Similar Limited Protection Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron Infection in Vaccinated Individuals With HIV and Comparable Controls.

Background: Little is known about the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron infection in people with human immunodeficiency virus (HIV; PWH) with vaccine-induced or hybrid immunity. We assessed the incidence of Omicron infection in 209 AGEhIV coronavirus disease 2019 substudy participants with well-controlled HIV on antiretroviral therapy and 280 comparable controls, who had received at least the primary vaccination series. Methods: From September 2020 onward, participants were assessed every 6 months for the incidence of SARS-CoV-2 infection, per SARS-CoV-2 nucleocapsid antibody assay or self-reported positive antigen or polymerase chain reaction test. Between 1 January and 31 October 2022, the cumulative incidence of Omicron infection and associated risk factors were estimated using a conditional risk-set Cox proportional hazards model. Results: The cumulative incidence of a first Omicron infection was 58.3% by 31 October 2022, not significantly different between groups. HIV status was not independently associated with acquiring Omicron infection. Former and current smoking, as well as an increased predicted anti-spike immunoglobulin G titer were significantly associated with a lower risk of Omicron infection. The majority of infections were symptomatic, but none required hospitalization. Conclusions: People with well-controlled HIV and controls in our cohort experienced a similarly high proportion of Omicron infections. More booster vaccinations significantly reduced the risk of infection. Clinical Trial Registration. NCT01466582.

Sexual behaviour and incidence of sexually transmitted infections among men who have sex with men (MSM) using daily and event-driven pre-exposure prophylaxis (PrEP): Four-year follow-up of the Amsterdam PrEP (AMPrEP) demonstration project cohort.

BACKGROUND: An increasing number of countries are currently implementing or scaling-up HIV pre-exposure prophylaxis (PrEP) care. With the introduction of PrEP, there was apprehension that condom use would decline and sexually transmitted infections (STIs) would increase. To inform sexual health counselling and STI screening programmes, we aimed to study sexual behaviour and STI incidence among men who have sex with men (MSM) and transgender women who use long-term daily or event-driven PrEP. METHODS AND FINDINGS: The Amsterdam PrEP demonstration project (AMPrEP) was a prospective, closed cohort study, providing oral daily PrEP and event-driven PrEP to MSM and transgender women from 2015 to 2020. Participants could choose their PrEP regimen and could switch at each three-monthly visit. STI testing occurred at and, upon request, in-between 3-monthly study visits. We assessed changes in numbers of sex partners and condomless anal sex (CAS) acts with casual partners over time using negative binomial regression, adjusted for age. We assessed HIV incidence and changes in incidence rates (IRs) of any STI (i.e., chlamydia, gonorrhoea, or infectious syphilis) and individual STIs over time using Poisson regression, adjusted for age and testing frequency. A total of 367 participants (365 MSM) commenced PrEP and were followed for a median 3.9 years (interquartile range [IQR] = 3.4-4.0). Median age was 40 years (IQR = 32-48), 315 participants (85.8%) self-declared ethnicity as white and 280 (76.3%) had a university or university of applied sciences degree. Overall median number of sex partners (past 3 months) was 13 (IQR = 6-26) and decreased per additional year on PrEP (adjusted rate ratio [aRR] = 0.86/year, 95% confidence interval [CI] = 0.83-0.88). Overall median number of CAS acts with casual partners (past 3 months) was 10 (IQR = 3-20.5) and also decreased (aRR = 0.92/year, 95% CI = 0.88-0.97). We diagnosed any STI in 1,092 consultations during 1,258 person years, resulting in an IR of 87/100 person years (95% CI = 82-92). IRs of any STI did not increase over time for daily PrEP or event-driven PrEP users. Two daily PrEP users, and no event-driven PrEP users, were diagnosed with HIV during their first year on PrEP. Study limitations include censoring follow-up due to COVID-19 measures and an underrepresentation of younger, non-white, practically educated, and transgender individuals. CONCLUSIONS: In this prospective cohort with a comparatively long follow-up period of 4 years, we observed very low HIV incidence and decreases in the numbers of casual sex partners and CAS acts over time. Although the STI incidence was high, it did not increase over time. TRIAL REGISTRATION: The study was registered at the Netherlands Trial Register (NL5413) https://www.onderzoekmetmensen.nl/en/trial/22706.

Concordance between daily diary reported pre-exposure prophylaxis intake and intraerythrocytic tenofovir diphosphate in the Amsterdam Pre-exposure Prophylaxis demonstration project.

OBJECTIVE: We assessed the association and concordance between self-reported oral pre-exposure prophylaxis (PrEP) intake in a diary app and intraerythrocytic drug metabolite concentrations. DESIGN: AMPrEP was a prospective demonstration study providing daily and event-driven PrEP to MSM in Amsterdam, the Netherlands (2015-2020). METHODS: Participants could record their PrEP intake in a diary app. Dried blood spots (DBS) were taken at 6, 12, 24, and 48 months and analysed for tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentrations. We included TFV-DP measurements preceded by diary completion on at least 90% of days in the 6 weeks prior. We examined the association between self-reported PrEP intake (i.e. number of pills) and TFV-DP concentrations using tobit regression with a random intercept per participant. We also calculated concordance between categorized PrEP intake (i.e. <2, 2-3, 4-6 or 7 pills per week) and categorized TFV-DP concentrations (i.e. <350, 350-699,700-1249 or ≥1250 fmol/punch) using weighted Cohen's kappa. Last, we calculated concordance between self-reported recent PrEP intake (yes/no, in past 2 days) and quantifiability of FTC-TP (yes/no) using Cohen's kappa. RESULTS: Seven hundred and fifty-nine DBS measurements from 282 MSM were included. Self-reported PrEP intake was strongly and positively associated with TFV-DP concentration ( ß â€Š= 0.77, 95% CI = 0.70-0.84, P  < 0.0001). Concordance between categorized PrEP intake and TFV-DP concentration was moderate ( κ  = 0.44, 95% CI = 0.39-0.50). Concordance between self-reported recent PrEP intake and FTC-TP quantifiability was perfect ( κ  = 0.83, 95% CI 0.76-0.90). CONCLUSION: Self-reported PrEP intake in a diary app is strongly correlated with actual use, and therefore reliable for comparing PrEP adherence between groups. Still, suboptimal criterion validity according to clinically relevant categories warrants caution when assessing 6-week reported adherence for individuals.

Diagnostic accuracy of HPV16 early antigen serology for HPV-driven oropharyngeal cancer is independent of age and sex.

A growing proportion of head and neck cancer (HNC), especially oropharyngeal cancer (OPC), is caused by human papillomavirus (HPV). There are several markers for HPV-driven HNC, one being HPV early antigen serology. We aimed to investigate the diagnostic accuracy of HPV serology and its performance across patient characteristics. Data from the VOYAGER consortium was used, which comprises five studies on HNC from North America and Europe. Diagnostic accuracy, that is, sensitivity, specificity, Cohen's kappa and correctly classified proportions of HPV16 E6 serology, was assessed for OPC and other HNC using p16INK4a immunohistochemistry (p16), HPV in situ hybridization (ISH) and HPV PCR as reference methods. Stratified analyses were performed for variables including age, sex, smoking and alcohol use, to test the robustness of diagnostic accuracy. A risk-factor analysis based on serology was conducted, comparing HPV-driven to non-HPV-driven OPC. Overall, HPV serology had a sensitivity of 86.8% (95% CI 85.1-88.3) and specificity of 91.2% (95% CI 88.6-93.4) for HPV-driven OPC using p16 as a reference method. In stratified analyses, diagnostic accuracy remained consistent across sex and different age groups. Sensitivity was lower for heavy smokers (77.7%), OPC without lymph node involvement (74.4%) and the ARCAGE study (66.7%), while specificity decreased for cases with <10 pack-years (72.1%). The risk-factor model included study, year of diagnosis, age, sex, BMI, alcohol use, pack-years, TNM-T and TNM-N stage. HPV serology is a robust biomarker for HPV-driven OPC, and its diagnostic accuracy is independent of age and sex. Future research is suggested on the influence of smoking on HPV antibody levels.

SARS-CoV-2 vaccination uptake in six ethnic groups living in Amsterdam, the Netherlands: A registry-based study within the HELIUS cohort.

OBJECTIVE: Ethnic minority groups have experienced a disproportionate burden of COVID-19, and should therefore be especially encouraged to receive SARS-CoV-2 vaccination. This study compared first-dose uptake of the primary SARS-CoV-2 vaccination series across six ethnic groups in Amsterdam, the Netherlands in 2021. METHODS: We analyzed data from participants of the population-based HELIUS cohort. We linked their data to the SARS-CoV-2 vaccination registry data of the Public Health Service of Amsterdam. We included registry data from January 6, 2021 (the start of the Dutch vaccination campaign) until September 6, 2021 (a date by which all adults in the Netherlands could have received one or two vaccine doses). SARS-CoV-2 vaccination uptake was defined as having received at least one vaccine dose of the primary vaccination series. We examined the association between ethnicity and vaccination uptake using multivariable logistic regression, while accounting for the age and sex distribution of ethnic groups in Amsterdam. RESULTS: We included 19,006 participants (median age 53 years [interquartile range 41-62], 57% female). SARS-CoV-2 vaccination uptake was highest in the South-Asian Surinamese group (60.3%, 95%CI = 58.2-62.3%), followed by the Dutch (59.6%, 95%CI = 58.0-61.1%), Ghanaian (54.1%, 95%CI = 51.7-56.5%), Turkish (47.7%, 95%CI = 45.9-49.6%), African Surinamese (43.0%, 95%CI = 41.2-44.7%), and Moroccan (35.8%, 95%CI = 34.1-37.5%) groups. After adjusting for age, sex, perceived social support, and presence of relevant comorbidities, participants of African Surinamese, Ghanaian, Turkish and Moroccan origin were significantly less likely to be vaccinated than those of Dutch origin. CONCLUSIONS: Prevention strategies should continue tailoring to specific ethnic groups to encourage vaccination uptake and reduce barriers to vaccination.