Schering-Plough Reports Long-Term Vicriviroc Data From Phase II Open-Label Extension Study in Treatment-Experienced HIV-Infecte...(Adverse events occurring in 5 percent or...),Health

Date:9/14/2009

Adverse events occurring in 5 percent or more of patients were sinusitis, cough and insomnia, consistent with findings in the double-blind phase of the VICTOR-E1 study. One patient discontinued therapy upon simultaneous diagnosis of Hodgkin's lymphoma and Kaposi's sarcoma, which were not considered treatment-related. Another patient discontinued therapy due to pregnancy. Nineteen patients experienced an adverse event of interest during the open-label portion of the study: 11 (13 percent) upper respiratory track infection, 6 (7 percent) dyslipidemia, 3 (4 percent) malignancy, 2 cardiovascular (2 percent), 1 premalignancy (1 percent) and 1 herpes simplex virus infection (1 percent). There were no treatment-emergent deaths, seizures or liver-related adverse events. Resistance to vicriviroc was infrequent and developed slowly, generally after prolonged treatment. Treatment failure occurred in 11 patients, eight of whom had one or fewer active drugs in their optimized background therapy.

"These long-term results with vicriviroc added to optimized background therapy are encouraging and show potential for durable viral suppression and sustained elevated CD4 counts in treatment-experienced HIV-infected patients," said Jihad Slim, M.D., division of infectious diseases, Saint Michael's Medical Center, Newark, N.J., and an investigator for the vicriviroc clinical program. "Importantly, vicriviroc was generally well tolerated, with most patients continuing on treatment for as long as two years."

Vicriviroc, currently in Phase III development, is an extracellular inhibitor of HIV infection. Unlike other classes of HIV drugs that work to inhibit viral replication within human CD4 cells, most of which are part of the immune system, vicriviroc is a member of the CCR5 receptor antagonist class, and is designed to prevent the virus from infecting healthy CD4 cells by blocking its predominant entry route, the CCR5 co-rec
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