ABSTRACT
Over the last 5 years, therapies for hepatitis C virus (HCV) infection have improved significantly, achieving sustained virologic response (SVR) rates of up to 100% in clinical trials in patients with HCV genotype 1. We investigated the effectiveness and safety of ombitasvir/paritaprevir/ritonavir±dasabuvir in an early access programme. This was a retrospective, multicentre, national study that included 291 treatment-naïve and treatment-experienced patients with genotype 1 or 4 HCV infection. Most patients (65.3%) were male, and the mean age was 57.5 years. The mean baseline viral load was 6.1 log, 69.8% had HCV 1b genotype, 72.9% had cirrhosis and 34.7% were treatment-naïve. SVR at 12 weeks posttreatment was 96.2%. Four patients had virological failure (1.4%), one leading to discontinuation. There were no statistical differences in virological response according to genotype or liver fibrosis. Thirty patients experienced serious adverse events (SAEs) (10.3%), leading to discontinuation in six cases. Hepatic decompensation was observed in five patients. Four patients died during treatment or follow-up, three of them directly related to liver failure. Multivariate analyses showed a decreased probability of achieving SVR associated with baseline albumin, bilirubin and Child-Pugh score B, and a greater probability of developing SAEs related to age and albumin. This combined therapy was highly effective in clinical practice with an acceptable safety profile and low rates of treatment discontinuation.
Subject(s)
Antiviral Agents/therapeutic use , Genotype , Hepacivirus/classification , Hepatitis C, Chronic/drug therapy , Adult , Aged , Aged, 80 and over , Drug Therapy, Combination/adverse effects , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/pathology , Female , Hepacivirus/genetics , Hepacivirus/isolation & purification , Hepatitis C, Chronic/virology , Humans , Male , Middle Aged , Retrospective Studies , Spain , Sustained Virologic Response , Treatment OutcomeABSTRACT
BACKGROUND: the role that cytomegalovirus (CMV) plays in inflammatory bowel disease (IBD) is controversial. The diagnosis of CMV infection in IBD depends on viral identification with hematoxylin-eosin (HE) or immunohistochemistry (IHC). Our aim was to compare the sensitivity of HE and IHC for this diagnosis in IBD patients. PATIENTS AND METHODS: a case-control study. Our database was searched for IBD patients with HE- or IHC-based CMV-positivity from 1997 to 2007. Controls were selected among IBD inpatients matched for age and year of diagnosis with CMV. Their clinical characteristics were analyzed. HE and IHC were performed on biopsies from cases and controls at 6 months before and after inclusion in the study. In the statistical analysis, p values below 0.05 were considered significant. RESULTS: ten IBD patients with CMV infection were identified. IBD-CMV patients were more steroid-resistant or steroid-dependent (p = 0.03), and underwent a higher number of colonic biopsies (p = 0.03). From 97 biopsies analyzed, 12 were HE-negative and IHC-positive, and 3 showed reversed results. The sensitivity of HE was 58.6%, 95% CI (38.9-78.3), and that of IHC was 89.7%, 95% CI (76.8-100). We did not find a good level of agreement between both techniques: kappa value 0.55, 95% CI (0.36-0.75). CMV positivity with IHC was associated with the use of more than one immunosuppressant drug, OR 13.5, 95%CI (1.2-152.2). Antiviral treatment was useful for CMV patients with steroid-dependent and steroid-refractory IBD. CONCLUSIONS: IHC shows a 30% higher sensitivity than HE for the diagnosis of CMV infection in IBD patients. There is no good level of agreement between both histological techniques.
Subject(s)
Cytomegalovirus Infections/pathology , Adult , Aged , Biopsy/methods , Case-Control Studies , Colon/pathology , Cytomegalovirus Infections/complications , Female , Humans , Inflammatory Bowel Diseases/complications , Male , Middle Aged , Rectum/pathology , Sensitivity and Specificity , Virology/methodsABSTRACT
Consumption of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA) inhibitors, known as statins, has been associated with elevated transaminase levels but rarely with acute hepatitis. Recently, several cases of acute hepatitis secondary to atorvastatin therapy have been published. We report the case of a 72-year-old man who developed acute cholestatic hepatitis after reinitiating treatment with atorvastatin at a higher dose than that previously prescribed. After treatment discontinuation, the patient made a full recovery, with normalization of clinical and laboratory findings.
Subject(s)
Chemical and Drug Induced Liver Injury/etiology , Heptanoic Acids/adverse effects , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Pyrroles/adverse effects , Acute Disease , Aged , Atorvastatin , Cholestasis/chemically induced , Heptanoic Acids/administration & dosage , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Male , Pyrroles/administration & dosageABSTRACT
AIM: Short segments of intestinal metaplasia (IM) at the esophagogastric junction is an unclear entity. Several studies have reported wide variations in its prevalence and in the factors associated with its development. Recently, this entity has been divided into esophageal IM and cardiac IM, as two different lesions in etiopathogenesis and prognosis. We studied the prevalence of these conditions and their association with gastroesophageal reflux disease (GERD) and Helicobacter pylori infection. METHODS: In 161 patients, biopsies were obtained from the distal esophagus (2), just below the Z line (3), and in the gastric antrum (4). IM was diagnosed on the basis of staining of goblet cells with Alcian blue and was classified as esophageal if ILZ < IEG or cardiac ILZ = IEG. H. pylori was determined by rapid urease (CLO-test) and histology. Diagnosis of GERD was based on typical symptoms, endoscopy, and histology. In 54 patients with IM (73%) esophageal manometry and 24-hour pH-metry was also performed. RESULTS: IM was detected in 74 patients (46%); IM was esophageal in 33 patients (20.5%) and cardiac in 41 patients (25.4%). Patients with IM were significantly older than those without (p = 0.007) and took proton pump inhibitors more frequently (p = 0.004). No correlation was found between reflux symptoms, esophageal lesions or histological changes with either type of IM. No differences between esophageal or cardiac IM were detected by esophageal pH-metry. H. pylori infection was unrelated to cardiac IM, but these patients had a lower frequency of endoscopic and histological changes in the distal esophagus. CONCLUSIONS: Intestinal metaplasia is a common finding in patients sent for gastroscopy and is probably an acquired lesion that increases in prevalence with age. We found no associations between esophageal IM and GERD, evaluated by typical symptoms, endoscopic and histological changes and pH-metry. H. pylori infection showed no relation to cardiac IM.
