Table 4.

Use of dolutegravir in special population

Conditions	Findings	Comment
Pregnancy	Categorized as pregnancy category B. No adequate and well-controlled studies in pregnant women because animal reproduction studies are not always predictive of human response.8,72	To be used with caution.
Nursing mother	In animal studies DTG was present in rat milk, human data are not available.72	No clear evidence.
Pediatric	Safety and efficacy of use of DTG has not been established in pediatric patients younger than 12 years and weighing <40 kg.	No clear evidence.
Elderly	The data of safety in patients aged over 65 years is very limited.	To be used with caution.
Renal	The plasma concentration of DTG was found to be decreased in subjects with severe renal impairment compared to those in the healthy controls; however, no dose adjustment was necessary where renal impairment was mild-to-moderate.73,74 No data on renal dialysis patients.	Caution in severe renal impairment.
Hepatic	There have not been any differences between subjects with moderate hepatic impairment and hepatic subjects.63,75,76	No dose adjustment in mild or moderate hepatic impairment.
Hepatitis B and C coinfection	DTG can be safely used with boceprevir and telaprevir.30,63	No dose adjustment.

Abbreviation: DTG, dolutegravir.