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news.GlaxoSmithKline and Vertex Pharmaceuticals have presented positive results from a study evaluating the safety, tolerability and antiviral activity of the investigational HIV-1 protease inhibitor, brecanavir, formerly known as GW640385.
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Interim findings following 24 weeks of dosing demonstrated potent antiviral activity for brecanavir in both PI-sensitive and PI-resistant HIV-infected adults. These data were presented at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy held in Washington DC.
Out of 31 patients in the study, 81% had plasma HIV-1 RNA below the level of detection of standard assays at week 24, and 77% had viral load below the level of detection of ultra sensitive assays. Patients with PI-sensitive and highly PI-resistant virus had similar response rates.
“These results support the ongoing development program for brecanavir, which is anticipated to enter phase III development in 2006,” said Dr Lynn Marks, senior vice president of the Infectious Disease Medicines Development Centre at GSK. “If approved, brecanavir may be useful in treating patients infected with strains of HIV that have become resistant to multiple protease inhibitors.”
Once inside a human immune cell, HIV uses enzymes within that cell to make copies of itself. Protease is one such enzyme involved in HIV replication. HIV protease inhibitors block the HIV protease enzyme, yielding copies of HIV that cannot infect new cells.