OBJECTIVE:Recurrent Respiratory Papillomatosis (RRP) is caused by human papillomavirus (HPV) types 6 and 11, and afflicts children (Jo-RRP, Juvenile-onset RRP) and adults (Ao-RRP, adult-onset RRP). The study objective was to describe the disease burden of RRP from three patient-relevant perspectives: economic, clinical, and humanistic. METHODS:A retrospective descriptive analysis of responses to questionnaires captured within a linked Coordination of Rare Diseases (CoRDS) and the Recurrent Respiratory Papillomatosis Foundation (RRPF) (CoRDS/RRPF) patient registries from May 1, 2019, to July 31, 2023 was performed. Categorical variables were summarized using counts and proportions and continuous variables were summarized using means (standard deviations) and medians (interquartile ranges). RESULTS:Responses from 122 participants, 55% (67/122) Jo-RRP and 45% (55/122) Ao-RRP, were included. Forty-one percent (41/99) traveled more than 100 miles round trip to receive specialty care, and 61% (52/85) spent > 5% of their family income to pay for care. RRP resulted in increased absences from school [94% (17/18) for participants aged < 22] and work [85.5% (65/76) for participants aged > 22]. Moreover, 64.9% (48/74) of respondents perceived that RRP negatively impacted their careers. Feelings of isolation (70%) and depression (45.1%) were common, but less than 25% of respondents reported seeking mental health assistance. CONCLUSION:RRP leads to clinical, financial, and psychosocial burdens. Increased public awareness regarding HPV infection of the airway is needed, as this disease is preventable through HPV vaccination. LEVEL OF EVIDENCE: 5:

Health care disruptions associated with the COVID-19 pandemic have caused persistent decreases in human papillomavirus (HPV) vaccination uptake in Germany. The objective of this study was to estimate the cumulative deficit in first doses of the HPV vaccine administered to girls in Germany since the beginning of the pandemic and the projected time to recover from this deficit at different catch-up vaccination uptake levels, focusing on girls 9–14 years of age. This study used a published HPV vaccination modeling tool. Retrospective vaccination data from 2019 were used to calculate the baseline vaccination rate, while data from 1 January 2020 to 31 December 2023 were used to estimate the size and duration of the HPV vaccination deficit accrued since the beginning of the COVID-19 pandemic. We modeled scenarios in which the rate of monthly vaccinations increased from the 2023 average to 5

Background HPV-related oropharyngeal squamous cell carcinoma (OPSCC) is increasing in incidence, yet there are few well-designed oral HPV epidemiology studies in general populations. This study assessed oral HPV prevalence and risk-factors among a general population in Europe and the United States (US). Methods The cross-sectional study was conducted between November 2020 and July 2023 in 105 dental offices in France, Germany, Spain, the United Kingdom (UK) and US. Participants were aged 18-60 and visiting dental clinics for routine examination. Participants provided oral gargle specimen for HPV DNA and genotyping and completed behavioral questionnaires. HPV DNA detection and genotyping was performed using SPF10/DEIA/ LiPA25 at central laboratories. Findings Of 7674 participants, mean (SD) age was 40.0 (11.9), and 45.8% were males. Among men, any oral HPV prevalence ranged between countries from 6.6% to 15.0% and 1.8%-4.5% for high-risk (HR) types. Among women, any oral HPV prevalence ranged between countries from 3.6% to 6.8% and 0.2%-2.1% for HR types. HR infection among men was associated with older age (AOR 1.04; 95% CI: 1.02, 1.06); marijuana use (AOR 1.92; 95% CI: 1.19-3.11); increasing number of lifetime female oral sex partners; and by country, residing in the UK compared to Spain (AOR 2.89; 95% CI: 1.30-6.43). HR infection among women was associated with lifetime marijuana use (AOR 2.33; 95% CI: 1.18-4.60) and by country, residing in France compared to Spain (AOR 4.46; 95% CI: 1.26-15.77). Interpretation Oral HPV burden was highest among older men who may be at risk of developing OPSCC. Funding Funding for this research was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Copyright (c) 2025 Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. and The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/). 2025;79: Published https://doi.org/10. 1016/j.eclinm.2024. 103018

This study aims to explore the contrasting trends of decreasing cervical cancer (CC) rates among women and increasing oropharyngeal cancer (OPC) rates among men. The analysis examines public health initiatives, including CC screening programs and HPV vaccination efforts, alongside the changing epidemiology of OPC. Declines in CC incidence are attributed to improved screening and HPV vaccination. Conversely, OPC rates are rising among men, linked primarily to HPV infection and lack of established screening programs. Data indicate a higher OPC burden in men compared to CC in women in several countries. Addressing the rising OPC trend requires a multifaceted approach, including gender-neutral HPV vaccination, the development of OPC screening methods, and increased public awareness. Sustained efforts in HPV-related cancer prevention are crucial to mitigate these opposing trends.

BackgroundThe economic and mortality burden of cancer is high worldwide. In Europe, cancer was responsible for 1.3 million deaths in 2020 and incurred an estimated cost of 50 billion from premature mortality. Human papillomavirus (HPV) and hepatitis B virus (HBV) are among the leading causes of infection-related cancers despite the availability of effective vaccines against these infections. This analysis estimated the mortality and productivity loss of HBV- and HPV-associated cancers that could be preventable through vaccination across European regions.Materials and methodsInstitute for Health Metrics Evaluation (IHME) data were used to estimate mortality, years of life lost (YLL), and the value of years of life lost (VYLL) from five HBV- and HPV-related cancers (oral cavity, oropharynx, larynx, cervical, and liver cancers) across 40 European countries in 2019. Preventable deaths and YLL were estimated based on fractions attributable to infections. Data from the World Bank on GDP per capita were used to estimate the VYLL. The robustness of these results was explored with sensitivity and scenario analyses.ResultsIn 2019, 31,906 cancer deaths resulted in an economic burden of 18,521,614,725 due to productivity losses across Europe. HPV-related cervical cancer had the highest mortality (19,473 deaths) and economic burden (10,706,253,185). HBV-related liver cancer and HPV-related larynx, oral cavity, and oropharynx cancers also had a substantial burden, particularly in males. Eastern Europe had the highest YLL (308,179; 39%) and Western Europe was responsible for the greatest VYLL (8,281,306,504; 45%), although the highest VYLL per death was in Northern Europe (923,638). HPV-related oropharynx cancer had the highest VYLL per death (656,607).ConclusionHPV- and HBV-related cancer deaths are associated with substantial mortality and productivity losses in Europe, which could be reduced by the continued prioritization and implementation of prophylactic public health measures including systematic awareness, vaccination, and screening efforts.

There is limited understanding of epidemiology and time trends of human papilloma virus (HPV)-driven head and neck cancers (HNC) in Japan, especially outside of the oropharynx. To assess HPV-driven HNC, a non-interventional study (BROADEN) of HNC patients diagnosed in 2008-2009 and 2018-2019 was conducted in Japan. Adult patients with oropharyngeal, nasopharyngeal, laryngeal, hypopharyngeal or oral cavity cancers were included in this study. HPV was centrally tested using p16INK4a immunohistochemistry, HPV-DNA PCR and HPV E6*I mRNA. HPV attributability required positivity in at least two tests (p16INK4a immunohistochemistry, HPV-DNA PCR, HPV E6*I mRNA) in the oropharynx, and HPV-DNA and HPV E6*I mRNA positivity for non-oropharynx sites. Nineteen hospitals included a total of 1108 patients, of whom 981 had valid samples. Men accounted for 82% of HNC diagnoses. Patients in the earlier cohort were younger and included a higher percentage of smokers. There was an increasing trend of HPV-driven oropharyngeal cancer over the last decade, from 44.2% to 51.7%. HPV attribution in nasopharyngeal cancers was 3.2% in 2008-2009 and 7.5% in 2018-2019; and 4.4% and 0% for larynx respectively. In total, 95.2% of HPV-driven HNC were attributed to HPV genotypes included in the 9-valent HPV vaccine being HPV16 the most prominent genotype. These results suggest that an epidemiologic shift is happening in Japan, with a decrease in smoking and alcohol use and an increase in HPV-driven HNC. The increasing trend of HPV-driven HNC in Japan highlights the need for preventive strategies to mitigate the rise of HPV-driven HNC.

Abstract Aims The aim of this systematic literature review was to provide updated information on human papillomavirus (HPV) prevalence in locally and regionally advanced (LA) and recurrent/metastatic (RM) head and neck cancer (HNC) worldwide. Methods Electronic searches were conducted on clinicaltrials.gov, MEDLINE/PubMed, Embase, and ASCO/ESMO journals of congresses for interventional studies (IS; Phase I–III trials) as well as MEDLINE and Embase for non‐interventional studies (NIS) of LA/RM HNC published between January 01, 2010 and December 31, 2020. Criteria for study selection included: availability of HPV prevalence data for LA/RM HNC patients, patient enrollment from January 01, 2010 onward, and oropharyngeal cancer (OPC) included among HNC types. HPV prevalence per study was calculated as proportion of HPV+ over total number of enrolled patients. For overall HPV prevalence across studies, mean of reported HPV prevalence rates across studies and pooled estimate (sum of all HPV+ patients over sum of all patients enrolled) were assessed. Results Eighty‐one studies (62 IS; 19 NIS) were included, representing 9607 LA/RM HNC cases, with an overall mean (pooled) HPV prevalence of 32.6% (25.1%). HPV prevalence was 44.7% (44.0%) in LA and 24.3% (18.6%) in RM. Among 2714 LA/RM OPC patients from 52 studies with available data, mean (pooled) value was 55.8% (50.7%). The majority of data were derived from Northern America and Europe, with overall HPV prevalence of 46.0% (42.1%) and 24.7% (25.3%) across studies conducted exclusively in these geographic regions, respectively (Northern Europe: 31.9% [63.1%]). A “p16‐based” assay was the most frequently reported HPV detection methodology (58.0%). Conclusion Over the last decade, at least one quarter of LA/RM HNC and half of OPC cases studied in IS and NIS were HPV+. This alarming burden is consistent with a potential implication of HPV in the pathogenesis of at least a subgroup of HNC, underscoring the relevance of HPV testing and prophylaxis to HNC prevention and management.

BackgroundHuman papillomavirus (HPV) causes several cancers such as cervical cancer and some head and neck (oral cavity, pharynx, and larynx), vulval, vaginal, anal, and penile cancers. As HPV vaccination is available, there is potential to prevent these cancers attributed to HPV and consequently the burden associated with them. The aim of this analysis was to estimate the number of HPV-related cancer deaths and the productivity costs due to years of life lost (YLL) in the United Kingdom (UK).MethodA model was developed utilizing UK 2019 mortality data sourced from country-specific databases for England, Scotland, Wales, and Northern Ireland for the following HPV-related cancers: head and neck (ICD-10 C00-14 and C32), cervix uteri (C53), vaginal (C51), vulval (C52), anal (C21), and penile (C60). The proportion of deaths and years of life lost (YLL) due to HPV were estimated using HPV attributable fractions for each anatomic location from the published literature. Labor force participation, retirement ages, and mean annual earnings, discounted at 3.5% annually, were applied to YLL to calculate the present value of future lost productivity (PVFLP).ResultsA total of 1817 deaths due to HPV-related cancers were reported in the UK in 2019 resulting in 31,804 YLL. Restricting to only YLL that occurred prior to retirement age yielded a total YPLL of 11,765 and a total PVFLP of 187,764,978 pound.ConclusionsThere is a high disease burden in the UK for HPV-related cancers, with a large economic impact on the wider economy due to productivity losses. Implementing and reinforcing public health measures to maintain high HPV vaccination coverage in both males and females may further facilitate reduction of this burden.

Juvenile- and adult-onset recurrent respiratory papillomatosis (JORRP and AORRP) are rare but serious conditions that are caused by oral human papillomavirus (HPV) infections. The proliferation of wart-like growths throughout the respiratory tract can result in medical problems, including death. The current treatment scheme is surgery, though prevention of HPV infection through vaccination is available. A previously developed model for JORRP and AORRP was adapted to the United States using data on disease burden and HPV infection. The model was validated against post-vaccination reductions in disease and used to forecast the future burden of JORRP and AORRP, estimating the impact that HPV vaccination will have on these diseases. Between 2007 (the beginning of HPV vaccination in the US) and 2021, this model estimates that approximately 1393 lives, 22,867 Quality-Adjusted-Life-Years, and over USD 672 million in treatment costs have been saved by HPV vaccination. There is also a substantial reduction in JORRP and AORRP burden, with a 95% reduction in incidence by 2040. Moreover, between 2040 and 2121, the model predicts 3–11 total cases of HPV6/11-related JORRP in the US, and 36–267 total cases of HPV6/11-related AORRP. HPV vaccination in the United States has driven, and will continue to drive, substantial reductions in the public health and economic burden of HPV6/11-related JORRP and AORRP.

Recurrent respiratory papillomatosis (RRP) is a chronic disease caused by human papillomavirus (HPV), characterized by recurrent papillomas in the respiratory tract. Presenting as either juvenile-onset RRP (JoRRP) or adult-onset RRP (AoRRP), the severity of the disease is subjective and unpredictable. Lack of curative therapies necessitates disease management involving repeated surgical removal of lesions. The review aimed to assess the clinical, humanistic and economic burden associated with RRP. Systematic literature reviews of Embase®, MEDLINE® and Cochrane databases were conducted for epidemiology, clinical, humanistic, and economic burden, from database inception to November 30, 2022. Conference abstracts were also searched (2019–2022). Key inclusion criteria consisted of juveniles or adults with RRP/laryngeal papillomatosis, with no restriction on study country, interventions, or comparators. Outcomes of interest included incidence, prevalence, risk factors, symptomatic presentation, HPV genotype, cost burden, resource use and health related quality of life (HRQoL). In JoRRP, the incidence rate ranged from 0.2–2.1 per 100,000 and the prevalence rate ranged from 0.8–4.3 per 100,000. Incidence and prevalence of AoRRP were 0.2–3.9 and 0.4–8.4 per 100,000, respectively. Limited studies reported the subsequent impact of introducing national prophylactic HPV immunisation programs on JoRRP epidemiology, but where available, they were associated with significantly reduced incidence rates. Symptomatic presentations were diverse, with voice impact and breathing difficulties commonly reported. More aggressive disease was linked to earlier age of onset and HPV11 genotype. Healthcare utilisation was largely driven by surgical interventions, due to lack of curative treatments. Cost burden was substantial, with JoRRP associated with triple the costs of AoRRP in the US. Patients with JoRRP and AoRRP experienced considerable HRQoL impairment, particularly relating to voice disorder. Extensive clinical, humanistic and economic disease burden was reported for both JoRRP and AoRRP, as it is a chronic condition, with propensity to recur and spread. Feasibility of improving HPV prophylactic vaccination coverage against HPV6/HPV11 should be explored to reduce incidence, alongside efforts to improve treatment of JoRRP and AoRRP patients. Despite the existing literature, RRP remains a poorly understood disease, and future research on risk factors and medical options are needed.

Background Persistent human papillomavirus (HPV) infection is a known cause of a subset of head and neck cancers (HNCs). In the last two decades, the proportion of HNCs attributable to HPV infection has increased worldwide, notably the oropharyngeal cancers. However, the trend of HPV-related HNC burden is not clearly understood yet in China. Thus, the absolute burden of HPV-related head and neck cancers in China (BROADEN-China) will be conducted to estimate the proportion of HNCs attributable to HPV infection, per anatomic site, by genotype, in three time periods (2008–2009, 2013–2014 and 2018–2019).Methods and analysis BROADEN-China is a nationwide, multisite, cross-sectional study. A stratified, multistage, non-randomised cluster sampling method will be used to select 2601 patients with HNC from 14 hospitals across seven regions, based on population density in China. Patients with formalin-fixed paraffin-embedded tissue samples collected prior to treatment induction during three time periods will be included, and factors (eg, smoking status, alcohol consumption, betel nut chewing, Epstein-Barr virus, teeth loss, etc) associated with HNC will be assessed. HPV testing (HPV-DNA, HPV-mRNA and p16INK4a immunohistochemistry) and histological diagnosis of the tissue samples will be conducted at a central laboratory.The study protocol and all required documents have been submitted for review and approval to the Independent Ethics Committees of all the participating sites. The informed consent was waived for all participants and all the recorded data will be treated as confidential.We have included 14 hospitals as our participating sites, of which Henan Cancer Hospital is the leading site. The study has been approved by the independent ethics committees of the leading site on 3 December 2020. The other 13 participating site names of ethics committee and IRB that have approved this study.

10542 Background: Cancer has a high clinical and economic burden, with ~10 million deaths globally in 2020. In Europe, the total cost of cancer was €199 billion in 2018. Infections are responsible for approximately 13% of cancer cases worldwide. Human papillomavirus (HPV) and hepatitis B (HBV) are among the most important infections associated with cancer for which vaccines are available. However, global vaccination rates for these cancer-causing infections remain low (~12% for HPV; 42% for HBV). Elimination of vaccine-preventable cancers is a public health priority, and the World Health Organization (WHO) has proposed a strategy to eliminate cervical cancer and viral hepatitis by 2030. This analysis aims to estimate the global burden and economic impact due to vaccine-preventable cancer mortality. Methods: The number of deaths and Years of Life Lost (YLL) in 2019 from liver cancer caused by hepatitis B (ICD-10 C22), head and neck cancers (ICD-10 C00-14 and C32), and cancer of the cervix uteri (ICD-10 C53) were sourced from the Institute for Health Metrics Evaluation (IHME) Global Burden of Disease. Deaths and YLL were applied to attributable fractions for each vaccine-preventable cancer based on published data. The Value of YLL (VYLL) was estimated by multiplying the GDP per capita (World Bank; in USD) and YLL for each cancer, in each WHO region. Sensitivity and scenario analyses were performed to test the robustness of results. Results: In 2019, there were 479,750 potentially vaccine-preventable cancer deaths and 14,561,049 YLL (38% in males) across WHO regions (Table). The estimated economic impact due to vaccine-preventable cancer deaths was over $171 billion globally with the Americas and European region accounting for 63% of the total cost ($107 billion). Cervical cancer had the highest mortality burden (52% of total deaths). Globally, 78% of non-cervical HPV-related cancer deaths were in males. Conclusions: In 2019, 1,314 people died per day due to vaccine-preventable cancers leading to substantial YLL and economic impact. The overall burden is likely to be higher since several other HPV-related cancers were not included in this analysis. Improved implementation of HPV and HBV vaccination programs should be prioritized to decrease this burden.[Table: see text]

IMPORTANCE In the US, oropharyngeal cancer, predominantly caused by high-risk (HR) human papillomavirus (HPV) infection, is the most frequent HPV-associated cancer, surpassing cervical cancer. However, little is known about oral HPV prevalence and genotype distribution in the general population. OBJECTIVE To assess oral HPV prevalence and factors associated with HR and low-risk infection in a general US population. DESIGN, SETTING, AND PARTICIPANTS PROGRESS (Prevalence of Oral HPV Infection, a Global Assessment) was a cross-sectional observational study conducted between November 2021 and March 2022 in 43 dental offices in the US (24 urban, 13 urban cluster, and 6 rural sites), spanning 21 states. Eligible participants were aged 18 to 60 years, visiting dental clinics for routine dental examination. Dental clinics used targeted sampling to recruit equal distributions of men and women and across age groups. EXPOSURE Participants provided an oral gargle specimen for HPV DNA and genotyping and completed behavioral questionnaires, and dentists reported oral health status. Detection of HPV DNA and genotyping was performed using the SPF10/DEIA/LiPA25 system at a central laboratory. MAIN OUTCOME Oral HPV prevalence. RESULTS Of the 3196 participants enrolled, mean (SD) age was 39.6 (12.1) years, and 55.5% were women. Oral HPV prevalence was 6.6%(95% CI, 5.7%-7.4%) for any HPV genotype, and 2.0% (95% CI, 1.5%-2.5%), 0.7%(95% CI, 0.4%-1.0%), and 1.5%(95% CI, 1.1%-1.9%) for HR, HPV-16, and 9-valent-HPV vaccine types, respectively. Among HPV-positive participants, HPV-16 was the most prevalent genotype (12.4% among men and 8.6% among women). Prevalence of HPV was higher in men than women and highest among men aged 51 to 60 years (16.8%, 6.8%, and 2.1% for any HPV, HR HPV, and HPV-16, respectively). Factors associated with HR oral infection included being male (adjusted odds ratio [AOR], 3.1; 95% CI, 1.2-8.5), being aged 51 to 60 years (AOR, 3.3; 95% CI, 1.5-7.3), having 26 or more lifetime male sex partners (AOR, 6.5; 95% CI, 2.3-18.7), and having 6 to 25 lifetime female oral sex partners (AOR, 3.4; 95% CI, 1.3-8.7). CONCLUSIONS AND RELEVANCE In this cross-sectional study, oral HPV burden was highest among older men who may be at higher risk of developing oropharyngeal cancer. In addition to male sex and older age, HR oral HPV infection was also associated with sexual behaviors, including increasing number of male sex partners and female oral sex partners.

Introduction Human papillomavirus (HPV) infection is the most common sexually transmissible infection worldwide. Although the prevalence of cervical HPV infection has been extensively reported in women worldwide, few epidemiological studies have examined the prevalence of non-cervical HPV infection among both women and men, especially in China. Methods and analysis PROGRESS-Plus is a national, multisite, cross-sectional study that aims to estimate the prevalence of non-cervical HPV infection in women and men aged 18–60 years residing in mainland China. More specifically, PROGRESS-Plus will estimate the prevalence rate of HPV DNA in oral samples from both women and men, and that of anogenital samples from men. The secondary study objectives are to (1) report the aforementioned prevalence rates by HPV genotype, age and geographical region, (2) examine the concordance (ie, prevalence of the same HPV genotype) between the oral and anogenital samples among men, (3) explore risk factors associated with oral (in both women and men) and anogenital (in men only) HPV infection and (4) describe study participants’ health-related quality of life, health behaviour, sexual behaviour and health status. Ethics and dissemination The study protocol and all required documents have been submitted for review and approval to the Independent Ethics Committees of all the participating sites. All participants will provide their written informed consent on study entry, and all the recorded data will be treated as confidential.

BACKGROUND:Persistent human papillomavirus (HPV) infection is an important risk factor for a subset of head and neck cancers (HNCs). However, estimates of the HPV-attributable fraction of oropharyngeal cancers vary greatly, and the proportion is increasing. Growing evidence indicates smaller proportions of oral cavity and laryngeal cancers are also HPV-attributable, but this requires further investigation. The primary objective of the BROADEN study is to estimate the fraction of HNCs attributable to HPV in selected European and Asian countries by anatomic site. Secondary objectives are to determine HPV genotypes involved and to describe primary tumor and patient characteristics by HPV status.METHODS:BROADEN is a non-interventional, cross-sectional study of patients with HNC in China, France, Germany, Italy, Japan, Portugal, and Spain. The HPV-attributable HNC fraction will be determined within pre-defined time-periods (2008-2009, 2013-2014 [China only], 2018-2019). Approximately 9000 patients from an estimated 90 hospitals with reference HNC diagnostic units and local reference pathology laboratories will participate. Sample size estimates were generated by grouped anatomic site (oropharynx, oral cavity, nasopharynx, hypopharynx, and larynx) and country. HPV testing (HPV-DNA and p16 immunohistochemistry [IHC]) will be performed at a central laboratory on formalin-fixed paraffin-embedded tissue samples. All HPV-DNA-positive samples and HPV-DNA-negative/p16 IHC-positive samples, plus 10% of remaining HPV DNA-negative (control) samples will be tested for HPV mRNA.DISCUSSION:BROADEN is a large global epidemiologic study to estimate current and recent past HPV burden in oropharyngeal and non-oropharyngeal HNCs. BROADEN is expected to provide robust estimates of HPV attributability by anatomic site in participating countries.

Background: Head and neck cancers are increasingly associated with human papillomavirus (HPV) infection. Previous studies of oral HPV indicate considerable heterogeneity across geographic regions and by sex, but studies differ in methodologies used and risk groups included. Understanding the natural history of oral HPV in the general population is important to assess HPV-related disease burden and plan effective prevention programs. In this study, we aim to assess the prevalence, incidence, and persistence of oral HPV among adult men and women. Factors independently associated with oral HPV will also be evaluated.Methods: The PROGRESS (PRevalence of Oral hpv infection, a Global aSSessment) study is a non-interventional study of 7877 healthy men and women aged 18-60 years, from France, Germany, Spain, the United Kingdom (UK) and the United States (US). Oral HPV prevalence will be measured using a commercially available PCR DNA test. In the US, participants will be followed prospectively every 6 months for 24 months to assess incidence, clearance, and persistence of oral HPV infection. Eligible individuals presenting for regular dental check-ups will be recruited from participating dental offices via systematic consecutive sampling. Participant dentists will collect clinical characteristics, and participants will complete self-reported study questionnaires and provide an oral rinse and gargle (ORG) specimen for HPV-DNA detection and genotyping at each study visit. HPV-DNA detection and genotyping will be performed in two reference laboratories, using the SPF10/DEIA/LiPA25 system. Discussion: PROGRESS study aims to fill knowledge gaps concerning the natural history of oral HPV using a standardized methodology. PROGRESS will also assess factors associated with oral HPV prevalence and natural history in the general population.

Background: Routine human papillomavirus (HPV) immunization in Belgium is currently regionally managed, with school-aged girls receiving the 9-valent HPV (9vHPV) vaccine in Flanders and Wallonia-Brussels with a national catch-up program for females only. This study will assess whether expanding these programs to gender-neutral vaccination (GNV) with the 9vHPV vaccine is a cost-effective strategy in Belgium. Methods: A validated HPV-type transmission dynamic model estimated the potential health and economic impact of regional vaccination programs, comparing GNV versus female-only vaccination (FOV) with the 9vHPV vaccine in individuals aged 11–12 years in Flanders, GNV with the 9vHPV vaccine versus FOV with the 2-valent HPV (2vHPV) vaccine in individuals aged 12–13 years in Wallonia-Brussels, and national catch-up GNV versus FOV with the 9vHPV vaccine for those aged 12–18 years. Vaccination coverage rates of 90, 50, and 50% in both males and females were used in the base cases for the three programs, respectively, and sensitivity analyses were conducted. All costs are from the third-party payer perspective, and outcome measures were reported over a 100-year time horizon. Results: GNV with the 9vHPV vaccine was projected to decrease the cumulative incidence of HPV 6/11/16/18/31/33/45/52/58-related diseases relative to FOV in both Flanders and Wallonia-Brussels. Further reductions were also projected for catch-up GNV with the 9vHPV vaccine, including reductions of 6.8% (2,256 cases) for cervical cancer, 7.1% (386 cases) and 18.8% (2,784 cases) for head and neck cancer in females and males, respectively, and 30.3% (82,103 cases) and 44.6% (102,936 cases) for genital warts in females and males, respectively. As a result, a GNV strategy would lead to reductions in HPV-related deaths. Both regional and national catch-up GNV strategies were projected to reduce cumulative HPV-related disease costs and were estimated to be cost-effective compared with FOV with incremental cost-effectiveness ratios of €8,062, €4,179, and €6,127 per quality-adjusted life-years in the three programs, respectively. Sensitivity analyses were consistent with the base cases. Conclusions: A GNV strategy with the 9vHPV vaccine can reduce the burden of HPV-related disease and is cost-effective compared with FOV for both regional vaccination programs and the national catch-up program in Belgium.

Introduction: Head and neck cancers (HNC) accounted for over 450,000 deaths and 900,000 cases in 2018 worldwide. Of those, 38,000 cases were attributable to human papillomavirus (HPV). HNC is two to four times more prevalent in men than in women. The incidence of oropharyngeal cancers (OPC) and oral cavity cancers caused by HPV has increased in recent decades. Given the substantial burden of HPV-related HNC in males, this study aimed to assess whether and how national agencies included HPV-related HNC when evaluating HPV genderneutral vaccination (GNV) programs. Methods: A systematic literature review was conducted in MEDLINE (R) and EMBASE (R), and on the websites of selected national agencies. Results: Searches identified a potential 205 records; seventeen were eligible for the review. Seventy percent of assessments were published by European countries and most were recent (2014-2019). Eleven (65%) reports considered OPC when discussing HNC, and a few included other anatomic sites. All reports that considered incidence data were in consensus that incidence of OPC was higher in men and showed that the mortality rates for HPV-related HNC were also higher in men. When looking at the economic impact, the incremental cost-effectiveness ratios in the assessments varied widely, as the inputs into the analyses were heterogeneous. However, several reports concluded GNV programs were likely to be cost-effective versus not vaccinating males. Conclusion: The burden of HPV-related HNC in the general male population has been recognized by several Heatlth Technology Assessment (HTA) agencies and National Immunization Technical Advisory Groups (NITAGs) when evaluating HPV GNV programs. The assessments identified on GNV programs strongly indicate a cost-effective clinical benefit. Nevertheless, the epidemiological burden of HNC may have been underestimated in some countries due to limited data. Further research is crucial to obtain more robust data that will help address the information gap in epidemiological and economic burden of HPV-associated HNC in men. (C) 2021 The Authors. Published by Elsevier Ltd.

Abstract Background An infection with high-risk human papillomavirus (HPV) is the obligatory aetiological factor for the development of cervical cancer. In Switzerland, the prevention strategy for cervical cancer is based on primary prevention via HPV vaccination and secondary prevention with an opportunistic screening programme for precancerous lesions. Vaccination is recommended to 11–26 years old male and female persons. The objective of the study was to assess the epidemiological impact on cervical cancer of switching from the currently implemented programme with the 4-valent vaccine to the 9-valent vaccine, in an 11–26 years old gender-neutral vaccination programme in Switzerland. Methods A previously validated dynamic transmission model of HPV infections was adapted and calibrated to the Swiss setting assuming an 80% coverage rate in HPV-vaccination and lifelong vaccine type-specific protection. A gender-neutral vaccination programme (males and females) for 11–26 years old with a 9-valent HPV vaccine was compared with the current 11–26 years old gender-neutral 4-valent vaccination programme. Sensitivity analyses were conducted in order to test the impact of lower vaccination coverage rates and a shorter duration of protection on the model outcomes. Results In Switzerland, a 9-valent gender-neutral vaccination programme would result in an additional prevention of 2979 cervical cancer cases, 13,862 CIN3 and 15,000 CIN2 cases, compared with the 4-valent gender-neutral vaccination programme over 100 years. These additional disease cases avoided would correspond to a 24, 36 and 48% cumulative incidence decrease in cervical cancer, CIN3 and CIN2 cases, respectively. It would also prevent additional 741 cervical cancer-related deaths over 100 years. A substantial additional reduction in cervical cancer and precancerous lesions burden is still observed when varying the vaccination coverage rate from 30 to 60% or reducing the duration of protection from lifelong to 20 years. Conclusions The switch to the 9-valent vaccine in Switzerland to prevent cervical diseases showed an important contribution in terms of public health impact compared with the 4-valent vaccine in an 11–26 years old gender-neutral population, even with very conservative assumptions such as low coverage rates or low duration of protection and limiting analysis to only cervical disease.

e13108 Background: Human papillomavirus (HPV) causes about 5% of all cancer cases worldwide. Global male-specific incidence of HPV-related cancers, including anal (AC), penile (PC) and head and neck (HNC) cancer, is largely unknown. This study aims to summarize global incidence and HPV prevalence of these cancers in men. Methods: The systematic literature review was conducted following PRISMA guidelines. MEDLINE and EMBASE were searched for studies published in English between Jan 2008-Mar 2018 containing male-specific AC/PC/HNC incidence data, or HPV prevalence in AC/PC/HNC adult patients. Results: Fifty-six studies reported AC incidence in men between 1962-2014. The rate ranged between 0-1.5/100,000 persons in the general population. Globally, AC incidence increased over time. In the US, AC incidence in HIV-positive men increased from 10.5 to 20.7/100,000 person-years (PYs) from 1980-1989 to 1990-1995, and from 47 to 270/100,000 PYs between 1984 and 2013 in HIV-positive men who have sex with men (MSM). Prevalence of any HPV among men with AC ranged between 20-96%, HPV-16 and -18 being the most prevalent (14-100% vs 8-24%). PC incidence among men was reported in 14 studies between 1962-2015. The rate ranged between 0-10.2/100,000 persons (0-12.8/100,000 PY), with higher incidence rates in older men. Prevalence of any HPV among men with PC ranged between 6.3-100%, HPV-11 and -16 being the most prevalent (0.7-80% vs 18.1-79.2%). HNC incidence among men was reported in 66 studies between 1973-2014. Global cancer registry data reported a range of HNC incidence from 1.4-42.2/100,000, declining over time depending on the geographical location. The corresponding incidence range for oropharyngeal cancer (OPC) was 0.4-17.8/100,000, with higher incidence rates for men aged 55 and above and a rapid increase during the past decade in well-developed regions. Prevalence of any HPV ranged between 0-93.8%, HPV-16 and -18 being the most prevalent (1.2-86% vs 2.5-46.9%). Conclusions: This review demonstrates the existing burden of HPV-related cancers globally. Overall, the incidence of HPV-related AC and OPC appears to have increased among men between 1962 and 2015, highlighting a growing unmet medical need and the importance of preventing HPV infection.