What you need to know:
- The product will be made initially available in Benin, Kenya, Malawi, Nigeria, Uganda and Zimbabwe in first half of 2021.
Uganda and Kenya are among six African countries set to receive new generic strawberry-flavoured tablets for treating children living with human immunodeficiency virus (HIV) in the first half of 2021.
The countries — also include Benin, Malawi, Nigeria and Zimbabwe — will benefit from the Unitaid and Clinton Health Access Initiative (CHAI) partnership with generic drug makers that led to the development of dolutegravir (DTG) of 10 milligrams for treating children living with HIV.
“The product will be made initially available in Benin, Kenya, Malawi, Nigeria, Uganda and Zimbabwe in first half of 2021, with plans for rapid scale-up of dispersible DTG 10mg across a broad set of countries,” said the agency.
The World Health Organisation (WHO) recommended DTG for children over the age of four weeks and weighing more than three kilogrammes but to date only those weighing 20kg or more access medication due to lack of age-appropriate formulations. Unitaid, CHAI and Ministries of Health with the US President’s Emergency Plan for Aids Relief (Pepfar) are driving early access to the new product in several countries to generate feedback to inform wider adoption.
Kenya’s Health Cabinet Secretary Mutahi Kagwe said the country intends to be first-adopter of new paediatric DTG formulation.
“We are delighted that for the first time Kenya and other countries can provide children same quality of treatment as adults,” he said.
Unitaid-CHAI new pricing agreement with generic manufacturers Viatris Inc of US and India’s Macleods Pharmaceuticals Ltd will avail the new dispersible DTG at Shs131,900 per child yearly from about Shs1,465,604.
The agreement will also lower total annual cost of paediatric HIV treatment from Shs1,758,700 per child to less than Shs439,700.
It is estimated 1.7 million children around the world live with HIV but only half of them receive any treatment while 100,000 die every year. For many of the children, the HIV virus is not suppressed because of lack of availability of effective drugs that are palatable and properly adapted for them.
“Children in low- and middle-income countries often wait years to access the same medications as adults, hindering quality of life or even resulting in preventable deaths,” said Unitaid’s executive director Philippe Duneton.
US Food and Drug Administration (FDA) on November 19 approved Viatris paediatric DTG tablets of 10mg under Pepfar which permits products that are not approved for marketing in U.S. because of patent protection or other restrictions to be distributed in other countries where they are needed.
“FDA’s decision clears the way for Viatris to deliver this urgently needed treatment to some of most vulnerable children in regions home to 99 per cent of children living with HIV,” said Viatris president Mr Rajiv Malik.
This is the first time a generic product has been positively reviewed within several months of the originator product receiving FDA approval, reducing gap from three years for adult version of same medicine, to five months.