Hyderabad: Hyderabad-based Laurus Labs, Unitaid and the Clinton Health Access Initiative (CHAI) have partnered to accelerate the development, commercialisation, and registration of the second- and third-line HIV treatment darunavir boosted with ritonavir (DRV/r) for children.
Despite being available in high-income countries for over a 15-year period, a generic, fixed-dose combination pediatric version of DRV/r is still not available. Through this agreement, Unitaid and CHAI are working with Laurus to address this critical need and ensure CLHIV (Children Living with HIV/AIDS) have access to second- and third-line HIV treatment.
Second-line treatment is treatment for a disease or condition after the initial treatment (first-line treatment) has failed, stopped working, or has side effects that aren’t tolerated. Third line antiretroviral therapy is for patients whose first line and second-line therapies have failed.
Unitaid ED Dr Philippe Duneton said, “Enabling children and young people to have access to the best possible HIV treatment is a key priority for Unitaid – whether that’s first, second, or third-line treatment. This agreement is a welcome step towards having a long-awaited pediatric formulation of DRV/r available, as we strive to achieve the global goal of 90% of people living with HIV receiving antiretroviral therapy.”
Second- and third-line therapies are critical for CLHIV where the World Health Organization (WHO)-recommended first-line treatment dolutegravir (DTG) may not be an option due to medication resistance or intolerance. Currently available second- and third-line treatments are often difficult for children to take due to bitter taste and difficult forms of administration.
“A pediatric version of DRV/r has been a global health priority since 2013, but is still not available, leaving thousands of children without the lifesaving medication they need,” said Ann Veneman, interim Co-CEO of CHAI.
“The innovative incentive programme announced will enable development of an effective pediatric medication that will save the lives of children living with HIV,” Veneman added.
Understanding the small market size for a pediatric version of DRV/r, the initiative has provided Laurus with a financial incentive for a portion of its development and commercialisation costs. CHAI will work closely with Laurus Labs to provide technical and regulatory support to enable accelerated generic development and regulatory submission of the medication.
Dr Satyanarayana Chava, founder & CEO, Laurus Labs, said, “The collaboration between Laurus Labs, CHAI, and Unitaid can positively impact over 1,00,000 CLHIVs and help them in leading a better life especially in their formative years.”
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