Increased hepatitis C virus vaccine clinical trial literacy following a brief intervention among people who inject drugs.
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ABSTRACT:
SUBMITTER: White B
PROVIDER: S-EPMC3567229 | biostudies-other | 2013 Jul
REPOSITORIES: biostudies-other
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Increased hepatitis C virus vaccine clinical trial literacy following a brief intervention among people who inject drugs.
White Bethany B Madden Annie A Hellard Margaret M Kerr Thomas T Prins Maria M Page Kimberly K Dore Gregory J GJ Maher Lisa L
Drug and alcohol review 20121101 4
<h4>Introduction and aims</h4>While people who inject drugs are at high risk of hepatitis C virus (HCV) infection and will be the target population for future HCV vaccine trials, little is known about clinical trial literacy (CTL) in this group. We assessed the impact of a brief intervention (BI) designed to improve HCV vaccine CTL among people who inject drugs in Sydney, Australia.<h4>Design and methods</h4>People who inject drugs enrolled in a community-based prospective observational study be ...[more]
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Project description:Most people who inject drugs (PWID) are infected with hepatitis C virus (HCV), and PWID have the highest risk of HCV infection of any risk group. The incidence of HCV infection is 5%-25% per year, demonstrating continued need for HCV infection prevention in PWID. Existing data in chimpanzees and PWID suggest that protective immunity against persistent HCV infection is achievable. Due to the high incidence of infection, PWID are both the most likely to benefit from a vaccine and a population in which vaccine efficacy could be tested. Challenges to testing a vaccine in PWID are significant. However, the first HCV vaccine trial in at-risk HCV-uninfected PWID was initiated in 2012. The results will likely guide future vaccine development and strategies for vaccination of this and other high-risk populations.
| S-EPMC3722079 | biostudies-literature
Project description:BackgroundComprehensive information on the incidence and duration of hepatitis C virus (HCV) infection for people who inject drugs (PWID) in Ireland is not available. We created an incidence curve of injecting drug use in Ireland and subsequently estimated incidence of hepatitis C virus (HCV) infection.MethodsAnonymised data from the National Drug Treatment Reporting System (NDTRS) were used to identify all people who inject drugs (PWIDs) and who entered drug treatment for the first time between 1991 and 2014. A curve, estimating the incidence of injecting, was created to plot PWIDs by year of commencing injecting. The curve was adjusted for missing data on PWIDs in treatment and for PWIDs who were never treated. An adjustment was made to account for injectors who had never shared injecting equipment. The incidence of HCV infection and chronic infection in PWIDs was estimated by applying published rates.ResultsBetween 1991 and 2014, 14,320 injectors were registered on NDTRS. The majority were young (median age 25 years), male (74%), lived in Dublin (73%) and injected an opiate (e.g. heroin) (94%). The estimated total number of injectors up to the end of 2014 was 16,382. An estimated 12,423 (95% CI 10,799-13,161) were infected with HCV, and 9,317 (95% CI 8,022-9,996) became chronically infected. The estimated annual number of new HCV infections among PWIDs increased steeply from the late 1970s and peaked in 1998. By 2014, almost 30% of injectors were estimated to have been infected for over 20 years.ConclusionsThis is the first comprehensive national estimate of the incidence of HCV in PWIDs in Ireland and will inform planning and developing appropriate health care services.
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Project description:Antiviral nucleoside analogues (ANA) are newly used therapeutics acting against the hepatitis C virus (HCV). This class of drug is well known to exhibit toxicity on mitochondrial DNA (mtDNA). People who inject drugs (PWID) are particularly affected by HCV infection and cumulated mitotoxic drug exposure from HIV treatments (antiretrovirals, ARV) and other illicit drugs. This study aims to explore the impact of direct-acting antiviral (DAA) treatments on mtDNA among PWID. A total of 470 actively injecting heroin users were included. We used quantitative PCR on whole blood to determine the mitochondrial copy number per cell (MCN) and the proportion of mitochondrial DNA deletion (MDD). These parameters were assessed before and after DAA treatment. MDD was significantly increased after HCV treatment, while MCN did not differ. MDD was even greater when subjects were cotreated with ARV. In multivariate analysis, we identified that poly-exposure to DAA and daily heroin injection or regular consumption of methamphetamines were positively associated with high MCN loss while DAA and ARV treatments or methadone use were identified as risk factors for having mtDNA deletion. These observations deserve attention since they were previously associated with premature cell ageing or cell transformation and therefore call for a long-term follow-up.
| S-EPMC8584601 | biostudies-literature
Project description:People who inject drugs have a greater risk of infectious disease and mortality than other substance abusers and nondrug users. Variation in risk behavior among people who inject drugs is likely associated with comorbid mental health disorders.Examine the association between a history of mood disorder and recent risk behavior among people who inject drugs.With baseline data from a behavioral HIV prevention clinical trial in a population of people who inject drugs, we used logistic regression models to compare the risk behaviors of people who report a past diagnosis of bipolar disorder (n = 113) or depression (n = 237) to a comparison group with no history of diagnosed mental illness (n = 446). We also assessed differences between groups before and after adjusting for demographic characteristics and current depressive symptoms.While there were no differences between groups in frequency of drug use, people who inject drugs who report a history of mood disorders reported more injection risk behaviors, drug overdoses, sex exchanges, and multiple partners than those with no history of mental illness. Adjusting the comparison for demographic characteristics and current depressive symptoms had little impact on these findings. Variation in risk between depression and bipolar disorder groups was minimal. Conclusions/Importance: People who inject drugs and have mood disorders have unique and significant social, clinical, and risk reduction needs. Despite the limited validity of self-reported mental health history, simply asking about a history of mood disorder may be effective for identifying a particularly vulnerable population of people who inject drugs.
| S-EPMC5578394 | biostudies-other
Project description:A barrier to hepatitis C virus (HCV) treatment among people who inject drugs (PWID) has been a concern that interferon-based HCV treatment may increase injecting risk behaviours. This study evaluated recent (past month) injecting risk behaviours during follow-up among PWID that did and did not receive HCV treatment.The Australian Trial in Acute Hepatitis C (ATAHC) was a prospective study of natural history and treatment of recent HCV infection. Analyses were performed using generalized estimating equations.Among 124 participants with a history of injecting drug use (median age 32 years), 69% were male, and 68% were treated for HCV infection. HCV treatment was not associated with an increase in recent injecting drug use (adjusted odds ratio (aOR) 1.06, 95% CI 0.93, 1.21) or recent used needle and syringe borrowing during follow-up (aOR 0.99, 95% CI 0.89, 1.08). HCV treatment was associated with a decrease in recent ancillary injecting equipment sharing during follow-up (aOR 0.85, 95% CI 0.74, 0.99). Further, among treated participants who remained in follow-up (n=24), ancillary injecting equipment sharing significantly decreased from 54% at enrolment to 17% during follow-up (P=0.012).HCV treatment was not associated with drug use or used needle and syringe borrowing during follow-up, but was associated with decreased ancillary injecting equipment sharing during follow-up. Programs to enhance HCV assessment and treatment among PWID should be expanded, given that HCV treatment does not lead to increases in injecting risk behaviours and has previously been demonstrated to be safe and effective among PWID.
| S-EPMC4577441 | biostudies-literature
Project description:ImportanceThe success of direct-acting antiviral therapies for chronic hepatitis C virus (HCV) infection led the World Health Organization to set elimination targets by 2030. For the United States to achieve these benchmarks, public health responses must target high-risk populations, such as people who inject drugs (PWID), a group with high rates of HCV incidence and low rates of treatment uptake.ObjectiveTo evaluate potential improvements in the HCV care cascade among PWID, focusing on improved testing, treatment uptake, and access to harm reduction.Design, setting, and participantsThis decision analytic model used a differential equation-based dynamic transmission model based on data from New Hampshire, an illustrative state with a large number of PWID and limited HCV treatment infrastructure. Surveillance data through 2020 was used for model parameterization, and the final analysis was conducted in May 2021.Main outcomes and measuresModel forecasts of chronic HCV cases and advanced-stage HCV outcomes from 2022 to 2045.ResultsA total of 6 scenarios were tested: (1) the base case, (2) improved harm reduction, (3) improved testing, (4) improved treatment, (5) improved testing and treatment, and (6) improved testing, treatment, and harm reduction. All scenarios with improved testing, treatment uptake, and/or access to harm reduction were associated with decreases in forecasted HCV prevalence and HCV-associated mortality compared with the base case. Improving harm reduction, testing, and treatment individually were forecast to reduce prevalence of HCV in 2045 from 69.7% in the base case to 62.8%, 45.7%, and 35.5%, respectively. Combining treatment and testing improvements was associated with a 2045 prevalence of 0.3%; adding harm reduction improvements was associated with further reductions in prevalence forecasts (to 0.2%), with fewer total treatments (10 960 vs 13 219 from 2022-2045).Conclusions and relevanceIn this modeling study, no single intervention was projected to achieve World Health Organization HCV elimination targets. Scenarios with improvements in both testing and treatment were associated with a prevalence of less than 3% by 2030 and achieved elimination targets. Adding improvements in harm reduction was associated with faster reductions in prevalence and fewer treatments.
| S-EPMC8335578 | biostudies-literature
Project description:Objectives To develop and validate a scoring tool based on demographic and injecting risk behaviours to identify those who require additional, non-routine serological screening for hepatitis C virus (HCV) by assessing their personal risk. Design Cross-sectional and prospective cohorts. Setting People who inject drugs (PWID) and attended Needle and Syringe Programs (NSP) in Australia during the period from 1998 to 2008. Participants Cross-sectional data included 16?127 PWID who attended NSP in Australia. Prospective data included 215 HCV-negative PWID who were recruited through street-based outreach, methadone clinics in Australia. Primary and secondary outcome measures HCV seroprevalence in the cross-sectional and HCV seroconversions in the prospective data sets. Results Current study included 16?127 PWID who attended NSP in Australia. Type of drug last injected, frequency and duration of injecting, sharing needles and syringes or other injecting equipment and imprisonment history were associated with HCV infection in all age groups. Strong relationships between an individual's 'HCV score' and their risk of testing HCV antibody positive were observed. An estimated 78% (95% CI 75% to 81%), 82% (95% CI 80% to 84%), 80% (95% CI 78% to 82%) and 80% (95% CI 77% to 82%) of HCV infections across the age groups (<25, 25-29, 30-39 and ?40 years) would be avoided if participants in the upper four quintiles of HCV scores fell instead into the lowest quintile. Conclusions Knowledge of HCV status has important implications for public health and care and treatment. Risk assessment strategies may assist in alerting PWID who are at increased risk of HCV infection to present for testing.
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Project description:This study examines correlates of hepatitis C virus (HCV) genetic clustering among community-recruited people who inject drugs enrolled in the AIDS Linked to the IntraVenous Experience cohort in Baltimore between 1988 and 1989. HCV RNA was extracted and the core/envelope-1 region was sequenced. Clusters were identified from maximum likelihood trees with 1000 bootstrap replicates using a 70% aLRT and a 4% genetic-distance threshold in Cluster Picker. Overall, 46% of participants were in a cluster, including 122 genotype-1a and 36 genotype-1b clusters with an average of 2-3 genetically linked HCV infections. The largest cluster consists of 9 participants. In univariable analysis, black race (PR?=?1.66 [95% CI: 1.12-2.45]), age <35?years (PR?=?1.18 [95% CI: 1.02-1.37]), and injection drug use of cocaine alone (PR?=?1.30 [95% CI: 1.02-1.65]) were significantly associated with being in a cluster. Conversely, a history of medication-associated treatment (MAT) was negatively associated with being in a cluster (PR?=?0.82 [95% CI: 0.71-0.95]). In multivariable analysis, black race (APR?=?1.62 [95% CI: 1.11-2.38]) remained independently associated being in a cluster while MAT (APR?=?0.85 [95% CI: 0.74-0.99]) remained negatively associated with clustering. Our findings suggest strong locally-propagated transmission networks during the early epidemic that was driven by younger PWID. In light of the current opioid epidemic in the US, these findings suggest an urgent need for preventive interventions to mitigate the growth of large HCV transmission networks.
| S-EPMC7460273 | biostudies-literature
Project description:Hepatitis C virus (HCV) chronically infects over 180 million people worldwide, with over 350,000 estimated deaths attributed yearly to HCV-related liver diseases. It disproportionally affects people who inject drugs (PWID). Currently there is no preventative vaccine and interventions feature long treatment durations with severe side-effects. Upcoming treatments will improve this situation, making possible large-scale treatment interventions. How these strategies should target HCV-infected PWID remains an important unanswered question. Previous models of HCV have lacked empirically grounded contact models of PWID. Here we report results on HCV transmission and treatment using simulated contact networks generated from an empirically grounded network model using recently developed statistical approaches in social network analysis. Our HCV transmission model is a detailed, stochastic, individual-based model including spontaneously clearing nodes. On transmission we investigate the role of number of contacts and injecting frequency on time to primary infection and the role of spontaneously clearing nodes on incidence rates. On treatment we investigate the effect of nine network-based treatment strategies on chronic prevalence and incidence rates of primary infection and re-infection. Both numbers of contacts and injecting frequency play key roles in reducing time to primary infection. The change from "less-" to "more-frequent" injector is roughly similar to having one additional network contact. Nodes that spontaneously clear their HCV infection have a local effect on infection risk and the total number of such nodes (but not their locations) has a network wide effect on the incidence of both primary and re-infection with HCV. Re-infection plays a large role in the effectiveness of treatment interventions. Strategies that choose PWID and treat all their contacts (analogous to ring vaccination) are most effective in reducing the incidence rates of re-infection and combined infection. A strategy targeting infected PWID with the most contacts (analogous to targeted vaccination) is the least effective.
| S-EPMC3815209 | biostudies-literature
Project description:Background and aimsThe advent of highly effective hepatitis C (HCV) treatments has questioned the need for a vaccine to control HCV amongst people who inject drugs (PWID). However, high treatment costs and ongoing reinfection risk suggest it could still play a role. We compared the impact of HCV vaccination amongst PWID against providing HCV treatment.MethodsDynamic HCV vaccination and treatment models among PWID were used to determine the vaccination and treatment rates required to reduce chronic HCV prevalence or incidence in the UK over 20 or 40 years. Projections considered a low (50% protection for 5 years), moderate (70% protection for 10 years) or high (90% protection for 20 years) efficacy vaccine. Sensitivities to various parameters were examined.ResultsTo halve chronic HCV prevalence over 40 years, the low, moderate and high efficacy vaccines required annual vaccination rates (coverage after 20 years) of 162 (72%), 77 (56%) and 44 (38%) per 1000 PWID, respectively. These vaccination rates were 16, 7.6 and 4.4 times greater than corresponding treatment rates. To halve prevalence over 20 years nearly doubled these vaccination rates (moderate and high efficacy vaccines only) and the vaccination-to-treatment ratio increased by 20%. For all scenarios considered, required annual vaccination rates and vaccination-to-treatment ratios were at least a third lower to reduce incidence than prevalence. Baseline HCV prevalence had little effect on the vaccine's impact on prevalence or incidence, but substantially affected the vaccination-to-treatment ratios. Behavioural risk heterogeneity only had an effect if we assumed no transitions between high and low risk states and vaccinations were targeted or if PWID were high risk for their first year.ConclusionsAchievable coverage levels of a low efficacy prophylactic HCV vaccine could greatly reduce HCV transmission amongst PWID. Current high treatment costs ensure vaccination could still be an important intervention option.
| S-EPMC4880220 | biostudies-literature