Unidad Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valme, Sevilla, Spain.
Enferm Infecc Microbiol Clin. 2013 Aug-Sep;31(7):424-9. doi: 10.1016/j.eimc.2012.12.004. Epub 2013 Feb 28.
Pegylated interferon plus ribavirin (Peg-IFN/RBV) therapy leads to improvements in liver stiffness measurements (LSM) in hepatitis C virus (HCV)-infected patients. However, the rate of LSM return to normal values in response to Peg-IFN/RBV is unclear. Thus, our aim was to assess the probability and factors associated with LSM normalization in HCV-infected patients receiving Peg-IFN/RBV.
This prospective observational longitudinal study included 160 HCV-infected patients, 111 (69%) with human immunodeficiency virus and receiving Peg-IFN/RBV, with baseline LSM ≥ 7kPa. The outcome variable was LSM normalization, i.e. a stable decrease in LSM below 7kPa after starting Peg-IFN/RBV.
After starting Peg-IFN/RBV, 56 [35%, 95% confidence interval (95% CI): 28-42%] patients showed LSM normalization. The probability of LSM normalization was 21% (95% CI: 13.2-32.4%) at 12 months, and 51.3% (95% CI: 39.9-63.9%) at 24 months after Peg-INF/RBV initiation for individuals with sustained virological response (SVR), and 8.3% (95% CI: 4-16.6%) at 12 months and 11.3% (95% CI: 6-20.7%) at 24 months for those without SVR (p<0.001). For individuals with LSM ≥ 7kPa 24 weeks after the pre-planned end of treatment, LSM normalizations were only observed among those with SVR. Achievement of SVR [Hazard ratio (HR, 95% CI): 6.84 (3.39-13.81)] and lack of baseline cirrhosis [HR (95% CI): 4.17 (1.69-10)] were independently associated with LSM normalization after starting Peg-IFN/RBV.
LSM normalizations during Peg-IFN/RBV treatment are more likely, and occur earlier among patients with SVR. In addition, LSM normalizations continue 24 weeks after the scheduled end of therapy, but only among individuals who reach SVR.
聚乙二醇干扰素联合利巴韦林(Peg-IFN/RBV)治疗可改善丙型肝炎病毒(HCV)感染患者的肝硬度测量值(LSM)。然而,对于 Peg-IFN/RBV 治疗后 LSM 恢复正常的比例尚不清楚。因此,我们的目的是评估接受 Peg-IFN/RBV 治疗的 HCV 感染患者中 LSM 正常化的概率和相关因素。
这是一项前瞻性观察性纵向研究,纳入了 160 例 HCV 感染患者,其中 111 例(69%)合并人类免疫缺陷病毒感染,基线 LSM≥7kPa。主要结局变量为 LSM 正常化,即 Peg-IFN/RBV 治疗开始后 LSM 持续稳定下降至<7kPa。
开始 Peg-IFN/RBV 治疗后,56 例(35%,95%置信区间(95%CI):28-42%)患者的 LSM 正常化。对于获得持续病毒学应答(SVR)的患者,在 Peg-INF/RBV 治疗开始后 12 个月和 24 个月时,LSM 正常化的概率分别为 21%(95%CI:13.2-32.4%)和 51.3%(95%CI:39.9-63.9%),而对于未获得 SVR 的患者,在 12 个月和 24 个月时,LSM 正常化的概率分别为 8.3%(95%CI:4-16.6%)和 11.3%(95%CI:6-20.7%)(p<0.001)。对于治疗结束后 24 周时 LSM 仍≥7kPa 的患者,仅在获得 SVR 的患者中观察到 LSM 正常化。获得 SVR(风险比[HR],95%CI:6.84(3.39-13.81))和无基线肝硬化(HR,95%CI:4.17(1.69-10))是 Peg-IFN/RBV 治疗开始后 LSM 正常化的独立相关因素。
SVR 患者 Peg-IFN/RBV 治疗期间 LSM 正常化的可能性更高,且发生更早。此外,治疗结束后 24 周时仍可继续 LSM 正常化,但仅发生在获得 SVR 的患者中。