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Juluca®

Juluca® is ViiV Healthcare’s first 2-drug regimen, once-daily, single-pill that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine. 

Juluca® was approved by the US Food and Drug Administration (FDA) on 21st November 2017 and is indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed 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 Juluca¹.  Juluca® will allow patients to reduce the number of antiretrovirals (ARVs) that they take, whilst maintaining the efficacy of traditional three-drug regimens in a small, single-pill regimen.¹,2

Global Regulatory applications are planned and ongoing.

[1] Juluca US label information

[2] ViiV Healthcare announces detailed positive phase III results for investigational two-drug regimen of dolutegravir and rilpivirine for HIV treatment. Available at: https://www.viivhealthcare.com/media/press-releases/2017/february/viiv-healthcare-announces-detailed-positive-phase-iii-results-for-investigational-two-drug-regimen-of-dolutegravir-and-rilpivirine-for-hiv-treatment.aspx. Last accessed October 2017.

 

 

Prescribing information

United States

Prescribing Information and Medication Guide for Juluca®