Juluca® (Dolutegravir and Rilpivirine) Approved in US as First 2-drug Regimen, Once-daily, Single Pill - a Complete Regi

JULUCA, a two-drug combination of dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), 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 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.

DOSAGE AND ADMINISTRATION 

- One tablet taken orally once daily with a meal. - Rifabutin coadministration: Take an additional 25-mg tablet of rilpivirine with JULUCA once daily with a meal for the duration of the rifabutin coadministration.

DOSAGE FORMS AND STRENGTHS 

Each tablet contains: 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride). CONTRAINDICATIONS 

- Previous hypersensitivity reaction to dolutegravir or rilpivirine. - Coadministration with dofetilide. - Coadministration with drugs where significant decreases in rilpivirine plasma concentrations may occur, which may result in loss of virologic response.

WARNINGS AND PRECAUTIONS 

- Severe skin and hypersensitivity reactions characterised by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with the individual components. Discontinue JULUCA immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. - Hepatotoxicity has been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen. Monitoring for hepatotoxicity is recommended. - Depressive disorders have been reported with the use of rilpivirine- or dolutegravir-containing regimens. Immediate medical evaluation is recommended for severe depressive symptoms.

ADVERSE REACTIONS 

The most common adverse reactions (all Grades) observed in at least 2% of subjects were diarrhoea and headache.

To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-888-844-8872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

DRUG INTERACTIONS 

- Because JULUCA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. - Refer to the full prescribing information for important drug interactions with JULUCA. - Drugs that induce or inhibit CYP3A4 or UGT1A1 may affect the plasma concentrations of the components of JULUCA. - Drugs that increase gastric pH or containing polyvalent cations may decrease plasma concentrations of the components of JULUCA - Consider alternatives to prescribing JULUCA with drugs with a known risk of Torsade de Pointes.

USE IN SPECIFIC POPULATIONS 

- Lactation: Breastfeeding is not recommended due to the potential for HIV transmission.

About ViiV Healthcare 

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit http://www.viivhealthcare.com.

About GSK  

GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com.

References 

1) Juluca US label information 2) Llibre JM, Hung C-C, Brinson C, et al. SWORD 1 & 2: Switch to DTG + RPV maintains virologic suppression through 48 weeks, a Phase III study. Presented at: Conference on Retroviruses and Opportunistic Infections; February 13-16, 2017; Seattle, WA, USA. 3) World Health Organization. Global Update on the health sector response to HIV, 2014. July 2014. Available at: http://apps.who.int/iris/bitstream/10665.... Last accessed November 2017. 4) World Health Organization. HIV/AIDS Fact Sheet. Available at: http://www.who.int/mediacentre/factsheet.... Last accessed November 2017.

ViiV Healthcare Media enquiries: Patricia O'Connor, +44-208-047-5982 Marc Meachem, +1-919-483-8756 GSK Global Media enquiries: Simon Steel, +44(0)20-8047-3763 David Daley, +44(0)20-8047-2615 Analyst/Investor enquiries: Sarah Elton-Farr, +44(0)20-8047-5194 Tom Curry, +1-215-751-5419 Gary Davies, +44(0)20-8047-5503 James Dodwell, +44(0)20-8047-2406 Jeff McLaughlin, +1-215-751-7002

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