Phase 2b Data Show SVR12 in Cirrhotic HCV Patients Treated with Interferon-Free Regimen

BARCELONA, Spain and RIDGEFIELD, Conn., April 19, 2012 /PRNewswire/ -- New data from a descriptive sub-analysis of patients with compensated liver cirrhosis show that up to 43 percent of genotype-1a (GT1a) and up to 71 percent of GT1b hepatitis C virus (HCV) patients achieved sustained viral response (SVR12). SVR12 has been highly correlated with SVR24, which is a recognized indicator of viral cure. This descriptive sub-analysis from SOUND-C2, a Phase 2b study evaluating interferon-free treatment with Boehringer Ingelheim's investigational direct-acting antiviral (DAA) compounds BI 201335 and BI 207127 plus ribavirin (RBV), includes HCV GT1a and 1b patients with compensated liver cirrhosis, regardless of IL-28B allele status.

Presented today (poster #1420) at the International Liver Congress™, the 47th Annual Meeting of the European Association of the Study of the Liver (EASL 2012), in Barcelona, Spain, this analysis from the SOUND-C2 study is the first dataset for an interferon-free regimen in HCV patients with compensated liver cirrhosis. SVR12 results from the SOUND-C2 study were highlighted today during an official EASL press conference and will be presented in full as part of an oral abstract session on Saturday, April 21 (oral abstract #101).

"HCV patients with cirrhosis are in urgent need of treatment to preserve liver function," said Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany and one of the study investigators. "The results from this analysis of SOUND-C2 show the potential to achieve viral cure at rates similar to those seen with current therapies but without interferon in advanced genotype-1 HCV patients and warrant further evaluation."

Liver cirrhosis, where liver cells are either damaged or killed and replaced by scar tissue, causes liver function to deteriorate over time and increases the risk of liver cancer and liver transplant. In the United States, HCV is one of the most common causes of cirrhosis, with up to 20 percent of chronic HCV patients developing the condition. 

"Today, one in five patients with HCV develops cirrhosis.  It's important to investigate treatment options to determine if they are both effective and well tolerated in this patient population," said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Through our HCVerso™ clinical trial program, we are working with HCV experts from around the world to continue to design programs that investigate treatment with BI 201335 and BI 207127 in real-world settings, with the aim of extending a cure to more patients."

SVR12 Descriptive Sub-Analysis of Cirrhotic Patients in SOUND-C2
The SOUND-C2 open-label Phase 2b study includes 362 treatment-naive GT1 HCV patients, randomized into five interferon-free treatment groups, each with 120 mg BI 201335 once-daily (QD), but with different dosing of BI 207127 and treatment durations.

This descriptive sub-analysis includes 37 patients with biopsy or Fibroscan confirmed cirrhosis. All 37 patients had compensated liver disease: 24 were GT1b and 30 had IL-28B genotype CT/TT. Patients who received the three times daily (TID) dose of BI 207127 (Arms A, B and C) were pooled.

None of the patients in this descriptive sub-analysis treated with BI 207127 twice-daily (BID) experienced relapse after treatment completion.  One of the 13 patients (8 percent) in the BI 207127 TID pooled group (Arms A, B and C) of the analysis experienced relapse.  Breakthrough occurred in five patients (38 percent) in the BID Arm, four patients (19 percent) in the pooled group (Arms A, B and C) and two patients (67 percent) in the BI 207127 TID Arm with no RBV (Arm E).

Seven patients (19 percent) in the descriptive sub-analysis discontinued treatment early due to adverse events (AEs), with rash, photosensitivity, and jaundice caused by isolated hyperbilirubinemia (not associated with liver dysfunction) being the most commonly reported. Four patients (19 percent) in the BI 207127 TID pooled group (Arms A, B and C) experienced serious AEs compared with two patients (15 percent) in the BI 207127 BID Arm (Arm D). No discontinuations due to rash, jaundice, or photosensitivity occurred in the BID arm of the analysis.

The investigators noted that further evaluation of interferon-free treatment with BI 201335 and BI 207127 in patients with cirrhosis is warranted.

Other BI data being presented at the EASL Annual Meeting include:

About Hepatitis C Virus (HCV)
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease, transplant and failure that affects as many as 170 million people globally, with three to four million new infections occurring each year. In the United States, an estimated 4.1 million Americans have been infected with HCV, of which approximately 3.2 million have chronic HCV infection. The majority – about 75 to 85 percent – of HCV cases will develop into chronic infection. It is estimated 20 percent of patients with chronic HCV will develop cirrhosis within 20 years of infection. The mortality rate after cirrhosis has developed is 2 – 5 percent per year. Chronic HCV infection is the cause of an estimated 8,000 to 10,000 deaths annually in the United States.

About Boehringer Ingelheim in Hepatitis C Virus (HCV)
Boehringer Ingelheim has a long-standing commitment to virology, including developing innovative therapies for HCV and HIV/AIDS. Through pioneering science, BI strives to achieve a far reaching and inclusive HCV cure that may ease the impact of the disease. In partnership with the scientific community, our clinical trial program, HCVerso™, is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat.

BI 201335, an investigational oral HCV NS3/4A protease inhibitor that has shown the potential to improve cure rates as compared to PegIFN/RBV therapy alone, has completed clinical trials through Phase 2b (SILEN-C studies). A multi-study Phase 3 trial program currently is underway to evaluate BI 201335 combined with PegIFN/RBV in treatment-naive, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV.

BI 207127, an NS5B RNA-dependent polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined with BI 201335 and RBV, is currently being investigated in Phase 2 trials in interferon-sparing regimens.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

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