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Information presented to studends as part of Capstone project

Information presented to studends as part of Capstone project

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Hpv Educational Presentation Presentation Transcript

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