Children living with HIV who weigh at least 44 pounds can safely take the adult dose of the key integrase inhibitor dolutegravir.
This finding from a new study conducted among children in sub-Saharan Africa means that antiretroviral (ARV) dosing for many HIV-positive children can be considerably simplified, thus improving access to treatment. Previously, children younger than 12 or those weighing less than 88 pounds had to take dolutegravir (sold under the brand name Tivicay) at doses lower than the 50 milligram dose approved for adults. And unlike adults, these children had to take those pills more than once a day.
“This led to problems because these lower dosages are not easily available in low- and middle-income countries,” David M. Burger, PharmD, of Radboud University Medical Center, in Nijmegen, the Netherlands, said in a press release. “As a result, national programs could not be started properly and the risk of errors in dosage and intake increased. In short, there was a need to achieve a simpler and more practical dosage of dolutegravir for children.”
So now that the new study, which Burger led, has prompted the World Health Organization to recommend the adult dose of dolutegravir for children weighing 44 pounds or more, this revision is expected to facilitate greater access to ARV treatment for children.
Burger and his team conducted a substudy of the ODYSSEY trial in which they enrolled 62 children living with HIV in Uganda and Zimbabwe who were youner than 18 and as young as six years old. The children were divided into different weight classes and provided different doses of dolutegravir. Then they were monitored for nearly six months. The investigators analyzed the children’s metabolism of the drug and looked for any safety concerns.
The study authors concluded that the 50 mg adult dose of dolutegravir is well metabolized by children who weigh at least 44 pounds and appears safe for them.
The Food and Drug Administration also recently approved this adult dose of dolutegravir for children weighing at least 44 pounds.
To read the study, click here.
To read a press release about the study, click here.