Exploratory trial of ombitasvir and ABT-450/r with or without ribavirin for HCV genotype 1, 2, and 3 infection - 17/01/15
, Greg Sullivan b , Maribel Rodriguez-Torres c , Michael Bennett d , Fred Poordad a , Mudra Kapoor e , Prajakta Badri e , Andrew Campbell e , Lino Rodrigues e , Yiran Hu e , Tami Pilot-Matias e , Regis A. Vilchez e Summary |
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 (25 mg QD) and ABT-450/r (200/100 mg 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.
Le texte complet de cet article est disponible en PDF.Highlights |
• | This phase 2 study enrolled treatment-naïve patients with HCV genotype 1, 2, or 3. |
• | Treatment-naïve, non-cirrhotics received 12 weeks of ombitasvir and ABT-450/r ± RBV. |
• | Ombitasvir and ABT-450/r ± RBV was well-tolerated with a low discontinuation rate. |
• | The RBV-containing regimen showed in vivo activity in patients of each genotype. |
• | The RBV-free regimen showed in vivo activity in patients with HCV genotype 1 or 2. |
Keywords : Hepatitis C virus, HCV genotype 2, HCV genotype 3, Interferon-free therapy, Sustained virologic response, SVR12, SVR24
Plan
Vol 70 - N° 2
P. 197-205 - février 2015 Retour au numéro
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