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IL28B in the Era of DAA Therapy: Ten Years Too Late?

IL28B in the Era of DAA Therapy: Ten Years Too Late?. Donald M. Jensen, MD Professor of Medicine Director, Center for Liver Disease University of Chicago. IL28B in the Era of DAA Therapy: What’s not to like?. Can we avoid the toxicity of DAAs and use dual therapy in IL28B CC patients?

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IL28B in the Era of DAA Therapy: Ten Years Too Late?

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  1. IL28B in the Era of DAA Therapy:Ten Years Too Late? Donald M. Jensen, MD Professor of Medicine Director, Center for Liver Disease University of Chicago

  2. IL28B in the Era of DAA Therapy:What’s not to like? • Can we avoid the toxicity of DAAs and use dual therapy in IL28B CC patients? • Is knowledge of IL28B CC status helpful in encouraging patients to be treated with the hope of eRVR+ RGT? • Can we use IL28B TT or CT information in patients with “mild” disease to wait for newer therapies with better outcomes?

  3. Dual versus Triple Therapy • The argument: Dual therapy for IL28B CC is more cost-effective than triple therapy: • For patients with IL28B CC: SVR rates (~90%) are about the same with P/R as if T/P/R was used right from the start • It is more cost-effective to treat IL28B CC subjects initially with PEG/RBV and reserve TVR-based triple therapy to those who do not respond. Gellad et al: AASLD 2011

  4. Dual versus Triple Therapy • However,…. • This two step strategy means that at least 36% of patients will require a subsequent course of triple therapy • It assumes that 100% of P/R failures will undergo re-treatment - not supported by clinical experience data. • Evolution of therapy may demonstrate that these uniquely responsive patients may achieve a comparably high rate of SVR with only 12 weeks of triple therapy without the need for a PEG/RBV tail (trial in progress) • Finally, patients may refuse a non-DAA containing therapy • But, if government or insurance mandated…….

  5. Duration of Therapy: 24 vs 48 weeks • The argument: Those with geno-1, IL28B CC are more likely to have an eRVR and qualify for 24 weeks (RGT) therapy. • However,…. • Regardless of IL28B status, an eRVR still requires actual measurement of undetectable HCV RNA at weeks 4 and 12 • It’s on-treatment virologic responses that really matter, not pre-treatment dispositions

  6. Selecting Candidates for Therapy • Argument: IL28B CT or TT with ‘mild disease’ may be able to wait for future therapies However,… • How do we define ‘mild’? What is the accuracy? • E.g. Liver bx: 25-30% may miss cirrhosis • Surrogate testing not perfect either • Could argue that all ‘mild’ cases be deferred given the toxicity of DAA triple therapy, not just IL28B T? • When is IFN-free therapy anticipated? 2014-2015?

  7. Selecting Candidates for Therapy • Argument: IL28B may identify a cohort of uniquely sensitive subjects for short course IFN-free therapy However,…. • As therapies become more effective (>90% SVR), the role of IL28B will decline as a predictor (e.g. PILLAR) • In the absence of IFN, will there even be a role for l-IFN responsiveness? (e.g. PROTON)

  8. Summary • How will IL28B be utilized in the era of DAA triple therapy? • Predict shorter treatment duration • Identify patients who may benefit from dual therapy However,… • True utilization may depend upon real life clinical experience with triple therapy and retrospective analysis of IL28B Ten years too late????

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