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Screening: Hepatitis C

Table 3. Randomized Controlled Trials of Pegylated Interferon plus Ribavirin in Patients with Hepatitis C Virus Infection*

Study, Year (Reference)	Patients Enrolled/ Analyzed	Interventions	Sustained Viral Response 6 Months after Treatment	Adverse Events	Internal Validity Rating	Relevance to Screening
Fried, 2002¹²²	1149/1121	a. INF alfa-2b, 3 MU 3 times per wk + ribavirin 1000-1200 mg/d b. PEG INF alfa-2a, 180 µg/kg of body weight once weekly c. PEG INF alfa-2a 180 µg/kg once weekly + ribavirin 1000-1200 mg/d	44% 29% 56%^a (a vs c, b vs c p<0.001)	For a vs. b vs. c Dose reduction: not clear Discontinuation (%): 32 vs. 32 vs. 22 Fatigue (%): 55 vs. 44 vs. 54 Headache (%): 52 vs. 51 vs. 47 Fever (%): 56 vs. 38 vs. 43 Myalgia (%): 50 vs. 42 vs. 42 Nausea (%): 33 vs. 26 vs. 29 Depression (%): 30 vs. 20 vs. 22 Dermatitis (%): 22 vs. 11 vs. 21 Deaths: 3, none thought to be related to treatment	Good	Fair: required liver biopsy findings consistent with chronic hepatitis and elevated ALT level within the past 6 months.
Manns, 2001¹²³	1530/1530	a. INF alfa 2b, 1.5 µg/kg 3 times/wk + ribavirin 1000-1200 mg/d b. Pegylated INF alfa 2b, 1.5 µg/kg once weekly for 4 wk then 0.5 µg/kg for 44 wks + ribavirin 1000-1200 mg/d for 48 wk c. PEG INF alfa 2b, 1.5 µg/kg once weekly + ribavirin 800 mg/d for 48 wk	47% 47% 54%^b (a vs c p=0.01)	For a vs. b vs. c Dose reduction (%): 34 vs. 36 vs. 42 Discontinuation (%): 13 vs. 13 vs. 14 Fatigue(%): 60 vs. 62 vs. 64 Headache(%): 58 vs. 58 vs. 62 Myalgia(%): 50 vs. 48 vs. 56 Fever(%): 33 vs. 44 vs. 46 Diarrhea(%): 17 vs. 16 vs. 22 Depression(%): 34 vs. 29 vs. 31 Injection site reaction(%): 36 vs. 59 vs. 58 Deaths: 0	Good	Fair: required liver biopsy findings consistent with chronic hepatitis and elevated ALT levels
Glue, 2000¹²⁴	72/72	a. Pegylated INF alfa 2b, 0.35 µg/gk once weekly b. Pegylated INF alfa 2b, 0.70 µg/kg once weekly c. Pegylated INF alfa 2b, 1.40 µg/kg once weekly d. Pegylated INF alfa 2b, 0.35 µg/kg once weekly + ribavirin 600-800 mg/d e. Pegylated INF alfa 2b, 0.70 µg/kg once weekly + ribavirin 600-1200 mg/d f. Pegylated INF alfa 2b, 1.40 µg/kg once weekly + ribavirin 600-1200 mg/d	0% 44% 42% 17% 53% 60%	Dose reduction: NR Dose discontinued: 1 patient (treatment group not specified) Influenza symptoms(%): 17-44 Headache(%): 50-56 Asthenia(%): 0-22 Mean reduction in hemoglobin level: 1.5-2.5 g/dL	Fair Allocation concealment inadequate, not clear if groups similar at baseline, outcomes assessors not blinded.	Unclear: numbers screened and eligible not reported, baseline characteristics inadequately described.

Study, Year
(Reference)

Patients Enrolled/
Analyzed

Interventions

Sustained
Viral
Response
6 Months
after
Treatment

Adverse Events

Internal Validity Rating

Relevance to Screening

Fried, 2002¹²²

1149/1121

a. INF alfa-2b, 3 MU 3 times per wk + ribavirin 1000-1200 mg/d

b. PEG INF alfa-2a, 180 µg/kg of body weight once weekly

c. PEG INF alfa-2a 180 µg/kg once weekly + ribavirin 1000-1200 mg/d

44%

29%

56%^a

(a vs c,
b vs c
p<0.001)

For a vs. b vs. c

Dose reduction:
not clear

Discontinuation (%):
32 vs. 32 vs. 22

Fatigue (%):
55 vs. 44 vs. 54

Headache (%):
52 vs. 51 vs. 47

Fever (%):
56 vs. 38 vs. 43

Myalgia (%):
50 vs. 42 vs. 42

Nausea (%):
33 vs. 26 vs. 29

Depression (%):
30 vs. 20 vs. 22

Dermatitis (%):
22 vs. 11 vs. 21

Deaths: 3, none thought to be related to treatment

Good

Fair: required liver biopsy findings consistent with chronic hepatitis and elevated ALT level within the past 6 months.

Manns, 2001¹²³

1530/1530

a. INF alfa 2b, 1.5 µg/kg 3 times/wk + ribavirin 1000-1200 mg/d

b. Pegylated INF alfa 2b, 1.5 µg/kg once weekly for 4 wk then 0.5 µg/kg for 44 wks + ribavirin 1000-1200 mg/d for 48 wk

c. PEG INF alfa 2b, 1.5 µg/kg once weekly + ribavirin 800 mg/d for 48 wk

47%

54%^b

(a vs c
p=0.01)

For a vs. b vs. c

Dose reduction (%):
34 vs. 36 vs. 42

Discontinuation (%):
13 vs. 13 vs. 14

Fatigue(%):
60 vs. 62 vs. 64

Headache(%):
58 vs. 58 vs. 62

Myalgia(%):
50 vs. 48 vs. 56

Fever(%):
33 vs. 44 vs. 46

Diarrhea(%):
17 vs. 16 vs. 22

Depression(%):
34 vs. 29 vs. 31

Injection site reaction(%):
36 vs. 59 vs. 58

Deaths: 0

Good

Fair: required liver biopsy findings consistent with chronic hepatitis and elevated ALT levels

Glue, 2000¹²⁴

72/72

a. Pegylated INF alfa 2b, 0.35 µg/gk once weekly

b. Pegylated INF alfa 2b, 0.70 µg/kg once weekly

c. Pegylated INF alfa 2b, 1.40 µg/kg once weekly

d. Pegylated INF alfa 2b, 0.35 µg/kg once weekly + ribavirin 600-800 mg/d

e. Pegylated INF alfa 2b, 0.70 µg/kg once weekly + ribavirin 600-1200 mg/d

f. Pegylated INF alfa 2b, 1.40 µg/kg once weekly + ribavirin 600-1200 mg/d

44%

42%

17%

53%

60%

Dose reduction: NR

Dose discontinued: 1 patient (treatment group not specified)

Influenza symptoms(%): 17-44

Headache(%): 50-56

Asthenia(%): 0-22

Mean reduction in hemoglobin level: 1.5-2.5 g/dL

Fair

Allocation concealment inadequate, not clear if groups similar at baseline, outcomes assessors not blinded.

Unclear: numbers screened and eligible not reported, baseline characteristics inadequately described.

* ALT = alanine aminotransferase; HCV = hepatitis C virus; INF = interferon; NR = not reported; PCR = polymerase chain reaction.
^a P<0.001 for 1 vs. 3, 2 vs. 3.
^b P=0.01 for 1 vs. 3.

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