Gentile Ivan, Buonomo Antonio Riccardo, Coppola Carmine, Staiano Laura, Amoruso Daniela Caterina, Saturnino Maria Rosaria, Maraolo Alberto Enrico, Portunato Federica, De Pascalis Stefania, Martini Salvatore, Crispo Manuel, Macera Margherita, Pinchera Biagio, Zappulo Emanuela, Scotto Riccardo, Coppola Nicola
Department of Clinical Medicine and Surgery - Section of Infectious Diseases. University of Naples Federico II.
Department of Internal Medicine - Unit of Hepatology and Interventional Ultrasonography. OORR Area Stabiese, Plesso Nuovo Gragnano, Naples, Italy.
New Microbiol. 2019 Apr;42(2):94-100. Epub 2019 Apr 29.
Approximately 71 million people are chronically infected with HCV worldwide. Recently, interferonfree therapies effective against HCV became available and nowadays, therapeutic strategies include a combination of two or three drugs with different mechanisms of action. In the present study, we reported real-life SVR rates in a large cohort of four prescribing centers in a high-endemic area of Southern Italy. We conducted a prospective multicenter study among all the patients with chronic HCV infection, who received therapy with the first available interferon-free therapies between March 2015 and December 2017 and who referred to one of the 4 DAA-prescribing centers in Campania, Southern Italy. Patients with Child C cirrhosis, a diagnosis of active HCC at the baseline or who refused the consent form, were excluded. Nine-hundred fifty-three patients were enrolled. Most of the enrolled patients had HCV genotype 1b infection (66.4%), were older than 65 years (64.1%) and had advanced liver fibrosis (Metavir > F4) (73.5%). The overall SVR12 rate was 98.5%. Patients with clinical cirrhosis had a similar SVR12 rate compared with those without cirrhosis (97.8% vs 99.2%, p=0.09), while patients with decompensated cirrhosis had a significantly lower rate of SVR12 compared with those without decompensated disease (95.3% vs 99.0%, p<0.05). Patients aged more than 65 years had a similar rate of SVR12 compared with patients aged ≤ 65 years (98.6% vs 98.0%, p=0.57). Among patients >65 years, those with clinical cirrhosis, as well as those with advanced liver fibrosis, had a similar SVR12 rate compared with the patients with a Metavir score < F4 (98.3% vs 99.0%, p=0.70 and 98.6% vs 98.6%, p=1.00, respectively). In the present, real-life study, DAA regimens are effective and safe in patients with chronic HCV infection, regardless of age and stage of liver disease, providing very high rates of SVR12 (98.5%).
全球约有7100万人慢性感染丙型肝炎病毒（HCV）。最近，出现了对HCV有效的无干扰素疗法，如今，治疗策略包括联合使用两种或三种作用机制不同的药物。在本研究中，我们报告了意大利南部一个高流行地区四个处方中心的一大群患者的实际持续病毒学应答（SVR）率。我们对所有慢性HCV感染患者进行了一项前瞻性多中心研究，这些患者在2015年3月至2017年12月期间接受了首批可用的无干扰素疗法治疗，并转诊至意大利南部坎帕尼亚的4个直接抗病毒药物（DAA）处方中心之一。排除Child C级肝硬化患者、基线时诊断为活动性肝细胞癌（HCC）的患者或拒绝签署知情同意书的患者。共纳入953例患者。大多数纳入患者感染HCV基因1b型（66.4%），年龄大于65岁（64.1%），并有晚期肝纤维化（梅塔维分级> F4）（73.5%）。总体SVR12率为98.5%。临床肝硬化患者的SVR12率与无肝硬化患者相似（97.8%对99.2%，p = 0.09），而失代偿期肝硬化患者的SVR12率显著低于无失代偿疾病的患者（95.3%对99.0%，p<0.05）。年龄大于65岁的患者的SVR12率与年龄≤65岁的患者相似（98.6%对98.0%，p = 0.57）。在年龄大于65岁的患者中，临床肝硬化患者以及晚期肝纤维化患者的SVR12率与梅塔维评分< F4的患者相似（分别为98.3%对99.0%，p = 0.70和98.6%对98.6%，p = 1.00）。在本项实际研究中，DAA方案对慢性HCV感染患者有效且安全，无论其年龄和肝病阶段如何，均可提供非常高的SVR12率（98.5%）。
