Milella M, Santantonio T, Pietromatera G, Maselli R, Casalino C, Mariano N, Genchi C, Pastore G
Clinic of Infectious Diseases, University of Bari, Italy.
Ital J Gastroenterol Hepatol. 1999 Apr;31(3):211-5.
Interferon-alpha treatment of chronic hepatitis C is beneficial in only 20-30% of patients. This study evaluates if combination therapy with Interferon-alfa plus ribavirin is effective in inducing a response in patients who did not respond to, or relapsed after, a standard Interferon-alfa treatment.
A total of 88 patients, 49 non-responders and 39 relapsers to previous Interferon-alfa therapy, were randomized to receive either natural Interferon-alfa (6 MU t.i.w.) plus ribavirin (1000 mg/daily) or natural Interferon-alfa alone (6 MU t.i.w.) for 6 months. All were followed for 12 months after stopping therapy. Serum aminotransferase levels were assessed monthly and HCV RNA was evaluated by RT-PCR (Amplicor, Roche) at end of therapy and the end of follow-up.
After treatment, a higher response rate defined as return to normal of aminotransferases and absence of serum HCV RNA was observed among patients treated with Interferon-alfa-ribavirin: 4/28 (14%) vs 1/21 (5%) non-responder patients and 9/19 (47%) vs 5/20 (25%) in the relapsers group. At the end of follow-up, a sustained response was found only in the combination treatment group: 4% and 32% in non-responder and relapser patients, respectively.
Our results suggest that retreatment with natural Interferon-alfa plus ribavirin is more effective than Interferon-alfa alone in increasing the response rate in patients with chronic hepatitis C who relapse after a previous standard IFN treatment whereas it is less effective in non-responder patients.
仅20%-30%的慢性丙型肝炎患者接受α干扰素治疗有益。本研究评估α干扰素联合利巴韦林的联合疗法对那些对标准α干扰素治疗无反应或治疗后复发的患者诱导产生反应是否有效。
总共88例患者，其中49例对先前α干扰素治疗无反应者和39例复发者，被随机分为接受天然α干扰素（6MU，每周3次）加利巴韦林（每日1000mg）或仅接受天然α干扰素（6MU，每周3次）治疗6个月。所有患者在停止治疗后随访12个月。每月评估血清转氨酶水平，并在治疗结束时及随访结束时通过逆转录聚合酶链反应（Amplicor，罗氏公司）评估HCV RNA。
治疗后，接受α干扰素-利巴韦林治疗的患者中，定义为转氨酶恢复正常且血清HCV RNA阴性的更高反应率被观察到：在无反应患者中为4/28（14%）对1/21（5%），在复发患者组中为9/19（47%）对5/20（25%）。随访结束时，仅在联合治疗组中发现持续反应：无反应患者和复发患者分别为4%和32%。
我们的结果表明，对于先前标准干扰素治疗后复发的慢性丙型肝炎患者，天然α干扰素加利巴韦林再治疗在提高反应率方面比单独使用α干扰素更有效，而对无反应患者效果较差。
