FDA approves new anti-HIV treatment Rukobia for patients with limited choice

The U.SFood and Drug AdministrationAdministrationapproved Rukobia, a new antiretroviral drug used in various HIV drugs that cannot be successfully treated for drug resistance, intolerance or safety issuesinfected"This approval marks the possibility that patients who no longer have an HIV treatment option may benefit from this new antiretroviral drug," said Jeff Murray, associate director of the Antiviral Stakes division at the FDA'sDrug Evaluation and Research Centerassessed the safety and effectiveness of Rukobia twice daily oral treatment in 371 patients who had received anti-HIV treatment for more than 15 years (71%) and had received five or more different HIV treatments (85%) or a medical history of AIDS (86%)Although antiretroviral drugs are being taken, there are still high levels of the virus (HIV-RNA) in the bloodresults showed a significant drop in HIV-RNA levels in the blood of patients treated with Rukobia after the eighth day of treatment compared to the placebo groupAfter 24 weeks of Rukobia with other antiretroviral drugs, 53% achieved HIV RNA inhibition and HIV levels were low to undetectableAfter 96 weeks, 60% of patients still have HIV RNA suppressedRukobia's most common adverse reaction is nauseaSerious adverse reactions include changes in theimmunesystem and elevated liver enzymes in patients infected with hepatitis B or C virus at the same time The FDA previously awarded the drug the title of Fast Track, Priority Review, and Breakthrough Therapy