Table 3.
Common Clinical Adverse Events, Resistance-Associated HCV Variants, and Hematologic Abnormalities, According to Treatment Group.*
| Adverse Event | Group 1 (N = 363) | Group 2 (N = 368) | P Value for Group 2 vs. Group 1 | Group 3 (N = 366) | P Value for Group 3 vs. Group 1 |
|---|---|---|---|---|---|
| Investigator-reported clinical adverse events — no. (%) | |||||
| Fatigue | 217 (60) | 196 (53) | 0.09 | 209 (57) | 0.50 |
| Headache | 153 (42) | 168 (46) | 0.37 | 167 (46) | 0.37 |
| Nausea | 153 (42) | 175 (48) | 0.16 | 159 (43) | 0.76 |
| Anemia | 107 (29) | 182 (49) | <0.001 | 179 (49) | <0.001 |
| Pyrexia | 121 (33) | 123 (33) | 0.99 | 118 (32) | 0.81 |
| Chills | 102 (28) | 134 (36) | 0.02 | 121 (33) | 0.15 |
| Dysgeusia | 64 (18) | 137 (37) | <0.001 | 156 (43) | <0.001 |
| Insomnia | 118 (33) | 117 (32) | 0.87 | 122 (33) | 0.81 |
| Boceprevir-resistance–associated variants — no. (%) | |||||
| Overall | 59/350 (17) | 52/354 (15) | |||
| HCV RNA level at wk 4 | |||||
| Decrease of ≥1 log10 IU/ml from baseline | 10/232 (4) | 13/231 (6) | |||
| Decrease of <1 log10 IU/ml from baseline | 49/95 (52) | 38/94 (40) | |||
| Hematologic variables — no. (%) | |||||
| Decreased absolute neutrophil count | |||||
| Grade 3: 500 to <750 per mm3 | 50 (14) | 87 (24) | <0.001 | 90 (25) | <0.001 |
| Grade 4: <500 per mm3 | 16 (4) | 21 (6) | 0.50 | 29 (8) | 0.06 |
| Use of granulocyte-stimulating agent | 21 (6) | 43 (12) | 0.006 | 31 (8) | 0.20 |
| Decreased platelet count | |||||
| Grade 3: 25,000 to <50,000 per mm3 | 5 (1) | 11 (3) | 0.21 | 13 (4) | 0.09 |
| Grade 4: <25,000 per mm3 | 0 | 1 (<1) | 0.99 | 1 (<1) | 0.99 |
| Decreased hemoglobin concentration† | |||||
| Grade 3: 6.5 to <8.0 g/dl | 6 (2) | 7 (2) | 0.99 | 12 (3) | 0.23 |
| Grade 4: <6.5 g/dl | 0 | 2 (1) | 0.50 | 1 (<1) | 0.99 |
| Red-cell transfusion | 2 (1) | 11 (3) | 0.02 | 9 (2) | 0.06 |
| Erythropoietin use | |||||
| Patients | 87 (24) | 159 (43) | <0.001 | 159 (43) | <0.001 |
| Days | 0.01 | 0.005 | |||
| Mean | 121 | 94 | 156 | ||
| Median | 109 | 85 | 149 |
The table lists (in decreasing order of overall frequency) all specified adverse events occurring during the treatment period or within 30 days after the end of treatment, regardless of the cause of the event, that were reported in 30% or more of patients in any of the three treatment groups. Table S2B in the Supplementary Appendix lists the adverse events reported in 15% or more of patients in any treatment group, as well as laboratory abnormalities of grade 0, 1, or 2. Terms are from the Medical Dictionary for Regulatory Activities (version 13.0). The nominal P values were calculated with the use of Fisher’s exact test for categorical variables and the t-test for continuous variables; they were not corrected for multiple comparisons.
Toxicity grades for decreased hemoglobin levels are modified World Health Organization grades based on nadir hemoglobin levels during the treatment period.