HIV-infected and uninfected women with normal cervical cytology (Pap test) and a negative test result for oncogenic (tumor inducing) human papillomavirus DNA at study enrollment had a similar risk of cervical precancer and cancer after 5 years of follow-up, according to a study in the July 25 issue of JAMA, a theme issue on HIV/AIDS.
Howard D. Strickler, M.D., M.P.H., of the Albert Einstein College of Medicine of Yeshiva University, New York, presented the findings of the study at a JAMA media briefing at the International AIDS Conference.
“U.S. cervical cancer screening guidelines for human immunodeficiency virus (HIV)-uninfected women 30 years or older have recently been revised, increasing the suggested interval between Papanicolaou (Pap) tests from 3 years to 5 years among those with normal cervical cytology results who test negative for oncogenic human papillomavirus (HPV). Whether a 3-year or 5-year screening interval could be used in HIV-infected women who are cytologically normal and oncogenic HPV-negative is unknown,” according to background information in the article.
Dr. Strickler and colleagues conducted a study to examine the 3-year and 5-year risk of cervical precancer and cancer defined by cytology (i.e., high-grade squamous intraepithelial lesion or greater [HSIL+]) and histology (cervical intraepithelial neoplasia 2 or greater [CIN-2+]), in HIV-infected women (n = 420) and HIV-uninfected women (n = 279). The participants, who at the beginning of the study had a normal Pap test result and were negative for oncogenic HPV, were enrolled in a multi-institutional U.S. cohort of the Women's Interagency HIV Study, between October 2001 and September 2002, with follow-up through April 2011. Semiannual visits at 6 clinical sites included Pap testing and, if indicated, cervical biopsy.
Overall, no oncogenic HPV was detected in 369 (88 percent) of the HIV-infected women and 255 (91 percent) of the HIV-uninfected women with normal cervical cytology at enrollment. Two cases of HSIL+ were observed during the 5 years of observation, 1 among the HIV-uninfected women and 1 among the HIV-infected women with a CD4 cell count of 500 cells/µL or greater. Overall, the cumulative incidence of HSIL+ was 0.3 percent in HIV-infected women and 0.4 percent in HIV-uninfected women.
Based on a total of 15 cases, the authors found that the cumulative incidence of CIN-2+ over 5 years of follow-up was 2 percent in HIV-infected women with CD4 cell count less than 350 cells/µL, 2 percent in those with CD4 cell count of 350 to 499 cells/µL, 6 percent in those women with CD4 cell count of 500 cells/µL or greater, and 5 percent in HIV-uninfected women.
When the researchers combined the data among HIV-infected women, they found that the overall 5-year cumulative incidence of CIN-2+ in HIV-infected women was 5 percent. “Of the CIN-2+ cases, 2 were CIN-3 (an HIV-infected woman with a baseline CD4 cell count of 350-499 cells/µL, and an HIV-uninfected woman). The overall 5-year cumulative incidence of CIN-3+ was 0.5 percent in HIV-infected women and 0.7 percent in HIV-uninfected women. No cancers were observed.”
“In summary, the results of this prospective study suggest that HIV-infected women undergoing long-term clinical follow-up who are cytologically normal and oncogenic HPV-negative have a risk of cervical precancer similar to that in HIV-uninfected women through 5 years of follow-up. Additional observational studies or a randomized clinical trial may be necessary before clinical guideline committees consider whether to expand current recommendations regarding HPV co-testing to HIV-infected women. More broadly, the current investigation highlights the potential for a new era of molecular testing, including HPV as well as other biomarkers, to improve cervical cancer screening in HIV-infected women,” the authors conclude.