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Recent HCV treatment developments: In pursuit of perfectovir Professor Greg Dore Kirby Institute, UNSW Australia; & St Vincent’s Hospital, Sydney.

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Presentation on theme: "Recent HCV treatment developments: In pursuit of perfectovir Professor Greg Dore Kirby Institute, UNSW Australia; & St Vincent’s Hospital, Sydney."— Presentation transcript:

1 Recent HCV treatment developments: In pursuit of perfectovir Professor Greg Dore Kirby Institute, UNSW Australia; & St Vincent’s Hospital, Sydney

2 201320112015201220162014 IFN-free DAA combination PEG-IFN + RBV PEG-IFN + RBV + DAA Treatment complexity HCV treatment strategies: Australia Dore GJ. MJA 2012 (revised)

3 201320112015201220162014 IFN-free DAA combination PEG-IFN + RBV PEG-IFN + RBV + DAA Treatment complexity HCV treatment strategies: United States Dore GJ. MJA 2012 (revised)

4 HCV life cycle Liang TJ & Ghany MG. NEJM 2013;368:1907-1917

5 HCV therapeutic development Welsch & Zeuzum. Gastroenterology 2012;142:1351-1355 X ? X

6 Key recent HCV therapeutic development findings: Sofosbuvir (nucleotide analogue) and Simeprevir (protease inhibitor) licensure for GT1 has revealed the future = IFN-free dual DAA short duration therapy (12 weeks) Several highly curative GT1 IFN-free DAA regimens will be available HCV GT3 therapeutic solution less advanced, but pangenotypic regimens likely HIV does not impair response to IFN-free DAA therapy HCV resistance will not be a major clinical issue Ultimately limited individualisation required

7 Key attributes of perfectovir Extremely high efficacy (>95%) Minimal toxicity Once daily dosing Pangenotypic Short duration (4-6 weeks) HCV therapeutic development

8 Key attributes of perfectovir Extremely high efficacy (>95%) Minimal toxicity Once daily dosing Pangenotypic Short duration (4-6 weeks) HCV therapeutic development

9 SVR12 % NEUTRINO: PEG-IFN/RBV/Sofosbuvir Genotype 1 (+4/5/6) treatment naïve, 12 weeks Lawitz E et al. NEJM 2013;368:1878-1887

10 SVR12 % Abbvie: ABT-450/r/Ombitasvir/Dasabuvir Genotype 1, treatment naïve and experienced Sapphire-I & II Pearl-II & III Pearl-IV & Turquoise-II Zeuzem S, et al. NEJM 2014;370:1604-1614; Poordad F, et al. NEJM 2014; Feld JJ, et al. NEJM 2014

11 SVR 12 % Genotype 1, treatment naive and experienced Afdhal N, et al. NEJM 2014;370:1483-1493; Afdhal N, et al. NEJM 2014; Kowdley KV, et al. NEJM 2014 ION-1 (16% cirrhosis) ION-2 (20% cirrhosis) ION-3 Gilead: Sofosbuvir/Ledipasvir

12 SVR 12 % Genotype 1, treatment naive and experienced, 12 weeks Jacobson I, et al. AASLD 2013 COSMOS: Sofosbuvir/Simeprevir

13 SVR 12 % Sofosbuvir/Ribavirin vs PEG-IFN/RBV Genotype 2, treatment naive, 12 weeks vs 24 weeks Lawitz E et al. NEJM 2013;368:1878-1887

14 SVR 12 % Zeuzem S et al, AASLD 2013 Sofosbuvir/Ribavirin Genotype 3, treatment naïve and experienced, 24 weeks

15 Key attributes of perfectovir Extremely high efficacy (>95%) Minimal toxicity Once daily dosing Pangenotypic Short duration (4-6 weeks) HCV therapeutic development

16 HCV prevalence and genotype distribution Hajarizadeh B, Grebely J, Dore GJ. Nat Rev Gastroenterol Hepatol 2013

17 SVR12 % Everson GT, et al. ILC2014 Sofosbuvir/GS-5816 Treatment naïve, F0-3, 12 weeks

18 Key attributes of perfectovir Extremely high efficacy (>95%) Minimal toxicity Once daily dosing Pangenotypic Short duration (4-6 weeks) HCV therapeutic development

19 SVR 12 % Sofosbuvir/Ledipasvir Genotype 1, treatment naïve, F0-2 Lawitz E et al, AASLD 2013; Gane E et al, AASLD 2013

20 SVR 12 % Lawitz E et al, AASLD 2013; Gane E et al, AASLD 2013 Sofosbuvir/Ledipasvir Genotype 1, treatment naïve, F0-2

21 SVR 12 % Lawitz E et al, AASLD 2013; Gane E et al, AASLD 2013 Sofosbuvir/Ledipasvir Genotype 1, treatment naïve, F0-2

22 SVR 12 % Genotype 1, treatment naïve, F0-3 Kohli A et al, AASLD 2013 Sofosbuvir/Ledipasvir/3 rd DAA

23 SVR12 % Kohli A et al, AASLD 2013 Sofosbuvir/Ledipasvir/3 rd DAA Genotype 1, treatment naïve, F0-3

24 HCV regimen approval timelines: Australia

25 2020 PEG + RBV 201620142018201520192017 PEG + RBV + TPV/BCP HCV regimen approval timelines: Australia

26 2020 PEG + RBV 201620142018201520192017 PEG + RBV + TPV/BCP PEG + RBV + Sofosbuvir / Simeprevir (G1)PBACTGA IFN-free: Sofosbuvir + Ribavirin (G2/3)PBACTGA HCV regimen approval timelines: Australia

27 2020 PEG + RBV 201620142018201520192017 PEG + RBV + TPV/BCP PEG + RBV + Sofosbuvir / Simeprevir (G1)PBACTGA IFN-free: Sofosbuvir + Ribavirin (G2/3)PBACTGA IFN-free: ABT450/r + Ombitasvir + Dasabuvir +/- Ribavirin (G1) IFN-free: Sofosbuvir + Ledipasvir (G1)TGAPBAC TGAPBAC HCV regimen approval timelines: Australia

28 2020 PEG + RBV 201620142018201520192017 PEG + RBV + TPV/BCP PEG + RBV + Sofosbuvir / Simeprevir (G1)PBACTGA IFN-free: Sofosbuvir + Ribavirin (G2/3)PBACTGA IFN-free: ABT450/r + Ombitasvir + Dasabuvir +/- Ribavirin (G1) IFN-free: Sofosbuvir + Ledipasvir (G1)TGAPBAC TGAPBAC IFN-free: Sofosbuvir + GS-5816 (GT1-6)TGAPBAC HCV regimen approval timelines: Australia

29 A few caveats High drug pricing Probable disease stage restriction for IFN-free DAA therapy Potential treatment caps But Several pharma companies should ensure competitive pricing Ability to cure close to 100% should empower the sector HCV therapeutic development

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