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.
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.



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.



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.



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.
Service d'Hépatologie, Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Cochin.|INSERM U-1223-Institut Pasteur.|Université Paris Descartes.
Philippe
P
Sogni
INSERM, ISPED, Centre INSERM U1219-Bordeaux Population Health.
Camille
C
Gilbert
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Saint-Antoine.|Institut Pierre Louis d'Epidémiologie et de Santé Publique, Université Pierre et Marie Curie, UMR S1136, Paris.
Karine
K
Lacombe
Département d'Infectiologie, Centre Hospitalier Universitaire de Dijon.|Université de Bourgogne, Dijon.
Lionel
L
Piroth
Service de Médecine Interne et Cancérologie, Hôpital l'Archet, Centre Hospitalier Universitaire de Nice.|Université de Nice-Sophia Antipolis, Nice.
Eric
E
Rosenthal
Service des Maladies infectieuses et tropicales, CHU Lyon, Hôpital de la Croix Rousse, Lyon.
Patrick
P
Miailhes
Service des maladies infectieuses et tropicales, AP-HP, Hôpital Bichat Claude Bernard.
Anne
A
Gervais
INSERM, ISPED, Centre INSERM U1219-Bordeaux Population Health.
Laure
L
Esterle
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Tenon, Paris.
Julie
J
Chas
Service d'Immuno-Hématologie Clinique, AP-HP de Marseille, Hôpitaux Sud.
Isabelle
I
Poizot-Martin
Service Immunologie clinique et maladies infectieuses, Immunologie clinique, AP-HP, Hôpital Henri Mondor, Créteil.
Stéphanie
S
Dominguez
Département de Médecine Interne et Immunologie Clinique, AP-HP, Hôpital Pitié-Salpétrière, Paris.
Anne
A
Simon
Service de médecine interne, hôpital Saint-André, Centre Hospitalier Universitaire de Bordeaux.|Université de Bordeaux.
Philippe
P
Morlat
Université de Bordeaux.|Service Maladies infectieuses et tropicales Bordeaux, Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux.
Didier
D
Neau
Unité VIH, Hôpital Foch, Suresnes.
David
D
Zucman
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Avicenne.|Université Paris 13 Nord, Bobigny.
Olivier
O
Bouchaud
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Saint-Louis, Paris.
Caroline
C
Lascoux-Combe
Service de médecine interne, maladies infectieuses et immunologie clinique, Centre Hospitalier Universitaire de Reims.|Université de Reims, Champagne-Ardenne.
Firouzé
F
Bani-Sadr
Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan, Médecine interne.|Université Toulouse III, Paul Sabatier.
Laurent
L
Alric
Service Médecine interne et Immunologie clinique, AP-HP, Hôpital Bicêtre, Hôpitaux universitaires Paris Sud.|Université Paris Sud.
Cécile
C
Goujard
Université Paris Sud.|Service Maladies infectieuses et tropicales, AP-HP, Hôpital Bicêtre, Hôpitaux universitaires Paris Sud, Le Kremlin-Bicêtre.
Daniel
D
Vittecoq
Service Maladies infectieuses et tropicales, Centre Hospitalier Universitaire de Nantes.
Eric
E
Billaud
Service Maladies infectieuses et tropicales, Centre Hospitalier de Perpignan.
Hugues
H
Aumaître
Université Paris Sud.|Service Médecine interne et immunologie, AP-HP, Groupe Hospitalier Paris Sud, Hôpital Antoine-Béclère, Clamart.
François
F
Boué
Service Maladies infectieuses et tropicales, AP-HP, Hôpital Pitié-Salpétrière,Paris.
Marc-Antoine
MA
Valantin
INSERM, ISPED, Centre INSERM U1219-Bordeaux Population Health.|Université Bordeaux, ISPED, Centre INSERM U1219-Bordeaux Population Health.|Centre Hospitalier de Bordeaux Hôpital Pellegrin, Pôle Santé Publique.
François
F
Dabis
Université Paris Descartes.|Service Maladies infectieuses et tropicales, AP-HP, Hôpital Cochin, Paris, France.
Dominique
D
Salmon
INSERM, ISPED, Centre INSERM U1219-Bordeaux Population Health.|Université Bordeaux, ISPED, Centre INSERM U1219-Bordeaux Population Health.|Centre Hospitalier de Bordeaux Hôpital Pellegrin, Pôle Santé Publique.
Linda
L
Wittkop
D000998:Antiviral Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology; D016174:Hepacivirus; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012254:Ribavirin; D000069474:Sofosbuvir; D000072230:Sustained Virologic Response; D016896:Treatment Outcome
D000998:Antiviral Agents; D012254:Ribavirin; D000069474:Sofosbuvir
cirrhosis; direct-acting antiviral treatment; hepatitis C virus (HCV); human immunodficiency virus (HIV); virologic response