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AbstractIntroductionSimplified hepatitis C virus (HCV) diagnostic strategies have the potential to improve HCV diagnoses and treatment. We aimed to investigate the impact of simplified HCV diagnostic strategies on HCV incidence and its effect on HCV diagnosis and treatment among men who have sex with men (MSM) regardless of HIV status and use of HIV pre‐exposure prophylaxis (PrEP) in Taiwan.MethodsA compartmental deterministic model was developed to describe the natural history of HCV disease progression, the HCV care cascade and the HIV status and PrEP using among MSM. The model was calibrated to available data for HCV and HIV epidemiology and population demographics in Taiwan. We simulated the epidemic from 2004 and projected the impact of simplified testing strategies on the HCV epidemic among MSM over 2022–2030.ResultsUnder the current testing approach in Taiwan, total HCV incidence would increase to 12.6 per 1000 person‐years among MSM by 2030. Single‐visit point‐of‐care RNA testing had the largest impact on reducing the number of new HCV infections over 2022–2030, with a 31.1% reduction (interquartile range: 24.9%−32.8%). By 2030, single‐visit point‐of‐care HCV testing improved HCV diagnosis to 90.9%, HCV treatment to 87.7% and HCV cure to 81.5% among MSM living with HCV. Compared to status quo, prioritized simplified HCV testing for PrEP users and MSM living with diagnosed HIV had considerable impact on the broader HCV epidemic among MSM. A sensitivity analysis suggests that reinfection risk would have a large impact on the effectiveness of each point‐of‐care testing scenario.ConclusionsSimplified HCV diagnostic strategies could control the ongoing HCV epidemic and improve HCV testing and treatment among Taiwanese MSM. Single‐visit point‐of‐care RNA testing would result in large reductions in HCV incidence and prevalence among MSM. Efficient risk‐reduction strategies will need to be implemented alongside point‐of‐care testing to achieve HCV elimination among MSM in Taiwan.

AbstractIntroductionOver the last two decades, the incidence of hepatitis C virus (HCV) co‐infection among men who have sex with men (MSM) living with HIV began increasing in post‐industrialized countries. Little is known about transmission of acute or recent HCV, in particular among MSM living with HIV co‐infection, which creates uncertainty about potential for reinfection after HCV treatment. Using phylogenetic methods, clinical, epidemiological and molecular data can be combined to better understand transmission patterns. These insights may help identify strategies to reduce reinfection risk, enhancing effectiveness of HCV treatment as prevention strategies. The aim of this study was to identify multi‐risk profiles and factors associated with phylogenetic pairs and clusters among people with recent HCV infection.MethodsData and specimens from five studies of recent HCV in Australia and New Zealand (2004 to 2015) were used. HCV Core‐E2 sequences were used to infer maximum likelihood trees. Clusters were identified using 90% bootstrap and 5% genetic distance threshold. Multivariate logistic regression and latent class analyses were performed.ResultsAmong 237 participants with Core‐E2 sequences, 47% were in a pair/cluster. Among HIV/HCV co‐infected participants, 60% (74/123) were in a pair/cluster, compared to 30% (34/114) with HCV mono‐infection (p < 0.001). HIV/HCV co‐infection (vs. HCV mono‐infection; adjusted odds ratio (AOR), 2.37, 95% confidence interval (CI), 1.45, 5.15) was independently associated with phylogenetic clustering. Latent class analysis identified three distinct risk profiles: (1) people who inject drugs, (2) HIV‐positive gay and bisexual men (GBM) with low probability of injecting drug use (IDU) and (3) GBM with IDU & sexual risk behaviour. Class 2 (vs. Class 1, AOR 3.40; 95% CI, 1.52, 7.60), was independently associated with phylogenetic clustering. Many clusters displayed homogeneous characteristics, such as containing individuals exclusively from one city, individuals all with HIV/HCV co‐infection or individuals sharing the same route of acquisition of HCV.ConclusionsClusters containing individuals with specific characteristics suggest that HCV transmission occurs through discrete networks, particularly among HIV/HCV co‐infected individuals. The greater proportion of clustering found among HIV/HCV co‐infected participants highlights the need to provide broad direct‐acting antiviral access encouraging rapid uptake in this population and ongoing monitoring of the phylogeny.

Background: Simple, affordable diagnostic tools are essential to facilitate global hepatitis C virus (HCV) elimination efforts. Objectives: This study evaluated the clinical performance of core antigen (HCVcAg) assay from plasma samples to monitor HCV treatment efficacy and HCV viral recurrence. Study design: Plasma samples from a study of response-guided pegylated-interferon/ribavirin therapy for people who inject drugs with chronic HCV genotype 2/3 infection were assessed for HCV RNA (AmpliPrep/COBAS Taqman assay, Roche) and HCVcAg (ARCHITECT HCV Ag, Abbott Diagnostics) during and after therapy. The sensitivity and specificity of the HCVcAg assay was compared to the HCV RNA assay (gold standard). Results: A total of 335 samples from 92 enrolled participants were assessed (mean 4 time-points per participant). At baseline, end of treatment response (ETR) and sustained virological response (SVR) visits, the sensitivity of the HCVcAg assay with quantifiable HCV RNA threshold was 94% (95% CI: 88%, 98%), 56% (21%, 86%) and 100%, respectively. The specificity was between 98 to 100% for all time-points assessed. HCVcAg accurately detected all six participants with viral recurrence, demonstrating 100% sensitivity and specificity. One participant with detectable (non-quantifiable) HCV RNA and non-reactive HCVcAg at SVR12 subsequently cleared HCV RNA at SVR24. Conclusions: HCVcAg demonstrated high sensitivity and specificity for detection of pre-treatment and post-treatment viraemia. This study indicates that confirmation of active HCV infection, including recurrent viraemia, by HCVcAg is possible. Reduced on-treatment sensitivity of HCVcAg may be a clinical advantage given the moves toward simplification of monitoring schedules. ; This study was funded by the Australian Government Department of Health and Ageing. The views expressed in this publication do not necessarily represent the position of the Australian Government. The Kirby Institute is affiliated with the Faculty of Medicine, University of New South Wales. The opinions expressed in this paper are those of the authors and do not necessarily represent that of Merck Sharp and Dohme. Support from Abbott Diagnostics for the supply of reagents is gratefully acknowledged. GD is supported by a National Health and Medical Research Council Practitioner Research Fellowships. JG is supported by a National Health and Medical Research Council Career Development Fellowship. BH is supported by a National Health and Medical Research Council Early Career Fellowship. The ARCHITECT HCV Ag kits for this study were kindly provided by Abbott.