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. 2010 Nov 8;13(Suppl 4):P45. doi: 10.1186/1758-2652-13-S4-P45

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.