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BACKGROUND: Horses are often fed high amounts of starch in their diets despite the well-established benefits of a fibre-based diet to promote gut health and animal welfare. The aim of the present study was to compare the effects of two different diets - one based on high amounts of starch (HS) vs. one base on high amounts of fibre (HF) - on specific parameters of the gut environment across different intestinal compartments of the horse digestive tract. To this end differences in the gastrointestinal environment between HS vs. HF fed horses were assessed in terms of dry matter, organic matter and ash content; the particle size distribution and volatile fatty acid composition were also investigated. RESULTS: Nineteen Bardigiano horses of 14.3 ± 0.7 months of age and destined to slaughter were divided into two group pens - one fed with high amounts of starch (HS; n = 9; 43% hay plus 57% starch-rich pelleted feed); vs. fed with high amounts of fibre (HF; n = 10; 70% hay plus 30% fibre-rich pelleted feed). Horses fed HS diet presented a higher dry matter content in the right dorsal colon. Moreover, they showed a higher organic matter and ash content in the sternal flexure, pelvic flexure, right dorsal colon and rectum. In these latter intestinal compartments, horses fed a HS diet also showed a higher proportion of particles retained on an 8 mm sieve and a higher proportion of particles that washed through the finest sieve (< 1 mm). Moreover, the total amounts of volatile fatty acids as well as valeric acid were found to be significantly higher in horses fed the HS vs. HF diet. CONCLUSIONS: A high-starch diet causes significant changes in the horse gut environment. We observed an increase in the dry matter content in the right dorsal colon, as well as reduced particle sizes and an increase in the production of valeric acid in all the gut compartments studied. High-starch diets should be avoided in favour of fibre-based diets with the goal of safeguarding gut health in horses.
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Alimentación Animal , Almidón , Alimentación Animal/análisis , Animales , Dieta/veterinaria , Fibras de la Dieta , Digestión , Ácidos Grasos Volátiles , Tracto Gastrointestinal , CaballosRESUMEN
OBJECTIVES: The purpose of the present randomized controlled clinical trial was to compare the use of donkey milk-derived fortifier (DF) with commercial bovine milk-derived fortifier (BF) in very preterm or very-low-birth-weight newborns, in terms of feeding tolerance. METHODS: This trial included 156 newborns born at <32 weeks of gestational age and/or with a birth weight ≤1500âg. Newborns were randomized 1:1 to receive enteral feeding with either a BF-arm, or a new, DF-arm for 21 days. The fortification protocol was the same for both study arms, and the 2 diets were designed to be isoproteic and isocaloric. Feeding tolerance was assessed by a standardized protocol. RESULTS: The risk of feeding intolerance tended to be lower in DF-arm than in BF-arm, with a relative risk reduction of 0.63 (95% confidence interval: -0.29, +0.90). The mean number of episodes per newborn of feeding intolerance and feeding interruptions (any duration) were consistently lower in the DF-arm than in the BF-arm. Episodes of bilious gastric residuals and vomiting were significantly lower in the DF-arm. Time needed to reach full enteral feeding (150âmLâ·âkgâ·âday) and daily weight increase between the first day of exclusive enteral feeding (ie, without administering intravenous fluids) and discharge were similar in the BF- and DF-arms. CONCLUSIONS: These results suggest that DF improve feeding tolerance when compared with standard bovine-derived fortifiers, with a similar auxological outcome.
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Nutrición Enteral/métodos , Alimentos Fortificados , Recien Nacido Prematuro/crecimiento & desarrollo , Recién Nacido de muy Bajo Peso/crecimiento & desarrollo , Leche Humana , Leche , Animales , Equidae , Femenino , Humanos , Fenómenos Fisiológicos Nutricionales del Lactante , Recién Nacido , Masculino , Estado Nutricional , Aumento de PesoRESUMEN
BACKGROUND: Fortification of human milk is a standard practice for feeding very low birth weight infants. However, preterm infants often still experience suboptimal growth and feeding intolerance. New fortification strategies and different commercially available fortifiers have been developed. Commercially available fortifiers are constituted by a blend of ingredients from different sources, including plant oils and bovine milk proteins, thus presenting remarkable differences in the quality of macronutrients with respect to human milk. Based on the consideration that donkey milk has been suggested as a valid alternative for children allergic to cow's milk proteins, due to its biochemical similarity to human milk, we hypothesized that donkey milk could be a suitable ingredient for developing an innovative human milk fortifier. The aim of the study is to evaluate feeding tolerance, growth and clinical short and long-term outcomes in a population of preterm infants fed with a novel multi-component fortifier and a protein concentrate derived from donkey milk, in comparison to an analogous population fed with traditional fortifier and protein supplement containing bovine milk proteins. METHODS: The study has been designed as a randomized, controlled, single-blind clinical trial. Infants born <1500 g and <32 weeks of gestational age were randomized to receive for 21 days either a combination of control bovine milk-based multicomponent fortifier and protein supplement, or a combination of a novel multicomponent fortifier and protein supplement derived from donkey milk. The fortification protocol followed is the same for the two groups, and the two diets were designed to be isoproteic and isocaloric. Weight, length and head circumference are measured; feeding tolerance is assessed by a standardized protocol. The occurrence of sepsis, necrotizing enterocolitis and adverse effects are monitored. DISCUSSION: This is the first clinical study investigating the use of a human milk fortifier derived from donkey milk for the nutrition of preterm infants. If donkey milk derived products will be shown to improve the feeding tolerance or either of the clinical, metabolic, neurological or auxological outcomes of preterm infants, it would be an absolute innovation in the field of feeding practices for preterm infants. TRIAL REGISTRATION: ISRCTN - ISRCTN70022881 .
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Alimentos Fortificados , Proteínas de la Leche/uso terapéutico , Leche Humana , Encuestas Nutricionales/estadística & datos numéricos , Estado Nutricional , Aumento de Peso/efectos de los fármacos , Animales , Equidae , Humanos , Recien Nacido Prematuro/crecimiento & desarrollo , Recién Nacido de muy Bajo Peso/crecimiento & desarrollo , Italia , Proteínas de la Leche/administración & dosificación , Proyectos de InvestigaciónRESUMEN
This study aimed to evaluate the effects of Lactobacillus acidophilus D2/CSL (L-1 × 109 cfu/kg feed/day) on biochemical parameters, faecal score (FS), cecal pH, gut morphometry, microbiota and cecal short-chain fatty acid (SCFAs) in rabbits. Three zootechnical trials were performed and in each trial 30 rabbits were allotted to two groups; a probiotic group (L) and a control group (C). At slaughter (day 45), samples of blood, duodenum, jejunum, ileum, liver and spleen were collected and submitted to histomorphometric analyses. Blood biochemical analyses, cecal microbiota and SCFAs determination were also performed. In trial 1 and 3, L. acidophilus D2/CSL did not affect productive parameters (p > 0.05). However, L group of trial 1 showed a lower morbidity and mortality compared to the control. In trial 2, C group showed a higher daily feed intake (p = 0.018) and a positive statistical tendency for live weight and average daily gain (p = 0.068). On the contrary, albumin was higher and ALFA-1 globulin was lower in the C group compared to L (p < 0.05). In all the trials, FS, cecal pH, histomorphometry, microbiota and SCFAs were unaffected. In conclusion, L. acidophilus D2/CSL did not impair growth performances, gut and rabbit's health, reducing morbidity and mortality.
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BACKGROUND: The natural history of primary biliary cirrhosis (PBC) is still debated. AIMS: To evaluate: (i) long-term survival in a large cohort of PBC patients observed prospectively at a single centre and (ii) mortality in relation to baseline characteristics and ursodeoxycholic acid (UDCA) treatment. METHODS: We considered all consecutive patients between 1973 and 2007 (327 subjects; 310 females, 17 males). RESULTS: The mean follow-up was 9.1±7.7 years. The patients' age at diagnosis for representative periods (1973-1980, 1981-1990, 1991-2000, 2001-2007) increased progressively from 47.7±1.5 to 53.2±1.2, to 65.2±2.1 and then 63.6±2.9 years. The proportion of asymptomatic patients at diagnosis increased from 30 to 48% in the last decade, while associated symptoms of extrahepatic autoimmunity remained unchanged. Eighty patients (24.4%) died, 74 of them because of liver failure (12 patients developed hepatocellular carcinoma); nine patients underwent liver transplantation. From 1988 onwards, all patients were treated with UDCA (n=288). The mean age at death for the sample as a whole was 67.2±1.3 years. The survival probability at 20 years was 82% for patients with histological stages I-II at entry, 64% for those with stage III and 42% for those with stage IV (P=0.0007). Mortality was significantly reduced in patients treated with UDCA (P=0.012), whereas it was independently associated with oesophageal varices (P=0.015). Patients treated with UDCA had a better prognosis than those untreated, irrespective of the histological stage. Early treated subjects with a good response to UDCA have an 85% chance of survival at 20 years. CONCLUSIONS: The clinical presentation of PBC has been changing over the years. Its early detection and early treatment improve the related survival rates.
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Colagogos y Coleréticos/uso terapéutico , Cirrosis Hepática Biliar/tratamiento farmacológico , Cirrosis Hepática Biliar/mortalidad , Ácido Ursodesoxicólico/uso terapéutico , Causas de Muerte , Progresión de la Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Italia/epidemiología , Cirrosis Hepática Biliar/diagnóstico , Fallo Hepático/mortalidad , Fallo Hepático/patología , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: Most of the maize silage stored in horizontal silos is exposed to air and can be spoiled by fungi. Potentially toxigenic fungi have been found in maize silage, and about 300 mycotoxins have been detected. Among these mycotoxins, the most harmful for feed and food safety are aflatoxins. The aim of the study was to set up a specific method to detect aflatoxins in maize silage, and to investigate whether aflatoxin contamination in maize silage depends on the level of field contamination of the crop, and whether the occurrence of aerobic spoilage during ensiling has any effect on the final contamination of the silage. RESULTS: A method for the determination of aflatoxin B(1), B(2), G(1) and G(2) in maize silage using high-performance liquid chromagraphy with fluorescence detection has been developed and validated. Recoveries of aflatoxin B(1), B(2), G(1), and G(2) spiked over the 0.25 to 5 µg kg(-1) range averaged 74-94%. The results of laboratory scale and farm scale ensiling experiments indicated that aflatoxins could increase when silage is exposed to air during conservation or during the feed-out phase. CONCLUSIONS: The method here proposed to detect aflatoxins in silages has proved to be sensitive and is able to detect levels of 0.1 and 0.5 ng mL(-1) for AFB(1) and AFG(1), and between 0.025 and 0.125 ng mL(-1) for AFB(2) and AFG(2). This study also provides evidence of aflatoxin accumulation in whole crop maize silage as a result of aerobic exposure.
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Aflatoxinas/análisis , Agricultura/métodos , Contaminación de Alimentos , Ensilaje/análisis , Ensilaje/microbiología , Zea mays/química , Zea mays/microbiología , Aerobiosis , Cromatografía Líquida de Alta Presión , Recuento de Colonia Microbiana , Fermentación , Contaminación de Alimentos/prevención & control , Hongos/aislamiento & purificación , Italia , Lactobacillus/metabolismo , Límite de Detección , Oxígeno/química , Oxígeno/metabolismo , Permeabilidad , Plásticos/química , Reproducibilidad de los Resultados , Espectrometría de Fluorescencia , Factores de TiempoRESUMEN
Roasting is known to affect the protein profile and allergenicity of hazelnuts (Corylus avellana cv TGL). The aim of the study was to investigate whether roasting techniques based on different heat transfer methods (hot air and infrared), differently affect the protein solubility and the IgE-binding capacities of both the soluble and insoluble hazelnut protein fractions. The immune-reactivity of the Cor a 9, Cor a 11 and Cor a 14 allergens resulted to be stable after roasting at 140 °C, for both types of treatment, while roasting at 170 °C caused a reduction in IgE-binding, which was particularly noticeable after infrared processing, that led to an almost complete disappearance of allergenicity. Microscopical analyses showed that roasting caused cytoplasmic network disruption, with a loss of lipid compartmentalization, as well as an alteration of the structure of the protein bodies and of the cell wall organization.
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Alérgenos/inmunología , Culinaria/métodos , Corylus/metabolismo , Rayos Infrarrojos , Proteínas de Plantas/inmunología , Alérgenos/química , Niño , Cromatografía Líquida de Alta Presión , Hipersensibilidad a los Alimentos/sangre , Hipersensibilidad a los Alimentos/patología , Calor , Humanos , Inmunoglobulina E/sangre , Inmunoglobulina E/inmunología , Proteínas de Plantas/química , Estabilidad Proteica , Espectrometría de Masas en TándemRESUMEN
BACKGROUND: A survey was carried out on conventional (n = 11) and organic (n = 4) swine farms in northwest Italy in order to investigate the occurrence of ochratoxin A (OTA) in feed and serum samples collected from September 2006 to March 2009. Each farm was sampled twice and a total of 30 feed samples and 285 serum samples were collected. OTA levels were determined through extraction, immunoaffinity column purification and high-performance liquid chromatography analysis coupled with fluorimetric detection. RESULTS: All feed samples resulted to be contaminated with OTA at levels ranging from 0.22 to 38.4 microg kg(-1). The OTA concentrations found in organic feed samples were significantly higher (P < 0.05) than those found in conventional feed samples. All serum samples resulted to be contaminated with OTA at levels ranging from 0.03 to 6.24 ng mL(-1). The OTA concentrations found in organic serum samples were significantly higher (P < 0.001) than those found in conventional serum samples. CONCLUSION: None of the feed samples contained more than the maximum level (50 microg OTA kg(-1), considering a feed moisture content of 120 g kg(-1)) recommended by the European Commission for OTA in complementary and complete swine feedstuffs. The OTA contamination of organic feed and serum samples was found to be significantly higher than that of conventional feed and serum samples.
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Alimentación Animal/análisis , Crianza de Animales Domésticos/métodos , Contaminación de Alimentos/estadística & datos numéricos , Ocratoxinas/análisis , Ocratoxinas/sangre , Alimentación Animal/normas , Animales , Cromatografía Líquida de Alta Presión , Estudios Transversales , Unión Europea , Italia , Ocratoxinas/aislamiento & purificación , Estadística como Asunto , Sus scrofaRESUMEN
Fortification of human milk (HM) for preterm and very low-birth weight (VLBW) infants is a standard practice in most neonatal intensive care units. The optimal fortification strategy and the most suitable protein source for achieving better tolerance and growth rates for fortified infants are still being investigated. In a previous clinical trial, preterm and VLBW infants receiving supplementation of HM with experimental donkey milk-based fortifiers (D-HMF) showed decreased signs of feeding intolerance, including feeding interruptions, bilious gastric residuals and vomiting, with respect to infants receiving bovine milk-based fortifiers (B-HMF). In the present ancillary study, the urinary metabolome of infants fed B-HMF (n = 27) and D-HMF (n = 27) for 21 days was analyzed by 1H NMR spectroscopy at the beginning (T0) and at the end (T1) of the observation period. Results showed that most temporal changes in the metabolic responses were common in the two groups, providing indications of postnatal adaptation. The significantly higher excretion of galactose in D-HMF and of carnitine, choline, lysine and leucine in B-HMF at T1 were likely due to different formulations. In conclusion, isocaloric and isoproteic HM fortification may result in different metabolic patterns, as a consequence of the different quality of the nutrients provided by the fortifiers.
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Nutrición Enteral/métodos , Alimentos Fortificados , Recien Nacido Prematuro/orina , Leche Humana/metabolismo , Estado Nutricional , Animales , Carnitina/orina , Bovinos , Colina/orina , Equidae , Femenino , Galactosa/orina , Humanos , Recién Nacido , Leucina/orina , Lisina/orina , Masculino , Metaboloma , Leche Humana/químicaRESUMEN
Ageing is often characterised by nutritional deficiencies and functional alterations of the digestive and immune system. The aim of the present study was to analyse the impact of consumption of conventional milk with A1/A2 beta-casein, compared to milk containing only the A2 beta-casein variant, characterised by a protein profile favouring gut health. Twenty-four ageing Balb-c mice (20 months old) were fed for 4 weeks, with either a control diet (CTRL), a diet supplemented with bovine milk containing A1/A2 beta-casein (A1A2) or a diet containing A2/A2 beta-casein (A2A2). Lymphocyte subpopulations, enzymatic activities, cytokine secretion, gut morphology and histopathological alterations were measured in different gut segments, while short-chain fatty acids (SCFAs) content and microbiota composition were evaluated in faecal samples. The A2A2 group showed higher content of faecal SCFAs (in particular, isobutyrate) of intestinal CD4+ and CD19+ lymphocytes in the intraepithelial compartment and improved villi tropism. The A1A2 group showed higher percentages of intestinal TCRγδ+ lymphocytes. Faecal microbiota identified Deferribacteriaceae and Desulfovibrionaceae as the most discriminant families for the A2A2 group, while Ruminococcaceae were associated to the A1A2 group. Taken together, these results suggest a positive role of milk, in particular when containing exclusively A2 beta-casein, on gut immunology and morphology of an ageing mice model.
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Caseínas/administración & dosificación , Caseínas/farmacología , Suplementos Dietéticos , Microbioma Gastrointestinal , Mucosa Intestinal/inmunología , Mucosa Intestinal/microbiología , Leche , Fenómenos Fisiológicos de la Nutrición/fisiología , Animales , Caseínas/clasificación , Citocinas/metabolismo , Ácidos Grasos Volátiles/metabolismo , Femenino , Inflamación , Mucosa Intestinal/metabolismo , Mucosa Intestinal/patología , Linfocitos/inmunología , Masculino , Ratones Endogámicos BALB C , Leche/química , Modelos AnimalesRESUMEN
Preterm and low birth weight infants require specific nutrition to overcome the accumulated growth deficit, and to prevent morbidities related to postnatal growth failure. In order to guarantee an adequate nutrient-intake, mother's own milk, when available, or donor human milk, are usually fortified with additional nutrients, in particular proteins. Fortification with processed ingredients may result in additional intake in oxidative compounds, deriving from extensive heat treatments, that are applied during processing. The aim of the present work was to compare the in vitro antioxidant activity and oxidative compound content conveyed by different preterm infant foods and fortifiers, namely raw and pasteurized human milk, two different preterm infant formulas, three bovine milk-based fortifiers and two experimental donkey milk-based fortifiers. Univariate and multivariate statistical analyses revealed significant differences between the different products. The use of human milk minimizes the intake of dietary oxidative compound in comparison to infant formulas, irrespective of pasteurization or fortification, especially as far as malondialdehyde content is concerned. The addition of fortifiers to human milk increases its antioxidant capacity, and the choice of the protein source (hydrolysed vs. whole proteins) differently impacted the resulting total antioxidant capacity of the diet.
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Due to increasing attention from consumers on non-bovine milk types, and to the increase in the number of small dairy donkey farms in Italy, farmers require more advanced and reliable processing devices, in order to guarantee a safe product of high quality. To this aim, a new small-scale High-Temperature Short-Time (HTST) pasteurizer (72 °C for 15 s), prototyped by the authors, was tested on donkey milk. The efficacy of the HTST device was tested on raw donkey milk microflora by enumeration of total aerobic bacteria, Enterobacteriaceae and Bacillus cereus. The biochemical quality was assessed by determining the protein profile by monodimensional electrophoresis and by measuring lysozyme activity. The HTST apparatus was able to reduce the total bacteria count, and to completely eradicate Enterobacteriaceae. Bacillus cereus, when present, was decreased with low efficiency. Changes in the protein profile were observed in milk pasteurized in accordance with both processes, although HTST seemed to limit casein degradation. Lysozyme activity was not substantially affected in comparison to raw donkey milk. In conclusion, a tailored small-volume HTST device could be safely applied to pasteurize donkey milk in on-farm pasteurization processes on small dairy donkey farms.
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BACKGROUND: The breeding of lactating donkeys is increasing in Western Europe; with it the evaluation of body condition is growing in importance since it is considered a key principle for their welfare. However, assessment of body condition is a complex task, since several factors are involved. The aim of the present study is to investigate which animal-based indicators are the most reliable to describe the body condition of lactating donkeys. For this purpose, new animal-based indicators, which are easy to measure in field conditions (including body measurements, fatty neck score (FNS), dental score), are recorded and their relationship with BCS (a proxy measure for overall adiposity) was assessed. The ones that reveal an association with the BCS are included in an integrated principal component analysis to understand which are the most related to BCS. METHODS: Fifty-three healthy lactating donkeys of various breeds, including 7 Martina Franca, 10 Ragusano, 2 Romagnolo and 34 crossbreeds, were evaluated. The animal-based indicators that were recorded were: length (OP, olecranon tuber-pinbone and SH, shoulder-hip), heart girth (HG), abdominal circumference (AC), neck length (NL), neck height (NH) and neck thickness (NT) at 0.50 and neck circumference (NC) at 0.25, 0.50 and 0.75, body condition score (BCS) and fatty neck score (FNS). The owners' evaluation of the BCS was also considered. A dental assessment was performed and the month of lactation and age of each animal was recorded. RESULTS: No correlation was found between BCS and the other morphometric body measurements. On the contrary the FNS was correlated with the morphometric measurements of the neck (positive correlation to 0.50 NH and 0.50 NT, 0.50 NC, 0.75 mean NC, and negative correlation to the mean NC:NH and mean NC:NT, 0.50 NC:NT and 0.50 NC:NH ratios). A significant inverse relationship was identified between BCS and dental score. A Principal Component analysis (PCA) separated the BCS classes on the first principal component (PC1). PC1 revealed a meaningful positive correlation between the BCS and the neck measurements (NT, NH and FNS), with high positive loadings, while a negative correlation was found for dental abnormalities. The owners' evaluation of BCS was different from the expert evaluator' assessment, since they tended to give higher score that was slightly but significantly correlated to AC. DISCUSSION: A new scoring system, called Fatty Neck Score (FNS), has been proposed for the judgement of the adiposity status of donkey neck. The results suggest that caregivers might use the proposed animal based indicators (BCS, FNS and dental scores) together as a tool for the evaluation of the body condition of lactating donkeys. Our findings highlight that caregivers need to be trained in order to be able to properly record these indicators. Ultimately use of these indicators may help to improve the welfare of lactating donkeys.
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BACKGROUND: The immunoreactivity of methionine-enkephalin (Met-enkephalin), one of the endogenous opioid peptides, is expressed in the liver in different types of chronic diseases. This finding suggests that the liver may be a source of endogenous opioids in disease state. In-vitro studies have shown that morphine, which exerts its effect by binding to opioid receptors, enhances hepatitis C virus replication and that it interferes with the antiviral effects of interferon. Thus, it was hypothesized that liver-derived endogenous opioids, which also bind to opioid receptors, may interfere with the response to antiviral therapy with interferon. AIM: To correlate the expression of Met-enkephalin immunoreactivity (MEIR) in the liver of patients with chronic hepatitis C with their response to treatment with pegylated interferon and ribavirin. METHODS: We sought to investigate the expression of the immunoreactivities of Met-enkephalin and of the δ-opioid receptor 1 (DOR1), to which Met-enkephalin binds, preferentially, in liver samples from 23 patients with chronic hepatitis C who had undergone antiviral therapy. Twelve patients obtained a sustained virological response, and 11 patients were relapsers after or nonresponders to treatment. Among the 12 patients with sustained virological response, one patient (8.3%) expressed MEIR and another one expressed DOR1 immunoreactivity (8.3%), whereas none of the patients expressed both immunoreactivities. Among the group of nonresponders/relapsers, one patient expressed MEIR (9%), two patients expressed DOR1 immunoreactivity (18.2%), and seven patients expressed both (63.6%). The difference between responders and nonresponders in the expression of both immunoreactivities was significantly different (P<0.001). CONCLUSION: Our data are in favor of the hypothesis that enhanced expression of MEIR and DOR1 immunoreactivity correlates with poor response to antiviral therapy that includes interferon. Thus, this study provides a rationale to study the effect of opiate antagonists in combination with antiviral therapy with interferon and ribavirin in patients who express MEIR in the liver and who have not responded to or who have relapsed after treatment with those antiviral medications.
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Antivirales/uso terapéutico , Encefalina Metionina/metabolismo , Hepatitis C Crónica/tratamiento farmacológico , Hígado/metabolismo , Adulto , Biomarcadores/metabolismo , Quimioterapia Combinada , Femenino , Hepatitis C Crónica/metabolismo , Humanos , Interferón alfa-2 , Interferón-alfa/uso terapéutico , Masculino , Persona de Mediana Edad , Receptores Opioides delta/metabolismo , Proteínas Recombinantes/uso terapéutico , Recurrencia , Estudios Retrospectivos , Ribavirina/uso terapéutico , Insuficiencia del TratamientoRESUMEN
BACKGROUND: The efficacy of retreatment with pegylated interferon (PEG-IFN) plus ribavirin for patients relapsing after a previous treatment remains to be fully elucidated, although extended treatment seems to be the best option in such cases. AIM: To evaluate the efficacy of two extended protocols in patients with genotypes 1 or 4, or those with genotypes 2 or 3. METHODS: A total of 181 patients who had relapsed after a previous antiviral treatment with PEG-IFNα2a plus weight-based ribavirin were offered retreatment with the same dose of both PEG-IFN plus ribavirin, to be continued for 48 weeks in those with genotypes 2 or 3 (group 1), and for 72 weeks in those with genotypes 1 or 4 (group 2). RESULTS: A total of 59 patients (32.5%) refused the retreatment, while 122 (78 men, 44 women) patients were enrolled in the study: 41 were allocated in group 1 and 81 in group 2. Cirrhosis at baseline (staging 5/6 according to Ishak's score was recorded in 11 patients, six in group 1 and five in group 2). Nine patients (7.3%) in group 2 discontinued the treatment (due to lack of response). The remaining patients completed the treatment and were followed-up for at least 12 months after the treatment. Sustained virological response (SVR) rate was 82.9% in group 1 and 50.6% in group 2. CONCLUSION: Patients with chronic hepatitis C with 'easy genotypes' relapsers to a previous antiviral treatment have more than 80% probability of achieving a SVR with a 48-week retreatment. Patients with 'difficult genotypes' have more than 50% chance of a SVR after a 72-week extended treatment.
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Antivirales/uso terapéutico , Hepatitis C Crónica/tratamiento farmacológico , Adulto , Anciano , Antivirales/administración & dosificación , Esquema de Medicación , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Genotipo , Hepacivirus/genética , Hepatitis C Crónica/virología , Humanos , Interferón alfa-2 , Interferón-alfa/administración & dosificación , Interferón-alfa/uso terapéutico , Masculino , Persona de Mediana Edad , Polietilenglicoles/administración & dosificación , Polietilenglicoles/uso terapéutico , Proteínas Recombinantes , Recurrencia , Retratamiento , Ribavirina/administración & dosificación , Ribavirina/uso terapéutico , Resultado del TratamientoRESUMEN
BACKGROUND: Patients with chronic hepatitis C and persistently normal alanine transaminase levels have recently been included in the guidelines for antiviral treatment. AIM: To evaluate the efficacy of PEG-interferon α-2a and weight-based ribavirin doses in patients with these characteristics in a single Italian centre. MATERIALS AND METHODS: Patients with chronic hepatitis C and at least three normal alanine transaminase values over a 12-month period were offered a treatment with PEG-interferon α-2a 180 mg/week and ribavirin (800 mg/day for weight <60 kg; 1000 mg/day for weight >60 and <75 kg; 1200 mg/day for weight >75 kg) for 24 weeks (according to genotype 2 or 3) or for 48 weeks (according to genotype 1 or 4). Each patient at baseline underwent liver stiffness (LS) examination using Fibroscan. Data were analysed according to the intention-to-treat criteria. RESULTS: A total of 227 patients (55 men, 172 women) were enrolled into the study: 65 (28.6%) had genotype 1, 144 (63.4%) genotype 2, nine (4.0%) genotype 3 and nine (4.0%) genotype 4. Patients with genotype 2 or 3 (N=153 with easy genotypes) were allocated in group 1 and those with genotype 1 or 4 (N=74 with difficult genotypes) in group 2. According to the LS measurement, patients were classified as follows: 159 (70.0%) presented absent or mild fibrosis (LS=2.5-7.0 kPa), 61 (26.9%) patients had significant fibrosis (LS=7.1-9.5) and seven (3.1%) patients had severe fibrosis (LS >9.6). Twelve patients (5.3%) dropped out within 4 months because of side-effects, whereas 215 patients completed the study. Overall, 13 patients were considered nonresponders (5.7%) and six patients (2.6%) were relapsers to the therapy. The sustained virological response (SVR) rate was 85.4% and it was higher in 'easy' genotypes (2 or 3) compared with 'difficult' genotypes (1 or 4) (92.2 vs. 74.3%, P<0.001). No statistical difference was found in the SVR rate between patients presenting absent or mild fibrosis as against those with significant fibrosis. Multivariate analysis, including factors correlated with SVR, showed that easy genotype and female sex are significantly associated with a SVR. CONCLUSION: Patients with chronic hepatitis C and persistently normal transaminases have an 85.4% chance to clear the virus with conventional antiviral treatment. Female patients in fertile age with easy genotypes have a 100% chance to reach a SVR.