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Table 6. HCV PI (BOC or TVR): RGT criteria and futility rules

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Table 6. HCV PI (BOC or TVR): RGT criteria and futility rules

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BOC-PegIFN/RBVTVR-PegIFN/RBV
HCV, hepatitis C virus; PegIFN, peginterferon; PI, protease inhibitor; RBV, ribavirin; RGT, response-guided therapy; TVR, telaprevir.
Candidates for RGT Noncirrhotics:
Treatment-naive: 28 weeks
Prior relapser/partial responder: 36 weeks
Noncirrhotics:
Treatment-naive: 24 weeks
Prior relapser: 24 weeks
Criteria for RGT HCV RNA undetectable (<10-15 IU/ml) weeks 8-24 HCV RNA undetectable (<10-15 IU/ml) weeks 4 and 12
Futility rules (stop all treatment if any of the following occur)

Week 12: HCV RNA ≥100 IU/ml

Or

Week 24: HCV RNA detectable

Or

HCV RNA rebounds at any timepoint (≥1 log10increase from the nadir HCV RNA)

Week 4 or 12: HCV RNA >1,000 IU/ml

Or

Week 24: HCV RNA detectable

Or

HCV RNA rebounds at any timepoint (≥1 log10 increase from the nadir HCV RNA)