Table 3 . Reasons given by the investigator for discontinuation.
| Germany (N = 167) | Portugal (N = 185) | Spain (N = 165) | Overall (N = 517) | |
|---|---|---|---|---|
| ATV/r discontinuation, n (%) | 62 (37.1) | 78 (42.2) | 83 (50.3) | 223 (43.1) |
| Reasons for discontinuation, a n (%) | ||||
| Virologic failure b | 5 (3.0) | 19 (10.3) | 11 (6.7) | 35 (6.8) |
| Adverse event | 34 (20.4) | 17 (9.2) | 31 (18.8) | 82 (15.9) |
| Nausea | 2 (1.2) | 1 (0.5) | 2 (1.2) | 5 (1.0) |
| Vomiting | 1 (0.6) | 3 (1.6) | 3 (1.8) | 7 (1.4) |
| Renal failure | 3 (1.8) | 0 | 2 (1.2) | 5 (1.0) |
| Hyperbilirubinemia-related c | 19 (11.4) | 10 (5.4) | 17 (10.3) | 46 (8.9) |
| Poor/non-compliance | 4 (2.4) | 9 (4.9) | 2 (1.2) | 15 (2.9) |
| Concomitant disease | 1 (0.6) | 0 | 0 | 1 (0.2) |
| Patient request | 8 (4.8) | 2 (1.1) | 3 (1.8) | 13 (2.5) |
| Drug interaction | 2 (1.2) | 3 (1.6) | 3 (1.8) | 8 (1.5) |
| Medical decision/regimen simplification | 7 (4.2) | 21 (11.4) | 21 (12.7) | 49 (9.5) |
| Consent unavailable for 1-year extension | 2 (1.2) | 11 (5.9) | 14 (8.5) | 27 (5.2) |
| Other | 1 (0.6) | 3 (1.6) | 0 | 4 (0.8) |
| Unknown | 0 | 1 (0.5) | 1 (0.6) | 2 (0.4) |
a
Patients could discontinue ATV treatment for more than one reason.
b
Virologic failure reported by the investigator as reason for discontinuation.
c
The number of patients with at least one hyperbilirubinemia-related discontinuation was calculated: four patients (three from Germany and one from Portugal) each had two hyperbilirubinemia-related reasons recorded; therefore, four of these reasons were excluded from this calculation.