METAVIR F3-F4 criteria consensus

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Presentation transcript:

METAVIR F3-F4 criteria consensus (agreed at RIZIV-INAMI 23.12.2014) EITHER A LIVER BIOPSY, or EITHER 1 ELASTOGRAPHY TEST (cut-offs see slide 2) + 1 BIOLOGICAL FIBROSIS SCORE (cut-offs see slide 3) maximum age of lab values to be used for biological tests = 1 year results to be kept in file of patient (scores & lab values used for the test) 1 EXCEPTION: PATIENTS WITH HEMOPHILIA : * 2 BIOLOGICAL FIBROSIS SCORES CAN BE APPLIED (cut-off see above), or * 1 ELASTOGRAPHY TEST + 1 BIOLOGICAL FIBROSIS SCORE

chronic hepatitis C Fibroscan1 cut-offs of ELASTOGRAFY for fibrosis assesment F3-F4 chronic hepatitis C (agreed at RIZIV-INAMI 23.12.2014) Fibroscan1 Valid if 10 correct measurements, success rate > 60%, IQR < 30% F3 ≥ 9.5 kPA F4 ≥ 12.5 kPA Shear wave elastografie2 F3 ≥ 8.7 kPA F4 ≥ 10.4 kPA 3. Acoustic radiation forse impulse (ARFI, Siemens technique)3,4 F3 ≥ 1,55 m/s F4 ≥ 1,80 m/s 1Castera et al. Gasteroenterology 2005 2Ferraioli et al Hepatology 2012 3Friedrich-Rust et al J Viral Hepat 2012 4Ferraioli et al J Ultrasound Med 2014

(agreed at RIZIV-INAMI 23.12.2014) cut-offs of BIOLOGICAL FIBROSIS-SCORES for assesment F3-F4 in chronic hepatitis C (agreed at RIZIV-INAMI 23.12.2014) Fibrotest (Biopredictive): Elelements : α2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT F3: 0.59-0.72 F3-F4: 0.73-0.74 F4: ≥0.75 Apri (ast-platelet ratio) In a pure HCV cohort F3: ≥ 1 F4: ≥ 1.6 Reference: Holmberg, Clin Infect Dis 2013 Fib-4 (age, AST,ALT, platelets) F3: ≥ 2.1 F3-F4: ≥ 3.25 F4: ≥ 3.85 References: Vallet-Pichard, Hepatology 2007, Holmberg, Clin Infect Dis 2013, Martinez APT 2011 Useful website: www.hepatitisc.uw.edu/page/clinical-calculators

Update 8-2016 Genotype 1 Genotype 4 Treatment options for antiviral therapy F3-F4 patients in Belgium Update 8-2016 Genotype 1 Genotype 4 Non-cirrhotic (F3) `SOF + SIM 12 wk1 SOF + DCV 12 wk2 Ritonavir-boosted Paritaprevir + Ombitasvir + Dasabuvir 12 wk (G1b)3 Ritonavir-boosted Paritaprevir + Ombitasvir + Dasabuvir + RBV 12 wk (G1a)3 LDV/SOF 12 wk4,5* *8 wk if naïve and HCVRNA < 6.106 UI/mL6 SOF + SIM 12 wk2 Ritonavir-boosted Paritaprevir + Ombitasvir + RBV 12 wk3 LDV/SOF2,7 12 wk Cirrhotic compensated SOF + SIM + RBV 12 wk2** SOF + DCV + RBV 12 wk2** LDV/SOF + RBV 12 wk2** Ritonavir-boosted Paritaprevir + Ombitasvir + Dasabuvir 12 wk (G1b) +/- RBV2,8 Ritonavir-boosted Paritaprevir + Ombitasvir + Dasabuvir + RBV 24 wk (G1a)2 **In case of poor RBV tolerance, prolonge to 24 wk without RBV SOF + SIM + RBV 12 wk2* SOF + DCV + RBV 12 wk2* LDV/SOF + RBV 12 wk2* Ritonavir-boosted Paritaprevir + Ombitasvir + RBV 12 wk15 *In case of poor RBV tolerance, prolonge to 24 wk without RBV 1st generation PI-experienced SOF + DCV + RBV 12 wk2 LDV/SOF + RBV 12 wk2 Not applicable SOF/SIM failure SOF + DCV or LDV/SOF failure LDV/SOF +RBV 24 wk2 SOF + SMV +RBV 24 wk2

Update 8-2016 Genotype 1 Genotype 4 Treatment options for antiviral therapy F3-F4 patients in Belgium Update 8-2016 Genotype 1 Genotype 4 Decompensated SOF + DCV + RBV 12 wk2,9* LDV/SOF + RBV 12 wk2,10* *In case of poor RBV tolerance, prolonge to 24 wk without RBV SOF + DCV + RBV 12 wk2* LDV/SOF + RBV 12 wk2* Post-LT (F0-F2) LDV/SOF + RBV 12 wk2,10 (prolonge to 24 wk without RBV) Ritonavir-boosted Paritaprevir + Ombitasvir + Dasabuvir 12 wk + RBV2 LDV/SOF + RBV 12 wk2 (prolonge to 24 wk without RBV) Ritonavir-boosted Paritaprevir + Ombitasvir + RBV 12 wk2 Post-LT (F3-F4) LDV/SOF + RBV 12 wk2,10 SOF + SIM + RBV 12 wk2 SOF + DCV + RBV 12 wk2,9 (In case of poor RBV tolerance, prolonge to 24 wk without RBV) Ritonavir-boosted Paritaprevir + Ombitasvir + Dasabuvir 12 wk + RBV (G1b)2 Ritonavir-boosted Paritaprevir + Ombitasvir + Dasabuvir 24 wk + RBV (G1a)2 SOF + DCV + RBV 12 wk2 Ritonavir-boosted Paritaprevir + Ombitasvir + RBV 24 wk2 IN POST-TRANSPLANT : BEWARE OF INTERACTION WITH IS !

Update 8-2016 Genotype 2 Genotype 3 Genotype 5 Treatment options for antiviral therapy F3-F4 patients in Belgium Update 8-2016 Genotype 2 Genotype 3 Genotype 5 Non-cirrhotic (F3) SOF + RBV 12 wk11 SOF + DCV +/- RBV 12 wk2 (only post –LT with F3-F4) SOF + PR 12 wk2,14 SOF + DCV 12 wk2,12 SOF + PR 12wk13 Cirrhotic compensated SOF + DCV + RBV 24 wk2 1st generation PI-experienced Not applicable Decompensated SOF + DCV 24-48 wk2 (only in patients listed for LT) In case of poor RBV tolerance, SOF + DCV 24 wk without RBV (up to 48 wk if listed for LT) SOF + DCV + RBV 12 wk2 In case of poor RBV tolerance, prolonge SOF + DCV to 24 wk without RBV (up to 48 wk if listed for LT)

References 1 Cosmos-HCV Target – SVR 86-93% 2 EASL clinical practice guidelines 3Pear III-IV, NEJM 2014 4ION 1, NEJM 2014 5ION 2, NEJM 2014 6ION 3, NEJM 2014 7Abergel, EASL 2015 8Turquoise III, J Hepatol 2015 9ALLY-1, EASL 2015 10SOLAR 1,2, EASL 2015 11 VALENCE, FISSON, POSITRON, Triohealth– SVR 79-100% 12ALLY-3, EASL 2015 13Neutrino – SVR 96% - all stages 14BOSON, Gastroenterology 2015 15Agate-1 – Asselah T et al, Lancet Gastroenterol Hepatol, 2016