Twice-daily INCIVO® (Telaprevir), in Combination With Peginterferon Alfa and Ribavirin, is Effective in Treating People Living With Genotype-1 Chronic Hepatitis C Virus

Beerse, Belgium (ots/PRNewswire) -

NOT INTENDED FOR US JOURNALISTS

- OPTIMIZE study results to be presented in late-breaking poster
presentation at the American Association for the Study of Liver
Diseases (AASLD) 2012 show

non-inferior sustained virological response (SVR12) rates in
previously untreated genotype-1 patients receiving an INCIVO(R)
(telaprevir) based regimen twice-daily versus

every eight hours -

Janssen Research & Development Infectious Diseases - Diagnostics
BVBA (Janssen) will present results from the OPTIMIZE Phase 3 trial
for INCIVO(R) (telaprevir), during a late-breaking poster
presentation at the 63rd annual meeting of the American Association
for the Study of Liver Diseases (AASLD) in Boston
(http://www.aasld.org/lm2012). The study, which was completed in
September, investigates the efficacy and safety of the twice-daily
dosing (BID) of telaprevir versus dosing every eight hours (q8h) in
people chronically infected with genotype-1 hepatitis C virus (HCV)
who had not been previously treated.[1]

"This is the first Phase 3 study to evaluate twice daily dosing of
the new class of protease inhibitors for the treatment of hepatitis
C, so this will be significant news for patients and clinicians,"
said Maria Buti, Lead Study Investigator and Professor of Medicine at
Hospital General Universitari VAll d'Hebron, Barcelona. "Telaprevir
has already halved the treatment duration for the majority of people
with hepatitis C whilst significantly improving cure rates, compared
to previous standard of care, peginterferon alfa and ribavirin (PR).
These data offers hope for yet further improvements to treatment
regimens, with no compromise on cure rates."

The results demonstrated that BID dosing of telaprevir 1,125mg in
combination with peginterferon alfa and ribavirin (PR), achieved
similar cure rates, also known as sustained virological response
(SVR12) to q8h dosing of telaprevir 750mg (74.3% versus 72.8%),
thereby meeting its primary objective of non-inferiority versus q8h
dosing.[1] The safety and tolerability of telaprevir was comparable
across dosing arms and consistent with previous studies. The most
common adverse events experienced were fatigue, pruritus, anemia,
nausea and rash.[1]

OPTIMIZE was a randomized, open-label, multicenter Phase 3 study
in patients with genotype-1 chronic HCV infection who had not been
previously treated. During the study, 744 patients were randomized to
either BID dosing of telaprevir 1,125mg or q8h dosing of telaprevir
750mg (current INCIVO(R) label), in combination with PR. At 12 weeks,
telaprevir treatment ended and patients continued on PR alone for up
to week 24 or week 48 depending on their viral response at week 4.
Patients were followed up for a further 12 weeks to monitor cure
rates (SVR12).[1]

Additional telaprevir data to be presented at AASLD will include:

- Efficacy and safety of telaprevir in patients co-infected with
HCV and HIV[2]

- Interim analysis results from the telaprevir Global Early Access
Programme highlighting the efficacy and safety of treatment amongst
genotype-1 HCV patients with severe fibrosis or compensated
cirrhosis[3]

- Factors predictive of anemia development in
treatment-experienced patients receiving telaprevir plus PR in the
REALIZE trial[4]

- Rate of disappearance of telaprevir resistant variants using
clonal and population sequence data from Phase 3 studies[5]

- 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)[6]

- Deep sequencing of the HCV NS3/4A region confirms low prevalence
of telaprevir-resistant variants both at baseline and end of study[7]

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 naïve, 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.[8] INCIVO 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 was approved by the European Commission on 19 September 2011.

Telaprevir was developed by Janssen Research & Development
Infectious Diseases - Diagnostics BVBA, one of the Janssen
Pharmaceutical Companies, in collaboration with Vertex
Pharmaceuticals Incorporated (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.[8]

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 patientsand 2.6% of
patients discontinued telaprevir combination treatment for rash
events compared to none of those receiving peginterferon alfa and
ribavirin.[8]

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 combination
treatment due to anemia compared to 0.5% receiving peginterferon alfa
and ribavirin.[8]

About HCV

HCV is a blood-borne infectious disease that affects the
liver.[9],[10] With an estimated 130-210 million people infected
worldwide,[11]and three to four million people newly infected each
year, HCV puts a significant burden on patients and society.[12]
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 available data).[13] Chronic infection with
HCV can lead to liver cancer and other serious and fatal liver
diseases.[14] About one-quarter of the liver transplants performed in
25 European countries in 2004 were attributable to HCV (latest
available data).[13] The previously accepted standard treatment for
HCV was peginterferon alfa combined with ribavirin,[14] however this
only cleared the virus for 40-50 percent of genotype-1 chronic HCV
patients.[15],[16]

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 Research &
Development Infectious Diseases - Diagnostics BVBA is part of the
Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit
http://www.janssenrnd.com for more information.

1. Buti M, Agarwal K, Horsmans Y, et al. OPTIMIZE Trial:
Non-inferiority of twice-daily telaprevir versus administration of
every 8 hours in treatment-naïve, genotype 1 HCV infected patients.
2012. American Association for the Study of Liver Diseases (AASLD)
Abstract.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. Incivo(R) Summary of Product Characteristics, updated 2011

9. 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.

10. Centres for Disease Control and Prevention. Hepatitis C FAQs.
[cited 2009 Dec 17] Available from:
http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission

11. 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.

12. WHO. State of the art of vaccine research and development.
Viral Cancers. Available from
http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf).

13. Mühlberger, 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.

14. Lang K, Weiner DB. Immunotherapy for HCV infection: next
steps. Expert Review of Vaccines 2008;7(7): 915-923.

15. 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.

16. The Hepatitis C Trust. Treatments: Potential New Drugs. [cited
2010 Feb 20] Available from: http://www.hepctrust.org.uk/treat
ment/potential-new-drugs/Drugs+that+target+the+virus.

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