The U.S. Food and Drug Administration has approved a new medicine called Tivicay PD (dolutegravir) for children with HIV. This drug comes as a powder that can be mixed with liquid, making it easier for young kids to take. It is approved for children who are at least 4 weeks old and weigh at least 3 kilograms (about 6.6 pounds). Tivicay PD is for children who have not taken HIV medicines before, or who have taken them but have not used a type of drug called an integrase strand transfer inhibitor (INSTI).
This approval gives doctors a new tool to treat HIV in a group that can be hard to treat. The dose is based on the child's weight, and it can be given with or without food. However, Tivicay PD is not the same as the regular Tivicay tablet, so they cannot be swapped milligram for milligram. For children who weigh at least 14 kg, the tablet form may also be an option.
The approval is based on studies that looked at how the drug works in the body and its safety in children. It is important to know that this drug is not recommended for children who have already taken an INSTI and have certain drug resistance. Also, if a child takes other medicines that affect certain liver enzymes, the dose may need to be adjusted.
If you are a parent or caregiver, talk to your child's doctor about whether Tivicay PD is right for them. This approval does not mean a cure for HIV, but it offers a new way to manage the infection in young children.