Clinical Management: Treatment of HCV Mono-infection
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1 Clinical Management: Treatment of HCV Mono-infection Curtis Cooper, MD, FRCPC Associate Professor-University of Ottawa The Ottawa Hospital- Infections Diseases Viral Hepatitis Program- Director
2 Industry Investigator: Merck, Vertex, Roche, BI, Janssen, GS, BMS, Abbvie, Idenix Consultant /Advisor: Merck, Vertex, Roche, BI, GS, Abbvie Speaker: Merck, Roche, BI, BMS Government OHTN CIHR Health Canada Ontario MOH CADTH Disclosures
3 Overview Current & Emerging Therapies Best Practices & Clinical Practice Guidelines
4 Therapies for Hepatitis C Virus PEG-IFN α / RBV +/- Protease Inhibitor Duration of Tx / RGT Definition of Therapeutic Success Plasma HCV RNA undetectable 6 months post therapy (Sustained Virologic Response=Cure)
5 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.
6 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
7 Advances Soon to Come
8 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
9 Direct Acting Antiviral Drug (DAA) Combinations
10 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 10
11 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 #
12 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 12
13
14 SMV 150mg od x 12/52 91% meet RGT criteria for 24/52
15 Advances soon to come. Sofosbuvir Simeprevir Faldaprevir Still dealing with complex patients, complex IFN-based regimens and toxicities
16 Interferon-Sparing Regimens
17 COSMOS- AASLD 2013
18 Highlights of AASLD 2012 clinicaloptions.com/hepatitis ELECTRON: SOF-Ledipasvir-RBV -Noncirrhotic, GT1 Interim analysis of nonrandomized phase II study with sofosbuvir ± 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 * *Data reported for 3 pts only. Data collection ongoing. Gane EJ, et al. AASLD Abstract 229.
19 SVR12 (%) Highlights of AASLD 2012 clinicaloptions.com/hepatitis AVIATOR: SVR12 ABT-450/r-ABT-267-ABT-333-RBV 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.
20 HCV RNA < LLOQ TD or TND (%) HCV RNA < LLOQ TD or TND (%) Highlights of AASLD 2012 clinicaloptions.com/hepatitis Daclatasvir-Asunaprevir-BMS (mitt 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 0 Wk 4 Wk 12 EOT SVR4 SVR12 Everson GT, et al. AASLD Abstract LB-3.
21 IFN-Sparing, All Oral Regimens High SVR rates Shorter Duration Excellent Tolerance Funding Issues
22 HCV Guidelines
23 Discussion
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