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Paediatric HIV

Cipla is spearheading the fight to end the neglect of Paediatric HIV with the launch of Lopinavir/Ritonavir pellets in South Africa.

It’s heart-breaking to give so many treatments to a kid at the same time,” Sani Nojiyeza, mother of Mel, a two-year-old living with HIV and TB in KwaMashu township in Durban, South Africa. Image credit: Scholars and Gentlemen/DNDi.

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.1 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.2 Only 54% of children aged 0–14 years living with HIV had access to treatment2 and more than 300 children still die of HIV every day.3

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.

Pellet technology

Cipla, in partnership with Drugs for Neglected diseases initiative 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.3 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 will be submitted to the South African Health Products Regulatory Authority (SAHPRA) for approval during 2020.

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 42% alcohol; making adherence to treatment very challenging – many of the children spit the medicine out 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 improving 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.3

None shall be denied

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.4 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.”

References

  1. Bhardwaj, S. et al. Implementation Research for the Prevention of Mother-to-Child HIV Transmission in Sub-Saharan Africa: Existing Evidence, Current Gaps, and New Opportunities. Curr HIV/AIDS Rep. 12, 246–255 (2015).
  2. The Joint United Nations Programme on AIDS/HIV. Fact Sheet – World AIDS Day 2019. Global HIV Statistics. 6 (2019).
  3. Drugs for Neglected Diseases Initiative. Ending the Neglect of Paediatric HIV. (2018).
  4. Cipla. HIV/AIDS. Available at: https://www.cipla.com/our-offerings/our-therapies/hiv-aids.