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The new formulation is dispersible and strawberry flavored, allowing younger children living with HIV to be treated with the best medications available
New pricing agreement with Viatris and Macleods will significantly reduce annual pediatric HIV treatment costs from over $ 480 per child to less than $ 120 per child[1]
Innovative partnership accelerated development of first generic dispersible pediatric formulation of dolutegravir (DTG), the recommended first-line treatment for HIV
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 worldwide are living with HIV, but only half of them receive treatment and 100,000 die each year. For many of these children, the HIV virus is not being suppressed, in part due to the lack of availability of effective drugs that are palatable and adequately adapted for them.
The new pricing agreement with generic manufacturers Viatris and Macleods means that a new dispersible formulation of the recommended first-line HIV treatment dolutegravir (DTG) will be launched at an annual cost of $ 36 per child, reduced from approximately $ 400.[2].
The innovative partnership between Unitaid, CHAI and ViiV Healthcare[3], along with Mylan (now a subsidiary of Viatris), has achieved the fastest regulatory approval ever under the US FDA’s PEPFAR program of a generic drug for pediatric HIV.
“Children in low- and middle-income countries often wait years to access the same drugs as adults, hampering their quality of life or even leading to preventable deaths,” said Philippe Duneton, Executive Director of Unitaid. “This revolutionary 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 continue treatment and saving thousands of lives. “
Many children living with HIV have a poor response to treatment because they are on antiretroviral drugs that are not dosed correctly or are bitter to the taste. Despite being the first-line treatment recommended by the World Health Organization for children since 2018, a cheap DTG has not been available so far for children weighing less than 20 kg, due to the lack of dispersible tablets considered suitable formulations. age.
“Time to fight against substandard HIV treatment outcomes in children,” said Dr. Meg Doherty, director of global HIV, hepatitis and sexually transmitted diseases programs at WHO. . “Today we can finally ensure that countries have quick access to the appropriate formulations needed to fully implement WHO guidelines; so that no children are left behind. WHO welcomes the approval and marketing of the new pediatric DTG 10 mg. Congratulations to all partners involved for demonstrating how quickly we can bring new formulations to the market when we work together: clear proof that solidarity produces results. “
This new strawberry flavored 10mg DTG dispersible tablet is more inviting for children. This will enable them to continue taking drugs and prevent thousands of premature deaths every year, transforming pediatric treatment for HIV in low- and middle-income countries.
The deal will also significantly reduce the total annual cost of pediatric HIV treatment from $ 480 per child to less than $ 120. With global healthcare budgets tighter than ever, such significant savings – ranging from $ 60 million to $ 260 million over five years – will change the game.
This announcement coincides with the provisional approval by the United States Food and Drug Administration (FDA) of Viatris’ first dispersible generic pediatric DTG product on November 19, 2020. This is the first time a generic product has been positively reviewed within several months of receipt of the product originator FDA approval, which reduces the gap from three years for the adult version of the same medicine to just five months. This archiving strategy represents a major innovation that could dramatically reduce the time it takes for new pediatric drugs to reach children in low- and middle-income countries. Provisional approval for the Macleods product is expected in early 2021.
CHAI CEO Iain Barton said, “This groundbreaking collaboration will allow, for the first time, children living with HIV in low- and middle-income countries to access the same first-line ARV drugs at the same time as high-income ones. countries. The partnership should serve as a model to remove the barriers that hinder the development of pediatric formulations to deliver premium drugs quickly and cost-effectively. “
Unitaid, CHAI and national health ministries are collaborating with the US President’s Emergency Plan for AIDS Relief (PEPFAR) to promote early access to the product in several countries to generate early use feedback, to help inform about wider adoption and scale-up.
“PEPFAR is deeply committed to optimizing HIV treatment for people of all ages,” said Ambassador Deborah L. Birx, US Global AIDS Coordinator and US Special Representative for Health Diplomacy global. “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 work with global and local partners to support the accelerated introduction and widespread use of pediatric DTG among the children we serve. “
The product will initially be available in Benin, Kenya, Malawi, Nigeria, Uganda and Zimbabwe in the first half of 2021, with plans for a rapid increase of 10 mg dispersible DTG in a large group of countries.
Cabinet Secretary of the Ministry of Health in Kenya, Hon. Mûtahi Kagwe said: “This announcement marks a radical change in the quality of HIV treatment for children. Kenya intends to be the first to adopt the new pediatric formulation of DTG 10 mg, which will improve treatment, reduce unpleasant side effects and help children adhere to their treatment and live a healthy life. We are delighted that for the first time Kenya and other countries will be able to provide children with the same quality of treatment as adults, which has been made possible thanks to the development of this new formulation. “
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[1] $ 480 per year based on the average price of first-line therapy currently available and recommended using ABC / 3TC dispersible tablets and LPV / r pellets or granules for a 10.0-13.9 kg child; $ 120 per year based on currently available ABC / 3TC dispersible tablets and new 10 mg DTG scoring dispersible tablet for a 10.0-13.9 kg child (based on WHO weight ranges). Current product prices for USAID GHSC-PSM September 2020 Electronic Product Catalog. [2] $ 404 is the average annual cost of LPV / r pellets and granules for a 10.0-13.9kg baby. Current product prices for USAID GHSC-PSM September 2020 Electronic Product Catalog. [3] ViiV Healthcare has provided a technical transfer package to support the development of this new formulationBase notes
DTG has been recommended by the World Health Organization (WHO) as the preferred first-line treatment regimen for children over four weeks of age and over 3 kg since 2018, but to date only children weighing 20 kg or most were able to access the drug due to the lack of age-appropriate dispersible formulations for younger children.
During the COVID-19 pandemic, it is more important than ever to ensure that all people living with HIV achieve and maintain viral suppression. An unsuppressed viral load exposes a person living with HIV to a greater risk of contracting co-infections, such as tuberculosis.
The product development collaboration between Unitaid, CHAI and ViiV Healthcare has been driven by Unitaid’s investment in CHAI since 2016 to bring the best HIV drugs to market faster and integrate them into treatment programs in communities in countries in developing countries that need it most. The initiative provided Viatris and Macleods with a financial incentive for development and registration. ViiV Healthcare, the creator of DTG, shared technical knowledge and skills and CHAI provided technical and regulatory support that enabled accelerated generic development and regulatory submission. ViiV Healthcare received FDA approval for its 5 mg dolutegravir pediatric dispersible tablet in June 2020.
The new generic formulations of DTG manufactured by Viatris and Macleods will be available at a lower price in 121 countries covered by ViiV Healthcare’s pediatric DTG voluntary licensing agreements via the Medicines Patent Pool, which covers 99% of children living with the HIV. By supporting better treatment and with recent advances in the early detection of children born with HIV, we finally have the tools to achieve the goal of ending HIV-related infant mortality.
Media contacts:
- Charlotte Baker, Unitaid, Geneva | Phone. +44 7904 460 181 | [email protected]
- Regan Lachapelle, CHAI, Boston | Phone. +1 857-208-2788 | [email protected]
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