ViiV Healthcare Announces FDA Approval to Lower the Weight Limit for dolutegravir in Children and Adolescents Living Wit

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

Adverse Reactions: The most commonly reported (greater than or equal to2%) adverse reactions of moderate to severe intensity in treatment-naive adult subjects in any one trial receiving Tivicay in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).  

Drug Interactions: Co-administration of Tivicay with certain inducers of UGT1A and/or CYP3A may reduce plasma concentrations of dolutegravir and require dose adjustments of Tivicay. Administer Tivicay 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, Tivicay and supplements containing calcium or iron can be taken with food. Consult the full Prescribing Information for Tivicay for more information on potentially significant drug interactions, including clinical comments.

Pregnancy Category B: Tivicay should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

Nursing Mothers: Breastfeeding is not recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.

Paediatric Patients: Safety and efficacy of Tivicay have not been established in paediatric patients weighing less than 30kg or in any paediatric patients who are INSTI-experienced.

Full US Prescribing Information for Tivicay is available at: https://www.gsksource.com/pharma/content...

About the Medicines Patent Pool 

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with six patent holders for twelve HIV antiretrovirals and for one hepatitis C direct-acting antiviral. Its generic partners have distributed more than three billion doses of low-cost medicines to 117 countries. The MPP was founded and remains fully funded by UNITAID.

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. Shionogi (TYO: 4507) 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 new HIV medicines, 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

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4. UNAIDS. 90-90-90. An ambitious treatment target to help end the AIDS epidemic. Available at: http://www.unaids.org/sites/default/files/media_asset/90-90-.... Last accessed: June 2016 

5. IMPAACT P1093 Study Protocol Final Version 4.0 13 April 2016. Available at: http://impaactnetwork.org/studies/P1093..... Last accessed June 2016 

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CONTACT: ViiV Healthcare Global/US Media enquiries: Sébastien Desprez,+44 7920 567 707; Patricia O'Connor, +44 208 047 5982; CaraVivarelli-O'Neil, +1 919 483 0301; Marc Meachem, +1 919 483 8756; GSKGlobal Media enquiries: David Mawdsley, +44 (0) 20 8047 5502; Simon Steel,+44 (0) 20 8047 5502; Claire Brough, +44 (0) 20 8047 5502, CatherineHartley, +44 (0) 20 8047 5502; David Daley, +44 (0) 20 8047 5502