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FDA Approves Extended CMV Treatment for High-Risk Kidney Transplant Recipients NEW YORK -- August 10, 2010 -- The US Food and Drug Administration (FDA) approved increasing the length of therapy with valganciclovir hydrochloride (Valcyte) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease. The supplemental approval is based on data that showed longer prophylactic treatment with valganciclovir hydrochloride reduced the incidence of CMV disease in high-risk adult kidney transplant recipients from 36.8% (for patients who received 100 days of treatment) to 16.8% (for patients who received treatment for 200 days) at 1 year after receiving a transplanted kidney (P < .0001). The overall safety profile of valganciclovir hydrochloride did not change with the extension of prophylaxis in high-risk kidney transplant recipients. In the IMPACT study, 326 high-risk kidney allograft recipients were randomised to receive valganciclovir hydrochloride 900 mg once-daily for 100 days followed by 100 days of placebo or valganciclovir hydrochloride 900 mg once-daily for 200 days post-transplant. The primary endpoint was the proportion of patients who developed protocol-defined CMV disease within the first 52 weeks post-transplant. Secondary endpoints included safety, time to CMV disease, time to CMV infection, acute rejection, and graft loss. The most common adverse events occurring in the valganciclovir hydrochloride -treated patients (200 day and 100 day groups) were low white blood cell counts (26% vs 38%), diarrhoea (26% vs 31%), and peripheral oedema (21% vs 19%). The most serious adverse events in the valganciclovir hydrochloride-treated patients were hypertension (12% vs 13%), transplant rejection (6% vs 9%), and tremors (17% vs 12%). Four deaths, unrelated to treatment with valganciclovir hydrochloride, occurred in the 100-day treatment group. These were attributed to haemorrhage (1), sepsis (1) or septic shock (2). The percentage of kidney transplant recipients with CMV disease at 24 months post-transplant was 38.7% (63/163) for the 100 day dosing regimen and 21.3% (33/155) for the 200 day dosing regimen (P = .0008). SOURCE: Genentech E-mail this page to a friend or colleague! To print, use this version