RESUMO
OBJECTIVE: Multiple strategies have been utilised to reduce the incidence of HIV, including PrEP and rapid antiretroviral therapy initiation. The study objectives were to evaluate the efficacy, safety, satisfaction, treatment adherence, and system retention obtained with rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in naïve patients. METHODS: This phase IV, multicenter, open-label, single-arm, 48-week clinical trial enrolled patients between January 2020 and June 2022. Adherence to treatment was evaluated with the SMAQ questionnaire and patient satisfaction with the EQ-5D. RESULTS: Two hundred eight participants were enrolled with mean age of 35.6 years; 87.6% were males; mean CD4 count was 393.5 cells/uL (<200 cells/uL in 22.1%); viral load log was 5.6 (VL>100 000 cop/mL in 43.3%); 22.6% had AIDS, and 4.3% were coinfected with HBV. BIC/FTC/TAF was initiated on the day of their first visit to the HIV specialist in 98.6% of participants, and 9.6% were lost to follow-up. The efficacy at week 48 was 84.1 % by intention-to- treat (ITT), 94.6% by modified ITT, and 98.3% by per protocol analysis. The regimen was discontinued in two subjects (0.9%) during week 1 for grade 3 adverse events. Treatment adherence (weeks 4 [90%, IQR: 80-99%] vs. 48 [90%, IQR: 80-95%; P = 0.49]) and patient satisfaction (weeks 4 [90%, IQR: 80-99%] vs. 48 [90%, IQR: 80-95 P = 0.49]) rates were very high over the 48- week study period. CONCLUSIONS: BIC/FTC/TAF is an appropriate option for rapid ART initiation in naïve HIV patients, offering high efficacy, safety, durability, treatment adherence, retention in the healthcare system, and patient satisfaction. Number Clinical Trial registration: NCT06177574.
Assuntos
Alanina , Fármacos Anti-HIV , Emtricitabina , Infecções por HIV , Compostos Heterocíclicos de 4 ou mais Anéis , Piperazinas , Piridonas , Tenofovir , Humanos , Masculino , Feminino , Adulto , Infecções por HIV/tratamento farmacológico , Tenofovir/uso terapêutico , Tenofovir/análogos & derivados , Emtricitabina/uso terapêutico , Fármacos Anti-HIV/uso terapêutico , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Piridonas/uso terapêutico , Alanina/uso terapêutico , Alanina/análogos & derivados , Piperazinas/uso terapêutico , Combinação de Medicamentos , Carga Viral/efeitos dos fármacos , Pessoa de Meia-Idade , Adenina/análogos & derivados , Adenina/uso terapêutico , Adesão à Medicação , Amidas/uso terapêutico , Compostos Heterocíclicos com 3 Anéis/uso terapêutico , Satisfação do Paciente , Contagem de Linfócito CD4 , Resultado do Tratamento , Adulto JovemRESUMO
Introduction. Nebulized devices are commonly used in the treatment of respiratory infection, and other respiratory diseases. It has been reported nosocomial infections in cystic fibrosis patients as a result of the use of contaminated devices. However, little is known about nosocomial infections secondary to aerosolized therapy in COPD patients admitted for acute exacerbation. Methods. Thirty consecutive patients (13 males) were included. All of them received aerosolized medication. Each patient used their own facemask and nebulizer cup, which were stored in the room after its use. Samples from nebulizer cups were obtained on days 0, 4 and 7. In addition, sputum samples were obtained on day 0 (prior to any nebulization) and on day 7, and cultivated in enriched media. Results. Only nine nebulizer cups had positive microbiological cultures. Coagulase negative staphylococci (CoNS) were isolated in all cases. Sputum samples could be obtained in 27 patients. None grew CoNS after 7 days of aerosolized therapy. Gram-negative non-fermenting bacilli were isolated in three patients without concomitant grown in nebulizer cups. Conclusions. We did not find any nosocomial infection related to aerosolize medications in COPD patients admitted for acute exacerbation (AU)
Introducción. Los dispositivos para nebulizaciones se emplean frecuentemente en el tratamiento de las infecciones, y otras patologías respiratorias. Existen comunicaciones sobre infecciones nosocomiales en pacientes con fibrosis quística como resultado de la utilización de dispositivos contaminados. Sin embargo, poco se sabe acerca de las infecciones nosocomiales secundarias a la terapia en aerosol en pacientes con EPOC ingresados por exacerbación aguda. Métodos. Treinta pacientes consecutivos (13 varones) fueron incluidos. Todos ellos recibieron la medicación en forma de aerosol. Cada paciente utilizó su propia máscara y cazoletas de nebulización, que se dejaron en la habitación después de su uso. Las muestras de las cazoletas de nebulización se obtuvieron en los días 0, 4 y 7. Además, se obtuvieron muestras de esputo en el día 0 (antes de cualquier nebulización) y en el día 7, cultivándose en medio enriquecido. Resultados. Sólo nueve cazoletas de nebulización tuvieron algún cultivo positivo, siendo estafilococos coagulasa negativos (ECN) en todos los casos. Se obtuvieron muestras de esputo en 27 pacientes. En ningún caso se obtuvo crecimiento de ECN tras 7 días de tratamiento con aerosolterapia. Finalmente en tres pacientes se obtuvo crecimiento de un bacilo gramnegativo no fermentador en el esputo sin crecimiento en las muestras de las cazoletas de nebulización. Conclusiones. En nuestro estudio no se demostró ninguna infección nosocomial relacionada con el empleo de aerosolterapia en los pacientes con EPOC ingresados por exacerbación aguda (AU)
Assuntos
Humanos , Administração por Inalação , Infecção Hospitalar/epidemiologia , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/complicações , Fatores de RiscoRESUMO
INTRODUCCIÓN Y OBJETIVO: Las secuencias de proteasa y transcriptasa reversa del VIH-1 aportan una información muy valiosa para el manejo de la infección por VIH, más allá de la información de resistencias a los antirretrovirales. En nuestro estudio la hemos utilizado para evaluar las cadenas de transmisión, la transmisión de resistencias entre ellos, y para conocer la distribución espacial de los diferentes subtipos utilizando técnicas de georreferenciación. MÉTODOS: Hemos estudiado 693 pacientes diagnosticados de VIH-1 durante el periodo 2005-2012, todos ellos residentes en Andalucía Oriental. La secuencia del gen pol (transcriptasa reversa y proteasa) se generó utilizando Trugene® HIV Genotyping Kit (Siemens, NAD). La historia evolutiva fue inferida a través de MEGA 5.2 mediante el método de Neighbor-Joining. Para la filogeografía y el estudio de resistencias utilizamos ArcGIS y REGA. RESULTADOS: Doscientos noventa y ocho pacientes se asociaron en 77 clusters diferentes. La mayoría de los cluster estaban formados por parejas (n = 49), de hombres que practican sexo con hombres (n = 26), de nacionalidad española (n = 37), con una edad menor a 45 años (73,5%). Las áreas de mayor heterogeneidad de subtipos fueron el área metropolitana de Granada y las zonas de costa de Almería y Granada. Hemos encontrado 5 cluster con más de 10 individuos. En 15 cluster detectamos mutaciones de resistencia. CONCLUSIONES: Presentamos datos que demuestran que el estudio epidemiológico de los diferentes clusters de transmisión de VIH mediante análisis filogenético se presenta como una herramienta potente y de gran utilidad para la vigilancia y control epidemiológico de la propagación del VIH, que puede ayudar a diseñar actuaciones eficaces para prevenir la diseminación del VIH
INTRODUCTION AND OBJECTIVE: Protease and reverse transcriptase HIV-1 sequences provide useful information for patient clinical management, as well as information on resistance to antiretrovirals. The aim of this study is to evaluate transmission events, transmitted drug resistance, and to georeference subtypes among newly diagnosed patients referred to our center. METHODS: A study was conducted on 693 patients diagnosed between 2005 and 2012 in Southern Spain. Protease and reverse transcriptase sequences were obtained for resistance to cART analysis with Trugene® HIV Genotyping Kit (Siemens, NAD). MEGA 5.2, Neighbor-Joining, ArcGIS and REGA were used for subsequent analysis. RESULTS: The results showed 298 patients clustered into 77 different transmission events. Most of the clusters were formed by pairs (n = 49), of men having sex with men (n = 26), Spanish (n = 37), and below 45 years of age (73.5%). Urban areas from Granada, and the coastal areas of Almeria and Granada showed the greatest subtype heterogeneity. Five clusters were formed by more than 10 patients, and 15 clusters had transmitted drug resistance. CONCLUSIONS: The study data demonstrate how the phylogenetic characterization of transmission clusters is a powerful tool to monitor the spread of HIV, and may contribute to design correct preventive measures to minimize it