17 results on '"Beachler, Daniel C."'
Search Results
2. Safety of the BNT162b2 COVID-19 Vaccine in Children Aged 5 to 17 Years
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Hu, Mao, Wong, Hui Lee, Feng, Yuhui, Lloyd, Patricia C., Smith, Elizabeth R., Amend, Kandace L., Kline, Annemarie, Beachler, Daniel C., Gruber, Joann F., Mitra, Mahasweta, Seeger, John D., Harris, Charlalynn, Secora, Alex, Obidi, Joyce, Wang, Jing, Song, Jennifer, McMahill-Walraven, Cheryl N., Reich, Christian, McEvoy, Rowan, Do, Rose, Chillarige, Yoganand, Clifford, Robin, Cooper, Danielle D., Shoaibi, Azadeh, Forshee, Richard, and Anderson, Steven A.
- Abstract
IMPORTANCE: Active monitoring of health outcomes after COVID-19 vaccination offers early detection of rare outcomes that may not be identified in prelicensure trials. OBJECTIVE: To conduct near–real-time monitoring of health outcomes following BNT162b2 COVID-19 vaccination in the US pediatric population aged 5 to 17 years. DESIGN, SETTING, AND PARTICIPANTS: This population-based study was conducted under a public health surveillance mandate from the US Food and Drug Administration. Participants aged 5 to 17 years were included if they received BNT162b2 COVID-19 vaccination through mid 2022 and had continuous enrollment in a medical health insurance plan from the start of an outcome-specific clean window until the COVID-19 vaccination. Surveillance of 20 prespecified health outcomes was conducted in near real time within a cohort of vaccinated individuals from the earliest Emergency Use Authorization date for the BNT162b2 vaccination (December 11, 2020) and was expanded as more pediatric age groups received authorization through May and June 2022. All 20 health outcomes were monitored descriptively, 13 of which additionally underwent sequential testing. For these 13 health outcomes, the increased risk of each outcome after vaccination was compared with a historical baseline with adjustments for repeated looks at the data as well as a claims processing delay. A sequential testing approach was used, which declared a safety signal when the log likelihood ratio comparing the observed rate ratio against the null hypothesis exceeded a critical value. EXPOSURE: Exposure was defined as receipt of a BNT162b2 COVID-19 vaccine dose. The primary analysis assessed primary series doses together (dose 1 + dose 2), and dose-specific secondary analyses were conducted. Follow-up time was censored for death, disenrollment, end of the outcome-specific risk window, end of the study period, or a receipt of a subsequent vaccine dose. MAIN OUTCOMES: Twenty prespecified health outcomes: 13 were assessed using sequential testing and 7 were monitored descriptively because of a lack of historical comparator data. RESULTS: This study included 3 017 352 enrollees aged 5 to 17 years. Of the enrollees across all 3 databases, 1 510 817 (50.1%) were males, 1 506 499 (49.9%) were females, and 2 867 436 (95.0%) lived in an urban area. In the primary sequential analyses, a safety signal was observed only for myocarditis or pericarditis after primary series vaccination with BNT162b2 in the age group 12 to 17 years across all 3 databases. No safety signals were observed for the 12 other outcomes assessed using sequential testing. CONCLUSIONS AND RELEVANCE: Among 20 health outcomes that were monitored in near real time, a safety signal was identified for only myocarditis or pericarditis. Consistent with other published reports, these results provide additional evidence that COVID-19 vaccines are safe in children.
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- 2023
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3. Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases
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Wong, Hui-Lee, Hu, Mao, Zhou, Cindy Ke, Lloyd, Patricia C, Amend, Kandace L, Beachler, Daniel C, Secora, Alex, McMahill-Walraven, Cheryl N, Lu, Yun, Wu, Yue, Ogilvie, Rachel P, Reich, Christian, Djibo, Djeneba Audrey, Wan, Zhiruo, Seeger, John D, Akhtar, Sandia, Jiao, Yixin, Chillarige, Yoganand, Do, Rose, Hornberger, John, Obidi, Joyce, Forshee, Richard, Shoaibi, Azadeh, and Anderson, Steven A
- Abstract
Several passive surveillance systems reported increased risks of myocarditis or pericarditis, or both, after COVID-19 mRNA vaccination, especially in young men. We used active surveillance from large health-care databases to quantify and enable the direct comparison of the risk of myocarditis or pericarditis, or both, after mRNA-1273 (Moderna) and BNT162b2 (Pfizer–BioNTech) vaccinations.
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- 2022
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4. An Evaluation of the Effect of the OxyContin Reformulation on Unintentional Fatal and Nonfatal Overdose
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Beachler, Daniel C., Hall, Kelsey, Garg, Renu, Banerjee, Geetanjoli, Li, Ling, Boulanger, Luke, Yuce, Huseyin, and Walker, Alexander M.
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- 2022
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5. Tumor Necrosis Factor Inhibitors and the Risk of Cancer among Older Americans with Rheumatoid Arthritis.
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D'Arcy, Monica E., Beachler, Daniel C., Pfeiffer, Ruth M., Curtis, Jeffrey R., Mariette, Xavier, Seror, Raphaele, Mahale, Parag, Rivera, Donna R., Yanik, Elizabeth L., and Engels, Eric A.
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Background: TNF inhibitors (TNFi) effectively treat rheumatoid arthritis but may increase patient risk of some malignancies, particularly lymphomas or skin cancers. Methods: We used Surveillance, Epidemiology, and End Results (SEER)-Medicare data to conduct a case-control study in patients with rheumatoid arthritis (2007-2015). Cases were individuals with a first cancer diagnosed in SEER registries (ages 66-99, 22 cancer sites, N = 10,263). Skin cancer cases [nonmelanoma skin cancer (NMSC, N = 501), basal cell carcinoma (BCC, N = 161), squamous cell carcinoma (SCC, N = 150)] and cancer-free controls (N = 30,475) were selected from Medicare beneficiaries residing in SEER areas. Cases and controls had prior Medicare claims-based evidence for rheumatoid arthritis, and TNFi exposure was ascertained from part B and part D claims. Logistic regression was used to estimate adjusted odds ratios (aOR). Results: TNFi exposure was present in 16.2% of controls and 12.8% to 33.7% of cancer cases, varying by site. TNFi use was associated with increased risk of NMSC overall (aOR 1.32, 95% confidence interval 1.06-1.63), non-Hodgkin lymphoma (NHL) overall (1.28, 1.06-1.56) and, specifically, follicular lymphoma (2.63, 1.63-4.24). TNFi exposure was not associated with other SEER cancer sites, BCC or SCC specifically, or other common NHL subtypes. Conclusions: Among older adults with rheumatoid arthritis, TNFi exposure was associated with elevated risk of NMSC and NHL, driven specifically by follicular lymphoma. Exposure was not associated with increased risk for other cancer sites. Impact: Our results support a role for TNF in lymphomagenesis. Given the association with NMSC, patients initiating TNFi therapy may benefit from skin cancer screening and sun protection measures. [ABSTRACT FROM AUTHOR]
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- 2021
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6. Prior presumed coronavirus infection reduces COVID-19 risk: A cohort study.
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Aran, Dvir, Beachler, Daniel C., Lanes, Stephan, and Overhage, J. Marc
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Background: Immunological cross-reactivity between common cold coronaviruses (CCC) and SARS-CoV-2 might account for the reduced incidence of COVID-19 in children. Evidence to support speculation includes in vitro evidence for humoral and cellular cross-reactivity with SARS-CoV-2 in specimens obtained before the pandemic started.Method: We used retrospective health insurance enrollment records, claims, and laboratory results to assemble a cohort of 869,236 insured individuals who had a PCR test for SARS-CoV-2. We estimated the effects of having clinical encounters for various diagnostic categories in the year preceding the study period on the risk of a positive test result.Findings: After adjusting for age, gender and care seeking behavior, we identified that individuals with diagnoses for common cold symptoms, including acute sinusitis, bronchitis, or pharyngitis in the preceding year had a lower risk of testing positive for SARS-CoV-2 (OR=0.76, 95%CI=0.75, 0.77). No reduction in the odds of a positive test for SARS-CoV-2 was seen in individuals under 18 years. The reduction in odds in adults remained stable for four years but was strongest in those with recent common cold symptoms.Interpretation: While this study cannot attribute this association to cross-immunity resulting from a prior CCC infection, it is one potential explanation. Regardless of the cause, the reduction in the odds of being infected by SARS-CoV-2 among those with a recent diagnosis of common cold symptoms may have a role in shifting future COVD-19 infection patterns from endemic to episodic. [ABSTRACT FROM AUTHOR]- Published
- 2020
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7. Testosterone Therapy in Relation to Prostate Cancer in a U.S. Commercial Insurance Claims Database.
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Cook, Michael B., Beachler, Daniel C., Parlett, Lauren E., Cochetti, Philip T., Finkle, William D., Lanes, Stephan, and Hoover, Robert N.
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Background: We conducted a study to assess whether testosterone therapy (TT) alters prostate cancer risk using a large U.S. commercial insurance research database. Methods: From the HealthCore Integrated Research Database (HIRD), we selected men ages 30 years or greater who were new users of TT during 2007 to 2015. We selected two comparison groups: (i) unexposed (matched 10:1) and (ii) new users of phosphodiesterase type 5 inhibitor (PDE5i). Incident prostate cancer was defined as diagnosis of prostate cancer within 4 weeks following prostate biopsy. Propensity scores and inverse probability of treatment weights were used in Poisson regression models to estimate adjusted incidence rates, incidence rate ratios (IRR), and 95% confidence intervals (CI). Subgroup analyses included stratification by prostate cancer screening, hypogonadism, and follow-up time. Results: The adjusted prostate cancer IRR was 0.77 (95% CI, 0.68-0.86) when comparing TT with the unexposed group and 0.85 (95% CI, 0.79-0.91) in comparison with the PDE5i group. Inverse associations between TT and prostate cancer were observed in a majority of subgroup analyses, although in both comparisons estimates generally attenuated with increasing time following initial exposure. Among TT users, duration of exposure was not associated with prostate cancer. Conclusions: Men who received TT did not have a higher rate of prostate cancer compared with the unexposed or PDE5i comparison groups. The inverse association between TT and prostate cancer could be the result of residual confounding, contraindication bias, or undefined biological effect. [ABSTRACT FROM AUTHOR]
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- 2020
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8. Validation of an Algorithm for Claims-based Incidence of Prostate Cancer.
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Parlett, Lauren E., Beachler, Daniel C., Lanes, Stephan, Hoover, Robert N., and Cook, Michael B.
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ALGORITHMS ,DATABASES ,LONGITUDINAL method ,PROSTATE tumors ,RESEARCH evaluation ,DISEASE incidence ,ACQUISITION of data - Abstract
Background: Prostate cancer is a commonly studied outcome in administrative claims studies, but there is a dearth of validated case identifying algorithms. The long-term development of the disease increases the difficulty in separating prevalent from incident prostate cancer. The purpose of this validation study was to assess the accuracy of a claims algorithm to identify incident prostate cancer among men in commercial and Medicare Advantage US health plans.Methods: We identified prostate cancer in claims as a prostate cancer diagnosis within 28 days after a prostate biopsy and compared case ascertainment in the claims with the gold standard results from the Georgia Comprehensive Cancer Registry (GCCR).Results: We identified 74,008 men from a large health plan claims database for possible linkage with GCCR. Among the 382 prostate cancer cases identified in claims, 312 were also identified in the GCCR (positive predictive value [PPV] = 82%). Of the registry cases, 91% (95% confidence interval = 88, 94) were correctly identified in claims. Claims and registry diagnosis dates of prostate cancer matched exactly in 254/312 (81%) cases. Nearly half of the false-positive cases also had claims for prostate cancer treatment. Thirteen (43%) false-negative cases were classified as noncases by virtue of having a biopsy and diagnosis >28 days apart as required by the algorithm. Compared to matches, false-negative cases were older men with less aggressive prostate cancer.Conclusions: Our algorithm demonstrated a PPV of 82% with 92% sensitivity in ascertaining incident PC. Administrative health plan claims can be a valuable and accurate source to identify incident prostate cancer cases. [ABSTRACT FROM AUTHOR]- Published
- 2019
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9. An Examination of HPV16 Natural Immunity in Men Who Have Sex with Men (MSM) in the HPV in Men (HIM) Study.
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Beachler, Daniel C., Pinto, Ligia A., Kemp, Troy J., Nyitray, Alan G., Hildesheim, Allan, Viscidi, Raphael, Schussler, John, Kreimer, Aimée R., and Giuliano, Anna R.
- Abstract
Background: Evidence suggests that natural antibodies developed after HPV16 infection may protect some women but not men against subsequent HPV16 reacquisition. Less is known whether antibodies developed following HPV16 infection are protective among men who have sex with men (MSM). Methods: Four hundred seventy-five MSM from the Human Papillomavirus Infection in Men (HIM) study were tested for serum antibodies to HPV16 L1 using enzyme-linked immunosorbent assays, and for anal and genital HPV16 DNA using PCR consensus primer system (PGMY 09/11). Adjusted Cox regression was used to evaluate whether baseline HPV16 seropositivity impacts subsequent genital or anal HPV16 DNA. Results: The risk of subsequent genital HPV16 [aHR = 1.05, 95% confidence interval (CI) = 0.66-1.68] and anal HPV16 infections among MSM (aHR = 2.34, 95% CI = 0.92-5.98) was similar or nonsignificantly higher in HPV16-seropositive than HPV16-seronegative MSM. The risk of genital HPV16 was also similar between HPV16-seronegative and HPV16-seropositive MSM in the highest tertile of HPV16 antibody levels and when restricting to those with new sex partners during follow-up (P > 0.20). Among the 118 MSM who were HPV16 seropositive, 90% remained HPV16 seropositive up to 4 years later. When tested together, MSM with the highest antibody titers (top tertile) had similar levels to females (mean = 130.3 vs. 134.5 EU/mL, P = 0.84). Conclusions: Despite years of HPV16 seropositivity persistence and antibody titers comparable with females, this study suggested no evidence of HPV16 natural antibodies protecting against subsequent genital or anal HPV16 infection in MSM. [ABSTRACT FROM AUTHOR]
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- 2018
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10. Validation of an Algorithm for Claims-based Incidence of Prostate Cancer
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Parlett, Lauren E., Beachler, Daniel C., Lanes, Stephan, Hoover, Robert N., and Cook, Michael B.
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Supplemental Digital Content is available in the text.
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- 2019
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11. Conditional power for assessing population interventions
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Walker, Alexander M, Coplan, Paul M, and Beachler, Daniel C
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Aim:To calculate conditional power in comparative two-period studies with previously observed baseline data. Method:Isolate the variability attributable to the yet-to-observed data and modify the standard power formulae. Results:For illustration, we examine rates of opioid overdose before and after a reformulation of one opioid product. The null hypothesis posited no impact of the reformulation, alternative hypotheses posited possible impacts, and ancillary hypotheses posited different secular pre-post changes directly observable in comparators. Conditional power varied with the size of the comparator population and with the assumed pre-post change for the comparator. Conclusion:Pre-post designs can be initiated after the baseline period is over. Power calculations that are conditioned on observed baseline data account differently for variability in the baseline and follow-up periods.
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- 2018
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12. Chronic Sinusitis and Risk of Head and Neck Cancer in the US Elderly Population
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Beachler, Daniel C. and Engels, Eric A.
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IMPORTANCE: Chronic sinusitis may be involved in the etiology of certain head and neck cancers (HNCs), due to immunodeficiency or inflammation. However, the risk of specific HNCs among people with chronic sinusitis is largely unknown. OBJECTIVE: To evaluate the associations of chronic sinusitis with subsequent HNC, including nasopharyngeal cancer (NPC), human papillomavirus–related oropharyngeal cancer (HPV-OPC), and nasal cavity and paranasal sinus cancer (NCPSC), in an elderly US population. DESIGN, SETTING, AND PARTICIPANTS: We used the Surveillance, Epidemiology, and End Results (SEER)-Medicare database to conduct a case-cohort study of US individuals aged 65 years or older during 2004 through 2011. The study included 483 546 Medicare beneficiaries from SEER areas in a 5% random subcohort, and 826 436 from the entire source population who developed cancer (including 21 716 with HNC). MAIN OUTCOMES AND MEASURES: Incidence of HNCs including NPC, HPV-OPC, and NCPSC. RESULTS: Most individuals were female (57.7%), and the mean (SD) age at entry was 72.6 (8.0) years. Chronic sinusitis was associated with risk of developing HNC (adjusted hazard ratio [aHR], 1.37; 95% CI, 1.27-1.48), particularly NPC (aHR, 3.71; 95% CI, 2.75-5.02), HPV-OPC (aHR, 1.33; 95% CI, 1.13-1.57), and NCPSC (aHR, 5.49; 95% CI, 4.56-6.62). Most of this increased risk was limited to risk within 1 year of the chronic sinusitis diagnosis, as associations were largely attenuated 1 year or more after chronic sinusitis (NPC: aHR, 1.60; 95% CI, 0.96-2.65; HPV-OPC: aHR, 1.07; 95% CI, 0.86-1.32; NCPSC: aHR, 2.47; 95% CI, 1.84-3.31). All 3 HNC subtypes had cumulative incidence of less than 0.07% 8 years after chronic sinusitis diagnosis. CONCLUSIONS AND RELEVANCE: Chronic sinusitis is associated with certain HNCs, particularly NPC and NCPSC. These HNCs are rare, and most of the increased HNC risk is limited to within 1 year of chronic sinusitis diagnosis, consistent with surveillance or detection bias. The associations were weaker over longer intervals, suggesting at most a modest role for sinusitis-related inflammation and/or immunodeficiency.
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- 2017
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13. HPV16 E6 seropositivity among cancer-free men with oral, anal or genital HPV16 infection
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Beachler, Daniel C., Waterboer, Tim, Pierce Campbell, Christine M., Ingles, Donna J., Lang Kuhs, Krystle A., Nyitray, Alan G., Hildesheim, Allan, Pawlita, Michael, Kreimer, Aimée R., and Giuliano, Anna R.
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Antibodies against the Human papillomavirus 16 (HPV16) E6 oncoprotein appear years prior to clinical diagnosis of anal and oropharyngeal cancer, but whether they develop around the time of HPV infection is unclear. Serum samples from 173 cancer-free men from the Human Papillomavirus Infection in Men (HIM) Study were tested for HPV antibodies and DNA. HPV16 E6 seropositivity was low among men with oral HPV16-infection (1/28; 3.6%, 95%CI=0.0–18.4%), anal HPV16-infection (1/61; 1.6%, 95%CI=0.0–8.8%), and 24-month persistent genital HPV16-infection (1/84; 1.2%, 0.0–6.5%). This suggests E6 seroconversion may not occur around the time of oral, anal, or genital HPV16 acquisition.
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- 2016
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14. HPV vaccination initiation after the routine-recommended ages of 11–12 in the United States
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Beachler, Daniel C., Gonzales, Felisa A., Kobrin, Sarah C., and Kreimer, Aimée R.
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Since 2006, routine HPV vaccination has been recommended for females aged 11–12 in the US. However not much is known about the extent of and factors associated with HPV vaccination after the ages of 11–12.
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- 2016
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15. Risk Factors for Oral HPV Infection among a High Prevalence Population of HIV-Positive and At-Risk HIV-Negative Adults.
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Beachler, Daniel C., Weber, Kathleen M., Margolick, Joseph B., Strickler, Howard D., Cranston, Ross D., Burk, Robert D., Wiley, Dorothy J., Minkoff, Howard, Reddy, Susheel, Stammer, Emily E., L. Gillison, Maura, and D'Souza, Gypsyamber
- Abstract
The article focuses on a study on the risk factors for oral human papillomavirus (HPV) infection in HIV-positive and at-risk HIV-negative adults. Risk factors include sexual behavior, tobacco use and HIV-related immunosuppression. HIV-positive individuals are said to be more likely to have a prevalent oral HPV infection diagnosis. The study showed that HIV-positive and at-risk HIV-negative women and men who have sex with men (MSM) are prone to oral HPV infection.
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- 2012
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16. Oral human papillomavirus infection and head and neck cancers in HIV-infected individuals
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Beachler, Daniel C. and D'Souza, Gypsyamber
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HIV-infected individuals are living longer due to effective antiretroviral therapy and may therefore have a greater opportunity to develop human papillomavirus (HPV)-associated malignancies. This review describes the risk factors and burden of oral HPV infection and HPV-associated head and neck cancer (HNC) among HIV-infected individuals.
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- 2013
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17. Natural history of oral papillomavirus infection in men
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Beachler, Daniel C and D'Souza, Gypsyamber
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- 2013
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