S-adenosyl-methionine and betaine improve early virological response in chronic hepatitis C patients with previous nonresponse.
S-adenosyl-methionine and betaine improve early virological response in chronic hepatitis C patients with previous nonresponse.
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DOI：
10.1371/journal.pone.0015492
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发表时间：
2010-11-08
期刊：
影响因子：
3.7
通讯作者：
Heim MH
中科院分区：
文献类型：
--
作者：
Filipowicz M;Bernsmeier C;Terracciano L;Duong FH;Heim MH
聚乙二醇化干扰素α (pegIFNα)和利巴韦林治疗慢性丙型肝炎（CHC）在大约一半的患者中产生持续的反应。病毒通过Jak-STAT通路干扰IFNα信号转导可能是导致治疗失败的一个重要因素。s -腺苷- l-蛋氨酸（SAMe）和甜菜碱在表达丙型肝炎病毒（HCV）蛋白的培养细胞中增强ifn - α信号，并增强ifn - α对丙型肝炎病毒复制子的抑制作用。我们进行了一项临床研究，目的是评估SAMe和甜菜碱加用pegIFNα/利巴韦林治疗CHC的疗效和安全性。在这项开放标签的试点研究中，29例既往（peg）IFNα/利巴韦林治疗失败的CHC患者接受SAMe、甜菜碱、pegIFNα2b和利巴韦林治疗。治疗持续时间为6个月或12个月，取决于基因型，如果没有达到早期病毒学反应（EVR），该方案包括在第12周停止规则。在整个治疗过程中评估病毒学和生化反应以及安全性。29例患者入组并按照研究方案进行治疗。79%的患者感染了基因型1,72%的患者患有晚期纤维化，76%的患者之前接受过pegIFNα/利巴韦林治疗，只有14%的患者在之前的治疗中达到了EVR。当接受研究药物治疗时，17名患者（59%）出现EVR，但只有3名患者（10%）实现了持续病毒学应答（SVR）。发现SAMe和甜菜碱与pegIFNα/利巴韦林一起使用是安全的。pegIFNα/利巴韦林中加入SAMe和甜菜碱可改善CHC的早期病毒学反应。ClinicalTrials.gov NCT00310336
Treatment of chronic hepatitis C (CHC) with pegylated interferon α (pegIFNα) and ribavirin results in a sustained response in approximately half of patients. Viral interference with IFNα signal transduction through the Jak-STAT pathway might be an important factor underlying treatment failure. S-adenosyl-L-methionine (SAMe) and betaine potentiate IFNα signaling in cultured cells that express hepatitis C virus (HCV) proteins, and enhance the inhibitory effect of IFNα on HCV replicons. We have performed a clinical study with the aim to evaluate efficacy and safety of the addition of SAMe and betaine to treatment of CHC with pegIFNα/ribavirin. In this open-label pilot study, 29 patients with CHC who failed previous therapy with (peg)IFNα/ribavirin were treated with SAMe, betaine, pegIFNα2b and ribavirin. Treatment duration was 6 or 12 months, depending on genotype, and the protocol comprised a stopping rule at week 12 if early virological response (EVR) was not achieved. Virological and biochemical response and safety were assessed throughout the treatment. 29 patients were enrolled and treated according to the study protocol. 79% of the patients were infected with genotype 1, 72% had advanced fibrosis, 76% had previously received pegIFNα/ribavirin, and only 14% achieved EVR to the previous treatment. When treated with the study medications, 17 patients (59%) showed an EVR, only 3 (10%) however achieved a sustained virological response (SVR). SAMe and betaine were found to be safe when used with pegIFNα/ribavirin. The addition of SAMe and betaine to pegIFNα/ribavirin improves early virological response in CHC. ClinicalTrials.gov NCT00310336
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