Kasr-El-Aini Nephrology and Dialysis Center, Cairo University, Egypt.
Rheumatology Unit, Department of Internal Medicine, Cairo University, Egypt.
J Adv Res. 2016 May;7(3):391-402. doi: 10.1016/j.jare.2016.02.006. Epub 2016 Mar 2.
Egypt, the single country with highest incidence of HCV infection in the world, has embarked on a government-sponsored mass treatment program using several combinations of DAAs. Recognizing the importance of extrahepatic manifestations, independently of the hepatic, a subcommittee was assigned to develop national guidelines for respective prioritizing indications and protocols. It evaluated the benefit of treating patients with different extrahepatic manifestations, and reviewed relevant clinical trials and guidelines concerning DAA combinations available in Egypt. The latter included Sofosbuvir plus either peg-interferon, Simeprevir, Ledipasvir or daclatasvir, and the Viekera family comprising paritaprevir/ritonavir + ombitasvir with (GT-1) or without (GT-4) Dasabuvir. Any of these protocols may be used with or without Ribavirin according to indication. A blueprint was subjected to peer debate in dedicated workshops in two national meetings and subsequently to an online professional review, eventually leading to a final report that was adopted by the health authorities. Seven compelling and 10 optional indications were identified for treating patients with predominantly extrahepatic manifestations. The former include kidney disease at different stages, cryoglobulinemic vasculitis and non-Hodgkin lymphoma. Selected treatment protocols, were encoded and their use was prioritized on the basis of evidence of efficacy and safety. We concluded that any of the studied protocols may be used, preferably with ribavirin, for 12-week treatment in all patients with extrahepatic manifestations without cirrhosis and with eGFR above 30 ml/min/1.73 sqm. Ribavirin should be included in protocols for treating patients with compensated cirrhosis. Daclatasvir-based protocols are recommended for decompensated cirrhosis, while the Viekera family is recommended in patients with eGFR < 30 ml/min/1.73 sqm, including those on dialysis. In kidney-transplanted patents, caution is due to avoidance of the pharmacokinetic interaction with the Cytochrome-P450 enzyme system, in-between immunosuppressive agents and most DAAs, particularly the Viekera family.
埃及是全球 HCV 感染率最高的单一国家，已启动政府资助的大规模治疗计划，使用多种 DAA 组合。认识到肝外表现的重要性，独立于肝脏，成立了一个小组委员会制定国家指南，确定各自的优先治疗指征和方案。它评估了治疗不同肝外表现患者的益处，并审查了有关在埃及可用的 DAA 组合的相关临床试验和指南。后者包括索非布韦加聚乙二醇干扰素、simeprevir、雷迪帕韦或达卡他韦，以及包含 paritaprevir/ritonavir + ombitasvir（GT-1）或不包含（GT-4）Dasabuvir 的 Viekera 家族。根据适应证，这些方案中的任何一种都可以与利巴韦林联合或不联合使用。该蓝图在两次全国会议的专门研讨会上进行了同行辩论，随后进行了在线专业审查，最终形成了一份最终报告，该报告被卫生当局采纳。为治疗主要表现为肝外表现的患者确定了 7 项强制性和 10 项选择性治疗指征。前者包括不同阶段的肾病、冷球蛋白血症性血管炎和非霍奇金淋巴瘤。选定的治疗方案被编码，并根据疗效和安全性证据对其使用进行了优先级排序。我们得出结论，对于没有肝硬化且 eGFR 高于 30 ml/min/1.73 m2 的所有肝外表现患者，任何一种研究方案都可以使用，最好与利巴韦林联合使用，治疗 12 周。利巴韦林应包含在代偿性肝硬化患者的治疗方案中。对于失代偿性肝硬化，建议使用达卡他韦方案，对于 eGFR < 30 ml/min/1.73 m2 的患者，包括透析患者，建议使用 Viekera 家族。在接受肾移植的患者中，由于需要避免与细胞色素 P450 酶系统的药物相互作用，以及与大多数 DAA，特别是 Viekera 家族的药物相互作用，因此需要谨慎。
