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. Author manuscript; available in PMC: 2016 Mar 21.
Published in final edited form as: Lancet. 2015 Jan 13;385(9973):1107–1113. doi: 10.1016/S0140-6736(14)61228-9

Table 3.

Adverse Events and Laboratory Abnormalities During Treatment Period

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