Table 4.

Clinical outcome

	Entry	2 weeks (N=25)	4 weeks (N=25)	3 months (n=24)	6 months (N=25)	8 months (N=25	12 months (N=25)
HIV RNA levels
< 20 copies/mL or TND	21 (84%)	22 (88%)	23 (92%)	22 (88%)	22 (88%)		22 (88%)
20 to < 200 copies/mL	2 (8%)	3 (12%)	1 (4%)	1 (4%)	2 (8%)		0 (0%)
200 to 1000 copies/mL	0 (0%)	0 (0%)	0 (0%)	1 (4%)	0 (0%)		2 (8%)
> 1000 copies/mL	2 (8%)	0 (0%)	1 (4%)	1 (4%)	1 (4%)		1 (4%)
Dolutegravir concentrations
Median (range) C24h (mg/L)		0.86 (0 -7.0)$	1.5 (0.5-5.0)			1.4 (0.1-3.3)
Median (range) Crandom (mg/L)				6.0 (0 - 9.5)	2.2 (0 -9.6)
Side effects
Headache		6 (24%)	7 (28%)	7 (29%)	5 (20%)	2 (8%)
Dizziness		1 (4%)	0 (0%)	3 (13%)	2 (8%)	0 (0%)
Insomnia		1 (4%)	3 (12%)	2 (8%)	2 (8%)	0 (0%)
Anxiety		1 (4%)	1 (4%)	1 (4%)	1 (4%)	1 (4%)
Depression		2 (8%)	1 (4%)	1 (4%)	2 (8%)	0 (0%)
Nausea		2 (8%)	2 (8%)	2 (8%)	1 (4%)	2 (8%)
Vomiting		2 (8%)	1 (4%)	0 (0%)	0 (0%)	0 (0%)
Diarrhea		3 (12%)	2 (8%)	3 (13%)	2 (8%)	1 (4%)
Abdominal pain		8 (32%)	5 (20%)	2 (8%)	1 (4%)	3 (12%)
Rash		2 (8%)	3 (12%)	1 (4%)	0 (0%)	1 (4%)
Fatigue		2 (8%)	3 (12%)	2 (8%)	2 (8%)	0 (0%)
Other		2 (8%)	0 (0%)	1 (4%)	0 (0%)	0 (0%)
Grade 3 or 4 lab events
Anemia	0 (0%)	0 (0%)	0 (0%)
Neutropenia	0 (0%)	2 (8%)	1 (4%)
Thrombocytopenia	0 (0%)	0 (0%)	0 (0%)
Elevated creatinine	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Total bilirubin	0 (0%)	0 (0%)	0 (0%)
Elevated transaminase	0 (0%)	0 (0%)	0 (0%)
Alkaline phosphatase	0 (0%)	0 (0%)	0 (0%)

TND, target not detected, C_24h, concentration at 12 hours post-dose, C_random, random concentration at study visit

^$timed C_24h sample, but dose before sample was not observed.