Results from a substudy of the ODYSSEY trial show that children being treated for tuberculosis (TB) and HIV at the same time can safely have the anti-HIV medicine dolutegravir twice a day. These results were published yesterday in The Lancet HIV journal.
Around 50,000 children are co-infected with both TB and HIV each year. Treating the two diseases at the same time is complicated, as a commonly used TB drug, rifampicin, interferes with how HIV medicines are absorbed and processed in the body. This means people being treated for both diseases often need to take higher doses of some of their HIV drugs to get the same effect.
ODYSSEY was a trial looking at the use of the anti-HIV drug dolutegravir in children aged 4 weeks to 18 years. A substudy of the trial looked at what doses are needed in children who are also being treated for TB. Blood samples were taken from 20 children several times in a day to allow researchers to measure the amount of dolutegravir in their body over time, to check it was enough to keep the HIV under control.
ODYSSEY found that taking dolutegravir twice a day while children were receiving rifampicin for their TB was safe and provided enough dolutegravir to keep the HIV under control. Once children complete their course of rifampicin, they can go back to having dolutegravir once a day.
This is the first study to look at how rifampicin affects dolutegravir levels in children living with HIV. It provides evidence that twice daily dolutegravir is safe, effective and practical for children being treated for TB at the same time as HIV.
The ODYSSEY trial was sponsored by the Penta Foundation, and coordinated by the MRC Clinical Trials Unit at UCL, as well as INSERM, PHPT and HIV-NAT. The substudy reported in this paper took place in research centres in South Africa, Uganda and Zimbabwe. It was funded by ViiV Healthcare and the Penta Foundation.