We are delighted to announce the joint launch of a partnership to speed up development and introduction of optimized pediatric formulations of dolutegravir for children living with HIV in resource-limited settings. Dolutegravir is the HIV drug of choice in high-income countries, which has fewer side effects and a simpler dosing regimen than older drugs.
The new initiative includes an incentive program and is a key feature of Unitaid’s US$34 million Optimal Antiretroviral (ARV) grant to the Clinton Health Access Initiative (CHAI). The optimal ARV grant aims to bring optimized HIV drugs to market more quickly than in the past and integrate them into treatment programmes in communities that need them most. As part of this, CHAI is also working closely with health ministries, community leaders and other partners to support introduction in resource-limited settings.
Accelerating the development of pediatric ARVs and increasing access to HIV testing for children in resource-limited settings is a strategic investment priority for Unitaid. As part of this programme, and with funding from Unitaid, CHAI and ViiV Healthcare will work together to improve the availability of pediatric formulations of dolutegravir. A key aspect of the initiative to-date has been the competitive selection of two generic manufacturers, Mylan Laboratories Limited and Macleods Pharmaceuticals Limited. The initiative provides Mylan and Macleods with a financial incentive award from Unitaid, as well as the technical expertise of ViiV Healthcare, to catalyze the development, manufacturing and supply of generic formulations of pediatric dolutegravir.
ViiV Healthcare, the company that researched and developed dolutegravir, continues to press ahead with the clinical development and registration of its own pediatric formulations of dolutegravir. ViiV Healthcare is also enabling generic pharmaceutical companies to manufacture and sell generic versions of the medicine in resource-limited settings through existing royalty-free licensing agreements that have been granted both directly and via the Medicines Patent Pool.
This initiative is an important step towards our commitments under the Rome Action Plan agreed in November 2017 at the Vatican, to ramp up access to pediatric HIV treatment with innovative medicines like dolutegravir.
Less than half of the 1.8 million children under 15 living with HIV receive antiretroviral therapy, according to recent UNAIDS data. Children in low- and middle-income countries account for more than 90 percent of the global pediatric HIV burden. Treatment options are limited because it can take years to commercialize proper HIV medicines for children.
Joint Statement – Unitaid, Viiv Healthcare and CHAI
