Lionel Piroth1, Linda Wittkop2, Karine Lacombe3, Eric Rosenthal4, Camille Gilbert5, Patrick Miailhes6, Patrizia Carrieri7, Julie Chas8, Isabelle Poizot-Martin9, Anne Gervais10, Stéphanie Dominguez11, Didier Neau12, David Zucman13, Eric Billaud14, Philippe Morlat15, Hugues Aumaitre16, Caroline Lascoux-Combe17, Anne Simon18, Olivier Bouchaud19, Elina Teicher20, Firouzé Bani-Sadr21, Laurent Alric22, Daniel Vittecoq23, François Boué24, Claudine Duvivier25, Marc-Antoine Valantin26, Laure Esterle5, François Dabis27, Philippe Sogni28, Dominique Salmon29. 1. Centre Hospitalier Universitaire de Dijon, Département d'Infectiologie, Dijon, France; Université de Bourgogne, Dijon, France. 2. Univ. Bordeaux, ISPED, Inserm, Bordeaux Population Health Research Center, team MORPH3EUS, UMR 1219, CIC-EC 1401, F-33000 Bordeaux, France; CHU de Bordeaux, Pole de sante publique, Service d'information medicale, F-33000 Bordeaux, France. Electronic address: Linda.Wittkop@isped.u-bordeaux2.fr. 3. Assistance Publique des Hôpitaux de Paris, Hôpital Saint-Antoine, Service Maladies infectieuses et tropicales, Paris, France; UMPC (Université Pierre et Marie Curie), UMR S1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France. 4. Centre Hospitalier Universitaire de Nice, Service de Médecine Interne, Hôpital l'Archet, Nice, France; Université de Nice-Sophia Antipolis, Nice, France. 5. Univ. Bordeaux, ISPED, Inserm, Bordeaux Population Health Research Center, team MORPH3EUS, UMR 1219, CIC-EC 1401, F-33000 Bordeaux, France. 6. Service des Maladies Infectieuses et Tropicales, CHU Lyon, Hôpital de la Croix Rousse, Lyon, France. 7. Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France. 8. Assistance Publique des Hôpitaux de Paris, Hôpital Tenon, Service Maladies infectieuses et tropicales, Paris, France. 9. Aix Marseille Univ, APHM Sainte-Marguerite, Service d'Immuno-hématologie clinique, Marseille, France. 10. Assistance Publique des Hôpitaux de Paris, Hôpital Bichat Claude Bernard, Service des Maladies Infectieuses et tropicales, Paris, France. 11. Assistance Publique des Hôpitaux de Paris, Hôpital Henri Mondor, Service Immunologie clinique et Maladies Infectieuses, Immunologie clinique, Créteil, France. 12. Centre Hospitalier Universitaire de Bordeaux, Service Maladies infectieuses et tropicales Bordeaux, Hôpital Pellegrin, Bordeaux, France. 13. Hôpital Foch, unité VIH, Suresnes, France. 14. Centre Hospitalier Universitaire de Nantes, Service Maladies infectieuses et tropicales, Nantes, France. 15. Centre Hospitalier Universitaire de Bordeaux, Service de Médecine Interne, hôpital Saint-André, Bordeaux, France. 16. Centre Hospitalier de Perpignan, Service Maladies infectieuses et tropicales, Perpignan, France. 17. Assistance Publique des Hôpitaux de Paris, Hôpital Saint-Louis, Service Maladies infectieuses et tropicales, Paris, France. 18. Assistance Publique des Hôpitaux de Paris, Hôpital Pitié-Salpétrière, Département de Médecine Interne et Immunologie Clinique, Paris, France. 19. Assistance Publique des Hôpitaux de Paris, Hôpital Avicenne, Service Maladies infectieuses et tropicales, Bobigny, France; Université Paris 13 Nord, Bobigny, France. 20. Assistance Publique des Hôpitaux de Paris, GH Paris Sud : Service Médecine Interne et Immunologie clinique, Hôpital Bicêtre, Le Kremlin-Bicêtre; Centre Hépato-Biliaire, Hôpital Paul-Brousse,Villejuif, France. 21. Centre Hospitalier Universitaire de Reims, Service de Médecine Interne, Maladies Infectieuses et immunologie clinique, Reims, France; Université de Reims, Champagne-Ardenne, Reims, France. 22. Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan, Service Médecine Interne-Pôle Digestif, Toulouse, France; UMR 152 IRD Université Toulouse III, Paul Sabatier, Toulouse, France. 23. Université Paris Sud, Le Kremlin-Bicêtre, France; Assistance Publique des Hôpitaux de Paris, Hôpital Bicêtre, Hôpitaux universitaires Paris Sud, Service Maladies infectieuses et tropicales, Le Kremlin-Bicêtre, France. 24. Université Paris Sud, Le Kremlin-Bicêtre, France; Assistance Publique des Hôpitaux de Paris, Groupe Hospitalier Paris Sud, Hôpital Antoine-Béclère, Service Médecine Interne et immunologie, Clamart, France. 25. Assistance Publique des Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Service de Maladies Infectieuses et Tropicales, Centre d'infectiologie Necker-Pasteur, IHU Imagine, Paris, France. 26. Assistance Publique des Hôpitaux de Paris, Hôpital Pitié-Salpétrière, Service Maladies infectieuses et tropicales, Paris, France. 27. Univ. Bordeaux, ISPED, Inserm, Bordeaux Population Health Research Center, team MORPH3EUS, UMR 1219, CIC-EC 1401, F-33000 Bordeaux, France; CHU de Bordeaux, Pole de sante publique, Service d'information medicale, F-33000 Bordeaux, France. 28. Assistance Publique des Hôpitaux de Paris, Hôpital Cochin, Service d'Hépatologie, Paris, France; INSERM U-1223 - Institut Pasteur, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France. 29. Assistance Publique des Hôpitaux de Paris, Hôpital Cochin, Service Maladies infectieuses et tropicales, Paris, France.
Abstract
BACKGROUND & AIMS: There is little data available on the use of new oral direct-acting antiviral (DAA) regimens to treat human immunodeficiency virus and hepatitis C virus (HIV/HCV) co-infected patients in real-life settings. Here, the efficacy and safety of all-oral DAA-based regimens in HIV/HCV-co-infected patients enrolled in the French nationwide ANRS CO13 HEPAVIH observational cohort are reported. METHODS: HIV/HCV-co-infected patients enrolled in the ANRS CO13 HEPAVIH observational cohort were included if they began an all-oral DAA-based regimen before 1st May 2015 (12-week regimens) or 1st February 2015 (24-week regimens). Treatment success (SVR12) was defined by undetectable HCV-RNA 12weeks after treatment cessation. Exact logistic regression analysis was used to identify factors associated with SVR12. RESULTS: A total of 323 patients (74% men) with a median age of 53years were included, 99% of whom were on combination antiretroviral therapy (cART). HIV RNA load was <50 copies/ml in 88% of patients; median CD4 cell count was 540/mm3; 60% of patients were cirrhotic; 68% had previously received unsuccessful anti-HCV treatment. cART was protease inhibitor (PI)-based in 23%, non-nucleoside reverse transcriptase inhibitor (NNRTI)-based in 15%, and integrase inhibitor (II)-based in 38%, while 24% of patients received other regimens. The SVR12 rate was 93.5% overall (95% confidence interval [CI]: 90.2-95.9), 93.3% (88.8-96.4) in patients with cirrhosis and 93.8% (88.1-97.3) in patients without cirrhosis. The SVR12 rates were 93.1% (84.5-97.7), 91.8% (80.4-97.7) and 95.8% (90.5-98.6) respectively, in patients receiving PI-based, NNRTI-based and II-based cART. In adjusted analysis, SVR12 was not associated with HIV RNA load, the cART regimen, cirrhosis, prior anti-HCV treatment, the duration of anti-HCV therapy, or ribavirin use. The most common adverse effects were fatigue and digestive disorders. CONCLUSIONS: New all-oral DAA regimens were well-tolerated and yielded high SVR12 rates in HIV/HCV-co-infected patients. LAY SUMMARY: We evaluated efficacy and safety of all-oral DAA regimens in a large French nationwide observational cohort study of HIV/HCV co-infected patients. Sustained virological response 12weeks after treatment cessation was 93.5% overall. The all-oral DAA regimens were well-tolerated and most common adverse effects were fatigue and digestive disorders.
BACKGROUND & AIMS: There is little data available on the use of new oral direct-acting antiviral (DAA) regimens to treat human immunodeficiency virus and hepatitis C virus (HIV/HCV) co-infectedpatients in real-life settings. Here, the efficacy and safety of all-oral DAA-based regimens in HIV/HCV-co-infectedpatients enrolled in the French nationwide ANRS CO13 HEPAVIH observational cohort are reported. METHODS:HIV/HCV-co-infectedpatients enrolled in the ANRS CO13 HEPAVIH observational cohort were included if they began an all-oral DAA-based regimen before 1st May 2015 (12-week regimens) or 1st February 2015 (24-week regimens). Treatment success (SVR12) was defined by undetectable HCV-RNA 12weeks after treatment cessation. Exact logistic regression analysis was used to identify factors associated with SVR12. RESULTS: A total of 323 patients (74% men) with a median age of 53years were included, 99% of whom were on combination antiretroviral therapy (cART). HIV RNA load was <50 copies/ml in 88% of patients; median CD4 cell count was 540/mm3; 60% of patients were cirrhotic; 68% had previously received unsuccessful anti-HCV treatment. cART was protease inhibitor (PI)-based in 23%, non-nucleoside reverse transcriptase inhibitor (NNRTI)-based in 15%, and integrase inhibitor (II)-based in 38%, while 24% of patients received other regimens. The SVR12 rate was 93.5% overall (95% confidence interval [CI]: 90.2-95.9), 93.3% (88.8-96.4) in patients with cirrhosis and 93.8% (88.1-97.3) in patients without cirrhosis. The SVR12 rates were 93.1% (84.5-97.7), 91.8% (80.4-97.7) and 95.8% (90.5-98.6) respectively, in patients receiving PI-based, NNRTI-based and II-based cART. In adjusted analysis, SVR12 was not associated with HIV RNA load, the cART regimen, cirrhosis, prior anti-HCV treatment, the duration of anti-HCV therapy, or ribavirin use. The most common adverse effects were fatigue and digestive disorders. CONCLUSIONS: New all-oral DAA regimens were well-tolerated and yielded high SVR12 rates in HIV/HCV-co-infectedpatients. LAY SUMMARY: We evaluated efficacy and safety of all-oral DAA regimens in a large French nationwide observational cohort study of HIV/HCV co-infectedpatients. Sustained virological response 12weeks after treatment cessation was 93.5% overall. The all-oral DAA regimens were well-tolerated and most common adverse effects were fatigue and digestive disorders.
Authors: Daniela K van Santen; Jannie J van der Helm; Giota Touloumi; Nikos Pantazis; Roberto Muga; Barbara Gunsenheimer-Bartmeyer; M John Gill; Eduard Sanders; Anthony Kelleher; Robert Zangerle; Kholoud Porter; Maria Prins; Ronald B Geskus Journal: AIDS Date: 2019-02-01 Impact factor: 4.177