Page 33 - Christiana Care Focus December 2018

Human papillomavirus (HPV) is a virus that is transmitted most commonly through vaginal or anal sex. It is reported that 80 percent of people will become infected with HPV in their lifetime.1 According to the CDC, in the United States alone, 33,700 people are diagnosed with cancer caused by HPV each year.2 HPV can resolve on its own, but complications such as cancer and genital warts can occur after becoming infected with HPV.1
In 2014, the FDA approved the Human Papillomavirus (9-valent) vaccine (Gardasil®9) for the prevention of nine types of HPV that cause certain cancers along with genital warts in women and men aged 13 through 26.3 In women, this vaccination is indicated to prevent cervical, vulvar, vaginal and anal cancer caused by HPV types 16, 18, 31, 45, 52, and 58.3 In men, this vaccination is indicated to prevent anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58.3 This vaccine was also approved for prevention of genital warts caused by HPV types 6 and 11 in both men and women.3
In October 2018, the FDA approved the expansion of Gardasil®9 to both men and women aged 27 through 45.4 This expansion is based on results of a study that was completed with the 4-valent vaccine. The four HPV types in the 4-valent are also included in the 9-valent vaccine. The primary endpoint was disease or infection related to HPV types 6, 11, 16, and 18.5 The reported efficacy against the primary was 90.5 percent (95 percent CI 73.7-97.5).5 There were 4/1,615 cases of in the vaccine group and 41/1,607 in those who received placebo.5 The vaccine is now indicated for those aged nine through 45.4 The dosing and administration of the vaccine is as follows:
| Pharmacy Services
Therapeutic Notes
Expanded age indication for Gardasil® 9
Jessica Leri, Pharm.D.
NEW VACCINATION SCHEDULE3
AGE
REGIMEN
SCHEDULE
9 through 14 years
2-dose
0, 6 to 12 months*
3-dose
0, 2, 6 months
15 through 45 years
3-dose
0, 2, 6 months
*if 2nd dose is administered earlier than 5 months after 1st dose, a 3rd dose should be given at least 4 months after the 2nd dose
Side effects from Gardasil®9 include local pain and swelling as well as fever, nausea and dizziness.3 It is contraindicated in patients who had a previous allergic reaction to Gardasil®9, or those who have a severe allergic reaction to yeast, which is a vaccine component.3 Gardasil®9 is not recommended for use during pregnancy.3
The Advisory Committee on Immunization Practices (ACIP) has not endorsed the new age expansion of Gardasil®9. Insurance companies will not cover the vaccination. It is unlikely the expanded indication will be utilized in routine practice until officially endorsed by ACIP. The cost for the Gardasil®9 vaccination is approximately $205 per shot.6 The Gardasil®9 vaccine is currently available. The decision to become vaccinated for those aged 27 through 45 will be decided by the provider and the patient. 
References
1. HumanPapillomavirus(HPV).(2016,December20).Retrievedfromhttps://www.cdc.gov/hpv/parents/whatishpv.html
2. Human Papillomavirus (HPV). (2018, August 23). Retrieved from https://www.cdc.gov/hpv/hcp/hpv-important.html
3. Gardasil (Human Papillomavirus 9-valent Vaccine, Recombinant) [package insert]. Whitehouse Station, NJ: Merck & Co, Inc; 2018.
4. OfficeoftheCommissioner.(2018,October5).PressAnnouncements-FDAapprovesexpandeduseofGardasil9toincludeindividuals27through45yearsold.Retrievedfromhttps:// www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622715.htm
5. MuñozN,ManalastasJrR,PitisuttithumP,etal.Safety,immunogenicity,andefficacyofquadrivalenthumanpapillomavirus(types6,11,16,18)recombinantvaccineinwomenaged 24-45 years: a randomised, double-blind trial. Lancet. 2009; 373:1949-57.
6. Vaccines for Children Program (VFC). (2018, September 04). Retrieved from https://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html
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