Sofosbuvir is the first directly-acting antiviral for the treatment of hepatitis C virus. First, the regimens were combinations with sofosbuvir+ribavirin (SR) or with sofosbuvir+ribavirin and pegylated-interferon α-2a (SPR) with cure rates around 90%. The aim of this study was to report the results of these combinations in ‘real-life’ in France.
Main features of patients treated with SR or SPR in 24 hospitals were collected. Undetectable hepatitis C virus week 12 viral load after treatment defined sustained virological response (SVR12). Statistics were performed using StatView software for descriptive analysis and χ2 for the sub-groups comparisons.
Two hundred and eleven patients were analyzed. The average age was 56.1. One hundred and seventy-one (89%) patients had a fibrosis score of at least 3. Seventy-nine patients were infected by a genotype 1 (G1). One hundred and thirteen patients were treated with SR and 95 with SPR. In naive patients: with SPR for 12 weeks, SVR12 was 93% in G1, 100% in G3 and 83% in G4. With SR for 12 weeks, SVR12 was 100% in G2 patients (6/6). The safety of these regimens was satisfactory with only two patients who had to stop P due to severe side effects. Multivariate analysis shows a higher SVR in SPR versus SR (odds ratio=1.28; P=0.05) and in G2 or G3 versus others (odds ratio=1.56; P=0.04). Moreover, Child–Pugh score B or C (P=0.02), platelets count under 100G/l (P=0.05) or a past event of ascites (P=0.04) was independently associated with less SVR.
This multicenter large study confirms the good results of SR for 12 weeks in G2 naive patients. Finally, a decompensated cirrhosis, a past event of ascites and a baseline low platelet count were strongly associated with poor response.
bLaboratory of Virology, General Hospital GHPSO, Creil
cHepatogastroenterology Unit, Tenon University Hospital, APHP, Paris
dHepatogastroenterology Unit, General Hospital, Perpignan
eHepatogastroenterology Unit, University Hospital, Caen
fHepatogastroenterology Unit, General Hospital, Hyères
gHepatogastroenterology Unit, General Hospital GHICL, Lomme
hHepatogastroenterology Unit, General Hospital CHIC, Créteil
iHepatogastroenterology Unit, General Hospital, Orléans
jHepatogastroenterology Unit, General Hospital, Pau
kHepatogastroenterology Unit, General Hospital, Bry-sur-Marne
lDepartment of Internal Medicine, European Hospital, Marseille, France
* Armand Garioud and Ratmony Heng contributed equally to the writing of this article.
Correspondence to Armand Garioud, MD, Hepatogastroenterology Unit, General Hospital GHPSO, Boulevard Laennec, Creil 60100, France Tel: +33 344 616 444; fax: +33 344 616 440; e-mail: email@example.com
Received January 28, 2019
Accepted April 19, 2019