FDA Approves First Two-Drug Regimen for HIV
Juluca is the first complete treatment regimen containing only 2-drugs, instead of 3 or more in standard treatment.
The US Food and Drug Administration (FDA) has approved Juluca, the first complete treatment regimen containing only 2 drugs to treat certain adults with HIV-1, compared to three or more drugs included in standard HIV treatment.
Juluca, a fixed-dose tablet, contains 2 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, with 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 2 clinical trials, SWORD 1 and SWORD 2, consisting of 1,024 participants whose virus was suppressed on their current anti-HIV medications.
Trial participants were randomly assigned to continue current anti-HIV drugs or switch to Juluca, and results showed Juluca was effective in keeping the virus suppressed and comparable with patients’ current anti-HIV drugs.
The primary efficacy endpoint was the number of patients with plasma HIV-1 RNA less than 50 copies/mL who remained on ART.
Juluca successfully achieved the primary endpoint, as at week 48, 95% of both treatment groups achieved viral suppression.
Key secondary endpoints included evaluation of the development of viral resistance, measurements of safety and tolerability and changes in renal, bone and cardiovascular biomarkers.
The studies also included exploratory measures assessing changes in health-related quality of life, willingness to switch and adherence to treatment regimens.
Only 0.6% of patients treated with dolutegravir and rilpivirine did not achieve viral suppression, while 1.2% of the ART cohort failed to meet the metric.
The most common side effects of Juluca were diarrhea and headache. Serious side effects included skin rash and allergic reactions, liver problems, and depression or mood changes.
Juluca combines dolutegravir, an HIV-1 integrase strand transfer inhibitor, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor.
It’s not recommended to prescribe Juluca with other anti-HIV medications, as drug interactions may occur. The FDA warns that Juluca is contraindicated with dofetilide and drugs in which significant decreases in rilpivirine plasma occur, which may cause a loss of viral suppression.
According to the FDA, the recommended dose is 1 tablet per day with a meal and will be available as 50mg/25mg fixed-dose tablets.
The FDA declined to comment to MD Magazine.
A press release has been made available.
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