Human Papilloma VirusnUpdated 02/8/2008, Expires 02/8/2010nwww.
.orgnProvider Numbers Available on WebsitenThis course was written for RN.ORG by an outside consultant and RN.ORG has exclusive rightsnfor distribution but is not responsible for the contents.nCOURSE OBJECTIVESnUpon completion of this self-study module, the learner will be able to:n1. Define HPVn2. List at least 3 of the different types of HPVn3. Discuss the options available to patients with HPVn4. Define the Registered Nurses role when talking with patients aboutnHPVn5. Explain to patients the when the injections are given and whyn6. Explain ways to control Cervical Cancern7. Why HPV is importantnThe Facts about HPVnWho should get this vaccine?nThis vaccine is recommended for 11-12 year-old girls. The vaccine can bengiven to girls as young as 9 years old, at the discretion (judgment) of thenhealthcare provider. The vaccine is also recommended for 13-26 year-oldngirls/women who have not yet received or completed the vaccine series.nThese recommendations were made by the federal Advisory Committee onnImmunization Practices (ACIP)—a national group of leading experts, whichnadvises the Centers for Disease Control and Prevention (CDC) on vaccinenissues. The ACIP decides whether vaccines should be recommended, and ifnso, who should get them, and at what ages.nHow effective is this vaccine?nThe vaccine has mainly been studied in young women who had not beennexposed to any of the four vaccine HPV types. These studies found thenvaccine to be 100% effective in preventing cervical precancers caused by thenvaccine HPV types. These studies also found it to be almost 100% effectivenin preventing precancers of the vulva and vagina, and genital warts that arencaused by the vaccine HPV types. The vaccine was less effective in youngnwomen who had already been exposed to a vaccine HPV type. This vaccinendoes not treat existing HPV, genital warts, precancers or cancers.nWill sexually active females benefit from the vaccine?nFemales who are sexually active may also benefit from the vaccine. But theynmay get less benefit from the vaccine since they may have already acquirednone or more vaccine HPV type(s). Still, they would get protection againstnthe vaccine HPV types they have not yet acquired. Few young women areninfected with all four vaccine HPV types. Currently, there is no test availablento tell whether a girl/woman has had any or all of the four vaccine HPVntypes.nHow and when is the vaccine delivered?nThe vaccine is given through a series of three injections over a six-monthnperiod. The second and third doses should be given two and six monthsn(respectively) after the first dose.nIs the HPV vaccine safe?nThe FDA has approved the HPV vaccine as safe and effective. This vaccinenhas been tested in over 11,000 females (ages 9-26 years) in many countriesnaround the world. These studies have shown no serious side effects. Thenmost common side effect is soreness at the injection site.nDoes this vaccine contain thimerosal or mercury?nNo. There is no thimerosal or mercury in the HPV vaccine. It is made up ofnproteins from the outer coat of the virus (HPV). There is no infectiousnmaterial in this vaccine.nHow much will the HPV vaccine cost?nThe retail price of the vaccine is $120 per dose ($360 for full series).nWill girls/women who have been vaccinated still need cervical cancernscreening?nYes. There are three reasons why women will still need regular cervicalncancer screening. First, the vaccine will NOT provide protection against allntypes of HPV that cause cervical cancer, so vaccinated women will still be atnrisk for some cancers. Second, some women may not get all required dosesnof the vaccine (or they may not get them at the right times), so they may notnget the vaccine’s full benefits. Third, women may not get the full benefit ofnthe vaccine if they receive it after they’ve already acquired a vaccine HPVntype.nWill the HPV vaccine be covered by insurance plans?nWhile some insurance companies may cover the vaccine, others may not.nMost large group insurance plans usually cover the costs of recommendednvaccines. However, there is often a short lag-time after a vaccine isnrecommended, before it is available and covered by health plans.nWhat kind of government programs may be available to cover HPVnvaccine?nFederal health programs such as Vaccines for Children (VFC) will cover thenHPV vaccine. The VFC program provides free vaccines to children andnadolescents under 19 years of age, who are either uninsured, Medicaideligible,nAmerican Indian, or Alaska Native. There are over 45,000 sites thatnprovide VFC vaccines, including hospital, private, and public clinics. ThenVFC Program also allows children and adolescents to get VFC vaccinesnthrough Federally Qualified Health Centers or Rural Health Centers, if theirnprivate health insurance does not cover the vaccine.nSome states also provide free or low-cost vaccines at public healthndepartment clinics to people without health insurance coverage for vaccines.nWhy is HPV important?nGenital HPV is a common virus that is passed on through genital contact,nmost often during vaginal and anal sex. About 40 types of HPV can infectnthe genital areas of men and women. While most HPV types cause nonsymptoms and go away on their own, some types can cause cervical cancernin women. These types also have been linked to other less common genitalncancers, including cancers of the anus, vagina, and vulva (area around thenopening of the vagina). Other types of HPV can cause warts in the genitalnareas of men and women, called genital warts.nHow common is HPV?nAt least 50% of sexually active people will get HPV at some time in theirnlives. Every year in the U.S., about 6.2 million people get HPV. HPV isnmost common in young women and men who are in their late teens and earlyn20s.nAnyone who has ever had genital contact with another person can get HPV.nBoth men and women can get it – and pass it on to their sex partnerswithoutneven realizing it.nHow common are Genital Warts?nAbout 1% of sexually active adults in the U.S. (about 1 million people) havenvisible genital warts at any point in time.nIs HPV the same thing as HIV or Herpes?nHPV is NOT the same as HIV or Herpes (Herpes simplex virus or HSV).nWhile these are all viruses that can be sexually transmitted— HIV and HSVndo not cause the same symptoms or health problems as HPV.nCan HPV and its associated diseases be treated?nThere is no treatment for HPV. But there are treatments for the healthnproblems that HPV can cause, such as genital warts, cervical cell changes,nand cancers of the cervix, vulva, vagina and anus.nHow is HPV related to cervical cancer?nSome types of HPV can infect a woman’s cervix (lower part of the womb)nand cause the cells to change. Most of the time, HPV goes away on its own.nWhen HPV is gone, the cervix cells go back to normal. But sometimes, HPVndoes not go away. Instead, it lingers (persists) and continues to change thencells on a woman’s cervix. These cell changes can lead to cancer over time,nif they are not treated.nHow common is cervical cancer in the United States (U.S.)? How manynwomen die from it?nThe American Cancer Society estimates that in 2006, over 9,700 women willnbe diagnosed with cervical cancer and 3,700 women will die from thisncancer in the U.S.nAre there other ways to prevent cervical cancer?nRegular Pap tests and follow-up can prevent most, but not all, cases ofncervical cancer. Pap tests can detect cell changes (or “precancers”) in thencervix before they turn into cancer. Pap tests can also detect most, but notnall, cervical cancers at an early, curable stage. Most women diagnosed withncervical cancer in the U.S. have either never had a Pap test, or not had a Papntest in the last 5 years.nThere is also an HPV DNA test available for use with the Pap test, as part ofncervical cancer screening. This test is used for women over 30 or for womennwho get an unclear (borderline) Pap test result. While this test can tell if anwoman has HPV on her cervix, it cannot tell which types of HPV she has.nWhat HPV types does the vaccine protect against?nThe new HPV vaccine protects against the two HPV types that cause mostn(70%) cervical cancers (types 16 and 18), and the two HPV types that causenmost (90%) genital warts (types 6 and 11).nWhat does the vaccine not protect against?nBecause the vaccine does not protect against all types of HPV, it will notnprevent all cases of cervical cancer or genital warts. About 30% of cervicalncancers will not be prevented by the vaccine, so it will be important fornwomen to continue getting screened for cervical cancer (regular Pap tests).nAlso, the vaccine does not prevent about 10% of genital warts—nor will itnprevent other STIs— so it will still be important for sexually active adults tonreduce exposure to HPV and other STIs.nHow long does vaccine protection last? Will a booster shot be needed?nThe length of vaccine protection (immunity) is usually not known when anvaccine is first introduced. So far, studies have followed women for fivenyears and found that they are protected. More research is being done to findnout how long protection will last, and if a booster vaccine is needed yearsnlater.nWhy is the vaccine only recommended for girls/women ages 9 to 26?nThe vaccine has been extensively tested in 9-to-26 year-old girls/women, butnresearch on the vaccine’s efficacy has only recently begun with males, andnwith women older than 26 years of age. The FDA will consider licensing thenvaccine for these other groups when the research is completed to show that itnis safe and effective in those groups.nWhy is HPV vaccine recommended for such young girls?nIdeally, females should get the vaccine before they are sexually active—nsince this vaccine is most effective in girls/women who have not yetnacquired any of the HPV vaccine types. Girls/women who have not beenninfected with any vaccine HPV type will get the full benefits of the vaccine.nShould girls/women be screened before getting vaccinated?nNo. Girls/women should not get an HPV test or Pap test to determine if theynshould get the vaccine. An HPV test or a Pap test can tell that a woman maynhave HPV, but these tests cannot tell the specific HPV type(s) that a womannhas. Even girls/women with one vaccine HPV type could get protectionnagainst the other vaccine HPV types they have not yet acquired.nWhat about vaccinating boys?nWe do not yet know if the vaccine is effective in boys or men. It is possiblenthat vaccinating males will have health benefits for them by preventingngenital warts and rare cancers, such as penile and anal cancer. It is alsonpossible that vaccinating boys/men will have indirect health benefits forngirls/women. Studies are now being done to find out if the vaccine works tonprevent HPV infection and disease in males. When more information isnavailable, this vaccine may be licensed and recommended for boys/men asnwell. Currently, the vaccine is licensed only for use in females ages 9 to 26.nShould pregnant women be vaccinated?nThe vaccine is not recommended for pregnant women. There has beennlimited research looking at vaccine safety for pregnant women and theirndeveloping fetus. So far, studies suggest that the vaccine has not causednhealth problems during pregnancy, nor has it caused health problems for theninfant-- but more research is still needed. For now, pregnant women shouldncomplete their pregnancy before getting the vaccine. If a woman finds outnshe is pregnant after she has started getting the vaccine series, she shouldncomplete her pregnancy before finishing the three-dose series.nWill girls/women be protected against HPV and related diseases, even ifnthey don’t get all three doses?nIt is not yet known how much protection girls/women would get fromnreceiving only one or two doses of the vaccine. For this reason, it is verynimportant that girls/women get all three doses of the vaccine.nWill girls be required to get vaccinated before they enter school?nThere are no federal laws that require children or adolescents to getnvaccinated. All school and daycare entry laws are state laws—so they varynfrom state to state. To find out what vaccines are needed for children ornadolescents to enter school or daycare in your state, check with your statenhealth department or board of education.nAre there other HPV vaccines in development?nAnother HPV vaccine is in the final stages of clinical testing, but it is not yetnlicensed. This vaccine would protect against the two types of HPV that causenmost (70%) cervical cancers (types 16, 18).nAre there other ways to prevent HPV?nThe only sure way to prevent HPV is to abstain from all sexual activity.nSexually active adults can reduce their risk by being in a mutually faithfulnrelationship with someone who has had no other or few sex partners, or bynlimiting their number of sex partners. But even persons with only onenlifetime sex partner can get HPV, if their partner has had previous partners.nIt is not known how much protection condoms provide against HPV, sincenareas that are not covered by a condom can be exposed to the virus.nHowever, condoms may reduce the risk of genital warts and cervical cancer.nThey can also reduce the risk of HIV and some other sexually transmittedninfections (STIs), when used consistently and correctly (i.e. all the time andnthe right way).nBibliographynAmerican Cancer Society. Detailed Guide: Cervical Cancer. What are thenKey Statistics about Cervical Cancer? Last updated October 31, 2005.nCDC,
www.cdc.gov, February 3, 2008nFood and Drug Administration (FDA). FDA News: FDA Licenses NewnVaccine for Prevention of Cervical Cancer and Other Diseases in FemalesnCaused by Human Papillomavirus.nHarper DM, Franco EL, Wheeler C, et al; HPV Vaccine Study Group.nSustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccinenagainst human papillomavirus types 16 and 18: follow-up from anrandomised controlled trial. Lancet. 2006; 367(9518): 1247-1255.nHo GY, Bierman R, Beardsley L, et al. Natural history of cervicovaginalnpapillomavirus infection as measured by repeated DNA testing in adolescentnand young women. N Engl J Med. 1998; 338(7):423-428.nKoutsky LA. Epidemiology of genital human papillomavirus infection. Am JnMed. 2005; 102(5A):3-8.nMao C, Koutsky LA, Ault KA, et al. Efficacy of human papillomavirus-16nvaccine to prevent cervical intraepithelial neoplasia: a randomized controlledntrial. Obstet Gynecol. 2006; 107(1):18-27.nNational Institutes of Health (NIH). NIH Consensus Statement: CervicalnCancer. 2004; 14:1-38.nVilla LL, Costa RLR, Petta CA, et al. Prophylactic quadrivalent humannpapillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine innyoung women: a randomised double-blind placebo-controlled multicentrenphase II efficacy trial. The Lancet Oncology, 2005; 6(5): 271-278.nWeinstock H, Berman S, Cates W, Jr. Sexually transmitted diseases amongnAmerican youth: incidence and prevalence estimates, 2000. Perspect SexnReprod Health. 2004; 36(1):6-10.nContent reviewed: February 2008