Today Tibotec, a division of Janssen-Cilag Ltg, announces a new treatment option for children living with HIV. Two new lower dose 75mg and 150mg formulations of Prezista (darunavir) twice daily, co-administered with low-dose ritonavir, are now available for paediatric HIV-1 infected patients. Additionally, the current 600mg darunavir tablet has also been approved for paediatric use.
“With fewer treatment options than adults, the darunavir formulations designed especially for children provide an important new option for these patients” said Dr Gareth Tudor-Williams, Consulting Paediatrician at St Mary’s Hospital, London. “There are approximately two million children living with HIV worldwide, and this is a welcome addition to the treatments we can use to enable them to survive into productive adulthood.”
Also commenting on the approval, Paddy McMaster, Chair of the Children’s HIV Association, said, “There are a significant number of children living in the UK who have HIV and AIDS. The approval of darunavir for use in children will help us provide excellent care for these kids infected with HIV.“
The paediatric indication for darunavir is based on 48-week analyses of plasma HIV RNA levels and CD4+ cell counts from DELPHI, a study in which antiretroviral treatment-experienced HIV-1 infected paediatric patients (6 to <18 years of age) received twice-daily darunavir/r in combination with other antiretroviral agents.
It is estimated that there are over 1,100 children living with HIV in the UK. According to the World Health Organization (WHO), there were more than two million children globally living with HIV at the end of 2007. The WHO also estimated that 200,000 children were receiving antiretroviral therapy in 2007, compared to 127,000 in 2006 and 75,000 in 2005.