Hepatitis C Virus Care Research Articles

The Hepatitis C Care Cascade During the Direct-Acting Antiviral Era in a United States Commercially Insured Population.

BackgroundPeriodic surveillance of the hepatitis C virus (HCV) care cascade is important for tracking progress toward HCV elimination goals, identifying gaps in care, and prioritizing resource allocation. In the pre-direct-acting antiviral (DAA) era, it was estimated that 50% of HCV-infected individuals were diagnosed and that 16% had been prescribed interferon-based therapy. Since then, few studies utilizing nationally representative data from the DAA era have been conducted in the United States.MethodsWe performed a cross-sectional study to describe the HCV care cascade in the United States using the Optum de-identified Clinformatics® Data Mart Database to identify a nationally representative sample of commercially insured beneficiaries between January 1, 2014 and December 31, 2019. We estimated the number of HCV-viremic individuals in Optum based on national HCV prevalence estimates and determined the proportion who had: (1) recorded diagnosis of HCV infection, (2) recorded HCV diagnosis and underwent HCV RNA testing, (3) DAA treatment dispensed, and (4) assessment for cure.ResultsAmong 120,311 individuals estimated to have HCV viremia in Optum during the study period, 109,233 (90.8%; 95% CI, 90.6%–91.0%) had a recorded diagnosis of HCV infection, 75,549 (62.8%; 95% CI, 62.5%–63.1%) had a recorded diagnosis of HCV infection and underwent HCV RNA testing, 41,102 (34.2%; 95% CI, 33.9%–34.4%) were dispensed DAA treatment, and 25,760 (21.4%; 95% CI, 21.2%–21.6%) were assessed for cure.ConclusionsGaps remain between the delivery of HCV-related care and national treatment goals among commercially insured adults. Efforts are needed to increase HCV treatment among people diagnosed with chronic HCV infection to achieve national elimination goals.

Hepatitis C antibody prevalence and behavioral correlates in people who inject drugs attending harm reduction services in Lisbon, Portugal.

The hepatitis C virus (HCV) infection is an important public health problem, affecting millions of people worldwide. People who inject drugs (PWID) are at increased risk of HCV infection due to, among other factors, widespread unsafe injecting practices, such as sharing of infected equipment or unprotected sexual practices. In Portugal, there is a lack of data regarding the proportion of infected persons through injecting drug use. This study aimed to evaluate the anti-HCV prevalence and behavioral correlates of infection in PWID attending harm reduction services in the Metropolitan Area of Lisbon, Portugal. A cross-sectional study with a purposive sample of PWID was undertaken between March 2018 and March 2020. Participants were recruited through the harm-reduction services of a nongovernmental organization. A rapid diagnostic test for anti-HCV screening was performed. Data on drug consumption history and current practices, past HCV testing, care and treatment history, and knowledge regarding hepatitis C were also collected through a questionnaire applied by trained inquirers. A total of 176 PWID participated in this study. An overall prevalence of 70.5% of anti-HCV positive in this population was found. Those with an anti-HCV positive testing result tended to start consuming at a younger age and have a higher consumption of benzodiazepines in the last 30 days. Sharing needles and other injecting material is a frequent risk behavior among this group. Also, they are more likely to have attended an opioid agonist treatment and to have undertaken previous hepatitis C and HIV tests in the past. This study represents an important effort to better understand the HCV prevalence and behavioral correlates of infection among PWID in Portugal, as well as to better estimate those in need of HCV treatment.

A qualitative investigation of organizational challenges and facilitators to screening individuals experiencing homelessness for hepatitis C virus (HCV) in Houston, Texas.

BackgroundIndividuals experiencing homelessness may be at a disproportionately high risk for hepatitis C (HCV) because they may be more likely to engage in HCV risk behaviors. Community organizations that provide services to these vulnerable individuals can effectively screen, diagnose, and navigate them into HCV care. However, screening people experiencing homelessness for HCV at such organizations is limited by various challenges that remain understudied, including budgetary considerations and strategies to improve teamwork and communication. Accordingly, this study investigated the organizational challenges and facilitators to HCV screening of individuals experiencing homelessness as reported by homeless services providers.MethodsStaff (N = 21) at two community organizations in Houston, Texas, completed an interviewer-administered survey and a semi-structured interview in August 2020 to assess the challenges and facilitators to screening people experiencing homelessness for HCV. Interviews were coded, and a thematic analysis was conducted to identify challenges as well as facilitators to HCV screening among individuals experiencing homelessness.ResultsAlmost half of participants were employed in social services (42.86%; n = 9), while the remainder were employed in management/administration and health services. Barriers to HCV screening included funding, logistics, and resource-related challenges; and limited communication and collaboration around HCV screening. Facilitators to HCV screening included providing HCV education and training for all staff; and incentivizing, formalizing, and funding HCV screening.ConclusionsCommunity organizations can help minimize barriers to HCV screening among individuals experiencing homelessness by providing staff with training specific to HCV, client education around HCV and the screening process, and providing clients with incentives for participation, as well as by maximizing community and clinic partnerships to provide linkage to care and services to this high-risk population.

Hepatitis C virus in people with serious mental illness: an analysis of the care cascade at a tertiary health service with a pilot 'identify and treat' strategy.

People with serious mental illness (SMI) are underserved from a hepatitis C virus (HCV) screening and treatment perspective. To examine the HCV care cascade in people with SMI and to pilot a supported HCV treatment integration programme. HCV prevalence was retrospectively analysed from 4492 consecutive individuals admitted to a tertiary hospital mental health service between January 2017 and December 2018. Subcohort analysis of screening patterns and predictors of seropositive infection was performed. Referral pathways and community care integration were analysed for HCV-positive individuals, and a prospective community-based 'identify and treat' HCV programme was assessed. Screening for HCV had been performed in 18.6% (835/4492) of the cohort. Seroprevalence was 4.6% (207/4492). HCV seropositivity was associated with age >40 years (odds ratio (OR) = 9.30; confidence interval (CI) 3.69-23.45; P < 0.01), injecting drug use (OR=24.26; CI 8.99-65.43; P < 0.01) and previous incarceration (OR=12.26; CI 4.51-33.31; P < 0.01). In a cohort of treatment-eligible individuals, 43.3% (90/208) had neither been referred to specialist services or general practitioners for HCV management. Amongst those referred to specialist services, 64.7% (57/88) did not attend scheduled follow up, and 48.3% (15/31) of attendees were lost to follow up. Through an intensified community access programme, 10 people were successfully treated for HCV, although 22 could not be engaged. People with SMI are underserved by traditional models of HCV healthcare. Intensified community-based support can partially bolster the treatment cascade, although investment in innovative screening and management strategies are required to achieve healthcare parity.

A retrospective, descriptive study of hepatitis C testing, prevalence, and care continuum among adults on probation

BackgroundDespite constituting the largest segment of the correctional population, individuals on court-ordered probation remain largely unstudied with respect to hepatitis C virus (HCV) testing and linkage-to-care. We conducted a retrospective, descriptive analysis to estimate prevalence of diagnosed HCV and the subsequent HCV care cascade among a cohort of individuals enrolled in an adult probation program over a 25-month period in Denver, Colorado.MethodsWe utilized probabilistic matching with first and last name, sex, and birthdate to identify individuals enrolled in probation between July 1, 2016 and July 30, 2018 who had a medical record at the participating safety-net healthcare institution as of December 31, 2019. Electronic medical record data were queried for evidence of HCV testing and care through June 30, 2021. The state HCV registry was also queried for prevalence of reported HCV cases among the cohort.ResultsThis cohort included 8,903 individuals; 6,920 (78%) individuals had a medical record at the participating institution, and of these, 1,037 (15%) had ever been tested for HCV (Ab or RNA) and 308 (4% of those with a medical record, 30% of those tested) had detectable HCV RNA. Of these, 105 (34%) initiated HCV treatment, 89 (29%) had a subsequent undetectable HCV viral load, and 65 (21%) had documentation of HCV cure. Eleven percent of the total cohort had records of positive HCV Ab or RNA tests in the state HCV registry.ConclusionsThis study demonstrates the importance of HCV screening and linkage-to-care for individuals enrolled in probation programs. A focus on this population could enhance progress towards HCV elimination goals.

Viral blood-borne infections testing and linkage to care cascade among persons who experience homelessness in the United States: a systematic review and meta-analysis

BackgroundPersons who experience homelessness remain at increased risk for three viral blood-borne infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). We assessed the yield of testing and linkage to care programs targeting this population for these infections in the United States (US).MethodsWe searched PubMed, Embase, Web of Science, and Cochrane Central for peer-reviewed articles through August 27, 2020. Additionally, we searched the grey literature. Two individuals independently reviewed all relevant studies to check for eligibility and extracted data for each step in the care cascade. We used random-effects model to generate weighted pooled proportions to assess yield at each step. Cumulative proportions were calculated as products of adjacent-step pooled proportions. We quantitatively synthesized data from the studies that focused on non-drug injecting individuals.ResultsWe identified 24 studies published between 1996–2019 conducted in 19 US states. Seventeen studies screened for HIV, 12 for HCV, and two screened for HBV. For HIV, 72% of approached were recruited, 64% had valid results, 4% tested positive, 2% were given results, and 1% were referred and attended follow-up. Of positives, 25% were referred to treatment and started care. For HCV, 69% of approached were recruited, 63% had valid results, 16% tested positive, 14% were given results, and 3% attended follow-up. Of positives, 30% were referred for treatment and 19% started care. The yield at each care cascade step differs widely by recruitment strategy (for example, for HIV: 71.6% recruited of reached under service-based with zero yield under healthcare facility-based and outreach).ConclusionsA very large proportion of this population reached for HIV and HCV care were lost in the follow-up steps and never received treatment. Future programs should examine drop-out reasons and intervene to reduce health disparities in this population.

Impact of COVID-19 pandemic on HCV care cascade in Rwanda: Ecological study from July 2019 to June 2021.

Content available: Author Interview and Audio Recording

Addressing inequities in access to care among Indigenous peoples with chronic hepatitis C in Alberta, Canada

Indigenous peoples worldwide continue to suffer disproportionate health inequities resulting from ongoing and intergenerational colonial trauma, including psychological, social, physical, and spiritual effects. 1 Mitchell TL Maracle DT Post-traumatic stress and the health status of Aboriginal populations in Canada. Int J Indig Health. 2005; 2: 14-23 Google Scholar In Canada, contemporary colonial traumas include, but are not limited to, the displacement of Indigenous peoples (First Nations, Inuit, and Métis) from their land and resources, historical banning of cultural ceremony and language, forced removal and abuse of children via the residential school and child welfare systems, and the federal Indian Act (a paternalistic and racist imposition of colonial systems controlling access to food, land, resources, naming, health care, education, and even status as an Indigenous person). Although Canada is considered a wealthy nation, the continued impact of these abuses result in impoverished socioeconomic status and disruption of wellness for many Indigenous peoples. The compounding effect over successive generations has contributed to disproportionately higher rates of substance abuse, suicide, and many diseases, including liver disease resulting from chronic hepatitis C virus (HCV) infection, in these populations. 2 Mitchell T Arseneau C Colonial Trauma: Complex, continuous, collective, cumulative and compounding effects on the health of Indigenous peoples in Canada and beyond. Int J Indig Health. 2019; 14: 74-94 Crossref Google Scholar Health inequities in Indigenous peoples are often highlighted in health research without sufficient explanation of the role of systemic drivers, which further victimises or stigmatises Indigenous populations. 3 Fayed ST King A King M et al. In the eyes of Indigenous people in Canada: exposing the underlying colonial etiology of hepatitis C and the imperative for trauma-informed care. Can Liv J. 2018; 1: 115-129 Crossref Google Scholar In this Comment, we describe the creation and implementation of a co-design approach centred on respectful relationships with Indigenous communities in the province of Alberta, Canada, to address systemic and longstanding inequities regarding access to HCV care.

Association of Referral Source and Substance Use with Hepatitis C Virus Outcomes at a Southern Academic Medical Center.

Therapeutic advances make the cure of chronic hepatitis C virus (HCV) infection achievable for individuals aware of their diagnosis who can access care. Identifying barriers to accessing care is critical to achieve population-level HCV elimination and improve the cascade of care from diagnosis to cure. To identify barriers to HCV care, we performed a retrospective observational analysis of outcomes for patients with chronic HCV referred to an infectious diseases clinic at an academic medical center in Charleston, South Carolina between January 1, 2015 and January 1, 2020. We categorized outcomes in the cascade of care between "never presenting for evaluation" and "completed treatment with documented cure." Patient demographic factors, referral source, ZIP code of residence, insurance status, clinical characteristics, antiviral regimen, psychiatric and substance use history, and route of infection were assessed for associations with care outcomes. Of 407 referrals, 32% of patients never presented for an initial evaluation, an outcome that was associated with active substance use, mental health disease, and referral from an emergency department or obstetrics-gynecology provider. Of the patients who presented for an initial evaluation, 78% of patients initiated treatment. Active substance use was the only variable associated with lack of therapy initiation after presenting for an initial evaluation (odds ratio 2.5, 95% confidence interval 1.07-5.84). Once treatment had been initiated, no clinical or demographic variables were associated with odds of achieving documented or presumed HCV cure. Active substance use, mental health disease, and referral from an emergency department or obstetrics-gynecology provider were associated with a lower odds of presenting for evaluation and initiation of HCV treatment. Innovative models to improve access to care and increase outreach to vulnerable populations will be essential to eliminate HCV.

Closing the hepatitis C treatment gap: United States strategies to improve retention in care.

The hepatitis C virus (HCV) treatment landscape is shifting given the advent of direct-acting antivirals and a global call to action by the World Health Organization. Eliminating HCV is now an issue of healthcare delivery. Treatment is limited by the complexity of the HCV care continuum, expensive therapy and competing health burdens experienced by an underserved HCV population. The objective of this literature review was to assess strategies to improve retention in HCV care, with particular focus on those implemented in the United States. We identified barriers in HCV care retention and propose solutions to increase HCV treatment delivery. The following recommendations are herein described: improving the cohesion of health services through localized care and integrated case management, expanding the supply of non-specialist HCV treatment providers, leveraging patient navigators and care coordinators, improving adherence through directly observed therapy and reducing cost barriers through value-based payment and pharmaceutical subscription models.

Can Telemedicine Optimize the HCV Care Cascade in People Who Use Drugs? Features of an Innovative Decentralization Model and Comparison with Other Micro-Elimination Strategies.

Simple SummaryThe global fight against the hepatitis C virus (HCV) involves the processes of micro-elimination of populations at risk. People who use drugs (PWUDs) represent a viral reservoir, due to the historical challenge in treating this population. In particular, the difficulties in the linkage to care of these patients, as well as low adherence to therapies and follow-up and the risk of re-infection make PWUDs a “difficult-to-treat” population. In view of this, the testing of effective management and treatment models for chronic HCV infection in PWUDs is crucial for promoting its elimination. Telemedicine could be a successful solution in the integration and decentralization of care services.People who use drugs (PWUDs) are a crucial population in the global fight against viral hepatitis. The difficulties in linkage to care, the low adherence to therapy, the frequent loss to follow-up and the high risk of re-infection make the eradication process of the hepatitis C virus (HCV) really hard in this viral reservoir. Several management and treatment models have been tested with the aim of optimizing the HCV care cascade in PWUDs. Models of decentralization of the care process and integration of services seem to provide the highest success rates. Giving this, telemedicine could favor the decentralization of diagnostic-therapeutic management, key for the implementation of linkage to care, reduction of waiting times, optimization of adherence and results and reduction of the costs. The purpose of this literature review is to examine the role and possible impact of telemedicine in optimizing the HCV care cascade, comparing the different care models that have shown to improve the linkage to care and therapeutic adherence in this special population.

Estimating the causal effect of treatment with direct-acting antivirals on kidney function among individuals with hepatitis C virus infection.

BackgroundDirect-acting antivirals (DAA) are highly effective at treating Hepatitis C virus (HCV) infection, with a cure rate >95%. However, the effect of DAAs on kidney function remains debated.MethodsWe analyzed electronic health record data for DAA-naive patients with chronic HCV infection engaged in HCV care at Boston Medical Center between 2014 and 2018. We compared the following hypothetical interventions using causal inference methods: 1) initiation of DAA and 2) no DAA initiation. For patients with normal kidney function at baseline (eGFR>90 ml/min/1.73m2), we estimated and compared the risk for reaching Stage 3 chronic kidney disease (CKD) (eGFR≤60 ml/min/1.73m2) under each intervention. For patients with baseline CKD Stages 2–4 (15<eGFR≤90 ml/min/1.73m2), we estimated and compared the mean change in eGFR at 2 years after baseline under each intervention. We used the parametric g-formula to adjust our estimates for baseline and time-varying confounders.ResultsFirst, among 1390 patients with normal kidney function at baseline the estimated 2-year risk difference (95% CI) of reaching Stage 3 CKD for DAA initiation versus no DAA was -1% (-3, 2). Second, among 733 patients with CKD Stage 2–4 at baseline the estimated 2-year mean difference in change in eGFR for DAA initiation versus no DAA therapy was -3 ml/min/1.73m2 (-8, 2).ConclusionsWe found no effect of DAA initiation on kidney function, independent of baseline renal status. This suggests that DAAs may not be nephrotoxic; furthermore, in the short-term, HCV clearance may not improve CKD.

Reaching people receiving opioid agonist therapy at community pharmacies with hepatitis C virus: an international randomised controlled trial.

Conventional healthcare models struggle to engage those at risk of hepatitis C virus (HCV) infection. This international study evaluated point-of-care (PoC) HCV RNA diagnostic outreach and direct-acting antiviral (DAA) treatment for individuals receiving opioid agonist therapy (OAT) in community pharmacies. We assessed the effectiveness of a roving nurse-led pathway offering PoC HCV RNA testing to OAT clients in community pharmacies relative to conventional care. Pharmacies in Scotland, Wales, and Australia were randomised to provide PoC HCV RNA testing or conventional referral. Pharmacists directed OAT clients to on-site nurses (intervention) or local clinics (control). Infected participants were treated with DAAs, alongside OAT. Primary outcome was the number of participants with sustained virologic response at 12 weeks (SVR) and analysed using mixed effects logistic regression in the intention-to-treat (ITT) population. Forty pharmacies were randomised. The ITT population contained 1410 OAT clients. In the conventional arm (n= 648), 62 (10%) agreed to testing, 17 (27%) were tested, 6 (35%) were positive and 5 (83%) initiated treatment. In the intervention arm (n= 762), 148 (19%) agreed to testing, 144 (97%) were tested, 23 (16%) were positive and 22 (96%) initiated treatment. SVR was obtained by 2 (40%; conventional) and 18 (82%; intervention). Intervention arm participants had higher odds of testing, OR 16.95 (7.07-40.64, p< 0.001); treatment, OR 4.29 (1.43-12.92, p= 0.010); and SVR, OR 8.64 (1.82-40.91, p= 0.007). Nurse-led PoC diagnosis in pharmacies made HCV care more accessible for OAT clients relative to conventional care. However, strategies to improve testing uptake are required. NCT03935906.

Feasibility of hepatitis C virus testing and linkage in community supervision offices: Great potential but persistent challenges.

Persons involved with the justice system have an elevated risk of hepatitis C virus (HCV) yet remain marginalized from treatment. Efforts to eliminate HCV will require targeted interventions within the justice system effective at providing diagnosis and treatment. We implemented a novel HCV screening and treatment intervention for persons under community supervision in Rhode Island, USA during April 2018--March 2020. Participants received rapid point-of-care HCV antibody testing onsite and referral to community laboratory and treatment services as indicated. We assessed the HCV care cascade to identify areas for improvement. Overall, 483 individuals were screened for HCV antibody; 85 (18%) were positive. A minority of participants with positive HCV antibody tests (n=25/85, 29%) presented to community laboratories for confirmatory testing. Among participants that received HCV viral load results and linked to a treatment provider (n=12), four initiated treatment, three had record of completing treatment, and two were confirmed to have achieved cure. Linkage to HCV viral load testing and treatment was challenging in this community supervision population, with substantial loss to follow-up at each step of the HCV cascade. Community supervision remains an important venue for case identification but substantial barriers to accessing HCV treatment exist. Innovative HCV diagnosis and treatment strategies are needed for community supervision populations.

Predictors of linkage to hepatitis C virus care among people living with HIV with hepatitis C infection and the impact of loss to HIV follow-up.

ObjectiveHalf of the people living with HIV (PLWH) with hepatitis C virus (HCV) remain untreated for HCV. We examined predictors of HCV linkage to care among PLWH and the impact of HIV lost to care.Design and methodsWe conducted a retrospective review of PLWH/HCV from our HIV clinics between 2014 and 2017, and examined predictors of HCV linkage to care. We used the Kaplan–Meier method to estimate the probability of HIV retention and HCV linkage over time.ResultsOf 615 PLWH/HCV, 34% linked to HCV care and 21% were cured. Higher odds of linkage to HCV care were among blacks (adjusted odds ratio [aOR]: 2.95, 95% confidence interval [CI]: 1.59, 5.47), prior injection drug users (IDUs; aOR: 2.89, 95% CI: 1.39, 6.01), Medicare (aOR: 3.09, 95% CI: 1.56, 6.11), and cirrhotics (aOR: 2.80, 95% CI: 1.52, 5.14). Reduced odds for linkage were in active IDU (aOR: 0.16, 95% CI: 0.05, 0.45) and those seen by an advanced practice provider (aOR: 0.53, 95% CI: 0.30, 0.92). The main reason for failure to link to HCV care was lost to HIV care. At 3 years, the overall probability of being retained in HIV care was 53%; among those who had an HCV evaluation visit, it was 75% vs. 41% with no HCV evaluation visit. Accounting for loss to follow‐up, PLWH/HCV had a 65% probability of having an HCV evaluation at 3 years.

Low disease awareness as a contributing factor to the high prevalence of hepatitis C infection in Tzukuan, a hyperendemic area of southern Taiwan.

Understanding the barriers and tackling the hurdles of hepatitis C virus (HCV) care cascades is key to HCV elimination. The current study aimed to investigate the rates of disease awareness, link-to-care, and treatment uptake of HCV in a hyperendemic area in Taiwan. Tzukuan residents from 2000 to 2018 were invited to participate in the questionnaire-based interviews for HCV. The rates of disease awareness, accessibility, and anti-HCV therapy were evaluated in anti-HCV-seropositive participants. Among 10,348 residents, 1789 (17.3%) were anti-HCV seropositive. Of these 1789 anti-HCV-seropositive participants, data of 594 participants from questionnaire-based interviews in 2005-2018 were analyzed for HCV care cascades. Overall, 24.9% of anti-HCV-seropositive HCV participants had disease awareness, 53.9% of aware participants had accessibility, and 79.8% of assessed participants had received HCV treatment, with a community effectiveness of 10.7%. HCV prevalence decreased over time, from 21.2% in the early cohort to 9.3% in the recent cohort. Disease awareness increased over time, from 15.6% to 41.7%, with the community effectiveness increasing from 1.3% to 28.8%. Lower education levels and normal liver biochemistry were associated with a lower rate of disease awareness. Notably, 68% of participants with abnormal liver biochemistry and 69% of those with advanced fibrosis (FIB-4 > 3.25) were unaware of their HCV disease. We demonstrated huge gaps in disease awareness, link-to-care, and treatment uptake in the HCV care cascade in an HCV-hyperendemic area, even in the initial era of direct-acting antiviral agents. There is an urgent need to overcome these hurdles to achieve HCV elimination.

M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID

BackgroundOpioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes.MethodsThe Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial (M2HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated.DiscussionThe results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings.Trial registrationClinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201.

Peer-facilitated treatment access for hepatitis C: the Live Hep C Free project

BackgroundThis commentary explores the lessons learned during implementation of a peer-facilitated hepatitis C virus (HCV) testing and treatment access project called the Live Hep C Free (LHCF) project in contributing to micro-elimination efforts.Case presentationThe LHCF project aims to facilitate access to on-the-spot HCV testing, treatment, and care in priority settings through partnership between a peer worker (PW) and a clinical nurse. Since the start of the project in January 2018, 4515 people were engaged about HCV and encouraged to access on-site HCV health care, and over 1000 people were screened for HCV and liver health, while almost 250 people accessed HCV treatment through the project. This commentary is intended to prompt discussion about incorporating peer-centred HCV health programs into priority sites. HCV care-delivery models such as the LHCF project can continue to contribute to micro-elimination of HCV in key settings to increase treatment uptake amongst high prevalence and/or marginalised populations and support progress toward national elimination targets.ConclusionsThe LHCF project has been able to highlight the benefits of incorporating trustworthy, efficient, and convenient peer-centred health services to engage and support vulnerable populations through HCV testing and treatment, particularly individuals who have historically been disconnected from the health care system. Additional attention is needed to ensure ongoing funding support to sustain the project and deliver at scale and in expanding evaluation data to examine the operation and outcomes of the project in more detail.

Reaching Hard-to-Reach People Who Use Drugs: A Community-Based Strategy for the Elimination of Hepatitis C.

BackgroundElimination of hepatitis C virus (HCV) among people who use drugs (PWUD) remains a challenge even in countries in which HCV care is provided free of cost. We assessed whether an innovative community-based, respondent-driven sampling (RDS) survey, coupled with HCV screening and immediate treatment, could be efficient to detect and cure current PWUD with chronic HCV in a large city of Southern France.MethodsAt a community site with peers, PWUD (cannabis not included) were enrolled after confirmation by a urine drug test. Participants were then screened for hepatitis B virus, HCV, and human immunodeficiency virus and benefited from onsite HCV treatment evaluation and prescription. Peer support was provided during treatment, and a systematic visit was scheduled 12 weeks after the end of treatment. The cost of the intervention was estimated.ResultsFive hundred fifty-four participants were enrolled. Most were male (78.8%) with a median age of 39 years (interquartile range, 33–46). Cocaine (73.1%) and heroine (46.8%) were the main drugs consumed. Overall, 32.6% of PWUD (N = 181) were HCV seropositive, 49 (27.1%) of which had detectable HCV ribonucleic acid and were thus eligible for treatment. Ten of these patients had severe fibrosis. Hepatitis C virus treatment was initiated for 37 (75.5%) patients, 30 (81.1%) of whom completed their treatment and 27 (73.0%) achieved sustained viral response at week 12. The total cost was 161 euros € per screened patient and 1816€ per patient needing treatment.ConclusionsA community-based RDS survey approach, involving peers, proved efficient and cost-effective to reach and cure PWUD for HCV. This innovative strategy could be key for the final step of HCV elimination. Clinical trial registration. ClinicalTrials.gov, NCT04008927.

An on-site community-based model for hepatitis C screening, diagnosis, and treatment among people who inject drugs in Kerman, Iran: The Rostam study.

People who inject drugs (PWID) are at high risk for hepatitis C virus (HCV) infection and its complications in many countries, including Iran. This pilot study aimed to evaluate the effect of a community-based HCV model of care on HCV testing and treatment initiation among PWID in Kerman, Iran. This study is part of the Rostam study and is a non-randomized trial evaluating the effect of on-site HCV- antibody rapid testing, venipuncture for HCV RNA testing, and treatment eligibility assessment on HCV testing and treatment initiation among PWID. Recruitment, interviews, and HCV screening, diagnosis, and treatment were all conducted at a community-based drop-in center (DIC) serving PWID clients. A total of 171 PWID (median age of 39 years and 89.5% male) were recruited between July 2018 and May 2019. Of 62 individuals who were HCV antibody positive, 47 (75.8%) were HCV RNA positive. Of RNA-positive individuals, 36 (76.6%) returned for treatment eligibility assessment. Of all the 36 participants eligible for treatment, 34 (94.4%) initiated HCV antiviral therapy. A sustained virologic response at 12 weeks post-treatment was 76.5% (26/34) in the intention-to-treat (ITT group) analysis and 100% (23/23) in the per-protocol (PP group) analysis. Our integrated on-site community-based HCV care model within a DIC setting suggested that HCV care including HCV testing and treatment uptake can be successfully delivered outside of hospitals or specialized clinics; a model which is more likely to reach PWID and can provide significant progress towards HCV elimination among this population.