Roche Pharmaceuticals

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

Basel, Switzerland (ots/PRNewswire) - Results of the landmark VICTOR study presented today at the American Transplant Congress, San Francisco, USA, have shown that Valcyte (oral valganciclovir) is as effective and as well tolerated as intravenous ganciclovir, the current gold-standard for the treatment of cytomegalovirus (CMV) infection in solid organ transplant patients(1),(2). This is good news for both physicians and patients as it means that effective anti-CMV medication can now be administered orally: a more convenient and economic option when compared to the intravenous alternative. Professor Anders Hartmann, Professor of Nephrology, University of Oslo, Norway, and the study's principal investigator said: "The results of the VICTOR study will enable clinicians to modernise their CMV management practices with confidence. These important data show that oral valganciclovir has clinical equivalence to the current gold-standard treatment, intravenous ganciclovir, but with the added obvious patient benefits that are present in every oral formulation. "Compared to intravenous ganciclovir, oral valganciclovir treatment is more convenient for patients, as it can be self-administered at home. This means that many hospitalised transplant patients with CMV disease can be discharged sooner, resulting in reduced physician workloads, and much-needed episodal cost-savings." CMV is the single most common viral infection in organ transplant Recipients(3), and is also very common among the general population. It is estimated that 50-80% of all adults have been infected with the virus(4). CMV infection usually develops during the first few months after transplantation and may cause complications in the lungs, kidneys, nervous system, stomach, liver, brain, and eyes(3),(5). The randomised, interventional study involved 321 solid organ transplant recipients with virologic and clinical evidence of CMV disease after transplantation. One-hundred-and-sixty-four patients received a 21-day course of oral valganciclovir (VGCV; 900 mg/day b.d.), and one-hundred-and-fifty-seven patients received intravenous ganciclovir (GCV; 5 mg/kg/day b.d.). Following that, all patients received a 28-day maintenance course of valganciclovir (900 mg/day q.d.). Clinical resolution of CMV disease was similar at all time points. At Day 21, clinical success (as assessed by the investigator) was achieved in 83.6% of patients in the VGCV treatment group and 84.0% in the GCV arm. At Day 49, success rates were 96.6% for VGCV versus 93.0% for GCV. Viral clearance did not differ between treatment groups at Day 21 (VGCV: 45.1% vs GCV: 48.4%) or at Day 49 (82.7% vs 87.3%). Both treatments were well tolerated, compliance rates were similar, and there was no difference in the adverse event profile, including leukopenia. The investigators concluded that these findings would have major implications for the management of CMV disease, for patients, physicians, and health-care providers(1),(2). About valganciclovir (Valcyte(R)) Valcyte, the oral pro-drug of ganciclovir, is indicated for the prevention of CMV disease in kidney, kidney-pancreas, and heart transplant patients at high risk. Valcyte is not approved for use in liver transplantation. The efficacy and safety of Valcyte in other solid organ transplants, such as lung transplant, have not been established. The clinical toxicity of Valcyte, which is metabolised to ganciclovir, includes granulocytopenia, anaemia and thrombocytopenia. In animal studies, ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis. Valcyte tablets should not be administered if the absolute neutrophil count is less than 500 cells/microlitre, the platelet count is less than 25,000/microlitre, or the haemoglobin count is less than 8 g/dL. Severe leukopenia, neutropenia, anaemia, thrombocytopenia, pancytopenia, bone marrow depression, and aplastic anaemia have been observed in patients treated with Valcyte tablets (and ganciclovir). Other adverse events reported with a frequency of greater than or equal to 5% included diarrhoea, tremors, fever, nausea, headache, vomiting, insomnia, and allograft rejection. About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com. All trademarks used or mentioned in this release are protected by law. Additional information: About the VICTOR study The VICTOR study was a comparative, randomised, phase IV, intervention study involving 321 solid organ transplant recipients with virologic and clinical evidence of CMV disease after transplantation. The primary study objective was to compare the efficacy and safety of oral valganciclovir (VGCV; 900 mg/day b.d.; n=164) with intravenous ganciclovir (GCV; 5 mg/kg/day b.d.; n=157). The study's primary endpoint was non-inferiority in the eradication of CMV viremia at day 21. The study population consisted of kidney (n=73.8%), heart (n=5.6%), liver (n=7.2%) and other/combined (n=13.4%) transplant recipients. There was clinical diagnosis of tissue invasive disease in 46% of patients. Patients received their allocated study drug for 21 days. All patients then received valganciclovir maintenance therapy (900 mg/day q.d.) for a further 28 days. CMV viral loads were determined centrally at Days 0, 3, 7, 10, 14, 17, 21, 28, 35, 42 and 49. During the first 21 days, the study drug was discontinued in 11 (6.7%) of the patients in the VGCV group versus 7 (4.5%) in the GCV group (p=NS). Viral clearance did not differ between treatment groups at Day 21 (VGCV: 45.1% versus GCV: 48.4%) and at Day 49 (82.7% versus 87.3%). Median viral load half-life was 11.5 days in the VGCV arm and 10.4 days in the GCV arm (p=NS). Median Kaplan Meier estimates of time to viral eradication were similar in both treatment arms (21 days for VGCV versus 19 days for GCV). Clinical resolution of CMV disease was similar at all time points. At Day 21, clinical success, as assessed by the investigators, was achieved in 83.6% of patients in the VGCV treatment group and 84.0% in the GCV arm; at Day 49, these rates were 96.6% and 93.0% respectively. The most important factor influencing time to eradication was the initial viral load. Both treatments were well tolerated, compliance was similar, and there was no difference in the adverse event profile, including leukopenia. The investigators concluded that for SOT recipients with CMV disease, oral VGCV has comparable safety and efficacy to IV GCV, and that each treatment provides equivalent viral clearance kinetics. They added that these findings would have major implications for the management of CMV disease, for patients, physicians and health-care providers. 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/451788_7 4. PatientPlus. Cytomegalovirus (CMV). Accessed on 30 April 2006 at: http://www.patient.co.uk/showdoc/40000377/ 5. KidsHealth. Infections: Cytomegalovirus. Accessed on 30 April 2006 at: http://kidshealth.org/parent/infections/bacterial_viral/cyto megalovirus.html 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 ots Originaltext: Roche Pharmaceuticals Im Internet recherchierbar: http://www.presseportal.ch Contact: 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

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