08 November 2017 | Statement

CHAI seeks generic manufacturer for paediatric HIV drug dolutegravir

The Clinton Health Access Initiative (CHAI) today announced a request for proposals to select a generic manufacturer that could develop a paediatric version of the antiretroviral drug dolutegravir (DTG).

CHAI is working under the Unitaid-funded project “Accelerating patient access to optimal antiretrovirals” to make optimal antiretroviral (ARV) therapies more affordable and more accessible in low- and middle-income countries. In 2015, the World Health Organization recommended dolutegravir as an alternative first-line treatment for adults and adolescents. It has become the drug of choice for people living with HIV in high-income countries.

Dolutegravir has significant benefits compared to other anti-HIV medications currently available. It has few side effects and is taken just once daily, so patients are likely to stick with their regimens. The drug is effective against HIV even when the virus mutates, so the virus is unlikely to develop to develop resistance.

These attributes make DTG an optimal ARV that can significantly improve treatment for a large number of children in poorer countries. ViiV Healthcare, the originator company for DTG, is collaborating in the project to speed the development of DTG for paediatric populations in low- and middle-income countries. Children living with HIV in such countries currently have very limited optimal treatment options, and the highly effective DTG can offer a significant improvement for children over current options.

To start the paediatric DTG development programme, CHAI will undergo a competitive selection process to identify a partner or partners that manufacture generics. The Request for Proposals (RfP) is open to those companies that have either a direct license from ViiV Healthcare or have a license for paediatric DTG from the Medicines Patent Pool (MPP).

Find out more:Request for Proposal (RfP) for Selection of Generic Manufacturer for Development of Pediatric Dolutegravir (DTG)” – CHAI website

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