FDA Approves Rukobia for HIV Patients with Limited Treatment Options

The US Food and Drug Administration (FDA) has approved a drug called Rukobia, which is a new type of anti-retroviral medication for adults that live with HIV. The therapy is designed for those that have tried multiple other HIV medications which have not been successful in treating the patient.

The drug is indicated for patients who have failed to respond to other treatments due to resistance, intolerance or safety considerations. In other words, this drug gives an option to patients who have 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 Dr. Jeff Murray, 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 infection — helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications, to potentially live longer, healthier lives.”

The safety and efficacy of the twice-daily, oral drug, Rukobia, was demonstrated in 371 patients who participated in a clinical trial. The patients were heavily treatment experienced adults who continued to have levels of the virus in their blood despite being on other drugs.

According to a statement, “272 participants were treated in the main trial arm, and an additional 99 participants received Rukobia in a different arm of the trial. 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). Participants in the main cohort of the trial received either Rukobia or a placebo twice daily for eight days, in addition to their failing antiretroviral regimen.”

On the eighth day of the trial, participants who had taken the drug, Rukobia, were seeing a significant decrease in levels of HIV RNA in their blood, compared to those that were taking the placebo. Then after the eighth day, all the participants in the trial received this drug along with the anti-retroviral drug, and after 24 hours, 53 percent of participants achieved HIV RNA suppression. This means that levels of HIV were low enough to be considered undetectable. Finally, after 96 weeks, 60 percent of the participants continued to have HIV RNA suppression.

The FDA granted this application as Fast Track, Priority Review and Breakthrough Therapy Designation. The FDA granted approval of Rukobia to ViiV Healthcare.