Pivotal Phase III trial of Trogarzo to treat HIV is published in NEJM.- Theratechnologies Inc.
Theratechnologies Inc. is pleased to announce that results from the phase III clinical trial used to obtain FDA approval for Trogarzo (ibalizumab-uiyk) injection in the United States were published in the The New England Journal of Medicine (NEJM). Furthermore, the NEJM published an article, authored by the Office of the Antimicrobial Products of the FDA, giving rationale for the design of the phase III trial of Trogarzo that led to its approval.
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. 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.
See- "Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1."-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. DOI: 10.1056/NEJMoa1711460.
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