Roche meets endpoint in Phase III cytomegalovirus disease study

Roche has announced that a Phase III study investigating the efficacy and safety of extended preventative therapy with Valcyte met its primary endpoint of reducing the number of kidney transplant patients who develop cytomegalovirus disease within the first year post-transplant.

Valcyte is indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk and is administered for up to 100 days post-transplant. The successful Impact study was designed to investigate whether extending therapy with Valcyte to 200 days post-transplant will further reduce the incidence of CMV disease in high risk kidney transplant patients.

The Impact study is a global, multi-center (65 centers in 13 countries), double-blind study that randomized 326 high-risk (donor CMV seropositive/recipient CMV seronegative) kidney allograft recipients to one of two treatment groups: 100 days Valcyte (900mg once daily) post-transplant followed by 100 days placebo; 200 days Valcyte (900mg once daily) post-transplant.

The primary endpoint of the study was the proportion of patients who developed CMV disease within the first 52 weeks (12 months) post-transplant. Secondary endpoints for the study include safety and tolerability, time to CMV disease, time to CMV infection, acute rejection and graft loss.

Atul Humar, director of Transplant Infectious Diseases and primary investigator of the study, said: We expect this study to provide clinically important results about the benefits of 200-day prophylaxis with Valcyte that will translate into tangible improvements in patient care.