The U.S. Food and Drug Administration said Wednesday it has approved Juluca, a two-drug HIV treatment regimen designed to reduce the number of drugs - and therefore side effects - that people living with HIV need to take to suppress the virus.
Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is suppressed on a stable regimen for at least six months, with no history of treatment failure and no other substitutions that resist the components of Juluca.
HIV is a virus that attacks the immune system, which is our body’s natural defense against illness. The virus destroys a type of white blood cell in the immune system called a T-helper cell and makes its copies inside these cells. According to the U.S. Centers for Disease Control and Prevention, an estimated 1.1 million people America are living with HIV, and the disease remains a significant cause of death for specific populations.
Juluca’s safety and efficacy in adults were evaluated in two clinical trials of 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Researchers randomly assigned participants to continue their current anti-HIV medicines or to switch to Juluca. Results showed Juluca was effective in keeping the virus suppressed and comparable to those who continued to take their existing anti-HIV drugs.
The most common side effects in patients taking Juluca were diarrhea and headache. Serious side effects included skin rash and allergic reactions, liver problems and depression or mood changes. Juluca should not be given with other anti-HIV drugs and may have drug interactions with other commonly used medications.
“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.
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