Sex differences in the effectiveness and tolerability of dolutegravir plus rilpivirine as a switch strategy in people living with HIV.

INTRODUCTION: Dolutegravir + rilpivirine (DTG + RPV) is an effective antiretroviral therapy regimen approved in clinical guidelines as a switch therapy for virologically suppressed people with HIV. Our study aimed to compare the effectiveness and tolerability of DTG + RPV in women and men in real-world clinical practice. METHODS: This was a retrospective analysis of treatment-experienced people with HIV from a large HIV unit who switched to DTG + RPV. We analysed treatment effectiveness, rates of adverse events and discontinuation, and metabolic changes after 48 weeks of treatment. HIV-RNA levels <50 copies/mL were analysed at 48 weeks using both intention-to treat analysis (where missing data were interpreted as failures) and per-protocol analysis (excluding those with missing data or changes due to reasons other than virological failure). Outcomes were compared between women and men based on sex at birth. RESULTS: A total of 307 patients were selected (71 women and 236 men). No transgender people were included. At baseline, women had lived with HIV infection and received antiretroviral therapy for longer than men (23.2 vs 17.4 years and 18.9 vs 14.2 years, respectively). In the intention-to-treat analysis, 74.6% (95% confidence interval [CI] 63.4-83.3%) of women and 83.5% (95% CI 78.2-87.7) of men had HIV-RNA <50 copies/mL. In the per-protocol analysis, 96.4% (95% CI 87.7-99) of women and 99% (95% CI 98.9-99.7) of men had HIV-RNA levels <50 copies/mL. Two women and two men had HIV-RNA >50 copies/mL at 48 weeks. Discontinuation due to adverse events was more frequent in women than in men: 12.7% vs 7.2% (p < 0.02). Neuropsychiatric and gastrointestinal events were the most frequently reported. A median (interquartile range) weight gain of 1.9 kg (0-4.2) in women and 1.2 kg (-1-3.1) in men was reported (median of differences between baseline visit and week 48); the remaining changes in metabolic parameters were neutral. CONCLUSIONS: DTG + RPV exhibited good and similar virological effectiveness in women and men in real-world settings. However, poorer tolerability and more treatment interruptions were observed in women.

Incidence of Diabetes Mellitus and Associated Factors in the Era of Antiretroviral Drugs With a Low Metabolic Toxicity Profile.

Objective: The incidence of type 2 diabetes mellitus (T2DM) has risen dramatically. Among people living with HIV (PLHIV), chronic disease (now >15 cases/1000 in the general population worldwide) and long-term exposure to antiretroviral therapy (ART) can alter metabolic processes early, favoring insulin resistance and T2DM. We retrospectively studied the incidence of T2DM and associated factors in the Cohort of the Spanish AIDS Research Network, a prospective cohort of PLHIV enrolled at diagnosis and before initiation of ART. Methods: PLHIV were aged >18 years and ART naive at inclusion. The incidence of new diagnoses of T2DM after initiation of ART (per 1000 person-years) was calculated. Predictors of a diagnosis of T2DM were identified by a Cox proportional hazards model adjusted for statistically significant and clinically relevant variables. Results: Cumulative incidence was 5.9 (95% CI, 5.1-6.7) per 1000 person-years, increasing significantly in persons aged >50 years to 14.4 (95% CI, 10.4-19.3). Median time to diagnosis of T2DM was 27 months. Only age and higher education were significant. Interestingly, higher education was associated with a 33% reduction in the incidence of T2DM. Having received tenofovir disoproxil fumarate + (lamivudine or emtricitabine) + rilpivirine was almost significant as a protective factor (hazard ratio, 0.49; 95% CI, .24-1.01; P = .05). Conclusions: The incidence of T2DM in PLHIV in Spain was high, especially in persons aged >50 years. Age was the factor most closely associated with onset, and educational level was the factor most associated with reduced risk. We highlight the lack of association between HIV-related factors and T2DM and show that, within nonnucleoside reverse transcriptase inhibitors, rilpivirine could prove more benign for metabolic comorbidities.

Eficacia en vida real del cambio a bictegravir/ emtricitabina/tenofovir alafenamida en pacientes previamente tratados con pautas triples que contienen rilpivirina / Real-world efficacy of switching to bictegravir/ emtricitabine/tenofovir alafenamide in pretreated patients with triple therapy containing rilpivirine

Objetivo. Analizar la eficacia y tolerabilidad de la estrategia de cambio desde regímenes basados en rilpivirina (RPV)a bictegravir/emtricitabina/tenofovir alafenamida (B/F/TAF) enla vida real.Métodos. Estudio unicéntrico, observacional y retrospectivo. Se seleccionaron pacientes que cambiaron de un régimencon RPV a B/F/TAF antes de febrero del 2020 analizándose losresultados después de 24 y 48 semanas. Se determinó el porcentaje que permanecía con carga viral indetectable, así comolos cambios en linfocitos CD4+, parámetros metabólicos y función renal.Resultados. Se incluyeron en el estudio 42 pacientes. 32de los 35 (91,4%) que completaron las 48 semanas de seguimiento tenían carga viral indetectable. El recuento de linfocitos CD4+ permaneció estable a las 24 y a las 48 semanas. Eltipo de análogos recibidos previamente no influyó en la respuestaConclusión. El cambio desde una triple terapia con RPV aB/F/TAF es una estrategia segura y eficaz en la vida real. (AU)

Objective. To analyze the efficacy and tolerability of thestrategy to change from rilpivirine (RPV) based regimens tobictegravir / emtricitabine / tenofovir alafenamide (B/F/TAF).Methods. Single-center, observational and retrospectivestudy. Patients who made the change to B/F/TAF before February 2020 were selected, analyzing the results after 24 and48 weeks. The percentage that remained with an undetectableviral load was determined, as well as the changes in CD4 +lymphocytes, metabolic parameters and renal function.Results. A total of 42 patients were included. Thirty-twoof the 35 patients (91.4%) who completed the 48 weeks offollow-up had an undetectable viral load. The CD4 + lymphocyte count remained stable at 24 and 48 weeks. The responseto B/F/TAF was not influenced by the two analogs previouslyreceived.Conclusion. Switching from triple therapy with RPV toB/F/TAF is a safe and effective strategy in real life. (AU)

Past and future of HIV infection. A document based on expert opinion / Pasado y futuro de la infección por VIH. Un documento basado en la opinión de expertos

HIV infection is now almost 40 years old. In this time, along with the catastrophe and tragedy that it has entailed, it has also represented the capacity of modern society to take on a challenge of this magnitude and to transform an almost uniformly lethal disease into a chronic illness, compatible with a practically normal personal and relationship life. This anniversary seemed an ideal moment to pause and reflect on the future of HIV infection, the challenges that remain to be addressed and the prospects for the immediate future. This reflection has to go beyond merely technical approaches, by specialized professionals, to also address social and ethical aspects. For this reason, the Health Sciences Foundation convened a group of experts in different aspects of this disease to discuss a series of questions that seemed pertinent to all those present. Each question was presented by one of the participants and discussed by the group. The document we offer is the result of this reflection. (AU)

La infección por VIH cumple ahora casi 40 años de existencia. En este tiempo, junto a la catástrofe y la tragedia que ha supuesto, ha representado también la capacidad de la sociedad moderna de asumir un reto de esta magnitud y de transformar, gracias al tratamiento antirretroviral, una enfermedad mayoritariamente letal en una enfermedad crónica, compatible con una vida personal y de relación prácticamente normales. Este aniversario parecía un momento idóneo para pararse a reflexionar sobre el futuro de la infección VIH, los retos que todavía quedan por abordar y las perspectivas para el inmediato futuro. Esa reflexión tiene que ir más allá de planteamientos meramente técnicos, de profesionales especializados, para abordar aspectos sociales y éticos. Por este motivo, la Fundación de Ciencias de la Salud convocó a un grupo de expertos en distintos aspectos de esta infección para discutir una serie de preguntas que parecieron pertinentes a todos los convocados. Cada pregunta era expuesta por uno de los participantes y discutida por el grupo. El documento que ofrecemos es el resultado de esa reflexión. (AU)

Infección por Helicobacter pylori en la población VIH+: una comorbilidad en la que pensar / Helicobacter pylori infection in the HIV + population: a comorbidity to think about

INTRODUCCIÓN: Las alteraciones gastrointestinales, son frecuentes en VIH+. Helicobacter pylori puede ser una causa infradiagnosticada. MATERIAL Y MÉTODOS: Se realizó una búsqueda retrospectiva de pacientes VIH+ con infección por H. pylori entre enero de 1998 hasta diciembre de 2017. RESULTADOS: Se incluyeron 132 pacientes. La dispepsia fue la sintomatología más frecuente. Un 88,5% tuvo gastritis crónica atrófica. Se consiguió la erradicación en 102 (77,3%). La curación fue más frecuente con pauta cuádruple (p = 0,004) y en los más jóvenes (p = 0,041). CONCLUSIÓN: La infección por H. pylori podría ser responsable de manifestaciones digestivas inespecíficas en los pacientes VIH+

INTRODUCTION: Gastrointestinal disorders are frequent in HIV+. Helicobacter pylori may be an underdiagnosed cause. MATERIAL AND METHODS: Patients with HIV and H. pylori were described since January 1998 up to December 2017. RESULTS: A total de 132 patients were included. The most frequent symptom was dyspepsia. 88.5% had chronic atrophic gastritis. Eradication was achieved in 102 (77.3%). Healing was more frequent with quadruple regimen (p = 0.004) and in the youngest (p = 0.041). CONCLUSION: H. pylori infection could be responsible for nonspecific digestive manifestations in HIV + patients

Abacavir/lamivudina + atazanavir no potenciado en la práctica clínica diaria: doce años de experiencia / Abacavir/lamivudine + unboosted atazanavir in routine clinical practice: Twelve years experience

Objetivo: Describir la eficacia en práctica clínica de abacavir, lamivudina y atazanavir sin potenciar (ABC/3TC+ATV) en pacientes pretratados. Pacientes y métodos: Se realizó un estudio observacional retrospectivo para describir las características clínicas y la evolución de los pacientes que, por prescripción facultativa, habían recibido tratamiento con ABC/3TC+ATV desde noviembre de 2004 hasta el 15 de junio de 2015. Resultados: Se incluyeron 236 pacientes. La mediana de edad (IQR) fue de 45años (42-50) y el 69% eran varones. Los principales motivos para su indicación fueron toxicidad en 130 pacientes (56%), simplificación en 60 (20%) y fracaso virológico (FV) en 29 (14%). El tratamiento previo contenía un inhibidor de la proteasa (IP) en 115 pacientes (48,7%), 3 inhibidores de la transcriptasa inversa análogos de nucleósido (ITIAN) en 56 (28%) y 2ITIAN y un inhibidor de la transcriptasa inversa no análogo de nucleósido (ITINAN) en 19 (8,1%). Tras una mediana de 2,2años (IQR0,8-5,3), 66 (28%) pacientes continuaban con la misma pauta, se retiró en 170 (72%), en 30 de ellos por FV (12,7%) y en 22 (9,3%) por pérdidas de seguimiento. Conclusión: En pacientes seleccionados, ABC/3TC+ATV es una alternativa de simplificación eficaz y bien tolerada, usada principalmente para minimizar la toxicidad (AU)

Objective: To describe the experience using the combination abacavir, lamivudine plus non-boosted atazanavir (ABC/3TC+ATV) in a group of pretreated patients. Patients and methods: We performed a retrospective observational study to describe baseline characteristics and the evolution of patients who had received or were treating with ABC/3TC+ATV, from November 2004 and June 15th 2015, in the clinical setting. Results: Overall, 236 patients were included in the study. Median age (IQR) was 45 (42-50) years and 69% were male. The main reasons for using this combination were previous toxicity in 130 patients (56%), simplification in 60 (20%) and virologic failure in 29 (14%). Previous treatment was based in boosted protease inhibitor in 115 patients (48.7%), 3 analogs in 56 (28%) and non-analogous based in 19 (8.1%). Median treatment length was 2.2 years (IQR0.8-5.3). A total of 66 (28%) patients continue receiving ABC/3TC+ATV (median time 5.7, IQR2.2-8.3), treatment was changed in 170 patients (72%) (median time 1.6 years, IQR0.7-3.6), and 22 (9.3%) patients were lost. Virological failure was assessed in 30 patients. Conclusion: In selected patients, ABC/3TC+ATV is a durable and attractive therapeutic alternative (AU)

Metabolismo glucídico en la hipertensión arterial: papel de la sobrecarga oral de la glucosa / Abnormal glycemic metabolism in essential hypertension. Role of the oral glucose tolerance test

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Hipersensibilidad al alopurinol: tratamiento desensibilizante / Hypersensitivity to alopurinol: desensitizing treatment

Introducción: La incidencia de episodios adversos relacionados con la administración de alopurinol es menor del 5 por ciento. Entre un 1 y un 2 por ciento de los enfermos tratados con alopurinol presenta un síndrome de hipersensibilidad que comporta una mortalidad próxima al 25 por ciento. Hemos recogido nuestra experiencia con la desensibilización oral al alopurinol en pacientes con intolerancia a este fármaco y que lo precisaban para normalizar la uricemia. Pacientes y métodos: Seis pacientes con gota primaria e insuficiencia renal moderada tuvieron que suspender la administración de alopurinol por erupción cutánea con características alérgicas. Los 6 pacientes aceptaron un programa de desensibilización oral con una dosis creciente de alopurinol (primer día, 50 µg; día 91, 300 mg). Resultados: Los 6 pacientes toleraron la administración de alopurinol oral tras el régimen de desensibilización, llegando a alcanzar una dosis de 300 mg/día. La uricemia se normalizó en todos y no presentaron nuevos episodios de artritis gotosa aguda. Tres enfermos, al recibir una dosis de 100-200 mg/día, experimentaron una nueva reacción cutánea que obligó a suspender el tratamiento. Tras iniciar una pauta de desensibilización más lenta los 3 enfermos toleraron dosis habituales de alopurinol (300 mg/día). Conclusiones: La desensibilización oral al alopurinol es un procedimiento eficaz y sencillo, indicado en pacientes con reacciones alérgicas a este fármaco y que requieren invariablemente su administración. (AU)