Hepatitis C prevalence and risk factors in Georgia, 2015: setting a baseline for elimination.

BACKGROUND: The country of Georgia launched the world's first Hepatitis C Virus (HCV) Elimination Program in 2015 and set a 90% prevalence reduction goal for 2020. We conducted a nationally representative HCV seroprevalence survey to establish baseline prevalence to measure progress toward elimination over time. METHODS: A cross-sectional seroprevalence survey was conducted in 2015 among adults aged ≥18 years using a stratified, multi-stage cluster design (n = 7000). Questionnaire variables included demographic, medical, and behavioral risk characteristics and HCV-related knowledge. Blood specimens were tested for antibodies to HCV (anti-HCV) and HCV RNA. Frequencies were computed for HCV prevalence, risk factors, and HCV-related knowledge. Associations between anti-HCV status and potential risk factors were calculated using logistic regression. RESULTS: National anti-HCV seroprevalence in Georgia was 7.7% (95% confidence interval (CI) = 6.7, 8.9); HCV RNA prevalence was 5.4% (95% CI = 4.6, 6.4). Testing anti-HCV+ was significantly associated with male sex, unemployment, urban residence, history of injection drug use (IDU), incarceration, blood transfusion, tattoos, frequent dental cleanings, medical injections, dialysis, and multiple lifetime sexual partners. History of IDU (adjusted odds ratio (AOR) = 21.4, 95% CI = 12.3, 37.4) and blood transfusion (AOR = 4.5, 95% CI = 2.8, 7.2) were independently, significantly associated with testing anti-HCV+ after controlling for sex, age, urban vs. rural residence, and history of incarceration. Among anti-HCV+ participants, 64.0% were unaware of their HCV status, and 46.7% did not report IDU or blood transfusion as a risk factor. CONCLUSIONS: Georgia has a high HCV burden, and a majority of infected persons are unaware of their status. Ensuring a safe blood supply, implementing innovative screening strategies beyond a risk-based approach, and intensifying prevention efforts among persons who inject drugs are necessary steps to reach Georgia's HCV elimination goal.

Hepatitis C Virus in Women of Childbearing Age, Pregnant Women, and Children.

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 <5years from 2011 to 2016. 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.

Hepatitis C care cascade among persons born 1945-1965: 3 medical centers.

OBJECTIVES: Effective screening, diagnosis, and treatment are needed to reduce chronic hepatitis C virus (HCV) infection-associated morbidity and mortality. In order to successfully increase HCV treatment, it is necessary to identify and understand gaps in linkage of antibody-positive patients with newly identified HCV to subsequent HCV RNA testing, clinical evaluation, and treatment. STUDY DESIGN: To estimate attainment of HCV care cascade steps among antibody-positive patients with newly identified HCV, we conducted chart reviews of patients with a new positive HCV antibody test at 3 academic medical centers participating in the Birth-Cohort Evaluation to Advance Screening and Testing of Hepatitis C (BEST-C) study. METHODS: We tracked receipt of RNA testing, clinical evaluation, treatment initiation, and treatment completion among individuals born between 1945 and 1965 who were newly diagnosed as HCV antibody-positive between December 2012 and October 2015 at 3 BEST-C centers, predominantly from the participating medical centers' primary care practices and emergency departments. RESULTS: Of the 130 HCV-seropositive individuals identified, 118 (91%) had an RNA or genotype test, 75 (58%) were RNA-positive, 73 (56%) were linked to care, 22 (17% overall; 29% among RNA-positive) started treatment, and 21 (16%; 28% among RNA-positive) completed treatment. CONCLUSIONS: This analysis showed that although linkage to care was largely successful in the target birth cohort, the largest gap in the HCV care cascade was seen in initiating treatment. Greater emphasis on linking patients to clinical evaluation and treatment is necessary in order to achieve the public health benefits promised by birth-cohort testing.

Human Papillomavirus Vaccine Effectiveness Against Incident Genital Warts Among Female Health-Plan Enrollees, United States.

We examined the effectiveness of human papillomavirus vaccination by dose number and spacing against incident genital warts in a cohort of 64,517 female health-plan enrollees in the United States during 2006-2012. Eligible recipients were classified into groups by regimen: 0, 1, 2 (<6 months apart), 2 (≥6 months apart), or 3 doses. They were followed until a genital wart diagnosis, loss to follow-up, or the end of study. Propensity score weights were used to balance baseline differences across groups. To account for latent genital warts before vaccination, we applied 6- and 12-month buffer periods from last and first vaccine dose, respectively. Incidence rates and hazard ratios were calculated using Poisson regression and Cox models. The propensity score-weighted incidence rate per 100,000 person-years was 762 among unvaccinated participants. Using 6- and 12-month buffer periods, respectively, incidence rates were 641 and 257 for 1 dose, 760 and 577 for the 2-dose (<6-month interval) regimen, 313 and 194 for the 2-dose (≥6-month interval) regimen, and 199 and 162 among 3-dose vaccinees; vaccine effectiveness was 68% and 76% for the 2-dose (≥6-month interval) regimen and 77% and 80% in 3-dose vaccinees compared with unvaccinated participants. Vaccine effectiveness was not significant among vaccinees receiving 1-dose and 2-dose (<6-month interval) regimens compared with unvaccinated participants. Our findings contribute to a better understanding of the real-world effectiveness of HPV vaccination.

Hepatitis C Antibody Testing in a Commercially Insured Population, 2005-2014.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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 (p<0.0001). 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 (p<0.0001). CONCLUSIONS: 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.

Human Papillomavirus Vaccination and Age at First Sexual Activity, National Health and Nutrition Examination Survey.

The National Health and Nutrition Examination Survey (NHANES) collects information on human papillomavirus (HPV) vaccination history as well as sexual activity. We evaluated data from NHANES to assess report of HPV vaccination with ≥1 dose and 3 doses among females and males aged 11 to 26 years during 2007-2014. We also examined age at first vaccine dose and age at first sexual activity among females aged 14 to 26 years. Vaccination significantly increased in females aged 13 to 26 years, but not among 11- to 12-year-old girls, and remained low for both females and males. In NHANES 2011-2014, among females with known age at first vaccine dose, 43.1% reported having had sex before or in the same year they received their first HPV vaccine, and this varied by race/ethnicity. Clinicians should provide strong recommendations consistent with guidelines, including routine vaccination of girls and boys at age 11 or 12 years.

Prevalence of 9-Valent Human Papillomavirus Types by Race/Ethnicity in the Prevaccine Era, United States, 2003-2006.

Before any vaccine introduction, overall DNA prevalence of any 9-valent human papillomavirus (9vHPV) types, HPV 31/33/45/52/58, and HPV 16/18 was 16.0%, 9.5%, and 6.2%, respectively, among female participants in National Health and Nutrition Examination Survey. Non-Hispanic black females were more likely to have infection with HPV 31/33/45/52/58, but not HPV 16/18, compared to non-Hispanic white females.

Increased Hepatitis C Virus (HCV) Detection in Women of Childbearing Age and Potential Risk for Vertical Transmission - United States and Kentucky, 2011-2014.

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.

Early Syphilis Among Men Who Have Sex with Men in the US Pacific Northwest, 2008-2013: Clinical Management and Implications for Prevention.

Substantial increases in syphilis during 2008-2013 were reported in the US Pacific Northwest state of Oregon, especially among men who have sex with men (MSM). The authors aimed to characterize the ongoing epidemic and identify possible gaps in clinical management of early syphilis (primary, secondary, and latent syphilis ≤1 year) among MSM in Multnomah County, Oregon to inform public health efforts. Administrative databases were used to examine trends in case characteristics during 2008-2013. Medical records were abstracted for cases occurring in 2013 to assess diagnosis, treatment, and screening practices. Early syphilis among MSM increased from 21 cases in 2008 to 229 in 2013. The majority of cases occurred in HIV-infected patients (range: 55.6%-69.2%) diagnosed with secondary syphilis (range: 36.2%-52.4%). In 2013, 119 (51.9%) cases were diagnosed in public sector medical settings and 110 (48.0%) in private sector settings. Over 80% of HIV-infected patients with syphilis were in HIV care. Although treatment was adequate and timely among all providers, management differed by provider type. Among HIV-infected patients, a larger proportion diagnosed by public HIV providers than private providers were tested for syphilis at least once in the previous 12 months (89.6% vs. 40.0%; p < 0.001). The characteristics of MSM diagnosed with early syphilis in Multnomah County remained largely unchanged during 2008-2013. Syphilis control measures were well established, but early syphilis among MSM continued to increase. The results suggest a need to improve syphilis screening among private clinics, but few gaps in clinical management were identified.

Birth Cohort Testing for Hepatitis C Virus - Indian Health Service 2012-2015.

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.

Identification and Clinical Management of Persons with Chronic Hepatitis C Virus Infection - Cherokee Nation, 2012-2015.

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.

Use of claims data to estimate annual cervical cancer screening percentages in Portland metropolitan area, Oregon.

BACKGROUND: Human papillomavirus (HPV) vaccine should reduce cervical dysplasia before cervical cancer. However, dysplasia diagnosis is screening-dependent. Accurate screening estimates are needed. PURPOSE: To estimate the percentage of women in a geographic population that has had cervical cancer screening. METHODS: We analyzed claims data for (Papanicolau) Pap tests from 2008-2012 to estimate the percentage of insured women aged 18-39 years screened. We estimated screening in uninsured women by dividing the percentage of insured Behavioral Risk Factor Surveillance Survey respondents reporting previous-year testing by the percentage of uninsured respondents reporting previous-year testing, and multiplying this ratio by claims-based estimates of insured women with previous-year screening. We calculated a simple weighted average of the two estimates to estimate overall screening percentage. We estimated credible intervals using Monte-Carlo simulations. RESULTS: During 2008-2012, an annual average of 29.6% of women aged 18-39 years were screened. Screening increased from 2008 to 2009 in all age groups. During 2009-2012, the screening percentages decreased for all groups, but declined most in women aged 18-20 years, from 21.5% to 5.4%. Within age groups, compared to 2009, credible intervals did not overlap during 2011 (except age group 21-29 years) and 2012, and credible intervals in the 18-20 year group did not overlap with older groups in any year. CONCLUSIONS: This introduces a novel method to estimate population-level cervical cancer screening. Overall, percentage of women screened in Portland, Oregon fell following changes in screening recommendations released in 2009 and later modified in 2012.

The impact and cost-effectiveness of nonavalent HPV vaccination in the United States: Estimates from a simplified transmission model.

INTRODUCTION: The objective of this study was to assess the incremental costs and benefits of the 9-valent HPV vaccine (9vHPV) compared with the quadrivalent HPV vaccine (4vHPV). Like 4vHPV, 9vHPV protects against HPV types 6, 11, 16, and 18. 9vHPV also protects against 5 additional HPV types 31, 33, 45, 52, and 58. METHODS: We adapted a previously published model of the impact and cost-effectiveness of 4vHPV to include the 5 additional HPV types in 9vHPV. The vaccine strategies we examined were (1) 4vHPV for males and females; (2) 9vHPV for females and 4vHPV for males; and (3) 9vHPV for males and females. In the base case, 9vHPV cost $13 more per dose than 4vHPV, based on available vaccine price information. RESULTS: Providing 9vHPV to females compared with 4vHPV for females (assuming 4vHPV for males in both scenarios) was cost-saving regardless of whether or not cross-protection for 4vHPV was assumed. The cost per quality-adjusted life year (QALY) gained by 9vHPV for both sexes (compared with 4vHPV for both sexes) was < $0 (cost-saving) when assuming no cross-protection for 4vHPV and $8,600 when assuming cross-protection for 4vHPV. CONCLUSIONS: Compared with a vaccination program of 4vHPV for both sexes, a vaccination program of 9vHPV for both sexes can improve health outcomes and can be cost-saving.

Prevalence of HPV After Introduction of the Vaccination Program in the United States.

BACKGROUND: Since mid-2006, human papillomavirus (HPV) vaccination has been recommended for females aged 11 to 12 years and through 26 years if not previously vaccinated. METHODS: HPV DNA prevalence was analyzed in cervicovaginal specimens from females aged 14 to 34 years in NHANES in the prevaccine era (2003-2006) and 4 years of the vaccine era (2009-2012) according to age group. Prevalence of quadrivalent HPV vaccine (4vHPV) types (HPV-6, -11, -16, and -18) and other HPV type categories were compared between eras. Prevalence among sexually active females aged 14 to 24 years was also analyzed according to vaccination history. RESULTS: Between the prevacccine and vaccine eras, 4vHPV type prevalence declined from 11.5% to 4.3% (adjusted prevalence ratio [aPR]: 0.36 [95% confidence interval (CI): 0.21-0.61]) among females aged 14 to 19 years and from 18.5% to 12.1% (aPR: 0.66 [95% CI: 0.47-0.93]) among females aged 20 to 24 years. There was no decrease in 4vHPV type prevalence in older age groups. Within the vaccine era, among sexually active females aged 14 to 24 years, 4vHPV type prevalence was lower in vaccinated (≥1 dose) compared with unvaccinated females: 2.1% vs 16.9% (aPR: 0.11 [95% CI: 0.05-0.24]). There were no statistically significant changes in other HPV type categories that indicate cross-protection. CONCLUSIONS: Within 6 years of vaccine introduction, there was a 64% decrease in 4vHPV type prevalence among females aged 14 to 19 years and a 34% decrease among those aged 20 to 24 years. This finding extends previous observations of population impact in the United States and demonstrates the first national evidence of impact among females in their 20s.

Seroprevalence of 9 Human Papillomavirus Types in the United States, 2005-2006.

BACKGROUND: A 9-valent human papillomavirus (HPV) vaccine, licensed in 2014, prevents 4 HPV types targeted by the quadrivalent vaccine (6/11/16/18) and 5 additional high-risk (HR) types (31/33/45/52/58). Measuring seropositivity before vaccine introduction provides baseline data on exposure to types targeted by vaccines. METHODS: We determined seroprevalence of HPV 6/11/16/18/31/33/45/52/58 among 4943 persons aged 14-59 years who participated in the National Health and Nutrition Examination Survey, 2005-2006. RESULTS: Among females, seroprevalence was 40.5% for any of the 9 vaccine types, 30.0% for any 7 HR types (16/18/31/33/45/52/58), 19.0% for any 5 additional types (31/33/45/52/58), and 18.3% for 16/18. Compared with non-Hispanic whites, non-Hispanic blacks had higher seroprevalence of 31/33/45/52/58 (36.8% vs 15.9%) and 16/18 (30.1% vs 17.8%), while Mexican Americans had higher seroprevalence of 31/33/45/52/58 (23.6% vs 15.9%) (P < .05 for all). In multivariable analyses of data from females, race/ethnicity, number of sex partners, and age were associated with 16/18 and 31/33/45/52/58 seropositivity. Seropositivity was lower among males than among females (P < .001 for all type categories). CONCLUSIONS: In 2005-2006, about 40% of females and 20% of males had serological evidence of exposure to ≥1 of 9 HPV types. Seroprevalence of all type categories, especially HPV 31/33/45/52/58 among females, varied by race/ethnicity.

Human Papillomavirus Vaccination Coverage Among School Girls in a Demonstration Project - Botswana, 2013.

What is already known on this topic? Human papillomavirus (HPV) infection is common and aggressive in persons infected with human immunodeficiency virus (HIV). With an HIV prevalence of 28% among females aged 15­49, cervical cancer is the leading cause of cancer death among women in Botswana. Before 2013, HPV vaccine had not been used in the public sector in Botswana.What is added by this report? Efforts to expand services for cervical cancer through the Pink Ribbon Red Ribbon initiative focused on HPV-related disease in Botswana. A demonstration project for HPV vaccination was developed by the Ministry of Health for school girls aged ≥9 years in primary schools in one community. A total of 1,967 (79%) of 2,488 eligible girls received 3 doses of vaccine in the immunization effort that was centered in schools.What are the implications for public health practice? Preventing HPV infection in girls is an important component of a national comprehensive cervical cancer control program. HPV vaccination programming is challenging, and demonstration projects can prepare countries for national introduction. The success of the initial HPV vaccination effort in Botswana led to an expanded project in 2014, with implementation of nationwide rollout of the HPV vaccine in 2015. It might be beneficial for future HPV vaccination campaigns to include strategies to reach out-of-school girls.

Monitoring Effect of Human Papillomavirus Vaccines in US Population, Emerging Infections Program, 2008-2012.

In 2007, five Emerging Infections Program (EIP) sites were funded to determine the feasibility of establishing a population-based surveillance system for monitoring the effect of human papillomavirus (HPV) vaccine on pre-invasive cervical lesions. The project involved active population-based surveillance of cervical intraepithelial neoplasia grades 2 and 3 and adenocarcinoma in situ as well as associated HPV types in women >18 years of age residing in defined catchment areas; collecting relevant clinical information and detailed HPV vaccination histories for women 18-39 years of age; and estimating the annual rate of cervical cancer screening among the catchment area population. The first few years of the project provided key information, including data on HPV type distribution, before expected effect of vaccine introduction. The project's success exemplifies the flexibility of EIP's network to expand core activities to include emerging surveillance needs beyond acute infectious diseases. Project results contribute key information regarding the impact of HPV vaccination in the United States.

Population-based trends in high-grade cervical lesions in the early human papillomavirus vaccine era in the United States.

BACKGROUND: Cervical intraepithelial neoplasia grade 2, 3, and adenocarcinoma in situ (CIN2+) lesions can be monitored as early indicators of human papillomavirus (HPV) vaccine impact. Changes to screening utilization will affect observed reductions in CIN2+ rates and complicate the interpretation of vaccine impact. METHODS: From 2008 to 2012, 9119 cases of CIN2+ among 18- to 39-year-old residents of catchment areas in California, Connecticut, New York, and Oregon were reported to the HPV-IMPACT Project, a sentinel system for monitoring the population impact of HPV vaccine. Age-stratified CIN2+ incidence rates were calculated for each catchment. Annual cervical screening was estimated for California, New York, and Oregon catchments with administrative and survey data. The Cochran-Armitage test was used to examine trends. RESULTS: From 2008 to 2012, the incidence of CIN2+ significantly decreased among 18- to 20-year-olds (California, from 94 to 5 per 100,000 women; Connecticut, from 450 to 57 per 100,000 women; New York, from 299 to 43 per 100,000 women; and Oregon, from 202 to 37 per 100,000 women; Ptrend < .0001) and among 21- to 29-year-olds in Connecticut (from 762 to 589 per 100,000 women) and New York (from 770 to 465 per 100,000 women; Ptrend < .001); rates did not differ among 30- to 39-year-olds. During the same period, screening rates also declined, with the largest decreases among 18- to 20-year-olds (from 67% in Oregon to 88% in California) and with smaller declines among 21- to 29-year-olds (13%-27%) and 30- to 39-year-olds (3%-21%). CONCLUSIONS: The declines in CIN2+ detection in young women were likely due to reduced screening but could also reflect the impact of vaccination. These data illustrate challenges in interpreting CIN2+ ecologic trends in the new era of cervical cancer prevention and emphasize the importance of information such as HPV types detected in lesions to assess the impact of HPV vaccine on cervical precancers.

Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices.

During its February 2015 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended 9-valent human papillomavirus (HPV) vaccine (9vHPV) (Gardasil 9, Merck and Co., Inc.) as one of three HPV vaccines that can be used for routine vaccination. HPV vaccine is recommended for routine vaccination at age 11 or 12 years. ACIP also recommends vaccination for females aged 13 through 26 years and males aged 13 through 21 years not vaccinated previously. Vaccination is also recommended through age 26 years for men who have sex with men and for immunocompromised persons (including those with HIV infection) if not vaccinated previously. 9vHPV is a noninfectious, virus-like particle (VLP) vaccine. Similar to quadrivalent HPV vaccine (4vHPV), 9vHPV contains HPV 6, 11, 16, and 18 VLPs. In addition, 9vHPV contains HPV 31, 33, 45, 52, and 58 VLPs. 9vHPV was approved by the Food and Drug Administration (FDA) on December 10, 2014, for use in females aged 9 through 26 years and males aged 9 through 15 years. For these recommendations, ACIP reviewed additional data on 9vHPV in males aged 16 through 26 years. 9vHPV and 4vHPV are licensed for use in females and males. Bivalent HPV vaccine (2vHPV), which contains HPV 16, 18 VLPs, is licensed for use in females. This report summarizes evidence considered by ACIP in recommending 9vHPV as one of three HPV vaccines that can be used for vaccination and provides recommendations for vaccine use.