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All-oral Direct-acting Antiviral Regimens in HIV/Hepatitis C Virus–coinfected Patients With Cirrhosis Are Efficient and Safe: Real-life Results From the Prospective ANRS CO13–HEPAVIH Cohort

Philippe Sogni 1, 2, 3, * Camille Gilbert 4 Karine Lacombe 5, 6 Lionel Piroth 7, 8 Eric Rosenthal 9, 10 Patrick Miailhes 11 Anne Gervais 12 Laure Esterle 13, 14 Julie Chas 15 Isabelle Poizot-Martin 16 Stéphanie Domínguez 17 Anne Simon 18 Philippe Morlat 19, 20 Didier Neau 21, 20 David Zucman 22 Olivier Bouchaud 23, 24 Caroline Lascoux-Combe 25 Firouze Bani-Sadr 26 Laurent Alric 27, 28 Cécile Goujard 29 Daniel Vittecoq 30 Eric Billaud 31 Hugues Aumaitre 32 François Boue 33 Marc-Antoine Valantin 34 François Dabis 13, 14 Dominique Salmon 35, 3 Linda Wittkop 13, 3
* Corresponding author
1 Service d'hépatologie médicale [CHU Cochin]
2 Dynamiques des Réponses immunes - Dynamics of Immune Responses
3 UPD5 - Université Paris Descartes - Paris 5
4 BPH - Bordeaux population health
5 Service des maladies infectieuses et tropicales [CHU Saint-Antoine]
6 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
7 Département d'infectiologie (CHU de Dijon)
8 UB - Université de Bourgogne
9 UNS - Université Nice Sophia Antipolis (... - 2019)
10 Hôpital l'Archet
11 Service des Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse, CHU-HCL]
12 Service des maladies infectieuses et tropicales
13 Epidémiologie et Biostatistique [Bordeaux]
14 ISPED - Institut de Santé Publique, d'Epidémiologie et de Développement
15 Service des maladies infectieuses et tropicales [CHU Tenon]
16 Service d'Immuno-hématologie clinique [Hôpital Sainte Marguerite - APHM]
17 Service d'immunologie clinique [Créteil]
18 Service d'immunologie [CHU Pitié-Salpétrière]
19 Service de médecine interne et maladies infectieuses [Bordeaux]
20 UB - Université de Bordeaux
21 Service des maladies infectieuses et tropicales, hôpital Pellegrin
22 Service des maladies infectieuses et tropicales [Hôpital Foch]
23 Service des maladies infectieuses et tropicales
24 UP13 - Université Paris 13
25 Service de maladies infectieuses et tropicales [Saint-Louis]
26 Unité des Maladies Infectieuses et Tropicales
27 Hôpital Purpan [Toulouse]
28 UT3 - Université Toulouse III - Paul Sabatier
29 GHU Paris-Sud - Laboratoire d'Immunologie [AP-HP Hôpital Kremlin-Bicêtre]
30 Service de médecine interne et maladies infectieuses
31 Service de maladies infectieuses et tropicales [Nantes]
32 Centre Hospitalier Saint Jean de Perpignan
33 Service de médecine interne, immunologie clinique [Béclère]
34 Service des maladies infectieuses et tropicales [CHU Pitié-Salpêtrière]
35 Service de médecine interne et centre de référence des maladies rares [CHU Cochin]
Abstract : BACKGROUND: Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected patients with cirrhosis have long been considered to be difficult to treat, and real-life efficacy and tolerance data with all-oral direct-acting antiviral (DAA) combinations in these patients are scarce. METHODS: Cirrhotic HIV/HCV-coinfected patients enrolled in the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) CO13 HEPAVIH cohort initiating an all-oral DAA regimen were consecutively included. A negative HCV RNA result at 12 weeks of follow-up or thereafter was assumed as a sustained virologic response (SVR12). Adjusted exact logistic regression was used to study factors associated with treatment outcome. RESULTS: We included 189 patients who initiated an all-oral DAA regimen with the following characteristics: median age 53.2 years; 74.6% male; Centers for Disease Control and Prevention classification A/B/C: 37%/31%/32%; Child-Pugh class A/B/C: 91%/8%/1%; 87% with HIV RNA <50 copies/mL; 99% on antiretrovirals; median CD4 count: 489 cells/µL; HCV treatment naive 29%; HCV genotype 1/2/3/4: 58%/4%/17%/21%. Sofosbuvir (SOF) + daclatasvir ± ribavirin (RBV) was used in 123 patients, SOF + RBV in 30, SOF + simeprevir in 11, and SOF + ledipasvir in 23. An SVR12 was reported in 93.1% of the patients (95% confidence interval, 88.5%-96.3%). In adjusted analyses, no difference was found between 12 or 24 weeks of treatment, in patients receiving RBV or not, and in treatment-naive vs experienced patients. Premature stop of DAA was reported for 8 patients. One patient died during treatment (unknown cause), and 12 other patients developed liver-related events. CONCLUSIONS: In this prospective real-life cohort, all-oral DAA regimens were well tolerated and associated with a high virologic efficacy in cirrhotic HIV/HCV-coinfected patients. This should not alleviate the surveillance for liver-related events in these patients.
Keywords : virologic response human immunodficiency virus (HIV) cirrhosis direct-acting antiviral treatment hepatitis C virus (HCV)
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HCL | UPEC-UPEM | UNIV-BOURGOGNE | ANRSCO13 | UNIV-PARIS13 | USPC | UNIV-PARIS5 | IPLESP | UNICE | UPMC | UNIV-COTEDAZUR | UNIV-NANTES | SORBONNE-UNIVERSITE | SU-MEDECINE | UNIV-PARIS7 | UNIV-TLSE3 | UPEC | PASTEUR | UNIV-PARIS | POLITIQUES-PUBLIQUES

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Philippe Sogni, Camille Gilbert, Karine Lacombe, Lionel Piroth, Eric Rosenthal, et al.. All-oral Direct-acting Antiviral Regimens in HIV/Hepatitis C Virus–coinfected Patients With Cirrhosis Are Efficient and Safe: Real-life Results From the Prospective ANRS CO13–HEPAVIH Cohort. Clinical Infectious Diseases, Oxford University Press (OUP), 2016, 63 (6), pp.763-770. ⟨10.1093/cid/ciw379⟩. ⟨inserm-01993207⟩

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