TABLE 3.
Adverse events and laboratory abnormalities by treatment group in patients with and without cirrhosish
| AE or laboratory abnormality | No. (%) by treatment group and cirrhosis status: |
|||||
|---|---|---|---|---|---|---|
| Pooled TIDa |
BID28W |
TID28W-NR |
||||
| Cirrhosisb (n = 21) | No cirrhosis (n = 217) | Cirrhosisb (n = 9) | No cirrhosis (n = 69) | Cirrhosisb (n = 3) | No cirrhosis (n = 43) | |
| Patients with any AEc | 20 (95) | 203 (94) | 9 (100) | 64 (93) | 2 (67) | 42 (98) |
| Severe AEs | 3 (14) | 18 (8) | 1 (11) | 8 (12) | 1 (33) | 3 (7) |
| Serious AEs | 4 (19)d | 12 (6) | 1 (11)e | 7 (10) | 0 (0) | 3 (7) |
| Treatment discontinuation due to AEs | 6 (29)f | 27 (12) | 1 (11)e | 5 (7) | 0 (0) | 5 (12) |
| Rate of AE by preferred term | ||||||
| Rash | 8 (38) | 53 (24) | 3 (33) | 12 (17) | 2 (67) | 11 (26) |
| Photosensitivity reaction | 6 (29) | 63 (29) | 1 (11) | 19 (28) | 0 (0) | 11 (26) |
| Diarrhea | 11 (52) | 93 (43) | 1 (11) | 28 (41) | 1 (33) | 11 (26) |
| Nausea | 8 (38) | 117 (54) | 5 (56) | 34 (49) | 1 (33) | 25 (58) |
| Vomiting | 8 (38) | 68 (31) | 3 (33) | 17 (25) | 1 (33) | 12 (28) |
| Jaundice | 7 (33) | 55 (25) | 2 (22) | 14 (20) | 0 (0) | 2 (5) |
| Changes in laboratory values (grade 3–4)g | ||||||
| Hemoglobin (g/dl) | ||||||
| 6.5–6.9 | 1 (5) | 4 (2) | 1 (11) | 0 (0) | 0 (0) | 0 (0) |
| <6.5 | 0 (0) | 0 (0) | 1 (11) | 0 (0) | 0 (0) | 0 (0) |
| White blood cells (no./mm3) | ||||||
| 1,000–1,499 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| <1,000 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Platelets (no./mm3) | ||||||
| 25,000–49,499 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| <25,000 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| ALT (× ULN) | ||||||
| 5.1–10 | 0 (0) | 1 (<1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| >10 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Total bilirubin (× ULN) | ||||||
| 2.6–5 | 11 (52) | 58 (27) | 4 (44) | 16 (23) | 0 (0) | 6 (14) |
| >5 | 0 (0) | 14 (6) | 2 (22) | 8 (12) | 0 (0) | 0 (0) |
The TID16W, TID28W, and TID40W treatment arms were pooled because of the small number of patients with cirrhosis in these treatment arms.
Cirrhosis was determined by the investigator based on Fibroscan, biopsy, and/or other clinical parameters.
Adverse events were reported according to MedDRA (Medical Dictionary for Regulatory Activities; http://www.meddra.org/) definitions (version 15) and were defined as mild (awareness of sign[s] or symptom[s] which is/are easily tolerated), moderate (enough discomfort to cause interference with usual activity), or severe (incapacitating or causing inability to work or to perform usual activities).
One case each of postnarcotic psychotic ideation, pulmonary embolism (underlying thrombophilia), nausea and vomiting, and rash and photosensitivity.
Anemia.
Rash (n = 3, with no cases of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrosis, or drug reaction with eosinophilia and systemic symptoms), photosensitivity (n = 2, one patient with photosensitivity and rash), vomiting (n = 1), and jaundice (n = 2, reported posttreatment, associated with vomiting in one case and decreased appetite in one case).
Laboratory abnormalities were reported according to the Division of AIDS grading system (grades 3 to 4 are presented).
AE, adverse event; ALT, alanine aminotransferase; BID, twice daily; NR, no ribavirin; TID, three times daily; ULN, upper limit of normal.