Finding Cases of Hepatitis C for Treatment Using Automated Screening in the Emergency Department is Effective, but What Is the Cost?

Case detection remains a major challenge for hepatitis C virus (HCV) elimination. We have previously published results from a pilot of an emergency department (ED) semiautomated screening program, SEARCH; Screening Emergency Admissions at Risk of Chronic HCV. Several refinements to SEARCH have been developed to streamline and reduce cost. All direct costs of HCV testing until direct-acting antiviral (DAA) therapy initiation were calculated. Cost was assessed in 2018 Australian Dollars. A cost analysis of the initial program and refinements are presented. Sensitivity analysis to understand impact of variation in staff time, laboratory test cost, changes in HCV antibody (Ab) prevalence, RNA positivity percentage, and rate of linkage to care was conducted. Impact of refinements (SEARCH (2)) to cost is presented. The total SEARCH pilot, testing 5000 patients was estimated to cost $110,549.52 (range $92,109.79-$129,581.24) comprising of $68,278.67 for HCV Ab testing, $21,568.99 for follow-up and linkage to care of positive patients and $20,701.86 to prepare HCV RNA positive patients for treatment. Internal program refinements resulted in a 25% cost reduction. Following refinements, the cost of HCV antibody screening was $8.46 per test and the total cost per positive HCV Ab, positive HCV RNA, and per treated patient were $611.77, $2,168.64, and $3,566.11, respectively. Our sensitivity analysis indicates costs per HCV case found are modest so long as HCV Ab prevalence was at least 1%. ED screening is an affordable strategy for HCV case detection and elimination.

Using FIB-4 score as a screening tool in the assessment of significant liver fibrosis (F2) in patients with transfusion-dependent beta thalassaemia: a cross-sectional study.

OBJECTIVE: To evaluate the performance of the fibrosis-4 (FIB-4) score as a screening tool to detect significant liver fibrosis (F2) compared with transient elastography (TE), among chronic transfusion-dependent beta-thalassaemia (TDT) patients in a resource-poor setting. DESIGN: A cross-sectional study. SETTING: Adolescent and Adult Thalassaemia Care Centre (University Medical Unit), Kiribathgoda, Sri Lanka. PARTICIPANTS: 45 TDT patients who had undergone more than 100 blood transfusions with elevated serum ferritin >2000 ng/mL were selected for the study. Patients who were serologically positive for hepatitis C antibodies were excluded. OUTCOME MEASURES: TE and FIB-4 scores were estimated at the time of recruitment in all participants. Predefined cut-off values for F2, extracted from previous TE and FIB-4 scores studies, were compared. A new cut-off value for the FIB-4 score was estimated using receiver operating characteristics curve analysis to improve the sensitivity for F2 prediction. RESULTS: Of the selected 45 TDT patients, 22 (49%) were males. FIB-4 score showed a significant linear correlation with TE (r=0.52;p<0.0003). The FIB-4 score was improbable to lead to a false classification of TDT patients to have F2 when the FIB-4 cut-off value was 1.3. On the other hand, it had a very low diagnostic yield in missing almost all (except one) of those who had F2. Using a much-lowered cut-off point of 0.32 for FIB-4, we improved the pick-up rate of F2 to 72%. CONCLUSIONS: Regardless of the cut-off point, the FIB-4 score cannot be used as a good screening tool to pick up F2 in patients with TDT, irrespective of their splenectomy status. On the contrary, at a 1.3 cut-off value, though FIB-4 is a very poor detector for F2 fibrosis, it will not erroneously diagnose F2 fibrosis in those who do not have it.

Risk factors for hepatitis C virus infection at a large urban emergency department.

In 2020, Centers for Disease Control and Prevention (CDC) released guidelines recommending HCV screening in all adults 18 years and older. In the current study, we aimed to identify risk factors for HCV infection in an ED population. We performed a retrospective analysis of ED patients ≥ 18 years who were screened for HCV between 28 November 2018, and 27 November 2019, at a single urban, quaternary referral academic hospital. An HCV-antibody immunoassay (HCV-Ab) was used for screening; positive results were confirmed by measuring HCV ribonucleic acid (RNA). The outcome of interest was the number of new HCV diagnoses (presence of viremia by HCV RNA testing). Multiple logistic regression models were used to identify risk factors associated with a new HCV diagnosis. 16,722 adult patients were screened for HCV (mean age: 46 ± 15 years; 51% female). HCV seroprevalence was 5%. Independent risk factors for HCV included increasing age [10-year aOR 1.26 (95% CI 1.23, 1.30)], male sex [aOR 1.25 (95% CI 1.03, 1.51)], undomiciled housing status [aOR 2.8 (95% CI 2.3, 3.5)], history of tobacco use [aOR 3.0 (95% CI 2.3, 3.9)], history of illicit drug use [aOR 3.6 (95% CI 2.9, 4.5)], Medicaid insurance status [aOR 4.0 (95% CI 2.9, 5.5)] and Medicare insurance status [aOR 1.6 (95% CI 1.1, 2.2)].The ED services a high-risk population with regards to HCV infection. These data support universal screening of ED patients for HCV. Risk factor profiles could improve targeted screening at institutions without universal testing protocols.

Analysis of the association between areal socioeconomic deprivation levels and viral hepatitis B and C infections in Japanese municipalities.

BACKGROUND: We investigated the association between municipal socioeconomic deprivation levels and the positivity of hepatitis B surface antigen (HBsAg) and the prevalence of hepatitis C virus (HCV) among individuals who have never participated in hepatitis screening using Japanese national screening data. METHODS: The hepatitis virus screening data analyzed included the 5-year age group-specific number of participants aged 40 years or older, number of HBsAg-positive persons, and number of HCV carriers for each municipality from 2013 to 2017. Principal component analysis was used to derive a socioeconomic deprivation level using the socioeconomic characteristics of municipalities. Bayesian spatial Poisson regression analysis was conducted to investigate the association between the socioeconomic deprivation level and the results of screening. Data on 1,660 municipalities were used in the analysis. RESULTS: The data of 4,233,819 participants in the HBV screening and 4,216,720 in the HCV screening were used in the analysis. A principal component interpreted as level of rurality (principal component 1) and another principal component interpreted as level of low socioeconomic status among individuals (principal component 2) were extracted as the major principal components. Their principal component scores were used as the deprivation levels of municipalities. Spatial regression analysis showed that the deprivation level derived from the sum of the scores of principal components 1 and 2 was significantly and positively associated with HBsAg positivity and HCV prevalence. In addition, the deprivation level derived only from the score of principal component 2 was also significantly and positively associated with the outcomes. Conversely, the deprivation level derived only from the score of principal component 1 was not associated with the outcomes. Moreover, population density was significantly and positively associated with HBsAg positivity and HCV prevalence. CONCLUSIONS: This study suggested that participation in hepatitis virus screening is important and meaningful, particularly for areas with a higher lower socioeconomic level in Japan.

Hepatitis C incidence among patients attending primary care health services that specialise in the care of people who inject drugs, Victoria, Australia, 2009 to 2020.

BACKGROUND: Monitoring trends in hepatitis C virus (HCV) incidence is critical for evaluating strategies aimed at eliminating HCV as a public health threat. We estimate HCV incidence and assess trends in incidence over time among primary care patients. METHODS: Data were routinely extracted, linked electronic medical records from 12 primary care health services. Patients included were aged ≥16 years, tested HCV antibody negative on their first test recorded and had at least one subsequent HCV antibody or RNA test (January 2009-December 2020). HCV incident infections were defined as a positive HCV antibody or RNA test. A generalised linear model assessed the association between HCV incidence and calendar year. RESULTS: In total, 6711 patients contributed 17,098 HCV test records, 210 incident HCV infections and 19,566 person-years; incidence was 1.1 per 100 person-years (95% confidence interval (CI): 0.9 to 1.2). Among 559 (8.2%) patients ever prescribed opioid-related pharmacotherapy (ORP) during the observation period, 135 infections occurred during 2,082 person-years (incidence rate of 6.5 per 100 person-years (95% CI: 5.4 to 7.7)). HCV incidence declined 2009-2020 overall (incidence rate ratio per calendar year 0.8 (95% CI: 0.8 to 0.9) and among patients ever prescribed ORT (incidence rate ratio per calendar year 0.9, 95% CI: 0.75 to 1.0). CONCLUSION: HCV incidence declined among patients at primary care health services including among patients ever prescribed ORP and during the period following increased access to DAA therapy.

Hepatitis C virus infection screening reduces mortality and is cost-effective independently of the intervention test.

INTRODUCTION: Chronic infection due to hepatitis C virus (HCV) is frequently asymptomatic even in advanced stages of liver disease. Implementation of a screening program based on different HCV tests may enable an earlier diagnosis of HCV liver disease and subsequent application of highly effective treatment. PATIENTS AND METHODS: A Markov model which compares three different screening strategies for hepatitis C versus no screening in low-risk prevalence (general population) and high-risk prevalence population (people who inject drugs or prison population) was designed, taking into account age at the start of screening and participation. The three strategies were: 1) serological detection of antibodies against the HCV, 2) dried blood spot test (DBS) to detect antibodies against HCV and 3) detection of RNA from HCV. Quality-adjusted life-years (QALY) were taken as a measurement of effectiveness. The incremental cost-effectiveness ratio (ICER) was calculated and a deterministic and probabilistic sensitivity analysis was performed. RESULTS: All three screening strategies were found to be cost-effective with an ICER of €13,633, €12,015 and €12,328/QALY for AntiHCV, DBS-AntiHCV and DBS-RNA HCV, respectively. There was a decrease in mortality due to liver disease in comparison to no screening for AntiHCV (40.7% and 52%), DBS-AntiHCV (45% and 80%) and DBS-RNA HCV (45.2% and 80%) for low-prevalence and high-prevalence populations, respectively. CONCLUSION: All test interventions for HCV screening are cost-effective for the early detection of HCV infection, also achieving a reduction in mortality. Thus, implementation of screening programs for HCV should not be halted by decisions on monetary policy.

HCV core antigen plays an important role in the fight against HCV as an alternative to HCV-RNA detection.

OBJECTIVE: To discuss the clinical significance of HCV-cAg testing in the diagnosis, activity determination, and monitoring of therapeutic effectiveness of HCV infection and its advantages compared with HCV-RNA and anti-HCV antibodies detection. METHODS: By summarizing the published literature, the advantages and significance of HCV core antigen detection were sought. RESULTS: The expression of HCV-cAg is highly consistent with that of HCV-RNA, but compared with HCV-RNA, detection of HCV-cAg is easy to operate, time saving, and low cost. HCV-cAg can be detected within 12~15 days after infection, and the window period can be shortened by5~7 weeks. HCV-cAg is a serological indicator of virus replication, which can distinguish previous infection of HCV or current infection. HCV-cAg detection is more suitable for immunocompromised, hemodialysis, organ transplant patients. HCV-cAg also can be used to monitor antiviral efficacy and predict sustained virological response (SVR). CONCLUSION: HCV core antigen has similar clinical sensitivity to NAT and can be used as a substitute for HCV-RNA in the diagnosis of virus infection. Combined detection of HCV-cAg and antibody serology can help doctors detect HCV infection earlier, accurately diagnose different stages of HCV infection, and evaluate the therapeutic effect of antiviral drugs, which are beneficial in the prevention and treatment of hepatitis C.

Point-of-care rapid testing for hepatitis C antibodies at New Zealand needle exchanges.

AIM: The study's principal aim was to ascertain the viability of point-of-care rapid testing for hepatitis C (HCV) antibodies by non-clinician frontline peer needle exchange staff. Secondary aims included identifying HCV-exposed clients, improving their access to treatment, assessing their knowledge of HCV and strengthening client-staff relationships. METHOD: Peer staff at three South Island needle exchange services (two urban, one mobile) were trained to administer point-of-care rapid HCV antibody tests, to clients, with finger-stick blood sampling, along with a short self-report questionnaire. Clients testing HCV antibody positive were offered on-site venepuncture by clinical staff, to confirm reactive rapid test results. RESULTS: Two hundred and four people were tested across the three sites. Of these, 131 (64.2%) tested HCV antibody positive (reactive) and by the study's conclusion confirmatory venepuncture testing (n=55) had produced 14 new diagnoses and seven people had commenced treatment. Additionally, the study successfully assessed clients' previous HCV testing rates and their knowledge of test results. Through the interactions involved in testing participants, needle exchange staff reported strengthened relationships with clients. CONCLUSION: This study demonstrated the viability of administering rapid point-of-care HCV antibody tests to needle exchange clients by non-clinician frontline peer staff. The efficacy of point-of-care testing and its appropriateness for use in this context to identify HCV-exposed needle exchange clients was demonstrated by the high proportion of participants receiving a reactive result, the identification of viremic clients and their support into treatment.

Hepatitis C Among High-Risk Alabamians: Disease Burden and Screening Effectiveness.

BACKGROUND: The effectiveness of hepatitis C testing and linkage-to-care (LTC) is poorly characterized in low-resource jurisdictions facing gaps in harm reduction, including illegality of syringe exchange services. Effectiveness of a community-based test/LTC program was evaluated in Alabama. METHODS: In 2016-2018, shelters, drug treatment centers (DTCs), AIDS organizations, and Federally Qualified Health Centers (FQHCs) engaged in screening/LTC. A coordinator navigated individuals to confirm viremia and link to substance use treatment or primary care with hepatitis C prescribers. RESULTS: Point-of-care (POC) tested 4293 individuals (10% [427] antibody-positive, 71% [299/419] RNA performed, 80% [241/299] viremia confirmed) and 93% linked to care (225/241). Electronic medical record (EMR)-based reflex strategy screened 4654 (15% [679] antibody positive, 99% [670/679] RNA performed, 64% [433/679] viremia confirmed) and 85% linked to care (368/433). We observed higher odds of RNA confirmation in EMR-based reflex versus POC (OR, 2.07; P < .0001) and higher odds of LTC in EMR-based reflex versus POC (OR, 1.51; P < .0001). Overall, 53% individuals tested were nonbaby boomers. CONCLUSIONS: In Alabama, screening at high-risk settings identified significant hepatitis C burden and reflex testing outperformed point-of-care linkage indicators. Colocating testing in DTCs and treatment in FQHCs provided key LTC venues to at-risk younger groups.

Sensitivity and specificity of commercially available rapid diagnostic tests for viral hepatitis B and C screening in serum samples.

Early diagnosis of chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections is pivotal for optimal disease management. Sensitivity and specificity of 19 rapid diagnostic test (RDT) kits by different manufacturers (ABON, CTK Biotech, Cypress Diagnostics, Green Gross, Human Diagnostic, Humasis, InTec, OraSure, SD Bioline, Wondfo) were assessed on serum samples of 270 Mongolians (90 seropositive for hepatitis B surface antigen (HBsAg), 90 seropositive for hepatitis C antibody (HCV-Ab), 90 healthy subjects). All tested RDTs for detection of HBsAg performed with average sensitivities and specificities of 100% and 99%, respectively. Albeit, overall sensitivity and specificity of RDTs for detection of HCV-Ab was somewhat lower compared to that of HBsAg RDTs (average sensitivity 98.9%, average specificity 96.7%). Specificity of RDTs for detection of HCV-Ab was dramatically lower among HBsAg positive individuals, who were 10.2 times more likely to show false positive test results. The results of our prospective study demonstrate that inexpensive, easy to handle RDTs are a promising tool in effective HBV- and HCV-screening especially in resource-limited settings.

Hepatitis C Management at Federally Qualified Health Centers during the Opioid Epidemic: A Cost-Effectiveness Study.

BACKGROUND: The opioid epidemic has been associated with an increase in hepatitis C virus (HCV) infections. Federally qualified health centers (FQHCs) have a high burden of hepatitis C disease and could serve as venues to enhance testing and treatment. METHODS: We estimated clinical outcomes and the cost-effectiveness of hepatitis C testing and treatment at US FQHCs using individual-based simulation modeling. We used individual-level data from 57 FQHCs to model 9 strategies, including permutations of HCV antibody testing modality, person initiating testing, and testing approach. Outcomes included life expectancy, quality-adjusted life-years (QALY), hepatitis C cases identified, treated and cured; and incremental cost-effectiveness ratios. RESULTS: Compared with current practice (risk-based with laboratory-based testing), routine rapid point-of-care testing initiated and performed by a counselor identified 68% more cases after (nonreflex) RNA testing in the first month of the intervention and led to a 17% reduction in cirrhosis cases and a 22% reduction in liver deaths among those with cirrhosis over a lifetime. Routine rapid testing initiated by a counselor or a clinician provided better outcomes at either lower total cost or at lower cost per QALY gained, when compared with all other strategies. Findings were most influenced by the proportion of patients informed of their anti-HCV test results. CONCLUSIONS: Routine anti-HCV testing followed by prompt RNA testing for positives is recommended at FQHCs to identify infections. If using dedicated staff or point-of-care testing is not feasible, then measures to improve immediate patient knowledge of antibody status should be considered.

Socio-demographic and ecological factors associated with anti-HCV prevalence in people who inject drugs: A systematic review.

BACKGROUND: The World Health Organization (WHO) aim to eliminate hepatitis C virus (HCV) as a public health threat by 2030. People who inject drugs (PWID) are a key risk group for HCV transmission globally. We explored socio-demographic and ecological variables associated with HCV antibody (anti-HCV) prevalence among samples of PWID. METHODS: We systematically searched for and screened journal articles and online reports published between January 2011 and June 2017. Serologically confirmed anti-HCV prevalence among PWID and other study-level socio-demographic variables were extracted. Country-level ecological indicators were sourced from online databases. We used generalized linear models to investigate associations between anti-HCV prevalence estimates and other study-level and country-level variables. RESULTS: There were 223 studies from 84 countries contributing 569 estimates of anti-HCV prevalence among PWID. Among study-level indicators, higher levels of anti-HCV prevalence were associated with higher HIV prevalence (B = 0.20; 95 % Confidence Interval [95 %CI] = 0.12, 0.29, p < 0.001) and year of data collection (B=-0.08; 95 %CI=-0.15, -0.02; p = 0.011). At a national level, higher Human Development Index scores (B=4.37; 95 %CI=0.12, 8.63, p = 0.044) were associated with higher levels of anti-HCV in samples. IMPLICATIONS: Serological surveillance data are increasingly available globally; however, there are still geographical gaps in quantification of HCV prevalence among PWID that must be addressed to inform efforts to achieve HCV elimination. Anti-HCV prevalence was lower in samples of PWID from countries with lower Human Development Index scores, which points to an opportunity to provide targeted intervention and potentially control transmission rates of infection in countries characterized by poor population health, education, and income.

Hepatitis C virus core antigen is cost-effective in community-based screening of active hepatitis C infection in Taiwan.

BACKGROUND AND PURPOSE: Hepatitis C virus (HCV) core antigen is highly sensitive and specific in viremic HCV diagnosis. This study evaluated the cost-effectiveness of HCV core antigen (HCVcAg) in community-based screening for active HCV infection. METHODS: Between 2017/07 and 2018/07, community-based screenings for active HCV infection with two-step (anti-HCV for screening and HCVRNA for diagnosis) and one-step processes (HCVcAg for screening and diagnosis) were conducted in two districts in Kaohsiung City. While HCVcAg test was positive at ≥3 fmol/L, the lowest level of HCV-RNA detection was 12 IU/mL. We analyzed the cost-effectiveness of two algorithms in identifying active HCV infection. RESULTS: There were two large-scale screenings using the two-step process with a total of 2452 residents enrolled; while six hundred and forty-four residents participated in continuous small-scale screening with the one-step process. The prevalence of anti-HCV and positive HCVcAg was 3.4% and 2.8%. The viremic rate was 1.4% and 2.8% for two- and one-step processes (p < 0.001). While all positive HCVcAg were viremic, 42.4% of positive anti-HCV patients had viremia. The positive predictive value was 42.2% and 100% for two- and one-step processes in detecting active HCV infection (p < 0.001). In identifying one active HCV infection, the cost was $755.3 and $711.1 dollars for two- and one-step processes respectively. CONCLUSION: Compared to the two-step process in community-based screening, continuous screening with the HCVcAg test as a one-step tool for active HCV infection was cost-effective in areas with low seroprevalence of HCV in Taiwan.

Prevalence of tuberculosis, HIV/AIDS, and hepatitis; in a prison of Balochistan: a cross-sectional survey.

BACKGROUND: Human Immunodeficiency Virus (HIV), Hepatitis, and Tuberculosis (TB) are three primary communicable infections have the likely potential to cause severe morbidity in prison settings. The prison has the most favorable environment for the transmission of infections. We conducted this survey to determine the prevalence and feasibility of rapid diagnostic tests in an active screening of these infectious diseases in prison. METHODS: This cross-sectional survey conducted in central Jail Gaddani, one of the largest prisons in the Balochistan province of Pakistan. All prisoners, jail staffs, and staff's family members participated. Informed consent obtained from each participant before the screening. Van equipped with digital X-ray linked with Computer-Aided Detection for TB (CAD4TB) software used for testing. Sputum samples tested on Xpert for MTB/RIF assay and blood specimens collected for HIV and hepatitis serology. Diagnosed TB patients enrolled for treatment at Basic Management Unit (BMU), reactive on hepatitis Rapid Diagnostic Tools (RDTs) were referred for further testing and management, while HIV reactive referred to Anti Retro Viral (ARV) center for Anti Retro Viral Treatment (ART). RESULTS: A total of 567 participants offered screening, 63% (356) prisoners, 23% (129) staff's family members, and 14% (82) jail staffs. Among tested 10.3% (58/562) were hepatitis seropositive (Hepatitis-C 41 [7.29%] Hepatitis-B, 16 [2.84%] Hepatitis B&C both, 01 [0.17%]). In reactive participants, 49 were prisoners, 08 were jail staffs, and 01 was the staff's family member. HIV seropositive was 4% (24/566), and all were prisoners. Almost 99% (565/567) screened by digital X-ray, 172 (30%) were with abnormal CAD4TB suggestion (score > 50), out of them sputum of 26% (148) tested on Xpert, and 2% (03) found Mycobacterium tuberculosis Positive (MTB+). A total of five TB patients were detected; out of two were diagnosed clinically. Co-morbidities observed in 15 patients, (01 TB/HIV co-infected, 12 HIV/HCV, 01 HIV/HBV, and 01 HBV/HCV). CONCLUSION: The high frequency of infectious diseases in prison is alarming. For limiting the transmission of infections among prison and community, immediate steps are needed to be taken for improvement of prisons condition by application of recommended screening protocols at the time of the first entry of prisoners in prisons.

Streamlining the screening cascade for active Hepatitis C in Russia: A cost-effectiveness analysis.

OBJECTIVE: Screening for hepatitis C in Russia is a complex process that involves several visits and stepwise testing, limiting adherence and substantially reducing the yield in the identification of active infections. We aimed to evaluate the cost-effectiveness of different screening algorithms from a health system perspective. METHODS: A decision analytic model was applied to a hypothetical adult population eligible to participate in a general screening program for hepatitis C in Russia. The standard pathway (I: Screen for anti-HCV antibodies followed by a nucleic acid test for HCV RNA on antibody positives) was compared to three alternatives (II: Screen for antibodies, a reflexed test for HCV antigen on antibody positives, and RNA on antigen negatives; III: Screen for antibodies, a reflexed test for HCV antigen on antibody positives; IV: Screen for antigen). Each strategy considered a cascade of events (referral, adherence, testing, diagnosis) that must occur for screening to be effective. The primary measure of effectiveness was the number of diagnosed active infections. Calculations followed a health system perspective with costs derived from 2017 reimbursement rates and a willingness-to-pay of 2,000RUB ($82) per diagnosed active infection. Model was tested with deterministic and probabilistic sensitivity analyses. RESULTS: Non-adherence to screening stages reduced the capture rate of active infections in Strategy I from 79.0% to 40.6%. Strategies II, III, and IV were less affected and identified 69%, 67%, and 104% more infections. Average costs per diagnosed infection were decreased by 41% from 89,599RUB ($3,681) for I to 53,072RUB ($2,180), 53,004RUB ($2,177), and 59,633RUB ($2,450) for II, III, and IV, respectively. With a probability of 97%, Strategy III was most cost-effective with an incremental cost-effectiveness ratio vs. I of -1,373RUB (CI: -5,011RUB to -2,033RUB; $-56; CI: -$206 to -$84). Below a willingness-to-pay of 91,000RUB ($3,738), Strategy IV was not cost-effective. Sensitivity analyses confirmed the robustness of results. CONCLUSIONS: Testing strategies for hepatitis C with HCV antigen on HCV antibody positive cases offer a streamlining opportunity for population screening programs. Those shall increase the chances for detecting active infections and are cost-effective over current practice in Russia.

Screening, diagnosis and care cascade for viral hepatitis B and C in Yaoundé, Cameroon: a qualitative study of patients and health providers coping with uncertainty and unbearable costs.

OBJECTIVES: To document patients' and healthcare professionals' (HCP) experiences with hepatitis B virus (HBV) and hepatitis C virus (HCV) diagnosis and care, as well as consequences of these infections on patients' life trajectories in Cameroon, an endemic country in sub-Saharan Africa. DESIGN: Qualitative sociological study combining in-depth interviews and observations of medical consultations. Interviews and observations transcripts were thematically analysed according to the following themes: circumstances and perceptions surrounding hepatitis screening, counselling and disclosure, information provided by HCP on hepatitis prevention and treatment, experience of access to care and treatment, social/economic trajectories after diagnosis. SETTING: HIV and gastroenterology/medical services in two reference public hospitals in Yaoundé (Cameroon). PARTICIPANTS: 12 patients affected by HBV and/or HCV (co-infected or not with HIV), 14 HCP, 14 state and international stakeholders. FINDINGS: Many patients are screened for HBV and HCV at a time of great emotional and economic vulnerability. The information and counselling delivered after diagnosis is limited and patients report feeling alone, distressed and unprepared to cope with their infection. After screening positive, patients struggle with out-of-pocket expenditures related to the large number of tests prescribed by physicians to assess disease stage and to decide whether treatment is needed. These costs are so exorbitant that many decide against clinical and biological follow-up. For those who do pay, the consequences on their social and economic life trajectories are catastrophic. CONCLUSION: Large out-of-pocket expenditures related to biological follow-up and treatment pose a real challenge to receiving appropriate care. Free or reasonably priced access to hepatitis B and C treatments can only be effective and efficient at reducing the hepatitis disease burden if the screening algorithm and the whole pretherapeutic assessment package are simplified, standardised and subsidised by comprehensive national policies orientated towards universal healthcare.

The efficiency of several one-step testing strategies for the diagnosis of hepatitis C.

BACKGROUND: implementing one-step strategies for hepatitis C diagnosis would help shorten the time to treatment access. Thus avoiding disease progression and complications, while facilitating hepatitis C virus (HCV) elimination. OBJECTIVE: to assess the validity and certainty of potential one-step strategies for the diagnosis of HCV infection and their associated cost and efficiency. METHODS: the study design is an economic appraisal of efficiency (cost/efficacy) using decision trees and deterministic sensitivity analysis. The analysis was performed from the payer perspective (Spanish National Health System), which exclusively considers the direct costs. Only the differential costs (diagnostic testing costs) were taken into account and the study was set in Spain. The efficacy of a diagnostic strategy was defined as the percentage of patients with an active HCV infection who received a positive diagnosis and the efficiency was defined as the cost per patient with a correctly diagnosed and active infection. RESULTS: the one-step strategies evaluated for the diagnosis of HCV had an acceptable validity and certainty due to the high sensitivity and specificity of the considered tests. The Ab-Ag strategy was the most efficient, followed by Ab-Ag-VL and Ab-VL. Ab-Ag was the most efficient due to the lower cost per patient tested, although the efficacy was lower than the Ab-VL efficacy. CONCLUSION: the study findings may help to establish more appropriate one-step diagnostic approaches whilst considering the efficacy and efficiency.

Prevalence and sociodemographic disparities of Hepatitis C in Baby Boomers and the US adult population.

BACKGROUND: The US Baby Boomer (BB) generation is associated with high rates of Hepatitis C virus (HCV) infection. There is limited literature detailing age-specific risk factors for HCV infection. Using a nationally representative sample, this study examines US adult HCV prevalence and age-specific risk factors for chronic HCV infection. METHODS: We analyzed data from National Health and Nutrition Examination Survey (NHANES) for years 1999-2012. Age was divided into three categories: BB, younger than BB (YG) and older than BB (OG). HCV status was determined by the presence of a positive HCV antibody and a positive HCV RNA. Sociodemographic variables were analyzed by HCV status. Multivariable logistic regression models adjusting for sociodemographic variables were fitted to identify age-specific risk factors for HCV positivity. RESULTS: The overall prevalence of chronic HCV was 1.19% with a US population estimate of 2,347,852 US adults. BB had the highest prevalence at 2.23%, accounting for over 74% of all chronic HCV cases. HCV prevalence was highest among all ages (1.83%) and BB (2.71%) in 2001-2002 survey cycle. Among BB, males, non-Hispanic blacks, positive blood transfusion history, current and former smoker, and living below the poverty line were significant predictors of chronic HCV positivity. CONCLUSION: This study highlights the elevated prevalence of chronic HCV among BB and identifies age-specific risk factors for chronic HCV infection. As the BB population ages, it is important to use these generation-specific risk factors that can guide health professionals in targeted screening and public health prevention efforts.

Cost Effectiveness of Universal Screening for Hepatitis C Virus Infection in the Era of Direct-Acting, Pangenotypic Treatment Regimens.

BACKGROUND & AIMS: Most persons infected with hepatitis C virus (HCV) in the United States were born from 1945 through 1965; testing is recommended for this cohort. However, HCV incidence is increasing among younger persons in many parts of the country and treatment is recommended for all adults with HCV infection. We aimed to estimate the cost effectiveness of universal 1-time screening for HCV infection in all adults living in the United States and to determine the prevalence of HCV antibody above which HCV testing is cost effective. METHODS: We developed a Markov state transition model to estimate the effects of universal 1-time screening of adults 18 years or older in the United States, compared with the current guideline-based strategy of screening adults born from 1945 through 1965. We compared potential outcomes of 1-time universal screening of adults or birth cohort screening followed by antiviral treatment of those with HCV infection vs no screening. We measured effectiveness with quality-adjusted life-years (QALY), and costs with 2017 US dollars. RESULTS: Based on our model, universal 1-time screening of US residents with a general population prevalence of HCV antibody greater than 0.07% cost less than $50,000/QALY compared with a strategy of no screening. Compared with 1-time birth cohort screening, universal 1-time screening and treatment cost $11,378/QALY gained. Universal screening was cost effective compared with birth cohort screening when the prevalence of HCV antibody positivity was greater than 0.07% among adults not in the cohort born from 1945 through 1965. CONCLUSIONS: Using a Markov state transition model, we found a strategy of universal 1-time screening for chronic HCV infection to be cost effective compared with either no screening or birth cohort-based screening alone.

Outcomes and costs of single-step hepatitis C testing in primary care, Birmingham, United Kingdom.

OBJECTIVES: In UK laboratories, the diagnostic algorithm for chronic hepatitis C (HCV) infection commonly requires two serological assays to confirm anti-HCV-antibody positivity in a serum sample followed by HCV RNA detection in a second whole-blood sample (two-step testing algorithm). A single-step algorithm (both anti-HCV antibodies and RNA tested on an initial serum specimen) has been advocated to reduce attrition rates from the care pathway. STUDY DESIGN: To investigate the feasibility, clinical impact and relative costs of switching from a two-step to single-step testing algorithm in the laboratory, a pilot study on unselected primary care requests was undertaken. METHODS: All primary care patients tested for HCV infection from December 2013 to April 2016 were included. The single-step testing algorithm was introduced in March 2015. Before this, the two-step algorithm was used. Patients were followed up until August 2016. RESULTS: RNA quantitation in plasma was within one log of serum values for 21 paired samples. Although all patients in the single-step algorithm received an RNA test, only 70% completed the two-step testing algorithm; differences in referral rates to specialist care was due to 30% of HCV antibody-positive patients in the two-step algorithm not having follow-up whole-blood sampling for HCV RNA testing. Costs per new diagnosis and new diagnosis referred to specialist care were lower in single-step testing by £94.32 and £144.25, respectively. CONCLUSION: This study provides further evidence that a single-step testing algorithm, as recommended in the UK Standards for Microbiology Investigation, works in practice and should be the standard of care for screening for chronic HCV.