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Table 3 Treatment modifications and selected adverse events under therapy

From: The influence of HAART on the efficacy and safety of pegylated interferon and ribavirin therapy for the treatment of chronic HCV infection in HIV-positive individuals

 

HIV-negative

 

HIV-positive

 
  

No HAART

NRTI-containing

NRTI-free

 

Arm A

Arm B

Arm C1

Arm C2

 

n = 50

n = 49

n = 49

n = 20

Elevations serum ALT [%]

    Grade 1/2**

64

61

78

90

    Grade 3/4

-

10

6

5

Anemia [%]

    

    Grade 1/2**

10

2

22

5

    Grade 3/4

-

-

-

-

    Maximum Hb loss [g/dl]

3.1 (1.1 - 5.1)

3.0 (0.6 - 5.3)

2.9 (0.8 - 5.7)

3.3 (0.8 - 4.4)

Leucopenia [%]

    Grade 1/2**

40

25

69

55

    Grade 3/4*

0

4

12

10

Thrombocytopenia [%]

    Grade 1/2

44

35

51

55

    Grade 3/4

4

-

10

5

Clinical adverse events [%]

    Grade 1/2

70

63

63

90

    Grade 3/4

12

18

8

5

Dose reduction PegIFN [%]†*

22

8

14

5

    % of total dose received

84

87

81

88

Dose reduction RBV [%]†

28

8

25

15

    % of total dose received

86

81

79

90

Treatment discont. AEs [%]

8

18

8

10

  1. * Statistically significant difference comparing arm A with arms B and C (HIV-positive vs. HIV-negative)
  2. ** Statistically significant difference comparing arm B versus C1 versus C2
  3. †Percent of patients who were dose reduced for pegylated interferon (PegIFN) or ribavirin (RBV) and respective percent of the cumulative dose received.
  4. Data shown as percent of patients or median (95% range)
  5. NRTI nucleos(t)ide reverse transcriptase inhibitor, ALT serum alanine aminotransferase, Treatment discont. AEs Treatment discontinuation due to adverse events.