| |
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. |
