BOEHRINGER-INGELHEIM

• 80 percent of patients achieved early treatment success* with faldaprevir^{^} plus PegIFN/RBV highlighting the potential to reduce treatment duration from 48 to 24 weeks
• Interim results indicate potent activity of faldaprevir in HCV/HIV co-infected patients

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Interim study results from STARTverso^TM 4 presented today at CROI⁺ show that 80 percent of hepatitis C (HCV) patients also infected with HIV achieved early treatment success with faldaprevir (BI 201335) combined with pegylated interferon and ribavirin (PegIFN/RBV).¹ These patients have a high unmet medical need due to limited treatment options; up to 10 million people² are co-infected with HIV and HCV worldwide and it is estimated that only around one-third of those diagnosed actually receive HCV treatment.³

These interim results from STARTVerso^TM 4, demonstrate early treatment success in a majority of patients regardless of whether they were treatment-naïve or relapsed after prior treatment for HCV. Patients who achieved early treatment success may be eligible for 24 weeks rather than the standard 48 weeks of treatment with PegIFN/RBV. Interim on-treatment data show that 84 percent of patients had undetectable levels of HCV at week 12 of treatment with this regimen.¹

“Several factors influence the likelihood of treatment success in HCV mono-infected patients, including personal genetic makeup, viral genotype and stage of liver disease. Co-infection with HIV contributes additional factors, including potential drug-drug interactions that influence treatment decisions and outcomes,” said lead study Investigator Douglas Dieterich, MD, Professor of Medicine, Liver Diseases at Mount Sinai Medical Center, New York, NY. “The early virologic response data from STARTVerso^TM  4 are encouraging, especially given the inclusion of patients with cirrhosis, and we look forward to the final trial outcomes.”

A diverse range of patients, including the more challenging to cure, are being treated in this study; 17 percent have liver cirrhosis, an advanced form of liver disease, and 22 percent of patients had relapsed after previous treatment with PegIFN/RBV.

Additional data presented at this meeting examined the drug-drug interactions (DDI) of faldaprevir with commonly-prescribed HIV medications darunavir/ritonavir, efavirenz, and tenofovir. The three Phase I studies demonstrated that there was no clinically relevant effect of faldaprevir on these HIV medications.⁴

“We are proud to present interim Phase III results from STARTVerso^TM 4 in patients co-infected with HCV and HIV; the potential for a shorter treatment duration for these patients is important, particularly in reducing the length of time they are exposed to possible side effects associated with a year-long course of interferon,” said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. “Patients with HCV/HIV co-infection have a high unmet clinical need. The encouraging efficacy results and manageable interactions with HIV medications suggest faldaprevir in combination with PegIFN/RBV could be a viable treatment option for this important patient population.”

The most frequent adverse events (AEs) in STARTVerso^TM 4 were nausea (37%), fatigue (33%), diarrhoea (27%), headache (23%), and weakness (22%). The safety results of this study were thus comparable to those observed in HCV mono-infected treatment-naïve patients in prior faldaprevir clinical studies.¹

Faldaprevir is an oral once-daily protease inhibitor, specifically designed to target and inhibit viral replication in the liver. Interferon-based therapy with faldaprevir is effective in a broad spectrum of genotype-1 patients. In addition to the results presented today, the ongoing Phase III trial programme, STARTVerso, evaluates faldaprevir combined with PegIFN/RBV in treatment-naïve and treatment-experienced genotype-1 HCV patients.

No. No. No.

*early treatment success = week 4 HCV below limit of quantification [BLQ] and week 8 HCV below limit of detection [BLD]

^{^} faldaprevir is an investigational compound and not yet approved. Its safety and efficacy have not yet been fully established

⁺ CROI: Conference on Retroviruses and Opportunistic Infections, Atlanta, GA

NOTES TO EDITORS

About STARTVerso4

STARTVerso^TM 4 is an open-label, Phase III study assessing the efficacy and safety of Boehringer Ingelheim’s oral once-daily protease inhibitor faldaprevir in combination with PegIFN/RBV. The study includes 308 individuals co-infected with HCV and HIV who were treatment-naïve or had relapsed after previous HCV therapy, and were either HIV treatment-naïve or being treated with antiretroviral therapy. The trial includes patients with cirrhosis (17 percent had F4 cirrhosis or Fibroscan >13 kPa).

• Group 1: 12 or 24 weeks of faldaprevir 240mg once-daily in addition to 24 or 48 weeks of PegIFN/RBV
• Group 2: 24 weeks of faldaprevir 120mg once-daily in addition to 24 or 48 weeks of PegIFN/RBV

About HCV

HCV is a blood-borne infectious disease which replicates in the liver and is a leading cause of chronic liver disease, liver cancer and transplantation. Chronic HCV is a major public health issue and one of the most prevalent infectious diseases worldwide, affecting around 150 million people, with 3-4 million new cases occurring each year.⁵

HCV infection can often remain undiagnosed due to the asymptomatic nature of the disease.⁵ Consequently, a large number of patients first present to their physician when they experience symptoms or already have liver disease. Patients with advanced liver disease are challenging to cure, have the highest unmet need and urgently require more effective and better tolerated options than the currently available standard of care. Of patients with chronic HCV, 20 percent will develop liver cirrhosis, of which 2-5 percent will die every year.⁶ Advanced liver disease due to HCV currently represents the main cause for liver transplantation in the western world.⁶

About HCV/HIV co-infection

As both viruses share similar modes of transmission, a large number of individuals with HIV infection also have HCV. It is estimated that up to 10 million people have HCV/HIV co-infection worldwide.² In patients with HCV/HIV co-infection, the HCV viral load is higher and as a result, cases of advanced liver disease (i.e. cirrhosis) are more frequent.³ However, only around one-third of HCV/HIV co-infected patients receive HCV treatment due to poor compliance, ineligibility for treatment and/or the sub-optimal efficacy of current approved therapies.^3,7,8,9

About Boehringer Ingelheim in HCV

Through robust science, Boehringer Ingelheim’s goal is to find answers to the most pressing challenges faced by a diverse population of hepatitis C patients and ultimately deliver an interferon-free cure. The company’s rigorously designed hepatitis C clinical trial programme, HCVerso™, includes a broad population that reflects the type of patients that physicians see every day in clinical practice. Boehringer Ingelheim is developing faldaprevir, an optimised protease inhibitor and the backbone for both interferon-based and interferon-free treatment.

Faldaprevir (BI 201335) is an oral once-daily protease inhibitor, specifically designed to target and inhibit viral replication in the liver. Interferon-based therapy with faldaprevir is studied in a broad spectrum of genotype-1 patients. The STARTVerso^TM trial programme, which includes treatment-naïve, treatment-experienced and HIV co-infected patients, is nearly complete.

BI 207127 is a potent investigational non-nucleoside NS5B polymerase inhibitor. Phase III HCVerso^TM trials, investigating the interferon-free regimen of BI 207127 in combination with faldaprevir and ribavirin, are well underway.

Boehringer Ingelheim

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 medications 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 achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

For more information please visit www.boehringer-ingelheim.com

References

1. Dieterich D, Soriano V, Nelson M et al. STARTVerso 4: High Rates of Early Virologic Response in HCV Genotype 1/HIV-coinfected Patients Treated with Faldaprevir plus PegIFN and RBV. CROI 2013

2. Acharya V and Atta M. HIV and Hepatitis C Coinfection: Hard on Kidneys. Nephrology Times 2010; 3 (9): 13-14.

3. Rodriguez-Torres M. Focus on drug interactions: the challenge of treating hepatitis C virus infection with direct acting antiviral drugs in the HIV-positive patient. Curr Opin Infect Dis. 2013 Feb;26(1):50-7.

4. Sabo JP, Kort J, Haschke M. et al. Pharmacokinetic Interactions of Darunavir/Ritonavir, Efavirenz and Tenofovir with the HCV Protease Inhibitor Faldaprevir in Healthy Volunteers. CROI 2013

5. World Health Organisation. WHO factsheet 164: Hepatitis C. 2012. Available at: http://www.who.int/mediacentre/factsheets/fs164/en/ [Last accessed on 26/02/13]

6. Soriano, Vincent et al. New Therapies for Hepatitis C Virus Infection. Clinical Infectious Disease, February 2009; 48: 313-320

7. Fleming CA, Craven DE, Thornton D et al. Hepatitis C virus and human immunodeficiency virus coinfection in an urban population: low eligibility for interferon treatment. Clin Infect Dis. 2003 Jan 1;36(1):97-100.

8. Salmon-Ceron D, Cohen J, Winnock M et al. Engaging HIV-HCV co-infected patients in HCV treatment: the roles played by the prescribing physician and patients' beliefs (ANRS CO13 HEPAVIH cohort, France). BMC Health Serv Res. 2012 Mar 12;12:59.

9. Niederau C, Huppe D, Zehntar E et al. Chronic hepatitis C: treat or wait? Medical decision making in clinical practice. World J Gastroenterol. 2012 Mar 28;18(12):1339-47.

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