Clinical and Epidemiological Characteristics of the 2022 Mpox Outbreak in Spain (CEME-22 Study).

Background: We conducted a multicentric national study (SEIMC-CEME-22), to describe the clinical and epidemiological profile of the mpox outbreak in Spain, including the management of the disease. Methods: This was a retrospective national observational study conducted by Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC) and Foundation SEIMC-GESIDA. We included patients with a confirmed mpox diagnosis before 13 July 2022, and attended at the Spanish health network (the early phase of the outbreak). Epidemiological, clinical, and therapeutic data were collected. Results: Of a total of 1472 patients from 52 centers included, 99% of them were cisgender men, mostly middle-aged, and 98.6% were residents in Spain. The main suspected route of transmission was sexual exposure, primarily among MSM. Occupational exposure was reported in 6 patients. Immunosuppression was present in 40% of patients, mainly due to human immunodeficiency virus (HIV). Only 6.5% of patients had been vaccinated against orthopoxvirus. Virus sequencing was performed in 147 patients (all B.1 lineage). Rash was the most frequent symptom (95.7%), followed by fever (48.2%), adenopathies (44.4%) myalgias (20.7%), proctitis (17%), and headache (14.7%). Simultaneously diagnosed sexually transmitted infections included syphilis (n = 129), gonococcal infection (n = 91), HIV (n = 67), chlamydia (n = 56), hepatitis B (n = 14), and hepatitis C (n = 11). No therapy was used in 479 patients (33%). Symptomatic therapies and antibiotics were used in 50% of cases. The most used therapy regimens were systemic corticoids (90 patients), tecovirimat (6 patients), and cidofovir (13 patients). Smallpox immunoglobulins were used in 1 patient. Fifty-eight patients were hospitalized, and 1 patient died. Conclusions: Mpox outbreak in Spain affected primarily middle-aged men who were sexually active and showed a high rate of HIV infection. A range of heterogeneous therapeutics options was performed.

Predictors of poor health-related quality of life among people living with HIV aged ≥60 years in the PISCIS cohort: Findings from the Vive+ project.

INTRODUCTION: Advancements in and accessibility to effective antiretroviral therapy has improved the life expectancy of people living with HIV, increasing the proportion of people living with HIV reaching older age (≥60 years), making this population's health-related quality of life (HRQoL) more relevant. Our aim was to identify the determinants of poor HRQoL in people living with HIV aged ≥60 years and compare them with those of their younger counterparts. METHODS: We used data from the 'Vive+' study, a cross-sectional survey conducted between October 2019 and March 2020, nested within the PISCIS cohort of people living with HIV in Catalonia and the Balearic Islands, Spain. We used the 12-item short-form survey (SF-12), divided into a physical component summary (PCS) and a mental component summary (MCS), to evaluate HRQoL. We used the least absolute shrinkage and selection operator for variable selection and used multivariable regression models to identify predictors. RESULTS: Of the 1060 people living with HIV (78.6% males) who participated in the study, 209 (19.7%) were aged ≥60 years. When comparing older people living with HIV (≥60 years) and their younger counterparts, older people exhibited a worse PCS (median 51.3 [interquartile range {IQR} 46.0-58.1] vs. 46.43 [IQR 42.5-52.7], p < 0.001) but a similar MCS (median 56.0 [IQR 49.34-64.7] vs. 57.0 [IQR 48.9-66.3], p = 0.476). In the multivariable analysis, cognitive function correlated with a PCS (ß correlation factor [ß] -0.18, p = 0.014), and depressive symptoms and satisfaction with social role correlated with an MCS (ß 0.61 and ß -0.97, respectively, p < 0.001) in people living with HIV aged ≥60 years. CONCLUSION: Depressive symptoms, poor cognitive function, and lower satisfaction with social roles predict poorer HRQoL in older people living with HIV. These factors need to be considered when designing targeted interventions.

HIV and SARS-CoV-2 Co-infection: Epidemiological, Clinical Features, and Future Implications for Clinical Care and Public Health for People Living with HIV (PLWH) and HIV Most-at-Risk Groups.

PURPOSE OF REVIEW: The purpose of this review is to use the currently available clinical and epidemiological data, to identify key aspects to improve both the clinical management and public health response to SARS-CoV-2/HIV co-infection among HIV vulnerable populations and people living with HIV (PLWH). RECENT FINDINGS: While at the beginning of the COVID-19 pandemic, the lack of robust information on SARS-CoV-2/HIV co-infection, prevented a clear picture of the synergies between them, currently available data strongly support the importance of common structural factors on both the acquisition and clinical impact of these infections and the relevance of age, comorbidities, and detectable HIV viral load as associated worse prognostic factors among PLWH. Although more information is needed to better understand the biological, clinical, and epidemiological relationship between both infections, a syndemic approach to prevent SARS-CoV-2 among HIV high-risk groups and PLWH, targeting these populations for SARS-CoV-2 vaccines and protocolizing early identification of PLWH with worse COVID-19 prognosis factors, is crucial strategies to decrease the overall impact of SARS-CoV-2 /HIV co-infection.

Recent trends in sexually transmitted infections among adolescents, Catalonia, Spain, 2012-2017.

Monitoring sexually transmitted infections (STIs) in adolescents is essential to inform STI prevention strategies at primary and secondary levels in this key population. We aim to describe recent trends in STIs among adolescents and to analyse their socio-demographic and behavioural characteristics in Catalonia, Spain between 2012 and 2017. Data on Chlamydia trachomatis (CT) infection, gonorrhoea and syphilis cases aged from 13 to 19 years reported to the Catalan Mandatory Notifiable System from 2012 to 2017 were analysed. Diagnosis rates were calculated and a descriptive analysis was performed. Between 2012 and 2017, CT infection, gonorrhoea and syphilis cases reported among adolescents aged 13-19 years accounted for more than one-eleventh of all reported cases in Catalonia. The rate of the three nationally-notifiable STIs increased dramatically among adolescents. CT infection rates rose from 13 to 144.1 per 100,000 adolescents between 2012 and 2017, an increase of 1007%; gonorrhoea cases increased by 246% (from 13.4 to 45.4/100,000) and syphilis cases increased by 247% (from 1.7 to 5.9/100,000). Gonorrhoea and syphilis cases affected mainly males while CT infection cases were mostly in females (84%). Adolescents are being increasingly affected by CT infection, gonorrhoea and syphilis. A broader array of intervention strategies aimed at adolescents should be reinforced through strong prevention campaigns, improved sexual health information, as well as encouragement of regular offers of STI screening by healthcare providers.

Evaluation of the Xpert HCV VL Fingerstick point-of-care assay and dried blood spot HCV-RNA testing as simplified diagnostic strategies among people who inject drugs in Catalonia, Spain.

BACKGROUND: Catalonia requires decentralized and simplified strategies for the diagnosis of viremic HCV infection among people who inject drugs (PWID). We aimed to perform a direct comparison of the diagnostic performance between two, single-step strategies for the screening and diagnosis of viremic HCV infection in PWID attending a drug consumption room (DCR) in Barcelona: i) on-site HCV-RNA testing using the point-of-care test (PoCT) Xpert HCV VL Fingerstick; and ii) on-site dried blood spots (DBS) collection for HCV-RNA testing at the laboratory (in-house assay). Additionally, we aimed to assess participants' preferences in receiving HCV-RNA testing results and feasibility of same-day delivery of PoCT results. METHODS: The real-world, clinical performance of these two strategies was established in comparison with the reference method (HCV viral load testing with the Xpert HCV Viral Load assay at the laboratory from venous plasma collected at the DCR). HCV genotypes/subtypes and HIV status were also determined by sequencing and serology, respectively. A questionnaire including preferences regarding the delivery of test results was administered. RESULTS: The prevalence of HCV-RNA was 63.0% (of which 25.8% were co-infected with HIV). The RNA-PoCT showed a sensitivity of 98.4% for detectable viral loads (>4 IU/mL) and of 100% for quantifiable viral loads (≥10, ≥1000 and ≥3000 IU/mL). For the DBS-based assay, a sensitivity of 93.7% was obtained for detectable viral loads, 96.7% for the quantifiable ≥10 IU/mL threshold, and 98.3% for both the quantifiable ≥1000 and ≥3000 IU/mL thresholds. No significant differences were detected between the sensitivity values of these two strategies, and the specificity was 100% in both cases. Half of the participants preferred to receive the HCV-RNA result on the same day, and 80% of participants received their RNA-PoCT results on the same day. CONCLUSIONS: Both the HCV-RNA PoCT and the DBS-based assay are highly reliable tools for the simplified diagnosis of viremic HCV infection among current PWID. These strategies allow for on-site sample collection and delivery of test results, facilitating decentralized care in harm reduction services.

Discontinuation of dolutegravir, elvitegravir/cobicistat and raltegravir because of toxicity in a prospective cohort.

OBJECTIVES: The aim of the study was to assess the rates of discontinuation of integrase inhibitor regimens because of any neuropsychiatric adverse event (NPAE) and the factors associated with discontinuation. METHODS: A population-based, prospective, multicentre cohort study was carried out. Treatment-naïve subjects starting therapy with a regimen containing integrase inhibitors, or those switching to such a regimen, with plasma HIV-1 RNA < 50 HIV-1 RNA copies/mL in 14 hospitals in Catalonia or the Balearic Islands (Spain) were included in the study. Every discontinuation because of adverse events (AEs) was double-checked directly with treating physicians. Multivariable Cox models identified factors correlated with discontinuation. RESULTS: A total of 4165 subjects (37% treatment-naïve) started regimens containing dolutegravir (n = 1650; 91% with abacavir), raltegravir (n = 930) or elvitegravir/cobicistat (n = 1585). There were no significant differences among regimens in the rate of discontinuation because of any AE. Rates of discontinuation because of NPAEs were low but higher for dolutegravir/abacavir/lamivudine [2.1%; 2.9 (95% confidence interval (CI) 2.0, 4.2) discontinuations/100 patients/year] versus elvitegravir/cobicistat (0.5%; 0.8 (95% CI 0.3, 1.5) discontinuations/100 patients/year], with significant differences among centres for dolutegravir/abacavir/lamivudine and NPAEs (P = 0.003). We identified an association of female gender and lower CD4 count with increased risk of discontinuation because of any AE [Incidence ratio (IR) 2.3 (95% CI 1.4, 4.0) and 1.8 (95% CI 1.1, 2.8), respectively]. Female gender, age > 60 years and abacavir use were not associated with NPAE discontinuations. NPAEs were commonly grade 1-2, and had been present before and improved after drug withdrawal. CONCLUSIONS: In this large prospective cohort study, patients receiving dolutegravir, raltegravir or elvitegravir/cobicistat did not show significant differences in the rate of discontinuation because of any toxicity. The rate of discontinuations because of NPAEs was low, but was significantly higher for dolutegravir than for elvitegravir/cobicistat, with significant differences among centres, suggesting that greater predisposition to believe that a given adverse event is caused by a given drug of some treating physicians might play a role in the discordance seen between cohorts.

The COBATEST network: monitoring and evaluation of HIV community-based practices in Europe, 2014-2016.

OBJECTIVE: The objective of this paper is to describe the data collected by the CBVCT services from the Community-based testing (COBATEST) network, from 2014 to 2016, in order to provide an insight into community-based voluntary counselling and testing (CBVCT) services' testing activity in Europe. METHODS: A descriptive analysis of HIV testing activity in CBVCT services that are using the COBATEST tools was performed for the period 2014-2016. RESULTS: During the study period, a total of 30 329 HIV tests were performed on 27 934 individuals, of which 1.8% were reactive. Of these reactive tests, 75.8% had a confirmatory test, 92.2% of those were confirmed as positive, and 90.38% of the confirmed positives were linked to care. The total number of tests performed over the study period increased 19.31%. The proportion of confirmatory tests increased from 63.0% to 90.0% and proportion linked to care increased from 84.1% to 93.8%. Most of the tested individuals were men (70.6%), aged between 21 and 35 years (58.5%) and non-foreign born (68.1%). A high proportion of individuals tested were men who have sex with men (MSM; 42.2%). The percentage of reactive screening tests was particularly high among transgender people (8.37%) and among male sex workers (6.38%). Repeat testers had a higher percentage of reactive tests (2.02%) than those tested for first time (1.1%). CONCLUSIONS: These results prove the feasibility of collecting standardized data from CBVCT services in different countries across Europe and demonstrate the usefulness of such data.

Early detection of HIV infection and of asymptomatic sexually transmitted infections among men who have sex with men.

OBJECTIVE: To provide data on incidence of early diagnosis of HIV infections and define prevalence and incidence of asymptomatic sexually transmitted infections (STI) in men who have sex with men (MSM). METHODS: We assessed a prospective cohort study of HIV-uninfected MSM at high risk for HIV infection. Participants were selected through a risk-assessment questionnaire, and they were screened for HIV infection (quarterly) and for other STI (yearly): syphilis, and hepatitis A, B and C (serology); Chlamydia trachomatis and Neisseria gonorrhoeae in penis and rectum; and human papillomavirus in anus and mouth (PCR). RESULTS: Between November 2009 and October 2012, a total of 258 HIV-uninfected MSM at high risk for HIV infection were included and followed up for a median of 2 years (interquartile range 1.4, 2.5). Nineteen acute HIV infections were diagnosed (incidence, 3.9 per 100 person-years). Prevalence of STI at baseline was follows: syphilis 8.4% (95% confidence interval (CI) 5.4-12.7); hepatitis C virus (HCV) 2.0% (95% CI 0.7-4.8); C. trachomatis in penis 3.2% (95% CI 1.5-6.5) and in rectum 6.5% (95% CI 3.9-10.5); N. gonorrhoeae in penis 2.0% (95% CI 0.8-5.0) and in rectum 6.1% (95% CI 3.6-10.1); human papillomavirus in anal canal 75.7% (95% CI 68.8-81.5) and in mouth 3.8% (95% CI 1.8-7.7). CONCLUSIONS: The implementation of the Check-Ear Project in a MSM community centre allowed for the identification of early HIV infections and asymptomatic STI among MSM. The high incidence of HIV infections and the high prevalence of STI strongly support the recommendation of periodic screenings among sexually active MSM.

Community-based screening of hepatitis C with a one-step RNA detection algorithm from dried-blood spots: Analysis of key populations in Barcelona, Spain.

Alternative strategies are required to enhance the diagnosis of silent hepatitis C virus (HCV) infections in key populations at risk. Among them, HCV prevalence and bio-behavioural data are scarce for HIV-negative men who have sex with men (MSM) and men and trans-women sex workers. We sought to describe and assess the potential benefits of a community-based one-step HCV screening and confirmatory strategy for these populations in Barcelona. The screening strategy based on a real-time RT-PCR assay for HCV-RNA detection in dried-blood spots (DBS) was validated and implemented in addition to an antibody point-of-care test in a community centre. HCV prevalence was assessed, and bio-behavioural data were collected. The molecular assay was precise, reproducible, sensitive and specific. Four HIV-negative MSM reported being currently infected (0.75% HCV self-reported prevalence). Implementation of DBS testing was easy, and acceptability was >95%, but no silent HCV case was diagnosed (N = 580). High-risk sexual practices and drug use for sex were reported frequently. HIV prevalence was 4.7% in MSM and 10% in sex workers. Self-reported prevalence of other STIs ranged from 11.3% to 36.2%. In conclusion, HCV-RNA testing in DBS showed a good performance, but the assessed one-step strategy does not seem beneficial in this setting. Although no silent HCV infections were detected, the observed high-risk behaviours and prevalence of other STIs suggest that HCV spread should be periodically monitored among these populations in Barcelona by means of behavioural surveillance, rapid antibody testing and molecular confirmation in DBS.

Can we afford to offer pre-exposure prophylaxis to MSM in Catalonia? Cost-effectiveness analysis and budget impact assessment.

Pre-exposure prophylaxis (PrEP) effectiveness has been well established. This study aims to assess the cost-effectiveness of providing PrEP, estimate the number of eligible MSM, and its budget impact in Catalonia. Cost-effectiveness analysis compared costs of on daily basis and "on demand" PrEP to prevent one infection with lifetime costs of one HIV infection. We estimated the total cost of providing PrEP by estimating number of eligible MSM, and included in the budget impact assessment antiretroviral and laboratory costs. Costs were lower for the on-demand PrEP group by €64015.1 and the incremental benefit was nearly 15 life-years and 17 quality-adjusted life-years gained. The incremental cost-effectiveness ratio (ICER) was cost-effective at €6281.62 when undiscounted PrEP was given daily. On-demand PrEP can be considered cost-saving in 20 years if the price is reduced by 90%. The number of eligible MSM in Catalonia ranges from 5,989 to 10,972. At current antiretroviral costs, the annual cost would range between €25.3-46.7 million/year (on demand PrEP), and €42.9-78.7 million/year (daily basis PrEP). PrEP is most cost-effective if targeted towards groups with high incidence rates of over 3%/year. Beneficial ICER depends on reducing the current price of Truvada® and ensuring that effectiveness is maintained at high levels.

Differences between migrants and Spanish-born population through the HIV care cascade, Catalonia: an analysis using multiple data sources.

Migrants are considered a key group at risk for HIV infection. This study describes differences between migrants and the Spanish-born population as they progress through the HIV care cascade in Catalonia, Spain. This study found that among people reached by prevention activities, migrants had a higher number of barriers to access HIV testing services than Spanish-born people, driven primarily by shared risk factors. Between 2001 and 2013, 9829 new HIV diagnoses were reported in Catalonia, the proportion of migrants increasing from 24% in 2001 to 41% in 2013. Compared with Spanish-born people, migrants had a higher proportion of women at diagnosis (24·6% vs. 16·7%), and were younger (median age of 33 vs. 37). The most frequent at-risk population was MSM (men who have sex with men) in both migrants and Spanish-born people, (40% and 43%, respectively), although there were significant differences by region of origin. People from sub-Saharan Africa had the highest proportion of late diagnosis (63·7%). Compared with the Spanish-born population, migrants on follow-up had a lower proportion of people on antiretroviral therapy (ART) (93·7% vs. 90·8%, P < 0·001) and with viral suppression (87·2% vs. 82·9%, P < 0·001). Migrants have higher number of barriers to access HIV testing services, lower retention rates and proportions on ART as compared with Spanish-born people, these differences not being uniform between migrants from different regions.

Awareness of Pre-exposure Prophylaxis for HIV, Willingness to Use It and Potential Barriers or Facilitators to Uptake Among Men Who Have Sex with Men in Spain.

There is a lack of data on pre-exposure prophylaxis (PrEP) effectiveness in Spain. We described the awareness of and willingness to use PrEP and examined potential barriers and facilitators to their use among men who have sex with men recruited either online or in voluntary HIV testing centers in Spain. Nearly a third of men (28.7 %) were aware of PrEP and 57.6 % said they would be willing to use it if available, 16.6 % saying they would be unwilling to use PrEP and 25.8 % not being sure. Men who had heard of PrEP were more forceful in their opinions on willingness to use PrEP (willing/not willing: 29.8 %/32.6 % vs. don't know: 21.8 %). The greatest consensus regarding more acceptable PrEP attributes was in the mode of delivery and its cost. Doctors (91 %) or pharmacists (85.3 %) were the preferred providers. The results confirm the need to inform and educate on PrEP and define implementation strategies.

Delivery of HIV test results, post-test discussion and referral in health care settings: a review of guidance for European countries.

OBJECTIVES: HIV testing and counselling (HTC) guidelines support and promote best practice among service providers. Few European countries have national HTC guidelines and most rely on guidance from regional and international bodies. This study examines recommendations in current pan-European and global guidelines regarding test result delivery, post-test discussion and referral pathways in health care settings, and reviews the types of evidence upon which recommendations are based. METHODS: A systematic review and comparative content analysis of relevant guidelines identified through a literature search and review of targeted organization websites were carried out. RESULTS: One global and three pan-European guidelines were reviewed. There was general consensus that any test result should be confidential and delivered privately to a patient; positive results should be delivered in person by a health care professional; negative test results could also be delivered by telephone, text message or post. Analyses show conflicting guidance relating to the provision of post-test counselling, and inconsistencies in referral pathways to specialist treatment for positive test results. There is limited reference to published evidence in support of recommendations. Instead there is heavy reliance on expert opinion/consultation and other previous/existing guidelines when developing guidelines. Scientific evidence, where stated, is often more than ten years old, and based predominantly on US/UK research. CONCLUSIONS: While largely in agreement, current pan-European and global HTC guidelines have inconsistencies, particularly regarding post-test counselling and referral pathways to specialized services. Our findings highlight the need for an up-to-date review of more current evidence from wider European settings to support the process of expert consultation.

Who are the men who have sex with men in Spain that have never been tested for HIV?

OBJECTIVES: The aims of the study were to describe the sociodemographic profile of men who have sex with men (MSM) who have never been tested for HIV and to analyse factors associated with never having been tested. METHODS: The European MSM Internet Survey (EMIS) was implemented in 2010 in 38 European countries on websites for MSM and collected data on sociodemographics, sexual behaviour, and other sexual health variables. A logistic regression analysis was conducted to assess variables associated with never having been tested for HIV. RESULTS: Of the 13,111 respondents living in Spain, 26% had never been tested for HIV. Those who had never been tested were significantly more likely to live in a settlement with fewer than 100,000 inhabitants, be younger than 25 years old, have a lower education level, be a student, and identify themselves as bisexual. In the multivariate analysis, to have never been tested for HIV was associated with being born in Spain [odds ratio (OR) 1.35; 95% confidence interval (CI) 1.192-1.539], living outside large settlements (OR 1.37; 95% CI 1.216-1.534), being younger than 25 years old (OR 2.94; 95% CI 2.510-3.441), being out to no one or only a few people (OR 2.16; 95% CI 1.938-2.399), having had no nonsteady partners in the last 12 months (OR 1.26; 95% CI 1.109-1.422), and being not at all confident to access HIV testing (OR 3.66; 95% CI 2.676-5.003), among others factors. CONCLUSIONS: The profile of the MSM who had never been tested for HIV indicates that most of them were men who were hard to reach (young, bisexual men, in the closet). Interventions should aim to improve access to and the convenience of testing.