Health care costs associated with hepatitis C virus infection in First Nations populations in Ontario: a retrospective matched cohort study.

BACKGROUND: Colonization and marginalization have affected the risk for and experience of hepatitis C virus (HCV) infection for First Nations people in Canada. In partnership with the Ontario First Nations HIV/AIDS Education Circle, we estimated the publicly borne health care costs associated with HCV infection among Status First Nations people in Ontario. METHODS: In this retrospective matched cohort study, we used linked health administrative databases to identify Status First Nations people in Ontario who tested positive for HCV antibodies or RNA between 2004 and 2014, and Status First Nations people who had no HCV testing records or only a negative test result (control group, matched 2:1 to case participants). We estimated total and net costs (difference between case and control participants) for 4 phases of care: prediagnosis (6 mo before HCV infection diagnosis), initial (after diagnosis), late (liver disease) and terminal (6 mo before death), until death or Dec. 31, 2017, whichever occurred first. We stratified costs by sex and residence within or outside of First Nations communities. All costs were measured in 2018 Canadian dollars. RESULTS: From 2004 to 2014, 2197 people were diagnosed with HCV infection. The mean net total costs per 30 days of HCV infection were $348 (95% confidence interval [CI] $277 to $427) for the prediagnosis phase, $377 (95% CI $288 to $470) for the initial phase, $1768 (95% CI $1153 to $2427) for the late phase and $893 (95% CI -$1114 to $3149) for the terminal phase. After diagnosis of HCV infection, net costs varied considerably among those who resided within compared to outside of First Nations communities. Net costs were higher for females than for males except in the terminal phase. INTERPRETATION: The costs per 30 days of HCV infection among Status First Nations people in Ontario increased substantially with progression to advanced liver disease and finally to death. These estimates will allow for planning and evaluation of provincial and territorial population-specific hepatitis C control efforts.

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.

HCV Seroprevalence among HIV Patients and Associated Comorbidities at One Primary Health Facility in Rwanda.

Hepatitis C virus (HCV) and HIV have emerged as major viral infections within the past two decades, and their coinfection poses a big challenge with a significant impact in terms of morbidity and mortality associated with liver disease and renal failure. The current study aimed at assessing the prevalence of HCV infection and associated comorbidities among HIV patients at one primary health facility in Rwanda. In total, 417 HIV-positive patients were recruited and included in the study from January 1, 2019 up to June 30, 2019. All participants were screened for HCV infection by using the SD Bioline HCV antibody rapid test. In addition, underlying medical conditions were also recorded as comorbidities. Among 417 participants, 52 exhibited HCV-positive results (12.5%). The group of 41- to 50- and 51- to 60-year-olds had higher prevalence of HIV/HCV coinfection than other age-groups with 3.6% and 4.6%, respectively. Furthermore, five underlying medical conditions were found as comorbidities among the study participants. Those with HIV/HCV coinfection showed higher comorbidities than those with mono-infection including liver toxicity, P value 0.005; tuberculosis, P value 0.005; renal failure, P value 0.003; hypertension, P value 0.001; and diabetes mellitus, P value 0.001. The relative risk ratio of having comorbidities in those groups was 4.09. To conclude, the prevalence of HCV/HIV coinfection is high, and there was a statistical significant association of having comorbidities in HIV/HCV-coinfected group compared with the group of HIV mono-infection, which suggests more intervention in this vulnerable group of patients.

Reduced incidence of hepatitis C in 9 villages in rural Egypt: Progress towards national elimination goals.

BACKGROUND & AIMS: Egypt has a major HCV burden and a well established treatment programme, with an ambitious goal of HCV elimination. Our aim was to assess the impact of a comprehensive HCV prevention, test and treat programme on the incidence of new HCV infections in 9 villages in rural Egypt. METHODS: An HCV "educate, test and treat" project was implemented in 73 villages across 7 governorates in Egypt between 06/2015 and 06/2018. In 2018, in 9 of the villages we re-tested individuals who originally tested HCV antibody (HCV-Ab) and HBsAg negative using rapid diagnostic tests (RDTs); confirmatory HCV RNA testing was performed for positive cases. The incidence rate per 1,000 person-years (py) was calculated, and risk factors for incident HCV infections assessed through an interviewer-administered questionnaire in 1:3 age- and gender-matched cases and controls. RESULTS: Out of 20,490 individuals who originally tested HCV-Ab negative in the 9 villages during the 2015-2016 implementation of the "educate, test and treat" programme, 19,816 (96.7%) were re-tested in 2018. Over a median of 2.4 years (IQR 2.1-2.7), there were 19 new HCV infections all of which were HCV RNA positive (incidence rate 0.37/1,000 py) (95% CI 0.24-0.59). Compared to a previous estimate of incidence in the Nile Delta region (2.4/1,000 py) from 2006, there was a substantial reduction in overall incidence of new HCV infections. Exposures through surgery (odds ratio 51; 95% CI 3.5-740.1) and dental procedures (odds ratio 23.8; 95% CI 2.9-194.9) were significant independent predictors of incident infections. CONCLUSIONS: This is the first study to show a substantial reduction in incidence of new HCV infections in a sample of the general population in Egypt following attainment of high testing and treatment coverage. New infections were significantly associated with healthcare-associated exposures. LAY SUMMARY: Egypt has a major national HCV testing and treatment programme with the goal of eliminating HCV infection. We assessed the impact of a comprehensive HCV prevention, test and treat programme in 73 villages that achieved high coverage of testing and treatment on the subsequent incidence of new HCV infections in nine of the villages. We re-tested people who were previously HCV antibody negative and found that the rate of new HCV infections was greatly reduced compared to previous estimates. We also found that exposure through surgery and dental procedures were associated with these new infections. This highlights the importance of continued strengthening of infection control and prevention measures, alongside treatment scale-up.

Impact of the 2020 COVID-19 Pandemic on Ambulatory Hepatitis C Testing.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) has led to unprecedented modifications to healthcare delivery in the U.S. To preserve resources in preparation for a COVID-19 surge, Boston Medical Center (BMC) implemented workflows to decrease ambulatory in-person visits effective March 16th, 2020. Telemedicine was incorporated into clinical workflows and much preventive care, including Hepatitis C (HCV) testing, was not routinely performed. OBJECTIVE: To explore the impact that the COVID-19 rapid restructuring response has had on HCV testing and identification hospital-wide and in ambulatory settings. METHODS: BMC utilizes reflex confirmatory testing for HCV. When a sample is HCV Ab positive, it is automatically reflexed for confirmatory RNA and genotype testing. HCV test results for patients were collected daily. We compared unique patient tests for 3.5 month periods before and after March 16th, 2020. Descriptive statistics showed total tests and total new HCV RNA+ before versus after, both hospital-wide and in ambulatory clinics alone. Mean daily tests completed were compared. RESULTS: Hospital-wide, total HCV testing decreased by 49.6%, and new HCV+ patient identification decreased by 42.1%. In ambulatory clinics, testing decreased by 71.9%, and new HCV+ identification decreased by 63.3%. Hospital-wide, mean daily tests decreased by 22.9 tests per day (95% CI: 17.9-28.0, P < .001), and mean daily new HCV+ identification decreased by 0.36 (95% CI: 0.20-0.53, P < .001). In ambulatory clinics, mean daily tests decreased by 22.1 tests per day (95% CI: 17.5-26.7, P < .001) and mean daily HCV+ decreased by 1.40 (95% CI: 1.03-1.76, P < .001). CONCLUSION: The COVID-19 systematic emergency response led to decreased HCV testing and identification, and in this regard telemedicine acts as a barrier to HCV care. Other public health initiatives must be monitored in the context of telemedicine workflows. Continued monitoring of HCV screening trends is vital, and adaptive approaches to work toward the goal of HCV elimination are needed.

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.

Assessment of Key Elements in the Innate Immunity System Among Patients with HIV, HCV, and Coinfections of HIV/HCV.

BACKGROUND: Coinfection of Hepatitis C virus (HCV) with human immunodeficiency virus (HIV) has a higher risk of mortality than HCV or HIV monoinfection. HCV and HIV infections are specified by systemic inflammation, but the inflammation process in HCV/HIV coinfection is much complicated and is not well characterized. OBJECTIVE: The aim of this study was to analyze the expression of TLR-3, TLR-7, IL-10, IFN-1 (IFN-α, IFN-ß), and TNF-α in HIV, HCV and HIV/HCV co-infected patients. METHODS: Forty-five patients including HIV group (n=15), HCV group (n=15), HIV/HCV coinfection group (n=15) and healthy control group (n=15) participated. Peripheral blood mononuclear cells (PBMCs) were obtained. PBMC-RNA, HCV and HIV RNA were extracted from all subjects and cDNA was synthesized. The viral load analyzed by reverse transcription-quantitative PCR (RT-qPCR), and the expression levels of IFN-α, IFN-ß, TLR-3, TLR-7, TNF, and IL-10 mRNA were quantified in PBMCs. RESULTS: The levels of IFN-I, IL-10, and TNF-α were overexpressed in all patients' groups (p<0.05), TLR-7 was upregulated in all groups, but this upregulation was not statistically significant (p>0.05). TLR-3 showed a decrease in all patient groups (p<0.05). The statistical analysis demonstrated that TLR-3 has a negative correlation with HIV load, whereas other genes positively correlated with HIV load. In addition, TLR-3, TNF-α, and IFN-I were negatively correlated with HCV load, whereas TLR-7 and IL-10 s were positively correlated with HCV load. CONCLUSION: Our results showed a significant relationship between the expression level of innate immunity genes and inflammation in HCV, HIV, and HIV/HCV coinfected patients.

Assessment of a poly-epitope candidate vaccine against Hepatitis B, C, and poliovirus in interaction with monocyte-derived dendritic cells: An ex-vivo study.

Design and application of epitope-based polyvalent vaccines have recently garnered attention as an efficient alternative for conventional vaccines. We previously have reported the in silico design of HHP antigen which encompasses the immune-dominant epitopes of Hepatitis B surface antigen (HBsAg), Hepatitis C core protein (HCVcp) and Poliovirus viral proteins (VPs). It has been shown that the HHP has desirable conformation to expose the epitopes, high antigenicity and other desired physicochemical and immunological properties. To confirm the accuracy of these predictions, the ex-vivo immunogenicity of the HHP was assessed. The HHP gene was chemically synthesized in pET28a and expressed in E. coli (BL21). The expressed protein was purified and its immunological potency was evaluated on dendritic cells (DCs) as antigen presenting cells (APCs). Functional analysis was assessed in co-cultivation of autologous T-cells with matured DCs (mDCs). T-cell activation, proliferation and cytokines secretion were evaluated using flowcytometry and ELISA methods. Our results indicated that the HHP could induce the DC maturation. The mDCs were able to trigger T-cell activation and proliferation. In silico design and ex-vivo confirmation of immunological potential could pave the way to introduce efficient immunogens for further analysis. The ability of HHP in DC maturation and T-cell activation makes it an amenable vaccine candidate for further in-vivo studies.

Identifying Barriers to the Treatment of Chronic Hepatitis C Infection.

BACKGROUND AND AIMS: Chronic hepatitis C (CHC) viral infection has a major impact on our health care system. The emergence of direct-acting antiviral agents (DAA) has made treatment simple (oral), efficacious, and safe. However, treatment is expensive and access is variable. Despite great treatment outcomes, only a minority of patients with CHC receive antiviral therapy. This study identifies the barriers to treatment in CHC infection. METHODS: Study recruited all hepatitis C antibody-positive patients between 2012 and 2016 from a large academic teaching hospital in New York City. Demographic information, clinical data, and insurance information were reviewed. Statistical analysis performed with OR and p < 0.05 reported. RESULT: A total of 1,548 patients with hepatitis C antibody-positive titer were included in the initial analysis. One thousand and twenty-four patients were forwarded to the final analysis after exclusion of 524 patients (for distant resolved hepatitis C viral [HCV] infection [n = 42], patients cured with interferon-based regimens [n = 94], patients with comorbid conditions [n = 176], and patients with an incomplete medical chart [n = 212]). In the intention to treat cohort of 1,024 patients, 204 patients achieved a sustained virological response after receiving DAAs (n = 204/1,024 - 20%). The majority of patients had not received DAAs (n = 816/1,024 patients - 80%). Multiple factors resulted in hepatitis C viral infection (HCV) patients not receiving DAAs including the following primary factors: (a) lost to follow-up clinic visits and poor adherence to clinic appointments (n = 548 [67%]; p value <0.0001), (b) active substance abuse (alcoholism and IV drug abuse; n = 165 [20%]; p value 0.22), (c) patients with significant psychiatric illness (n = 103 [12.7%]; p value 0.015), and subgroup analysis revealed that 188 (188/1,024 - 12%) patients had human immunodeficiency virus-1 (HIV-1) and HCV coinfection. Majority of HCV/HIV coinfected patients had not received DAAs (n = 176 [97%]; p value <0.0001, OR 4.46). The etiology of nontreatment in coinfected HIV/HCV patients was 73.3% poor adherence, 11.5% active substance abuse including alcohol and IV drug use, and 9% significant psychiatric illness and 6.2% multiple reasons for not receiving HCV treatment. CONCLUSION: Multifactorial barriers are preventing hepatitis C patients from receiving effective DAA therapy. Primary factors include poor compliance, substance abuse, and significant psychiatric illness, with significant overlap between these groups. Subgroup analysis showed a substantial number of high-risk patients with HIV/HCV coinfection did not receive DAA therapy. A multidisciplinary clinic approach with a hepatologist, ID physicians, social worker, and behavioral health psychologist and case manager should provide a solution to improve diagnosis and treatment with DAA.

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.

Assessment of the Prevalence of Non-Organ-Specific Autoantibodies in Egyptian Patients with HCV.

The relation between non-organ specific autoantibodies (NOSA) and hepatitis C virus (HCV) infection has been investigated within different communities resulting in different prevalence rates and patterns. The purpose of this study was to investigate the prevalence of some NOSA such as RF-IgG, ANA, ASMA, and LKM-1 in Egyptian patients with HCV group as compared with Egyptian healthy controls group. A total of 186 HCV positive serum samples in addition to 81 samples from healthy control were screened for the presence of some common autoantibodies (RF-IgG, ANA, ASMA, and LKM-1) using ELISA technique for ANA, ASMA, and LK-1 while RF-IgG was assayed by latex agglutination technique. The presence of these autoantibodies was tested in relation to some demographic variables and viral titers. Associations were assessed using logistic regression analysis adjusted for potential confounders. Among patients, 100 (53.7%) of 186 and 6 (7.4%) of 81 healthy control group were positive for at least one autoantibody. Furthermore, 2 patients (1%) were positive for three autoantibodies, whereas 22 patients (11.7%) were positive for 2 autoantibodies. The most prevalent autoantibody in anti-HCV-positive group was RF-IgG (87, 46.7%) followed by ASMA (26, 14%). The frequency of autoantibodies was bit higher in women as compared to men. Taken together, this study reports a non-significant difference in prevalence of NOSA between patients with HCV infection and healthy individuals except for ASMA. Likewise, no significant difference was found in prevalence of such autoantibodies when correlated with some demographic variables.

HCV and HBV prevalence based on home blood self-sampling and screening history in the general population in 2016: contribution to the new French screening strategy.

BACKGROUND: The advent of effective direct-acting antivirals (DAAs), has prompted an assessment of the French Hepatitis C virus (HCV) screening strategy, which historically targeted high-risk groups. One of the options put forward is the implementation of combined (i.e., simultaneous) HCV, Hepatitis B virus (HBV) and HIV screening for all adults at least once during their lifetime ("universal combined screening"). However, recent national survey-based data are lacking to guide decision-making regarding which new strategy to implement. Accordingly, we aimed to provide updated data for both chronic hepatitis C (CHC) and B (CHB) prevalence and for HCV and HBV screening history, using data from the BaroTest and 2016 Health Barometer (2016-HB) studies, respectively. METHODS: 2016-HB was a national cross-sectional phone based health survey conducted in 2016 among 20,032 randomly selected individuals from the general population in mainland France. BaroTest was a virological sub-study nested in 2016-HB. Data collected for BaroTest were based on home blood self-sampling on dried blood spots (DBS). RESULTS: From 6945 analyzed DBS, chronic hepatitis C (CHC) and B (CHB) prevalence was estimated at 0.30% (95% Confidence Interval (CI): 0.13-0.70) and 0.30% (95% CI: 0.13-0.70), respectively. The proportion of individuals aware of their status was estimated at 80.6% (95% CI: 44.2-95.6) for CHC and 17.5% (95% CI: 4.9-46.4) for CHB. Universal combined screening would involve testing between 32.6 and 85.3% of 15-75 year olds according to whether we consider only individuals not previously tested for any of the three viruses, or also those already tested for one or two of the viruses. CONCLUSIONS: Our data are essential to guide decision-making regarding which new HCV screening recommendation to implement in France. They also highlight that efforts are still needed to achieve the WHO's targets for eliminating these diseases. Home blood self-sampling may prove to be a useful tool for screening and epidemiological studies.

The case for a universal hepatitis C vaccine to achieve hepatitis C elimination.

BACKGROUND: The introduction of highly effective direct-acting antiviral (DAA) therapy for hepatitis C has led to calls to eliminate it as a public health threat through treatment-as-prevention. Recent studies suggest it is possible to develop a vaccine to prevent hepatitis C. Using a mathematical model, we examined the potential impact of a hepatitis C vaccine on the feasibility and cost of achieving the global WHO elimination target of an 80% reduction in incidence by 2030 in the era of DAA treatment. METHODS: The model was calibrated to 167 countries and included two population groups (people who inject drugs (PWID) and the general community), features of the care cascade, and the coverage of health systems to deliver services. Projections were made for 2018-2030. RESULTS: The optimal incidence reduction strategy was to implement test and treat programmes among PWID, and in settings with high levels of community transmission undertake screening and treatment of the general population. With a vaccine available, the optimal strategy was to include vaccination within test and treat programmes, in addition to vaccinating adolescents in settings with high levels of community transmission. Of the 167 countries modelled, between 0 and 48 could achieve an 80% reduction in incidence without a vaccine. This increased to 15-113 countries if a 75% efficacious vaccine with a 10-year duration of protection were available. If a vaccination course cost US$200, vaccine use reduced the cost of elimination for 66 countries (40%) by an aggregate of US$7.4 (US$6.6-8.2) billion. For a US$50 per course vaccine, this increased to a US$9.8 (US$8.7-10.8) billion cost reduction across 78 countries (47%). CONCLUSIONS: These findings strongly support the case for hepatitis C vaccine development as an urgent public health need, to ensure hepatitis C elimination is achievable and at substantially reduced costs for a majority of countries.

Modeling indicates efficient vaccine-based interventions for the elimination of hepatitis C virus among persons who inject drugs in metropolitan Chicago.

BACKGROUND AND AIMS: Persons who inject drugs (PWID) are at highest risk for acquiring and transmitting hepatitis C (HCV) infection. The recent availability of oral direct-acting antiviral (DAA) therapy with reported cure rates >90% can prevent HCV transmission, making HCV elimination an attainable goal among PWID. The World Health Organization (WHO) recently proposed a 90% reduction in HCV incidence as a key objective. However, given barriers to the use of DAAs in PWID, including cost, restricted access to DAAs, and risk of reinfection, combination strategies including the availability of effective vaccines are needed to eradicate HCV as a public health threat. This study aims to model the cost and efficacy of a dual modality approach using HCV vaccines combined with DAAs to reduce HCV incidence by 90% and prevalence by 50% in PWID populations. METHODS: We developed a mathematical model that represents the HCV epidemic among PWID and calibrated it to empirical data from metropolitan Chicago, Illinois. Four medical interventions were considered: vaccination of HCV naive PWID, DAA treatment, DAA treatment followed by vaccination, and, a combination of vaccination and DAA treatment. RESULTS: The combination of vaccination and DAAs is the lowest cost-expensive intervention for achieving the WHO target of 90% incidence reduction. The use of DAAs without a vaccine is much less cost-effective with the additional risk of reinfection after treatment. Vaccination of naïve PWID alone, even when scaled-up to all reachable PWID, cannot achieve 90% reduction of incidence in high-prevalence populations due to infections occurring before vaccination. Similarly, the lowest cost-expensive way to halve prevalence in 15 years is through the combination of vaccination and DAAs. CONCLUSIONS: The modeling results underscore the importance of developing an effective HCV vaccine and augmenting DAAs with vaccines in HCV intervention strategies in order to achieve efficient reductions in incidence and prevalence.

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.

Drug Misuse and Hepatitis C Virus Infection Profiles for Three Generations of Patients Being Monitored for Prescription Drug Adherence.

OBJECTIVES: Two epidemics in the United States are related: opioid drug injection and hepatitis C virus (HCV) infection. This study quantifies the relationship between illicit/prescription drug misuse and HCV infection in 3 population generations: baby boomers (born 1945-1965, inclusive), pre-baby boomers, and post-baby boomers. METHODS: This retrospective study included prescription drug consistency (March-December 2015) and HCV (2011-2015) patient test results performed at a large national clinical reference laboratory. HCV positivity, drug use consistency/inconsistency with prescribed drug information, type of inconsistent use, and inconsistent use of individual drug classes were assessed. RESULTS: This study evaluated 39,231 prescription drug monitoring and HCV sets of test results from 18,410 patients. Of these patients, 25.1% tested positive for HCV and 57.3% demonstrated drug test results that were inconsistent with the prescribed medication(s). The types of drug test inconsistency differed substantially between HCV-positive and -negative patients, particularly testing positive for both non-prescribed drugs and prescribed drugs. Specimens from HCV-positive baby boomer and post-baby boomers demonstrated non-prescribed use of opioids and many other drug classes more often than from HCV-negative patients. CONCLUSIONS: The rates of inconsistent drug test results and types of drugs misused suggest that HCV-positive patients are more likely than HCV-negative patients to display high-risk behavior, even beyond opioid use. This difference is most pronounced in the post-baby boomer generation. Healthcare professionals should consider these patterns and how they differ by generation when monitoring for both prescription and illicit drugs, the results of which can impact treatment decisions including prescribing analgesics.

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.

Integrated Hepatitis C Testing and Linkage to Care at a Local Health Department Sexually Transmitted Disease Clinic: Determining Essential Resources and Evaluating Outcomes.

Guidance about integration of comprehensive hepatitis C virus (HCV)-related services in sexually transmitted disease (STD) clinics is limited. We evaluated a federally funded HCV testing and linkage-to-care program at an STD clinic in Durham County, North Carolina. During December 10, 2012, to March 31, 2015, the program tested 733 patients for HCV who reported 1 or more HCV risk factor; 81 (11%) were HCV-infected (ie, HCV antibody-positive and HCV ribonucleic acid-positive). Fifty-one infected patients (63%) were linked to care. We concluded that essential program resources include reflex HCV ribonucleic acid testing; a dedicated bridge counselor to provide test results, health education, and linkage-to-care assistance; and referral relationships for local HCV management and treatment.