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FDA Approves Two-Drug Regimen For People that Are Undetectable


The approved drug, Juluca, is the first complete treatment regimen containing these two drugs to treat certain adults who are virologically suppressed.

According to a news release, the U.S. Food and Drug Administration (FDA) has approved Juluca, indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL), on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure, and no known substitutions associated with resistance to the individual components of Juluca.

It's only approved for those with undetectable viral loads.

“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, told End Points News.

Juluca is the first 2-drug regimen (2DR) comprising dolutegravir 50mg (ViiV Healthcare), an integrase strand transfer inhibitor and rilpivirine 25mg (Janssen Therapeutics, Division of Janssen Products LP), a non-nucleoside reverse transcriptase inhibitor.

Deborah Waterhouse, CEO of ViiV Healthcare said, “The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care.  This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the U.S., to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”




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