Department of Hepatology and Gastroenterology, National Liver Institute, Menoufia University, Shebeen El-Kom, Egypt.
Department of Hepatology and Gastroenterology, National Liver Institute, Menoufia University, Shebeen El-Kom, Egypt.
Int J Infect Dis. 2018 Oct;75:109-114. doi: 10.1016/j.ijid.2018.07.025. Epub 2018 Aug 2.
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.
To compare efficacy of brand and generic DAAs used in the national treatment program in Egypt.
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.
Most patients were males (61.4%), treatment naïve (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.
Generic and brand DAAs are equally effective for achieving SVR and improving aminotransferases.
直接作用抗病毒药物（DAAs）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（LMICs）的承受能力。尽管一些 DAA 以较低的价格在准入项目中提供，但在资源有限且 HCV 感染人群庞大的情况下，它们仍然负担不起。廉价仿制药可能会满足这种经济需求，但比较其与原药临床疗效的研究有限。
比较埃及国家治疗方案中使用的品牌和仿制药的疗效。
纳入符合 HCV 治疗条件的患者（n=971）。他们接受 12 周的索非布韦-达拉他韦（SOF-DCV）或 SOF-利迪帕韦（SOF-LDV）治疗。利巴韦林（RBV）添加到肝硬化患者和 SOF 经验患者中。不耐受 RBV 的肝硬化患者无 RBV 治疗 24 周。
大多数患者为男性（61.4%）、初治患者（88.6%）、无肝硬化（61.7%），平均年龄为 51.3±11.31 岁。在接受品牌或仿制药治疗的患者中，年龄、肝功能检查、肌酐、血小板、MELD 评分、基线 HCV-RNA 和瞬时弹性成像等基线特征无差异。总体持续病毒学应答（SVR）率为 98.1%，仿制药和品牌药物的 SVR 率相似（98.2%比 98.1%；p=1），两种方案的 SVR 率也相似（SOF-DCV±RBV：品牌：98.1%，仿制药 97.8%；p=0.729，SOF-LDV±RBV：品牌 98.2%，仿制药 100%；p=0.729）。AST 和 ALT 在开始治疗时均明显下降，无论使用的是仿制药还是原药。
仿制药和品牌 DAA 对实现 SVR 和改善氨基转移酶均同样有效。
