Darunavir for second-line treatment of children living with HIV in Africa

Globally, access to effective combination antiretroviral therapy for children with HIV is increasing. With more children on first-line therapy, an important unmet medical need is effective second-line treatment in case first line agents are not tolerated or not effective enough.

Until recently, the HIV-protease inhibitor lopinavir/ritonavir was the only available agent for second-line treatment but this agent has several disadvantage including twice-daily dosing, a poor taste and need for refrigeration of the solution.

In the CHAPAS-4 trial we have investigated in a pharmacokinetic substudy a more potent HIV-protease inhibitor, darunavir/ritonavir, in 59 children between 4-15 years old failing current first-line therapy for HIV. The selected doses resulted in adequate exposure to darunavir in all weight categories and was well-tolerated. Because in the larger CHAPAS-4 trial darunavir/ritonavir was found to be the most effective HIV-protease inhibitor, these results will have a major impact on the availability and use of this agent for children living with HIV in Africa and other low/middle income regions.

The project was a close collaboration between the Departments of Pharmacy of Radboud university medical center  and the Department of Clinical Pharmacology of the University of Cape Town, South Africa. Lufina Tsirizani, Shagha Mohsenian Naghani and Hylke Waalewijn performed the study; David Burger, Roeland Wasmann and Angela Colbers supervised the project.

Photo from left to right; Angela Colbers, Shaghayegh Mohsenian Naghani, David Burger