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Juluca®

Juluca is ViiV Healthcare’s first 2-drug regimen, once-daily, single-pill that combines the integrase inhibitor (IN) 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 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 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.¹

On 16th May 2018, the European Commission (EC) approved Juluca for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.2 Marketing authorisation was also granted by Health Canada on 18th May 2018.3

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.4

Regulatory applications are on-going in other markets worldwide.

 

[1] Juluca US label information

[2] Juluca European label information

[3] Juluca Canadian label information

[4] 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 May 2018.