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

October 16, 2012

BEERSE, Belgium, October 16, 2012 /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/treatment/potential-new-drugs/Drugs+that+target+the+virus.

SOURCE Janssen Pharmaceutical


Source: PR Newswire