By Sharon Atieno
Though the medicines for HIV for children are very effective and potent, the taste is unpalatable making it unbearable for infants and young children.
The syrup-based treatment of lopinavir/ritonavir (LPV/r) recommended by World Health Organization (WHO) contains 40% alcohol.
“The syrup was very bitter. If you woke him up in the morning to give him the drugs, he would often shout in protest,” says Pamela Akoth, a mother of a child living with HIV.
Some children vomit it back while some keep spitting it, thus undermining its effectiveness.The fluid often left pain in the faces of the children after they took it.
In 2015, the U.S Food and Drug Administration (FDA) approved an oral “2-in-1” formulation of LPV/r. Unlike the syrup one, the pellet can be taken with breast milk or food and requires no refrigeration.
“The 2-in-1 pellets have improved my daughter’s health and made things so much easier. Before I kept the syrups in a container of wet soil under my bed-when I travelled, I had to carry it. Now I can store the pellets on my shelf and take them with us,” says Anne Wanza, mother of Mary living with HIV.
However, the 2-in-1 pellets are not fully “taste-masked” meaning they still have a bitter taste if not given quickly with food or drink. Also, they are not adopted for the youngest children who may have difficulty swallowing the small pellets. Moreover, the other two antiretroviral (ARVs) have to be given separately as dispersible tablets.
In addition, resistance is growing to another class of ARVs given to children known as non-nucleoside reverse transcriptase inhibitors (NNRTIs), with over 60% resistance reported in countries like South Africa, according to a 2017 WHO HIV Drug Resistance report.
At the same time, regimens containing NNRTIs such as efavirenz and nevirapine (with which majority of HIV-positive children are currently being treated) are on the verge of being deprioritized because of poor viral suppression of children on NNRTI-based regimens.
UNAIDS estimates that in 2018 there were 1.1 million children (0-14 years) living with HIV in East and Southern Africa, of these 62% were on treatment.
With half of all HIV positive children dying before the age of two and 80% dying before they turn 5 years due to lack of access to drugs or tolerance to them, there is need to come up with new formulations which are child-sensitive.
The Drugs for Neglected Diseases initiative (DNDi) in partnership with Cipla, an Indian pharmaceutical company has developed a new “4-in-1” combination called Quadrimune. It contains abacavir, lamivudine, lopinavir and ritonavir in the form of granule-filled capsules which can be used with water, milk, breast milk and food.
In addition to improved taste-masking, the 4-in-1 has been formulated into granules, with individual particle sizes that are nine times smaller than the 2-in-1 pellets, facilitating swallowing by the very young infants.
If approved by the FDA, the 4-in-1 formulation will go a long way in transforming HIV treatment for paediatric patients.
FDA recently approved a supplemental new drug application (sNDA) for Symtuza (darunavir,cobicistat, emtricitabine, tenofovir alafenamide; Janssen) for the treatment of HIV-1 in children weighing at least 40kg who are treatment-naïve or virologically suppressed on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir.
However, there is need for more investment and research in the treatment of paediatric HIV.
