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Hartwell D, Jones J, Baxter L, et al. Peginterferon Alfa and Ribavirin for Chronic Hepatitis C in Patients Eligible for Shortened Treatment, Re-Treatment or in HCV/HIV Co-Infection: A Systematic Review and Economic Evaluation. Southampton (UK): NIHR Journals Library; 2011 Apr. (Health Technology Assessment, No. 15.17.)

Appendix 4Inclusion criteria worksheet for systematic review of clinical effectiveness

Trial name or number
Design: RCT or systematic review

Exclude any conference abstracts from 2006 or earlier
Yes



Next question
Unclear



Next question
No



EXCLUDE
EXCLUDE1
(E1) (not the appropriate study design)
Population: Adult patients with chronic hepatitis C, restricted to one or more of the following groups:
  • re-treated following previous relapse or non-response to PEG and RBV (or PEG monotherapy)
  • HCV/HIV co-infected
  • eligible for shortened course of treatment
(Note: Can be mild/moderate or severe hepatitis C)
Yes



Next question
Unclear



Next question
No



EXCLUDE
EXCLUDE2
(E2) (not the appropriate patient group)
Intervention: Patients re-treated following previous relapse or non-response to PEG and RBV (or PEG monotherapy, and/or HIV/HCV co-infected)
  1. PEG + RBV
  2. PEG monotherapy
Compared with BSC/placebo
Yes



Next question
Unclear



Next question
No



EXCLUDE
EXCLUDE3
(E3) (not the appropriate intervention)
Intervention: (Patients eligible for shortened course of treatment):
  • genotype 2/3 patients with LVL and RVR, shorten tx from 24 to 16 weeks (PEG α-2a only)
  • genotype 1 patients with LVL and RVR, shorten tx from 48 to 24 weeks (PEG α-2a or α-2b)
  • genotype 4 patients with RVR, shorten tx from 48 to 24 weeks (PEG α-2a only)
  1. PEG + RBV
  2. PEG monotherapy
Compared with ‘standard’ duration courses of PEG/RBV (up to 24 or 48 weeks as appropriate)
Outcomes: SVR, defined as undetectable HCV RNA for at least 6 months after treatment cessationYes



Next question
Unclear



Next question
No



EXCLUDE
EXCLUDE4
(E4) (not the appropriate outcome measures)
Final decisionINCLUDEUNCLEAR (Discuss)EXCLUDEResults of discussion:

LVL, low viral load (≤ 800,000 IU/ml PEG α-2a; ≤ 600,000 IU/ml PEG α-2b); PEG, peginterferon; RBV, ribavirin; RVR, rapid virological response [HCV RNA undetectable at week 4 (genotype 2/3); HCV RNA undetectable at week 4 and 24 (genotype 1/4)]; tx, treatment.

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Cover of Peginterferon Alfa and Ribavirin for Chronic Hepatitis C in Patients Eligible for Shortened Treatment, Re-Treatment or in HCV/HIV Co-Infection: A Systematic Review and Economic Evaluation
Peginterferon Alfa and Ribavirin for Chronic Hepatitis C in Patients Eligible for Shortened Treatment, Re-Treatment or in HCV/HIV Co-Infection: A Systematic Review and Economic Evaluation.
Health Technology Assessment, No. 15.17.
Hartwell D, Jones J, Baxter L, et al.
Southampton (UK): NIHR Journals Library; 2011 Apr.

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