Temporal changes in the genotypes of Paslahepevirus balayani in southern Spain and their possible link with changes in pig trade imports.

Introduction: Paslahepevirus balayani (HEV) is an endemic zoonotic disease ranked as a major cause of acute hepatitis in Europe. Most infections occurring in Europe are due to the endemic several subtypes of genotype 3, through the consumption of raw or undercooked pork, observing a genotype geographical distribution pattern among countries Because of global changes in the pig and pork trading markets, subtype distribution might vary. We aimed to evaluate the temporal distribution of HEV genotypes in patients from southern Spain with acute hepatitis to determine whether these changes were related to the pig import trade during the study period between 2018 and 2022. Methods: Prospective longitudinal study including patients with acute hepatitis from southern Spain between 2018 and 2022. HEV RNA and antibodies was tested in all patients. In patients with detectable HEV RNA, genotype was obtained. To determine the number of imported pigs and their origins, we checked the official data from the Spanish statistics on international trade of Spanish Minister of Industry during by country of origin during the same study period. Results: A total of 659 patients with acute hepatitis were included in the study. Among them, 162 (24.5%) had at least one marker (IgM or RNA) of acute HEV infection. Among the 71 patients with detectable viral RNA, genotypes could be obtained for 58 (81.6%). The most prevalent HEV genotype was 3f (n = 48; 78.6%), showing a decreasing prevalence of over time, from 100% in 2018 to 70.6% in 2022. Since 2021, the emergence of other genotypes has been determined. A significant increase in the number of animals imported was observed since the beginning of the study. Denmark experienced a significant rise, from 0.03% in 2018 of total imports to 10.4% in 2022. Conclusions: HEV molecular diversity is changing in Spain, could be linked to changes in fattening pig import origin.

Optimization of the molecular diagnosis of the acute hepatitis E virus infection.

To evaluate the diagnostic value of the combination of two broad-range PCR assays targeting two different and conserved regions of the viral genome for the diagnosis of acute Hepatitis E virus (HEV) infection. Patients with acute hepatitis were prospectively recruited. In all, HEV-IgM antibodies were tested together with evaluation of HEV viraemia by two PCR assays (ORF3 and ORF1). The number of individuals exhibiting negative IgM antibody results but carrying viral RNA was calculated by each PCR assay. Four-hundred and seventy individuals were included, of whom 145 (30.8%) were diagnosed as having acute HEV. Of them, 122 (84.1%) exhibited HEV-IgM antibodies, and 81 (55.8%) had detectable viral RNA for at least one PCR. Using the ORF3 molecular assay, 70 (48.3%) individuals were identified with HEV infection. When the ORF1 molecular assay was applied, 49 (33.8%) individuals were identified. The ORF3 assay detected viral RNA in 32 patients not detected by the ORF1 assay. In contrast, the ORF1 assay could amplify viral RNA in 11 patients who were not detected by the ORF3 assay. The parallel use of two broad-range PCR assays significantly increased the performance of the molecular diagnosis of HEV.

Orthohepevirus C infection as an emerging cause of acute hepatitis in Spain: First report in Europe.

BACKGROUND & AIM: Hepatitis E virus (HEV) was considered the only member of the Hepeviridae family with zoonotic potential. Nevertheless, this consideration has been reassessed owing to several reported cases of acute and chronic hepatitis linked to the Orthohepevirus C genus. Because the circulation of Orthohepevirus C in rodents has been described worldwide, the risk of zoonotic transmission is plausibly global. METHODS: Orthohepevirus C RNA was retrospectively evaluated in 2 cohorts of patients in Spain. The first cohort included patients with acute hepatitis without etiological diagnosis after screening for hepatotropic virus infection. The second cohort included patients diagnosed with acute HEV infection, defined as positivity for anti-HEV-IgM antibodies and/or detectable HEV RNA in serum. RESULTS: Cohort 1 comprised 169 patients (64.4% male, median age 43 years) and cohort 2 comprised 98 individuals (68.3% male, median age 45 years). Of the individuals included in Cohort 1, two (1.18%; 95% CI 0.2-3.8) had detectable Orthohepevirus C RNA in serum. In Cohort 2, of the 98 included patients, 58 showed detectable HEV RNA, while 40 only showed positivity for IgM antibodies. Among those bearing only IgM antibodies, Orthohepevirus C RNA was detected in 1 (2.5%; 95% CI 0.06-13.1) individual. All strains were consistent with genotype C1. The infection resulted in mild self-limiting acute hepatitis in 2 patients. Infection caused severe acute hepatitis in the remaining patient who died as a result of liver and renal failure. CONCLUSIONS: We described 3 cases of Orthohepevirus C in patients with acute hepatitis, resulting in the first description of this infection in Europe. The prevalence obtained in our study suggests that Orthohepevirus C could be an emerging disease in Europe. LAY SUMMARY: We describe the first cases of acute hepatitis related to rat hepatitis E virus in Europe. The prevalence found in our study suggest that rat hepatitis E virus could be considered an emerging disease in Europe.

Vaccinated Patients Admitted in ICU with Severe Pneumonia Due to SARS-CoV-2: A Multicenter Pilot Study.

Background: The aim of this study was to analyze the percentage of patients admitted to the ICU having received the vaccine against COVID-19, to describe the clinical profile of vaccinated patients admitted to the ICU, and to assess the humoral immune response to vaccination. Methods: In this multicenter prospective descriptive cohort study, consecutive critically ill patients with confirmed SARS-CoV-2 pneumonia who received at least one dose of the SARS-CoV-2 vaccine were included. The time of study was from 1 July to 10 August of 2021. Results: Of the 94 consecutive patients from seven Andalusian ICUs admitted during the time of study, 50 (53.2%) received at least one dose of anti SARS-CoV-2 vaccine. No patient was admitted having previously had SARS-CoV-2 infection. The B.1.617.2 (Delta) variant was the most frequently identified, in 80.76% of cases. Patients with a complete vaccination with non-optimal antibody levels were immunocompromised. Fifteen patients were admitted to the ICU with Acute Respiratory Distress Syndrome (ARDS) without having completed their vaccination; the clinical profile was younger and with less comorbidities compared to patients with full vaccination. There were no differences in severity of ARDS. Conclusions: Most of the patients who were admitted to the ICU having received a dose of the vaccine were not optimally vaccinated; fully vaccinated patients who did not obtain optimal serum antibody levels were patients considered immunocompromised.

Limited Value of Single Sampling for IgM Antibody Determination as a Diagnostic Approach for Acute Hepatitis E Virus Infection.

The objective was to evaluate the accuracy of a single determination of IgM antibodies for hepatitis E virus (HEV) diagnosis in patients with acute hepatitis. A prospective study included patients with suspicion of HEV infection, defined as individuals with acute hepatitis showing negative results for serological and molecular markers of other hepatitis viruses. All patients were evaluated for hepatitis E virus infection, including both IgM antibodies and viral RNA determinations. Hepatitis E virus infection was defined as positivity for any of these markers. A total of 182 patients were included in the study, of whom 68 (37.4%) were diagnosed with HEV infection. Of these, 29 (42.6%) were positive for both IgM and HEV RNA, 25 (36.8%) were positive only for IgM antibodies, and 14 (20.6%) were positive only for HEV RNA. Considering only those individuals who were positive for IgM antibodies, 54 of the 68 total cases (79.4%) could be identified, showing a percentage of false-negative individuals of 20.6%. The diagnostic algorithm of hepatitis E virus infection in patients with acute hepatitis should include the determination of both IgM antibodies and HEV RNA because single sampling for IgM antibody determination led to an important proportion of misdiagnosed cases. IMPORTANCE In immunocompetent patients with a suspicion of hepatitis E virus (HEV) infection, single IgM antibody testing is typically applied. In this prospective study, we aimed to evaluate the accuracy of three different HEV screening approaches in patients with acute hepatitis, including approaches based on IgM determination, HEV RNA detection, and the combination of both. Our study shows that any diagnostic algorithm for HEV infection in patients with acute hepatitis should be based on the determination of both markers (IgM antibodies and HEV RNA) because single sampling for IgM antibodies results in an unacceptable number of false-negative results (20%). According to our results, the determination of HEV RNA should not be limited to immunosuppressed individuals because a high proportion of cases could be misdiagnosed.

Human Immunodeficiency Virus (HIV) Infection Is Associated With Lower Risk of Hepatocellular Carcinoma After Sustained Virological Response to Direct-acting Antivirals in Hepatitis C Infected Patients With Advanced Fibrosis.

BACKGROUND: The aim of this study was to assess the impact of human immunodeficiency virus (HIV) infection on the risk of developing hepatocellular carcinoma (HCC) in patients infected with hepatitis C virus (HCV) who achieve sustained virological response (SVR) with direct-acting antiviral (DAA). METHODS: Multisite prospective cohort study, where HCV-monoinfected patients and HIV/HCV-coinfected individuals were included if they met: (1) SVR with DAA-based combination; (2) liver stiffness (LS) ≥9.5 kPa previous to treatment; (3) LS measurement at the SVR time-point. The main endpoint was the occurrence of HCC. Propensity score (PS) was calculated to address potential confounders due to unbalanced distribution of baseline characteristics of HIV/HCV-coinfected and HCV-monoinfected patients. RESULTS: In total, 1035 HCV-infected patients were included, 667 (64%) coinfected with HIV. After a median (Q1-Q3) follow-up time of 43 (31-49) months, 19 (1.8%) patients developed HCC (11 [3.0%]; HCV-monoinfected, 8[1.2%]; HIV/HCV-coinfected individuals; P = .013). In the multivariable analysis, HIV coinfection was associated with a lower adjusted risk of developing HCC (subhazard ratio [sHR] = 0.27, 95% confidence interval [CI]: .08-.90; P = .034). Predictors of HCC emergence were: HCV genotype 3 (sHR = 7.9, 95% CI: 2.5-24.9; P < .001), MELD score at SVR >10 (sHR = 1.37, 95% CI: 1.01-1.86; P = .043) and LS value at SVR (sHR = 1.03, 95% CI: 1.01-1.06, for 1 kPa increase; P = .011). Using inverse probability weighting method on the PS, HIV-infected patients had a lower risk of HCC (powered HR = 0.33, 95% CI: .11-.85). CONCLUSIONS: Among HCV-infected patients with advanced fibrosis, who achieve SVR with DAA, HIV coinfection seems to be associated with a lower risk of HCC occurrence. The underlying causes for this finding need to be investigated.

Sample pooling for SARS-CoV-2 RT-PCR screening.

OBJECTIVE: To evaluate the efficacy of sample pooling compared to the individual analysis for the diagnosis of coronavirus disease 2019 (COVID-19) by using different commercial platforms for nucleic acid extraction and amplification. METHODS: A total of 3519 nasopharyngeal samples received at nine Spanish clinical microbiology laboratories were processed individually and in pools (342 pools of ten samples and 11 pools of nine samples) according to the existing methodology in place at each centre. RESULTS: We found that 253 pools (2519 samples) were negative and 99 pools (990 samples) were positive; with 241 positive samples (6.85%), our pooling strategy would have saved 2167 PCR tests. For 29 pools (made out of 290 samples), we found discordant results when compared to their correspondent individual samples, as follows: in 22 of 29 pools (28 samples), minor discordances were found; for seven pools (7 samples), we found major discordances. Sensitivity, specificity and positive and negative predictive values for pooling were 97.10% (95% confidence interval (CI), 94.11-98.82), 100%, 100% and 99.79% (95% CI, 99.56-99.90) respectively; accuracy was 99.80% (95% CI, 99.59-99.92), and the kappa concordant coefficient was 0.984. The dilution of samples in our pooling strategy resulted in a median loss of 2.87 (95% CI, 2.46-3.28) cycle threshold (Ct) for E gene, 3.36 (95% CI, 2.89-3.85) Ct for the RdRP gene and 2.99 (95% CI, 2.56-3.43) Ct for the N gene. CONCLUSIONS: We found a high efficiency of pooling strategies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA testing across different RNA extraction and amplification platforms, with excellent performance in terms of sensitivity, specificity and positive and negative predictive values.

Towards the elimination of hepatitis C: implementation of reflex testing in Andalusia

BACKGROUND AND AIM: undiagnosed hepatitis C virus (HCV) infection and/or inadequate access to care are barriers to the elimination of HCV. Reflex testing has proven to facilitate referral to care, treatment and viral elimination. In this study, a reflex testing program was implemented in Andalusia and its impact on access to care was evaluated. PATIENTS AND METHODS: an observational, retrospective and prospective study was performed across diagnostic laboratories responsible for HCV diagnosis in southern Spain. After surveying the barriers to performing reflex testing, the number of patients that were not referred for care in 2016 was retrospectively studied (pre-reflex cohort). Subsequently, several measures were proposed to overcome the identified barriers. Finally, reflex testing was implemented and its impact evaluated. RESULTS: the pre-reflex cohort included information from 1,053 patients. Slightly more than half of the patients (n = 580; 55%) visited a specialist for treatment evaluation during a median period of 71 days (interquartile range = 35-134) since the date of diagnosis. The post-reflex cohort (September 2017 to March 2018) included 623 patients. Only 17% (n = 106) of the patients had not been referred for care or evaluated for treatment in a median period of 52 days (interquartile range = 28-86). CONCLUSIONS: in 2016, nearly half of new HCV diagnoses in southern Spain were not referred for care. Barriers to the implementation of reflex testing were overcome in our study. Moreover, this strategy was effectively implemented in 2017. Reflex testing contributed to improving referral for care. This program will contribute to the micro-elimination of hepatitis C in Spain

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Towards the elimination of hepatitis C: implementation of reflex testing in Andalusia.

BACKGROUND AND AIM: undiagnosed hepatitis C virus (HCV) infection and/or inadequate access to care are barriers to the elimination of HCV. Reflex testing has proven to facilitate referral to care, treatment and viral elimination. In this study, a reflex testing program was implemented in Andalusia and its impact on access to care was evaluated. PATIENTS AND METHODS: an observational, retrospective and prospective study was performed across diagnostic laboratories responsible for HCV diagnosis in southern Spain. After surveying the barriers to performing reflex testing, the number of patients that were not referred for care in 2016 was retrospectively studied (pre-reflex cohort). Subsequently, several measures were proposed to overcome the identified barriers. Finally, reflex testing was implemented and its impact evaluated. RESULTS: the pre-reflex cohort included information from 1,053 patients. Slightly more than half of the patients (n = 580; 55%) visited a specialist for treatment evaluation during a median period of 71 days (interquartile range = 35-134) since the date of diagnosis. The post-reflex cohort (September 2017 to March 2018) included 623 patients. Only 17% (n = 106) of the patients had not been referred for care or evaluated for treatment in a median period of 52 days (interquartile range = 28-86). CONCLUSIONS: in 2016, nearly half of new HCV diagnoses in southern Spain were not referred for care. Barriers to the implementation of reflex testing were overcome in our study. Moreover, this strategy was effectively implemented in 2017. Reflex testing contributed to improving referral for care. This program will contribute to the micro-elimination of hepatitis C in Spain.

Current position of viral load versus hepatitis C core antigen testing. / Posición actual de la carga viral frente a la determinación de antígeno core del virus de la hepatitis C.

Quantification of hepatitis C virus (HCV) RNA (viral load) is the most widely used marker to diagnose and confirm active HCV infection. The HCV core antigen forms part of the internal structure of the virus and, like HCV RNA, its detection also indicates viral replication and presents certain advantages over viral load testing such as its lower cost, the greater stability of the target, the possibility of working with the same primary tube as that used for HCV serology, and the rapidity of obtaining results, since there is no need to work in batches, unlike the situation with most viral load platforms. Although the core antigen has lower analytical sensitivity than HCV RNA for the detection of low viremia levels, several studies and guidelines have already shown their utility in the identification of patients with active HCV infection. This article summarises current platforms for viral load determination, including point-of-care systems, and also reviews the indications attributed to this marker by the main HCV treatment guidelines. The article also reviews the characteristics of HCV core antigen, the available platforms for its determination, its correlation with viral load determination, and the indications for this marker in the distinct guidelines.

Posición actual de la carga viral frente a la determinación de antígeno core del virus de la hepatitis C / Current position of viral load versus hepatitis C core antigen testing

La cuantificación del ARN del virus de la hepatitis C -VHC- (carga viral) constituye el marcador más utilizado para diagnosticar y confirmar la infección activa por el VHC. El antígeno core del VHC forma parte de la estructura interna del virus y, al igual que el ARN del VHC, su detección indica también replicación viral, y presenta algunas ventajas frente a la carga viral como los costes que conlleva, que son menores que los de la carga viral, la estabilidad de la diana, que es superior que la de la carga viral, la posibilidad de trabajar con el mismo tubo primario que el que se utiliza para la serología de VHC y la rapidez para obtener resultados, ya que no es necesario trabajar en lotes como ocurre con la mayoría de las plataformas de carga viral. Aunque el antígeno core presenta menor sensibilidad analítica que el ARN del VHC para la detección de viremias bajas, diversos estudios y guías han puesto ya de manifiesto su utilidad para la identificación de pacientes con infección activa por VHC. En este capítulo se resumirán las plataformas actuales para la determinación de carga viral, incluyendo los sistemas "point of care"; se revisarán igualmente las indicaciones que las principales guías de tratamiento de hepatitis C atribuyen a este marcador. Además, se revisarán las características del antígeno core del VHC, las plataformas existentes para su determinación, la correlación que existe con la determinación de carga viral y las indicaciones que las distintas guías reconocen para este marcador

Quantification of hepatitis C virus (HCV) RNA (viral load) is the most widely used marker to diagnose and confirm active HCV infection. The HCV core antigen forms part of the internal structure of the virus and, like HCV RNA, its detection also indicates viral replication and presents certain advantages over viral load testing such as its lower cost, the greater stability of the target, the possibility of working with the same primary tube as that used for HCV serology, and the rapidity of obtaining results, since there is no need to work in batches, unlike the situation with most viral load platforms. Although the core antigen has lower analytical sensitivity than HCV RNA for the detection of low viremia levels, several studies and guidelines have already shown their utility in the identification of patients with active HCV infection. This article summarises current platforms for viral load determination, including point-of-care systems, and also reviews the indications attributed to this marker by the main HCV treatment guidelines. The article also reviews the characteristics of HCV core antigen, the available platforms for its determination, its correlation with viral load determination, and the indications for this marker in the distinct guidelines

La simplificación del proceso de diagnóstico de la hepatitis C crónica es una estrategia coste-efectiva / The simplification of the diagnosis process of chronic hepatitis C is cost-effective strategy

INTRODUCCIÓN: Los circuitos de diagnóstico de la hepatitis C son complejos. El diagnóstico de infección activa en la misma muestra simplificaría el proceso estableciendo un acceso rápido al tratamiento. Nuestro objetivo fue estimar el impacto sanitario y económico del diagnóstico de la infección crónica en un solo paso (D1P) comparado con el diagnóstico tradicional (DTRA) en Andalucía (8,39 millones de personas). MÉTODOS: Se realizó un árbol de decisión para estimar la derivación de los pacientes con infección crónica, pérdidas de seguimiento, acceso al tratamiento y costes del diagnóstico de la infección, para ambos procesos. Los costes unitarios, en euros (€) de 2018, de los recursos sanitarios (visitas médicas, anticuerpos, carga viral y genotipo), sin considerar el coste farmacológico, se obtuvieron de fuentes públicas de Andalucía. RESULTADOS: del total de la población estimada (269.526 pacientes), 1.389 pacientes serían derivados al especialista en el D1P y 1.063 en el DTRA, siendo tratados 1.320 y 1.009, respectivamente. Con el D1P ningún paciente con carga viral negativa sería remitido al especialista, frente a los 540 con el DTRA. El D1P generaría un ahorro de costes de 184.928 € frente al DTRA (15.671.493 vs 15.856.421 €). Al comparar el D1P frente a DTRA, el ahorro por paciente con carga viral positiva derivado al especialista sería de 3.644 € (11.279 vs 14.923 €). CONCLUSIONES: El diagnóstico en un solo paso conseguirá un aumento de pacientes diagnosticados, aumentará el acceso de los pacientes crónicos al tratamiento y generará un ahorro de costes, demostrando su eficiencia en el sistema sanitario en Andalucía

BACKGROUND: The cascade of care of the hepatitisC are complex. The diagnosis of active infection in the same serum sample would simplify the process establishing a rapid access for patients to treatment. Our objective was to estimate the impact on healthcare and economic outcomes of the diagnosis of chronic infection in one-step diagnosis compared to standard diagnosis in Andalusia (8.39 million people). METHODS: A decision tree was developed to estimate the referral of patients with chronic infection, loss of follow-up, access to treatment and costs of the diagnosis of the infection, for both processes. The unit costs (€, 2018) of the health resources (medical visits, antibodies, viral load and genotype), without considering the pharmacological cost, were obtained form public sources in Andalusia. RESULTS: Of the total estimated population (269,526 patients), 1,389 patients would be referred to the specialised care in the one-step diagnosis and 1,063 in de standard diagnosis, being treated 1,320 and 1,009, respectively. In one-step diagnosis, no negative viral loud patient would be referred to specialist versus 540 with standard diagnosis. One-step diagnosis would generate a cost saving of €184,928 versus standard diagnosis (€15,671,493 vs €15,856,421). When compared one-step diagnosis to standard diagnosis, the savings per patient with positive viral load referred to specialist would be € 3,634 (€ 11,279 vs € 14,923). CONCLUSION: The one-step diagnosis will achieve an increase in diagnosed patients, will increase the access of chronic patient to treatment and will generate cost savings, demonstrating its efficiency in the system in Andalusia

The simplification of the diagnosis process of chronic hepatitis C is cost-effective strategy. / La simplificación del proceso de diagnóstico de la hepatitis C crónica es una estrategia coste-efectiva.

BACKGROUND: The cascade of care of the hepatitisC are complex. The diagnosis of active infection in the same serum sample would simplify the process establishing a rapid access for patients to treatment. Our objective was to estimate the impact on healthcare and economic outcomes of the diagnosis of chronic infection in one-step diagnosis compared to standard diagnosis in Andalusia (8.39 million people). METHODS: A decision tree was developed to estimate the referral of patients with chronic infection, loss of follow-up, access to treatment and costs of the diagnosis of the infection, for both processes. The unit costs (€, 2018) of the health resources (medical visits, antibodies, viral load and genotype), without considering the pharmacological cost, were obtained form public sources in Andalusia. RESULTS: Of the total estimated population (269,526 patients), 1,389 patients would be referred to the specialised care in the one-step diagnosis and 1,063 in de standard diagnosis, being treated 1,320 and 1,009, respectively. In one-step diagnosis, no negative viral loud patient would be referred to specialist versus 540 with standard diagnosis. One-step diagnosis would generate a cost saving of €184,928 versus standard diagnosis (€15,671,493 vs €15,856,421). When compared one-step diagnosis to standard diagnosis, the savings per patient with positive viral load referred to specialist would be €3,634 (€11,279 vs €14,923). CONCLUSION: The one-step diagnosis will achieve an increase in diagnosed patients, will increase the access of chronic patient to treatment and will generate cost savings, demonstrating its efficiency in the system in Andalusia.

HIV infection does not increase the risk of liver complications in hepatitis C virus-infected patient with advanced fibrosis, after sustained virological response with direct-acting antivirals.

OBJECTIVE: To assess the impact of HIV coinfection on the risk of developing liver-related complications in HCV-infected patients with advanced fibrosis treated with direct-acting antivirals (DAA) after sustained virological response (SVR). DESIGN: Prospective cohort study. SETTING: Multicenter. SUBJECTS: Patients from the GEHEP and HEPAVIR cohorts were selected if they fulfilled the following criteria: treatment against HCV with all oral DAA combination; SVR achievement, defined as undetectable plasma HCV RNA 12 weeks after the end of therapy; pretreatment liver stiffness equal to or higher than 9.5 kPa; liver stiffness measurement at the time of SVR. MAIN OUTCOME MEASURE(S): The primary variable was the time until the development of a liver complication or requiring liver transplant. RESULTS: Seven hundred and seventeen patients were included and 507 (71%) were coinfected with HIV. After a median follow-up time of 21 (14-25) months, 15 (2.1%) patients developed a liver complication and/or underwent a liver transplant and 15 (2.0%) died. The probability of remaining free of hepatic complications or transplant at 1 and 2 was, respectively, 99 and 96% in HCV-monoinfected patients and 99 and 98% in coinfected patients (P = 0.648). In a multivariate analysis, in which nonliver-related death was considered as a competing event, HIV coinfection was not associated with the appearance of hepatic complications or requiring liver transplant [hazard ratio = 0.24; 95% CI (0.03-1.93), P = 0.181]. Having presented hepatic decompensation prior to SVR [hazard ratio = 29.06; 95% CI (3.91-216.16), P < 0.001] and the value of liver stiffness at the SVR time-point (hazard ratio = 1.12; 95% CI (1.07-1.18), P < 0.001] were associated with a higher probability of development of liver events. CONCLUSION: HIV coinfection is not associated with a higher probability of developing liver complications in HCV-infected patients with advanced fibrosis, who achieved SVR with interferon-free regimens.

Relapse or reinfection after failing hepatitis C direct acting antiviral treatment: Unravelled by phylogenetic analysis.

Despite high response rates associated to hepatitis C virus (HCV) treatment, no protective immunity is acquired, allowing for reinfection and continued infectiousness. Distinguishing between relapse and reinfection is crucial for patient counselling and to choose the most appropriate retreatment. Here, refined phylogenetic analysis using multiple genes served to assess genotype and reinfection for 53 patients for whom the virus was sampled before start of therapy and at time of sustained virological response evaluation at week 12. At baseline, genotypes were determined as HCV1a (41.5%), HCV1b (24.5%), HCV4 (18.9%) and HCV3a (15.1%), while six cases revealed to be discordantly assigned by phylogeny and commercial assays. Overall, 60.4% was co-infected with HIV. The large majority was classified as people who inject drugs (78.6%), often co-infected with HIV. Transmission was sexual in seven cases, of which five in HIV-positive men-who-have-sex-with-men. Overall, relapse was defined for 44 patients, while no conclusion was drawn for four patients. Five patients were reinfected with a different HCV strain, of which three with a different genotype, showing that phylogeny is needed not only to determine the genotype, but also to distinguish between relapse and intra-subtype reinfection. Of note, phylogenies are more reliable when longer fragments of the viral genome are being sequenced.

Seguridad en el laboratorio de Microbiología Clínica / Safety in the Microbiology laboratory

La actividad de un laboratorio de Microbiología origina riesgos de distinto tipo, especialmente biológicos, que pueden afectar a la salud de sus trabajadores, de los visitantes y a la comunidad. Los exámenes de salud (vigilancia y prevención), la concienciación individual de autoprotección, la identificación de los peligros y la evaluación del riesgo, la adopción de medidas de contención apropiadas y el empleo de técnicas microbiológicas escrupulosas permiten hacer del laboratorio un lugar seguro, como así demuestran las estadísticas de accidentes o de infecciones contraídas en el laboratorio. Formación e información son las herramientas clave para elaborar un plan de seguridad completo para el laboratorio. En este artículo se revisan los fundamentos teóricos y los conceptos básicos de la seguridad, incluyendo normativas legales. Además se elaboran directrices de tipo práctico para que cada laboratorio planifique su propia seguridad en función de sus características y de su idiosincrasia

The normal activity in the laboratory of microbiology poses different risks - mainly biological - that can affect the health of their workers, visitors and the community. Routine health examinations (surveillance and prevention), individual awareness of self-protection, hazard identification and risk assessment of laboratory procedures, the adoption of appropriate containment measures, and the use of conscientious microbiological techniques allow laboratory to be a safe place, as records of laboratory-acquired infections and accidents show. Training and information are the cornerstones for designing a comprehensive safety plan for the laboratory. In this article, the basic concepts and the theoretical background on laboratory safety are reviewed, including the main legal regulations. Moreover, practical guidelines are presented for each laboratory to design its own safety plan according its own particular characteristics

[Safety in the Microbiology laboratory]. / Seguridad en el laboratorio de Microbiología Clínica.

The normal activity in the laboratory of microbiology poses different risks - mainly biological - that can affect the health of their workers, visitors and the community. Routine health examinations (surveillance and prevention), individual awareness of self-protection, hazard identification and risk assessment of laboratory procedures, the adoption of appropriate containment measures, and the use of conscientious microbiological techniques allow laboratory to be a safe place, as records of laboratory-acquired infections and accidents show. Training and information are the cornerstones for designing a comprehensive safety plan for the laboratory. In this article, the basic concepts and the theoretical background on laboratory safety are reviewed, including the main legal regulations. Moreover, practical guidelines are presented for each laboratory to design its own safety plan according its own particular characteristics.

Adecuación de la solicitud de urocultivos e impacto de sus resultados en el tratamiento de la infección urinaria en Atención Primaria / Adequacy of requesting urine cultures and their impact on urinary tract infection treatment in primary care

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Diseño de un laboratorio de microbiología clínica / Designing a clinical microbiology laboratory

El laboratorio de microbiología debe ser un lugar seguro, eficiente y cómodo para los trabajadores y agradable para los visitantes; según la norma ISO 15189, debe disponer de un espacio suficiente, de forma que su carga de trabajo se pueda realizar sin comprometer la calidad ni la seguridad de todo el personal, trabajador o visitante. Además, debe optimizar la comodidad de sus ocupantes, respetar la privacidad del paciente, controlar el acceso a las distintas zonas del laboratorio y contar con un lugar de almacenamiento que permita asegurar la continua integridad de las muestras, manuales y reactivos. En el diseño de las instalaciones deben converger las necesidades de los especialistas, técnicos y demás personal que desarrolla su actividad laboral en este entorno, sin olvidar a los pacientes, sus acompañantes y demás visitas. Resumen El laboratorio de microbiología clínica tiene unas peculiaridades que lo hacen diferente a otros laboratorios diagnósticos. Su objetivo fundamental es el aislamiento y cultivo de microorganismos patógenos, actividad que genera un riesgo para el personal y que, de acuerdo con los agentes biológicos que se manejen, obliga a un determinado nivel de bioseguridad. Por otro lado, la correcta interpretación de los cultivos microbiológicos depende de la capacidad del laboratorio de evitar o minimizar la presencia de flora contaminante, y es fundamental el correcto tratamiento de las muestras y cultivos (condiciones asépticas, cabinas de bioseguridad) (..) (AU)

The microbiology laboratory should be a safe, efficient, and comfortable place for those working there, and a pleasant place for visitors. According to the ISO 15189 standard, it should be spacious enough for the workload to be carried out without jeopardizing quality or the safety of the persons present, whether workers or visitors, and provide optimal comfort to all occupants. In addition, the setup should respect the privacy of patients, and provide controlled access to the different laboratory areas and a safe place for storing clinical samples, manuals, and reagents. In the design of the facilities, the needs of specialists, technicians, and other personnel must converge, without forgetting patients, their relatives, and other visitors. The clinical microbiology laboratory has certain characteristics that make it different from other diagnostic laboratories. Its main activity involves isolation, propagation, and handling of pathogenic microorganisms that pose a risk to the laboratory personnel. To minimize this risk, the laboratory must meet a certain level of biosafety. Moreover, correct interpretation of microbiological cultures depends on the capacity of the laboratory to avoid or minimize the presence of contaminants; hence, proper handling of samples and cultures (aseptic conditions, biosafety cabinet) is mandatory. A number of documents and regulations, from very general to highly specific (biosafety), affect the design of the microbiology laboratory. The aim of this report is to establish the minimum requirements and recommendations for designing clinical microbiology laboratories, based on a review of current regulations. It is contemplated as an aid to microbiology specialists who are designing or planning to reform their laboratories (AU)