Cervical Cancer and Gardasil 9

What causes cervical cancer and who is at risk? The human papilloma virus (HPV) has been detected in virtually all-invasive cervical cancers and has been confirmed as the major cause of this cancer. Primarily having sex with an infected partner spreads HPV. Though most sexually active young women become infected with this virus, only a few women remain infected. Some of the virulent viral strains cause cancer by activating the cancer causing genes. Cervical cancer is more rampant and fatal in African Americans than in Caucasians. Hispanic females are at risk of invasive disease because of lower rate of screening. Women most at risk for cervical cancer are those with a history of multiple sexual partners, sexual intercourse at an early age (17 years or younger), or both. Some studies have shown a correlation between long-term use of oral contraceptive and cervical cancer. Infection with HIV is also risk factors for cervical cancer. Early age at first birth (younger than 20 years old) and increasing parity (3 or more full term births) are also associated with an increased risk of cervical cancer; these are also likely due to exposure to HPV through sexual intercourse. Low socioeconomic status is associated with an increased risk of cervical cancer. Cigarette smoking increases the risk of squamous cell cancer of the cervix.

What are symptoms of cervical cancer? Most women with dysplasia do not experience any symptoms. Screening tests, therefore, are very important. When the cancer becomes invasive, abnormal or unusual bleeding can occur. Bleeding may stop and start again between regular periods or there may be bleeding after menopause. Unexpected bleeding can also occur after intercourse or a pelvic exam. Periods sometimes last longer or are heavier than usual.

How is cervical cancer detected? Screening tests for cervical cancer include cervical cytology and testing for oncogenic subtypes of human papillomavirus. Follow-up of abnormalities in screening tests with colposcopy and cervical biopsy may result in a diagnosis of CIN, glandular neoplasia, or cervical cancer. CIN may be low grade (CIN 1) or high grade (CIN 2, 3). Women with low-grade CIN have a low potential for developing cervical malignancy, while those with high-grade lesions are at higher risk of progression to malignancy. In managing women with CIN, the goal is to prevent possible progression to invasive cancer while avoiding overtreatment of lesions that are likely to regress.

Abnormal Pap smear – What next? For a definitive diagnosis, the next step is usually colposcopy, during which the cervix is visualized under low power magnification. The physician takes samples of suspicious cells for biopsies. A biopsy will determine the stage of the precancerous growth or whether frankly invasive cancer is present.

What are the available vaccines? What is Gardasil 9? Human papillomavirus (HPV) is a sexually transmitted pathogen that causes anogenital and oropharyngeal disease in males and females. Persistent viral infection with high-risk HPV genotypes causes virtually all cancers of the cervix. The high-risk HPV genotypes (or “types”) 16 and 18 cause approximately 70 percent of all cervical cancers worldwide, and types 31, 33, 45, 52, and 58 cause an additional 20 percent. HPV types 16 and 18 also cause nearly 90 percent of anal cancers and a significant proportion of oropharyngeal cancer, vulvar and vaginal cancer, and penile cancer. HPV types 6 and 11 cause approximately 90 percent of anogenital warts. Vaccines have been developed to protect against acquisition of HPV infection and development of subsequent HPV-associated disease.

VACCINES — Three different vaccines, which vary in the number of HPV types they contain and target, have been clinically developed, although not all are available in all locations: ●Quadrivalent HPV vaccine (Gardasil) targets HPV types 6, 11, 16, and 18. ●9-valent vaccine (Gardasil 9) targets the same HPV types as the quadrivalent vaccine (6, 11, 16, and 18) as well as types 31, 33, 45, 52, and 58. ●Bivalent vaccine (Cervarix) targets HPV types 16 and 18. In the United States, only the 9-valent vaccine is available Who can get vaccine and when? Indications and age range — In accordance with the Advisory Committee on Immunization Practices (ACIP) in the United States, we recommend routine HPV vaccination for all females and males. The ACIP recommended age ranges for vaccination are as follows: ●Females – HPV vaccine is recommended at 11 to 12 years. It can be administered starting at 9 years of age, and catch-up vaccination is recommended for females aged 13 to 26 years who have not been previously vaccinated or who have not completed the vaccine series. ●Males – HPV vaccine is recommended at 11 to 12 years. It can be administered as starting at 9 years of age, and catch-up vaccination is recommended for males aged 13 to 21 years who have not been previously vaccinated or who have not completed the vaccine series. Among males 22 to 26 years old, catch-up HPV vaccination is recommended if they are men who have sex with men or immunocompromised (including HIV-infected males). Otherwise, “permissive use” of HPV vaccination is recommended for this age range. Permissive use means that the vaccine is recommended but not considered to be of sufficient priority to include on routine vaccination schedules. Vaccines recommended on a permissive basis may not be covered by a patient’s health insurance provider. The main reason that routine catch-up HPV vaccination is not recommended for individuals older than 26 years is the increased likelihood of prior exposure to HPV vaccine types with age, which reduces the potential individual benefit and thus the cost-effectiveness of HPV vaccination. Studies have suggested that HPV vaccination is immunogenic, efficacious, and safe in older women. However, clinicians and patients should be aware that HPV vaccination of individuals older than 26 years may not be covered by insurance providers or other payers. Immunization schedule — In the United States, the recommended dosing schedule depends on the age of the patient at vaccine initiation: ●Individuals initiating the vaccine series before 15 years of age – Two doses of HPV vaccine should be given at 0 and at 6 to 12 months. If the second dose was administered less than five months after the first, the dose should be repeated a minimum of 12 weeks after the second dose and a minimum of five months after the first. ●Individuals initiating the vaccine series at 15 years of age or older – Three doses of HPV vaccine should be given at 0, 1 to 2 (typically 2), and 6 months. The minimum intervals between the first two doses is four weeks, between the second and third doses is 12 weeks, and between the first and third dose is five months. If a dose was administered at a shorter interval, it should be repeated once the minimum recommended interval since the most recent dose has passed. ●Immunocompromised patients – Three doses of HPV vaccine should be given at 0, 1 to 2, and 6 months regardless of age. HPV vaccination during pregnancy is typically avoided because of limited information about safety; however, data from inadvertent use in this setting are increasingly available and reassuring What are the possible side effects? As with all vaccines, there may be some side effects with GARDASIL 9. GARDASIL 9 has been shown to be generally well tolerated in women and girls as young as 9 years of age. The most commonly reported side effects included pain, swelling, itching, and redness at the injection site. Systemic adverse effects included headache, fever, nausea, dizziness however these adverse effects occurred in <0.1 percent.

Will it help if HPV is already positive? You may benefit from GARDASIL9 if you already have HPV. This is because most people are not infected with all the nine types of HPV contained in the vaccine.

Used in conjunction with screening pap smears, GARDASIL 9 can help significantly reduce the human and economic burden of cervical cancer and other HPV-related diseases in the United States.

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