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After a successful phase 3 study, a breakthrough therapy to treat multi-drug resistant (MDR) HIV-1 is expected to launch in the United States in 2017.
After a successful phase 3 study, a breakthrough therapy to treat multidrug resistant (MDR) HIV-1 is expected to launch in the United States in 2017.
Theratechnologies’ phase 3 trial of ibalizumab, which received breakthrough therapy designation by FDA, showed that patients with MDR HIV-1 experienced a significant decrease in viral load after receiving a loading dose of ibalizumab 2,000 mg intravenously-in addition to their failing antiretroviral therapies (ART) or no therapy.
“These results are particularly exciting as ibalizumab, if approved by the FDA, would be the first long-acting biologic to show such efficacy in patients with highly resistant HIV-1,” said Jacob Lalezari, MD, medical director of Quest Clinical Research, a division of eStudySite. “The study suggests that when combined with other agents, ibalizumab could help these patients in dire need of new treatments options, and could change the way multidrug resistant HIV is managed in the future.”
Seven days after the loading dose, 83% of patients achieved a greater than 0.5 log10 decrease from baseline compared with 3% during the seven-day control period. During the same period, 60% of patients achieved a decrease of greater than 1.0 log10. The average viral load decrease for the total population was 1.1 log10. There were no treatment-related serious adverse events or discontinuations reported during the initial 7-day treatment period.
“Ibalizumab is the first biologic long-acting investigational antiretroviral treatment (ART) to show efficacy in patients infected with MDR HIV-1. It is also the first anti-CD4 binding site humanized monoclonal antibody to enter clinical trials for HIV-1 and has a unique mechanism of action compared to other ART regimens currently available or in development,” said Christian Marsolais, chief medical officer for Theratechnologies.
Ibalizumab’s phase 3 trial, completed in late October, is the last pivotal clinical trial required for the submission of the Biologics License Application (BLA). “We have started preparing for the anticipated launch in the U.S. in 2017,” Marsolais said.
While many patients can control HIV-1 infection with current treatments, “some are in dire need of new treatment options because of HIV-1 MDR,” Theratechnologies said in a press statement. “As HIV multiplies in the body, the virus sometimes mutates to produce drug-resistant strains. When this occurs, HIV medicines that previously controlled a person’s virus may no longer be effective, causing treatment to fail.”
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