New developments in HCV research and their implications for front-line practice

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1 New developments in HCV research and their implications for front-line practice Dr. Curtis Cooper Associate Professor, University of Ottawa Director, Ottawa Hospital Viral Hepatitis Program June 17, 2013

2 New developments in HCV research and their implications for front-line practice Curtis Cooper, MD, FRCPC Associate Professor-University of Ottawa The Ottawa Hospital- Infections Diseases Viral Hepatitis Program- Director

3 Industry Investigator: Merck, Vertex, Roche, BI, Janssen, GS, BMS, ABT Consultant /Advisor: Merck, Vertex, Roche, BI, GS Speaker: Merck, Roche, BI, BMS Government CADTH OHTN CIHR PCIRN Health Canada Ontario MOH Disclosures

4 Overview Overview of HCV and Current Standard of Care Future Therapies HIV-HCV co-infection issues New Treatment Guidelines Sexual Transmission of HCV Effective Service Delivery Models Other relevant topics

5 Therapies for Hepatitis C Virus PEG-Interferon α / Ribavirin Duration of Tx / RGT Definition of Therapeutic Success Plasma HCV RNA undetectable 6 months post therapy (Sustained Virologic Response=Cure)

6 Direct Acting Antivirals capsid envelope protein Protease / Helicase RNA-dependent RNA Polymerase c22 33c c cor e E1 E2 NS 2 NS 3 NS 4 NS5a / NS5b hypervariable region

7 Direct Acting Antiviral Drug (DAA) Combinations

8 Highlights From AASLD 2010 clinicaloptions.com/hepatitis Boceprevir and Telaprevir Boceprevir, a potent inhibitor of HCV NS3 protease Telaprevir, a potent inhibitor of HCV NS3/4A protease Dosed in combination with standard-of-care peginterferon alfa-2/ ribavirin Key Phase III Studies Boceprevir SPRINT-2: naive GT1 patients RESPOND-2: nonresponder GT1 patients Telaprevir ADVANCE: naive GT1 patients ILLUMINATE: responseguided therapy in naive GT1 patients

9 Patients (%) Patients (%) Highlights From AASLD 2010 clinicaloptions.com/hepatitis SPRINT-2: Response Rates According to Race 4-wk PR + response-guided BOC + PR 4-wk PR + 44 weeks BOC + PR 48-wk PR 100 Nonblack Patients 100 Black Patients P < P =.044 P = n = SVR Relapse SVR Relapse Poordad F, et al. AASLD Abstract LB-4.

10 SVR (%) Highlights From AASLD 2010 clinicaloptions.com/hepatitis RESPOND-2: SVR Rates According to Treatment Arm and Prior Response P <.0001 vs control (both arms) wk PR + response-guided BOC + PR (n = 162) 4-wk PR + 44-wk BOC + PR (n = 161) 48-wk PR (n = 80) * Overall RR RGT 15% FD 12% 0 95/ / 161 Overall 17/ 80 23/ 30/ /29 Previous Nonresponders 72/ / / 51 Previous Relapsers Control 32% Bacon BR, et al. AASLD Abstract 216.

11 Patients (%) Highlights From AASLD 2010 clinicaloptions.com/hepatitis ADVANCE: Overall SVR and Relapse Rates P <.0001 for both treatment arms vs control wk TVR + PR + 16/40-wk PR (n = 364) 12-wk TVR + PR + 12/36-wk PR (n = 363) 48-wk PR (n = 361) 20 0 n = SVR Jacobson IM, et al. AASLD Abstract 211.

12 SVR (%) Highlights From AASLD 2010 clinicaloptions.com/hepatitis PROVE 3: SVR Rates According to Prior Response wk TVR + PR + 12-wk PR (n = 115) 24-wk TVR + PR + 24-wk PR (n = 113) 24-wk TVR + P (n = 111) 48-wk PR (n = 114) * 53* Overall Prior Nonresponders *P <.001 vs control. P =.02 vs control. McHutchison JG, et al. N Engl J Med. 2010;362: Prior Relapsers Prior Breakthrough

13 SVR12 (%) Highlights of AASLD 2012 clinicaloptions.com/hepatitis OPTIMIZE: Efficacy of Telaprevir BID vs Telaprevir q8h in GT1 HCV Infection SVR12 rates similar with TVR BID and q8h dosing regimens in all subgroups Similar safety and tolerability profile in both treatment arms TVR q8h/pr TVR BID/PR n/ N = 92/ / / / / 57 CC CT TT IL28B GT 38/ / / / / 105 F0-2 F3/4 Liver Disease Status Buti M, et al. AASLD Abstract LB-8. Reproduced with permission.

14 Summary Slide Much improved SVR rates in treatment naive and experienced populations Many are not eligible for these regimens Side effect profile remains very challenging Required intensive support and follow-up

15 Advances Soon to Come

16 Sofosbuvir (SOF, GS-7977) HCV-specific nucleotide polymerase inhibitor (chain terminator) Potent pan-genotypic antiviral activity against HCV GT1 6 High barrier to resistance Once-daily, oral, 400-mg tablet Favorable clinical pharmacology profile No food effect No significant drug interactions Generally safe and well-tolerated in clinical studies to date (> 2,000 patients) No safety signal in preclinical/clinical studies 16

17 Patients with HCV RNA <LLOQ (%) Phase 3: NEUTRINO GT 1, 4, 5, 6 Treatment-Naïve SVR12 by HCV Genotype 295/ /292 27/28 7/7 Overall GT 1 GT 4 GT 5,6 Open label, single arm study of PegIFN-Ribavirin-SOF x 12/52 Error bars represent 95% confidence intervals Lawitz E, et al. EASL Amsterdam, The Netherlands. Oral #

18 Patients with HCV RNA <LLOQ (%) Phase 3: FISSION GT 2, 3 Treatment-Naïve Primary Endpoint and Virologic Response 231/251 76/ / / / /224 NA Week 2 Week 4 Week 12 Week 24 On treatment 188/ / /243 Week 12 Post-treatment Study met primary endpoint of non-inferiority (P<0.001) Relapse accounted for nearly all virologic failures There was 1 instance of virologic breakthrough from a patient who had suspected non-adherence based on undetectable drug plasma levels No S282T mutations observed by population or deep sequencing (1% cutoff) Error bars represent 95% confidence intervals Gane E, et al. EASL Amsterdam, The Netherlands. Oral #5 18

19

20 SMV 150mg od x 12/52 91% meet RGT criteria for 24/52

21 Advanced are soon to come. Sofosbuvir Simeprevir Faldaprevir Daclatasvir HIV Experience- still deal with complex patients and toxicities

22 Interferon-Sparing Regimens

23 Sulkowski. EASL 2013

24 Highlights of AASLD 2012 clinicaloptions.com/hepatitis ELECTRON: Sofosbuvir, GS-5885, and RBV in Noncirrhotic Pts With GT1 HCV Interim analysis of nonrandomized phase II study with sofosbuvir (nucleoside polymerase inhibitor) ± GS-5885 (NS5A inhibitor) Wk 12 Patients, % EOT SVR4 SVR12 Treatment naive (n = 25) Null responders (n = 10) SOF + RBV SOF + RBV Treatment naive (n = 25) Null responders (n = 9) SOF + GS RBV SOF + GS RBV * No SAEs related to study drugs; AE profile consistent with RBV toxicity profile *Data reported for 3 pts only. Data collection ongoing. Gane EJ, et al. AASLD Abstract 229.

25 SVR12 (%) Highlights of AASLD 2012 clinicaloptions.com/hepatitis AVIATOR: SVR12 Rates With ABT-450/ RTV, ABT-267, ABT-333, and RBV SVR12 rates higher in pts with GT1b HCV but also high in pts with GT1a HCV 12-wk regimen with all 3 DAAs + RBV produced highest SVR12 rates No drug-related SAEs reported; 2 pts discontinued tx due to drug-related AEs Treatment-Naive Patients Null Responders Observed data (above bar) ITT (within bar) n = a 1b 1a 1b 1a 1b 1a 1b 1a 1b 1a 1b 1a 1b ABT-450 ABT-267 ABT-333 RBV ABT-450 ABT-333 RBV ABT-450 ABT-267 RBV ABT-450 ABT-267 ABT-333 ABT-450 ABT-267 ABT-333 RBV ABT-450 ABT-267 RBV ABT-450 ABT-267 ABT-333 RBV 8 wks 12 wks 12 wks Kowdley KV, et al. AASLD Abstract LB-1. Reproduced with permission.

26 HCV RNA < LLOQ TD or TND (%) HCV RNA < LLOQ TD or TND (%) Highlights of AASLD 2012 clinicaloptions.com/hepatitis Response to Daclatasvir, Asunaprevir, and BMS in Modified ITT Analysis HCV RNA < LLOQ TD or TND Missing data 24-Wk Treatment (n = 16) 12-Wk Treatment (n = 16) Wk 4 Wk 12 EOT SVR4 Wk 4 Wk 12 EOT SVR4 SVR12 Both regimens generally well tolerated, with no discontinuations due to AEs Infrequent SAEs, grade 3/4 AEs, or grade 3/4 lab abnormalities Everson GT, et al. AASLD Abstract LB-3. Reproduced with permission.

27 Summary Slide High SVR rates Excellent Tolerance DDI remain an issue HIV co-infection studies remain to be conducted

28 HIV-HCV Co-Infection Most issues the same as in HCV monoinfection Published trials with Boceprevir and Telaprevir DDI issues

29 HIV-HCV Guidelines

30 Sexual Transmission of HCV Depends on the kind of sex Currently an epidemic in MSM Treatment of Acute HCV

31 Treatment Models Multi-D maximizes patient care and treatment outcomes How do we get these clinics funded? How will this change over time?

32 Treat now or Wait? Treat those who need treatment now Consider those who are ready for treatment now You may lose the opportunity later Treatment will remain difficult to tolerate Treatment will remain expensive Who will provide the treatment?... Sending the message that HCV treatment is not important

33 Funding Major Issue Drug costs will dictate funding criteria Who is going to advocate?

34 Discussion

35 CATIE Forum

36 Reflecting on our response to HCV 1. What is the most effective treatment service delivery model for marginalized HCV clients/patients? 2. What are the challenges for ASOs and other CBOs trying to integrate HCV services into their work? 3. What new linkages could your organization make with other service providers?

37 Thank you Next English webinars: 1. Integrated approaches to treatment and prevention July 9, 1pm EST 2. Working from a sexual health or harm-reduction perspective: Integration of HIV, HCV, tuberculosis and other sexually transmitted and blood-borne infections (STBBIs) July 22, 1pm EST Please evaluate this webinar!

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