The Human Papillomavirus: <br />Colleen R. Barrett, MSN, FNP-BC<br />Doctor of Nursing Practice Student, <br />Robert Morr...
The Human Papillomavirus<br />HPV is the most common STI in the United States (Fontenot, et al., 2007)<br />6.2 Million US...
The Human Papillomavirus<br />Worldwide, HPV infection is the most common viral infection of the anogenital tract <br />Li...
The Human Papillomavirus<br />A DNA tumor virus<br />Can infect almost all human skin surfaces<br />all types of squamous ...
The Human Papillomavirus<br />Sexually transmitted<br />Sexual intercourse not required for transmission<br />Can be trans...
The Human Papillomavirus<br />Virus can be asymptomatic<br />Prevalence highest among women younger than 25<br />Second pe...
Pathogenesis<br />Incubation period usually 3 to 4 months<br />Range is from 1 month to 2 years<br />Can clear spontaneous...
Risk Factors for HPV <br />Sexual behavior <br />Frequency of sexual intercourse<br />Early onset of sexual activity<br />...
Types of HPV<br />High Risk HPV types<br />16, 18, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 66, 68<br />(oncogenic type...
Types of HPV<br />HPV 1 causes plantar warts (verrucaplantaris)<br />HPV 6 and 11 cause anogenital warts (condylomaacumina...
HPV Related Illness<br />Anogenital warts<br />Cervical dysplasias<br />Cervical cancer<br />Squamous cell carcinomas and ...
Oral HPV<br />
HPV Related Illness<br />Of all STI’s, HPV and Hepatitis B are the largest causes of cervical and hepatocellularcarcinomas...
Anogenital Warts<br />One of the most common sexually transmitted diseases in the United States<br />Individuals without o...
Penile and Vulvar HPV (Genital Warts)<br />
HPV and Cervical Dysplasia<br />HPV infection is associated with a 4-fold increased risk of developing pre-cancerous cervi...
HPV and Cervical Dysplasia<br />Most HPV infections clear spontaneously<br />Persistent infection will usually lead to cer...
HPV and Cervical Dysplasia<br />Atypical Squamous Cells of Undetermined Significance (ASCUS)<br />Low Grade Squamous Intra...
HPV and Cervical Cancer<br />U.S. in 2006<br />U.S. in 2007<br />9,700 new diagnoses<br />3,700 cases resulted in death<br...
HPV and Cervical Cancer<br />HPV is associated with 99.7% of all cervical cancers worldwide<br />Once HPV has been contrac...
HPV and Cervical Cancer<br />Worldwide:<br />370,000 cases of cervical cancer diagnosed annually<br />270,000 cases will r...
HPV and Cervical Cancer<br />Cervical cancer screening programs in developed countries have reduced the incidence of invas...
Progression of Cervical Disease<br />
Normal Cervix and Cervical Cancer  <br />
Lack of Awareness of HPV<br />Numerous surveys on college campuses in US and Canada<br />Students unaware of the existence...
HPV  Vaccine<br />Gardasil earned FDA approval June 2006<br />Quadrivalent vaccine (Gardasil) contains protection from HPV...
Gardasil Vaccine<br />Approved for females ages 9 to 26 years of age<br />Three series vaccine given at 0, 2 and 6 months<...
Gardasil Vaccine<br />Two major clinical trials ongoing<br />Females United to Unilaterally Reduce Endo/Ectocervical Disea...
Gardasil Study Designs<br />FUTURE I GRoup<br />FUTURE II Group<br />5,455 subjects<br />16-24 years of age<br />62 study ...
Study Results<br />FUTURE I:<br />Per protocol population<br />Vaccine 100% effective in preventing vaginal, vulvar, perin...
Study Results<br />FUTURE I:<br />Efficacy also found in the unrestricted population<br />Efficacy of vaccine against vacc...
Study Results<br />FUTURE I <br />Unrestricted population<br />Efficacy of vaccine against vaccine type HPV found to be 98...
Study Results<br />FUTURE I:<br />Analysis regardless of HPV status at entry to study<br />Vaccine efficacy 73% for all gr...
Study Results<br />FUTURE II:<br />Per protocol population:  vaccine efficacy 98% for prevention of HPV 16/18 related high...
Study Results<br />FUTURE II: <br />Analysis regardless of HPV status at entry to study<br />Vaccine efficacy 44% for High...
Gardasil Vaccine<br />Vaccination is prophyllactic (preventative)<br />Vaccine will not alter the course of disease or inf...
Gardasil Vaccine<br />Side Effects:<br />Injection site irritation  (redness, itching, swelling, pain)<br />Fever<br />Syn...
Post Market Analysis<br />Most commonly reported adverse events<br />Dizziness<br />Syncope<br />Injection site pain<br />...
Post Market Analysis<br />Monitoring for and investigating reports of:<br />GuillaineBarre Syndrome<br />Seizure<br />Sync...
References<br />Adams, M., Jasani B., & Fiander, A. (2007). Human papillomavirus (HPV) prophylactic vaccination: Challenge...
References<br />Buttin, B. M., Herzog, T. J., and Mutch, D. G. (2006).  Abnormal cytology and human papillomavirus.  In M....
References<br />Future I Study Investigators. (2007). Quadrivalent vaccine against human papillomavirus to prevent anogeni...
References<br />Schmiedeskamp, M. R.,  Kockler, D. R.  Human papillomavirus vaccines.  Annals of Pharmacotherapy, 2006; 40...
Questions and Answers….<br />
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Hpv Educational Presentation

  1. 1. The Human Papillomavirus: <br />Colleen R. Barrett, MSN, FNP-BC<br />Doctor of Nursing Practice Student, <br />Robert Morris University<br />
  2. 2. The Human Papillomavirus<br />HPV is the most common STI in the United States (Fontenot, et al., 2007)<br />6.2 Million US residents contract HPV annually<br />>50% of sexually active men and women will acquire the infection at some point in their lives.<br />(CDC, 2007)<br />
  3. 3. The Human Papillomavirus<br />Worldwide, HPV infection is the most common viral infection of the anogenital tract <br />Lifetime risk of acquiring infection is as high as 70% <br />(Block ,et al., 2006)<br />
  4. 4. The Human Papillomavirus<br />A DNA tumor virus<br />Can infect almost all human skin surfaces<br />all types of squamous epithelium <br />Can cause Cancer in most sites it infects<br />
  5. 5. The Human Papillomavirus<br />Sexually transmitted<br />Sexual intercourse not required for transmission<br />Can be transmitted through intimate contact<br />
  6. 6. The Human Papillomavirus<br />Virus can be asymptomatic<br />Prevalence highest among women younger than 25<br />Second peak in incidence after age 55<br />Incidence distributed equally throughout society<br />Widely spread even in relatively low risk populations<br />
  7. 7. Pathogenesis<br />Incubation period usually 3 to 4 months<br />Range is from 1 month to 2 years<br />Can clear spontaneously or can progress to pre-cancerous or cancerous cervical abnormalities<br />
  8. 8. Risk Factors for HPV <br />Sexual behavior <br />Frequency of sexual intercourse<br />Early onset of sexual activity<br />Number of lifetime sexual partners<br />Male partner’s number of lifetime partners<br />Age <br />Ethnicity<br />Smoking or living with smokers<br />OC use, pregnancy, and immunosuppression are also factors<br />(Buttin, Herzog, and Mutch, 2006)<br />
  9. 9. Types of HPV<br />High Risk HPV types<br />16, 18, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 66, 68<br />(oncogenic types)<br />Low risk HPV types<br />6, 11, 26, 42, 44, 54, 70, 73<br />(non-oncogenic)<br />(Buttin, Herzog, and Mutch, 2006)<br />
  10. 10. Types of HPV<br />HPV 1 causes plantar warts (verrucaplantaris)<br />HPV 6 and 11 cause anogenital warts (condylomaacuminatum)<br />HPV 16 and 18 cause cervical cancer<br />
  11. 11. HPV Related Illness<br />Anogenital warts<br />Cervical dysplasias<br />Cervical cancer<br />Squamous cell carcinomas and dysplasias of the penis, anus, vagina, and vulva<br />DNA of HPV has been detected in tissue of oral and tonsillar cancers(Vokes, 2008)<br />
  12. 12. Oral HPV<br />
  13. 13. HPV Related Illness<br />Of all STI’s, HPV and Hepatitis B are the largest causes of cervical and hepatocellularcarcinomasrespectively<br />The two most common malignancies in the developing world <br />(Holmes, 2008)<br />
  14. 14. Anogenital Warts<br />One of the most common sexually transmitted diseases in the United States<br />Individuals without obvious disease may transmit infection<br />
  15. 15. Penile and Vulvar HPV (Genital Warts)<br />
  16. 16. HPV and Cervical Dysplasia<br />HPV infection is associated with a 4-fold increased risk of developing pre-cancerous cervical abnormalities (Glass)<br />48% of women will develop evidence of HPV infection within 3 years of initiation of sexual activity (Schmiedeskamp, et al., 2006)<br />
  17. 17. HPV and Cervical Dysplasia<br />Most HPV infections clear spontaneously<br />Persistent infection will usually lead to cervical abnormalities within 24 months<br />
  18. 18. HPV and Cervical Dysplasia<br />Atypical Squamous Cells of Undetermined Significance (ASCUS)<br />Low Grade Squamous Intraepithelial Lesions (LSIL)<br />Cervical intraepithelial neoplasia I (CIN I)<br />High Grade Squamous Intraepithelial Lesions (HSIL)<br />CIN II and III, Carcinoma in situ<br />
  19. 19. HPV and Cervical Cancer<br />U.S. in 2006<br />U.S. in 2007<br />9,700 new diagnoses<br />3,700 cases resulted in death<br />(American Cancer Society, 2006)<br />11,150 new diagnoses<br />3,670 cases resulted in death<br />(Holmes, 2008)<br />
  20. 20. HPV and Cervical Cancer<br />HPV is associated with 99.7% of all cervical cancers worldwide<br />Once HPV has been contracted, relative risk for development of cervical cancer is 20 to 70%<br />Only about 1% of women infected with oncogenic HPV will go on to develop cervical cancer. <br />(Buttin, Herzog, Mutch, 2006)<br />
  21. 21. HPV and Cervical Cancer<br />Worldwide:<br />370,000 cases of cervical cancer diagnosed annually<br />270,000 cases will result in death<br />(Block, et al., 2006)<br />Number one cause of cancer death among women in developing countries<br />
  22. 22. HPV and Cervical Cancer<br />Cervical cancer screening programs in developed countries have reduced the incidence of invasive cervical cancer by approx. 80%<br />20 to 25% of women considered to be high risk are still missed by screening programs<br />(Adams, Jasani, Fiander, 2007)<br />
  23. 23. Progression of Cervical Disease<br />
  24. 24. Normal Cervix and Cervical Cancer <br />
  25. 25. Lack of Awareness of HPV<br />Numerous surveys on college campuses in US and Canada<br />Students unaware of the existence of HPV<br />Unaware of link between HPV and cervical cancer<br />
  26. 26. HPV Vaccine<br />Gardasil earned FDA approval June 2006<br />Quadrivalent vaccine (Gardasil) contains protection from HPV 6, 11, 16, and 18 <br />Bi-valent vaccine will soon be available; provides protection from HPV 16 and 18 only.<br />
  27. 27. Gardasil Vaccine<br />Approved for females ages 9 to 26 years of age<br />Three series vaccine given at 0, 2 and 6 months<br />
  28. 28. Gardasil Vaccine<br />Two major clinical trials ongoing<br />Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE)<br />Both studies designed, managed and analyzed by Merck (company that manufactures and sells the vaccine).<br />Both are double blind, randomized, placebo controlled trials.<br />
  29. 29. Gardasil Study Designs<br />FUTURE I GRoup<br />FUTURE II Group<br />5,455 subjects<br />16-24 years of age<br />62 study sites, 16 countries<br />Subjects drawn from communities near universities.<br />Subjects followed for 3 years after 1st dose.<br />12,167 subjects <br />15 to 26 years of age<br />90 study sites, 13 countries<br />Looked at HPV types 16 and 18 only<br />Followed for 3 years after 1st dose<br />
  30. 30. Study Results<br />FUTURE I:<br />Per protocol population<br />Vaccine 100% effective in preventing vaginal, vulvar, perineal, perianal intraepithelial lesions or warts associated with vaccine type HPV<br />100% effective in preventing CIN grades 1 to 3 or adenocarcinoma in situ (AIS) associated with vaccine type HPV <br />(Future I study group, 2007) <br />
  31. 31. Study Results<br />FUTURE I:<br />Efficacy also found in the unrestricted population<br />Efficacy of vaccine against vaccine type HPV found to be 95% for all grades of external anogenital or vaginal lesions<br />
  32. 32. Study Results<br />FUTURE I <br />Unrestricted population<br />Efficacy of vaccine against vaccine type HPV found to be 98% for all grades of cervical lesions.<br />HPV disease incidence in the vaccine group did not continue to grow. <br />
  33. 33. Study Results<br />FUTURE I:<br />Analysis regardless of HPV status at entry to study<br />Vaccine efficacy 73% for all grades of vaccine type HPV anogenital and vaginal lesions combined<br />Vaccine efficacy 55% for all vaccine-type HPV induced cervical lesions combined <br />
  34. 34. Study Results<br />FUTURE II:<br />Per protocol population: vaccine efficacy 98% for prevention of HPV 16/18 related high grade cervical lesions<br />Unrestricted population: vaccine efficacy 95% for prevention of HPV 16/18 related high grade cervical lesions<br />(Future II Study Group, 2007)<br />
  35. 35. Study Results<br />FUTURE II: <br />Analysis regardless of HPV status at entry to study<br />Vaccine efficacy 44% for High grade HPV 16/18 related cervical disease<br />Cervical abnormalities related to HPV 16/18 did not continue to grow in the vaccine group<br />
  36. 36. Gardasil Vaccine<br />Vaccination is prophyllactic (preventative)<br />Vaccine will not alter the course of disease or infection present prior to being vaccinated. <br />No waning of immunity was found after 5 years of follow up<br />
  37. 37. Gardasil Vaccine<br />Side Effects:<br />Injection site irritation (redness, itching, swelling, pain)<br />Fever<br />Syncope has been noted anecdotally<br />
  38. 38. Post Market Analysis<br />Most commonly reported adverse events<br />Dizziness<br />Syncope<br />Injection site pain<br />nausea<br />
  39. 39. Post Market Analysis<br />Monitoring for and investigating reports of:<br />GuillaineBarre Syndrome<br />Seizure<br />Syncope<br />Anaphylaxis<br />Appendicitis<br />Stroke<br />Thrombus<br />Pulmonary Embolus<br />
  40. 40. References<br />Adams, M., Jasani B., & Fiander, A. (2007). Human papillomavirus (HPV) prophylactic vaccination: Challenges for public health and implications for screening. Vaccine, 25, 3007-3013.<br />American Cancer Society. Cancer Facts and Figures. Atlanta, Ga.: American Cancer Society, 2006.<br />Block, S., Nolan, T., Sattler, C., Barr, E., Giacoletti, K. E. D., Marchant, C. D. et al. (2006). Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) l1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics, 118(5), 2135-2145.<br />
  41. 41. References<br />Buttin, B. M., Herzog, T. J., and Mutch, D. G. (2006). Abnormal cytology and human papillomavirus. In M. Curtis, S. Overholt, & M. Hoplkins (Eds.), Glass’ Office Gynecology (pp 80-106). Lippincott Willimas & Wilkins. <br />Center for Disease Control and Prevention. Human papillomavirus: HPV information for clinicians. Available at: www.cdc.gov/std/hpv. <br />Fontenot, H. B., Collins Fantasia, H., & Allen, J., D. (2007, October 1). HPV in adolescents: Making the wake up call. Advance for Nurse Practitioners, 15(10), 73-76.<br />
  42. 42. References<br />Future I Study Investigators. (2007). Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. The New England Journal of Medicine, 356(19), 1928-1943.<br />Future II study group. (2007, May 1). Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. The New England Journal of Medicine, 356(19), 1915-1927.<br />Holmes, K. K. (1992). Sexually transmitted infections: overview and clinical approach. In A. S. Faiuci, et al. (Eds.), Harrison’s Principles of Internal Medicine, 17th edition (pp 548-551). The McGraw Hill Companies, Inc<br />
  43. 43. References<br />Schmiedeskamp, M. R., Kockler, D. R. Human papillomavirus vaccines. Annals of Pharmacotherapy, 2006; 40(7-8): 1344-1352. <br />Vokes, E. (2008). Head and neck cancer. In A. S. Faiuci, et al. (Eds.), Harrison’s Principles of Internal Medicine, 17th edition (pp 548-551). The McGraw Hill Companies, Inc. <br />
  44. 44. Questions and Answers….<br />

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