کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
6104708 | 1211141 | 2013 | 6 صفحه PDF | دانلود رایگان |
Background & AimsABT-450 (combined with low-dose ritonavir, ABT-450/r) is a potent HCV NS3 protease inhibitor, and ABT-072 is a non-nucleoside NS5B polymerase inhibitor. The goal of this study was to evaluate the safety, tolerability, and efficacy of the peginterferon-free combination of ABT-450/r and ABT-072 with ribavirin in treatment-naïve patients with IL28B CC genotype, infected with HCV genotype 1.MethodsThis was a phase 2a, multicenter, open-label, single-arm study in 11 treatment-naïve, non-cirrhotic HCV GT1-infected patients with IL28B rs12979860 genotype CC. Patients received ABT-450/r 150/100Â mg once daily and ABT-072 400Â mg once daily with weight-based ribavirin 1000-1200Â mg/day dosed twice daily for 12Â weeks.ResultsEight (73%) patients were male, 9 (82%) were Caucasian (including 3 who self-identified as Hispanic); mean baseline HCV RNA was 6.9Â log10Â IU/ml (range 6.5-7.3Â log10Â IU/ml). All 11 patients completed 12Â weeks of treatment and maintained HCV RNA <25Â IU/ml from weeks 4 through 12 of treatment. Ten patients (91%) achieved sustained virologic response 24Â weeks post-treatment, with a second patient relapsing 36Â weeks post-treatment. There were no deaths, serious or severe adverse events, or premature discontinuations. Adverse events were mostly mild and the most frequent were headache, fatigue, nausea, and dry skin.ConclusionsA 12-week regimen of ABT-450/r and ABT-072 with ribavirin was well tolerated with 9/11 patients achieving sustained virologic response through 36Â weeks of post-treatment observation. These findings suggest that peginterferon-free regimens may have the potential to cure a high proportion of HCV genotype 1-infected patients.
Journal: Journal of Hepatology - Volume 59, Issue 1, July 2013, Pages 18-23