Estimated Prevalence and Awareness of Hepatitis C Virus Infection Among US Adults: National Health and Nutrition Examination Survey, January 2017-March 2020.

During January 2017-March 2020, approximately 2.2 million noninstitutionalized civilian US adults had hepatitis C; one-third were unaware of their infection. Prevalence was substantially higher among persons who were uninsured or experiencing poverty. Unrestricted access to testing and curative treatment is needed to reduce disparities and achieve 2030 elimination goals.

Prevalence of Hepatitis B Virus Infection Among US Adults Aged 20-59 Years With a History of Injection Drug Use: National Health and Nutrition Examination Survey, 2001-2016.

BACKGROUND: Hepatitis B virus (HBV) can transmit through needle sharing. The national HBV infection prevalence in persons who inject drugs remains ill-defined. We estimated the prevalence of total HBV core antibody (anti-HBc) positivity, indicating a previous or ongoing HBV infection, among adults aged 20-59 years with an injection drug use (IDU) history. We compared select characteristics by anti-HBc status. METHODS: Using 2001-2016 National Health and Nutrition Examination Survey data, we calculated the anti-HBc positivity prevalence among adults with IDU histories and among the general US population. For adults with IDU histories, we compared sex, age group, birth cohort, race/ethnicity, health insurance coverage, and hepatitis A immunity by anti-HBc status. Using marginal structural models, we calculated model-adjusted prevalence rates and ratios to determine the characteristics associated with anti-HBc positivity among adults with IDU histories. RESULTS: From 2001-2016, the anti-HBc positivity prevalence was 19.7% (95% confidence interval [CI] 16.0-24.0%) among those with IDU histories, compared with 4.6% (95% CI 4.3-5.0%) in the general population. The HBV surface antigen positivity prevalence was 0.4% (95% CI 0.3-0.5%) in the general population. Among adults with IDU histories, 19.8% reported prior-year IDU and 28.5% had a hepatitis A immunity. CONCLUSIONS: One-fifth of adults with IDU histories had a previous or ongoing HBV infection: a rate over 4 times higher than the prevalence in the general population. One-fifth of adults with IDU histories reported prior-year use. Programs promoting safe IDU practices, drug treatment, and hepatitis A and B vaccinations should be key components of viral hepatitis prevention.

Deaths Associated With Hepatitis C Virus Infection Among Residents in 50 States and the District of Columbia, 2016-2017.

BACKGROUND: Mortality associated with hepatitis C virus (HCV) has been well-documented nationally, but an examination across regions and jurisdictions may inform health-care planning. METHODS: To document HCV-associated deaths sub-nationally, we calculated age-adjusted, HCV-associated death rates and compared death rate ratios (DRRs) for 10 US regions, 50 states, and Washington, D.C., using the national rate and described rate changes between 2016 and 2017 to determine variability. We examined the mean age at HCV-associated death, and rates and proportions by sex, race/ethnicity, and birth year. RESULTS: In 2017, there were 17 253 HCV-associated deaths, representing 4.13 (95% confidence interval [CI], 4.07-4.20) deaths/100 000 standard population, in a significant, 6.56% rate decline from 4.42 in 2016. Age-adjusted death rates significantly surpassed the US rate for the following jurisdictions: Oklahoma; Washington, D.C.; Oregon; New Mexico; Louisiana; Texas; Colorado; California; Kentucky; Tennessee; Arizona; and Washington (DRRs, 2.87, 2.77, 2.24, 1.62, 1.57, 1.46, 1.36, 1.35, 1.35, 1.35, 1.32, and 1.32, respectively; P < .05). Death rates ranged from a low of 1.60 (95% CI, 1.07-2.29) in Maine to a high of 11.84 (95% CI, 10.82-12.85) in Oklahoma. Death rates were highest among non-Hispanic (non-H) American Indians/Alaska Natives and non-H Blacks, both nationally and regionally. The mean age at death was 61.4 years (range, 56.6 years in West Virginia to 64.1 years in Washington, D.C.), and 78.6% of those who died were born during 1945-1965. CONCLUSIONS: In 2016-2017, the national HCV-associated mortality declined but rates remained high in the Western and Southern regions and Washington, D.C., and among non-H American Indians/Alaska Natives, non-H Blacks, and Baby Boomers. These data can inform local prevention and control programs to reduce the HCV mortality burden.

Susceptibility to Hepatitis A Virus Infection in the United States, 2007-2016.

BACKGROUND: Despite national immunization efforts, including universal childhood hepatitis A (HepA) vaccination recommendations in 2006, hepatitis A virus (HAV)-associated outbreaks have increased in the United States. Unvaccinated or previously uninfected persons are susceptible to HAV infection, yet the susceptibility in the US population is not well known. METHODS: Using National Health and Nutrition Examination Survey 2007-2016 data, we estimated HAV susceptibility prevalence (total HAV antibody negative) among persons aged ≥2 years. Among US-born adults aged ≥20 years, we examined prevalence, predictors, and age-adjusted trends of HAV susceptibility by sociodemographic characteristics. We assessed HAV susceptibility and self-reported nonvaccination to HepA among risk groups and the "immunization cohort" (those born in or after 2004). RESULTS: Among US-born adults aged ≥20 years, HAV susceptibility prevalence was 74.1% (95% confidence interval, 72.9-75.3%) during 2007-2016. Predictors of HAV susceptibility were age group 30-49 years, non-Hispanic white/black, 130% above the poverty level, and no health insurance. Prevalences of HAV susceptibility and nonvaccination to HepA, respectively, were 72.9% and 73.1% among persons who reported injection drug use, 67.5% and 65.2% among men who had sex with men, 55.2% and 75.1% among persons with hepatitis B or hepatitis C, and 22.6% and 25.9% among the immunization cohort. Susceptibility and nonvaccination decreased over time among the immunization cohort but remained stable among risk groups. CONCLUSIONS: During 2007-2016, approximately three-fourths of US-born adults remained HAV susceptible. Enhanced vaccination efforts are critically needed, particularly targeting adults at highest risk for HAV infection, to mitigate the current outbreaks.

Hepatitis B Vaccination and Screening Among Foreign-born Women of Reproductive Age in the United States: 2013-2015.

Background: Mother-to-child transmission of hepatitis B can be prevented with vaccination and screening. Foreign-born women living in the United States may have lower vaccination coverage and greater lifetime exposure to hepatitis B virus than US-born women. This study compares self-reported hepatitis B vaccination and screening between US-born and foreign-born women of reproductive age and examines predictors. Methods: National Health Interview Survey data from 2013-2015 were pooled to estimate the prevalence of lifetime history of hepatitis B vaccination and screening self-reported by women aged 18-44 years who were born in the United States or elsewhere (foreign born). The significance of world region of birth, birth-year cohort, and immigration-related characteristics was considered. Results: Among women of reproductive age (n = 24216), the reported hepatitis B vaccination coverage rate was 33% lower for foreign-born (27.3%) than for US-born (40.9%) women (t test, P < .05). Vaccination coverage was low for women who were born in Mexico/Central America/Caribbean islands (18.4%), South America (25.3%), and the Indian subcontinent (31.7%). Education, income, and insurance coverage were associated with vaccination in both groups. Screening was reported by 28.5% of foreign-born versus 31.9% of US-born women (t test, P < .05). The lowest reported screening prevalence occurred among foreign-born Hispanic or Latina Mexican (21.0%) and Puerto Rican (21.9%) women. Factors associated with screening prevalence among foreign-born women included English fluency, recent US residency, and citizenship. Conclusions: Foreign-born women of reproductive age had lower hepatitis B vaccination and screening coverage than US-born women of reproductive age.

Hepatitis C Virus Infection Among Reproductive-Aged Women and Children in the United States, 2006 to 2014.

BACKGROUND: In the United States, hepatitis C virus (HCV) infection has increased among young persons who inject drugs, but the extent of this epidemic among reproductive-aged women and their children is unknown. OBJECTIVE: To estimate numbers and describe characteristics of reproductive-aged women with HCV infection and of their offspring. DESIGN: Analysis of the National Notifiable Diseases Surveillance System (NNDSS) from 2006 to 2014 and the Quest Diagnostics Health Trends national database from 2011 to 2014. SETTING: United States. PARTICIPANTS: 171 801 women (aged 15 to 44 years) and 1859 children (aged 2 to 13 years) with HCV infection reported to the NNDSS; 2.1 million reproductive-aged women and 56 684 children who had HCV testing by Quest Diagnostics. MEASUREMENTS: NNDSS HCV case reports and Quest laboratory data regarding unique reproductive-aged women and children who were tested for HCV infection. RESULTS: The number of reproductive-aged women with acute and past or present HCV infection in the NNDSS doubled, from 15 550 in 2006 to 31 039 in 2014. Of 581 255 pregnant women tested by Quest from 2011 to 2014, 4232 (0.73% [95% CI, 0.71% to 0.75%]) had HCV infection. Of children tested by Quest, 0.76% (CI, 0.69% to 0.83%) had HCV infection, but the percentage was 3.2-fold higher among children aged 2 to 3 years (1.62% [CI, 1.34% to 1.96%]) than those aged 12 to 13 years (0.50% [CI, 0.41% to 0.62%]). Applying the Quest HCV infection rate to annual live births from 2011 to 2014 resulted in an estimated average of 29 000 women (CI, 27 400 to 30 900 women) with HCV infection, who gave birth to 1700 infants (CI, 1200 to 2200 infants) with the infection each year. LIMITATIONS: Only a fraction of HCV infections is detected and reported to the NNDSS. Quest data are potentially biased, because women who are asymptomatic, do not access health care, or have unreported risks may be less likely to be tested for HCV infection. CONCLUSION: These data suggest a recent increase in HCV infection among reproductive-aged women and may inform deliberations regarding a role for routine HCV screening during pregnancy. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention.

Prevalence of chronic hepatitis B virus (HBV) infection in U.S. households: National Health and Nutrition Examination Survey (NHANES), 1988-2012.

UNLABELLED: The number of persons with chronic hepatitis B virus (HBV) infection in the United States is affected by diminishing numbers of young persons who are susceptible because of universal infant vaccination since 1991, offset by numbers of HBV-infected persons migrating to the United States from endemic countries. The prevalence of HBV infection was determined by serological testing and analysis among noninstitutionalized persons age 6 years and older for: antibody to hepatitis B core antigen (anti-HBc), indicative of previous HBV infection; hepatitis B surface antigen (HBsAg), indicative of chronic (current) infection; and antibody to hepatitis B surface antigen (anti-HBs), indicative of immunity from vaccination. These prevalence estimates were analyzed in three periods of the National Health and Nutrition Examination Survey (NHANES): 1988-1994 (21,260 persons); 1999-2008 (29,828); and 2007-2012 (22,358). In 2011-2012, for the first time, non-Hispanic Asians were oversampled in NHANES. For the most recent period (2007-2012), 3.9% had anti-HBc, indicating approximately 10.8 (95% confidence interval [CI]: 9.4-12.2) million noninstitutionalized U.S. residents having ever been infected with HBV. The overall prevalence of chronic HBV infection has remained constant since 1999: 0.3% (95% CI: 0.2-0.4), and since 1999, prevalence of chronic HBV infection among non-Hispanic blacks has been 2- to 3-fold greater than the general population. An estimated 3.1% (1.8%-5.2%) of non-Hispanic Asians were chronically infected with HBV during 2011-2012, which reflects a 10-fold greater prevalence than the general population. Adjusted prevalence of vaccine-induced immunity increased 16% since 1999, and the number of persons (mainly young) with serological evidence of vaccine protection from HBV infection rose from 57.8 (95% CI: 55.4-60.1) million to 68.5 (95% CI: 65.4-71.2) million. CONCLUSION: Despite increasing immune protection in young persons vaccinated in infancy, an analysis of chronic hepatitis B prevalence in racial and ethnic populations indicates that during 2011-2012, there were 847,000 HBV infections (which included ~400,000 non-Hispanic Asians) in the noninstitutionalized U.S. POPULATION.

Rising Mortality Associated With Hepatitis C Virus in the United States, 2003-2013.

In the United States, hepatitis C virus (HCV)-associated mortality is increasing. From 2003-2013, the number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined. The increasing HCV-associated mortality trend underscores the urgency in finding, evaluating, and treating HCV-infected persons.

Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010.

BACKGROUND: Knowledge of the number of persons with chronic hepatitis C virus (HCV) infection in the United States is critical for public health and policy planning. OBJECTIVE: To estimate the prevalence of chronic HCV infection between 2003 and 2010 and to identify factors associated with this condition. DESIGN: Nationally representative household survey. SETTING: U.S. noninstitutionalized civilian population. PARTICIPANTS: 30,074 NHANES (National Health and Nutrition Examination Survey) participants between 2003 and 2010. MEASUREMENTS: Interviews to ascertain demographic characteristics and possible risks and exposures for HCV infection. Serum samples from participants aged 6 years or older were tested for antibody to HCV; if results were positive or indeterminate, the samples were tested for HCV RNA, which indicates current chronic infection. RESULTS: Based on 273 participants who tested positive for HCV RNA, the estimated prevalence of HCV infection was 1.0% (95% CI, 0.8% to 1.2%), corresponding to 2.7 million chronically infected persons (CI, 2.2 to 3.2 million persons) in the U.S. noninstitutionalized civilian population. Infected persons were more likely to be aged 40 to 59 years, male, and non-Hispanic black and to have less education and lower family income. Factors significantly associated with chronic HCV infection were illicit drug use (including injection drugs) and receipt of a blood transfusion before 1992; 49% of persons with HCV infection did not report either risk factor. LIMITATION: Incarcerated and homeless persons were not surveyed. CONCLUSION: This analysis estimated that approximately 2.7 million U.S. residents in the population sampled by NHANES have chronic HCV infection, about 500,000 fewer than estimated in a similar analysis between 1999 and 2002. These data underscore the urgency of identifying the millions of persons who remain infected and linking them to appropriate care and treatment. PRIMARY FUNDING SOURCE: None.

Causes of death and characteristics of decedents with viral hepatitis, United States, 2010.

BACKGROUND: Previous research indicates that the mortality burden from viral hepatitis is growing, particularly among middle-aged persons. To monitor progress toward prevention goals, it is important to continue to document characteristics and comortalities of these deaths. This study sought to examine demographic characteristics and the most frequent causes of death among decedents with a viral hepatitis-related death. METHODS: A cross-sectional study was performed on approximately 2.4 million death records from 2010. We calculated mortality rates for decedents with and without hepatitis A, B, and C virus (HAV, HBV, and HCV) and relative risks for the most frequently cited conditions in decedents with and without HBV and HCV. RESULTS: In 2010, there were 18 473 (0.7%) deaths with HAV, HBV, and HCV listed among causes of death, disproportionately in those aged 45-64 years. Among the 10 frequent causes of death, decedents listing HBV or HCV died, on average, 22-23 years earlier than decedents not listing these infections. HBV- and HCV-infected decedents aged 45-64 years had an increased risk of having the following conditions reported than decedents without these infections: cancer of liver and intrahepatic bile duct; fibrosis, cirrhosis, and other liver diseases; alcohol-related liver disease; gastrointestinal hemorrhage; human immunodeficiency infection; acute and unspecified renal failure; and septicemia (HCV only). CONCLUSIONS: Decedents with other causes of death that include HBV or HCV died 22-23 years earlier than decedents not listing these infections. These data suggest and support the need for prevention, early identification, and treatment of HBV and HCV.

Estimating acute viral hepatitis infections from nationally reported cases.

OBJECTIVES: Because only a fraction of patients with acute viral hepatitis A, B, and C are reported through national surveillance to the Centers for Disease Control and Prevention, we estimated the true numbers. METHODS: We applied a simple probabilistic model to estimate the fraction of patients with acute hepatitis A, hepatitis B, and hepatitis C who would have been symptomatic, would have sought health care tests, and would have been reported to health officials in 2011. RESULTS: For hepatitis A, the frequencies of symptoms (85%), care seeking (88%), and reporting (69%) yielded an estimate of 2730 infections (2.0 infections per reported case). For hepatitis B, the frequencies of symptoms (39%), care seeking (88%), and reporting (45%) indicated 18 730 infections (6.5 infections per reported case). For hepatitis C, the frequency of symptoms among injection drug users (13%) and those infected otherwise (48%), proportion seeking care (88%), and percentage reported (53%) indicated 17 100 infections (12.3 infections per reported case). CONCLUSIONS: These adjustment factors will allow state and local health authorities to estimate acute hepatitis infections locally and plan prevention activities accordingly.

Hepatitis C Virus Testing, Infection, and Cases Reported Through Public Health Surveillance During Expanded Screening Recommendations, United States, 2013-2021.

OBJECTIVES: Hepatitis C virus (HCV) infection is the most common bloodborne infection in the United States. We assessed trends in HCV testing, infection, and surveillance cases among US adults. METHODS: We used Quest Diagnostics data from 2013-2021 to assess trends in the numbers tested for HCV antibody and proportion of positivity for HCV antibody and HCV RNA. We also assessed National Notifiable Diseases Surveillance System 2013-2020 data for trends in the number and proportion of hepatitis C cases. We applied joinpoint regression for trends testing. RESULTS: Annual HCV antibody testing increased from 1.7 million to 4.8 million from 2013 to 2021, and the positivity proportion declined (average, 0.2% per year) from 5.5% to 3.7%. The greatest percentage-point increase in HCV antibody testing occurred in hospitals and substance use disorder treatment facilities and among addiction medicine providers. HCV RNA positivity was stable at about 60% in 2013-2015 and declined to 41.0% in 2021 (2015-2021 average, -3.2% per year). Age-specific HCV RNA positivity was highest among people aged 40-59 years during 2013-2015 and among people aged 18-39 years during 2016-2021. The number of reported hepatitis C cases (acute and chronic) declined from 179 341 in 2015 to 105 504 in 2020 (average decline, -13 177 per year). The proportion of hepatitis C cases among those aged 18-39 years increased by an average of 1.4% per year during 2013-2020; among individuals aged 40-59 years, it decreased by an average of 2.3% per year during 2013-2018. CONCLUSIONS: HCV testing increased, suggesting improved universal screening. Various data sources are valuable for monitoring elimination progress.

Awareness of infection, knowledge of hepatitis C, and medical follow-up among individuals testing positive for hepatitis C: National Health and Nutrition Examination Survey 2001-2008.

UNLABELLED: Many persons infected with hepatitis C virus (HCV) are unknown to the healthcare system because they may be asymptomatic for years, have not been tested for HCV infection, and only seek medical care when they develop liver-related complications. We analyzed data from persons who tested positive for past or current HCV infection during participation in the National Health and Nutrition Examination Survey (NHANES) from 2001 through 2008. A follow-up survey was conducted 6 months after examination to determine (1) how many participants testing positive for HCV infection were aware of their HCV status before being notified by NHANES, (2) what actions participants took after becoming aware of their first positive test, and (3) participants' knowledge about hepatitis C. Of 30,140 participants tested, 393 (1.3%) had evidence of past or current HCV infection and 170 (43%) could be contacted during the follow-up survey and interviewed. Only 49.7% were aware of their positive HCV infection status before being notified by NHANES, and only 3.7% of these respondents reported that they had first been tested for HCV because they or their doctor thought they were at risk for infection. Overall, 85.4% had heard of hepatitis C; correct responses to questions about hepatitis C were higher among persons 40-59 years of age, white non-Hispanics, and respondents who saw a physician after their first positive HCV test. Eighty percent of respondents indicated they had seen a doctor about their first positive HCV test result. CONCLUSION: These data indicate that fewer than half of those infected with HCV may be aware of their infection. The findings suggest that more intensive efforts are needed to identify and test persons at risk for HCV infection.

An assessment of the performance of self-reported vaccination status for hepatitis B, National Health and Nutrition Examination Survey 1999-2008.

OBJECTIVES: We sought to assess the performance of self-reported vaccination with hepatitis B vaccine (HepB) compared with serological status for hepatitis B markers in the general US civilian population. METHODS: Using 1999 through 2008 National Health and Nutrition Examination Survey data, we calculated 3 measures of agreement between self-reported HepB vaccination status and serological status: percent concordance, and positive (PPV) and negative predictive values (NPV) of self-report. Logistic regression was used to identify factors associated with agreement between self-report and serological status. RESULTS: Overall agreement was 83% (95% CI = 82.3, 83.7), NPV of self-report was high (0.95; 95% CI = 0.93, 0.95) and PPV was low (0.53; 95% CI = 0.51, 0.54). Birth year relative to the 1991 recommendation for universal infant HepB vaccination had a strong association with agreement, however, the association was positive for those who reported receiving at least 3 doses and negative for those who reported receiving no doses. CONCLUSIONS: Although the low PPV in our study could be attributable in part to waning of vaccine-induced anti-HBs over time, national adult HepB vaccination coverage may be lower than previously estimated because national estimates usually depend on self-report of vaccine receipt.

The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007.

BACKGROUND: The increasing health burden and mortality from hepatitis B virus (HBV) and hepatitis C virus (HCV) in the United States are underappreciated. OBJECTIVE: To examine mortality from HBV; HCV; and, for comparison, HIV. DESIGN: Analysis of U.S. multiple-cause mortality data from 1999 to 2007 from the National Center for Health Statistics. SETTING: All U.S. states and the District of Columbia. PARTICIPANTS: Approximately 22 million decedents. MEASUREMENTS: Age-adjusted mortality rates from HBV, HCV, and HIV. Logistic regression analyses of 2007 data generated 4 independent models per outcome (HCV- or HBV-related deaths) that each included 1 of 4 comorbid conditions and all sociodemographic characteristics. RESULTS: Between 1999 and 2007, recorded deaths from HCV [corrected] increased significantly to 15,106, whereas deaths from HIV declined to 12,734 by 2007. Factors associated with HCV-related deaths included chronic liver disease, HBV co-infection, alcohol-related conditions, minority status, and HIV co-infection. Factors that increased odds of HBV-related death included chronic liver disease, HCV co-infection, Asian or Pacific Islander descent, HIV co-infection, and alcohol-related conditions. Most deaths from HBV and HCV occurred in middle-aged persons. LIMITATION: A person other than the primary physician of the decedent frequently completed the death certificate, and HCV and HBV often were not detected and thus not reported as causes of death. CONCLUSION: By 2007, HCV had superseded HIV as a cause of death in the United States, and deaths from HCV and HBV disproportionately occurred in middle-aged persons. To achieve decreases in mortality similar to those seen with HIV requires new policy initiatives to detect patients with chronic hepatitis and link them to care and treatment. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention.

Rising Trends in Emergency Department Visits Associated With Hepatitis C Virus Infection in the United States, 2006-2014.

OBJECTIVE: Emergency departments (EDs) are critical settings for hepatitis C care in the United States. We assessed trends and characteristics of hepatitis C-associated ED visits during 2006-2014. METHODS: We used data from the 2006-2014 Nationwide Emergency Department Sample to estimate numbers, rates, and costs of hepatitis C-associated ED visits, defined by either first-listed diagnosis of hepatitis C or all-listed diagnosis of hepatitis C. We assessed trends by demographic characteristics, liver disease severity, and patients' disposition by using joinpoint analysis, and we calculated the average annual percentage change (AAPC) from 2006 to 2014. RESULTS: During 2006-2014, the rate per 100 000 visits of first-listed and all-listed hepatitis C-associated ED visits increased significantly from 10.1 to 25.4 (AAPC = 13.0%; P < .001) and from 484.4 to 631.6 (AAPC = 3.4%; P < .001), respectively. Approximately 70% of these visits were made by persons born during 1945-1965 (baby boomers); 30% of visits were made by Medicare beneficiaries and 40% by Medicaid beneficiaries. Significant rate increases were among visits by baby boomers (first-listed: AAPC = 13.8%; all-listed: AAPC = 2.6%), persons born after 1965 (first-listed: AAPC = 14.3%; all-listed: AAPC = 9.2%), Medicare beneficiaries (first-listed: AAPC = 18.0%; all-listed: AAPC = 3.9%), and persons hospitalized after ED visits (first-listed: AAPC = 20.0%; all-listed: AAPC = 2.3%; all P < .001). Increasing proportions of compensated cirrhosis were among visits by baby boomers (first-listed: AAPC = 11.5%; all-listed: AAPC = 6.3%). Annual hepatitis C-associated total ED costs increased by 400.0% (first-listed) and 192.0% (all-listed) during 2006-2014. CONCLUSION: Public health efforts are needed to address the growing burden of hepatitis C care in the ED.

Sofosbuvir-Based Regimens for Chronic Hepatitis C in a Well-Insured U.S. Population: Patient Characteristics, Treatment Adherence, Effectiveness, and Health Care Costs, 2013-2015.

BACKGROUND: Chronic hepatitis C (CHC) is a leading cause of morbidity and mortality and has imposed a high health care burden in the United States. Direct-acting antiviral (DAA) regimens are well tolerated and highly effective for CHC therapy but were initially marketed at a high price. Studies of their real-world use with a nationwide population are limited. OBJECTIVE: To examine patient characteristics, treatment adherence, effectiveness, and health care costs in a large U.S. population with commercial and Medicare supplemental insurance plans who received simeprevir (SIM), sofosbuvir (SOF), or ledipasvir/sofosbuvir (LED/SOF) during the years 2013-2015. METHODS: Patients with at least 1 diagnosis code for CHC and at least 1 claim for SIM, SOF, or LED/SOF prescriptions were selected. The date of the first claim for SIM, SOF, or LED/SOF was defined as the index date. Analyses were stratified by 4 regimens: SOF + SIM ± ribavirin (RBV), SOF + peginterferon alpha-2a or 2b (PEG) + RBV, SOF + RBV, and LED/SOF ± RBV. Adherence was defined by the proportion of days covered (PDC) ≥ 80%. Sustained virologic response (SVR12) was defined as a hepatitis C virus (HCV) RNA load of ≤ 25 IU/mL measured at ≥ 12 weeks following the end of the days supply of the last DAA refill. Health care costs such as DAA drug costs and medical costs (inpatient costs plus outpatient costs) were described. RESULTS: Of 10,808 CHC patients, approximately two thirds were male, and mean age was 55 years. The proportion of patients with compensated cirrhosis among each regimen ranged from 7.4% in LED/SOF ± RBV to 13.8% in SOF + SIM ± RBV, and the proportion of patients with decompensated cirrhosis ranged from 3.9% in LED/SOF ± RBV to 10.7% in SOF + SIM ± RBV. The majority of patients (89.0%) used the newer regimen LED/SOF ± RBV in 2015. Adherence rates were estimated at 80.5%, 81.5%, 85.7%, and 91.4% for SOF + SIM ± RBV (n = 1,761); SOF + PEG + RBV (n = 1,314); SOF + RBV (n = 1,994); and LED/SOF ± RBV (n = 5,739), respectively. Regimen-specific adherence predictors included sex, age group, payer type, health plan, and treatment option with RBV. Being born during 1945-1965, liver disease severity, and Charlson Comorbidity Index levels did not predict adherence in any regimen. Overall SVR12 was 92.6% in 203 patients with available HCV RNA results: 100% (41/41) in SOF + SIM ± RBV; 83.3% (25/30) in SOF + PEG + RBV; 90.6% (29/32) in SOF + RBV; and 93% (93/100) in LED/SOF ± RBV. While the drug costs for these DAA regimens were initially high, they had decreased 18.9% (P < 0.001) during 2013-2015. Medical costs decreased 9.2% (P < 0.001) 1 year after the index dates. CONCLUSIONS: These results indicate that DAA drug costs decreased steadily during 2013-2015 and that 89% of patients on SOF-based DAA regimens took newer, lower-cost regimens with adherence rates above 80%. Available data show that SVR12 rates were close to those obtained in clinical studies. Medical costs also significantly decreased 1 year after the index dates. DISCLOSURES: No outside funding supported this study. All authors are U.S. federal employees of the Centers for Disease Control and Prevention. The authors declare that they have no competing interests. The findings and conclusions in this research are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Chronic disease in health emergencies: in the eye of the hurricane.

INTRODUCTION: Inadequately controlled chronic diseases may present a threat to life and well-being during the emergency response to natural disasters. An estimate of the possible numbers of people who may require treatment for chronic diseases should help in planning a response, but such information for local areas is not easily accessible. We explored how a current surveillance system could be used to provide estimates of the potential needs for emergency treatment of chronic diseases in the wake of a natural disaster. METHODS: We used data from adults aged 18 years or older who participated in the Behavioral Risk Factor Surveillance System (BRFSS) in 2004 to estimate the prevalence and numbers of people with diabetes, heart disease, stroke, hypertension, and current asthma who lived in the New Orleans-Metairie-Kenner, La, metropolitan statistical area. RESULTS: About 9.0% of participants had diabetes, 4.6% had angina or coronary heart disease, 3.0% had had a myocardial infarction, 2.0% had had a stroke, and 6.3% had current asthma. About 25.4% adults had at least one of the above conditions. CONCLUSION: A surveillance system such as the BRFSS can provide potentially useful baseline information about the numbers of people with chronic diseases and the treatment that they receive; this information can assist the medical and public health community in assessing the needs of people with chronic diseases after disasters and in planning relief efforts.