Incidencia, manejo y coste de los efectos adversos hematológicos y dermatológicos durante las 12 primeras semanas de tratamiento con triple terapia para hepatitis C / Incidence, management and costs of adverse effects in chronic hepatitis C patients on triple therapy with telaprevir or boceprevir: First 12 weeks of treatment
Enferm. infecc. microbiol. clín. (Ed. impr.)
; 33(5): 331-336, mayo 2015. tab
Article
in Spanish
| IBECS
| ID: ibc-141581
Responsible library:
ES1.1
Localization: BNCS
RESUMEN
INTRODUCCIÓN:
El objetivo es analizar la incidencia, el manejo y el coste asociado a los efectos adversos (EA) hematológicos y dermatológicos en pacientes con hepatitis C crónica en tratamiento con telaprevir (TVR) o boceprevir (BOC).MÉTODO:
Estudio observacional y prospectivo de una cohorte de pacientes que iniciaron tratamiento con TVR o BOC asociado a peg-interferón-alfa y ribavirina con un seguimiento de 12 semanas.RESULTADOS:
Se incluyeron 53 pacientes (TVR n = 36; BOC n = 17). Los EA más frecuentes fueron trombocitopenia (83% TVR vs. 88% BOC), seguida de neutropenia (89% TVR vs. 82% BOC). El 32% de los pacientes manifestaron EA dermatológicos. En 11 pacientes fue necesaria la suspensión del tratamiento (todos ellos tratados con TVR), siendo el motivo principal la toxicidad (64%). El 66% de los pacientes precisaron algún fármaco para el tratamiento de los EA, siendo la eritropoyetina el fármaco más empleado. En 8 pacientes fue necesaria asistencia de urgencia y 2 fueron hospitalizados debido a los EA. El coste total de los recursos adicionales fue de 32.522 Euros (625 [DE = 876] Euros/paciente) (TVR 759 [DE = 1.022] Euros/paciente vs. BOC 349 [DE = 327] Euros/paciente]; p > 0,05). Los pacientes con toxicidad grados iii-iv consumieron mayor número de recursos adicionales con mayor coste en comparación con los pacientes con toxicidad grados i-ii (849 [DE = 1.143] Euros/paciente vs. 387 [DE = 397] Euros/paciente; p = 0,053).CONCLUSIÓN:
La incorporación de los nuevos inhibidores de proteasa al tratamiento convencional conlleva una mayor incidencia de EA hematológicos que la descrita en los ensayos clínicos. Esta elevada incidencia de EA hace necesaria la utilización de recursos adicionales que incrementan el coste total de la terapiaABSTRACT
INTRODUCTION:
The aim of the study was to analyze the incidence, management and cost associated to hematological and dermatological adverse effects (AE) in chronic hepatitis C patients on triple therapy (TT) with telaprevir (TVR) or boceprevir (BOC).METHODS:
An analysis was made on the data recorded on patients who started treatment with TVR or BOC associated with peginterferon alfa and ribavirin in a 12-week follow-up period.RESULTS:
Fifty-three patients were included (TVR n = 36; BOC n = 17). Thrombocytopenia (83% TVR vs. 88% BOC) followed by neutropenia (89% TVR vs. 82% BOC) were the most common AE. Dermatological AE were observed in 32% of patients. Eleven patients required treatment discontinuation (all of them received TVR), and toxicity was the main reason for discontinuation (64%). The percentage of patients who required supportive treatment for management of AE was 66%. The most used supportive treatment was erythropoietin. Eight patients required emergency health care, and 2 were hospitalized due to AE. Total cost of additional supportive resources was 32,522 Euros (625 [SD = 876] Euros/patient) (TVR 759 [SD = 1,022] Euros/patient vs. BOC 349 [SD = 327] Euros/patient; P > .05). Patients with grade iii-iv toxicity required greater supportive care with higher costs, compared to patients with grade i-ii toxicity (849 [SD = 1,143] Euros/patient vs. 387 [SD = 397] Euros/patient; P = .053).CONCLUSION:
The addition of new protease inhibitors to conventional treatment leads to a higher incidence of hematological AE in our study, compared to data described in clinical trials. The elevated incidence of AE involves the use of supportive care, increasing total costs of therapy
Full text:
Available
Collection:
National databases
/
Spain
Health context:
Sustainable Health Agenda for the Americas
Health problem:
Goal 4: Health financing
Database:
IBECS
Main subject:
Antiviral Agents
/
Protease Inhibitors
/
Hepatitis C, Chronic
/
Drug-Related Side Effects and Adverse Reactions
Type of study:
Etiology study
/
Health economic evaluation
/
Incidence study
/
Observational study
/
Risk factors
/
Screening study
Limits:
Humans
Language:
Spanish
Journal:
Enferm. infecc. microbiol. clín. (Ed. impr.)
Year:
2015
Document type:
Article
Institution/Affiliation country:
Hospital Universitario Doctor Peset/España