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FDA Approves Juluca, First Two-Drug HIV Regimen

Big news has been announced in the realm of HIV, a virus that remains a major global public health issue. Today, the US Food and Drug Administration has OK’ed Juluca—the first complete treatment regimen that contains only two drugs to treat individuals infected with HIV-1, compared with the standard HIV treatment that consists of three or more drugs.

Juluca, a fixed-dose tablet, is comprised of two previously approved drugs: dolutegravir (ViiV Healthcare) and rilpivirine (Janssen). It’s approved to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least 6 months, who have no history of treatment failure and no known substitutions associated with resistance to the individual components of the drug.

“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” Debra Birnkrant, MD, director, Division of Antiviral Products in the FDA’s Center for Drug and Evaluation, said in a statement.

The safety and efficacy of Juluca were evaluated in two clinical trials consisting of 1,024 participants who achieved viral suppression via their current anti-HIV medications.

Trial participants were randomly assigned to continue current anti-HIV drugs or switch to Juluca. Results showed that Juluca was effective in keeping the virus suppressed and comparable with patients’ current anti-HIV drugs.

The most common side effects of Juluca were diarrhea and headache. However, serious side effects included skin rash and allergic reactions, liver problems, and depression or mood changes.

It’s important to note that it is not recommended to prescribe Juluca with other anti-HIV medications, as drug interactions may occur.
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