Dataset Information

Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial.

ABSTRACT:

Background & aims

There have been calls to integrate HCV testing into existing services, including harm reduction and HIV prevention and treatment, but there are few empirical trials to date. We evaluated the impact of integrating HCV testing/education into integrated care centers (ICCs) delivering HIV services to people who inject drugs (PWID) across India, using a cluster-randomized trial.

Methods

We compared ICCs with usual care in the PWID stratum (12 sites) of a 22-site cluster-randomized trial. In 6 sites, ICCs delivering HIV testing, harm reduction, other preventive services and linkage to HIV treatment were scaled from opioid agonist therapy centers and operated for 2?years. On-site rapid HCV antibody testing was integrated after 1?year. To assess impact, we conducted baseline and evaluation surveys using respondent-driven sampling (RDS) across the 12 sites (n?=?11,993 recruited at baseline; n?=?11,721 recruited at evaluation). The primary outcome was population-level self-reported HCV testing history.

Results

At evaluation, HCV antibody prevalence ranged from 7.2-76.6%. Across 6 ICCs, 5,263 ICC clients underwent HCV testing, of whom 2,278 were newly diagnosed. At evaluation, PWID in ICC clusters were 4-fold more likely to report being tested for HCV than in usual care clusters, adjusting for baseline testing (adjusted prevalence ratio [aPR] 3.69; 95% CI 1.34-10.2). PWID in ICC clusters were also 7-fold more likely to be aware of their HCV status (aPR 7.11; 95% CI 1.14-44.3) and significantly more likely to initiate treatment (aPR 9.86; 95% CI 1.52-63.8).

Conclusions

We provide among the first empirical data supporting the integration of HCV testing into HIV/harm reduction services. To achieve elimination targets, programs will need to scale-up such venues to deliver comprehensive HCV services. CLINICALTRIALS.

Gov identifier

NCT01686750.

Lay summary

Delivering hepatitis C virus (HCV) testing to people who inject drugs (PWID) in places where they also have access to HIV prevention and treatment services is an effective way to improve uptake of HCV testing among communities of PWID. To achieve the World Health Organization's ambitious elimination targets, integrated programs will need to be scaled up to deliver comprehensive HCV services.

SUBMITTER: Solomon SS

PROVIDER: S-EPMC7173404 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Publications

Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial.

Solomon Sunil Suhas SS Quinn Thomas C TC Solomon Suniti S McFall Allison M AM Srikrishnan Aylur K AK Verma Vinita V Kumar Muniratnam S MS Laeyendecker Oliver O Celentano David D DD Iqbal Syed H SH Anand Santhanam S Vasudevan Canjeevaram K CK Saravanan Shanmugam S Thomas David L DL Sachdeva Kuldeep Singh KS Lucas Gregory M GM Mehta Shruti H SH

Journal of hepatology 20191008 1

<h4>Background & aims</h4>There have been calls to integrate HCV testing into existing services, including harm reduction and HIV prevention and treatment, but there are few empirical trials to date. We evaluated the impact of integrating HCV testing/education into integrated care centers (ICCs) delivering HIV services to people who inject drugs (PWID) across India, using a cluster-randomized trial.<h4>Methods</h4>We compared ICCs with usual care in the PWID stratum (12 sites) of a 22-site clust ...[more]

PMID: 31604081

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Project description:BackgroundIn 2019, Mexico became the first Latin American country committed to hepatitis C virus (HCV) elimination, but the amount of intervention scale-up required is unclear. In Tijuana, HCV among people who inject drugs (PWID) is high; yet there is minimal and intermittent harm reduction, and involuntary exposure to compulsory abstinence programs (CAP) occurs which is associated with increased HCV risk. We determined what combination intervention scale-up can achieve HCV elimination among current and former PWID in Tijuana.MethodsWe constructed a dynamic, deterministic model of HCV transmission, disease progression, and harm reduction among current and former PWID parameterized to Tijuana (~10,000 current PWID, 90% HCV seropositive, minimal opiate agonist therapy [OAT] or high coverage needle/syringe programs [HCNSP]). We evaluated the number of direct-acting antiviral (DAA) treatments needed from 2019 to achieve elimination targets (80% incidence reduction, 65% mortality reduction by 2030) with: (a) DAAs alone, (b) DAAs plus scale-up of OAT+HCNSP (up to 50% coverage of OAT and HCNSP separately, producing 25% of PWID receiving both), (c) DAAs plus CAP scale-up to 50%. Scenarios examined the number of DAAs required if prioritized to current PWID or provided regardless of current injection status, and impact of harm reduction interruptions.ResultsModeling suggests among ~30,000 current and former PWID in Tijuana, 16,160 (95%CI: 12,770-21,610) have chronic HCV. DAA scale-up can achieve the incidence target, requiring 770 treatments/year (95%CI: 640-970) if prioritized to current PWID. 40% fewer DAAs are required with OAT+HCNSP scale-up to 50% among PWID, whereas more are required with involuntary CAP scale-up. Both targets can only be achieved through treating both current and former PWID (1,710 treatments/year), and impact is reduced with harm reduction interruptions.ConclusionsElimination targets are achievable in Tijuana through scale-up of harm reduction and DAA therapy, whereas involuntary CAP and harm reduction interruptions hamper elimination.

Project description:Background and aimsIn Latin America, Mexico was first to launch a hepatitis C virus (HCV) elimination strategy, where people who inject drugs (PWID) are a main risk group for transmission. In Tijuana, HCV seroprevalence among PWID is > 90%, with minimal harm reduction (HR). We evaluated cost-effectiveness of strategies to achieve the incidence elimination target among PWID in Tijuana.MethodsModeling study using a dynamic, cost-effectiveness model of HCV transmission and progression among active and former PWID in Tijuana, to assess the cost-effectiveness of incidence elimination strategies from a health-care provider perspective. The model incorporated PWID transitions between HR stages (no HR, only opioid agonist therapy, only high coverage needle-syringe programs, both). Four strategies that could achieve the incidence target (80% reduction by 2030) were compared with the status quo (no intervention). The strategies incorporated the number of direct-acting anti-viral (DAA) treatments required with: (1) no HR scale-up, (2) HR scale-up from 2019 to 20% coverage among PWID, (3) HR to 40% coverage and (4) HR to 50% coverage. Costs (2019 US$) and health outcomes [disability-adjusted life years (DALYs)] were discounted 3% per year. Mean incremental cost-effectiveness ratios (ICER, $/DALY averted) were compared with one-time per capita gross domestic product (GDP) ($9698 in 2019) and purchasing power parity-adjusted per capita GDP ($4842-13 557) willingness-to-pay (WTP) thresholds.ResultsDAAs alone were the least costly elimination strategy [$173 million, 95% confidence interval (CI) = 126-238 million], but accrued fewer health benefits compared with strategies with HR. DAAs + 50% HR coverage among PWID averted the most DALYs but cost $265 million, 95% CI = 210-335 million). The optimal strategy was DAAs + 50% HR (ICER $6743/DALY averted compared to DAAs only) under the one-time per-capita GDP WTP ($9698).ConclusionsA combination of high-coverage harm reduction and hepatitis C virus treatment is the optimal cost-effective strategy to achieve the HCV incidence elimination goal in Mexico.

Project description:Background and aimsPeople who inject drugs (PWID) experience high incarceration rates, and previous incarceration is associated with elevated hepatitis C virus (HCV) transmission risk. In Scotland, national survey data indicate lower HCV incidence in prison than the community (4.3 versus 7.3 per 100 person-years), but a 2.3-fold elevated transmission risk among recently released (< 6 months) PWID. We evaluated the contribution of incarceration to HCV transmission among PWID and the impact of prison-related prevention interventions, including scaling-up direct-acting antivirals (DAAs) in prison.DesignDynamic mathematical modelling of incarceration and HCV transmission, using approximate Bayesian computation for model calibration.SettingScotland, UK.ParticipantsA simulated population of PWID.MeasurementsPopulation-attributable fraction (PAF) of incarceration to HCV transmission among PWID. Decrease in HCV incidence and chronic prevalence due to current levels of prison opiate substitution therapy (OST; 57% coverage) and HCV treatment, as well as scaling-up DAAs in prison and/or preventing the elevated risk associated with prison release.FindingsIncarceration contributes 27.7% [PAF; 95% credible interval (CrI) -3.1 to 51.1%] of HCV transmission among PWID in Scotland. During the next 15 years, current HCV treatment rates (10.4/6.8 per 1000 incarcerated/community PWID annually), with existing prison OST, could reduce incidence and chronic prevalence among all PWID by a relative 10.7% (95% CrI = 8.4-13.3%) and 9.7% (95% CrI = 7.7-12.1%), respectively. Conversely, without prison OST, HCV incidence and chronic prevalence would decrease by 3.1% (95% CrI = -28.5 to 18.0%) and 4.7% (95% CrI = -11.3 to 14.5%). Additionally, preventing the heightened risk among recently released PWID could reduce incidence and chronic prevalence by 45.0% (95% CrI = 19.7-57.5%) and 33.3% (95% CrI = 15.6-43.6%) or scaling-up prison HCV treatments to 80% of chronic PWID prison entrants with sufficient sentences (>16 weeks) could reduce incidence and prevalence by 45.6% (95% CrI = 38.0-51.3%) and 45.5% (95% CrI = 39.3-51.0%), respectively.ConclusionsIncarceration and the elevated transmission risk following prison release can contribute significantly to hepatitis C virus transmission among people who inject drugs. Scaling-up hepatitis C virus treatment in prison can provide important prevention benefits.

Project description:BackgroundThe standard pathways of testing and treatment for hepatitis C virus (HCV) infection in tertiary healthcare are not easily accessed by people who inject drugs (PWID). The aim of this study was to evaluate the efficacy of integrated treatment of chronic HCV infection among PWID.Methods and findingsINTRO-HCV is a multicenter, randomized controlled clinical trial. Participants recruited from opioid agonist therapy (OAT) and community care clinics in Norway over 2017 to 2019 were randomly 1:1 assigned to the 2 treatment approaches. Integrated treatment was delivered by multidisciplinary teams at opioid agonist treatment clinics or community care centers (CCCs) for people with substance use disorders. This included on-site testing for HCV, liver fibrosis assessment, counseling, treatment, and posttreatment follow-up. Standard treatment was delivered in hospital outpatient clinics. Oral direct-acting antiviral (DAA) medications were administered in both arms. The study was not completely blinded. The primary outcomes were time-to-treatment initiation and sustained virologic response (SVR), defined as undetectable HCV RNA 12 weeks after treatment completion, analyzed with intention to treat, and presented as hazard ratio (HR) and odds ratio (OR) with 95% confidence intervals. Among 298 included participants, 150 were randomized to standard treatment, of which 116/150 (77%) initiated treatment, with 108/150 (72%) initiating within 1 year of referral. Among those 148 randomized to integrated care, 145/148 (98%) initiated treatment, with 141/148 (95%) initiating within 1 year of referral. The HR for the time to initiating treatment in the integrated arm was 2.2 (1.7 to 2.9) compared to standard treatment. SVR was confirmed in 123 (85% of initiated/83% of all) for integrated treatment compared to 96 (83% of initiated/64% of all) for the standard treatment (OR among treated: 1.5 [0.8 to 2.9], among all: 2.8 [1.6 to 4.8]). No severe adverse events were linked to the treatment.ConclusionsIntegrated treatment for HCV in PWID was superior to standard treatment in terms of time-to-treatment initiation, and subsequently, more people achieved SVR. Among those who initiated treatment, the SVR rates were comparable. Scaling up of integrated treatment models could be an important tool for elimination of HCV.Trial registrationClinicalTrials.gov.no NCT03155906.

Project description:Background and aimsThe INTRO-HCV randomized controlled trial conducted in Norway over 2017-2019 found that integrated treatment, compared with standard-of-care hospital treatment, for hepatitis C virus (HCV) with direct-acting antivirals (DAAs) improved treatment outcomes among people who inject drugs (PWID). We evaluated cost-effectiveness of the INTRO-HCV intervention.DesignA Markov health state transition model of HCV disease progression and treatment with cost-effectiveness analysis from the health-provider perspective. Primary cost, utility, and health outcome data were derived from the trial. Costs and health benefits (quality-adjusted life-years, QALYs) were tracked over 50 years. Probabilistic and univariate sensitivity analyses investigated DAA price reductions and variations in HCV treatment and disease care cost assumptions, using costs from different countries (Norway, United Kingdom, United States, France, Australia).Setting and participantsPWID attending community-based drug treatment centers for people with opioid dependence in Norway.MeasurementsIncremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained, compared against a conventional (€70 000/QALY) willingness-to-pay threshold for Norway and lower (€20 000/QALY) threshold common among high-income countries.FindingsIntegrated treatment resulted in an ICER of €13 300/QALY gained, with 99% and 71% probability of being cost-effective against conventional and lower willingness-to-pay thresholds, respectively. A 30% lower DAA price reduced the ICER to €6 900/QALY gained, with 91% probability of being cost-effective at the lower willingness-to-pay threshold. A 60% and 90% lower DAA price had 36% and >99% probability of being cost-saving, respectively. Sensitivity analyses suggest integrated treatment was cost-effective at the lower willingness-to-pay threshold (>60% probability) across different assumptions on HCV treatment and disease care costs with 30% DAA price reduction, and became cost-saving with 60%-90% price reductions.ConclusionsIntegrated hepatitis C virus treatment for people who inject drugs in community settings is likely cost-effective compared with standard-of-care referral pathways in Norway and may be cost-saving in settings with particular characteristics.

Dataset Information

Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial.

Background & aims

Methods

Results

Conclusions

Gov identifier

Lay summary

Publications

Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial.

Similar Datasets

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