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首页> 外文期刊>International journal of infectious diseases : >High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C
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High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C

机译：通用和品牌直接作用抗病毒药治疗慢性丙型肝炎的高功效

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Background Direct acting antivirals (DAAs) are highly effective for treatment of hepatitis C (HCV) but brand products are priced beyond the means of most low and middle income countries (LMICs). Although a few DAAs are offered at reduced prices in access programs, they are still beyond affordability in limited resource settings with a large HCV infected population. Cheap generics might fill this economic need, but studies comparing their clinical efficacy to that of original products are limited. Aim To compare efficacy of brand and generic DAAs used in the national treatment program in Egypt. Methods HCV treatment eligible patients (n = 971) were enrolled. They were treated with 12 weeks of either sofosbuvir-daclatasvir (SOF-DCV) or SOF-ledipasvir (SOF-LDV). Ribavirin (RBV) was added to patients with cirrhosis and to SOF experienced patients. Patients with cirrhosis who were RBV intolerant were treated for 24 weeks without RBV. Results Most patients were males (61.4%), treatment na?ve (88.6%), without cirrhosis (61.7%), and the mean age was 51.3 ± 11.31 years. Baseline characteristics were not different in patients treated with brand or generic medications regarding age, liver tests, creatinine, platelets, MELD score, baseline HCV-RNA and transient elastography. Overall sustained virologic response (SVR) rate was 98.1%, which was similar for generic and brand drugs (98.2% vs. 98.1%; p = 1), and similar with both regimens used (SOF-DCV ± RBV: brand: 98.1%, generic 97.8%; p = 0.729, SOF-LDV ± RBV: brand 98.2%, generic 100%; p = 0.729). AST and ALT decreased significantly with initiation of therapy with both generic and original drugs. Conclusion Generic and brand DAAs are equally effective for achieving SVR and improving aminotransferases.
机译：背景技术直接作用抗病毒药（DAA）对丙型肝炎（HCV）的治疗非常有效，但品牌产品的价格超出了大多数中低收入国家（LMIC）的承受能力。尽管在访问程序中以优惠的价格提供了一些DAA，但在受HCV感染的人口众多的有限资源环境中，它们仍然无法承受。廉价的仿制药可能会满足这种经济需求，但是将它们的临床功效与原始产品进行比较的研究有限。目的比较埃及国民治疗计划中使用的品牌和通用DA​​A的功效。方法纳入HCV治疗合格患者（971例）。他们接受了12周的sofosbuvir-daclatasvir（SOF-DCV）或SOF-ledipasvir（SOF-LDV）治疗。肝硬化患者和有SOF经验的患者均加入了利巴韦林（RBV）。 RBV不耐受的肝硬化患者接受24周无RBV治疗。结果多数患者为男性（61.4％），初次接受治疗（88.6％），无肝硬化（61.7％），平均年龄为51.3±11.31岁。在年龄，肝脏检查，肌酐，血小板，MELD评分，基线HCV-RNA和瞬时弹性成像方面，使用品牌或非专利药物治疗的患者的基线特征无差异。总体持续病毒学应答（SVR）率为98.1％，与非专利药和品牌药相似（98.2％比98.1％; p = 1），并且两种方案均相似（SOF-DCV±RBV：品牌：98.1％ ，通用97.8％; p = 0.729，SOF-LDV±RBV：品牌98.2％，通用100％; p = 0.729）。 AST和ALT随仿制药和原始药物的治疗开始显着降低。结论通用DAA和品牌DAA在实现SVR和改善转氨酶方面均同样有效。

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