Published November 21, 2017
In November, the FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with HIV-1.
Juluca 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 less than 50 copies/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.
Additionally, the Tivicay (dolutegravir) label was updated for consistency with the new Juluca approval. The following changes were made to the Tivicay label:
- To expand the indication to include the use of Tivicay in combination with rilpivirine as a complete regimen to replace the current antiretroviral regimen in those who are virologically supressed on a stable antiretroviral regimen for the last 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral.
- To update the WARNINGS AND PRECAUTIONS section to include subsections 5.2 Hepatoxicity and 5.3 Risk of Adverse Reactions or Loss of VIrologic Response Due to Drug Interactions.