Sood Ajit, Midha Vandana, Hissar Syed, Kumar Manoj, Suneetha Pothakamuri V, Bansal Manu, Sood Nina, Sakhuja Puja, Sarin Shiv K
Department of Medicine, Dayanand Medical College & Hospital, Ludhiana, India.
J Gastroenterol Hepatol. 2008 Feb;23(2):203-7. doi: 10.1111/j.1440-1746.2007.05057.x. Epub 2007 Jul 20.
In chronic hepatitis C virus (HCV) infection with genotype 3, therapy with pegylated interferon (peg-IFN) alfa-2b in a dose of 1.5 mug/kg/week and ribavirin (800-1000 mg/day) is recommended for 24 weeks. Reduced doses of peg-IFN may increase compliance and decrease cost and adverse events. This study aimed to assess the safety and efficacy of two different regimens of peg-IFN alfa-2b, in combination with ribavirin, in genotype 3 patients.
A total of 103 liver biopsy-proven chronic HCV patients with genotype 3, having alanine aminotransferase levels >1.2 x ULN and positive HCV-RNA were randomized into two groups: group I (n = 76; age, 43.1 +/- 11.4 years; male/female, 67/9) received peg-IFN 1.0 mug/kg/week + ribavirin 10.6 mg/kg/day, while group II (n = 27; age, 37.3 +/- 11.6 years; male/female, 21/6) received peg-IFN 1.5 microg/kg/week + ribavirin 10.6 mg/kg/day. Patients in both groups were treated for 24 weeks. End of treatment viral response (ETVR) and sustained viral response (SVR) after a 6-month follow-up period were assessed.
In both groups I and II, one patient was lost to follow-up, while one patient in group II withdrew due to side-effects. ETVR was seen in 72/76 (94.7%) of patients in the low dose group and 24/27 (88.9%) of patients in the high dose group (P = 0.375). SVR was seen in 60/76 (78.9%) of patients in the low dose group and 25/27 (92.6%) of patients in the high dose group (P = 0.145). Age (Pearson correlation coefficient = 0.263; P = 0.008) and fibrosis (correlation coefficient, 0.263; P = 0.008) showed a significant correlation with the SVR.
In patients with genotype 3, peg-IFN at 1.0 microg/kg/week with ribavirin is as effective as peg-IFN at 1.5 mug/kg/week with ribavirin.
在慢性丙型肝炎病毒（HCV）3型感染中，推荐使用剂量为1.5μg/kg/周的聚乙二醇化干扰素（peg-IFN）α-2b联合利巴韦林（800 - 1000mg/天）进行24周的治疗。降低peg-IFN的剂量可能会提高依从性、降低成本并减少不良事件。本研究旨在评估两种不同方案的peg-IFNα-2b联合利巴韦林治疗3型患者的安全性和疗效。
共有103例经肝活检证实为慢性HCV 3型感染、丙氨酸氨基转移酶水平>1.2×ULN且HCV-RNA阳性的患者被随机分为两组：第一组（n = 76；年龄，43.1±11.4岁；男/女，67/9）接受peg-IFN 1.0μg/kg/周 + 利巴韦林10.6mg/kg/天，而第二组（n = 27；年龄，37.3±11.6岁；男/女，21/6）接受peg-IFN 1.5μg/kg/周 + 利巴韦林10.6mg/kg/天。两组患者均接受24周的治疗。评估治疗结束时的病毒学应答（ETVR）以及6个月随访期后的持续病毒学应答（SVR）。
在第一组和第二组中，各有1例患者失访，而第二组中有1例患者因副作用退出。低剂量组72/76（94.7%）的患者出现ETVR，高剂量组24/27（88.9%）的患者出现ETVR（P = 0.375）。低剂量组60/76（78.9%）的患者出现SVR，高剂量组25/27（92.6%）的患者出现SVR（P = 0.145）。年龄（Pearson相关系数 = 0.263；P = 0.008）和纤维化（相关系数，0.263；P = 0.008）与SVR显著相关。
在3型患者中，1.0μg/kg/周的peg-IFN联合利巴韦林与1.5μg/kg/周的peg-IFN联合利巴韦林效果相当。
