Acharya Subrat K, Sreenivas V, Gupta Siddharth Datta, Kumar Shakti, Chawla Yogesh K, Tandon Anurag, Habeeb Aejaz, Kar Premashish, Chowdhury Abhijit, Choudhuri Gourdas, Sarin Shiv K, Amarapurkar Dn, Arankalle Vidya, Gupte Mohan D, Gupta Sushma, Mukherjee Deepali, Seth Divya, Goyal Rohit, Tandon Badri N
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
J Clin Exp Hepatol. 2012 Mar;2(1):10-8. doi: 10.1016/S0973-6883(12)60079-6. Epub 2012 Apr 12.
Pegylated-interferon-alfa (PEG-IFN-α) with ribavirin is an established treatment in chronic hepatitis due to hepatitis C virus (HCV) (CH-C). Such treatment is expensive and in resource-poor countries such as India, alternative less expensive therapy is needed.
Multicenter randomized controlled trial comparing two treatment regimens (interferon-alfa-2b [IFN-α-2b] 3 million unit/day [MU/day] and ribavirin 1000 mg/day [I+R] vs IFN-α-2b 3 MU/day and glycyrrhizin 250 mg [I+G]) in CH-C. Viral, host characteristics and therapeutic responses were assessed (ICMR-6 months trial for chronic hepatitis-CTRI/2008/091/000105).
One hundred and thirty-one patients meeting the inclusion criteria were randomized to I + G (n=64) or I+R (n=67) during the period February 2002 to May 2005. About 85% (I+G=53, I+R=58) completed 6 months of treatment and 89% of them (I+G=46, I+R=53) completed 6 months of follow-up after completion of treatment. Hepatitis C virus genotype 3 was the major type detected (71% patients). The mean log10 viral load (copies/mL), histological activity index, and fibrosis stage for all patients were 5.1 ± 0.98, 5 ± 2, and 2± 1.5, respectively. Sustained viral response (SVR) was significantly higher in I + R group than in I + G group (65.7% vs 46.9%, OR=2.2, P = 0.03). Treatment with I + G was associated with significantly lower frequencies of leukopenia (2% vs 17%, P <0.01) and anemia (8% vs 40%, P <0.001) as compared to treatment with I + R.
Genotype 3 HCV infection with low viral load is prevalent in India. Daily IFN with ribavirin showed significantly better responses. Leukopenia and anemia were significantly more in ribavirin group. Responses observed with IFN + ribavirin were similar to the reported response rates with PEG-IFN suggesting that this modality may be considered as a cheaper alternative of treatment for chronic hepatitis C.
聚乙二醇化干扰素-α（PEG-IFN-α）联合利巴韦林是丙型肝炎病毒（HCV）所致慢性肝炎（CH-C）的既定治疗方法。这种治疗费用高昂，在印度等资源匮乏的国家，需要更便宜的替代疗法。
一项多中心随机对照试验，比较两种治疗方案（干扰素-α-2b[IFN-α-2b]300万单位/天[MU/天]与利巴韦林1000毫克/天[I+R]对比IFN-α-2b 3 MU/天与甘草酸250毫克[I+G]）用于CH-C的治疗。评估病毒、宿主特征及治疗反应（慢性肝炎ICMR-6个月试验-CTRI/2008/091/000105）。
2002年2月至2005年5月期间，131例符合纳入标准的患者被随机分为I+G组（n=64）或I+R组（n=67）。约85%（I+G组53例，I+R组58例）完成了6个月的治疗，其中89%（I+G组46例，I+R组53例）在治疗结束后完成了6个月的随访。丙型肝炎病毒基因型3是检测到的主要类型（71%的患者）。所有患者的平均log10病毒载量（拷贝/毫升）、组织学活动指数和纤维化分期分别为5.1±0.98、5±2和2±1.5。持续病毒学应答（SVR）在I+R组显著高于I+G组（65.7%对46.9%，OR=2.2，P=0.03）。与I+R治疗相比，I+G治疗的白细胞减少（2%对17%，P<0.01）和贫血（8%对40%，P<0.001）发生率显著更低。
低病毒载量的基因型3 HCV感染在印度很普遍。每日使用干扰素联合利巴韦林显示出显著更好的疗效。利巴韦林组白细胞减少和贫血明显更多。观察到的干扰素+利巴韦林的疗效与报道的聚乙二醇化干扰素的应答率相似，表明这种治疗方式可被视为慢性丙型肝炎更便宜的替代治疗方法。
