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Background Human papillomavirus (HPV) vaccine has been recommended in the United States since 2006 for routine vaccination of girls at age 11–12 years and through age 26 years for women not previously vaccinated. Changes in vaccine-type HPV (VT) prevalence can be used to evaluate vaccine impact, including herd effects. Methods We determined type-specific HPV in cytology specimens from women aged 20–29 years screened for cervical cancer at Kaiser Permanente Northwest in 2007 and in two vaccine era periods: 2012–2013 and 2015–2016. Detection and typing used L1 consensus PCR with hybridization for 37 types, including quadrivalent vaccine types (HPV 6/11/16/18). Results Among 20–24 year-olds in 2012–2013 and 2015–2016, 44% and 64% had a history of ≥1-dose vaccination. VT prevalence decreased from 13.1% in 2007 to 2.9% in 2015–2016 (prevalence ratio [PR] = 0.22; 95% confidence interval [CI] 0.17–0.29). HPV 31 prevalence was also lower in the vaccine periods compared with 2007. VT prevalence in 2015–2016 among 20–24 year-olds was lower in both vaccinated, 1.3% (PR = 0.10; 95% CI 0.06–0.16), and unvaccinated women, 5.8% (PR = 0.45; 95% CI 0.33–0.61). Among 25–29 year-olds, 21% and 32% had a history of ≥1-dose vaccination. VT prevalence decreased from 8.1% in 2007 to 5.0% in 2015–2016 (PR = 0.62; 95% CI 0.50–0.78). Non-VT high risk prevalence was higher in the vaccine periods compared with the pre-vaccine era in both age groups, however, not in 2015–2016 compared with 2012–2013. Conclusion Within 9–10 years of vaccine introduction, VT prevalence decreased 78% among 20–24 year-olds and 38% in 25–29 year-olds. There were declines in both vaccinated and unvaccinated women, showing evidence of direct and herd protection.

Objectives The role of HPV in oral cavity cancers was investigated using two markers of viral exposure. Materials and methods HPV DNA and p16INK4a expression were evaluated in tumor tissue from a U.S. population-based sample of 122 invasive oral cavity cancer cases. Results HPV DNA was detected in 38 of 122 (31%) oral cavity tumors. Seven genotypes were detected including HPV 16, which was found in 22% of tumors. p16INK4a was expressed in 30% of tumors and was poorly correlated with HPV DNA detection (Kappa Conclusions Based on both HPV DNA and p16INK4a, HPV is etiologically linked to a limited subset of oral cavity cancers. However, the role of HPV in oral cavity cancer may vary widely by subsite and may have increased over time, similar to trends observed for oropharyngeal cancer.

Background Human papillomavirus (HPV) is a common sexually transmitted infection. Men who have sex with men (MSM) and transgender women (TGW) are at high risk for anal HPV infection and subsequent anal cancer. This study assessed the association of partner discordances with prevalent high-risk anal HPV (HRAHPV) among MSM and TGW. Methods Participants were enrolled in the cross-sectional young men's HPV study of gay, bisexual, and other MSM, and TGW, aged 18 to 26 years, from 2 cities. Participants completed a confidential standardized computer-assisted interview and provided self-collected anal swabs for type-specific HPV DNA testing. Multivariate analyses were conducted for 3 discordances of interest (i.e., partner age, race/ethnicity, and concurrent partner) to calculate adjusted odds ratios (aOR) and 95% confidence intervals (CI). Results Eight hundred sixty-two participants were included for partner race/ethnicity discordance, 601 for partner age discordance, and 581 for concurrent partner analysis. Most reported being older than 21 years, cisgender male, and gay. Adjusted odds of HRAHPV were not significantly increased among participants reporting partner age discrepancy >10 years (aOR, 0.89; 95% CI, 0.51-1.56), partner race/ethnicity discordance (aOR, 0.88; CI, 0.62-1.24), or partner with concurrent partners (aOR, 0.85; 95% CI, 0.50-1.42), compared with those who did not. Conclusions This analysis did not identify any partner discordances associated with HRAHPV. Because HPV infection can persist for years, sexual mixing patterns with early partners might be more relevant than the most recent sex partner. Prevalence of HRAHPV was high and could be preventable by preexposure vaccination, as recommended for everyone through age 26 years including MSM and TGW.

Background The first HPV vaccines licensed targeted two HPV types responsible for most cervical cancers. A 9-valent vaccine (9vHPV), targeting 5 additional types, was introduced in 2016 and is currently the only HPV vaccine available in the United States. Previous studies demonstrated high rates of HPV infection in Alaska Native (AN) women. We sought to measure prevalence of high risk HPV types in AN women undergoing colposcopy and to determine those preventable by vaccination. Methods For this cross-sectional study, we recruited women who were undergoing colposcopy for clinical indications at Alaska Native Medical Center to obtain cervical brush biopsy samples. Specimens were shipped to Atlanta, Georgia for DNA extraction, HPV detection, and typing using L1 PCR with type-specific hybridization to detect 37 HPV types. Results Four hundred eighty eight specimens from 489 women were tested. At least one HPV type was found in 458 (94%) specimens. Of 458 participants who were HPV positive, 332 (72%) had two or more types. At least one type targeted by 9vHPV was detected in 95% of participants with CIN 3 (21/22), 82% with CIN 2 (37/45), and 65% with CIN 1 (119/184). (p p Conclusions A substantial proportion of AN women attending colposcopy clinic had evidence of HPV 16/18 infection, as well as other high risk types targeted by 9vHPV. At least one 9vHPV type was detected in 62% of the participants overall, and 95% of participants with CIN3. AN women are expected to benefit from vaccination against HPV 16/18, and will have greater benefit from 9vHPV. Information from this study could be used to develop public health strategies to increase vaccine uptake, or to track HPV genotype prevalence over time.

Background Men who have sex with men (MSM) are at risk for cancers attributable to human papillomavirus (HPV), including oropharyngeal cancer. Human papillomavirus vaccination is recommended for US MSM through age 26 years. Oral HPV infection is associated with oropharyngeal cancer. We determined oral HPV prevalence and risk factors among young MSM. Methods The Young Men's HPV study enrolled MSM aged 18 through 26 years from clinics in Chicago and Los Angeles during 2012 to 2014. Participants self-reported demographics, sexual behaviors, vaccination and human immunodeficiency virus (HIV) status. Self-collected oral rinse specimens were tested for HPV DNA (37 types) by L1-consensus PCR. We calculated adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) for risk factors associated with oral HPV among participants not previously vaccinated. Results Oral HPV was detected in 87 (9.4%) of 922; 9-valent vaccine types were detected in 37 (4.0%) of 922. Among HIV-positive participants, 17 (19.3%) of 88 had oral HPV detected. Oral HPV was more prevalent among those reporting first sex at 18 years of age or younger (aPR, 2.44; 95% CI, 1.16-5.12); HIV infection (aPR, 1.99; 95% CI, 1.14-3.48); greater than 5 sex partners within the past month (aPR, 1.93; 95% CI, 1.13-3.31); performing oral sex on greater than 5 partners within the last 3 months (aPR, 1.87; 95% CI, 1.12-3.13); and having greater than 5 male sex partners within the last 3 months (aPR, 1.76; 95% CI, 1.08-2.87). Only 454 (49.2%) of 922 were aware that HPV can cause oropharyngeal cancers. Conclusions Many oral HPV infections were with types targeted by vaccination. Oral HPV infections were significantly associated with HIV and sexual behaviors. Fewer than half of participants were aware that HPV could cause oropharyngeal cancer.

Prevalence of human papillomavirus (HPV) infections was assessed among 1033 young men who have sex with men (MSM) aged 18-26 years. HPV (any type) was detected in 742 (71.8%) anal specimens and 101 (9.8%) oral specimens. Although HPV was detected in specimens from both anatomical sites in 83 (8.0%) participants, type-specific concordance for at least 1 HPV type was found in only 35 (3.4%) participants. HIV and smoking were associated with higher prevalence at both sites and frequency of concordant types. Coinfections of identical HPV types were rare, suggesting independent infection events and/or different modes of clearance.

Background Human papillomavirus (HPV) prevalence is high among men who have sex with men (MSM), yet little is known about HPV among transgender women (TGW). We assessed HPV prevalence and knowledge among TGW compared with MSM. Methods We enrolled TGW and MSM aged 18 to 26 years from clinics in Chicago and Los Angeles during 2012 to 2014. Participants self-reported gender identity, HIV status, HPV knowledge, and vaccination status. Self-collected anal and oral specimens were tested for HPV DNA (37 types); serum was tested for HPV antibodies (4 vaccine types). Prevalence among unvaccinated TGW and MSM was compared using prevalence ratios (PRs) and 95% confidence intervals (CIs). Participants without DNA or serologic evidence of HPV were considered naive. Results Among 1033 participants, 49 were TGW. Among 44 TGW and 855 MSM who were unvaccinated, any HPV DNA was detected in anal specimens from 39 (88.6%) TGW and 606 (70.9%) MSM (PR, 1.3; 95% CI, 1.1-1.4), and oral specimens from 4 (9.1%) TGW and 81 (9.5%) MSM (PR, 1.0; 95% CI, 0.4-2.5). Antibodies were detected among 37 (84.1%) TGW and 467 (54.6%) MSM (PR, 1.5; 95% CI, 1.3-1.8). Most participants were naive to 1 or more HPV vaccine type/s, including 29 (65.9%) TGW and 775 (90.6%) MSM (PR, 0.7; 95% CI, 0.6-0.9). Most TGW (55.1%) had never heard of HPV vaccine. Conclusions Among TGW, HPV prevalence was high and knowledge was low. Most were still naive to 1 or more HPV vaccine type. Although vaccination ideally occurs prior to exposure, findings support existing national recommendations to vaccinate TGW and MSM, and suggest additional outreach might increase vaccination.

Background Highly effective human papillomavirus (HPV) vaccines are used in many national programs in 3- or 2-dose schedules. We examined HPV vaccine effectiveness against HPV prevalence by number of doses. Methods We collected residual liquid-based cytology samples from US women aged 20–29 years who were screened for cervical cancer. Women continuously enrolled from 2006 through the specimen collection date were analyzed. Specimens were tested using the Linear Array assay. We analyzed prevalence of quadrivalent HPV vaccine (4vHPV) types (HPV 6,11,16,18) and other HPV-type categories and determined prevalence ratios (PRs) and 95% confidence intervals (CIs) for 1, 2, and 3 compared with no vaccine doses. Results Among 4269 women, 1052 (24.6%) were unvaccinated, 2610 (61.1%) received 3 doses, 304 (7.1%) received 2 doses, and 303 (7.1%) received 1 dose. The 4vHPV-type prevalence was 7.4% among unvaccinated women compared with 1.7%, 1.0%, and 1.0% among 1-, 2-, and 3-dose recipients. Among women vaccinated at ≤18 years, adjusted PRs for 1, 2, and 3 doses were 0.06 (95% CI, 0.01–0.42), 0.05 (95% CI, 0.01–0.39), and 0.06 (95% CI, 0.04–0.12). Conclusions Among women who received their first dose at age ≤18, estimated HPV vaccine effectiveness was high regardless of number of doses.

We examined p16 expression in tumors from a population-based sample of laryngeal cancer cases diagnosed in the U.S. Samples had been previously genotyped for HPV DNA.Overall, p16 expression was observed in laryngeal tissue from 8 of 101 (7.9%) cases. p16 expression was observed in 2 of 16 (12.5%) cases previously determined to be HPV DNA positive. The two cases dually positive for p16 and HPV DNA were non-keratinizing SCC and papillary SCC tumors that were positive for genotypes 18 and 35/89, respectively. Positivity for p16 and/or HPV DNA was not associated with 5-year survival (log-rank p value=0.55). Our findings support a limited role of HPV in laryngeal carcinogenesis. p16 is not a reliable surrogate for HPV status in laryngeal cancers and is not a predictor of laryngeal cancer survival. Keywords: Larynx, Laryngeal cancer, Human papillomavirus, HPV, P16(INK4A), P16

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.

BACKGROUND Gay, bisexual, and other men who have sex with men (MSM) are at high risk for human papillomavirus (HPV) infection; vaccination is recommended for US males, including MSM through age 26 years. We assessed evidence of HPV among vaccine-eligible MSM and transgender women to monitor vaccine impact. METHODS During 2012-2014, MSM aged 18-26 years at select clinics completed a computer-assisted self-interview regarding sexual behavior, human immunodeficiency virus (HIV) status, and vaccinations. Self-collected anal swab and oral rinse specimens were tested for HPV DNA (37 types) by L1 consensus polymerase chain reaction; serum was tested for HPV antibodies (4 types) by a multiplexed virus-like particle-based immunoglobulin G direct enzyme-linked immunosorbent assay. RESULTS Among 922 vaccine-eligible participants, the mean age was 23 years, and the mean number of lifetime sex partners was 37. Among 834 without HIV infection, any anal HPV was detected in 69.4% and any oral HPV in 8.4%, yet only 8.5% had evidence of exposure to all quadrivalent vaccine types. In multivariate analysis, HPV prevalence varied significantly (P < .05) by HIV status, sexual orientation, and lifetime number of sex partners, but not by race/ethnicity. DISCUSSIONS Most young MSM lacked evidence of current or past infection with all vaccine-type HPV types, suggesting that they could benefit from vaccination. The impact of vaccination among MSM may be assessed by monitoring HPV prevalence, including in self-collected specimens.

Human papillomavirus (HPV) self-testing is an emerging cervical cancer screening strategy, yet few mail-based HPV self-testing programs have been implemented in the United States. We report the results of a pilot study of a mail-based program, the Health Outcomes through Motivation and Education Project.In 2015 to 2016, we recruited 103 women from Appalachian Ohio who were aged 30 to 65 years and had not received a Papanicolaou (Pap) test in at least 3 years. Women were mailed an HPV self-test and randomized to receive either (a) self-test instructions developed by the device manufacturer and a standard information brochure about cervical cancer (control group) or (b) self-test instructions developed by the Health Outcomes through Motivation and Education Project and a photo story information brochure about cervical cancer (intervention group). Logistic regression compared study arms on HPV self-test return and receipt of a Pap test.Overall, 80 (78%) women returned their HPV self-test. Return was similar among the intervention and control groups (78% vs. 77%; odds ratio, 1.09; 95% confidence interval, 0.43-2.76). Among returners, 26% had an oncogenic HPV type detected in their sample. Women who returned their self-test reported high levels of satisfaction and positive experiences with the self-testing process. Few women overall received a Pap test (11%), and Pap testing was similar among the intervention and control groups (14% vs. 8%; odds ratio, 1.91; 95% confidence interval, 0.52-6.97).Mail-based HPV self-testing programs are a potentially promising strategy for reaching underscreened women in Appalachia. Efforts are needed to better understand how to optimize the success of such programs.

The presence of human papillomavirus (HPV) DNA in oropharyngeal squamous cell cancer (OPSCC) tissue appears to be a strong predictor of improved prognosis, but this observation has not been explored in a population-based sample with generalisable findings.Follow-up data from a large sample of OPSCC patients identified through six population-based cancer registries in the United States of America (USA) were used to characterise the association of tumour HPV status with survival.HPV DNA was detected in tumour tissue from 71% (378 in 529) of the OPSCC patients. A total of 65% of patients with HPV16-associated tumours survived 5 years compared to 46% of patients with other HPV types and 28% of patients with HPV-negative tumours (p log-rank test0.0001). The OPSCC patients with detectable HPV16 DNA had a 62% reduced hazard of death at 5 years, and patients with other HPV types had a 42% reduced hazard of death at 5 years compared to HPV-negative patients. Compared to non-Hispanic Whites, Blacks with OPSCC had a 2.6-fold greater risk of death at 5 years after adjustment for HPV status and other prognostic variables. Both surgery and radiation therapy were associated with a reduced 5-year risk of death, but no evidence was found for an interaction between HPV status and radiotherapy or surgery on survival time.Data from this US study suggest that HPV16-positive OPSCC patients survive longer than HPV-negative patients regardless of treatment, highlighting the prognostic importance of HPV status for this malignancy. Optimal treatment regimens for OPSCC could be tailored to each patient's HPV status and prognostic profile.

Author(s): Conley, Lois J; Bush, Timothy J; Darragh, Teresa M; Palefsky, Joel M; Unger, Elizabeth R; Patel, Pragna; Steinau, Martin; Kojic, E Milu; Martin, Harold; Overton, E Turner; Cu-Uvin, Susan; Hammer, John; Henry, Keith; Wood, Kathleen; Brooks, John T; SUN Study Group | Abstract: BackgroundAnal cancer rates are higher for human immunodeficiency virus (HIV)-infected adults than for uninfected adults. Limited published data exist characterizing the incidence of precursor lesions detected by anal cytology.MethodsThe Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy was a prospective cohort of 700 HIV-infected participants in 4 US cities. At baseline and annually thereafter, each participant completed a behavioral questionnaire, and healthcare professionals collected anorectal swabs for cytologic examination and human papillomavirus (HPV) detection and genotyping.ResultsAmong 243 participants with negative baseline results of anal cytology, 37% developed abnormal cytology findings (incidence rate, 13.9 cases/100 person-years of follow-up; 95% confidence interval [CI], 11.3-16.9) over a median follow-up duration of 2.1 years. Rates among men having sex with men, among women, and among men having sex with women were 17.9 cases/person-years of follow-up (95% CI, 13.9-22.7), 9.4 cases/person-years of follow-up (95% CI, 5.6-14.9), and 8.9 cases/person-years of follow-up (95% CI, 4.8-15.6), respectively. In multivariable analysis, the number of persistent high-risk HPV types (adjusted hazard ratio [aHR], 1.17; 95% CI, 1.01-1.36), persistent high-risk HPV types except 16 or 18 (aHR, 2.46; 95% CI, 1.31-4.60), and persistent types 16 or 18 (aHR, 3.90; 95% CI, 1.78-8.54) remained associated with incident abnormalities.ConclusionsThe incidence of abnormal anal cytology findings was high and more likely to develop among persons with persistent high-risk HPV.

In August 2014, the Viral Special Pathogens Branch of the US Centers for Disease Control and Prevention established a field laboratory in Sierra Leone in response to the ongoing Ebola virus outbreak. Through March 2015, this laboratory tested >12 000 specimens from throughout Sierra Leone. We describe the organization and procedures of the laboratory located in Bo, Sierra Leone.

BACKGROUND In the United States, human papillomavirus (HPV) vaccine is recommended for 11- or 12-year-olds, and for young adults not previously vaccinated. Early vaccine impact can be measured by reductions in vaccine-type (VT) HPV prevalence. METHODS Consecutive residual cervical specimens were retained from women aged 20-29 years at Kaiser Permanente Northwest in 2007, 2012, and 2013. HPV genotypes were determined using L1 consensus polymerase chain reaction with type-specific hybridization to detect 37 types, including VT HPV (HPV type 6, 11, 16, and 18). We compared HPV prevalence in 2007 and 2012-2013, and we evaluated predictors of VT HPV and any-HPV prevalence in 2012-2013. RESULTS In 2012-2013, 31.9% of 4181 women had initiated HPV vaccination. VT HPV prevalence decreased from 10.6% in 2007 to 6.2% in 2012-2013 (P < .001). In 2012-2013, VT HPV prevalence was significantly lower among those who initiated vaccination

BACKGROUND: Prevention of pre-invasive cervical lesions is an important benefit of HPV vaccines, but demonstrating impact on these lesions is impeded by changes in cervical cancer screening. Monitoring vaccine-types associated with lesions can help distinguish vaccine impact from screening effects. We examined trends in prevalence of HPV 16/18 types detected in cervical intraepithelial neoplasia 2,3, and adenocarcinoma in situ (CIN2+) among women diagnosed with CIN2+ from 2008 to 2012 by vaccination status. We estimated vaccine effectiveness against HPV 16/18-attributable CIN2+ among women who received ≥1 dose by increasing time intervals between date of first vaccination and the screening test that led to detection of CIN2+ lesion. METHODS: Data are from a population-based sentinel surveillance system to monitor HPV vaccine impact on type-specific CIN2+ among adult female residents of five catchment areas in California, Connecticut, New York, Oregon, and Tennessee. Vaccination and cervical cancer screening information was retrieved. Archived diagnostic specimens were obtained from reporting laboratories for HPV DNA typing. RESULTS: From 2008 to 2012, prevalence of HPV 16/18 in CIN2+ lesions statistically significantly decreased from 53.6% to 28.4% among women who received at least one dose (P(trend) 48 months prior to the screening test that led to CIN2+ diagnosis. CONCLUSIONS: Population-based data from the United States indicate significant reductions in CIN2+ lesions attributable to types targeted by the vaccines and increasing HPV vaccine effectiveness with increasing interval between first vaccination and earliest detection of cervical disease.

Background Differences in human papillomavirus (HPV) prevalence among males and females have been reported. Using the 2013-2014 National Health and Nutrition Examination Survey, we evaluated sex differences in prevalence overall and by demographic and sexual behavior characteristics. Methods Self-collected penile and cervicovaginal swabs from participants aged 14-59 were tested for HPV DNA. Prevalences of any HPV and high-risk HPV (HR-HPV) were estimated for sexually experienced males and females. Overall and in models stratified by demographic characteristics and behaviors, prevalence was compared in males and females using prevalence ratios (PR). Results Overall, males had higher prevalence than females of any HPV (PR, 1.14; 95% confidence interval [CI], 1.03-1.27) and HR-HPV (PR, 1.24; 95% CI, 1.07-1.43). Prevalences were lower among males than females at ages 14-19 and higher at ages 40-49 and 50-59. Sex differences in models stratified by race/ethnicity, poverty, sexual behaviors, and smoking were observed. After adjusting for lifetime sex partners, most sex differences were attenuated, but males had lower prevalences at ages 14-19 and 20-24 and higher HR-HPV prevalence among non-Hispanic blacks. Conclusions Any HPV and HR-HPV prevalences were significantly higher in males; sex differences varied by age group and race/ethnicity. Lifetime partners explained many of the differences by sex.

Background: Two currently available vaccines targeting human papillomavirus (HPV) types 16 and 18 could prevent 70% of cervical cancers and 50% of high-grade cervical lesions. Next-generation vaccines against additional types, such as a candidate 9-valent vaccine against HPV6/11/16/18/31/33/45/52/58, could further reduce HPV-associated disease burden. Methods: HPV was typed in archived tissues from women ages 21 to 39 years residing in five catchment areas in the United States with cervical intraepithelial neoplasia 2/3 and adenocarcinoma in situ (CIN2+) using L1 consensus PCR and type-specific hybridization. Type attribution was estimated using weights to account for lesions with multiple types detected. Results: From 2008 to 2011, 5,498 of 6,306 (87.2%) specimens obtained from 8,469 women with CIN2+ had valid typing results; HPV DNA was detected in 97.3%. Overall, 50.1% of lesions were attributable to HPV16/18, ranging from 50.3% to 52.4% among those ages 21 to 34 years, and significantly declined in 35 to 39 year-olds (43.5%). HPV16/18 attribution was higher in non-Hispanic whites (56.4%) versus racial/ethnic minorities (range, 41.8%–45.9%; P < 0.001). HPV31/33/45/52/58 attribution was 25.0% overall and increased with age (P < 0.001). A higher proportion of CIN2+ was attributable to HPV31/33/45/52/58 in non-Hispanic black (29.9%), Hispanic (29.2%), and Asian (33.1%) women compared with non-Hispanic whites (22.8%; P < 0.001). Conclusions: Overall, 75% of lesions were attributable to 7 oncogenic HPV types: 50% to HPV16/18 and 25% to HPV31/33/45/52/58. HPV16/18 had the largest attributable fraction in CIN2+ across all subpopulations, although to a lesser extent in older women and racial/ethnic minorities. Impact: Vaccines targeting additional oncogenic HPV types could prevent more high-grade cervical lesions, especially among racial/ethnic minorities. Cancer Epidemiol Biomarkers Prev; 24(2); 393–9. ©2014 AACR.

Introduction The 2006 introduction of human papillomavirus vaccine targeted against genotypes 6, 11, 16, and 18 should result in decreased cervical dysplasia in vaccinated women. However, new cervical cancer guidelines to increase screening intervals complicate interpretation of trends. The hypothesis is that cervical dysplasia would decrease only in young vaccine-eligible women, and not older women. Methods The authors identified Davidson County, Tennessee, women aged 18–39 years with cervical intraepithelial neoplasia (CIN) grade 2 or greater and adenocarcinoma in situ, denoted as CIN2+, through pathology reports from laboratories serving this population. Biopsy specimens for human papillomavirus genotyping were collected. Trends in CIN2+ rates and associated human papillomavirus genotypes, 2008 through 2013, were examined. Results The authors identified 2,031 women with CIN2+. Rates of CIN2+ fell from 188.9 to 58.7 per 100,000 women aged 18–20 years (annual percentage change= –24.2, 95% CI= –41.4, –2.1) and from 495.6 to 332.4 per 100,000 women aged 21–24 years (annual percentage change= –10.2%, 95% CI= –16.3, –3.4). There was no significant change in CIN2+ rates for women aged 25–29 or 30–39 years. In biopsy specimens from 1,319 of 2,031 (65%) women, at least one human papillomavirus genotype was identified in 1,270 (96%). The prevalence of at least one of four vaccine human papillomavirus genotypes (6, 11, 16, and 18) declined from 59% in 2008 to 52% in 2013 ( p =0.003). Conclusions Diagnosis of CIN2+ decreased in women aged 18–24 years, but not in older women. Both changes in screening and human papillomavirus vaccination could have contributed to the decline of CIN2+ in young women.

Background Human papillomavirus (HPV) vaccine was recommended in 2006 for routine vaccination of US females aged 11-12 years. Most vaccine used through 2014 was quadrivalent vaccine (4vHPV), which prevents HPV-6, -11, -16, and -18 infection. To evaluate vaccine impact, we measured HPV prevalence in the National Health and Nutrition Examination Survey (NHANES). Methods We analyzed HPV DNA types detected in self-collected cervicovaginal specimens and demographic, sexual behavior, and self-reported vaccination data from females 14-34 years old. We estimated HPV prevalence in the prevaccine (2003-2006) and vaccine eras (2007-2010 and 2011-2014). Results Among 14- to 19-year-olds, 4vHPV-type prevalence decreased from 11.5% (95% confidence interval [CI], 9.1%-14.4%) in 2003-2006 to 3.3% (95% CI, 1.9%-5.8%) in 2011-2014, when ≥1-dose coverage was 55%. Among 20- to 24-year-olds, prevalence decreased from 18.5% (95% CI, 14.9%-22.8%) in 2003-2006 to 7.2% (95% CI, 4.7%-11.1%) in 2011-2014, when ≥1-dose coverage was 43%. Compared to 2003-2006, 4vHPV prevalence in sexually active 14- to 24-year-olds in 2011-2014 decreased 89% among those vaccinated and 34% among those unvaccinated. Vaccine effectiveness was 83%. Conclusions Within 8 years of vaccine introduction, 4vHPV-type prevalence decreased 71% among 14- to 19-year-olds and 61% among 20- to 24-year-olds. Estimated vaccine effectiveness was high. The decrease in 4vHPV-type prevalence among unvaccinated females suggests herd protection.

ObjectiveWe conducted a baseline study of human papillomavirus (HPV) type prevalence in invasive cervical cancers (ICCs) using data from 7 cancer registries (CRs) in the United States. Cases were diagnosed between 1994 and 2005 before the implementation of the HPV vaccines.Materials and Meth

To describe the human papillomavirus (HPV) genotype distribution in invasive vaginal cancers diagnosed before the introduction of the HPV vaccine and evaluate if survival differed by HPV status.Four population-based registries and three residual tissue repositories provided formalin-fixed, paraffin-embedded tissue from microscopically confirmed primary vaginal cancer cases diagnosed between 1994 and 2005 that were tested by L1 consensus polymerase chain reaction with type-specific hybridization in a central laboratory. Clinical, demographic, and all-cause survival data were assessed by HPV status.Sixty cases of invasive vaginal cancer were included. Human papillomavirus was detected in 75% (45) and 25% (15) were HPV-negative. HPV 16 was most frequently detected (55% [33/60]) followed by HPV 33 (18.3% [11/60]). Only one case was positive for HPV 18 (1.7%) Multiple types were detected in 15% of the cases. Vaginal cancers in women younger than 60 years were more likely to be HPV 16- or HPV 18-positive (HPV 16 and 18) than older women, 77.3% compared with 44.7% (P=.038). The median age at diagnosis was younger in the HPV 16 and 18 (59 years) group compared with other HPV-positive (68 years) and no HPV (77 years) (P=.003). The HPV distribution did not significantly vary by race or ethnicity or place of residence. The 5-year unadjusted all-cause survival was 57.4% for women with HPV-positive vaginal cancers compared with 35.7% among those with HPV-negative tumors (P=.243).Three fourths of all vaginal cancers in the United States had HPV detected, much higher than previously found, and 57% could be prevented by current HPV vaccines.

Data from the National Health and Nutrition Examination Survey, 2009–2010, indicated that the prevalence of human papillomavirus (HPV) infection among women was 42.7% in the cervix and 3.8% in the oral cavity. The prevalence of oral HPV infection was 5-fold higher among women with than among those without cervical HPV infection (7.0% vs 1.4%; prevalence ratio, 4.9 [95% confidence interval, 2.7–8.7]). Among the 3% of women with HPV detected at both sites, complete type concordance was detected in 6.6%, and partial agreement was detected in 37.7%. These data suggest that HPV infections at these 2 sites are not independent, although type-specific concordance is low.

To test the hypothesis that self-collected urine could be used to detect high-risk human papillomavirus (HPV) DNA with sensitivity and specificity comparable to those of standard cervical testing.Women attending a gynecology clinic for evaluation of abnormal cytology were recruited. Fifty-two participants (21-60years of age) collected urine samples, and clinicians collected cervical brush samples. When appropriate, cervical biopsies were obtained during colposcopy. HPV detection and typing were performed on DNA extracts from each sample, using commercial reagents for L1 consensus polymerase chain reaction (PCR) and type-specific hybridization. HPV 16 viral load was determined by quantitative PCR in HPV 16-positive samples. A diagnostic test analysis was conducted for urine samples.Fifty paired samples were analyzed, with 76% agreement between samples. The 12 discrepant pairs were all urine negative/cervix positive. The most common HPV types detected were 16, 51, 53, and 62. The urine test correctly identified 100% of the uninfected and 65% of the infected patients.The results indicate that HPV DNA detection using urine is less sensitive than cervical sampling in a population with abnormal cytology. Further exploration is warranted to determine clinical utility when other options are unavailable.

Background There are no population-based HPV prevalence estimates in males because optimal sampling methods are unclear. Objectives To evaluate the acceptability, feasibility, and validity of different male genital self-sampling methods for HPV detection. Study design A total of 450 males, 14–59 years old, were randomly assigned to one of three genital sampling methods: (1) dry polyester-tipped swab; (2) dry foam swab; and (3) emery paper and wetted polyester-tipped swab. Samples were both self-collected and collected by a clinician. Subjects were queried on the acceptability of sampling methods. HPV was genotyped using an L1 consensus PCR assay. Results Specimen adequacy (92–96%, p = 0.28) and HPV detection (44–49%, p = 0.68) were comparable across the three methods. Concordance for HPV detection was observed between self- and clinician-collected specimen pairs for all methods (κ = 0.70–0.80). The collection procedure was reported to be very easy by 69% of dry polyester-tipped swab users and 64% of dry foam swab users compared to 48% of emery-wet swab users (p = 0.004). Similarly, 43–44% of dry swab and foam users reported the collection to be very comfortable compared to 24% of emery-wet swab users (p = 0.002). Pain was reported by 10% of emery-wet swab users compared to 3% and 5% of dry swab and foam users, respectively (p = 0.03). Self-collection by the emery-wet swab method required an average of 6 min compared to 3.3–3.5 min for the two dry methods (p Conclusions The dry collection methods are optimal for use in large epidemiologic studies or surveillance efforts based on their acceptability and feasibility.

Background. Human papillomavirus (HPV) vaccination was introduced into the routine immunization schedule in the United States in late 2006 for females aged 11 or 12 years with catch-up vaccination recommended for those aged 13-26 years. In 2010 3-dose vaccine coverage was only 32% among 13-17 year-olds. Reduction in the prevalence of HPV types targeted by the quadrivalent vaccine (HPV-6 -11 -16 and -18) will be one of the first measures of vaccine impact. Methods. We analyzed HPV prevalence data from the vaccine era (2007-2010) and the prevaccine era (2003-2006) that were collected during National Health and Nutrition Examination Surveys. HPV prevalence was determined by the Linear Array HPV Assay in cervicovaginal swab samples from females aged 14-59 years; 4150 provided samples in 2003-2006 and 4253 provided samples in 2007-2010. Results. Among females aged 14-19 years the vaccine-type HPV prevalence (HPV-6 -11 -16 or -18) decreased from 11.5% (95% confidence interval [CI] 9.2-14.4) in 2003-2006 to 5.1% (95% CI 3.8-6.6) in 2007-2010 a decline of 56% (95% CI 38-69). Among other age groups the prevalence did not differ significantly between the 2 time periods (P > .05). The vaccine effectiveness of at least 1 dose was 82% (95% CI 53-93). Conclusions. Within 4 years of vaccine introduction the vaccine-type HPV prevalence decreased among females aged 14-19 years despite low vaccine uptake. The estimated vaccine effectiveness was high.

As immunization programs for human papillomavirus (HPV) are implemented more widely around the world, interest is increasing in measuring their impact. One early measurable impact of HPV vaccine is on the prevalence of specific HPV types in a population. In low-resource settings, a potentially attractive strategy would be to monitor HPV prevalence using clinical cervical cancer screening test results to triage specimens for HPV typing. We assessed this approach in a nationally representative population of U.S. females aged 14–59 years. Using self-collected cervico-vaginal swab specimens from 4,150 women participating in the National Health and Nutrition Examination Survey during 2003–2006, we evaluated type-specific HPV prevalence detected by the Roche linear array (LA) research test on all specimens, compared with type-specific HPV prevalence detected by LA conducted only on specimens positive by the digene hybrid capture 2 (HC-2) clinical test. We calculated weighted prevalence estimates and their 95% confidence intervals (CIs), and examined relative type-specific HPV prevalence according to the two testing approaches. The population prevalence of oncogenic HPV vaccine types 16/18 was 6.2% (CI:5.4–7.1) by LA if all specimens were tested, and 2.4% (CI:1.9–3.0) if restricted to positive HC-2. Relative prevalence of individual HPV types was similar for both approaches. Compared with typing all specimens, a triage approach would require testing fewer specimens, but a greater reduction in HPV prevalence or a larger group of specimens would be needed to detect vaccine impact. Further investigation is warranted to inform type-specific HPV monitoring approaches around the world.

Two human papillomavirus (HPV) vaccines are available to prevent cervical cancer. One early measure of HPV vaccine impact would be a reduction in vaccine-related HPV types (HPV 6, 11, 16, or 18, or HPV 16, 18) in cervical samples from young women. We aimed to assess feasibility of specimen collection and baseline HPV prevalence in an integrated healthcare delivery system. Residual cervical specimens collected during routine cervical cancer screening (2006–2008) were retained consecutively from eligible females aged 11–29 years, stratified by age group. Specimens were evaluated for 37 HPV genotypes using the Roche Linear Array assay. Of 10,124 specimens submitted, 10,103 (99 %) were adequate for HPV testing. Prevalence of HPV 6, 11, 16, or 18 genotype was 11.4 % overall and was the highest in the youngest age group (18.1 % in the 11–19-year-olds, 12.5 % in the 20–24-year-olds, and 7.0 % in the 25–29-year-olds). HPV types 6, 11, 16, or 18 prevalence could be measured over time to assess early HPV vaccine impact using residual specimens from an integrated healthcare delivery system, particularly if sampling focused on young women.

Background We report the first nationally representative prevalence data on genital human papillomavirus (HPV) in males in the United States, using findings from the National Health and Nutrition Examination Surveys, 2013-2014. Methods Using penile swabs from males aged 14-59 years, we estimated the HPV DNA prevalence and prevalence ratios (PRs) with respect to sexual behaviors and demographic characteristics. Results The prevalence of any HPV was 42.2% (95% confidence interval [CI], 38.3%-46.1%) and of high-risk (HR) HPV was 23.4% (95% CI, 21.3%-25.6%). Prevalence of any HPV was 12.5% in 14-19 year olds and was higher in older age groups, through ages 25-29 years, and then similar through age 59 years. After adjustment for age and race, any HPV prevalence was associated with lifetime number of sex partners (≥15 vs 1-2; PR, 3.27; 95% CI, 2.12-5.02) and past-year number of sex partners (≥2 vs 0; PR, 1.26; 95% CI, 1.09-1.46). Comparisons of consecutively older age groups revealed that the prevalence of quadrivalent HPV vaccine types (4vHPV), types 6, 11, 16, and 18, was significantly higher only between ages 25-29 and 20-24 years (PR, 2.79; 95% CI, 1.31-5.96), whereas the prevalence of other HPV types was significantly higher only between ages 20-24 and 14-19 years (PR, 3.39; 95% CI, 2.49-4.61). Conclusions Overall, 42.2% of US males aged 14-59 years have detectable genital HPV infections. Differences in the age-specific prevalence of 4vHPV types and non-4vHPV types suggest that the vaccination program has had an impact on the prevalence of HPV types 6, 11, 16, and 18 among males.

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.

J Oral Pathol Med (2012) 41: 288–291 Background: Oral human papillomavirus (HPV) is associated with several health complications especially in combination with HIV infections. Screening may be useful, but methodologies and results have varied widely in previous studies. We conducted a pilot study in an HIV-positive population to evaluate HPV detection in four different oral sample types. Methods: Upon enrollment, an oral-rinse (OR) sample was collected in 10 ml saline. Additional samples of the buccal mucosa, tonsils, and oral lesion if present were collected with cytology brushes. DNA was extracted using LC-MagNAPure, and the Linear Array HPV genotyping Assay (Roche) was used for HPV genotyping. Results: In samples from 100 HIV-positive participants, HPV was detected in 39 (%) of the oral rinses, 13 (%) mucosal and 11 (12.9%) tonsil brushings. Of seven lesion brushings collected, four were HPV positive. All participants with HPV detected in mucosal, tonsil, or lesion brushings were also positive in the OR sample. Among the rinse samples, 27 different genotypes were detected with HPV84 (n = 6), HPV55 (n = 5), and HPV83 (n = 5) being the most common. Multiple infections were detected in 17 samples (range 2–9, mean 1.9 types). As potential cofactors, only receptive oral sex was significantly associated with HPV (P = 0.018, odds ratio 2.9, 95% CI 1.2–6.9). Conclusion: Sampling is a significant factor for oral prevalence studies. Oral rinse provides the best representation for HPV in the oral cavity. To evaluate associated cofactors other than receptive oral sex, larger studies with case–control design are necessary.

DNA from archived FFPE can be used for papillomavirus genotyping, but potential problems include paraffin as a physical barrier, DNA cross-linking, and PCR inhibitors. To address these complications, we combined a commercially available DNA isolation kit (Qiagen DNeasy) with a heat treatment and evaluated the resulting DNA with regards to HPV typing. DNA was extracted from 10-μm sections from 150 FFPE cancer samples. One protocol followed the manufacturer's recommendation, including paraffin removal by xylene and tissue lysis at 56°C. A second section was directly incubated at 120°C and subsequently lysed at 65°C. After spin-column purification, both extracts were tested with a linear array HPV genotyping assay. Additionally, cellular DNA yield, HPV16 DNA copies, and PCR inhibitors were assessed by real-time qPCR assays. Inadequate linear array HPV genotyping assay results were significantly more frequent (P = 0.0003) in xylene-treated (29/150, 19.3%) than in heat-treated extracts (8/150, 5.3%). HPV detection also differed, with 94/150 (62.7%) and 110/150 (73.3%) positive results, respectively (P = 0.0026). The heat method also yielded more PCR-amplifiable cellular DNA (8.2-fold; P < 0.001) and HPV16 copies (6.5-fold; P = 0.009), although PCR inhibitors also had a greater effect (P = 0.035). Aggressive heat treatment demonstrated an advantage over traditional xylene purification protocols, resulting in higher DNA yields and increased sensitivity for HPV testing.

Type-specific surveillance of human papillomavirus (HPV) has been proposed as an early indicator of vaccine impact. Longitudinal comparison of HPV typing results requires stable assays with high type-specific reproducibility. Assays are evolving and the impact of even minor changes in the assay format may be difficult to anticipate. We initiated a population-based study of HPV with the prototype line blot (PLB) assay. These reagents were replaced by the research use only Linear Array (LA) HPV Genotyping kit. The assays are similar in principle and earlier comparisons found increased sensitivity and detection of more types per sample with LA; however, in samples from women with cervical abnormalities, the overall concordance was good. Slight changes in sensitivity may be more significant in samples from a general population with lower viral loads in the samples. Residual extracts from 3001 self-collected vaginal swabs from women in the general US population originally tested with PLB were retested with LA. With LA, all the samples were hybridized. PLB hybridization was restricted to samples with probable amplicon in gel electrophoresis. For HPV detection, the agreement between the 2 assays was 78.6% (κ=0.55) with a positive concordance of 52.8%. However, this masks the observation that repeat testing with LA led to the detection of HPV in nearly twice as many samples. Agreement improves if comparison was restricted to the samples hybridized. These results emphasize that assay comparisons should consider the clinical-epidemiologic context of sample collection. Studies designed to examine temporal trends in type-specific prevalence should archive residual material to permit retesting if assays change.

Background: Few studies have examined genetic variants of HPV 16 in cancers other than cervical. Methods: Residual DNA extracts from samples collected from seven cancer registries as part of a pilot study to determine type-specific HPV prevalence in US cancers prior to vaccine introduction were used. Of the 1395 histologically confirmed tumors with HPV PCR results, 1045 (74.9%) were HPV 16 positive. Valid E6 pyrosequencing allowed variant determination in 836 (80%) of the HPV 16 tumors (107 anal, 337 cervical, 30 penile, 25 vaginal, 69 vulvar and 268 oropharyngeal). Variants were designated using both geographic and group terminology for lineages. Age, sex and race/ethnicity were obtained from the registry data. Results: European (A) lineages were the most prevalent in all cancer sites, ranging from 77.5% for penile to 95.7% for anal cancers. Within the A lineage, the E-p and E-T350G variants were the most common, ranging from 28-41% and 20.5 – 33% respectively. Other non-European variants (lineage B, C, ...

This study sought to determine the prevaccine type-specific prevalence of human papillomavirus (HPV)-associated cancers in the United States to evaluate the potential impact of the HPV types in the current and newly approved 9-valent HPV vaccines.The Centers for Disease Control and Prevention partnered with seven US population-based cancer registries to obtain archival tissue for cancers diagnosed from 1993 to 2005. HPV testing was performed on 2670 case patients that were fairly representative of all participating cancer registry cases by age and sex. Demographic and clinical data were evaluated by anatomic site and HPV status. Current US cancer registry data and the detection of HPV types were used to estimate the number of cancers potentially preventable through vaccination.HPV DNA was detected in 90.6% of cervical, 91.1% of anal, 75.0% of vaginal, 70.1% of oropharyngeal, 68.8% of vulvar, 63.3% of penile, 32.0% of oral cavity, and 20.9% of laryngeal cancers, as well as in 98.8% of cervical cancer in situ (CCIS). A vaccine targeting HPV 16/18 potentially prevents the majority of invasive cervical (66.2%), anal (79.4%), oropharyngeal (60.2%), and vaginal (55.1%) cancers, as well as many penile (47.9%), vulvar (48.6%) cancers: 24 858 cases annually. The 9-valent vaccine also targeting HPV 31/33/45/52/58 may prevent an additional 4.2% to 18.3% of cancers: 3944 cases annually. For most cancers, younger age at diagnosis was associated with higher HPV 16/18 prevalence. With the exception of oropharyngeal cancers and CCIS, HPV 16/18 prevalence was similar across racial/ethnic groups.In the United States, current vaccines will reduce most HPV-associated cancers; a smaller additional reduction would be contributed by the new 9-valent vaccine.

Objective The primary cervical cancer screening strategy for women over age 30 is high-risk human papillomavirus (HPV) testing combined with Papanicolaou (Pap) testing (cotesting) every 5 years. This combination strategy is a preventive service that is required by the Affordable Care Act to be covered with no cost-sharing by most health insurance plans. The cotesting recommendation was made based entirely on prospective data from an insured population that may have a lower proportion of women with HPV positive and Pap negative results (ie, discordant results). The discordant group represents a very difficult group to manage. If the frequency of discordant results among underserved women is higher, health care providers may perceive the cotesting strategy to be a less favorable screening strategy than traditional Pap testing every 3 years. Study Design The Centers for Disease Control and Prevention's Cervical Cancer Study was conducted at 15 clinics in 6 federally qualified health centers across Illinois. Providers at these clinics were given the option of cotesting for routine cervical cancer screening. Type-specific HPV detection was performed on residual extracts using linear array. Results Pap test results were abnormal in 6.0% and HPV was positive in 7.2% of the underserved women screened in this study (mean age, 45.1 years). HPV prevalence decreased with age, from 10.3% among 30- to 39-year-olds to 4.5% among 50- to 60-year-olds. About 5% of the women had a combination of a positive HPV test and normal Pap test results; HPV 16/18 was identified in 14% of discordant women. Conclusion The rate of discordant results among underserved women was similar to those reported throughout the US in a variety of populations. Typing for HPV 16/18 appears to assist in the management in a small proportion of women with discordant results.

Background. Human papillomavirus (HPV) is estimated to play an etiologic role in 40%-50% of penile cancers worldwide. Estimates of HPV prevalence in U.S. penile cancer cases are limited. Methods. HPV DNA was evaluated in tumor tissue from 79 invasive penile cancer patients diagnosed in 1998-2005 within the catchment areas of 7 U.S. cancer registries. HPV was genotyped using PCR-based Linear Array and INNO-LiPA assays and compared by demographic, clinical, and pathologic characteristics and survival. Histological classification was also obtained by independent pathology review. Results. HPV DNA was present in 50 of 79 (63%) of invasive penile cancer cases. Sixteen viral genotypes were detected. HPV 16, found in 46% (36/79) of all cases (72% of HPV-positive cases) was the most prevalent genotype followed equally by HPV 18, 33, and 45, which each comprised 5% of all cases. Multiple genotypes were detected in 18% of viral positive cases. HPV prevalence did not significantly vary by age, race/ethnicity, population size of geographic region, cancer stage, histology, grade, penile subsite, or prior cancer history. Penile cases diagnosed in more recent years were more likely to be HPV positive. Overall survival did not significantly vary by HPV status. Conclusions. The relatively high prevalence of HPV in our study population provides limited evidence of a more prominent and, possibly, increasing role of infection in penile carcinogenesis in the U.S. compared to other parts of the world.

This study aimed to conduct a representative survey of human papillomavirus (HPV) prevalence and its genotype distribution in invasive anal cancer specimens in the United States.Population-based archival anal cancer specimens were identified from Florida, Kentucky, Louisiana, and Michigan cancer registries and Surveillance, Epidemiology, and End Results (SEER) tissue repositories in Hawaii, Iowa, and Los Angeles. Sections from 1 representative block per case were used for DNA extraction. All extracts were assayed first by linear array and retested with INNO-LiPA if inadequate or HPV negative.Among 146 unique invasive anal cancer cases, 93 (63.7%) were from women, and 53 (36.3%) were from men. Human papillomavirus (any type) was detected in 133 cases (91.1%) and 129 (88.4%) contained at least 1 high risk-type, most (80.1%) as a single genotype. Human papillomavirus type 16 had the highest prevalence (113 cases, 77.4%); HPV types 6, 11, 18, and 33 were also found multiple times. Among HPV-16-positive cases, 37% were identified as prototype variant Ep, and 63% were nonprototypes: 33% Em, 12% E-G131G, 5% Af1, 4% AA/NA-1, 3% E-C109G, 3% E-G131T, 2% As, and 1% Af2. No significant differences in the distributions of HPV (any), high-risk types, or HPV-16/18 were seen between sex, race, or age group.The establishment of prevaccine HPV prevalence in the United States is critical to the surveillance of vaccine efficacy. Almost 80% of anal cancers were positive for the vaccine types HPV-16 or HPV-18, and in 70%, these were the only types detected, suggesting that a high proportion might be preventable by current vaccines.

OBJECTIVE: To characterize the prevalence and distribution of genital human papillomavirus (HPV) types among women in Jamaica, and to explore risk factors associated with HPV infection. METHODS: This was a cross-sectional study that took place in April-July 2010 with 852 sexually-active women, 16-49 years of age, who had attended a selected public or private primary health clinic in one of Jamaica's four health authority regions. Sociodemographic data was collected from each participant by trained study staff. Each participant had a gynecological examination that included a clinical Pap test and a cervical sample for HPV detection and typing-performed using the Research Use Only Linear Array (LA) genotyping assay (Roche Diagnostics Corp., Indianapolis, Indiana, United States). Overall and type-specific prevalence of HPV infection was calculated for 37 HPV types included in the LA genotyping assay. RESULTS: HPV DNA was detected in 460 of the 852 women (54.0%). Oncogenic HPV was detected in 297 women (34.9%) and HPV types 16/18 were found in 86 women (10.1%). The most frequently occurring HPV types were: 16 (6.2%); 35 (6.0%); 62 and 83 (5.5%); 61 and 58 (5.4%); 84 (4.7%); 18 (4.3%); and, 66 and 81 (4.2%). HPV prevalence was highest among women who were single, young (16-19 years), and had had more than three sexual partners in their lifetime. CONCLUSIONS: These results, coupled with high rates of cervical cancer, support introducing HPV vaccines while maintaining and strengthening cervical cancer screening services. Policy decisionmaking that reflects these results is instrumental to establishing a comprehensive cervical cancer program in Jamaica.

Background Vaccination against human papillomavirus (HPV) types 16 and 18 is recommended for girls aged 11 or 12 years with catch-up vaccination through age 26 in the U.S. Cervical intraepithelial neoplasia (CIN) grade 2 or 3 and adenocarcinoma in situ (CIN2+) are used to monitor HPV vaccine impact on cervical disease. This report describes vaccination status in women diagnosed with CIN2+ and examines HPV vaccine impact on HPV 16/18-related CIN2+. Methods As part of a vaccine impact monitoring project (HPV-IMPACT), females 18–31 years with CIN2+ were reported from pathology laboratories in CA, CT, NY, OR, TN from 2008 to 2011. One diagnostic block was selected for HPV DNA typing with Roche Linear Array. Demographic, abnormal Papanicolaou (Pap) test dates and vaccine status information were collected. The abnormal Pap test immediately preceding the CIN2+ diagnosis was defined as the ‘trigger Pap’. Results Among 5083 CIN2+ cases reported to date, 3855 had vaccination history investigated; 1900 had vaccine history documented (vaccinated, with trigger Pap dates, or unvaccinated). Among women who initiated vaccination >24 months before their trigger Pap, there was a significantly lower proportion of CIN2+ lesions due to 16/18 compared to women who were not vaccinated (aPR = .67, 95% CI: .48–.94). Among the 1900 with known vaccination status, 20% initiated vaccination on/after their trigger screening. Women aged 21–23 years were more likely to initiate vaccination on/after the trigger Pap compared to 24–26 year olds (29.0% vs. 19.6%, p = .001), as were non-Hispanic blacks compared to non-Hispanic whites (27.3% vs. 19.0%, p = .001) and publicly compared to privately insured women (38.1% vs. 17.4%, p Conclusion We found a significant reduction in HPV 16/18-related lesions in women with CIN2+ who initiated vaccination at least 24 months prior to their trigger Pap. These preliminary results suggest early impact of the HPV vaccine on vaccine-type disease, but further evaluation is warranted.

Background HPV typing using formalin fixed paraffin embedded (FFPE) cervical tissue is used to evaluate HPV vaccine impact, but DNA yield and quality in FFPE specimens can negatively affect test results. This study aimed to evaluate 2 commercial assays for HPV detection and typing using FFPE cervical specimens. Methods Four large North Carolina pathology laboratories provided FFPE specimens from 299 women ages18 and older diagnosed with cervical disease from 2001 to 2006. For each woman, one diagnostic block was selected and unstained serial sections were prepared for DNA typing. Extracts from samples with residual lesion were used to detect and type HPV using parallel and serial testing algorithms with the Linear Array and LiPA HPV genotyping assays. Findings LA and LiPA concordance was 0.61 for detecting any high-risk (HR) and 0.20 for detecting any low-risk (LR) types, with significant differences in marginal proportions for HPV16, 51, 52, and any HR types. Discordant results were most often LiPA-positive, LA-negative. The parallel algorithm yielded the highest prevalence of any HPV type (95.7%). HR type prevalence was similar using parallel (93.1%) and serial (92.1%) approaches. HPV16, 33, and 52 prevalence was slightly lower using the serial algorithm, but the median number of HR types per woman (1) did not differ by algorithm. Using the serial algorithm, HPV DNA was detected in >85% of invasive and >95% of pre-invasive lesions. The most common type was HPV16, followed by 52, 18, 31, 33, and 35; HPV16/18 was detected in 56.5% of specimens. Multiple HPV types were more common in lower grade lesions. Conclusions We developed an efficient algorithm for testing and reporting results of two commercial assays for HPV detection and typing in FFPE specimens, and describe HPV type distribution in pre-invasive and invasive cervical lesions in a state-based sample prior to HPV vaccine introduction.

Background: Recommendations for high-risk human papillomavirus (HR-HPV) testing as an adjunct to cytology for cervical cancer screening differ by age group, because HR-HPV tests lack adequate specificity in women aged Methods: Women ages 18 to 69 (n = 1,658) were enrolled and completed structured interviews to elicit data on behavioral risk factors prior to their examinations. HPV genotyping was done on exfoliated cervical cell samples. We estimated relative risks (RR) for HPV types and cofactors for CIN3+, overall and stratified by age group. Results: After 2 years of follow-up, we identified 178 CIN3+, 1,305 CIN0–2, and 175 indeterminate outcomes. Nonvaccine HR-HPV types were only associated with CIN3+ among women ≥30 (RR = 2.3, 95% CI: 1.5–3.4; Conclusion: Subgroup variation by age in the risk of CIN3+ points to the importance of the timing of exposures in relation to CIN3+ detection. Impact: Future screening strategies need to consider natural history and secular trends in cofactor prevalence in the pursuit of appropriately sensitive and specific screening tools applied to appropriate age groups. Cancer Epidemiol Biomarkers Prev; 21(1); 111–21. ©2011 AACR.

Human papillomavirus type 16 (HPV-16) genotype variants have been the subject of several investigations, but study participants have rarely been sampled more than once. In this study, among a cohort of human immunodeficiency virus (HIV)-infected adults, HPV-16 variants were investigated in samples collected concurrently from the anus and cervix, as well as in serial samples collected from the same anatomical site at 12-month intervals. HPV-16 variants in stored extracts of cervical and anal samples were determined from subjects with multiple visits and at least one sample positive for HPV-16. Seven polymorphic nucleotide positions within the E6 region were analysed by pyrosequencing to determine genotype variants. Of 364 samples examined, 176 anal and 39 cervical swabs from 84 different subjects yielded unequivocal sequences of eight major HPV-16 variants. Eight samples contained probable novel HPV-16 variants and in one sample two variants were detected. In eight out of 29 (27.6 %) anal–cervical sample pairs positive for HPV-16, discordant variants were found. From 57 anal and nine cervical sample series of HPV-16-positive samples, a change in HPV-16 variant status over time was seen in nine (13.6 %) instances (seven anal and two cervical) from eight different participants. Changes in HPV-16 variants in HIV-infected adults were seen most frequently when different anatomical sites were sampled, but were also observed over time.

Background Type-specific detection of human papillomavirus (HPV) is increasingly important for monitoring temporal and age-specific changes in type-specific prevalence in support of HPV vaccination efforts. The impact of sampling, extraction and assay characteristics on HPV results is increasingly recognized. Inter-assay comparability studies have been performed, but the robustness of type-specific results has neither been emphasized nor has the degree of intra-assay reproducibility been addressed. Objectives Here we describe the general and type-specific reproducibility of the linear array HPV genotyping test (Roche Molecular Diagnostics, Indianapolis, IN). Study design Extracts of 276 cervical samples from two ongoing epidemiologic HPV studies were retested while blinded to prior results. The testing involved five different reagent lots and three technologists. Results Concordance for HPV detection (sample positive versus negative for any of the 37 types) was high (98.2%, kappa = 0.959). Type-specific concordance for individual HPV types was also high (99.4%, kappa = 0.915), and most samples (83.0%) showed complete concordance for all types. Conclusions Type-specific reproducibility of the linear array HPV genotyping test is good but not perfect. The results suggest that type-specific performance should be included in the evaluation of HPV typing formats.