Persistent infection with human papillomavirus 16 or 18 is strongly linked with high-grade cervical disease

• Published in: Human vaccines & immunotherapeutics Vol. 12; no. 3; pp. 768 - 772
• Main Authors: Radley, David, Saah, Alfred, Stanley, Margaret
• Format: Journal Article
• Language: English
• Published: United States Taylor & Francis 03.03.2016
• Subjects: Adenocarcinoma - epidemiology; Adolescent; Adult; cervical cancer; cervical intraepithelial neoplasia; Cervical Intraepithelial Neoplasia - epidemiology; Chronic Disease; Clinical Trials as Topic; Female; Follow-Up Studies; HPV; Human papillomavirus 16 - isolation & purification; Human papillomavirus 18 - isolation & purification; Humans; Middle Aged; Papillomavirus Infections - complications; Papillomavirus Infections - pathology; Papillomavirus Infections - virology; Prentice criteria; Short Report; statistics; surrogate endpoint; Uterine Neoplasms - epidemiology; Young Adult; Prentice criteria; surrogate endpoint; cervical cancer; cervical intraepithelial neoplasia; HPV; statistics
• ISSN: 2164-5515; 2164-554X; 2164-554X
• DOI: 10.1080/21645515.2015.1088616

We investigated the relationship between high-grade cervical disease (cervical intraepithelial neoplasia [CIN] 2, CIN3 or adenocarcinoma in situ) and persistent infection with HPV16 and/or HPV18 (HPV16/18) among 3970 women who received placebo in 3 clinical trials of a quadrivalent HPV vaccine. Statistical analysis (odds ratios, sensitivity, specificity, negative and positive predictive values, negative and positive likelihood ratios) showed that patients with a persistent infection with HPV16/18 had a much greater risk of HPV16/18-related high-grade cervical disease. Furthermore, subjects without a persistent infection with HPV16/18 were unlikely to have HPV16/18-related high-grade cervical disease. These results suggest that persistent infection with HPV16/18 meets the criteria for a surrogate endpoint for HPV16/18-related high-grade cervical disease and may be used as such in future clinical studies with prophylactic HPV vaccines and in natural history studies.