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  • 9-Valent HPV Vaccine: Why Are Prescribers Using More of It?

    Study shows that the most recently approved human papillomavirus (HPV) vaccine may provide additional protection against cervical cancer, related diseases, and infections.

    A randomized, international, double‑blind study of the immunogenicity, efficacy, and side effect profile of the 9-valent HPV (9vHPV) vaccine was conducted in 14,215 women, 16‑26 years of age. The women were randomized to receive the 9vHPV vaccine or the quadrivalent HPV (qHPV) vaccine on day 1 and at months 2 and 6. The 9vHPV vaccine includes the HPV types in the qHPV vaccine (6, 11, 16, and 18) and five additional HPV types (31, 33, 45, 52, and 58).

    According to the study, the incidence of high-grade cervical, vulvar, and vaginal disease among all participants, irrespective of results on HPV testing, was 14.0 per 1000 person-years in both vaccine groups. In the per-protocol efficacy population:

    • The incidence rate of high‑grade disease related to the five additional HPV types covered in the 9vHPV vaccine (HPV‑31, 33, 45, 52, and 58) was 0.1 per 1000 person-years in the 9vHPV group and 1.6 per 1000 person‑years in the qHPV group.
    • The incidence rate of high‑grade cervical epithelial neoplasia, adenocarcinoma in situ, and cervical cancer related to HPV‑31, 33, 45, 52, and 58 types was 0.1 per 1000 person‑years in the 9vHPV group and 1.5 per 1000 person‑years in the qHPV group.
    • The incidence rate of persistent infection that lasted at least 6 months related to HPV‑31, 33, 45, 52, and 58 was 2.1 per 1000 person-years in the 9vHPV group and 52.4 per 1000 person-years in the qHPV group.

    The authors of the study concluded that the efficacy of the 9vHPV vaccine is similar to that of the qHPV vaccine in preventing disease related to HPV‑6, 11, 16, and 18. The study also demonstrated the 9vHPV vaccine's efficacy against additional high‑risk HPV types. The study mentions the vaccine's potential "to increase overall prevention of cervical cancer from approximately 70% to approximately 90%." However, longer-term follow-up is needed to determine the durability of the vaccine's protection.

    The human papillomavirus 9‑valent vaccine, recombinant (Gardasil 9) was approved in December 2014 by the FDA, and covers 9 HPV types. Gardasil 9 is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers; genital warts; and precancerous or dysplastic lesions caused by HPV in females 9‑26 years of age. Gardasil 9 is also approved for the prevention of anal cancer, genital warts, and precancerous or dysplastic lesions caused by HPV in males 9‑26 years of age. A possible explanation for the increasing popularity of Gardasil 9 over the traditional HPV vaccines, Gardasil and Cervarix, among healthcare providers is Gardasil 9's potential to protect patients from a broader list of HPV types. Gardasil 9 will soon be the only HPV vaccine available in the United States. According to the Centers for Disease Control and Prevention, Gardasil will no longer be available when the last doses expire in May 2017. Cervarix became unavailable as of November 2016 when the last doses expired.

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    FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV. U.S. Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426485.htm. Updated December 11, 2014. Accessed February 7, 2017.

    Gardasil 9 Drug Label Information. DailyMed website. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a21f4f4b-b891-4f25-b747-cb9ec7d865d6. Updated January 20, 2017. Accessed February 7, 2017.

    HPV (Human Papillomavirus) VIS. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv.html. Updated December 2, 2016. Accessed February 7, 2017.

    Joura EA, Giuliano AR, Iversen O-E, et al. N Engl J Med 2015;372:711-23.