Sofosbuvir with peginterferon-ribavirin for 12 weeks in previously treated patients with hepatitis C genotype 2 or 3 and cirrhosis.
Sofosbuvir with peginterferon-ribavirin for 12 weeks in previously treated patients with hepatitis C genotype 2 or 3 and cirrhosis.
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DOI：
10.1002/hep.27567
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发表时间：
2015-03
期刊：
影响因子：
13.5
通讯作者：
Membreno, Fernando E.
中科院分区：
文献类型：
--
作者：
Lawitz, Eric;Poordad, Fred;Brainard, Diana M.;Hyland, Robert H.;An, Di;Dvory-Sobol, Hadas;Symonds, William T.;McHutchison, John G.;Membreno, Fernando E.
索非布韦（SOF）联合利巴韦林（RBV）治疗12周或24周分别是目前治疗丙型肝炎病毒（HCV）基因型2型和3型感染患者的标准。然而，在临床试验中，治疗经验丰富的患者，特别是那些肝硬化，有次优的持续病毒学应答（SVR）率。我们评估了索非布韦加聚乙二醇干扰素和利巴韦林（SOF+Peg-IFN+RBV）治疗经验丰富的HCV基因型2和3型患者（伴或不伴肝硬化）12周的疗效和安全性。我们在这项开放标签、非随机、非对照的2期研究中招募了47例患者。主要终点是研究治疗停止后12周时发生SVR的患者比例（SVR 12）。SVR 12的总体发生率为89%（95%置信区间[CI]：77-97）。SVR 12在基因2型患者中的发生率高于基因3型患者，分别为96%（95%CI：78-100）和83%（95%CI：62-95）。在有和没有肝硬化的患者中，SVR 12的发生率相似：对于基因型2，93%的肝硬化患者和100%的没有肝硬化的患者达到了SVR 12，而对于基因型3，在有和没有肝硬化的患者中，SVR 12的发生率都是83%。1例患者因不良事件停止研究治疗，4例患者发生严重不良事件。最常见的不良事件是流感样疾病、疲劳、贫血和中性粒细胞减少症。结论：在有治疗经验的HCV基因型2和3的患者中，12周的SOF+Peg-IFN+RBV给药提供了高SVR率，而与肝硬化状态无关。未发现安全性问题。（肝病学2015;61：769-775）
Sofosbuvir (SOF) in combination with ribavirin (RBV) for 12 or 24 weeks is the current standard of care for patients infected with hepatitis C virus (HCV) genotypes 2 and 3, respectively. However, in clinical trials treatment-experienced patients, particularly those with cirrhosis, had suboptimal sustained virological response (SVR) rates. We assessed the efficacy and safety of sofosbuvir plus peginterferon and ribavirin (SOF+Peg-IFN+RBV) administered for 12 weeks to treatment-experienced patients with HCV genotypes 2 and 3, with and without cirrhosis. We enrolled 47 patients in this open-label, nonrandomized, uncontrolled phase 2 study. The primary endpoint was the proportion of patients with SVR at 12 weeks after cessation of study treatment (SVR12). The overall rate of SVR12 was 89% (95% confidence interval [CI]: 77-97). Rates of SVR12 were higher in patients with genotype 2 than in those with genotype 3, 96% (95% CI: 78-100) and 83% (95% CI: 62-95), respectively. Rates of SVR12 were similar in patients with and without cirrhosis: for genotype 2, 93% of patients with cirrhosis and 100% of patients without cirrhosis achieved SVR12, and for genotype 3, the SVR12 rate was 83% in patients both with and without cirrhosis. One patient discontinued study treatment because of an adverse event and four patients experienced serious adverse events. The most common adverse events were influenza-like illness, fatigue, anemia, and neutropenia. Conclusion: In treatment-experienced patients with HCV genotypes 2 and 3, 12-week administration of SOF+Peg-IFN+RBV provided high SVR rates, irrespective of cirrhosis status. No safety concerns were identified. (Hepatology 2015;61:769–775)
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影响因子：
5.2
作者：
Naggie, Susanna;Patel, Keyur;McHutchison, John
通讯作者：
McHutchison, John
影响因子：
158.5
作者：
Shiffman, Mitchell L.;Suter, Fredy;Younossi, Z.
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DOI：
10.1097/meg.0b013e32835eb8bf
发表时间：
2013-07-01
影响因子：
2.1
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Karatapanis, Stylianos
DOI：
10.1002/hep.27095
发表时间：
2014-07
期刊：
Hepatology (Baltimore, Md.)
影响因子：
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作者：
Kanwal F;Kramer JR;Ilyas J;Duan Z;El-Serag HB
通讯作者：
El-Serag HB
影响因子：
158.5
作者：
Zeuzem, Stefan;Dusheiko, Geoffrey M.;Esteban, Rafael
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Esteban, Rafael