Hepatitis C Virus Treatment Initiation Research Articles

Best Practices for Hepatitis C Linkage to Care in Pregnant and Postpartum Women: Perspectives from the TiP-HepC Community of Practice

There is an increasing burden of hepatitis C virus (HCV) among persons of reproductive age, including pregnant and breastfeeding women, in many regions worldwide. Routine health services during pregnancy present a critical window of opportunity to diagnose and link women with HCV infection for care and treatment to decrease HCV-related morbidity and early mortality. Effective treatment of HCV infection in women diagnosed during pregnancy also prevents HCV-related adverse events in pregnancy and HCV vertical transmission in future pregnancies. However, linkage to care and treatment for women diagnosed in pregnancy remains insufficient. Currently, there are no best practice recommendations from professional societies to ensure appropriate peripartum linkage to HCV care and treatment. We convened a virtual Community of Practice (CoP) to understand key challenges to the HCV care cascade for women diagnosed with HCV in pregnancy, highlight published models of integrated HCV services for pregnant and postpartum women, and preview upcoming research and programmatic initiatives to improve linkage to HCV care for this population. Four-hundred seventy-three participants from 43 countries participated in the CoP, including a diverse range of practitioners from public health, primary care, and clinical specialties. The CoP included panel sessions with representatives from major professional societies in obstetrics/gynecology, maternal fetal medicine, addiction medicine, hepatology, and infectious diseases. From this CoP, we provide a series of best practices to improve linkage to HCV treatment for pregnant and postpartum women, including specific interventions to enhance co-location of services, treatment by non-specialist providers, active engagement and patient navigation, and decreasing time to HCV treatment initiation. The CoP aims to further support antenatal providers in improving linkage to care by producing and disseminating detailed operational guidance and recommendations and supporting operational research on models for linkage and treatment. Additionally, the CoP may be leveraged to build training materials and toolkits for antenatal providers, convene experts to formalize operational recommendations, and conduct surveys to understand needs of antenatal providers. Such actions are required to ensure equitable access to HCV treatment for women diagnosed with HCV in pregnancy and urgently needed to achieve the ambitious targets for HCV elimination by 2030.

Hepatitis C treatment outcomes among people who inject drugs experiencing unstable versus stable housing: Systematic review and meta-analysis.

The prevalence of hepatitis C virus (HCV) among people who inject drugs (PWID) is between 50-70%. Prior systematic reviews demonstrated that PWID have similar direct acting antiviral treatment outcomes compared to non-PWID; however, reviews have not examined treatment outcomes by housing status. Given the links between housing and health, identifying gaps in HCV treatment can guide future interventions. We conducted a systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We searched six databases for articles from 2014 onward. Two reviewers conducted title/abstract screenings, full-text review, and data extraction. We extracted effect measures for treatment initiation, adherence, completion, success, and reinfection by housing status. Studies underwent quality and certainty assessments, and we performed meta-analyses as appropriate. Our search yielded 473 studies, eight of which met inclusion criteria. Only the treatment initiation outcome had sufficient measures for meta-analysis. Using a random-effects model, we found those with unstable housing had 0.40 (0.26, 0.62) times the odds of initiating treatment compared to those with stable housing. Other outcomes were not amenable for meta-analysis due to a limited number of studies or differing outcome definitions. Among PWID, unstable housing appears to be a barrier to HCV treatment initiation; however, the existing data is limited for treatment initiation and the other outcomes we examined. There is a need for more informative studies to better understand HCV treatment among those with unstable housing. Specifically, future studies should better define housing status beyond a binary, static measure to capture the nuances and complexity of housing and its subsequent impact on HCV treatment. Additionally, researchers should meaningfully consider whether the outcome(s) of interest are being accurately measured for individuals experiencing unstable housing.

Slicing through silos: Development and evaluation of a hospital-based telehealth hepatitis C virus treatment program

BackgroundThere exist many barriers to hepatitis C virus (HCV) treatment for those with substance use disorder (SUD) or who lack access to routine medical care. A hospital-based telehealth program was developed to provide treatment opportunities for hospitalized patients living with HCV. MethodsThis single site prospective cohort study conducted from July 2022 to March 2023 aimed to measure linkage to care with an HCV clinician and initiation of HCV treatment in hospitalized patients. Patients were assessed in-person by a social worker then seen via telehealth by a clinician who prescribed either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir. Treatment was initiated with pharmacist assistance. The team conducted in-person and/or telephonic outreach during and after hospitalization. Cure was confirmed by sustained virologic response at 12 weeks (SVR12) post-treatment. ResultsA total of 25 patients were enrolled and completed telehealth visits. All patients had a history of SUD and 18 (72 %) were unstably housed. Nineteen patients (76 %) initiated treatment, and 14 (56 %) successfully completed treatment. Twelve patients (48 %) completed post-treatment labs, including two who prematurely discontinued treatment. Eleven patients (44 %) achieved confirmed cure with SVR12. Conclusion: A hospital-based, multidisciplinary telehealth program can be an innovative care model to successfully treat HCV in a difficult-to-treat patient populations.

Outcomes and Barriers Associated with Telehealth-Based Hepatitis C Treatment During Early Phases of the COVID-19 Pandemic.

The COVID-19 pandemic has presented challenges for hepatitis C virus (HCV) treatment given the need for thorough evaluation by specialists, treatment coordination, follow-up visits, laboratory monitoring, and potential health behavior impacts on patients. The objective of this study was to evaluate HCV treatment during the beginning of the COVID-19 pandemic, when care was conducted virtually, by examining patient demographics associated with treatment initiation and discontinuation rates. This retrospective study included 73 patients with quantifiable HCV RNA evaluated by gastroenterologists and infectious disease clinicians and referred to an HCV clinical pharmacy team for treatment coordination from March 1, 2020, to September 30, 2020. Data collection included baseline demographics, clinical characteristics, and treatment characteristics. Patients were followed until June 15, 2021. Forty-three patients (59%) initiated HCV treatment while 30 patients (41%) did not. Patient demographics were not associated with HCV treatment initiation rates except for presence of alcohol use disorder within the past 6 months (P = .003). Of the 43 patients that initiated HCV treatment, 9 patients (21%) discontinued their treatment. Twenty-two of 25 patients (88%) with laboratory analysis achieved sustained virologic response. There were no demographic or geographic disparities between patients that initiated HCV treatment and those that did not during the study period. Results of this study suggest that active alcohol use disorder diagnosis may be associated with HCV treatment noninitiation. This study emphasizes the need for further research to define the standards of care in assessing active alcohol use disorder during HCV treatment evaluation.

A contactless cure: Leveraging telehealth to improve hepatitis C treatment at a safety-net hospital.

Hepatitis C virus (HCV) causes significant mortality worldwide. HCV is highly curable but access to care is limited for many patients. The Grady Liver Clinic (GLC), a primary care-based HCV clinic, utilizes a multidisciplinary team to provide comprehensive care for a medically underserved patient population in Atlanta, Georgia. The GLC added a telehealth option for HCV treatment at the start of the COVID-19 pandemic. We describe the outcomes of utilizing telehealth in this population. We performed a retrospective chart review of patients who initiated HCV treatment from March 2019 to February 2020 (pre-pandemic) and March 2020 to February 2021 (pandemic). Charts were abstracted for patient demographics and characteristics, treatment regimen, and treatment outcomes. Our primary outcome was HCV cure rate of the pre-pandemic compared to the pandemic cohorts and within the different pandemic cohort visit types. We performed an intention-to-treat (ITT) analysis for all patients who took at least one dose of a direct-acting antiviral (DAA) regardless of therapy completion, and a per-protocol (PP) analysis of those who completed treatment and were tested for HCV cure. SVR12 rates were >95% on ITT analysis, with no significant difference between pre-pandemic and pandemic cohorts. There was also no significant difference within the pandemic group when treatment was provided traditionally, via telehealth, or via a hybrid of these. Our findings support the use of telehealth as a tool to expand access to HCV treatment in a medically underserved patient population.

Does a simplified algorithm and integrated HCV care model improve linkage to care, retention, and cure among people who inject drugs? A pragmatic quality improvement randomized controlled trial protocol

BackgroundAs many as 2.4 million Americans are affected by chronic Hepatitis C Virus (HCV) in the United States.In 2018, the estimated number of adults with a history of HCV infection in San Diego County was 55,354 (95% CI: 25,411–93,329). This corresponded to a seroprevalence of 2.1% (95% CI: 2.1–3.4%). One-third of infections were among PWID. Published research has demonstrated that direct-acting antivirals (DAAs) have high efficacy and can now be used by primary care providers to treat HCV. In addition, limited evidence exists to support the effectiveness of simplified algorithms in clinical trial and real-world settings. Even with expanded access to HCV treatment in primary care settings, there are still groups, especially people who inject drugs (PWID) and people experiencing homelessness, who experience treatment disparities due to access and treatment barriers. The current study extends the simplified algorithm with a streetside ‘one-stop-shop’ approach with integrated care (including the offer of buprenorphine prescriptions and abscess care) using a mobile clinic situated adjacent to a syringe service program serving many homeless populations. Rates of HCV treatment initiation and retention will be compared between patients offered HCV care in a mobile clinic adjacent to a syringe services program (SSP) and homeless encampment versus those who are linked to a community clinic’s current practice of usual care, which includes comprehensive patient navigation.MethodsA quasi-experimental, prospective, interventional, comparative effectiveness trial with allocation of approximately 200 patients who inject drugs and have chronic HCV to the "simplified care" pathway (intervention group) or the "usual care" pathway (control group). Block randomization will be performed with a 1:1 randomization.DiscussionPrevious research has demonstrated acceptable outcomes for patients treated using simplified algorithms for DAAs and point-of-care testing in mobile medical clinics; however, there are opportunities to explore how these new, innovative systems of care impact treatment initiation rates or other HCV care cascade outcomes among PWID.Trial registrationWe have registered our study with ClinicalTrials.gov, a resource of the United States National Library of Medicine. This database contains research studies from United States and other countries around the world. Our study has not been previously published. The ClinicalTrials.gov registration identifier is NCT04741750.

Effect of integrated hepatitis C virus treatment on psychological distress in people with substance use disorders

People with substance use disorders (SUD) have a high prevalence of chronic hepatitis C virus (HCV) infection and mental health disorders. We aimed to assess the impact of integrated HCV treatment on psychological distress measured by Hopkins-symptom-checklist-10 (SCL-10). This multi-center randomized controlled trial evaluated psychological distress as a secondary outcome of integrated HCV treatment (INTRO-HCV trial). From 2017 to 2019, 289 participants were randomly assigned to receive either integrated or standard HCV treatment with direct-acting antiviral therapy. Integrated HCV treatment was delivered in eight decentralized outpatient opioid agonist therapy clinics and two community care centers; standard treatment was delivered in internal medicine outpatient clinics at centralized hospitals. Participants in the integrated treatment arm had a sustained virologic response of 93% compared to 73% for those in standard treatment arm. Psychological distress was assessed using SCL-10 prior to initiation of HCV treatment and 12 weeks after treatment completion. The mean SCL-10 score prior to HCV treatment was 2.2 (standard deviation [SD]: 0.7) for patients receiving integrated HCV treatment and 2.2 (SD: 0.8) for those receiving standard HCV treatment. Twelve weeks after the end of treatment, the mean SCL-10 score change was − 0.1 (− 0.3;0.0) in the integrated compared to the standard arm. Psychological distress did not substantially change during the treatment period and was not significantly different between the treatment arms.

Initiation of oral hepatitis C virus treatment: Which barriers are pertinent for ambulatory individuals with a history of illicit substance use? A qualitative interview study.

The World Health Organization has set a goal to eradicate hepatitis C virus (HCV) by the year 2030. Nonadherence to HCV treatment has substantial economic implications due to high treatment costs, among others. Barriers to start HCV treatment may be critical. The aim of this study was to assess pertinent barriers to HCV treatment in ambulatory patients with a history of illicit substance use and to compare them to the literature. Barriers to HCV treatment mentioned by the key risk group (i.e., people who inject drugs) were retrieved from literature through a pragmatic literature search. From 34 published articles, we identified 80 modifiable barriers that were bundled in 23 items within the four topics "Personal difficulties and barriers to treatment," "Personal motivation to be treated," "Knowledge about the disease," and "Received information about the medicine." In-depth semistructured interviews were performed face-to-face with ambulatory patients from the University Psychiatric Clinics in Basel, Switzerland. Transcripts were coded inductively. Interviews were performed with seven individuals (mean age: 48.3 years; range: 38-63 years; one woman) treated with oral direct-acting antivirals between 2014 and 2022. Thirteen barriers to start HCV treatment were mentioned that corresponded to the five categories: information, attitudes, swallowing difficulties, social environment, and unfavorable lifestyle. The barrier "swallowing difficulties" emerged exclusively from the statements provided by the interviewees. Barriers to the initiation of HCV treatment indicated by our interviewees clearly differed from the literature. Notably, the challenge of swallowing medicines may be particularly relevant for physicians prescribing and pharmacists dispensing HCV medication.

2499. What Are We Waiting for? Chronic Hepatitis C Treatment Initiation During Inpatient Admission

Abstract Background Chronic hepatitis C virus (HCV) infection is highly prevalent among people who inject drugs. This vulnerable population experiences many barriers to engaging with the healthcare system. Evaluating and treating HCV during a hospital stay can be an opportunity to cure and prevent adverse HCV complications in a population that can be difficult to reach in an outpatient setting. Methods This was a retrospective review of treatment outcomes of patients who started on treatment for HCV infection with direct acting antivirals (DAAs) while hospitalized at an academic medical center between January 2022 and January 2023. DAAs were dispensed by outpatient pharmacies and brought into the hospital for patient use. Various teams were involved in the treatment of these patients and level of support varied between groups, ranging from full social services and pharmacy support to follow-up clinic visits only. Data collected included demographics, insurance type, injection drug use, housing status, DAA agents used, treatment duration and completion status, and sustained virological response (SVR) 12 or more weeks post-treatment. Results A total of 17 patients began treatment with DAAs while hospitalized. Sixteen (94%) were treated with glecaprevir-pibrentasvir for 8 weeks, while 1 (6%) received sofosbuvir-velpatasvir for 12 weeks. Sixteen (94%) reported using injection drugs and 12 (71%) reported unstable housing. All patients had government-managed health insurance, with 16 having Medicaid. Twelve (71%) patients completed treatment: 9 of 12 patients who completed treatment attained SVR12 and 3 were lost to follow up after treatment completion. Of the 5 patients who did not finish treatment, 2 attained SVR12 despite incomplete therapy, 1 is not yet due for SVR12, and 2 were lost to follow up. Conclusion In a vulnerable population with barriers to outpatient care, in-hospital evaluation and DAA initiation is a valuable opportunity to cure. Further evaluation is needed to optimize and implement strategies for inpatient HCV treatment initiation. Disclosures All Authors: No reported disclosures

Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations

Disparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors. To determine the feasibility, acceptability, and safety of HCV treatment at the point of HCV infection diagnosis disclosure in a nonclinical community setting. In this single-arm nonrandomized controlled trial conducted between July 1, 2020, and October 31, 2021, street-outreach recruitment targeted people experiencing homelessness and injecting drugs in an urban US community who were eligible for simplified HCV treatment. Study procedures were designed to reflect the community environment and services needed to provide HCV testing, disclosure, and treatment in a nonclinical site. The test-and-treat No One Waits (NOW) model of care provided a 2-week starter pack of 400 mg of sofosbuvir and 100 mg of velpatasvir at time of HCV RNA results disclosure. Participants were transitioned to insurance-provided sofosbuvir-velpatasvir when feasible to complete a 12-week treatment course. The primary end point was sustained virologic response at posttreatment week 12 or later (SVR12). Acceptability end points were treatment initiation and completion. Safety end points were treatment discontinuation because of a late exclusion criterion and adverse events. Of the 492 people (median [IQR] age, 48 [37-58] years; 62 [71%] male) who underwent anti-HCV testing, 246 (50%) tested anti-HCV positive, and 111 (23%) tested HCV RNA positive and were eligible for simplified HCV treatment. Eighty-nine of the 111 eligible participants (80%) returned for confirmatory RNA results, and 87 (98%) accepted and initiated HCV treatment. Seventy (80%) were currently injecting drugs, 83 (97%) had an income below the poverty line, and 53 (61%) were currently unsheltered. Most had HCV genotype 1a (45 [52%]) or 3 (20 [23%]). Sixty-nine (79%) completed 12 weeks of sofosbuvir-velpatasvir treatment, 2 stopped treatment because of low adherence, and 16 were lost to follow-up. Of the 66 participants who completed treatment and had a successful blood draw, 61 (92%) had undetectable HCV RNA at treatment completion. Of the 87 treated patients, 58 achieved SVR12, leading to a treatment response of 67% (95% CI, 56%-76%) among the intention-to-treat group and 84% (95% CI, 73%-92%) among the per-protocol group. There were no adverse events, late exclusions, or deaths. In this nonrandomized controlled trial of HCV treatment at the point of diagnosis, the NOW model of care reduced steps between HCV testing and treatment initiation and resulted in high levels of treatment initiation, completion, and cure. The NOW model of care can expand the current HCV test-and-treat toolkit by reaching a broader population of marginalized communities and expediting curative therapy. ClinicalTrials.gov Identifier: NCT03987503.

Hepatitis C Treatment Uptake Following Dried Blood Spot Testing for Hepatitis C RNA in New South Wales, Australia: The NSW DBS Pilot Study.

Dried blood spot (DBS) testing for hepatitis C virus (HCV) RNA provides a sampling option that avoids venepuncture and can be carried out in a nonclinical setting. Large-scale evaluations are needed to understand how DBS testing can reduce HCV burden. This study estimated prevalence of, and factors associated with, HCV RNA and treatment initiation among people enrolled in a state-wide pilot of people testing in the NSW DBS Pilot in New South Wales, Australia. People at risk of HIV/HCV could participate via (1) self-registration online with a DBS collection kit delivered and returned by conventional postal service; or (2) assisted DBS sample collection at a community site or prison. Logistic regression was used to identify factors associated with detectable HCV RNA and treatment initiation within 6 months of testing. Between September 2017 and December 2020, 5960 people were tested for HCV (76% men, 35% Aboriginal and/or Torres Strait Islander, 55% recently injected drugs): 21% online self-registration, 34% assisted registration in the community, 45% assisted registration in prison. Fifteen percent had detectable HCV RNA (878/5960). Overall, 44% (n = 386/878) of people with current HCV initiated treatment within 6 months (13% online self-registration, 27% assisted registration in the community, 61% assisted registration in prison). Testing in prison compared with the community (adjusted odds ratio [aOR], 4.28; 95% CI, 3.04-6.03) was associated with increased odds of treatment initiation. Being a woman compared with a man (aOR, 0.68; 95% CI, 0.47-0.97) was associated with reduced treatment initiation. The NSW DBS Pilot demonstrates the feasibility of using DBS to promote HCV testing and treatment in community and prison settings.

Reflex Hepatitis C Virus Viral Load Testing Following an Initial Positive Hepatitis C Virus Antibody Test: A Global Systematic Review and Meta-analysis.

Many people who have a positive hepatitis C virus (HCV) antibody (Ab) test never receive a confirmatory HCV RNA viral load (VL) test. Reflex VL testing may help address this problem. We undertook a systematic review to evaluate the effectiveness of reflex VL testing compared with standard nonreflex approaches on outcomes across the HCV care cascade. We searched 4 databases for studies that examined laboratory-based reflex or clinic-based reflex VL testing approaches, with or without a nonreflex comparator, and had data on the uptake of HCV RNA VL test and treatment initiation and turnaround time between Ab and VL testing. Both laboratory- and clinic-based reflex VL testing involve only a single clinic visit. Summary estimates were calculated using random-effects meta-analyses. Fifty-one studies were included (32 laboratory-based and 19 clinic-based reflex VL testing). Laboratory-based reflex VL testing increased HCV VL test uptake versus nonreflex testing (RR: 1.35; 95% CI: 1.16-1.58) and may improve linkage to care among people with a positive HCV RNA test (RR: 1.47; 95% CI: .81-2.67) and HCV treatment initiation (RR: 1.03; 95% CI: .46-2.32). The median time between Ab and VL test was <1 day for all laboratory-based reflex studies and 0-5 days for 13 clinic-based reflex testing. Laboratory-based and clinic-based HCV reflex VL testing increased uptake and reduced time to HCV VL testing and may increase HCV linkage to care. The World Health Organization now recommends reflex VL testing as an additional strategy to promote access to HCV VL testing and treatment. PROSPERO CRD42021283822.

Hepatitis C Treatment Initiation Among US Medicaid Enrollees

Direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) infection is highly effective but remains underused. Understanding disparities in the delivery of DAAs is important for HCV elimination planning and designing interventions to promote equitable treatment. To examine variations in the receipt of DAA in the 6 months following a new HCV diagnosis. This retrospective cohort study used national Medicaid claims from 2017 to 2019 from 50 states, Washington DC, and Puerto Rico. Individuals aged 18 to 64 years with a new diagnosis of HCV in 2018 were included. A new diagnosis was defined as a claim for an HCV RNA test followed by an International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnosis code, after a 1-year lookback period. Outcome was receipt of a DAA prescription within 6 months of diagnosis. Logistic regression was used to examine demographic factors and ICD-10-identified comorbidities associated with treatment initiation. Among 87 652 individuals, 43 078 (49%) were females, 12 355 (14%) were age 18 to 29 years, 35 181 (40%) age 30 to 49, 51 282 (46%) were non-Hispanic White, and 48 840 (49%) had an injection drug use diagnosis. Of these individuals, 17 927 (20%) received DAAs within 6 months of their first HCV diagnosis. In the regression analyses, male sex was associated with increased treatment initiation (OR, 1.24; 95% CI, 1.16-1.33). Being age 18 to 29 years (OR, 0.65; 95% CI, 0.50-0.85) and injection drug use (OR, 0.84; 95% CI, 0.75-0.94) were associated with decreased treatment initiation. After adjustment for state fixed effects, Asian race (OR, 0.50; 95% CI, 0.40-0.64), American Indian or Alaska Native race (OR, 0.68; 95% CI, 0.55-0.84), and Hispanic ethnicity (OR, 0.81; 95% CI, 0.71-0.93) were associated with decreased treatment initiation. Adjustment for state Medicaid policy did not attenuate the racial or ethnic disparities. In this retrospective cohort study, HCV treatment initiation was low among Medicaid beneficiaries and varied by demographic characteristics and comorbidities. Interventions are needed to increase HCV treatment uptake among Medicaid beneficiaries and to address disparities in treatment among key populations, including younger individuals, females, individuals from minoritized racial and ethnic groups, and people who inject drugs.

Trends in hepatitis C virus coinfection and its cascade of care among adults living with HIV in Asia between 2010 and 2020.

Chronic hepatitis C virus (HCV) infection contributes to substantial morbidity and mortality among adults living with HIV. Cascades of HCV care support monitoring of program performance, but data from Asia are limited. We assessed regional HCV coinfection and cascade outcomes among adults living with HIV in care from 2010-2020. Patients ≥18 years old with confirmed HIV infection on antiretroviral therapy (ART) at 11 clinical sites in Cambodia, China, India, Indonesia, South Korea, Thailand and Vietnam were included. HCV- and HIV-related treatment and laboratory data were collected from those with a positive HCV antibody (anti-HCV) test after January 2010. An HCV cascade was evaluated, including proportions positive for anti-HCV, tested for HCV RNA or HCV core antigen (HCVcAg), initiated on HCV treatment, and achieved sustained virologic response (SVR). Factors associated with screening uptake, treatment initiation, and treatment response were analyzed using Fine and Gray's competing risk regression model. Of 24,421 patients, 9169 (38%) had an anti-HCV test, and 971 (11%) had a positive result. The proportion with positive anti-HCV was 12.1% in 2010-2014, 3.9% in 2015-2017, and 3.8% in 2018-2020. From 2010 to 2014, 34% with positive anti-HCV had subsequent HCV RNA or HCVcAg testing, 66% initiated HCV treatment, and 83% achieved SVR. From 2015 to 2017, 69% with positive anti-HCV had subsequent HCV RNA or HCVcAg testing, 59% initiated HCV treatment, and 88% achieved SVR. From 2018 to 2020, 80% had subsequent HCV RNA or HCVcAg testing, 61% initiated HCV treatment, and 96% achieved SVR. Having chronic HCV in later calendar years and in high-income countries were associated with increased screening, treatment initiation or achieving SVR. Older age, injecting drug use HIV exposure, lower CD4 and higher HIV RNA were associated with reduced HCV screening or treatment initiation. Our analysis identified persistent gaps in the HCV cascade of care, highlighting the need for focused efforts to strengthen chronic HCV screening, treatment initiation, and monitoring among adult PLHIV in the Asia region.

Optimizing point-of-care testing strategies for diagnosis and treatment of hepatitis C virus infection in Australia: a model-based cost-effectiveness analysis

Timely diagnosis and treatment of hepatitis C virus (HCV) is critical to achieve elimination goals. This study evaluated the cost-effectiveness of point-of-care testing strategies for HCV compared to laboratory-based testing in standard-of-care. Cost-effectiveness analyses were undertaken from the perspective of Australian Governments as funders by modelling point-of-care testing strategies compared to standard-of-care in needle and syringe programs, drug treatment clinics, and prisons. Point-of-care testing strategies included immediate point-of-care HCV RNA testing and combined point-of-care HCV antibody and reflex RNA testing for HCV antibody positive people (with and without consideration of previous treatment). Sensitivity analyses were performed to investigate the cost per treatment initiation with different testing strategies at different HCV antibody prevalence levels. The average costs per HCV treatment initiation by point-of-care testing, from A$890 to A$1406, were up to 35% lower compared to standard-of-care ranging from A$1248 to A$1632 depending on settings. The average costs per treatment initiation by point-of-care testing for three settings ranged from A$1080 to A$1406 for RNA, A$960-A$1310 for combined antibody/RNA without treatment history consideration, and A$890-A$1189 for combined antibody/RNA with treatment history consideration. When HCV antibody prevalence was <74%, combined point-of-care HCV antibody and point-of-care RNA testing were the most cost-effective strategies. Modest increases in treatment uptake by 8%-31% were required for immediate point-of-care HCV RNA testing to achieve equivalent cost per treatment initiation compared to standard-of-care. Point-of-care testing is more cost-effective than standard of care for populations at risk of HCV. Testing strategies combining point-of-care HCV antibody and RNA testing are likely to be cost-effective in most settings. National Health and Medical Research Council.

Linkage to hepatitis C treatment in two opioid substitution treatment units in Gothenburg, Sweden: a retrospective cohort study

BackgroundChronic infection with the hepatitis C virus (HCV) is common in people with former or current injection drug use. Among the patients in the opioid substitution treatment (OST) program in Gothenburg, Sweden, more than 50% had been infected with HCV. However, many patients did not have any follow-up for their infection and the linkage to treatment could be improved.MethodsA model of care for HCV was introduced at an OST unit in Gothenburg, Sweden, in 2017. The aim was to increase testing and linkage to HCV treatment. A nurse and a medical doctor, both specialized in infectious diseases, performed on-site testing at the OST unit with transient liver elastography (Fibroscan) to evaluate the fibrosis stage and initiated HCV treatment. This study retrospectively reviewed the patients’ medical records to assess information regarding participation in the model of care, hepatitis C status, linkage to treatment and treatment outcome.ResultsAmong the 225 patients enrolled in OST at baseline, 181 were still in the OST program at the end of study (December 31st, 2018). In total, 29 patients, most of whom did not attend the Clinic of Infectious Diseases, were referred to the model of care. By the end of study, 17 patients (100% of those treated) reached sustained virologic response. In parallel, an additional 19 patients got treatment directly at the Clinic of Infectious Diseases.ConclusionIntegrating HCV screening and examination in an OST unit successfully linked patients to treatment. However, not all patients received treatment. To reach the goal of eliminating HCV, different models of care are needed.

Effect of Hepatitis C Treatment on Risk of Developing Cardiovascular Disease and Cardiac Arrhythmias

Background: Chronic hepatitis C virus (HCV) infection affects more than 70 million people worldwide, is a systemic disease and has been implicated as a risk factor for cardiovascular disease (CVD). Objective: We sought to study the association between risk of CVD between 0-12 month and 12-24 months of HCV treatment initiation. Methods: 567,956 Hepatitis C patients without prior history of CVD were identified in the Cerner Health Facts database. Of these, 1446 patients received HCV treatment. We included both demographic and as covariates in the multivariate logistic regression model. To control for baseline differences among treatment and control groups, propensity score matching (PSM) comparative analysis was used to adjust for potential confounding baseline characteristics between these two groups, and finally 2892 patients (1:1 match) (1446 in each group) were enrolled in the final analysis. Results: There was no statistically significant association between CVD and treatment of HCV (at both 0-12 and 12-24 months). The odds of developing CVD for females were 1.52 times greater than males during the first 12 months of treatment. Advanced age was also associated with a high risk of CVD during the initial 12 months (OR 1.05 95% CI 1.03-1.07). HCV patients with HIV were 45% less likely to experience CVD Expanded =0.55, 95% CI: 0.33- 0.91, p&lt;0.05) compared to those without HIV for 12-24 months. Treatment’s association with the development of cardiac arrhythmias was not statistically significant between 0-12 months or 12-24 months. Older age was associated with a higher risk of cardiac arrhythmias following 0-12 months after treatment with OR 1.08 95% CI 1.04-1.12. There was also a significantly high risk of arrhythmias with hypothyroidism for 0-12 months (OR 4.23 95% CI 1.48-12.08) Conclusion: Female sex and advanced age were associated with increased odds of CVD, and advanced age and hypothyroidism were associated with increased odds of arrhythmias development during the first 12 months of treatment. Further studies are needed to explore this in a prospective fashion.

Delays in fibrosis staging reduce the likelihood of achieving hepatitis C treatment and cure

Background Updated 2021 hepatitis C virus (HCV) treatment guidelines no longer recommend fibrosis staging for treatment-naïve patients without cirrhosis; however, numerous US state Medicaid plans continue to restrict initiation of HCV therapy by fibrosis stage. The study objective was to determine whether delays from HCV diagnosis to fibrosis staging impact the likelihood of initiating/completing HCV treatment and achieving sustained virologic response (SVR). Methods A retrospective cohort study was performed among patients diagnosed with chronic HCV by an urban US emergency department who subsequently underwent fibrosis staging. Time elapsed from HCV diagnosis to hepatic fibrosis staging was evaluated on the likelihood of treatment initiation, treatment completion and SVR. Results Among fibrosis staging modalities, hepatic ultrasounds occurred more quickly following HCV diagnosis (3.5 months, IQR = 12.4 months), compared to FibroSure (8.5 months, IQR = 20.4 months) and FibroScan (9.9 months, IQR = 18.0 months) (p<.001). Each six-month delay in fibrosis staging decreased the likelihood of initiating treatment by 5% (adjusted relative risk (aRR)=0.95; 95% confidence interval (CI)=0.91–0.998; p=.04) and the likelihood of SVR by 7% (aRR = 0.93; 95% CI = 0.87–0.995; p=.04) after adjusting for insurance, race/ethnicity and history of HIV testing. Conclusions Delays in hepatitis fibrosis staging were significantly associated with decreased likelihood of HCV treatment initiation and SVR.

Impact of hepatitis C virus point-of-care RNA viral load testing compared with laboratory-based testing on uptake of RNA testing and treatment, and turnaround times: a systematic review and meta-analysis

Point-of-care (POC) hepatitis C virus (HCV) RNA nucleic acid test viral load assays are being used increasingly as an alternative to centralised, laboratory-based standard-of-care (SOC) viral load assays to reduce loss to follow-up. We aimed to evaluate the impact of using POC compared with SOC approaches on uptake of HCV RNA viral load testing and treatment, and turnaround times from testing to treatment along the HCV care cascade. We searched PubMed, Embase, and Web of Science for studies published in English between Jan 1, 2016, and April 13, 2022. We additionally searched for accepted conference abstracts (2016-20) not identified in the main search. The contacts directory of the WHO Global Hepatitis Programme was also used to solicit additional studies on use of POC RNA assays. We included studies if they evaluated use of POC HCV RNA viral load with or without a comparator laboratory-based SOC assay, and had data on uptake of viral load testing and treatment, and turnaround times between these steps in cascade. We excluded studies with a sample size of ten or fewer participants. The POC studies were categorised according to whether the POC assay was based onsite at the clinic, in a mobile unit, or in a laboratory. Studies using the POC assay or comparator SOC assays were further stratified according to four models of care: whether HCV testing and treatment initiation were performed in the same or different site, and on the same or a different visit. The comparator was centralised, laboratory-based HCV RNA SOC assays. For turnaround times, we calculated the weighted median of medians with 95% CIs. We analysed viral load testing and treatment uptake using random-effects meta-analysis. The quality of evidence was rated using the GRADE framework. This study is registered with PROSPERO, CRD42020218239. We included 45 studies with 64 within-study arms: 28 studies were in people who inject drugs, were homeless, or both; four were in people incarcerated in prison; nine were in the general or mixed (ie, includes high-risk groups) populations; and four were in people living with HIV. All were observational studies. The pooled median turnaround times between HCV antibody test and treatment initiation was shorter with onsite POC assays (19 days [95% CI 14-53], ten arms) than with either laboratory-based POC assays (64 days [64-64], one arm) or laboratory-based SOC assays (67 days [50-67], two arms). Treatment uptake was higher with onsite POC assays (77% [95% CI 72-83], 34 arms) or mobile POC assays (81% [60-97], five arms) than with SOC assays (53% [31-75], 12 arms); onsite and mobile POC assay vs SOC assay p=0·029). For POC and SOC arms, higher RNA viral load testing uptake was seen with the same-site models for testing and treatment than with different-site models (all within-category p≤0·0001). For onsite and mobile POC arms, there was higher treatment uptake for same-site than different-site models (within-category p<0·0001). Four studies had direct within-study POC versus SOC comparisons for RNA viral load testing uptake (pooled relative risk 1·11 [95% CI 0·89-1·38]), and there were ten studies on treatment uptake (1·32 [1·06-1·64]). Overall, the quality of evidence was rated as low. Compared with use of laboratory-based SOC HCV viral load testing, the use of POC assays was associated with reduced time from antibody test to treatment initiation and increased treatment uptake. The effect of POC viral load testing is greatest when positioned within a simplified care model in which testing and treatment are provided at the same site, and, where possible, on the same day. POC HCV RNA viral load testing is now recommended in WHO guidelines as an alternative strategy to laboratory-based viral load testing. Unitaid.

Hepatitis C care cascade before and during the direct-acting antiviral eras in New South Wales, Australia: A population-based linkage study.

The hepatitis C virus (HCV) care cascade characterization is important for monitoring progress towards HCV elimination. This study evaluated HCV care cascade and factors associated with treatment during pre-DAA (2011-2012 and 2013-2015) and DAA (2016-2018) eras in New South Wales (NSW), Australia. We conducted a cohort study of people with an HCV notification (1993 to 2017) through end 2018, linked to administrative datasets, including HCV treatment and non-hospital services. Those aged <18 years, died within first 6 months of study period or notification, and who had successful HCV treatment in period before were excluded. Sex-specific spontaneous viral clearance was incorporated to estimate treatment-eligible population. The study population in each period were cumulative and brought forward from one period to the next. Among 115,667 people with HCV notification, 87,063 fulfilled eligibility criteria. During 2011 to 2012, 2013 to 2015, and 2016 to 2018, cumulative HCV notifications were 71,677, 77,969, and 80,017; 52,016, 56,793, and 57,467 were eligible for treatment; 29%, 48%, and 64% confirmed HCV RNA positive; and 0.6%, 5%, and 38% initiated HCV treatment, respectively. Birth cohort 1945 to 1964 (vs. ≥1965), males, non-Aboriginal ethnicity, regional/rural area of residence, and HCV/HIV co-infection were associated with higher treatment uptake. Incarceration and drug dependence were associated with higher treatment uptake during the DAA era. In Australia, many marginalized populations including those incarcerated and those with drug dependence have equitable treatment uptake in the DAA era. Targeted strategies are required to enhance treatment uptake for females and Aboriginal populations.