“While most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug-resistant HIV, limiting their treatment options,” Jeff Murray, M.D., deputy director of the FDA’s Division of Antiviral Products, said in a statement.Trogarzo is administered intravenously once every 14 days. This is a biologically-based alternative HIV treatment developed in Taiwan and manufactured in China.
The safety and efficacy of Trogarzo were evaluated in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1. After 24 weeks of Trogarzo plus other antiretroviral drugs, 43 percent of the trial’s participants achieved HIV RNA suppression. Trogarzo is produced by TaiMed Biologics, based in Taiwan. WuXi Biologics, the manufacturing partner, is based in East China’s Jiangsu province. The most common adverse reactions to Trogarzo were diarrhea, dizziness, nausea, and rash. More severe side effects included rash and immune reconstitution syndrome.