Welcome!

News Feed Item

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, November 10, 2012 /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® (telaprevir)-based regimen -

Janssen Infectious Diseases-Diagnostics BVBA (Janssen) today presented results from a new phase 2 study which shows that an INCIVO® (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®

INCIVO® (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.[10]  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 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®.

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 ≥ 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 ≥ 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® 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-naïve, 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® 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. 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.
  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


SOURCE Janssen Pharmaceutical

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
DevOps has often been described in terms of CAMS: Culture, Automation, Measuring, Sharing. While we’ve seen a lot of focus on the “A” and even on the “M”, there are very few examples of why the “C" is equally important in the DevOps equation. In her session at @DevOps Summit, Lori MacVittie, of F5 Networks, explored HTTP/1 and HTTP/2 along with Microservices to illustrate why a collaborative culture between Dev, Ops, and the Network is critical to ensuring success.
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great dea...
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
SYS-CON Events announced today that Telecom Reseller has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
What if you could build a web application that could support true web-scale traffic without having to ever provision or manage a single server? Sounds magical, and it is! In his session at 20th Cloud Expo, Chris Munns, Senior Developer Advocate for Serverless Applications at Amazon Web Services, will show how to build a serverless website that scales automatically using services like AWS Lambda, Amazon API Gateway, and Amazon S3. We will review several frameworks that can help you build serverle...
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 20th Cloud Expo, which will take place on June 6-8, 2017 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 add...
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...