RESUMEN
Sixteen months have passed since I had the honor of being appointed editor-in-chief of Revista Española de Enfermedades Digestivas (The Spanish Journal of Gastroenterology) (REED) and thank the Spanish Society of Digestive Diseases (SEPD) for trusting me in this new phase of the REED history. Four months later, in November 2021, Dr Juan-Ramon Larrubia joined the journal as Executive Editor. We thank the former Editor-in-Chief and deputy-editor Enrique Peéez-Cuadrado and Javier A. Cienfuegos, respectively, their devoted work putting the journal on an upward trajectory since 2016, one year before the REED centenary, they set the bar very high (AU)
Asunto(s)
Humanos , Publicaciones Periódicas como Asunto/tendencias , Factor de Impacto de la Revista , Gastroenterología , EspañaRESUMEN
INTRODUCCIÓN: Hay pocos estudios publicados acerca de los factores predictivos de respuesta al tratamiento de la hepatitis C con sofosbuvir y simeprevir. OBJETIVO: Conocer qué factores influyen en la respuesta a simeprevir (SIM) y sofosbuvir (SOF) en pacientes infectados por los genotipos 1 o 4 de la hepatitis C. PACIENTES Y MÉTODOS: Estudio prospectivo observacional de cohortes en 12 hospitales. La efectividad se evaluó con respuesta virológica sostenida (RVS12). RESULTADOS: Se incluyeron 204 pacientes (62,3% varones, edad media 55 años). Ciento ochenta y seis (91,2%) genotipo 1 (60,3% 1b, 25% 1a) y 18 (8,8%) genotipo 4. Ciento treinta y dos (64,7%) cirróticos (87,9% Child A), 33 (16,2%) F3, 31 (15,2%) F2, 8 (3,9%) F0-1. Un 80,8% MELD < 10. Noventa y tres (45,6%) naive. Se asoció ribavirina en 68 (33,3%). Carga viral basal media 2.151.549 UI/ML (DE: 2.391.840). Duración tratamiento 12 semanas en 93,1%. Cuatro suspendieron tratamiento: suicidio, brote psicótico, hiperbilirrubinemia y recurrencia hepatocarcinoma. Ciento noventa (93,1%) alcanzaron RVS12. No hubo diferencias RVS12 en función del genotipo, duración tratamiento, empleo de ribavirina, tratamiento previo, CV y plaquetas basales. En análisis univariante, negatividad carga viral a las 4 semanas (p = 0,042), ausencia de cirrosis (p = 0,021), albúmina basal ≥ 4g/dl (p:0,001) y MELD<10 (p < 0,0001) se asociaron con mayor RVS12. En estudio multivariante solo hubo relación significativa entre puntuación MELD basal < 10 y mayor RVS12 (p < 0,001). CONCLUSIONES: La combinación de simeprevir y sofosbuvir es muy eficaz en pacientes infectados por los genotipos 1 y 4 de la hepatitis C. Es un tratamiento seguro, especialmente en pacientes sin ribavirina. Esta combinación es más efectiva en pacientes con puntuación MELD inferior a 10
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