Single-tablet regimen of emtricitabine/tenofovir disoproxil fumarate plus cobicistat-boosted elvitegravir increase adherence for HIV postexposure prophylaxis in sexual assault victims.

BACKGROUND: Postexposure prophylaxis (PEP) is a recommended public health intervention after a sexual assault to prevent HIV infection. METHODS: We conducted a retrospective case-control study on how use of a single-tablet regimen (STR) of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild) affected adherence to PEP and attendance of a follow-up visit to the STI clinic compared with those who received a multitablet regimen (MTR). Data from sexual assault victims consulting for PEP were prospectively recorded between January 2011 and December 2017. Data were systematically collected on patient demographics, time of medical contact, source risk factors, type of exposure, attendance to follow-up visit, reported completion of PEP and adherence based on pharmacy records. RESULTS: A total of 422 patients received PEP following a sexual assault, of whom 52% had documented completion of a 28-day PEP regimen and 71% attended a follow-up clinic visit. Patients who received an elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)-based STR had a similar likelihood of attending their first follow-up visit (OR: 0.97; 95% CI: 0.64 to 1.48, p=0.90) but were more likely to complete the PEP regimen (OR: 1.70; 95% CI: 1.16 to 2.50, p=0.007). After adjusting for confounders, those who were prescribed an STR regimen were more likely to complete the PEP regimen (OR: 1.66, 95% CI: 1.09 to 2.53, p=0.019) than those who were prescribed an MTR such as stavudine/lamivudine/lopinavir/ritonavir or zidovudine/lamivudine/indinavir/ritonavir. CONCLUSIONS: Sexual assault victims who were prescribed an STR based on EVG/COBI/FTC/TDF were more likely to complete PEP than those who were prescribed an MTR.

Cotrimoxazole versus sulfadoxine-pyrimethamine for intermittent preventive treatment of malaria in HIV-infected pregnant women in Bangui, Central African Republic: A pragmatic randomised controlled trial.

OBJECTIVE: The main objective of the MACOMBA (Maternity and Control of Malaria-HIV co-infection in Bangui) trial was to show that cotrimoxazole (CTX) is more effective than sulphadoxine-pyremethamine-IPTp (IPTp-SP) to prevent placental malaria infection (primary end point) among HIV-positive pregnant women with a CD4+ count ≥350 cells/mm3 in Bangui, CAR. METHODS: MACOMBA is a multicentre, open-label randomised trial conducted in four maternity hospitals in Bangui. Between 2013 and 2017, 193 women were randomised and 112 (59 and 53 in CTX and IPTp-SP arms, respectively) were assessed for placental infection defined by microscopic parasitaemia or PCR. RESULTS: Thirteen women had a placental infection: five in the CTX arm (one by microscopic placental parasitaemia and four by PCR) and eight by PCR in the SP-IPTp (8.5% vs. 15.1%, p = 0.28). The percentage of newborns with low birthweight (<2500 g) did not differ statistically between the two arms. Self-reported compliance to CTX prophylaxis was good. There was a low overall rate of adverse events in both arms. CONCLUSION: Although our results do not allow us to conclude that CTX is more effective, drug safety and good compliance among women with this treatment favour its widespread use among HIV-infected pregnant women, as currently recommended by WHO.

Pre-exposure prophylaxis (PrEP) for men who have sex with men in Europe: review of evidence for a much needed prevention tool.

In many Western countries with good coverage of antiretroviral treatment (ART) programmes the annual number of HIV infections is still high and not (yet) declining among men who have sex with men (MSM). This might indicate that antiretroviral treatment roll-out alone will not turn around the course of the epidemic and that new, additional tools are needed. Antiretrovirals used as prevention tools for people not yet infected with HIV, such as pre-exposure prophylaxis (PrEP) could be such important additional tools. PrEP is a new type of biomedical prevention, which involves the use of antiretrovirals before, during and after (periods of) sexual exposure to HIV. In this review, we will focus on PrEP as a new prevention tool for MSM at high risk in Europe, including its evidence for effectiveness, challenges for implementation, ongoing European demonstration studies; as well as how PrEP relates to other existing prevention tools. In light of European Medicines Agency's recent recommendation for approval of PrEP we briefly review the potential implications.

What are the characteristics of, and clinical outcomes in men who have sex with men prescribed HIV postexposure prophylaxis following sexual exposure (PEPSE) at sexual health clinics in England?

OBJECTIVES: To explore the risk factors for, and clinical outcomes in men who have sex with men (MSM) prescribed HIV postexposure prophylaxis following sexual exposure (PEPSE) at sexual health clinics (SHCs) in England. METHODS: National STI surveillance data were extracted from the genitourinary medicine clinic activity dataset (GUMCADv2) for 2011-2014. Quarterly and annual trends in the number of episodes where PEPSE was prescribed were analysed by gender and sexual risk. Risk factors associated with being prescribed PEPSE among MSM attendees were explored using univariable and multivariable logistic regression. Subsequent HIV acquisition from 4 months after initiating PEPSE was assessed using multivariable Cox proportional hazards models, stratified by clinical risk profiles. RESULTS: During 2011-2014, there were 24 004 episodes where PEPSE was prescribed at SHCs, of which 69% were to MSM. The number of episodes where PEPSE was prescribed to MSM increased from 2383 in 2011 to 5944 in 2014, and from 1384 to 2226 for heterosexual men and women. 15% of MSM attendees received two or more courses of PEPSE. Compared with MSM attendees not prescribed PEPSE, MSM prescribed PEPSE were significantly more likely to have been diagnosed with a bacterial STI in the previous 12 months (adjusted OR (95% CI)-gonorrhoea: 11.6 (10.5 to 12.8); chlamydia: 5.02 (4.46 to 5.67); syphilis: 2.25 (1.73 to 2.93)), and were more likely to subsequently acquire HIV (adjusted HR (aHR) (95% CI)-single PEPSE course: 2.54 (2.19 to 2.96); two or more PEPSE courses: aHR (95% CI) 4.80 (3.69 to 6.25)). The probability of HIV diagnosis was highest in MSM prescribed PEPSE who had also been diagnosed with a bacterial STI in the previous 12 months (aHR (95% CI): 6.61 (5.19 to 8.42)). CONCLUSIONS: MSM prescribed PEPSE are at high risk of subsequent HIV acquisition and our data show further risk stratification by clinical and PEPSE prescribing history is possible, which might inform clinical practice and HIV prevention initiatives in MSM.

High HIV incidence in men who have sex with men attending for postexposure prophylaxis: a service evaluation.

BACKGROUND/AIMS: There are limited outcome data for men who have sex with men (MSM) who have received HIV postexposure prophylaxis (PEP). The objective of this service evaluation was to determine HIV incidence and repeat PEP use among MSM PEP recipients in London, UK. METHODS: Retrospective electronic case-note review of all MSM who were prescribed PEP between January and April 2013 at a central London sexual health service. RESULTS: 530 MSM received PEP between 1 January and 30 June 2013. Of these, 449 had more than 30 days subsequent follow-up at our service. Median age was 31 years. PEP indication was unprotected anal intercourse, 98% (receptive 88% and insertive 10%) and other, 2%. Up to 1 November 2015, total follow-up was 756 person-years. 183 users received repeat PEP. The total number of repeat PEP courses was 442. 57 MSM newly acquired HIV: the HIV incidence was 7.6 per 100 person-years. CONCLUSIONS: PEP was associated with a high risk of subsequent HIV seroconversion in this cohort; this group may be appropriate candidates for pre-exposure prophylaxis.

Overlapping HIV prevention strategies; case report of pre-exposure and postexposure prophylaxes used for a single risk event between two men.

A range of prevention strategies have been considered in an attempt to reduce HIV transmission. The use of continuous antiretrovirals (ARVs) in high-risk HIV-negative individuals (pre-exposure prophylaxis or PrEP) and the short-term use of ARVs following a high-risk exposure (postexposure prophylaxis or PEP) are among these strategies. We report a case of the contemporaneous use of PEP and PrEP in a sexual liaison between two men.In an attempt to reduce the number of new cases of HIV infection, a range of prevention strategies have been advocated. Prior to the availability of ARV therapy, the key prevention measure was condom promotion and modifying sexual behaviour such as partner number reduction within high-risk groups. This was followed by: the introduction of PEP, treating all HIV cases with ARVs to reduce the probability of transmission (treatment as prevention) and in the past few years the use of PrEP. Case-control, observational and randomised clinical trial data exist to support these strategies. We describe what we believe is the first reported use of PrEP and PEP in a sexual liaison between two men in Sydney.

Experiences of HIV postexposure prophylaxis (PEP) among highly exposed men who have sex with men (MSM).

OBJECTIVES: HIV postexposure prophylaxis (PEP) is indicated after sexual exposure with high risk of transmission. Men who have sex with men (MSM) are the main target of PEP. The aim of our study was to investigate the experience and shortcomings of PEP among people with a high risk of HIV exposure. DESIGN AND METHODS: Subjects with ongoing follow-up for HIV infection and PEP history were selected for the qualitative study. Semistructured interviews were conducted at the patients' homes. They were audio-recorded, transcribed and deidentified before data analysis, double coding and thematic analysis with an inductive approach. RESULTS: Twenty-three patients were eligible for the qualitative study. Thirteen interviews were carried out. All patients were 20-60-year-old MSM. The median time between PEP and HIV diagnosis was 3.3 years (interquartile range (IQR)25-75=0.9-4.9). Many participants reported negative PEP experiences: awkward access to the PEP clinic, uneasiness and shame in the hospital setting, unpleasant interaction and moral disapprobation from the medical staff, treatment intolerance and prevention messages that were 'inconsistent with real life' CONCLUSION: Our data highlight PEP management failures among its target population that may have compromised any subsequent attempts to seek out PEP. Practitioners should be more aware of MSM sexual contexts and practices. PEP consultations should provide the opportunity to discuss prevention strategies with highly exposed HIV-negative subjects, which may include pre-exposure prophylaxis.

Get2PrEP2-A Provider Messaging Strategy to Improve PrEP Uptake: A Randomized Controlled Quality Improvement Project.

Introduction: HIV preexposure prophylaxis (PrEP), a key strategy for preventing HIV transmission, requires awareness and access to PrEP services. Although all patients should be made aware of HIV PrEP; the diagnosis of bacterial sexually transmitted infections (STIs) is an important indicator of potential HIV PrEP need. In a previous evaluation of Get2PrEP (G2P), we found that an electronic medical record laboratory comments did not increase the frequency of PrEP discussions between patients and providers. In Get2PrEP2 (G2P2), we hypothesized that active, personalized messaging to providers about HIV PrEP would increase the documentation of PrEP discussions, referrals, and/or provision of HIV PrEP to individuals diagnosed with an STI. Methods: G2P2 was a parallel 3-arm, unblinded, randomized controlled design. Participants were allocated 2:1 to intervention or control. Participants in the intervention arm were further allocated to receive provider messaging through the electronic medical record chat message or e-mail. Results: The 191 randomized encounters resulted in a modest 7.8% (odds ratio, 1.078; confidence interval, 1.02-1.13) increase in documented PrEP discussions in intervention encounters versus none in the standard care group. There was no statistical difference by intervention modality. All documented discussions occurred in the outpatient or emergency department and were more frequent in women and those aged <25 years. Discussion: An e-mail or electronic medical record chat message sent to providers of patients testing positive for an STI had a small but significant effect on documented patient-provider PrEP discussions. Further investigation is required to determine whether provider messaging can increase PrEP uptake among eligible patients and longer-term outcomes.

[Occupational and non occupational exposure to viral risk]. / Exposition à risque de transmission virale (AES).

The transmission of an infectious disease can occur through exposure to blood or other potentially infectious body fluids, particularly in the event of skin-puncture injuries for healthcare workers, and during sexual intercourse. These situations are known as accidental blood exposures and sexual exposures respectively. Combined actions carried out have allowed to significantly reduce risks, either to healthcare professionals (by standard precautions, provision of safety devices, Hepatitis B vaccination made compulsory in the 1990s, antiretroviral post-exposure prophylaxis that should be initiated as soon as possible after exposure), or to people engaging in unprotected sex (by prevention messages, condom promotion, and antiretroviral post-exposure prophylaxis). In any case, treatment of people infected by chronic diseases such as HBV or HIV, as well as possible drug eradication of HCV, are key for decreasing post-exposure risk of disease transmission. Post-exposure prophylaxis should be initiated as early as possible and intended for use only in patients with high-risk exposures. Knowledge of source person serostatus, information of exposed person on prevention, benefits and risks of treatment, and follow-up procedure are key points. Procedures to be followed in the event of an exposure must be known by all. Arrangements set up to allow risk assessment and management of exposed people rely on hospital services operating on a permanent basis.

Perfil epidemiológico dos usuários da profilaxia pós-exposição ao vírus da imunodeficência humana / Epidemiological profile of users of post-exposure prophylaxis to human immunodeficiency viruses / Perfil epidemiológico de usuarios de profilaxis post- exposición al virus de la inmunodeficiencia humana

A Profilaxia Pós-Exposição (PEP) ao Virus da Imunodeficiência Humana (HIV) trata-se de uma urgência médica que deve ser realizada durante 28 dias com medicamentos específicos em indivíduos que tiveram uma exposição com materiais biológicos e situações específicas considerados de risco no intervalo de até 72 horas em indivíduos não reagentes ao vírus do HIV. Objetivo: descrever o perfil epidemiológico dos usuários da PEP no município de Parnaíba, Piauí. Metodologia: Trata-se de um estudo transversal retrospectivo com abordagem quantitativa dos casos de pessoas residentes em Parnaíba, que utilizaram a PEP no período do estudo de 2017 a 2021 analisados por estatística descritiva. Resultados: Foram registrados 202 pacientes que utilizaram a PEP. Dentre estes a maioria foram homens cis com 129 (64%), na faixa etária de 30 a 59 anos foi de (49%) nos casos, a orientação sexual de héteros com (44%), a maioria dos pacientes possuíam o ensino médio (62%), a raça/cor foi maior em pardos (52%). O tipo de exposição mais ocorrente foi sexo consentido (79%), realizaram o tratamento sem intercorrência (84%) dos casos, 62% utilizaram álcool e/ou outras drogas e maioria dos pacientes (57%) referiam não conhecer a situação sorológica dos seus parceiros sexuais. Conclusão: A PEP tem sido uma das formas de prevenção combinada que minimiza as possibilidades de infecção pelo HIV. Percebeu-se que o aumento da população adulta-jovem tem buscado a prevenção, possivelmente devido as práticas consideradas de risco que apresentam maior ocorrência entre os casos.

Post-Exposure Prophylaxis (PEP) to the Human Immunodeficiency Virus (HIV) is a medical emergency that must be performed for 28 days with specific medications in individuals who have been exposed to biological materials and specific situations considered at risk in the interval up to 72 hours in HIV-negative individuals. Objective: to describe the epidemiological profile of PEP users in the city of Parnaíba, Piauí. Methodology: This is a retrospective cross-sectional study with a quantitative approach to the cases of people residing in Parnaíba, who used the PEP in the study period from 2017 to 2021, analyzed using descriptive statistics. Results: 202 patients who used PEP were registered. Among these, the majority were cis men with 129 (64%), in the age group of 30 to 59 years old (49%) in cases, the sexual orientation of heterosexuals with (44%), most patients had high school (62%), race/color was higher in pardos (52%). The most frequent type of exposure was consensual sex (79%), underwent treatment without intercurrence (84%) of cases, 62% used alcohol and/or other drugs and most patients (57%) reported not knowing the serological status of the their sexual partners. Conclusion: PEP has been one of the forms of combined prevention that minimizes the possibilities of HIV infection. It was noticed that the increase in the young adult population has sought prevention, possibly due to practices considered to be risky, with a higher occurrence among cases.

La Profilaxis Post-Exposición (PEP) al Virus de la Inmunodeficiencia Humana (VIH) es una emergencia médica que debe realizarse durante 28 días con medicamentos específicos en individuos que han estado expuestos a materiales biológicos y situaciones específicas consideradas de riesgo en el intervalo hasta 72 horas en personas VIH negativas. Objetivo: describir el perfil epidemiológico de los usuarios de PEP en la ciudad de Parnaíba, Piauí. Metodología: Se trata de un estudio transversal retrospectivo con abordaje cuantitativo de los casos de personas residentes en Parnaíba, que utilizaron el PEP en el período de estudio de 2017 a 2021, analizados mediante estadística descriptiva. Resultados: Se registraron 202 pacientes que usaron PEP. Entre estos, la mayoría eran hombres cis con 129 (64%), en el grupo de edad de 30 a 59 años (49%) en los casos, la orientación sexual de los heterosexuales con (44%), la mayoría de los pacientes tenían estudios secundarios (62 %), raza/color fue mayor en pardos (52%). El tipo de exposición más frecuente fue sexo consentido (79%), realizó tratamiento sin intercurrencia (84%) de los casos, 62% consumía alcohol y/u otras drogas y la mayoría de los pacientes (57%) refirieron no conocer el estado serológico de sus pacientes. parejas sexuales. Conclusión: La PEP ha sido una de las formas de prevención combinada que minimiza las posibilidades de infección por el VIH. Se percibió que el aumento de la población adulta joven ha buscado la prevención, posiblemente por prácticas consideradas de riesgo, con mayor ocurrencia entre los casos.

Avaliação do uso da Profilaxia Pré-Exposição ao HIV: coorte retrospectiva / Evaluation of the use of pre-exposure HIV prophylaxis: retrospective cohort / Evaluación del uso de profilaxis pre-exposición al VIH: cohorte retrospectiva

Objetivo: Identificar o perfil da população que buscou a Profilaxia Pré-Exposição ao HIV (PrEP) no Paraná e, entre os usuários da PrEP, avaliar modificações nos comportamentos de risco de adquirir infecções sexualmente transmissíveis (IST's), além de alterações nos exames laboratoriais de monitoramento. Métodos: Coorte retrospectiva com dados secundários obtidos do Sistema de Controle Logístico de Medicamentos acessados em 2018 e 2019. Investigou-se o perfil sociodemográfico da população que buscou a PrEP, de forma a correlacioná-lo aos segmentos prioritários para o uso do medicamento profilático. Entre os usuários, avaliaram-se dados comportamentais, testes diagnósticos para IST's, funções renal e hepática referentes a diferentes momentos no decorrer do uso. Os resultados comparados deram-se por meio dos testes Wilcoxon e Exato de Fisher. Resultados: 255 pessoas buscaram a PrEP. Predominaram-se o sexo masculino (92,28%), homossexuais (78,04%), de 20 a 39 anos (83,53%), brancos (71,76%), com 12 ou mais anos de estudo (74,90%). Para uso da PrEP elegeram-se 188 pessoas. Entre estas, durante o uso, observou-se aumento de práticas sexuais sem preservativo (p=0,012), diminuição no número de parceiros e do consumo de álcool (p=0,001), aumento da atividade de enzimas hepáticas ALT/AST (p=0,018), sem diferença no diagnóstico do HIV e outras IST's. Conclusão: Homens que fazem sexo com homens predominaram na busca pela profilaxia. Entre os usuários da PrEP, apesar do aumento de práticas sexuais desprotegidas, não houve aumento do diagnóstico de IST's no período do estudo. O medicamento da PrEP demonstrou bom perfil de segurança nos exames laboratoriais de seguimento.

Objective: To identify the profile of the population that sought HIV Pre-Exposure Prophylaxis (PrEP) in Paraná; and assess, among PrEP users, changes in risk behaviors for acquiring sexually transmitted infections (STIs) as well as changes in monitoring laboratory tests. Methods: Retrospective cohort with secondary data obtained from the Drug Logistics Control System accessed in 2018 and 2019. The sociodemographic profile of the population that sought PrEP was investigated to correlate it with priority segments for the use of prophylactic medication. Among users, behavioral data, diagnostic tests for STIs, kidney, and liver functions were evaluated at different times during use. The results were compared using the Wilcoxon and Fisher's Exact tests. Results: 255 people sought PrEP. Males predominated (92.28%), homosexuals (78.04%), from 20 to 39 years old (83.53%),white people (71.76%), with 12 or more years of schooling (74.90%). For the use of PrEP, 188 people were elected. Among them, during the usage, was noticed an increase in sexual practices without a condom (p=0.012), a decrease in the number of partners and alcohol consumption (p=0.001), an increase in the activity of liver enzymes ALT/AST (p=0.018), with no difference in the diagnosis of HIV and other STI's. Conclusion: Men who have sex with men predominated in the search for prophylaxis. Among PrEP users, despite the increase in unprotected sexual practices, there was no increase in the diagnosis of STIs during the study period; PrEP drugs showed a good safety profile in follow-up laboratory tests.

Objetivo: Identificar el perfil de la población que fue en busca de la Profilaxis pre-exposición al VIH (PrEP) en Paraná y, de entre los usuarios de la PrEP, evaluar los cambios de conducta de riesgo para tener infecciones de transmisión sexual (ITS) además de las alteraciones de las pruebas de laboratorios para el monitoreo. Métodos: Cohorte retrospectiva con datos secundarios del Sistema de Control Logístico de Medicamentos con acceso en 2018 y 2019. Se investigó el perfil sociodemográfico de la población que fue en busca de la PrEP, para correlacionarlo con los segmentos prioritarios para el uso del medicamento profiláctico. De los usuarios se ha evaluado los datos comportamentales, las pruebas de diagnósticos para las ITS, las funciones renales y hepática referente a distintos momentos durante el uso. Los resultados comparados se han dado a través de las pruebas de Wilcoxon y el Exacta de Fisher. Resultados: 255 personas han buscado la PrEP. Hubo el predominio para el sexo masculino (92,28%), homosexuales (78,04%), entre los 20 y 39 años (83,53%), blancos (71,76%), con 12 o más años de estudio (74,90%). Se há elegido 188 personas para el uso de la PrEP. De entre ellas, durante el uso, se observó el aumento de las prácticas sexuales sin condón (p=0,012), la disminución del número de compañeros y del consumo del alcohol (p=0,001), el aumento de la actividad de enzimas hepáticas ALT/AST (p=0,018), sin diferencia en el diagnóstico del VIH y de otras ITS. Conclusión: Los hombres que tienen sexo con hombres prevalecieron para la búsqueda de la profilaxis. De entre los usuarios de la PrEP, a pesar del aumento de las prácticas sexuales sin protección no hubo el aumento del diagnóstico de ITS en el período del estudio. El medicamento de la PrEP demostró un perfil bueno de seguridad en las pruebas de laboratorios de seguimiento.