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1.
J Viral Hepat ; 24(6): 464-471, 2017 06.
Article in English | MEDLINE | ID: mdl-27976490

ABSTRACT

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/1.73m2 ) or 5 (eGFR<15 mL/min/1.73m2 or requiring dialysis) and HCV infection by genotypes 1 and 4 between April 2015 and October 2015 in nine Spanish centres. 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 and 36 (78.2%) CKD stage 5. Seventeen (36.9%) had cirrhosis. SVR12 rate in the intention-to-treat population was 95.7%. Twenty-one (45.6%) received RBV, which was discontinued in two (9.5%) patients. Anaemia (haemoglobin <10 g/dl) occurred in 12 patients (57.1%) with RBV vs 10 (40.0%) without RBV (P=.246). Renal function remained stable during antiviral therapy. Nine patients (19.5%) experienced serious adverse events unrelated to antiviral therapy. Concomitant medication was discontinued or modified in 41.3% of patients. In conclusion, the effectiveness of OBV/PTV/r±DSV±RBV in patients with CKD 4-5 was similar to that observed in those with normal renal function and was not associated with severe adverse events.


Subject(s)
Antiviral Agents/therapeutic use , Drug Therapy, Combination/methods , Hepatitis C, Chronic/complications , Hepatitis C, Chronic/drug therapy , Renal Insufficiency/complications , Renal Insufficiency/therapy , Adult , Aged , Antiviral Agents/adverse effects , Drug Interactions , Drug Therapy, Combination/adverse effects , Drug-Related Side Effects and Adverse Reactions , Female , Genotype , Hepacivirus/classification , Hepacivirus/genetics , Hepacivirus/isolation & purification , Humans , Male , Middle Aged , Retrospective Studies , Spain , Sustained Virologic Response , Treatment Outcome
2.
Transplant Proc ; 48(9): 3013-3016, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27932134

ABSTRACT

BACKGROUND: Patients with hepatitis C virus (HCV) genotype 4 infection are poorly represented in clinical trials of 2nd-generation direct-acting antivirals (DAAs), and more data are needed to help guide treatment decisions. We still have even fewer data concerning liver transplant patients. Simeprevir (SIM) and sofosbuvir (SOF) combination is useful to treat this genotype. The aim of this study was to know the efficacy and safety of the combination SIM + SOF ± ribavirin (RBV) in a group of liver transplant patients with HCV genotype 4 infection in Spain in real life. METHODS: This was a multicenter retrospective study, including 28 HCV genotype 4 patients from 11 liver transplant centers who were treated with SIM + SOF ± RBV. We included in the analysis demographic, clinical, and virologic data and details of serious adverse events (SAEs), including mortality rate 6 months after treatment. RESULTS: All patients were male, mean age 52 ± 9.43 years, and 50% were IL28B CT and 37.5% TT; 46.42% of them were pretreated and 76.9 were null responders. Fibrosis stage 4 was found in 38.7% of patients; in 67.8% of those cases the diagnosis of fibrosis was made with the use of Fibroscan, in 21.4% by liver biopsy. The average Fibroscan was 13.86 KPa. The average Model for End-Stage Liver Disease (MELD) score of cirrhotic patients was 10.9 and the Child-Pugh score was A in 70%, B in 20%, and C in 10%. We included RBV in 75% of patients, and treatment duration was 12 weeks in all patients. The sustained virologic response at week 12 (SVR12) was 95.23%. There were no discontinuations due to SAEs, but the mortality rate at 6 months after treatment was 7.14%. All deceased patients were cirrhotic, Child C, and with an average MELD score of 20. CONCLUSIONS: The combination SIM + SOF ± RBV to treat HCV genotype 4 in liver transplant patients is an option with high rates of SVR12 and very safe, similarly to genotype 1. There was no treatment-related mortality, but when it is administered in advanced stages of fibrosis it may not be enough to prevent mortality associated with cirrhotic hepatitis C recurrence after transplantation.


Subject(s)
Antiviral Agents/therapeutic use , Hepatitis C, Chronic/drug therapy , Liver Transplantation/methods , Simeprevir/therapeutic use , Sofosbuvir/therapeutic use , Drug Combinations , Drug Therapy, Combination , Genotype , Hepacivirus/genetics , Humans , Liver Cirrhosis/surgery , Male , Middle Aged , Patient Safety , Retrospective Studies , Ribavirin/therapeutic use , Spain , Treatment Outcome
4.
Scand J Gastroenterol ; 37(9): 1012-6, 2002 Sep.
Article in English | MEDLINE | ID: mdl-12374224

ABSTRACT

We describe the case of a 58-year-old woman with autoimmune enteropathy associated with thyroiditis, gastritis, transitory neutropenia, sicca syndrome and severe axonal polyneuropathy of autoimmune origin. Enterocyte autoantibodies were not detected. However, predisposition to autoimmune disease was indicated by the presence of high titres of anti-gastric parietal cell, anti-thyroglobulin, anti-thyroid peroxidase and anti-neutrophil antibodies. CD4+ and CD8+ lymphocytes were equally distributed in the lamina propria of the small intestine, but CD8+ cells were highly represented among intraepithelial lymphocytes.


Subject(s)
Autoimmune Diseases/complications , Gastritis/complications , Sjogren's Syndrome/complications , Thyroiditis, Autoimmune/complications , Autoantibodies/analysis , Autoimmune Diseases/drug therapy , Autoimmune Diseases/pathology , Autoimmunity , CD4-Positive T-Lymphocytes/immunology , CD8-Positive T-Lymphocytes/immunology , Diarrhea/complications , Female , Gastritis/drug therapy , Gastritis/pathology , Glucocorticoids/therapeutic use , Humans , Malabsorption Syndromes/complications , Middle Aged , Neutropenia/complications , Polyneuropathies/complications , Polyneuropathies/drug therapy , Polyneuropathies/pathology , Prednisolone/therapeutic use , Sjogren's Syndrome/drug therapy , Sjogren's Syndrome/pathology , Thyroiditis, Autoimmune/drug therapy , Thyroiditis, Autoimmune/pathology , Treatment Outcome
6.
Nutr Hosp ; 10(4): 237-9, 1995.
Article in Spanish | MEDLINE | ID: mdl-7662763

ABSTRACT

The nutritional support through an enteral route in patients diagnosed with Guillain-Barré syndrome, may be affected by the digestive alterations derived from the non-autonomic affliction. Even though the percutaneous endoscopic gastro-jejunostomy is still an infrequent technique in intensive-care units, its use in certain patients may ease the application of enteral nutrition. We present a case of Guillain-Barré syndrome, treated with enteral nutrition in an ICU during 100 days, 85 of which were by means of a gastro-jejunostomy tube, with good results.


Subject(s)
Endoscopy, Gastrointestinal/methods , Gastrostomy/methods , Jejunostomy/methods , Polyradiculoneuropathy/therapy , Aged , Critical Care/methods , Diarrhea/etiology , Enteral Nutrition/adverse effects , Enteral Nutrition/methods , Humans , Male
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