Barrajón Pérez L, Soler Company E, Lorente Fernández L, Pérez Pons JC
Servicio de Farmacia. Hospital Arnau de Vilanova-Lliria. Valencia (España)
Rev. OFIL 2016, 26;4:243-250
Fecha de recepción: 12/08/2016 – Fecha de aceptación: 15/09/2016
Laura Barrajón Pérez
Servicio de Farmacia
Hospital Arnau de Vilanova
C/San Clemente, 12
Correo electrónico: firstname.lastname@example.org
Objectives: To describe and analyze patients with chronic hepatitis C treated with direct-acting antivirals and evaluate its safety and effectiveness. Secondary objectives: to identify predictive factors associated with hepatitis C antiviral therapy response; determine the appropriateness of antiretroviral therapy to avoid interactions; and to compare the results of patients with genotype 1 treated with direct-acting antivirals with historic controls treated with boceprevir or telaprevir at our institution.
Methods: 12 months, retrospective observational study, which included all patients treated with direct-acting antivirals (sofosbuvir, simeprevir, daclatasvir, ledipasvir, ombitasvir, paritaprevir, dasabuvir). Effectiveness evaluation: sustained viral response 12 weeks after treatment. Safety assessment: adverse events occurring during treatment.
Results: 355 patients were included, 50.4% cirrhotic. 345 patients were evaluable for effectiveness: 97.4% achieved sustained viral response, 2.6% failed. Subgroup analysis showed effectiveness in 98.4% of monoinfected patients vs 94.7% in patients coinfected with HIV (p=0.06); in the latter group, effectiveness was 91.7% in patients with cirrhosis vs 97.8% in patients without cirrhosis (p=0.049). Safety: 155 (43.7%) patients experienced adverse events, 9 (2.5%) of them were severe, and 3 (0.84%) needed treatment suspensions. 35 out of 97 coinfected patients needed antiretroviral therapy modification to avoid interactions (50.4% caused by simeprevir).
Conclusions: New generation of direct-acting antivirals against HCV is effective and safe in clinical practice. Our effectiveness and safety results are within the range established by major published works.
Key Words: Hepatitis C, effectiveness, safety, direct-acting antiviral agents.