15307
document
Twenty-four vs. forty-eight weeks of re-therapy with interferon alpha 2b and ribavirin in interferon alpha monotherapy relapsers with chronic hepatitis C. BACKGROUND/AIM Roughly 50 % of patients with chronic hepatitis C , who relapsed after a previous monotherapy with interferon alpha , will respond in a sustained fashion to 24 weeks of re-therapy with the combination of interferon alpha plus ribavirin . Whether prolonging treatment duration to 48 weeks will further increase sustained response rates remains ill defined . In this randomised controlled pilot trial we compared the efficacy and tolerability of a 24 week with that of a 48 week course of combination therapy with interferon alpha and ribavirin in interferon monotherapy relapsers with chronic hepatitis C. METHODS Interferon alpha monotherapy relapsers with chronic hepatitis C were randomised to receive interferon alpha 2b ( 3 x 3 MIU sc weekly ) and oral ribavirin ( 1000/1200 mg po daily ) for either 24 weeks or 48 weeks . Virological response was evaluated by HCV RNA PCR at week 10 ( initial response ) , at the end of treatment ( end of- treatment response ) and at the end of 24 weeks follow-up ( sustained response ) . Only patients with negative HCV RNA at week 10 continued treatment . Adverse events were recorded at regular intervals . RESULTS Thirty-seven patients were enrolled , 19 ( 6 females , median age 43 ) in the 24 week and 18 ( 5 females , median age 40 ) in the 48 week treatment arm . Baseline characteristics were similar in both groups . At treatment week 10 , 12/19 ( 63 % ) in the 24 week group and 14/18 ( 78 % ) patients in the 48 week group had lost HCV RNA in serum ( p = 0.33 ) . All initial responders remained HCV RNA negative throughout the treatment period . Sustained response rates were 10/19 ( 53 % ) in the 24 week group and 13/18 ( 72 % ) in the 48 week group ( p = 0.31 ) . Three patients discontinued treatment early ( two due to moderate adverse events , one due to non-compliance ) . Dose modifications were necessary in 9 patients , 4 in the 24 week and 5 in the 48 week group for anaemia , neutropenia , nausea and depression , respectively . CONCLUSION Prolonging interferon / ribavirin combination therapy in interferon alpha monotherapy relapsers with chronic hepatitis C from 24 to 48 weeks may increase sustained response rates . Larger controlled trials using pegylated interferon alpha and ribavirin in relapsers with chronic hepatitis C seem warranted .
15308
Intervention_Pharmacological
interferon alpha 2b
15309
Intervention_Pharmacological
ribavirin
15310
Intervention_Other
combination of
15311
Intervention_Pharmacological
interferon alpha
15312
Intervention_Other
plus
15313
Intervention_Pharmacological
ribavirin
15314
Intervention_Pharmacological
interferon alpha 2b
15315
Intervention_Pharmacological
oral ribavirin
15316
Outcome_Other
efficacy
15317
Outcome_Other
tolerability
15318
Outcome_Adverse-effects
Adverse events
15319
Outcome_Mental
lost
15320
Outcome_Physical
HCV RNA in serum
15321
Outcome_Physical
HCV RNA negative
15322
Outcome_Other
Sustained response rates
15323
Outcome_Adverse-effects
moderate adverse events
15324
Outcome_Physical
anaemia
15325
Outcome_Physical
neutropenia
15326
Outcome_Physical
nausea
15327
Outcome_Physical
depression
15328
Outcome_Other
sustained response rates
15329
Participant_Condition
interferon alpha monotherapy relapsers
15330
Participant_Condition
chronic hepatitis C.
15331
Participant_Condition
interferon monotherapy relapsers
15332
Participant_Condition
chronic hepatitis C.
15333
Participant_Condition
Interferon alpha monotherapy relapsers
15334
Participant_Condition
chronic hepatitis C
15335
Participant_Condition
negative HCV RNA
15336
Participant_Sample-size
Thirty-seven
15337
Participant_Sample-size
19
15338
Participant_Sample-size
6
15339
Participant_Sex
females
15340
Participant_Age
43
15341
Participant_Sample-size
18
15342
Participant_Sample-size
5
15343
Participant_Sex
females
15344
Participant_Age
40
15345
Participant_Sample-size
Three
15346
Participant_Condition
relapsers with chronic hepatitis C