索磷布韦在终末期肾病行血液透析治疗合并急性丙型肝炎患者中的安全性和有效性
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摘要
目的评估索磷布韦为基础的治疗方案在终末期肾病行血液透析治疗合并急性丙型肝炎患者群体中应用的安全性和有效性。方法纳入33位研究对象持续接受半量索磷布韦(200 mg)联合全量达卡他韦(90 mg)治疗24周,于治疗第0、4、8、12、16、20、24、28、32和36周分别检测血清HCV RNA、ALT、TBil水平,并评估药物相关不良反应。结果所有患者均在治疗结束后12周达到了持续病毒学反应(sustained virologic responses, SVRs),并且无药物相关的严重不良事件出现。结论半量索磷布韦(200 mg)联合全量达卡他韦(90 mg)的治疗对于终末期肾脏疾病行血液透析合并急性丙型肝炎的患者有效且安全。
Objective To evaluate the safety and efficacy of sofosbuvir-based therapy in end-stage renal disease patients undergoing hemodialysis complicated with acute hepatitis C. Methods Totally 33 subjects who met the inclusion criteria received a half dose of sofosbuvir(200 mg) and a full dose of daclatasvir(90 mg) daily for 24 weeks. Then we detected the levels of HCV RNA, ALT, and TBil at 0, 4, 8, 12, 16, 20, 24, 28, 32 and 36 weeks respectively and evaluated the adverse drug reactions. Results All the patients made a sustained virological response at 12 weeks after the end of treatment, and there were no drug-related serious adverse events. Conclusion A half dose of sofosbuvir(200 mg once daily) plus a full dose of daclatasvir(90 mg once daily) was safe and effective for treatment of acute HCV infection in patients who were undergoing ESRD and were on hemodialysis.
Objective To evaluate the safety and efficacy of sofosbuvir-based therapy in end-stage renal disease patients undergoing hemodialysis complicated with acute hepatitis C. Methods Totally 33 subjects who met the inclusion criteria received a half dose of sofosbuvir(200 mg) and a full dose of daclatasvir(90 mg) daily for 24 weeks. Then we detected the levels of HCV RNA, ALT, and TBil at 0, 4, 8, 12, 16, 20, 24, 28, 32 and 36 weeks respectively and evaluated the adverse drug reactions. Results All the patients made a sustained virological response at 12 weeks after the end of treatment, and there were no drug-related serious adverse events. Conclusion A half dose of sofosbuvir(200 mg once daily) plus a full dose of daclatasvir(90 mg once daily) was safe and effective for treatment of acute HCV infection in patients who were undergoing ESRD and were on hemodialysis.
引文
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[19] FLISIAK R,JANCZEWSKA E,WAWRZYNOWICZ-SYCZEWSKA M,et al.Real-world effectiveness and safety ofombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C:AMBER study[J].Aliment Pharmacol Ther,2016.44(9):946-956.
[20] DESNOYER A,POSPAI D,LE MP,et al.Pharmacokinetics,safety and efficacy of a full dosesofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C[J].J Hepatol,2016,65(1):40-47.
[21] ZABALETA A,RIEZU-BOJ JI,LARREA E,et al.Gene expression analysis during acute hepatitis C virus infection associatesdendritic cell activation with viral clearance[J].J Med Virol,2016,88(5):843-851.
[22] KATO S,CHMIELEWSKI M,HONDA H,et al.Aspects of immune dysfunction in end-stage renal disease[J].Clin J Am Soc Nephrol,2008,3(5):1526-1533.
[2] AMIN EK,ZAHRAN A.Hepatitis C virus status inhemodialysis patients in Menoufia Government,Egypt,five years apart:Do we have any improvement[J].Saudi J Kidney Dis Transpl,2017,28(5):1126-1132.
[3] BERENGUER M.Treatment of chronic hepatitis C inhemodialysis patients[J].Hepatology,2008,48(5):1690-1699.
[4] MAHESHWARI A,RAY S,THULUVATH PJ.Acute hepatitis C[J].Lancet,2008,372(9635):321-332.
[5] LIU CH,LIANG CC,LIU CJ,et al.Pegylated interferon alfa-2a monotherapy for hemodialysis patients with acute hepatitis C[J].Clin Infect Dis,2010,51(5):541-549.
[6] OTSUBO S,KAWATA T,TAKASAKI M,et al.Treatment of a serotype-1 hepatitis C virus infection using interferon-beta in a patient with a high RNA titer who had been receiving long-termhemodialysis therapy[J].Intern Med,2011,50(7):733-737.
[7] TSENG PL,CHEN TC,CHIEN YS,et al.Efficacy and safety ofpegylated interferon alfa-2b and ribavirin combination therapy versus pegylated interferon monotherapy in hemodialysis patients:A comparison of 2 sequentially treated cohorts[J].Am J Kidney Dis,2013,62(4):789-795.
[8] HE T,LOPEZ-OLIVO MA,HUR C,et al.Systematic review:Cost-effectiveness of direct-actingantivirals for treatment of hepatitis C genotypes 2-6[J].Aliment Pharmacol Ther,2017,46(8):711-721.
[9] LIU H,ZHANG T,YAN Y,et al.Sofosbuvir and ribavirin in acute hepatitis C-infected patient with decompensated cirrhosis Y[J].Medicine,2016,95(49):e5555.
[10] MILLARD JD,HENRY J,RIZVI SS,et al.Direct-actingantivirals for acute hepatitis C in HIV-infected MSM[J].Aids,2016,30(13):2137-2139.
[11] DETERDING K,SPINNER CD,SCHOTT E,et al.Ledipasvir plus sofosbuvir fixed-dose combination for 6 weeks in patients with acute hepatitis C virus genotype 1 monoinfection (HepNet Acute HCV IV):An open-label,single-arm,phase 2 study[J].Lancet Infect Dis,2017,17(2):215-222.
[12] PRINAPORI R,RICCI E,MENZAQHI B,et al.Decrease of renal function in HCV and HIV/HCV-infected patients withtelaprevir-based therapy[J].Aids,2015,29(15):2061-2062.
[13] WANCHOO R,THAKKAR J,SCHWARTZ D,et al.Harvoni (Ledipasvir with Sofosbuvir)-induced renal injury[J].Am J Gastroenterol,2016,111(1):148-149.
[14] MAAN R,AI WARZOOQI SH,KLAIR JS,et al.The frequency of acute kidney injury in patients with chronic hepatitis C virus infection treated withsofosbuvir-based regimens[J].Aliment Pharmacol Ther,2017,46(1):46-55.
[15] Hepatitis C guidance:AASLD-IDSA recommendations for testing,managing,and treating adults infected with hepatitis C virus[J].Hepatology,2015,62(3):932-954.
[16] EASL Recommendations on Treatment of Hepatitis C 2016[J].JHepatol,2017,66(1):153-194.
[17] POL S,JADOUL M,VALLET-PICHARD A.An update on the management of hepatitis C virus-infected patients with stage 4-5 chronic kidney disease while awaiting the revised KDIGO Guidelines[J].Nephrol Dial Transplant,2017,32(1):32-35.
[18] PAWLOTSKY JM.Reply to:“Contradictory advice for people who inject drugs in the 2016 EASL Recommendations on Treatment of Hepatitis C”[J].JHepatol,2017,66(5):1103.
[19] FLISIAK R,JANCZEWSKA E,WAWRZYNOWICZ-SYCZEWSKA M,et al.Real-world effectiveness and safety ofombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C:AMBER study[J].Aliment Pharmacol Ther,2016.44(9):946-956.
[20] DESNOYER A,POSPAI D,LE MP,et al.Pharmacokinetics,safety and efficacy of a full dosesofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C[J].J Hepatol,2016,65(1):40-47.
[21] ZABALETA A,RIEZU-BOJ JI,LARREA E,et al.Gene expression analysis during acute hepatitis C virus infection associatesdendritic cell activation with viral clearance[J].J Med Virol,2016,88(5):843-851.
[22] KATO S,CHMIELEWSKI M,HONDA H,et al.Aspects of immune dysfunction in end-stage renal disease[J].Clin J Am Soc Nephrol,2008,3(5):1526-1533.