IR- XR post48an (%) IR-IR post48bn (%) XR-XR post48cn (%) TotalN (%)
Number of patients 130 (100) 13 (100) 276 (100) 419 (100)
AEs reported in >5% of patients
Nasopharyngitis 15 (11.5) 1 (7.7) 44 (15.9) 60 (14.3)
Diarrhea 11 (8.5) 0 (0) 37 (13.4) 48 (11.5)
Bronchitis 10 (7.7) 1 (7.7) 34 (12.3) 45 (10.7)
Back pain 10 (7.7) 0 (0) 23 (8.3) 33 (7.9)
Sinusitis 9 (6.9) 0 (0) 22 (8.0) 31 (7.4)
Upper respiratory tract infection 9 (6.9) 1 (7.7) 20 (7.2) 30 (7.2)
Depression 7 (5.4) 0 (0) 22 (8.0) 29 (6.9)
Cough 6 (4.6) 1 (7.7) 20 (7.2) 27 (6.4)
Hypertension 7 (5.4) 0 (0) 15 (5.4) 22 (5.3)
SAEs in >0.5% of patients
Total with SAEs 17 (13.1) 3 (23.1) 54 (19.6) 74 (17.7)
Pneumonia 1 (0.8) 1 (7.7) 12 (4.3) 4 (1.0)
Depression 3 (2.3) 0 (0) 1 (0.4) 4 (1.0)
Basal cell carcinoma 0 (0.0) 0 (0) 3 (1.1) 3 (0.7)
Anal fissure 1 (0.8) 0 (0) 2 (0.7) 3 (0.7)
Hemorrhoids 1 (0.8) 0 (0) 2 (0.7) 3 (0.7)
Myocardial infarction 0 (0.0) 0 (0) 3 (1.1) 3 (0.7)
Humerus fracture 1 (0.8) 0 (0) 2 (0.7) 3 (0.7)
Notes: AE=adverse event; FAS=full analysis set; IR=immediate release; NVP=nevirapine; SAE=serious adverse event; XR=extended release.
aPatients who received NVP IR during the first 48 weeks, and then switched to NVP XR.
bPatients who remained on NVP IR after week 48.
cPatients who remained on NVP XR after week 48.
Table 3: Most common adverse events and serious adverse events post week 48 (FAS).