Today marks the official launch of UNIVERSAL, the newly funded European-African clinical research partnership that aims to develop two antiretroviral formulations for children living with HIV and to speed up their availability at low cost for low- and middle-income countries (LMICs).
Access to antiretroviral treatment for children under the age of 15 living with HIV continues to lag behind adults. UNAIDS data indicate that of the estimated 1.8 million children with HIV in 2019, only 53% had access to treatment compared to 68% of adults (UNAIDS 2020).
Many of these children do not receive optimal paediatric treatment formulations, or state-of-the-art drugs. Studies show that adults living with HIV on effective antiretroviral therapy have significant gains in life expectancy, and we believe that children should be able to benefit from similar gains.
UNIVERSAL will develop, evaluate and register two new antiretroviral formulations for infants and children newly diagnosed with HIV initiating antiretroviral therapy, and for children failing first line therapy who need to switch to a new treatment regimen.
These two new formulations contain approved drugs already used in adult care in high-income settings: dolutegravir combined with emtricitabine/tenofovir alafenamide; and darunavir/ritonavir. The World Health Organization (WHO) has prioritised them as being the critical optimal formulations needed to achieve the best outcomes for children living with HIV.
“Having fixed-dose combinations of HIV drugs in single dosage forms that can be given once daily means minimising pill burden in children, a big step forward compared to the many antiretroviral drugs currently available to younger children that need twice a day dosing”, explains Marc Lallemant – scientific coordinator of UNIVERSAL.
From our Principal Investigators at the African sites, “Harmonising treatment options between adults and children will make it easier for governments to procure and distribute and for caregivers to prescribe”.
According to Professor Carlo Giaquinto, the Project coordinator and President of the Penta Foundation, “This is a crucial partnership. Working with the Clinton Health Access Initiative – who is funded by Unitaid for the product development and regulatory activities, and key partners in the Pharmaceutical industry, we will ensure these formulations are rapidly filed to the relevant regulatory agencies, produced and made available to the children and adolescents who urgently need them”.
Additionally, this new partnership will invest in improving the capacity of African partners to develop and implement future clinical trials that can lead to regulatory approval and undertake long-term safety studies. Only by working and liaising continually with local communities, researchers and healthcare professionals can we move closer to achieving the United Nations Sustainable Development Goal 3, which explicitly calls for the end of the HIV and AIDS epidemic by 2030.
The project is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP2) and involves 15 partners from Cameroon, Spain, Netherlands, Uganda, France, Mali, United Kingdom, Senegal, Ivory Coast, Switzerland, United States and Zimbabwe.