Expanding Hepatitis C Virus Treatment in the New Mexico State Prison System: Using the ECHO Model for Provider and Prison Peer Education

Chan J., Akiyama M., Julian E., Joseph R., McGahee W., Rosner Z., Yang P., MacDonald R.

IntroductionThere is scant data on implementation of large scale direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) in jails in the United States. New York City (NYC) Health + Hospitals/Correctional Health Services (CHS) aimed to scale up HCV treatment in the NYC jail system. This study describes the trends in annual HCV treatment in NYC jails compared to Medicaid-funded treatment in the NYC community from 2014-2020.MethodsIn this observational study, we extracted annual counts of DAA prescriptions for HCV for those (1) in the NYC community who were covered by Medicaid, and (2) those detained in NYC jails for 2014-2020. Data sources were NYC Department of Health and Mental Hygiene (DOHMH) annual reports and CHS treatment records, respectively. We used linear regression analysis to test for significant trends in annual treatment in these two cohorts during 2015-2019.ResultsFrom 2015-2019, treatments started in NYC jails increased annually (p=0.001), while Medicaid-funded prescriptions in the NYC community declined since a peak in 2015 (p

Spaulding A.C., Kennedy S.S., Osei J., Sidibeh E., Batina I.V., Chhatwal J., Akiyama M.J., Strick L.B.

Abstract Background Prior studies demonstrate that eliminating hepatitis C virus (HCV) in the United States (US) heavily depends on treating incarcerated persons. Knowing the scope of the carceral HCV epidemic by state will help guide national elimination efforts. Methods Between 2019 and 2023, all state prison systems received surveys requesting data on hepatitis C antibody and viremic prevalence. We supplemented survey information with publicly available HCV data to corroborate responses and fill in data gaps. Results Weighting HCV prevalence by state prison population size, we estimate that 15.2% of the US prison population is HCV seropositive and 8.7% is viremic; 54.9% of seropositive persons have detectable RNA. Applying prevalence estimates to the total prison population at year-end 2021, 91 090 persons with HCV infection resided in a state prison. Conclusions With updated and more complete HCV data from all 50 states, HCV prevalence in state prisons is nearly 9-fold higher than the US general population. The heterogeneity in HCV prevalence by state prison system may reflect variable exposure before arrest and/or differences in treatment availability during incarceration. Elimination of HCV in the country depends on addressing the carceral epidemic, and one of the first steps is understanding the size of the problem.

Hajarizadeh B., Grebely J., Byrne M., Marks P., Amin J., McManus H., Butler T., Cunningham E.B., Vickerman P., Martin N.K., McHutchison J.G., Brainard D.M., Treloar C., Chambers G.M., Grant L., et. al.

SummaryBackground Limited empirical evidence exists for the effectiveness of hepatitis C virus (HCV) treatment-as-prevention. The Surveillance and Treatment of Prisoners with hepatitis C (SToP-C) study aimed to assess the effect of HCV treatment-as-prevention in the prison setting. Methods SToP-C was a prospective study, including a before-and-after analysis, within a cohort of people incarcerated in two maximum-security prisons (male) and two medium-security prisons (one male, one female) in New South Wales, Australia. All prison inmates aged at least 18 years were eligible for enrolment. After HCV testing, participants were monitored for risk behaviours and HCV infection, among three sub-populations: uninfected (HCV antibody-negative); previously infected (HCV antibody-positive, HCV RNA-negative); and infected (HCV antibody and HCV RNA-positive). Uninfected participants were followed up every 3–6 months to detect HCV primary infection and previously infected participants were followed up every 3–6 months to detect re-infection. Participants with HCV infection were assessed for treatment, initially standard-of-care treatment (administered by prison health services) from 2014 to mid-2017, then direct-acting antiviral (DAA) treatment scale-up from mid-2017 onwards (12 weeks of sofosbuvir plus velpatasvir, administered through SToP-C). Participants were followed up until study closure in November, 2019. The primary study outcome was HCV incidence before and after DAA treatment scale-up among participants at risk of HCV primary infection or re-infection. This study is registered with ClinicalTrials.gov, NCT02064049. Findings Between Oct 30, 2014, and Sept 30, 2019, 3691 participants were enrolled in the SToP-C study. 719 (19%) participants had detectable HCV RNA, 2240 (61%) were at risk of primary HCV infection, and 725 (20%) were at risk of re-infection at baseline. DAA treatment was initiated in 349 (70%) of 499 eligible participants during the treatment scale-up period. The HCV incidence analysis comprised 1643 participants at risk of HCV infection or re-infection during longitudinal follow-up (median age 33 years [IQR 27–42]; 1350 [82%] male). 487 (30%) of 1643 participants reported injecting drugs in prison. HCV incidence decreased from 8·31 per 100 person-years in the pre-treatment scale-up period to 4·35 per 100 person-years in the post-treatment scale-up period (incidence rate ratio [IRR] 0·52 [95% CI 0·36–0·78]; p=0·0007). The incidence of primary infection decreased from 6·64 per 100 person-years in the pre-treatment scale-up period to 2·85 per 100 person-years in the post-treatment scale-up period (IRR 0·43 [95% CI 0·25–0·74]; p=0·0019), whereas the incidence of re-infection decreased from 12·36 per 100 person-years to 7·27 per 100 person-years (0·59 [0·35–1·00]; p=0·050). Among participants reporting injecting drugs during their current imprisonment, the incidence of primary infection decreased from 39·08 per 100 person-years in the pre-treatment scale-up period to 14·03 per 100 person-years in the post-treatment scale-up period (IRR 0·36 [95% CI 0·16–0·80]; p=0·0091), and the incidence of re-infection decreased from 15·26 per 100 person-years to 9·34 per 100 person-years (0·61 [0·34–1·09]; p=0·093). The adjusted analysis (adjusted for age, Indigenous Australian ethnicity, duration of stay in prison, previous imprisonment, injecting drug use status, and prison site) indicated a significant reduction in the risk of HCV infection between the pre-DAA treatment scale-up and post-DAA treatment scale-up periods (adjusted hazard ratio 0·50 [95% CI 0·33–0·76]; p=0·0014). Interpretation DAA treatment scale-up was associated with reduced HCV incidence in prison, indicative of a beneficial effect of HCV treatment-as-prevention in this setting. These findings support broad DAA treatment scale-up within incarcerated populations. Funding Australian National Health and Medical Research Council Partnership Project Grant and Gilead Sciences.

Akiyama M.J., Kronfli N., Cabezas J., Sheehan Y., Thurairajah P.H., Lines R., Lloyd A.R.

Summary Hepatitis C virus (HCV) is a global public health problem in correctional settings. The International Network on Health and Hepatitis in Substance Users–Prisons Network is a special interest group committed to advancing scientific knowledge exchange and advocacy for HCV prevention and care in correctional settings. In this Review, we highlight seven priority areas and best practices for improving HCV care in correctional settings: changing political will, ensuring access to HCV diagnosis and testing, promoting optimal models of HCV care and treatment, improving surveillance and monitoring of the HCV care cascade, reducing stigma and tackling the social determinants of health inequalities, implementing HCV prevention and harm reduction programmes, and advancing prison-based research.

Godin A., Kronfli N., Cox J., Alary M., Maheu-Giroux M.

In Canada, hepatitis C virus (HCV) transmission primarily occurs among people who inject drugs (PWID) and people with experience in the prison system bare a disproportionate disease burden. These overlapping groups of individuals have been identified as priority populations for HCV micro-elimination in Canada, which is currently not on track to achieve its elimination targets. Considering the missed opportunities to intervene in provincial prisons, this study aims to estimate the population-level impact of prison-based interventions and post-release risk reduction strategies on HCV transmission among PWID in Montréal, a Canadian city with high HCV burden. A dynamic HCV transmission model among PWID was developed and calibrated to community and prison bio-behavioural surveys in Montréal. Then, the relative impact of prison-based testing and treatment or post-release linkage to care (both 90% testing and 75% treatment coverage), alone or in combination with strategies that reduce the heightened post-release transmission risk by 50%, was estimated from 2018 to 2030, and compared to counterfactual scenarios. Prison-based test-and-treat strategies could lead to the greatest declines in incidence (48%; 95%CrI: 38–57%) over 2018–2030 and prevent the most new first chronic infections (22%; 95%CrI: 16−28%) among people never exposed to HCV. Prison testing and post-release linkage to care lead to a slightly lower decrease in incidence and prevented fraction of new chronic infections. Combining test-and-treat with risk reduction measures could further its epidemiological impact, preventing 35% (95%CrI: 29−40%) of new first chronic infections. When implemented concomitantly with community-based treatment scale-up, prison-based interventions had synergistic effects, averting a higher fraction of new first chronic infections. Offering HCV testing and treatment in provincial prisons, where incarcerations are frequent and sentences short, could change the course of the HCV epidemic in Montréal. Prison-based interventions with potential integration of post-release risk reduction measures should be considered as an integral part of HCV micro-elimination strategies in this setting.

Janjua N.Z., Krajden M., Yoshida E.M., Adu P.A., Pearce M.E., Bartlett S.R., Jeong D., Darvishian M., Binka M., Alvarez M., Butt Z.A., Cook D., Ramji A., Yu A., Wong S., et. al.

Abstract Background Clinical trials show high efficacy of sofosbuvir/velpatasvir (SOF/VEL), but there are limited data from “real-world” settings. We aimed to evaluate SOF/VEL effectiveness for all hepatitis C virus (HCV) genotypes (GTs) in British Columbia (BC), Canada. Methods We used the BC Hepatitis Testers Cohort, which includes all HCV cases in the province (1990–2015) linked to administrative databases, including prescriptions to end of 2018. We measured sustained virologic response (SVR; negative RNA ≥10 weeks after treatment end) and identified characteristics associated with non-SVR. Conservatively, we excluded individuals with no assessment for SVR if their last RNA test after treatment initiation was negative (but included if positive). Results Of 2821 eligible participants, most were infected with GT1 (1076, 38.1%) or GT3 (1072, 38.0%), and a minority (278, 9.9%) were treated with RBV. SVR was 94.6% (2670/2821) overall and 94.5% (1017/1076) for GT1, 96.4% (512/531) for GT2, and 93.7% (1004/1072) for GT3. When disaggregated by GT, treatment regimen, and cirrhosis/treatment experience, SVR was lowest (30/40, 75.0%) among treatment-experienced GT3 individuals treated with RBV. Characteristics associated with non-SVR in multivariable analysis included younger age, RBV addition, and being a person with HIV (PWH) or who injects/injected drugs (PWID). When treatment regimen (±RBV) was removed from multivariable model, treatment experience was associated with non-SVR for GT3. Of 151 non-SVR individuals, 56.3% were nonvirological failures (treatment incomplete/no assessment for SVR) and 43.7% were virological failures (nonresponse/relapse). A disproportionately high percentage of non-SVR among PWID was due to nonvirological failure. Conclusions SOF/VEL was highly effective in this “real-world” population-based cohort. Additional support is required for PWID/PWH to reach SVR.

Zhang X., Lin D., Pforsich H., Lin V.W.

Physicians play a critical role in healthcare delivery. With an aging US population, population growth, and a greater insured population following the Affordable Care Act (ACA), healthcare demand is growing at an unprecedented pace. This study is to examine current and future physician job surplus/shortage trends across the United States of America from 2017 to 2030. Using projected changes in population size and age, the authors developed demand and supply models to forecast the physician shortage (difference between demand and supply) in each of the 50 states. Letter grades were then assigned based on projected physician shortage ratios (physician shortage per 100 000 people) to evaluate physician shortages and describe the changing physician workforce in each state. On the basis of current trends, the number of states receiving a grade of “D” or “F” for their physician shortage ratio will increase from 4 in 2017 to 23 by 2030, with a total national deficit of 139 160 physician jobs. By 2030, the West is forecasted to have the greatest physician shortage ratio (69 physician jobs per 100 000 people), while the Northeast will have a surplus of 50 jobs per 100 000 people. There will be physician workforce shortages throughout the country in 2030. Outcomes of this study provide a foundation to discuss effective and efficient ways to curb the worsening shortage over the coming decades and meet current and future population demands. Increased efforts to understand shortage dynamics are warranted.

Ghany M.G., Morgan T.R.

Bradley H., Hall E.W., Rosenthal E.M., Sullivan P.S., Ryerson A.B., Rosenberg E.S.

Hepatitis C virus (HCV) infection is a leading cause of liver-related morbidity and mortality, and more than 2 million adults in the United States are estimated to be currently infected. Reducing HCV burden will require an understanding of demographic disparities and targeted efforts to reduce prevalence in populations with disproportionate disease rates. We modeled state-level estimates of hepatitis C prevalence among U.S. adults by sex, birth cohort, and race during 2013-2016. National Health and Nutrition Examination Survey data were used in combination with state-level HCV-related and narcotic overdose-related mortality data from the National Vital Statistics System and estimates from external literature review on populations not sampled in the National Health and Nutrition Examination Survey. Nationally, estimated hepatitis C prevalence was 1.3% among males and 0.6% among females (prevalence ratio [PR] = 2.3). Among persons born during 1945 to 1969, prevalence was 1.6% compared with 0.5% among persons born after 1969 (PR = 3.2). Among persons born during 1945 to 1969, prevalence ranged from 0.7% in North Dakota to 3.6% in Oklahoma and 6.8% in the District of Columbia. Among persons born after 1969, prevalence was more than twice as high in Kentucky, New Mexico, Oklahoma, and West Virginia compared with the national average. Hepatitis C prevalence was 1.8% among non-Hispanic black persons and 0.8% among persons of other races (PR = 2.2), and the magnitude of this disparity varied widely across jurisdictions (PR range: 1.3-7.8). Overall, 23% of prevalent HCV infections occurred among non-Hispanic black persons, whereas 12% of the population was represented by this racial group. These estimates provide information on prevalent HCV infections that jurisdictions can use for understanding and monitoring local disease patterns and racial disparities in burden of disease.

Backus L.I., Belperio P.S., Shahoumian T.A., Loomis T.P., Mole L.A.

Real-world effectiveness data are needed to inform hepatitis C virus (HCV) treatment decisions. The uptake of ledipasvir/sofosbuvir (LDV/SOF) regimens across health care settings has been rapid, but variations often occur in clinical practice. The aim of this study was to assess sustained virologic response (SVR) of LDV/SOF±ribavirin (RBV) in routine medical practice. This observational, intent-to-treat cohort was comprised of 4,365 genotype 1, treatment-naive, HCV-infected veterans treated with LDV/SOF±RBV. SVR rates were 91.3% (3,191/3,495) for LDV/SOF and 92.0% (527/573) for LDV/SOF+RBV (P = 0.65). African American race (odds ratio 0.70, 95% confidence interval 0.54-0.90, P = 0.004) and FIB-4 >3.25 (odds ratio 0.56, 95% confidence interval 0.43-0.71, P < 0.001) were independently associated with decreased likelihood of SVR; age, sex, body mass index, decompensated liver disease, diabetes, genotype 1 subtype, and regimen did not predict SVR. In models limited to those who completed 12 weeks of treatment, African American race was no longer a significant predictor of SVR but FIB-4 >3.25 (odds ratio 0.35, 95% confidence interval 0.24-0.50, P < 0.001) remained. Among those without cirrhosis (defined by FIB-4 ≤3.25) and with baseline HCV RNA

He T., Li K., Roberts M.S., Spaulding A.C., Ayer T., Grefenstette J.J., Chhatwal J.

The prevalence of hepatitis C virus (HCV) in U.S. prisoners is high; however, HCV testing and treatment are rare. Infected inmates released back into society contribute to the spread of HCV in the general population. Routine hepatitis screening of inmates followed by new therapies may reduce ongoing HCV transmission.To evaluate the health and economic effect of HCV screening and treatment in prisons on the HCV epidemic in society.Agent-based microsimulation model of HCV transmission and progression of HCV disease.Published literature.Population in U.S. prisons and general community.30 years.Societal.Risk-based and universal opt-out hepatitis C screening in prisons, followed by treatment in a portion of patients.Prevention of HCV transmission and associated disease in prisons and society, costs, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratio (ICER), and total prison budget.Implementing risk-based and opt-out screening could diagnose 41,900 to 122,700 new HCV cases in prisons in the next 30 years. Compared with no screening, these scenarios could prevent 5500 to 12,700 new HCV infections caused by released inmates, wherein about 90% of averted infections would have occurred outside of prisons. Screening could also prevent 4200 to 11,700 liver-related deaths. The ICERs of screening scenarios were $19,600 to $29,200 per QALY, and the respective first-year prison budget was $900 to $1150 million. Prisons would require an additional 12.4% of their current health care budget to implement such interventions.Results were sensitive to the time horizon, and ICERs otherwise remained less than $50,000 per QALY.Data on transmission network, reinfection rate, and opt-out HCV screening rate are lacking.Universal opt-out HCV screening in prisons is highly cost-effective and would reduce HCV transmission and HCV-associated diseases primarily in the outside community. Investing in U.S. prisons to manage hepatitis C is a strategic approach to address the current epidemic.National Institutes of Health.

Rich J.D., Allen S.A., Williams B.A.

From a public health standpoint, the high concentration of patients in correctional institutions with hepatitis C — now a curable contagious disease — presents a critical opportunity to curtail this epidemic.

Arora S., Thornton K., Murata G., Deming P., Kalishman S., Dion D., Parish B., Burke T., Pak W., Dunkelberg J., Kistin M., Brown J., Jenkusky S., Komaromy M., Qualls C.

The Extension for Community Healthcare Outcomes (ECHO) model was developed to improve access to care for underserved populations with complex health problems such as hepatitis C virus (HCV) infection. With the use of video-conferencing technology, the ECHO program trains primary care providers to treat complex diseases.We conducted a prospective cohort study comparing treatment for HCV infection at the University of New Mexico (UNM) HCV clinic with treatment by primary care clinicians at 21 ECHO sites in rural areas and prisons in New Mexico. A total of 407 patients with chronic HCV infection who had received no previous treatment for the infection were enrolled. The primary end point was a sustained virologic response.A total of 57.5% of the patients treated at the UNM HCV clinic (84 of 146 patients) and 58.2% of those treated at ECHO sites (152 of 261 patients) had a sustained viral response (difference in rates between sites, 0.7 percentage points; 95% confidence interval, -9.2 to 10.7; P=0.89). Among patients with HCV genotype 1 infection, the rate of sustained viral response was 45.8% (38 of 83 patients) at the UNM HCV clinic and 49.7% (73 of 147 patients) at ECHO sites (P=0.57). Serious adverse events occurred in 13.7% of the patients at the UNM HCV clinic and in 6.9% of the patients at ECHO sites.The results of this study show that the ECHO model is an effective way to treat HCV infection in underserved communities. Implementation of this model would allow other states and nations to treat a greater number of patients infected with HCV than they are currently able to treat. (Funded by the Agency for Healthcare Research and Quality and others.).

Jürgens R., Nowak M., Day M.

Akiyama M.J., Thornton K., Voyles N., Vincent L.

Abstract