title: Progression of HPV infection to detectable cervical lesions or clearance in adult women: Analysis of the control arm of the VIVIANE study.
abstract: The control arm of the phase III VIVIANE (Human PapillomaVIrus: Vaccine Immunogenicity ANd Efficacy; NCT00294047) study in women >25 years was studied to assess risk of progression from cervical HPV infection to detectable cervical intraepithelial neoplasia (CIN). The risk of detecting CIN associated with the same HPV type as the reference infection was analysed using Kaplan-Meier and multivariable Cox models. Infections were categorised depending upon persistence as 6-month persistent infection (6MPI) or infection of any duration. The 4-year interim analysis included 2,838 women, of whom 1,073 (37.8%) experienced 2,615 infections of any duration and 708 (24.9%) experienced 1,130 6MPIs. Infection with oncogenic HPV types significantly increased the risk of detecting CIN grade 2 or greater (CIN2+) versus non-oncogenic types. For 6MPI, the highest risk was associated with HPV-33 (hazard ratio [HR]: 31.9 [8.3-122.2, p < 0.0001]). The next highest risk was with HPV-16 (21.1 [6.3-70.0], p < 0.0001). Similar findings were seen for infections of any duration. Significant risk was also observed for HPV-18, HPV-31, and HPV-45. Concomitant HPV infection or CIN grade 1 or greater associated with a different oncogenic HPV type increased risk. Most women (79.3%) with an HPV infection at baseline cleared detectable infections of any duration, and 69.9% cleared a 6MPI. The risk of progression of HPV infection to CIN2+ in women >25 years in this study was similar to that in women 15-25 years in PATRICIA.
authors.affiliation: Vaccines Trials Group, Telethon Institute for Child Health Research, Perth, WA and Sydney University Discipline of Paediatrics and Child Health, Children's Hospital Westmead, Sydney, NSW, Australia.
authors.forename: S Rachel
authors.initials: SR
authors.lastname: Skinner
authors.affiliation: Departments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
authors.forename: Cosette M
authors.initials: CM
authors.lastname: Wheeler
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
authors.forename: Barbara
authors.initials: B
authors.lastname: Romanowski
authors.affiliation: Unit of Infections and Cancer, Cancer Epidemiology Research Program, Institut Català d'Oncologia (ICO), IDIBELL, CIBER-ESP, L'Hospitalet de Llobregat, Catalonia, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Castellsagué
authors.affiliation: National Institute of Public Health, Cuernavaca, Mexico.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Lazcano-Ponce
authors.affiliation: Department of Obstetrics and Gynecology, San Pablo Colleges Medical Center, San Pablo City, Laguna, Philippines.
authors.forename: M Rowena
authors.initials: MR
authors.lastname: Del Rosario-Raymundo
authors.affiliation: Division de Investigacion Oncosalud-AUNA, Lima, Peru.
authors.forename: Carlos
authors.initials: C
authors.lastname: Vallejos
authors.affiliation: City Clinical Hospital, Moscow, Russian Federation.
authors.forename: Galina
authors.initials: G
authors.lastname: Minkina
authors.affiliation: Departmento de Ginecologia, Instituto Português de Oncologia de Coimbra, Portugal.
authors.forename: Daniel
authors.initials: D
authors.lastname: Pereira Da Silva
authors.affiliation: Canadian Center for Vaccinology, IWK Health Center and Capital Health, Dalhousie University, Halifax, NS, Canada.
authors.forename: Shelly
authors.initials: S
authors.lastname: McNeil
authors.affiliation: Scientific Center of Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation, Moscow, Russian Federation.
authors.forename: Vera
authors.initials: V
authors.lastname: Prilepskaya
authors.affiliation: City Medical Center, St Petersburg, Russian Federation.
authors.forename: Irina
authors.initials: I
authors.lastname: Gogotadze
authors.affiliation: University of British Columbia, The Women's Health Research Institute, Vancouver, British Columbia, Canada.
authors.forename: Deborah
authors.initials: D
authors.lastname: Money
authors.affiliation: Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville/Department of Microbiology, The Royal Children's Hospital, Parkville/Murdoch Children's Research Institute, Parkville/Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Garland
authors.affiliation: City Children's Hospital N40, Ekaterinburg, Russian Federation.
authors.forename: Viktor
authors.initials: V
authors.lastname: Romanenko
authors.affiliation: Geisel School of Medicine at Dartmouth, Hanover, NH, USA and University of Louisville School of Medicine, Louisville, KT, USA.
authors.forename: Diane M
authors.initials: DM
authors.lastname: Harper
authors.affiliation: Section of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado, USA.
authors.forename: Myron J
authors.initials: MJ
authors.lastname: Levin
authors.affiliation: Department of Pediatrics, University of South Dakota Sanford School of Medicine/Sanford Children's Specialty Clinic, Sioux Falls, SD, USA.
authors.forename: Archana
authors.initials: A
authors.lastname: Chatterjee
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Brecht
authors.initials: B
authors.lastname: Geeraerts
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Frank
authors.initials: F
authors.lastname: Struyf
authors.affiliation: GSK Vaccines, King of Prussia, PA, USA.
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
authors.affiliation: 4Clinics, Paris, France.
authors.forename: Marie-Cécile
authors.initials: MC
authors.lastname: Bozonnat
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Dominique
authors.initials: D
authors.lastname: Rosillon
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Laurence
authors.initials: L
authors.lastname: Baril
mesh_terms: D000328:Adult; D052685:Alphapapillomavirus / Q000145:classification; D017326:Clinical Trials, Phase III as Topic; D018450:Disease Progression; D055088:Early Detection of Cancer; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000150:complications* / Q000517:prevention & control / Q000821:virology; D053918:Papillomavirus Vaccines / Q000276:immunology; D062486:Public Health Surveillance; D012306:Risk; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology / Q000209:etiology* / Q000473:pathology*; D002578:Uterine Cervical Dysplasia / Q000453:epidemiology / Q000209:etiology / Q000473:pathology
chemical_list: D053918:Papillomavirus Vaccines
keywords: CIN; HPV; VIVIANE; adult women; natural history