Hepatitis C treatment with all-oral direct-acting antivirals: Effectiveness and tolerance in a multicenter, prospective, observational study from French general hospitals (APROVVIE, ANGH).
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Pariente Alexandre, Arpurt Jean-Pierre, Rémy André-Jean, Rosa-Hézode Isabelle, Causse Xavier, Heluwaert Frédéric, Macaigne Gilles, Henrion Jean, Renou Christophe, Schnee Matthieu, Salloum Hatem, Hommel Séverine, Pilette Christophe, Arotcarena Ramuntxo, Barjonet Georges, Lison Hortensia, Bourhis François, Jouannaud Vincent, Pauwels Arnaud, Le eaBricquir Yann, Geagea Edmond, Condat Bertrand, Ripault Marie-Pierre, Zanditenas David, de Montigny-Lenhardt Stéphanie, Labadie Hélène, Tissot Bertrand, Maringe Eric, Cadranel Jean-François, Hagège Hervé, Lesgourgues Bruno, Association nationale des gastroentérologues des hôpitaux (ANGH)
Аннотация
METHODS: Data from patients treated with all-oral DAAs in 24 French non-academic hospital centers from March 1, 2014 to January 1, 2016, were prospectively recorded. The sustained virological response 12-24 weeks after treatment (SVR 12-24) was estimated and severe adverse events (SAE) were evaluated and their predictive factors were determined using logistic regression.
RESULTS: Data from 1123 patients were analyzed. The population was 69% genotype (G) 1, 13% G3, 11.5% G4, 5% G2, 49% with cirrhosis and 55% treatment-experienced. The treatment regimens were sofosbuvir/ledipasvir (38%), sofosbuvir/daclatasvir (32%), sofosbuvir/simeprevir (17%), ombitasvir+paritaprevir+ritonavir (5%) (with dasabuvir 3.5%), and sofosbuvir/ribavirin (8%). Ribavirin was given to 24% of patients. The SVR 12-24 was 91.0% (95% CI: 89.2-92.5%). Sofosbuvir-ribavirin was less effective than other regimens. The independent predictors of SVR 12-24 by logistic regression were body weight, albumin, previous hepatocellular carcinoma and treatment regimen (sofosbuvir/ribavirin vs. others). Sixty-four severe adverse events (SAE) were observed in 59 [5.6%] patients, and were independently predicted by cirrhosis and baseline hemoglobin. Serum creatinine increased during treatment (mean 8.5%, [P<10-5]), satisfying criteria for acute kidney injury in 62 patients (7.3%). Patient-reported overall tolerance was excellent, and patient-reported fatigue decreased during and after treatment.
CONCLUSIONS: Second generation DAAs combinations are as effective and well tolerated in a « real-world » population as in clinical trials. Further studies are needed on renal tolerance.