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Pharmaceuticals / Inspections and Audits

FDA Approves Two-Drug Regimen for HIV Suppression

Nov. 28, 2017

The FDA approved ViiV Healthcare’s Juluca, the first complete two-drug regimen for HIV.

The fixed-dose tablet contains two previously approved drugs, dolutegravir and rilpivirine, compared to the three or more drugs in standard HIV treatment, to treat infections suppressed on a stable regimen for at least six months.

“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, director of CDER’s Division of Antiviral Products.

Safety and efficacy were evaluated in two clinical trials of 1,024 patients randomly assigned to continue their current therapy or switch to Juluca. Results showed Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs.

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