TABLE 4.
AEs reported during 12 or 24 weeks of faldaprevir plus pegylated interferon α-2a and ribavirin treatment
| AE | No. (%) of patients with AEs reported by faldaprevir treatment duration |
|
|---|---|---|
| 12 wk (n = 80) | 24 wk (n = 79) | |
| Any | 75 (94) | 71 (90) |
| Seriousa | 3 (4) | 3 (4) |
| Leading to discontinuation of faldaprevir | 4b (5) | 5c (6) |
| Anemia | 8 (10) | 14 (17.7) |
| Jaundice (total) | 3 (3.8) | 4 (5.1) |
| Mild | 3 (3.8) | 3 (3.8) |
| Moderate | 0 | 1 (1.3) |
| Severe | 0 | 0 |
| Most common (>20% of patients in either arm) | ||
| Gastrointestinal disorders | ||
| Nausea | 27 (34) | 17 (22) |
| Skin disorders | ||
| Pruritus | 24 (30) | 26 (33) |
| Rash | 18 (23) | 17 (22) |
| Dry skin | 12 (15) | 16 (20) |
| Nervous system disorders | ||
| Headache | 14 (18) | 18 (23) |
| General disorders | ||
| Asthenia | 18 (23) | 13 (17) |
| Fatigue | 17 (21) | 13 (17) |
a
Serious AEs in the 12-week group included anemia (two cases) and depression (one case). Serious AEs in the 24-week group included anemia, neutropenia, epilepsy, and erythema.
b
One patient discontinued all treatment on day 8 due to prostate cancer diagnosed during screening. The three other patients who discontinued faldaprevir reported multiple AEs.
c
One patient reported anemia, one reported rash, and the other three who discontinued faldaprevir reported multiple AEs.