Child-friendly antiretrovirals in the pipeline

Researchers have developed child-friendly antiretroviral (ARV) formulations that are safe, easy to administer and heat-stable.

The improved first-line therapy will be administered to infants and children under age three, who have been neglected by pharmaceutical research and development.

The new four-in-one (abacavir/lamivudine/lopinavir/ritonavir) formulation being developed by Drugs for Neglected Diseases Initiative is said be well tolerated and requires one daily dose.

Since 2013, the World Health Organisation has recommended regimens that include a class of antiretrovirals called protease inhibitors namely lopinavir/ritonavir (LPV/r), for infants and young children.

However, the only available version was a bitter-tasting syrup that requires refrigeration and contains 40 per cent alcohol. It is also expensive and requires special storage and transportation considerations.

The new formulation will be in the form of granules in a capsule, which is opened and given to children with soft food or breast milk.

TREATMENT

With promising preliminary results, treatment could be available by the end of the year, and phase two trials will take place in sub-Saharan countries that are most affected by paediatric HIV, to test efficacy and safety of the treatment. This data will provide evidence for worldwide scale-up.

Despite major efforts to increase the number of children on HIV treatment and a continuing reduction in mother-to-child transmission of HIV, in 2016, only 43 per cent of HIV-positive children received antiretroviral therapy globally.

While this is an impressive increase from 15 per cent in 2009, it is considerably lower than the some 54 per cent of adults on treatment.

Kenya has an estimated 6,613 new HIV infections among children annually, 120,000 HIV-positive children and 78,700 on anti-retroviral treatment. In 2016, about 4, 800 children died due to HIV/AIDS.

The treatment gap in this population is attributed to suboptimal paediatric ARV formulations.

A study published in PLOS One in January revealed that bitter medication and lack of appropriate formulations and fixed-dose combinations for children lead to underdosing and consequently, development of resistance to antiretroviral medicines.

Unpalatable medication has also been a hindrance to viral load suppression in children, thereby increasing possibility of children becoming severely ill.