Citation

Moreno-Planas JM, Larrubia-Marfil JR, Sánchez-Ruano JJ, Morillas-Ariño J, Patón-Arenas R, Sáiz-Chumillas RM, Tébar-Romero E, Lucendo-Villarín A, Gancedo-Bringas P, Solera-Muñoz M, Vicente-Gutiérrez MDM, Martínez-Alfaro E. Enferm. Infecc. Microbiol. Clin. (Engl. Ed.) 2018; 36(5): 277-283.

Copyright

(Copyright © 2018, Elsevier Publishing)

DOI

10.1016/j.eimc.2017.05.001

PMID

28641865

Abstract

INTRODUCTION: There are few published studies on predictors of response to treatment with sofosbuvir and simeprevir in HCV patients.
OBJECTIVE: The objective of the study was to analyse possible predictors of response to simeprevir (SMV) and sofosbuvir (SOF) in patients infected with hepatitis C genotypes 1 or 4.
PATIENTS AND METHODS: Prospective observational cohort study in 12 hospitals. The primary efficacy endpoint was SVR rate 12 weeks after end of treatment (SVR12).
RESULTS: 204 patients (62.3% male, mean age 55 years) were included: 186 (91.2%) genotype 1 (60.3% 1b 25% 1a) and 18 (8.8%) genotype 4. 132 (64.7%) cirrhotic (87.9% Child A), 33 (16.2%) F3, 31 (15.2%) F2, 8 (3.9%) F0-1. 80.8% MELD<10. 93 (45.6%) naive. Ribavirin was added in 68 (33.3%). Mean baseline viral load 2,151,549 IU/ml (SD: 2,391,840). Treatment duration 12 weeks in 93.1%. 4 discontinued therapy: suicide, psychotic attack, hyperbilirubinaemia and liver cancer recurrence. 190 (93.1%) achieved SVR12. There were no differences in SVR12 depending on the genotype, treatment duration, ribavirin use, prior therapy, viral load (VL) or baseline platelets. In univariate analysis, undetectable VL at 4 weeks (p=0.042), absence of cirrhosis (p=0.021), baseline albumin ≥ 4g/dl (p=0.001) and MELD<10 (p<0.0001) were associated with higher SVR12. In multivariate analysis, only baseline MELD score <10 patients had higher SVR12 (p<0.001).
CONCLUSIONS: The combination of simeprevir and sofosbuvir in patients infected with genotype 1 and 4 hepatitis C is highly effective. It is a safe therapy, especially in patients without ribavirin. This combination was more effective in patients with a MELD score below 10.

Language: en

Keywords

Humans; Adult; Aged; Female; Male; Middle Aged; Severity of Illness Index; Prospective Studies; Aged, 80 and over; Treatment Outcome; Treatment; Models, Theoretical; Hepatitis C; Hepatitis C, Chronic; Antiviral Agents; Tratamiento; Kidney Failure, Chronic; Antivirales de acción directa; Direct-acting antivirals; Simeprevir; Sofosbuvir