New formulation is dispersible and strawberry-flavoured, enabling the youngest children living with HIV to be treated with the best available medication
New price agreement with Viatris and Macleods will significantly lower cost for yearly paediatric HIV treatment from over $480 per child to under $120 per child[1]
Innovative partnership has accelerated development of first generic paediatric dispersible formulation of dolutegravir (DTG), the recommended first-line HIV treatment
A long-awaited HIV treatment designed specifically for children will now be available in low-and middle-income countries, thanks to a landmark agreement from Unitaid and the Clinton Health Access Initiative (CHAI).
1.7 million children around the world live with HIV, but only half of them receive any treatment and 100,000 die every year. For many of these children, the HIV virus is not suppressed, due in part to the lack of availability of effective drugs that are palatable and properly adapted for them.
The new pricing agreement with generic manufacturers Viatris and Macleods means a new dispersible formulation of the recommended first-line HIV treatment dolutegravir (DTG) will be launched at a yearly cost of $36 per child, reduced from around $400[2].
The innovative partnership between Unitaid, CHAI and ViiV Healthcare[3], together with Mylan (now a subsidiary of Viatris), has resulted in the fastest ever regulatory approval under the US FDA PEPFAR programme of a generic paediatric HIV drug.
“Children in low- and middle-income countries often wait years to access the same medications as adults, hindering their quality of life, or even resulting in preventable deaths,” said Unitaid’s Executive Director Philippe Duneton. “This groundbreaking agreement will bring quality assured dispersible DTG to children at a record pace. Ensuring access to this treatment will transform the lives of children living with HIV, helping them to remain on treatment and saving thousands of lives.”
Many children living with HIV have a poor response to treatment because they take anti-retroviral medication that is not correctly dosed or bitter to taste. Despite being the World Health Organisation-recommended first-line treatment for children since 2018, an affordable DTG has been unavailable to children under 20kg so far, due to a lack of dispersible tablets which are considered age-appropriate formulations.
“It’s time to fight back against substandard HIV treatment outcomes in children,” said Dr Meg Doherty, Director of Global HIV, Hepatitis and STI Programmes at WHO. “Today we can finally guarantee that countries have rapid access to the appropriate formulations needed to fully implement WHO guidelines; so that no child is left behind. WHO welcomes the approval and commercialisation of the new pediatric DTG 10 mg. Congratulations to all the partners involved for showing how quickly we can bring new formulations to market when we work together – clear proof that solidarity delivers results.”
This new DTG 10 mg strawberry-flavoured, dispersible tablet is more inviting to children. It will enable them to successfully remain on medication and prevent thousands of premature deaths each year, transforming paediatric HIV treatment in low and middle-income countries.
The agreement will also significantly lower the total annual cost of paediatric HIV treatment from $480 per child to less than $120. With global health budgets more constrained than ever, such significant savings – in the range of US$60-260 million over five years – will be a game-changer.
This announcement coincides with the U.S. Food and Drug Administration’s (FDA) tentative approval of the first generic paediatric dispersible DTG product from Viatris on November 19th 2020. This is the first time a generic product has been positively reviewed within several months of the originator product receiving FDA approval, reducing the gap from three years for the adult version of the same medicine, to just five months. This filing strategy represents a major innovation which could drastically reduce the time it takes for new paediatric medications to reach children in low- and middle-income countries. Tentative approval for Macleods’ product is expected in early 2021.
CHAI CEO Iain Barton said: “This innovative collaboration will, for the first-time, enable children living with HIV in low-and middle-income countries to access the same first-line ARV medication at the same time as those in high-income countries. The partnership should serve as a model to remove barriers that hinder development of paediatric formulations to deliver top-line medications quickly and affordably.”
Unitaid, CHAI, and national Ministries of Health are partnering with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) to drive early access to the product in several countries to generate feedback on early use, to help inform wider adoption and scale-up.
“PEPFAR is deeply committed to optimizing HIV treatment for individuals of all ages,” said Ambassador Deborah L. Birx, U.S. Global AIDS Coordinator and U.S. Special Representative for Global Health Diplomacy. “The availability of pediatric DTG formulations offers a significant opportunity for young children living with HIV to access robust, child-friendly treatment that will directly improve their health. PEPFAR will continue to collaborate with global and local partners to support the accelerated introduction and widespread use of pediatric DTG among the children we serve.”
The product will be made initially available in Benin, Kenya, Malawi, Nigeria, Uganda and Zimbabwe in the first half of 2021, with plans for rapid scale-up of dispersible DTG 10 mg across a broad set of countries.
Cabinet Secretary for the Ministry of Health in Kenya, the Hon. Mûtahi Kagwe, said: “This announcement marks a dramatic shift for the quality of HIV treatment for children. Kenya intends to be a first-adopter of the new paediatric DTG 10mg formulation, which will improve treatment, reduce unpleasant side effects, and help children to adhere to their treatment and live healthy lives. We are delighted that for the first time Kenya and other countries can provide children the same quality of treatment as adults, which has been made possible through the development of this new formulation.”
Related:
[1] $480 per year based on average price of currently available, recommended first line therapy using ABC/3TC dispersible tablets and LPV/r pellets or granules for a child from 10.0-13.9 kg; $120 per year based on currently available ABC/3TC dispersible tablets and new DTG 10 mg scored dispersible tablet for a child from 10.0-13.9 kg (based on WHO weight bands). Current product prices per USAID GHSC-PSM September 2020 Product e-Catalog.
[2] $404 is the average annual cost of LPV/r pellets and granules for a child from 10.0-13.9 kg. Current product prices per USAID GHSC-PSM September 2020 Product e-Catalog.
[3] Viiv Healthcare provided a Technical Transfer package to support the development of this new formulation
Background notes
DTG has been recommended by the World Health Organization (WHO) as the preferred first-line treatment regimen for children over the age of four weeks and greater than 3 kg since 2018, but to date only children weighing 20 kg or more have been able to access the medication due to a lack of dispersible, age-appropriate formulations for younger children.
During the COVID-19 pandemic, it is more critical than ever to ensure that all people living with HIV achieve and maintain viral suppression. An unsuppressed viral load puts a person living with HIV at increased risk of contracting co-infections, such as tuberculosis.
The product development collaboration between Unitaid, CHAI, and ViiV Healthcare was spearheaded through Unitaid’s investment in CHAI since 2016 to bring the best HIV medications to market more quickly and integrate them into treatment programs in communities in developing countries that need them the most. The initiative provided Viatris and Macleods with a financial incentive for development and registration. ViiV Healthcare, the originator of DTG, shared technical knowledge and expertise and CHAI provided technical and regulatory support that enabled accelerated generic development and regulatory submission. ViiV Healthcare received FDA approval of their paediatric dispersible 5mg dolutegravir tablet in June 2020.
The new generic formulations of DTG manufactured by Viatris and Macleods will be available at the lower price to 121 countries covered by ViiV Healthcare’s pediatric DTG voluntary licensing agreements via the Medicines Patent Pool, covering 99% of children living with HIV. Through supporting better treatment, and with recent advances in earlier diagnosis of infants born with HIV, we finally have the tools to achieve the goal of ending HIV-related child mortality.
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