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IMPACT Study Shows Longer Valcyte Treatment Provides Better Protection Against Cytomegalovirus (CMV) Disease CMV is the Most Serious Viral Infection Affecting Transplant Patients

Basel, Switzerland (ots/PRNewswire)

- For Non-US Media Only
New Phase III study results presented for the first time today at
the ninth annual American Transplant Congress 2009 (ATC) demonstrate
that doubling the duration of preventive therapy ('prophylaxis') with
Valcyte (oral valganciclovir), significantly reduces the incidence of
CMV disease by 56% in high-risk kidney transplant patients within the
first year post-transplant.(1)
CMV is a major cause of morbidity and mortality during the first
six months after transplantation(2),(3) and is a key concern for
transplant recipients and physicians. While 100-day Valcyte
prophylaxis has been the standard for providing protection against
CMV infection and disease, studies have shown that over 30% of
patients can develop late onset CMV disease after treatment has
ceased.1,(4),(5)
"As transplant physicians, we go to significant lengths to
safeguard the health of the organ and patient post-transplant. We
already recognise the terrible damage that CMV can cause to graft and
patient," said Primary Investigator, Dr. Atul Humar, Director,
Transplant Infectious Diseases and Associate Professor, Department of
Medicine, University of Alberta, Canada. "Today's results show that
continuing to treat with Valcyte for longer can help make a
difference."
The IMproved Protection Against Cytomegalovirus in Transplant
(IMPACT) study shows that 200-day Valcyte prophylaxis significantly
reduces the proportion of patients with CMV disease within the first
year post-transplant to 16%, compared to 37% with 100-day Valcyte
prophylaxis (p<0.0001).1 No significant difference was detected in
overall safety and tolerability, demonstrating that extended
treatment poses no additional risk to patients.1
Roche has submitted a marketing authorisation application (MAA)
to the European Medicines Agency (EMEA) for 200-day prophylaxis
therapy based on the results of the IMPACT study. Further analyses
will also be presented later this year at the European Society for
Organ Transplantation (ESOT) in Paris, France, 30 August - 2
September.
About the IMPACT Study
IMPACT is a global, multi-centre (65 centres in 13 countries),
double-blind study that randomised 326 high-risk (donor CMV
seropositive/recipient CMV seronegative) kidney allograft recipients
to one of two treatment groups:
- 100 days of Valcyte (900 mg once daily) post-transplant followed by 100
      days placebo
    - 200 days of Valcyte (900 mg once daily) post-transplant
The primary endpoint was the proportion of patients who developed
CMV disease within the first 52 weeks (12 months) post-transplant.
Secondary endpoints included safety and tolerability, time to CMV
disease, time to CMV infection, acute rejection and graft loss.
The results demonstrated that 200-day Valcyte prevented CMV
disease in 84% of patients and significantly reduced the incidence of
CMV disease by 56%, compared to the current standard of care (100-day
Valcyte therapy) (p<0.0001). In addition, extending Valcyte
prophylaxis up to 200 days significantly reduced CMV viremia (spread
of the CMV virus into the bloodstream and a known risk factor for
developing CMV disease) from 51% with 100-day Valcyte prophylaxis to
37% with 200-day Valcyte prophylaxis (p=0.0149).
About CMV
CMV belongs to the family of herpes viruses(6) and is very common
among the general population. It is estimated that 50-80% of all
adults have been infected with the CMV virus.(7) In the majority of
cases the virus lies dormant in the body throughout life, but can be
reactivated at times when the immune system is weakened (for example,
transplant patients and AIDS patients).(8) CMV is the most important
serious infection complicating solid organ
transplantation.(9),(10),(11) Transplant patients may already be
infected with CMV prior to transplantation or receive a donor organ
infected with CMV. CMV infection usually develops during the first
few months after transplantation and may cause complications in the
lungs, kidneys, nervous system, liver and gastrointestinal tract.11
If left untreated, the mortality rate can be as high as 90%.(12)
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in
pharmaceuticals and diagnostics. Roche is the world's largest biotech
company with truly differentiated medicines in oncology, virology,
inflammation, metabolism and CNS. Roche is also the world leader in
in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer
in diabetes management. Roche's personalised healthcare strategy aims
at providing medicines and diagnostic tools that enable tangible
improvements in the health, quality of life and survival of patients.
In 2008, Roche had over 80,000 employees worldwide and invested
almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6
billion Swiss francs. Genentech, United States, is a wholly owned
member of the Roche Group. Roche has a majority stake in Chugai
Pharmaceutical, Japan. For more information: http://www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
References
(1) Humar A, Lebranchu Y, Vincenti F et al. The IMPACT Study:
Valganciclovir Prophylaxis for Until 200 Days Post-Transplant in High
Risk Kidney Recipients Substantially Reduces the Incidence of CMV
Disease. Presented at the American Transplant Congress 2009, Boston,
USA. Monday 1 June. Abstract #201
(2) Hodson EM, Craig JC, Strippoli GFM et al. Antiviral
medications for preventing cytomegalovirus disease in solid organ
transplant recipients (Review). Cochrane Database of Systematic
Reviews 2009;1:1-252
(3) Fishman JA, Rubin RH. Infection in Organ-Transplant
Recipients. New Eng J Med 1998;338 (24):1741-1751
(4) Paya C, Humar A, Dominguez E et al. Efficacy and Safety of
Valganciclovir vs. Oral Ganciclovir for Prevention of Cytomegalovirus
in Solid Organ Transplant Recipients. Am J Transplantation
2004;4:611-620
(5) Limaye AP, Bakthavatsalam R, Kim HW et al. Impact of
Cytomegalovirus in Organ Transplant Recipients in the Era of
Antiviral Prophylaxis. Transplantation 2006;81(12):1645-52
(6) Centers for Disease Control and Prevention. Frequently Asked
Questions About CMV. Available at: http://www.cdc.gov/cmv/faqs.htm
(Last accessed on 27 March 2009)
(7) PatientUK. Cytomegalovirus (CMV). Available at:
http://www.patient.co.uk/showdoc/40000377/ (Last accessed on 27 March
2009)
(8) Health Protection Agency North West. Cytomegalovirus
Information Leaflet. Available at:
http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1194947317758 (Last
accessed on 27 March 2009)
(9) Leroy F, Sechet A, Abou Ayache R et al. Cytomegalovirus
Prophylaxis With Intravenous Polyvalent Immunoglobin in High-Risk
Renal Transplant Recipients. Trans Proceedings 2006;38:2324-2326
(10) van Son WJ, de Maar EF, van der Bij W et al. Overcoming the
Problem of Cytomegalovirus Infection after Organ Transplantation:
Calling for Heracles? Intervirology 1999;42:285-290
(11) Stitt NL 2003. Infection in the Transplant Recipient. Organ
Transplant (Medscape Online). Available at:
http://www.medscape.com/viewarticle/451788 (Last accessed on 27 March
2009)
(12) Pescovitz MD. Prevention and Treatment of Cytomegalovirus
Disease in Solid Organ Transplant Recipients: The Clinical and
Economic Impact of Evolving Strategies. Am J Health-Syst Pharm
2003;60(23):S3-S4.

Contact:

For further information, please contact: Julia Pipe, International
Communications Manager, Roche Transplant, Mobile tel:
+41-79-263-9715, Office tel: +41-61-687-4376, E-mail:
julia.pipe@roche.com; Helen Swift, Tonic Life Communications, Office
tel: +44-20-7798-9924, E-mail: helen.swift@toniclc.com

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