The Drugs for Neglected Diseases initiative (DNDi) welcomes the Medicines Patent Pool announcement this World AIDS Day that it has negotiated an agreement with AbbVie, which is placing two key paediatric HIV medicines, lopinavir and ritonavir, into the Pool. The agreement means that where 99% of children with HIV live, there will be no intellectual property barriers to the development or delivery of much-needed improved paediatric antiretroviral (ARV) formulations, including a key lopinavir/ritonavir-based treatment that DNDi and its partner Cipla are developing for infants and young children. Importantly, the MPP-AbbVie agreement includes South Africa, which has the highest burden of paediatric HIV in the world.
‘With intellectual property barriers formally lifted from lopinavir and ritonavir, the two key components of the World Health Organization’s recommended first-line antiretroviral regimen for paediatrics, more children with HIV will be able to access improved formulations more rapidly’, said Dr Marc Lallemant, Head of the Paediatric HIV Programme at DNDi. ‘This is particularly the case for South Africa, where children are given the current liquid formulation that has an unbearable taste, is full of alcohol, and is difficult for caregivers to administer.’
The ‘Global Pediatric ARV Commitment-to-Action’ was also announced today, by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the Paediatric HIV Treatment Initiative (PHTI) – a collaboration between UNITAID, the Clinton Health Access Initiative (CHAI), MPP, and DNDi. These key partners have joined forces to accelerate development of priority paediatric ARVs within the next three years, through incentivizing drug manufacturers to develop and supply ARVs, and through facilitating regulatory approval, adoption, and rapid uptake in hard-hit countries as soon as the drugs are available.
‘Paediatric HIV has long been comparable to a neglected disease, with a lack of child-friendly formulations and poor diagnostic options contributing to a high death rate in HIV-positive children’, said Dr Bernard Pécoul, Executive Director, DNDi. ‘Today’s agreements are another promising step towards reducing the unacceptable HIV treatment gap between kids and adults. Let us hope these commitments will translate into immediate action.’
DNDi’s work in Paediatric HIV/AIDS
DNDi is currently working with Cipla Ltd and other partners to develop an improved first-line therapy for infants and toddlers living with HIV. The project aims to develop two solid 4-in-1 fixed-dose combinations: lopinavir/ritonavir/zidovune/lamivudine (LPV/r/AZT/3TC) and lopinavir/ritonavir/abacavir/ lamivudine (LPV/r/ABC/3TC). DNDi and Cipla will also develop a stand-alone solid granule version of ritonavir to be added to paediatric treatment when children are co-infected with tuberculosis (TB), as additional ‘boosts’ of ritonavir, to do away with the negative interaction between the TB medicine rifampicin and ARVs.
This project is made possible with support from UNITAID, the French Development Agency (AFD), Médecins Sans Frontières (MSF), and the UBS Optimus Foundation. Read DNDi‘s paediatric HIV overview, “Accelerating the Development and Delivery of Antiretroviral Treatment for Children with HIV/AIDS” [pdf]
About Paediatric HIV/AIDS
An estimated 3.2 million children under the age of 15 years are living with HIV/AIDS, and 91% of them live in sub-Saharan Africa. Each day, some 650 children are newly infected with HIV and 520 die from AIDS-related complications. Only one-quarter of HIV-positive children who need treatment are receiving it. Without treatment, one-third of children born with HIV will die before their first birthday, 50% will die before they turn two, and 80% will die before they are five years old.
About the Drugs for Neglected Diseases initiative (DNDi)
DNDi is a not-for-profit research and development organization working to deliver new treatments for neglected diseases, in particular human African trypanosomiasis, Chagas disease, leishmaniasis, filaria, and paediatric HIV. DNDi was established in 2003 by Médecins Sans Frontières/Doctors Without Borders (MSF), Oswaldo Cruz Foundation of Brazil, Indian Council for Medical Research, Kenya Medical Research Institute, Ministry of Health of Malaysia, and Institut Pasteur of France. The WHO Special Programme for Research and Training in Tropical Diseases (WHO-TDR) serves as a permanent observer. Since 2003, DNDi has delivered six treatments for neglected patients: two fixed-dose drug combinations for malaria (ASAQ and ASMQ); nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness; sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa; a set of combination therapies for visceral leishmaniasis in Asia; and a paediatric formulation of benznidazole for Chagas disease.