Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis.
Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis.
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DOI：
10.1002/hep.27972
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发表时间：
2015-10
期刊：
影响因子：
13.5
通讯作者：
Redman, Rebecca
中科院分区：
文献类型：
--
作者：
Kumada, Hiromitsu;Chayama, Kazuaki;Rodrigues, Lino, Jr.;Suzuki, Fumitaka;Ikeda, Kenji;Toyoda, Hidenori;Sato, Ken;Karino, Yoshiyasu;Matsuzaki, Yasushi;Kioka, Kiyohide;Setze, Carolyn;Pilot-Matias, Tami;Patwardhan, Meenal;Vilchez, Regis A.;Burroughs, Margaret;Redman, Rebecca
GIFT-I是一项3期试验，评估了12周的奥比他韦（OBV）/帕利匹韦（PTV）/利托那韦（r）联合治疗日本丙型肝炎病毒基因型1b感染患者的疗效和安全性。它包括一项在无肝硬化患者中进行的双盲、安慰剂对照子研究和一项在代偿性肝硬化患者中进行的开放标签子研究。无肝硬化的患者以2：1的比例随机分配至每日一次OBV/PTV/r（25 mg/150 mg/100 mg; A组）或安慰剂（B组）。肝硬化患者接受开放标签OBV/PTV/r（C组）。主要疗效终点是A组中符合干扰素条件、未经治疗且无肝硬化且丙型肝炎病毒RNA ≥ 100，000 IU/mL的患者治疗后12周的持续病毒学应答率。共有321例无肝硬化患者随机接受双盲研究药物给药（106例接受双盲安慰剂，随后接受开放标签OBV/PTV/r），42例肝硬化患者入组并接受开放标签OBV/PTV/r给药。在主要疗效人群中，治疗后12周的持续病毒学应答率为94.6%（106/112，95%置信区间90.5 - 98.8）。A组、B组（开放标签）和C组治疗后12周的持续病毒学应答率分别为94.9%（204/215）、98.1%（104/106）和90.5%（38/42）。总体而言，接受OBV/PTV/r的患者中有3.0%（11/363）发生病毒学失败。在接受OBV/PTV/r的三个患者组中，因不良事件而停药的发生率为0%-2.4%。任何组中患者最常见的不良事件是鼻咽炎。结论：在这个广泛的丙型肝炎病毒基因型1b感染的日本患者人群中，无论是否有肝硬化，OBV/PTV/r治疗12周都非常有效，并显示出良好的安全性。（肝病学2015;62：1037 - 1046）
GIFT‐I is a phase 3 trial evaluating the efficacy and safety of a 12‐week regimen of coformulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) for treatment of Japanese hepatitis C virus genotype 1b–infected patients. It consists of a double‐blind, placebo‐controlled substudy of patients without cirrhosis and an open‐label substudy of patients with compensated cirrhosis. Patients without cirrhosis were randomized 2:1 to once‐daily OBV/PTV/r (25 mg/150 mg/100 mg; group A) or placebo (group B). Patients with cirrhosis received open‐label OBV/PTV/r (group C). The primary efficacy endpoint was the rate of sustained virological response 12 weeks posttreatment in interferon‐eligible, treatment‐naive patients without cirrhosis and hepatitis C virus RNA ≥100,000 IU/mL in group A. A total of 321 patients without cirrhosis were randomized and dosed with double‐blind study drug (106 received double‐blind placebo and later received open‐label OBV/PTV/r), and 42 patients with cirrhosis were enrolled and dosed with open‐label OBV/PTV/r. In the primary efficacy population, the rate of sustained virological response 12 weeks posttreatment was 94.6% (106/112, 95% confidence interval 90.5‐98.8). Sustained virological response 12 weeks posttreatment rates were 94.9% (204/215) in group A, 98.1% (104/106) in group B (open‐label), and 90.5% (38/42) in group C. Overall, virological failure occurred in 3.0% (11/363) of patients who received OBV/PTV/r. The rate of discontinuation due to adverse events was 0%‐2.4% in the three patient groups receiving OBV/PTV/r. The most frequent adverse event in patients in any group was nasopharyngitis. Conclusion: In this broad hepatitis C virus genotype 1b–infected Japanese patient population with or without cirrhosis, treatment with OBV/PTV/r for 12 weeks was highly effective and demonstrated a favorable safety profile. (Hepatology 2015;62:1037‐1046)
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影响因子：
4.9
作者：
Kati, Warren;Koev, Gennadiy;Collins, Christine
通讯作者：
Collins, Christine
DOI：
10.1002/hep.27705
发表时间：
2015-05
期刊：
Hepatology (Baltimore, Md.)
影响因子：
--
作者：
Chayama K;Notsumata K;Kurosaki M;Sato K;Rodrigues L Jr;Setze C;Badri P;Pilot-Matias T;Vilchez RA;Kumada H
通讯作者：
Kumada H
影响因子：
29.4
作者：
Andreone, Pietro;Colombo, Massimo G.;Bernstein, Barry
通讯作者：
Bernstein, Barry
影响因子：
25.7
作者：
Menon, Rajeev M.;Badri, Prajakta S.;Dutta, Sandeep
通讯作者：
Dutta, Sandeep
影响因子：
3.2
作者：
Behrends, Matthias;Martinez-Palli, Graciela;Niemann, Claus U.;Cohen, Sara;Ramachandran, Rageshree;Hirose, Ryutaro
通讯作者：
Hirose, Ryutaro