Paediatric HIV, tuberculosis (TB) and hepatitis C remain neglected diseases, due to the limited number of appropriate formulations of optimal treatment regimens adapted to the needs of infants and children.
- In 2018, just 54% of the 1.7 million children (0-14 years) living with HIV globally received life-saving antiretroviral (ARV) therapy, of which many were sub-optimal formulations.
- In 2017, an estimated one million children fell ill with TB, and 233,000 died from the infection, including children with HIV-associated TB.
- Mother-to-child transmission of hepatitis C affects 4-8% of infants; for those born to HIV co-infected mothers, Hepatitis C virus transmission is even higher at 11-25%.
The Medicines Patent Pool (MPP) works in partnership with key stakeholders in the paediatric space, including international, non-governmental, civil society, pharmaceutical and other organisations, to accelerate the development and uptake of adapted formulations of optimal paediatric HIV, TB and hepatitis C drugs.
- MPP is a proud partner of the Global Accelerator for Paediatric Formulations (GAP-f), a WHO initiative with the support of the Clinton Health Access Initiative, the Elizabeth Glaser Pediatric AIDS Foundation, Penta Child Health Research, and MPP. In this initiative, MPP is part of the GAP-f Secretariat and co-leads the GAP-f Business Development Working Group.
- MPP participates in key paediatric mechanisms such as the WHO-led Paediatric ARV Drug Optimization (PADO) groups for HIV, TB and hepatitis C, and the Paediatric ARV Working Group (PAWG).
- Throughout its interactions with manufacturers, MPP highlights the demand for recommended and priority paediatric drug formulations listed in WHO guidelines and PADO lists, while exploring with patent holders practical ways to further expand access to optimal formulations for paediatric populations.
Specific efforts to address paediatric HIV
In the HIV space, MPP has signed licenses for all the drugs already developed for paediatric use that are included in WHO guidelines. In addition, MPP licences exist for a number of drugs that are still being studied for use in children or that could potentially be important for the paediatric population.
There are four royalty-free MPP licensing agreements specifically for paediatric HIV medicines. These licences allow generic supply in countries where the vast majority of children living with HIV in low- and middle-income countries reside:
- Paediatric licence for abacavir (with ViiV Healthcare)
- Paediatric licence for dolutegravir (with ViiV Healthcare)
- Paediatric licence for lopinavir/ritonavir (with AbbVie)
- Paediatric licence for raltegravir (with Merck, Sharp & Dohme, MSD)
Other MPP licences in the HIV space allow sublicensees to manufacture treatments for paediatric use without any royalties on paediatric sales:
- Licence for atazanavir (with Bristol-Myers Squibb, BMS)
- Licence for bictegravir (with Gilead Sciences)
- Licence for cobicistat (with Gilead Sciences)
- Licence on elvitegravir (with Gilead Sciences)
- Licence on emtricitabine (with Gilead Sciences)
- Licence for lopinavir/ritonavir (with AbbVie)
- Licence for patents related to darunavir (with U.S. National Institutes of Health, NIH)
- Licence for solid drug nanoparticle technology (with University of Liverpool)
- Licence for tenofovir alafenamide (with Gilead Sciences)
- Licence for tenofovir disoproxil fumarate (with Gilead Sciences)
As part of high-level dialogues on scaling up early diagnosis and treatment of children and adolescents convened at the Vatican, MPP made the following commitments:
- Facilitate access to the best available medicines for children. Specifically, MPP will continue to work with patent holders to in-license paediatric drugs as prioritized by the WHO/PADO, and to sublicense to generic manufacturers to ensure that appropriate formulations are rapidly developed, registered and made available in as many developing countries as possible (2017 commitment) .
- Inform all countries in the paediatric license group on the status of paediatric ARV patents (2018 commitment).
Specific efforts to address paediatric TB
In TB, MPP has signed a collaborative agreement with Otsuka with the goal of making delamanid more available to children infected with multidrug-resistant TB. In addition, MPP signed a memorandum of understanding with TB Alliance committing both parties to explore potential avenues of collaboration to ensure that appropriate and affordable TB drug formulations reach children in need. Moreover, MPP licences in the TB space are royalty-free (including for paediatrics):
- Licences for sutezolid (with Johns Hopkins University and Pfizer)
Specific efforts to address paediatric hepatitis C
MPP licences in the hepatitis C space are either royalty-free or allow sublicensees to manufacture treatments for paediatric use without any royalties on paediatric sales:
- Licence for daclatasvir (with Bristol-Myers Squibb, BMS)
- Licence for glecaprevir/pibrentasvir (with AbbVie)
- Licence for ravidasvir (with Pharco Pharmaceuticals).
Specific efforts to address other paediatric illnesses
As part of its expanded mandate covering patented essential medicines with high medical value beyond those for HIV, TB and hepatitis C, and other medicines with strong potential for future inclusion on the WHO Model List of Essential Medicines (EML), MPP will continue to support development of and access to adapted paediatric drug formulations. Special attention will be given to the WHO Model List of Essential Medicines for Children (EMLc). This work will take place as part of the GAP-f, or through other ongoing MPP licensing work.
Read related MPP stories:
- “First Person” Series article on Offering children living with HIV the best available treatment options, by Martina Penazzato (WHO) on the occasion of World AIDS Day 2019
- Article on Accelerating access to treatment for children with HIV must be a public health priority, by Charles Gore (Executive Director, MPP) on the occasion of World AIDS Day 2018