Post-treatment LSM rather than change during treatment predicts decompensation in patients with cACLD after HCV cure.

BACKGROUND & AIMS: Baveno VII has defined a clinically significant (i.e., prognostically meaningful) decrease in liver stiffness measurement (LSM) in cACLD as a decrease of ≥20% associated with a final LSM <20 kPa or any decrease to <10 kPa. However, these rules have not yet been validated against direct clinical endpoints. METHODS: We retrospectively analysed patients with cACLD (LSM ≥10 kPa) with paired liver stiffness measurement (LSM) before (BL) and after (FU) HCV cure by interferon-free therapies from 15 European centres. The cumulative incidence of hepatic decompensation was compared according to these criteria, considering hepatocellular carcinoma and non-liver-related death as competing risks. RESULTS: A total of 2,335 patients followed for a median of 6 years were analysed. Median BL-LSM was 16.6 kPa with 37.1% having ≥20 kPa. After HCV cure, FU-LSM decreased to a median of 10.9 kPa (<10 kPa: 1,002 [42.9%], ≥20 kPa: 465 [19.9%]) translating into a median LSM change of -5.3 (-8.8 to -2.4) kPa corresponding to -33.9 (-48.0 to -15.9) %. Patients achieving a clinically significant decrease (65.4%) had a significantly lower risk of hepatic decompensation (subdistribution hazard ratio: 0.12, 95% CI 0.04-0.35, p <0.001). However, these risk differences were primarily driven by a negligible risk in patients with FU-LSM <10 kPa (5-year cumulative incidence: 0.3%) compared to a high risk in patients with FU-LSM ≥20 kPa (16.6%). Patients with FU-LSM 10-19.9 kPa (37.4%) also had a low risk of hepatic decompensation (5-year cumulative incidence: 1.7%), and importantly, the risk of hepatic decompensation did not differ between those with/without an LSM decrease of ≥20% (p = 0.550). CONCLUSIONS: FU-LSM is key for risk stratification after HCV cure and should guide clinical decision making. LSM dynamics do not hold significant prognostic information in patients with FU-LSM 10-19.9 kPa, and thus, their consideration is not of sufficient incremental value in the specific context of HCV cure. IMPACT AND IMPLICATIONS: Liver stiffness measurement (LSM) is increasingly applied as a prognostic biomarker and commonly decreases in patients with compensated advanced chronic liver disease achieving HCV cure. Although Baveno VII proposed criteria for a clinically significant decrease, little is known about the prognostic utility of LSM dynamics (changes through antiviral therapy). Interestingly, in those with a post-treatment LSM of 10-19.9 kPa, LSM dynamics did not provide incremental information, arguing against the consideration of LSM dynamics as prognostic criteria. Thus, post-treatment LSM should guide the management of patients with compensated advanced chronic liver disease achieving HCV cure.

A Model Based on Noninvasive Markers Predicts Very Low Hepatocellular Carcinoma Risk After Viral Response in Hepatitis C Virus-Advanced Fibrosis.

BACKGROUND AND AIMS: Patients with hepatitis C virus (HCV) and advanced fibrosis remain at risk of hepatocellular carcinoma (HCC) after sustained viral response (SVR) and need lifelong surveillance. Because HCC risk is not homogenous and may decrease with fibrosis regression, we aimed to identify patients with low HCC risk based on the prediction of noninvasive markers and its changes after SVR. APPROACH AND RESULTS: This is a multicenter cohort study, including patients with HCV and compensated advanced fibrosis that achieved SVR after direct antivirals. Clinical and transient elastography (TE) data were registered at baseline, 1 year, and 3 years after the end of treatment (EOT). All patients underwent liver ultrasound scan every 6 months. Patients with clinical evaluation 1 year after EOT were eligible. Univariate and multivariate Cox regression analysis were performed, and predictive models were constructed. HCC occurrence rates were evaluated by Kaplan-Meier. Nine hundred and ninety-three patients were eligible (56% male; 44% female; median age 62 years), 35 developed HCC (3.9%), and the median follow-up was 45 months (range 13-53). Baseline liver stiffness measurement (LSM) (HR 1.040; 95% CI 1.017-1.064), serum albumin (HR 0.400; 95% CI 0.174-0.923), 1-year DeltaLSM (HR 0.993; 95% CI 0.987-0.998), and 1-year FIB-4 score (HR 1.095; 95% CI 1.046-1.146) were independent factors associated with HCC. The TE-based HCC risk model predicted 0% of HCC occurrence at 3 years in patients with score 0 (baseline LSM ≤ 17.3 kPa, albumin >4.2 g/dL, and 1-year DeltaLSM > 25.5%) versus 5.2% in patients with score 1-3 (Harrell's C 0.779; log-rank 0.002). An alternative model with FIB-4 similarly predicted HCC risk. CONCLUSIONS: A combination of baseline and dynamic changes in noninvasive markers may help to identify patients with a very low risk of HCC development after SVR.

Real-world evidence of the effectiveness of ombitasvir-paritaprevir/r ± dasabuvir ± ribavirin in patients monoinfected with chronic hepatitis C or coinfected with human immunodeficiency virus-1 in Spain.

AIM: We describe the effectiveness and safety of the interferon-free regimen ombitasvir/paritaprevir/ritonavir plus dasabuvir with or without ribavirin (OBV/PTV/r ± DSV ± RBV) in a nationwide representative sample of the hepatitis C virus (HCV) monoinfected and human immunodeficiency virus-1/hepatitis C virus (HIV/HCV) coinfected population in Spain. MATERIAL AND METHODS: Data were collected from patients infected with HCV genotypes 1 or 4, with or without HIV-1 coinfection, treated with OBV/PTV/r ± DSV ± RBV at 61 Spanish sites within the initial implementation year of the first government-driven "National HCV plan." Effectiveness was assessed by sustained virologic response at post-treatment week 12 (SVR12) and compared between monoinfected and coinfected patients using a non-inferiority margin of 5% and a 90% confidence interval (CI). Sociodemographic and clinical characteristics or patients and adverse events (AEs) were also recorded. RESULTS: Overall, 2,408 patients were included in the intention-to-treat analysis: 386 (16%) were patients with HIV/HCV. Patient selection reflected the real distribution of patients treated in each participating region in Spain. From the total population, 96.6% (95% CI, 95.8-97.3%) achieved SVR12. Noninferiority of SVR12 in coinfected patients was met, with a difference between monoinfected and coinfected patients of -2.2% (90% CI, -4.5% - 0.2%). Only genotype 4 was associated with non-response to OBV/PTV/r ± DSV ± RBV treatment (p<0.001) in the multivariate analysis. Overall, 286 patients (11.9%) presented AEs potentially related to OBV/PTV/r ± DSV, whereas 347 (29.0%) presented AEs potentially related to ribavirin and 61 (5.1%) interrupted ribavirin. CONCLUSIONS: Our results confirm that OBV/PTV/r ± DSV ± RBV is effective and generally well tolerated in a representative sample of the HCV monoinfected and HCV/HIV coinfected population in Spain within the experience of a national strategic plan to tackle HCV.

[Therapeutic update in hepatitis C]. / Actualización terapéutica en la hepatitis C.

Hepatitis C virus infection is a major health burden affecting 130-170 million people worldwide. Approximately 10-30% of those with chronic hepatitis C will progress to cirrhosis over 20-30 years. The development of new direct-acting antivirals has changed the management of the disease, allowing efficacious Interferon-free therapies superior to prior treatment regimens with minimal side effects, even in some subgroups previously thought to be difficult to cure such as cirrhotic patients.

Actualización terapéutica en la hepatitis C / Therapeutic update in hepatitis C

La infección por el virus de hepatitis C es un problema de salud que afecta a 130-170 millones de personas en todo el mundo. Aproximadamente un 10-30% de pacientes con hepatitis crónica C progresarán a cirrosis en 20-30 años. El desarrollo de nuevos agentes antivirales de acción directa ha cambiado el manejo de la enfermedad, permitiendo el tratamiento libre de Interferón con eficacia superior a los regímenes terapéuticos previos y mínimos efectos adversos, incluso en algunos subgrupos previamente considerados difíciles de curar como los pacientes cirróticos (AU)

Hepatitis C virus infection is a major health burden affecting 130-170 million people worldwide. Approximately 10-30% of those with chronic hepatitis C will progress to cirrhosis over 20-30 years. The development of new direct-acting antivirals has changed the management of the disease, allowing efficacious Interferon-free therapies superior to prior treatment regimens with minimal side effects, even in some subgroups previously thought to be difficult to cure such as cirrhotic patients (AU)

Arteritis de Takayasu y enfermedad de Crohn: ¿una asociación infrecuente? / No disponible

No disponible

Ictericia asociada al tratamiento con pregabalina / No disponible

No disponible

[Extraintestinal manifestations in inflammatory bowel disease: differences between Crohn's disease and ulcerative colitis]. / Manifestaciones extraintestinales en la enfermedad inflamatoria intestinal: diferencias entre la enfermedad de Crohn y la colitis ulcerosa.

BACKGROUND AND OBJECTIVE: The true prevalence of the extraintestinal manifestations (EM) associated with inflammatory bowel disease (IBD) may vary depending on the geographic area, IBD population, location and duration of the disease, medication and diagnostic accuracy. The aim of this study was determine the prevalence of the major EM of IBD and their differences between Crohn's disease (CD) and ulcerative colitis (UC). PATIENTS AND METHOD: A prospective study with a total of 566 patients (295 CD with median follow up 11.6 years [range: 2-32 years] and 271 UC with median follow up 10.4 years [range: 2-36 years]. Data related to the clinical course, EM and laboratory tests were obtained at diagnosis and during follow-up. RESULTS: EM related with IBD appeared al least once in 46.6% of the patients. Joints manifestations were the most common EM. The EM were equal frequent in UC (51.5%) as in CD (42.2%). Hepatobiliary manifestations (odds ratio [OR] = 1.91; 95% confidence interval [CI] 1.15-3.16; p = 0.007), venous thromboembolism (OR = 4.26; 95% CI, 1.3-15.4; p = 0.006) and arthralgias (OR = 1.59; 95% CI, 1.01-2.5; p = 0.035) were more frequent in UC than CD. Erythema nodosum (OR = 2.35; 95% CI, 1.13-5.0; p = 0.013) and peripheral arthritis (OR = 1.95; 95% CI, 1.02-3.74; p = 0.029) were more frequent in CD. The prevalences of ocular, and the rest of joint manifestations were not different according to UC or CD. CONCLUSIONS: Prevalence of EM in Spanish IBD patients is among the highest ever reported. The distribution of the EM observed is different between CD and UC. It is necessary to know to allow to prompt diagnosis and prevent undesirable complications.

Manifestaciones extraintestinales en la enfermedad inflamatoria intestinal: diferencias entre la enfermedad de Crohn y la colitis ulcerosa / Extraintestinal manifestations in inflammatory bowel disease: differences between Crohn's disease and ulcerative colitis

Fundamento y objetivo: La prevalencia de las manifestaciones extraintestinales (MEI) en la enfermedad inflamatoria intestinal (EII) varía en función de las áreas geográficas, el tipo de EII, la localización, la duración de la enfermedad y el tratamiento y la rapidez en el diagnóstico. El objetivo de este trabajo ha sido determinar la prevalencia de las principales MEI en la EII y las diferencias existentes entre la enfermedad de Crohn (EC) y la colitis ulcerosa (CU). Pacientes y método: Estudio prospectivo en el que se incluyó a 566 pacientes con EII (295 con EC y seguimiento medio de 11,6 años [extremos: 2-32 años] y 271 con CU y seguimiento medio de 10,4 años [extremos: 2-36 años]. Los datos referidos a las MEI y tests de laboratorio se obtuvieron en el momento del diagnóstico y durante las visitas posteriores. Resultados: La aparición de al menos una MEI se observó en el 46,6% de los pacientes. Las MEI fueron frecuentes tanto en la CU (51,5%) como en la EC (42,2%). Las manifestaciones hepatobiliares (odds ratio [OR] = 1,91; intervalo de confianza [IC] del 95%, 1,15-3,16), la enfermedad tromboembólica venosa (OR = 4,26; IC del 95%, 1,3-15,4) y las artralgias (OR = 1,59; IC del 95%, 1,01-2,5) fueron más frecuentes en la CU que en la EC. El eritema nodoso (OR = 2,35; IC del 95%, 1,13-5,0) y las artritis periféricas (OR = 1,95; IC del 95%, 1,02-3,74) fueron más frecuentes en la EC. La prevalencia de las manifestaciones oculares y del resto de manifestaciones articulares no difirió entre la CU y la EC. Conclusiones: La prevalencia de las MEI en los pacientes con EII españoles es una de las más altas publicadas. La frecuencia del tipo de MEI es diferente entre los pacientes con EC y CU, un aspecto que es importante conocer para realizar un diagnóstico adecuado de la EII y de sus complicaciones

Background and objective: The true prevalence of the extraintestinal manifestations (EM) associated with inflamatory bowel disease (IBD) may vary depending on the geographic area, IBD population, location and duration of the disease, medication and diagnostic accuracy. The aim of this study was determine the prevalence of the major EM of IBD and their differences between Crohn's disease (CD) and ulcerative colitis (UC). Patients and method: A prospective study with a total of 566 patients (295 CD with median follow up 11.6 years [range: 2-32 years] and 271 UC with median follow up 10.4 years [range: 2-36 years]. Data related to the clinical course, EM and laboratory tests were obtained at diagnosis and during follow-up. Results: EM related with IBD appeared al least once in 46.6% of the patients. Joints manifestations were the most common EM. The EM were equal frequent in UC (51.5%) as in CD (42.2%). Hepatobiliary manifestations (odds ratio [OR] = 1.91; 95% confidence interval [CI] 1.15-3.16; p = 0.007), venous thromboembolism (OR = 4.26; 95% CI, 1.3-15.4; p = 0.006) and arthralgias (OR = 1.59; 95% CI, 1.01-2.5; p = 0.035) were more frequent in UC than CD. Erythema nodosum (OR = 2.35; 95% CI, 1.13-5.0; p = 0.013) and peripheral arthritis (OR = 1.95; 95% CI, 1.02-3.74; p = 0.029) were more frequent in CD. The prevalences of ocular, and the rest of joint manifestations were not different according to UC or CD. Conclusions: Prevalence of EM in Spanish IBD patients is among the highest ever reported. The distribution of the EM observed is different between CD and UC. It is necessary to know to allow to prompt diagnosis and prevent undesirable complications