Paediatric HIV A Neglected Disease

THERE are currently 1.8 million children living with HIV in Sub Saharan Africa, while 180 000 new HIV infections are recorded among children every year.  52% of these children were receiving antiretroviral therapy in 2017.

By Michael Gwarisa

In Zimbabwe however the number of children on ARVs has declined owing to a decline in mother to child transmission of HIV according to data released by the National Aids Council (NAC) and UNAIDS which indicates that the number of children on ART decreased from 89% in 2017 to 65% in 2018.

However, according to a a report by released by the Drugs For Neglected Diseases (DND) Initiative, the needs of children living with HIV are neglected by pharmaceutical companies and because the market for paediatric HIV medicines is small, they have never been a priority for commercial drug development.

Treatment coverage among children living with HIV is unacceptably low, with only 52% of HIV-positive children receiving treatment in 2017. Half of these children continue to receive suboptimal regimens, putting them at risk of resistance and treatment failure.

“Very young children cannot swallow tablets intended for adults. Until recently, the only paediatric formulation for one of the main antiretrovirals (ARVs) to treat HIV was a foul-tasting syrup that not only contains 40% alcohol but must also be refrigerated – a challenge for the many living without electricity,” said the report.

The report also indicated that caregivers struggle to get infants and young children to take the syrup, as they are likely to spit it out or refuse it entirely. Children also require special dosing because when they do not get the proper dosage of an ARV, they can develop resistance to a drug, which has serious consequences for their health and future treatment options.

“The initial priority of DNDi’s pediatric HIV programme was to introduce optimal formulations for children as soon as possible. To do this, DNDi has been running a study with over 1,000 children in Kenya, Uganda, and Tanzania – one of the biggest pediatric HIV cohorts in the world – to help increase uptake of a ‘2-in-1’ oral pellet formulation.

“The 2-in-1, developed by Cipla, combines two recommended ARVs (lopinavir and ritonavir) and can replace foul-tasting syrups that require refrigeration and older paediatric ARVs that are no longer recommended.”

Meanwhile, in February 2018, interim results of the study were released, showing that 83% of the children in the study had successfully suppressed HIV levels after 48 weeks of treatment with the 2-in-1 oral pellets, compared to just 55% at the beginning of the study. These results show that the 2-in-1 is effective and well-tolerated by children.

The LIVING study is providing key data on optimized treatment regimens for young children. Nevertheless, the pellets still have a bitter taste and need to be taken with separate abacavir and lamivudine tablets – which complicates the job of caregivers. Hope for optimal treatment lies in a new 4-in-1, which will contain all four recommended drugs in a single formulation, and be better taste-masked for kids.

“DNDi is getting closer to its goal of helping deliver a 4-in-1 treatment that is easy to use, safe, effective, palatable, and does not require refrigeration. Cipla, DNDi’s partner, is planning to submit an application for regulatory approval in late 2019.

“DNDi will soon start the LOLIPOP study of the 4-in-1 in Uganda to provide clinical data on infants and young children, and produce the necessary evidence for worldwide scale-up.”

Along with the paediatric formulations of new-generation antiretrovirals being developed by others, the 4-in-1 will be an important tool in closing the substantial treatment gap between adults and young children in coming years.

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