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Clin Infect Dis. 2016 Sep 15;63(6):763-770. doi: 10.1093/cid/ciw379. Epub 2016 Jun 17.

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.

Author information

1
Service d'Hépatologie, Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Cochin.
2
INSERM U-1223-Institut Pasteur.
3
Université Paris Descartes.
4
INSERM, ISPED, Centre INSERM U1219-Bordeaux Population Health.
5
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Saint-Antoine.
6
Institut Pierre Louis d'Epidémiologie et de Santé Publique, Université Pierre et Marie Curie, UMR S1136, Paris.
7
Département d'Infectiologie, Centre Hospitalier Universitaire de Dijon.
8
Université de Bourgogne, Dijon.
9
Service de Médecine Interne et Cancérologie, Hôpital l'Archet, Centre Hospitalier Universitaire de Nice.
10
Université de Nice-Sophia Antipolis, Nice.
11
Service des Maladies infectieuses et tropicales, CHU Lyon, Hôpital de la Croix Rousse, Lyon.
12
Service des maladies infectieuses et tropicales, AP-HP, Hôpital Bichat Claude Bernard.
13
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Tenon, Paris.
14
Service d'Immuno-Hématologie Clinique, AP-HP de Marseille, Hôpitaux Sud.
15
Service Immunologie clinique et maladies infectieuses, Immunologie clinique, AP-HP, Hôpital Henri Mondor, Créteil.
16
Département de Médecine Interne et Immunologie Clinique, AP-HP, Hôpital Pitié-Salpétrière, Paris.
17
Service de médecine interne, hôpital Saint-André, Centre Hospitalier Universitaire de Bordeaux.
18
Université de Bordeaux.
19
Service Maladies infectieuses et tropicales Bordeaux, Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux.
20
Unité VIH, Hôpital Foch, Suresnes.
21
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Avicenne.
22
Université Paris 13 Nord, Bobigny.
23
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Saint-Louis, Paris.
24
Service de médecine interne, maladies infectieuses et immunologie clinique, Centre Hospitalier Universitaire de Reims.
25
Université de Reims, Champagne-Ardenne.
26
Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan, Médecine interne.
27
Université Toulouse III, Paul Sabatier.
28
Service Médecine interne et Immunologie clinique, AP-HP, Hôpital Bicêtre, Hôpitaux universitaires Paris Sud.
29
Université Paris Sud.
30
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Bicêtre, Hôpitaux universitaires Paris Sud, Le Kremlin-Bicêtre.
31
Service Maladies infectieuses et tropicales, Centre Hospitalier Universitaire de Nantes.
32
Service Maladies infectieuses et tropicales, Centre Hospitalier de Perpignan.
33
Service Médecine interne et immunologie, AP-HP, Groupe Hospitalier Paris Sud, Hôpital Antoine-Béclère, Clamart.
34
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Pitié-Salpétrière,Paris.
35
Université Bordeaux, ISPED, Centre INSERM U1219-Bordeaux Population Health.
36
Centre Hospitalier de Bordeaux Hôpital Pellegrin, Pôle Santé Publique.
37
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Cochin, Paris, France.

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:

cirrhosis; direct-acting antiviral treatment; hepatitis C virus (HCV); human immunodficiency virus (HIV); virologic response

PMID:
27317796
DOI:
10.1093/cid/ciw379
[Indexed for MEDLINE]

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