Monday, March 4, 2013

Boehringer Ingelheim announces interim results from a Phase III trial in HIV patients co-infected with chronic hepatitis C

Boehringer Ingelheim announces interim results from a Phase III trial in HIV patients co-infected with chronic hepatitis C

* Reuters is not responsible for the content in this press release.

Mon Mar 4, 2013 12:15pm EST
* 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

INGELHEIM, Germany--(Business Wire)--
For media outside of the U.S.A., UK and Canada only

Interim study results from STARTversoTM 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 STARTVersoTM 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

"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 STARTVersoTM 4 are encouraging, especially given
the inclusion of patients with cirrhosis, and we look forward to the final trial

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 STARTVersoTM 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 STARTVersoTM 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. 


*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 


About STARTVerso4

STARTVersoTM 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 STARTVersoTM 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 HCVersoTM 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

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: [Last accessed on

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

Boehringer Ingelheim
Corporate Communications
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Reinhard Malin
Phone: +49 6132 - 77 90815
Fax: +49 6132 - 77 6601
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