First Two- Drug, Single Tablet Complete Regimen Approved By FDA

Today The #FDA approved JULUCA the first 2 drug complete regimen to treat select individuals who are virally suppressed. The regimen contains integrase inhibitor dolutegravir and NNRTI rilpivirine.

 

Dolutegravir is also known as TIVICAY® and is marketed by ViiV Healthcare. Dolutegravir is also one of the components of Triumeq. Rilpivirine is known as EDURANT® and is marketed by Janssen Therapeutics. Rilpivirine is also a component of COMPLERA® and ODEFSEY®.

 

JULUCA® was approved for people living with HIV who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months and have no prior history of treatment failure – and no known resistance to the individual components of JULUCA®   JULUCA® is the first complete HIV regimen containing two drugs that is without the traditional NRTI backbone.   JULUCA® received FDA approval based on data from the two pivotal Phase 3 SWORD studies, which are identical, randomized, multicenter, open-label, non-inferiority studies designed to assess the safety and efficacy of switching to the two-drug regimen of dolutegravir and rilpivirine compared with remaining on current antiretroviral regimen (CAR). The studies included more than one thousand patients who previously achieved stable viral suppression for at least six months on other antiretroviral regimens (integrase inhibitor, NNRTI, or boosted protease inhibitor-based) and had no history of virologic failure or known resistance to dolutegravir or rilpivirine.   Juluca will soon be in pharmacies so it’s important to understand the drug and have discussions with your healthcare providers which include your doctor and HIV pharmacist to make sure the drug is right for you READ THE FDA PRESS RELEASE HERE

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