Horsmans Yves, Berg Thomas, Desager Jean-Pierre, Mueller Tobias, Schott Eckart, Fletcher Simon P, Steffy Kevin R, Bauman Lisa A, Kerr Bradley M, Averett Devron R
Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Unit de Pharmacologie Clinique, Brussels, Belgium.
Hepatology. 2005 Sep;42(3):724-31. doi: 10.1002/hep.20839.
Immune-based therapy is the mainstay treatment for chronic hepatitis C virus (HCV) infection but causes multiple side effects and achieves durable viral clearance in only approximately 50% of patients. Most new investigational anti-HCV compounds are direct-acting antivirals for which durability of response and risk of viral mutations and resistance are not yet known. Therefore, continuing discovery and development of new immune-based treatments is desirable. Toll-like receptors (TLRs) are pathogen recognition receptors that initiate the innate immune response. The responsiveness of HCV or other ongoing chronic systemic infections to treatment with a selective TLR agonist has not been reported. Isatoribine is a selective agonist of TLR7. In a proof-of-concept study, we found that once-daily 7-day treatment with intravenous isatoribine 800 mg caused a significant (P = .001) reduction of plasma HCV RNA (mean, -0.76; range, -2.85 to +0.21 log(10) units) in otherwise untreated patients (n = 12) who were chronically infected with HCV. Viral load reduction occurred in patients infected with genotype 1 as well as non-genotype 1 HCV. The reduction of viral load was correlated with induction of markers of a heightened immune antiviral state, including 2'-, 5'- oligoadenylate synthetase levels in whole blood. This treatment was well tolerated, with a low frequency of mild to moderate adverse events. In conclusion, systemic administration of the selective TLR7 agonist isatoribine resulted in dose-dependent changes in immunologic biomarkers and a statistically significant antiviral effect with relatively few and mild side effects.
基于免疫的疗法是慢性丙型肝炎病毒(HCV)感染的主要治疗方法,但会引发多种副作用,且仅在约50%的患者中实现持久的病毒清除。大多数新的抗HCV研究化合物都是直接作用抗病毒药物,其疗效的持久性以及病毒突变和耐药风险尚不清楚。因此,持续发现和开发新的基于免疫的治疗方法是很有必要的。Toll样受体(TLR)是启动先天性免疫反应的病原体识别受体。尚未有关于HCV或其他持续慢性全身感染对选择性TLR激动剂治疗反应性的报道。异硫鸟嘌呤是TLR7的选择性激动剂。在一项概念验证研究中,我们发现,对于12例未经治疗的慢性HCV感染患者,每天静脉注射800mg异硫鸟嘌呤,连续治疗7天,可使血浆HCV RNA显著降低(P = .001)(平均降低-0.76;范围为-2.85至+0.21 log(10)单位)。1型HCV感染患者以及非1型HCV感染患者的病毒载量均有所降低。病毒载量的降低与免疫抗病毒状态增强标志物的诱导相关,包括全血中2',5'-寡腺苷酸合成酶水平。该治疗耐受性良好,轻度至中度不良事件发生率较低。总之,选择性TLR7激动剂异硫鸟嘌呤的全身给药导致免疫生物标志物出现剂量依赖性变化,并产生具有统计学意义的抗病毒效果,且副作用相对较少且轻微。