Child-Friendly Antiretroviral Formulation Launching In South Africa This Week

Almost all parents can attest to the struggle experienced at mealtimes – think aeroplane noises and bribery – to get an infant or toddler to just eat their veggies. Now, imagine trying to administer a metallic tasting medicine, which must be squirted into the child’s mouth with a syringe twice daily or trying to get them to swallow a tablet whole. This is the struggle that mothers of children living with HIV (CLHIV) have had to endure daily with the paediatric antiretroviral (ARVs) formulations available.

In recent years, there has been significant advances in the prevention of mother-to-child HIV transmission in sub-Saharan Africa. However, according to UNAIDS, there were about 160 000 new infections among children in 2018 and it’s estimated that 1.7 million under the age of 15 are living with HIV. Only 54% of children aged 0–14 years living with HIV had access to treatment and more than 300 children still die of HIV every day.

Cipla has prioritised the development of optimal child-friendly antiretroviral formulations for CLHIV, specifically infants and young children who are at highest risk of dying without access to treatment.

Cipla, in partnership with Drugs for Neglected diseases (DNDi), have developed a fixed-dose 4-in-1 combination of abacavir/lamivudine/lopinavir/ritonavir for infants and young children under three years of age which meets the World Health Organisation (WHO) guidelines. This innovative formulation presented as capsules containing strawberry flavoured granules (the size of granulated sugar) can be used with food or milk. The 4-in-1, called Quadrimune, will be submitted to the South African health regulatory authorities (SAHPRA) for approval during 2020.

This week, however, Cipla is launching a 2-in-1 combination of lopinavir/ ritonavir (LPV/r), Lopimune, in South Africa. Lopimune is a pellet formulation, making it significantly more palatable than the current LPV/r oral solution, which is available to children in South Africa. The oral solution has a bitter, lingering taste and contains 40% alcohol; making adherence to treatment very challenging – many of the children spit out the medicine or vomit it out. In comparison, the pellets can be mixed into foods such as porridge or milk, making it easier to administer and thus improves adherence to treatment. Another significant advantage, particularly in South Africa, is that unlike the oral solution, the pellets do not require refrigeration.

Beyond the advantages of administration and the ease of storage, results of studies conducted in Kenya, Uganda and Tanzania have shown very high levels of adherence and clinical improvements, as well as lower HIV viral loads, showing that improved formulations can lead to better treatment outcomes. The LIVING study findings have shown that 83% of children on the pellets are virally suppressed after 48 weeks, compared to 55% at the start of the study.

Over the past two decades, Cipla has revolutionised HIV therapy, ensuring “none shall be denied” by making lifesaving ARVs affordable. In 2001, Cipla introduced a world-first three-in-one fixed-dose combination, made available at less than $1 per day in comparison to the prevailing $12 000 cost per patient per year. Apart from making medication more accessible, this also helped to improve adherence by lessening the pill burden.

However, what is still needed is an intensified commitment to optimal paediatric HIV formulations to specifically address the needs of infants and CLHIV – something effective and easy to administer. 

Paul Miller, CEO of Cipla South Africa: “As Cipla has demonstrated over the past 20 years, we’re committed to ensuring access to innovative, effective and easy-to-administer formulations which can help to improve adherence and subsequently result in better treatment outcomes. We will make every effort to intensify our commitment to help scale up treatment of paediatric HIV.”