Randomised trials included in a systematic review on interferon alfa with or without ribavirin for interferon naive patients, relapsers, and non-responders with chronic hepatitis C

Trial No of patients (losses to follow up) Generation of allocation sequence Allocation concealment Double blind Interventions: dose and duration of therapy
Trials including previously untreated (naive) patients
Barbaro 2000w1 C: 215 (33) Adequate Central randomisation No Interferon 3 MU 3 times/week (48 weeks) versus interferon 3 MU 3 times/week plus ribavirin 1000-1200 mg/day (24 weeks)
I: 213 (27)
Berg 1998w2 C: 35 (NR) NR NR No Interferon 6 MU 3 times/week with or without ribavirin 14 mg/kg/day (12 weeks)
I: 29 (NR)
Berg 1999w3 C: 93 (3) NR Central randomisation No Interferon 6 MU 3 times/week with or without ribavirin 14 mg/kg/day (12 weeks)
I: 92 (3)
Chemello 1995w4 C: 15 (0) Adequate Sealed envelopes No Interferon 3 MU 3 times/week with or without ribavirin 15 mg/kg/day (26 weeks)
I: 15 (0)
Gross 1999w5 C: 35 (0) NR NR Yes Interferon 5 MU 3 times/week plus ribavirin 1000-1200 mg/day or placebo (24 weeks)
I: 34 (0)
Koshy 2000w6 C: 60 (0) NR NR No Interferon 5 MU 3 times/week with or without ribavirin 1000-1200 mg/day (24 weeks)
I: 52 (0)
Lai 1996w7 C: 21 (1) NR NR Yes Interferon 3 MU 3 times/week with or without ribavirin 1200 mg/day (24 weeks)
I: 19 (0)
Mangia 1999w8 C: 70 (10) NR NR No Interferon 5-6 MU 3 times/week with or without ribavirin 1000-1200 mg/day (52 weeks)
I: 69 (9)
McHutchison 1998w9 C: 228+228 (18+48) Adequate NR Yes Interferon 3 MU 3 times/week plus ribavirin 1000-1200 mg/day or placebo (24 or 48 weeks)
I: 228+228 (21+32)
Pawlotsky 1998w10 C: 6 (NR) NR NR No Interferon 3 MU/day versus interferon 3 MU 3 times/week with or without ribavirin 1000-1200 mg/day (12 weeks)
I: 5+5 (NR)
Pol 2000w11 C: 46+44+39 (NR) NR NR Yes Interferon 6 MU 3 times/week (26 weeks) then 3 MU 3 times/week (26 weeks) with or without ribavirin 1000-1200 mg/day (13, 26, or 52 weeks) versus interferon 10 MU 3 times/week (13 weeks) then 6 MU 3 times/week (13 weeks) then 3 MU 3 times/week (26 weeks)
I: 95+83 (NR)
Poynard 1998w12 C: 281+278 (29+75) Adequate Central randomisation Yes Interferon 3 MU 3 times/week plus ribavirin 1000-1200 mg/day (24 weeks) versus interferon 3 MU 3 times/week plus ribavirin 1000-1200 mg/day or placebo (48 weeks)
I: 281 (55)
Reichard 1998w13 C: 50 (7) Adequate Sealed envelopes Yes Interferon 3 MU 3 times/week plus ribavirin 1000-1200 mg/day or placebo (24 weeks)
I: 50 (3)
Ricchiuti 1999w14 C: 24 (NR) NR NR No Interferon 6 MU/day (4 weeks) then 6 MU 3 times/week (20 weeks) with or without ribavirin 1000-1200 mg/day (20 weeks)
I: 26 (NR)
Taliani 1999w15 C: 17 (NR) NR NR No Interferon 6 MU 6 days/week with or without ribavirin 1000-1200 mg/day (26 weeks) versus interferon 6 MU 3 times/week
I: 18+17 (NR)
Trials including patients who relapsed after having responded to previous treatment
Bellobuono 1999w16 C: 30 (NR) NR NR No Interferon 5 MU 3 times/week with or without ribavirin 1000 mg/day (26 weeks)
I: 30 (NR)
Caremani 1996w17 C. 18 (0) NR NR No Interferon 3 MU 3 times/week with or without ribavirin 80 (800?)* mg/day (26 weeks)
I: 18 (2)
Davis 1998w18 C: 173 (20) Adequate Central randomisation Yes Interferon 3 MU 3 times/week plus ribavirin 1000-1200 mg/day or placebo (24 weeks)
I: 172 (5)
Marcellin 1999w19 C: 49 (NR) Adequate Central randomisation Yes Interferon 4.5 MU 3 times/week plus ribavirin 1000 mg/day or placebo (24 weeks)
I: 50 (NR)
Portal 2000w20 C: 23 (NR) NR NR Yes Interferon 6 MU 3 times/week (24 weeks) then 3 MU 3 times/week (24 weeks) with or without ribavirin 600 mg/day (24 weeks)
I: 26 (NR)
Ricchiuti 199621 C: 10 (NR) NR NR No Interferon 6 MU 3 times/week with or without ribavirin 1000 mg/day (26 weeks)
I: 10 (NR)
Trials including patients who did not respond to previous treatment with interferon
Andreone 1999aw22 C: 16 (2) Adequate Sealed envelopes No Interferon 6 MU 3 times/week (39 weeks) with or without ribavirin 800 mg/day (17 weeks)
I: 16 (1)
Andreone 1999bw23 C: 26 (2) Adequate Central randomisation No Interferon 3 MU 3 times/week with or without ribavirin 800 mg/day (26 weeks)
I: 24 (3)
Ascione 1998w24 C: 10 (NR) NR NR No Interferon 6 MU 3 times/week with or without ribavirin 1000 mg/day (26 weeks)
I: 10 (NR)
Barbaro 1998aw25 C: 152 (17) Adequate Central randomisation No Interferon 6 MU 3 times/week with or without ribavirin 1000-1200 mg/day (24 weeks)
I: 151 (5)
Bellobuono 2000w26 C: 24 (NR) NR NR No Interferon 3 MU 3 times/week plus ribavirin 1000 mg/day (48 weeks) versus interferon 6 MU 3 times/week
I: 24 (NR)
Ferenci 1999w27 C: 81 (17) Adequate Central randomisation No Interferon 5 MU 3 times/week (12 weeks) then 5-10 MU 3 times/week with or without ribavirin 1000-1200 mg/day (26 weeks)
I: 77 (15)
Gerotto 1999w28 C: 9 (NR) NR NR No Interferon 6 MU 3 times/week (8 weeks) then 6 MU 3 times/week with or without ribavirin 1000-1200 mg/day (26 weeks)
I: 6 (NR)
Gross 1999w29 C: 9+23 (NR) NR NR Yes Interferon 5 MU 3 times/week (4 weeks) then 5 MU 3 times/week plus ribavirin or placebo (24 weeks) versus interferon 5 MU/day (4 weeks) then 5 MU 3 times/week plus ribavirin or placebo (24 weeks) (dose of ribavirin not reported)
I: 14+18 (NR)
Lédinghen 1998w30 C: 70+60 (NR) NR NR No Interferon 3 MU/day (24 weeks) then 3 MU 3 times/week (24 weeks) plus ribavirin 1000 mg/day (48 weeks) versus interferon 6 MU 3 times/week (24 weeks) then 3 MU 3 times/week (24 weeks) with or without ribavirin 1000 mg/day (48 weeks)
I: 57 (NR)
Pol 1999w31 C: 62 (8) NR NR No Interferon 6 MU 3 times/week (13 weeks) then 3 MU 3 times/week (13 weeks) with or without ribavirin 1000-1200 mg/day (17 weeks)
I: 65 (6)
Scotto 1996w32 C: 10 (0) NR NR No Interferon 3 MU 3 times/week (26 weeks) with or without ribavirin 800 mg/day (8 weeks)
I: 10 (0)
Sostegni 1998w33 C: 33 (4) NR NR No Interferon 3 MU 3 times/week with or without ribavirin 1000 mg/day (26 weeks)
I: 30 (2)
Toccaceli 1997w34 C: 13 (1) NR NR No Interferon 3 MU 3 times/week with or without ribavirin 800 mg/day (26 weeks)
I: 11 (0)
Vandelli 2000w35 C: 31 (NR) NR NR No Interferon 6 MU/day (4 weeks) then 6 MU 3 times/week (48 weeks) with or without ribavirin 14 mg/kg/day (52 weeks)
I: 31 (NR)
Wood 1998w36 C: 13 (NR) NR NR No Interferon 10 MU/day (1.5 weeks) then 5 MU/day (10.5 weeks) then 5 MU 3 times/week (24 weeks) with or without ribavirin 1000 mg/day (34.5 weeks)
I: 13 (NR)
Trials including patients who relapsed or did not respond to previous treatment with interferon
Barbaro 1998bw37 C: 215 (NR) NR NR No Interferon 6 MU 3 times/week versus 3 MU 3 times/week plus ribavirin 1000-1200 mg/day (13 weeks)
I: 215 (NR)
Barbaro 1999w38 C: 200 (23) Adequate Central randomisation No Interferon 6 MU 3 times/week versus 3 MU 3 times/week plus ribavirin 1000-1200 mg/day (24 weeks)
I: 200 (11)
Bell 1999w39 C: 27 (3) Adequate NR No Interferon 4.5 MU 3 times/week with or without ribavirin 1000-1200 mg/day (26 weeks)
I: 26 (5)
Bellobuono 1997w40 C: 24 (5) NR NR No Interferon 3-6 MU 3 times/week with or without ribavirin 1000 mg/day (26 weeks)
I: 24 (2)
Brillanti 1995w41 C: 15 (NR) NR NR No Interferon 3 MU 3 times/week with or without ribavirin 800 mg/day (26 weeks)
I: 15 (NR)
Bugliescu 2000w42 C: 19 (NR) NR NR No Interferon 3 MU 3 times/week with or without ribavirin 1000-1200 mg/day (52 weeks)
I: 19 (NR)
Cavaletto 2000w43 C: 50 (2) Adequate Central randomisation No Interferon 6 MU 3 times/week (8 weeks) then 6 MU 3 times/week with or without ribavirin 800-1000 mg/day (26 weeks)
I: 50 (0)
Milella 1999w44 C: 47 (0) NR NR No Interferon 6 MU 3 times/week with or without ribavirin 1000 mg/day (24 weeks)
I: 41 (0)
Nunes 1999w45 C: 63 (NR) NR NR Yes Interferon 3 MU 3 times/week plus ribavirin 1000 mg/day or placebo (8 weeks)
I: 51 (NR)
Salmeron 1999w46 C: 31 (4) NR NR No Interferon 3 MU 3 times/week with or without ribavirin 600 mg/day (26 weeks)
I: 31 (3)
Trials including naive patients and patients who relapsed after previous treatment with interferon
Khakoo 1998w47 C: 12 (0) Adequate Sealed envelopes No Interferon 3 MU 3 times/week with or without ribavirin 1200 mg/day (6 weeks)
I: 12 (0)
Trials in which previous therapy was not reported
Sarin 1999w48 C: 24 (0) NR NR No Interferon 3 MU 3 times/week (26 weeks) versus 3 MU 3 times/week (52 weeks) plus ribavirin 800-1000 mg/day (26 weeks)
I: 22 (0)

C=Combination therapy: interferon plus ribavirin.

I=Interferon alone.

NR=not reported.

MU=million units.

*Dose in title and abstract are different.
 
 

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