Napoli N, Giannelli G, Antonaci A, Antonaci S
Department of Internal Medicine, Immunology and Infectious Diseases, Section of Internal Medicine, University of Bari Medical School, Bari, Italy.
J Viral Hepat. 2008 Apr;15(4):300-4. doi: 10.1111/j.1365-2893.2007.00944.x.
In patients with chronic hepatitis C, rapid virological response (RVR) at week 4 of treatment seems to be strongly associated with a high probability of achieving a sustained virological response (SVR). The aim of this study was to investigate the outcome of different pegylated interferon-alpha2b (Peg-IFN-alpha2b) dosages plus ribavirin (RBV) in patients with RVR. Forty-five naïve patients chronically infected with hepatitis C virus (HCV)-1b started Peg-IFN-alpha2b (1.5 microg/kg/week) in combination with weight-based RBV doses (800-1200 mg/day). Thirty-one patients (68.9%) attained RVR at week 4 of therapy, while four further patients showed negative HCV-RNA values for the first time at week 12 and were considered early virological responders (EVR). The 31 RVR patients were randomized to receive either RBV plus 1.5 microg/kg/week (17 pts) or 1.0 microg/kg/week (14 pts) of Peg-IFN-alpha2b for the remaining 44 weeks. The two groups were matched for age, sex, baseline alanine aminotransferase levels, viral load and fibrosis score. After 6 months of post-treatment follow-up, the prevalence of SVR was 94.1% (16/17) among RVR patients treated with 1.5 microg/kg/week and 92.8% (13/14) in RVR patients treated with 1.0 microg/kg/week (P = not significant). A high-baseline viral load (P = 0.01) and bridging fibrosis/cirrhosis (P = 0.02) negatively influenced the likelihood of achieving RVR. On the contrary, the ability of RVR patients to achieve SVR did not correlate with these baseline characteristics in either of the treatment group. Finally, the SVR rate among EVR patients who responded after more than 4 weeks of treatment was significantly lower than among RVR patients (1/4 = 25%vs 29/31 = 93.5%; P = 0.0058), because of a high prevalence of post-treatment relapse among patients with EVR.
在慢性丙型肝炎患者中,治疗第4周时的快速病毒学应答(RVR)似乎与实现持续病毒学应答(SVR)的高概率密切相关。本研究的目的是调查不同剂量聚乙二醇化干扰素α-2b(Peg-IFN-α2b)联合利巴韦林(RBV)治疗有RVR的患者的疗效。45例初治的慢性丙型肝炎病毒(HCV)-1b感染患者开始接受Peg-IFN-α2b(1.5μg/kg/周)联合根据体重调整剂量的RBV(800 - 1200mg/天)治疗。31例患者(68.9%)在治疗第4周时达到RVR,另有4例患者在第12周时首次出现HCV-RNA阴性,被视为早期病毒学应答者(EVR)。31例RVR患者被随机分为两组,在接下来的44周内分别接受RBV联合1.5μg/kg/周(17例)或1.0μg/kg/周(14例)的Peg-IFN-α2b治疗。两组在年龄、性别、基线丙氨酸氨基转移酶水平、病毒载量和纤维化评分方面相匹配。治疗后随访6个月,接受1.5μg/kg/周治疗的RVR患者中SVR的发生率为94.1%(16/17),接受1.0μg/kg/周治疗的RVR患者中SVR的发生率为92.8%(13/14)(P = 无显著性差异)。高基线病毒载量(P = 0.01)和桥接纤维化/肝硬化(P = 0.02)对实现RVR的可能性有负面影响。相反,在任何一个治疗组中,RVR患者实现SVR的能力与这些基线特征均无相关性。最后,治疗4周后才出现应答的EVR患者中的SVR率显著低于RVR患者(1/4 = 25%对29/31 = 93.5%;P = 0.0058),因为EVR患者治疗后复发率较高。