E-DRUG: DNDi Launches New Programme for Treatment Needs of Children with HIV & AIDS
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DNDi Launches New Drug Development Programme to Address Treatment Needs of
Children with HIV and AIDS
Rome/Geneva (18 July 2011) Today at the 6th International AIDS Society
(IAS) Conference on HIV Pathogenesis, Treatment and Prevention, the Drugs
for Neglected Diseases initiative (DNDi) announced the launch of a new drug
development programme to address critical unmet treatment needs of children
with HIV and AIDS.
Because HIV transmission in young children has largely been eliminated in
high-income countries due to effective prevention of mother-to-child
transmission (PMTCT) interventions, little market incentive exists for
pharmaceutical companies to develop antiretroviral (ARV) drugs adapted for
children. The World Health Organisation (WHO) recommends immediate
antiretroviral therapy (ART) for all HIV-positive children less than two
years old, but the safety and correct dosing of key ARVs have not been
established in very young children, and appropriate child-adapted
formulations do not exist. Current paediatric ARV formulations are
unpalatable for these children, are impractical for caregivers due to
multiple liquid preparations that have to be adjusted according to weight,
and have undesirable interactions with tuberculosis (TB) drugs.
There are millions of children with HIV-related disease in low- and middle-income
countries, but their needs are absent from the HIV research and development
agenda, and this is largely because they are poor and voiceless and do not
represent a lucrative market, said Dr. Bernard Pécoul, Executive Director
of DNDi. Working with partners, we hope to help fill this terrible gap and
offer improved treatment options for children with HIV and AIDS.
Last year, Médecins Sans Frontières/Doctors Without Borders (MSF), UNITAID,
and other organisations called upon DNDi to apply its expertise to
paediatric HIV and AIDS based on its track record in delivering new medicines
for neglected diseases. DNDi, a not-for-profit R&D organization, develops
new treatments for neglected patients suffering from sleeping sickness,
leishmaniasis, Chagas disease, and malaria.
Our medical teams in the field have for years faced difficulty treating
young children with HIV due to the lack of appropriate treatment tools,
says Dr. Unni Karunakara, International President of MSF. We will do
everything possible to accelerate the development of and access to improved
formulations for children with HIV and AIDS, and look forward to being able to
introduce better, affordable medicines to treat HIV-positive babies and
children where we work.
After an in-depth needs assessment and consultation with experts including
those from endemic countries such as South Africa, Uganda, Cote dIvoire,
and Thailand, and from public sector research institutions such as the US
National Institutes of Health, UK Medical Research Council, and Agence
Nationale de Recherche sur le Sida in France ideal specifications for
improved treatments were developed. There is consensus around the need to
develop an improved first-line protease inhibitor-based regimen for children
under three years of age, irrespective of prior exposure to ARVs, and this
will be DNDis first priority.
Ideally, this new first-line paediatric HIV therapy needs to be easy to
administer and better tolerated by children than current drugs, as well as
heat stable, easily dispersible, and dosed once daily or less. It must also
carry minimal risk for developing resistance and be suitable for infants and
very young children, with minimum requirements for weight adjustments.
Finally, any new formulations must be compatible with TB drugs, and,
importantly, affordable.
Paediatric HIV has indeed been a neglected area for innovation in drug
development," said Dr. Gottfried Hirnschall, Director of WHOs HIV and AIDS
Department. "Children's access to HIV treatment has been low with only 28%
of the children in need of HIV treatment receiving it at the end of 2009.
WHO appreciates DNDi's focus on new paediatric HIV treatments, and we look
forward to working together to deliver more and better medicines for
children in need.
DNDis paediatric HIV programme will be led by the newly appointed Marc
Lallemant, MD, formerly head of the Programs for HIV Prevention and
Treatment (PHPT), a clinical research consortium of Chiang Mai University,
Harvard School of Public Health, and IRD (Institut de Recherche pour le
Développement), based in Chiang Mai, Thailand. He has studied and conducted
research on HIV in pregnant women and children and on the prevention of
mother-to-child transmission of HIV since 1985. Dr. Lallemant led two major
clinical trials on PMTCT (PHPT 1 and 2), which served as the basis for WHO
recommendations for PMTCT in resource-limited settings. He is also involved
in paediatric HIV research with PENTA, the European clinical research
network and the NIH-funded International Maternal Pediatric Adolescent AIDS
Clinical Trials Group (IMPAACT).
Children living with HIV- related disease are a neglected population, and pediatric
AIDS can be considered a neglected disease, says Dr. Lallemant. While we
must make every effort to eliminate new HIV infections among infants through
large-scale access to PMTCT and maternal ART, we cannot neglect the millions
of children currently and newly infected with the virus who are in dire need
of treatment today.