The South African Health Products Regulatory Authority (SAHPRA) has approved a sweet-tasting, heat-stable, ‘4-in-1’ fixed-dose combination of four antiretroviral (ARV) treatments composed of abacavir, lamivudine, lopinavir, and ritonavir that is specifically designed for infants and young children with HIV. This combination treatment has been developed by Cipla Limited and the not-for-profit Drugs for Neglected Diseases initiative (DNDi).
This new formulation represents a significant improvement over protease inhibitor-containing paediatric ARV formulations
that have been used in South Africa for decades. It does not require refrigeration, has a sweet taste and is easy to administer
to infants and children of different weights and ages, a major improvement for both children and their caregivers over
previously available formulations. The country has 238,000 children under the age of 15 living with HIV – the highest in the
‘It is highly significant that this first regulatory approval of the 4-in-1 formulation is from a country that has a high-burden of
HIV among children,’ said Dr Irene Mukui, Head of HIV, DNDi. ‘SAHPRA’s accelerated review is notable and encouraging for
other high-burden countries, and we acknowledge this show of commitment by the South African authorities. Now, it is our
hope that all the necessary steps will be taken – first in South Africa and then in other countries – to ensure the broadest
possible access to this optimal formulation for young children who need it.’
The ‘4-in-1’ combination contains an antiretroviral combination that is recommended by the World Health Organization
(WHO) as an alternative first-line regimen for infants and young children with HIV – in the form of granule-filled capsules.
Caretakers will be able to give the medicine to children by sprinkling the granules over soft food like porridge or dissolving it
in water or milk.
Commenting on the development, Umang Vohra, Managing Director and Global CEO, Cipla said, ‘We are guided by our
strong sense of responsibility to address unmet patient needs and we are committed to bringing novel solutions to improve
lives. This approval has come at an important time when so many children are suffering from HIV at such a young age. We
will continue in our endeavour to enable access to life saving solutions for all.’
Until recently, the only WHO-recommended lopinavir-based treatment available for babies and very young children in South
Africa consisted of a syrup that contained 40% alcohol and required refrigeration. Caregivers struggled to give this bitter-
tasting formulation to young children, leading to poor adherence. Caregivers without refrigeration had a very difficult time
storing the formulations – sometimes burying them in the ground to keep them cold.
Now, there are multiple new child-friendly formulations of WHO-recommended regimens being introduced – including
paediatric formulations of dolutegravir-containing regimens – representing a long-awaited and long overdue ‘treatment
revolution’ for children with HIV.
Without treatment, half of children with HIV will die before turning two. Worldwide, 2.78 million children and adolescents
are living with HIV – 88% of them in sub-Saharan Africa – but only 54% have access to treatment, according to UNICEF.