Hepatitis C virus infection is uncommon at baseline and during follow-up among individuals using PrEP in the Dutch national PrEP programme between 2019 and 2022.

OBJECTIVES: Studies showed that men who have sex with men (MSM), including those using pre-exposure prophylaxis (PrEP), are at increased risk of hepatitis C virus (HCV) infection. We evaluated HCV prevalence and incidence, along with their associated determinants, in a cohort of PrEP-using individuals in the Netherlands. METHODS: In 2019, the Netherlands launched a 5-year national programme that offers subsidised PrEP to eligible individuals. We used prospectively collected data from individuals registered in this programme between 2019 and 2022. Individuals underwent annual testing for HCV antibodies and additional HCV-RNA testing when antibodies were present. We calculated the prevalence of past/current HCV infection at first visit and overall incidence rate (IR) during follow-up. Univariable logistic and Poisson regression models were used to identify determinants associated with past/current prevalent or incident HCV infection, respectively. Behavioural factors referred to those occurring in the previous 6 months. RESULTS: A total of 10 563 (n=10 319, 97.7% MSM) were included. At first visit, 66 of 10 563 (0.6%) had a past/current HCV infection, which was associated with older age [odds ratio (OR) per 10 years=1.57, 95% confidence interval (CI)=1.31 to 1.88], the use of PrEP before first visit (OR=3.03, 95% CI=1.79 to 5.13), receptive condomless anal sex (CAS) (OR=2.73, 95% CI=1.25 to 5.98), chemsex (OR=2.44, 95% CI=1.49 to 3.99) and injecting drug use (IDU) (OR=6.61, 95% CI=2.35 to 18.61). Among 9851 individuals contributing to 17 150 person-years (PYs) of follow-up, 64 incident HCV infections (IR=0.37 per 100 PYs, 95% CI=0.29 to 0.48) were identified. Factors associated with incident HCV infection were receptive CAS [incidence rate ratio (IRR)=2.59, 95% CI=1.12 to 6.02], chemsex (IRR=1.78, 95% CI=1.06 to 2.98), sexually transmitted infection diagnosis (IRR=2.30, 95% CI=1.23 to 4.31) and IDU (IRR=6.15, 95% CI=2.20 to 17.18). CONCLUSIONS: Past/current prevalence and incidence of HCV were low among individuals in the Dutch PrEP programme. Infections were associated with behaviour known to be associated with HCV. Instead of annual HCV testing, as stated in most PrEP care guidelines, testing frequency for HCV could be based on behaviours associated with HCV acquisition.

Psychological Functioning in Non-binary Identifying Adolescents and Adults.

Gender diverse individuals who do not conform to society's binary gender expectations are more likely to experience difficulties in acceptance and in recognition of gender, compared to binary-identifying transgender people. This may accentuate the feeling that their gender identity is not socially recognized or validated. This study aimed to investigate psychological functioning among gender diverse adolescents and adults who identify beyond the binary gender spectrum. In both study populations, 589 clinically-referred gender diverse adolescents from the UK (n = 438 birth-assigned females and n = 151 birth-assigned males), and 632 clinically-referred gender diverse adults from the Netherlands (n = 278 birth-assigned females and n = 354birth-assigned males), we found that a higher degree of psychological problems was predicted by identifying more strongly with a non-binary identity. For adolescents, more psychological problems were related to having a non-binary gender identity and being assigned female at birth. In the adult population, experiencing psychological difficulties was also significantly related to having a stronger non-binary identity and having a younger age. Clinicians working with gender diverse people should be aware that applicants for physical interventions might have a broader range of gender identities than a binary transgender one, and that people with a non-binary gender identity may, for various reasons, be particularly vulnerable to psychological difficulties.

Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial.

BACKGROUND: As highly effective therapy against hepatitis C virus (HCV) infection is available with rapid uptake, there is newfound optimism for HCV elimination. Nevertheless, certain key populations have a high risk of HCV reinfection, in particular men who have sex with men (MSM) in Western European countries. Modelling data indicate that HCV elimination will not be feasible without reduction in risk behaviour, thus supporting the need for effective interventions aimed at reducing risk behaviour and preventing reinfections in MSM. METHODS: The ICECREAM study is an international, multi-centred, phase 2, 3-arm randomised trial comparing run-in and intervention periods enrolling MSM with a history of a cured or spontaneously cleared HCV infection. Individuals are followed in routine care for 6 months (i.e. run-in period) and then randomly allocated (1:1:1) to one of the following: a tailored, interactive online risk-reduction behavioural intervention, a validated home-based HCV-RNA self-sampling test service using dried blood spots, or a combination of both. After randomisation, individuals are followed every 6 months until 18 months (i.e. intervention period). Interventions are delivered in addition to standard of care. Online questionnaire measuring risk behaviour over the past 6 months is administered at every visit. The primary outcome is the proportion at risk of HCV infection during run-in versus intervention periods assessed by using the HCV-MOSAIC risk score. The risk score consists of six self-reported HCV-related risk behaviours. Secondary outcomes include incidence of HCV reinfection, changes in the individual risk behaviour items and changes in sexual well-being since changes in sexual behaviour may have an impact on sexual experience. Two hundred forty-six MSM aged 18 years or older will be invited to participate. DISCUSSION: The ICECREAM study is a trial aimed at establishing interventions that could effectively decrease the incidence of HCV re-infection in MSM with a previous HCV infection. By offering an online behavioural risk-reduction intervention and HCV-RNA self-sampling, both of which are aimed to influence risk behaviour, we are able to provide products to at-risk MSM that could further reduce population-level HCV incidence and ultimately help reach HCV micro-elimination. TRIAL REGISTRATION: ClinicalTrials.gov NCT04156945. Registered on November 8, 2019.

Screening for Hepatitis C Virus Reinfection Using a Behaviour-Based Risk Score among Men Who Have Sex with Men with HIV: Results from a Case-Control Diagnostic Validation Study.

We assessed the predictive capacity of the HCV-MOSAIC risk score, originally developed for primary early HCV infection, as a screening tool for HCV reinfection in 103 men who have sex with men (MSM) with HIV using data from the MOSAIC cohort, including MSM with HIV/HCV-coinfection who became reinfected (cases, n = 27) or not (controls, n = 76) during follow-up. The overall predictive capacity of the score was assessed using the area under the receiver operating characteristic (AUROC) curve. The effects of covariates on the receiver operating characteristic (ROC) curve were assessed using parametric ROC regression. The score cut-off validated for primary early infection (≥2.0) was used, from which the sensitivity and specificity were calculated. The AUROC was 0.74 (95% confidence interval (CI) = 0.63-0.84). Group sex significantly increased the predictive capacity. Using the validated cut-off, sensitivity was 70.4% (95%CI = 49.8-86.2%) and specificity was 59.2% (95%CI: 47.3-70.4%). External validation from a cohort of 25 cases and 111 controls, all MSM with HIV, resulted in a sensitivity of 44.0% (95%CI = 24.4-65.1) and specificity of 71.2% (95%CI = 61.8-79.4). The HCV-MOSAIC risk score may be useful for identifying individuals at risk of HCV reinfection. In sexual health or HIV-care settings, this score could help guide HCV-RNA testing in MSM with a prior HCV infection.