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FDA Approves First Long-Acting Treatment for Multidrug Resistant HIV Infection

For the first time, the Food and Drug Administration (FDA) has authorized the release of an HIV treatment that does not have to be taken daily, giving people with multidrug resistant HIV infection a new treatment option they urgently need.

The agency’s groundbreaking action earlier this month permits pharmaceutical companies Theratechnologies and TaiMed Biologics to begin marketing their long-acting monoclonal antibody treatment Trogarzo to HIV-positive adults who are failing on their current antiretroviral regimens. As the first ever long-acting HIV treatment, Trogarzo is administered via intravenous infusion once every two weeks.

Phase three clinical trials found that the majority of patients taking Trogarzo, in combination with other HIV medicines, achieved at least a 70% reduction in viral load within seven days of their first dosage. Many of these patients began the study with extremely high viral loads and weakened immunity, but by the study’s end, saw significant increases in T-cell count.

Those infected with multidrug resistant HIV are at substantially increased risk for disease progression and HIV transmission to partners. Researchers, physicians, and patients have long been concerned with the lack of options to treat multidrug resistant HIV infection, which helped Trogarzo gain designation by the FDA as a breakthrough therapy with priority review status.

In a company press release, Luc Tanguay, Chief Executive Officer of Theratechnologies, emphasized the significance of this long-acting treatment for people infected with “difficult-to-treat” multidrug resistant HIV.

“We look forward to bringing this much-needed therapy to patients in the U.S. within six weeks,” said Tanguay. “We are grateful to the patients, investigators, as well as the FDA who supported the clinical development of Trogarzo, and are helping address this critical, unmet medical need.”

On average, patients in the clinical trial experienced approximately 98% reduction in viral load after taking Trogarzo for 24 weeks. About 25,000 people in the United States are infected with multidrug resistant HIV and, therefore, may be candidates for Trogarzo. Many of these patients have been treated with over ten antiretroviral drugs in the past.

Nelson Vergel, a participant in the clinical trial who began taking this medicine six years ago, hailed Trogarzo as a new “source of hope” and “peace of mind” that helped him reach an undetectable viral load after failing previous treatment regimens.

“I’ve struggled with multidrug resistant HIV for almost 30 years and it was completely debilitating to feel like I had run out of options - I made no long-term plans,” added Vergel. “I feel incredibly lucky to have been able to participate in the clinical trial program.”

Side effects of this new treatment – including rash, nausea, and diarrhea – occurred in less than 10% of trial participants and are remarkably mild compared to other HIV treatments. As the body’s immune system starts to improve, patients taking Trogarzo may begin to fight off infections that were previously hidden in the body, but doctors can help manage these symptoms.

After almost a decade in clinical trials, Trogarzo is also the first FDA-approved HIV treatment that uses antibodies to block the HIV virus from infecting T-cells. Edwin DeJesus, Medical Director of the Orlando Immunology Center where Trogarzo was tested, highlighted the efficacy of this new treatment mechanism in helping his patients.

“As a clinician,” said DeJesus, “I am excited that we will now have another option with a different mechanism of action for our heavily pretreated patients who are struggling to keep their viral load below detection because their HIV is resistant to multiple drugs.”

Over 10,000 people in the United States are failing their current HIV maintenance regimen and urgently need a new treatment to achieve viral suppression. For these individuals, Trogarzo is a breakthrough with the potential to halt HIV disease progression and the potential to even reverse immune system decline.