HCV therapy : Clinical case
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1 HCV therapy : Clinical case PHC 2018 Paris January 14th, 2018 Tarik Asselah (MD, PhD) Professor of Medicine Hepatology, Chief INSERM UMR 1149, Hôpital Beaujon, Clichy, France.
2 Disclosures Professor Asselah is an employee of AP-HP (Beaujon s Hospital) and University of Paris Principal investigator for research grants Funds paid to AP-HP Professor Asselah is a consultant, expert and speaker for: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, Merck Sharp Dohme, Roche. Professor Asselah has received grants from : ANR, CNRS, APHP, INSERM, University of Paris, ANRS 2
3 First Clinical Case : Patient with HCV Genotype 4 infection French Male, 48 years old Adressed by GP in July 2015 for HCV genotype 4 infection Past History Former drug user in the 80 s (PWID), stopped in 1989 Treatment with IFN declined by the patient (affraid of side effects) Lost to follow-up up Habitus Moderate alcohol cunsomption (40 g/d) Tobacco cunsomption : 30 p/y Weight 85 Kg; height 178 cm Physical examination no signs of liver disease
4 Q1 - What is the number of Persons Living With HCV worldwide (estimation) with genotype distribution?
5 Estimated 70 Million Persons Living With HCV Prevalence (Viremic) 0% to < 0.6% 0.6% to < 0.8% 0.8% to < 1.3% 1.3% to < 2.9% 2.9% to < 6.7% Polaris Observatory HCV Collaborators. Lancet Gastroenterol Hepatol. 2017;2:
6 Epidemiology Incidence rate (per ) WHO region Map key Best estimate Africa 31,0 America 6,4 Middle East 62,5 Europa South Est Asia a 61,8 14,8 Hutin J-F, Suisse, WHO, EASL 2017 West Pacific 6,0 Total 23,7 Asselah et al. Eliminating Hepatitis C within Low Income Countries the need to cure Genotypes 4, 5, 6. Journalof Hepatology, 2018 in press
7 First Clinical Case : Patient with HCV Genotype 4 infection Laboratory analysis AST: 60 (ULN 40 IU/L) ALT: 75 (ULN 40 IU/L) Gamma GT: 150 (ULN 50 IU/L) Alkaline phosphatase: 140 (ULN 130 IU/L) Total Bilirubin: 15 (<17 µmol/l) Prothrombin Time: 100 % Factor V 100 % Platelet count: /mm3 Virology HCV Genotype 4 HCV RNA IU/ml HBS-Ag and HIV negative
8 First Clinical Case : Patient with HCV Genotype 4 infection FibroScan: 6.0 kpa APRI : 0.6
9 Q2 How do you interpret these fibrosis tests?
10 Q3 - What do you recommend for this patient?
11 Q3 - What do you recommend for this patient? A Stop alcohol prior to start HCV therapy B Stop alcohol and start HCV therapy C Stop tobacco D Diet and exercise for overweight E Look for concomittant treatment for DDI
12 Q4 - What do you expect from HCV cure?
13 Q4 - What do you expect from HCV cure? Improving survival Decreasing the incidence of cirrhosis Decreasing hepatocellular carcinoma Improving overall quality of life
14 Treatment recommendations for GT 4 treatmentnaïve and treatment-experienced patients without and with compensated cirrhosis Treatment recommendations for GT 4 patients without cirrhosis TN GT 4 TE LDV/SOF SOF/VEL + RBV 24 weeks OMV/PTV/ RTV GRZ/EBV SOF + DCV SOF + SMV + RBV + RBV, if HCV RNA 800,000 (5.9 log) IU/mL or + R BV 16 weeks, if HCV RNA >800,000 (5.9 log) IU/mL + RBV + RBV 24 weeks 24 weeks SOF + DCV + RBV for and SOF + DCV for 24 weeks are not approved in the EU for non-cirrhotic GT 4 patients; SOF + DCV for is not approved in the EU for cirrhotic GT 4 patients. Regimens not included in the SmPC posology table (Table 1) are shown in grey. DCV: daclatasvir; EBV: elbasvir; GRZ: grazoprevir; LDV: ledipasvir; OMV: ombitasvir; PTV: paritaprevir; EASL. J Hepatol 2017;66: RTV: ritonavir; SMV: simeprevir; SOF: sofosbuvir; TE: treatment-experienced; TN: treatment-naïve; VEL: velpatasvir
15 Q5 - What are the data with the recently approved DAAs?
16 O N F N F O O H N SOF LDV Jan 2014 May 2014 SOF + SMV ± RBV weeks SMV VEL SOF/LDV ± RBV 8 24 weeks SOF + RBV weeks Sept 2014 Nov 2014 SOF + DCV ± RBV weeks OMV/PTV/RTV ± DSV ± RBV weeks O O F F O O S VOX SOF/VEL/VOX July 2016 July 2017 GRZ/EBV ± RBV weeks GLE/PIB 8 PTV DCV N O SOF/VEL ± RBV Jan 2015 H N O N H GLE GRZ EBV OMV DSV PIB Asselah, Marcellin & Schinazi. Liver Int 2018, in PIB
17 Velpatasvir/Sofosbuvir: A Single Tablet Regimen (STR) SOF Nucleotide NS5B polymerase inhibitor Sofosbuvir (SOF)1,2 Potent antiviral activity against HCV GT 1 6 Once-daily, oral, 400-mg tablet VEL NS5A inhibitor Velpatasvir (VEL; GS-5816)3-5 Picomolar potency against GT 1 6 2nd-generation inhibitor with improved resistance profile SOF/VEL Single Tablet Regimen (STR) SOF VEL Once daily, oral, STR (400/100 mg) 1. Jacobson IM, et al. N Engl J Med 2013;368: ; 2. Lawitz E, et al. N Engl J Med 2013;368: ; 3. Cheng G, et al. EASL 2013, poster 1191; 4. German P, et al. EASL 2013, poster 1195; 5. Lawitz E, et al. EASL 2013, poster 1082.
18 SVR12 (%) Velpatasvir/Sofosbuvir (Epclusa ) for across all genotypes (ASTRAL-1, ASTRAL-2 and ASTRAL-3) 2 relapses 2 LTFU 1 D/C 323/ death 2 D/C 1 D/C 1015/ relapses 237/ / / / 35 41/ 41 2% of patients experienced one or more SAE; no SAEs were considered study drug related 2 patients discontinued treatment due to AEs Agarwal K, et al. EASL 2016; Poster #SAT- AE: adverse event; D/C: discontinuation; LTFU: lost to follow-up; SAE: serious adverse event 195; Jacobson I, et al. EASL 2016; Poster #SAT-168
19 Glecaprevir/Pibrentasvir (Mavyret ) Glecaprevir Pibrentasvir (ABT-493) (ABT-530) pangenotypic NS3/4A protease inhibitor pangenotypic NS5A inhibitor 2nd generation3 2nd generation3 Collectively: G/P In vitro:1,2 Clinical PK & metabolism: High barrier to resistance Potent against common NS3 polymorphisms (eg., positions 80, 155, and 168) and NS5A polymorphisms (eg., positions 28, 30, 31 and 93) Additive/synergistic antiviral activity Once-daily oral dosing Minimal metabolism and primary biliary excretion Negligible renal excretion (<1%) G/P is co-formulated and dosed once daily as three 100 mg/40 mg pills for a total dose of 300 mg/120 mg. Glecaprevir was identified by AbbVie and Enanta. 1. Ng TI, et al. Abstract 636. CROI, Ng TI, et al. Abstract 639. CROI, 2014.
20 Glecaprevir/Pibrentasvir (Mavyret) in Patients with HCV GT1, 2, 4-6 Infection with or without Compensated Cirrhosis MAVIRET for 8 Weeks in TN/TE NC Patients: ENDURANCE-1 and SURVEYOR-2 99 SVR12 (%) n 596 N 606 BT 1 Relapse MAVIRET for 12 Weeks in TN/TE CC Patients: EXPEDITION Non-VF* 7 ITT population All analyses are using the TN, treatment-naïve; TE, treatment-experienced with IFN or pegifn ± RBV, or SOF + RBV ± pegifn; NC, non-cirrhotic; CC, compensated cirrhotic; ITT, intent-to-treat; BT, breakthrough; VF, virologic failure. *Includes patients who discontinued due to adverse events, lost to follow-up, or withdrew. MAVIRET Summary of Product Characteristics; Accessed August Asselah T, et al. Clin Gastroenterol Hepatol. 2017
21 Where are we in 2017? Need to increase screening Universal access (linkage to care) Efforts for PWID population Achieve HCV elimination
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