Post AASLD Update in HCV Torino, 10 Gennaio Fattori che possono influenzare il trattamento: RVR e Lead in

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1 Post AASLD Update in HCV Torino, 10 Gennaio 2013 Fattori che possono influenzare il trattamento: RVR e Lead in Alessia Ciancio Università di Torino Città della Salute e delle Scienze

2 Will predictors usefull with SOC continue to be usefull with PI Tx? Viral factors - HCV subtype - HCV RNA levels Host factors Unmodifiable - Race/ethnicity - Genetics - Age/advanced fibrosis SVR On treatment factors Duration of regimen Cumulative dose exposure Adherence RVR Host factors Modifiable Metabolic syndrome GT Iron overload

3 Open issues Is RVR important in triple therapy? Is IL28B essential in DAA treatment? Should we use the lead-in? And should we use it with both drugs? Is there need for precise staging of the disease? Is there difference between G1a and G1b?

4 Genotype 1 treatment naïve patients achieving RVR Peg+Rbv 20% SVR >90% Peg+Rbv+ BOC SVR >90% 44% Peg+Rbv + Telaprevir SVR >90% 58%.Jacobson IM, et al. N Engl J Med 2011;364:

5 SVR rates in patients eligible for shortened treatment duration Telaprevir Boceprevir Patients (%) Patients (%) n/n= 212/ /212 95/145 91/95 162/ /162 Naïves Relapsers* Early responders SVR in early responders Naïves Early responder: Telaprevir: undetectable HCV RNA at Weeks 4 and 12; BOC: undetectable HCV RNA at Weeks 8 24 *SVR rate from REALIZE with 48 weeks of overall treatment; retrospective analysis from the PROVE3 trial and Study 107 showed Adda SVRN, et al. CDDW/CASL 2012:A26 Telaprevir EU rates of % in prior relapsers with undetectable HCV RNA at Weeks 4 and 12 who received 24 weeks of overall treatment SmPC; Poordad F, et al. N Engl J Med 2011;364:

6 German Tubingen cohort: patients with undetectable HCV RNA (interim analysis) 100 Boceprevir based therapy (n=27) Patients (%) Wk 4 Wk 8 Wk 12 Wk 18 Wk 24 Per protocol ITT Berg C, et al. 2012

7 French ATUs: on-treatment efficacy results in F4 prior relapsers and partial responders (telaprevir) Telaprevir Boceprevir Patients with undetectable HCV RNA (%) 157/223 84/122 59/179 Week 4 Week 4 and 12 Week 8

8 RVR Conclusions RVR is important : - in naive pts to choose between triple therapy and SOC - to choose pts eligible for shortened treatment duration - to motivate patients to stay on therapy

9 Open issues Is RVR important in triple therapy? Is IL28B essential in DAA treatment? Should we use the lead-in? And should we use it with both drugs? Is there need for precise staging of the disease? Is there difference between G1a and G1b?

10 Predictors of SVR in previously non responders: RESPOND 2 study Baseline predictors Effect IL 28B rs genotype: CC vs TT Odds Ratio (95% CI) p value 2.0 ( ) 0.27 IL 28B rs genotype: CC vs CT 2.3 ( ) 0.06 IL 28B rs genotype: CT vs TT 0.86 ( ) 0.77 Baseline HCV RNA: 400,000 vs. >400,000 IU/mL 2.6 ( ) 0.12 Cirrhosis: no vs yes 2.0 ( ) 0.18 BMI: 30 vs. > ( ) 0.33 Genotype: 1b vs 1a/other/missing 1.1 ( ) 0.77 Race: non black vs black ( ) 0.68 Previous response: relapser vs nonresponder 2.6 ( ) Poordad F et al, Gastroenterology 2012

11 IL28B is no longer an important predictor of SVR when lead-in response is considered Baseline predictors Including TW4 response Odds Ratio Odds Ratio Effect p value p value (95% CI) (95% CI) IL 28B rs genotype: CC vs TT 2.0 ( ) ( ) 0.65 IL 28B rs genotype: CC vs CT 2.3 ( ) ( ) 0.13 IL 28B rs genotype: CT vs TT 0.86 ( ) ( ) 0.48 Baseline HCV RNA: 400,000 vs. >400,000 IU/mL 2.6 ( ) ( ) 0.20 Cirrhosis: no vs yes 2.0 ( ) ( ) 0.16 BMI: 30 vs. > ( ) ( ) 0.35 Genotype: 1b vs 1a/other/missing 1.1 ( ) ( ) 0.54 Race: non black vs black ( ) ( ) 0.71 Previous response: relapser vs nonresponder Log decline in HCV RNA at TW 4 ( 1 vs < 1 log 10 ) 2.6 ( ) ( ) ( ) 0.01 Poordad F et al, Gastroenterology 2012

12 IL28B vs RGT: detailed on-treatment monitoring provides similar information 49% Treatment duration: 24 wks 25% undetectable* Treatment duration: 48 or 72 wks 45% undetectable Baseline genotype distribution Overall Week 4 Weeks 8/12 Week 12 non-responders 16% 26% 4% 8% 14% 26% 26% 58% 44% 52% 60% 66% NR: non-responder; RGT: response-guided therapy *HCV RNA analyzed by PCR (LLOD 50 IU/mL) Mangia A, et al. Hepatology 2011;54:772 80

13 Open issues Is RVR important in triple therapy? Is IL28B essential in DAA treatment? Should we use the lead-in? And should we use it with both drugs? Is there need for precise staging of the disease? Is there difference between G1a and G1b?

14 Lead-in to sort-out pts less likely to respond with a protease inhibitor < 1 log decline 1 log decline SVR (%) SVR (%) REALIZE (TVR) [1] 0 RESPOND 2* (BOC) [2] 1. Foster G, et al. EASL Abstract Vierling JM, et al. EASL Abstract 481. *Pooled data from RGT and BOC/PR48.

15 REALIZE (telaprevir): SVR by Week 4 response according to prior response category (LI T12PR48 arm) <1 log 10 HCV RNA reduction after 4-week Peg-IFN/RBV lead-in phase Proportion of patients in each category with <1 log 10 HCV RNA reduction 10% 40% 59% 1 log 10 HCV RNA reduction after 4-week Peg-IFN/RBV lead-in phase 90% 94 60% 41% SVR (%) Prior relapsers Prior partial responders Prior null responders Prior relapsers Prior partial responders Prior null responders n/n= 8/13 10/18 6/41 106/113 16/27 15/28 SVR was defined as undetectable HCV RNA 24 weeks after last planned dose Foster GR, et al. J Hepatol 2011;54(Suppl. 1):S3

16 RESPOND-2: SVR by Week 4 Lead-in Response according to F3 and F4 score SVR% <1.0 log 10 decline F3/4 F3 F4 33 PR 0/3 0/0 0/3 BOCRGT 3/12 2/6 0/5 BOCPR48 2/16 1/5 1/11 SVR% >1.0 log 10 decline PR 2/11 2/5 0/6 BOCRGT 11/20 6/9 5/11 BOCPR48 20/23 4/5 16/ F3/4 F3 F4 89 Bruno S, et al. J Hepatol, IN PRESS

17 SPRINT-2/RESPOND-2: Separate Retrospective Subanalysis by IL28 Highest SVR rates in patients treated with boceprevir-based regimen who experienced a 1 log 10 decline in HCV RNA after 4-wk lead-in phase, regardless of IL28B genotype 100 PR48 BOC RGT BOC/PR SVR (%) n/n = 0 Wk 4 Response 0/ 2 2/ 3 < 1 log 50 2/ 4 56/ 75 83/ / / / / 45 37/ log < 1 log 1 log < 1 log CC CT TT 32 83/ / / / / / 26 23/ 28 1 log 26/ 34 Poordad F, et al. EASL Abstract 12.

18 Lead-in Conclusions 9-16% with < 1 log 10 decline in HCV RNA during lead-in can still become undetectable after 4 weeks of triple therapy, despite poor IFN responsiveness. Lead-in should not be used for futility as 33% with < 1 log 10 decline during lead-in achieve SVR Lead-in may be clinically usefull if physician is willing to take decision at week 4: SOC vs PI or stop therapy 100 ESTEBAN, EASL 2012 SVR (%) / 203/ 36/ 200/ 3/ 133/ n/n = BOC RGT BOC/PR48 PR48 Poordad F, et al. EASL Abstract 12. Poordad F, et al. N Engl J Med. 2011;364: < 1 log 10 decline in HCV RNA 1 log 10 decline in HCV RNA

19 Predictors of SVR in Poor IFN Responders (SPRINT 2 and RESPOND 2 studies combined) Pre treatment factors predictive of SVR Genotype 1b F0/1/2 BL viral load < IU/mL TW8 virologic response No patient with <3 log decline at TW8 achieved SVR Patients with undetectable HCV RNA at TW8 had best chance to achieve SVR Bacon B, Bruno S, et al., AASLD 2011

20 RESPOND 2: SVR in Early (Week 8 HCV RNA negative) and Late (Week 8 HCV RNA positive) Responders by Fibrosis Score SVR % /5951/59 24/4628/57 8/10 18/20 5/19 2/8 Early Responder Late Responder Early Responder F0/1/2 F3/4 BOC RGT BOC/PR48 Late Responder

21 Utility of Week 8 HCV RNA Testing in Experienced Patients Receiving Boceprevir Containing Regimens Week 12 Stopping Rule (n ¼ 670) Patients Stopped by Week 12 Rule (n) Additional Patients Stopped by Week 24 Rule (n) Total Patients Stopped (n) SVR Missed With Week 12 Rule (n) > 9.3 IU/mL (LLD) >25 IU/mL (LLQ) > 50 IU/mL (LLQ) > 100 IU/mL (LLQ) >1000 IU/mL (LLQ) <2-log decline from the baseline <3-log decline from the baseline Jacobson IM at al Hepatology 2012; 56:

22 TREATMENT-EXPERIENCED PATIENTS (PARTIAL AND NULL RESPONDERS), Metavir F0-F3 Lead in TW 4 HCV RNA 1 log decay < 1 log decay Add BOC or TVR ADD BOC or TVR BOC TVR BOC TVR TW 8 HCV RNA TW 12 HCV RNA ER LR 24 weeks 48 weeks <1000 UI/ml 24/48 weeks < 3 log decay STOP TREATMENT >1000 UI/ml STOP Bruno S and Mangia A DLD 2012 in press

23 Open issues Is RVR important in triple therapy? Is IL28B essential in DAA treatment? Should we use the lead-in? And should we use it with both drugs? Is there need for precise staging of the disease? Is there difference between G1a and G1b?

24 SVR rates by fibrosis stage in Boceprevir-treated patients

25 SVR rates by fibrosis stage in Telaprevir patients

26 Dosing Duration in All Patients with Compensated Cirrhosis TVR + Peg-IFN + RBV Peg-IFN + RBV >1000 IU/mL: Stop 3 drugs >1000 IU/mL: Stop 3 drugs Detectable: Stop PR Detectable: Stop PR Peg-IFN + RBV BOC+ Peg-IFN + RBV 100 IU/mL: Stop 3 drugs Detectable: Stop 3 drugs Telaprevir EU SmPC; Boceprevir EU SmPC

27 Open issues Is RVR important in triple therapy? Is IL28B essential in DAA treatment? Should we use the lead-in? And should we use it with both drugs? Is there need for precise staging of the disease? Is there difference between G1a and G1b?

28 Genotype 1b vs 1a Pts infected before 1955 are more often 1b 1 a was introduced later In more than 6000 Italian pts, the PROBE study showed that a better SVR was marginally associated with subtype 1 a (OR 1.4; 95% CI ) The AIFA study showed that naive pt 1 a infected had 6% higher SVR rates than 1b (37.1% vs 31.6%, p=<0.001).

29 SVR rate in treatment naive patients ADVANCE study SPRINT-2 study G1a G1b 0 G1a G1b PR-TVR PR PR-BOC PR Jacobson, NEJM 2011; Poordad NEJM 2011

30 Higher rates of viral break-through during Telaprevir / PEG / Riba Triple therapy for patients infected with G1a vs 1b Differences between subtypes? 100 NS3 protease sequence % HCV-1a HCV-1b 155 GIFRAAV GIFRAAV 40 HCV-1a AGG AAG (R155K) 20 8% HCV-1b CGG AAG (R155K) 0 11/12 GT 1a 1/12 GT 1b McHutchison et al., NEJM 2009 Sarrazin et al., Gastroenterology 2010

31 SVR rates (%) according to GENOTYPE, FIBROSIS STAGE and baseline VL in PATIENTS WITH POOR IFN RESPONSE (<1 log decline at TW4) COMBINED SPRINT 2 AND RESPOND 2 STUDIES Viral load Fibrosis G1a G1b HCV RNA (IU/ml) METAVIR % Patient number % Patient number F F > F F

32 Conclusions

33

34 IL28B vs RGT: detailed on-treatment monitoring provides similar information 49% Treatment duration: 24 wks 25% undetectable* Treatment duration: 48 or 72 wks 45% undetectable Baseline genotype distribution Overall Week 4 Weeks 8/12 Week 12 non-responders 16% 26% 4% 8% 14% 26% 26% 58% 44% 52% 60% 66% NR: non-responder; RGT: response-guided therapy *HCV RNA analyzed by PCR (LLOD 50 IU/mL) Mangia A, et al. Hepatology 2011;54:772 80

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