Assessment of different post-exposure prophylaxis regimens for prevention of HIV infection in exposed individuals

[eng] • PEP completion rates for sexual assault victims will be lower compared to other individuals for whom PEP is prescribed. • TDF/FTC+EVG/c, as a once-daily single tablet regimen, will be a more feasible, and safe option for PEP in terms of improving adherence and completion rates compared to LPV/r prophylaxis regimens. • When administered as prophylaxis, EVG/c and LPV/r will achieve sufficient concentrations in the rectal mucosa to prevent HIV infection in seronegative individuals. • TDF/FTC+EVG/c, as a once-daily single tablet regimen, will have a higher completion rate for post-exposure prophylaxis compared to other prophylaxis regimens such as LPV/r, MCV, DRV/c, and RAL. • DOR/3TC/TDF will be a safe and tolerable single tablet regimen for post-exposure prophylaxis allowing for a higher rate of PEP completion than other reference PEP regimens. GENERAL OBJECTIVE: To comprehensively study the characteristics, safety, tolerability, efficacy, completion, and retention of care while identifying potential factors influencing these outcomes of different PEP regimens among diverse groups receiving PEP. PRIMARY OBJETIVES: 1. To determine the characteristics of PEP users in Barcelona and to analyze the frequency of other STIs and risk factors that render them eligible for PEP treatment. 2. To assess the pharmacokinetics, pharmacodynamics, and immune homeostasis of different PEP treatment regimens to prevent ex-vivo infection. 3. To calculate the rates of non-completion of PEP regimens among different risk groups. 4. To identify the factors linked to non-completion of PEP regimens among diverse risk groups. 5. Analyze the adverse event, adherence, follow-up rates of different post-exposure prophylaxis regimens.[spa] La profilaxis post-exposición (PEP) es una medida para prevenir el VIH utilizada en el contexto posterior a una potencial exposición al mismo. No existen estudios en humanos que puedan valorar su eficacia, por lo que los datos se han extrapolado de modelos animales en donde se consiguió experimentalmente evitar la infección. A partir de los datos de estos estudios, se concluyen dos supuestos para que la PEP sea efectiva: 1. La PEP se debe iniciar en un período inferior a las 72 horas desde el inicio de la exposición. 2. La PEP se debe mantener por un período de 28 días. A finales de 1980 obtienen los primeros resultados en un estudio de casos y controles en humanos en donde se vio una reducción significativa de la infección del 88%. Posteriormente se realizaron muchos estudios descriptivos y observacionales con una calidad de evidencia baja, y escasos ensayos clínicos que vienen a valorar la tolerabilidad de los distintos regímenes de PPE mas no su eficacia por las limitaciones éticas y metodológicas de los mismos, por lo que los datos clínicos son incompletos, heterogéneos y de calidad científico metodológica baja. A su vez y de igual importancia son las consideraciones farmacocinéticas y farmacodinámicas del uso de la PEP, como se ha demostrado en los estudios de PrEP en hombres y mujeres donde los resultados han sido muy discordantes y que además de atribuirse a la mala adherencia, el comportamiento farmacocinético y farmacodinámico (Pk/PD) de los mismos varían según el tipo de tejido y fármaco. Existen pocos estudios que valoren los PK/PD para las distintas pautas de PEP en los distintos compartimentos

Impact of Sexualized Substance Use and Other Risk Practices on HCV Microelimination in gbMSM Living with HIV: Urgent Need for Targeted Strategies

In the original publication of the article, the article funding note was incorrectly published, the correct one should read as: This study has been funded by Instituto de Salud Carlos III through the project ‘‘PI18/00583’’ and co-funded by European Regional Development Fund ‘‘A way to make Europe’’. This has been corrected in this paper. © The Author(s) 2022

Do ART and chemsex drugs get along? Potential drug-drug Interactions in a cohort of people living with HIV who engaged in chemsex: a retrospective observational study.

Introduction: People living with HIV (PLWH) who engaged in chemsex are at risk of potential drug-drug interactions (pDDIs) with recreational drugs. This study aimed to characterize pDDIs between antiretroviral treatment (ART) and chemsex drugs and evaluate their association with unscheduled relevant hospital consultations. Methods: We conducted a single-center, retrospective, observational study in a series of gay, bisexual, and other men who have sex with men (gbMSM) living with HIV who engaged in chemsex and who attended a tertiary hospital in Barcelona, Spain, from February 2018 through August 2019. Associations between all recorded pDDIs and relevant unscheduled consultations were estimated using the incidence rate (IR) per 100 person-years of those events compared between patients with no pDDI (green flag) or moderate severity pDDI (orange flag) with patients with high severity pDDI (red flag) using the incidence rate ratio (IRR). Results: Among 172 PLWH engaged in chemsex, 249 ART regimens were prescribed: 44% based on integrase inhibitors, 30% on boosted ART, and 26% based on non-nucleoside reverse transcriptase inhibitors. The substances and recreational drugs most frequently used were erectile dysfunction agents (83%), methamphetamine (79%), GHB (77%), and alkyl nitrites (71%). Polydrug use was reported in 52%. We observed 2048 pDDIs. Of these, 23% were orange flag pDDIs; 88% related to boosted ARTs. The IR of the 285 unscheduled relevant episodes in patients with orange flag pDDIs was 64.67 (95% CI 40.07-89.28). The IRR of green flag pDDIs was 1.05 (95% CI 0.60-1.8; p = 0.876). Conclusion: One in four pDDIs were of moderate severity but no significant increase in the incidence of unscheduled relevant consultations was observed. A high number of unscheduled consultations, predominantly for psychiatric events and intoxication, were observed. Beyond using non-boosted ART to minimize pDDIs, other factors related to the practice of chemsex must be addressed, in order to offer a better approach

Assessment of different post-exposure prophylaxis regimens for prevention of HIV infection in exposed individuals

Programa de Doctorat en Medicina i Recerca Translacional[eng] • PEP completion rates for sexual assault victims will be lower compared to other individuals for whom PEP is prescribed. • TDF/FTC+EVG/c, as a once-daily single tablet regimen, will be a more feasible, and safe option for PEP in terms of improving adherence and completion rates compared to LPV/r prophylaxis regimens. • When administered as prophylaxis, EVG/c and LPV/r will achieve sufficient concentrations in the rectal mucosa to prevent HIV infection in seronegative individuals. • TDF/FTC+EVG/c, as a once-daily single tablet regimen, will have a higher completion rate for post-exposure prophylaxis compared to other prophylaxis regimens such as LPV/r, MCV, DRV/c, and RAL. • DOR/3TC/TDF will be a safe and tolerable single tablet regimen for post-exposure prophylaxis allowing for a higher rate of PEP completion than other reference PEP regimens. GENERAL OBJECTIVE: To comprehensively study the characteristics, safety, tolerability, efficacy, completion, and retention of care while identifying potential factors influencing these outcomes of different PEP regimens among diverse groups receiving PEP. PRIMARY OBJETIVES: 1. To determine the characteristics of PEP users in Barcelona and to analyze the frequency of other STIs and risk factors that render them eligible for PEP treatment. 2. To assess the pharmacokinetics, pharmacodynamics, and immune homeostasis of different PEP treatment regimens to prevent ex-vivo infection. 3. To calculate the rates of non-completion of PEP regimens among different risk groups. 4. To identify the factors linked to non-completion of PEP regimens among diverse risk groups. 5. Analyze the adverse event, adherence, follow-up rates of different post-exposure prophylaxis regimens.[spa] La profilaxis post-exposición (PEP) es una medida para prevenir el VIH utilizada en el contexto posterior a una potencial exposición al mismo. No existen estudios en humanos que puedan valorar su eficacia, por lo que los datos se han extrapolado de modelos animales en donde se consiguió experimentalmente evitar la infección. A partir de los datos de estos estudios, se concluyen dos supuestos para que la PEP sea efectiva: 1. La PEP se debe iniciar en un período inferior a las 72 horas desde el inicio de la exposición. 2. La PEP se debe mantener por un período de 28 días. A finales de 1980 obtienen los primeros resultados en un estudio de casos y controles en humanos en donde se vio una reducción significativa de la infección del 88%. Posteriormente se realizaron muchos estudios descriptivos y observacionales con una calidad de evidencia baja, y escasos ensayos clínicos que vienen a valorar la tolerabilidad de los distintos regímenes de PPE mas no su eficacia por las limitaciones éticas y metodológicas de los mismos, por lo que los datos clínicos son incompletos, heterogéneos y de calidad científico metodológica baja. A su vez y de igual importancia son las consideraciones farmacocinéticas y farmacodinámicas del uso de la PEP, como se ha demostrado en los estudios de PrEP en hombres y mujeres donde los resultados han sido muy discordantes y que además de atribuirse a la mala adherencia, el comportamiento farmacocinético y farmacodinámico (Pk/PD) de los mismos varían según el tipo de tejido y fármaco. Existen pocos estudios que valoren los PK/PD para las distintas pautas de PEP en los distintos compartimentos