PAEDIATRIC HIV CARE

Addressing the challenges of the HIV epidemic in vulnerable populations is central to our mission at ViiV Healthcare of “Leaving no PLHIV behind”. This is particularly true for children and adolescents affected by HIV who have unique needs.

Despite progress, paediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic.

Latest statistics show there are 1.7m children under 15 years of age living with HIV, with only half having access to treatment.1 Major obstacles persist for children including the availability of HIV testing and diagnosis, continued mother-to-child transmission, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals (ARVs).2,3

Age-appropriate formulations are essential in ensuring infants and children around the world have access to HIV treatment. While the annual number of new infections among children has almost halved since 20104, drug development for children living with HIV lags 8 to 10 years behind that of adults. 5

“When I attended a meeting at the Vatican in 2017, we made a pledge that ViiV Healthcare would work together with the HIV community to further accelerate its work to address HIV in children.”

Deborah Waterhouse, CEO, ViiV Healthcare

As the only company 100% focused on HIV, we’re committed to addressing the gaps in paediatric HIV treatment and management of care. We have a responsibility to ensure medicines are adapted to meet the needs of children. We are fully committed to the clinical development of age-appropriate formulations to ensure no child living with HIV is left behind.

For over 25 years, we have worked directly with the communities most affected by HIV and AIDS through our industry-leading, global programme Positive Action. It’s vision for the next decade is ‘healthy communities in a world free of AIDS’. The programme enables us to work closely with, and alongside our communities and partners to support mothers, children and adolescents living with HIV. These partnerships are vital to improve access to paediatric treatment and care services and support those communities who are most affected by the disease as we work together to find ways to achieve the UN 2030 target to end AIDS.

Everything we do is about bringing positive change towards the end of AIDS. Our long-standing history and commitment to making a difference in this space was recognised by the global community when we received the first Public Recognition Award from the Global Paediatric Antiretroviral Commitment to Action for our efforts to expand access to HIV/AIDS treatment for children.

“We have a responsibility to ensure medicines are adapted to meet the needs of children. As an infectious disease physician who has specialised in paediatrics, I joined ViiV Healthcare to support the effort to end the HIV epidemic. I am proud that we are at the forefront of innovation, ensuring no child living with HIV is left behind.”

Dr Harmony P. Garges, Chief Medical Officer, ViiV Healthcare

Research and Development 

Our scientists are dedicated to developing optimised formulations specifically for children living with HIV. With 89% of new HIV infections in children found in sub-Saharan Africa, we are working with the community and focused on creating solutions that can be implemented in the developing world where the burden of HIV is highest.1

Our collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) on the P1093 study, has enabled us to develop an age-appropriate formulation of dolutegravir (DTG). 

We are also working with Paediatric European Network of Treatment of AIDS (Penta) as part of the ODYSSEY clinical trial to support our commitment to deliver a dispersible tablet formulation of DTG, as well as a simplified dosing regimen for paediatric HIV patients. For current licenced indications see our prescribing information.

Today, we are involved with several clinical studies focusing purely on paediatrics. We are always looking to the future, providing funding to the Penta EPIICAL Consortium, in the drive to find remission and cure strategies for children living with HIV. Find out more about our R&D.

 

Access

Alongside our partners we continue to accelerate access to medicines. Our voluntary licence agreements enable generic manufacturers to develop paediatric formulations of abacavir and dolutegravir in the 121 countries where 99% of children living with HIV live.6

Currently 18 generic manufacturers hold voluntary licences for paediatric formulations of DTG: one direct licence and 17 through the Medicines Patent Pool. 6,7

Click for details about the worldwide registration status of ongoing regulatory filings and registration of paediatric Tivicay.

Building on a successful partnership with the Clinton Health Access Initiative (CHAI) and Mylan to develop and introduce a dispersible formulation of ABC/3TC for children, ViiV Healthcare, CHAI and Unitaid have together established an innovative new public-private partnership. This partnership aims to expedite the development and introduction of optimised paediatric formulations of DTG, providing generic partners with financial and technical incentives to develop and manufacture generic DTG for the treatment of HIV in children across resource-limited settings. Find the full press release here.

Our work is focused on priorities set by the World Health Organization (WHO)-led Paediatric ARV Drug Optimisation (PADO) group. We also collaborate with other major partners in the HIV community such as the International AIDS Society (IAS) as the founding and major sponsor of the Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) – now the IAS platform for Paediatric HIV. The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) is another close partner who we work with to increase access to life-saving medicines for children.

Working with the Communities

Positive Action exists to further our mission of ensuring no person living with HIV is left behind, by working directly with vulnerable communities most affected by HIV. We work closely with, and alongside our Non - Governmental Organisation (NGO) and Community Based Organisation (CBO) partners, to identify ways to invest in and implement effective, innovative and sustainable programmes that support communities facing the toughest obstacles in HIV and AIDS.

Through Positive Action we address the epidemic in children by supporting local community-based organisations and interventions that work towards the prevention and elimination of mother-to-child transmission of HIV. Since 2010, our Positive Action programme has supported over 400 projects across four continents in over 30 countries. It is specifically designed to help children living with HIV, reaching 2.2m children and training over 124,000 health workers.

Starting in 2020, our two immediate priorities for Positive Action global programmes are ending paediatric AIDS and improving community-based harm reduction programmes.

Our Positive Action programme also tackles the barriers that can increase a child’s vulnerability to HIV. By addressing behavioural, structural and societal obstacles, Positive Action aims to improve the provision and quality of care from childhood all the way to adulthood.

As part of our mission to be a transformational partner that champions people and communities to end AIDS, Positive Action offers more than money. It co-creates partnerships, facilitates cohesive actions, enables access to technical assistance, capacity building and other non-financial inputs, as well as convening spaces for learning and strategic thinking. Building on what has worked over the past 25 years, Positive Action has developed a new 10-year strategy designed to support community and other strategic partners, provide clarity around our grant’s programmes, and maximise the impact we have in the global HIV response.

Find out more about Positive Action here.

References:
  1. UNAIDS. Fact sheet. Available at: https://www.unaids.org/en/resources/fact-sheet Last accessed: December 2019
  2. UNAIDS. Get on the fast-track. The life-cycle approach to HIV. Available at: https://www.unaids.org/sites/default/files/media_asset/Get-on-the-Fast-Track_en.pdf Last accessed: December 2019
  3. UNAIDS. Children and HIV – 2016 Fact Sheet. Available at: https://www.unaids.org/sites/default/files/media_asset/FactSheet_Children_en.pdf Last accessed: December 2019.
  4. UNAIDS. Ending AIDS. Progress towards the 90-90-90 targets. Available at: https://www.unaids.org/sites/default/files/media_asset/Global_AIDS_update_2017_en.pdf Last accessed: December 2019
  5. JIAS. Shortening the decade-long gap between adult and paediatric drug formulations: a new framework based on the HIV experience in low- and middle-income countries. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5978668/ Last accessed: December 2019.
  6. Five years on, 3.9 million people in the developing world have access to HIV treatment dolutegravir, thanks to accessoriented voluntary licensing agreements. ViiV Healthcare press release, 30 July 2019. Available at: https://viivhealthcare.com/en-gb/media/press-releases/2019/july/five-years-on--3-9-million-people-in-the-developing-world-have-a/ Last accessed: December 2019.
  7. Medicines Patent Pool – Dolutegravir. Available at: https://medicinespatentpool.org/licence-post/dolutegravir-adult-dtg/ Last accessed: December 2019.