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FDA Approves First 2-Drug Regimen for HIV

FDA news release; 2017 Nov 21

The US Food and Drug Administration approved Juluca (dolutegravir and rilpivirine), the first 2-drug regimen to treat certain adults with human immunodeficiency virus type 1 (HIV-1). The approval was granted to ViiV Healthcare (Research Triangle Park, NC).

Indications: Juluca, a 2-drug combination of dolutegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure, and no known substitutions associated with resistance to the individual components of Juluca.

Dosage and administration: Take 1 tablet orally once daily with a meal. Take an additional 25-mg tablet of rilpivirine with Juluca once daily with a meal for the duration of the rifabutin coadministration.

Safety and efficacy: Juluca’s safety and efficacy in adults were evaluated in 2 clinical trials of 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Results showed Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV regimen.

Adverse reactions: The most common adverse reactions in ≥2% of subjects were diarrhea and headache.

Citation:

US Food and Drug Administration. FDA approves first two-drug regimen for certain patients with HIV. FDA Web site. November 21, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586305.htm.... Accessed November 27, 2017.

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