Conrado Rodriguez - Academia.edu (original) (raw)

Papers by Conrado Rodriguez

Digestive and Liver Disease, 2019

(SOF/VEL/VOX) is approved for retreatment of hepatitis C (HCV) patients with a previous failure t... more (SOF/VEL/VOX) is approved for retreatment of hepatitis C (HCV) patients with a previous failure to direct-acting antivirals (DAA), however real-life data are still limited. SOF/VEL/VOX is an effective and safe retreatment for HCV patients failing a previous DAA course in a real-life setting. Epidemiological and clinical characteristics of the 179 patients enrolled are shown in Table 1.

2022 44th Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC), Jul 11, 2022

DOAJ (DOAJ: Directory of Open Access Journals), Aug 1, 2008

Journal of clinical and translational hepatology, Oct 10, 2020

Background and Aims: In the REALM (Randomized, Observational Study of Entecavir to Assess Long-Te... more Background and Aims: In the REALM (Randomized, Observational Study of Entecavir to Assess Long-Term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Patients with Chronic HBV Infection) study, 12,378 patients with chronic hepatitis B virus (HBV) infection received up to 10 years of randomized therapy with entecavir or another HBV nucleos(t)ide analogue. Monitored clinical outcome events (COEs) included malignant neoplasms, HBV disease progression events, and deaths. An external event adjudication committee (EAC) was convened to provide real-time review of reported COEs to optimize data quality, and minimize potential adverse effects of the large cohort, interdisciplinary outcome assessments, geographic scope, and long duration. Methods: The EAC comprised an international group of hepatologists and oncologists with expertise in diagnosis of targeted COEs. The EAC reviewed and adjudicated COEs according to prospectively defined diagnostic criteria captured in the EAC charter. Operational processes, including data collection and query procedures, were implemented to optimize efficiency of data recovery to maximize capture of adjudicated COEs, the primary study outcome measure. Results: A total of 1724 COEs were reported and 1465 of these events were adjudicated by the EAC as reported by the investigators (85.0% overall concordance). Concordance by COE type varied: deaths, 99.6%; hepatocellular carcinoma (HCC), 83.3%; non-HCC malignancies, 88.0%; non-HCC HBV disease progression, 68.2%. Reasons for lack of concordance were most commonly lack of adequate supporting data to support an adjudicated diagnosis or evidence that the event pre-dated the study. Conclusions: The REALM EAC performed a critical role in ensuring data quality and consistency; EAC performance was facilitated by well-defined diagnostic criteria, effective data capture, and efficient operational processes. Trial registration: ClinicalTrials.gov NCT00388674.

Digestive Diseases and Sciences, Jun 28, 2007

Macro-creatine-kinases are isoenzymes of creatinine-kinases (CK). They have been classified in tw... more Macro-creatine-kinases are isoenzymes of creatinine-kinases (CK). They have been classified in two types: type 1 (CK bound to an immunoglobulin) and type 2 (an oligomeric mitochondrial CK). CK type 1 has been found in patients with ulcerative colitis (UC) but not in Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease (CD). However, there are no studies evaluating macro-creatinkinase prevalence in inflammatory bowel disease (IBD). We included 159 consecutive patients (72 UC, 85 CD; 2 indeterminate colitis). Creatin-kinase total activity and isoenzymes activities were determined. Twelve (16.7%) patients with UC and one of the two patients with indeterminate colitis had serum macro-creatinkinase type 1 while no CD patients displayed this macromolecule (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0,001). Sensitivity, specificity, positive and negative predictive value, and positive and negative likelihood ratio were calculated for ulcerative colitis versus Crohn&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s disease diagnosis, being 16.7, 98.9, 92.3, 59, 14.5, and 0.84% respectively. There was no correlation with age, gender, time from diagnosis, associated diseases, concomitant medication or disease activity. In conclusion our data suggests that the presence of macro-CK in IBD favors the diagnosis of ulcerative colitis. Further studies are necessary to understand the significance of this finding in a subset of patients with IBD.

Hepatology, Nov 10, 2020

Background and Aims Patients with hepatitis C virus (HCV) and advanced fibrosis remain at risk of... more 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.

DOAJ (DOAJ: Directory of Open Access Journals), Nov 1, 2009

The incidence of inflammatory bowel disease (IBD) varies widely according to geographical area an... more The incidence of inflammatory bowel disease (IBD) varies widely according to geographical area and has been reported to have increased in the last few years. No data are available on the current incidence of this disease in Madrid (Spain). to determine the incidence of inflammatory bowel disease in the area of influence of University Hospital Fundación Alcorcón (Madrid), and to compare our results with those from other Spanish and European series. A prospective, population-based study was performed to determine the incidence of IBD in the area of University Hospital Fundación Alcorcón in Madrid between 2003 and 2005. Total population: 213,587 inhabitants (177,490 older than 14 years). Crude rates and age- and sex-specific rates adjusted to the European standard population were calculated. A retrospective study (1998-2003) was also performed. A total of 69 cases were diagnosed -Crohn s disease (CD): 35, ulcerative colitis (UC): 33, indeterminate colitis: 1- in the prospective period. Crude rates of CD and UC were 7.92 and 7.47 cases/100,000 inhabitants/year, respectively (the population aged 0-14 years). Specific rates were 8.0 (95% CI, 7.03-8.97) and 7.47 (95% CI, 6.5-8.4), respectively. Mean age at diagnosis was 31.02+/- 10.76 and 39.91+/-16.19 years for CD and UC, respectively. Incidence in the retrospective study was 7.13 and 6.22 cases/100,000 inhabitants/year, respectively for CD and UC. The incidence of CD and UC in Madrid has increased in the last decades, with rates close to those in northern European countries for CD, higher than those recently published in Spanish prospective studies and similar to those previously described in Spain and southern countries for UC. Rates were higher in the prospective period than in the retrospective one.

Gastroenterología y Hepatología Continuada, 2004

Journal of Viral Hepatitis, Dec 9, 2016

Patients with HCV genotype 3 (GT3) infection and cirrhosis are currently the most difficult to cu... more Patients with HCV genotype 3 (GT3) infection and cirrhosis are currently the most difficult to cure. We report our experience with sofosbuvir+daclatasvir (SOF+DCV) or sofosbuvir/ledipasvir (SOF/LDV), with or without ribavirin (RBV) in clinical practice in this population. This was a multicenter observational study including cirrhotic patients infected by HCV GT3, treated with sofosbuvir plus an NS5A inhibitor (May 2014-October 2015). In total, 208 patients were included: 98 (47%) treatment-experienced, 42 (20%) decompensated and 55 (27%) MELD score >10. In 131 (63%), treatment was SOF+DCV and in 77 (37%), SOF/LDV. Overall, 86% received RBV. RBV addition and extension to 24 weeks was higher in the SOF/LDV group (95% vs 80%, P=.002 and 83% vs 72%, P=.044, respectively). A higher percentage of decompensated patients were treated with DCV than LDV (25% vs 12%, P=.013). Overall, SVR12 was 93.8% (195/208): 94% with SOF+DCV and 93.5% with SOF/LDV. SVR12 was achieved in 90.5% of decompensated patients. Eleven treatment failures: 10 relapses and one breakthrough. RBV addition did not improve SVR (RR: 1.08; P=.919). The single factor associated with failure to achieve SVR was platelet count <75×10E9/mL (RR: 3.50, P=.019). In patients with MELD <10, type of NS5A inhibitor did not impact on SVR12 (94% vs 97%; adjusted RR: 0.49). Thirteen patients (6.3%) had serious adverse events, including three deaths (1.4%) and one therapy discontinuation (0.5%), higher in decompensated patients (16.7% vs 3.6%, P<.006). In patients with GT3 infection and cirrhosis, SVR12 rates were high with both SOF+DCV and SOF/LDV, with few serious adverse events.

Revista Espanola De Enfermedades Digestivas, 2022

European Journal of Health Economics, Nov 10, 2022

Hepatitis C virus (HCV) infection causes a substantial economic burden, not only in terms of heal... more Hepatitis C virus (HCV) infection causes a substantial economic burden, not only in terms of healthcare costs, but also in labour productivity losses. The main objective of this study is to provide objective and comparable information about the trend in labour productivity losses caused by premature HCV-associated deaths in Spain in recent years (2009-2018). We used nationwide data from several official sources to create a simulation model based on the human capital approach and to estimate the flows in labour productivity losses due to deaths identified in the period considered. Based on a pessimistic scenario, the annual number of deaths due to HCV infections decreased by 19.7% between 2009 and 2018. The years of potential labour productive life lost (YPLPLL) decreased by 38.1%. That reduction led to a decrease in annual labour productivity losses from €236 million in 2009 to €156 million in 2018 (-33.8%). The aggregate HCV-related labour productivity losses between 2009 and 2018 ranged from €1742 million (optimistic scenario) to €1949 million (pessimistic scenario), with an intermediate estimation of €1846 million (moderately optimistic scenario). These results show a substantial reduction in annual deaths, working-age deaths, YPLPLL, and labour productivity losses associated with HCV infection over this period.

Journal of Hepatology, Apr 1, 2019

Revista Espanola De Enfermedades Digestivas, Nov 1, 2009

Introduction: the incidence of inflammatory bowel disease (IBD) varies widely according to geogra... more Introduction: the incidence of inflammatory bowel disease (IBD) varies widely according to geographical area and has been reported to have increased in the last few years. No data are available on the current incidence of this disease in Madrid (Spain). Aim: to determine the incidence of inflammatory bowel disease in the area of influence of University Hospital Fundación Alcorcón (Madrid), and to compare our results with those from other Spanish and European series. Patients and methods: a prospective, population-based study was performed to determine the incidence of IBD in the area of University Hospital Fundación Alcorcón in Madrid between 2003 and 2005. Total population: 213,587 inhabitants (177,490 older than 14 years). Crude rates and age-and sex-specific rates adjusted to the European standard population were calculated. A retrospective study (1998-2003) was also performed. Results: a total of 69 cases were diagnosed-Crohn´s disease (CD): 35, ulcerative colitis (UC): 33, indeterminate colitis: 1-in the prospective period. Crude rates of CD and UC were 7.92 and 7.47 cases/100,000 inhabitants/year, respectively (the population aged 0-14 years). Specific rates were 8.0 (95% CI, 7.03-8.97) and 7.47 (95% CI, 6.5-8.4), respectively. Mean age at diagnosis was 31.02± 10.76 and 39.91±16.19 years for CD and UC, respectively. Incidence in the retrospective study was 7.13 and 6.22 cases/100,000 inhabitants/year, respectively for CD and UC. Conclusions: the incidence of CD and UC in Madrid has increased in the last decades, with rates close to those in northern European countries for CD, higher than those recently published in Spanish prospective studies and similar to those previously described in Spain and southern countries for UC. Rates were higher in the prospective period than in the retrospective one

Hepatology Communications, 2022

The value of noninvasive tools in the diagnosis of autoimmune hepatitis (AIH)–related cirrhosis a... more The value of noninvasive tools in the diagnosis of autoimmune hepatitis (AIH)–related cirrhosis and the prediction of clinical outcomes is largely unknown. We sought to evaluate (1) the utility of liver stiffness measurement (LSM) in the diagnosis of cirrhosis and (2) the performance of the Sixth Baveno Consensus on Portal Hypertension (Baveno VI), expanded Baveno VI, and the ANTICIPATE models in predicting the absence of varices needing treatment (VNT). A multicenter cohort of 132 patients with AIH‐related cirrhosis was retrospectively analyzed. LSM and endoscopies performed at the time of cirrhosis diagnosis were recorded. Most of the patients were female (66%), with a median age of 54 years. Only 33%‐49% of patients had a LSM above the cutoff points described for the diagnosis of AIH‐related cirrhosis (12.5, 14, and 16 kPa). Patients with portal hypertension (PHT) had significantly higher LSM than those without PHT (15.7 vs. 11.7 kPa; P = 0.001), but 39%‐52% of patients with PHT ...

Liver International, 2021

BACKGROUND & AIMS Patients with chronic hepatitis C and stage 3 fibrosis are thought to remai... more BACKGROUND & AIMS Patients with chronic hepatitis C and stage 3 fibrosis are thought to remain at risk of hepatocellular carcinoma after sustained virological response. We investigated this risk in a large cohort of patients with well-defined stage 3 fibrosis. METHODS We performed a multicenter, ambispective, observational study of chronic hepatitis C patients with sustained virological response after treatment with direct-acting antivirals started between January-December 2015. Baseline stage 3 was defined in a 2-step procedure: we selected patients with transient elastography values of 9.5-14.5 kPa and subsequently excluded those with nodular liver surface, splenomegaly, ascites, or collaterals on imaging, thrombopenia, or esophago-gastric varices. Patients were screened twice-yearly using ultrasound. RESULTS The final sample comprised 506 patients (median age, 57.4 years; males, 59.9%; diabetes, 17.2%; overweight, 44.1%; genotype 3, 8.9%; HIV coinfection, 18.4%; altered liver values, 15.2%). Median follow-up was 33.7 (22.1-39.1) months. Five hepatocellular carcinomas and 1 cholangiocarcinoma were detected after a median of 29.4 months (95%CI: 26.8-39.3), with an incidence of 0.47/100 patients/year (95%CI: 0.17-1.01). In the multivariate analysis only males older than 55 years had a significant higher risk (hazard ratio 7.2 [95%CI: 1.2-41.7; p=0.029]) with an incidence of 1.1/100 patients/year (95%CI: 0.3-2.8). CONCLUSIONS In a large, well-defined cohort of patients with baseline hepatitis C stage-3 fibrosis, the incidence of primary liver tumours was low after sustained virological response and far from the threshold for cost-effectiveness of screening, except in males older than 55 years.

Journal of Hepatology, 2020

Revista Española de Enfermedades Digestivas, 2019

BACKGROUND AND AIMS non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver di... more BACKGROUND AND AIMS non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disorder in the western world. Although NAFLD prevalence is higher in patients with a BMI > 25 kg /m2, it is unclear if there are differences between overweight and obese patients. The associated biochemical, dietary and genetic parameters were compared between overweight and obese patients with NAFLD. METHODS patients with biopsy-proven NAFLD (n = 203) were enrolled in a cross-sectional study. The MEDAS questionnaire was used to assess adherence to the Mediterranean diet. Biochemical, anthropometrical parameters and the I148M variant (rs738409) of the PNPLA3 gene and rs180069 of the TNF-α gene were evaluated. RESULTS overweight patients had higher serum adiponectin levels (22.5 ± 21.9 vs 11.2 ± 18.1 ng/ml; p < 0.05) and lower resistin (3.3 ± 1.7 vs 8.1 ± 8 ng/ml; p < 0.001) and leptin concentrations (22.9 ± 21.9 vs 55.8 ± 45 ng/ml; p < 0.001) than obese patients. Non-alcoholic steatohepatitis (NASH) was more frequent in the obese group (59.3% vs 41.3%; p = 0.02). The multivariate analysis showed adherence to the Mediterranean diet to be an independent protective factor for NASH and liver fibrosis in overweight patients (OR 0.7, 95% CI 0.5-0.8). CONCLUSIONS NASH was more prevalent in obese patients than in overweight subjects. HOMA-IR and adherence to the Mediterranean diet provided protection against fibrosis in overweight patients. Adherence to the Mediterranean diet was the only independent factor associated with NASH in these patients.

Journal of Hepatology, 2019

Background and aims: Response to ursodeoxycholic acid (UDCA) therapy in patients with primary bil... more Background and aims: Response to ursodeoxycholic acid (UDCA) therapy in patients with primary biliary cholangitis (PBC) is assessed by different validated biochemical criteria, which identify those patients that could benefit from further therapies. Nevertheless, these criteria have been evaluated at 12 and 24 months of treatment and, therefore this may delay the start the use of new agents in patients with suboptimal response. The aim of the current study has been to evaluate the performance of the known criteria three months after starting UDCA therapy. Method: The study was carried out in cohort of PBC patients from a single centre, who started UDCA therapy with 13-16 mg/kg/d. The clinical features and liver biochemistries were assessed before and after 3, 6, 12 and 24 months of UDCA therapy. Ludwig's histologic stage was documented in 87 patients. The biochemical criteria (Barcelona, Paris I, Toronto and Paris II) were calculated at 3, 6, 12 and 24 months. The performance of these criteria was evaluated at 3 months as compared with those validated at 12 months (Toronto at 24 months). Results: 95 patients (age 53 (44-65 years, 90.4% female) were included with alkaline phosphatase (AP) of 1.45 (1.1-2.9) times upper normal levels (UNL). After a year of treatment, non-response to UDCA was: Paris I 25.5%, Barcelona and Paris II 42.1%, and Toronto 21.4%. Lack of response was also evaluated with the aforementioned criteria at 3 months: Barcelona 52%, Paris I 28.8%, Paris II 48.6% and Toronto 31.8%. The sensitivity (S), specificity (Sp) and area under de curve (AUC) at 3 months were: Barcelona 72.7% S, 82.5% Sp and AUC 0.76; Paris I 88.6%S, 83.3% Sp and AUC 0.86; Toronto 100% S, 64.7% Sp and AUC 0.84; Paris II 80% S, 87.5% Sp and AUC 0.84. When patients with Ap < 1.5 ULN were excluded, the specificity of all criteria at 3-months increased over 80%, with a decrease in sensitivity below 70%, except Paris I with S 77.5%. Patients with no response at 3 months that became responders at 12 months had early disease (histologic stage I 100% vs 50%, p = 0.01), lower median bilirubin (0.75 [0.6-0.9] vs 1.2 [0.8-1.3]mg/dL, p = 0.04), and bilirubin < 1mg/dL (87.5% vs 40%, p = 0.02). No other clinical, histological and biochemical differences were observed. Conclusion: The good performance of the biochemical response criteria to UDCA after 3-months suggests that these criteria are able to identify early non-responders and therefore, patients requiring additional therapies.

Journal of viral hepatitis, Jan 15, 2016

Limited data are available on direct-acting antivirals for treating hepatitis C virus (HCV) infec... more Limited data are available on direct-acting antivirals for treating hepatitis C virus (HCV) infection in patients with severe renal impairment. The aim of this study was to evaluate the effectiveness and safety of ombitasvir/paritaprevir/ ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) in patients with stage 4 or 5 chronic kidney disease (CKD) and HCV genotype 1 or 4 infection in real clinical practice, and to investigate pharmacological interactions. This retrospective study included patients treated with OBV/PTV/r+DSV±RBV or OBV/PTV/r+RBV with CKD stage 4 (eGFR: 15-29 mL/min/1.73m(2) ) or 5 (eGFR<15 mL/min/1.73m(2) or requiring dialysis) and HCV infection by genotype 1 and 4 between April-2015 and October-2015 in 9 Spanish centers. Sustained virological response at 12 weeks (SVR12) was assessed, and clinical and laboratory data, fibrosis stage, adverse events and pharmacological interactions were reported. Forty-six patients were included; 10 (21.7%) had CKD stage 4, ...