Access To Hepatitis C Virus Treatment Research Articles

An Analysis of Social Determinants of Health and Their Implications for Hepatitis C Virus Treatment in People Who Inject Drugs: The Case of Baltimore.

Sixty-eight percent of the nearly 3.5 million people living with hepatitis C virus (HCV) in the United States are people who inject drugs (PWID). Despite effective treatments, uptake remains low in PWID. We examined the social determinants of health (SDoH) that affect the HCV care cascade. We conducted a secondary analysis of data from 720 PWID in a cluster-randomized trial. We recruited PWID from 12 drug-affected areas in Baltimore. Inclusion criteria were injection in the prior month or needle sharing in the past 6 months. Intake data consisted of a survey and HCV testing. Focusing on SDoH, we analyzed self-report of (1) awareness of HCV infection (in those with active or previously cured HCV) and (2) prior HCV treatment (in the aware subgroup). We used descriptive statistics and logistic regression for statistical analyses. The 342 participants were majority male and Black with a median age of 52 years. Women were more likely to be aware of their status but less likely to be treated. Having a primary care provider and HIV-positive status were associated with increased awareness and treatment. Unhoused people had 51% lower odds of HCV treatment. People who reported that other PWID had shared their HCV status with them had 2.3-fold higher odds of awareness of their own status. Further study of gender disparities in HCV treatment access is needed. Increased social support was associated with higher odds of HCV treatment, suggesting an area for future interventions. Strategies to identify and address SDoH are needed to end HCV.

Hepatitis C Treatment for Patients Without Insurance in a Student-Run Free Clinic: Analysis of Demographics, Cost, and Outcomes

Background: Hepatitis C virus (HCV) predominantly affects marginalized patients, who have been reported to lack access to effective treatment. A high overlap exists between those at risk for HCV and those cared for by student-run free clinics. The purpose of this study is to present how one student-run free clinic provides accessible HCV care to patients as a model for other free clinics to offer similar services.
 Methods: Data was reviewed from the electronic medical record and MedData Services, a software for management of patient assistance program (PAP) applications. Data collected included information regarding HCV diagnosis, treatment, and medication access process.
 Results: At our clinic, there were 23 patients with a documented diagnosis or prior history of HCV infection. Treatment was initiated in 83% (n = 19) of patients, and 89% (n = 17) of these patients completed treatment. Most patients (84%, n = 16) received HCV medications directly through Shade Tree Clinic. All but three patients were treated with Harvoni®. All patients with available laboratory data (n = 13) at >12 weeks status-post treatment had achieved sustained viral response. PAP applications were successfully approved for 89% (n = 17) of submitted applications (n = 19), representing the primary avenue for our clinic to access HCV treatments.
 Conclusions: Our experience with HCV demonstrates that effective HCV treatment is feasible in a student-run free clinic setting.

Scaling and Sustaining Facilitated Telemedicine to Expand Treatment Access Among Underserved Populations: A Qualitative Study.

Background: Opioid treatment programs are an essential component of the management of opioid use disorder (OUD). They have also been proposed as "medical homes" to expand health care access for underserved populations. We utilized telemedicine as a method to increase access for hepatitis C virus (HCV) care among people with OUD. Methods: We interviewed 30 staff and 15 administrators regarding the integration of facilitated telemedicine for HCV into opioid treatment programs. Participants provided feedback and insight for sustaining and scaling facilitated telemedicine for people with OUD. We utilized hermeneutic phenomenology to develop themes related to telemedicine sustainability in opioid treatment programs. Results: Three themes emerged on sustaining the facilitated telemedicine model: (1) Telemedicine as a Technical Innovation in Opioid Treatment Programs, (2) Technology Transcending Space and Time, and (3) COVID-19 Disrupting the Status Quo. Participants identified skilled staff, ongoing training, technology infrastructure and support, and an effective marketing campaign as key to maintaining the facilitated telemedicine model. Participants highlighted the study-supported case manager's role in managing the technology to transcend temporal and geographical challenges for HCV treatment access for people with OUD. COVID-19 fueled changes in health care delivery, including facilitated telemedicine, to expand the opioid treatment program's mission as a medical home for people with OUD. Conclusions: Opioid treatment programs can sustain facilitated telemedicine to increase health care access for underserved populations. COVID-19-induced disruptions promoted innovation and policy changes recognizing telemedicine's role in expanding health care access to underserved populations. ClinicalTrials.gov Identifier: NCT02933970.

Barriers to Hepatitis C Virus Care and How Federally Qualified Health Centers Can Improve Patient Access to Treatment.

Despite the availability of direct-acting antiviral agents (DAAs) for hepatitis C virus (HCV) treatment, disparities in HCV care and treatment persist for underserved populations due to demographic-based and insurance-based barriers. We aim to examine the effect of barriers on HCV treatment access for a federally qualified health center (FQHC) population. We retrospectively evaluated medical records of adults diagnosed with chronic HCV at an FQHC clinic from 2016 to 2020 with follow-up through 2021. Univariate and bivariate analyses were used to describe the patient population and significant associations between predictors of linkage to HCV care and treatment access. Adjusted multivariate logistic regression analyses were used to identify predictors of starting HCV treatment. Of 279 total patients with chronic HCV, 162 patients started treatment (58%), 138 patients (50%) completed treatment, and 99 patients (35%) achieved sustained virological response (SVR). Of the total patients, 145 (52%) were seen by their primary care physician (PCP) for their HCV care and treatment, and 134 (48%) were seen by a provider that specializes in management and treatment of HCV (HCV provider). Patients seen by an HCV provider in addition to their PCP were more likely to have had their prior authorization requests for HCV treatment denied by their insurance providers than patients seen only by their PCP for HCV care (30% vs. 14%, P = 0.001). We believe that this discrepancy stems from two issues. One, prior authorizations are reviewed by insurance providers who are not specially trained in HCV management, so the verbiage used perplexes these reviewers, possibly causing them to issue denials. Two, insurance providers often require HCV genotype testing for DAA medication eligibility, and HCV providers order genotype tests for patients only when HCV treatments have failed to cure patients, so this requirement becomes another barrier to DAA medications. Patients who spoke a non-English language, lived in the USA for less than 10 years, and showed inability to pay for treatment had received treatment despite these characteristics being common barriers to HCV treatment. On multivariate regression, factors independently associated with patients starting treatment included prior denial for DAA medication (odds ratio (OR), 8.88; 95% confidence interval (CI), 3.22 - 24.6; P < 0.001) and being seen by an HCV provider (OR, 24.8; 95% CI, 11.7 - 52.5; P < 0.001). However, the most significant barrier to HCV treatment access for the FQHC population was eligibility restrictions from insurance providers. Demographic-based barriers (e.g., age, race, and income) often impede HCV care and treatment, but insurance-based barriers are the greatest challenge currently that affects treatment outcomes in our study population. Removing these restrictions would, in our opinion, help to increase treatment levels to underserved populations.

Disparities in Access to Hepatitis C Treatment Among Arizona Medicaid Beneficiaries With Chronic Hepatitis C.

High costs of direct-acting antivirals (DAAs) have led to their restricted access for patients with hepatitis C virus (HCV). The aim was to assess how HCV treatment access and predictors of HCV treatment changed in the post-DAA period compared with pre-DAA period. A retrospective cohort study using Arizona Medicaid data was conducted for patients with HCV to compare treatment initiation rates between pre-DAA (January 2008-October 2013) and post-DAA (November 2013-December 2018) periods. Multivariable logistic regression was used, controlling for demographic and clinical variables. Twenty-four thousand and ninety and 28,756 patients during the pre-DAA and post-DAA periods were identified. Overall, 12.6% were treated in the post-DAA period compared with 7.8% in the pre-DAA period ( P <0.001). The relative increase in the HCV treatment initiation rate from the pre-DAA to the post-DAA period was significant greater for Black beneficiaries compared with White beneficiaries ( P =0.002). Hispanic beneficiaries were less likely to be treated in the post-DAA period [adjusted odds ratios (aOR): 0.88; CI: 0.79-0.98] compared with White beneficiaries. Those with mental illness (aOR: 0.71; 95% CI: 0.63-0.80) and substance use disorders (aOR: 0.63; 95% CI: 0.58-0.68) were less likely to be treated in the post-DAA period. Although treatment initiation increased and disparities for Black beneficiaries compared with White beneficiaries attenuated in the post-DAA period, only 13% of Arizona Medicaid patients with HCV received DAA treatment. Disparities in DAA access remained among Hispanic patients and those with mental illness and substance use disorders.

Hepatitis C Elimination During a Global Pandemic: A Case Study of Resilience in Action.

Until the COVID-19 pandemic, San Francisco's hepatitis C virus (HCV) elimination initiative, End Hep C SF, was expanding and refining HCV testing and treatment strategies citywide, making progress toward local HCV elimination goals. Although a shelter-in-place health order issued in March 2020 categorized HCV testing as an "essential service," most HCV testing and treatment immediately stopped until COVID-19-safe protocols could be implemented. During the 14 months of pandemic-related organizational closures, End Hep C SF transitioned to a 100% virtual model, maintaining regularly scheduled meetings. Community-based HCV antibody testing decreased 80% from February to April 2020, and HCV treatment initiation also decreased, although both services started to rebound in mid-to-late 2020, partially as a result of End Hep C SF collaborations. End Hep C SF service providers, clinicians, and advocates reported that the continuous communication and common agenda of End Hep C SF-2 principles of the collective impact initiative-served as a familiar touchpoint and helpful source of information during this isolating and uncertain time. Ultimately, End Hep C SF allowed us to continue HCV elimination strategies through 6 lessons learned: maintaining HCV treatment access through telehealth and mobile services; leveraging research studies that provided HCV testing and treatment; offering HCV screening and linkage to care in tandem with COVID-19-related initiatives; being flexible and inventive, such as administering HCV treatment to residents of shelter-in-place hotels; establishing a data dashboard to track HCV testing and treatment; and relying on partnerships to solve problems and avoid burnout.

High hepatitis C virus seropositivity, viremia, and associated risk factors among trans women living in San Francisco, California.

Trans women have been understudied in the Hepatitis C virus (HCV) epidemic, yet data suggest they may be at elevated risk of the disease. Using data collected from the Centers for Disease Control and Prevention’s (CDC) National HIV Behavioral Surveillance (NHBS) survey, we measured HCV seropositivity, viremia, and associated risk factors for HCV infection among trans women in San Francisco from June 2019 to February 2020. Respondent-driven sampling (RDS) was used to obtain a diverse, community-based sample of 201 trans women, of whom 48 (23.9%, 95% CI 17.9% - 30.0%) were HCV seropositive. HCV seropositivity significantly increased with increasing age (adjusted prevalence ratio [APR] 1.04 per year, 95% CI 1.01–1.07) and history of injection drug use (APR 4.44, 95% CI 2.15–9.18). We also found that many had HCV viremia as twelve (6.0% of the total sample, 95% CI 2.7% - 9.3%) were RNA-positive for HCV. Trans women are highly impacted by HCV and could benefit from access to regular and frequent HCV screening and treatment access. HCV screening could be offered regularly in trans-specific health services, in the community, in jails and prisons, and integrated syringe exchange programs where treatment access or referral are also available.

Treatment of Chronic Hepatitis C in Young Children Reduces Adverse Outcomes and Is Cost-Effective Compared with Deferring Treatment to Adulthood

To evaluate the cost-effectiveness of treating young children with chronic hepatitis C virus (HCV) with new direct-acting antivirals. A state-transition model of chronic HCV was developed to conduct a cost-effectiveness analysis comparing treatment at age 6years vs delaying treatment until age 18years. Model inputs were derived from recently conducted systematic reviews, published literature, and government statistics. Medical care costs were obtained from linked population level laboratory and administrative data (Ontario, Canada). Outcomes are expressed in expected quality-adjusted life-years and costs (CAD$). Analysis included a base-case to estimate the expected value and one-way and probabilistic sensitivity analyses to evaluate the impact of uncertainty of the model inputs. After 20years, treating 10 000 children early would prevent 330 cases of cirrhosis, 18 cases of hepatocellular carcinoma, and 48 liver-related deaths. The incremental cost-effectiveness ratio of early treatment compared to delayed treatment was approximately $12 690/quality-adjusted life-years gained and considered cost-effective. Model results were robust to variation in fibrosis progression rates, disease state-based costs, treatment costs, and utilities. Delaying treatment until age 18years results in an increased lifetime risk of late-stage liver complications. Early treatment in children is cost effective. Our work supports clinical and health policies that broaden HCV treatment access to young children.

Sharing the cure: Building primary care and public health infrastructure to improve the hepatitis C care continuum in Maryland.

In 2014, trained healthcare provider capacity was insufficient to deliver care to an estimated 70 000 persons in Maryland with chronic hepatitis C virus (HCV) infection. The goal of Maryland Community Based Programs to Test and Cure Hepatitis C, a public health implementation project, was to improve HCV treatment access by expanding the workforce. Sharing the Cure (STC) was a package of services deployed 10/1/14-9/30/18 that included enhanced information technology and public health infrastructure, primary care provider training and practice transformation. Nine primary care sites enrolled. HCV clinical outcomes were documented among individuals who presented for care at sites and met criteria for HCV testing including risk factor or birth cohort (born between 1945 and 1965) based testing. Fifty-three providers completed the STC training. STC providers identified 3237 HCV antibody-positive patients of which 2624 (81%) were RNA+. Of those HCV RNA+, 1739 (66%) were staged, 932 (36%) were prescribed treatment, 838 (32%) started treatment, 721 (27%) completed treatment and 543 (21%) achieved cure. Among 1739 patients staged, 693 (40%) patients had a liver fibrosis assessment score<F2, rendering them ineligible for treatment under Maryland Medicaid guidelines. HCV RNA testing among HCV antibody-positive people increased from 40% (baseline) to 95% among STC providers. Of 554 patients with virologic data reported, 543 (98%) achieved cure. Primary care practices can effectively serve as HCV treatment centers to expand treatment access. However, criteria by insurance providers in Maryland were a major barrier to treatment.

Measuring hepatitis C virus elimination as a public health threat: Beyond global targets.

An increasing number of countries are committing to meet the World Health Organization (WHO) targets to eliminate hepatitis C virus (HCV) as a public health threat by 2030. These include service coverage targets (90% diagnosed and 80% of diagnosed patients treated) and impact targets (80% and 65% reductions in incidence and mortality, respectively, compared to 2015 levels). Currently, a dozen countries are on track to reach 2030 WHO HCV targets. However, while striving for the WHO targets is important, it should be recognized that progress on impact targets is derived from mathematical models projecting decreases in incidence and mortality on a global scale. Despite HCV treatment access in many counties for a number of years, limited empirical data are available to evaluate progress towards elimination. In some countries, substantial incidence and mortality reductions based on reaching the WHO service coverage targets may be unachievable. For example, in countries with ageing hepatitis C-infected populations, even if they have a quality hepatitis C response, high hepatitis C-related morbidity at baseline may not be reversible even with increased HCV treatment uptake and diagnosis. Finally, WHO targets are not necessarily easily or reliably measurable. Measuring relative impact targets requires high-quality data at baseline (ie 2015) and longitudinal data to assess temporal trends. In this commentary, we propose alternative additional measures to track progress on reducing the HCV burden, offer examples where the WHO targets may not be informative or achievable, and potential practical solutions.

Strategies for Improving Hepatitis C Treatment Access in the United States: State Officials Address High Drug Prices, Stigma, and Building Treatment Capacity.

Curative treatments for hepatitis C virus (HCV) can alter the course of a devastating epidemic, but high drug prices have contributed to restrictions on HCV treatment access. We aimed to learn how state health agencies have responded to the challenges of treatment access for HCV. Qualitative study using semistructured key informant interviews focused on aspects of HCV treatment access between June 2016 and March 2017. Content analysis was used to identify dominant themes. United States. Eighteen health officials and treatment advocates across 6 states selected using purposive sampling. Drug pricing is the most important barrier to access, encouraging restrictive authorization criteria from payers that in turn discourage providers from offering treatment. However, payers have not experienced the budget impact that was initially feared. Although authorization criteria are being lifted for fee-for-service Medicaid programs, ensuring that managed care organizations follow suit remains a challenge. The effect of stigma, a shortage of treating providers, and lack of political motivation are additional challenges to expanding treatment. The response to the human immunodeficiency virus epidemic can augment or inform strategies for HCV treatment delivery, but this is limited by the absence of dedicated funding. While treatment eligibility criteria for HCV treatment are improving, many other barriers remain to achieving the scale-up needed to end the epidemic. Political disinterest, stigma, and a lack of specialty providers are continued barriers in some jurisdictions. States may need to invest in strategies to overcome these barriers, such as engaging in public and provider education and ensuring that treatment by primary care providers is reimbursed. Despite uncertainty about how federal policy changes to Medicaid may affect states' ability to respond, states can identify opportunities to improve access.

Hepatitis C cascade of care among people who inject drugs in Vancouver, Canada

Background: People who inject drugs (PWID) have high rates of hepatitis C virus (HCV) infection. Little is known about the rates of diagnosis and treatment for HCV among PWID. Therefore, this study aims to characterize the cascade of care in Vancouver, Canada, to improve HCV treatment access and delivery for PWID. Methods: Data were derived from 3 prospective cohort studies of PWID in Vancouver, Canada, between December 2005 and May 2015. The progression of participants was identified through 5 steps in the cascade of care: (1) chronic HCV; (2) linkage to HCV care; (3) liver disease assessment; (4) initiation of treatment; and (5) completion of treatment. Predictors of undergoing liver disease assessment for HCV treatment were identified using a multivariable extended Cox regression model. Results: Among 1571 participants with chronic HCV, 1359 (86.5%) had ever been linked to care, 1257 (80.0%) had undergone liver disease assessment, 163 (10.4%) had ever started HCV treatment, and 71 (4.5%) had ever completed treatment. In multivariable analyses, human immunodeficiency virus (HIV) seropositivity, use of methadone maintenance therapy, and hospitalization in the past 6 months were independently and positively associated with undergoing liver disease assessment (all P < .001), whereas daily heroin injection was independently and negatively associated with undergoing liver disease assessment (P < .001). Conclusions: Among this cohort of PWID, few had been started on or completed treatment for HCV. These findings highlight the need to improve the prescribing of HCV treatment among PWID with active substance use.

Treatment advocate tactics to expand access to antiviral therapy for HIV and viral hepatitis C in low- to high-income settings: making sure no one is left behind.

IntroductionWorldwide, 71 million people are infected with hepatitis C virus (HCV), which, without treatment, can lead to liver failure or hepatocellular carcinoma. HCV co‐infection increases liver‐ and AIDS‐related morbidity and mortality among HIV‐positive people, despite ART. A 12‐week course of HCV direct‐acting antivirals (DAAs) usually cures HCV – regardless of HIV status. However, patents and high prices have created access barriers for people living with HCV, especially people who inject drugs (PWID). Inadequate access to and coverage of harm reduction interventions feed the co‐epidemics of HIV and HCV; as a result, the highest prevalence of HCV is found among PWID, who face additional obstacles to treatment (including stigma, discrimination and other structural barriers). The HIV epidemic occurred during globalization of intellectual property rights, and highlighted the relationship between patents and the high prices that prevent access to medicines. Indian generic manufacturers produced affordable generic HIV treatment, enabling global scale‐up. Unlike HIV, donors have yet to step forward to fund HCV programmes, although DAAs can be mass‐produced at a low and sustainable cost. Unfortunately, although voluntary licensing agreements between originators and generic manufacturers enable low‐income (and some lower‐middle income countries) to buy generic versions of HIV and HCV medicines, most middle‐income countries with large burdens of HCV infection and HIV/HCV co‐infection are excluded from these agreements. Our commentary presents tactics from the HIV experience that treatment advocates can use to expand access to DAAs.DiscussionA number of practical actions can help increase access to DAAs, including new research and development (R&D) paradigms; compassionate use, named‐patient and early access programmes; use of TRIPS flexibilities such as compulsory licences and patent oppositions; and parallel importation via buyers’ clubs. Together, these approaches can increase access to antiviral therapy for people living with HIV and viral hepatitis in low‐, middle‐ and high‐income settings.ConclusionsThe HIV example provides helpful parallels for addressing challenges to expanding access to HCV DAAs. HCV treatment access – and harm reduction – should be massively scaled‐up to meet the needs of PWID, and efforts should be made to tackle stigma and discrimination, and stop criminalization of drug use and possession.

Hepatitis C Virus Treatment Access Among Human Immunodeficiency Virus and Hepatitis C Virus (HCV)-Coinfected People Who Inject Drugs in Guangzhou, China: Implications for HCV Treatment Expansion.

Background. Hepatitis C virus (HCV) treatment access among human immunodeficiency virus (HIV)/HCV-coinfected people who inject drugs is poor, despite a high burden of disease in this population. Understanding barriers and facilitators to HCV treatment uptake is critical to the implementation of new direct-acting antivirals.Methods. We conducted in-depth interviews with patients, physicians, and social workers at an HIV treatment facility and methadone maintenance treatment centers in Guangzhou, China to identify barriers and facilitators to HCV treatment. We included patients who were in various stages of HCV treatment and those who were not treated. We used standard qualitative methods and organized data into themes.Results. Interview data from 29 patients, 8 physicians, and 3 social workers were analyzed. Facilitators and barriers were organized according to a modified Consolidated Framework for Implementation Research schematic. Facilitators included patient trust in physicians, hope for a cure, peer networks, and social support. Barriers included ongoing drug use, low HCV disease knowledge, fragmented reimbursement systems, HIV exceptionalism, and stigma.Conclusions. Expanding existing harm reduction programs, HIV treatment programs, and social services may facilitate scale-up of direct-acting antivirals globally. Improving integration of ancillary social and mental health services within existing HIV care systems may facilitate HCV treatment access.

Hepatitis C virus therapeutic development: in pursuit of "perfectovir".

The next decade will be a crucial period in the public health response to hepatitis C virus (HCV) infection. The rapid development of direct-acting antiviral (DAA) therapy for HCV infection has brought considerable optimism to the HCV sector, with the realistic hope that therapeutic intervention will soon provide near-optimal efficacy with well-tolerated short-duration, all-oral regimens. As the zenith in HCV therapeutic development approaches, there remain several key obstacles to the broad implementation of interferon-free DAA regimens. The extent of HCV screening and disease assessment, global and national public health prioritization, and drug pricing will determine the potential impact on disease burden derived from introduction of these exciting new HCV therapies. Public health partnerships and advocacy will be crucial to remove barriers to enhanced HCV treatment access.

Hepatitis C treatment access and uptake for people who inject drugs: a review mapping the role of social factors

BackgroundEvidence documents successful hepatitis C virus (HCV) treatment outcomes for people who inject drugs (PWID) and interest in HCV treatment among this population. Maximising HCV treatment for PWID can be an effective HCV preventative measure. Yet HCV treatment among PWID remains suboptimal. This review seeks to map social factors mediating HCV treatment access.MethodWe undertook a review of the social science and public health literature pertaining to HCV treatment for PWID, with a focus on barriers to treatment access, uptake and completion. Medline and Scopus databases were searched, supplemented by manual and grey literature searches. A two step search was taken, with the first step pertaining to literature on HCV treatment for PWID and the second focusing on social structural factors. In total, 596 references were screened, with 165 articles and reports selected to inform the review.ResultsClinical and individual level barriers to HCV treatment among PWID are well evidenced. These include patient and provider concerns regarding co-morbidities, adherence, and side effect management. Social factors affecting treatment access are less well evidenced. In attempting to map these, key barriers fall into the following domains: social stigma, housing, criminalisation, health care systems, and gender. Key facilitating factors to treatment access include: combination intervention approaches encompassing social as well as biomedical interventions, low threshold access to opiate substitution therapy, and integrated delivery of multidisciplinary care.ConclusionCombination intervention approaches need to encompass social interventions in relation to housing, stigma reduction and systemic changes in policy and health care delivery. Future research needs to better delineate social factors affecting treatment access.

Enhancing hepatitis C treatment uptake and outcomes for injection drug users

Enhancing hepatitis C treatment uptake and outcomes for injection drug users