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. 2019 Mar 28;69(3):514–522. doi: 10.1093/cid/ciy913

Table 4.

Adverse Events (During Study Treatment, Through to 28 Days After End of Study Treatment) and Treatment Discontinuations

Event Ledipasvir/Sofosbuvir for 8 Weeks
(N = 27)
≧Grade 2 AEs, n (%) 9 (33)
Grade 4 AE, n (%) 0
Serious AE, n (%) 1
Treatment D/C due to AE, n (%) 0
Death, n (%) 0
Grade 3‒4 laboratory abnormality, n (%) 0

Grade 2 AEs consist of fatigue, nasal discharge, nasal congestion, vomiting, abdominal pain, or cough; Grade 3 AEs consist of traumatic skull fractures, varicella zoster, or oral pain due to dental work.

Grade 2 Lab AEs consist of elevated total bilirubin, elevated lipase, elevated potassium, elevated non-fasting glucose, elevated AST, ALT, or alkaline phosphatase; Grade 3 Lab AEs consist of elevated lipase, elevated total bilirubin, or elevated AST.

Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; D/C, discontinuation.