Boehringer Ingelheim's Faldaprevir-Based Treatment Regimen Achieved Viral Cure in up to 80 per cent of Patients with Hepatitis C in Phase 3 Pivotal Trial(1)

• STARTVerso™1 data presented in treatment-naïve patients with genotype-1 hepatitis C treated with investigational faldaprevir and pegylated interferon/ribavirin^1,2
• Statistically significant viral cure rates achieved versus placebo plus PegIFN/RBV with similar rates of treatment discontinuation
• The majority of patients qualified for shorter treatment duration of 12 weeks faldaprevir/24 weeks PegIFN/RBV and achieved viral cure (SVR12) ^*1

BURLINGTON, ON, April 23, 2013 /CNW/ - Boehringer Ingelheim (Canada) Ltd. today announced results from the pivotal Phase 3 STARTVerso™1 trial of faldaprevir (BI 201335)^† in combination with pegylated interferon and ribavirin (PegIFN/RBV).^1,2 In previously untreated patients with genotype-1 hepatitis C virus (HCV) who received once-daily faldaprevir plus PegIFN/RBV, 79% and 80% in the 120mg and 240mg arms, respectively, achieved viral cure when measured 12 weeks after treatment was completed (SVR12).¹ This is compared with 52% of patients receiving PegIFN/RBV plus placebo (p0.0001).¹

In addition, protocol-defined early treatment success (ETS)^‡ was achieved by 87 and 89% of patients treated with the faldaprevir-based regimen (120mg or 240mg, respectively), meaning they were eligible for an overall shorter treatment duration of 12 weeks faldaprevir/24 weeks PegIFN/RBV.¹ Of those patients who completed treatment early, 86 and 89% (120mg or 240mg, respectively) went on to achieve viral cure (SVR12).¹ This demonstrates that an overall treatment regimen of 24 weeks was sufficient to achieve viral cure in most patients, cutting treatment duration in half when compared to treatment with PegIFN/RBV alone (48 weeks).¹ A goal in HCV treatment innovation is to reduce the amount of time patients are exposed to treatment with interferon.³

STARTVerso™1 included a diverse range of genotype-1a and 1b patients, including patients with compensated cirrhosis (a condition where the liver is heavily scarred but still able to function), who are challenging to treat and cure.^1,3,4,5,6 The results will be presented tomorrow at EASL's International Liver Conference™ (ILC) as part of the official press conference and by Professor Peter Ferenci as a late-breaking oral presentation on April 27 (abstract #3281).^1,7

"As a physician who treats many patients with hepatitis C, the results of this study are encouraging as they show that faldaprevir is a highly effective treatment in patients with hepatitis C genotype 1a and 1b, with or without cirrhosis," said Dr. Robert Myers, Associate Professor and Director of the Viral Hepatitis Clinic at the University of Calgary. "Since there remains an unmet medical need for effective and well-tolerated hepatitis C treatments, new options are welcome by both clinicians and the patients they treat."

Serious adverse events were experienced by 6% (n=8) of placebo patients, 7% (n=17) of patients receiving 120mg faldaprevir and 7% (n=17) of patients receiving 240mg faldaprevir. Anemia (11%, 13%, 12%), rash (6%, 8%, 9%) and gastrointestinal issues (3%, 7%, 12%) were the most common Grade 2-4 adverse events in the placebo, faldaprevir 120mg and faldaprevir 240mg patients. No rash events were life-threatening; 1% of patients discontinued treatment in each study arm due to rash. Adverse events led to discontinuation of study medications in 4% (n=5), 4% (n=10) and 5% (n=14) of placebo, faldaprevir 120mg and faldaprevir 240mg arms, respectively.

In separate abstracts at EASL's ILC meeting, sub-analyses from Boehringer Ingelheim's interferon-free Phase 2b SOUND-C2 study are also being presented.⁸ These include data regarding viral response rates by level of fibrosis (abstract #1227)⁹, predictors of anemia (abstract #1186)¹⁰ and pharmacokinetic modeling of the relationship between virologic response and the level of faldaprevir or BI 207127^§ found in the blood (abstract #1212).¹¹ The SOUND-C2 trial evaluated the interferon-free combination of faldaprevir and BI 207127, an investigational non-nucleoside NS5B polymerase inhibitor, plus ribavirin.⁸

Presentation abstracts can be accessed through the congress website.

About STARTVerso™1
STARTVerso™1 is a double-blind, placebo-controlled Phase 3 trial of faldaprevir in combination with PegIFN/RBV.² The study enrolled and treated 652 treatment-naïve patients from Europe and Japan who were infected with chronic genotype-1 HCV.¹ Patients were randomized to receive PegIFN/RBV in combination with a once-daily dose of 120mg faldaprevir, 240mg faldaprevir or placebo.¹ Treatment duration depended on whether patients met criteria for ETS, protocol-defined early treatment success (week 4 below limit of quantification [BLQ] and week 8 below limit of detection [BLD]).¹

• Group 1: All patients received 24 weeks of placebo with PegIFN/RBV followed by 24 weeks of PegIFN/RBV (48 weeks total treatment).²
• Group 2: All patients received 12 weeks of 120mg faldaprevir with PegIFN/RBV. Patients who met ETS criteria received an additional 12 weeks of PegIFN/RBV (24 weeks total treatment). Patients who did not meet ETS criteria received an additional 12 weeks of 120mg faldaprevir with PegIFN/RBV followed by 24 weeks of PegIFN/RBV (48 weeks total treatment).²
• Group 3: All patients received 12 weeks 240mg faldaprevir with PegIFN/RBV followed by 12 weeks of PegIFN/RBV. Patients who met ETS criteria stopped treatment after 24 weeks total treatment. Patients who did not meet ETS criteria received an additional 24 weeks of PegIFN/RBV (48 weeks total treatment).²

About Boehringer Ingelheim in Hepatitis C Virus (HCV)
In partnership with the scientific community, our clinical trial program, HCVerso^TM, is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat. The HCVerso^TM program includes the pivotal STARTVerso^TM and HCVerso^TM clinical trial programs.

Faldaprevir, also known as BI 201335, is an investigational, oral protease inhibitor that is specifically designed to target viral replication in the liver. Boehringer Ingelheim is developing faldaprevir as a core component of both interferon-based and interferon-free hepatitis C treatment regimens. STARTVerso™1 is the first of an ongoing multi-study Phase 3 trial program that is evaluating faldaprevir combined with PegIFN/RBV. Three additional trials in treatment-naïve, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV are near clinical completion. As part of our long-term commitment to HCV, the company is exploring other combinations of investigational HCV compounds that work in complementary ways, including pegylated interferon-free regimens.

About Hepatitis C
Hepatitis C is a blood-born infectious disease and a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In Canada, an estimated 245,000 individuals or nearly 1 per cent of the population are infected with hepatitis C.¹² Approximately 1,000 deaths are estimated to be caused by hepatitis C each year in Canada.¹³ The number of hepatitis C-associated illnesses, including cirrhosis, liver failure, liver death and the need for liver transplants will likely double or triple in the next decade.¹³

About Boehringer Ingelheim (Canada) Ltd.
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 44,000 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 endeavours.

In 2011, Boehringer Ingelheim posted net sales of 13.2 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 and is home to more than 750 employees across the country. For more information please visit www.boehringer-ingelheim.ca

___________________________
^* Sustained virological response is considered a viral cure when the virus is undetectable 12 weeks after completion of treatment (SVR12).
^†Faldaprevir (BI 201335) and BI 207127 are investigational compounds. Their safety and efficacy has not yet been fully established and it is currently not authorized for sale in Canada.
^‡ETS = protocol-defined early treatment success (week 4 below limit of quantification [BLQ] and week 8 below limit of detection [BLD]).

References

1.	Ferenci, P. et al. Faldaprevir Plus Pegylated Interferon Alfa-2A and Ribavirin in Chronic HCV Genotype-1 Treatment- Naïve Patients. EASL 2013.
2.	DOF. Boehringer Ingelheim. Medical Marketing and Medico Takeaway Packet. December 2012.
3.	Jazwinski and Muir. Direct-Acting Antiviral Medications for Chronic Hepatitis C Virus Infection. October 2012.
4.	National Institute of Health. National Digestive Disease Information Clearing House. September 2011.
5.	Ghany, M. An Update on Treatment of Genotype 1 Chronic Hepatitis C Virus Infection: 2011 Practice Guidelines by the American Association for the Study of Liver Diseases. September 2011.
6.	STARTVerso1 EXPERT MEETING: TOP-LINE DATA FROM STARTVERSO 1. Wulf P. Bocher. March 2013.
7.	The International Liver Congress. Home Page. Accessible via: http://www2.kenes.com/liver- congress/pages/home.aspx. Last Accessed March 22, 2013.
8.	Zeuzem, S. et al. Interferon-Free Combination Treatment With the HCV NS3/4A Protease Inhibitor Faldaprevir (BI 201335) and the Non-Nucleoside NS5B Inhibitor BI 207127 Ribavirin: Final Results Of Sound-C2 And Predictors Of Response.
9.	Zeuzem, S. et al. An Analysis of Response Rates by Fibrosis Stage in Patients Treated with Faldaprevir, BI 207127 and Ribavirin and the SOUND-C2 Study. EASL 2013. #1227.
10.	Asselah, T. et al. ITPA Gene Variants Predict haemolytic Ribavirin Induced Anaemia in Patients Treated with the Interferon-Free Regimen of Faldaprevir, BI 207171 and Ribavirin in SOUND-C2. EASL 2013. #1186.
11.	Olson, S. et al. The relationship between sustained virological response and plasma concentrations of faldaprevir or BI-207127 in HCV GT1-infected patients in SOUND-C2. EASL 2013. #1212.
12.	Myers, R. et al. An update on the management of chronic hepatitis C: Consensus guidelines from the Canadian Association for the Study of the Liver. Can J Gastroenterol, Vol. 26, No 6, June 2012.
13.	Zou, S. et al. Epidemiology and Health Care Planning: Estimating the Burden of Hepatitis C in Canada. Health Canada.

 

 

SOURCE: Boehringer Ingelheim

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Sara McClelland
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Boehringer Ingelheim (Canada) Ltd.
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