How to optimize treatment in G3 patients? Jérôme GOURNAY, MD Hépatologie Centre Hospitalier Universitaire de Nantes France
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1 How to optimize treatment in G3 patients? Jérôme GOURNAY, MD Hépatologie Centre Hospitalier Universitaire de Nantes France Paris Hepatitis Conference, January 12, 2016
2 Disclosures I have received funding from Abbvie, Aptalis, Bayer, BMS, Gilead, Mayoly Spindler, Merck
3 Case Presentation (1) Man born in 1955, caucasian Intravenous drug use : Diagnosis of HCV G3a in 1995 systematic check-up proposed by public health insurance Alcohol: 40 units per week 76 kg / 175 cm Liver biopsy #1 in 1996: METAVIR A3F2, steatosis 80%
4 Case Presentation (1) Man born in 1955, caucasian Intravenous drug use : Diagnosis of HCV G3a in 1995 systematic check-up proposed by public health insurance Alcohol: 40 units per week 76 kg / 175 cm Liver biopsy #1 in 1996: METAVIR A3F2, steatosis 80% Treatment #1 in 1997: standard IFN No effect on ALT, poor tolerance Discontinuation after 3 months Liver biopsy #2 in 2001: METAVIR A2F2, steatosis 30% Treatment #2 in 2002: PEG-IFN α-2b + RBV (1000 mg/d) Hb: 16,4 g/dl 8,3 g/dl Discontinuation after 3 weeks Reduction of alcohol consumption: 15 units per week
5 PEG-IFN + RBV 24 weeks (n = 639) GT3 Naive naive patients, 4 UK centers SVR (%) Asian (n=317) Non Asian (n=322) >40 (n=437) <40 (n=201) Yes (n=161) No (n=436) Shoeb D, et al. Eur J Gastroenterol Hepatol 2014;23: (slide: G Foster, PHC 2015) 5
6 Case Presentation (2) Treatment #3 ( ): PEG-IFN α-2a + RBV Progressive increase of RBV dose to 800 mg/d Hb: 16,3 g/dl 10,2 g/dl (no use of EPO) Duration 48 weeks HCV RNA undetectable at W12 relapse FibroScan 14,5 kpa in 2008 (AST 119 IU/L, ALT 281 IU/L) FibroScan 17,5 kpa in 2011 (AST 103 IU/L, ALT 207 IU/L) Treatment #4 (2011): PEG-IFN α-2a 90 µg/week (maintenance*) No effect on ALT: discontinuation after 24 weeks Stop alcohol in 2011 Di Bisceglie AM et al. HALT-C trial, NEJM 2008;359:
7 Case Presentation (2) Treatment #3 ( ): PEG-IFN α-2a + RBV Progressive increase of RBV dose to 800 mg/d Hb: 16,3 g/dl 10,2 g/dl (no use of EPO) Duration 48 weeks HCV RNA undetectable at W12 relapse FibroScan 14,5 kpa in 2008 (AST 119 IU/L, ALT 281 IU/L) FibroScan 17,5 kpa in 2011 (AST 103 IU/L, ALT 207 IU/L) Treatment #4 (2011): PEG-IFN α-2a 90 µg/week (maintenance*) No effect on ALT: discontinuation after 24 weeks Stop alcohol in 2011 FibroScan 34,3 kpa in 2013 (AST 106 IU/L, ALT 196 IU/L) Liver biopsy #3 in 2013: METAVIR A3F3, steatosis 15% Hepatic dysmorphy (US), no oesopageal varice Marked asthenia, no diabetes, 80 kg / 175 cm Di Bisceglie AM et al. HALT-C trial, NEJM 2008;359:
8 Question (1) In january 2014 (7th PHC), what would have been your recommendation? 1. Carefull follow-up and HCC screening and wait for new DAA combination 2. Treatment using Sofosbuvir, PEG-IFN, and RBV for 12 weeks 3. Treatment using Sofosbuvir and RBV for 12 weeks 4. Treatment using Sofosbuvir and RBV for 24 weeks
9 Sofosbuvir + PEG-IFN +RBV 12 weeks GT3 Naive or TE ELECTRON & PROTON LONESTAR-2 overall Cirrhosis - Cirrhosis + SVR 12 (%) 38/39 20/24 10/12 10/12 Naive Treatment experienced (TE) Gane EJ et al. CROI 2013 Lalezari J et al. EASL 2011 Lawitz E et al. AASLD 2013 Lawitz E et al. Hepatology 2015;61:769-75
10 SOF + RBV 24 weeks GT3 Naive & TE VALENCE Non cirrhotic Cirrhotic SVR 12 (%) Zeuzem S et al. N Engl J Med 2014;370:
11 Question (1) In january 2014 (7th PHC), what would have been your recommendation? 1. Carefull follow-up and HCC screening and wait for new DAA combination 2. Treatment using Sofosbuvir, PEG-IFN, and RBV for 12 weeks 3. Treatment using Sofosbuvir and RBV for 12 weeks 4. Treatment using Sofosbuvir and RBV for 24 weeks
12 Question (1) In january 2014 (7th PHC), what would have been your recommendation? 1. Carefull follow-up and HCC screening and wait for new DAA combination 2. Treatment using Sofosbuvir, PEG-IFN, and RBV for 12 weeks 3. Treatment using Sofosbuvir and RBV for 12 weeks 4. Treatment using Sofosbuvir and RBV for 24 weeks
13 Case Presentation (3) Treatment #5 (2014): SOF + RBV Hb: 16,1 g/dl 9,2 g/dl (no use of EPO) RBV dose 1000 mg/d mg/d (difficult to maintain) Duration 24 weeks (january to june) SOF + RBV HCV RNA level (log IU/mL) HCV RNA ALT ALT (IU/L) weeks
14 Case Presentation (3) Treatment #5 (2014): SOF + RBV Hb: 16,1 g/dl 9,2 g/dl (no use of EPO) RBV dose 1000 mg/d mg/d (difficult to maintain) Duration 24 weeks (january to june) SOF + RBV HCV RNA level (log IU/mL) HCV RNA ALT ALT (IU/L) weeks
15 Man, 59 yo FibroScan 34,3 kpa in 2013 AST 106 IU/L, ALT 196 IU/L Liver biopsy #3 in 2013: METAVIR A3F3, steatosis 15% Hepatic dysmorphy (US), no oesopageal varice Marked asthenia, no diabetes, 80 kg / 175 cm Relapse after 24 weeks of SOF + RBV Why did the treatment fail?
16 Sofosbuvir + RBV ± PEG-IFN GT2 & GT3 Naive or TE BOSON SOF+RBV / 16 wk SOF+RBV / 24 wk SOF+PEG+RBV / 12 wk SVR12 (%) GT treatment-experienced patients with cirrhosis GT naive or treatment-experienced patients with or without cirrhosis Key baseline characteristics: 92% GT3, ~ 38% IL28B CC, ~ 53% previously treated, ~ 37% with cirrhosis Foster GR, et al. Gastroenterology 2015;149: (presented at EASL 2015, abs LO5)
17 Sofosbuvir + RBV ± PEG-IFN GT3 Naive or TE BOSON SOF + RBV 16 wks SOF + RBV 24 wks SOF + PegIFN/RBV 12 wks SVR12 (%) n/n = Treatment Naive No Cirrhosis Cirrhosis No Cirrhosis Cirrhosis Treatment Experienced Foster GR, et al. Gastroenterology 2015;149: (presented at EASL 2015, abs LO5)
18 Question (2) In january 2015 (8th PHC), what would have been your recommendation? JE SUIS CHARLIE 1. Carefull follow-up and HCC screening and wait for new pangenotypic DAA combination 2. Treatment using Sofosbuvir, PEG-IFN, and RBV for 12 weeks 3. Treatment using Sofosbuvir and Ledipasvir for 24 weeks 4. Treatment using Sofosbuvir and Daclastasvir for 24 weeks
19 Sofosbuvir + Daclatasvir ± RBV 24 weeks GT2-3 Naive Naïfs SVR12 (%) 120/ / / Sulkowski MS et al. N Engl J Med. 2014;370:
20 Sofosbuvir + Ledipasvir ± RBV GT3 Naive ELECTRON LDV/SOF SVR 12 (%) 64 LDV/SOF+RBV 16/25 26/26 16/25 26/26 12 weeks Gane EJ, EASL 2014 Gane EJ et al. Gastroenterology 2015;149:
21 Ledispasvir + Sofosbuvir + RBV 12 Weeks GT3 TE Two-center, open label study SVR 12 (%) Overall Hemoglobin < 10 g/dl: 2 patients (4%) Hemoglobin < 8.5 g/dl: No Cirrhosis cirrhosis Gane EJ, AASLD 2014, Poster LB-11 Gane EJ et al. Gastroenterology 2015;149:
22 Sofosbuvir + Daclatasvir 12 weeks GT3 Naive or TE ALLY 3 90,1 86,3 96,3 SVR 12 (%) 62, Naive Treatment experienced No cirrhosis Cirrhosis Nelson DR, AASLD 2014 Nelson DR et al. Hepatology 2015;61:
23 Sofosbuvir + Daclatasvir 12 weeks GT3 TE ALLY 3: treatment experienced patients SVR 12 (%) 86,3 88,1 71, Overall PEG-INF + RBV Sofosbuvir regimen Alisporivir regimen Previous treatment Nelson DR, AASLD 2014 Nelson DR et al. Hepatology 2015;61:
24 Sofosbuvir + Daclatasvir 12 weeks GT3 Naive or TE ALLY 3 Overall Treatment-naive Treatment-experienced 96,3 97,3 94,1 SVR12, % 62,5 57,9 69, Absent Present Absent Present Absent Present Cirrhosis Among cirrhotic patients, 34% (11/32) had baseline platelet < 100,000/mm3 Nelson DR, AASLD 2014 Nelson DR et al. Hepatology 2015;61:
25 French experts recommendations (january 2015)
26 Question (2) In january 2015 (8th PHC), what would have been your recommendation? JE SUIS CHARLIE 1. Carefull follow-up and HCC screening and wait for new pangenotypic DAA combination 2. Treatment using Sofosbuvir, PEG-IFN, and RBV for 12 weeks 3. Treatment using Sofosbuvir and Ledipasvir for 24 weeks 4. Treatment using Sofosbuvir and Daclastasvir for 24 weeks
27 Question (2) In january 2015 (8th PHC), what would have been your recommendation? JE SUIS CHARLIE 1. Carefull follow-up and HCC screening and wait for new pangenotypic DAA combination 2. Treatment using Sofosbuvir, PEG-IFN, and RBV for 12 weeks 3. Treatment using Sofosbuvir and Ledipasvir for 24 weeks 4. Treatment using Sofosbuvir and Daclastasvir for 24 weeks
28 Case Presentation (5) Treatment #6 (2015): SOF + DCV Duration 24 weeks (february to august) SOF + DCV HCV RNA level (log IU/mL) HCV RNA ALT ALT (IU/L) weeks
29 Case Presentation (6) Treatment #6 (2015): SOF + DCV 24 weeks (february to august) FibroScan 19,6 kpa in december 2015 AST 26 UI/L, ALT 40 UI/L, GGT 111 UI/L (December 2015) No more fatigue SOF + DCV HCV RNA level (log IU/mL) HCV RNA ALT ALT (IU/L) weeks
30 Man, 60 yo FibroScan 34,3 kpa in 2013 AST 106 IU/L, ALT 196 IU/L Liver biopsy #3 in 2013: METAVIR A3F3, steatosis 15% Marked asthenia, no diabetes, 80 kg / 175 cm Relapse after 24 weeks of SOF + RBV SVR after 24 weeks of SOF + DCV Why did the treatment work?
31 Sofosbuvir + Ledipasvir ± RBV Sofosbuvir + Daclatasvir ± RBV GT3 Naïve / TE Observational cohort of NHSE (UK) At physician s discretion, patients received SOF + LDV or DCV ± RBV Decompensated cirrhosis (CP B: 64%; CP C: 13%) Treatment duration 12 weeks P < SVR (%) Foster GR, et al. EASL Abstract O002
32 Sofosbuvir + Daclatasvir + RBV GT3 Naïve / TE ALLY-3+ All patients (F3 and compensated F4) Compensated F SVR (%) overall wk wk ARN VHC < LLOQ (%) overall wk wk Breakthrough Relapse Death Breakthrough Relapse Death Leroy V, AASLD 2015, Abs. LB3
33 Sofosbuvir + Daclatasvir + RBV GT3 Naïve / TE ALLY-3+ All patients F4 treatment experienced SVR 12 (%) SVR 12 (%) Naive Treatment experienced Overall wk wk Leroy V, AASLD 2015, Abs. LB3
34 Sofosbuvir + Daclatasvir ± RBV GT3 Naive or TE French Early Access Program 284/ 561 patients (completed therapy with SVR12 data) Baseline characteristics: Male: 75%, F4: 79%, F3: 15%, Previously treated: 73%, Liver Transp: 8.5% SOF + DCV SOF + DCV + RBV SVR12 (%) Hézode C, AASLD 2015, Abs. 206 No difference regarding RBV use
35 Sofosbuvir + Daclatasvir ± RBV GT3 Naive or TE French Early Access Program 284/ 561 patients (completed therapy with SVR12 data) Baseline characteristics: Male: 75%, F4: 79%, F3: 15%, Previously treated: 73%, Liver Transp: 8.5% 80 Child-Pugh A 90 Child-Pugh B or C SVR12 (%) SOF + DCV ± RBV 12 weeks SOF + DCV 24 weeks SOF + DCV + RBV 24 weeks Hézode C, AASLD 2015, Abs wk: No difference regarding RBV use
36 Next generation DAAs for HCV GT3
37 Next generation DAAs for HCV GT3 Near Future (2016)
38 Sofosbuvir + Velpatasvir Sofosbuvir + RBV 38 GT3 Naive or TE ASTRAL 3 Cirrhosis: 30% Treatment-experienced: 26% p < 0, SVR 12 (%) SOF + VEL 12 weeks SOF + RBV 24 weeks Foster GR et al. N Engl J Med 2015;373:
39 Sofosbuvir + Velpatasvir Sofosbuvir + RBV 39 GT3 Naive or TE ASTRAL 3 Cirrhosis: 30% Treatment-experienced: 26% SOF/VEL SOF + RBV SVR 12 (%) relapses 2 others relapses 7 others No cirrhosis 3 relapses Cirrhosis 7 relapses 5 others relapses relapses 1 others No cirrhosis 4 relapses Cirrhosis 15 relapses 1 other No previous treatment Previous treatment Foster GR et al. N Engl J Med 2015;373:
40 Sofosbuvir + Velpatasvir Sofosbuvir + RBV 40 GT3 Naive or TE ASTRAL 3 Total, n = % SVR12 84 % No RAV NS5A (n = 231) 16 % RAV NS5A (n = 43) 88 % SVR12 225/231 38/43 SVR 12 : 84 % (21/25) in patients with Y93H mutation Foster GR et al. N Engl J Med 2015;373:
41 Next generation DAAs for HCV GT3 In the long term (2017 and after)
42 ABT ABT weeks 42 GT3 Naive or TE SURVEYOR 2 ABT 493 : NS3/4A protease pangenotypic inhibitor ABT 530 : NS5A pangenotypic inhibitor Treatment naive: 90-93%, non cirrhotic SVR 12 (%) ABT mg 200 mg 200 mg 200 mg ABT mg 120 mg 120 mg 40 mg Kwo P, AASLD 2015, Abs. 248
43 SOF/VEL + GS GT3 Naive or TE LEPTON GS-9857: pangenotypic protease (NS3/4A) inhibitor SVR 12 (%) relapses 1 consent withdrawal Naive cirrhotic SOF/VEL + GS weeks Treatment exp. cirrhotic SOF/VEL + GS weeks Gane EJ, AASLD 2015, Abs. 38
44 Grazoprevir + Elbasvir ± RBV Grazoprevir + MK MK GT3 Naïve C-CREST 1 & 2A GZR/EBR + RBV 12 weeks Grazoprevir (GZR): protease inhibitor Elbasvir (EBR): NS5A inhibitor 80 GZR/MK-8408/MK-3682 (300 mg) 8 weeks Grazoprevir (GZR): protease inhibitor MK-8404: NS5A inhibitor MK-3682: NS5B inhibitor SVR 12 (%) GZR/MK-8408/MK-3682 (450 mg) 8 weeks Grazoprevir (GZR): protease inhibitor MK-8404: NS5A inhibitor MK-3682: NS5B inhibitor Naïve non cirrhotic Gane EJ, AASLD 2015, Abs. LB15
45 Question (3) In january 2017 (10th PHC), what will be your recommendation in a patient who relapse after 24 weeks SOF + RBV treatment? 1. Carefull follow-up and HCC screening and wait for new triple DAAs combination (such as GZR + MK MK-3682 or SOF/VEL + GS-3682) 2. Treatment using Sofosbuvir + Daclastasvir for 24 weeks 3. Treatment using Sofosbuvir + Velpatasvir for 12 weeks 4. Treatment using Grazoprevir + Elbasvir + ribavirin for 12 weeks
46 Question (3) In january 2017 (10th PHC), what will be your recommendation in a patient who relapse after 24 weeks SOF + RBV treatment? 1. Carefull follow-up and HCC screening and wait for new triple DAAs combination (such as GZR + MK MK-3682 or SOF/VEL + GS-3682) 2. Treatment using Sofosbuvir + Daclastasvir for 24 weeks 3. Treatment using Sofosbuvir + Velpatasvir for 12 weeks 4. Treatment using Grazoprevir + Elbasvir + ribavirin for 12 weeks
47 Conclusion 2 situations GT3 without cirrhosis: easy to cure GT3 with cirrhosis: difficult to manage Extending therapy to 24 weeks may be an option RBV may play a role Sub-optimal treatment must be avoid (SOF + RBV, SOF/LDV + RBV) Which combination in january 2016? Without cirrhosis: SOF + DCV 12 weeks With cirrhosis: SOF + DCV ± RBV 24 weeks SOF + PEG-IFN + RBV 12 weeks (compensated)
48 Thank you for your attention
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