FDA Approves New HIV Treatment for Patients With Limited Treatment Options
"This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options," said Jeff Murray, M.D., deputy director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research.
- "This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options," said Jeff Murray, M.D., deputy director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research.
- "The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infectionhelping people living with hard-to-treat HIV who are at greater risk for HIV-related complications, to potentially live longer, healthier lives."
- Most participants had been treated for HIV for more than 15 years (71 percent), had been exposed to five or more different HIV treatment regimens before entering the trial (85 percent) and/or had a history of AIDS (86 percent).
- After 24 weeks of Rukobia plus other antiretroviral drugs, 53 percent of participants achieved HIV RNA suppression, where levels of HIV were low enough to be considered undetectable.