Table 2. Treatment-emergent adverse reactions occurring in ≥15% of subjects in any treatment arm1.
| Regimens without interferon | Regimens containing interferon | ||||
| Adverse event |
Placebo (12 weeks) (n = 71) |
Sofosbuvir plus ribavirina (12 weeks) (n = 650) |
Sofosbuvir plus ribavirina (24 weeks) (n = 250) |
Peginterferon alfa plus ribavirinb (24 weeks) (n = 243) |
Sofosbuvir plus peginterferon alfa and ribavirin (12 weeks) (n = 327) |
| Fatigue | 24% | 38% | 30% | 55% | 59% |
| Headache | 20% | 24% | 30% | 44% | 36% |
| Nausea | 18% | 22% | 13% | 29% | 34% |
| Insomnia | 4% | 15% | 16% | 29% | 25% |
| Pruritus | 8% | 11% | 27% | 17% | 17% |
| Anemia | 0% | 10% | 6% | 12% | 21% |
| Asthenia | 3% | 6% | 21% | 3% | 5% |
| Rash | 8% | 8% | 9% | 18% | 18% |
| Decreased appetite | 10% | 6% | 6% | 18% | 18% |
| Chills | 1% | 2% | 2% | 18% | 17% |
| Influenza-like illness | 3% | 3% | 6% | 18% | 16% |
| Pyrexia | 0% | 4% | 4% | 14% | 18% |
| Diarrhea | 6% | 9% | 12% | 17% | 12% |
| Neutropenia | 0% | < 1% | < 1% | 12% | 17% |
| Myalgia | 0% | 6% | 9% | 16% | 14% |
| Irritability | 1% | 10% | 10% | 16% | 13% |
a
Patients received weight-based ribavirin dosing.
b
Patients received ribavirin 800 mg regardless of weight.