Sarin Shiv K, Goyal Ankur, Kumar Sudheer, Guptan Rajkumar C, Hashmi Abid Zaffar, Sakhuja Pooja, Malhotra Veena
Department of Gastroenterology, G.B. Pant Hospital, New Delhi 110002, India.
Hepatobiliary Pancreat Dis Int. 2004 Feb;3(1):42-8.
Standard combination-therapy of ribavirin with alternate day interferon (IFN) in patients with chronic hepatitis C (CHC) has been reported to achieve 30%-55% sustained viral response. Early reduction of viral load by daily dosage of IFN could enhance viral clearance. However, the duration of daily dosage protocol and the likely side-effects have not been well studied. We compared the efficacy and safety of a 4- vs 12-week daily IFN dosage in patients with CHC.
Fifty-nine, histologically proven CHC patients having ALT levels >1.5 x ULN were divided randomly into 2 groups, group I was given IFN 3 MIU daily for 4 weeks, followed by tiw up to 12 months and group II was given IFN 3 MIU daily for 12 weeks, followed by tiw up to 12 months. Ribavirin was given in a dose of 800-1200 mg/d for 12 months.
Fifty-two of the 59 patients (group I=28; group II=24) completed the study. The pretreatment variables and the prevalence of HCV genotype 1 were comparable between the groups. Nine patients (29%) in group I and 6 (25%) in group II had stage 3, 4 fibrosis. At the end of 4, 12, 24 and 52 weeks, HCV RNA negativity was observed in 27%, 54%, 65% and 71% in group I and 38%, 54%, 71% and 75% in group II, respectively (P=ns). Four of the eight (50%) patients with genotype 1 and 30 (69.8%) of 43 patients with genotype non-1 responded to therapy (P=ns). Sustained viral response was achieved in 61% and 71% in groups I and II, respectively. None of the variables predicted non-response precisely. No serious adverse effects were observed and they were comparable between the two groups.
Daily IFN dosage with ribavirin is safe and can achieve response in up to 65% patients. Since the efficacy of a 4-week daily dosage of IFN is comparable to a 12-week schedule, we recommend the former regimen.
据报道，慢性丙型肝炎（CHC）患者采用利巴韦林与隔日干扰素（IFN）的标准联合疗法可实现30%-55%的持续病毒学应答。每日使用IFN早期降低病毒载量可增强病毒清除率。然而，每日给药方案的持续时间以及可能的副作用尚未得到充分研究。我们比较了CHC患者每日使用IFN 4周与12周的疗效和安全性。
59例经组织学证实的CHC患者，其丙氨酸氨基转移酶（ALT）水平>1.5倍正常上限（ULN），被随机分为2组。I组患者每日给予IFN 3百万国际单位（MIU），持续4周，随后每周三次（tiw）给药12个月；II组患者每日给予IFN 3 MIU，持续12周，随后tiw给药12个月。利巴韦林剂量为800-1200mg/d，给药12个月。
59例患者中的52例（I组=28例；II组=24例）完成了研究。两组之间的预处理变量和HCV 1型的患病率相当。I组9例患者（29%）和II组6例患者（25%）有3、4期纤维化。在4周、12周、24周和52周结束时，I组HCV RNA阴性率分别为27%、54%、65%和71%，II组分别为38%、54%、71%和75%（P=无显著差异）。8例1型患者中的4例（50%）和43例非1型患者中的30例（69.8%）对治疗有反应（P=无显著差异）。I组和II组的持续病毒学应答率分别为61%和71%。没有变量能准确预测无反应情况。未观察到严重不良反应，两组之间相当。
每日使用IFN联合利巴韦林是安全的，可达65%的患者有反应。由于每日使用IFN 4周的疗效与12周方案相当，我们推荐前一种方案。
