Laurus Labs, Unitaid and Clinton Health Access Initiative announce agreement to accelerate second- and third-line HIV medication for children

Laurus Labs, along with Unitaid and Clinton Health Access Initiative (CHAI), has announced an agreement to accelerate the second- and third-line HIV treatment darunavir boosted with ritonavir (DRV/r) for children. The development is underway based on an agreement launched in June 2021, Larus Labs said in a statement.

The statement also said that 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 the company to address this critical need and ensure that Children Living with HIV/AIDS (CLHIV) have access to high-quality second- and third-line HIV treatment.

Speaking in this regard, Dr Philippe Duneton, Executive Director, Unitaid, 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 per cent of people living with HIV receiving anti-retroviral 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, the statement added.

“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 life-saving medication they need,” said Ann Veneman, interim Co-CEO, CHAI.

“The innovative incentive programme announced will enable the development of an effective pediatric medication that will save the lives of children living with HIV,” Veneman further said.

The product development collaboration among Unitaid, CHAI and Laurus Labs 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 programmes in low- and middle-income countries that need them the most, the statement notified.

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 their 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, it further said.

Commenting on the collaboration in the development of the new second-line and third-line pediatric treatment, Dr Satyanarayana Chava, Founder and CEO, Laurus Labs, said, “We are excited about this innovative mechanism to accelerate the availability of pDRV/r regimen for children living with HIV.

The collaboration between Laurus Labs, CHAI and Unitaid can positively impact over 100,000 CLHIVs and help them in leading a better life especially in their formative years,” he said.