New Data Show Oral Valcyte(R) (valganciclovir) as Effective as iv Ganciclovir for Treatment of CMV Disease in Transplant

Full results of the VICTOR study will be published at a later date.

About cytomegalovirus (CMV) infection and disease

CMV, otherwise known as cytomegalovirus, is a virus that infects people of all ages. It is similar in structure to the viruses that cause herpes and chickenpox(6).

CMV infection is very common among the general population. It is estimated that 50-80% of all adults have been infected with the virus(4). CMV is also the single most common viral infection in organ transplant recipients(3).

CMV is usually spread through transmission of body fluids, including urine, saliva, breast milk, blood, tears, semen, and vaginal fluids. Typically, a person becomes infected with CMV when they come in frequent, regular contact with these infected body fluids(6). The most common way for transplant recipients to contract CMV infection is when their donor has been infected with the virus.

Most cases of CMV infection remain undiagnosed, because the infected person usually has few or no symptoms. However, symptomatic CMV disease develops when a person's immune system cannot control their CMV infection. In the vast majority of cases, the immune system renders the virus harmless. However, CMV can be particularly serious in people who have received organ transplants and whose immune systems are weakened (i.e. through the use of immunosuppressive medications)(5).

CMV infection usually develops during the first few months after transplantation and may cause complications in the lungs, nervous system, stomach, liver, brain, and eyes(3),(5).

CMV is strongly associated with the following diseases:(3),(4)

-- hepatitis

-- pancreatitis

-- stomach ulcers

-- gastrointestinal infection

-- pneumonia.

It can also increase the risk of organ rejection(3).

Organ recipients who are already infected, or who receive an infected organ, can prevent the progression to CMV disease by using antiviral drugs such as ganciclovir and valganciclovir(6). Normally, this anti-CMV medication is given during the first few months after transplantation, as this is when the risk of contracting CMV disease is greatest. However, anti-CMV medication may be prescribed later than six months post-transplantation if doses of immunosuppressive medications are increased following a rejection episode.

References:

1. Hartmann A. Oral valganciclovir is as effective and safe as IV ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. Data presented at the American Transplant Congress, San Francisco, US, 5-9 May 2007. Abstract number 950336.

2. Humar A. Oral valganciclovir and intravenous ganciclovir have comparable cytomegalovirus (CMV) viral clearance kinetics in the treatment of CMV disease. Data presented at the American Transplant Congress, San Francisco, US, 5-9 May 2007. Abstract number 950110.

3. Medscape. Infection in the Transplant Recipient: CMV. Accessed on 30 April 2006. at: http://www.medscape.com/viewarticle/4517...

4. PatientPlus. Cytomegalovirus (CMV). Accessed on 30 April 2006 at: http://www.patient.co.uk/showdoc/4000037...

5. KidsHealth. Infections: Cytomegalovirus. Accessed on 30 April 2006 at: http://kidshealth.org/parent/infections/...

6. Centers for Disease Control and Prevention. Frequently Asked Questions About CMV. Accessed on 30 April 2006 at: http://www.cdc.gov/cmv/faqs.htm

Media relations contacts: 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; Steve Dawber, Freelance Medical Journalist, Mobile tel: +44-7966-197-701, Office tel: +44-1925-211-909, E-mail: steve.dawber@btinternet.com