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AbbVie (ABBV) Hepatitis C Drugs Knock Out Virus at Eight Weeks  
4/23/2013 7:15:27 AM

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AMSTERDAM
, April 23, 2013 /PRNewswire/ -- (NYSE: ABBV) Results from "Aviator," AbbVie's phase IIb clinical trial of its investigational direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) infection, continue to demonstrate high sustained viral response (SVR) rates against genotype 1 HCV, across patient types. Data show greater than 90 percent SVR were achieved in patients new to treatment and in patients who had previously failed treatment with pegylated interferon and ribavirin (null responders). In addition, similar high SVR rates observed after 12 and 24 weeks of treatment in the Phase IIb trial reinforce the adequacy of the 12-week treatment duration for the investigational interferon-free, triple DAA combination. The triple-DAA combination is currently being studied in Phase III clinical trials. Results will be featured in the official press conference at the 2013 International Liver Congress® (ILC) in Amsterdam on Wednesday, April 24 at 11:00 CEST and presented on Thursday, April 25.

"These new results from the Aviator study further demonstrate that this investigational all-oral therapy combination can achieve high sustained viral response after 12 weeks of treatment," said Kris Kowdley, M.D., Director of the Liver Center of Excellence and Director of Research in the Digestive Disease Institute at Virginia Mason Medical, and Clinical Professor of Medicine at the University of Washington in Seattle. "The consistency of high sustained viral response rates that we have seen in clinical trials across populations is encouraging, especially given the proportion of patients with these characteristics who have failed with interferon plus ribavirin treatment."

"AbbVie's clinical development program aims to improve virologic cure rates, including in patients who have historically been harder to treat with current therapies, such as prior null responders. While further studies are required to confirm these findings, we remain encouraged by the high viral response rates and the safety profile we have seen in the Aviator study," said Barry Bernstein, divisional vice president, infectious disease development, AbbVie. "Our Phase III trials are progressing well and we remain focused on bringing an interferon-free treatment option to patients with HCV genotype 1 infection."

About Study M11-652 (Aviator)
The objective of this phase 2b study was to assess the safety, and efficacy of ABT-450/r (dosed 100/100 to 200/100mg once daily), ABT-267 (25mg once daily), ABT-333 (400mg twice daily) and ribavirin in non-cirrhotic treatment-naive patients and prior peg-interferon/ribavirin null responders administered for 8, 12 or 24 weeks. Enrollment was open to GT1-infected patients regardless of IL28B host genotype and ribavirin dosing was weight-based.

A summary of key data from the trial is below:


Treatment-Naive

Null Responders

Duration

8 weeks

12 weeks

24 Weeks

12 weeks

24 weeks

Regimen

ABT-450/r

ABT-267

ABT-333

RBV

ABT-450/r

ABT-333

RBV

ABT-450/r

ABT-267

RBV

ABT-450/r

ABT-267

ABT-333

ABT-450/r

ABT-267

ABT-333

RBV

ABT-450/r

ABT-267

ABT-333

RBV

ABT-450/r

ABT-267

RBV

ABT-450/r

ABT-267

ABT-333

RBV

ABT-450/r

ABT-267

ABT-333

RBV

Number dosed

80

41

79

79

79

80

45

45

43

Breakthrough

0

1

1

1

0

0

0

3

1

Relapse

10

4

8

5

1

2

5

0

0

SVR12 (ITT)

89%

85%

91%

90%

99%

93%

89%

93%

98%

SVR24 (ITT)

88%

83%

89%

87%

96%

90%

89%

93%

95%

For the 12-week triple-DAA regimen with ribavirin being studied in Phase 3 trials:

  • 99% of treatment-naive patients achieved SVR12, 96% achieved SVR24 in this intent-to-treat analysis
  • 93% of prior null responders achieved SVR12 and SVR24
  • The single relapse with this regimen occurred at post-treatment week two

With the triple-DAA plus ribavirin regimen, comparable SVR24 response rates were also seen in treatment naive patients and null responder patients across HCV subtype, IL28B genotype and baseline HCV-RNA levels and severity of fibrosis.

SVR24 by patient subtype in the "Aviator" study

Characteristic

Treatment Naive

Null Responders

GT1a

91% (n=108)

93% (n=55)

GT1b

98% (n=5

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