Intravenous HIV Treatment Seeks FDA Approval

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A new way to treat HIV is in the works.

Ibalizumab, an intravenous drug, is currently in phase three of a clinical trial and so far the results look good.

“It’s an intravenous agent given every two weeks,” explained Dr. Brinda Emu, Assistant Professor of Medicine, Infectious Diseases at Yale School of Medicine, in a telephone conference call Thursday from Seattle. “It’s really exciting. This is a new era of HIV treatment.”

In the 24-week trial, patients with documented resistant to three classes of drugs prescribed to treat HIV were given an injection of Ibalizumab. The majority of the patients, Emu said, had been infected with the virus for many years – on average 20 years – and were part of an unmet population.

“I think it is life-saving,” Emu said of Ibalizumab, adding that those enrolled in the trial had developed a mutation of the virus that was “most difficult to treat” and were "extremely vulnerable."

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Data released from a Canadian lab shows patients in the Ibalizumab trial experienced a rise in CD4+ T cells and a reduction of viral load. Forty-three percent of the patients achieved an undetectable viral load status.

“CD4+ T cells play an important role in protecting the body from infection. The higher the CD4+ T cell count, the better able you are to fight HIV and other infections,” said Emu. “This meaningful increase in CD4+ T cell counts is particularly important for patients with multidrug resistant virus, as they often have the most advanced disease. These data suggest that for these patients, Ibalizumab could be an important new treatment option,” added Emu.

The U.S. Food and Drug Administration has designated Ibalizumab as both an “Orphan Drug” and “Breakthrough Therapy.” Data from the recently completed phase three study will be submitted as part of a biologics license application to the FDA.

Emu said what makes Ibalizumab different from other HIV treatment is its intravenous administration instead of a pill dosage. If patients tolerate the drug, Emu said, it could be given in 30-minute injections every two weeks.

“There is an urgent need for a drug with a new mechanism of action for patients infected with multidrug resistant HIV-1,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer, Theratechnologies Inc., a Montreal based pharmaceutical company. “These results continue to support the submission of a Biologics License Application (BLA) to the FDA, and if approved by the FDA, Ibalizumab will be the first antiretroviral treatment with a new mechanism of action to be approved in close to 10 years,” added Marsolais.

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