WASHINGTON, March 6 (Xinhua) -- The United States Food and Drug Administration (FDA) approved on Tuesday a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past and whose HIV infections cannot be successfully treated with other currently available therapies.
Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.
"Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options may be able to improve their outcomes," said Jeff Murray, deputy director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research.
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 and putting them at a high risk of HIV-related complications and progression to death, according to FDA.
The safety and efficacy of Trogarzo were evaluated in a clinical trial of 40 heavily treatment-experienced patients with multi-drug resistant HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral drugs. Many of the participants had previously been treated with 10 or more antiretroviral drugs.
The majority of participants experienced a significant decrease in their HIV-RNA levels one week after Trogarzo was added to their failing antiretroviral regimens.
After 24 weeks of Trogarzo plus other antiretroviral drugs, 43 percent of the trial's participants achieved HIV RNA suppression, FDA said.
A total of 292 patients with HIV-1 infection have been exposed to Trogarzo IV infusion. The most common adverse reactions to Trogarzo were diarrhea, dizziness, nausea and rash. Severe side effects included rash and changes in the immune system.
