Predictive variables of sustained virological response after early discontinuation of triple therapy with telaprevir for genotype-1 HCV infection / Variables pronósticas de respuesta virológica sostenida tras la interrupción precoz del tratamiento triple con telaprevir de la infección por genotipo 1 del virus de la hepatitis C

BACKGROUND: Pivotal phase studies of telaprevir (TLV) and boceprevir (BOV) showed 10-56% rates of early treatment interruption. However, there have been no reports on the sustained virological response (SVR) rates of these patients. AIM: To assess the SVR rate in a large cohort of patients who discontinued triple therapy with TLV or BOV for reasons other than stopping rules and to identify variables predicting SVR. MATERIAL AND METHOD: A survey was sent to 15 hospitals in Catalonia asking them to report all TLV/BOV treatments finished by 31 May 2014. Demographic, clinical, laboratory, liver fibrosis and therapeutic data were recorded for treatments with early discontinuation. Logistic regression analysis, ROC curves and prognostic assessment of the variables identified were calculated. RESULTS: Twelve hospitals responded to the survey, representing 467 treatments and 121 (21.2%) early discontinuations, 76 (62.8%) due to stopping rules and 45 (37.2%) for other reasons. Early discontinuation was more frequent with BOV [38.2% (50/131) versus 21.1% (71/336) p < 0.005], mainly due to stopping rules [78% (39/50) versus 52.1% (37/71); p = 0.004]. SVR was achieved in 21/121 patients (17.4%), 19/71 (26.8%) treated with TLV and 2/50 (4.0%) treated with BOV. In patients discontinuing treatment for reasons other than stopping rules, SVR was achieved in 19/37 (55.9%) treated with TLV and in 2/11 (18.2%) treated with BOV. The SVR rate in patients treated with TLV who discontinued due to a severe adverse event was 61.5% (16/26). A logistic regression analysis was performed only with triple therapy with TLV and early discontinuation. The predictive variables of SVR were undetectable HCV-RNA at treatment week 4 and treatment length longer than 11 weeks. Treatment duration longer than 11 weeks showed the best accuracy (0.794), with a positive predictive value of 0.928. CONCLUSIONS: Early discontinuation of TLV-based triple therapy due to reasons other than stopping rules still have a significant SVR rate (55.9%). Undetectable HVC-RNA at week 4 of treatment and treatment duration longer than 11 weeks are predictive of SVR in this subset of patients

ANTECEDENTES: Los estudios de registro de telaprevir (TLV) y boceprevir (BOV) han mostrado tasas de interrupción precoz del tratamiento del 10-56%, pero no se ha comunicado la respuesta virológica sostenida (RVS) de estos pacientes. OBJETIVOS: Analizar la RVS, y los factores predictivos de esta, en una cohorte extensa de pacientes que pararon precozmente el tratamiento triple con TLV/BOV por causas diferentes a reglas de parada. MATERIAL Y MÉTODO: Se envió a 15 de hospitales de Cataluña un cuestionario relativo a los tratamientos con TLV/BOV finalizados antes del 31 de mayo de 2014, incluyendo información clínica, analítica, elastométrica y terapéutica de aquellos interrumpidos precozmente. Se realizaron análisis de regresión logística, curvas ROC y estimaciones pronósticas de las variables identificadas. RESULTADOS: Contestaron la encuesta 12 hospitales, sumando un total de 467 tratamientos con 121 (21,2%) interrupciones precoces del mismo, 76 (62,8%) por reglas de parada y 45 (37,2%) por otras causas. Hubo más paradas precoces en los tratamientos con BOV (38,2% [50/131] versus 21,1% [71/336]; p < 0,005), principalmente debidas a reglas de parada (78% [39/50] versus 52,1% [37/71]; p = 0,004). Alcanzaron RVS 21/121 pacientes (17,4%), 19/71 (26,8%) tratados con TLV y 2/50 (4,0%) tratados con BOV. En los pacientes que pararon el tratamiento por causas distintas a reglas de parada se alcanzó la RVS en 19/37 (55,9%) tratados con TLV y en 2/11 (18,2%) tratados con BOV. Los pacientes tratados con TLV que pararon el tratamiento por efecto adverso grave tuvieron una tasa de RVS del 61,5% (16/26). El análisis de regresión logística se hizo solo con los tratamientos triples con TLV parados precozmente. Las variables predictivas de RVS fueron el ARN-VHC indetectable en semana 4 y la duración del tratamiento mayor de 11 semanas. El mejor valor pronóstico (0,794) lo tuvo la duración total del tratamiento mayor de 11 semanas, con un VPP de 0,928. CONCLUSIONES: Los pacientes que paran precozmente el tratamiento triple con TLV por causas diferentes a reglas de parada conservan una tasa de RVS relevante (55,9%) en esta cohorte. El ARN-VHC indetectable en semana 4 y la duración del tratamiento mayor de 11 semanas son predictivas de RVS de este subgrupo de pacientes

Predictive variables of sustained virological response after early discontinuation of triple therapy with telaprevir for genotype-1 HCV infection.

BACKGROUND: Pivotal phase studies of telaprevir (TLV) and boceprevir (BOV) showed 10-56% rates of early treatment interruption. However, there have been no reports on the sustained virological response (SVR) rates of these patients. AIM: To assess the SVR rate in a large cohort of patients who discontinued triple therapy with TLV or BOV for reasons other than stopping rules and to identify variables predicting SVR. MATERIAL AND METHOD: A survey was sent to 15 hospitals in Catalonia asking them to report all TLV/BOV treatments finished by 31 May 2014. Demographic, clinical, laboratory, liver fibrosis and therapeutic data were recorded for treatments with early discontinuation. Logistic regression analysis, ROC curves and prognostic assessment of the variables identified were calculated. RESULTS: Twelve hospitals responded to the survey, representing 467 treatments and 121 (21.2%) early discontinuations, 76 (62.8%) due to stopping rules and 45 (37.2%) for other reasons. Early discontinuation was more frequent with BOV [38.2% (50/131) versus 21.1% (71/336) p<0.005], mainly due to stopping rules [78% (39/50) versus 52.1% (37/71); p=0.004]. SVR was achieved in 21/121 patients (17.4%), 19/71 (26.8%) treated with TLV and 2/50 (4.0%) treated with BOV. In patients discontinuing treatment for reasons other than stopping rules, SVR was achieved in 19/37 (55.9%) treated with TLV and in 2/11 (18.2%) treated with BOV. The SVR rate in patients treated with TLV who discontinued due to a severe adverse event was 61.5% (16/26). A logistic regression analysis was performed only with triple therapy with TLV and early discontinuation. The predictive variables of SVR were undetectable HCV-RNA at treatment week 4 and treatment length longer than 11 weeks. Treatment duration longer than 11 weeks showed the best accuracy (0.794), with a positive predictive value of 0.928. CONCLUSIONS: Early discontinuation of TLV-based triple therapy due to reasons other than stopping rules still have a significant SVR rate (55.9%). Undetectable HVC-RNA at week 4 of treatment and treatment duration longer than 11 weeks are predictive of SVR in this subset of patients.

Factores pronósticos asociados a la mortalidad de los pacientes con hepatitis alcohólica grave / Prognostic factors associated with mortality in patients with severe alcoholic hepatitis

La hepatitis alcohólica grave se asocia a una mortalidad precoz elevada. El objetivo de nuestro estudio fue identificar los factores pronósticos asociados a la mortalidad intrahospitalaria, la mortalidad a medio y a largo plazo de la hepatitis alcohólica grave, así como evaluar los diferentes índices pronósticos en una cohorte de pacientes de nuestro hospital. Realizamos un análisis de 66 episodios consecutivos que ingresaron durante el periodo 2000-2008. Se recogieron y analizaron los datos clínicos y analíticos al ingreso, a la semana, al mes, a los 6 meses y al año, así como datos sobre el tratamiento recibido y las complicaciones asociadas durante el ingreso. Se calcularon y evaluaron los diferentes índices pronósticos de la literatura. La mortalidad asociada a un episodio de hepatitis alcohólica grave se produjo sobre todo durante el primer mes, con una tasa media de mortalidad del 16,9 %. Las complicaciones infecciosas se relacionaron con una menor supervivencia intrahospitalaria. Los valores de MELD, urea y bilirrubina a los 7 días de ingreso fueron los únicos factores independientes de supervivencia intrahospitalaria (OR = 1,14; 1,012 y 1,1, respectivamente) y a los 6 meses (OR = 1,15; 1,014 y 1,016, respectivamente). A los 12 meses, solo los valores de MELD y urea a los 7 días fueron factores independientes de supervivencia. En nuestra cohorte el MELD fue el mejor índice pronóstico para predecir la mortalidad asociada a un episodio de hepatitis alcohólica grave (AU)

Severe alcoholic hepatitis is associated with high early mortality. This study aimed at identifying prognostic factors associated with in-hospital, medium- and long-term mortality of severe alcoholic hepatitis and to evaluate the different prognostic scoring systems on a cohort of patients in our hospital. To this end, we conducted a retrospective analysis of 66 episodes admitted between 2000 and 2008. Clinical and laboratory data on admission, at 7 days, 1 month, 6 months, and after one year were collected and analyzed, as were the details on the treatment and complications that occurred during hospitalization; the different prognostic indices used in the literature were calculated. Death event associated with an episode of severe alcoholic hepatitis occurs primarily during the first month, with an average mortality rate of 16.9. Infectious complications were associated with lower in-hospital survival. MELD score, urea and bilirubin values one week after admission were independently associated with both in-hospital survival (OR = 1.14, 1.012 and 1.1, respectively), and survival at 6 months (OR = 1, 15; 1.014 and 1.016, respectively). Only MELD score and urea values at 7 days were independent predictors of survival twelve months after the acute hepatitis episode. MELD score, urea, and bilirubin 7 days after admission were the only independent in-hospital survival and also long-term survival factors 6 months and one year after the episode. In our cohort, the MELD score was the best prognostic index to predict mortality associated with an episode of severe alcoholic hepatitis (AU)

[Prognostic factors associated with mortality in patients with severe alcoholic hepatitis]. / Factores pronósticos asociados a la mortalidad de los pacientes con hepatitis alcohólica grave.

Severe alcoholic hepatitis is associated with high early mortality. This study aimed at identifying prognostic factors associated with in-hospital, medium- and long-term mortality of severe alcoholic hepatitis and to evaluate the different prognostic scoring systems on a cohort of patients in our hospital. To this end, we conducted a retrospective analysis of 66 episodes admitted between 2000 and 2008. Clinical and laboratory data on admission, at 7 days, 1 month, 6 months, and after one year were collected and analyzed, as were the details on the treatment and complications that occurred during hospitalization; the different prognostic indices used in the literature were calculated. Death event associated with an episode of severe alcoholic hepatitis occurs primarily during the first month, with an average mortality rate of 16.9. Infectious complications were associated with lower in-hospital survival. MELD score, urea and bilirubin values one week after admission were independently associated with both in-hospital survival (OR = 1.14, 1.012 and 1.1, respectively), and survival at 6 months (OR = 1, 15; 1.014 and 1.016, respectively). Only MELD score and urea values at 7 days were independent predictors of survival twelve months after the acute hepatitis episode. MELD score, urea, and bilirubin 7 days after admission were the only independent in-hospital survival and also long-term survival factors 6 months and one year after the episode. In our cohort, the MELD score was the best prognostic index to predict mortality associated with an episode of severe alcoholic hepatitis.

[How many reach their goal? Outcome of abstracts presented at the XXIV AAEEH (Spanish Liver Study Association) Congress and their progress over time]. / 'Cuántos alcanzan la meta? Destino de los resúmenes presentados en el XXIV Congreso de la Asociación Española para el Estudio del Hígado y su evolución en el tiempo.

INTRODUCTION: The aim of the abstracts presented at scientific meetings is their publication in a peer-review journal. In this study, we analysed the publication rates of the abstracts submitted to the 24th AEEH meeting (1999) and also to see if this was stable over time. MATERIAL AND METHODS: We assessed the publication rates of the abstracts presented at the 24th AEEH meeting in journals included in MEDLINE. As a comparison tool, we did the same with the abstracts submitted to the 34th Annual Meeting of the European Association for the Study of the Liver (EASL). The same procedure was carried out on the three subsequent editions of AEEH meetings to evaluate the continuity in the long term. RESULTS: Of the abstracts submitted at the 24th AEEH meeting, 52.8% (93/176) were published: 71.4% of those had been accepted for oral presentation, 54% as a poster and 41% were non-accepted abstracts. From the 34th EASL Annual Meeting, 27.1% (248/913) of the submitted abstracts were published (p < 0.001 compared to AEEH), 52.5% of those were accepted for oral communication, 33.1% accepted as a poster communication and 18.1% from non-accepted abstracts. Moreover, this high publication rate of the abstracts of AEEH meeting at 1999, was maintained during the following three years (47.55 and 54%, respectively). CONCLUSIONS: a) The publication rate of abstracts presented at 24th AEEH meeting was excellent and superior in comparison to the EASL rate of the same year; b) almost three quarters of abstracts accepted for oral presentation and more than half of those accepted as a poster were finally published, and c) high publication rates seem to be maintained over time.

¿Cuántos alcanzan la meta? Destino de los resúmenes presentados en el XXIV Congreso de la Asociación Española para el Estudio del Hígado y su evolución en el tiempo / How many reach their goal? Outcome of abstracts presented at the XXIV AAEEH (Spanish Liver Study Association) Congress and their progress over time

Introducción: El objetivo de los resúmenes presentados a los congresos científicos es su publicación en una revista basada en la revisión previa por expertos. En el presente estudio se analizó la tasa de publicación de los resúmenes presentados al XXIV Congreso de la Asociación Española para el Estudio del Hígado (AEEH) (1999) y si dicha tasa se mantiene a lo largo del tiempo. Material y métodos: Se evaluó la tasa de publicación en revistas incluidas en MEDLINE de los resúmenes presentados al XXIV Congreso de la AEEH. Como comparación se realizó el mismo proceso con los resúmenes presentados al 34th Annual Meeting de la European Association for the Study of the Liver (EASL). Para valorar la continuidad en el tiempo se procedió de igual forma para las siguientes 3 ediciones del Congreso de la AEEH. Resultados: En el XXIV Congreso de la AEEH se publicaron el 52,8% (93/176) de los resúmenes presentados: un 71,4% de los aceptados para sesión oral, un 54% de los aceptados para póster y un 41% de los resúmenes no aceptados. En el 34th Annual Meeting de la EASL se publicaron el 27,1% (248/913) de los resúmenes presentados (p < 0,001 respecto a la AEEH), el 52,5% de los aceptados para la comunicación oral, el 33,1% de los aceptados para la comunicación en póster y el 18,1% de los no aceptados. Además, el alto índice de publicación de los resúmenes del congreso de la AEEH en 1999 se mantuvo durante los siguientes 3 años (el 47,55 y el 54%, respectivamente). Conclusiones: a) La tasa de publicación de los resúmenes presentados al XXIV Congreso de la AEEH fue excelente y superior al de la EASL del mismo año; b) cerca de las tres cuartas partes de los resúmenes aceptados para la sesión oral y algo más de la mitad de los aceptados para la sesión en póster fueron publicados, lo que refleja el alto grado de acierto del Comité de Selección, y c) esta elevada tasa de publicación parece mantenerse en el tiempo

Introduction: The aim of the abstracts presented at scientific meetings is their publication in a peer-review journal. In this study, we analysed the publication rates of the abstracts submitted to the 24th AEEH meeting (1999) and also to see if this was stable over time. Material and methods: We assessed the publication rates of the abstracts presented at the 24th AEEH meeting in journals included in MEDLINE. As a comparison tool, we did the same with the abstracts submitted to the 34th Annual Meeting of the European Association for the Study of the Liver (EASL). The same procedure was carried out on the three subsequent editions of AEEH meetings to evaluate the continuity in the long term. Results: Of the abstracts submitted at the 24th AEEH meeting, 52.8% (93/176) were published: 71.4% of those had been accepted for oral presentation, 54% as a poster and 41% were non-accepted abstracts. From the 34th EASL Annual Meeting, 27.1% (248/913) of the submitted abstracts were published (p < 0.001 compared to AEEH), 52.5% of those were accepted for oral communication, 33.1% accepted as a poster communication and 18.1% from non-accepted abstracts. Moreover, this high publication rate of the abstracts of AEEH meeting at 1999, was maintained during the following three years (47.55 and 54%, respectively). Conclusions: a) The publication rate of abstracts presented at 24th AEEH meeting was excellent and superior in comparison to the EASL rate of the same year; b) almost three quarters of abstracts accepted for oral presentation and more than half of those accepted as a poster were finally published, and c) high publication rates seem to be maintained over time