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If approved, ibalizumab will be the first antiretroviral treatment with a new mechanism of action to be approved in nearly a decade.
Scientists are always looking for ways to improve HIV prevention and treatment for the most vulnerable, which includes patients with strong multi-drug resistance. Now, thanks to data released from a pivotal Phase 3 trial for the drug ibalizumab, we might be seeing the newest form of antiretroviral therapy getting approved by the FDA.
Theratechnologies Inc. announced the results from the trial, and according to the data, patients with multi-drug resistant HIV-1 experienced a mean increase in T-cells after 24 weeks of treatment with ibalizumab, plus an optimized background regime.
“This meaningful increase in T-cell counts is particularly important for patients with multi-drug resistant virus, as they often have the most advanced disease,” Dr. Brinda Emu, Assistant Professor of Medicine, Infectious Diseases at Yale, said. “These data suggest that for these patients, ibalizumab could be an important new treatment option,” added Dr. Emu.
The people who took part in the Phase 3 study saw a significant decrease in viral load after receiving a single dose of ibalizumab in addition to their current antiretroviral therapy, which has mostly failed to work on their strain of HIV. Some participants weren't on ART at all.
Over the 24 weeks, viral loads consistently decreased. And at the end of the period, 43 percent were undetectable while 50 percent had an extremely low viral load, lower than 200 copies/mL.
“There is an urgent need for a drug with a new mechanism of action for patients infected with multidrug resistant HIV-1,” Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies Inc. said, “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.”
The primary objective of the study was to watch the antirviral activity of ibalizumab seven days after the first dose. Only a single arm dose was added to their existing regime, nothing else. And judging by these results, the future of antiretroviral therapy has a lot more possibilities!
