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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
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