Genotypic tropism testing of proviral DNA to guide maraviroc initiation in aviraemic subjects: 48-week analysis of results from the PROTEST study.

OBJECTIVES: Maraviroc (MVC) is a suitable drug for aviraemic subjects on antiretroviral treatment (ART) developing toxicity. Its prescription requires prior tropism testing. It is unknown if proviral DNA genotypic tropism testing is reliable for guiding MVC initiation in aviraemic subjects, so this study was carried out to address this issue. METHODS: PROTEST was a phase 4, prospective, single-arm clinical trial carried out in 24 HIV care centres in Spain. MVC-naïve HIV-1-infected patients with HIV-1 RNA < 50 copies/mL on stable ART during the previous 6 months who required an ART change because of toxicity and who had R5 HIV, as determined by proviral DNA genotypic tropism testing, initiated MVC with two nucleoside reverse transcriptase inhibitors (NRTIs) and were followed for 48 weeks. Virological failure was defined as two consecutive viral load measurements > 50 copies/mL. RESULTS: Tropism results were available for 141 of 175 (80.6%) subjects screened: 60% had R5 and 85% of these (n = 74) were finally included in the study. Previous ART included protease inhibitors (PIs) in 62% of subjects, nonnucleoside reverse transcriptase inhibitors (NNRTIs) in 36%, and integrase inhibitors (INIs) in 2%. Main reasons for treatment change were dyslipidaemia (42%), gastrointestinal symptoms (22%) and liver toxicity (15%). MVC was given alongside tenofovir (TDF)/emtricitabine (FTC) (54%) and abacavir (ABC)/lamivudine (3TC) (40%) in most patients. Eighty-four per cent of patients maintained a viral load < 50 copies/mL to week 48, whereas 16% discontinued treatment: two withdrew informed consent, one had an R5 to X4 shift between screening and baseline, one was lost to follow-up, one developed an adverse event (rash), two died from non-study-related causes, and five developed protocol-defined virological failure. CONCLUSIONS: Initiation of MVC plus two NRTIs in aviraemic subjects based on genotypic tropism testing of proviral HIV-1 DNA is associated with low rates of virological failure for up to 1 year.

Características particulares en el medio penitenciario del envejecimiento de los internos infectados por el VIH / No disponible

La progresiva disminución de la mortalidad asociada a la infección por el VIH-1, y la consecuente cronificación de la enfermedad, está provocando un envejecimiento de la población infectada cuya repercusión en el medio penitenciario no es bien conocida. Existe una tendencia hacia el envejecimiento del conjunto de internos en centros penitenciarios españoles, y posiblemente esto también está ocurriendo entre los infectados por el VIH-1. Al analizar en un centro penitenciario la posible influencia del envejecimiento en la prevalencia de comorbilidades en pacientes infectados, se aprecia un significativo aumento de patologías médicas crónicas en los mayores de 50 años. Sería necesario confirmar estos datos en estudios más amplios para poder planificar en caso necesario estrategias de control de estas enfermedades concomitantes (AU)

No disponible

[Vascular risk factors in HIV-infected patients in a penitentiary center]. / Factores de riesgo vascular en pacientes infectados por el VIH en un centro penitenciario.

OBJECTIVE: There is little data regarding vascular risk factors (VRF) in HIV-infected inmates. In this study, we have studied the prevalence of VRF in HIV-infected patients, analyzing the differences with a non-infected population. PATIENTS AND METHOD: HIV-infected inmates (n=80) and two non-HIV controls selected for each patient and matched for age and sex (n=160) were included in a descriptive cross-sectional study. We analyzed the VRF, and risk was assessed according to the SCORE, Framingham and REGICOR functions. RESULTS: In the studied population (mean age: 38.1 years; 92.5% men), HIV-infected patients had a significantly higher prevalence of cigarette smoking (97.5 vs 78.8%), diabetes (8.8 vs 1.3%), serum triglyceride s>150 mg/dl (43.8 vs 26.3%), low HDL-cholesterol levels (61.3 vs 40.6%), HCV infection (87.5 vs 22.5%), and cocaine consumption (77.5 vs 39.4%). The non-infected group had significantly higher prevalence of total cholesterol>200mg/dl and/or LDL-cholesterol >130 mg/dl (45.6 vs 28.8%), obesity (14.4 vs 2.5%), sedentary lifestyle (67.5 vs 42.5%) and increased waist circumference (14.4 vs 3.8%). All the evaluated inmates were considered to be at a low risk by SCORE and REGICOR, and 1.3% to be at a high risk by Framingham in both groups. CONCLUSION: The prevalence of VRF in HIV-infected patients of the studied prison was much higher to that of the HIV-negative subjects. However, the estimation of the cardiovascular risk was low.

Factores de riesgo vascular en pacientes infectados por el VIH en un centro penitenciario / Vascular risk factors in HIV-infected patients in a penitentiary center

Objetivo. Los factores de riesgo vascular (FRV) en pacientes penitenciarios infectados por el VIH (VIH+) no se conocen en toda su extensión. Hemos estudiado la prevalencia de estos factores en pacientes VIH+, en comparación con una población no infectada (VIH–). Pacientes y método. Estudio descriptivo transversal en el que se incluyeron pacientes VIH+ (n=80) de un centro penitenciario. Por cada paciente se analizaron dos internos VIH−, emparejados por edad y sexo (n=160). Se analizaron los FRV, y se estimó el riesgo vascular según las funciones de SCORE, Framingham y REGICOR. Resultados. Los 80 pacientes seleccionados (92,5% varones) tenían una edad media de 38,1 años. Los enfermos VIH+ presentaron una prevalencia significativamente mayor de tabaquismo (97,5 frente al 78,8%), infección por el VHC (87,5 frente al 22,5%), consumo de cocaína (77,5 frente al 39,4%), niveles bajos de colesterol-HDL (61,3 frente al 40,6%), triglicéridos elevados (43,8 frente al 26,3%), y diabetes mellitus (8,8 frente al 1,3%) que los internos VIH−. Entre los VIH− hubo significativamente más pacientes con niveles de colesterol total >200 mg/dl y/o colesterol-LDL >130 mg/dl (45,6 vs. 28,8%), con obesidad (14,4 vs. 2,5%), sedentarismo (67,5 vs. 42,5%) y con un perímetro abdominal de riesgo (14,4 vs. 3,8%). Todos los internos tuvieron una estimación de riesgo bajo según las ecuaciones SCORE y REGICOR, tan solo un 1,3%, según la ecuación de Framingham, mostraron un riesgo elevado. Conclusiones. La prevalencia de los FRV en los pacientes VIH+ del centro penitenciario estudiado fue muy superior a la de los sujetos VIH−. Sin embargo, la estimación del riesgo vascular fue reducida(AU)

Objective. There is little data regarding vascular risk factors (VRF) in HIV-infected inmates. In this study, we have studied the prevalence of VRF in HIV-infected patients, analyzing the differences with a non-infected population. Patients and method. HIV-infected inmates (n=80) and two non-HIV controls selected for each patient and matched for age and sex (n=160) were included in a descriptive cross-sectional study. We analyzed the VRF, and risk was assessed according to the SCORE, Framingham and REGICOR functions. Results. In the studied population (mean age: 38.1 years; 92.5% men), HIV-infected patients had a significantly higher prevalence of cigarette smoking (97.5 vs 78.8%), diabetes (8.8 vs 1.3%), serum triglycerides>150mg/dl (43.8 vs 26.3%), low HDL-cholesterol levels (61.3 vs 40.6%), HCV infection (87.5 vs 22.5%), and cocaine consumption (77.5 vs 39.4%). The non-infected group had significantly higher prevalence of total cholesterol>200mg/dl and/or LDL-cholesterol >130mg/dl (45.6 vs 28.8%), obesity (14.4 vs 2.5%), sedentary lifestyle (67.5 vs 42.5%) and increased waist circumference (14.4 vs 3.8%). All the evaluated inmates were considered to be at a low risk by SCORE and REGICOR, and 1.3% to be at a high risk by Framingham in both groups. Conclusion. The prevalence of VRF in HIV-infected patients of the studied prison was much higher to that of the HIV-negative subjects. However, the estimation of the cardiovascular risk was low(AU)

[Autonomy and patient prisoners]. / Autonomía y pacientes reclusos.

The authors study a recent Spanish High Court decision declaring liability on the Administration's part for the death of an inmate in a prison hospital. We analyse the Court's decision using legal, ethical, medical and social perspectives. The conclusions are that: 1. the Administration has no legitimate right to force a prisoner to take medical treatment, except in circumstances in which there is a grave and definite risk to the patient's life, or when the patient lacks capacity or when there is the risk of harm to the health of third parties; 2. That in the case of health decision making that might affect a patient, the Court has mounted a frontal attack on the autonomy of patients in prison; 3. That from a medical point of view the decision is discriminatory since it does not apply the same standards of measurement to all chronic illnesses that might be found in the prison context; 4. That it is inapplicable in daily practice due to the fact that its strictness of application would seriously affect the already highly fragile ordered coexistence that exists in a prison.

Autonomía y pacientes reclusos / Autonomy and patient prisoners

Los autores estudian una reciente sentencia de la Sala 3ª del Tribunal Supremo en la que se declara la responsabilidad patrimonial de la Administración por la muerte de un paciente preso. Se analizan los argumentos de la Sala desde una perspectiva jurídica, ética, médica y social. Concluyen que: 1: la Administración no está legitimada para imponer tratamientos médicos a los reclusos, salvo que medie riesgo grave y cierto para su vida, incapacidad para decidir o riesgo para la salud de terceros; 2: que la sentencia supone un ataque frontal a la autonomía de los pacientes presos en la toma de decisiones sanitarias que les afecten; 3: que desde un punto de vista médico es discriminatoria, ya que no mide por el mismo rasero a todas las enfermedades crónicas que se pueden dar en prisión y 4: que resulta inasumible en la práctica diaria, porque su estricta aplicación alteraría considerablemente la ya de por sí frágil ordenada convivencia en un centro penitenciario

The authors study a recent Spanish High Court decision declaring liability on the Administration’s part for the death of an inmate in a prison hospital. We analyse the Court’s decision using legal, ethical, medical and social perspectives. The conclusions are that: 1. the Administration has no legitimate right to force a prisoner to take medical treatment, except in circumstances in which there is a grave and definite risk to the patient’s life, or when the patient lacks capacity or when there is the risk of harm to the health of third parties; 2. That in the case of health decision making that might affect a patient, the Court has mounted a frontal attack on the autonomy of patients in prison; 3. That from a medical point of view the decision is discriminatory since it does not apply the same standards of measurement to all chronic illnesses that might be found in the prison context; 4. That it is inapplicable in daily practice due to the fact that its strictness of application would seriously affect the already highly fragile ordered coexistence that exists in a prison

[Simplified scale for medication adherence related problems in anti-retroviral therapy]. / Escala simplificada para detectar problemas de adherencia (ESPA) al tratamiento antirretroviral.

OBJECTIVE: The purpose is to describe an own-developed scale for medication adherence evaluation of HIV patients under antiretroviral therapy, and to compare it with other previously described methods. METHODS: The six-item scale was compared with a pharmacy record about the delivery of medication. Accordance between scale and a four-item Morisky-type scale (measure 1) and a percentage of doses taken as prescribed during the past two weeks (measure 2) was computed. RESULTS: The own-scale showed 93% sensitivity, 70% specificity, a likelihood ratio of 3.08 and good agreement compared with the pharmacy record (k = 0.62, p < 0.001). Agreement between the scale and measure 1 and measure 2 was very weak (k = 0.12, p = 0.446 and k = 0.10, p = 0.273 respectively). 39.7% of patients was considered as adherent according with the own-scale and was observed correlation between adherence and clinical outcomes. CONCLUSION: The scale appears to be a valid instrument to check and detect adherence related problems compared with the pharmacy medication record. Easiness to use make feasible to consider as an adequate tool to detect non-adherent patients or patients with adherence related problems into the daily clinical practice.

Escala simplificada para detectar problemas de adherencia (ESPA) al tratamiento antirretroviral / No disponible

Objetivo: Se describe una escala simplificada para detectarproblemas de adherencia (ESPA) al tratamiento antirretroviral enpacientes VIH+ y se compara con otros métodos empleados habitualmenteen la práctica clínica.Método: La escala consta de seis preguntas cuya respuesta puedeser afirmativa o negativa y, dependiendo del valor obtenido, se identificaun potencial problema de adherencia. Se comparó la ESPA conregistros de dispensación y se determinó la concordancia con unamedida de tipo Morisky (medida 1) y con el porcentaje de dosis tomadasadecuadamente en las últimas dos semanas (medida 2).Resultados: Comparada con los registros de dispensación, laESPA mostró elevada sensibilidad (93%), especificidad (70%), unarazón de verosimilitud positiva de 3,08 y buena concordancia(k = 0,62, p < 0,001). La concordancia entre la escala y las medidas1 y 2 fue muy débil (k = 0,12, p = 0,446 y k = 0,10, p = 0,273,respectivamente). El 39,7% de los pacientes se consideró comoadherentes de acuerdo a la ESPA, y se observó una buena relaciónentre adherencia y las variables clínicas.Conclusiones: La ESPA parece un instrumento válido paradetectar problemas de adherencia con respecto a los registros dedispensación. Por su comodidad, es posible considerarla comouna herramienta adecuada para detectar pacientes no adherentesen la práctica clínica

Objective: The purpose is to describe an own-developed scalefor medication adherence evaluation of HIV patients under antiretroviraltherapy, and to compare it with other previouslydescribed methods.Methods: The six-item scale was compared with a pharmacyrecord about the delivery of medication. Accordance betweenscale and a four-item Morisky-type scale (measure 1) and a percentageof doses taken as prescribed during the past two weeks(measure 2) was computed.Results: The own-scale showed 93% sensitivity, 70% specificity,a likelyhood ratio of 3.08 and good agreement comparedwith the pharmacy record (k = 0.62, p < 0.001). Agreementbetween the scale and measure 1 and measure 2 was veryweak (k = 0.12, p = 0.446 and k = 0.10, p = 0.273 respectively).A 39.7% of patients was considered as adherent accordingwith the own-scale and was observed correlation between adherenceand clinical outcomes.Conclusion: The scale appears to be a valid instrument tocheck and detect adherence related problems compared with thepharmacy medication record. Easyness to use make feasible toconsider as an adequate tool to detect non-adherent patients orpatients with adherence related problems into the daily clinicalpractice

La ecografía en la patología del tubo digestivo en los pacientes pediátricos

La ecografía representa una exploración en tiempo real, accesible, barata, no ionizante y que en manos experimentadas posee una gran utilidad en los procesos patológicos más frecuentes que afectan al tubo digestivo en pacientes en edades pediátricas. Constituye, dada su inocuidad, una exploración de primera línea a realizar dentro de la batería diagnóstica que poseemos los radiólogos para el despistaje de la patología digestiva (AU)