PracticeUpdate Dermatology Best of 2018

EXPERT OPINION 27

References 1. Oxman MN, Levin MJ, Johnson GR, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 2005;352(22):2271-2284. 2. Schmader KE, Levin MJ, Gnann JW, et al. Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years. Clin Infect Dis 2012;54(7):922-928. 3. Schmader KE, Oxman MN, Levin MJ, et al. Persistence of the efficacy of zoster vaccine in the shingles prevention study and the short-term persistence substudy. Clin Infect Dis 2012;55(10):1320-1328. 4. Morrison VA, Johnson GR, Schmader KE, et al. Long- term persistence of zoster vaccine efficacy. Clin Infect Dis 2014;60(6):900-909. 5. Willis ED, Woodward M, Brown E, et al. Herpes zoster vaccine live: a 10 year review of post-marketing safety experience. Vaccine 2017;35(52):7231-7239. 6. Dooling KL, Guo A, Patel M, et al. Recommendations of the Advisory Committee on immunization practices for use of herpes zoster vaccines. MMWR Morb Mortal Wkly Rep 2018;67(3):103-108. 7. Lal H, Cunningham AL, Godeaux O, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med 2015;372(22):2087-2096. 8. Grupping K, Campora L, Douha M, et al. Immunogenicity and safety of the HZ/su adjuvanted herpes zoster subunit vaccine in adults previously vaccinated with a live attenuated herpes zoster vaccine. J Infect Dis 2017;216(11):1343-1351. 9. Godeaux O, Kovac M, Shu D, et al. Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial. Hum Vaccin Immunother 2017;13(5):1051-1058. 10. Garland SM, Kjaer SK, Muñoz N, et al. Impact and effectiveness of the quadrivalent human papillomavirus vaccine: a systematic review of 10 years of real-world experience. Clin Infect Dis 2016;63(4):519-527. 11. Monie A, Hung CF, Roden R, Wu TC. Cervarix: a vaccine for the prevention of HPV 16, 18-associated cervical cancer. Biologics 2008;2(1):97-105. 12. Muñoz N, Kjaer SK, Sigurdsson K, et al. Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV- associated genital diseases in young women. J Natl Cancer Inst 2010;102(5):325-339. 13. Lehtinen M, Paavonen J, Wheeler CM, et al. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of- study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol 2012;13(1):89-99. 14. Costa APF, Cobucci RNO, da Silva JM, et al. Safety of human papillomavirus 9-valent vaccine: a meta-analysis of randomized trials. J Immunol Res 2017;2017:3736201. 15. U.S. Food and Drug Administration. FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old. Accessed October 25, 2018. 16. Joura EA, Giuliano AR, Iversen OE, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med 2015;372(8):711-723. 17. Huh WK, Joura EA, Giuliano AR, et al. Final efficacy, immunogenicity, and safety analyses of a nine- valent human papillomavirus vaccine in women aged 16-26 years: a randomised, double-blind trial. Lancet 2017;390(10108):2143-2159. 18. Kjaer SK, Nygård M, Dillner J, et al. A 12-year follow-up on the long-term effectiveness of the quadrivalent human papillomavirus vaccine in 4 Nordic countries. Clin Infect Dis 2018;66(3):339-345. 19. Naud PS, Roteli-Martins CM, De Carvalho NS, et al. Sustained efficacy, immunogenicity, and safety of the HPV- 16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination. Hum Vaccin Immunother 2014;10(8):2147-2162. 20. Moreira ED Jr, Block SL, Ferris D, et al. Safety profile of the 9-valent HPV vaccine: a combined analysis of 7 phase III clinical trials. Pediatrics 2016;138(2). pii: e20154387. 21. Moreira ED, Giuliano AR, de Hoon J, et al. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Hum Vaccin Immunothe r 2017;14(2):396-403.

persons. 16,17 There is no difference in the efficacy of the two Gardasil vaccines against disease related to HPV types 6, 11, 16, and 18. 16 By offering protection against five additional oncogenic types, however, Gardasil 9 has the potential to protect against 90% of cervical can- cers compared with the 70% offered by Gardasil and Cervarix. 14,17 There is also the potential for Gardasil 9 to protect against most oral cancers and some skin cancers. The duration of protection against targeted HPV types has been found to last at least 10 years with Gar- dasil, at least 9 years with Cervarix, and at least 6 years with Gardasil 9 based on currently available data. 17-19 Gardasil 9 is generally well-tolerated, with a safety profile similar to that of Gar- dasil and Cervarix. The most common adverse event reported is injection-site reaction of mild-to-moderate intensity, which is slightly more common with Gar- dasil 9. 20,21 Systemic symptoms (eg, fever, nausea, vomiting, gastritis, dizziness, myalgia, and diarrhea) are less com- mon, and serious adverse events (eg, syncope, allergic reaction/anaphylaxis, persistent headache, hypertension, gas- troenteritis, bronchospasm, and venous thromboembolism) are rare. 20,21 www.practiceupdate.com/c/75539

in 2009, and Gardasil 9 (nonavalent) in 2014. Gardasil protects against HPV types 6, 11, 16, and 18, and is approved for use in females and males ages 9 through 26. 10 Cervarix protects against HPV types 16 and 18, and is approved for use in females ages 10 through 25. 11 Gardasil and Cervarix are nearly 100% effective in preventing cervical, vul- var, and vaginal diseases caused by vaccine-type HPV in patients who are vaccine-naïve and HPV-uninfected, and also significantly reduces the incidence of all cervical intraepithelial neoplasia and external genital lesions, irrespec- tive of causal HPV type. 12,13 Vaccine efficacy decreases to 75% and 45% with Gardasil and Cervarix, respectively, in those who received at least one prior vaccine dose (catch-up patients) and in HPV-infected persons. 12,13 In 2017, Gardasil 9 became the only HPV vaccine available in the United States. Gardasil 9 protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 and was initially approved for use in females and males ages 9 through 26. 14 In October 2018, the FDA approved expanded use of Gardasil 9 to include people ages 27 through 45. 15 Gardasil 9 is also nearly 100% effective in pre- venting disease related to targeted HPV types among HPV-uninfected

VOL. 2 • NO. 4 • 2018