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达卡他韦与低剂量索磷布韦:一种用于估算肾小球滤过率<30 mL/min的丙型肝炎患者的有效泛基因型治疗方案。

Daclatasvir and reduced-dose sofosbuvir: An effective and pangenotypic treatment for hepatitis C in patients with estimated glomerular filtration rate <30 mL/min.

作者信息

Goel Amit, Bhadauria Dharmendra S, Kaul Anupma, Verma Prashant, Mehrotra Mayank, Gupta Amit, Sharma Raj K, Rai Praveer, Aggarwal Rakesh

机构信息

Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.

Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.

出版信息

Nephrology (Carlton). 2019 Mar;24(3):316-321. doi: 10.1111/nep.13222.

DOI:10.1111/nep.13222
PMID:29327401
Abstract

AIM

Sofosbuvir is a key agent for HCV treatment. It is not recommended for patients with chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) <30 mL/min. We report real-life experience of treating a cohort of CKD patients with eGFR <30 mL/min using daclatasvir and half-daily dose of sofosbuvir.

METHODS

Adults patients who (i) had eGFR<30 mL/min and detectable HCV RNA and (ii) were treated with interferon and ribavirin free, DAA based regimens were included. All patients were treated with daily doses of daclatasvir 60 mg and sofosbuvir 200 mg. The planned duration of treatment was 12 weeks, except for 24 weeks in those with either clinical evidence of cirrhosis or on immunosuppressive drugs. The end-points of the study were: (i) 12 weeks of follow-up after treatment completion, (ii) treatment discontinuation, or (iii) death or loss to follow-up.

RESULTS

Thirty-six (88%) among 41 included patients (median [range] age: 48 [19-75] years; 25 [61%] male; genotype 1/3/4 were 17/ 22/2; cirrhosis 5) completed the treatment, two discontinued and three died during treatment. On an intention-to-treat basis, HCV RNA were undetectable at 4 weeks of treatment, treatment completion and after 12 weeks of follow-up in 40/41 (97.6%), 37/41 (90.2%) and 37/41 (90.2%), respectively. None of the patients had a relapse.

CONCLUSIONS

Daclatasvir and half-daily dose of sofosbuvir was effective against genotype 1 and 3 HCV infection in patients with eGFR <30 mL/min. This combination could be a pangenotypic treatment option for such patients.

摘要

目的

索磷布韦是丙型肝炎病毒(HCV)治疗的关键药物。不推荐用于慢性肾脏病(CKD)且估算肾小球滤过率(eGFR)<30 mL/min的患者。我们报告了使用达卡他韦和半日常规剂量索磷布韦治疗一组eGFR<30 mL/min的CKD患者的实际经验。

方法

纳入符合以下条件的成年患者:(i)eGFR<30 mL/min且HCV RNA可检测到;(ii)接受基于直接抗病毒药物(DAA)的方案治疗,未使用干扰素和利巴韦林。所有患者均接受每日剂量60 mg达卡他韦和200 mg索磷布韦治疗。计划治疗疗程为12周,有肝硬化临床证据或正在使用免疫抑制药物的患者为24周。研究终点为:(i)治疗完成后12周随访;(ii)治疗中断;(iii)死亡或失访。

结果

41例纳入患者中36例(88%)(中位年龄[范围]:48[19 - 75]岁;25例[61%]为男性;基因1/3/4型分别为17/22/2例;5例有肝硬化)完成治疗,2例治疗中断,3例在治疗期间死亡。在意向性分析中,治疗4周、治疗完成时及随访12周时,40/41例(97.6%)、37/41例(90.2%)和37/41例(90.2%)患者的HCV RNA检测不到。所有患者均未复发。

结论

达卡他韦和半日常规剂量索磷布韦对eGFR<30 mL/min的基因1型和3型HCV感染患者有效。该联合用药可为这类患者提供泛基因型治疗选择。

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