HEPATITIS C. Current approach and Therapeutic considerations

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1 HEPATITIS C Current approach and Therapeutic considerations

2 Disease Burden Approximately 3.2 million people in the U.S. infected (1.3%) with HCV Responsible for 16,000 death per year in the U.S. (CDC 2010) Untreated, mortality projected to rise to 35,000 deaths per year over the next years. 15,000 cases of HCC per year, 50% are HCV associated Annual risk of HCC with cirrhosis 1-7% Armstrong et al, Ann Int Med Rein et al, Ann Int Med 2012, Ly et al, Ann Int Med 2012

3 Model of disease burden for untreated HCV Retirement Career Change Rein et al Digestive and Liver disease 2011

4 HCV screening and surveillance Surveillance of all high risk populations Injection drug users Receipt of blood products prior to 1990 High risk sexual behaviour HIV positive individuals 2011 CDC recommends screening of all baby boomers ( ) Estimates suggest that 45-80% of HCV infections have not been identified. Screening could identify up to 800,000 new cases.

5 HCV evaluation History Risk factor: Date of onset surrogate marker of duration Age -> more rapid disease progression with Advanced age at time of infection Advancing age Disease modifying factors HIV co-infection Alcohol use HBV Metabolic syndrome, NAFLD, DM

6 HCV evaluation Confirm HCV RNA positive Assess genotype (and subtype) Comorbidities/complications Metabolic syndrome/dm Iron overload Autoimmune disease Cryoglobulinaemia Renal disease -> urinalysis (MPGN without cryo s) Peripheral rash Neuropathy Baseline ultrasound Cirrhosis Vascular disease

7 Stage of fibrosis Liver biopsy Non-invasive markers of fibrosis Serum Indirect tests and indices Direct markers Elastography Fibroscan Ultrasound MR

8 Issues with liver biopsy Limitations Invasive 20% of patients experience pain Bleeding: % of patients Difficult to repeat frequently Sampling error 50,000 th of the liver 30% of biopsies taken between R and L lobe of liver had discrepancy of at least one stage Studies suggest biopsies of at least 2.5 cms needed Interpretation Significant inter and intraobserver variability.

9 Fibrosis staging

10 Noninvasive markers of liver fibrosis As a general rule: poor discrimination between stages of fibrosis, but reasonable performance for diagnosis of cirrhosis Indirect markers AST/ALT ratio: > 1 suggestive of cirrhosis APRI: AST/platelet ratio index. Fair to good performance. Fib-4: AST, ALT, age and platelets Similar to slightly superior performance c/w APRI

11 Non-invasive markers of fibrosis Direct markers (Commercially available) FibroTest (FibroSure U.S.) Age, sex, haptoglobin, alpha 2 macroglobulin, apolipoprotein A1, GGT, T bilirubin. Correlates with disease outcome Fibrospect: TIMP, alpha 2 macroglobulin and hyaluronic acid (HA) Only reports significant fibrosis (>F2) Hepascore: HA, alpha 2 macroglobulin, GGT and T bilirubin

12 Problems with serum markers Not liver specific Markers such as hyaluronic acid, procollagen increased in fibrotic skin diseases, arthritis etc.. May not be accurate in concomitant kidney disease (decreased renal clearance) Affected by aberrant results Gilbert s syndrome Haemolysis Inflammatory disorders

13 Elastography Fibroscan: Vibration induced elastography ARFI: Acoustic radiation force imaging Ultrasound based MR elastography

14 Fibroscan

15 Elastography Fair discrimination between stages of fibrosis In cirrhosis predictive of complications including portal hypertension, HCC etc. Increased stiffness measurements observed: Postprandial Congestive heart failure High serum transaminases (>5x ULN) Infiltrative disorders of the liver (sarcoidosis)

16 Test performance Significant fibrosis Cirrrhosis Test AUROC Sens Spec AUROC Sens Spec APRI % 95% % 94% Fib % 79% % 92% FibroSure % 96% % 81% FibroSpect % 70% Hepascore % 79% % 86% Fibroscan ARFI

17 Current Approach Discrepant results, Atypical features Liver biopsy Initial clinical Eval No cirrhosis Cirrhosis APRI Fibrosure Elastography HCC surveillance Varicies screening Consistent results Cirrhosis

18 Decision to treat Treat Stage F3-F4 (high priority) F4 commence HCC surveillance and EGD for varices Cirrhosis esp with features of liver decompensation refer to hepatologist. Stage F2 Individualize therapy Bias should be to offer treatment. Increased by Older age F0-1 HIV/HBV coinfection Concomitant DM, NAFLD Renal disease Individualise therapy (as above) Reasonable to defer for social, substance abuse, cost etc..

19 Hepatitis C structure and replication

20 HCV Replication

21 Classes of new drugs for the treatment of hepatitis C Drug class Example Pangenotypic Barrier to resistance Viral inhibition Protease inhibitors Simeprevir Faldaprevir Asuneprevir No (G1,?G4) Moderate Cross-resistance ++ High Nucleotide inhibitors of HCV polymerase Sofosbuvir Mericitabine Yes High High Non-nucleoside inhibitors of HCV polymerase Filibuvir Telgobuvir Deleobuvir No Low Low/mod Replication complex inhibitors Daclatasvir Ledipasvir Yes Low to medium Low/mod

22 Other targets for HCV treatment Viral entry: Monoclonal antibodies to SRB-1 and lectins have been shown to inhibit viral entry Viral assembly Target lipid binding and post-translational modification Cyclophilin inhibitors (host protein) Cyclophilin involved in viral replication complex Allosporuvir, Debio 025. MicroRNA-122 inhibitors Miravirsen

23 Investigational HCV Agents Class Drug Dosing NS3/4A protease inhibitor ABT-450/RTV 150/100 mg NS3 protease inhibitor Asunaprevir 200 mg BID NS3/4A protease inhibitor Faldaprevir 120 mg or 240 mg QD NS3 protease inhibitor GS mg QD NS3/4A protease inhibitor MK mg QD NS3/4A protease inhibitor Simeprevir 150 mg QD NS5B nonnucleoside polymerase inhibitor ABT mg BID NS5B nonnucleoside polymerase inhibitor BMS mg or 150 mg BID NS5B nonnucleoside polymerase inhibitor Deleobuvir 600 mg BID NS5B nonnucleoside polymerase inhibitor GS mg QD NS5B nucleotide polymerase inhibitor Sofosbuvir 400 mg QD NS5A inhibitor ABT mg QD NS5A inhibitor Daclatasvir 30 mg BID or 60 mg QD NS5A inhibitor Ledipasvir 90 mg QD NS5A inhibitor MK or 50 mg QD NS5A inhibitor PI mg QD

24 Principles of therapy One potent agent (Protease inhibitor or nucleotide analogue) + one or two equal or less potent agents. Therapy used should have: High expected sustained viral response rate (>85-90%) Therapy tailored to genotype and?subtype. Be cognoscente of prior treatment history and response patterns Protease resistance is a class effect Careful with drug-drug interactions (PIs and daclatasvir are Cyp3a metabolised) Pharmacokinetics and dosing: e.g. Sofosbuvir in CKD (GFR< 30) not defined.

25 QUEST-1: Simeprevir + P/R RGT in Treatment-Naive GT 1 HCV Randomized, double-blind, placebo-controlled phase III trial 12% to 13% had cirrhosis, 56% to 57% had GT 1a HCV Stratified by GT 1 subtype, IL28B genotype Wk 12 Wk 24 Wk 48 Treatment-naive pts with GT 1 HCV (N = 394) Simeprevir 150 mg QD + P/R* (n = 264) Placebo + P/R (n = 130) P/R P/R P/R *Response-guided therapy: Patients with HCV RNA < 25 IU/mL at Wk 4 and HCV RNA undetectable at Wk 12 received a total of 24 wks of therapy. Those not achieving this on-treatment response received 48 wks of therapy. P/R, peginterferon alfa-2a 180 µg/wk + ribavirin mg/day. Jacobson I, et al. EASL Abstract 1425.

26 HCV RNA Undetectable (%) SVR12 (%) QUEST-1: Virologic Response to Simeprevir + P/R Treatment Virologic Outcomes SMV + P/R P/R SVR12 by RGT Group 85% of pts in SMV arm met RGT criteria n/ N = 202/ 254 Wk / 65/ n/ N = 203/224 6/28 SVR12 24 Wks 48 Wks Jacobson I, et al. EASL Abstract Reproduced with permission. SMV Arm: Total Duration of RGT

27 SVR12 (%) SVR12 (%) QUEST-1: SVR12 by Fibrosis Level, Subtype, and Baseline Resistance SMV + P/R P/R n/n = 188/229 60/113 18/31 5/17 No Cirrhosis Cirrhosis /147 36/74 GT 1a 105/117 29/56 GT 1b GT 1a/other HCV With baseline Q80K vs Pbo Without baseline Q80K vs Pbo GT 1b HCV Differences in SVR12 by Subgroup (95% CIs) 28.2 ( ) 4.7 (-14.6 to 24.1) 40.3 ( ) 42.1 ( ) SMV (n) Pbo (n) Favors Placebo Favors SMV Jacobson I, et al. EASL Abstract Reproduced with permission.

28 HCV RNA < LLOQ (%) NEUTRINO: Sofosbuvir + P/R for 12 Wks in Treatment-Naive GT 1/4/5/6 HCV Patients Open-label, single-arm study of sofosbuvir 400 mg QD + P/R for 12 wks in treatment-naive patients with GT 1/4/5/6 HCV 17% had cirrhosis; 89% had GT 1, 9% had GT 4, < 1% had GT 5, 2% had GT 6 HCV n/n = 321/ / /327 Wk 4 EOT SVR12 P/R: pegifn alfa-2a 180 µg/wk + RBV mg/day Lawitz E, et al. EASL Abstract Reproduced with permission.

29 SVR12 (%) SVR12 (%) NEUTRINO: SVR12 With Sofosbuvir + P/R According to Genotype and Fibrosis Level SVR12 According to Genotype SVR12 According to Fibrosis Level n/n = 261/292 27/28 7/7 GT 1 GT 4 GT 5, /273 43/54 No Cirrhosis Cirrhosis Lawitz E, et al. EASL Abstract Reproduced with permission.

30 COSMOS: Simeprevir + Sofosbuvir ± RBV in Genotype 1 HCV Patients Planned interim analysis of randomized phase IIa study 2 cohorts with same study design evaluating impact of duration and RBV Primary endpoint: SVR12 Randomized 2:1:2:1 Wk 12 Wk 24 Patients With GT1 HCV Cohort 1: Previous null responders, F0-F2 (N = 80) Cohort 2: Naives and previous null responders, F3-F4 (N = 87) Simeprevir + Sofosbuvir + RBV Simeprevir + Sofosbuvir Simeprevir + Sofosbuvir + RBV Simeprevir + Sofosbuvir Simeprevir 150 mg QD; sofosbuvir 400 mg QD; weight-based RBV mg/day. Jacobson I, et al. AASLD Abstract LB-3.

31 SVR12 (%) SVR4 (%) COSMOS: SVR12 in F0-F2 Pts (All Arms) and SVR4 in F3-F4 Pts (12-Wk Arms Only) Cohort 1 (F0-F2 Nulls): SVR12 (N = 80, all arms) SMV + SOF + RBV SMV + SOF Cohort 2 (F3-F4 Naives/Nulls): SVR4 (N = 41, 12-wk arms) /24 14/15 26/27 13/14 12/12 7/7 14/15 7/7 24-Wk Arms 12-Wk Arms Naives Null Responders Relapse in 3 pts in Cohort 1 and 1 pt in Cohort 2; all with GT1a and Q80K polymorphism at BL AEs (anemia and indirect bilirubin increases) largely confined to RBV arms Jacobson I, et al. AASLD Abstract LB-3. Reproduced with permission..

32 COSMOS: SVR12 in Cohorts 1 and 2 by HCV Subgenotype and Baseline Q80K Cohort 1 (F0-F2 Nulls)* [1] Cohort 2 (F3-F4 Naives/Nulls)* [2] SVR12 (%) GT1b GT1a without Q80K GT1a with Q80K / 4 7/ 7 8/ 9 SMV/SOF + RBV 3/ 3 7/ 7 3/ 3 SMV/SOF 6/ 6 12/ 12 8/ 9 SMV/SOF+ RBV SMV/SOF SMV/SOF ± RBV 24 Wks 12 Wks Overall 4/ 4 4/ 4 *Excluding patients who discontinued for nonvirologic reasons. 5/ 6 7/ / /2 7 6/ 6 11/ 11/ SMV/SOF + RBV 4/ 4 7/ 7 4/ 4 SMV/SOF 5/ 5 13/ 14 7/ 8 SMV/SOF + RBV SMV/SOF SMV/SOF ± RBV 24 Wks 12 Wks Overall 3/ 3 7/ 8 3/ 3 18/ 38/ 25/ Sulkowski M, et al. EASL Abstract O7. 2. Lawitz E, et al. EASL Abstract O165.

33 Summary: Current situation Genotype 1 infection Simeprevir + PR: 24 weeks of therapy, requires PR. Suboptimal response in G1a infection. Sofosbuvir + PR 12 weeks treatment, requires PR Suboptimal response in cirrhotic patients/prior PR non-responders Sofosbuvir + simeprevir 12 weeks treatment Well tolerated Limited data in cirrhotic patients and prior IFN treated patients (n=7). Clinical experience rapidly increasing Decreased efficacy G1a (Q80K mutation)

34 SAPPHIRE I & II: ABT- 450/RTV/Ombitasvir + Dasabuvir + RBV in Noncirrhotic GT1 Pts Double-blind, placebo-controlled phase III trials in treatment-naive (SAPPHIRE I) and treatment-experienced (SAPPHIRE II) GT1 HCV pts Wk 12 Treatment-naive noncirrhotic pts with HCV GT1 [1,2] (N = 631) Treatment-experienced noncirrhotic pts with HCV GT1 [3,4] (N = 394) ABT-450/RTV/Ombitasvir + Dasabuvir + RBV (n = 473) Placebo (n = 158)* ABT-450/RTV/Ombitasvir + Dasabuvir + RBV (n = 297) Placebo (n = 97) 1. Feld JJ, et al. EASL Abstract O60. Reproduced with permission. 2. Feld JJ, et al. N Engl J Med. 2014;370: Zeuzem S, et al. EASL Abstract O1. 4. Zeuzem S, et al. N Engl J Med. 2014;370:

35 SVR12 (%) SAPPHIRE I: SVR12 With 3 DAAs + RBV in Treatment-Naive Pts by HCV Subtype High response rates in treatment-naive patients across subgenotypes ABT-450/ombitasvir + dasabuvir + RBV / 473 All Patients 307/ 322 GT1a 148/ 151 GT1b 1. Feld JJ, et al. EASL Abstract O60. Reproduced with permission. 2. Feld JJ, et al. N Engl J Med. 2014;370:

36 TURQUOISE II: ABT-450/RTV/Ombitasvir + Dasabuvir + RBV in Cirrhotic GT1 Pts Open-label phase III trial Inclusion criteria: GT1, compensated cirrhosis (Child-Pugh A), DAA naive, radiographic ascites and varices permitted, serum albumin 2.8 g/dl, total bilirubin < 3 mg/dl, serum AFP 100 ng/ml, INR 2.3, platelets Wk 12 60,000 cells/ml Wk 24 DAA-naive cirrhotic pts with HCV GT1 (N = 380) ABT-450/RTV/Ombitasvir + Dasabuvir + RBV (n = 208) ABT-450/RTV/Ombitasvir + Dasabuvir + RBV (n = 172) Poordad F, et al. EASL Abstract O163. Reproduced with permission.

37 SVR12 (%) TURQUOISE II: SVR12 With 3 DAAs + RBV in Cirrhotic Pts by HCV Subtype GT1a wks 24 wks GT1b / 64 52/ 56 Naive 14/ 15 13/ 13 11/ 11 10/ 10 Relapse Partial Response 40/ 50 39/ 42 Null Response 0 22/ 22 18/ 18 Naive 25/ 25 20/ 20 6/7 3/ 14/ 3 Relapse Partial Response /1 0 Null Response Virologic failure in 17/380 pts (4.5%); relapse more frequent with 12-wk vs 24-wk treatment (12 vs 1 pt), 7/12 relapsers by posttreatment Wk 12 were GT1a null responders Poordad F, et al. EASL Abstract O163. Reproduced with permission.

38 ION 1: SOF/LDV FDC ± RBV for 12 or 24 Wks in Treatment-Naive GT1 Patients Open-label phase III trial [1,2] 15% to 17% of participants had cirrhosis Wk 12 Wk 24 SOF/LDV (n = 214) Treatmentnaive pts with HCV GT1 (N = 865) SOF/LDV + RBV (n = 217) SOF/LDV (n = 217) SOF/LDV + RBV (n = 217) Sofosbuvir/ledipasvir 400/90 mg FDC tablet once daily; weight-based RBV mg/day. Mangia A, et al. EASL Abstract O164. Reproduced with permission. Afdhal N, et al. N Engl J Med. 2014;[Epub ahead of print].

39 SVR12 (%) ION 1: SVR12 With 12 or 24 Wks SOF/LDV ± RBV in Tx- Naive Pts by Cirrhosis Status No cirrhosis Cirrhosis / / 34 SOF/LDV 178/ / 33 SOF/LDV + RBV 181/ / 33 SOF/LDV 179/ / 36 SOF/LDV + RBV 12 Wks 24 Wks SVR12 rates did not differ by GT1a vs GT1b in any treatment arm Virologic failure: 1 breakthrough in 24-wk SOF/LDV; 2 relapses (1 in 12-wk SOF/LDV, 1 in 24-wk SOF/LDV) 16% of patients had NS5A resistance-associated variants at baseline; 96% of these achieved SVR12 Mangia A, et al. EASL Abstract O164. Reproduced with permission. Afdhal N, et al. N Engl J Med. 2014;.

40 SVR12 (%) ION 2: SVR12 With 12 or 24 Wks SOF/LDV ± RBV by Treatment History Failure on pegifn/rbv 40 Failure on PI / 43 62/ 66 LDV/SOF 45/ 47 62/ 64 LDV/SOF + RBV 58/ 58 49/ 50 LDV/SOF 12 Wks 24 Wks 58/ 59 51/ 51 LDV/SOF + RBV Virologic failure: 1 breakthrough in 24-wk SOF/LDV/RBV due to nonadherence; 11 relapses (7 in 12-wk SOF/LDV, 4 in 12-wk SOF/LDV/RBV) 14% of patients had NS5A resistance-associated variants at baseline; 89% of these achieved SVR12 Afdhal N, et al. EASL Abstract O109. Reproduced with permission. Afdhal N, et al. N Engl. J Med. 2014;370:

41 SVR12 (%) ION 2: SVR12 With 12 or 24 Wks of SOF/LDV ± RBV by Cirrhosis Status No cirrhosis Cirrhosis / 87 19/ 22 LDV/SOF 89/ 89 18/ 22 LDV/SOF + RBV 86/ 87 22/ 22 LDV/SOF 12 Wks 24 Wks 88/ 89 22/ 22 LDV/SOF + RBV SVR12 rates were significantly lower in cirrhotic vs noncirrhotic patients in the pooled 12-wk arms Afdhal N, et al. EASL Abstract O109. Reproduced with permission. Afdhal N, et al. N Engl J Med. 2014;370:

42 EASL HCV Guidelines 2014: Genotype 1 Genotype Genotype 1* Options for Therapy PegIFN/ribavirin + sofosbuvir: 12 wks (A1) PegIFN/ribavirin + simeprevir : 12 wks, followed by 12 wks of pegifn/ribavirin in previously untreated pts and prior relapsers (A1), or 36 wks of pegifn/ribavirin in previous partial responders and null responders (B1) PegIFN/ribavirin + daclatasvir (genotype 1b only; B1): 12 wks followed by 12 wks of pegifn/ribavirin alone or a further 12 wks of pegifn/ribavirin + daclatasvir (response-guided therapy) (B2) Sofosbuvir + ribavirin: 24 wks for interferon-intolerant pts only, where no other interferon-free option available (B2) Sofosbuvir + simeprevir: 12 wks (ribavirin may be added for previous nonresponders & cirrhotics) (B1) Sofosbuvir + daclatasvir: 12 wks in previously untreated pts; 24 wks in treatment-experienced patients (including TVR/BOC-experienced patients) (ribavirin may be added in previous nonresponders and cirrhotics) (B1) EASL. J Hepatology. 2014;60:

43 FISSION: Sofosbuvir/RBV vs PegIFN/RBV in Treatment-Naive GT 2/3 HCV Patients Randomized, controlled, open-label phase III noninferiority trial 20% to 21% had cirrhosis; 72% had GT 3 HCV Stratified by HCV GT (2 vs 3), HCV RNA (< vs 10 6 IU/mL), cirrhosis (yes vs no) Wk 12 Wk 24 Treatment-naive patients with GT 2/3 HCV (N = 499) Sofosbuvir 400 mg QD + RBV mg/day (n = 256) PegIFN alfa-2a 180 µg/wk + RBV 800 mg/day (n = 243) Gane E, et al. EASL Abstract 5.

44 HCV RNA < LLOQ (%) FISSION: Sofosbuvir/RBV Noninferior to P/R in Tx-Naive GT 2/3 HCV Patients Sofosbuvir + RBV PegIFN + RBV P < n/n = 249/ / / /224 NA 188/190 Wk 4 Wk 12 Wk / /243 SVR12 On Treatment Gane E, et al. EASL Abstract 5. Reproduced with permission.

45 SVR12 (%) FISSION: SVR12 According to Genotype and Fibrosis Level Sofosbuvir + RBV PegIFN + RBV n/n = 58/59 44/54 10/11 8/13 89/145 99/139 13/38 11/37 0 No Cirrhosis Cirrhosis No Cirrhosis Cirrhosis Genotype 2 Genotype 3 Gane E, et al. EASL Abstract 5. Reproduced with permission.

46 VALENCE: Sofosbuvir + RBV for 12 or 24 Wks in Naive and Exp d GT2/3 HCV Pts Phase III study in Europe Original protocol amended to lengthen treatment for all GT3 pts when emerging data suggested benefit of additional treatment for this group* Primary endpoint: SVR12 Wk 12 Wk 24 HCV-infected tx-naive or exp d pts (N = 323) GT2 GT3 Sofosbuvir 400 mg QD + RBV 1000 mg or 1200 mg/day (n = 73) Sofosbuvir 400 mg QD + RBV 1000 mg or 1200 mg/day (n = 250) *Small number of GT3 patients (n = 11) who had already completed 12 wks at time of protocol amendment were included in safety analysis with GT2 but analyzed separately for efficacy. Patients randomized to placebo in original protocol offered alternative treatment protocol. Zeuzem S, et al. AASLD Abstract Reproduced with permission.

47 SVR12 (%) SVR12 (%) VALENCE: SVR12 With 12 or 24 Wks of SOF + RBV in GT2 and GT3 Pts GT2 12-Wk Treatment (n = 73) GT3 24-Wk Treatment (n = 250) n/n = 29/30 2/2 30/33 7/8 n/n = 0 0 Naive, Noncirrhotic Naive, Cirrhotic Exp d Noncirrhotic No increase in AEs seen with longer duration treatment AEs seen consistent with RBV Exp d, Cirrhotic Zeuzem S, et al. AASLD Abstract Graphics used with permission /92 12/13 87/100 27/45 Naive, Noncirrhotic Naive, Cirrhotic Exp d Noncirrhotic Exp d, Cirrhotic

48 SVR12 (%) LONESTAR-2: Sofosbuvir + P/R for 12 Wks in Treatment-Exp d GT2/3 HCV Pts Single-arm trial of pts with treatment failure on P/R Approximately 50% with compensated cirrhosis Primary endpoint: SVR12 Pts with GT2 or GT3 HCV and previous treatment failure with P/R (N = 47) Sofosbuvir 400 mg QD + PegIFN 180 µg once wkly + RBV 1000 mg or 1200 mg/d Wk n/n = 96 22/23 GT /24 GT3 Lawitz E, et al. AASLD Abstract LB-4. Reproduced with permission. Similar rates of SVR12 in pts with and without cirrhosis

49 ELECTRON 2: SOF/LDV FDC ± RBV in Diverse Hard-to-Treat Patients Partially randomized, open-label phase II trial Treatment-naive GT3 (N = 51) SOF/LDV FDC (n = 25) SOF/LDV FDC + RBV (n = 26) Wk 12 SVR12, % GT1 and CTP class B cirrhosis (N = 20) GT1 relapsers after previous SOF-based regimen* (N = 19) SOF/LDV FDC (n = 20) SOF/LDV FDC + RBV (n = 19) Sofosbuvir/ledipasvir 400/90 mg FDC tablet once daily; weight-based RBV mg/day. *Includes 10 patients who received SOF + RBV for 12 wks, 8 patients who received SOF/LDV + RBV for 6 wks, and 1 patient who received SOF + GS RBV for 12 wks. Gane EJ, et al. EASL Abstract O6. Reproduced with permission.

50 Current status for treatment of G2 and G3 Genotype 2: Sofosbuvir and ribavirin for 12 weeks Consider extended therapy in cirrhotic patients??insurance Genotype 3: Sofosbuvir and ribavirin for 24 weeks Sofosbuvir and PR in treatment experienced cirrhotic patients Consider awaiting NS5 inhibitors +/- ribavirin Sofosbuvir, NS5 inhibitor +/- ribavirin

51 Pretransplant Sofosbuvir + RBV to Prevent Posttransplant HCV Recurrence Study 025: single-arm, open-label phase II study from 16 liver transplantation sites Listed for LT due to HCC meeting Milan criteria MELD exception for HCC CTP score 7 Excluded decompensated cirrhosis, renal impairment, living donor LT Pre-LT therapy: SOF 400 mg/day + RBV mg/day for 48 wks or until time of LT Characteristic SOF + RBV (N = 61) Median age, yrs (range) 59 (46-73) HCV genotype, % 1a 39 1b a Non-CC IL28B genotype, % 78 CTP score, % Previous HCV treatment, % 75 Post-LT immunosuppression: 12 wks tacrolimus + prednisone + Curry MP, et al. AASLD Abstract 213. Reproduced with permission. MMF

52 Duration of Undetectable HCV RNA Before Transplant Predicted Lack of Recurrence > 30 days TND 64% of pts HCV RNA negative 12 wks post-lt (93% at LT) Continuous days TND pre-lt only factor predicting HCV recurrence in multivariate analysis Only 1/24 pts with > 30 days TND experienced recurrence No recurrence (n = 28) Recurrence (n = 10) Median days TND (P <.001) No recurrence: 95 Recurrence: Days With HCV RNA Continuously TND Prior to Liver Transplant Curry MP, et al. AASLD Abstract 213. Reproduced with permission. 330

53 SOF + RBV in Patients With Cirrhosis and Portal Hypertension ± Decompensation Interim results of an open-label phase II trial Primary endpoint: SVR12 Wk 24 Current analysis Wk 48 Wk 72 HCV-infected patients with portal hypertension ± decompensated liver disease* (N = 50) Sofosbuvir + Ribavirin (n = 25) Observation (n = 25) Sofosbuvir + Ribavirin (n = 25) Sofosbuvir 400 mg once daily; ribavirin mg/day divided twice daily. *Among 25 patients allocated sofosbuvir + ribavirin, 10 had GT1a HCV, 9 had GT1b, 2 had GT2, 2 had GT3, and 2 had GT4. Afdhal N, et al. EASL Abstract O68. Reproduced with permission.

54 HCV RNA < LLOQ (%) Virologic Response to SOF + RBV in Patients With Portal Hypertension CTP A CTP B 20 0 Wk 2 Wk 4 Wk 8 Wk 12 Wk 24 Clinical Events, n SOF + RBV (n = 25) Ascites Observation (n = 25) Hepatic Encephalopathy SOF + RBV (n = 25) Afdhal N, et al. EASL Abstract O68. Reproduced with permission. Observation (n = 25) Baseline Wk Wk

55 SVR: Does the fibrosis regress? Anecdotal data show resolution of cirrhosis Poynard (n=933) (Fibrotest) Follow-up 10 years SVR (n=108) 43% demonstrated regression of fibrosis Net reduction in cirrhosis 5.3% 4 cases of primary liver cancer Poynard, J Hepatology 2013

56 Cumulative HCC Occurrence (%) Meta-analysis: Risk of HCC in HCV Pts With Advanced Fibrosis Following SVR 1000 patients with bridging fibrosis or cirrhosis who achieved SVR following IFN-based HCV therapy followed for median of 5.7 yrs Cirrhotics at greatest risk of HCC following SVR P = Cirrhosis Bridging Fibrosis 8-Yr HCC Rate, % (95% CI) 8.5 ( ) 1.8 (0-4.3) Yrs Van der Meer AJ, et al. AASLD Abstract 143. Reproduced with permission.

57 In summary We now have highly effective anti-viral therapy, and improved treatment options will be available at the end of the year All oral regimens should result in response rates > 90% Multi-drug regimens Multiple regimens Treatment selection and duration will depend upon Genotype (?subtype) Fibrosis stage Prior treatment history Still many questions regarding the optimal therapy in certain subgroups Prior treatment failure Renal failure Advanced liver disease Genotype 3, and 4.

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