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The new Treatments

The new Treatments. Dr John F Dillon. Curing one person Curing a population one person at a time. Curing one person Curing a population one person at a time. Uptake of therapy by 1,000 IDUs per year. Uptake of therapy by (up to) 2,000 IDUs per year. Uptake of therapy

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The new Treatments

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  1. The new Treatments Dr John F Dillon

  2. Curing one person Curing a population one person at a time

  3. Curing one person Curing a population one person at a time Uptake of therapy by 1,000 IDUs per year Uptake of therapy by (up to) 2,000 IDUs per year Uptake of therapy by 225 IDUs per year 3,000 3,000 3,000 Living IDUs with cirrhosis 2,000 2,000 2,000 1,000 1,000 1,000 0 0 0 2010 2020 2030 2010 2020 2030 2010 2020 2030 Decompensated cirrhosis Cirrhosis prevented from antiviral therapy* Compensated cirrhosis HCC * Excludes those prevented from antiviral therapy prior to 2008

  4. SVR = Cure • SVR rate of 70% • Means 7 out of 10 people are cured 100% SVR • 3 out of 10 are not cured 0% SVR • If we have prediction tools

  5. Combo DAA 8-12 weeks No IFN No RGT 95% PEG/RBV + 2nd DAA 12 weeks 90% Triple Rx Protease inhibitor + PEG/RBV 24 weeks 75% 2003-2011 2015 2014 HCV Therapy • 0 100% 75% PEG/RBV 48 weeks 45% Cure rate 50% IFN/RBV 48 weeks 27% IFN-α48 weeks 9% IFN-α24 weeks 4% 25% 0% 1998 1985-1989-1991

  6. Genotype 1

  7. GT 1, 4, 5, 6 Treatment-Naïve: SOF+PEG-IFN+RBV x 12 WeeksNEUTRINOPrimary Endpoint and Virologic Response > 90 Patients with HCV RNA <LLOQ (%) 299/327 321/325 326/327 295/327 Week 12/EOT Week 2 Week 4 Week 12 On treatment Post-treatment • Study met primary endpoint of superiority over historical control rate of 60% (P<0.001) • Relapse accounted for all virologic failures • No S282T mutations observed by population or deep sequencing (1% cutoff) • Lawitz E, et al. EASL 2013. Amsterdam, The Netherlands. Oral #1411 • Lawitz E, et al. N Engl J Med. 2013 Apr 23 [Epub ahead of print] Error bars represent 95% confidence intervals HCV1/UK/13-05/ABAR/1201c

  8. QUEST-1: Phase 3 trial of Simeprevir + PR in G1 treatment-naive patients Response Guided Therapy criteria met by 85% SVR in 91% of RGT patients No incremental rash/anemia Hyperbilrubinemia A NS3a PI a replacement for Boceprevir or telaprevir Jacobson IM et al, EASL 2013, Amsterdam, #1425

  9. NUC NS5B inhibitor sofosbuvir & Daclatasvir± Ribavirin (geno 1, n =45) Sulkowski M, et al. J Hepatol 2012; 56: S1422

  10. AbbVie Phase III Clinical Program Results fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) twice daily

  11. Genotype 3 The new tough kid on the block

  12. SVR12 Rates Across SOF-Based Studies HCV GT 3 Patients Noncirrhotic Cirrhotic Treatment-Experienced Treatment-Naïve 94% 92% 87% 100% 83% 83% 63% 61% 60% 80% 68% 61% SVR12 (%) 34% 60% 21% 40% 20% 25/40 10/12 86/92 57/84 89/145 10/12 87/100 3/14 13/38 12/13 14/23 27/45 0% HCV GT 3 patients treated with SOF + RBV for 24 weeks or SOF + RBV + PegIFN for 12 weeks achieved high SVR rates regardless of presence of cirrhosis or treatment experience Fusion SOF RBV 16 wk Valence SOF + RBV 24 wk LONESTAR-2 SOF + PegIFN + RBV 12 wk FISSION SOF + RBV 12 wk POSITRON SOF + RBV 12 wk VALENCE SOF + RBV 24 wk Lawitz E, et al. N Engl J Med. 2013 May 16;368(20):1878-87. Zeuzem S, et al. AASLD 2013. Washington, DC. #1085. Jacobson IM, et al. N Engl J Med. 2013 May 16;368(20):1867-77. Lawitz E, et al. AASLD 2013. Washington, DC. Oral #LB-4.

  13. NS3/NS4A PROTEASE INHIBITORS • BOCEPREVIR • TELAPREVIR • SIMEPREVIR • FALDAPREVIR • VANIPREVIR (MK-7009) • DANOPREVIR • ASUNAPREVIR • ABT-450 • MK-5172 • SOLAPREVIR • GS-9451

  14. POLYMERASE INHIBITORS (NS5b) • NUCLEOSIDE • MERICITABINE • NUCLEOTIDE • SOFOSBUVIR • VX-135 • NON-NUC’s • ABT-072 • ABT-333 • BI-207127

  15. NS5A COMPLEX INHIBITORS • DACLATASVIR • ABT-267 • LEDIPASVIR • MK-8742 • ACH-3102 • PP-1668

  16. CYCLOPHILIN INHIBITORS • ALISPORIVIR TLR7-INHIBITOR • GS-9620 NOVEL INTERFERONS • LAMBDA-IFN

  17. Future treatment Genotype 1 Genotype 3 SVR about 90% Interferon plus 2 oral drugs 12 weeks 2 or 3 Oral drugs 24 weeks With Prediction Interferon/ribavirin 16 weeks • SVR better than 90% with • 2 or 3 oral drugs for 8-12 weeks • OR • Interferon plus 1 or 2 drugs for 12 weeks

  18. So back to treating one person • The new treatments are much more expensive • SO • Get a lot more money? • In Scotland there will be some new money • Treat a lot less people? • Use some of the old treatments in some people. • Including a bit of Interferon

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