A mother of an HIV+ baby boy administering him bitter tasting ARV medication, Belville South, Cape Town, South Africa.
› HIV continues to be a major public health problem worldwide, particularly in sub-Saharan Africa, even though international efforts to combat HIV/AIDS since the turn of the millennium have led to an overall decrease in the number of new cases diagnosed and in the number of AIDS-related deaths. Children are the worst affected, and the majority of babies born with HIV are still not diagnosed or treated. Of the approximately 2.6 million children currently living with HIV, only 32% receive treatment. Although efforts in preventing mother-tochild transmission should reduce the market size of paediatric HIV in the long term, the increased testing of pregnant women and their children is paradoxically expected to increase the paediatric m a r ke t i n t h e s h o r t to medium term, and the need for paediatric treatment will continue to increase until at least 2020. Antiretroviral therapy is not able to cure the disease and needs to be taken for life, but it can control the virus and enable the patient to live a healthy life. Early treatment is essential, as without it 50% of children infected will die before their second birthday, and 80% before their fifth. Adapted paediatric treatments are needed for infants and young children that are safe, efficacious, and easy for the child to swallow, thus ensuring their best chance of survival to adulthood. Children in Africa are frequently also co-infected with
tuberculosis (TB), so HIV and TB treatments need to be compatible. Antiretroviral treatments typically combine three or more drugs with different modes of action. The only approved protease inhibitor for young children, lopinavir boosted with ritonavir (LPV/r), comes as an unpleasant tasting oral solution with a high alcohol content. It also requires refrigeration, is difficult to store due to its large volume, and expensive, making it unsuitable for resourcepoor settings. DNDi and partners have been working on developing a taste-masked, solid LPV/r oral formulation adapted for infants and young children, which would ultimately be combined with t wo nucleoside reverse tr anscriptase inhibitors (NRTIs) into a single ‘4-in-1’ unit or capsule. As a first step, LPV/r has been formulated into pellets by Cipla Ltd., which received the U.S. Food and Drug Administration (FDA) tentative approval for use in June 2015. These pellets can be sprinkled onto food, are alcohol-free, do not require a cold chain, and are cheaper to transport, although they still have an unpleasant taste. As such, the formulation provides a better treatment option for children and is currently undergoing evaluation in DNDi’s LIVING study in Africa, which will give valuable information on its use under normal living conditions.
Developing treatments for children living with HIV/AIDS
44 › DNDi Annual Report 2015