Direct-acting antiviral agents in the treatment of chronic hepatitis C-Real-life experience from clinical practices in Pakistan
Direct-acting antiviral agents in the treatment of chronic hepatitis C-Real-life experience from clinical practices in Pakistan
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DOI：
10.1002/jmv.25745
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发表时间：
2020-03-13
影响因子：
12.7
通讯作者：
Manzoor, Sobia
中科院分区：
文献类型：
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作者：
Mushtaq, Saima;Mansoor, Atika;Manzoor, Sobia
本研究旨在评估巴基斯坦慢性丙型肝炎患者的持续病毒学反应（SVR）、SVR的预测因素和可用的第二代通用直接作用抗病毒药物的安全性的临床有效性。这是一项回顾性研究，于2015年1月至2019年1月在巴基斯坦多个中心进行。样本包括感染慢性丙型肝炎病毒的患者，无论病毒基因型、肝硬化或既往治疗情况如何。本研究共纳入993例患者，大多数患者接受索非布韦联合daclatasvir(95%)，索非布韦联合daclatasvir和利巴韦林（4%），索非布韦联合利巴韦林（1%）。96%为慢性肝炎，3%为代偿性肝硬化，1%为失代偿性肝硬化。基因3型（99.6%）最为常见。所有治疗方案12周后的总SVR为98%。索非布韦与daclatasvir合用SVR12最高（98.5%），其次是索非布韦与daclatasvir和利巴韦林合用（90.2%）和索非布韦与利巴韦林合用（75%）。慢性丙型肝炎患者的SVR率（98.2%）高于肝硬化患者（92.1%），且首次治疗（98.8%）高于已使用干扰素的患者（90.1%）。在多元二元logistic回归分析中，12周时患者的教育程度、治疗策略、病毒载量、丙氨酸转氨酶与SVR有统计学意义。未发生需要停药的重大不良事件。非专利口服直接作用抗病毒药物（索非布韦和daclatasvir）获得了更高的SVR12率，并且在这个真实世界的基因3型感染患者的大型队列中耐受性良好。
This study aims to evaluate the clinical effectiveness in terms of sustained virological response (SVR), predictors of SVR and safety of available second-generation generic direct-acting antivirals in Pakistani chronic hepatitis C patients. This is a retrospective study conducted in multiple centers of Pakistan from January 2015 to January 2019. The samples include patients infected with chronic hepatitis C virus, regardless of virus genotype, cirrhosis, or prior treatment. A total of 993 patients were included in the present study, with the majority receiving sofosbuvir with daclatasvir (95%), sofosbuvir with daclatasvir and ribavirin (4%), and sofosbuvir with ribavirin (1%). There were 96% cases of chronic hepatitis, 3% cases compensated cirrhosis, and 1% cases of decompensated cirrhosis. Genotype 3 (99.6%) was the most common genotype. Overall SVR after 12 weeks was 98% for all treatment regimens. High SVR12 was observed with sofosbuvir in combination with daclatasvir (98.5%), then sofosbuvir in combination with daclatasvir and ribavirin (90.2%) and sofosbuvir in combination with ribavirin (75%). SVR rates were high in chronic hepatitis C patients (98.2%) as compared with cirrhotic patients (92.1%) and it was high in treatment-naive (98.8%) then interferon experienced patients (90.1%). In multivariate binary logistic regression analysis, patients' education status, treatment strategy, viral load, and alanine aminotransferase had a statistically significant association with SVR at 12 weeks. No major adverse events occurred which required treatment discontinuation. Generic oral direct acting antiviralss (sofosbuvir with daclatasvir) achieved higher SVR12 rates and were well tolerated in this large real-world cohort of genotype 3 infected patients.