Health · Medical Research · 5 hrs ago
FDA approves dolutegravir for some newborns with HIV from birth
The FDA approved dolutegravir for HIV treatment from birth for full-term infants weighing at least 2 kilograms.
The approval covers newborns up to four weeks old, with the drug used alongside other antiretroviral medicines.
Previously, dolutegravir was approved for adults and children aged four weeks and older.
Newborns process medicines differently, and their ability to clear drugs changes quickly in their first month.
A trial of 48 newborns found drug levels comparable to those in older patients and the medicine was generally well tolerated.
The Phase I study took place in South Africa, Thailand and the United States, and followed infants for 16 weeks to assess safety.
The expanded approval adds a treatment option for newborns, who have relatively few approved HIV medicines.
The FDA approved dolutegravir for treating HIV-1 in full-term newborns weighing at least two kilograms from birth to four weeks of age.
The medicine must be used with other antiretroviral medications.
The approval was informed by an international Phase I trial that identified a dosing regimen for newborns.
The trial enrolled 48 full-term newborns born to women living with HIV-1 and found the medicine was generally well tolerated.
The approval expands treatment options for newborns, who have relatively few approved antiretroviral medications.
- Who
- The FDA approved dolutegravir for eligible newborns with HIV-1.
- What
- The approval allows treatment from birth to four weeks of age, in combination with other antiretroviral medications.
- When
- The FDA announced the approval in August 2026.
- Where
- The approval applies in the United States; the trial was conducted in South Africa, Thailand and the United States.
- Why
- A clinical trial identified a dosing regimen that achieved appropriate drug levels in full-term newborns and provided safety data.
This story does not have two clearly opposing sides.
The FDA announced approval of dolutegravir for certain full-term infants with HIV-1 from birth.
News-Medical reported on the clinical trial that helped inform the approval.
- Minimum weight
- 2 kilograms
- Eligible age
- From birth up to four weeks
- Trial size
- 48 full-term newborns
- Trial follow-up
- 16 weeks
- Trial locations
- South Africa, Thailand and the United States
- Study name
- IMPAACT 2023
What people are saying
Our study provides important pharmacokinetic and safety data to guide dolutegravir dosing during this critical period of development.
For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs, despite the importance of starting treatment as early as possible.
This represents an important advance for the care of newborns, as early treatment with the most effective therapies can greatly improve health outcomes.