Fewer babies are being born HIV-positive, but treatment for the more than three million children living with HIV remains under-researched and underfunded. As part of efforts to boost access to paediatric HIV treatment, researchers are getting creative, moving to better pills, kid-friendly treatment "sprinkles", micro-tabs and even medicine-dispensing pacifiers.
Ahead of the International AIDS Conference, Indian generic drug manufacturer Cipla announced that it would partner with the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development organization, to produce an improved first-line antiretroviral (ARV) combination therapy specifically adapted for infants and toddlers living with HIV. The partnership is just one of the developments in paediatric treatment highlighted at the 19th International AIDS Conference in Washington DC.
Mother-to-child HIV transmission rates have fallen by almost 25 percent globally since 2009, according to the latest UNAIDS report. Governments and donors celebrated these gains and pledged to eliminate mother-to-child - or vertical - transmission by 2015.
Former UN Special Envoy for AIDS in Africa, Stephen Lewis, speaking at the conference, criticized the lack of progress in improving treatment options for the 3.4 million children living with HIV.
"You can't aim for the virtual elimination of paediatric HIV by 2015 at the continued expense of [treatment] scale-up for children living with HIV now, but that's exactly what appears to be happening," said Lewis. "[These children] deserve the right to life, they are not expendable causalities because they didn't fit into prevention of vertical transmission programmes."
The latest UNAIDS report shows that about 55 percent of adults living with HIV and in need of treatment are receiving ARVs globally, compared to just 25 percent of the children who need them. In some countries, patent laws still restrict access to some existing paediatric fixed-dose ARV combinations.
Paediatrician and researcher Dr Adeodata Kekitinwa, who works at the Mulago Referral Hospital in the Ugandan capital, Kampala, pointed out that HIV treatment for children is historically under-researched and less efficacious than adult formulations, making it harder to suppress HIV viral loads in children and infants compared to adult patients.
Promising pills and more
Cipla and the Clinical Trials Unit of the UK Medical Research Council have produced several ARV formulations for babies, and recently announced good results from a new granular, or sprinkle, formulation of lopinavir-ritonavir, a combination of ARVs.
In the recently released CHAPAS-2 trial, which compared the sprinkles with the conventional lopinavir-ritonavir syrup, caregivers reported that the sprinkles were easier for babies to swallow and easier for caregivers to transport and store than the syrup formulations.
According to Diana Gibb, a researcher on the study, the CHAPAS-2 trial also collected important data on how caregivers thought the sprinkles should be administered. For instance, many caregivers reported pouring sprinkles into the baby’s mouth and then immediately breastfeeding.
|You can't aim for the virtual elimination of paediatric HIV by 2015 at the continued expense of [treatment] scale-up for children living with HIV now, but that's exactly what appears to be happening|
While this data is yet to be analyzed, Gibbs said it was important for drug manufacturers and developers to understand what treatment options worked best for families. Kekitinwa said these considerations might also factor into trial designs, possibly looking at how drugs interact with breast milk.
Cipla's newly announced proposed four-in-one therapy will also be developed in sprinkle-form and have a child-friendly taste. The company aims to register the drug by 2015.
As more paediatric ARV formulations are developed, drug companies may be able to move beyond syrups and sprinkles to dissolving microfilms or bulk powders that would make it easier for healthcare providers to calculate doses based on children's rapidly changing body weight.
Bulk powders could also make drugs cheaper, as pharmaceutical companies would not have to alter the manufacturing process to cater for different age and weight groups. Better-tasting drugs could also eventually be administered in pacifier dispensers.
With an urgent need for more paediatric ARV formulations, the UN World Health Organization (WHO) recently formed a technical working group to draw up guidelines on formulation and dosing in an effort to help guide research and development, said Lulu Muhe, who works in WHO's Department of Child and Adolescent Health and Development.