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聚乙二醇干扰素α-2a联合基于体重或固定剂量利巴韦林治疗初治丙型肝炎病毒2型快速应答者:一项随机试验。

Peginterferon alfa-2a plus Weight-Based or Flat-Dose Ribavirin for Treatment-Naïve Hepatitis C Virus Genotype 2 Rapid Responders: A Randomized Trial.

作者信息

Liu Chen-Hua, Huang Chung-Feng, Liu Chun-Jen, Dai Chia-Yen, Huang Jee-Fu, Lin Jou-Wei, Liang Cheng-Chao, Yang Sheng-Shun, Lin Chih-Lin, Su Tung-Hung, Yang Hung-Chih, Chen Pei-Jer, Chen Ding-Shinn, Chuang Wan-Long, Kao Jia-Horng, Yu Ming-Lung

机构信息

Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.

Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan.

出版信息

Sci Rep. 2015 Oct 15;5:15255. doi: 10.1038/srep15255.

DOI:10.1038/srep15255
PMID:26469083
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4606559/
Abstract

The impact of ribavirin (RBV) dosage on sustained virologic response (SVR) rates remains elusive in hepatitis C virus genotype 2 (HCV-2) rapid responders receiving 16 weeks of peginterferon (Peg-IFN) plus RBV. Treatment-naïve HCV-2 patients with rapid virologic response (RVR) received Peg-IFN alfa-2a 180 μg/week plus weight-based RBV (1,000 or 1,200 mg/day; cut-off body weight: 75 kg) for 6 weeks, and then randomly received Peg-IFN alfa-2a 180 μg/week plus weight-based (1,000 or 1,200 mg/day; n = 247) or flat-dose (800 mg/day; n = 246) RBV for additional 10 weeks. The primary endpoint was SVR24. Patients receiving weight-based and flat-dose RBV therapies had comparable SVR24 rates (93.5% versus 91.9%, P = 0.49). The risk differences (RDs) of SVR24 receiving weight-based and flat-dose RBV arms were 7.1% [95% CI: 0.7% to 13.6%] in males, and -5.8% [95% CI: -12.1% to 0.5%] in females (interaction P = 0.01). The SVR24 rate was higher in males receiving ≥13 mg/kg/day than those receiving <13 mg/kg/day (96.3% versus 85.1%, P = 0.001). In conclusion, Peg-IFN alfa-2a plus weight-based or flat-dose RBV for 16 weeks provides comparable SVR24 rates in treatment-naïve HCV-2 rapid responders. However, males should receive weight-based RBV to achieve a high SVR24 rate.

摘要

在接受16周聚乙二醇干扰素(Peg-IFN)联合利巴韦林(RBV)治疗的2型丙型肝炎病毒(HCV-2)快速应答者中,RBV剂量对持续病毒学应答(SVR)率的影响仍不明确。初治的具有快速病毒学应答(RVR)的HCV-2患者接受每周180μg的聚乙二醇干扰素α-2a联合基于体重的RBV(1000或1200mg/天;体重临界值:75kg)治疗6周,然后随机接受每周180μg的聚乙二醇干扰素α-2a联合基于体重的(1000或1200mg/天;n = 247)或固定剂量(800mg/天;n = 246)RBV再治疗10周。主要终点是SVR24。接受基于体重和固定剂量RBV治疗的患者的SVR24率相当(93.5%对91.9%,P = 0.49)。接受基于体重和固定剂量RBV治疗组的SVR24的风险差异(RDs)在男性中为7.1%[95%CI:0.7%至13.6%],在女性中为-5.8%[95%CI:-12.1%至0.5%](交互作用P = 0.01)。接受≥13mg/kg/天的男性的SVR24率高于接受<13mg/kg/天的男性(96.3%对85.1%,P = 0.001)。总之,聚乙二醇干扰素α-2a联合基于体重或固定剂量的RBV治疗16周,在初治的HCV-2快速应答者中提供了相当的SVR24率。然而,男性应接受基于体重的RBV以实现高SVR24率。

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