1. Human Papillomavirus (HPV) and Garadsil® Tracci Nelson Allison Neumiller

2. Human Papillomavirus (HPV)  What is HPV? Viral infection spread through skin to skin sexual contact Viral infection spread through skin to skin sexual contact Group of over 100 different viruses Group of over 100 different viruses Can cause genital warts Can cause genital warts At least 30 known strains to cause various types of cancer most commonly cervical, penile and anal cancer At least 30 known strains to cause various types of cancer most commonly cervical, penile and anal cancercancer.about.com/od/cervicalcancer

3. Prevalence of HPV  The Center for Disease and Control (CDC) reports that approximately 50% of all sexually active people will get a strain of HPV.  6.2 million people in the United States each year contract a strain of HPV.  Men and women in their late teens and early 20s are the typical victims Center for Disease and Control (CDC) Center for Disease and Control (CDC)

4. How to Acquire HPV?  Types of Transmission Cutaneous (Skin to Skin) Cutaneous (Skin to Skin) Oral sexOral sex Genital Genital Sexual intercourseSexual intercourse Perinatal Perinatal Between mother and childBetween mother and child Extremely rareExtremely rare “a pregnant woman can pass HPV to her baby during vaginal delivery and that baby who is exposed to HPV very rarely develops warts in the throat or voice box.” –CDC“a pregnant woman can pass HPV to her baby during vaginal delivery and that baby who is exposed to HPV very rarely develops warts in the throat or voice box.” –CDC Center for Disease and Control (CDC) Center for Disease and Control (CDC) cancer.about.com/od/cervicalcancer cancer.about.com/od/cervicalcancer

5. HPV Induced Diseases  Genital Warts 8.2 million Americans acquire a new genital HPV infection each year 8.2 million Americans acquire a new genital HPV infection each year Caused by virus strains #6 and #11 Caused by virus strains #6 and #11 Symptoms for both female and male include: Symptoms for both female and male include: Soft, moist, pink or flesh-colored swellings in the genital areaSoft, moist, pink or flesh-colored swellings in the genital area Can be flat or raisedCan be flat or raised Single or multipleSingle or multiple Small or largeSmall or large Sometimes cauliflower shapedSometimes cauliflower shaped

6. HPV Induced Diseases Continued  Genital Warts Continued Symptoms continued: Symptoms continued: Can be painfulCan be painful Can appear any where within the groin region including the thigh and anusCan appear any where within the groin region including the thigh and anus Diagnosis is only through visual examination for both male and females Diagnosis is only through visual examination for both male and females Removed by topical or surgical treatments administered by patients or by health care professionals Removed by topical or surgical treatments administered by patients or by health care professionalsCDChttp://manbir-online.com/std/hiv.24.htm

7. HPV Induced Cancers  Cervical Cancer American Cancer Society predicts 9,700 women will be diagnosed with cervical cancer and 3,700 will die in 2006. American Cancer Society predicts 9,700 women will be diagnosed with cervical cancer and 3,700 will die in 2006. HPV infects the women’s cervix and augments the DNA within the cellular structure directly causing abnormal pap smears. HPV infects the women’s cervix and augments the DNA within the cellular structure directly causing abnormal pap smears. Center for Disease and Control (CDC)

8. HPV Induced Cancers Continued  Penile and Anal Cancers 0.2% of cancers of men are cancers of the penis 0.2% of cancers of men are cancers of the penis American Cancer Society predicts that 1,910 men will be diagnosed with anal cancer in 2006. American Cancer Society predicts that 1,910 men will be diagnosed with anal cancer in 2006. Center of Disease and Control (CDC)

9. Diagnosis of HPV  Women: HPV is typically diagnosed through pap smears HPV is typically diagnosed through pap smears Genital warts is diagnosed through visual examination Genital warts is diagnosed through visual examination HPV DNA test allows health care professionals to identify some of the 30 known strains of HPV HPV DNA test allows health care professionals to identify some of the 30 known strains of HPV Center for Disease and Control (CDC)

10. Diagnosis of HPV  Men: Unfortunately, there is no “official” diagnostic tool available to diagnosis HPV. Unfortunately, there is no “official” diagnostic tool available to diagnosis HPV. Genital warts, a strain of HPV, are diagnosed through a visual examination. Genital warts, a strain of HPV, are diagnosed through a visual examination. Center for Disease and Control (CDC)

11. Prevention of HPV  Women: Complete regular annual pap smears Complete regular annual pap smears Avoid risky behaviors Avoid risky behaviors AbstinenceAbstinence CondomsCondoms Vaccination ( Garadsil® ) Vaccination ( Garadsil® )  Men: Avoid risky behavior Avoid risky behavior AbstinenceAbstinence CondomsCondoms

12. Vaccine: Garadsil®  FDA released in June 2006  First vaccination released to help prevent cervical cancer and other reproductive diseases caused by HPV  Protects against 4 strains of HPV #6, #11, #16, #18  Approved for use in females ages 9-26 Food and Drug Administration (FDA)

13. Garadsil®: How is it Made?  Garadsil® is a recombinant vaccine Genetically engineered through the process and method of manipulating the genetic material of an organism Genetically engineered through the process and method of manipulating the genetic material of an organism In HPV, each of the 4 virus types are expressed in yeast to create large quantities of the protein which is later purified to make the vaccine In HPV, each of the 4 virus types are expressed in yeast to create large quantities of the protein which is later purified to make the vaccine The body’s response to the recombinant proteins that then protects against infection by the naturally occurring virus The body’s response to the recombinant proteins that then protects against infection by the naturally occurring virus Food and Drug Administration (FDA) Food and Drug Administration (FDA)

14. Garadsil®  Most effective in girls and women who are have not been sexually active since their chance of exposure to HPV is zero  Girls and women who have been exposed to sexual intercourse and are not infected with any the four strains of HPV that Garadsil® protects against, will receive full benefit  “currently no test to tell if a girl/woman has had any or all of these four HPV types however very few young women are infected with all four of these HPV types.” –CDC Food and Drug Administration (FDA)

15. Garadsil®  Garadsil® is not approved for girls under the age of 9 or for women over the age of 26  Garadsil® is not approved for men or young boys  Researching has been extended to include women over the age of 26, girls under the age of 9 and to include men and young boys into studies involving Garadsil® Center for Disease and Control (CDC) Center for Disease and Control (CDC)

16. Garadsil®: Pregnancy  Pregnant women are discouraged by health care professionals to participate in the promotion of the vaccination  “studies suggest that the vaccine has not caused health problems during pregnancy nor has it caused health problems for the infant—but more research is needed. For now, women should complete their pregnancy before getting the vaccine and should complete the pregnancy if she were to find out if she is pregnant after beginning the vaccine series.” Center for Disease and Control (CDC)

17. Garadsil®  Garadsil® is almost 100% effective in preventing 70% of cervical cancers and 90% of genital warts  Immunity of Garadsil® is unknown  “studies have followed women for five years and found that women are still protected. More research is being done to find out how long protection will last and if a booster vaccine is needed.” –CDC Center for disease and Control (CDC)

18. Garadsil®: Cost  Retail cost about $120 per dose, approximately $360 for the full series  Some insurance companies may pay while some may not however the praise Garadsil® is receiving from health care providers, insurance companies may eventually begin to pay Center for Disease and Control (CDC)

19. Garadsil®: Cost  Federal Assistance Vaccines for Children (VFC) Vaccines for Children (VFC) Federal health program that will provide the HPV vaccine free of charge to children and teens under the age of 19 who are either underinsured, Medicaid-eligible, American Indian or Alaska nativeFederal health program that will provide the HPV vaccine free of charge to children and teens under the age of 19 who are either underinsured, Medicaid-eligible, American Indian or Alaska native Available at over 45,000 hospitals, private clinics, and public clinicsAvailable at over 45,000 hospitals, private clinics, and public clinics Center for Disease and Control (CDC)

20. How Garadsil® is delivered?  Three Injections  Given over a 6 month period the first dose is given at the discretion of the patient and health care provider, the first dose is given at the discretion of the patient and health care provider, second dose is followed two months later second dose is followed two months later finally the third and final dose is given is given six months after the first dose. finally the third and final dose is given is given six months after the first dose.  Given typically in the upper arm Food and Drug Administration (FDA) Food and Drug Administration (FDA)

21. What to know before receiving Garadsil®  Vaccine series does not protect against all types of HPV or other types of STDS nor will it work for a treatment of HPV  Vaccine is not a replacement for annual pap smears  Talk to your health care provider thoroughly about all options prior to receiving the vaccination Center for Disease and Control (CDC) Center for Disease and Control (CDC)

22. Garadsil® Prescreening  Fortunately, there are no prescreening requirements for women and young girls  If girls or women would like to know if they have HPV, a pap test is available however it will not determine any specific strain if she posses any Center for Disease and Control (CDC)

23. Garadsil® and Men  Not approved for use in men and young boys  Approval has been granted by the FDA to extend research to include boys and men in their continued studies  Will reduce number of cancers and outbreak of genital warts  Upon approval of use, would benefit females indirectly as well as homosexual relationships Food and Drug Administration (FDA) Food and Drug Administration (FDA)

24. Federal Laws and Vaccinations  State of Minnesota requires of a child by the age of 12 to have the following vaccinations: Hepatitis B Hepatitis B Diphtheria Diphtheria Tetanus Tetanus Pertussis Pertussis Whopping Cough Whopping Cough Polio Polio MMR MMR Haemophilus influenzae type b (Hib) Haemophilus influenzae type b (Hib) Chicken pox (if child has not already acquired so) Chicken pox (if child has not already acquired so) (Minnesota Department of Health)

25. Garadsil® and State of Michigan  “[Michigan] will be the first in the nation [for] legislation requiring HPV vaccination for girls entering the sixth grade is headed for a final vote in the Michigan House of Representatives, where a committee approved the two related bills last week. The Senate has already passed the measure.” Washington Times Washington Times

26. Garadsil® and Controversy  Possibly indicating to parents their son or daughter will become sexually active at a very young age by receiving the vaccination at young age  Effectiveness over long period of time  Long term effects health health

27. Sexuality among Youth  “Government surveys have found that approximately 7% of children have had sexual intercourse before age 13; while about a quarter have done so by age 15. Millions of teens and young adults are contracting sexually transmitted diseases—HPV the most common.”-- (Martha Irvine from Hartford Courant Associated Press).

28. Conclusions  Garadsil® holds great promises for women and young girls  Unfortunately it is not approved for boys and men and older women, however with time it very well could be  Genetic engineering has made it possible for millions of women by giving them the option of receiving Garadsil®  Through these advances, technology only holds greater promises for the rest of the population and for future generations

29. Questions?