ABT-450/r–Ombitasvir and Dasabuvir with or without Ribavirin for HCV

作者：Péter Ferenci, David Bernstein, Jacob Lalezari, Daniel E. Cohen, Yan Luo, Curtis Cooper, Edward Tam, Rui Tato Marinho, Naoky Tsai, Anders Nyberg, Terry Box, Ziad Younes, Pedram Enayati, Sinikka Green, Yaacov Baruch, Bal Raj Bhandari, Florin Alexandru Căruntu, Thomas Sepe, Vladimir Chulanov, Ewa Janczewska, Giuliano Rizzardini, Judit Gervain, Ramón Planas, Christophe Moreno, Tarek Hassanein, Wangang Xie, Martin King, Thomas Podsadecki, K. Rajender Reddy · 发表于：New England Journal of Medicine · 年份：2014 · DOI：10.1056/nejmoa1402338 · 被引用次数：696 · 研究领域：Hepatitis C virus research、HIV/AIDS drug development and treatment、Hemophilia Treatment and Research

BACKGROUND: The interferon-free regimen of ABT-450 with ritonavir (ABT-450/r), ombitasvir, and dasabuvir with or without ribavirin has shown efficacy in inducing a sustained virologic response in a phase 2 study involving patients with hepatitis C virus (HCV) genotype 1 infection. We conducted two phase 3 trials to examine the efficacy and safety of this regimen in previously untreated patients with HCV genotype 1 infection and no cirrhosis. METHODS: We randomly assigned 419 patients with HCV genotype 1b infection (PEARL-III study) and 305 patients with genotype 1a infection (PEARL-IV study) to 12 weeks of ABT-450/r-ombitasvir (at a once-daily dose of 150 mg of ABT-450, 100 mg of ritonavir, and 25 mg of ombitasvir), dasabuvir (250 mg twice daily), and ribavirin administered according to body weight or to matching placebo for ribavirin. The primary efficacy end point was a sustained virologic response (an HCV RNA level of <25 IU per milliliter) 12 weeks after the end of treatment. RESULTS: The study regimen resulted in high rates of sustained virologic response among patients with HCV genotype 1b infection (99.5% with ribavirin and 99.0% without ribavirin) and among those with genotype 1a infection (97.0% and 90.2%, respectively). Of patients with genotype 1b infection, 1 had virologic failure, and 2 did not have data available at post-treatment week 12. Among patients with genotype 1a infection, the rate of virologic failure was higher in the ribavirin-free group than in the ...