Efficacy and Safety of Direct-Acting Antiviral Regimens in HIV/HCV-co-infected Patients \textendash French ANRS CO13 HEPAVIH Cohort
2 UB - Université de Bourgogne
3 INSERM U1219 - UB - ISPED - Team MORPH3EUS
4 CHU Bordeaux - Centre Hospitalier Universitaire de Bordeaux
5 CHU Saint-Antoine [AP-HP]
6 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
7 UNS - Université Nice Sophia Antipolis (1965 - 2019)
8 CHU - Hôpital Archet 2 [Nice]
9 Service de Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse - HCL]
10 SESSTIM - U912 INSERM - Aix Marseille Univ - IRD - Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale
11 CHU Tenon [AP-HP]
12 Service d'immuno-hématologie clinique (CISIH)
13 Service des maladies infectieuses et tropicales
14 Service d'immunologie clinique [Créteil]
15 Service des Maladies Infectieuses et Tropicales A [Bordeaux]
16 Hôpital Foch [Suresnes]
17 Service de maladies infectieuses et tropicales [Nantes]
18 Service de médecine interne et maladies infectieuses [Bordeaux]
19 CH Perpignan - Centre Hospitalier Saint Jean de Perpignan
20 Service des Maladies Infectieuses et Tropicales [CHU Saint Louis]
21 CHU Pitié-Salpêtrière [AP-HP]
22 Service des maladies infectieuses et tropicales
23 Service de Médecine Interne et Immunologie clinique [AP-HP Hôpital Bicêtre]
24 CHB - Centre Hépato-Biliaire [Hôpital Paul Brousse]
25 Unité des Maladies Infectieuses et Tropicales
26 URCA - Université de Reims Champagne-Ardenne
27 UT3 - Université Toulouse III - Paul Sabatier
28 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
29 UMR 152
30 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
31 UP11 - Université Paris-Sud - Paris 11
32 AP-HP - Hôpital Antoine Béclère [Clamart]
33 Centre d'infectiologie Necker-Pasteur [CHU Necker]
34 Service des Maladies infectieuses et tropicales [CHU Necker]
35 Dynamiques des Réponses immunes - Dynamics of Immune Responses
36 AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris]
37 Service Maladies infectieuses et tropicales [AP-HP Hôpital Cochin]
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Résumé
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.