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Protecting our patients from HPV and HPV-related diseases: the role of vaccines.

The clinical burden of disease resulting from human papillomavirus (HPV) infection is substantial and extends from genital warts to cytologic abnormalities to cervical, vaginal, and vulvar cancers and their associated precursor lesions. In addition, HPV is implicated in anal, penile, and head and neck cancers. Thus, HPV-related disease constitutes a significant burden for both men and women. Large phase 2 and 3 clinical trials with a quadrivalent preventive HPV vaccine (HPV 6/11/16/18) and phase 2 trials with a bivalent preventive HPV vaccine (HPV 16/18) have demonstrated that both products are highly efficacious in preventing type-specific HPV infections and HPV-related disease and are well tolerated. Nearly all recipients demonstrate a robust immunologic response that currently appears to be durable for 4 or more years. Immunogenicity data among girls 9 to 15 years of age were used to "bridge" efficacy data from quadrivalent HPV vaccine trials completed to date. In June 2006, the US Food and Drug Administration approved the quadrivalent HPV vaccine for use among females 9 to 26 years of age. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended the 3-dose series for girls 11 to 12 years of age, catch-up vaccination for girls and women 13 to 26 years of age, and permissive use as early as age 9. Computer models projecting the impact of these preventive HPV vaccines predict that they will be cost-effective and beneficial to the population; the use of preventive HPV vaccines will complement continued cytologic screening programs. Trials are under way to evaluate the duration of immune response as well as efficacy among men and women 27 years of age and older. Girls and women within the targeted age ranges should be offered vaccination to achieve the disease prevention potential of these vaccines.