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Sustained virologic response rates with telaprevir by response after 4 weeks of lead-in therapy in patients with prior treatment failure

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Published:25th Mar 2020
Background & Aims: For hepatitis C virus (HCV)-infected patients who have not responded to previous peginterferon/ribavirin treatment, it is unclear whether subsequent direct-acting antiviral therapy outcomes are better predicted by prior treatment response or by on-treatment response to a peginterferon/ribavirin lead-in. Methods: In REALIZE, treatment-experienced patients randomized to the lead-in telaprevir arm received 4 weeks of peginterferon alfa-2a (180?g/week) and ribavirin (1000�1200mg/day), then 12 weeks of telaprevir (750mg every 8 hours) plus peginterferon alfa-2a/ribavirin, followed by 32 weeks of peginterferon alfa-2a/ribavirin. This subanalysis only included patients in the lead-in telaprevir arm with available Week 4 on-treatment response data (n=240). Results: After 4 weeks of peginterferon/ribavirin, 90% of relapsers, 60% of partial responders, and 41% of null responders in the lead-in telaprevir arm had 1 log10 HCV RNA reduction. Sustained virologic response (SVR) rates for telaprevir-treated patients with 1 versus <1 log10 hcv rna reduction after the peginterferon ribavirin lead-in were 94% versus 62% in relapsers, 59% versus 56% in partial responders and 54% versus 15% in null responders. conclusions: in prior relapsers and partial responders there is no apparent benefit of assessing response after a peginterferon ribavirin lead-in with the aim of guiding telaprevir-based treatment. for patients known to be prior null responders, on-treatment response after a 4-week peginterferon ribavirin lead-in may provide clinically useful prognostic information. however, withholding telaprevir-containing therapy in uncategorised treatment-experienced patient populations (i.e. that could include prior relapsers or partial responders) using response after a peginterferon ribavirin lead-in could potentially exclude some patients with a high chance of svr.>

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