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What is HPV?

By the age of 50. 75-80%. What is HPV?. Estimated to be the most common sexually transmitted infection in the United States. A human papillomavirus (HPV) is a virus that infects the epidermis and mucous membranes. Over 130 HPV Types Lifecycle somewhat unknown.

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What is HPV?

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  1. By the age of 50 75-80% What is HPV? Estimated to be the most common sexually transmitted infection in the United States.

  2. A human papillomavirus (HPV) is a virus that infects the epidermis and mucous membranes. • Over 130 HPV Types • Lifecycle somewhat unknown. • Several months to years may elapse before the abnormal growth of cells

  3. Worldwide there are 490,000 cases of cervical cancer • 270,000 deaths • HPV types 16 and 18 cause 70% of cervical cancer cases. • HPV causes approximately 25% of cancers of the mouth and upper throat.

  4. EarlyDetection? • Pap smear • Abstinence • Condoms

  5. Research began in the 80s • 1993-US National Cancer Institute was able to generate HPV-16 virus like particles leading to the Gardasil vaccine.

  6. Two HPV vaccines are currently on the market, Gardasil and Cervarix • Both vaccines protect against two of the HPV types (HPV-16 and HPV-18) that can cause cervical cancer. • Gardasil also protects against two of the HPV types that cause genital warts (types 6 and 11).

  7. Gardasil is a 3 dose (injection) vaccine. • There have been 50 million doses distributed in the United States, and there have been 13,758 Vaccine Adverse Event Reportings. • 93% non-serious • Fainting, pain and swelling at the injection site, headache, nausea and fever • 7% considered to be serious • Death, permanent disability, life-threatening illness and hospitalization

  8. Long Term Effects • The vaccines have been shown to offer 100% protection against the development of cervical pre-cancers and genital warts caused by the HPV types in the vaccine, with few or no side effects. • The protective effects of the vaccine are expected to last a minimum of 4.5 years after the initial vaccination. • While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions (or dysplasia) is believed to result in the prevention of those cancers.

  9. NEW EVIDENCE • First introduced for women 25 years old or younger. • In November 2007, Merck presented new data on Gardasil. • Reduced infection of HPV 6, 11, 16, 18 in women through the age of 45.

  10. So what about males? • Males can carry HPV and transmit it sexually to their partners. • HPV can also cause genital warts, penile and anal cancer in men. • HPV more commonly causes genital warts in men; each year, about 200 out of 100,000 males are newly diagnosed with genital warts.

  11. Clinical trials presented to the Advisory Committee evaluated the efficacy and safety of Gardasil in boys and men 9 to 26 years of age. • Efficacy was evaluated in a randomized, double-blind, placebo-controlled trial.

  12. Clinical Trial • A 2005 study in San Francisco found that 95 percent of HIV-infected gay men also had anal HPV infection, of which 50 percent had precancerous HPV-caused lesions. • A Merck study of 4,000 boy’s ages 16 to 26 showed Gardasil to be effective in preventing 90 percent of cases of penile cancer and genital warts, caused by the same four strains of HPV that currently cause 70 percent of cases of cervical cancer.

  13. On a scale of 1 to 6, with one representing no interest in getting vaccinated for HPV and six representing a high interest in getting the vaccine, the average score of the men was about 3.9. • However, when informed that the vaccine could protect their partners from cervical cancer, their average interest in being vaccinated did not increase

  14. Clinical Trial • The overall prevalence of HPV was 65.4%. • HPV detection was highest at the penile shaft, followed by the scrotum (34.2% and 32.8%). • Detection was lowest in semen samples: 5.3% and 4.8%.

  15. What is being done? • As of October 16, 2009, The U.S. Food and Drug Administration approved the use of the vaccine Gardasil for the prevention of genital warts due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26. As of today, Merek is still working on the commercialization and distribution of the vaccine to healthcare providers.

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