Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients.
Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients.
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DOI：
10.1002/hep.27705
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发表时间：
2015-05
期刊：
影响因子：
--
通讯作者：
Kumada H
中科院分区：
文献类型：
--
作者：
Chayama K;Notsumata K;Kurosaki M;Sato K;Rodrigues L Jr;Setze C;Badri P;Pilot-Matias T;Vilchez RA;Kumada H
大约有200万日本人感染了丙型肝炎病毒，并有患上肝硬变、终末期肝病和肝细胞癌的风险。干扰素/利巴韦林(RBV)治疗失败的患者仍然面临风险，因为有效的治疗选择有限。这项2期随机开放研究评估了在聚乙二醇化干扰素/RBV治疗经验的日本丙型肝炎病毒亚型1b或2型感染患者中，每日一次的无干扰素和RBV的Ombitasvir(ABT-267)方案，以及与利托那韦(paritaprevir/ritonavir)配伍的NS3/4A蛋白酶抑制剂paritaprevir(ABT-450)。非肝硬变患者(年龄18~75岁)合并1b亚型感染，奥比塔韦25 mg联合帕罗帕韦/利托那韦100/100 mg或150/100 mg治疗12周或24周，2型感染患者奥比塔韦25 mg联合帕拉帕韦/利托那韦100/100 mg或150/100 mg治疗12周。治疗后24周持续病毒学应答(SVR)(SVR24)为主要终点。在整个研究中收集了不良事件。110名患者接受了≥1剂量的研究药物。在1b亚型队列中，SVR24的发生率很高(88.9%-100%)，无论其剂量或治疗时间长短。在基因2队列中，使用100 mg和150 mg的Paritapvir时，SVR24的发生率分别为57.9%和72.2%。2a亚型患者的SVR24频率(90%)高于2b亚型患者(27%)。SVR12与SVR24的符合率为100%。总体上最常见的不良反应是鼻咽炎(29%)和头痛(14%)。结论：在这一难以治疗的人群中，先前聚乙二醇化干扰素/RBV失败的患者中，奥比塔韦/paritaprevir/ritonavir在感染日本丙型肝炎病毒1b或2a的患者中显示出强大的抗病毒活性，具有良好的安全性。(《肝病》2015；61：1523-1532)
Approximately 2 million Japanese individuals are infected with hepatitis C virus and are at risk for cirrhosis, end‐stage liver disease, and hepatocellular carcinoma. Patients in whom interferon (IFN)/ribavirin (RBV) therapy has failed remain at risk as effective therapeutic options are limited. This phase 2, randomized, open‐label study evaluated an IFN‐ and RBV‐free regimen of once‐daily ombitasvir (ABT‐267), an NS5A inhibitor, plus paritaprevir (ABT‐450), an NS3/4A protease inhibitor dosed with ritonavir (paritaprevir/ritonavir), in pegylated IFN/RBV treatment–experienced Japanese patients with hepatitis C virus subtype 1b or genotype 2 infection. Patients without cirrhosis (aged 18‐75 years) with subtype 1b infection received ombitasvir 25 mg plus paritaprevir/ritonavir 100/100 mg or 150/100 mg for 12 or 24 weeks; patients with genotype 2 infection received ombitasvir 25 mg plus paritaprevir/ritonavir 100/100 mg or 150/100 mg for 12 weeks. Sustained virologic response (SVR) at posttreatment week 24 (SVR24) was the primary endpoint. Adverse events were collected throughout the study. One hundred ten patients received ≥1 dose of study medication. In the subtype 1b cohort, SVR24 rates were high (88.9%‐100%) regardless of paritaprevir dose or treatment duration. In the genotype 2 cohort, SVR24 rates were 57.9% and 72.2% with 100 mg and 150 mg of paritaprevir, respectively. The SVR24 rate was higher in patients with subtype 2a (90%) than 2b (27%). Concordance between SVR12 and SVR24 was 100%. The most common adverse events overall were nasopharyngitis (29%) and headache (14%). Conclusion: In this difficult‐to‐treat population of patients in whom prior pegylated IFN/RBV had failed, ombitasvir/paritaprevir/ritonavir demonstrated potent antiviral activity with a favorable safety profile among Japanese patients with hepatitis C virus genotype 1b or 2a infection. (Hepatology 2015;61:1523–1532)
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影响因子：
29.4
作者：
El-Serag HB
通讯作者：
El-Serag HB
日本患者中丙型肝炎病毒亚基型和1B的患病率：HCV NS5B基因型特异性区域的超深测序分析。
影响因子：
3.7
作者：
Wu S;Kanda T;Nakamoto S;Jiang X;Miyamura T;Nakatani SM;Ono SK;Takahashi-Nakaguchi A;Gonoi T;Yokosuka O
通讯作者：
Yokosuka O
影响因子：
158.5
作者：
Kowdley, Kris V.;Lawitz, Eric;Bernstein, Barry
通讯作者：
Bernstein, Barry
影响因子：
6.3
作者：
Hayashi, Norio;Seto, Chiharu;Goto, Shoichiro
通讯作者：
Goto, Shoichiro
影响因子：
29.4
作者：
Andreone, Pietro;Colombo, Massimo G.;Bernstein, Barry
通讯作者：
Bernstein, Barry