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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV
New England Journal of Medicine, Volume 370, No. 21, Year 2014
Notification
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Description
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 ribavirin group (7.8% vs. 2.0%). In both studies, decreases in the hemoglobin level were significantly more common in patients receiving ribavirin. Two patients (0.3%) discontinued the study drugs owing to adverse events. The most common adverse events were fatigue, headache, and nausea. CONCLUSIONS: Twelve weeks of treatment with ABT-450/r-ombitasvir and dasabuvir without ribavirin was associated with high rates of sustained virologic response among previously untreated patients with HCV genotype 1 infection. Rates of virologic failure were higher without ribavirin than with ribavirin among patients with genotype 1a infection but not among those with genotype 1b infection. Copyright © 2014 Massachusetts Medical Society.
Authors & Co-Authors
Lalezari, Jacob Paul
United States, San Francisco
Quest Clinical Research
Cohen, Daniel E.
United States, North Chicago
Abbvie
Cooper, Curtis L.
Canada, Ottawa
University of Ottawa
Tam, Edward
Unknown Affiliation
Marinho, Rui Tato
Unknown Affiliation
Baruch, Yaacov
Unknown Affiliation
Chulanov, Vladimir P.
Russian Federation, Moscow
Central Research Institute of Epidemiology
Janczewska, Ewa
Unknown Affiliation
Rizzardini, Giuliano
Italy, Milan
Ospedale Luigi Sacco - Polo Universitario
Gervain, Judit
Unknown Affiliation
Moreno, Christophe
Belgium, Brussels
Université Libre de Bruxelles
Hassanein, Tarek I.
Unknown Affiliation
Statistics
Citations: 638
Authors: 12
Affiliations: 12
Identifiers
Doi:
10.1056/NEJMoa1402338
ISSN:
00284793
Research Areas
Genetics And Genomics
Infectious Diseases
Study Design
Case-Control Study