Every parent knows how difficult it is for a child to take medicine when they are sick. It’s hard enough when they simply need to take a dose or two of cough syrup over the stretch of a week. Now imagine they need to swallow a pill every day for the rest of their lives. That is the challenge facing parents and doctors in the HIV community today.
It has become an unfortunate truth that children living with HIV are less likely to have access to antiretroviral therapy (ART) than adults living with the same disease. In fact, last year only 54% of children living with HIV received ART globally, compared with 62% of adults. Of those, more than a third were taking sub-optimal or age-inappropriate treatments. Without prompt diagnosis and treatment, half of HIV positive infants will die before the age of two, and only one in five will survive to the age of five.
The trouble is, simply receiving treatment isn’t enough; the medicine must be designed for children’s specific needs. Part of that is understanding the right pediatric dosage for an HIV drug. The other part is identifying a medication form that’s safe, easy-to-consume and accessible in hard-to-reach areas of the world where HIV prevalence is high.
For example, in the U.S. and Europe, pediatric medications often come as syrups. But that doesn’t work for babies in developing countries, where most cases of pediatric HIV occur, and the reasoning is two-fold. First, syrups are heavy, difficult to transport in bulk, and often require refrigeration – wholly impractical for countries with limited infrastructure. Second, depending on the drug, the final product may end up with a bitter taste that children only end up spitting out. The syrup form of one key second-line HIV drug, for instance, is made up of more than 40% alcohol.
As a result, parents in developing countries are typically provided with tiny tablets or capsules that contain a smaller dose of medicine. But while for adults, consuming medicine this way is simple, for a 6-month old, it’s near impossible. Parents often end up having to crush the medicine and fold it into their baby’s food or formula, which may not only change how the drug is absorbed in the child’s body, but also make it difficult to determine whether they have ultimately consumed the needed amount.
“Developing a formulation that is safe, commercially viable, heat-stable, and at the same time palatable is a massive challenge,” explains Abhijit Deshmukh, head of Global Oral Solid Dose R&D, for Mylan, a global pharmaceutical company. “Which is why — with difficult dosing instructions, an overall poor taste, and strict storage requirements — these liquid formulas can be a challenge for some children and families.”
Recognizing the immediate need for new ARV formulations that can help bridge these challenges, pharmaceutical companies like Mylan have made more focused and coordinated efforts to accelerate the availability of age-appropriate formulations.
In 2014, for instance, Mylan — together with ViiV, another pharmaceutical company — developed a child-appropriate version of a WHO-preferred drug that is used as part of a pediatric HIV combination: a tablet that disperses in a child’s drink.
This works well for two of the medicines that babies need for HIV therapy, but treatment options for parents remain dire unless all of the medicines needed for daily therapy are in a child-friendly formulation. Most HIV-positive infants must take three to four antiretrovirals each and every day.
For this reason, last year Mylan developed a new a child-appropriate form of a drug that WHO recommends to complete a full treatment regimen. This new version does not require continuous refrigeration. It comes in the form of heat-stable, sweet-tasting granules that parents can pour into liquid or food.
“The only way to combat the issue of incongruent pediatric HIV care is to accelerate global access to age-appropriate medicines,” commented Anil Soni, head of Global Infectious Disease at Mylan. “In countries where these new pediatric formulations have been successfully introduced, they have substantially changed the face of HIV infection among infants and children.”
It’s estimated that over the next year, more than 650,000 children will use a dispersible tablet as part of their HIV treatment, with almost another 100,000 children taking a granules-based therapy. In the past two years alone, use of WHO-recommended first- and second-line ARV treatment options for infants and children, such as dispersible tablets and granules-based treatment, increased by nearly 50%.
“Mylan is proud to be at the forefront of this evolution in pediatric care for children living with HIV. And, this is just the beginning,” Soni continued.
While considerable progress has been made in expanding access to pediatric treatment and creating antiretroviral formulations designed specifically for children, much still remains to be done. One critical step in the near-term is to combine all medicines HIV-positive children are required to take — whether for drug-sensitive or drug-resistant viruses — into one single dose, thereby simplifying the process and making treatment more effective. Additionally, it’s critical for healthcare leaders to figure out how to reach the other 50% of children who don’t have access to treatment — understanding that timely access to adequate HIV care is vital.
But the progress of the past gives us hope for the future; and that’s why, in the shadow of World AIDS Day, Dec. 1, it’s critical that we — as members of the medical community, and as global citizens — continuously measure our progress in the diagnosis and treatment of pediatric HIV, highlight opportunities to do more and provide HIV-positive children with access to the medicine they need.