ViiV Healthcare,  a global specialist HIV company, announced new collaborations with the goal of increasing access to its HIV medicine, dolutegravir (marketed under the name Tivicay), just two months after its approval by the European Medicines Agency (EMA) and eight months after approval by the US Food and Drug Administration (US FDA). Through an agreement with the Medicines Patent Pool (MPP), ViiV Healthcare will accelerate access to dolutegravir where the need is the greatest, in the countries where 99 per cent of children and 93.4 per cent of adults with HIV in the developing world live.

“Our new collaborations prioritise dolutegravir access for millions of children and adults with HIV, and represent another step in our ongoing commitment to improving access and delivering innovation in the areas of highest unmet need,” said Dr Dominique Limet, chief executive officer, ViiV Healthcare.“We recognise that important new agents have the potential to make a real difference in resource poor settings.In fact, the World Health Organisation has recently cited dolutegravir as a development priority for future anti-retroviral treatments for children–it is currently approved for children 12 years and older.Therefore, accelerating access to medicines like dolutegravir is of the utmost importance.”

In adults:the collaboration with MPP includes two distinct approaches to improve access for adults living with HIV in the developing world first, a royalty-free voluntary licence in all least-developed, all low-income and all sub-Saharan African countries; second, for specific middle-income countries including India, ViiV Healthcare has established the first-ever MPP license with a tiered royalty structure, where a small percentage of the sale price is paid based on the gross domestic product (GDP) of the specific country. The licenses will also allow for the possible development, manufacture and supply of dolutegravir-based fixed-dose combinations, including those with abacavir, if and when approved by local regulatory agencies.

Supporting children living with HIV, ViiV Healthcare will grant MPP a voluntary license for generic manufacturers to develop paediatric formulations of dolutegravir without paying a royalty in 121 countries where most (99 per cent) children with HIV live. Dolutegravir is currently approved for patients 12 years and older.  However, this license also includes a commitment for future lower dose tablets and age-appropriate formulations developed by ViiV Healthcare to meet the needs of younger children with HIV, if and when approved by a major regulatory authority.    

The announcement complements an earlier voluntary license for dolutegravir signed in 2013 with Aurobindo Pharma for adults and children for our standard voluntary license territories.

ViiV Healthcare is committed to improving scientific understanding and treatment options for infants and children living with HIV. This includes a broad range of initiatives supported through our Paediatric Innovation Seed Fund, which aims to improve paediatric HIV research, care and treatment in resource-limited settings. Additionally, the Positive Action for Children Fund supports 150 organisations across 30 countries to deliver programmes designed to prevent mother-to-child transmission of HIV.

FDA Indication and Usage in the US TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children aged 12 years and older and weighing at least 40 kg. The following should be considered prior to initiating TIVICAY: poor virologic response was observed in subjects treated with TIVICAY 50 mg twice daily with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R.

Contraindication: Co-administration of TIVICAY with dofetilide (anti-arrhythmic) is contraindicated due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events.

Tivicay (dolutegravir) is an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

It is available as a small, yellow, 50 mg tablet. Importantly, it can be taken with or without food and at any time of the day.

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (GSK) and Pfizer  dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder 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.