Uganda has been selected for the study on the initial first-line 4-in-1 paediatric HIV/Aids fixed-combination dose expected to address the urgent need for better medicines for children living with HIV before it is rolled out globally.
The 4-in-1 antiretroviral therapy (ART) combination drug (abacavir/lamivudine/lopinavir/ritonavir) commonly referred to as LPV/r is meant for HIV-infected children under the age of three years.
This includes those who have been exposed to drugs while in the womb, and those who are co-infected with TB.
The Uganda study called the “Living study” starts this May for eight months and will be conducted by the Drugs for Neglected Diseases initiative (DNDi) and its partners.
It will then be rolled out to Kenya, Tanzania, Zimbabwe, South Africa, Thailand, India and Switzerland early next year.
The study aims to increase access to optimal ART for children aged under three years, in order to improve coverage and adherence, and eventually, to reduce the number of child deaths.
It also aims to ensure that these easy-to-use formulations are affordable and can be rapidly introduced worldwide.
Bitter tasting medication
According to Olawale Salami, clinical project manager, for HIV in children at DNDi, data on safety, feasibility, and efficacy data on this new formulation will be generated to provide evidence for a worldwide rollout.
“The drug will replace existing paediatric HIV formulations with treatments that are more palatable, easy to store and better adapted to children’s needs,” said Dr Salami.
Studies report that caregivers have difficulty administering medication to children due to the bitter taste of the medications.
According to the latest UNAids 2017 report, only 43 per cent of children living with HIV received ART in 2016.
Existing paediatric HIV drugs taste bad, are difficult to administer, require refrigeration, and are unsuitable for children suffering from both HIV and tuberculosis.
The World Health Organisation recommends LVP/r as the first-line ART to initiate in children three years of age and younger and recommended it as the second-line treatment for children aged three years and above.
“The 4-in-1 will be taste-masked and heat-stable, which is a great improvement over the current high-alcohol content LPV/r syrup.”
Currently, the only available version of LPV/r was a bad-tasting syrup that requires refrigeration and contains 40 per cent alcohol.