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Don ’ t Blink: The Rapid Evolution of IFN-Free Therapy for HCV

Don ’ t Blink: The Rapid Evolution of IFN-Free Therapy for HCV. David L. Wyles , MD Associate Professor of Medicine University of California San Diego. From DL Wyles , MD, at Atlanta, GA: April 10, 2013, IAS-USA. Why do we need IFN-free regimens?. 100 HCV RNA+ Patients. Efficacy

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Don ’ t Blink: The Rapid Evolution of IFN-Free Therapy for HCV

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  1. Don’t Blink: The Rapid Evolution of IFN-Free Therapy for HCV David L. Wyles, MDAssociate Professor of MedicineUniversity of California San Diego From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  2. Why do we need IFN-free regimens? 100 HCV RNA+ Patients Efficacy • Poorly interferon responsive • African Americans • Prior IFN failure • Null responder cirrhotics Acceptance and tolerability • Poor patient acceptance • Providers reluctance • Resource intensive • Monitoring: toxicity • Support services Interferon ineligible populations • Decompensated ESLD • Severe psychiatric disease • Medical co-morbidities 60% Ineligible 40 Eligible Patients 30% refusal 28 Treated 75% dropout ornonresponse 5 Cured Falck-Ytter, Y. Annals, 2002.

  3. Limitation of first generation PIs • Complicated dosing regimens and treatment algorithms • Food restrictions • High potential for drug-drug interactions • Increased side effects (over Peg/RBV) • Limited efficacy in those with the greatest medical need

  4. Retreatment Success Depends on Fibrosis Stage and Previous Response TVR-based therapy; HCV mono-infected Zeuzem S. NEJM 2011.

  5. BOC and TVR Increase Adverse Events Telaprevir (TVR) Boceprevir (BOC) Jacobson I. NEJM 2011; Poordad F. NEJM 2011.

  6. IFN-Free Regimens for HCV gt1 $ SVR4 * SVR8 Lok A. NEJM 2012. Suzuki F. #14 EASL 2012. Everson G. AASLD 2012. Gane EJ AASLD 2012. Gilead pressreleaseFeb 2013. Sulkowski M. AASLD 2012. Gane EJ. CROI 2013. Lawitz E CROI 2013. Zeuzem S. #101 EASL 2012. Poordad F. EASL 2012. King M. CROI 2013.

  7. Lessons learned with IFN-free therapies • HCV cure is achievable without IFN • With much shorter durations • Subtype matters with less potent regimens • Ribavirin matters with less potent regimens • Cirrhotics and null responders can be effectively treated • Tolerability and side effects are improved

  8. Unknowns with IFN-free therapies • Efficacy in HCV/HIV subjects • No reason to suspect efficacy will suffer • Drug-drug interaction limiting factor • How restrictive will payers be? • SOF + DCV or SOF + SMV “off label” early 2014 • Impact of selected HCV resistance? • Decompensated cirrhosis data needed

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