Treatment of HCV infection in daily clinical practice. Which are the optimal options for Genotypes 2 and 3? Jiannis Vlachogiannakos
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1 Treatment of HCV infection in daily clinical practice. Which are the optimal options for Genotypes 2 and 3? Jiannis Vlachogiannakos Associate Professor of Gastroenterology Academic Department of Gastroenterology Medical School, National and Kapodistrian University of Athens Laiko General Hospital 1
2
3 Are we satisfied with the currently available treatments? 80% 90% %
4 1. Difficult population Experienced Cirrhotic
5 2. Duration of treatment 8 weeks 12 weeks 24 weeks
6 Ribavirin
7 3. Efficacy SVR > 95%
8 4. Cost All the above with the least cost
9 Recommendations for Testing, Managing, and Treating Hepatitis C Updated: July 6, Changes made July 8, Treatment naive Treatment experienced Non cirrhotic Cirrhotic
10 Genotype 2
11 Genotype 2 Sofosbuvir Sofosbuvir Sofosbuvir Ribavirin Velpatasvir Daclatasvir
12 SVR12 (%) SVR12 (%) Sofosbuvir + RBV in Genotype 2 patients FISSION 1 (naive) FUSION 2 (experienced) /59 10/11 12 w 12 w 0 25/26 23/23 6/10 7/9 12 w 16 w 12 w 16 w Non cirrhotics Cirrhotics Non cirrhotics Cirrhotics 1. Lawitz E, et al. N Engl J Med. 2013;368: Jacobson IM, et al. N Engl J Med. 2013; 368:
13 Sofosbuvir + RBV in Genotype 2 patients Clinical Trials and Real-World Phase 3 studies TRIO cohort HCV- TARGET VALOUR- HCV Cirrhosis: 17% 22% 23% %
14 Sofosbuvir + RBV in Genotype 2 patients with advanced fibrosis or cirrhosis Mangia A et al, J Hepatol 2017, in press
15 SVR, % DCV+SOF + RBV in patients with Gen 2 or 3 GT2 GT % 89% / / weeks Sulkowski et al. N Engl J Med 2014
16 SOF + DCV in patients with Genotype 2 SOF + DCV 12 wks, non cirrhotics (n=8 ) SOF + DCV 24 wks, Cirrhotics (n=11) Mangia A et al, Liver International 2016
17 SVR12 (%) ASTRAL-1: Sofosbuvir/ Velpatasvir in GT 1, 2, 4, 5, 6 Cirrhotics 19%; Experienced 32%; BL NS5A RAVs 42% n/n = 0 618/ / / / / 116 All Pts 1a 1b / 35 41/ 41 HCV Genotype Feld JJ, et al. AASLD Abstract LB-2. Feld JJ, et al. N Engl J Med. 2015
18 SVR12 (%) ASTRAL-2 : Sofosbuvir/Velpatasvir in GT2 HCV SOF/VEL 12 wks P =.018 Treatment Naive SOF + RBV 12 wks Treatment Experienced n/n = 0 133/ /132 99/ 92/ 96 15/ 15 All Pts No Cirrhosis Cirrhosis No Cirrhosis Cirrhosis 14/ 15 15/ 15 13/ 16 4/ 4 4/ 4 Foster GR, et al. N Engl J Med. 2015
19 Genotype 2 Sofosbuvir Sofosbuvir Sofosbuvir Ribavirin Velpatasvir Daclatasvir 12 weeks 12 weeks 12 weeks
20 Conclusions - 1 SOF/VEL is the currently recommended first-choice regimens for GT 2. SOF/DCV can be used as alternative treatment when SOF/VEL is not available. Those combinations are associated with excellent safety. Treatments of only 12 weeks with the addition of ribavirin is recommended in decompensated patients.
21 Genotype 3
22 Genotype 3 Sofosbuvir Sofosbuvir Sofosbuvir Sofosbuvir Ribavirin Daclatasvir Velpatasvir Peg-IFNa Ribavirin 24 weeks 12 weeks
23 SVR12 (%) Impact of Duration on Efficacy of SOF in Treatment-Naive GT3 Pts 24 weeks FUSION: 12 wks of SOF/RBV POSITRON: 12 wks of SOF/RBV VALENCE: 24 wks of SOF/RBV n/n = 0 85/ / 84 No Cirrhosis 86/ 92 13/ / 14 Cirrhosis 12/ 13 Genotype 3 Jacobson IM, et al. N Engl J Med. 2013;368: Zeuzem S, et al. N Engl J Med
24 SVR12 (%) Impact of Duration on Efficacy of SOF in Treatment-Experienced GT3 Pts 24 weeks? FUSION: 12 wks of SOF/RBV FUSION: 16 wks of SOF/RBV VALENCE: 24 wks of SOF/RBV n/n = 0 14/ 38 25/ 40 No Cirrhosis 87/ 19 5/ 26 14/ 23 Cirrhosis 27/ 45 Genotype 3 Jacobson IM, et al. N Engl J Med. 2013;368: Zeuzem S, et al. N Engl J Med
25 Genotype 3 Sofosbuvir Sofosbuvir Sofosbuvir Sofosbuvir Ribavirin Daclatasvir Velpatasvir Peg-IFNa Ribavirin 24 weeks 12 weeks
26 Sofosbuvir + Peg-IFN/RBV for 12 Weeks vs. Sofosbuvir/RBV for 16 or 24 Weeks: The BOSON Study SOF + RBV 16 weeks SOF + RBV 24 weeks SOF + PEG/RBV 12 weeks TN no cirrhosis TN cirrhosis TE no cirrhosis TE cirrhosis Foster G, et al. EASL Abstract LB-5.
27 SVR12 (%) SVR12 (%) ALLY-3: SOF + DCV x 12 Wks in GT3 HCV Pts No cirrhosis Cirrhosis / 101 Treatment- Naive Pts 44/ 51 Treatment- Experienced Pts / / 32 Overall 73/ 75 11/ 19 Treatment- Naive Pts 32/ 34 9/ 13 Treatment- Experienced Pts Nelson DR, et al. AASLD Abstract LB-3.
28 SVR12 (%) ALLY-3+ : SOF + DCV + RBV x 12 or 16 Wks in GT3 HCV Pts with advanced fibrosis or cirrhosis 12-wk DCV + SOF + RBV 16-wk DCV + SOF + RBV n/n = 0 21/ 24 All Pts 24/ 26 6/ 6 8/ 8 Advanced Fibrosis (F3) 15/ 18 16/ 18 Cirrhosis 14/ 16 12/ 14 Cirrhosis + Treatment Experienced Leroy V, et al. Hepatology 2016
29 NS5A RAS at Baseline and Post-failure in patients with cirrhosis in ALLY-3 and ALLY 3+
30 European DCV Compassionate Use Program SOF + DCV ± RBV in GT3 HCV Pts with advanced disease mitt Duration of SOF + DCV >20 weeks in 84% of patients Welzel TM, et al. GUT 2017, In Press
31 HCV RNA < LLOQ TD/TND (%) French Multicenter Compassionate Use Program 222 (78.7%) Cirrhotics , DCV + SOF 4 4 DCV + SOF + RBV 85, ,3 12 Weeks 24 Weeks Hezode C, et al. AASLD Abstract 206.
32 SVR12 (%) ASTRAL 3: Sofosbuvir and Velpatasvir for HCV Genotype 3 Infection 552 patients, 30% cirrhotics, 26% experienced P <.001 SOF/VEL 12 wks SOF + RBV 24 wks n/n = 0 264/ / / / / 80 55/ / / 204 All Pts No Yes Naive Experienced Cirrhosis 64/ 71 Treatment History 45/ 71 Foster GR, et al. N Eng J Med 2015.
33 ASTRAL 3: Effect of Drug Resistance on HCV Treatment Efficacy 97% SVR12 n = % SVR12 84% No Baseline NS5A RAVs (n = 231) 16% BL NS5A RAVs (n = 43) 225/231 38/43 Foster GR, et al. N Eng J Med 2015.
34
35 Treatment of patients with decompensated cirrhosis
36 SVR12 (%) SOF + NS5A Inhibitors ± RBV for 12 Wks in GT3 Pts With Decompensated Cirrhosis 192 patients at 17 centres n/n = 0 2/7 39/60 5/7 86/ Wks of LDV/SOF 12 Wks of LDV/SOF + RBV 12 Wks of DCV + SOF 12 Wks of DCV + SOF + RBV Foster GR, et al. J Hepatol 2016.
37 SVR12 (%) ASTRAL-4: Sofosbuvir/Velpatasvir in Decompensated Cirrhosis SOF/VEL 12 wks SOF/VEL + RBV 12 wks SOF/VEL 24 wks n/n = / 14 11/ 13 6/ 12 Genotype 3 Curry MP, et al. N Engl J Med. 2015
38 HCV Retreatment after DAA Failure
39 SVR12 (%) SOF/VEL + RBV Retreatment: Efficacy & Effect of RAVs Wk 24 HCV-infected pts without SVR in previous phase II trials of SOF/VEL (n = 41) or SOF/VEL + GS-9857 (n = 28) (N = 69) SOF/VEL 400/ mg QD + weight-based RBV 26% cirrhotics n/n = 20 33/ 34 13/14 3/3 10/13 0 NS5A RAVs: No Yes GT1 GT2 GT3 Gane EJ, et al. EASL Abstract PS024.
40 Genotype 3 Non-cirrhotics Cirrhotics Naive Experienced Naive Experienced Sofosbuvir Veltapasvir 12 wks 12 wks±rbv 12 wks±rbv 12 wks + RBV Sofosbuvir Daclatasvir 12 wks 12 wks± RBV 24 wks± RBV 24 wks + RBV
41
42
43 Does cost matter? Less cost, more patients on treatment
44 QUARTZ II/III STUDY Naïve or experienced Cirrhotic and non-cirrhotic patients. Shafran ST, et al. AASLD Abstract LB-16, Shafran ST, et al. AASLD Abstract 885
45 C-SWIFT STUDY Naïve patients Poordad F, et al. EASL Abstract 6.
46 New drugs New combinations
47 Conclusions - 2 SOF/VEL and SOF/DCV are the currently recommended regimens for GT 3. Patients with several negative predictive factors such as cirrhosis, treatmentexperienced and NS5A RAS have lower SVR rates. In these patients, addition of Ribavirin and/or extending therapy duration is the recommended strategy. In our therapeutic choice, we need to take into consideration the cost of the treatment. New generation drugs are currently in phase 3 clinical trials and is expected to be added in the therapeutic armamentarium soon. These combinations aim to increase SVR rates without the necessity of adding ribavirin and probably with shorter treatment duration, particularly in patients with negative predictive factors.
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