Ramos Huascar, Linares Pedro, Badia Ester, Martín Isabel, Gómez Judith, Almohalla Carolina, Jorquera Francisco, Calvo Sara, García Isidro, Conde Pilar, Álvarez Begoña, Karpman Guillermo, Lorenzo Sara, Gozalo Visitación, Vásquez Mónica, Joao Diana, de Benito Marina, Ruiz Lourdes, Jiménez Felipe, Sáez-Royuela Federico
Huascar Ramos, Ester Badia, Judith Gómez, Visitación Gozalo, Federico Sáez-Royuela, Department of Gastroenterology and Hepatology, Hospital Universitario de Burgos, 09006 Burgos, Spain.
World J Gastrointest Pharmacol Ther. 2017 May 6;8(2):137-146. doi: 10.4292/wjgpt.v8.i2.137.
To investigated the real-world effectiveness and safety of various regimens of interferon-free treatments in patients infected with hepatitis C virus (HCV).
We performed an observational study to analyze different antiviral treatments administered to 462 HCV-infected patients, of which 56.7% had liver cirrhosis. HCV RNA after 4 wk of treatment and at 12 wk after treatment sustained virologic response (SVR) as well as serious adverse events (SAEs) was analyzed first for the whole cohort and then separately in patients who met or did not meet the inclusion criteria of a clinical trial (CT-met and CT-unmet, respectively).
The most frequently prescribed treatment was simeprevir/sofosbuvir (36.4%), followed by sofosbuvir/ledipasvir (24.9%) and ombitasvir/paritaprevir/ritonavir (r)/dasabuvir (19.9%). Ribavirin (RBV) was administered in 198 patients (42.9%). SVRs occurred in 437/462 patients (94.6%). The SVRs ranged between 93.3% and 100% for genotypes 1-4. SVRs were achieved in 96.2% patients in the CT-met group 91.9% patients in the CT-unmet group ( = 0.049). Undetectable HCV RNA at week 4 occurred in 72.9% of the patients. In the univariate analysis, the factors associated with SVRs were lower liver stiffness, absence of cirrhosis, higher platelet count, higher albumin levels, no RBV dose reduction, undetectable HCV RNA at week 4 and CT-met group. In the multivariate analysis, only albumin was an independent predictor of treatment failure ( = 0.04). Eleven patients (2.4%) developed SAEs; 5.2% and 0.7% of the patients in the CT-unmet and CT-met groups, respectively ( = 0.003).
A high proportion of patients with HCV infection achieved SVRs. For patients who did not meet the CT criteria, treatment regimens must be optimized.
研究丙型肝炎病毒（HCV）感染患者接受各种无干扰素治疗方案的真实世界有效性和安全性。
我们进行了一项观察性研究，分析给予462例HCV感染患者的不同抗病毒治疗，其中56.7%患有肝硬化。首先对整个队列分析治疗4周后及治疗12周时的HCV RNA持续病毒学应答（SVR）以及严重不良事件（SAE），然后分别对符合或不符合临床试验纳入标准的患者（分别为CT符合组和CT不符合组）进行分析。
最常处方的治疗是西米普明/索磷布韦（36.4%），其次是索磷布韦/来迪帕司韦（24.9%）和奥比他韦/帕利瑞韦/利托那韦（r）/达沙布韦（19.9%）。198例患者（42.9%）使用了利巴韦林（RBV）。437/462例患者（94.6%）实现了SVR。1-4型基因型的SVR在93.3%至100%之间。CT符合组96.2%的患者和CT不符合组91.9%的患者实现了SVR（P = 0.049）。4周时HCV RNA检测不到的患者占72.9%。在单因素分析中，与SVR相关的因素包括较低的肝脏硬度、无肝硬化、较高的血小板计数、较高的白蛋白水平、未降低RBV剂量、4周时HCV RNA检测不到以及CT符合组。在多因素分析中，只有白蛋白是治疗失败的独立预测因素（P = 0.04）。11例患者（2.4%）发生了SAE；CT不符合组和CT符合组分别有5.2%和0.7%的患者发生SAE（P = 0.003）。
高比例的HCV感染患者实现了SVR。对于不符合CT标准的患者，必须优化治疗方案。
