Janssen launch MYINCIVOTM support programme

Posted on:28 Feb 12

High Wycombe, UK, 27th February 2012: Janssen has today launched a new partnership with Bupa Home Healthcare which will support chronic genotype-1 hep C patients undergoing an INCIVO®(telaprevir) based treatment regimen (telaprevir in combination with peginterferon alfa and ribavirin).

Speaking at the launch of the MYINCIVO™ Support Programme, Dr Peter Barnes, Medical Director at Janssen stated: “We recognise that treatment for hep C can be challenging and demands significant commitment from patients. We also recognise that the addition of telaprevir, one of a new class of medicines which directly targets the hep C virus, to the current standard treatment adds another element of complexity. That is why today we are launching this programme to support patients 24 hours a day, 7 days a week for the full duration of their treatment if they are initiated on a telaprevir based treatment regimen.”

Before the introduction of protease inhibitors, of which telaprevir is the latest, treatment for genotype-1 chronic hep C cleared the virus in only about 50% of patients, leaving the other 50% without a successful outcome following 12 months of treatment¹. Clinical trials have shown that a telaprevir based regimen is more effective than standard treatment in all genotype-1 patient types, including those with compensated liver disease such as cirrhosis. The addition of telaprevir to the current standard treatment (i.e. peginterferon alfa and ribavirin) cleared the virus in a significantly greater number of those patients who had previously been untreated (79% vs 46%, p<0.0001). In patients who had relapsed after previous treatment nearly four times as many cleared the virus in the telaprevir arm (84% vs 22%, p<0.0001)^2,3,4. In addition, treatment naive patients and prior treatment relapsers who achieve undetectable levels of hep C virus RNA on testing at weeks 4 and 12 can have their total treatment duration reduced to 24 weeks from the current 48 weeks with standard treatment5. A key factor in achieving these results was good adherence to treatment⁵.

In developing the MYINCIVO™ Support Programme Janssen worked with Bupa Home Healthcare, healthcare professionals and patient support groups to ensure patients have access to confidential advice and support to help them adhere to their medication, to take care of themselves, stay motivated and in control while going through treatment. Most importantly, the MYINCIVO™ Support Programme is intended to complement the care being provided by a patient’s hep C specialist healthcare professional and helps with continuity of the patient’s care and support. The MYINCIVO™ Support Programme can also be accessed by patients’ partners, carers or family members as appropriate.

Dr Mehmood Syed, Medical Director at Bupa Home Healthcare stated: “Providing tailored support to get better health outcomes for the individual is at the heart of this programme. We want to empower patients so that they have more control over their health as well as provide them with dedicated medical expertise and support when they need it”.

The programme is personalised to the needs of the individual patient via the MYINCIVO™ case management platform and the MYINCIVO™ dedicated nurse team are experienced in, and trained to provide additional advice and support on many issues. The MYINCIVO™ support programme is completely confidential between the patient, their hep C specialist healthcare professional and BUPA. It includes support such as a SMS text dose reminder service (to promote adherence), health coaching (to motivate, promote adherence, health & wellbeing), advice and information including healthy living, foods to eat while on treatment and dealing with symptoms and side-effects specific to patients who have been prescribed a telaprevir-based regimen.

The overall safety and tolerability profile of telaprevir is based on the phase II and III clinical development programme. The most frequently reported moderate adverse reactions (incidence = 5.0%) were anaemia, rash, pruritus, nausea, and diarrhoea, and the most frequently reported severe adverse reactions (incidence = 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea⁵.

Rash events were reported in 55% of patients with telaprevir based treatment compared with 33% in the control arm (peginterferon alfa and ribavirin only). More than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir based treatment in 4.8% of patients. Rash led to discontinuation in 5.8% of patients. Anaemia was reported in 32.1% of patients compared with 15% in the control arm (peginterferon alfa and ribavirin only). It led to discontinuation in approximately 3% of patients⁵.

In the UK, it is estimated that 216,000 to 466,000 individuals are chronically infected with hepatitis C, a virus that is carried in blood and predominantly affects the liver, of which only 80,000 have been diagnosed^6,7. Chronic hep C poses a public health burden. It is an infectious disease, with often no symptoms, that can lead to severe liver conditions. Of those who develop chronic hepatitis C an estimated 30% will develop cirrhosis (deterioration of the liver), others will develop liver cancer, some of whom may require liver transplantation¹. Chronic hep C is the most common reason for liver transplants in Europe⁸.

* INCIVO® (telaprevir), a direct acting antiviral (DAA) protease inhibitor (PI), was co-developed by Vertex Pharmaceuticals and Tibotec, an affiliate of Janssen Pharmaceutical Companies of Johnson & Johnson, and the company responsible for marketing telaprevir in Europe.

For more information contact
Simon Goldsborough, Munro & Forster Mobile: +44 (0) 7973 272915
Ronan Collins, Janssen Mobile: +44 (0) 7876 257746
James Thompson, Bupa Home Healthcare Mobile: +44 (0) 7894 416 823

References
1. TA200: Peginterferon Alfa and Ribavirin for the treatment of chronic hepatitis C. Part review of NICE technology appraisal guidance 75 and 106. Issued September 2010
2. Jacobson, Ira M. Telaprevir for Previously Untreated Hepatitis C Virus Infection. N Engl J Med. 2011; 364; 2405-16.
3. Zeuzem, Stefan MD. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011; 364; 2417-28.
4. Sherman et al. Duration of Initial Telaprevir Treatment for HCV Infection: A phase 3 study of treatment duration, N Engl J Med. 2011: 365; 1014-24.
5. Telaprevir Summary of Product Characteristics 2011.
6. Hepatitis C in the UK: Annual Report2011. London Health Protection Agency, July 2011
7. In The Dark: An audit of hospital hepatitis C services across England. The All-Party Parliamentary Hepatology Group, August 2010
8. Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Rev Vaccines. 2008;7(7): 915-923

For more information:
http://www.janssen.co.uk/

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Last updated on: 28/02/2012 12:08:35

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