Laguno Montserrat, Murillas Javier, Blanco José Luis, Martínez Esteban, Miquel Rosa, Sánchez-Tapias José M, Bargallo Xavier, García-Criado Angeles, de Lazzari Elisa, Larrousse María, León Agathe, Loncá Montserrat, Milinkovic Ana, Gatell Josep M, Mallolas Josep
Infectious Diseases Unit, the Pathology Service, Hospital Clínic Universitari de Barcelona-IDIBAPS, University of Barcelona, Spain.
AIDS. 2004 Sep 3;18(13):F27-36. doi: 10.1097/00002030-200409030-00003.
Current therapies for chronic hepatitis C virus (HCV) in HIV co-infected patients have a low success rate and are poorly tolerated. We have evaluated the efficacy and safety of interferon alfa-2b (IFN) + ribavirin (RBV) versus pegylated interferon alfa-2b (PEG-INF) + RBV.
Randomized, single-centre, open-label clinical trial including patients with: detectable HCV-RNA, alanine aminotransferase > 1.5-fold upper limit of normal, abnormal liver histology, CD4 cell count > 250 x 10/l and HIV RNA < 10 000 copies/ml. Patients were assigned to INF (3 x 10 units three times/week) or PEG-IFN (100-150 microg/week) plus RBV (800-1200 mg/day). Duration of treatment was 48 weeks (only 24 weeks for HCV genotypes 2 or 3 and baseline HCV RNA < 800 000 IU/ml). The primary endpoint was a sustained virological response (SVR).
Ninety-five patients were randomized (43 INF + RBV, 52 PEG-INF + RBV), 68% males, 82% injecting drug users; 63% genotypes 1 or 4 and 36% genotypes 2 or 3; 62% fibrosis index grade >/=2 and 30% bridging fibrosis/cirrhosis. SVR was significantly higher in the PEG-INF + RBV arm, 44% versus 21% (intent to treat; P = 0.017). Among patients with genotypes 1 or 4, SVR were 38% versus 7% (P = 0.007) and 53% versus 47% (P = 0.730) for genotypes 2 or 3. CD4 cell count but not its percentage dropped in both arms and HIV RNA viral load did not change from baseline. Side effects were very frequent in both arms leading to treatment discontinuation in 14 patients without statistical differences between arms (P = 0.565).
PEG-INF + RBV was significantly more effective than INF + RBV for the treatment of chronic hepatitis C in HIV co-infected patients, mainly of genotype 1 or 4.
目前用于治疗合并感染人类免疫缺陷病毒（HIV）的慢性丙型肝炎病毒（HCV）患者的疗法成功率较低且耐受性差。我们评估了干扰素α-2b（IFN）+利巴韦林（RBV）与聚乙二醇化干扰素α-2b（PEG-INF）+RBV的疗效和安全性。
一项随机、单中心、开放标签的临床试验，纳入符合以下条件的患者：HCV-RNA可检测到、丙氨酸氨基转移酶>正常上限的1.5倍、肝脏组织学异常、CD4细胞计数>250×10⁶/L且HIV RNA<10000拷贝/ml。患者被分配至IFN组（3×10⁶单位，每周三次）或PEG-IFN组（100-150μg/周）加RBV组（800-1200mg/天）。治疗持续时间为48周（对于HCV基因2型或3型且基线HCV RNA<800000IU/ml的患者仅为24周）。主要终点是持续病毒学应答（SVR）。
95例患者被随机分组（43例IFN+RBV组，52例PEG-IFN+RBV组），男性占68%，注射吸毒者占82%；基因1型或4型占患者的63%，基因2型或3型占36%；纤维化指数≥2级的患者占62%，桥接纤维化/肝硬化患者占30%。PEG-IFN+RBV组的SVR显著更高，意向性分析中分别为44%和21%（P=0.017）。基因1型或4型患者中，SVR分别为38%和7%（P=0.007），基因2型或3型患者中分别为53%和47%（P=0.730）。两组患者的CD4细胞计数均下降但百分比未下降，HIV RNA病毒载量与基线相比无变化。两组的副作用都很常见，导致14例患者停药，两组之间无统计学差异（P=0.565）。
对于合并感染HIV的慢性丙型肝炎患者，主要是基因1型或4型患者，PEG-IFN+RBV治疗的效果显著优于IFN+RBV。
