Risk of first cervical HPV infection and pre-cancerous lesions after onset of sexual activity: Analysis of women in the control arm of the randomized, controlled PATRICIA trial

Xavier Castellsagué, Jorma Paavonen, Unnop Jaisamrarn, Cosette M. Wheeler, S. Rachel Skinner, Matti Lehtinen, Paulo Naud, Song Nan Chow, Maria Rowena Del Rosario-Raymundo, Julio C. Teixeira, Johanna Palmroth, Newton S. De Carvalho, Maria Julieta V Germar, Klaus Peters, Suzanne M. Garland, Anne Szarewski, Willy A J Poppe, Barbara Romanowski, Tino F. Schwarz, Wiebren A A TjalmaF. Xavier Bosch, Marie Cecile Bozonnat, Frank Struyf, Gary Dubin, Dominique Rosillon, Laurence Baril, I. Denham, S. M. Garland, A. Mindel, S. R. Skinner, P. De Sutter, W. A J Poppe, W. Tjalma, N. S. De Carvalho, P. Naud, J. C. Teixeira, F. Y. Aoki, F. Diaz-Mitoma, M. Dionne, L. Ferguson, M. Miller, K. Papp, B. Ramjattan, B. Romanowski, P. H. Orr, R. Somani, D. Apter, T. Karppa, N. Kudjoi, L. Downs, HPV PATRICIA Study Group

Research output: Contribution to journalArticlepeer-review

23 Scopus citations

Abstract

Background: More information is needed about time between sexual initiation and human papillomavirus (HPV) infection and development of cervical precancer. Methods: The objectives were to investigate the time between first sexual activity and detection of first cervical HPV infection or development of first cervical intraepithelial neoplasia (CIN), and associated factors in women from the double-blind, multinational, 4-year PATRICIA trial. PATRICIA enroled women aged 15-25 years with no more than 6 lifetime sexual partners. Women were randomized 1:1 to the HPV-16/18 AS04-adjuvanted vaccine or to control, but only women from the control arm who began sexual intercourse during the study or within 6 months before enrolment, and had no HPV infection detected before the recorded date of their first sexual intercourse, were included in the present analysis. The time between onset of sexual activity and detection of the first cervical HPV infection or development of the first CIN lesion was analyzed using Kaplan-Meier and univariate and multivariable Cox proportional-hazards models. Results: A total of 9337 women were enroled in the control arm of PATRICIA of whom 982 fulfilled the required inclusion criteria for analysis. A cumulative total of 28%, 44%, and 62% of the subjects had HPV infection within 12, 24, and 48 months, respectively. The overall incidence rate was 27.08 per 100 person-years. The most common oncogenic types associated with 6-month persistent infection were HPV-16 (incidence rate: 2.74 per 100 person-years), HPV-51 (2.70), HPV-52 (1.66), HPV-66 (1.14), and HPV-18 (1.09). Increased infection risk was associated with more lifetime sexual partners, being single, Chlamydia trachomatis history, and duration of hormone use. CIN1+ and CIN2+ lesions were most commonly associated with HPV-16, with an overall incidence rate of 1.87 and 1.07 per 100 person-years, respectively. Previous cervical HPV infection was most strongly associated with CIN development. Conclusions: More than 25% of women were infected with HPV within 1 year of beginning sexual activity. Without underestimating the value of vaccination at older ages, our findings emphasize its importance before sexual initiation.

Original languageEnglish (US)
Article number551
JournalBMC infectious diseases
Volume14
Issue number1
DOIs
StatePublished - 2014

Bibliographical note

Funding Information:
DR, GD, FS and LB are paid employees of the GlaxoSmithKline group of companies, the funder of this study. GD, FS and LB own stocks or shares in GlaxoSmithKline Biologicals SA. GD has a patent issued in the HPV field, and a patent issued in the herpes simplex virus vaccine field. MCB has received consulting fees to 4Clinics (employer). XC reports grants via his institution from GlaxoSmithKline Biologicals SA during the conduct of the study, and grants and personal fees from GlaxoSmithKline Biologicals SA, grants and personal fees from Sanofi Pasteur, Merck Sharp & Dohme (SPMSD). TFS reports personal fees from GlaxoSmithKline Biologicals SA. NSDC has received grants from IPAMI and personal fees from Instituto de Ensino e Pesquisas Clinicas, Brazil, and travel support during the conduct of the study. PN has received grants from GlaxoSmithKline Biologicals SA. ML has received grants for HPV vaccination studies through his employer University of Tampere, Finland and from Merck & Co. Inc. and GlaxoSmithKline Biologicals SA. BR reports grants received by her institution for research studies from GlaxoSmithKline Biologicals SA and from Merck & Co. Inc., and she received grants via her professional corporation from GlaxoSmithKline Biologicals SA for speaking engagements and travel support to attend international meetings and present research data. CMW reports grants from GlaxoSmithKline Biologicals SA who funded the University of New Mexico to conduct the trial in which the women were enroled, and CMW has received reagents and equipment from Roche Molecular Systems through the University of New Mexico for HPV genotyping, and funding from GlaxoSmithKline Biologicals SA for HPV vaccine trials and travel related to publication activities through the University of New Mexico. JCT reports grants, personal fees and non-financial support from GlaxoSmithKline Biologicals SA, during the conduct of the study; grants, personal fees and non-financial support from GlaxoSmithKline Biologicals SA, outside the submitted work. JP (Paavonen) reports research funding from GlaxoSmithKline Biologicals SA through the Helsinki University Hospital Research Institute to conduct clinical trials on HPV vaccines. JP (Paavonen) has also received research funding from Merck Sharp & Dohme (MSD) through the Helsinki University Hospital Research Institute to conduct clinical trials on HPV vaccines, outside the submitted work. SRS reports grants from GlaxoSmithKline Biologicals SA during the conduct of the study and reimbursement to her institution for costs associated with travel to conferences to present data from this clinical trial and she received grants from CSL Ltd and an honorarium was paid to her institution from GlaxoSmithKline Biologicals SA for attendance at Advisory Board meeting. UJ received grants from GlaxoSmithKline Biologicals SA for the study through Chulalongkorn University, and also support for traveling to investigator meetings. SMG reports grants to perform phase III clinical trials via her institution from GlaxoSmithKline Biologicals SA, Merck & Co. Inc and from CSL, and she has received payment from GlaxoSmithKline Biologicals SA for development of an educational programme and received honorarium from Merck & Co. Inc, Sanofi Pasteur. FXB reports grants and personal fees from GlaxoSmithKline Biologicals for attending Advisory Boards, speakers bureau and research, grants and personal fees from Merck Sharp & Dohme, Sanofi Pasteur, and grants from Qiagen outside the submitted work. MRDRR reports payment of honorarium as Principal Investigator and support for travel to meetings for the study from GlaxoSmithKline Biologicals SA during the conduct of the study and payment for lectures including service on speakers bureaus from GlaxoSmithKline Biologicals SA outside the submitted work. JP (Palmroth) reports to have received travel support from Roche and Merck Sharp & Dohme for medical congresses abroad. KP, MJVG, SNC, and WAJP and WAAT have nothing to disclose.

Publisher Copyright:
© 2014 Castellsagué et al.

Keywords

  • CIN
  • HPV
  • Risk
  • Sexual intercourse
  • Time

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