Jordi Llaneras (1), Mar Riveiro-Barciela (1)(2), Sabela Lens (2)(3), Moisés Diago (4), Alba Cachero (5), Javier García-Samaniego (2)(6), Isabel Conde (7), Ana Arencibia (8), Juan Arenas (9), Francisco Gea (10), Xavier Torras (2)(11), José Luis Calleja (12), José Antonio Carrión (13), Inmaculada Fernández (14), Rosa María Morillas (2)(15), José Miguel Rosales (16), Isabel Carmona (17), Conrado Fernández-Rodríguez (18), Manuel Hernández-Guerra (19), Susana Llerena (20), Vanesa Bernal (21), Juan Turnes (22), Jesús M. González-Santiago (23), Silvia Montoliu (24), Blanca Figueruela (25), Ester Badia (26), Manuel Delgado (27), Miguel Fernández-Bermejo (28), Mercedes Iñarrairaegui (2)(29), Juan Manuel Pascasio (2)(30), Rafael Esteban (1)(2), Zoe Mariño (2)(3), Maria Buti (1)(2).

INTRODUCTION: Obeticholic acid (OCA) and fibrates therapy results in biochemical improvement in placebo-controlled trials in patients with primary biliary cholangitis and insufficient response to ursodeoxycholic acid. There is scarce information outside of clinical trials. Therefore, we have assessed the effectiveness and adverse events of these treatments. METHODS: Data from patients included in the ColHai registry treated with OCA, fibrates, or both were recorded during a year, as well as adverse events and treatment discontinuation. RESULTS: Eighty-six patients were treated with OCA, 250 with fibrates (81% bezafibrate; 19% fenofibrate), and 15 with OCA plus fibrates. OCA group had baseline significantly higher alkaline phosphatase (ALP) (P = 0.01) and lower platelets (P = 0.03) than fibrates. Both treatments significantly decreased ALP, gamma-glutamyl transferase (GGT), and transaminases and improved Globe score. Albumin and immunoglobulin type M improved in the fibrates group. ALP decrease was higher under fibrates, whereas alanine aminotransferase decline was higher under OCA. Although baseline transaminases and GGT were higher in patients with OCA plus fibrates, significant ALP, GGT, alanine aminotransferase, and Globe score improvement were observed during triple therapy. Adverse events were reported in 14.7% of patients (21.3% OCA; 17.6% fenofibrate; 10.7% bezafibrate), mainly pruritus (10.1% with OCA). Discontinuation was more frequent in fenofibrate treatment mainly because of intolerance or adverse events. DISCUSSION: Second-line therapy with OCA or fibrates improves hepatic biochemistry and the GLOBE score in primary biliary cholangitis patients with suboptimal response to ursodeoxycholic acid. Simultaneous treatment with OCA and fibrates improved ALP as well.

Background and Aims: In patients with non-severe acute or chronic autoimmune hepatitis (AIH) without cirrhosis, clinical practice guidelines recommend indistinct use of prednisone or budesonide. However, budesonide is infrequently used in clinical practice. We aimed to describe its use and compare its efficacy and safety with prednisone as first-line options. Approach and Results: This was a retrospective, multicenter study of 105 naive AIH patients treated with budesonide as the first-line drug. The control group included 276 patients treated with prednisone. Efficacy was assessed using logistic regression and validated using inverse probability of treatment weighting propensity score. The median time to biochemical response (BR) was 3.1 months in patients treated with budesonide and 4.9 months in those with prednisone. The BR rate was significantly higher in patients treated with prednisone (87% vs. 49% of patients with budesonide, p < 0.001). The probability of achieving BR, assessed using the inverse probability of treatment weighting propensity score, was significantly lower in the budesonide group (OR = 0.20; 95% CI: 0.11–0.38) at any time during follow-up, and at 6 (OR = 0.51; 95% CI: 0.29–0.89) and 12 months after starting treatment (0.41; 95% CI: 0.23–0.73). In patients with transaminases <2 × upper limit of normal, BR was similar in both treatment groups. Prednisone treatment was significantly associated with a higher risk of adverse events (24.2% vs. 15.9%, p = 0.047). Conclusions: In the real-life setting, the use of budesonide as first-line treatment is low, and it is generally prescribed to patients with perceived less disease activity. Budesonide was inferior to prednisone as a first-line drug but was associated with fewer side effects.

In this large cohort of cirrhotic patients managed in the real-world setting in Spain, SOF/SMV±RBV yielded to excellent SVR rates, especially in patients with compensated liver cirrhosis. In addition, this combination showed to be safe, with low rates of SAEs and early discontinuations.

Aim:The aim was to assess the clinical impact of direct-acting antiviral treatment in patients with compensated hepatitis C virus-related cirrhosis after one year of follow-up. Methods: An observational retrospective study was conducted on 129 consecutive patients with compensated cirrhosis treated in 2015, analyzing the evolution of liver function and the development of hepatocellular carcinoma and clinical decompensations. Results: The median follow-up time was 16 months. Most patients were males (73%), the mean age was 58.1 years and the most frequent genotype was 1b (52.2%). All participants were Child-Pugh A class at the start of the treatment and the median model for end-stage liver disease (MELD) score was 7. Four patients (4.4%) suffered a decompensation: three episodes of ascites and one acute on chronic liver failure. The incidence of de novo hepatocellular carcinoma during the follow-up was 3.6%. Seven patients (7.8%) improved MELD score more than one point and in 11 patients (12.2%) it worsened more than one point. There was a significant improvement in the mean platelets count [P < 0.001, 95% confidence interval (CI) : -26,360, -12,096] and in the mean albumin levels (P < 0.001, 95% CI: -322, -130) after treatment. Conclusion: Direct-acting antiviral treatment is not associated in the short term with a decrease in the development of hepatic decompensation or hepatocellular carcinoma compared to what it was reported for untreated compensated cirrhotic patients. There is an improvement in pre and post-treatment platelet counts and albumin levels showing a probable improvement of the hepatic function. Key words:Direct-acting antiviral therapy, compensated cirrhosis, hepatocellular carcinoma, clinical decompensation ABSTRACTArticle history:

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An ordinary system of differential equations leading to a simulation model is propose as methodological approach to analysis the incidence of infectious-contagious diseases, in this case using SARS-CoV-2 virus as pathogenic model. The dynamics of the model are drive by the interaction between susceptible cells contemplating respiratory epithelial cells and viral infection mediated by two types of lysis response. To perform the simulations, values of some variables and parameters were selected from referenced sources, considering that previous reports suggested that the viral load in the lower respiratory tract might reach its peak in the second week after the beginning of disease symptoms. The scenarios described in the simulations evidence the performance of the cell lysis response from susceptible cells that have been infected. The recommend model shows that an excess response from both the original virus and the mutated virus leads to an increase in the approximate time to control viral infection within the organism.

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