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首页> 外文期刊>European journal of gastroenterology and hepatology >Efficacy and safety of peginterferon alpha-2a (40 KD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe.
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Efficacy and safety of peginterferon alpha-2a (40 KD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe.

机译：聚乙二醇干扰素α-2a（40 KD）加利巴韦林在中欧和东欧未接受过治疗的慢性丙型肝炎患者中的疗效和安全性。

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OBJECTIVE: Assess the safety and efficacy of 24 or 48 weeks of treatment with peginterferon alpha-2a (40 KD) plus ribavirin in treatment-naive patients with chronic hepatitis C. METHODS: All patients in this open-label multinational study were assigned at the investigator's discretion to receive peginterferon alpha-2a (40 KD) 180 microg/week plus ribavirin (800 mg/day) for a total of 24 weeks or peginterferon alpha-2a (40 KD) 180 microg/week plus ribavirin (1000/1200 mg/day) for a total of 48 weeks. Treatment success was defined as sustained virological response [sustained virological response (SVR); hepatitis C virus RNA less than 50 IU/ml after completion of untreated follow-up]. RESULTS: A total of 789 treatment-naive patients were enrolled, of whom 91% (138 of 152) of nongenotype 1 patients and 77% (490 of 637) of genotype 1 patients completed 24 and 48 weeks of treatment, respectively. The overall SVR rate was 58% (459 of 789), and was 70 and 55% in nongenotype 1 and genotype 1 patients, respectively. Age (per 10-year decrement) and baseline hepatitis C virus RNA level (4 00 000 IU/ml) were significantly associated with SVR by multiple logistic regression analysis. The safety profile of peginterferon alpha-2a (40 KD) plus ribavirin was similar to that reported in pivotal trials, with no new or unexpected safety signals. CONCLUSION: The combination of peginterferon alpha-2a (40 KD) plus ribavirin was well tolerated and produced an overall SVR rate of 58% in treatment-naive patients. This study confirms that SVR rates achieved in pivotal clinical trials in Western Europe and the USA can be achieved in routine clinical practice in Central and Eastern Europe.
机译：目的：评估未接受治疗的慢性丙型肝炎患者接受聚乙二醇干扰素α-2a（40 KD）加利巴韦林治疗24或48周的安全性和有效性。方法：该开放标签跨国研究的所有患者均指定为研究者可酌情决定接受聚乙二醇干扰素α-2a（40 KD）180微克/周加利巴韦林（800 mg /天）共24周或接受聚乙二醇干扰素α-2a（40 KD）180微克/周加利巴韦林（1000/1200 mg /天），共48周。治疗成功的定义为持续的病毒学应答[持续的病毒学应答（SVR）;未治疗的随访完成后，丙型肝炎病毒RNA低于50 IU / ml]。结果：共有789名未接受治疗的患者入选，其中91％（152名中的138名）的非基因1型患者和77％（637名中的490名）的基因1型患者分别完成了24周和48周的治疗。总体SVR率为58％（789的459），非基因型1和基因型1的患者分别为70和55％。通过多对数回归分析，年龄（每10年递减）和丙型肝炎病毒RNA基线水平（ 400万IU / ml）与SVR显着相关。聚乙二醇干扰素α-2a（40 KD）加利巴韦林的安全性与关键试验中报道的相似，没有新的或未预期的安全性信号。结论：聚乙二醇干扰素α-2a（40 KD）联合利巴韦林的耐受性良好，初治患者总SVR率为58％。这项研究证实，在中欧和东欧的常规临床实践中，可以在西欧和美国进行的关键临床试验中达到SVR率。

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