48-week efficacy and safety of transitioning virologically stable HIV-1 patients from nevirapine IR 200 mg BID to nevirapine XR 400 mg QD (TRANxITION)

Table 1

Parameter	NVP XR QD (N=295)	IR NVP BID (N=148)	Difference (95% CI)
Virologic response (VL <50 copies/mL, TLOVR-FAS), n (%)	261 (88.5)	130 (87.8)	0.6 (-5.9, 7.1)*
CD4+ count cells/mm3 (LOCF), mean (SD)	52.1 (140.5)	81.6 (138.2)	-
AEs, n (%)	255 (86.4%)	108 (73.0%)	-
DAIDS Grade 3-4	19 (6.4%)	9 (6.1%)	-
SAEs, n (%)†	30 (10.2%)	12 (8.1%)	-

*Based on Cochran's statistic †None drug related, FAS = full analysis set; AE = adverse event; SAE = Serious adverse event
AEs were mostly mild-moderate in both groups with a higher reported rate of gastrointestinal AEs in XR. The proportion of patients with DAIDS Grade 3/4 AEs was similar in the XR and IR groups.