New formulation of dolutegravir will make modern ART available for babies and young children at less than $120 a year
Polly Clayden, HIV i-Base
The much-anticipated 10 mg, dispersible, scored, strawberry-flavoured, paediatric formulation of dolutegravir will soon be available to low- and middle-income countries, through a price agreement from Unitaid and CHAI with generic manufacturers Viatris and Macleods. [1, 2]
As well as providing greatly-improved HIV treatment this will significantly reduce the annual lower cost for paediatric ART from over $480 per child to under $120 per child.
The pricing agreement means the new dolutegravir formulation will be launched at a yearly cost of $36 per child, reduced from about $400.
This partnership between Unitaid, CHAI and ViiV Healthcare, together with Mylan (now a subsidiary of the newly-formed Viatris), has led to the fastest regulatory approval under the US FDA PEPFAR programme of a generic paediatric HIV drug to date.
CHAI also estimates that the agreement will result in significant savings for health budgets – in the region of US $60–260 million over five years.
The first FDA tentative approval of paediatric dispersible DTG product from Viatris was 19 November 2020.  Tentative approval for Macleods’ product is anticipated in early 2021.
The product will initially be made available in Benin, Kenya, Malawi, Nigeria, Uganda and Zimbabwe in the first half of 2021, with plans for rapid scale-up across a number of countries.
- CHAI press release. Groundbreaking agreement reduces by 75% the cost of HIV treatment for children in low-and middle-income countries. 30 November 2020.
- CHAI. Five things you should know about pediatric DTG. 30 November 2020.
- US FDA. PEPFAR database. Dolutegravir tablets for oral suspension. NDA 214521. 19 November 2020.
This report was first posted on 1 December 2020.