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More than 2 million adults have hepatitis C virus (HCV) infection in the United States, and new infections continue to increase. Without treatment, HCV infection can lead to advanced liver disease and death. Treatment is recommended for nearly everyone with hepatitis C, resulting in a cure in >95% of people treated and raising the possibility of hepatitis C elimination. Testing is the first step to accessing life-saving treatment. The Centers for Disease Control and Prevention recommends hepatitis C screening for all adults, all pregnant persons, and anyone with risk; yet about one-third of people with hepatitis C remain unaware of their infection. Testing begins with a hepatitis C antibody test, followed, when reactive, by a nucleic acid test to detect HCV RNA. This antibody-first, 2-step testing strategy misses early infections and can result in incomplete diagnoses. Advancements in hepatitis C diagnostics and the US regulatory landscape have created an opportunity to include viral-first testing strategies and improve hepatitis C diagnosis. This journal supplement features 8 articles detailing challenges and opportunities for improving hepatitis C diagnostics in support of advancing hepatitis C elimination in the United States. [ABSTRACT FROM AUTHOR]

The article focuses on the study that analyzes the progression of hepatitis C virus (HCV) clearance in the U.S. and the need to monitor progress towards national elimination goals.

Objectives: We measured patient engagement in the human immunodeficiency virus (HIV) continuum of care in Tennessee after implementation of enhanced surveillance activities to assess progress toward 2015 statewide goals. We also examined subgroup disparities to identify groups at risk for poor outcomes. Methods: We estimated linkage to care, retention in care, and viral suppression among HIV-infected people in Tennessee in 2013, overall and by subgroup, after implementation of enhanced laboratory reporting, address verification, and death-matching procedures. Results: Of 792 people newly diagnosed with HIV infection in 2013, 632 (79.8%) were linked to care, close to the 2015 goal of ≥80%. Of 15 473 people living and diagnosed with HIV infection before 2013, 8458 (54.7%) were retained in care, approaching the 2015 goal of ≥64.0%. A total of 8640 (55.8%) were virally suppressed, surpassing the 2015 goal of ≥51.0%. Compared with people living and diagnosed with HIV infection before 2013, newly diagnosed people were more likely to be younger, male, non-Hispanic black, and men who have sex with men (MSM). For linkage to care, retention in care, and viral suppression, younger and non-Hispanic black people fared worse, whereas females and those enrolled in the Ryan White program fared better. For retention in care and viral suppression, Hispanic people, injection drug users, and East Tennessee residents fared worse than those in Memphis, whereas MSM fared better. Nashville residents fared worse in retention in care than Memphis residents. Conclusion: Tennessee's HIV continuum of care in 2013 showed progress toward 2015 goals. Future efforts to improve the HIV continuum of care should be directed toward vulnerable groups and regions, particularly young, non-Hispanic black, and Hispanic people; injection drug users; and residents of the East Tennessee and Nashville regions. [ABSTRACT FROM AUTHOR]

New U.S. Centers for Disease Control and Prevention (CDC) guidelines for hepatitis C virus (HCV) testing of perinatally exposed infants and children released in 2023 recommend a nucleic acid test (NAT) for detection of HCV ribonucleic acid (i.e., NAT for HCV RNA) at 2–6 months of age to facilitate early identification and linkage to care for children with perinatally acquired HCV infection. Untreated hepatitis C can lead to cirrhosis, liver cancer, and premature death and is caused by HCV, a blood-borne virus transmitted most often among adults through injection drug use in the United States. Perinatal exposure from a birth parent with HCV infection is the most frequent mode of HCV transmission among infants and children. New HCV infections have been increasing since 2010, with the highest rates of infection among people aged 20–39 years, leading to an increasing prevalence of HCV infection during pregnancy. In 2020, the CDC recommended one-time HCV screening for all adults aged 18 years and older and for all pregnant persons during each pregnancy. Detecting HCV infection during pregnancy is key for the identification of pregnant persons, linkage to care for postpartum treatment, and identification of infants with perinatal exposure for HCV testing. It was previously recommended that children who were exposed to HCV during pregnancy receive an antibody to HCV (anti-HCV) test at 18 months of age; however, most children were lost to follow-up before testing occurred, leaving children with perinatal infection undiagnosed. The new strategy of testing perinatally exposed children at age 2–6 months was found to be cost-effective in increasing the identification of infants who might develop chronic hepatitis C. This report describes the current perinatal HCV testing recommendations and how they advance national hepatitis C elimination efforts by improving the health of pregnant and postpartum people and their children. [ABSTRACT FROM AUTHOR]

Introduction: There are limited and conflicting data regarding the impact of hepatitis C in pregnancy on adverse birth outcomes. Methods: Using the Surveillance for Emerging Threats to Pregnant People and Infants Network (SET-NET), a large surveillance cohort, we describe birth outcomes among a cohort of people with HCV in pregnancy in total and by reported substance use. Results: Among 1418 infants, 89% were born to people with reported substance use during pregnancy. The proportion born preterm was 20%, 13% were small-for-gestational age and 34% of term infants required intensive care. Conclusions: Assessments of recent changes to recommendations for HCV screening in pregnancy should evaluate the impact on maternal access to care for both HCV treatment as well as comorbidities such as substance use disorder which may contribute to adverse birth outcomes. Significance: Incidence of hepatitis C in pregnancy is increasing. Prematurity, small-for-gestational age, and intensive care unit admission were common among this surveillance cohort of infants born to people with hepatitis C in pregnancy with high frequency of substance use. Assessments of recent changes to recommendations for HCV screening in pregnancy should evaluate the impact on maternal access to care for both HCV treatment as well as comorbidities such as substance use disorder which may contribute to adverse birth outcomes. [ABSTRACT FROM AUTHOR]

Hepatitis C is a deadly, yet curable, disease. National hepatitis C elimination goals for 2030 call for at least 80% of persons with hepatitis C to achieve viral clearance. A welltolerated treatment results in sustained viral clearance in =95% of cases. Hepatitis C virus (HCV) clearance cascades characterize a sequence of steps that follow the progression from testing to sustained viral clearance. Monitoring HCV clearance cascades is important for tracking progress toward elimination goals and identifying gaps in diagnosis, treatment, and prevention. State-specific HCV clearance cascades based on laboratory results were developed using longitudinal data from a large national, commercial laboratory during January 1, 2013-December 31, 2022. State-level estimates of viral testing among persons with evidence of past or current HCV infection ranged from 51% (Hawaii) to 99% (South Dakota), and hepatitis C viral clearance among persons with diagnosed HCV infection ranged from 10% (West Virginia) to 51% (Connecticut). These are the first state-level estimates using CDC guidance and data from a large commercial laboratory with national coverage to generate HCV clearance cascades. These estimates reveal substantial gaps in hepatitis C diagnosis, treatment, and prevention and can help guide prioritization of activities and resources to achieve hepatitis C elimination goals. [ABSTRACT FROM AUTHOR]

The article comments on the development of a standardized, laboratory result-based hepatitis C virus (HCV) clearance cascade for public health jurisdictions. It identifies elements for constructing a population-level HCV cascade, as well as the important data-to-share opportunities measured by a laboratory result-based HCV cascade. It informs about the funding to support health departments to implement laboratory result-based HCV cascades and cites limitations of HCV cascade.

Current hepatitis C virus (HCV) testing guidance recommends a two-step testing sequence for diagnosis of HCV infection. Performing an HCV RNA test whenever an HCV antibody test is reactive (complete testing) is critical to achieve national HCV elimination goals. When an HCV antibody test is reactive and no HCV RNA test is performed, testing is considered incomplete. Historically, approximately one third of patients have incomplete testing. This update clarifies that all sites performing HCV screening should ensure single-visit sample collection. This approach allows for automatic HCV RNA testing when an HCV antibody test is reactive to avoid incomplete testing. Use of strategies that require multiple visits to collect HCV testing samples should be discontinued. Automatic HCV RNA testing on all HCV antibody reactive samples will increase the percentage of patients with current HCV infection who are linked to care and receive curative antiviral therapy. [ABSTRACT FROM AUTHOR]

Hepatitis A is a vaccine-preventable disease typically acquired through fecal-oral transmission. Hepatitis A virus (HAV) infection rates in the United States declined approximately 97% during 1995-2015 after the introduction and widespread pediatric use of hepatitis A vaccines (1). Since 2016, hepatitis A outbreaks have been reported in 37 states, involving approximately 44,650 cases, 27,250 hospitalizations, and 415 deaths as of September 23, 2022 (2). A report describing early outbreaks in four states during 2017 noted that most infections occurred among persons reporting injection or noninjection drug use or experiencing homelessness; this finding signaled a shift in HAV infection epidemiology from point-source outbreaks associated with contaminated food to large community outbreaks associated with person-to-person transmission (3). CDC analyzed interim data from 33 outbreak-affected states to characterize demographic, risk factor, and clinical outcome data from 37,553 outbreak-associated hepatitis A cases reported during August 1, 2016-December 31, 2020. Among persons with available risk factor or clinical outcome information, 56% reported drug use, 14% reported experiencing homelessness, and 61% had been hospitalized; 380 outbreak-associated deaths were reported. The most effective means to prevent and control hepatitis A outbreaks is through hepatitis A vaccination, particularly for persons at increased risk for HAV infection (4). The epidemiologic shifts identified during these outbreaks led to a 2019 recommendation by the Advisory Committee on Immunization Practices (ACIP) for vaccination of persons experiencing homelessness and reinforcement of existing vaccination recommendations for persons who use drugs (4). Substantial progress in the prevention and control of hepatitis A has been made; the number of outbreak-affected states has been reduced from 37 to 13 (2). Increased hepatitis A vaccination coverage, particularly through implementation of successful, nontraditional vaccination strategies among disproportionately affected populations (5), is needed to continue progress in halting current outbreaks and preventing similar outbreaks in the future. [ABSTRACT FROM AUTHOR]

Objective: Maternal hepatitis C virus (HCV) infection reported on birth certificates has been shown to underestimate HCV infection. We sought to determine the usefulness of HCV surveillance data for (1) quantifying the number of HCV-positive reproductive-aged women with a live birth, (2) comparing maternal HCV surveillance data with reported HCV infection status on birth certificates, and (3) delineating past versus current maternal infection to identify true perinatal exposures. Methods: We extracted data from January 1, 2013, through December 31, 2017, on birth certificate indication of HCV exposure from the Tennessee Birth Statistical File, and we ascertained indication of HCV exposure by using laboratory data from the Tennessee National Electronic Disease Surveillance System (NEDSS) Base System (NBS). We conducted a sensitivity analysis comparing birth certificate indication of HCV exposure with HCV laboratory data to determine whether true perinatal exposure had occurred. Results: During the study period, 6731 mothers with live births in Tennessee reported having HCV infection during pregnancy: 3295 (49.0%) had both laboratory and birth certificate indication of HCV infection, 2130 (31.6%) had indication of HCV infection on the laboratory report only, and 1306 (19.4%) had indication of HCV infection on the birth certificate only. Conclusions: Using data from a public health HCV surveillance system with birth certificate data may improve the identification of HCV-infected pregnant women and perinatally exposed infants. Surveillance systems that include complete reporting of all HCV RNA results can be used to distinguish past from present maternal HCV infection to focus limited public health resources on currently infected mothers and their exposed infants. [ABSTRACT FROM AUTHOR]

Introduction: Over 2 million adults in the United States have hepatitis C virus (HCV) infection, and it contributes to approximately 14,000 deaths a year. Eight to 12 weeks of highly effective direct-acting antiviral (DAA) treatment, which can cure ≥95% of cases, is recommended for persons with hepatitis C.Methods: Data from HealthVerity, an administrative claims and encounters database, were used to construct a cohort of adults aged 18-69 years with HCV infection diagnosed during January 30, 2019-October 31, 2020, who were continuously enrolled in insurance for ≥60 days before and ≥360 days after diagnosis (47,687). Multivariable logistic regression was used to assess the association between initiation of DAA treatment and sex, age, race, payor, and Medicaid restriction status; adjusted odds ratios (aORs) and 95% CIs were calculated.Results: The prevalence of DAA treatment initiation within 360 days of the first positive HCV RNA test result among Medicaid, Medicare, and private insurance recipients was 23%, 28%, and 35%, respectively; among those treated, 75%, 77%, and 84%, respectively, initiated treatment within 180 days of diagnosis. Adjusted odds of treatment initiation were lower among those with Medicaid (aOR = 0.54; 95% CI = 0.51-0.57) and Medicare (aOR = 0.62; 95% CI = 0.56-0.68) than among those with private insurance. After adjusting for insurance type, treatment initiation was lowest among adults aged 18-29 and 30-39 years with Medicaid or private insurance, compared with those aged 50-59 years. Among Medicaid recipients, lower odds of treatment initiation were found among persons in states with Medicaid treatment restrictions (aOR = 0.77; 95% CI = 0.74-0.81) than among those in states without restrictions, and among persons whose race was coded as Black or African American (Black) (aOR = 0.93; 95% CI = 0.88-0.99) or other race (aOR = 0.73; 95% CI = 0.62-0.88) than those whose race was coded as White.Conclusions and Implications For Public Health Practice: Few insured persons with diagnosed hepatitis C receive timely DAA treatment, and disparities in treatment exist. Unrestricted access to timely DAA treatment is critical to reducing viral hepatitis-related mortality, disparities, and transmission. Treatment saves lives, prevents transmission, and is cost saving. [ABSTRACT FROM AUTHOR]

Hepatitis B (HepB) vaccines have demonstrated safety, immunogenicity, and efficacy during the past 4 decades (1,2). However, vaccination coverage among adults has been suboptimal, limiting further reduction in hepatitis B virus (HBV) infections in the United States. This Advisory Committee on Immunization Practices (ACIP) recommendation expands the indicated age range for universal HepB vaccination to now include adults aged 19-59 years. Removing the risk factor assessment previously recommended to determine vaccine eligibility in this adult age group (2) could increase vaccination coverage and decrease hepatitis B cases. [ABSTRACT FROM AUTHOR]

Hepatitis B (HepB) vaccines have demonstrated safety, immunogenicity, and efficacy during the past 4 decades (1,2). However, vaccination coverage among adults has been suboptimal, limiting further reduction in hepatitis B virus (HBV) infections in the United States. This Advisory Committee on Immunization Practices (ACIP) recommendation expands the indicated age range for universal HepB vaccination to now include adults aged 19–59 years. Removing the risk factor assessment previously recommended to determine vaccine eligibility in this adult age group (2) could increase vaccination coverage and decrease hepatitis B cases. [ABSTRACT FROM AUTHOR]

Objective: We assessed trends and identified individual- and county-level factors associated with individual linkage to HIV care in Tennessee (TN). Methods: TN residents diagnosed with HIV from 2012–2016 were included in the analysis (n = 3,751). Individuals were assigned county-level factors based on county of residence at the time of diagnosis. Linkage was defined by the first CD4 or HIV RNA test date after HIV diagnosis. We used modified Poisson regression to estimate probability of 30-day linkage to care at the individual-level and the contribution of individual and county-level factors to this outcome. Results: Both MSM (aRR 1.23, 95%CI 0.98–1.55) and women who reported heterosexual sex risk factors (aRR 1.39, 95%CI 1.18–1.65) were more likely to link to care within 30-days than heterosexual males. Non-Hispanic Black individuals had poorer linkage than White individuals (aRR 0.77, 95%CI 0.71–0.83). County-level mentally unhealthy days were negatively associated with linkage (aRR 0.63, 95%CI: 0.40–0.99). Conclusions: Racial disparities in linkage to care persist at both individual and county levels, even when adjusting for county-level social determinants of health. These findings suggest a need for structural interventions to address both structural racism and mental health needs to improve linkage to care and minimize racial disparities in HIV outcomes. [ABSTRACT FROM AUTHOR]

The incidence of hepatitis C virus (HCV) infection in reproductive-aged adults quadrupled during the past decade. Hepatitis C can progress to advanced liver disease and be transmitted perinatally. Highly effective curative hepatitis C treatment is available but is not recommended in pregnancy. Using the Surveillance for Emerging Threats to Mothers and Babies Network, we describe timing of positive RNA testing among pregnant people with HCV (HCV RNA detected during or within one year prior to pregnancy). Four US jurisdictions reported 1161 pregnancies during 2018-2021 among people with hepatitis C: 75.9% were multiparous; and 21.4% had their first peri-pregnancy HCV RNA detected prior to pregnancy, indicating potential missed treatment opportunities to improve maternal health and prevent perinatal transmission. [ABSTRACT FROM AUTHOR]

The article reports on a study which compared six highly active antiretroviral therapy (HAART) regimens with some of them containing efavirenz (EFV), to evaluate pregnancy and birth outcomes among females enrolled in a clinical trial in Botswana. Health and longevity were restored in HAART-treated women who also became pregnant. The sample size is insufficient to estimate the risk of congenital malformation after exposure to EFV in early pregnancy.

Introduction: The COVID-19 pandemic has disrupted healthcare services, reducing opportunities to conduct routine hepatitis C virus antibody screening, clinical care, and treatment. Therefore, people living with undiagnosed hepatitis C virus during the pandemic may later become identified at more advanced stages of the disease, leading to higher morbidity and mortality rates. Further, unidentified hepatitis C virus-infected individuals may continue to unknowingly transmit the virus to others.Methods: To assess the impact of the COVID-19 pandemic, data were evaluated from a large national reference clinical laboratory and from national estimates of dispensed prescriptions for hepatitis C virus treatment. Investigators estimated the average number of hepatitis C virus antibody tests, hepatitis C virus antibody-positive test results, and hepatitis C virus RNA-positive test results by month in January-July for 2018 and 2019, compared with the same months in 2020. To assess the impact of hepatitis C virus treatment, dispensed hepatitis C virus direct-acting antiretroviral medications were examined for the same time periods. Statistical analyses of trends were performed using negative binomial models.Results: Compared with the 2018 and 2019 months, hepatitis C virus antibody testing volume decreased 59% during April 2020 and rebounded to a 6% reduction in July 2020. The number of hepatitis C virus RNA-positive results fell by 62% in March 2020 and remained 39% below the baseline by July 2020. For hepatitis C virus treatment, prescriptions decreased 43% in May, 37% in June, and 38% in July relative to the corresponding months in 2018 and 2019.Conclusions: During the COVID-19 pandemic, continued public health messaging, interventions and outreach programs to restore hepatitis C virus testing and treatment to prepandemic levels, and maintenance of public health efforts to eliminate hepatitis C infections remain important. [ABSTRACT FROM AUTHOR]

The study evaluates the effect of the 2020 Centers for Disease Control and Prevention and U.S. Preventive Services Task Force recommendations on hepatitis C virus (HCV) screening among pregnant persons nationally and by health insurance type. The study included 5,048,428 pregnant persons aged 15-44 years with either Medicaid or commercial health insurance who had obstetric panel testing performed by Quest Diagnostics, January 2011-June 2021. Antibody screening for HCV infection increased before and accelerated after the updated recommendations in early 2020. Disparities in HCV testing by health insurance status were substantial over the entire study period. Despite substantial progress in the proportion of pregnant persons screened for HCV infection, current testing rates fall short of universal recommendations. [ABSTRACT FROM AUTHOR]

Introduction: In April 2017, the Tennessee Department of Health (TDH) was notified of an increase in the number of persons newly diagnosed with HIV in eastern Tennessee in the same month. Two were identified as persons with a history of injection drug use (IDU) and named each other as syringe-sharing partners, prompting an investigation into a possible HIV cluster among persons with a history of IDU. Materials and Methods: TDH and public health staff members in eastern Tennessee collaborated to implement procedures outlined in TDH's HIV/hepatitis C virus (HCV) Outbreak Response Plan, including conducting enhanced interviewing and using a preestablished database for data collection and management. To complement contact tracing and enhanced interviewing, TDH partnered with the Centers for Disease Control and Prevention to conduct molecular HIV analyses. Results: By June 27, 2017, the investigation had identified 31 persons newly diagnosed with HIV infection; 8 (26%) self-reported IDU, 4 of whom were also men who have sex with men (MSM). Of the remaining 23 persons newly diagnosed with HIV infection, 10 were MSM who did not report IDU, 9 reported high-risk heterosexual contact, and 4 had other or unknown risk factors. Molecular analysis of the 14 HIV-1 polymerase genes (including 7 of the 8 persons self-reporting IDU) revealed 3 distinct molecular clusters, one of which included 3 persons self-reporting IDU. Practice Implications: This investigation highlights the importance of implementing an established Outbreak Response Plan and using HIV molecular analyses in the event of a transmission cluster or outbreak investigations. Future HIV outbreak surveillance will include using Global Hepatitis Outbreak Surveillance Technology to identify HCV gene sequences as a potential harbinger for HIV transmission networks. [ABSTRACT FROM AUTHOR]

Introduction: Hepatitis C is a leading cause of death from liver disease in the United States. Acute hepatitis C infection is often asymptomatic, and >50% of cases will progress to chronic infection, which can be life-threatening. Hepatitis C can be diagnosed with a blood test and is curable, yet new cases of this preventable disease are increasing.Methods: National Notifiable Diseases Surveillance System data were analyzed to determine the rate of acute hepatitis C cases reported to CDC by age group and year during 2009-2018 and the number and rate of newly reported chronic cases in 2018 by sex and age. The proportion of adults aged ≥20 years with hepatitis C who reported having ever been told that they had hepatitis C was estimated with 2015-2018 National Health and Nutrition Examination Survey data.Results: During 2018, a total of 3,621 cases of acute hepatitis C were reported, representing an estimated 50,300 cases (95% confidence interval [CI] = 39,800-171,600). The annual rate of reported acute hepatitis C cases per 100,000 population increased threefold, from 0.3 in 2009 to 1.2 in 2018, and was highest among persons aged 20-29 (3.1) and 30-39 years (2.6) in 2018. A bimodal distribution of newly reported chronic hepatitis C cases in 2018 was observed, with the highest proportions among persons aged 20-39 years and 50-69 years. Only 60.6% (95% CI = 46.1%-73.9%) of adults with hepatitis C reported having been told that they were infected.Conclusions and Implications For Public Health Practice: Increasing rates of acute hepatitis C among young adults, including reproductive-aged persons, have put multiple generations at risk for chronic hepatitis C. The number of newly reported chronic infections was approximately equal among younger and older adults in 2018. The new CDC hepatitis C testing recommendations advise screening all adults and pregnant women, not just persons born during 1945-1965, and those with risk factors. [ABSTRACT FROM AUTHOR]

BACKGROUND: Hepatitis C virus (HCV) prevalence doubled among pregnant women from 2009 to 2014, reaching 3.4 per 1000 births nationwide. Infants exposed to HCV may acquire HCV by vertical transmission. National guidelines recommend that infants exposed to HCV be tested; however, it is unclear if these recommendations are being followed. Our objectives were to determine if infants exposed to HCV were tested and to determine hospital- and patient-level factors associated with differences in testing. METHODS: In this retrospective cohort study of infants exposed to HCV who were enrolled in the Tennessee Medicaid program, we used vital statistics-linked administrative data for infants born between January 1, 2005, and December 31, 2014. Infants were followed until 2 years old. Multilevel logistic regression was used to assess the association of HCV testing and hospital- and patient-level characteristics. RESULTS: Only 23% of 4072 infants exposed to HCV were tested. Infants whose mothers were white versus African American (96.6% vs 3.1%; P <.001), used tobacco (78% vs 70%; P <.001), and had HIV (1.3% vs 0.4%; P = .002) were more likely to be tested. Infants exposed to HCV who had a higher median of well-child visits (7 vs 6; P <.001) were more likely to be tested. After accounting for maternal and infant characteristics and health care use patterns, African American infants were less likely to undergo general testing (adjusted odds ratio 0.32; 95% confidence interval, 0.13-0.78). CONCLUSIONS: Testing occurred in <1 in 4 infants exposed to HCV and less frequently among African American infants. Public health systems need to be bolstered to ensure that infants exposed to HCV are tested for seroconversion. [ABSTRACT FROM AUTHOR]

Objectives: From 2006 through 2012, the number of acute hepatitis C virus (HCV) infections increased 364% among persons aged ≤30, including reproductive-aged women, in Central Appalachian states. Outreach to reproductive-aged women with newly diagnosed HCV infection affords a unique opportunity to provide counseling, further testing, and linkage to treatment. We modeled a centrally located statewide effort to reach this population and their health care providers to ascertain pregnancy status, HCV risk factors, and opportunities for linkage to additional services. Methods: Using the Tennessee Department of Health's surveillance database, we identified women aged 18-45 residing in Tennessee with newly reported chronic HCV infection from May through October 2017. We contacted health care providers and patients to request information on pregnancy status and HCV risk factors as well as to provide linkage to treatment services. Results: Of 1548 women included in this study, health care provider or patient contact information was available for 1316 (85.0%) women. Of the 1316 women, 806 (61.2%) women had a health care provider or patient response, of whom 242 (30.0%) were pregnant. Of 296 patients contacted, 194 (65.5%) reported intranasal drug use, 193 (65.2%) reported having been incarcerated for more than 24 hours, and 180 (60.8%) reported injection drug use. Ninety-eight (33.1%) patients were referred for confirmatory testing, and 174 (58.8%) were referred to treatment. Conclusion: A high proportion of reproductive-aged women with newly diagnosed HCV infection were pregnant. Surveillance-informed outreach to this population was feasible and provided opportunities for counseling and linkage to confirmatory testing and treatment. Future studies should evaluate whether a similar model would enhance testing and linkage to care of HCV-exposed infants. [ABSTRACT FROM AUTHOR]

Objectives. To use statewide surveillance data to examine trends and disparities in mortality and progression from HIV to AIDS comprehensively in Tennessee over the past 20 years. Methods. Individuals diagnosed with HIV in Tennessee from 1996 to 2016 were identified through the Tennessee Department of Health Enhanced HIV/AIDS Reporting System. Clinical AIDS and all-cause mortality were the outcomes. Cox regression yielded adjusted hazard ratios (AHRs) for death and competing risk regression yielded adjusted subhazard ratios (SHRs) for AIDS, with death as the competing event. Results. Individuals with a history of heterosexual contact (AHR = 1.20; 95% confidence interval [CI] = 1.12, 1.29) and injection drug use (AHR = 1.27; 95% CI = 1.18, 1.38) had increased hazards of death relative to those with a history of male-to-male sexual contact. Hazards of death were lower among White (AHR = 0.79; 95% CI = 0.73, 0.85) and Hispanic (AHR = 0.50; 95% CI = 0.40, 0.63) individuals than among Black individuals. Those with heterosexual contact (SHR = 1.20; 95% CI = 1.12, 1.29) and injection drug use (SHR = 1.27; 95% CI = 1.18, 1.38) had a greater risk of AIDS than those with male-to-male sexual contact. White individuals (SHR = 0.85; 95% CI = 0.81, 0.90) had a lower risk of AIDS than Black individuals, and female individuals (SHR = 0.84; 95% CI = 0.79, 0.90) had a lower risk than male individuals. Conclusions. The trends, disparities, and outcomes assessed in our study will inform HIV testing and care linkage program design and implementation in Tennessee. [ABSTRACT FROM AUTHOR]

Background. Knowing which factors contribute to county-level vulnerability to a human immunodeficiency virus (HIV)/hepatitis C virus (HCV) outbreak, and which counties are most vulnerable, guides public health and clinical interventions. We therefore examined the impact of locally available indicators related to the opioid epidemic on prior national models of HIV/HCV outbreak vulnerability. Methods. Tennessee's 95 counties were the study sample. Predictors from 2012 and 2013 were used, mirroring prior methodology from the US Centers for Disease Control and Prevention (CDC). Acute HCV incidence was the proxy measure of county-level vulnerability. Seventy-eight predictors were identified as potentially predictive for HIV/HCV vulnerability. We used multiple dimension reduction techniques to determine predictors for inclusion and Poisson regression to generate a composite index score ranking county-level vulnerability for HIV/HCV. Results. There was overlap of high-risk counties with the national analysis (25 of 41 counties). The distribution of vulnerability reinforces earlier research indicating that eastern Tennessee is at particularly high risk but also demonstrates that the entire state has high vulnerability. Conclusions. Prior research placed Tennessee among the top states for opioid prescribing, acute HCV infection, and greatest risk for an HIV/HCV outbreak. Given this confluence of risk, the Tennessee Department of Health expanded upon prior work to include more granular, local data, including on opioid prescribing. We also explored nonfatal and fatal overdoses. The more complete statewide view of risk generated, not only in eastern counties but also in the western corridor, will enable local officials to monitor vulnerability and better target resources. [ABSTRACT FROM AUTHOR]

Introduction: Chronic Hepatitis C Virus (HCV) infection is common and can cause liver disease and death. Persons born from 1945 through 1965 ("Baby Boomers") have relatively high prevalence of chronic HCV infection, prompting recommendations that all Baby Boomers be screened for HCV. If chronic HCV is confirmed, evaluation for antiviral treatment should be performed. Direct-acting antivirals can cure more than 90% of people with chronic HCV. This sequence of services can be referred to as the HCV "cascade of cure” (CoC). The Tennessee (TN) Department of Health (TDH) and a health insurer with presence in TN aimed to determine the proportion of Baby Boomers who access HCV screening services and appropriately navigate the HCV CoC in TN. Methods: TDH surveillance data and insurance claim records were queried to identify the cohort of Baby Boomers eligible for HCV testing. Billing codes and pharmacy records from 2013 through 2015 were used to determine whether HCV screening and other HCV-related services were provided. The proportion of individuals accessing HCV screening and other steps along the HCV CoC was determined. Multivariable analyses were performed to identify factors associated with HCV screening and treatment. Results: Among 501,388 insured Tennessean Baby Boomers, 7% were screened for HCV. Of the 40,019 who received any HCV-related service, 86% were screened with an HCV antibody test, 20% had a confirmatory HCV PCR, 9% were evaluated for treatment, and 4% were prescribed antivirals. Hispanics were more likely to be screened and treated for HCV than non-Hispanic whites. HCV screening was more likely to occur in the Nashville-Davidson region than in other regions of TN, but there were regional variations in HCV treatment. Conclusions: Many insured Tennessean Baby Boomers do not access HCV screening services, despite national recommendations. Demographic and regional differences in uptake along the HCV CoC should inform public health interventions aimed at mitigating the effects of chronic HCV. [ABSTRACT FROM AUTHOR]

Hepatitis C virus (HCV) affects an estimated 3.5 million persons in the United States (1), making it the most common bloodborne infection in the country. Recent surveillance data showed increased rates of HCV infection among adolescents and adults who are predominantly white, live in nonurban areas, and have a history of injection drug use.* U.S. birth certificate data were used to analyze trends and geographic variations in rates of HCV infection among women giving birth during 2009-2014. Birth certificates from Tennessee were used to examine individual characteristics and outcomes associated with HCV infection, using a multivariable model to calculate adjusted odds of HCV-related diagnosis in pregnancy among women with live births. During 2009-2014, HCV infection present at the time of delivery among pregnant women from states reporting HCV on the birth certificate increased 89%, from 1.8 to 3.4 per 1,000 live births. The highest infection rate in 2014 (22.6 per 1,000 live births) was in West Virginia; the rate in Tennessee was 10.1. In adjusted analyses of Tennessee births, the odds of HCV infection were approximately threefold higher among women residing in rural counties than among those in large urban counties, 4.5-fold higher among women who smoked cigarettes during pregnancy, and nearly 17-fold higher among women with concurrent hepatitis B virus (HBV) infection. HCV infection among pregnant women is an increasing and potentially modifiable threat to maternal and child health. Clinicians and public health officials should consider individual and population-level opportunities for prevention and risk mitigation. [ABSTRACT FROM AUTHOR]

Background:Diarrhoea and pneumonia are common causes of childhood death in sub-Saharan Africa but there are few studies describing specific pathogens. Objectives:The study aimed to describe the pathogens associated with diarrhoea, pneumonia and oropharyngeal colonization in children born to HIV-infected women (HIV-exposed infants). Methods:The Mashi Study randomized 1200 HIV-infected women and their infants to breastfeed for 6 months with ZDV prophylaxis or formula-feed with 4 weeks of ZDV. Children were tested for HIV by PCR at 1, 4, 7, 9 and 12 months and by ELISA at 18 months. Pre-defined subsets of children were sampled during episodes of diarrhoea (n = 300) and pneumonia (n = 85). Stool was tested for bacterial pathogens, rotavirus and parasites. Children with pneumonia underwent bacterial blood culture, and testing of nasopharyngeal aspirates for viral pathogens by PCR. Oropharyngeal swabs were collected from a consecutive subset of 561 infants at the routine 3-month visit for bacterial culture. Results:The median age (range) at sampling was 181 days for diarrhoea (0–730) and 140 days for pneumonia (2–551). Pathogens were identified in 55 (18%) children with diarrhoea and 32 (38%) with pneumonia. No differences in pathogens by child HIV status (HIV-infectedvsHIV-uninfected) or feeding strategy were identified. Campylobacter was the most common diarrhoeal pathogen (7%). Adenovirus (22%) and other viruses (19%) were the primary pathogens isolated during pneumonias. More formula-fed infants had oropharyngeal colonization by pathogenic Gram-negative bacteria (16.8%vs6.2%,P = 0.003), which was associated with a non-significant increased risk of pneumonia (OR 2.2, 95% CI 0.8–5.7). Conclusion:A trend toward oropharyngeal bacterial colonization was observed in formula-fed infants. Although viruses were most commonly detected during pneumonia, respiratory colonization by Gram-negative bacteria may have contributed to pneumonia in formula-fed infants. [ABSTRACT FROM AUTHOR]

Abstract: Background: Single-dose nevirapine (sdNVP) is widely used to prevent mother-to-child transmission (PMTCT) of HIV-1. This may result in NVP resistance in both mother and infant. The significance of low levels of NVP resistance mutations in infants treated with NVP-containing antiretroviral treatment (ART) is unknown. Objectives: To determine the presence of pre-treatment NVP resistance in HIV-infected infants with and without prior NVP exposure. Study design: 33 HIV-1-infected infants in a PMTCT trial received NVP-containing ART (26 infants with prior NVP exposure). Plasma and buffy coat samples obtained prior to ART initiation were evaluated for drug resistance by bulk sequencing and allele-specific PCR (ASPCR). Results: ViroSeq™ identified NVP resistance in 3 of 33 infants; all failed first-line therapy. Pre-ART plasma NVP resistance by ASPCR was detected in 9 of 16 children experiencing virologic failure compared to 4 of 17 children without virologic failure (risk ratio 2.4, CI 0.94–7.8, p =0.08). Proviral resistance was not associated with virologic failure (risk ratio 1.2, CI 0.8–2.0, p =0.40). In the nevirapine-exposed infants, those who started ART before 7 months had higher risk of virologic failure (RR 2.3, CI 0.96–9.2, p =0.11). Conclusions: Low level drug resistance detected in plasma after NVP exposure prior to ART initiation may be associated with virologic failure on ART, while resistance in the DNA reservoir was not predictive of treatment outcome. [Copyright &y& Elsevier]

The first aim of the study is to assess the distribution of HIV-1 RNA levels in subtype C infection. Among 4,348 drug-naïve HIV-positive individuals participating in clinical studies in Botswana, the median baseline plasma HIV-1 RNA levels differed between the general population cohorts (4.1–4.2 log10) and cART-initiating cohorts (5.1–5.3 log10) by about one log10. The proportion of individuals with high (≥50,000 (4.7 log10) copies/ml) HIV-1 RNA levels ranged from 24%–28% in the general HIV-positive population cohorts to 65%–83% in cART-initiating cohorts. The second aim is to estimate the proportion of individuals who maintain high HIV-1 RNA levels for an extended time and the duration of this period. For this analysis, we estimate the proportion of individuals who could be identified by repeated 6- vs. 12-month-interval HIV testing, as well as the potential reduction of HIV transmission time that can be achieved by testing and ARV treating. Longitudinal analysis of 42 seroconverters revealed that 33% (95% CI: 20%–50%) of individuals maintain high HIV-1 RNA levels for at least 180 days post seroconversion (p/s) and the median duration of high viral load period was 350 (269; 428) days p/s. We found that it would be possible to identify all HIV-infected individuals with viral load ≥50,000 (4.7 log10) copies/ml using repeated six-month-interval HIV testing. Assuming individuals with high viral load initiate cART after being identified, the period of high transmissibility due to high viral load can potentially be reduced by 77% (95% CI: 71%–82%). Therefore, if HIV-infected individuals maintaining high levels of plasma HIV-1 RNA for extended period of time contribute disproportionally to HIV transmission, a modified ‘‘test-and-treat’’ strategy targeting such individuals by repeated HIV testing (followed by initiation of cART) might be a useful public health strategy for mitigating the HIV epidemic in some communities. [ABSTRACT FROM AUTHOR]

Risk factors for mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) via breast-feeding were evaluated in a randomized trial. HIV-infected women and their infants received zidovudine as well as single-dose nevirapine or placebo. Infants were randomized to formula-feed (FF) or breast-feed (BF) in combination with zidovudine prophylaxis. Of 1116 at-risk infants, 6 (1.1%) in the FF group and 7 (1.3%) in the BF group were infected between birth and 1 month (P = .99). Maternal receipt of nevirapine did not predict early MTCT in the BF group (P = .45). Of 547 infants in the BF group at risk for late MTCT, 24 (4.4%) were infected. Maternal HIV-1 RNA levels in plasma (P<.001) and breast milk (P<.001) predicted late MTCT. These findings support the safety of 1 month of breast-feeding in combination with maternal and infant antiretroviral prophylaxis. [ABSTRACT FROM AUTHOR]

The article focuses on the viral dynamics in primary human immunodeficiency virus-1 (HIV-1). It notes that most studies on primary HIV-1 infection does not delve on the evolution of viral parameters in the early phase of HIV-1 subtype C infection. It characterizes the kinetics of viral ribonucleic acid (RNA), proviral deoxyribonucleic acid (DNA), CD4+ T-cell count, and subsets of CD4+ T cells. It yields better understanding of the early phase of subtype C infection.

Background. Infants of human immunodeficiency virus (HIV)-infected women have high mortality, but the immunologic integrity and protection afforded by the breast milk of HIV-infected women is unknown. Methods. We determined morbidity and mortality by 24 months among breast-fed infants of 588 HIV-infected and 137 HIV-uninfected women followed-up in a clinical trial in Botswana. A matched case-control study compared clinical, behavioral, and breast milk immunologic parameters among 120 HIV-infected women by infant outcome. Breast milk factors were also compared between HIV-infected and HIV-uninfected women. Results. Twenty-four-month mortality was 29.5% among HIV-infected infants, 6.7% among HIV-exposed uninfected infants, and 1.6% among HIV-unexposed infants. No differences were detected in breast milk immunologic profiles of HIV-infected women whose infants were either ill or well. Discontinuation of breast-feeding was the strongest predictor of illness (P<.001 ). Levels in breast milk of pathogen-specific immunoglobulin (Ig) G and IgA to Haemophilus influenzae, Campylobacter jejuni, Helicobacter pylori, Streptococcus pneumoniae, and innate immune factors were not lower among HIV-infected women than among HIV-uninfected women. Conclusions. Mortality was higher among HIV-infected and HIV-exposed infants than among HIV-unexposed infants. However, the immunologic profiles of breast milk among HIV-infected women were intact, and discontinuation of breast-feeding was the primary risk for infant morbidity. Thus, the breast milk of HIV-infected women may confer protection against common infant pathogens. [ABSTRACT FROM AUTHOR]

Context Postnatal transmission of human immunodeficiency virus-1 (HIV) via breastfeeding reverses gains achieved by perinatal antiretroviral interventions. Objective To compare the efficacy and safety of 2 infant feeding strategies for the prevention of postnatal mother-to-child HIV transmission. Design, Setting, and Patients A 2 X 2 factorial randomized clinical trial with peri- partum (single-dose nevirapine vs placebo) and postpartum infant feeding (formula vs breastfeeding with infant zidovudine prophylaxis) interventions. In Botswana between March 27, 2001, and October 29, 2003,1200 HIV-positive pregnant women were randomized from 4 district hospitals. Infants were evaluated at birth, monthly until age 7 months, at age 9 months, then every third month through age 18 months. Intervention All of the mothers received zidovudine 300 mg orally twice daily from 34 weeks' gestation and during labor. Mothers and infants were randomized to receive single-dose nevirapine or placebo. Infants were randomized to 6 months of breastfeeding plus prophylactic infant zidovudine (breastfed plus zidovudine), or formula feeding plus 1 month of infant zidovudine (formula fed). Main Outcome Measures Primary efficacy (HIV infection by age 7 months and HIV-free survival by age 18 months) and safety (occurrence of infant adverse events by 7 months of age) end points were evaluated in 1179 infants. Results The 7-month HIV infection rates were 5.6% (32 infants in the formula-fed group) vs 9.0% (51 infants in the breastfed plus zidovudine group) (P=.04; 95% confidence interval for difference, -6.4% to -0.4%). Cumulative mortality or HIV infection rates at 18 months were 80 infants (13.9%, formula fed) vs 86 infants (15.1 % breastfed plus zidovudine) (P=.6O; 95% confidence interval for difference,-5.3% to 2.9%). Cumulative infant mortality at 7 months was significantly higher for the formula- fed group than for the breastfed plus zidovudine group (9.3% vs4.9%; P=.003), but this difference diminished beyond month 7 such that the time-to-mortality distributions through age 18 months were not significantly different (P=.21). Conclusions Breastfeeding with zidovudine prophylaxis was not as effective as formula feeding in preventing postnatal HIV transmission, but was associated with a lower mortality rate at 7 months. Both strategies had comparable HIV-free survival at 18 months. These results demonstrate the risk of formula feeding to infants in sub- Saharan Africa, and the need for studies of alternative strategies. [ABSTRACT FROM AUTHOR]

Background. The ability of highly active antiretroviral therapy (HAART) to reduce human immunodeficiency virus type 1 (HIV-1) RNA and DNA in breast milk has not been described. Methods. We compared breast-milk HIV-1 RNA and DNA loads of women in Botswana who received HAART (nevirapine, lamivudine, and zidovudine) and women who did not receive HAART. Results. Women in the HAART group received treatment for a median of 98 days (range, 67–222 days) at the time of breast-milk sampling; 23 (88%) of 26 had whole breast-milk HIV-1 RNA loads <50 copies/mL, compared with 9 (36%) of 25 women who did not receive HAART (P = .0001). This finding remained significant in a multivariate logistic-regression model (P = .0006). The whole-milk HIV-1 DNA load was unaffected by HAART. Of women who received HAART, 13 (50%) of 26 had HIV-1 DNA loads <10 copies/106 cells, compared with 15 (65%) of 23 who did not receive HAART (P = .39). Conclusions. HAART suppressed cell-free HIV-1 RNA in breast milk and may therefore reduce mother-to-child transmission (MTCT) of HIV-1 via breast-feeding. However, HAART initiated during pregnancy or early after delivery had no apparent effect on cell-associated HIV-1 DNA loads in breast milk. Clinical trials to determine MTCT among breast-feeding women receiving HAART are needed. [ABSTRACT FROM AUTHOR]

Background. The magnitude of infant antiretroviral (ARV) exposure from breast milk is unknown. Methods. We measured concentrations of nevirapine, lamivudine, and zidovudine in serum and whole breast milk from human immunodeficiency virus type 1 (HIV-1)-infected women in Botswana receiving ARV treatment and serum from their uninfected, breast-feeding infants. Results. Twenty mother-infant pairs were enrolled. Maternal serum concentrations of nevirapine were high (median, 9534 ng/mL at a median of 4 h after nevirapine ingestion). Median breast-milk concentrations of nevirapine, lamivudine, and zidovudine were 0.67, 3.34, and 3.21 times, respectively, those in maternal serum. The median infant serum concentration of nevirapine was 971 ng/mL, at least 40 times the 50% inhibitory concentration and similar to peak concentrations after a single 2-mg/kg dose of nevirapine. The median infant serum concentration of lamivudine was 28 ng/mL, and the median infant serum concentration of zidovudine was 123 ng/mL, but infants were also receiving zidovudine prophylaxis. Conclusions. HIV-1 inhibitory concentrations of nevirapine are achieved in breast-feeding infants of mothers receiving these ARVs, exposing infants to the potential for beneficial and adverse effects of nevirapine ingestion. Further study is needed to understand the impact of maternal ARV treatment on breast-feeding HIV-1 transmission, infant toxicity, and HIV-1 resistance mutations among infected infants. [ABSTRACT FROM AUTHOR]

Investigates the prevention of mother-to-child HIV transmission(MTCT) from breast milk in Botswana. Number of women assigned to breastfeed by self-report; Percentage of women with evidence of breast milk during the physical examination; Absence of adherence to five months of exclusive breastfeeding.

The article reports on the prevalence of acute Hepatitis A virus infection among previously vaccinated persons with HIV infection in Tennessee in 2018. The Tennessee Department of Health (TDH) examined the frequency at which the patients developed Hepatitis A virus infection. The Centers for Disease Control and Prevention (CDC) investigated the effect of monovalent vaccines and immune globulins (IG) on the patients.

Objectives: Tennessee was 1 of 8 states that received funding from the Care and Prevention in the United States Demonstration Project, which aimed to reduce HIV-related morbidity and mortality among racial/ethnic and sexual minority populations. The objective of this study was to describe implementation of a social network strategy (SNS) program, which leverages personal connections in social networks, to reach people with undiagnosed HIV infection for HIV testing. We targeted young black men who have sex with men (MSM) at 3 agencies in Memphis and Nashville, Tennessee, during 2013-2016. Methods: Specialists at the 3 agencies identified MSM with and without diagnosed HIV infection (ie, recruiters) who could recruit members from their social networks for HIV testing (ie, network associates). Both recruiters and network associates received OraQuick rapid and confirmatory HIV tests. We used χ2 and Fisher exact tests to assess differences in demographic characteristics, HIV testing, and care engagement status by agency. Results: Of 1752 people who were tested for HIV in the SNS program, 158 (9.0%) tested positive; of these, 80 (50.6%) were newly diagnosed with HIV. Forty-seven of the 78 (60.3%) people who were previously diagnosed with HIV were not in care in the previous 12 months; of these, 27 (57.4%) were reengaged in medical care. Of 80 people newly diagnosed with HIV, 44 (55.0%) were linked to care. Conclusions: The SNS program ascertained HIV status among a high-risk population in a heavily burdened region. Further program evaluation is needed to understand how to improve linkage to care among people with newly diagnosed HIV. [ABSTRACT FROM AUTHOR]

Background: A single dose of nevirapine during labor reduces perinatal transmission of human immunodeficiency virus type 1 (HIV-1) but often leads to viral nevirapine resistance mutations in mothers and infants. Methods: We studied the response to nevirapine-based antiretroviral treatment among women and infants who had previously been randomly assigned to a single, peripartum dose of nevirapine or placebo in a trial in Botswana involving the prevention of the transmission of HIV-1 from mother to child. All women were treated with antenatal zidovudine. The primary end point for mothers and infants was virologic failure by the 6-month visit after initiation of antiretroviral treatment, estimated within groups by the Kaplan–Meier method. Results: Of 218 women who started antiretroviral treatment, 112 had received a single dose of nevirapine and 106 had received placebo. By the 6-month visit after the initiation of antiretroviral treatment, 5.0% of the women who had received placebo had virologic failure, as compared with 18.4% of those who had received a single dose of nevirapine (P=0.002). Among 60 women starting antiretroviral treatment within 6 months after receiving placebo or a single dose of nevirapine, no women in the placebo group and 41.7% in the nevirapine group had virologic failure (P<0.001). In contrast, virologic failure rates did not differ significantly between the placebo group and the nevirapine group among 158 women starting antiretroviral treatment 6 months or more post partum (7.8% and 12.0%, respectively; P=0.39). Thirty infants also began antiretroviral treatment (15 in the placebo group and 15 in the nevirapine group). Virologic failure by the 6-month visit occurred in significantly more infants who had received a single dose of nevirapine than in infants who had received placebo (P<0.001). Maternal and infant findings did not change qualitatively by 12 and 24 months after the initiation of antiretroviral treatment. Conclusions: Women who received a single dose of nevirapine to prevent perinatal transmission of HIV-1 had higher rates of virologic failure with subsequent nevirapine-based antiretroviral therapy than did women without previous exposure to nevirapine. However, this applied only when nevirapine-based antiretroviral therapy was initiated within 6 months after receipt of a single, peripartum dose of nevirapine. (ClinicalTrials.gov number, NCT00197587.) N Engl J Med 2007;356:135-47. [ABSTRACT FROM AUTHOR]