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Hepatitis C virus (HCV) infection has been increasing among people who inject drugs (PWID), younger than 30 years, and living in rural or suburban areas. We examined injection-related behaviors of young PWID to determine factors associated with HCV infection.From September 2013-May 2015, respondent-driven and snowball sampling were used in 3 suburban areas of Wisconsin to recruit PWID 18-29 years who reported injection drug use in the previous 12 months. Participants were tested for HCV antibody (anti-HCV) and reported injection-related behaviors/practices via self-administered computer-based survey. We calculated anti-HCV prevalence and assessed associated factors using multivariable logistic regression.Forty-two percent (117/280) of participants were male, 83% (231/280) were white, and median age was 23 years. Overall HCV prevalence was 33%, but HCV prevalence among males was 39%. Adjusting for age, sex, race/ethnicity, education, relationship status, insurance status and income, anti-HCV positivity was associated with higher injection frequency (100 times in the past six months) (aOR = 3.07; 95% Confidence Interval (95% CI): 1.72-5.45), ever shared syringes (aOR = 5.15; 95% CI: 2.52-10.51), past week/last use receptive rinse water sharing (aOR = 1.88; 95% CI: 1.06-3.33), past week/last use receptive filter sharing (aOR = 3.25; 95% CI: 1.61-6.54), reusing syringes (aOR = 1.91, 95% CI: 1.08-3.37), history of overdose (aOR = 8.82; 95% CI: 2.26-3.95), and having ever injected another PWID (aOR = 8.82; 95%CI 3.94-19.76).Anti-HCV positivity is associated with high-risk injection practices. Young PWID would benefit from access to evidence-based interventions that reduce their risk of infection, link those infected to HCV treatment, and provide education to reduce further transmission. more...

Objective Approximately 2.4 million people in the United States are living with hepatitis C virus (HCV) infection. The objective of our study was to describe demographic and socioeconomic characteristics, liver disease–related risk factors, and modifiable health behaviors associated with self-reported testing for HCV infection among adults. Methods Using data on adult respondents aged ≥18 from the 2013-2017 National Health Interview Survey, we summarized descriptive data on sociodemographic characteristics and liver disease–related risk factors and stratified data by educational attainment. We used weighted logistic regression to examine predictors of HCV testing. Results During the study period, 11.7% (95% CI, 11.5%-12.0%) of adults reported ever being tested for HCV infection. Testing was higher in 2017 than in 2013 (adjusted odds ratio [aOR] = 1.27; 95% CI, 1.18-1.36). Adults with ≥some college were significantly more likely to report being tested (aOR = 1.60; 95% CI, 1.52-1.69) than adults with ≤high school education. Among adults with ≤high school education (but not adults with ≥some college), those who did not have health insurance were less likely than those with private health insurance (aOR = 0.78; 95% CI, 0.68-0.89) to get tested, and non–US-born adults were less likely than US-born adults to get tested (aOR = 0.77; 95% CI, 0.68-0.87). Conclusions Rates of self-reported HCV testing increased from 2013 to 2017, but testing rates remained low. Demographic characteristics, health behaviors, and liver disease–related risk factors may affect HCV testing rates among adults. HCV testing must increase to achieve hepatitis C elimination targets. more...

Hepatitis C virus (HCV) infection is a public health threat. The electronic health record (EHR) can be used to monitor patients along the HCV cure cascade and highlight opportunities for interventions to improve cascade outcomes. We developed an HCV patient registry using data from Grady Health System's (GHS) EHR and performed a cross-sectional analysis of 72 745 GHS patients who received anti-HCV testing from 2004 to 2016. We created a testing cascade: (1) anti-HCV reactive, (2) HCV RNA tested and (3) HCV RNA detectable; and a cure cascade: (1) HCV RNA detectable, (2) engaged in care, (3) treatment prescribed, (4) sustained virologic response (SVR) tested and (5) SVR documented. A total of 9893 (14%) had reactive anti-HCV tests of 72 745 patients tested, 5109 (52%) of these had HCV RNA tested, and 4224 (43%) were HCV RNA detectable. A total of 2738 (65%) of 4224 with detectable RNA were engaged in care, 909 (22%) were prescribed antiviral therapy, and 354 (8%) achieved SVR. Factors associated with HCV treatment included cirrhosis, tobacco use, depression, diabetes, obesity, alcohol use, male gender, black race and Medicare insurance. Uninsured patients were significantly less likely to be prescribed HCV treatment. In conclusion, using EHR data, we identified high anti-HCV prevalence and noted gaps in HCV RNA testing, linkage to care and treatment. The EHR can be used to evaluate the effectiveness of targeted interventions to overcome these gaps. more...

To estimate the clinical effects and cost-effectiveness of universal prenatal hepatitis C screening, and to calculate potential life expectancy, quality of life, and health care costs associated with universal prenatal hepatitis C screening and linkage to treatment.Using a stochastic individual-level microsimulation model, we simulated the lifetimes of 250 million pregnant women matched at baseline with the U.S. childbearing population on age, injection drug use behaviors, and hepatitis C virus (HCV) infection status. Modeled outcomes included hepatitis C diagnosis, treatment and cure, lifetime health care costs, quality-adjusted life years (QALY) and incremental cost-effectiveness ratios comparing universal prenatal hepatitis C screening to current practice. We modeled whether neonates exposed to maternal HCV at birth were identified as such.Pregnant women with hepatitis C infection lived 1.21 years longer and had 16% lower HCV-attributable mortality with universal prenatal hepatitis C screening, which had an incremental cost-effectiveness ratio of $41,000 per QALY gained compared with current practice. Incremental cost-effectiveness ratios remained below $100,000 per QALY gained in most sensitivity analyses; notable exceptions included incremental cost-effectiveness ratios above $100,000 when assuming mean time to cirrhosis of 70 years, a cost greater than $500,000 per false positive diagnosis, or population HCV infection prevalence below 0.16%. Universal prenatal hepatitis C screening increased identification of neonates exposed to HCV at birth from 44% to 92%.In our model, universal prenatal hepatitis C screening improves health outcomes in women with HCV infection, improves identification of HCV exposure in neonates born at risk, and is cost-effective. more...

The structure of electronic medical record data prevents easy population-level monitoring of hepatitis C virus (HCV) treatment uptake and cure. Using an HCV registry from a public hospital system in Atlanta, Georgia, we developed multiple algorithms that use serial HCV RNA test results as proxy measures for initiation of direct-acting antiviral (DAA) treatment and sustained virological response (SVR). We calculated sensitivity and positive predictive values (PPVs) by comparing the algorithms with the DAA initiation and SVR results from the registry. From December 2013 to August 2016, 1,807 persons actively infected with HCV were identified in the registry. Of those, 698 initiated DAA treatment on the basis of medical record abstraction; of 442 patients with treatment start and/or end dates, 314 had documented SVR. Treatment algorithm 2 (a detectable HCV RNA result followed by 2 sequential HCV RNA test results) and treatment algorithm 5 (a detectable HCV RNA result followed by 2 sequential HCV RNA test results >6 weeks apart) had the highest sensitivity (87% and 85%, respectively) and PPV (80% and 82%, respectively) combinations. Four SVR algorithms relied on fulfilling treatment algorithm definitions and having an undetectable HCV RNA test result ≥12 weeks after the last HCV RNA result; sensitivity for all 4 algorithms was 79%, and PPV was 92%-93%. Algorithms using serial quantitative HCV RNA results can serve as proxy measures for evaluating population-level DAA treatment and SVR outcomes. more...

AIM To investigate hepatitis C virus (HCV) testing recommendations from the United States and other high-income countries. METHODS A comprehensive search for current HCV testing recommendations from the top quartile of United Nations Human Development Index (HDI) countries (very high HDI) was performed using Google and reviewed from May 1 - October 30, 2014 and re-reviewed April 1 - October 2, 2017. RESULTS Of the 51 countries identified, 16 had HCV testing recommendations from a government body or recommendations issued collaboratively between a government and a medical organization. Of these 16 countries, 15 had HCV testing recommendations that were primarily risk-based and highlight behaviors, exposures, and conditions that are associated with HCV transmission in that region. In addition to risk-based testing, the HCV Guidance Panel (United States) incorporates recommendations for a one-time test for individuals born during 1945-1965 (the birth cohort) without prior ascertainment of risk into their guidance. In addition to the United States, six other countries either have an age-based testing recommendation or recommend one-time testing for all adults independent of risk factors typical of the region. CONCLUSION This review affirmed the similarities of the HCV Guidance Panel’s guidance with those of recommendations from very high HDI countries. more...

Summary Hepatitis B virus (HBV) is transmitted via blood or sexual contact. Persons with chronic HBV infection are at increased risk for cirrhosis and liver cancer and require medical care. This report updates and summarizes previously published recommendations from the Advisory Committee on Immunization Practices (ACIP) and CDC regarding the prevention of HBV infection in the United States. ACIP recommends testing all pregnant women for hepatitis B surface antigen (HBsAg), and testing HBsAg-positive pregnant women for hepatitis B virus deoxyribonucleic acid (HBV DNA); administration of HepB vaccine and hepatitis B immune globulin (HBIG) for infants born to HBV-infected women within 12 hours of birth, followed by completion of the vaccine series and postvaccination serologic testing; universal hepatitis B vaccination within 24 hours of birth, followed by completion of the vaccine series; and vaccination of children and adolescents aged more...

Background and aims Effective strategies are needed to address dramatic increases in hepatitis C virus (HCV) infection among people who inject drugs (PWID) in rural settings of the United States. We determined the required scale-up of HCV treatment with or without scale-up of HCV prevention interventions to achieve a 90% reduction in HCV chronic prevalence or incidence by 2025 and 2030 in a rural US setting. Design An ordinary differential equation model of HCV transmission calibrated to HCV epidemiological data obtained primarily from an HIV outbreak investigation in Indiana. Setting Scott County, Indiana (population 24 181), USA, a rural setting with negligible baseline interventions, increasing HCV epidemic since 2010, and 55.3% chronic HCV prevalence among PWID in 2015. Participants PWID. Measurements Required annual HCV treatments per 1000 PWID (and initial annual percentage of infections treated) to achieve a 90% reduction in HCV chronic prevalence or incidence by 2025/30, either with or without scaling-up syringe service programmes (SSPs) and medication-assisted treatment (MAT) to 50% coverage. Sensitivity analyses considered whether this impact could be achieved without re-treatment of re-infections, and whether greater intervention scale-up was required due to the increasing epidemic in this setting. Findings To achieve a 90% reduction in incidence and prevalence by 2030, without MAT and SSP scale-up, 159 per 1000 PWID (initially 24.9% of infected PWID) need to be HCV-treated annually. However, with MAT and SSP scaled-up, treatment rates are halved (89 per 1000 annually or 14.5%). To reach the same target by 2025 with MAT and SSP scaled-up, 121 per 1000 PWID (19.9%) need treatment annually. These treatment requirements are threefold higher than if the epidemic was stable, and the impact targets are unattainable without retreatment. Conclusions Combined scale-up of hepatitis C virus treatment and prevention interventions is needed to decrease the increasing burden of hepatitis C virus incidence and prevalence in rural Indiana, USA, by 90% by 2025/30. more...

Using commercial laboratory data, we found 80% of 29382 young persons currently infected with hepatitis C virus lived >10 miles from a syringe services program. The median distance was 37 miles, with greater distances in rural areas and Southern and Midwestern states. Strategies to improve access to preventive services are warranted. more...

Hepatitis C (HCV) and HIV have common modes of transmission but information about HCV transmission risk, prevention, and treatment among persons with coinfection is lacking. The Medical Monitoring Project produces nationally representative estimates describing adults with diagnosed HIV in the United States. Using medical record data recorded during 6/2013-5/2017, we identified persons with detectable HCV RNA documented during the past 24 months. Among persons with coinfection, we described HCV transmission risk factors and receipt of HCV prevention services during the past 12 months and prescription of HCV treatment during the past 24 months. Overall, 4.9% had documented active HCV coinfection, among whom 30.2% were men who have sex with men (MSM), 6.7% reported injection drug use, and 62.1% were prescribed HCV treatment. Among MSM, 45.5% reported condomless anal sex and 42.3% received free condoms. Among persons who used drugs, 30.8% received drug or alcohol counseling, and among persons who injected drugs, 79.2% received sterile syringes. Among persons with HIV/HCV coinfection, recent drug injection was uncommon and most received sterile syringes. However, 1 in 3 were MSM, of whom half reported recent HCV sexual transmission risk behaviors. More than one-third of those with coinfection were not prescribed curative HCV treatment. more...

Aims To examine the cost-effectiveness of hepatitis C virus (HCV) treatment of people who inject drugs (PWID), combined with medication-assisted treatment (MAT) and syringe-service programs (SSP), to tackle the increasing HCV epidemic in the United States. DesignHCV transmission and disease progression models with cost-effectiveness analysis using a health-care perspective. Setting Rural Perry County, KY (PC) and urban San Francisco, CA (SF), USA. Compared with PC, SF has a greater proportion of PWID with access to MAT or SSP. HCV treatment of PWID is negligible in both settings. Participants PWID data were collected between 1998 and 2015 from Social Networks Among Appalachian People, U Find Out, Urban Health Study and National HIV Behavioral Surveillance System studies. Interventions and comparator Three intervention scenarios modeled: baseline—existing SSP and MAT coverage with HCV screening and treatment with direct-acting antiviral for ex-injectors only as per standard of care; intervention 1—scale-up of SSP and MAT without changes to treatment; and intervention 2—scale-up as intervention 1 combined with HCV screening and treatment for current PWID. Measurements Incremental cost-effectiveness ratios (ICERs) and uncertainty using cost-effectiveness acceptability curves. Benefits were measured in quality-adjusted life-years (QALYs). Findings For both settings, intervention 2 is preferred to intervention 1 and the appropriate comparator for intervention 2 is the baseline scenario. Relative to baseline, for PC intervention 2 averts 1852 more HCV infections, increases QALYS by 3095, costs $21.6 million more and has an ICER of $6975/QALY. For SF, intervention 2 averts 36 473 more HCV infections, increases QALYs by 7893, costs $872 million more and has an ICER of $11 044/QALY. The cost-effectiveness of intervention 2 was robust to several sensitivity analysis. Conclusions Hepatitis C screening and treatment for people who inject drugs, combined with medication-assisted treatment and syringe-service programs, is a cost-effective strategy for reducing hepatitis C burden in the United States. more...

Objective To determine whether the homeless population experiences disparities in care and communication during inpatient hospitalizations in a safety-net hospital. Methods We administered a modified Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey to 112 age-sex- and education matched homeless and non-homeless adults at a university-affiliated-safety-net hospital from December 2017 through March 2018 and performed a retrospective review of medical records. Linear regression models were used to assess differences in responses to survey subscales, length of stay and other measures. Results Homeless participants trended toward poorer ratings for all HCAHPS subscales, reaching significance for the Communication about Medications subscale, with a mean score 1.2 (95% CI 0.48–1.76) points lower compared to non-homeless sample. Length of stay was not significantly different between homeless and non-homeless participants. Conclusion In an urban safety-net hospital, disparities in communications regarding medications between hospital staff and patients were found based on housing status. more...

Objective Using a large nationally representative dataset, we estimated the prevalence of self-reported hepatitis C testing among individuals who were recommended to be tested (i.e., baby boomer cohort born between 1945 and 1965) by the CDC and United States Preventive Services Task Force. Introduction Hepatitis C virus (HCV) infection is the most common blood-borne disease in the US and the leading cause of liver-related morbidity and mortality. Approximately 3.5 million individuals in the US were estimated to have been living with hepatitis C in 2010 and approximately half of them were unaware that they were infected. Among HCV infected individuals, those born between 1945 and 1965 (usually referred to as the baby boomer cohort) represents approximately 75% of current cases. Because of the substantial burden of disease among this age group, CDC expanded its existing hepatitis C risk-based testing recommendations to include a one-time HCV antibody test for all persons born between 1945 and 1965. The United States Preventive Services Task Force (USPSTF) subsequently made the same recommendation in June 2013. Description Methods The following question "Have you ever had a blood test for hepatitis C?" has been administered annually from 2013 through 2017 on the National Health Interview Survey (NHIS). The NHIS is a nationally representative cross-sectional face-to-face household interview of civilian noninstitutionalized individuals in the U.S. The NHIS survey uses a complex multistage probability design that includes stratification, clustering, and oversampling. We estimated the prevalence of hepatitis C testing for adults in the US during the study period from 2013 to 2017. In addition, we carried out stratified analyses comparing those with private insurance to those who did not have private insurance. We reported weighted estimates taking into account the NHIS survey design. The R statistical software (R Core Team, 2018) was used to estimate weighted prevalence estimates for hepatitis C testing. Results During the study period from 2013-2017, there were 148,674 adults who responded to the ever tested for hepatitis C question. In addition, 33.56% of these individuals were born between 1945 and 1965; among all adults, the weighted percentage of individuals that responded yes they had received a hepatitis C screening test was 12.82% (95% CI: 12.54-13.10%) while for baby boomers the estimate was 13.93% (95% CI: 13.51-14.35%). Figure 1 presents the annual trend in the hepatitis C test prevalence over the study period by birth cohorts. For both cohorts, there were significant increases over time in hepatitis C testing prevalence. The two trend lines began to diverge in 2015 with the baby boomer cohort reporting higher rates of hepatitis C testing. For the baby boomer cohort, there was also a substantial increase in reported hepatitis C testing in 2017 relative to 2016. Similar trends were found for the samples when we restricted the sample to only those with private insurance. Compared to the people with private insurance, the baby boomers with 'Non-private’ insurance, including Medicaid, Medicare, or military- government sponsored insurances, reported higher rates of testing. Conclusion Across the five-year period from 2013 through 2017, we found increasing rates of self-reported hepatitis C testing among non-institutionalized U.S. adults. For the baby boomer cohort, we saw a substantial increase in testing in 2017, which was likely due in part, to increased awareness among both physicians and patients of the CDC and USPSTF recommendation to have all baby boomers tested. Efforts to increase the awareness of these recommendations should continue. Additional targeted promotions among hard to reach populations should also be considered. How the Moderator Intends to Engage the Audience in Discussions on the Topic This panel will discuss strengths and weaknesses for monitoring hepatitis C testing using alternative data sources including self-reported data, insurance claims data, and laboratory testing data. more...

To better understand hepatitis C virus (HCV) epidemiology in Punjab state, India, we estimated the distribution of HCV antibody positivity (anti-HCV+) using a 2013–2014 HCV household seroprevalence survey. Household anti-HCV+ clustering was investigated (a) by individual-level multivariable logistic regression, and (b) comparing the observed frequency of households with multiple anti-HCV+ persons against the expected, simulated frequency assuming anti-HCV+ persons are randomly distributed. Village/ward-level clustering was investigated similarly. We estimated household-level associations between exposures and the number of anti-HCV+ members in a household (N= 1593 households) using multivariable ordered logistic regression. Anti-HCV+ prevalence was 3.6% (95% confidence interval 3.0–4.2%). Individual-level regression (N= 5543 participants) found an odds ratio of 3.19 (2.25–4.50) for someone being anti-HCV+ if another household member was anti-HCV+. Thirty households surveyed had ⩾2 anti-HCV+ members, whereas 0/1000 (P< 0.001) simulations had ⩾30 such households. Excess village-level clustering was evident: 10 villages had ⩾6 anti-HCV+ members, occurring in 31/1000 simulations (P= 0.031). The household-level model indicated the number of household members, living in southern Punjab, lower socio-economic score, and a higher proportion having ever used opium/bhuki were associated with a household's number of anti-HCV+ members. Anti-HCV+ clusters within households and villages in Punjab, India. These data should be used to inform screening efforts. more...

Background Hepatitis C virus (HCV) testing and treatment uptake in prisons remains low. We aimed to estimate clinical outcomes, cost-effectiveness (CE), and budgetary impact (BI) of HCV testing and treatment in United States (US) prisons or linkage to care at release. Methods We used individual-based simulation modeling with healthcare and Department of Corrections (DOC) perspectives for CE and BI analyses, respectively. We simulated a US prison cohort at entry using published data and Washington State DOC individual-level data. We considered permutations of testing (risk factor based, routine at entry or at release, no testing), treatment (if liver fibrosis stage ≥F3, for all HCV infected or no treatment), and linkage to care (at release or no linkage). Outcomes included quality-adjusted life-years (QALY); cases identified, treated, and cured; cirrhosis cases avoided; incremental cost-effectiveness ratios; DOC costs (2016 US dollars); and BI (healthcare cost/prison entrant) to generalize to other states. Results Compared to “no testing, no treatment, and no linkage to care,” the “test all, treat all, and linkage to care at release” model increased the lifetime sustained virologic response by 23%, reduced cirrhosis cases by 54% at a DOC annual additional cost of $1440 per prison entrant, and would be cost-effective. At current drug prices, targeted testing and liver fibrosis–based treatment provided worse outcomes at higher cost or worse outcomes at higher cost per QALY gained. In sensitivity analysis, fibrosis-based treatment restrictions were cost-effective at previous higher drug costs. Conclusions Although costly, widespread testing and treatment in prisons is considered to be of good value at current drug prices. more...

In the United States, hepatitis C virus (HCV) transmission is rising among people who inject drugs (PWID). Many regions have insufficient prevention intervention coverage. Using modeling, we investigated the impact of scaling up prevention and treatment interventions on HCV transmission among PWID in Perry County, Kentucky, and San Francisco, California, where HCV seroprevalence among PWID is >50%. A greater proportion of PWID access medication-assisted treatment (MAT) or syringe service programs (SSP) in urban San Francisco (established community) than in rural Perry County (young, expanding community). We modeled the proportion of HCV-infected PWID needing HCV treatment annually to reduce HCV incidence by 90% by 2030, with and without MAT scale-up (50% coverage, both settings) and SSP scale-up (Perry County only) from 2017. With current MAT and SSP coverage during 2017–2030, HCV incidence would increase in Perry County (from 21.3 to 22.6 per 100 person-years) and decrease in San Francisco (from 12.9 to 11.9 per 100 person-years). With concurrent MAT and SSP scale-up, 5% per year of HCV-infected PWID would need HCV treatment in Perry County to achieve incidence targets—13% per year without MAT and SSP scale-up. In San Francisco, a similar proportion would need HCV treatment (10% per year) irrespective of MAT scale-up. Reaching the same impact by 2025 would require increases in treatment rates of 45%–82%. Achievable provision of HCV treatment, alongside MAT and SSP scale-up (Perry County) and MAT scale-up (San Francisco), could reduce HCV incidence. more...

ObjectiveTo evaluate the use of commercial laboratory data for monitoring trends in HAV infections over time and identifying geographic and demographic characteristics of HAV case clusters for the purpose of targeting interventions.IntroductionHepatitis A virus (HAV) infections have persisted in the United States despite the availability of an effective vaccine. Recent outbreaks of HAV infections among unvaccinated adults attributed to consumption of HAV-contaminated food, or person-to-person contact in certain populations (e.g., men who have sex with men) or settings (e.g., homeless shelters) have emphasized the importance of targeted vaccination of at-risk adults.MethodsWe used commercial laboratory data from Quest Diagnostics (Quest) and Laboratory Corporation of America (LabCorp) to identify unique individuals within each database who tested positive for HAV IgM antibody (indicative of acute HAV infection) from January 2011 through June 2017. Though de-depulication across the two laboratories was not possible, comparison of case characteristics indicated limited possible overlap of cases ( more...

BACKGROUND The World Health Organization recently released recommendations stating that red blood cell (RBC) folate concentrations should be above 400 ng/L (906 nmol/L) for optimal prevention of folate-sensitive neural tube defects (NTDs). The objective of this study was to determine the distribution of folate insufficiency (FI) ( more...

Nurses are on the front lines of health care delivery, and many of them routinely administer immunizations. The authors describe the Centers for Disease Control and Prevention’s (CDC) vaccine safety monitoring systems, explaining how nurses can access inquiry channels and other immunization information resources. Examples of recent vaccine safety inquiries are also provided. more...

Some studies reported an increased risk of Guillain-Barré syndrome (GBS) within six weeks of influenza vaccination. It has also been suggested that this finding could have been confounded by influenza illnesses. We explored the complex relationship between influenza illness, influenza vaccination, and GBS, from an ecologic perspective using nationally representative data. We also studied seasonal patterns for GBS hospitalizations. Monthly hospitalization data (2000-2009) for GBS, and pneumonia and influenza (PI) in the Nationwide Inpatient Sample were included. Seasonal influenza vaccination coverage for 2004-2005 through the 2008-2009 influenza seasons (August-May) was estimated from the National Health Interview Survey data. GBS seasonality was determined using Poisson regression. GBS and PI temporal clusters were identified using scan statistics. The association between PI and GBS hospitalizations in the same month (concurrent) or in the following month (lagged) were determined using negative binomial regression. Vaccine coverage increased over the years (from 19.7% during 2004-2005 to 35.5% during 2008-2009 season) but GBS hospitalization did not follow a similar pattern. Overall, a significant correlation between monthly PI and GBS hospitalizations was observed (Spearman's correlation coefficient=0.7016, p0.0001). A significant (p=0.001) cluster of PI hospitalizations during December 2004-March 2005 overlapped a significant (p=0.001) cluster of GBS hospitalizations during January 2005-February 2005. After accounting for effects of monthly vaccine coverage and age, PI hospitalization was significantly associated (p0.0001) with GBS hospitalization in the concurrent month but not with GBS hospitalization in the following month. Monthly vaccine coverage was not associated with GBS hospitalization in adjusted models (both concurrent and lagged). GBS hospitalizations demonstrated a seasonal pattern with winter months having higher rates compared to the month of June. PI hospitalization rates were significantly correlated with hospitalization rates for GBS. Vaccine coverage did not significantly affect the rates of GBS hospitalization at the population level. more...

Hepatitis C virus (HCV) infection is a substantial and largely unrecognized public health problem. An estimated 3.5 million persons in the United States are currently living with HCV infection, at least half of whom are unaware of their infection (1-3). Persons born during 1945-1965 (the "baby boomer" birth cohort) have a sixfold higher prevalence (2.6%) than adults of other ages, and represent 81% of all persons chronically infected with HCV (4). Therefore, in addition to recommending testing for all persons at risk for HCV infection, CDC and the U.S. Preventive Services Task Force (USPSTF) recommend one-time HCV testing for the birth cohort (5,6). Compared with the national average, American Indian/Alaska Native (AI/AN) persons have approximately twofold the rate of acute HCV incidence and HCV associated mortality (2). In June 2012, the Indian Health Service (IHS) implemented HCV testing in the 1945-1965 birth cohort and created a nationally standardized performance measure to monitor implementation of the recommendation. As of June 2015, the proportion of the birth cohort screened for HCV increased from a baseline of 7.9% (14,402/182,503) to 32.5% (68,514/211,014) among the AI/AN population served by IHS nationwide; provider training and the use of clinical decision tools were associated with increases in HCV testing. With this fourfold increase in testing in just 3 years, IHS needs to prepare for the challenges associated with increased identification of persons living with HCV infection. more...

Objectives The US National Viral Hepatitis Action Plan calls for major efforts to expand hepatitis C virus (HCV) diagnosis and treatment; prenatal care settings are potential venues for expanding HCV testing. We aimed to characterize the HCV diagnostic cascade for women and infants and investigate factors associated with linkage and follow-up. Study design We used electronic health records for a 10-year cohort of 879 women with opioid use disorder from an obstetric clinic serving women with substance use disorders. Results Altogether, 744 women (85%) were screened for HCV; 510 (68%) were seropositive, of whom 369 (72%) had nucleic acid testing performed and of these 261 (71%) were viremic. Of 404 infants born to HCV-seropositive women, 273 (68%) were tested at least once for HCV, 180 (45%) completed the American Academy of Pediatrics-recommended perinatal HCV screening, and 5 (2.8%) were diagnosed with HCV infection and linked to care. More recent delivery date (2014-2015) was associated with maternal linkage to care (aOR, 2.5; 95% CI, 1.4-4.7). Maternal coinfection with HIV (aOR, 9.0; 95% CI, 1.1-72.8) and methadone maintenance therapy, compared with buprenorphine (aOR, 1.5; 95% CI, 0.9-2.5), were associated with higher rates of infant HCV testing. Conclusions HCV prevalence among pregnant women with opioid use is high and infant HCV screening is imperfect. Programmatic changes to improve both mother and infant follow-up may help to bridge identified gaps in the cascade to cure. more...

Introduction. Pregnant women should receive hepatitis B virus (HBV) testing with hepatitis B surface antigen (HBsAg), but it is unclear whether HBV-infected pregnant women are linked to care. Methods. We analyzed MarketScan™ commercial insurance claims. We included pregnant women, aged 10–50 years, with 42 weeks of continuous enrollment before (predelivery) and 6 months after (postdelivery) the first delivery claim for each unique pregnancy between 1/1/2011 and 6/30/2014. We identified claims for HBsAg testing by CPT code and described the care continuum among pregnancies with an associated ICD-9 HBV diagnosis code by demographic and clinical characteristics, including HBV-directed care ([HBV DNA or hepatitis B e antigen] and ALT test codes) and antiviral treatment (claims for tenofovir, entecavir, lamivudine, adefovir, or telbivudine) pre- and postdelivery. Results. There were 870,888 unique pregnancies (819,752 women) included. Before delivery, 714,830 (82%) pregnancies had HBsAg test claims, but this proportion decreased with subsequent pregnancies (p<0.0001): second (80%), third (71%), and fourth (61%). We identified 1,190 (0.14%) pregnancies with an associated HBV diagnosis code: most were among women aged ≥ 30 years (76%) residing in the Pacific (34%) or Middle Atlantic (18%) regions. Forty-two percent of pregnancies with an HBV diagnosis received HBV-directed care (42% predelivery and 39% postdelivery). Antiviral treatment was initiated before delivery in 128 (13%) of 975 pregnancies and postdelivery in 16 (1.6%) pregnancies. Conclusions. While most of these commercially insured pregnant women received predelivery HBV screening, we identified gaps in HBV testing and the HBV care continuum which highlight potential targets for public health interventions. more...

Introduction Perinatal transmission is an increasingly important mode of hepatitis C virus transmission. The authors characterized U.S. births among hepatitis C virus–infected women and evaluated trends in hepatitis C virus testing and positivity in women of childbearing age, pregnant women, and children aged less than 5years. Methods In 2017, National Center for Health Statistics birth certificate data (48 states and District of Columbia) were analyzed to assess the number of hepatitis C virus–infected women delivering live births in 2015, and commercial laboratory data were analyzed to assess hepatitis C virus testing and positivity among women of childbearing age, pregnant women, and children aged Results In 2015, a total of 0.38% (n=14,417) of live births were delivered by hepatitis C virus–infected women. Births delivered by hepatitis C virus–infected women, compared with births overall, occurred more often in women who were aged 20–29years (60.7% vs 50.9%); white, non-Hispanic (80.2% vs 52.8%); covered by Medicaid or other government insurance (79.2% vs 43.9%); and had rural residence (26.0% vs 14.0%). From 2011 to 2016 laboratory data, among women of childbearing age, hepatitis C virus testing increased by 39%, from 6.1% to 8.4%, and positivity increased by 36%, from 4.4% to 6.0%. Among pregnant women, hepatitis C virus testing increased by 135%, from 5.7% to 13.4%, and positivity increased by 39%, from 2.6% to 3.6%. Among children, hepatitis C virus testing increased by 25%, from 0.47% to 0.59%, and positivity increased by 13%, from 3.6% to 4.0%. Conclusions The potential for perinatal hepatitis C virus transmission exists. Expanded hepatitis C virus testing guidelines may address the burden of disease in this population. more...

Background The US Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force recommend one-time hepatitis C virus (HCV) testing for persons born 1945-1965 and targeted testing for high-risk persons. This strategy targets HCV testing to a prevalent population at high risk for HCV morbidity and mortality, but does not include younger populations with high incidence. To address this gap and improve access to HCV testing, age-based strategies should be considered. Methods We used a simulation of HCV to estimate the effectiveness and cost-effectiveness of HCV testing strategies: 1) standard of care (SOC) - recommendation for one-time testing for all persons born 1945-1965, 2) recommendation for one-time testing for adults ≥40 years (≥40 strategy), 3) ≥30 years (≥30 strategy), and 4) ≥18 years (≥18 strategy). All strategies assumed targeted testing of high-risk persons. Inputs were derived from national databases, observational cohorts and clinical trials. Outcomes included quality-adjusted life expectancy, costs, and cost-effectiveness. Results Expanded age-based testing strategies increased US population lifetime case identification and cure rates. Greatest increases were observed in the ≥18 strategy. Compared to the SOC, this strategy resulted in an estimated 256,000 additional infected persons identified and 280,000 additional cures at the lowest cost per QALY gained (ICER = $28,000/QALY). Conclusions In addition to risk-based testing, one-time HCV testing of persons 18 and older appears to be cost-effective, leads to improved clinical outcomes and identifies more persons with HCV than the current birth cohort recommendations. These findings could be considered for future recommendation revisions. more...

Restrictive policies on access to new, curative hepatitis C treatments represent a substantial barrier to treating patients infected with hepatitis C. This case series demonstrates challenges experienced by patients and practitioners in accessing these treatments and highlights several strategies for navigating the treatment preauthorization process. more...

This review highlights key studies and recently published data, policies, and recommendations related to hepatitis C virus (HCV) epidemiology, transmission, and treatment.HCV is a leading cause of liver-related deaths, cirrhosis, and hepatocellular carcinoma. Since 2011 and accelerating since 2013, new, safe, tolerable, and curative therapies have considerably altered clinical and public health frameworks related to the prevention, control and clinical management of HCV. Nevertheless, there are several populations in the United States that are important to consider because of disparities in HCV prevalence and transmission risk. Adults born during 1945-1965 have an estimated anti-HCV antibody prevalence of ~3%, which is six times higher than among other adults, are often unaware of their infections, and are at increased risk of having HCV-associated morbidity and mortality from decades of chronic infection. Since the early 2000s, increasing incidence of acute HCV infections among young, white, non-urban people who inject drugs have been reported. Despite promising therapeutic advances, significant challenges remain for reducing HCV-associated morbidity and mortality.The high burden of HCV and significant health consequences associated with chronic infection make HCV a critical public health priority. Advances in HCV treatment have created new opportunities for reducing HCV-associated morbidity and mortality. These treatments are safe, well-tolerated, and highly effective; however, benefits cannot be realized without a significant increase in the number of persons tested for HCV so that all chronically infected individuals can be aware of their diagnosis and linked to appropriate clinical care. more...

Objective In response to widespread pertussis outbreaks and infant deaths, in 2010, the California Department of Health (CDPH) and in 2011 the Advisory Committee on Immunization Practices (ACIP) advised that the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine be administered during pregnancy. The goals of this study were to describe Tdap coverage among pregnant women following these recommendations. Methods In this observational cohort study, we utilized electronic medical record and claims data from seven Vaccine Safety Datalink sites to identify pregnancies and Tdap administrations. All Tdap doses were classified as pre-pregnancy, during pregnancy or post-pregnancy/postpartum. For pregnancies ending in a live birth, we evaluated factors associated with Tdap vaccination. Results Among 289,141 live births at the California VSD sites, receipt of Tdap during pregnancy increased substantially in the years 2010, 2011, and 2012, when coverage was 15.9, 30.0 and 19.5%, respectively. Among 82,398 women with live births at the Oregon, Washington, Colorado, Wisconsin and Minnesota VSD sites, receipt of Tdap during pregnancy first increased in 2012, at 16.0%. Women receiving early prenatal care and other vaccine(s) during pregnancy had higher Tdap coverage. Conclusion We observed substantial increases in Tdap coverage during pregnancy following CDPH and ACIP recommendations. more...

Purpose We conducted weekly surveillance for pre-specified adverse events following receipt of the 2012–2013 influenza vaccines in the Vaccine Safety Datalink (VSD). Methods For each outcome, risk intervals (i.e., period after vaccination with a potentially increased risk) were defined on the basis of biologic plausibility and prior literature. Seizures following inactivated influenza vaccine (IIV) were monitored in children in three age groups (6–23 months, 24–59 months, and 5–17 years) using a self-controlled risk interval design. We also monitored for Guillain–Barre syndrome, encephalitis, and anaphylaxis following IIV in patients ≥6 months of age using a cohort design with historical controls. In the risk intervals following live attenuated influenza vaccine (LAIV), we collected weekly counts of Guillain–Barre syndrome, encephalitis, and anaphylaxis in patients ages 2–49. Among LAIV vaccinees, numbers of expected events based on rates in historical controls were calculated, adjusted for age and site. Results At the end of surveillance, approximately 3.6 million first doses of IIV and 250 000 first doses of LAIV had been administered in the VSD. No elevated risks were identified in risk intervals following 2012–2013 IIV, as compared with a self-matched control interval or to historical controls. For each outcome, fewer than three events occurred in the risk interval following 2012–2013 LAIV, and we thus were unable to estimate measures of relative risks. Conclusions No increased risk was identified for any of the pre-specified outcomes following 2012–2013 influenza vaccinations in the VSD. Published 2014. This article is a U.S. Government work and is in the public domain in the USA. more...

Background Hypersensitivity disorders following vaccinations are a cause for concern. Objective To determine the type and rate by age, gender, and vaccine received for reported hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines. Design A systematic review of reports to the Vaccine Adverse Event Reporting System (VAERS) following monovalent 2009 pandemic influenza A (H1N1) vaccines. Setting/patients US Civilian reports following vaccine received from October 1, 2009 through May 31, 2010. Measurements Age, gender, vaccines received, diagnoses, clinical signs, and treatment were reviewed by nurses and physicians with expertise in vaccine adverse events. A panel of experts, including seven allergists reviewed complex illnesses and those with conflicting evidence for classification of the event. Results Of 1984 reports, 1286 were consistent with immediate hypersensitivity disorders and 698 were attributed to anxiety reactions, syncope, or other illnesses. The female-to-male ratio was ≥4:1 for persons 20-to-59 years of age, but approximately equal for children under 10. One hundred eleven reports met Brighton Collaboration criteria for anaphylaxis; only one-half received epinephrine for initial therapy. The overall rate of reported hypersensitivity reactions was 10.7 per million vaccine doses distributed, with a 2-fold higher rate for live vaccine. Limitations Underreporting, especially of mild events, would result in an underestimate of the true rate of immediate hypersensitivity reactions. Selective reporting of events in adult females could have resulted in higher rates than reported for males. Conclusions Adult females may be at higher risk of hypersensitivity reactions after influenza vaccination than men. Although the risk of hypersensitivity reactions following 2009 pandemic influenza A (H1N1) vaccines was low, all clinics administering vaccines should be familiar with treatment guidelines for these adverse events, including the use of intramuscular epinephrine early in the course of serious hypersensitivity reactions. more...

OBJECTIVE: To characterize maternal and infant outcomes for pregnant women who received live H1N1 influenza vaccine and had no reported adverse events. METHODS: We identified Vaccine Adverse Event Reporting System reports, which described receipt of live H1N1 vaccine during pregnancy without an indication of an adverse event at the time of the report during October 2009 to June 2010. We reviewed the initial reports and obtained pregnancy outcome and infant data through 6 months of age from medical records. We reviewed the numbers and characteristics of pregnancy complications and infant outcomes including major birth defects and medically important infant conditions. Rates of spontaneous abortion, preterm birth, and major birth defects and their 95% confidence intervals were calculated. RESULTS: The Vaccine Adverse Event Reporting System received 113 reports stating receipt of live H1N1 vaccine during pregnancy with no adverse events reported. We obtained follow-up maternal records on 95 of the 113 (84%) live H1N1 reports (40.2% were vaccinated in the first trimester) and found: 87 live births (two twin pregnancies) and no maternal deaths occurred. Number and rates of pregnancy-specific adverse events included: 10 (10.5%, 5.8–18.3) spontaneous abortions; four (4.7%, 1.8–11.4) preterm deliveries at 35–36 weeks of gestation; three (3.4%, 1.2–9.7) infants had one or more major birth defects noted at birth: one cleft palate, one cleft lip, and one microtia (underdeveloped or absent external ear). Seven neonates and infants were hospitalized for medically important conditions. One infant death occurred in a 2.5-month-old boy as a result of pertussis. CONCLUSION: Rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates. No concerning patterns of medical conditions in infants were identified. LEVEL OF EVIDENCE: III more...

Background Determining the baseline mortality rate in a vaccinated population is necessary to be able to identify any unusual increases in deaths following vaccine administration. Background rates are particularly useful during mass immunization campaigns and in the evaluation of new vaccines. Purpose Provide background mortality rates and describe causes of death following vaccination in the Vaccine Safety Datalink (VSD). Methods Analyses were conducted in 2012. Mortality rates were calculated at 0–1 day, 0–7 days, 0–30 days, and 0–60 days following vaccination for deaths occurring between January 1, 2005, and December 31, 2008. Analyses were stratified by age and gender. Causes of death were examined, and findings were compared to National Center for Health Statistics (NCHS) data. Results Among 13,033,274 vaccinated people, 15,455 deaths occurred between 0 and 60 days following vaccination. The mortality rate within 60 days of a vaccination visit was 442.5 deaths per 100,000 person-years. Rates were highest in the group aged ≥85 years, and increased from the 0–1-day to the 0–60-day interval following vaccination. Eleven of the 15 leading causes of death in the VSD and NCHS overlap in both systems, and the top four causes of death were the same in both systems. Conclusions VSD mortality rates demonstrate a healthy vaccinee effect, with rates lowest in the days immediately following vaccination, most apparent in the older age groups. The VSD mortality rate is lower than that in the general U.S. population, and the causes of death are similar. more...

Background. Guillain-Barre syndrome (GBS) is an acute polyradiculoneuropathy, thought to be an autoimmune process. Although cases of GBS have been reported following a wide range of vaccines, a clear association has only been established with the 1976 H1N1 inactivated influenza vaccine. Methods. We identified hospitalized GBS cases from Kaiser Permanente Northern California (KPNC) from 1995 through 2006. The medical record of each suspected case was neurologist-reviewed according to the Brighton Collaboration GBS case definition; only confirmed cases were included in the analyses, and cases of Miller Fisher syndrome were excluded. Using a case-centered design, we compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire KPNC population. Results. We confirmed 415 incident cases of GBS (including Brighton levels 1, 2, and 3) during the study period (>30 million person-years). Incidence peaked during the winter months. The odds ratio of influenza vaccination within a 6-week interval prior to GBS, compared with the prior 9 months, was 1.1 (95% confidence interval [CI], .4–3.1). The risk in the 6-week interval compared to the prior 12 months for tetanus diphtheria combination, 23-valent pneumococcal polysaccharide, and for all vaccines combined was 1.4 (95% CI, .3–4.5), 0.7 (95% CI, .1– 2.9), and 1.3 (95% CI, .8–2.3), respectively. Conclusions. In this large retrospective study, we did not find evidence of an increased risk of GBS following vaccinations of any kind, including influenza vaccination. more...

Background Certain sociodemographic subgroups of HIV-infected patients may experience more chronic disease than others due to behavioural risk factors, advanced HIV disease or complications from extended use of combination antiretroviral therapy (cART), but recent comparative data are limited. Methods We studied HIV-infected adult patients in care during 2006–2010 who had been prescribed ≥6 months of cART. We analysed the prevalence of selected key chronic conditions and polymorbidity (having 2 or more out of 10 key conditions) by gender and race/ethnicity. Results Of the 3,166 HIV-infected patients (median age 47 years, CD4+ T-cell count 496 cells/mm3, duration of cART use 6.8 years), 21% were female, 57% were non-Hispanic White and over half were current or former tobacco smokers. The five most frequent conditions among women (median age 45 years) were dyslipidaemia (67.3%), hypertension (57.4%), obesity (31.7%), viral hepatitis B or C coinfection (29.0%) and low high-density lipoprotein cholesterol (HDLc; 27.3%). The five most frequent conditions in men (median age 47 years) were dyslipidaemia (81.2%), hypertension (54.4%), low HDLc (41.1%), elevated triglycerides (32.3%) and elevated non-HDLc (26.8%). In multivariable analyses, Hispanic patients had higher prevalence of obesity and diabetes than White patients; Black patients had higher prevalence of obesity and hypertension but lower rates of lipid abnormalities. Of all patients, 73.7% of women and 66.8% of men had polymorbidity, with no evidence of disparities by race/ethnicity. Conclusions Among contemporary cART-treated HIV-infected adults, chronic conditions and polymorbidity were common, underscoring the importance of chronic disease prevention and management among ageing HIV-infected patients. more...

Hepatitis C virus (HCV) infection is a leading cause of liver-related morbidity and mortality (1). Transmission of HCV is primarily via parenteral blood exposure, and HCV can be transmitted vertically from mother to child. Vertical transmission occurs in 5.8% (95% confidence interval = 4.2%-7.8%) of infants born to women who are infected only with HCV and in up to twice as many infants born to women who are also infected with human immunodeficiency virus (HIV) (2) or who have high HCV viral loads (3,4); there is currently no recommended intervention to prevent transmission of infection from mother to child (3). Increased reported incidence of HCV infection among persons aged ≤30 years (5,6) with similar increases among women and men in this age group (6), raises concern about increases in the number of pregnant women with HCV infection, and in the number of infants who could be exposed to HCV at birth. Data from one large commercial laboratory and birth certificate data were used to investigate trends in HCV detection among women of childbearing age,* HCV testing among children aged ≤2 years, and the proportions of infants born to HCV-infected women nationally and in Kentucky, the state with the highest incidence of acute HCV infection during 2011-2014 (6). During 2011-2014, commercial laboratory data indicated that national rates of HCV detection (antibody or RNA positivity(†)) among women of childbearing age increased 22%, and HCV testing (antibody or RNA) among children aged ≤2 years increased 14%; birth certificate data indicated that the proportion of infants born to HCV-infected mothers increased 68%, from 0.19% to 0.32%. During the same time in Kentucky, the HCV detection rate among women of childbearing age increased >200%, HCV testing among children aged ≤2 years increased 151%, and the proportion of infants born to HCV-infected women increased 124%, from 0.71% to 1.59%. Increases in the rate of HCV detection among women of childbearing age suggest a potential risk for vertical transmission of HCV. These findings highlight the importance of following current CDC recommendations to identify, counsel, and test persons at risk for HCV infection (1,7), including pregnant women, as well as consider developing public health policies for routine HCV testing of pregnant women, and expanding current policies for testing and monitoring children born to HCV-infected women. Expansion of HCV reporting and surveillance requirements will enhance case identification and prevention strategies. more...

BACKGROUND AND OBJECTIVE: An increased risk of febrile seizure (FS) was identified with concomitant administration of trivalent inactivated influenza vaccine (IIV3) and pneumococcal conjugate vaccine (PCV) 13-valent during the 2010–2011 influenza season. Our objective was to determine whether concomitant administration of IIV3 with other vaccines affects the FS risk. METHODS: We examined the risk of FS 0 to 1 day postvaccination for all routinely recommended vaccines among children aged 6 through 23 months during a period encompassing 5 influenza seasons (2006–2007 through 2010–2011). We used a population-based self-controlled risk interval analysis with a control interval of 14 to 20 days postvaccination. We used multivariable regression to control for receipt of concomitant vaccines and test for interaction between vaccines. RESULTS: Only PCV 7-valent had an independent FS risk (incidence rate ratio [IRR], 1.98; 95% confidence interval [CI], 1.00 to 3.91). IIV3 had no independent risk (IRR, 0.46; 95% CI, 0.21 to 1.02), but risk was increased when IIV3 was given with either PCV (IRR, 3.50; 95% CI, 1.13 to 10.85) or a diphtheria-tetanus-acellular-pertussis (DTaP)-containing vaccine (IRR, 3.50; 95% CI, 1.52 to 8.07). The maximum estimated absolute excess risk due to concomitant administration of IIV3, PCV, and DTaP-containing vaccines compared with administration on separate days was 30 FS per 100 000 persons vaccinated. CONCLUSIONS: The administration of IIV3 on the same day as either PCV or a DTaP-containing vaccine was associated with a greater risk of FS than when IIV3 was given on a separate day. The absolute risk of postvaccination FS with these vaccine combinations was small. more...

Background: From December 2012-March 2014, three randomized trials, each implementing a unique intervention in primary care settings (mail recruitment [repeated-mailing], an electronic health record best practice alert [BPA], and patient-solicitation [patient-solicitation]), evaluated HCV antibody testing, diagnosis, and costs for each of the interventions compared to standard-of-care testing. Multilevel multivariable models were used to estimate the adjusted risk ratio (aRR) for receiving an HCV antibody test, and costs were estimated using activity-based costing. Rationale: To estimate the effects of interventions conducted as part of the Birth-cohort Evaluation to Advance Screening and Testing for Hepatitis C study on hepatitis C virus (HCV) testing and costs among persons of the 1945-1965 birth-cohort (BC). Main Results: Intervention resulted in substantially higher HCV testing rates compared to standard-of-care (26.9% vs. 1.4% for repeated-mailing, 30.9% vs. 3.6% for BPA, and 63.5% vs. 2.0% for patient-solicitation), and significantly higher aRR for testing after controlling for sex, birth year, race, insurance type, and median household income (19.2 [95% Confidence Interval (CI) 9.7-38.2] for repeated-mailing, 13.2 [95% CI 3.6-48.6] for BPA, and 32.9 [95% CI 19.3-56.1] for patient-solicitation). The BPA intervention had the lowest incremental cost per completed test ($24 with fixed startup costs, $3 without) and also the lowest incremental cost per new case identified after omitting fixed startup costs ($1,691). Conclusion: HCV testing interventions resulted in an increase in BC testing compared to standard-of-care but also increased costs. The effect size and incremental costs of BPA intervention (excluding startup costs) support more widespread adoption compared to the other interventions. This article is protected by copyright. All rights reserved. more...

An estimated 3.5 million persons in the United States are living with hepatitis C virus (HCV) infection, resulting in approximately 20,000 deaths each year, primarily from cirrhosis or hepatocellular carcinoma (1,2). American Indian/Alaska Native (AI/AN) populations have the highest incidence of acute HCV infection among all U.S. racial/ethnic groups and are at greater risk for HCV-related mortality compared with the general population (3). In 2013, new antiviral drugs became available that make possible 8-12 week treatment regimens with fewer adverse events and are able to achieve sustained virologic response (SVR) in >90% of treated patients (4), equivalent to a cure of HCV infection. Also of note, HCV testing recommendations were expanded in 2012 by CDC and in 2013 by the U.S. Preventive Services Task Force to include one-time testing of persons born during 1945-1965 (the "baby boomer" cohort) in addition to anyone at increased risk for HCV infection (5,6). Given the availability of new HCV drugs, expanded testing recommendations, and high incidence of HCV infection in AI/AN populations, in October 2012, Cherokee Nation Health Services (CNHS) implemented a tribal HCV testing policy.* As part of the policy, CNHS added a reminder in the electronic health record (EHR) for clinical decision support and provided HCV education to primary care clinicians. From October 2012 to July 2015, among 92,012 persons with at least one CNHS clinic encounter, the cumulative number who received HCV screening for the first time increased from 3,337 (3.6%) to 16,772 (18.2%). The largest percentage of HCV screening was among persons born during 1945-1965. Of 715 persons who tested positive for HCV antibodies, 488 (68.3%) were tested for HCV RNA; among those 488 persons, 388 (79.5%) were RNA positive and were thus confirmed to have chronic HCV infection. Treatment was initiated for 223 (57.5%) of the 388 with chronic infection; 201 (90.1%) completed treatment, of whom 180 (89.6%) achieved SVR. CNHS has successfully increased HCV testing and treatment and is now collaborating with CDC and other external partners to develop an HCV elimination program for the Cherokee Nation that might serve as a model for similar settings. more...

Objective. Hepatitis B virus (HBV) infection continues to be a public health threat in the United States. As many as 2.2 million people are infected, approximately 70% of whom are foreign-born, and fewer than one-third are aware of their infection. We launched an HBV testing and linkage-to-care initiative among foreign-born people. Methods. As part of the Hepatitis Testing and Linkage to Care (HepTLC) initiative, which promoted viral hepatitis B and hepatitis C screening, posttest counseling, and linkage to care at 34 U.S. sites, nine U.S. programs in seven states conducted HBV screening from October 2012 to September 2014. The nine programs partnered with health-care centers and community-based organizations to recruit foreign-born people recommended for HBV testing. We assessed patient characteristics, region of origin, risk factors, hepatitis B surface antigen (HBsAg) status, and referral to medical care. Results. Of 23,144 participants tested for HBV, 1,317 (5.7%) were HBsAg positive. Of these, the median age was 47 years, 1,205 (91%) had at least one risk factor for HBV infection, 1,117 (85%) received posttest counseling, 1,098 (83%) were referred to care, and 606 (46%) attended a first medical appointment. The proportion of HBsAg-positive participants by region of origin included Africa (10%, 206/2,129), Western Pacific (6%, 616/9,673), Eastern Mediterranean (5%, 174/3,337), Southeast Asia (5%, 191/3,891), South America (2%, 6/252), Eastern Europe (2%, 6/262), and North America (1%, 17/1,936). Conclusion. Community-based HBV testing initiatives can identify substantial numbers of people with chronic HBV infection, inform them of their infection status, and provide posttest counseling and linkage to care. However, strategies are needed to improve linkage to HBV-directed medical care for foreign-born individuals living with chronic HBV infection. more...

In the U.S., the burden of hepatitis C virus (HCV) infection and associated sequelae is substantial. HCV prevalence is highest among those born in 1945-1965 (Birth Cohort). Newly diagnosed infections are increasing in younger people concurrent with rising opioid/heroin use. The Centers for Disease Control and Prevention (2012) and U.S. Preventive Services Task Force (2013) recommend HCV testing for at-risk individuals and one-time testing for the Birth Cohort. This study describes national trends in HCV antibody testing from 2005 to 2014.Using commercial and Medicare supplemental insurance claims data, people were identified who were continuously enrolled for ≥2 years during the 10-year study period, without prior HCV diagnosis (N=190,926,299). Current Procedural Terminology codes identified 3,382,267 unique antibody tests. Temporal trends in annual testing were evaluated using the Cochran-Armitage test, and primary ICD-9-CM diagnosis codes used at the time of testing were described. Data were analyzed in 2015 and 2016.Testing was highest among those aged 18-29 and 30-39 years, increasing by 123% (1.66% to 3.71%) and 108% (1.99% to 4.13%), respectively (p0.0001). Among the Birth Cohort, there was a 136% increase in HCV antibody testing from 2005 to 2014, with a 91% increase from 1.71% in 2011 to 3.26% 2014 (p0.0001).Although the increased HCV antibody testing observed among the Birth Cohort from 2011 to 2014 likely reflects early adoption of updated national testing recommendations, overall testing remains low in this commercially insured population, indicating a clear need for improvement. more...

In immunization safety research, individuals are considered at risk for the development of certain adverse events following immunization (AEFI) within a specific period of time referred to as the risk interval. These intervals should ideally be determined based on biologic plausibility considering features of the AEFI, presumed or known pathologic mechanism, and the vaccine. Misspecification of the length and timing of these intervals may result in introducing bias in epidemiologic and clinical studies of immunization safety. To date, little work has been done to formally assess and determine biologically plausible and evidence-based risk intervals in immunization safety research. In this report, we present a systematic process to define biologically plausible and evidence-based risk interval estimates for two specific AEFIs, febrile seizures and acute disseminated encephalomyelitis. In addition, we review methodologic issues related to the determination of risk intervals for consideration in future studies of immunization safety. more...

Inactivated influenza vaccines have been given to pregnant women since 1964. Since 2004, the Advisory Committee on Immunization Practices has recommended that pregnant women receive trivalent inactivated influenza vaccine at any time during pregnancy. Studies conducted before 2009 did not identify any safety concerns after trivalent inactivated influenza vaccine in mothers or their infants. During the 2009-2010 influenza A (H1N1) influenza vaccination program, several monitoring systems were established or enhanced to assess whether adverse events were associated with H1N1 2009 monovalent vaccines (2009 H1N1 influenza vaccines). Data from these systems did not identify any safety concerns in pregnant women who received 2009 H1N1 influenza vaccines or their infants. Although live attenuated influenza vaccines are not recommended in pregnant women, a small number of studies have not shown any safety concern among pregnant women or their infants who were inadvertently exposed to these vaccines. This review summarizes US and international safety data for influenza vaccines in pregnant women with an emphasis on 2009 H1N1 influenza vaccines. more...

Because of widespread distribution of the influenza A (H1N1) 2009 monovalent vaccine (pH1N1 vaccine) and the prior association between Guillain-Barré syndrome (GBS) and the 1976 H1N1 influenza vaccine, enhanced surveillance was implemented to estimate the magnitude of any increased GBS risk following administration of pH1N1 vaccine. The authors conducted active, population-based surveillance for incident cases of GBS among 45 million persons residing at 10 Emerging Infections Program sites during October 2009–May 2010; GBS was defined according to published criteria. The authors determined medical and vaccine history for GBS cases through medical record review and patient interviews. The authors used vaccine coverage data to estimate person-time exposed and unexposed to pH1N1 vaccine and calculated age- and sex-adjusted rate ratios comparing GBS incidence in these groups, as well as age- and sex-adjusted numbers of excess GBS cases. The authors received 411 reports of confirmed or probable GBS. The rate of GBS immediately following pH1N1 vaccination was 57% higher than in person-time unexposed to vaccine (adjusted rate ratio = 1.57, 95% confidence interval: 1.02, 2.21), corresponding to 0.74 excess GBS cases per million pH1N1 vaccine doses (95% confidence interval: 0.04, 1.56). This excess risk was much smaller than that observed during the 1976 vaccine campaign and was comparable to some previous seasonal influenza vaccine risk assessments. more...

Purpose The Centers for Disease Control and Prevention Emerging Infections Program implemented active, population-based surveillance for Guillain–Barre syndrome (GBS) following H1N1 vaccines in 10 states/metropolitan areas. We report additional analyses of these data using self-controlled methods, which avoid potential confounding from person-level factors and co-morbidities. Methods Surveillance officers identified GBS cases with symptom onset during October 2009–April 2010 and ascertained receipt of H1N1 vaccines. We calculated self-controlled relative risks by comparing the number of cases with onset during a risk interval 1–42 days after vaccination with cases with onset during fixed (days 43–84) or variable (days 43–end of study period) control intervals. We calculated attributable risks by applying statistically significant relative risks to an independent estimate of GBS incidence. Results Fifty-nine GBS cases received H1N1 vaccine with or without seasonal vaccine. The relative risk was 2.1 (95%CI 1.2, 3.5) by the variable-window and 3.0 (95%CI 1.4, 6.4) by the fixed-window analyses. The corresponding attributable risks per million doses administered were 1.5 (95%CI 0.3, 3.4) and 2.8 (95%CI 0.6, 7.4). Conclusions These attributable risks are similar to those of some previous formulations of seasonal influenza vaccine (about one to two cases per million doses administered), suggesting a low risk of GBS following the H1N1 vaccine that is not clearly higher than that of seasonal influenza vaccines. Published 2012. This article is a US Government work and is in the public domain in the USA. more...