ABT-072 / AbbVie - LARVOL DELTA

A pilot study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) (clinicaltrials.gov) - P2, N=11; Active, not recruiting -> Completed

Trial completion • Hepatitis C Virus

A 12-week interferon-free regimen of ABT-450/R, ABT-072, and ribavirin was well tolerated and achieved sustained virologic response in 91% treatment-naïve HCV IL28B-CC genotype-1-infected subjects (EASL 2012) - Presentation time: 19.04.2012, 16:00-18:00; P2, N=11; NCT01221298; ABT-450/r + ABT-072 + RBV is well tolerated and achieves SVR24 in 91% of treatment-naïve, non-cirrhotic HCV GT1-infected subjects with IL28B CC genotype after 12 weeks of treatment

P2 interim data • Hepatitis C Virus

HCV RNA assay sensitivity impacts the management of patients treated with direct-acting antivirals (Antivir Ther) - P2, N=74; CHAMPION-2 (NCT01074008); Sponsor: AbbVie; "HCV RNA level results were highly correlated, but CTM values were higher than those from ART....Use of ART HCV RNA level results led to a higher positive predictive value of week 4 viral load for the achievement of a sustained virological response 24 weeks after the end of treatment..."

P2 data • Hepatitis C Virus

ABT-072 or ABT-333 combined with pegylated interferon/ribavirin after 3-day monotherapy in HCV genotype 1 (GT1)-infected treatment-naïve subjects: 12-week sustained virologic response (SVR12) and safety results (EASL 2012) - Presentation time: 21.04.2012, 09:00-18:00; P2, N=51; ABT-072 and ABT-333 were well tolerated and demonstrated potent antiviral activity in treatment-naïve subjects when combined with P/R; SVR12 rates as high as 86% were achieved; Response rates were similar at both doses of ABT-333 & P/R; The ABT-333 400 mg BID dose was selected for further development

P2 data • Hepatitis C Virus