MedicalResearch.com: What is the background for this study?
Response: The phase III clinical trial was conducted to assess the efficacy and safety of Trogarzo™ (ibalizumab-uiyk) injection in patients with multidrug resistant HIV-1. The study design was approved by the FDA. Results obtained were included in the New Drug Application submitted to the FDA which approved Trogarzo™ on March 6, 2018.
The phase III, open-label study, enrolled 40 patients with multidrug-resistant (MDR) HIV-1 in whom multiple antiretroviral therapies had failed. All patients at baseline were experiencing viral failure. After a seven-day control period, patients received an intravenous 2000 mg loading dose of Trogarzo™ which was the only change made to their antiretroviral regimen. Through the 24-week treatment period of the study, patients were given a maintenance dose of 800 mg of Trogarzo™ every two weeks along with an optimized background regimen that included at least one additional fully active agent.
MedicalResearch.com: What are the main findings?
Response: The primary endpoint of the study was the proportion of patients with a viral load reduction of at least 0.5 log10 from baseline, 7 day after the loading dose.
The mean baseline viral load was 4.5 log10 while the mean CD4 cell count was 150 per microliter. Of the 40 patients, 33 (83%) had a decrease in viral load of at least 0.5 log10 from baseline. At the end of the 24-week treatment period, 43% of patients had a viral load lower than 50 copies per milliliter (considered below detection level) and 50% had a viral load of less than 200 copies per milliliter.
MedicalResearch.com: What should readers take away from your report?
Response: Results from the phase III clinical trial demonstrate that Trogarzo is a safe and effective treatment for multidrug resistant HIV-1 patients.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Up to 25,000 Americans with HIV are currently multidrug resistant, of which 12,000 are in urgent need of a new treatment option because their current treatment regimen is failing them and their viral load has risen to detectable levels, jeopardizing their health and making HIV transmittable.
According to the Centers for Disease Control and Prevention (CDC), HIV cannot be transmitted if it is being fully suppressed which is what was achieved in 50% of patients who previously had uncontrolled viral loads and decreasing CD4 count.
Brinda Emu, M.D., Jeffrey Fessel, M.D., Shannon Schrader, M.D., Princy Kumar, M.D., Gary Richmond, M.D., Sandra Win, M.D., Steven Weinheimer, Ph.D., Christian Marsolais, Ph.D., and Stanley Lewis, M.D.
August 16, 2018
N Engl J Med 2018; 379:645-654
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