S. Bourgeois, G. Robaeys, P. Deltenre, C. Moreno and J. Delwaide. on behalf of the PRACTICE study group (Belgium)

Transcription

1 Adherence but not loss to follow-up in genotype 1 and 4 chronic hepatitis C patients infected after substance use is similar in comparison with infection by other causes: data from a large real life trial. S. Bourgeois, G. Robaeys, P. Deltenre, C. Moreno and J. Delwaide on behalf of the PRACTICE study group (Belgium)

2 Disclosure slide Speakers bureau and consultancy for Janssen, MSD & Roche Will discuss very fresh on-label medications

3 Introduction (general) Hep C is very common In most patients the virus can be cleared with SOC (standard of care) SVR is related to compliance By patients & physicians Patients & physicians are aware of serious side-effects of SOC New medication for Gt 1-patients Still in combination with SOC

4 Introduction New treatments DAA s New patients Increasing proportion of patients infected by Intravenous Drug Use (IVDU) New challenge Issues of resistance and adherence in tough to treat patients

5 Potential Targets for Antiviral Intervention in the HCV Life Cycle and Their Location in the HCV Genome Manns MP et al. Nat Rev Drug Discovery. 2007;6:

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7 SVR rate (%) Evolution of HCV genotype 1 treatment 59 75% % IFN % IFN + RBV % Peg- IFN + RBV 2 4 DAA + Peg- IFN + RBV 5 8 Future? IFN: interferon; RBV: ribavirin Peg-IFN: peginterferon DAA: direct-acting antiviral SVR: sustained virologic response 1. McHutchison JG, et al. N Engl J Med 1998;339: ; 2. Fried M, et al. N Engl J Med 2002;347: Manns MP, et al. Lancet 2001;358:958 65; 4. Hadziyannis SJ, et al. Ann Intern Med 2004;140: Jacobson IM, et al. Hepatology 2010;52(Suppl):427A; 6. Sherman KE, et al. Hepatology 2010;52(Suppl.):401A 7. Poordad F, et al. Hepatology 2010;52(Suppl.):402A; 8. Foster GR, et al. Hepatol Int 2011;5(Suppl.1):14

8 Introduction New treatments DAA s New patients Increasing proportion of patients infected by Intravenous Drug Use (IVDU) New challenge Issues of resistance and adherence in tough to treat patients

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10 Transmission (n = 852 ptn) Niet vermeld 6% Onbekend Sexueel 14% 3% Household 1% Verticaal 1% HCW 0% Prikaccident 1% Hemofilie 2% Medisch 2% Transfusie 6% IVDA 64% IVDA Transfusie Medisch Hemofilie Prikaccident HCW Verticaal Household Sexueel Onbekend Niet vermeld

11 Introduction New treatments DAA s New patients Increasing proportion of patients infected by Intravenous Drug Use (IVDU) New challenge Issues of resistance and adherence in tough to treat patients

12 Introduction PRACTICE-trial Non-interventional phase IV survey to assess the antiviral effectiveness of PegIntron and Rebetol treatment according to the stage of liver fibrosis in naive patients with genotype 1/4/5/6 chronic hepatitis C Jan 2005 nov centers, 505 patients

13 Aim Are (ex-)ivdu patients good candidates for new treatment regimens (including DAA s)? To compare the adherence in real life to the present standard of care in IVDU patients vs. patients not infected after IVDU (genotype 1/4/5/6)

14 Methods To perform a retrospective cohort study by a sub-analysis of a noninterventional multicentre phase IV survey in Belgium Adherence was measured as being present for blood sampling for assessing end of treatment response at week 48.

15 Patient characteristics (all patients) Total Number 505 Male 60% Median age Median weight Median BMI 46y 75kg 25.3 kg/m²

16 Baseline characteristics IVDU

17 Patient characteristics Non-IVDU IVDU Number male 219 (54.6 %) 83 (79.8 %) Median age 49.6 y 39.4 y Caucasian 331 (82.5 %) 103 (99 %) Genotype (71.82 %) 88 (84.62 %) Genotype 4 96 (23.94 %) 16 (15.38 %)

18 Results: Sustained Viral Response With respect to IV drug use % SVR OR 0,78 (95% CI 0,5-1,22)

19 Results: Adherence with respect to patients infected by IVD % SVR OR 1,08 (95% CI 0,7-1,66)

20 Results Non-IVDU IVDU (N=401) (N=104) p-value Non-Responder at Week Lost to Follow-up <0.001 Patient Did not Wish to Continue Investigator Decision Disease Related Complications Survey Drug Side Effects

21 Results (IVDU vs non-ivdu) No significant difference in Co-infection Metavir-score Weight Hemoglobin & platelets Transaminases Baseline dose of interferon & riba

22 Conclusions Not only in randomized clinical trials but also in real life, adherence of difficult to treat genotype CHC patients is similar to non-ivdu patients However, more IVDU patients are lost to follow-up. Special efforts will be needed to diminish loss to follow-up in the future.

23 Comments We suggest that in dedicated centers, working in close relationship with addiction centers, outcome might be more favorable We refer to our poster-presentation: Ex-IDU are good candidates for treatment in the DAA-era: results from routine clinical practice on SVR & adherence

24 Comments 1. Teaching 2. Understanding 1. Motivation 2. Success

25 PRACTICE investigators Adler Michael Brenard Reginald de Galocsy Chantal Flamme Frédéric Assene Collins Brixko Christian De Maeyer Marc Francque Sven Baert Filip Callens Jos De Man Marc George Christophe Bakari Sidi Caucheteur Bernard Debroux Sébastien Geubel André Bastens Boris Chioccioli Christiano Degré Delphine Golstein Philippe Bataille Christian Christiaens Paul Deltenre Pierre Harlet Luc Boon Nathalie Codden Thierry Delwaide Jean Henrion Jean Botembe Nicole Colemont Luc D'Heygere François Hittelet Axel Bourgeois Nadine Colle Isabelle Dietze Matthias Holvoet Joannes Bourgeois Stefan Daumerie Caroline Elewaut Ann Hulstaert Jan Lambrecht Guy Mesureur Thierry Salamé Van Overberghe Bart Lammens Jean Michielsen Peter Sermeus Alexandra Van Vlierberghe Hans Lamproye Anne Moreno Christophe Sermon Filip Vanbiervliet Philippe Lamy Vincent Mulkay Jean-Pierre Servais Benoît Vanmoerkerke Ignace Langlet Philippe Nevens Frederik Sprengers Dirk Vergauwe Philippe Lasser Luc Nkuize Marcel Staels Filip Verhamme Marc Laukens Pierre Ponette Johan Steger Piet-Hein Verset Gontran Lefèbvre Véronique Preux Cécile Van den Bergh Luc Wain Etienne Lenaerts Anne Reynaert Hendrik Van Der Meersch Filip Wauters Anne Louis Edouard Robaeys Geert Van Overbeke Lode