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.
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.
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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