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Esquemas con sofosbuvir y simeprevir en hepatitis C / Sofosbuvir and Simeprevir-Based Schemes for the Management of Hepatitis C
Buenos Aires; IECS; ago. 2015.
Non-conventional in Spanish | BRISA/RedTESA, BRISA/RedTESA | ID: biblio-986370
Responsible library: BR1.1
RESUMEN

INTRODUCCIÓN:

La infección crónica por el virus de la hepatitis C (VHC) es una de las principales causas de cirrosis y carcinoma hepatocelular. El VHC es un virus ARN que posee seis genotipos (1 a 6) siendo el genotipo 1 el más frecuente en Argentina (70%). El objetivo principal de la terapia es curar la infección, lo cual se denomina respuesta virológica sostenida (RVS) y se refleja a través de la medición indetectable de ARN del VHC en sangre después de finalizada la terapia. El tratamiento con interferón pegilado (PegIFN) asociado a ribavirina (RBV) fue durante muchos años el principal esquema de tratamiento. Actualmente aparecieron nuevos esquemas más eficaces y seguros e inclusive capaces de ser administrados en poblaciones de sujetos con cirrosis descompensada como sofosbuvir (SOF), simeprevir (SIM), daclatasvir y ledipasvir entre otros. Se postula el uso de esquemas con SOF y SIM para el tratamiento de la hepatitis C crónica debido a que se podrían obtener mayores tasas de RVS, con menos efectos adversos y menor duración de tratamiento. TECNOLOGÍA SOF es un inhibidor análogo de la polimerasa del ARN viral, mientras que SIM es un inhibidor de la serina proteasa NS3-4a del VHC. Estos dos fármacos han sido evaluados en combinación con otras drogas para el manejo de hepatitis C (no se administran en monoterapia).

OBJETIVO:

Evaluar la evidencia disponible acerca de la eficacia, seguridad y aspectos relacionados a las políticas de cobertura del uso de esquemas con sofosbuvir y simeprevir en la hepatitis C crónica.

MÉTODOS:

Se realizó una búsqueda en las principales bases de datos bibliográficas (incluyendo Medline, Cochrane y CRD), en buscadores genéricos de Internet, agencias de evaluación de tecnologías sanitarias y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas (RS), ensayos clínicos controlados aleatorizados (ECAs), evaluaciones de tecnologías sanitarias (ETS) y económicas, guías de práctica clínica (GPC) y políticas de cobertura (PC) de otros sistemas de salud cuando estaban disponibles.

RESULTADOS:

Para SOF+RBV se identificaron dos ECAs; para SOF+PegIFN+RBV, dos ECAs; para SOF+SIM, un ECA; para SOF+ledipasvir, tres ECAs; para SOF+daclatasvir, un ECA; y para SIM+PegIFN+RBV, tres ECAs. Además se seleccionaron cinco GPC cuatro ETS y cinco PC.

CONCLUSIONES:

La evidencia es abundante y de buena calidad. Los esquemas que contienen sofosbuvir y simeprevir combinados con otras drogas para el manejo de hepatitis C han demostrado ser superiores comparados con el tratamiento estándar o triple terapia con telaprevir o boceprevir en diferentes grupos de pacientes. Aunque se encuentran contemplados por distintas guías de práctica clínica y evaluaciones de tecnologías sanitarias, su alto costo puede limitar la disponibilidad del tratamiento en los diferentes países.
ABSTRACT

INTRODUCTION:

Chronic hepatitis C virus (HCV) infection is one of the main causes of cirrhosis and hepatocellular carcinoma worldwide. HCV is an ARN virus with six genotypes (1 to 6); genotype 1 being the most common in Argentina (70%). The main objective of this therapy is to cure infection. This is called sustained virologic response (SVR) and it is reflected by measuring undetectable HCV ARN in blood once therapy is completed. Treatment with pegylated interferon (PegIFN) + ribavirin (RBV) has been the main management scheme for many years. New, more efficacious and safer schemes such as sofosbuvir (SOF), simeprevir (SIM), daclatasvir and ledipasvir among others have currently appeared; they can even be administered to subjects with decompensated cirrhosis. The use of SOF and SIM schemes has been proposed for the treatment of chronic hepatitis C because higher SVRs could be obtained, with lower adverse effect rates and shorter treatment length compared with the standard treatment. TECHNOLOGY SOF is a virus RNA analogue polymerase inhibitor, whereas SIM is an NS3-4a serine protease HCV inhibitor. These two drugs have been evaluated in combination with other drugs for hepatitis C management, that is to say, they are not administered as monotherapy.

PURPOSE:

To assess the available evidence on the efficacy, safety and aspects related to coverage polices on the use of sofosbuvir and simeprevir schemes for the management of patients with chronic hepatitis C.

METHODS:

A bibliographic search was carried out on the main databases (such as MEDLINE, Cochrane and CRD), in general Internet engines, in health technology assessment agencies and health sponsors. Priority was given to the inclusion of systematic reviews (SRs); controlled, randomized clinical trials (RCTs); health technology assessment (HTA) documents and economic evaluations; clinical practice guidelines (GCPs) and coverage policies (CPs) of other health systems, when available.

RESULTS:

For SOF+RBV two RCTs were identified. For SOF+PegIFN+RBV, two RCTs were identified. For SOF+SIM, one RCT was identified. For SOF+ledispavir, three RCTs were identified. For SOF+daclatasvir, one RCT was identified and finally for SIM+PegIFN+RBV, three RCTs, were identified. In addition, two CPGs, four HTA documents and five CPs were selected.

CONCLUSIONS:

There is plenty of evidence found and its good quality. Schemes with sofosbuvir and simeprevir combined with other drugs to manage hepatitis C have demonstrated to be better when compared with the standard treatment or triple therapy with telaprevir or boceprevir in different patient groups. Although they are considered in the different clinical practice guidelines and health technology assessment documents, their high cost may limit their treatment availability in the different countries.
Subject(s)
Full text: Available Collection: Tematic databases Health context: SDG3 - Health and Well-Being Health subject: Target 3.3: End transmission of communicable diseases Database: BRISA/RedTESA Main topic: Hepatitis C / Simeprevir / Sofosbuvir Type of study: Controlled clinical trial / Evaluation study / Practice guideline / Health technology assessment Demographic groups: Humans Language: Spanish Year: 2015 Document type: Non-conventional

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Full text: Available Collection: Tematic databases Health context: SDG3 - Health and Well-Being Health subject: Target 3.3: End transmission of communicable diseases Database: BRISA/RedTESA Main topic: Hepatitis C / Simeprevir / Sofosbuvir Type of study: Controlled clinical trial / Evaluation study / Practice guideline / Health technology assessment Demographic groups: Humans Language: Spanish Year: 2015 Document type: Non-conventional