Skip to main content
. 2017 Mar 12;2017(3):CD011644. doi: 10.1002/14651858.CD011644.pub2
Methods Randomised clinical trial.
Participants Country: USA.
Number randomised: 21.
Post‐randomisation dropouts: 0 (0%).
Revised sample size: 21.
Mean age: not stated.
Females: not stated.
Genotype 1: 13 (61.9%).
Genotype 3: not stated.
Other genotypes: not stated.
Mean follow‐up period in months (for all groups): 6.
Inclusion criteria
  • Seroconversion to anti‐HCV positive within 6 months of screening in a previously seronegative IV drug users.

  • Detectable serum HCV.

  • No contraindications to pegylated interferon.

Interventions Participants were randomly assigned to 2 groups.
Group 1: pegylated interferon‐alpha (n = 9).
Further details: pegylated interferon‐alpha (no further details of treatment regimen).
Group 2: no treatment (n = 12).
Duration of treatment: 6 months.
Outcomes Sustained virological response was reported but was not reported in sufficient details to include for analysis.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: information not available.
Allocation concealment (selection bias) Unclear risk Comment: information not available.
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Comment: information not available.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Comment: information not available.
Incomplete outcome data (attrition bias) All outcomes High risk Comment: there were post‐randomisation dropouts.
Selective reporting (reporting bias) High risk Comment: some important outcomes which would generally be assessed were not reported.
For‐profit bias Unclear risk Comment: information not available.
Other bias Low risk Comment: there was no other bias.

ALT: alanine transaminase; DNA: deoxy ribonucleic acid; HAV: hepatitis A virus; HBV: hepatitis B virus; HCV: hepatitis C virus; HCV‐RNA: hepatitis C virus ribonucleic acid; IM: intramuscular; ITT: intention‐to‐treat analysis; IU: international units; IV: intravenous; MU: million units.

HHS Vulnerability Disclosure