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AbbVie Presents New Phase 2 Data for Investigational, Once-Daily, Ribavirin-Free, Pan-Genotypic Regimen of ABT-493 and ABT-530 for Hepatitis C Genotypes 1-6

Press Release

- 97-98 percent SVR12 achieved with eight weeks of ABT-493 and ABT-530 in genotypes 1-3 hepatitis C virus patients without cirrhosis in SURVEYOR-1 and 2 studies(1,2)- 100 percent SVR12 achieved with 12 weeks of treatment in difficult-to-treat genotype 3 patients with compensated cirrhosis (Child-Pugh A) new to therapy (3)- 100 percent SVR12 achieved with 12 weeks of treatment in genotypes 4-6 patients without cirrhosis; eight-week duration investigated in this ongoing study (4)

BARCELONA, April 16, 2016 /PRNewswire/ -- AbbVie ABBV, +0.39% a global biopharmaceutical company, today announced that with eight weeks of treatment, 97-98 percent of genotype 1-3 (GT1-3) chronic hepatitis C virus (HCV) infected patients without cirrhosis treated with AbbVie's investigational, once-daily, ribavirin (RBV)-free, pan-genotypic regimen of ABT-493 and ABT-530 achieved sustained virologic response at 12 weeks post-treatment (SVR12). [1,2] Results for GT1 (n=33/34), GT2 (n=53/54) and treatment-naïve GT3 (n=28/29) patients were based on an Intent-to-Treat (ITT) analysis. [1,2] Additionally, 100 percent (n=34/34) of genotype 4-6 (GT4-6) chronic HCV infected patients without cirrhosis achieved SVR12 with 12 weeks of treatment. [4] These new data from the Phase 2 SURVEYOR-1 and SURVEYOR-2 studies will be presented at The International Liver Congress™ (ILC) 2016 in Barcelona, Spain.

"These results move us closer to our ultimate goal of providing a treatment option for as many hepatitis C patients as possible. We will continue to examine our investigational, pan-genotypic regimen through our dedicated clinical trial program, including an eight-week duration across all genotypes," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie.

In separate late-breaking data from the SURVEYOR-2 study, 100 percent of GT3 chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) new to therapy achieved SVR12 with 12 weeks of treatment both with and without RBV (n=24/24 in each arm). [3] No patients discontinued treatment due to adverse events. [3] Data in GT3 chronic HCV infected patients with and without cirrhosis were featured in the official ILC 2016 press program.

"The recent evolution in hepatitis C treatment has resulted in high cure rates for many patients with specific genotypes, but there remain distinct areas of unmet need," said Paul Kwo, M.D., professor of medicine at the Indiana University School of Medicine. "These new data show us the potential of ABT-493 and ABT-530 in genotype 3 patients new to therapy even with the added complication of compensated cirrhosis."

In a pooled analysis of 531 patients across both SURVEYOR studies, of five treatment regimens of ABT-493 and ABT-530 evaluated, the most commonly reported adverse events were fatigue (18 percent), headache (17 percent), nausea (13 percent) and diarrhea (10 percent). [5] Three patients across all study arms evaluated to date, two of whom received RBV, discontinued study drugs early due to adverse events. [5]

Overview of SURVEYOR-1 and SURVEYOR-2 Clinical Data Presented at ILC:

Patient Profile/Study

Patient number (n)/

Patient Population

Duration of Treatment

Treatment Regimen

SVR12 Rates

ITT*

GT1

Non-cirrhotic1

SURVEYOR-1

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n=34

Treatment-naïve=85%

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