SOUTH AFRICA – The South African Health Products Regulatory Authority (SAHPRA) has approved new antiretroviral (ARV) treatments specifically designed for infants and young children with HIV (human immunodeficiency virus) which is a promising step forward in the fight against the disease.

According to SAHPRA, the new HIV treatment for infants and young children is a sweet-tasting, heat-stable, ‘4-in-1’ fixed-dose combination of four antiretroviral treatments composed of abacavir, lamivudine, lopinavir and ritonavir.

The new HIV treatment is a major improvement for both children and their caregivers over previously available formulations as it does not require refrigeration and the sweet taste is easy to administer to infants and children of different weights and ages.

The revolutionary treatment will further support the South African Government in addressing the needs of HIV-positive infants and young children including treatment and care as the country has 238,000 children under the age of 15 living with HIV which is the highest prevalence rate in the world

Additionally, the approval of the 4-in-1 is a step towards closing the big HIV treatment gap in South Africa and ending the neglect of children with HIV where about 72% of South African adults are on life-saving HIV treatment but just half of children living with HIV in the country are on treatment.

The HIV treatment designed for young children has received its first approval from the South African Health Products Regulatory Authority to boost access to the 4-in-1 formulation for young children who need it in an effort to curb the high-burden of HIV among children.

The combination treatment developed by global pharmaceutical company Cipla Limited and the not-for-profit Drugs for Neglected Diseases initiative (DNDi) represents a significant improvement over protease inhibitor-containing paediatric ARV formulations that have been used in South Africa for decades.

Pharmaceutical giant Cipla and not-for-profit research and development organization DNDi have collaborated to launch the child-friendly 4-in-1 antiretroviral treatment for young children living with HIV in South Africa after gaining required regulatory approval.

Moreover, SAHPRA’s accelerated review is expected to encourage other high-burden countries to take the necessary steps to approve the ‘4-in-1’ combination for infants and young children with HIV to address unmet patient needs and novel solutions to improve lives.

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