Abstract
Objectives: To examine the safety and efficacy of ombitasvir and ABT-450 with ritonavir (ABT-450/r)±ribavirin (RBV) in treatment-naïve, non-cirrhotic adults with chronic HCV genotype 1-3 infection. Methods: Patients in this open-label, exploratory, phase 2, multicenter study received ombitasvir (25mg QD) and ABT-450/r (200/100mg QD)±RBV for 12 weeks. Primary efficacy endpoint was HCV RNA<lower limit of quantitation (LLOQ) from week 4 through 12. Sustained virologic response 12 weeks post-treatment (SVR12) was a secondary endpoint. Results: Sixty-one patients were enrolled. Among genotype 1-, 2-, and 3-infected patients, respectively, HCV RNA was<LLOQ from week 4 through 12 in 10 (100%; 95% CI 69-100), 9 (90%; 56-100), and 7 (70%; 35-93) receiving the RBV-containing regimen and 9 (90%; 56-100), 8 (80%; 44-97), and 2 (18%; 2-52) receiving the RBV-free regimen. Among genotype 1-, 2-, and 3-infected patients, respectively, SVR12 was achieved by 10 (100%), 8 (80%), and 5 (50%) receiving the RBV-containing regimen, and 6 (60%), 6 (60%), and 1 (9%) receiving the RBV-free regimen. The most common adverse events were fatigue, nausea, and headache. One patient discontinued due to an adverse event. Conclusions: In this study, ombitasvir and ABT-450/r±RBV regimens were generally well-tolerated. Sustained virologic response was achieved in most patients with HCV genotype 1 or 2 infection, but low SVR rates were observed in HCV genotype 3-infected patients.
Original language | English (US) |
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Pages (from-to) | 197-205 |
Number of pages | 9 |
Journal | Journal of Infection |
Volume | 70 |
Issue number | 2 |
DOIs | |
State | Published - Feb 1 2015 |
Keywords
- HCV genotype 2
- HCV genotype 3
- Hepatitis C virus
- Interferon-free therapy
- SVR
- Sustained virologic response
ASJC Scopus subject areas
- Microbiology (medical)
- Infectious Diseases