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Slide 1 of 8 From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA. IAS–USA David L. Wyles, MD Associate Professor of Medicine University of California.

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Presentation on theme: "Slide 1 of 8 From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA. IAS–USA David L. Wyles, MD Associate Professor of Medicine University of California."— Presentation transcript:

1 Slide 1 of 8 From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA. IAS–USA David L. Wyles, MD Associate Professor of Medicine University of California San Diego Don’t Blink: The Rapid Evolution of IFN-Free Therapy for HCV From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

2 Slide 2 of 8 From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA. Why do we need IFN-free regimens? 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 100 HCV RNA+ Patients 40 Eligible Patients 5 Cured 30% refusal 75% dropout or nonresponse 60% Ineligible 28 Treated Falck-Ytter, Y. Annals, 2002.

3 Slide 3 of 8 From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA. 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 Slide 4 of 8 From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA. Retreatment Success Depends on Fibrosis Stage and Previous Response Zeuzem S. NEJM 2011. TVR-based therapy; HCV mono-infected

5 Slide 5 of 8 From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA. BOC and TVR Increase Adverse Events Jacobson I. NEJM 2011; Poordad F. NEJM 2011. Adverse Event, %TVR Arms (n = 727) PegIFN/RBV Arm (n = 361) Pruritus45-5036 Nausea40-4331 Rash35-3724 Anemia37-3919 Diarrhea28-3222 Discontinuation due to AE91 Adverse Event, %BOC Arms (n = 78) PegIFN/RBV Arm (n = 363) Anemia4929 Dysgeusia37-4318 Discontinuation due to AE1416 Telaprevir (TVR) Boceprevir (BOC)

6 Slide 6 of 8 From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA. IFN-Free Regimens for HCV gt1 DrugsClassesPopulationDurationN SVR (1a/1b) Daclatasvir/ Asunaprevir NS5A/PI Nulls IFN intolerant 24 wks 11 43 36% (22/100) 77% DCV/ASU/ BMS-791325 NS5A/PI/N NI Naïve Non-cirrhotic 12 wks 24wks 16 94% 94% $ SOF/RBVNI Naïve Nulls 12 wks 25 10 84% 10% SOF/RBV GT 2/3 NI Naïve/intolerant Non-responders 12 wks 12/16 wks 253 100/95 67% (97/56) 50/73% SOF/DCV±RBV SOF/LDV/RBV NI/NS5A Naïve Naïve/Null 24wks 12wks 44 25/9 93-100% 100/100% SOF/SMV±RBVNI/PI Null (F0-F2) 12wks 27 14 96% * 93% * FAL/ BI-207127/RBV PI/NNI Naïve Cirrhosis 28 wks7868% (43/83) Mericitabine/ Danoprevir + RBV NI/PI Naïve (F0-F2) 24 wks6441% (26/71) ABT-450r/267/ 333±RBV PI/NS5A/N NI Naïve Nulls 12 79 45 99% 93% Lok A. NEJM 2012. Suzuki F. #14 EASL 2012. Everson G. AASLD 2012. Gane EJ AASLD 2012. Gilead press release Feb 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. $ SVR 4 * SVR 8

7 Slide 7 of 8 From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA. 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 Slide 8 of 8 From DL Wyles, MD, at Atlanta, GA: April 10, 2013, IAS-USA. 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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