Table 3.
Sofosbuvir + Ledipasvir for 12 weeks (n=20) | Sofosbuvir + Ledipasvir + GS-9669 for 6 weeks (n=20) | Sofosbuvir + Ledipasvir + GS-9451 for 6 weeks (n=20) | |
---|---|---|---|
Any adverse event during treatment –n(%) | 20 (100) | 20 (100) | 20 (100) |
Any serious adverse event during treatment - n(%) | 0 | 0 | 2(10) |
Common adverse events** - n(%) | |||
Night sweats | 0 | 2 (10) | 0 |
Constipation | 0 | 2 (10) | 1 (5) |
Vomiting | 1 (5) | 2 (10) | 0 |
Nausea | 1 (5) | 2 (10) | 1 (5) |
Shoulder pain | 2 (10) | 0 | 0 |
Common cold | 4 (20) | 1 (5) | 1 (5) |
Fatigue | 2 (10) | 2 (10) | 4 (20) |
Diarrhea | 1 (5) | 5 (25) | 3 (15) |
Headache | 5 (25) | 5 (25) | 0 |
Rash | 3 (15) | 1 (5) | 0 |
Abdominal pain | 2 (10) | 2 (10) | 0 |
Back Pain | 2 (10) | 0 | 1 (5) |
Laboratory abnormalities | |||
Any Grade 3 abnormality during treatment - n (%) | 4 (20) | 2 (10) | 4 (20) |
Hypophosphatemia | |||
Grade 3 | 0 | 2 (10) | 0 |
Elevated serum creatinine | |||
Grade 3 | 0 | 0 | 3 (15) |
Decreased hemoglobin | |||
Grade 3 | 0 | 0 | 1 (5) |
Elevated ALT | |||
Grade 3 | 1 (5) | 0 | 0 |
Elevated AST | |||
Grade 3 | 1 (5) | 0 | 0 |
Elevated LDL | |||
Grade 3 | 1 (5) | 0 | 0 |
Hyperglycemia | |||
Grade 3 | 1 (5) | 0 | 0 |
Hypoglycemia | |||
Grade 3 | 1 (5) | 0 | 0 |
Treatment period includes time on study medication and 30 days after discontinuation
Occurring in ≥10% of patients