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Background:The scale of the 2022 global mpox (formerly known as monkeypox) outbreak has been unprecedented. In less than 6 months, non-endemic countries have reported more than 67 000 cases of a disease that had previously been rare outside of Africa. Mortality has been reported as rare but hospital admission has been relatively common. We aimed to describe the clinical and laboratory characteristics and outcomes of individuals admitted to hospital with mpox and associated complications, including tecovirimat recipients. Methods:In this cohort study, we undertook retrospective review of electronic clinical records and pathology data for all individuals admitted between May 6, and Aug 3, 2022, to 16 hospitals from the Specialist and High Consequence Infectious Diseases Network for Monkeypox. The hospitals were located in ten cities in England and Northern Ireland. Inclusion criteria were clinical signs consistent with mpox and MPXV DNA detected from at least one clinical sample by PCR testing. Patients admitted solely for isolation purposes were excluded from the study. Key outcomes included admission indication, complications (including pain, secondary infection, and mortality) and use of antibiotic and anti-viral treatments. Routine biochemistry, haematology, microbiology, and virology data were also collected. Outcomes were assessed in all patients with available data. Findings:156 individuals were admitted to hospital with complicated mpox during the study period. 153 (98%) were male and three (2%) were female, with a median age of 35 years (IQR 30–44). Gender data were collected from electronic patient records, which encompassed full formal review of clincian notes. The prespecified options for data collection for gender were male, female, trans, non-binary, or unknown. 105 (71%) of 148 participants with available ethnicity data were of White ethnicity and 47 (30%) of 155 were living with HIV with a median CD4 count of 510 cells per mm3(IQR 349–828). Rectal or perianal pain (including proctitis) was the most common indication for hospital admission (44 [28%] of 156). Severe pain was reported in 89 (57%) of 156, and secondary bacterial infection in 82 (58%) of 142 individuals with available data. Median admission duration was 5 days (IQR 2–9). Ten individuals required surgery and two cases of encephalitis were reported. 38 (24%) of the 156 individuals received tecovirimat with early cessation in four cases (two owing to hepatic transaminitis, one to rapid treatment response, and one to patient choice). No deaths occurred during the study period. Interpretation:Although life-threatening mpox appears rare in hospitalised populations during the current outbreak, severe mpox and associated complications can occur in immunocompetent individuals. Analgesia and management of superimposed bacterial infection are priorities for patients admitted to hospital.

PURPOSE OF REVIEW The HIV population is ageing with rising rates of frailty though strategies of how best to manage it remain ill-defined. It also remains unclear what the prevalence of frailty is within this cohort, how best to diagnose it and what factors are associated. RECENT FINDINGS The prevalence of frailty remains unclear because of heterogenous results. Routine screening in those 50+ is recommended and whilst the Fried Frailty Phenotype is currently preferred the Clinical Frailty Scale could be considered. No biomarkers are currently recommended. Looking at associated factors, HIV neurocognitive impairment and long-term alcohol usage has been shown to be associated with developing frailty whilst those who are frail have been shown to be less active and more likely to fall. NAFLD with fibrosis has been shown to be an indicator of metabolic age and the Pooled Cohort Equations has been shown to be more effective in diagnosing cardiovascular risk in frail people living with HIV. SUMMARY Whilst the prevalence of frailty differs between countries, with the addition of prefrailty, this represents a large proportion of people living with HIV. Services must ensure strategies are in place to support those living with HIV and frailty. Further longitudinal studies are required.

People living with HIV (PLWH) on suppressive antiretroviral therapy (ART) can have residual immune dysfunction and often display poorer responses to vaccination. We assessed in a cohort of PLWH (n=110) and HIV negative controls (n=64) the humoral and spike-specific B-cell responses following 1, 2 or 3 SARS-CoV-2 vaccine doses. PLWH had significantly lower neutralizing antibody (nAb) titers than HIV-negative controls at all studied timepoints. Moreover, their neutralization breadth was reduced with fewer individuals developing a neutralizing response against the Omicron variant (BA.1) relative to controls. We also observed a delayed development of neutralization in PLWH that was underpinned by a reduced frequency of spike-specific memory B cells (MBCs) and pronounced B cell dysfunction. Improved neutralization breadth was seen after the third vaccine dose in PLWH but lower nAb responses persisted and were associated with global, but not spike-specific, MBC dysfunction. In contrast to the inferior antibody responses, SARS-CoV-2 vaccination induced robust T cell responses that cross-recognized variants in PLWH. Strikingly, a subset of PLWH with low or absent neutralization had detectable functional T cell responses. These individuals had reduced numbers of circulating T follicular helper cells and an enriched population of CXCR3+CD127+CD8+T cells after two doses of SARS-CoV-2 vaccination, which may compensate for sub-optimal serological responses in the event of infection. Therefore, normalisation of B cell homeostasis could improve serological responses to vaccines in PLWH and evaluating T cell immunity could provide a more comprehensive immune status profile in these individuals and others with B cell imbalances.

The population of people living with human immunodeficiency virus (HIV) is ageing and has an increasing burden of non-acquired immune deficiency syndrome (AIDS)-related morbidity and mortality, including frailty. Frailty is prevalent at a younger age in this population and is associated with multimorbidity, disability and death. This article examines the key interventions to ameliorate the advancement of frailty in people living with HIV. It explores methods of successfully delivering a multidisciplinary holistic approach to this complex patient group, using three case studies. The most effective frailty intervention is exercise. Group-based physiotherapy classes protect against functional decline and frailty symptomatology. Optimisation of medical and psychiatric comorbidities, including deprescribing when appropriate, is also essential. Addressing the social determinants of frailty, such as social isolation and loneliness, are beneficial, but are dependent on local charities and resources. More research is required to assess pharmacological and nutritional interventions in frailty. This requires a greater understanding of the exact pathophysiology of frailty, which remains poorly understood.

Objectives By 2030 the majority of the people living with HIV in the United Kingdom will be over the age of 50. HIV services globally must adapt to manage people living with HIV as they age. Currently these services are often designed based on data from the wider population or from the experiences of HIV clinicians. This article aims to help clinicians designing inclusive HIV services by presenting the most common needs identified during the first year of a specialist clinic for older people living with HIV at the Ian Charleson Day Centre, Royal Free Hospital in London, United Kingdom. Methods The records of all thirty-five patients attending the inaugural nine sessions were reviewed. Results The median age of attendees was 69 (53-93) with 77% being male, 63% being White, 49% being heterosexual and 97% being virally suppressed respectively. The majority (83%) met the criteria for frailty using the Fried frailty phenotype. Eighteen issues linked to ageing were identified with the most common being affective symptoms (51%), memory loss (37%) and falls (29%). Conclusions Whilst older people living with HIV are a heterogeneous group frailty is common and appears to present earlier. HIV services either need to adapt to meet these additional needs or must support users in transitioning to existing services. We feel that our multidisciplinary model is successful in identifying problems associated with ageing in people living with HIV and could be successfully replicated elsewhere.

As people age with HIV, their needs increase beyond solely managing HIV care. Ageing people with HIV, defined as people with HIV who are 50 years or older, face increased risk of both age-regulated comorbidities and ageing-related issues. Globally, health-care systems have struggled to meet these changing needs of ageing people with HIV. We argue that health systems need to rethink care strategies to meet the growing needs of this population and propose models of care that meet these needs using the WHO health system building blocks. We focus on care provision for ageing people with HIV in the three different funding mechanisms: President's Emergency Plan for AIDS Relief and Global Fund funded nations, the USA, and single-payer government health-care systems. Although our categorisation is necessarily incomplete, our efforts provide a valuable contribution to the debate on health systems strengthening as the need for integrated, people-centred, health services increase.

Persistence of HIV through integration into host DNA in CD4(+) T cells presents a major barrier to virus eradication. Viral integration may be curtailed when CD8(+) T cells are triggered to kill infected CD4(+) T cells through recognition of histocompatibility leukocyte antigen (HLA) class I-bound peptides derived from incoming virions. However, this has been reported only in individuals with "beneficial'' HLA alleles that are associated with superior HIV control. Through interrogation of the pre-integration immunopeptidome, we obtain proof of early presentation of a virion-derived HLA-A*02:01-restricted epitope, FLGKIWPSH (FH9), located in Gag Spacer Peptide 2 (SP2). FH9-specific CD8(+) T cell responses are detectable in individuals with primary HIV infection and eliminate HIV-infected CD4(+) T cells prior to virus production in vitro. Our data show that non-beneficial HLA class I alleles can elicit an effective antiviral response through early presentation of HIV virion-derived epitopes and also demonstrate the importance of SP2 as an immune target.

Introduction Human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) was traditionally associated with severe heart failure, pulmonary hypertension and myocarditis but this is rarely seen following the advent of antiretroviral therapy (ART). Previous studies in asymptomatic people living with HIV (PLWH) have revealed a high burden of cardiovascular disease (CVD), and subclinical myocardial inflammation as detected by cardiac magnetic resonance imaging (CMR). The H-ART to Heart study was designed to assess the prevalence of CVD in PLWH. In this sub-study, we aim to assess bio-markers, structural and functional cardiac changes associated with HIV using CMR. Methods In this cross-sectional study, we recruited asymptomatic Caucasian men who have sex with men (MSM) diagnosed with HIV > 10yrs ago, aged 35-55 years, with undetectable viral loads on ART. They were compared to HIV-negative age and ethnicity MSM matched controls. Those with Q-Risk3 CVD risk factors (hypertension, hyperlipidaemia, diabetes, smoking, inflammatory arthritis, depression, severe mental illness) or hepatitis co-infection were excluded. Assessments included blood pressure (BP); bloods for inflammation; transthoracic echocardiography for all participants and stress perfusion CMR with multiparametric mapping for PLWH. We compared CMR results with a previously selected control group of healthy volunteers with no cardiovascular risk factors. Results 45 participants were recruited (26 MLWH; 19 HIV- MSM), mean results for MLWH were as follows: duration of HIV 17.8±6.4yrs, duration on ART 10.7±5.2yrs, nadir CD4 count 318±145 cells/μL, current CD4 count 610±150 cells/μL and current viral load CMR data for LVEF was comparable to that reported by echocardiography, most parameters were similar between the groups aside from statistically significant higher T2 (46.2±1.6 v 44.4±2.5ms; P Conclusion From our small study of well treated asymptomatic MLWH with low CVD risk profiles, we were able to detect subtle differences in inflammatory biomarkers compared to controls, However this did not translate to evidence of detectable myocardial pathology classically associated with HIV (cardiomyopathy, myocarditis). There was no difference in LVEF%, LV Mass-I or native T1, a marker of diffuse fibrosis, which is different to previous published data, perhaps due to our strict inclusion criteria. However T2, a more specific marker of myocardial oedema, and more non-specific LGE were detected in MLWH. This may indicate an early signal of myocardial inflammation in well treated MLWH. Conflict of Interest None

Introduction 37.9 million people worldwide are living with HIV (human immunodeficiency virus), acquired immune deficiency syndrome (AIDS)-related deaths have reduced by 51% since the peak in 2004. 42% of those infected are BWLWH yet represent only 9% of those included in clinical trials. HIV/AIDS has been shown to be associated with the development of heart failure, pulmonary hypertension and myocarditis. Previous studies in asymptomatic PLWH have revealed a high burden of underlying CVD and subclinical myocardial inflammation as detected by CMR. The H-ART to Heart study is designed to examine the burden of cardiovascular disease (CVD) in asymptomatic PLWH compared to HIV negative controls (-) excluding traditional CV risk factors. Methods A cross-sectional study comparing asymptomatic BWLWH aged 35-55yrs (diagnosed >10 yrs, with undetectable viral loads) to HIV negative controls. Black African/Caribbean women without known CV risk factors (hypertension, hyperlipidaemia, diabetes, smoking, inflammatory arthritis, depression, severe mental illness) or hepatitis co-infection were included. Assessment included blood pressure (BP), bloods including NT-ProBNP. Echocardiography was performed in all participants and stress perfusion CMR with multiparametric mapping for BWLWH. We compared CMR results with a previously selected control group. Results 48 participants have been recruited (23 BWLWH,25 controls; mean age 47.7±4.1 v 44.7±6.2yrs, P=0.06; mean BP 125/77 v 123/79mmHg), mean results for BWLWH were as follows: duration of HIV 17.6±6.2 yrs, duration of ART 11.5±5.2 yrs, nadir CD4 count 262±158 cells/μL, current CD4 count 662±188 cells/μL and current viral load A MRI sub-study data showed no difference in LV mass, LVEDV, T1, T2 with no evidence of ischaemia or myocarditis between the groups, although number are small (Table 2). Conclusion Preliminary data from our study of asymptomatic low risk BWLWH without traditional CVD risk factors removed indicates raised PAP which cannot be explained by hypertension, diastolic dysfunction, ischaemia or previous myocarditis. The cause of the raised PAP is unclear and requires further investigation. Whether this finding is of importance in CV risk assessment of BWLWH remains to be seen. Conflict of Interest None

Background: Antiretroviral therapy (ART) cannot cure HIV infection because of a persistent reservoir of latently infected cells. Approaches that force HIV transcription from these cells, making them susceptible to killing—termed kick and kill regimens—have been explored as a strategy towards an HIV cure. RIVER is the first randomised trial to determine the effect of ART-only versus ART plus kick and kill on markers of the HIV reservoir. Methods: This phase 2, open-label, multicentre, randomised, controlled trial was undertaken at six clinical sites in the UK. Patients aged 18–60 years who were confirmed as HIV-positive within a maximum of the past 6 months and started ART within 1 month from confirmed diagnosis were randomly assigned by a computer generated randomisation list to receive ART-only (control) or ART plus the histone deacetylase inhibitor vorinostat (the kick) and replication-deficient viral vector T-cell inducing vaccines encoding conserved HIV sequences ChAdV63. HIVconsv-prime and MVA.HIVconsv-boost (the kill; ART + V + V; intervention). The primary endpoint was total HIV DNA isolated from peripheral blood CD4+ T-cells at weeks 16 and 18 after randomisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02336074. Findings: Between June 14, 2015 and Jul 11, 2017, 60 men with HIV were randomly assigned to receive either an ART-only (n=30) or an ART + V + V (n=30) regimen; all 60 participants completed the study, with no loss-to-follow-up. Mean total HIV DNA at weeks 16 and 18 after randomisation was 3·02 log10 copies HIV DNA per 106 CD4+ T-cells in the ART-only group versus 3·06 log10 copies HIV DNA per 106 CD4+ T-cells in ART + V + V group, with no statistically significant difference between the two groups (mean difference of 0·04 log10 copies HIV DNA per 106 CD4+ T-cells [95% CI −0·03 to 0·11; p=0·26]). There were no intervention-related serious adverse events. Interpretation: This kick and kill approach conferred no significant benefit compared with ART alone on measures of the HIV reservoir. Although this does not disprove the efficacy kick and kill strategy, for future trials enhancement of both kick and kill agents will be required.

A cohesive multidisciplinary team approach is key in the management of HIV in pregnancy. The primary aim is to prevent transmission to the neonate but also to support the mother in any issues arising from her pre-existing, or new, diagnosis of HIV. Specialist advice should be sought, wherever possible. Key areas discussed in this review include antenatal management of the mother (particularly pharmacological management), obstetric management, pharmacological treatment for the neonate and infant feeding. Due to progress made in both in HIV testing, and in the way all patients with HIV in the UK are managed over the last few decades, most women who present with HIV in pregnancy are aware of their diagnosis and on treatment. However, it is not entirely uncommon for women to be diagnosed in pregnancy and it is these cases that present the greater challenge. The cases in this review cover the most common scenarios encountered.

HIV pre-exposure prophylaxis (PrEP) has proven efficacy in reducing the risk of HIV infection in men who have sex with men (MSM), but has not yet been commissioned in the UK. The aim of this study was to investigate perceived need and benefit (or experience of) PrEP among HIV-negative MSM attending sexual health clinics. HIV-negative MSM attending three sexual health centres in London, UK were opportunistically invited to complete a questionnaire. Data collected comprised demographic data and sexual and drug use behaviours as well as questions regarding perceptions of risk and need for PrEP. Logistic regression analysis was undertaken to identify variables predicting acceptability of, and intention to use, PrEP. In addition, data were gathered in respondents already taking PrEP. Eight hundred and thirty-nine questionnaires were analysed. The median age of respondents was 35 years (IQR 28–41, range 18–78), 650 (77%) were of white ethnicity and 649 (77%) had a university education. Four hundred and fifty-six (54%) reported at least one episode of condomless anal sex in the preceding three months, 437 (52%) reported recreational drug use in the preceding three months and 311 (37%) had been diagnosed with a sexually transmitted infection within the preceding six months. Four hundred and sixty-three (64%) of 726 strongly agreed with the statement ‘I think I would benefit from PrEP’. Multivariate logistic regression analysis demonstrated that having receptive anal intercourse (RAI) without condoms, having an awareness of the risk of unprotected RAI and having belief in the effectiveness of PrEP were independent predictors for someone thinking they would benefit from taking PrEP. Eight percent of respondents (59/724) had already taken or were currently taking PrEP. The results suggest that individuals at risk are likely to perceive themselves as benefiting from PrEP. The majority perceived their risk of acquiring HIV and benefit from PrEP accurately. Overall they appeared to have little concern over the use of PrEP and generally positive attitudes. Further investigation is warranted to understand why those at risk do not perceive benefit from PrEP.

Routine screening for psychological and cognitive difficulties is recommended in BHIVA guidelines but screening questions are not specified and studies give varied recommendations. Our aim was to see if simple screening in the routine clinic could help better direct our referrals to psychology and highlight those patients requiring, and likely to benefit from, further assessment. We introduced brief questions to assess neurocognitive impairment (NCI) and mood into routine HIV visits, with an onward referral pathway for further investigation for those screening positive. Routine attendees to HIV outpatient care over 12 weeks completed brief screening for depression (PHQ-2) and anxiety (GAD-2) and answered three short questions to screen for possible neurocognitive impairment (NCI-3Q). Patients screening positive underwent further screening via our psychologists and/or referral for neuropsychometric testing. Patient demographics, HIV markers and treatment history were recorded. 97 HIV outpatients were screened; 44 (45%) initially screened positive for NCI and/or mood. 29/44 (66%) were referred for further screening and/or psychological assessment and 21/29 (72%) of those engaged. The Montreal Cognitive Assessment (MoCA) and International HIV Dementia Scale (IHDS) were conducted on seven patients; four of these received full neuropsychometric testing. A detectable viral load was associated with positive neurocognitive screening. Rates of NCI and mood disorder among those who were tested were consistent with previous studies. The PHQ-2 and GAD-2 did detect mood problems; however, our results suggest the NCI-3Q questions alone are not good at detecting those with possible NCI. Screening for NCI remains practically difficult in the routine outpatient setting and this pilot supports the need for clearer guidelines on detecting HIV related NCI.

Background Antiretroviral therapy (ART) has dramatically improved the prognosis in PLWH with survival nearing that of HIV negative people. PLWH may develop significant comorbidities as they age including cardiovascular disease (CVD) such as myocardial infarction, sudden cardiac death, heart failure, as well as subclinical evidence of myocardial inflammation. Overall, ART treated patients are at an increased CVD risk with some studies quoting a 2.2 fold relative risk. Aim To assess the incidence of functional, structural and tissue characterisation changes in PLWH using CMR with multiparametric mapping Methods 39 PLWH (34 men, mean age 55.8±10.9, mean duration of HIV 17.8±9.29 years) and 29 healthy volunteers (20 men, mean age 45.1±8.3) underwent CMR with late gadolinium enhancement (LGE) imaging, T1 and T2 mapping. Results Of PLWH, only 7 scans (18%) were normal. LV ejection fraction was significantly lower and LV mass significantly higher compared to controls. Native T1, a marker of diffuse fibrosis or increased myocardial water content was no different between the groups. T2, a more specific marker of myocardial oedema, was elevated in PLWH. Sixteen PLWH (41%) had evidence of LGE including 8 with an ischaemic pattern (7 sub-endocardial and one transmural) and 8 with a non-ischaemic pattern (5 with mid-wall enhancement and 3 with RV insertion point LGE. No controls had evidence of LGE. Student t-Test: PLWH versus controls PLWH (n=39) Control (n=29) P-value LVEF (%) 59±15 67±5 Conclusion This study identifies a number of cardiac changes associated with HIV and prolonged treatment with ART. The elevated LV mass may be associated with hypertension, commonly found in PLWH. The elevated myocardial T2 compared to controls may be due to chronic inflammation associated to prolonged HIV exposure. There was no evidence of diffuse fibrosis but focal areas of non-ischaemic scar were a common finding which may relate to previous myocarditis or HIV-related cardiomyopathy. A fifth of PLWH also had evidence of previous myocardial infarction. We propose to image asymptomatic PLWH to further classify, diagnose and treat a vulnerable group of patients who are now described as having a normal life expectancy.

Background With advances in antiretroviral therapy, most deaths in people with HIV are now attributable to non-communicable illnesses. The global burden of cardiovascular disease (CVD) in people living with HIV (PLWH) has tripled over the past 2 decades. A large meta-analysis suggests PLWH are twice as likely to develop CVD than the general population, however this data included a large proportion of individuals from sub-Saharan Africa and who were treatment naive. Data from the Swiss HIV Cohort Study suggests that PLWH have a similar degree of non-calcified/mixed plaque and high-risk plaque; less calcified coronary plaque; lower coronary atherosclerosis (CA) involvement; and lower severity scores than HIV-negative persons with similar Framingham risk scores. The British HIV Association advocate the use of Q-Risk 3 risk stratification tool despite the fact that HIV was not found to be a significant risk factor in the development and validation of this tool. For our UK population of PLWH a paucity of data exists despite a belief that PLWH are at increased risk of coronary atherosclerosis and cardiac death. Aim To assess survival after CA diagnosis and compare it to the general population. Methods A retrospective analysis from a large metropolitan hospital, of PLWH with a confirmed diagnosis of CA on invasive coronary angiography. Information from the HIV database and coronary angiogram database were combined. Notes were checked using the electronic patient records and mortality data was obtained from the NHS spine. The Global Registry of Acute Coronary Event (GRACE) risk scores were calculated at the time of CA diagnosis and survival rates were calculated using Kaplan–Meier analysis. These results were superimposed onto those from the UK-Belgium GRACE registry. Results We identified 52 PLWH who were diagnosed with CA based on angiography. 48 (92%) were men, mean age at time of procedure 50.7 (SD ± 9.3) years. 26 PLWH had HIV viral load 24 (46%) patients had an elective coronary angiogram, 13 (25%) had NSTEMI, 15 (29%) STEMI. 17 (32%) patients had hypercholesterolaemia, 8 (15%) hypertension, 9 (17%) were diabetics on oral medication, 3 (6%) on insulin, 24 (46%) ex-smokers, 7 (13%) smokers, 16 (31%) had known positive family history. Only 3 (6%) patients had renal failure on dialysis, the rest had a creatinine GRACE scores were performed on those with ACS (Acute Coronary Syndrome), 25 were categorised as low risk ( 140). Mean GRACE Score 80.7 (±19.6). Mean duration of HIV was 20.1 (±6.9) years, mean duration of follow up from procedure 2, 138 days. 8 patients died during this period (figure 1.) Conclusion We present UK data on PLWH and demonstrate that, despite an initial low GRACE risk score, the long term survival rates over 5 years tracks that of an intermediate risk group. We propose that PLWH should be screened and treated aggressively for CA if identified. Our results may represent a sub-group of PLWH who have more aggressive CVD and over represented cardiovascular risk factors. These patients were diagnosed a long time ago with low CD4 nadirs, and may have had long periods of detectable viraemia. Further work on a current UK cohort is required. Conflict of Interest None

Ongoing inflammation in controlled HIV infection contributes to non-AIDS comorbidities. High bilirubin appears to exhibit an anti-inflammatory effect in vivo. We therefore examined whether increased bilirubin in persons with HIV was associated with differences in markers of inflammation and cardiovascular, bone, renal disease, and neurocognitive (NC) impairment.This cross-sectional study examined inflammatory markers in individuals with stable HIV infection treated with two nucleoside reverse transcriptase inhibitors and a boosted protease inhibitor. Individuals recruited were those with a normal bilirubin (NBR; 0-17 μmol/L) or high bilirubin (2.5 × upper limit of normal). Demographic and anthropological data were recorded. Blood and urine samples were taken for analyses. Pulse wave velocity (PWV) measurement, carotid intimal thickness (CIT), and calcaneal stiffness (CSI) were measured. Males were asked to answer a questionnaire about sexual function; NC testing was performed using CogState.101 patients were screened, 78 enrolled (43 NBR and 35 HBR). Atazanavir use was significantly higher in HBR. Whilst a trend for lower CIT was seen in those with HBR, no significant differences were seen in PWV, bone markers, calculated cardiovascular risk (Framingham), or erectile dysfunction score. VCAM-1 levels were significantly lower in the HBR group. HBR was associated with lower LDL and triglyceride levels. NBR was associated with a calculated FRAX significantly lower than HBR although no associations were found after adjusting for tenofovir use. No difference in renal markers was observed. Component tests of NC testing revealed differences favouring HBR but overall composite scores were similar.High bilirubin in the context of boosted PI therapy was found not to be associated with differences in with the markers examined in this study. Some trends were noted and, on the basis of these, a larger, clinical end point study is warranted.

The HIV and Blood Borne Virus (BBV) Specialist Interest Group (SIG) has a remit to promote best clinical practice within the area of HIV/BBV (hepatitis B and C), to review evidence-based guidelines, to provide education, to fundraise and to comment on external consultations in this area on behalf of BASHH. Its 24 members are made up of consultants from across the country, as well as nursing and pharmacist members, staff and associate specialist doctors, community representation, and two specialist doctors in training. Our membership was recently reviewed to widen participation. We do not meet face to face, and the majority of our work is done via email. In the past year the SIG has commented on a number of consultations on behalf of BASHH. We formulated a response to the government consultation on the stance of the Department for International Development on HIV and AIDS. We responded to the National Institute for Health and Care Excellence (NICE) Quality Standard ‘HIV testing: encouraging uptake’, and also to …

Antiretroviral safety and efficacy and may differ in older versus younger HIV-infected patients. The objective of this study was to assess the pharmacokinetic (PK) profile in older HIV-infected subjects (60 years) switching combination antiretroviral therapy (cART) to a raltegravir (RAL) containing regimen.Nineteen HIV-infected patients over 60 years of age on effective cART (HIV-RNA 50 copies/ml) were enrolled in this prospective 24-week study. On day 1, patients switched to tenofovir/emtricitabine (245/200 mg once daily) and RAL (400 mg twice daily). On day 28, intensive PK sampling was undertaken in a fasted state and RAL plasma concentrations determined. Neurocognitive function was assessed at baseline and week 24 using a neuropsychological battery. RAL PK parameters were compared to those of two younger historical HIV-infected control groups that received twice-daily RAL co-administered with darunavir/ritonavir (DRV/r) 800/100 once daily by nonlinear mixed effects modelling.In HIV-infected subjects over the age of 60 (mean ± SD age: 66 ± 3.4 years, n = 19) switching to a RAL containing regimen, we observed no safety concerns, no plasma virological rebounds, and no differences in RAL apparent oral clearance when compared to younger HIV-infected populations (mean ± SD age: 41 ± 9.2 years, n = 38) based on population pharmacokinetic analysis. After 24 weeks of study therapy a decline in cognitive function was observed [change in (SD) global score of (0.91 (1.3), P = 0.018].No significant changes in RAL exposure associated with age were observed.

CINAMMON is a phase IV, open-label, single-arm, pilot study assessing maraviroc (MVC) in the central nervous system (CNS) when added to darunavir/ritonavir monotherapy (DRV/r) in virologically suppressed HIV-infected subjects. CCR5 tropic participants on DRV/r were recruited. Participants remained on DRV/r for 12 week (w) (control phase). MVC 150 mg qd was added w12-w36 (intervention phase). Lumbar puncture (LP) and neurocognitive function (Cogstate) examinations scheduled at baseline, w12 and w36; MRI before w12, again at w36. Primary endpoint was CSF inflammatory marker changes during intervention phase. Secondary endpoints included changes in NC function and MRI parameters. CSF/plasma DRV/r concentrations measured at w12 and w36, MVC at w36. Nineteen patients recruited, 15 completed (17M, 2F). Dropouts: headache (2), knee problem (could not attend, 1), personal reasons (1). Mean age (range) 45.4 years (27.2-65.1), 13/19 white, 10/19 MSM. No changes in selected CSF markers were seen w12-w36. Overall NC function did not improve w12-w36: total age adjusted z score improved by 0.27 (weighted paired t test; p = 0.11); for executive function only, age adjusted z score improved by 0.54 (p = 0.03). MRI brain parameters unchanged. DRV plasma:CSF concentration ratio unchanged between w12 (132) and w36 (112; p = 0.577, Wilcoxon signed-rank). MVC plasma:CSF concentration ratio was 35 at w36. No changes in neuroinflammatory markers seen. In this small study, addition of 24w MVC 150 mg qd to stable DRV/r monotherapy showed possible improvement in executive function with no global NC effect. Learning effect cannot be excluded. This effect should be further evaluated.

This article aims to review the term 'gay bowel syndrome', including the recent research looking at increased rates of bowel infections in men who have sex with men (MSM), particularly in light of the recent Shigella outbreaks in MSM in London and New York, and considers whether 'gay bowel syndrome' is a syndrome that really exists and is worthy of further research and specific treatment, or whether the term continues to be obsolete and not useful.Little or no recent research exists around the concept of a specific syndrome affecting the bowels of MSM. Rather, there seems to be a clustering of diseases in certain high-risk groups, especially those in urban areas with multiple sexual partners, recreational drug use, and possible concomitant HIV infection.All healthcare practitioners (including non-sexual health/HIV specialists) need to consider careful and thorough history taking (including sexual history) to identify those at risk.

International audience; To improve health outcomes in people living with HIV, adoption of evidence-based interventions (EBIs) using effective and transferable implementation strategies to optimise the delivery of healthcare is needed. ViiV Healthcare's Positive Pathways initiative was established to support the UNAIDS 90-90-90 goals. A compendium of EBIs was developed to address gaps within the HIV care continuum, yet it was unknown whether efforts existed to adapt and implement these EBIs across diverse clinical contexts. Therefore, this review sought to report on the use of implementation science in adapting HIV continuum of care EBIs. A systematic literature review was undertaken to summarise the evaluation of implementation and effectiveness outcomes, and report on the use of implementation science in HIV care. Ten databases were reviewed to identify studies (time-period: 2013-2018; geographic scope: United States, United Kingdom, France, Germany, Italy, Spain, Canada, Australia and Europe; English only publications). Studies were included if they reported on people living with HIV or those at risk of acquiring HIV and used interventions consistent with the EBIs. A broad range of study designs and methods were searched, including hybrid designs. Overall, 118 publications covering 225 interventions consistent with the EBIs were identified. These interventions were evaluated on implementation (N = 183), effectiveness (N = 81), or both outcomes (N = 39). High variability in the methodological approaches was observed. Implementation outcomes were frequently evaluated but use of theoretical frameworks was limited (N = 13). Evaluations undertaken to assess effectiveness were inconsistent, resulting in a range of measures. This review revealed extensive reporting on implementation science as defined using evaluation outcomes. However, high variability was observed in how implementation outcomes and effectiveness were defined, quantified, and reported. A more specific and consistent approach to conducting and reporting on implementation science in HIV could facilitate achievement of UNAIDS 90-90-90 targets.

With increasingly successful management of HIV, focus has shifted away from AIDS-related complications to other chronic co-morbidities. For HIV-related cognitive problems, the true aetiopathogenesis and epidemiology remains unclear. Rather than a systematic review, this paper presents the challenges and the opportunities we faced in establishing our own clinical service. Papers were identified using Pubmed and the terms "screening", "HIV" and "neurocognitive". This article covers the background of HIV-associated neurocognitive disorders (HAND) with a focus on HIV-related neurocognitive impairment (NCI), detailing classification, prevalence, diagnostic categories and diagnostic uncertainties. Screening is discussed, including a comparison of the available screening tools for cognitive deficits in HIV-infected patients and the importance of practice effects. Discussed also are the normal ranges and the lack thereof and potential investigations for those found to have impairments. We conclude by discussing the role of NCI screening in routine clinical care at the current time.

This study aimed to determine the prevalence of HIV neurocognitive impairment in HIV-infected men who have sex with men aged 18–50 years, using a simple battery of screening tests in routine clinical appointments. Those with suspected abnormalities were referred on for further assessment. The cohort was also followed up over time to look at evolving changes. HIV-infected participants were recruited at three clinical sites in London during from routine clinical visits. They could be clinician or self-referred and did not need to be symptomatic. They completed questionnaires on anxiety, depression, and memory. They were then screened using the Brief Neurocognitive Screen (BNCS) and International HIV Dementia Scale (IHDS). Two hundred and five HIV-infected subjects were recruited. Of these, 59 patients were excluded as having a mood disorder and two patients were excluded due to insufficient data, leaving 144 patients for analysis. One hundred and twenty-four (86.1%) had a normal composite z score (within 1 SD of mean) calculated for their scores on the three component tests of the BNCS. Twenty (13.9%) had an abnormal z score, of which seven (35%) were symptomatic and 13 (65%) asymptomatic. Current employment and previous educational level were significantly associated with BNCS scores. Of those referred onwards for diagnostic testing, only one participant was found to have impairment likely related to HIV infection. We were able to easily screen for mood disorders and cognitive impairment in routine clinical practice. We identified a high level of depression and anxiety in our cohort. Using simple screening tests in clinic and an onward referral process for further testing, we were not able to identify neurocognitive impairment in this cohort at levels consistent with published data.

Renal toxicity in a 73-year-old male, using tenofovir/emtricitabine as preexposure prophylaxis, is described. Reduced renal reserve, a higher exposure to comedications and comorbidities can present a challenge when assessing the risks and benefits of tenofovir-based preexposure prophylaxis in the ageing population.

PURPOSE OF REVIEW Postexposure prophylaxis (PEP) has become an important part of combined approaches to the prevention of onward HIV transmission. As PEP becomes more widely available after sexual as well as occupational exposure, there are ongoing debates about cost-effectiveness and utility. Different regions have adopted different PEP strategies and the availability of new antiretroviral drugs and classes means that options for PEP regimens are increasing. This review is timely and of importance as it summarizes the evidence supporting current PEP usage and discusses potential future strategies for PEP prescribing. RECENT FINDINGS This review covers the biology and risk of HIV transmission and evidence supporting the use of PEP. It gives a summary of current guidelines including which agents to use, the potential for drug-drug interactions, possible alternative and potential novel PEP regimens, cost-effectiveness and research on effects of PEP on sexual behaviour. SUMMARY While reinforcing current practice around PEP prescribing, this review discusses possible future developments including the use of new antiretroviral drugs, new classes of antiretroviral drugs or novel strategies for PEP which are likely to be areas of research in the near future.

15 pages, 8 figures.-- PMID: 18195071 [PubMed].-- PMCID: PMC2234371., The EuroVacc 02 phase I trial has evaluated the safety and immunogenicity of a prime-boost regimen comprising recombinant DNA and the poxvirus vector NYVAC, both expressing a common immunogen consisting of Env, Gag, Pol, and Nef polypeptide domain from human immunodeficiency virus (HIV)-1 clade C isolate, CN54. 40 volunteers were randomized to receive DNA C or nothing on day 0 and at week 4, followed by NYVAC C at weeks 20 and 24. The primary immunogenicity endpoints were measured at weeks 26 and 28 by the quantification of T cell responses using the interferon enzyme-linked immunospot assay. Our results indicate that the DNA C plus NYVAC C vaccine regimen was highly immunogenic, as indicated by the detection of T cell responses in 90% of vaccinees and was superior to responses induced by NYVAC C alone (33% of responders). The vaccine-induced T cell responses were (a) vigorous in the case of the env response (mean 480 spot-forming units/106 mononuclear cells at weeks 26/28), (b) polyfunctional for both CD4 and CD8 T cell responses, (c) broad (the average number of epitopes was 4.2 per responder), and (d) durable (T cell responses were present in 70% of vaccinees at week 72). The vaccine-induced T cell responses were strongest and most frequently directed against Env (91% of vaccines), but smaller responses against Gag-Pol-Nef were also observed in 48% of vaccinees. These results support the development of the poxvirus platform in the HIV vaccine field and the further clinical development of the DNA C plus NYVAC C vaccine regimen., The Ev02 clinical trial has been sponsored by the EuroVacc Foundation. The EuroVacc program has been supported by the European Commission fifth framework program under research grants QLK2-CT-1999-01321, QLK2-CT-2001-01316, and QLK2-CT-2002-01431.

Many novel agents are being developed for the management of HIV-1 infection. In currently available classes, there are new protease inhibitors, non-nucleoside and nucleotide reverse transcriptase inhibitors, all in various stages of development. Novel classes include co-receptor entry antagonists (e.g., CCR5 inhibitors) as well as integrase and maturation inhibitors. Data on the pharmacodynamics and the pharmacokinetics of these new agents continue to generate interest. This article will report on the known data of the pharmacokinetics of experimental antiretrovirals, particularly concentrating on recently presented data, and describe the main drug–drug interactions studied to date.

Background. The optimal penetration of antiretroviral agents into the central nervous system may be a balance between providing adequate drug exposure to inhibit human immunodeficiency virus (HIV) replication while avoiding concentrations associated with neuronal toxicities. Methods. Cerebrospinal fluid (CSF) exposure of efavirenz and the metabolites 7-hydroxy (7OH) and 8-hydroxy (8OH) efavirenz were assessed after at least 12 weeks of therapy in HIV-infected subjects randomized to commence antiretroviral regimens containing efavirenz at either 400 mg or 600 mg once daily. Results. Of 28 subjects (14 and 14 on efavirenz 400 mg and 600 mg, respectively), CSF HIV RNA was undetectable in all. Geometric mean CSF efavirenz, 7OH-, and 8OH-efavirenz concentrations (with 90% confidence intervals [CIs]) for the 400-mg and 600-mg dosing groups were 16.5 (13-21) and 19.5 (15-25) ng/mL; 0.6 (.4-.9) and 0.6 (.4-1) ng/mL; and 5.1 (4.0-6.4) and 3.1 (2.1-4.4) ng/mL, respectively. Efavirenz concentration in CSF was >0.51 ng/mL (proposed CSF 50% maximal inhibitory concentration for wild-type virus) in all subjects, and 8OH-efavirenz concentration in CSF was >3.3 ng/mL (a proposed toxicity threshold) in 11 of 14 and 7 of 14 subjects randomized to the 400 mg and 600 mg doses of efavirenz, respectively. Whereas CSF efavirenz concentration was significantly associated with plasma concentration (P

Introduction : Tenofovir is a commonly used component of antiretroviral therapy (ART) to reduce vertical transmission of HIV. Although systematic review of tenofovir use in pregnancy concluded it to be low risk for foetal abnormalities [ 1 ], data is limited on its impact on renal function in pregnant women. A recent South African study [ 2 ] concluded that renal dysfunction in HIV-infected pregnant women is significantly less common than in other HIV-infected adults, however there is currently no UK data. We aimed to investigate the effect of tenofovir on renal function in HIV-1 positive pregnant women in a UK clinic. Methods : We retrospectively analyzed data on renal function in pregnancy from a cohort of women attending a busy inner city London antenatal clinic. All women were screened for renal function throughout pregnancy via serum creatinine and estimated glomerular filtration rate (eGFR) calculated using modification of diet in renal disease (MDRD) and corrected for ethnicity. Results : Ninety-seven HIV-1 positive women were registered at Homerton Hospital antenatal service of a total of 105 pregnancies between January 2010 and September 2013. Tenofovir was prescribed in 71/105 pregnancies (67.6%). Of the 71 pregnancies, 41 were prescribed tenofovir pre-conception (57.7%). Of the pregnant women who started tenofovir in pregnancy, 21/31 (67.7%) were initiated before week 24 of pregnancy, in line with British HIV association (BHIVA) guidelines [ 3 ]. There was no deterioration in median serum creatinine or decline in eGFR in women prescribed tenofovir during pregnancy. At six weeks after delivery, in the 42 women who continued tenofovir therapy and had eGFR measured, one woman had eGFR=60, all others eGFR >90 ( Table 1 ). Conclusions : Consistent with current guidelines and experience, this study shows tenofovir did not cause decline in renal function in pregnancy in our cohort of HIV-1 positive women, whether started during pre-conception or during pregnancy. More evidence should be prospectively collected looking at effects of tenofovir on other measures of tubular renal function in pregnancy such as proteinuria and protein-creatinine ratio. (Published: 2 November 2014) Citation : Flanagan S et al. Journal of the International AIDS Society 2014, 17(Suppl 3) :19694 http://www.jiasociety.org/index.php/jias/article/view/19694 | http://dx.doi.org/10.7448/IAS.17.4.19694

Introduction : We have previously shown in the SSAT 044 study that unconjugated hyperbilirubinaemia in subjects receiving a boosted protease inhibitor (PI/r) has limited impact on renal, cardiovascular (CV) and bone biomarkers, as well as on neurocognitive performance, relative to those receiving PI/r with a normal bilirubin. We present here a secondary analysis comparing markers in those receiving abacavir- vs tenofovir- based antiretroviral therapy (ART). Materials and Methods : This cross-sectional study included 101 HIV-1 infected individuals stable (HIV RNA 6 months) on antiretroviral regimens including tenofovir (TDF)/emtricitabine or abacavir/lamivudine plus a ritonavir boosted PI. Results : Forty-three subjects had normal bilirubin (NBR) levels and 35 had high bilirubin (>2.5 times upper limit); the remaining 23 patients had intermediate bilirubin levels or violated the protocol. The mean age of participants was 48 years; 93% were male and 84% Caucasian; 22 received ABC-based therapy and 78 TDF. No differences were seen in cardiovascular markers: Framingham (10-year risk % median, IQR): ABC 8.1, 5.6–15.3; TDF 9.5, 4.8–13.4 (p=ns); pulse wave velocity and carotid intimal thickness also showed no significant differences. No differences were seen in bone parameters: Calcaneal Stiffness Index (median score, IQR): ABC −0.5, −0.8 to 0.8; TDF −0.5, 1.4–0.4 (p=ns); 10 year FRAX score (% median, IQR): ABC 5.0, 2.4–6.2; TDF 3.6, 2.5–5.8 (p=ns). There were differences in renal parameters as shown in Table 1. We show statistically significant differences in urine protein/creatinine ratio (uPCR) (10 vs 7; p=0.004) and urine albumin/creatinine ratio (uACR) (15 vs 8; p=0.002), with both being higher in the TDF group. Conclusions : Tenofovir use is associated with excess loss of proteins including those typically resorbed in the renal tubule. Abacavir use was not associated with an increase in biomarkers of CV risk or vascular dysfunction. (Published: 2 November 2014) Citation : Abstracts of the HIV Drug Therapy Glasgow Congress 2014 Barber T et al. Journal of the International AIDS Society 2014, 17(Suppl 3) :19562 http://www.jiasociety.org/index.php/jias/article/view/19562 | http://dx.doi.org/10.7448/IAS.17.4.19562

Studies have suggested CD8 lymphocytes may be a possible marker for inflammation, which is believed to be a contributing factor to neurocognitive impairment. Individuals enrolled in the MSM Neurocog Study were analysed. Those with depression, anxiety or mood disorders were excluded. Individuals with neurocognitive impairment were identified using the Brief NeuroCognitive Screen and compared to those with normal scores. CD4 and CD8 T cell values and CD4:CD8 ratios were compared between groups. In all, 144 men, aged 18–50 years, were included in the analysis. Twenty were diagnosed with neurocognitive impairment. We were unable to identify any significant difference between current, nadir or peak CD4 and CD8 counts. CD4:CD8 ratios and CD4:CD8 ratio inversion (

Despite ever improving advances in antiretroviral therapy, neurocognitive impairments such as asymptomatic and mild neurocognitive impairment remain a significant problem for the HIV-positive population. We distributed a post-neurocognitive impairment screening service evaluation questionnaire to assess satisfaction and anxiety. Subjects were HIV positive and aged 18-50. They were screened using the Brief Neurocognitive Score and International HIV Dementia Score as well as undergoing screening for anxiety (Generalised Anxiety Disorder Assessment [GAD-7]), depression (Participant Health Questionnaire Mood Scale [PHQ-9]) and memory (Everyday Memory Questionnaire [EMQ-R]). On completion, they were either reassured that the tests were normal or were referred for further investigation. Following assessment, subjects were asked to complete an anonymous satisfaction survey; 101 surveys were analysed. Forty-nine per cent of participants stated that they "felt better" following screening, 43% said it "made no difference", 6% stated it "worried me" and 1% "did not understand". On a scale of 0-10 of helpfulness, the mean score was 7.53. Forty-seven subjects indicated that they were referred for further investigation and 46 subjects that nothing else was needed; 8 reported they did not know. Those referred on rated satisfaction at a mean of 7.54/10 and those with normal screen as 7.09/10 (p = 0.46). Of the groups that were referred for further investigation, 6% said the test "worried them" compared to 4% in the non-referred group. Forty-nine per cent said they "felt better" despite an abnormal result compared to 50% in a normal screening result (p = 0.76). The results of this survey show that screening for neurocognitive impairment by this method is acceptable and helpful to participants. It did not lead to an increase in anxiety and there was no correlation between referred for further investigations and anxiety suggesting concerns about creating undue anxiety by screening and referral are unfounded.

The recent decade marked two quite important trends in the economic landscape of the European Union. The first one was the expansion of the Union to include former Soviet bloc countries, including the big enlargement of 2004 followed by the accession of Bulgaria and Romania in 2007. This was a huge challenge for the EU, as the impact of opening the economic space to markets so divergent in terms of economic development was largely unknown.The economic impact of the EU enlargement started to unravel, to a great extent, amidst the global financial crisis and the ensuing recession in Europe. This was a period of significant strain for public finances. Weak economic activity, increased unemployment combined with the relatively wide social welfare protection in most EU countries resulted in a sharp worsening of the fiscal balance. In fact, social expenditure (including old-age pensions) currently takes more than half of all government spending in most EU countries. As a share of GDP, its share has gradually grown to exceed 30%. In some countries, the last five years saw an increase in social expenditure of 5 percent (of GDP).At the same time, in recent years the free movement of people in the EU has gained speed. It has been facilitated by the gradual removal of all barriers to the employment of workers from the new Member States which were applied to a different extent by some of the old Member States. As a result, the number of EU migrants increased substantially between 2005 and 2013. By 2013, there were 13.7 million EU citizens living in another EU country, which is 2.7% of the entire population of the Union.This raises the valid question about the impact of the free movement of people on the economy of the destination country. Migrants change the demographic profile of cities and regions, they affect the labour market, they pay taxes and they claim benefits. The evaluation of the net fiscal impact of non-native EU-citizens residing in other EU countries is a complex task, requiring a number of credible key assumptions, detailed data on various items of public spending and revenues, in addition to precise information on migration flows and population, and this information is not always available. Most of the recent studies suggest that immigrants have a rather small impact on the host country’s public finances. Notwithstanding the methodologies used, coverage or assumptions, the bulk of academic research estimates the net fiscal impact of immigrants to vary in the range of ± 1% of GDP.The fiscal impact of migrants depends, to a great extent, on the way social security systems are financed; there is a different mix of social security contributions and general taxation in each EU country. The reliance on these contributions has been gradually eroding, as less than half of the social expenditure can be covered by the contribution. This is a result of both the introduction and enlargement of non-contributory benefit schemes and the demographic challenges faced by the health and pension systems in most countries. Moreover, even supplementing social contributions with personal income tax revenues cannot cover the entire cost of the welfare systems. The revenues from social contributions together with the taxes on individual or household income were 21.7% of GDP in EU-27 in 2005, and remained relatively stable throughout the years until 2012 when they reached 22.5% of GDP, according to Eurostat. At the same time, total social expenditure stood at 27% of GDP in the EU-27 in 2004, while in 2010 it exceeded 29%. The transfer from other government revenue (i.e. other taxes and levies) grew from 5.3% to 7.1% between 2005 and 2011. If direct taxes and contributions alone are taken into account, a typical employee in the EU is a net beneficiary of the social security system.This study was undertaken to estimate some aspects of the net fiscal impact of EU migrants in four EU countries – Austria, Germany, the Netherlands and the United Kingdom. The report outlines the role of migrants from EU countries as participants in the labour market, as taxpayers and as benefit recipients also.

The incidence of HIV-associated dementia has decreased significantly with the introduction of combination antiretroviral therapy; however, milder or more subtle forms of neurocognitive disorders associated with HIV appear to remain common. There is a lack of consensus on when to screen and on which methods are most appropriate for identifying patients at risk of neurocognitive impairment. Multiple factors (demographic, social, genetic, psychological and medical) can play a role in its aetiology and progression, including potential central nervous system toxicity of antiviral therapy. It is important to identify these factors in order to apply relevant management strategies. In this review, we discuss a series of case studies that address some of the challenges presented by the diagnosis and management of HIV-associated neurocognitive impairment in different patient types.

Background/introduction Quarterly monitoring of creatinine is likely to be recommended by WHO for those on PrEP, even though there were no significant differences in creatinine in placebo-controlled trials. Establishing the appropriate level of monitoring of PrEP is important. Methods PROUD is an open-label, randomised trial of Truvada as PrEP in MSM. HIV serology and serum creatinine was done at PrEP baseline (‘start’). Clinics were advised to collect creatinine or urinary protein-creatinine ratio (UPCR) if there was ≥1+ protein on urinalysis at the month 1 visit (m1). Here’we present the renal monitoring results at “start” and m1 with eGFR (ml/min/1.73m 2 ) calculated by the CKD-EPI equation. Results 445 (93%) of 481 had baseline creatinine, 13 (3%) had UPCR, and 23 (5%) neither. The median eGFR was 106. Only one was 90 dropped 20%, one to 59. He stopped PrEP and did not attend thereafter. Of the 7, none had abnormal urinalysis; 4 had UPCR – all normal. 41 (79%) of 52 with eGFR 60–90 at baseline remained at this level, the remainder increased to >90. Discussion/conclusion The mean change in eGFR at month 1 is not clinically significant. Excepting one individual who could not be further evaluated, there were no clinically meaningful changes at m1. Further work will explore the relationships between eGFR and proteinuria.

Background/introduction The FTD™ Urethritis Plus (FTDU) nucleic acid amplification test (NAAT) detects seven pathogens associated with urethritis, including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium, Trichomonas vaginalis, Mycoplasma hominis, Ureaplasma urealyticum and Ureaplasma parvum. Aim(s)/objectives To perform an initial diagnostic evaluation of FTDU performance for NG and CT, compared to routine clinic NAAT (BD Viper), in prospectively collected genital samples from symptomatic patients. Methods Alongside routine clinical samples, additional samples (n = 684) were taken from symptomatic patients: females (vulvovaginal swabs; VVS), men-who-have-sex-with-women (MSW) (urine) and men-who-have-sex-with-men (MSM) (rectal and pharyngeal swabs; urine). Results The prevalence of CT was 9.38% across sample sites tested (24 Female, 21 Male, 3 MSM Urine, 1 MSM Pharynx and 5 MSM Rectal positives). The prevalence of NG was 9.74% across sample sites tested (5 Female, 6 Male, 10 MSM Urine, 17 MSM Pharynx and 19 MSM Rectal positives). Discussion/conclusion FTDU was accurate for detecting CT from genital sites only and had poor sensitivity for NG at all sampling sites. This test could not be used for NG testing for urine or extra genital testing without supplementary testing according to the BASHH guidelines as the PPV is below 90%. Further work is required to establish its suitability for detecting the other organisms claimed.

Background/introduction LGBTI individuals are at significantly increased risk of STI’s and HIV, as well as sexual violence and discrimination. The need for specialist LGBTI services in level 3 GUM settings is increasingly recognised and also subscribes to BASHH equality and diversity standards. We established a new LGBTI specialist clinic and present here a service evaluation of its first 8 months. Aim(s)/objectives To evaluate a new LGBTI service. Methods Coding for all patients who accessed the service over an 8 month period was collated and used to garner basic information about diagnoses. A 4 week period was then chosen at random and individual patient notes were accessed to get more detailed information. Results There were 526 attendances for 450 individual patients. The rates of STI’s compared to our general clinics are tabled below. In the 4 week period there were 104 booked attendances. The age range was 19 – 75 (mean: 37.1). Of the 92 patients who attended 59% had at least one diagnosis with 13% having multiple diagnoses. 26% were HIV positive. Discussion/conclusion The high STI and HIV rates in this group suggest they will benefit from a specialist service. This involves a reconfiguration of staff compared to general clinics to account for increased requirements for treatments, injections and counselling. An additional qualitative assessment demonstrated that the clinic was also extremely well received by patients.

Background/introduction With the efficacy of HIV pre-exposure prophylaxis (PrEP) proven, provision of PrEP is currently being evaluated by commissioners. The question of who would wish to access PrEP, and where, is important in informing this process. Aim(s)/objectives To establish potential users’ attitudes towards, and experiences of, PrEP. Methods Ethical approval was obtained to conduct a multi-centre, prospective, anonymised questionnaire study of 1000 HIV negative MSM accessing sexual health clinics. Sexual behaviour, drug use, STI history and previous post exposure prophylaxis (PEP) use were collected. Opinions and attitudes towards PrEP and PrEP availability were assessed. Results Of 386 analysed questionnaires the majority were British-born (203, 53%), white (300, 78%) men. 345 (89%) reported anal sex within the last month with 168 (43%) and 139 (36%) reporting unprotected insertive and receptive anal intercourse, respectively (103, (26%) and 64, (17%) with multiple partners). 194 (50%) had recently used recreational drugs (within 3 months; 34% “Chemsex” substances). 157 (41%) reported a recent STI (6 months). 223 (58%) reported that they strongly believed they would benefit from PrEP. However, 42/223 (19%) reported no condomless sex. Concerns around taking PrEP were cited by 76 (20%). 167 (43%) expressed a preference for daily PrEP; 139 (38%) for coitally-driven. 311 (80%) supported PrEP delivery by sexual health clinics to MSM, and 233 (60%) to any-one who requests it. 112 (29%) agreed a prescription charge was appropriate. 17 respondents (4%) reported having already taken PrEP: 35% using medication acquired as PEP, and 30% acquiring PrEP privately. 7/17 (41%) reported decreased condom since commencing PrEP. Discussion/conclusion This comprehensive questionnaire study demonstrates a high willingness to use PrEP in a cohort of at-risk MSM. These data should inform the commissioning process of this efficacious biological intervention.

Background/introduction Mycoplasma genitalium (MG), a sexually transmitted infection (STI), is increasingly recognised as a cause of major reproductive health sequelae. Treatment has become increasingly difficult due to macrolide and fluoroquinolone antibiotic resistance. MG is not routinely tested for in most UK genitourinary medicine (GUM) clinics, and limited risk-factor data exist for infection in at-risk populations and in different anatomical sites. Aim(s)/objectives To determine risk factors for MG infection in symptomatic male and female patients accessing three London GUM clinics. Methods Patients aged ≥16 years, symptomatic of an STI (or Chlamydia, Gonorrhoea, Trichomonas vaginalis, or non-specific urethritis contact) were consented. Additional-to-routine samples provided were vulvovaginal swab (VVS) (females), first void urine (FVU) (men-who-have-sex-with-women (MSW), (men-who-have-sex-with-men (MSM)), pharyngeal and rectal swabs (MSM). Samples were tested using the FTD Urethritis Plus Test kit and positives confirmed by Polymerase Chain Reaction. Risk factors were analysed using univariate and multivariate logistic regression. Results MG was detected in: 10.7% (95% CI 7.9%–13.5%) patients; 7.9% (95% CI 4.86%–10.94%) VVS; 19.4% (95% CI 11.76%–27.04%) MSW urine; 1.6% (95% CI 0%–4.72%) MSM urine; 0% MSM pharynx; 8.1% (95% CI 1.31%–14.89%) MSM rectum. Discussion/conclusion MG positivity was highest in MSW compared to the other patient groups, with younger age being the only risk factor for infection, remaining after multivariate analysis. The presence of rectal MG despite a lack of urogenital infection in MSMs warrants further investigation with a larger cohort. Overall the results indicate high MG positivity across symptomatic male and female populations.

Background/introduction This clinic opened in 2015 offering a weekly specialist sexual health service for our LGBTQ community. Burden of pathology is high, suggesting a potentially more stressful environment for patients. All medical and non-medical staff were trained on LGBTQ sexual health issues and some on Club Drug related issues. Aim To assess patient satisfaction with the new service, a questionnaire was undertaken seven months after service commencement. Methods Over a four-week period, questionnaires were handed to patients by reception at booking. Thirty-six questionnaires were returned. Results Patients rated the service as excellent 81% (26/32) very good 14% (5/32) or good 3% (1/32). All patients who answered said they would attend again 100% (32/32). Most would recommend it to a friend 97% (32/33). Patient staff satisfaction was high, with 96% (29/30) stating they felt listened to. Patients felt treated with respect and dignity always 97% (31/32) or sometimes 3% (1/32). 83% (30/36) of patients attended specifically with LGBTQ concerns, of these 93% (28/30) felt confident in discussing concerns with staff, 7% (2/30) to some extent. 77% (24/31) indicated that drugs or alcohol were related to their visit. Only 21% (5/24) felt they could raise this topic with staff and 79% (19/24) stated they couldn’t. Discussion Staff training on managing vulnerable clients’ health needs enables confidant and approachable health care. This provides patients with opportunities to verbalise health anxieties, facilitating opportunistic healthcare interventions. Drug and Alcohol training for all staff will enhance the patient care package.