of our study confirm the effectiveness of generic sofosbuvir as a treatment option for HCV infection.
摘要：
目的：评估通用索非布韦（SOF）和品牌达克拉塔韦（DCV）治疗慢性丙型肝炎病毒（HCV）感染患者的有效性。
方法：本回顾性研究，我们于2017年8月至2022年7月在沙特阿拉伯的一家中心进行了研究,纳入了140例接受通用SOF和品牌DCV的HCV患者.主要结果是12周时的持续病毒学应答（SVR12）。
结果：大多数患者为女性（62.1％），感染基因型4（57.9％），和治疗初治120（85.7％）患者基线肝硬化55（39.3％）。患者平均年龄为61±13.6岁。在意向治疗分析中，131例（93.6%）患者取得SVR12。此外，85.7%,100%,100%,88.9%,和96.3％的基因型1a，1b,分别为2、3和4，实现了SVR12。在符合方案的分析中，131例（96.3%）患者的SVR为12。此外,92.3%,100%,100%,88.9%,98.7%的基因型1a患者，1b,分别为2、3和4，实现了SVR12。没有发生HCV病毒学突破。在亚组分析中，无论基线特征如何，SVR12率都具有可比性，如治疗史，肝硬化,和肝细胞癌。达到SVR12的患者治疗后血清肝酶和总胆红素水平显着改善。
结论：我们的研究结果证实了通用索非布韦作为HCV感染治疗选择的有效性。
方法：本回顾性研究，我们于2017年8月至2022年7月在沙特阿拉伯的一家中心进行了研究,纳入了140例接受通用SOF和品牌DCV的HCV患者.主要结果是12周时的持续病毒学应答（SVR12）。
结果：大多数患者为女性（62.1％），感染基因型4（57.9％），和治疗初治120（85.7％）患者基线肝硬化55（39.3％）。患者平均年龄为61±13.6岁。在意向治疗分析中，131例（93.6%）患者取得SVR12。此外，85.7%,100%,100%,88.9%,和96.3％的基因型1a，1b,分别为2、3和4，实现了SVR12。在符合方案的分析中，131例（96.3%）患者的SVR为12。此外,92.3%,100%,100%,88.9%,98.7%的基因型1a患者，1b,分别为2、3和4，实现了SVR12。没有发生HCV病毒学突破。在亚组分析中，无论基线特征如何，SVR12率都具有可比性，如治疗史，肝硬化,和肝细胞癌。达到SVR12的患者治疗后血清肝酶和总胆红素水平显着改善。
结论：我们的研究结果证实了通用索非布韦作为HCV感染治疗选择的有效性。
