Update in Women's Health

Update in Women's Health

Molly Carnes, MD, MS; and
Jane E. Mahoney, MD

From the University of Wisconsin, Madison, Wisconsin.

2003–2004 Series: Update Sessions from ACP's 2003 Annual Session

Women's health for the internist generally encompasses nonobstetric reproductive health, sex and gender differences in diseases that occur in both men and women, and conditions that occur predominantly or uniquely in women. This year's Update in Women's Health involves 11 manuscripts published in 2002 that potentially change standards of care. The manuscripts fall into the following categories: genitourinary conditions, hormone therapy, cardiovascular disease, and breast cancer.

Genitourinary Conditions

Human Papillomavirus Type 16 Vaccine Reduced the Incidence of Both HPV-16 Infection and HPV-16–Related Cervical Intraepithelial Neoplasia

Koutsky LA, Ault KA, Wheeler CM, et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002;347:1645-51. [PMID: 12444178]

Human papillomavirus (HPV) infection is a common sexually transmitted disease. The type 16 strain (HPV-16) infects approximately 20% of adults and causes approximately 50% of cases of cervical cancer (1). While most infections are benign, persistent infection is associated with an increased risk for cervical as well as other anogenital cancers. This randomized, double-blind, controlled trial focused on preventing HPV-16 infection with a prophylactic vaccine.

Of 2392 women (age 16 to 23 years) enrolled in the study, more than 800 were excluded because they showed signs of HPV infection at the time of enrollment. The study included 1533 women assigned to receive placebo or HPV-16 virus-like particle vaccine (40 µg per dose) administered by intramuscular injection at day 0, month 2, and month 6. The women returned for follow-up visits at month 7 (1 month after final injection), month 12, and so on up to 48 months.

At median follow-up, 17.4 months after the completion of the vaccination regimen, the incidence of persistent HPV-16 infection was 0 per 100 women at risk in the vaccine group, signifying an efficacy of 100% (95% CI, 90% to 100%) for the vaccine (P < 0.001). Antibody conversion occurred in 99.7% of women vaccinated. The incidence of HPV-16 infection in the placebo group was 3.8 per 100 women at risk. All 41 cases of persistent HPV-16 infection occurred …

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