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Background - Objectives

Access to HCV triple therapy with Telaprevir or Boceprevir in a real-life setting in HIV-HCV co-infected patients ANRS CO13 Hepavih Cohort.

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Background - Objectives

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  1. Access to HCV triple therapy with Telaprevir or Boceprevir in a real-life setting in HIV-HCV co-infected patientsANRS CO13 Hepavih Cohort Poizot-Martin I., Gilbert C., Carrieri P., Miailhes P., Billaud E., Dominguez S., Dabis F., Sogni P., Loko M.-A., Salmon D*.for the ANRS CO13 Hepavih group

  2. Background - Objectives • First generation anti-HCV protease inhibitors (PI) available in France since 2011 • Triple therapy with these PI leads to a 30% increase of virological response compared to that of standard PegIFN + Ribavirin • Our aim was to describe access to triple therapy and early results in a « real-life » prospective cohort of HIV-HCV co-infected patients

  3. Methods (1) • ANRS CO13 Hepavih Cohort: • French prospective multicenter cohort • 24 clinical centers • 1324 HIV-HCV co-infected patients • Population selection for analysis: • Positive HCV-RNA • HCV genotype 1 • With at least one follow-up visit since January 2011

  4. Methods (2) • Two groups of eligible patients werecompared: • One whoinitiated triple therapy • And one whodid not • Virological response and tolerance to anti-HCV treatment were also evaluated • Patients who stopped their treatment prematurely without virological data for the next visits were classified as virological failures

  5. Methods (3) • Rapid virological response (RVR4): • Undetectable (<15 UI/mL) HCV-RNA at week 4 after initiation* • Early virological response: - EVR12: Undetectable HCV-RNA at week 12* • Severe anemia: - Hb <9 g/dL or a 4.5 g/dL decrease * of triple therapy

  6. Results (1) ANRS CO13 Hepavih cohort1st June 2013 databaseN=1324 Eligible patients for analysisN=320 Initiation of a triple therapyN=114 (36%) No triple therapyN=206 (64%) Telaprevir n=81Boceprevir n=24Another molecule n=9 Outside clinical trials n=80(Telaprevir n=67, Boceprevir n=13)

  7. Results (3) Potential contra-indications to anti-HCV triple therapy * Naïve or non responders to previous HCV treatment§ Only few patients with available data

  8. Results (4) The 80 patients who initiated triple therapy outside clinical trials were evaluated for efficacy and safety> 100% received HAART with as 3rd agent: Raltegravir: 43Atazanavir: 22Darunavir: 2Saquinavir: 2 Lopinavir :2Efavirenz: 7 Rilpivirine: 2

  9. Results (5) Virological response Telaprevir Boceprevir W4 W24 W4 W24 W12 W12

  10. Results (6) Factors associated with VR24 Boceprevir Telaprevir Non responders Non responders Naïve Relapsers Naïve Relapsers Genotype 1A Genotype 1B Genotype 1A Genotype 1B Non- cirrhotic Cirrhotic Non- cirrhotic Cirrhotic

  11. Results (7) Virological response in cirrhotic non responders Telaprevir Boceprevir W4 W24 W4 W24 W12 W12

  12. Results (8) Virological response according to HAART VR24 * Others = Darunavir, Saquinavir, Rilpivirine, Lopinavir Atazanavir Efavirenz Others* Raltegravir

  13. Results (9) Adverse eventsduring the first 12 weeks Results are expressed as N (%) or median [IQR] 9 patients had a blood transfusion and 3 received EPO.

  14. Results (10) : Treatment interruptions 20/80 (25%) stoppedtheirtreatmentprematurely Median [IQR] treatment duration before stop: 4.6 months [2.7-6.25] Reasonsof treatment stop: * Level 1

  15. Conclusion • Triple therapy was started despite potential contra-indications to treatment, mainly psychiatric disorders, present in 34% of treated patients. On the contrary, non treated patients did not have contra indications in 58% of the cases. • Patients who initiated triple therapy with anti HCV PI were more often cirrhotic, and previously non responders to previous anti-HCV treatment, than patients who remained non treated. • The rate of virologicalresponses at W24 was high (74% for telaprevirand 60% for boceprevir), with a trend for a better VR in G1b and non cirrhotic patients. • One must be cautious until assessment of sustained virological response as relapses can occur during the last months or after 48 weeks.

  16. Acknowledgments Patients of the HEPAVIH Cohort Scientific Committee of the ANRS CO13 HEPAVIH Study Group:D Salmon (principal investigator), F Dabis (principal investigator), M Winnock, MA Loko, P Sogni, Y Benhamou, P Trimoulet, J Izopet, V Paradis, B Spire, P Carrieri, C Katlama, G Pialoux, MA Valantin, P Bonnard, I Poizot-Martin, B Marchou, E Rosenthal, D Garipuy, O Bouchaud, A Gervais, C Lascoux-Combe, C Goujard, K Lacombe, C Duvivier, D Vittecoq, D Neau, P Morlat, F BaniSadr, L Meyer, F Boufassa, S Dominguez, B Autran, AM Roque, C Solas, H Fontaine, L Serfaty, G Chêne, D Costagliola, D Zucman, A Simon, E Billaud, P Miailhes, J Polo Devoto, L. Piroth, S Couffin-Cadiergues (ANRS). Clinical Centres (ward / participating physicians):CHU Cochin, Paris (Médecine Interne et Maladies Infectieuses / D Salmon, H Mehawej; Hépato-gastro-entérologie / P Sogni; Anatomo-pathologie / B Terris, Z Makhlouf, G Dubost, F Tessier, L Gibault, F Beuvon, E Chambon, T Lazure; Virologie / A Krivine); CHU Pitié-Salpétrière, Paris (Maladies Infectieuses et Tropicales / C Katlama, MA Valantin, H Stitou; Hépato-gastro-entérologie / Y Benhamou; Anatomo-pathologie / F Charlotte; Virologie / S Fourati); CHU Pitié-Salpétrière, Paris (Médecine Interne / A Simon, P Cacoub, S Nafissa; Anatomo-pathologie / F Charlotte; Virologie / S Fourati), CHU Sainte-Marguerite, Marseille (Service d'Immuno-Hématologie Clinique - CISIH/ I Poizot-Martin, O Zaegel; P Geneau, Virologie / C Tamalet); CHU Tenon, Paris (Maladies Infectieuses et Tropicales / G Pialoux, P Bonnard, F Bani-Sadr, L Slama, T Lyavanc; Anatomo-pathologie / P Callard, F Bendjaballah; Virologie / C Le-Pendeven); CHU Purpan, Toulouse (Maladies Infectieuses et Tropicales / B Marchou ; Hépato-gastro-entérologie / L Alric, K Barange, S Metivier; A Fooladi, Anatomo-pathologie / J Selves; Virologie / F Nicot); CHU Archet, Nice (Médecine Interne / E Rosenthal ; Infectiologie / J Durant; Anatomo-pathologie / J Haudebourg, MC Saint-Paul) ; CHU Avicenne, Bobigny (Médecine Interne – Unité VIH / O Bouchaud; Anatomo-pathologie / M Ziol; Virologie / Y Baazia); Hôpital Joseph-Ducuing, Toulouse (Médecine Interne / M Uzan, A Bicart-See, D Garipuy, MJ Ferro-Collados; Anatomo-pathologie / J Selves; Virologie / F Nicot); CHU Bichat – Claude-Bernard, Paris (Maladies Infectieuses / Y Yazdanpanah, A Gervais; Anatomo-pathologie / H Adle-Biassette); CHU Saint-Louis, Paris (Maladies infectieuses / JM Molina, C Lascoux Combe; Anatomo-pathologie / P Bertheau, J Duclos; Virologie / P Palmer); CHU Saint Antoine (Maladies Infectieuses et Tropicales / PM Girard, K Lacombe, P Campa; Anatomo-pathologie / D Wendum, P Cervera, J Adam; Virologie / N Harchi); CHU Bicêtre, Paris (Médecine Interne / JF Delfraissy, C Goujard, Y Quertainmont; Virologie / C Pallier); CHU Paul-Brousse, Paris (Maladies Infectieuses / D Vittecoq); CHU Necker, Paris (Maladies Infectieuses et Tropicales / O Lortholary, C Duvivier, M Shoai-Tehrani), CHU Pellegrin, Bordeaux (des Maladies Infectieuses et Tropicales / D Neau, A Ochoa, E Blanchard, S Castet-Lafarie, C Cazanave, D Malvy, M Dupon, H Dutronc, F Dauchy, L Lacaze-Buzy; Anatomo-pathologie / P Bioulac-Sage; Virologie / P Trimoulet, S Reigadas), Hôpital Saint-André, Bordeaux (Médecine Interne et Maladies Infectieuses / P Morlat, D Lacoste, F Bonnet, N Bernard, M Bonarek Hessamfar, J Roger-Schmeltz, P Gellie, P Thibaut, F Paccalin, C Martell, M Carmen Pertusa, M Vandenhende, P Mercier, D Malvy, T Pistone, M Catherine Receveur, S Caldato; Anatomo-pathologie / P Bioulac-Sage; Virologie / P Trimoulet, S Reigadas); Hôpital du Haut-Levêque, Bordeaux (Médecine Interne / JL Pellegrin, JF Viallard, E Lazzaro, C Greib; Anatomo-pathologie / P Bioulac-Sage; Virologie / P Trimoulet, S Reigadas), Hôpital FOCH, Suresnes (Médecine Interne / D Zucman, C Majerholc ; Virologie / F Guitard), CHU Antoine Béclère, Clamart (Médecine Interne / F Boue, J Polo Devoto, I Kansau, V Chambrin, C Pignon, L Berroukeche, R Fior, V Martinez; Virologie / C Deback), CHU Henri Mondor, Créteil (Immunologie Clinique / Y Lévy, S Dominguez, JD Lelièvre, AS Lascaux, G Melica), CHU Hôtel Dieu, Nantes (Maladies Infectieuses et Tropicales / F Raffi, E Billaud, C Alavena; Virologie / A Rodallec), Hôpital de la Croix Rousse, Lyon (Maladies Infectieuses et Tropicales/D Peyramond, C Chidiac, P Miailhes, F Ader, F Biron, A Boibieux, L Cotte, T Ferry, T Perpoint, J Koffi, F Zoulim, F Bailly, P Lack, M Maynard, S Radenne, M Amiri; Virologie / Le-Thi Than-Thuy); CHU Dijon, Dijon (Département d'infectiologie / P Chavanet, L Piroth, M Duong Van Huyen, M Buisson, A Waldner Combernoux, S Mahy, R Binois, A Laure Simonet Lann, D Croisier-Bertin) Data collection, management and statistical analyses:D Beniken, AS Ritleng, M Azar, P Honoré, S Breau, A Joulie, M Mole, C Bolliot, F Touam, F André, H. Roukas, C Partouche, G Alexandre, A. Mélard, , J. Baume, , H Hue, D Brosseau, C Brochier, V Thoirain, M Rannou, D Bornarel, S Gohier, C. Chesnel, S Gillet, J Delaune, C Gilbert, L Dequae-Merchadou, A Frosch, J Cohen, G Maradan, C Taieb, F Marcellin, M Mora, C Protopopescu, C Lions, MA Loko, M Winnock.

  17. Back-up slides

  18. HCV-RNA undetectable at W4 and W12 Boceprevir Telaprevir Non responders Non responders Naïve Relapsers Naïve Relapsers Genotype 1A Genotype 1B Genotype 1A Genotype 1B Non- cirrhotic Cirrhotic Non- cirrhotic Cirrhotic

  19. Virological response Telaprevir Boceprevir W4 W24 W48 W4 W24 W48 W12 W12

  20. HCV-RNA undetectable at W12 Boceprevir Telaprevir Non responders Non responders Naïve Relapsers Naïve Relapsers Genotype 1A Genotype 1B Genotype 1A Genotype 1B Non- cirrhotic Cirrhotic Non- cirrhotic Cirrhotic

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