Characteristics and rates of infection by HIV in people receiving non-occupational post-exposure prophylaxis (nPEP) against HIV.

INTRODUCTION/OBJECTIVES: The use of non-occupational post-exposure prophylaxis (nPEP) emerges as a strategic intervention to reduce HIV infection risk following sexual encounters in our setting. Notwithstanding, there is a scarcity of contemporary data regarding adherence to this treatment, its effectiveness and tolerance. Our study aims to delve into these factors among individuals who have resorted to nPEP after high-risk sexual encounters. METHODS: We conducted a retrospective observational study of cases administered nPEP for HIV from 1 January 2018 to 31 December 2021 at a tertiary hospital in Madrid. The study included all adults over 18 years who sought care at the emergency department of the Fundación Jiménez Díaz Hospital following a risky sexual encounter and were subsequently recommended HIV nPEP treatment. RESULTS: 878 individuals received nPEP for HIV and underwent initial serological tests. Of these, 621 had comprehensive follow-ups. The prescribed regimen for all was raltegravir (RAL) 1200 mg combined with tenofovir/emtricitabine (TDF/FTC) 245/200 mg daily for 28 days. The study revealed a 1.1% rate (n=10) of previously undetected infection and a 0.16% (n=1) failure rate of nPEP. Regarding regimen tolerability, 5.6% (n=35) experienced symptoms linked to the treatment, yet none necessitated discontinuation of the regimen. On the contrary, six per cent (n=53) reported symptoms consistent with an STI during one of the medical visits; specifically, 4.4% had urethritis, and 1.6% had proctitis. CONCLUSION: nPEP with RAL/TDF/FTC demonstrates high efficacy and safety, contingent on proper adherence. There is an observed increase in STI prevalence in this cohort, with nearly half of the participants not engaging in appropriate follow-up after initiating nPEP.

48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort.

BACKGROUND: The main international guidelines indicate DTG/3TC therapy as one of the preferred regimens for people living with HIV (PLWH), due to its observed efficacy in randomized clinical trials. However, information in real-life cohorts is relatively scarce for first-line use. METHODS: A retrospective multicenter study of adult PLWH starting DTG+3TC as a first-line regimen before January 31st, 2020. Virological failure (VF) was defined as 2 consecutive HIV RNA viral load (VL) >50 copies/mL. RESULTS: 135 participants were included. Treatment was started without knowing baseline drug resistance testing (bDRT) results in 71.9% of cases, with baseline resistance mutations being later confirmed in 17 patients (12.6%), two of them with presence of M184V mutation. Effectiveness at week 48 was 85.2% (CI95%: 78.1-90.7%) (ITT missing = failure [M = F]) and 96.6% (CI 95%: 91.6-99.1%) (per-protocol analysis). Six patients (4.4%) discontinued treatment. One developed not confirmed VF after discontinuing treatment due to poor adherence; no resistance-associated mutations emerged. Three discontinued treatments due to central nervous system side effects (2.2%), and two due to a medical decision after determining the M184V mutation in bDRT. Finally, 14 (10.4%) were lost to follow-up, most of them due to the COVID-19 pandemic. CONCLUSIONS: In a real-life multicenter cohort of ART-naïve PLWH, treatment initiation with DTG + 3TC showed high effectiveness and favorable safety results, comparable to those of randomized clinical trials, without treatment-emergent resistance being observed through week 48. Starting treatment before receiving the results of baseline drug resistance testing did not have an impact on the regimen's effectiveness.

Initiation of antiretroviral therapy in treatment-naive adults with HIV infection at the first specialist appointment.

BACKGROUND: Fast initiation of ART has been associated with higher rates of retention in HIV care and viral suppression at 48 weeks and with lower mortality rates. However, scarce evidence exists in our setting, where diagnosis and treatment are carried out in different contexts. METHODS: An observational retrospective study evaluating efficacy and safety of ART prescribed at the first specialist appointment, without baseline laboratory data, in a tertiary hospital in downtown Madrid. Individuals with a new diagnosis of HIV infection who initiated treatment at their first appointment with an infectious diseases specialist before receiving baseline laboratory results were included, irrespective of the ART regimen chosen. RESULTS: One hundred and eight participants were included. The majority (99.1%) were MSM who had acquired infection during sexual intercourse. The efficacy of ART, without baseline laboratory results at the time of initiation, was 85.2% (92/108) in the ITT analysis and 91.7% (99/108) in the treatment-related discontinuation equals failure analysis. All but nine patients presented an undetectable viral load (<50 copies/mL) at 48 weeks from starting ART. No serious adverse effects associated with the strategy were observed. In total, 101 participants continued care at 48 weeks with retention in HIV care rate of 93.5% (101/108). CONCLUSIONS: Initiating ART at the first available opportunity without baseline laboratory data does not reduce efficacy or safety of ART and achieves rapid virological control with high rates of retention in HIV care.

COVID-19 in people living with HIV: A multicenter case-series study.

OBJECTIVES: Information on how COVID-19 affects people living with HIV (PLHIV) remains scarce. METHODS: An observational study was conducted in four public hospitals in Madrid. All HIV patients with confirmed or suspected COVID-19 were included and compared with COVID-19 patients without HIV infection. RESULTS: Sixty-three patients with HIV infection and confirmed or suspected COVID-19 were analyzed. The median age was 46 years (IQR: 37-56 years), and 88.9% were men. The median duration of HIV infection was 10.8 years (IQR: 6.5-16.8 years), and 96.8% were on antiretroviral therapy. 84.1% had previous comorbidities. The most common symptoms were fever (66.1%), cough (66.1%) and dyspnea (46.8%). Pneumonia was found in 47.5%, 28.6% of patients had severe disease, and 32.3% were admitted to hospital. The ICU admission rate and the mortality rate were both 3.17%. A significant association was observed between age, arterial hypertension, overweight, and diabetes mellitus and the severity of COVID-19. No association was observed between HIV-related factors and the severity of COVID-19. The rate of COVID-19 in HIV-patients was 1.68%. Similar hospitalization (31.74% vs 32.57%) and ICU admission (3.17% vs 2%) rates were observed with non-HIV infected patients. A lower mortality rate during hospitalization (10% vs 21.37%) and a lower global mortality rate (3.17% vs 6.96%) were also observed. CONCLUSIONS: Established poor prognostic factors for COVID-19 patients, such as age and comorbidities, remain the main determinants for PLHIV. Neither the HIV severity nor the type of ARV treatment seem to influence the outcome of COVID-19. Large prospective cohorts are needed in order to establish the differences between HIV-positive and HIV-negative patients.

Use of closed systems in the Hospital Pharmacy / Uso de los sistemas cerrados en el Servicio de Farmacia

Objective: In the setting of the increasing use of closed systems for reconstitution and preparation of these drugs, we intend to analyze the correct use of these systems in the Hospital Pharmacy, with the objective to minimize the risks of exposure not only for those professionals directly involved, but also for all the staff in the unit, taking also into account efficiency criteria. Method: Since some systems protect against aerosol formation but not from vapours, we decided to review which cytostatics should be prepared using an awl with an air inlet valve, in order to implement a new working procedure. We reviewed the formulations available in our hospital, with the following criteria: method of administration, excipients, and potential hazard for the staff handling them. We measured the diameters of the vials. We selected drugs with Level 1 Risk and also those including alcohol-based excipients, which could generate vapours. Outcomes: Out of the 66 reviewed formulations, we concluded that 11 drugs should be reconstituted with this type of awl: busulfan, cabazitaxel, carmustine, cyclophosphamide, eribulin, etoposide, fotemustine, melphalan, paclitaxel, temsirolimus and thiotepa; these represented an 18% of the total volume of formulations. Conclusions: The selection of healthcare products must be done at the Hospital Pharmacy, because the use of a system with an air valve inlet only for those drugs selected led to an outcome of savings and a more efficient use of materials. In our experience, we confirmed that the use of the needle could only be avoided when the awl could adapt to the different formulations of cytostatics, and this is only possible when different types of awls are available. Besides, connections were only really closed when a single awl was used for each vial. The change in working methodology when handling these drugs, as a result of this study, will allow us to start different studies about environmental contamination as a future line of work (AU)

Objetivo: En el contexto del auge de los sistemas cerrados para la reconstitución y preparación de estos fármacos, se propone analizar el uso correcto de estos sistemas en el servicio de farmacia, con el objetivo de minimizar los riesgos de exposición no solo de los trabajadores expuestos, sino de todos los trabajadores del servicio, atendiendo también a criterios de eficiencia. Método: Puesto que algunos sistemas protegen frente a la formación de aerosoles pero no frente a vapores, decidimos revisar qué citostáticos debían prepararse con un punzón que constase de una válvula de admisión de aire para implementar un nuevo procedimiento de trabajo. Se revisaron las presentaciones disponibles en nuestro hospital atendiendo a: vía de administración, excipientes y riesgo para el personal manipulador, y se midieron los diámetros de los viales. Se seleccionaron tanto los fármacos de riesgo 1 como aquellos cuyos excipientes incluyesen vehículos alcohólicos, susceptibles de formar vapores. Resultados: De las 66 presentaciones revisadas, un total de 11 fármacos debían reconstituirse con este tipo de punzón: busulfán, cabazitaxel, carmustina, ciclofosfamida, eribulina, etopósido, fotemustina, melfalán, paclitaxel, temsirolimús y tiotepa; representando un 18% respecto al volumen total de presentaciones. Conclusiones: La selección de los productos sanitarios debe realizarse desde los servicios de farmacia, ya que la utilización de un sistema con válvula de admisión de aire para tan solo los fármacos seleccionados supuso un ahorro y un empleo más eficiente del material. Desde nuestra experiencia comprobamos que el uso de la aguja solo podía relegarse si el punzón se adaptaba a las diferentes presentaciones de citostáticos, y esto solo se consigue disponiendo de varios tipos de punzones. Además, las conexiones solo estaban realmente cerradas si se utilizaba un punzón por cada vial. Con el cambio en la metodología de trabajo a la hora de manipular estos fármacos, producida como resultado de este estudio, se pretenden realizar estudios de contaminación ambiental en una línea de trabajo futuro (AU)

Use of closed systems in the Hospital Pharmacy.

OBJECTIVE: In the setting of the increasing use of closed systems for reconstitution and preparation of these drugs, we intend to analyze the correct use of these systems in the Hospital Pharmacy, with the objective to minimize the risks of exposure not only for those professionals directly involved, but also for all the staff in the unit, taking also into account efficiency criteria. METHOD: Since some systems protect against aerosol formation but not from vapours, we decided to review which cytostatics should be prepared using an awl with an air inlet valve, in order to implement a new working procedure. We reviewed the formulations available in our hospital, with the following criteria: method of administration, excipients, and potential hazard for the staff handling them. We measured the diameters of the vials. We selected drugs with Level 1 Risk and also those including alcohol-based excipients, which could generate vapours. OUTCOMES: Out of the 66 reviewed formulations, we concluded that 11 drugs should be reconstituted with this type of awl: busulfan, cabazitaxel, carmustine, cyclophosphamide, eribulin, etoposide, fotemustine, melphalan, paclitaxel, temsirolimus and thiotepa; these represented an 18% of the total volume of formulations. CONCLUSIONS: The selection of healthcare products must be done at the Hospital Pharmacy, because the use of a system with an air valve inlet only for those drugs selected led to an outcome of savings and a more efficient use of materials. In our experience, we confirmed that the use of the needle could only be avoided when the awl could adapt to the different formulations of cytostatics, and this is only possible when different types of awls are available. Besides, connections were only really closed when a single awl was used for each vial. The change in working methodology when handling these drugs, as a result of this study, will allow us to start different studies about environmental contamination as a future line of work.

Objetivo: En el contexto del auge de los sistemas cerrados para la reconstitución y preparación de estos fármacos, se propone analizar el uso correcto de estos sistemas en el servicio de farmacia, con el objetivo de minimizar los riesgos de exposición no solo de los trabajadores expuestos, sino de todos los trabajadores del servicio, atendiendo también a criterios de eficiencia. Método: Puesto que algunos sistemas protegen frente a la formación de aerosoles pero no frente a vapores, decidimos revisar qué citostáticos debían prepararse con un punzón que constase de una válvula de admisión de aire para implementar un nuevo procedimiento de trabajo. Se revisaron las presentaciones disponibles en nuestro hospital atendiendo a: vía de administración, excipientes y riesgo para el personal manipulador, y se midieron los diámetros de los viales. Se seleccionaron tanto los fármacos de riesgo 1 como aquellos cuyos excipientes incluyesen vehículos alcohólicos, susceptibles de formar vapores. Resultados: De las 66 presentaciones revisadas, un total de 11 fármacos debían reconstituirse con este tipo de punzón: busulfán, cabazitaxel, carmustina, ciclofosfamida, eribulina, etopósido, fotemustina, melfalán, paclitaxel, temsirolimús y tiotepa; representando un 18% respecto al volumen total de presentaciones. Conclusiones: La selección de los productos sanitarios debe realizarse desde los servicios de farmacia, ya que la utilización de un sistema con válvula de admisión de aire para tan solo los fármacos seleccionados supuso un ahorro y un empleo más eficiente del material. Desde nuestra experiencia comprobamos que el uso de la aguja solo podía relegarse si el punzón se adaptaba a las diferentes presentaciones de citostáticos, y esto solo se consigue disponiendo de varios tipos de punzones. Además, las conexiones solo estaban realmente cerradas si se utilizaba un punzón por cada vial. Con el cambio en la metodología de trabajo a la hora de manipular estos fármacos, producida como resultado de este estudio, se pretenden realizar estudios de contaminación ambiental en una línea de trabajo futuro.

Filgrastim therapy in a child with neutropenia induced by linezolid.

We describe the case of a young child with multidrug-resistant tuberculosis, treated with linezolid. The child developed severe neutropenia after 5 months of treatment. Filgrastim was used, a drug that officially is not indicated for non-cytostatic drug-induced neutropenia. This allowed the fast recovery of the patient's neutrophil-count. However, more experience with the off-label use of filgrastrim is needed in the pediatric population.