Phase 2 Results Show INCIVO® (telaprevir), in Combination With Peginterferon Alfa and Ribavirin, is Effective in Treating Patients Co-infected With Genotype-1 Chronic Hepatitis C Virus and HIV

Boston, Massachusetts (ots/PRNewswire) -

- Study presented at American Association for the Study of
Liver Diseases 2012 shows high sustained virological response
(SVR) in HCV/HIV co-infected patients

receiving INCIVO(R) (telaprevir)-based regimen -

Janssen Infectious Diseases-Diagnostics BVBA (Janssen) today
presented results from a new phase 2 study which shows that an
INCIVO(R) (telaprevir)-based regimen was effective in achieving a
sustained virological response at 24 weeks (SVR24) in patients
co-infected with both genotype-1 chronic hepatitis C virus (HCV) and
HIV (HCV/HIV) compared to patients receiving a placebo with the
standard HCV treatment, peginterferon alfa and ribavirin (74 vs. 45
percent).[1]

An estimated 130 to 210 million people are infected with HCV
worldwide[2], with HCV/HIV co-infections averaging about 40 percent
of HCV patients in Europe.[3] People co-infected with HCV/HIV have
more rapid fibrosis progression and liver disease than patients with
HCV alone.[3] Chronic HCV infections can lead to end-stage liver
disease, which is a major cause of death in HCV/HIV co-infected
patients.[3] Despite the added health consequences of co-infection,
only a small proportion of HCV/HIV co-infected patients receive
treatment for their hepatitis.[3]

"The new data further demonstrate the potential efficacy and
safety of telaprevir when used in combination with peginterferon alfa
and ribavirin in HCV/HIV co-infected patients. New effective
treatment regimens are particularly important for this patient group
due to their high risk of rapidly developing liver complications,"
said investigator, Kenneth E. Sherman, M.D., of the University of
Cincinnati College of Medicine.

The phase 2 study was a two-part randomized, double-blind,
placebo-controlled, parallel-group, trial of telaprevir with a
standard HCV treatment combination of peginterferon alfa and
ribavirin (PR) in previously untreated patients with genotype-1
chronic HCV/HIV co-infection. The study treated a total of 60 HCV/HIV
co-infected patients who did or did not receive a concomitant stable
antiretroviral therapy (ART) regimen.[1] During the study, no
patients receiving a telaprevir-based regimen experienced HIV RNA
breakthroughs and their CD4 T-cell count percentage remained
unchanged.[1]

The safety and tolerability of a telaprevir-based regimen for
treating HCV in HCV/HIV co-infected patients were comparable to that
previously observed in HCV mono-infected patients.[1] Adverse events
that occurred more frequently (>10 percent difference) in HCV/HIV
co-infected patients receiving telaprevir and PR compared to HCV/HIV
co-infected patients taking PR alone included pruritus (itchiness),
headache, nausea, rash and dizziness.[1]

"Now that ART for people living with HIV has improved so vastly
over the years in controlling their HIV, it has become increasingly
important to address the consequences of chronic HCV infection in
patients co-infected with HCV/HIV. Janssen remains committed to
addressing the unmet needs of patients and increasing the
availability of new treatment options for patient groups who have
been largely underserved until now", said Alessandra Baldini, Medical
Affairs Director, Janssen.

The analysis of the data from this study, AASLD Abstract Final
ID: 54, will be submitted for peer-review publication.

Additional telaprevir data being presented at AASLD
(http://www.aasld.org/lm2012 )includes:

- Non-inferior SVR rates in previously untreated genotype-1 HCV patients
receiving a telaprevir-based regimen twice-daily versus every eight hours.[4] Abstract
(Final ID: LB-8)
- Telaprevir Global Early Access Programme efficacy and safety data regarding
treatment among genotype-1 HCV patients with severe fibrosis or compensated
cirrhosis.[5]Abstract (Final ID: LB-15)
- Factors predictive of anemia development in treatment-experienced patients
receiving telaprevir plus PR in the REALIZE trial.[6] Abstract (Final ID: 771)
- Rate of disappearance of telaprevir-resistant variants using clonal and
population sequence data from Phase 3 studies.[7] Abstract (Final ID: 756)
- Evaluation of liver and plasma HCV RNA kinetics and telaprevir levels in
genotype-1 HCV patients treated with telaprevir using serial fine needle
aspirates.[8]Abstract (Final ID: 215)
- Deep sequencing of the HCV NS3/4A region confirms low prevalence of
telaprevir-resistant variants.[9] Abstract (Final ID: 1091)

About INCIVO(R)

INCIVO(R) (telaprevir), in combination with peginterferon alfa
and ribavirin, is indicated for the treatment of genotype-1 chronic
HCV in adult patients with compensated liver disease (including
cirrhosis) who are treatment naive, and who have previously been
treated with interferon alfa (pegylated or non pegylated) alone or in
combination with ribavirin, including relapsers, partial responders
and null responders.[10] INCIVO(R) is a small molecule, selective
inhibitor of the HCV serine protease, and a member of the new class
of medicine for the treatment of genotype-1 chronic HCV, direct
acting antivirals (DAAs). Unlike previous treatments, DAAs act
directly on viral enzymes and prevent the virus from replicating.
INCIVO(R) was approved by the European Commission on 19 September
2011.

Telaprevir was developed by Janssen Infectious Diseases -
Diagnostics BVBA, one of the Janssen Pharmaceutical Companies, in
collaboration with Vertex Pharmaceuticals (Vertex) and Mitsubishi
Tanabe Pharma Corporation (Mitsubishi Tanabe Pharma). Janssen has
rights to commercialize telaprevir in Europe, South America,
Australia, the Middle East and certain other countries. Vertex has
rights to commercialize telaprevir in North America where it is being
marketed under the brand name INCIVEK[TM]. Mitsubishi Tanabe Pharma
has rights to commercialize telaprevir in Japan and certain Far East
countries where it is being marketed as TELAVIC(R).

Important Safety Information

Please see full Summary of Product Characteristics or visit
http://www.emea.europa.eu for more details.

The overall safety profile of telaprevir is based on the Phase
2/3 clinical development programme containing 2,641 patients who
received a telaprevir-based regimen. In clinical trials, the
incidence of adverse events of at least moderate intensity was higher
in the telaprevir group than in the placebo group (both groups
receiving peginterferon alfa and ribavirin). The most frequently
reported adverse reactions (incidence greater than or equal to 5.0%)
of at least grade 2 in severity were anemia, rash, pruritus, nausea,
and diarrhoea during the telaprevir treatment phase, and the most
frequently reported adverse reactions (incidence greater than or
equal to 1.0%) of at least Grade 3 were anemia, rash,
thrombocytopenia, lymphopenia, pruritus, and nausea.[10]

Rash events were reported in 55% of patients with a
telaprevir-based regimen compared to 33% of patients treated with
peginterferon alfa and ribavirin only and more than 90% of rashes
were of mild or moderate severity. Severe rashes were reported with
telaprevir combination treatment in 4.8% of patients. Rash led to
discontinuation of telaprevir alone in 5.8% of patients and 2.6% of
patients discontinued telaprevir combination treatment for rash
events compared to none of those receiving peginterferon alfa and
ribavirin.[10]

Hemoglobin values of < 10 g/dl were observed in 34% of patients
who received telaprevir combination treatment and in 14% of patients
who received peginterferon alfa and ribavirin. In placebo-controlled
Phase 2 and 3 trials, 1.9% of patients discontinued telaprevir alone
due to anemia, and 0.9% of patients discontinued INCIVO(R)
combination treatment due to anemia compared to 0.5% receiving
peginterferon alfa and ribavirin.[10]

About HCV

HCV is a blood-borne infectious disease that affects the
liver.[11,12] With an estimated 130-210 million people infected
worldwide,[2] and three to four million people newly infected each
year, HCV puts a significant burden on patients and society.[13]
Estimations indicate that HCV caused more than 86,000 deaths and 1.2
million disability-adjusted life-years (DALYs) in the WHO European
region in 2002 (latest data available).[14] Chronic infection with
HCV can lead to liver cancer and other serious and fatal liver
diseases.[15] About one-quarter of the liver transplants performed in
25 European countries in 2004 were attributable to HCV (latest data
available).[14] The previously accepted standard treatment for HCV
was peginterferon alfa combined with ribavirin,[16] however this only
cleared the virus for 40-50 percent of genotype-HCV patients.[16,17]

About Janssen

At Janssen, we are dedicated to addressing and solving some of
the most important unmet medical needs of our time in oncology,
immunology, neuroscience, infectious diseases and vaccines, and
cardiovascular and metabolic diseases. Driven by our commitment to
patients, we develop innovative products, services and healthcare
solutions to help people throughout the world. Janssen Infectious
Diseases - Diagnostics BVBA is part of the Janssen Pharmaceutical
Companies of Johnson & Johnson. Please visit
http://www.janssenrnd.com for more information.

References:

1) Sulkowski MS, Sherman KE, Soriano V, et al. Telaprevir in Combination
with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Co-infected Patients: SVR24 Final
Study Results. 2012. American Association for the Study of Liver Diseases (AASLD)
Abstract (Final ID: 54).
2) European Association for the Study of the Liver. EASL Clinical Practice
Guidelines: Management of hepatitis C virus infection. Journal of Hepatology. 2011;
55: 245-264.
3) WHO EUROPE. Management of Hepatitis C and HIV co-infection - Clinical
protocol for the WHO European Region. Available at:
http://www.euro.who.int/data/assets/pdf_file/0008/78146/E90840_Chapter_6.pdf. Last
accessed September 12, 2012.
4) Buti M, Agarwal K, Horsmans Y, et al. OPTIMIZE Trial: Non-inferiority of
twice-daily telaprevir versus administration of every 8 hours in treatment-naive,
genotype 1 HCV infected patients. 2012. American Association for the Study of Liver
Diseases (AASLD) Abstract (Final ID: LB-8)
5) Colombo M et al. Treatment of Hepatitis C Genotype 1 Patients with Severe
Fibrosis or Compensated Cirrhosis: The International Telaprevir Early Access Program.
2012. American Association for the Study of Liver Diseases (AASLD) Abstract (Final ID:
LB-15)
6) Zeuzem S, DeMasi R, Baldini A, et al. Factors predictive of anemia
development in treatment-experienced patients receiving telaprevir (T;TVR) plus
peginterferon/ribavirin (PR) in the REALIZE trial. 2012. American Association for the
Study of Liver Diseases (AASLD) Abstract (Final ID: 771).
7) Sullivan J, De Meyer S, Haseltine E, et al. Rate of disappearance of
telaprevir resistant variants using clonal and population sequence data from Phase 3
studies. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract
(Final ID: 756).
8) Talal A, Dimova R, Zhang E, et al. Evaluation of Liver And Plasma HCV RNA
Kinetics And Telaprevir Levels In Genotype 1 HCV Patients Treated With Telaprevir
(TVR) Using Serial Fine Needle Aspirates (FNA). 2012. American Association for the
Study of Liver Diseases (AASLD) Abstract (Final ID: 215).
9) Dierynck I, De Meyer S, Thys K, et al. Deep Sequencing of the HCV NS3/4A
Region Confirms Low Prevalence of Telaprevir-resistant Variants Both at Baseline and
End of Study. 2012. American Association for the Study of Liver Diseases (AASLD)
Abstract (Final ID: 1091).
10) Incivo(R) Summary of Product Characteristics, updated 2011
11) Simin, M et al. Cochrane systematic review: pegylated interferon plus
ribavirin vs. interferon plus ribavirin for chronic hepatitis C. Alimentary
Pharmacology & Therapeutics. 2007; 25(10):1153-62.
12) Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009
Dec 17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission
13) WHO. State of the art of vaccine research and development. Viral Cancers.
Available from http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf
14) Muehlberger, N et al. HCV-related burden of disease in Europe: a systematic
assessment of incidence, prevalence, morbidity, and mortality. BMC Public Health.
2009; 9(34):1-14.
15) Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert
Review of Vaccines 2008;7(7): 915-923.
16) McHutchison, J et al. Peginterferon Alfa-2b or Alfa-2a with Ribavirin for
Treatment of Hepatitis C Infection. N Engl J Med. 2009; 361:580-93.
17) The Hepatitis C Trust. Treatments: Potential New Drugs. [cited 2010 Feb 20]
Available from:
http://www.hepctrust.org.uk/treatment/potential-new-drugs/Drugs+that+target+the+virus

ots Originaltext: Janssen Pharmaceutica
Im Internet recherchierbar: http://www.presseportal.de

Contact:
MEDIA Ronan Collins, +44(0)7876-257-746