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Table 3 On-treatment safety

From: A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3

Parameter, n (%) 24 weeks lambda/RBV N = 353 12 weeks lambda/RBV + DCV N = 349 24 weeks alfa/RBV N = 172
Total with AEs (all grades) 316 (90) 299 (86) 166 (97)
Death 0 1 (<1) 0
Grade 3–4 AEs 48 (14) 24 (7) 60 (35)
SAEs 22 (6) 10 (3) 4 (2)
AEs leading to discontinuation 26 (7) 10 (3) 15 (9)
Interferon dose reductions 25 (7) 10 (3) 50 (29)
For adverse events 8 (2) 6 (2) 47 (27)
For elevated liver function tests 18 (5) 5 (1) 3 (2)
Ribavirin dose reductions 21 (6) 12 (3) 33 (19)
For adverse events 16 (5) 11 (3) 33 (19)
For elevated liver function tests 5 (1) 1 (<1) 0
Notable AEs
 Fatigue 110 (31) 87 (25) 74 (43)
 Influenza-like illness 26 (7) 18 (5) 36 (21)
 Asthenia 43 (12) 35 (10) 23 (13)
 Pyrexia 20 (6) 23 (7) 41 (24)
 Pruritus 109 (31) 82 (23) 50 (29)
 Nausea 88 (25) 71 (20) 51 (30)
 Insomnia 110 (31) 74 (21) 50 (29)
 Headache 64 (18) 47 (13) 44 (26)
 Dizziness 34 (10) 46 (13) 38 (22)
 Myalgia 49 (14) 45 (13) 60 (35)
 Arthralgia 48 (14) 44 (13) 49 (28)
 Decreased appetite 68 (19) 51 (15) 55 (32)
 Anemia 14 (4) 14 (4) 35 (20)
 Neutropenia 1 (<1) 1 (<1) 53 (31)
 Depression 29 (8) 16 (5) 14 (8)
Composite AEs
 Interferon-associated flu-like symptomsa 41 (12) 32 (9) 63 (36)
 Musculoskeletal eventsb 90 (26) 72 (21) 85 (49)
Treatment-emergent grade 3–4 laboratory abnormalities
 Hemoglobin <9.0 g/L 2 (<1) 1 (<1) 8 (5)
 Platelet count <5 × 104/mm3 0 0 7 (4)
 Leukocytes <1.5 × 103/mm3 0 0 23 (13)
 Lymphocytes <5 × 102/mm3 1 (<1) 5 (1) 29 (17)
 Neutrophils <7.5 × 102/mm3 0 0 47 (27)
 ALT >5.0 × ULN 22 (6) 13 (4) 5 (3)
 AST >5.0 × ULN 33 (9) 12 (3) 5 (3)
 Gamma-glutamyl transferase >5.0 × ULN 16 (5) 6 (2) 2 (1)
 Total bilirubin >2.5 × ULN 27 (8) 9 (3) 0
 Direct bilirubin >1.2 mg/dL 20 (6) 10 (3) 0
Composite treatment-emergent grade 3–4 laboratory abnormalities
 Cytopenic abnormalitiesc 10 (3) 7 (2) 63 (36)
  1. AE adverse event, alfa peginterferon alfa-2a, ALT alanine aminotransferase, AST aspartate aminotransferase, Lambda peginterferon Lambda-1a, RBV ribavirin, SAE serious adverse event, ULN upper limit of normal
  2. aFlu-like symptoms defined as pyrexia, chills, or pain
  3. bMusculoskeletal events defined as myalgia, arthralgia, or back pain
  4. cCytopenic abnormalities defined as hemoglobin <10 g/dL, absolute neutrophils <750 cells/mm3, or platelets <50,000 cells/mm3