Ashish A. Deshmukh

Clinical effectiveness and cost-effectiveness of quadrivalent human papillomavirus vaccination in HIV-negative men who have sex with men to prevent recurrent high-grade anal intraepithelial neoplasia.

We examined the long-term clinical and economic benefits of quadrivalent human papillomavirus (qHPV) vaccine as a secondary/adjunct prevention strategy in the prevention of recurrent high-grade intraepithelial neoplasia (HGAIN) in HIV-negative men who have sex with men (MSM) and are 27 years or older. We constructed a Markov model to evaluate the clinical effectiveness and cost-effectiveness of two strategies: (1) no qHPV vaccine after treatment for HGAIN versus (2) qHPV vaccine after treatment for HGAIN. Model parameters, including natural history of anal cancer, vaccine efficacy measured in terms of hazard ratio (HR) (decrease in the risk of recurrent HGAIN), HGAIN treatment efficacy, utilities, and costs, were obtained from the literature. The outcomes were measured in terms of lifetime risk of anal cancer, lifetime cost, quality-adjusted life years, and incremental cost-effectiveness ratios (ICERs). Sensitivity analysis was conducted on all model parameters. We found that vaccinating HIV-negative MSM reduced the lifetime risk of anal cancer by 60.77% at an ICER of US

Long-Term Outcomes of Adding HPV Vaccine to the Anal Intraepithelial Neoplasia Treatment Regimen in HIV-Positive Men Who Have Sex with Men

87,240 per quality-adjusted life-year. The results were highly sensitive to vaccine efficacy, transition of HGAIN to anal cancer, cost of treatment for HGAIN, vaccine degree of protection over time, and the vaccine duration of protection and less sensitive to HPV clearance, cost of qHPV vaccine, and the transitions from normal to low-grade anal intraepithelial neoplasia (LGAIN) and normal to HGAIN. With an HR of 0.3, the ICER was well below a

Oral Human Papillomavirus Infection: Differences in Prevalence Between Sexes and Concordance With Genital Human Papillomavirus Infection, NHANES 2011 to 2014

50,000 willingness-to-pay threshold; with an HR of 0.5, the ICER was still below a threshold of

Total Lifetime and Cancer-related Costs for Elderly Patients Diagnosed With Anal Cancer in the United States

100,000. The most critical disease-related factor influencing the cost-effectiveness was the progression of HGAIN to anal cancer. At an annual transition probability below 0.001, the ICER was below

Cost-effectiveness Analysis Comparing Conventional, Hypofractionated, and Intraoperative Radiotherapy for Early-Stage Breast Cancer

50,000. Vaccinating HIV-negative MSM treated for HGAIN decreases the lifetime risk of anal cancer and is likely to be a cost-effective intervention.

Management of precancerous anal intraepithelial lesions in human immunodeficiency virus–positive men who have sex with men: Clinical effectiveness and cost-effectiveness

BACKGROUND Recent evidence shows that quadrivalent human papillomavirus (qHPV) vaccination in men who have sex with men (MSM) who have a history of high-grade anal intraepithelial neoplasia (HGAIN) was associated with a 50% reduction in the risk of recurrent HGAIN. We evaluated the long-term clinical and economic outcomes of adding the qHPV vaccine to the treatment regimen for HGAIN in human immunodeficiency virus (HIV)-positive MSM aged ≥27 years. METHODS We constructed a Markov model based on anal histology in HIV-positive MSM comparing qHPV vaccination with no vaccination after treatment for HGAIN, the current practice. The model parameters, including baseline prevalence, disease transitions, costs, and utilities, were either obtained from the literature or calibrated using a natural history model of anal carcinogenesis. The model outputs included lifetime costs, quality-adjusted life years, and lifetime risk of developing anal cancer. We estimated the incremental cost-effectiveness ratio of qHPV vaccination compared to no qHPV vaccination and decrease in lifetime risk of anal cancer. We also conducted deterministic and probabilistic sensitivity analyses to evaluate the robustness of the results. RESULTS Use of qHPV vaccination after treatment for HGAIN decreased the lifetime risk of anal cancer by 63% compared with no vaccination. The qHPV vaccination strategy was cost saving; it decreased lifetime costs by

Cost-effectiveness analysis of smoking-cessation counseling training for physicians and pharmacists

419 and increased quality-adjusted life years by 0.16. Results were robust to the sensitivity analysis. CONCLUSIONS Vaccinating HIV-positive MSM aged ≥27 years with qHPV vaccine after treatment for HGAIN is a cost-saving strategy. Therefore, expansion of current vaccination guidelines to include this population should be a high priority.

Prevalence and Risk of Penile Human Papillomavirus Infection: Evidence From The National Health and Nutrition Examination Survey 2013–2014

Human papillomavirus (HPV) infection causes cancer at several anatomical sites, including the oropharynx, anus, and penis in men and the oropharynx, anus, cervix, vagina, and vulva in women (1). Between 2008 and 2012, an average of 38793 cases of HPV-related cancer were diagnosed annually in the United States, 23000 (59%) in women and 15793 (41%) in men (2). Among these cases, the most common cancer was oropharyngeal squamous cell carcinoma (OPSCC), of which there were 3100 cases in women and 12638 in men (2). The incidence of HPV-related OPSCC among women generally plateaued (with a statistically insignificant increase of 0.57% per year) from 2002 to 2012 (3). In contrast, the incidence among men (7.8 per 100000) has increased dramatically (2.89% per year) and has already surpassed the incidence of cervical cancer in women (7.4 per 100000) (3). The increase in annual incidence was particularly high in men aged 50 to 59 years: 7.75% from 2002 to 2004 and 2.44% from 2004 to 2010 (3). These incidence trends are projected to continue and not reverse until after 2060, making OPSCC a significant public health concern (4, 5). Recent evidence shows that prophylactic HPV vaccination seems to protect against infection with vaccine-covered oral HPV subtypes (6) and thus holds promise for reversing the rising OPSCC incidence among men in the long term; however, the low uptake rate of the vaccine among boys remains a concern (79). Furthermore, the great majority of persons at risk for OPSCC are older than 26 years (4) and do not qualify for HPV vaccination or may already have been exposed to HPV. For this reason, epidemiologic studies on oral HPV infection are needed to guide the design and development of alternative OPSCC prevention strategies targeted toward persons at high risk. Examining the relationship between HPV infections occurring at different anatomical sites also is crucial to understanding HPV transmission dynamics. Therefore, our objective was twofold: to estimate the population-based prevalence and risk factors of oral HPV infection by sex and sexual orientation and to characterize the concordance of oral and genital HPV infection from the NHANES (National Health and Nutrition Examination Survey). Methods Survey Design and Population The NHANES is conducted by the National Center for Health Statistics of the Centers for Disease Control and Prevention to monitor the health and nutritional status of the U.S. population. Participants in NHANES 2011 to 2014 were noninstitutionalized U.S. civilians identified through a stratified, multistage probability sampling technique. Participants aged 18 to 69 years had a physical examination at a mobile examination center (MEC), followed by a household interview. Hispanic persons, African Americans, persons with low income, and those aged 60 years and older were oversampled to allow sufficient sizes for subgroup analysis. The medical examinations done at the MEC included medical, dental, and physiologic measurements and laboratory tests administered by highly trained medical personnel. The household interview component consisted of standardized questionnaires on demographics, socioeconomic status, diet, and sexual behavior administered through a personal or phone interview. Demographic and Behavioral Data The NHANES collected demographic data through a standard questionnaire administered in-home by trained interviewers using a computer-assisted personal interviewing system. Data on cigarette, alcohol, and marijuana use were collected during the MEC self-interview. Demographic data included age at the time of the interview, sex, race, marital status, and income. Income-to-poverty ratio was calculated by dividing income by the poverty guidelines of the U.S. Department of Health and Human Services specific to the survey year. Use of birth control pills and hormone therapy was self-reported by female participants. Self-reported sexual behavior datafor example, ever having had sex (vaginal, anal, or oral), sexual orientation, ever having had a same-sex sexual partner, number of oral sex partners during the past 12 months, age at first oral sex, and barrier use during oral sex in the past 12 monthswere collected at the MEC through a standardized questionnaire. History of herpes or warts and HPV infection also was self-reported. HIV positivity was based on HIV-antibody test results. Specimen Collection and Laboratory Methods A dental hygienist collected oral rinse specimens in sterile collection cups. Each participant was asked to swish a 10-mL sample of a mouthwash or sterile solution in his or her mouth and then expectorate the sample into the sterile cup. The MEC laboratory technologist transferred each sample from the collection cup to a 14-mL Falcon snap cap tube (Fisher Scientific) and shipped it to the laboratory for testing. Details of sample collection, quality control, and laboratory methods may be found in the MEC Laboratory Procedures Manual on the NHANES Web site (10) and in a previously published study (11). The specimens were analyzed as previously described (11). -Globinpositive samples were considered evaluable. Each purified DNA sample was analyzed by polymerase chain reaction assay. The Roche Linear Array HPV Genotyping test was used for detection of 37 HPV types, including high-risk types (HPV 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82) and low-risk types (HPV 6, 11, 40, 42, 54, 55, 61, 62, 64, 67, 69, 70, 71, 72, 81, 82 IS39 subtype, 83, 84, and 89 [cp6108]) (12). Concordance of Oral and Genital HPV Concurrent overall genital and oral HPV infection was defined as an infection in both the genital and oral regions, regardless of HPV type. Concurrent high-risk genital and oral HPV infection was defined as an infection with any high-risk type in both the genital and oral regions. Similarly, concurrent type-specific infection was defined as an infection with a specific HPV type (such as HPV 16) in the genital and oral regions. Details of specimen collection and laboratory methods for genital HPV detection among men and women may be found on the NHANES Web site and in previously published studies (13, 14). Statistical Analysis We estimated the prevalence of overall, high-risk, low-risk, and type-specific oral HPV, as well as prevalence by demographics and sexual behaviors, for men and women aged 18 to 69 years by using NHANES 2011 to 2014. Concordance of genital and oral HPV infection was estimated for adults aged 18 to 59 years by using NHANES 2013 to 2014. A survey designadjusted Wald F test was used for bivariate analyses, and the CochranArmitage test was performed to detect trends in prevalence. Prevalence estimates with a relative SE greater than 30% or based on 10 or fewer positive cases are noted; these are considered unstable and should be interpreted with caution. The differences in predicted probability between levels of risk factors for overall and high-risk oral HPV infection were estimated by using logistic regression models. Variables in logistic regression models were selected on the basis of bivariate associations. Statistical significance was tested at P < 0.05. All analyses were performed by using SAS 9.4 software (SAS Institute). For population estimates, we used SAS PROC SURVEY procedures, which included weight, cluster, and strata statements, to incorporate sampling weights. Role of the Funding Source The funders had no role in the study design or conduct or in the reporting of results. Results Analyses of overall and high-risk oral HPV infection included 4493 men and 4641 women (Supplement Figure 1). Supplement. Supplemental Tables and Figures Prevalence of Oral HPV Infection Among Men and Women The prevalence of overall oral HPV infection among men and women was 11.5% (95% CI, 9.8% to 13.1%) and 3.2% (CI, 2.7% to 3.8%), respectively, equating to 11 million men and 3.2 million women nationwide. Similarly, the prevalence of high-risk HPV infections was higher among men (7.3% [CI, 6.0% to 8.6%]; 7 million) than women (1.4% [CI, 1.0% to 1.8%]; 1.4 million) (P < 0.001). The type-specific prevalence of high-risk and low-risk HPV infection is shown in Figure 1, A and B, respectively. Notably, the prevalence of HPV 16, the most common type, was sixfold higher among men (1.8% [CI, 1.3% to 2.2%]; 1.7 million) than women (0.3% [CI, 0.1% to 0.5%]; 0.27 million) (P < 0.001). The prevalence of all high-risk and low-risk HPV types was consistently higher in men than women. The age-specific prevalence of vaccine-covered 9-valent, 4-valent, 2-valent, and HPV 16 subtypes among men and women is reported in Supplement Figure 2. Figure 1. Type-specific prevalence of oral HPV infection among men and women, NHANES 20112014. Errors bars represent 95% CIs. HPV= human papillomavirus; NHANES= National Health and Nutrition Examination Survey. A. Weighted prevalence of high-risk type-specific oral HPV infection among men and women. B. Weighted prevalence of low-risk type-specific oral HPV infection among men and women. Prevalence of Overall and High-Risk Oral HPV Infection by Demographic and Sexual Characteristics The prevalence of oral HPV infection by demographic characteristics is presented in Table 1. The overall prevalence in men followed a bimodal pattern, with prevalence peaks at ages 35 to 39 (12.2% [CI, 8.9% to 15.7%]) and 50 to 54 years (15.4% [CI, 10.2% to 20.5%]). The prevalence of high-risk HPV infection in men and overall and high-risk HPV infection in women did not differ significantly with regard to age. Non-Hispanic black men had the highest prevalence of overall (15.8%) and high-risk (8.8%) oral HPV infection, followed by white (overall, 11.7%; HR, 7.8%) and Hispanic (overall, 9.9%; high-risk, 5.5%) men. Table 1. Prevalence of Overall and High-Risk Oral HPV Infection in Men and Women, by Demographic Characteristics, NHANES 20112014 The prevalence of overall and high-risk oral HPV infection was significantly associated w

Clinical and Economic Evaluation of Treatment Strategies for T1N0 Anal Canal Cancer

Objective: To determine the lifetime and phase-specific cost of anal cancer management and the economic burden of anal cancer care in elderly (66 y and older) patients in the United States. Patients and Methods: For this study, we used Surveillance Epidemiology and End Results-Medicare linked database (1992 to 2009). We matched newly diagnosed anal cancer patients (by age and sex) to noncancer controls. We estimated survival time from the date of diagnosis until death. Lifetime and average annual cost by stage and age at diagnosis were estimated by combining survival data with Medicare claims. The average lifetime cost, proportion of patients who were elderly, and the number of incident cases were used to estimate the economic burden. Results: The average lifetime cost for patients with anal cancer was US

Use of forecasted assessment of quality of life to validate time‐trade‐off utilities and a prostate cancer screening decision‐analytic model

50,150 (N=2227) (2014 US dollars). The average annual cost in men and women was US