索磷布韦仿制药治疗沙特慢性丙型肝炎病毒感染患者的疗效。
Effectiveness of generic sofosbuvir in the treatment of chronic hepatitis C virus infection in Saudi patients.
机构信息
From the Hepatobiliary Sciences & Organs Transplant Department (AlGhamdi, AlAlwan, Alqahtani, Aloun, Abdelmahmoud, ATtraif), Hepatology Section and From the Department of Internal Medicine (AlHabobi), King Abdulaziz Medical City of National Guard; from King Saud Bin Abdulaziz University for health sciences (AlGhamdi, AlAlwan, AlThiab); from King Abdullah International Research Centre (AlGhamdi, AlAlwan, AlThiab), Ministry of National Guard Health Affairs; From the Department of Pharmaceutical Care Services (AlThiab), King Abdulaziz Medical City of National Guard; Form the College of Medicine (AlJumah), Dar Al-Uloom University, Riyadh, Kingdom of Saudi Arabia; and From the Department of Internal Medicine (Ghomraoui), Sisters of Charity Hospital, Buffalo, New York, United States of America.
出版信息
Saudi Med J. 2023 Dec;44(12):1240-1247. doi: 10.15537/smj.2023.44.12.20230481.
OBJECTIVES
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.
CONCLUSION
The findings of our study confirm the effectiveness of generic sofosbuvir as a treatment option for HCV infection.
目的
评估通用索磷布韦（SOF）和品牌达卡他韦（DCV）治疗慢性丙型肝炎病毒（HCV）感染患者的疗效。
方法
这是一项在沙特阿拉伯的一个单一中心进行的回顾性研究，时间为 2017 年 8 月至 2022 年 7 月，我们纳入了 140 例接受通用 SOF 和品牌 DCV 治疗的连续 HCV 感染患者。主要结局是 12 周持续病毒学应答（SVR12）。
结果
大多数患者为女性（62.1%），感染基因型 4（57.9%），120 例（85.7%）为初治患者，55 例（39.3%）患者存在基线肝硬化。患者平均年龄为 61±13.6 岁。意向治疗分析中，131 例（93.6%）患者达到 SVR12。此外，基因型 1a、1b、2、3 和 4 的 SVR12 分别为 85.7%、100%、100%、88.9%和 96.3%。在方案治疗分析中，131 例（96.3%）患者达到了 12 周的 SVR。此外，基因型 1a、1b、2、3 和 4 的 SVR12 分别为 92.3%、100%、100%、88.9%和 98.7%。未发生 HCV 病毒学突破。在亚组分析中，无论基线特征（如治疗史、肝硬化和肝细胞癌）如何，SVR12 率均相似。达到 SVR12 的患者在治疗后血清肝酶和总胆红素水平显著改善。
结论
本研究结果证实了通用索磷布韦作为 HCV 感染治疗选择的有效性。
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