According to FDA Center for Drug Evaluation and Research Division of Antivirals Deputy Director Dr. Jeff Murray, the approval means there is a new class of medications that can help HIV-positive patients that have no other choices in treatment.
He said these new antiretroviral drug classes is necessary for patients who have multi-drug resistant HIV infections and at higher risk for suffering from HIV-related complications so that they can live a longer, healthier life.
Rukobia, which is designed to be taken two times a day, was given to about 370 participants with high HIV-RNA virus levels. 272 participants received the drug in the main trial arm, with the remaining participants getting the drug injected in the other arm.
Trial participants were given either Rukobia or a placebo two times a day for eight days, along with taking their original regimen. On day 8, those who took Rukobia had lower levels of HIV-RNA in their blood, unlike those who were given the placebo. After day 8, everybody began taking Rukobia, and after 24 weeks of using Rukobia and other antiretroviral drugs, 53 percent of the participants had low, nearly undetectable HIV-RNA levels. 60 percent of those using Rukobia saw suppression of HIV-RNA after 96 weeks.
Researchers noted that the most prevalent adverse reaction was nausea, although in some cases where people have hepatitis B and C, people had high-level enzymes.
Written by Mark Riegel, MD
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