Periodontal Disease and Risk of Dementia in Medicare Patients with Hepatitis C Virus.

BACKGROUND: Periodontal disease and hepatitis C virus (HCV) represent chronic infectious states that are common in elderly adults. Both conditions have independently been associated with an increased risk for dementia. Chronic infections are thought to lead to neurodegenerative changes in the central nervous system possibly by promoting a proinflammatory state. This is consistent with growing literature on the etiological role of infections in dementia. Few studies have previously evaluated the association of periodontal disease with dementia in HCV patients. OBJECTIVE: To examine whether periodontal disease increases the risk of developing Alzheimer's disease and related dementias (ADRD) among HCV patients in Medicare claims data. METHODS: We used Medicare claims data for HCV patients to assess the incidence rate of ADRD with and without exposure to periodontal disease between 2014 and 2017. Cox multivariate regression was used to estimate the association between periodontal disease and development of ADRD, controlling for age, gender, race, ZIP-level income and education, and medical comorbidities. RESULTS: Of 439,760 HCV patients, the incidence rate of ADRD was higher in patients with periodontal diseases compared to those without (10.84% versus 9.26%, p < 0.001), and those with periodontal disease developed ADRD earlier compared to those without periodontal disease (13.99 versus 21.60 months, p < 0.001). The hazard of developing ADRD was 1.35 times higher in those with periodontal disease (95% CI, 1.30 to 1.40, p < 0.001) after adjusting for all covariates, including age. CONCLUSION: Periodontal disease increased the risk of developing ADRD among HCV patients in a national Medicare claims dataset.

Routine screening for hepatitis C in pregnancy is cost-effective in a large urban population in Ireland: a retrospective study.

OBJECTIVE: To investigate whether risk factor-based screening in pregnancy is failing to identify women with hepatitis C virus (HCV) infection and to assess the cost-effectiveness of universal screening. DESIGN: Retrospective study and model-based economic evaluation. SETTING: Two urban tertiary referral maternity units, currently using risk factor-based screening for HCV infection. POPULATION: Pregnant women who had been tested for hepatitis B, HIV but not HCV. METHODS: Anonymised sera were tested for HCV antibody. Positive sera were tested for HCV antigen. A cost-effectiveness analysis of a change to universal screening was performed using a Markov model to simulate disease progression and Monte Carlo simulations for probabilistic sensitivity analysis. MAIN OUTCOME MEASURES: Presence of HCV antigen and cost per quality-adjusted life year (QALY). RESULTS: In all, 4655 samples were analysed. Twenty had HCV antibodies and five HCV antigen. This gives an active infection rate of 5/4655, or 0.11%, compared with a rate of 0.15% in the risk-factor group. This prevalence is 65% lower than a previous study in the same hospitals from 2001 to 2005. The calculated incremental cost-effectiveness ratio (ICER) for universal screening was €3,315 per QALY gained. CONCLUSION: This study showed that the prevalence of HCV infection in pregnant women in the Dublin region has declined by 65% over the past two decades. Risk factor-based screening misses a significant proportion of infections. A change to universal maternal screening for hepatitis C would be cost-effective in our population. TWEETABLE ABSTRACT: Universal maternal screening for hepatitis C is cost-effective in this urban Irish population.

Assessing cost-effectiveness of hepatitis C testing pathways in Georgia using the Hep C Testing Calculator.

The cost of testing can be a substantial contributor to hepatitis C virus (HCV) elimination program costs in many low- and middle-income countries such as Georgia, resulting in the need for innovative and cost-effective strategies for testing. Our objective was to investigate the most cost-effective testing pathways for scaling-up HCV testing in Georgia. We developed a Markov-based model with a lifetime horizon that simulates the natural history of HCV, and the cost of detection and treatment of HCV. We then created an interactive online tool that uses results from the Markov-based model to evaluate the cost-effectiveness of different HCV testing pathways. We compared the current standard-of-care (SoC) testing pathway and four innovative testing pathways for Georgia. The SoC testing was cost-saving compared to no testing, but all four new HCV testing pathways further increased QALYs and decreased costs. The pathway with the highest patient follow-up, due to on-site testing, resulted in the highest discounted QALYs (123 QALY more than the SoC) and lowest costs ($127,052 less than the SoC) per 10,000 persons screened. The current testing algorithm in Georgia can be replaced with a new pathway that is more effective while being cost-saving.

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.

The role of a two-assay serological testing strategy for anti-HCV screening in low-prevalence populations.

HCV screening depends mainly on a one-assay anti-HCV testing strategy that is subject to an increased false-positive rate in low-prevalence populations. In this study, a two-assay anti-HCV testing strategy was applied to screen HCV infection in two groups, labelled group one (76,442 people) and group two (18,415 people), using Elecsys electrochemiluminescence (ECL) and an Architect chemiluminescent microparticle immunoassay (CMIA), respectively. Each anti-HCV-reactive serum was retested with the other assay. A recombinant immunoblot assay (RIBA) and HCV RNA testing were performed to confirm anti-HCV positivity or active HCV infection. In group one, 516 specimens were reactive in the ECL screening, of which CMIA retesting showed that 363 (70.3%) were anti-HCV reactive (327 positive, 30 indeterminate, 6 negative by RIBA; 191 HCV RNA positive), but 153 (29.7%) were not anti-HCV reactive (4 positive, 29 indeterminate, 120 negative by RIBA; none HCV RNA positive). The two-assay strategy significantly improved the positive predictive value (PPV, 64.1% & 90.1%, P < 0.05). In group two, 87 serum specimens were reactive according to CMIA screening. ECL showed that 56 (70.3%) were anti-HCV reactive (47 positive, 8 indeterminate, 1 negative by RIBA; 29 HCV RNA positive) and 31 (29.7%) were anti-HCV non-reactive (25 negative, 5 indeterminate, 1 positive by RIBA; none HCV RNA positive). Again, the PPV was significantly increased (55.2% & 83.9%, P < 0.05). Compared with a one-assay testing strategy, the two-assay testing strategy may significantly reduce false positives in anti-HCV testing and identify inactive HCV infection in low-seroprevalence populations.

Cost-effectiveness of a "treat-all" strategy using Direct-Acting Antivirals (DAAs) for Japanese patients with chronic hepatitis C genotype 1 at different fibrosis stages.

AIM: To evaluate the cost-effectiveness of therapeutic strategies initiated at different stages of liver fibrosis using three direct-acting antivirals (DAAs), sofosbuvir-ledipasvir (SL), glecaprevir-pibrentasvir (GP), and elbasvir plus grazoprevir (E/G), for Japanese patients with chronic hepatitis C (CHC) genotype 1. METHODS: We created an analytical decision model reflecting the progression of liver fibrosis stages to evaluate the cost-effectiveness of alternative therapeutic strategies applied at different fibrosis stages. We compared six treatment strategies: treating all patients regardless of fibrosis stage (TA), treating individual patients with one of four treatments starting at four respective stages of liver fibrosis progression (F1S: withholding treatment at stage F0 and starting treatment from stage F1 or higher, and three successive options, F2S, F3S, and F4S), and administering no antiviral treatment (NoRx). We adopted a lifetime horizon and Japanese health insurance payers' perspective. RESULTS: The base case analysis showed that the incremental quality-adjusted life years (QALY) gain of TA by SL, GP, and E/G compared with the strategies of starting treatments for patients with the advanced fibrosis stage, F2S, varied from 0.32 to 0.33, and the incremental cost-effectiveness ratios (ICERs) were US$24,320, US$18,160 and US$17,410 per QALY, respectively. On the cost-effectiveness acceptability curve, TA was most likely to be cost-effective, with the three DAAs at the willingness to pay thresholds of US$50,000. CONCLUSIONS: Our results suggested that administration of DAA treatment for all Japanese patients with genotype 1 CHC regardless of their liver fibrosis stage would be cost-effective under ordinary conditions.

Initiation of hepatitis C treatment in two rural Rwandan districts: a mobile clinic approach.

BACKGROUND: To eliminate hepatitis C, Rwanda is conducting national mass screenings and providing to people with chronic hepatitis C free access to Direct Acting Antivirals (DAAs). Until 2020, prescribers trained and authorized to initiate DAA treatment were based at district hospitals, and access to DAAs remains expensive and geographically difficult for rural patients. We implemented a mobile clinic to provide DAA treatment initiation at primary-level health facilities among people with chronic hepatitis C identified through mass screening campaigns in rural Kirehe and Kayonza districts. METHODS: The mobile clinic team was composed of one clinician authorized to manage hepatitis, one lab technician, and one driver. Eligible patients received same-day clinical consultations, counselling, laboratory tests and DAA initiation. Using clinical databases, registers, and program records, we compared the number of patients who initiated DAA treatment before and during the mobile clinic campaign. We assessed linkage to care during the mobile clinical campaign and assessed predictors of linkage to care. We also estimated the cost per patient of providing mobile services and the reduction in out-of-pocket costs associated with accessing DAA treatment through the mobile clinic rather than the standard of care. RESULTS: Prior to the mobile clinic, only 408 patients in Kirehe and Kayonza had been initiated on DAAs over a 25-month period. Between November 2019 and January 2020, out of 661 eligible patients with hepatitis C, 429 (64.9%) were linked to care through the mobile clinic. Having a telephone number and complete address recorded at screening were strongly associated with linkage to care. The cost per patient of the mobile clinic program was 29.36 USD, excluding government-provided DAAs. Providing patients with same-day laboratory tests and clinical consultation at primary-level health facilities reduced out-of-pocket expenses by 9.88 USD. CONCLUSION: The mobile clinic was a feasible strategy for providing rapid treatment initiation among people chronically infected by hepatitis C, identified through a mass screening campaign. Compared to the standard of care, mobile clinics reached more patients in a much shorter time. This low-cost strategy also reduced out-of-pocket expenditures among patients. However, long-term, sustainable care would require decentralization to the primary health-centre level.

Hepatitis C Rapid Point-of-Care Testing and Laboratory-based Non-invasive Assessment of Liver Fibrosis among Drug Abusers: An Experience from Iran.

BACKGROUND: People who use drugs, particularly injection drug users (IDUs) are known as the major source of hepatitis C virus (HCV) infection. This study was performed to determine the prevalence of HCV infection using rapid point-of-care testing and to assess liver fibrosis by non-invasive lab tests among addict populations of Mashhad, Iran. METHODS: In this cross-sectional study, drug users who referred to drug treatment and harm reduction centers of Mashhad were enrolled during March and December 2019. A rapid test kit was used to assess the presence of anti-HCV antibodies and a real-time PCR was performed to confirm the infection. The AST-platelet ratio index (APRI) and fibrosis-4 (FIB-4) score were used to investigate liver fibrosis in patients with positive HCV RNA. A P value <0.05 was considered as significant. RESULTS: A total of 390 drug users aged 15-74 years were assessed. Sixty-four individuals showed positive results for anti-HCV (16.4%), of whom 58 blood samples were available for PCR test. The viremic rate among the latter group was calculated at 84.5% (49/58); the total viremia prevalence was 12.8% (49/384). Multivariate analysis revealed that being single (P = 0.040) or divorced/ widow (P = 0.011) and history of drug injection (P<0.001) and tattoos (P = 0.021) were significantly associated with current HCV infection. Using APRI and FIB-4 indices, significant liver fibrosis was identified in 14.3% and 18.4% of cases, respectively. CONCLUSION: HCV infection screening using rapid tests and examining liver fibrosis by non-invasive lab tests appear to be practicable and useful among poor populations in settings such as drug treatment centers.

Decentralisation, integration, and task-shifting in hepatitis C virus infection testing and treatment: a global systematic review and meta-analysis.

BACKGROUND: Increasing access to hepatitis C virus (HCV) care and treatment will require simplified service delivery models. We aimed to evaluate the effects of decentralisation and integration of testing, care, and treatment with harm-reduction and other services, and task-shifting to non-specialists on outcomes across the HCV care continuum. METHODS: For this systematic review and meta-analysis, we searched PubMed, Embase, WHO Global Index Medicus, and conference abstracts for studies published between Jan 1, 2008, and Feb 20, 2018, that evaluated uptake of HCV testing, linkage to care, treatment, cure assessment, and sustained virological response at 12 weeks (SVR12) in people who inject drugs, people in prisons, people living with HIV, and the general population. Randomised controlled trials, non-randomised studies, and observational studies were eligible for inclusion. Studies with a sample size of ten or less for the largest denominator were excluded. Studies were categorised according to the level of decentralisation: full (testing and treatment at same site), partial (testing at decentralised site and referral elsewhere for treatment), or none. Task-shifting was categorised as treatment by specialists or non-specialists. Data on outcomes across the HCV care continuum (linkage to care, treatment uptake, and SVR12) were pooled using random-effects meta-analysis. FINDINGS: Our search identified 8050 reports, of which 132 met the eligibility criteria, and an additional ten reports were identified from reference citations and grey literature. Therefore, the final synthesis included 142 studies from 34 countries (20 [14%] studies from low-income and middle-income countries) and a total of 489 996 patients (239 446 [49%] from low-income and middle-income countries). Rates of linkage to care were higher with full decentralisation compared with partial or no decentralisation among people who inject drugs (full 72% [95% CI 57-85] vs partial 53% [38-67] vs none 47% [11-84]) and among people in prisons (full 94% [79-100] vs partial 50% [29-71]), although the CIs overlap for people who inject drugs. Similarly, treatment uptake was higher with full decentralisation compared with partial or no decentralisation (people who inject drugs: full 73% [65-80] vs partial 66% [55-77] vs none 35% [23-48]; people in prisons: full 72% [48-91] vs partial 39% [17-63]), although CIs overlap for full versus partial decentralisation. The results in the general population studies were more heterogeneous. SVR12 rates were high (≥90%) across different levels of decentralisation in all populations. Task-shifting of care and treatment to a non-specialist was associated with similar SVR12 rates to treatment delivered by specialists. There was a severe or critical risk of bias for 46% of studies, and heterogeneity across studies tended to be very high (I2>90%). INTERPRETATION: Decentralisation and integration of HCV care to harm-reduction sites or primary care showed some evidence of improved access to testing, linkage to care, and treatment, and task-shifting of care and treatment to non-specialists was associated with similarly high cure rates to care delivered by specialists, across a range of populations and settings. These findings provide support for the adoption of decentralisation and task-shifting to non-specialists in national HCV programmes. FUNDING: Unitaid.

Global prevalence of hepatitis C virus in women of childbearing age in 2019: a modelling study.

BACKGROUND: Treatment for infection with hepatitis C virus (HCV) during pregnancy has not yet been approved; however, interventions specifically targeting women, especially those of childbearing age (15-49 years), could prevent vertical transmission and community spread. To assess the impact of such interventions, improved prevalence estimates in this group are needed. We aimed to estimate the global prevalence of viraemic HCV in 2019 among women of childbearing age. METHODS: In this modelling study, we used previously developed models for 110 countries inputted with country-specific demographic and HCV epidemiology data. We did a literature review, searching PubMed, Embase, and grey literature for studies published between Jan 1, 2000, and June 30, 2018, reporting HCV antibody or viraemic prevalence in women of childbearing age. Studies from the literature review and studies in models were compared by use of a data quality scoring system and models were updated, as appropriate, when a better study was identified. We used these HCV disease burden models to calculate the 2019 prevalence of viraemic HCV in women of childbearing age. In countries without a model, prevalence was extrapolated by Global Burden of Disease (GBD) region. FINDINGS: An estimated 14 860 000 (95% uncertainty interval [UI] 9 667 000-18 282 000) women aged 15-49 years had HCV infection worldwide in 2019, corresponding to a viraemic prevalence of 0·78% (95% UI 0·62-0·86). Globally, HCV prevalence increased with age, rising from 0·25% (95% UI 0·20-0·27) in women aged 15-19 years to 1·21% (0·97-1·34) in women aged 45-49 years. China (16% of total infections) and Pakistan (15%) had the greatest numbers of viraemic infections, but viraemic prevalence was highest in Mongolia (5·14%, 95% CI 3·46-6·28) and Burundi (4·91%, 3·80-18·75). Of the countries with 500 cases or more, viraemic prevalence was lowest in Chile (0·07%, 95% UI 0·04-0·12). Among the GBD regions, eastern Europe had the highest viraemic prevalence (3·39%, 95% UI 1·88-3·54). By WHO region, the Eastern Mediterranean region had the highest viraemic prevalence (1·75%, 95% UI 1·26- 1·90). INTERPRETATION: Most research on HCV disease burden among women aged 15-49 years focuses on pregnant women. Using modelling, this analysis provides global and national estimates of HCV prevalence in all women of childbearing age. These data can inform preconception test-and-treat strategies to reduce vertical transmission and total disease burden. FUNDING: Gilead Sciences, John C Martin Foundation, private donors.

The challenges of administering a new treatment: the case of direct-acting antivirals for hepatitis C virus.

OBJECTIVES: We develop a patient prioritization scheme for treating patients infected with hepatitis C virus (HCV) and study under which scenarios it outperforms the current practices in Spain and Chile. STUDY DESIGN: We use simulation to evaluate the performance of prioritization rules under two HCV patient cohorts, constructed using secondary data of public records from Chile and Spain, during 2015-2016. METHODS: We use the results of a mathematical model, which determines individual optimal HCV treatment policies as an input for constructing a patient prioritization rule, when limited resources are present. The prioritization is based on marginal analysis on cost increases and health-outcome gains. We construct the Chilean and Spanish case studies and used Monte Carlo simulation to evaluate the performance of our methodology in these two scenarios. RESULTS: The resulting prioritizations for the Chilean and Spanish patients are similar, despite the significant differences of both countries, in terms of epidemiological profiles and cost structures. Furthermore, when resources are scarce compared with the number of patients in need of the new drug, our prioritization significantly outperforms current practices of treating sicker patients first, both in terms of cost and healthcare indicators: for the Chilean case, we have an increase in the quality-adjusted life years (QALYs) of 0.83 with a cost reduction of 8176 euros per patient, with a budget covering 2.5% of the patients in the cohort. This difference slowly decreases when increasing the available resources, converging to the performance indicators obtained when all patients are treated immediately: for the Spanish case, we have a decrease in the QALYs of 0.17 with a cost reduction of 1134 euros per patient, with a budget covering 20% of the patients in the cohort. CONCLUSION: Decision science can provide useful analytical tools for designing efficient public policies that can excel in terms of quantitative health performance indicators.

Applicability of a new specialty pharmacy-reported measure describing completion of therapy for hepatitis C.

BACKGROUND: In 2019, the Utilization Review Accreditation Commission (URAC) required a new reporting measure for specialty pharmacies related to completion of therapy for hepatitis C virus (HCV). OBJECTIVE: To calculate HCV completion of therapy according to URAC criteria and compare it with a calculation with additional pharmacy proposed adjustments to assess its applicability. METHODS: This was an observational study of patients who received HCV treatment with a direct-acting antiviral (DAA) from 1 specialty pharmacy. All patients with prescription claims at a pharmacy who had a first fill for a DAA medication between the 2 measurement periods of January 1, 2018-December 31, 2018, and January 1, 2019-December 31, 2019, were included. Additional information was collected via a retrospective chart review and from the pharmacy's electronic medication system. The cumulative gap according to URAC was calculated from claims data by summing the number of days between the last days supply of 1 claim for the prescribed DAA and the subsequent claims. The pharmacy-proposed cumulative gap was calculated using additional information from patient chart notes in order to account for a true start date. RESULTS: A total of 1,485 patients were identified as having a first fill of a DAA between the 2 measurement periods. The HCV completion of therapy measure calculated per the URAC definition was 83.4% in 2018 and 86.5% in 2019. The only variable significantly associated with a > 15-day gap according to the URAC definition was if the first DAA order was delivered to the prescriber's office instead of the patient's home for 2018 (χ2 [1, N = 573] = 16.8, P < 0.001) and 2019 (χ2 [1, N = 836] = 12.6, P < 0.001). Using the pharmacy-proposed adjustment, the modified HCV completion rates for 2018 and 2019 were 88.9% and 89.9%, respectively. CONCLUSIONS: The accrediting body's definition of completion of therapy may report a falsely high rate of gaps in HCV therapy due to not accounting for the actual DAA start date. This information may prove beneficial for the accrediting body, as it reviews its initial definition of the HCV completion of therapy measure. DISCLOSURES: No outside funding supported this study. Levesque reports participation in AbbVie's speaker's bureau with regard to its immunology portfolio. The other authors have no possible financial or personal relationships with commercial entities to disclose that may have a direct or indirect interest in the matter of this study.

Rapid visual detection of hepatitis C virus using a reverse transcription loop-mediated isothermal amplification assay.

OBJECTIVES: The aim was to develop a reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay for the detection of hepatitis C virus (HCV) in a single closed tube. METHODS: Plasma samples were collected from 200 HCV-infected patients. HCV-RNA was detected by one-step RT-LAMP processed at 65 °C for 60 min. The amplified products were detected by hydroxynaphthol blue (HNB)-dependent visual method and gel electrophoresis. Specificity was tested against other viruses. Sensitivity was determined using serial dilutions of extracted RNA. RESULTS: The RT-LAMP assay detected 97.5% of HCV-RNA genotype 1, 91.1% of genotype 3, and 100% of genotype 6. The color change was evidenced with the naked eye. The assay demonstrated a clinical sensitivity of 95.5% and specificity of 100%, as well as no cross-reactivity with other viruses (i.e., hepatitis B virus, HIV). The limit of detection was as low as 10 ng per reaction for HCV genotypes 1a and 6, while it was 100 ng for genotype 3a. The assay showed a 100% detection threshold at a viral load of 5.00 log10 IU/mL in the clinical samples tested. CONCLUSIONS: This study demonstrated the use of an RT-LAMP assay for the detection of HCV in a simple, rapid, and cost-effective manner, which will be useful in resource-limited settings to allow the identification of individuals in need of HCV treatment.

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.

Cost-effectiveness of Universal and Targeted Hepatitis C Virus Screening in the United States.

Importance: Between 2 and 3.5 million people live with chronic hepatitis C virus (HCV) infection in the US, most of whom (approximately 75%) are not aware of their disease. Despite the availability of effective HCV treatment in the early stages of infection, HCV will result in thousands of deaths in the next decade in the US. Objective: To investigate the cost-effectiveness of universal screening for all US adults aged 18 years or older for HCV in the US and of targeted screening of people who inject drugs. Design, Setting, and Participants: This simulated economic evaluation used cohort analyses in a Markov model to perform a 10 000-participant Monte Carlo microsimulation trail to evaluate the cost-effectiveness of HCV screening programs, and compared screening programs targeting people who inject drugs with universal screening of US adults age 18 years or older. Data were analyzed in December 2019. Exposures: Cost per quality-adjusted life-year (QALY). Main Outcomes and Measures: Cost per QALY gained. Results: In a 10 000 Monte Carlo microsimulation trail that compared a baseline of individuals aged 40 years (men and women) and people who inject drugs in the US, screening and treatment for HCV were estimated to increase total costs by $10 457 per person and increase QALYs by 0.23 (approximately 3 months), providing an incremental cost-effectiveness ratio of $45 465 per QALY. Also, universal screening and treatment for HCV are estimated to increase total costs by $2845 per person and increase QALYs by 0.01, providing an incremental cost-effectiveness ratio of $291 277 per QALY. Conclusions and Relevance: The findings of this study suggest that HCV screening for people who inject drugs may be a cost-effective intervention to combat HCV infection in the US, which could potentially decrease the risk of untreated HCV infection and liver-related mortality.

Hepatitis C Virus (HCV) Care Continuum Outcomes and HCV Community Viral Loads Among Patients in an Opioid Treatment Program.

BACKGROUND: Hepatitis C virus (HCV) remains endemic among people who use drugs (PWUD). Measures of HCV community viral load (CVL) and HCV care continuum outcomes may be valuable for ascertaining unmet treatment need and for HCV surveillance and control. METHODS: Data from patients in an opioid treatment program during 2013-2016 were used to (1) identify proportions of antibody and viral load (VL) tested, linked-to-care, and treated, in 2013-2014 and 2015-2016, and pre- and postimplementation of qualitative reflex VL testing; (2) calculate engaged-in-care HCV CVL and "documented" and "estimated" unmet treatment need; and (3) examine factors associated with linkage-to-HCV-care. RESULTS: Among 11 267 patients, proportions of HCV antibody tested (52.5% in 2013-2014 vs 73.3% in 2015-2016), linked-to-HCV-care (15.7% vs 51.8%), and treated (12.0% vs 44.7%) all increased significantly. Hispanic ethnicity was associated with less linkage-to-care, and Manhattan residence was associated with improved linkage-to-care. The overall engaged-in-care HCV CVL was 4 351 079 copies/mL (standard deviation = 7 149 888); local HCV CVLs varied by subgroup and geography. Documented and estimated unmet treatment need decreased but remained high. CONCLUSIONS: After qualitative reflex VL testing was implemented, care continuum outcomes improved, but gaps remained. High rates of unmet treatment need suggest that control of the HCV epidemic among PWUD will require expansion of HCV treatment coverage.

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.

The Hep-CORE policy score: A European hepatitis C national policy implementation ranking based on patient organization data.

BACKGROUND: New hepatitis C virus (HCV) treatments spurred the World Health Organization (WHO) in 2016 to adopt a strategy to eliminate HCV as a public health threat by 2030. To achieve this, key policies must be implemented. In the absence of monitoring mechanisms, this study aims to assess the extent of policy implementation from the perspective of liver patient groups. METHODS: Thirty liver patient organisations, each representing a country, were surveyed in October 2018 to assess implementation of HCV policies in practice. Respondents received two sets of questions based on: 1) WHO recommendations; and 2) validated data sources verifying an existing policy in their country. Academic experts selected key variables from each set for inclusion into policy scores. The similarity scores were calculated for each set with a multiple joint correspondence analysis. Proxy reference countries were included as the baseline to contextualize results. We extracted scores for each country and standardized them from 0 to 10 (best). RESULTS: Twenty-five countries responded. For the score based on WHO recommendations, Bulgaria had the lowest score whereas five countries (Cyprus, Netherlands, Portugal, Slovenia, and Sweden) had the highest scores. For the verified policy score, a two-dimensional solution was identified; first dimension scores pertained to whether verified policies were in place and second dimension scores pertained to the proportion of verified policies in-place that were implemented. Spain, UK, and Sweden had high scores for both dimensions. CONCLUSIONS: Patient groups reported that the European region is not on track to meet WHO 2030 HCV goals. More action should be taken to implement and monitor HCV policies.