Phase 3 Trial of Ibalizumab ART Therapy Reports Positive Results

At CROI 2917, Brinda Emu, MD, assistant professor of Medicine, Infectious Diseases, Yale University, shared results of a phase 3 registrational trial of ibalizumab - a new class of antiretroviral agents for HIV that's a monoclonal antibody that targets the CD4 receptor. According to Emu, it's a completely new mechanism of action. This phase 3 trial specifically enrolled patients with multi-drug resistant HIV. The week 24 results showed ibalizumab's benefit in reducing viral load and an increase in cells that measure immunologic function in patients.

"I think this is really exciting, because over the three decades that we have been treating HIV, the importance of continuing to discover and develop new classes of drugs is critical -- patients do become resistant to drugs, even though we have a fabulous armamentarium of antiretrovirals right now," said Brindu. She believed this study focused on a very small percentage of the American population of the infected individuals who are highly treatment experienced. "Even though we have a lot of drugs, because of the resistance profile of their virus, they don't have a lot of options, so what these results mean for the most vulnerable of our patients is that they have access now to a new class of drugs," Emu concluded.