Human papillomavirus (HPV) is the most prevalent sexually transmitted infection and is the causative agent for cervical cancer, the second most common cancer in women worldwide. Two specific, high-risk HPV types (HPV 16/18) are responsible for an estimated 70% of cases of cervical cancer. These high-risk HPV types are also implicated in other cancers, including those of the anus, penis, vagina, and vulva. Two low-risk HPV types (HPV 6/11) have been detected in approximately 90% of genital warts, a substantial source of emotional distress and an economic burden. HPV 6 and 11 also cause an estimated 90% of recurrent respiratory papillomatosis, a rare but debilitating disease that can occur in both infants and adults, in which papillomas obstruct the airway. The highest rates of HPV infection have consistently been found in sexually active women younger than 25 years of age, and it is likely that more than half of sexually active adults have been infected with at least one HPV type. Thus, vaccination of boys and girls before the initiation of sexual activity will be the most effective strategy for reducing the public health burden of HPV infection.

Prophylactic HPV vaccines have been formulated to protect against both high- and low-risk HPV types. Recently, the United States Food and Drug Administration approved a quadrivalent HPV vaccine, formulated to protect against both high- (16/18) and low- (6/11) risk HPV types, for girls and women from 9 to 26 years of age for the prevention of cervical cancer, cervical precancers, vulvar/vaginal precancers, low-grade cervical lesions, and genital warts. Results from two large phase 3 trials of this vaccine have demonstrated 100% effectiveness in preventing HPV 6/11/16/18-associated cervical and external genital diseases. The vaccine was safe and well-tolerated in these studies. Additionally, immunogenicity-bridging studies with the quadrivalent vaccine have demonstrated high antibody titers in children (age 9–15 years), suggesting that early vaccination is expected to yield the greatest public health benefit. A bivalent vaccine, which is formulated to protect against high-risk HPV types (16/18) only, is in earlier stages of development. A phase 2 trial of this vaccine demonstrated 100% efficacy in preventing HPV 16/18-related cervical intraepithelial lesions. Phase 3 trials of this bivalent vaccine are currently underway. Programs combining HPV vaccination with current cervical cytology screenings are expected to positively impact the overall cost and utilization of public health care resources.

This activity will review the epidemiology and natural history of HPV infection, recent clinical data with preventative HPV vaccines, and economic-modeling data supporting the cost-effectiveness of HPV vaccination.

This activity is designed for cancer researchers, clinicians, behavioral scientists, cancer association leaders, and other professionals who wish to learn more about preventing cervical cancer and other HPV-related diseases.

After completing this activity, participants should be better able to:

• Determine the risks associated with HPV infection
  
• Review the role of HPV vaccines in preventing cervical cancer and other HPV-related diseases
  
• Identify the potential impact of HPV vaccination on overall cost and utilization of health care resources

Eduardo L. Franco, MPH, DrPH
James McGill Professor of Epidemiology
and Oncology
CIHR Distinguished Scientist
Division of Cancer Epidemiology
McGill University
Montreal, Quebec

Daron G. Ferris, MD
Professor of Family Medicine, Obstetrics and Gynecology
Director, Gynecologic Cancer Prevention Center
Medical College of Georgia
Augusta, Georgia

Shalini L. Kulasingam, PhD
Research Assistant Professor
Division of Clinical and Epidemiological Research
Department of Obstetrics and Gynecology
Senior Fellow, Duke Center for Clinical Health Policy Research
Duke University
Durham, North Carolina

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SciMed assesses conflicts of interest with its faculty and all individuals who are in a position to control the content of CME activities. All relevant conflicts of interest that are identified are resolved by SciMed to ensure fair balance and scientific objectivity of the content presented in this activity. SciMed is committed to providing high quality CME activities that promote improvements in the quality of health care. When asked to report any potential conflict(s) of interest, faculty reported the following:

Eduardo L. Franco, MPH, DrPH
Consultant: Genprobe, GlaxoSmithKline, Merck & Co., Inc.

Daron G. Ferris, MD
Grants/Research Support: Merck & Co., Inc., GlaxoSmithKline
Speakers Bureau: Merck & Co., Inc.
Consultant: Merck & Co., Inc., GlaxoSmithKline

Shalini L. Kulasingam, PhD
Grants/Research Support: Merck & Co., Inc.

All SciMed personnel involved in the development of content for this activity have no conflicts to report.

The opinions or views expressed in this CME activity are those of the presenters and do not necessarily reflect the opinions or recommendations of SciMed or the commercial supporters. Participants should critically appraise the information presented and are encouraged to consult appropriate resources for information surrounding any product or device mentioned.