A new treatment option is available for patients with multi-drug resistant (MDR) HIV following the US Food and Drug Administration’s (FDA) approval of Trogarzo (ibalizumab-uiyk). The medication, developed by TaiMed Biologics USA Corp, is a new form of antiretroviral medication indicated for use in adult patients with HIV who have unsuccessfully tried other treatment options.
Around 1.2 million people in the United States live with diagnosed HIV, around 10,000 of whom have MDR HIV-1, according to figures from the Centers for Disease Control and Prevention. HIV drug resistance can occur during breaks in treatment, which give the virus the chance to mutate and increase its resistance to antiretroviral therapy.
Among the medications already indicated to treat HIV are Truvada (emtricitabine and tenofovir), Viread (tenofovir disoproxil fumarate) and Tivicay (dolutegravir). Last year, the first generic version of Truvada became available in the United States after it gained FDA approval in June 2017.
Trogarzo, the latest HIV treatment to pass FDA scrutiny, is an intravenous medication administered once every 14 days by a trained medical professional. This humanized monoclonal antibody is used in conjunction with other antiretroviral drugs. The FDA granted the application Fast Track, Priority Review, Orphan Drug, and Breakthrough Therapy designations.
Approval of the drug was granted on the back of a clinical trial of 40 patients who had received significant levels of treatment with antiretrovirals for MDR HIV-1 - with some on as many as 10 different medications - who still recorded high levels of the HIV-RNA virus in their blood. After 24 weeks, the trial demonstrated 43 percent of participants treated with Trogarzo achieved HIV-RNA suppression.
“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, MD, deputy director of the Division of Antiviral Products in the FDA Center for Drug Evaluation and Research.
Common Adverse Reactions to Trogarzo
Severe Side Effects of Trogarzo
- Immune system changes (immune reconstitution inflammatory syndrome)
- Rash
In other HIV-related news, the World Health Organization (WHO) recently updated its recommendations on preventing cryptococcal meningitis in patients with advanced HIV, recommending screening of these patients and treatment of the disease with fluconazole. New strategies need to be developed to manage HIV in order to reach the target of cutting HIV deaths by half by 2020, the WHO asserted.
For more information on Trogarzo, visit: http://www.trogarzo.com
