Use of oral DAA-based regimens in HIV-HCV co-infected patients in a real life setting - interim analysis from the ANRS CO13 HEPAVIH cohort

Background: It is widely recommended to treat chronic hepatitis C in HIV co-infected patients, considering its worse evolution and prognosis in these patients. Several new oral direct active agent (DAA)-based regimens can be used, with often quite similar antiviral activity.
Methods: HIV-HCV co-infected patients enrolled in the ANRS CO13 HEPAVIH cohort who initiated an oral DAA-based regimen were included. We report safety, end of treatment (EOT) response and sustained virologic response (HCV-RNA < 15 UI/mL) at 12 weeks (SVR12).
Results: We included 245 patients, of those, 133 patients reached EOT (54%) and 62 patients SVR12 (25%). Median age was 53 years [IQR: 49-55], 78% were male, 98% were on antiretroviral therapy (ART), 90% had an HIV viral load < 50 copies/mL, and median CD4 was 530/mm3 [IQR: 310-715]). Sixty-nine percent of the patients were cirrhotic, and 71% had failed to respond to previous treatment. HCV genotype (Gt) repartition was as follows: Gt1, 58%; Gt2, 4%; Gt3, 13%; Gt4, 25%.HCV-RNA was undetectable at the end of treatment (EOT) in 99% of the patients (95% confidence interval (CI): 96%-100%) and global SVR12 was 90% (CI: 80-96). Overall, EOT response was 100% in both non-cirrhotic and cirrhotic patients. Two premature stops for safety reasons were observed.EOT and SVR12 according to baseline characteristics and DAA prescribed regimen are presented in Table 1.
Table 1: Proportion of patients with EOT and SVR12 according to baseline characteristics and mostly prescribed anti-HCV treatment regimen

Cirrhotic statusGenotypeMost frequent combinations and durationsUndectable HCV viral oad at EOT (%, n/N)SVR 12 (%, n/N)
non cirrhotics1SOF + DCV 12W100% (7/7)100% (2/2)
non cirrhotics1SOF + LDV 12W100% (2/2)-
non cirrhotics1SOF + DCV 24W100% (4/4)-
non cirrhotics3SOF + PR 12W100% (2/2)100% (1/1)
non cirrhotics4SOF + LDV 12W100% (2/2)-
 4SOF + DCV 12W100% (3/3)100% (1/1)
Cirrhotics1SOF + DCV 24W100% (36/36)89% (17/19)
Cirrhotics3SOF + DCV 24W100% (6/6)100% (2/2)
Cirrhotics4SOF + DCV 24W100% (8/8)100% (3/3)
[Table 1]

DCV: Daclatasvir; LDV: Ledipasvir; PR: Pegylated interferon-ribavirin; SOF: Sofosbuvir; W: Weeks.

Conclusions: In this real-life prospective french national cohort, oral-DAAs based regimens showed high efficacy and excellent tolerability in HIV-HCV co-infected patients in a large variety of clinical settings.

D. Salmon-Ceron1,2, K. Lacombe3,4, L. Esterle5, C. Gilbert5, L. Piroth6, F. Bani-Sadr7, A. Laurent8, H. Aumaitre9, E. Billaud10, J. Chas11, S. Dominguez12, A. Gervais13, C. Lascoux-Combe14, P. Miaihles15, D. Neau16, I. Poizot-Martin17, E. Rosenthal18, D. Zucman19, F. Dabis20,21, P. Sogni2,22, L. Wittkop20,21, ANRS CO13 Hepavih
1APHP -Hôpital Cochin, Service de Médecine Interne et Pathologie Infectieuse VIH, Paris, France, 2Université Paris Descartes, Paris, France, 3APHP -Hôpital Saint Antoine, Service des Maladies Infectieuses et Tropicales, Paris, France, 4Université UPMC, Paris, France, 5Inserm U897 - Epidémiologie-Biostatistique, ISPED, Université Bordeaux, Bordeaux, France, 6CHU Dijon, Département d'Infectiologie, Dijon, France, 7CHU Reims - Hôpital Robert Debré, Service de Médecine interne et de Maladies Infectieuses et Tropicales, Reims, France, 8CHU Toulouse - Hôpital Purpan, Service de Médecine interne, Toulouse, France, 9CH Perpignan, Service des Maladies Infectieuses et Tropicales, Perpignan, France, 10CHU Nantes, Service des Maladies Infectieuses et Tropicales, Nantes, France, 11APHP - Hôpital Tenon, Maladies Infectieuses et Tropicales, Paris, France, 12APHP - Hôpital Henri Mondor, Immunologie clinique et maladies infectieuses, Créteil, France, 13APHP-Hôpital Bichat Claude Bernard, Maladies infectieuses et tropicales Hépato-gastro-entérologie, Paris, France, 14APHP - Hôpital Saint Louis, Service des Maladies Infectieuses et Tropicales, Paris, France, 15CHU Lyon, Service des Maladies Infectieuses et Tropicales, Lyon, France, 16CHU Bordeaux, Service des Maladies Infectieuses et Tropicales, Paris, France, 17APHM-Hôpital Sainte Marguerite, 9Service d'Immuno-Hématologie Clinique, Marseille, France, 18CHU Nice - Hôpital L'Archet 1, Service de Médecine interne Cancérologie, Nice, France, 19Hôpital Foch, Médecine interne, Suresnes, France, 20Université de Bordeaux, Inserm U897- Epidémiologie-Biostatistique, ISPED, Bordeaux, France, 21CHU de Bordeaux, Bordeaux, France, 22APHP - Hôpital Cochin, Département des maladies du foie - Hépatologie, Paris, France