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Quadrivalent HPV Recombinant Vaccine (Gardasil) for the Prevention of Cervical Cancer



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Am Fam Physician. 2007 Aug 15;76(4):573-574.

The quadrivalent human papillomavirus (HPV) recombinant vaccine (Gardasil) is the first vaccine developed to prevent cervical cancer, precancerous genital lesions, and genital warts caused by HPV types 6, 11, 16, and 18.1 These four types are responsible for 70 percent of cervical cancers and 90 percent of genital warts.2 The Advisory Committee on Immunization Practices recommends that females 9 to 26 years of age receive the vaccine.3

Name Dose Dose form Approximate cost*

Quadrivalent human papillomavirus recombinant vaccine (Gardasil)

A series of three intramuscular 0.5-mL doses, with the second dose given at least two months after the initial dose and the third dose given at least six months after the initial dose.

0.5-mL single-dose vial or 0.5-mL single-dose prefilled syringe

$147 per dose ($441 for the three-dose series)


*—Average wholesale cost, based on current Red Book, Montvale, N.J.: Medical Economics Data.

Name Dose Dose form Approximate cost*

Quadrivalent human papillomavirus recombinant vaccine (Gardasil)

A series of three intramuscular 0.5-mL doses, with the second dose given at least two months after the initial dose and the third dose given at least six months after the initial dose.

0.5-mL single-dose vial or 0.5-mL single-dose prefilled syringe

$147 per dose ($441 for the three-dose series)


*—Average wholesale cost, based on current Red Book, Montvale, N.J.: Medical Economics Data.

SAFETY

Clinical trials have not identified serious safety issues with the HPV vaccine. The vaccine may be administered concomitantly (at separate injection sites) with hepatitis B recombinant; tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis; and meningococcal vaccines. Coadministration with other vaccines has not been studied.1,3 The HPV vaccine is U.S. Food and drug Administration pregnancy category B, although the manufacturer does not recommend its use in pregnant women.1

TOLERABILITY

The HPV vaccine is well tolerated, and less than 0.1 percent of patients stop the series because of adverse effects. Minor injection site reactions are common, including pain (83.9 percent), swelling (25.4 percent), and erythema (24.6 percent). In approximately 5,000 patients receiving the vaccine, 10 to 13 percent experienced fever and less than 7 percent reported nausea or dizziness.1

EFFECTIVENESS

The HPV vaccine will protect against genital warts caused by HPV types 6, 11, 16, and 18 in 99 percent of women.1,3,4 It also decreases the risk of developing cervical dysplasia; however, the effect on cervical cancer, because of its low incidence, is not known. Four studies enrolling more than 20,000 females 16 to 26 years of age who were free of HPV infection showed that only four of the 7,858 patients who received all three doses of the HPV vaccine developed cervical intraepithelial neoplasia (CIN) grades 1, 2, or 3, or adenocarcinoma in situ (AIS) because of one of the four strains of HPV; this was compared with 83 of 7,861 patients receiving placebo (0.05 percent versus 1.1 percent, respectively).1 In other words, for every 100 persons who receive the HPV vaccine, one case of cervical dysplasia will be prevented over a two-year period (number needed to treat [NNT] = 100; 95% confidence interval [CI], 79 to 127). In a study of more than 16,000 females with unknown HPV status, fewer cases of CIN 1, 2, or 3, or AIS were reported in those who received the HPV vaccine than in those who did not during two years of follow-up (1.9 percent versus 3.6 percent; NNT = 60; 95% CI, 47 to 85).1 The vaccine's duration of protection is unknown, but protective antibodies have persisted for at least four years.4,5

PRICE

The cost for the three-dose series of HPV vaccine is $441. Many insurance plans will cover this vaccine for females who are within the recommended age group.

SIMPLICITY

The recommended dosing schedule for the HPV vaccine is a series of three doses, with the second dose given at least two months after the initial dose and the third dose given at least six months after the initial dose. The patient's HPV status does not need to be determined before vaccination,5 and women who already have a documented strain of HPV can still receive the vaccine.3 If the vaccination series is interrupted, it should be continued without restarting the entire series.3,4

The HPV vaccine is administered intra-muscularly into the deltoid or the upper anterolateral thigh. The vaccine should be refrigerated, and the suspension should be shaken before administration.1 Current recommendations do not change guidelines for cervical cancer screening in vaccinated females.3

Bottom line

The HPV vaccine is safe and effective in preventing genital warts and cervical changes that may lead to cervical cancer, and it is recommended as part of the vaccination series in females 11 to 12 years of age. It can be given to females as young as 9 or 10 years of age, and catch-up vaccination is recommended for those who are 13 to 26 years of age.1,3

Address correspondence to Angie L. Goeser, PharmD, at agoeser@creighton.edu. Reprints are not available from the author.

Author disclosure: Nothing to disclose.

REFERENCES

1. Gardasil (Quadrivalent human papillomavirus [types 6,11,16,18] recombinant vaccine) [Product information]. Whitehouse Station, N.J.: Merck & Co., Inc. Accessed November 9, 2006, at: http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf.

2. Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, et al. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005;6:271–8.

3. Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER, for the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices. Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2007;56(RR-2):1–24. Accessed March 12, 2007, at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr56e312a1.htm.

4. Zimmerman RK. HPV vaccine and its recommendations, 2007. J Fam Pract. 2007;56:S1–5.

5. Frazer IH, Cox JT, Mayeaux EJ Jr, Franco EL, Moscicki AB, Palefsky JM, et al. Advances in prevention of cervical cancer and other human papillomavirus-related diseases. Pediatr Infect Dis J. 2006;25(suppl 2):S65–81.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

The series coordinator for AFP is Allen F. Shaughnessy, PharmD, Tufts University Family Medicine Residency Program at Cambridge Health Alliance, Malden, Mass.


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