Abstract

BackgroundThe new nine-valent vaccine against human papillomavirus (HPV) includes the four HPV genotypes (6, 11, 16, and 18) that are targeted by the older quadrivalent HPV vaccine, plus five additional oncogenic types (31, 33, 45, 52, and 58) remain significantly associated with high grade lesions. We aimed to determine the prevalence of high-risk HPV genotypes in unvaccinated subjects and the association of these genotypes with the incidence of high-grade lesions. We also assessed which, if either, of these two HPV vaccines could have prevented these cases.MethodsThis cross-sectional study, conducted from 4 January 2010 to 30 December 2011, was composed of 595 women attending the Hospital General Universitario de Elche (Spain) gynaecology department who were positively screened for opportunistic cervical cancer by pap smears and HPV detection during a routine gynaecological health check. The pap smear results were classified using the Bethesda system. HPV genotyping was performed with the Linear Array HPV genotyping test, and viruses were classified by the International Agency for Research on Cancer assessment of HPV carcinogenicity. Odds ratios (ORs) with their 95% confidence intervals (95% CI) were estimated by logistic regression, adjusting for age and immigrant status. The prevented fraction among those exposed (PFe-adjusted) was determined as a measure of impact.ResultsAt least one of the additional five high-risk HPV genotypes present in the nine-valent HPV vaccine was detected in 20.5% of subjects. After excluding women with genotype 16 and/or 18 co-infection, high-risk genotypes (31, 33, 45, 52, and 58) were associated with a higher risk of intraepithelial lesion or malignancy: adjusted OR = 3.51 (95% CI, 1.29–9.56), PFe-adjusted = 0.72 (95% CI, 0.22–0.90). Genotypes that are still non-vaccine-targeted were detected in 17.98% of the women, but these were not significantly associated with high-grade lesions.ConclusionThe greater protection of the nine-valent HPV vaccine is likely to have a positive impact because, in the absence of genotype 16 or 18 infection, these five genotypes on their own remained significantly associated with high-grade lesions.

Highlights

  • The new nine-valent vaccine against human papillomavirus (HPV) includes the four HPV genotypes (6, 11, 16, and 18) that are targeted by the older quadrivalent HPV vaccine, plus five additional oncogenic types (31, 33, 45, 52, and 58) remain significantly associated with high grade lesions

  • Population During the study period (January 4,2010 to December 30,2011), women who came to the gynecology department of the Hospital General Universitario de Elche (Spain) for a routine gynecological check-up were treated according to the cervical cancer screening protocol: a combined Pap smear test and HPV screening

  • By sub-dividing these genotypes based on the ability of the new nine-valent HPV vaccine to protect against them, we found that the presence of highrisk genotypes not covered by the new nine-valent HPV vaccine was not associated with a significant increase in the risk of lesions, the presence of a high-risk genotype not covered by the quadrivalent HPV vaccine but covered by the new nine-valent HPV vaccine was associated with a significant increase in this risk

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Summary

Introduction

The new nine-valent vaccine against human papillomavirus (HPV) includes the four HPV genotypes (6, 11, 16, and 18) that are targeted by the older quadrivalent HPV vaccine, plus five additional oncogenic types (31, 33, 45, 52, and 58) remain significantly associated with high grade lesions. We aimed to determine the prevalence of high-risk HPV genotypes in unvaccinated subjects and the association of these genotypes with the incidence of high-grade lesions. Human papillomavirus (HPV) infection is the most common sexually transmitted infection in the United States and Europe [1]. It has been found that according to the severity of cervical lesions, the overall prevalence of HPV increases from 12% in women with normal cytology to 89% in women with CC [6]. HPV 16 and 18 are the two most prevalent types worldwide [7]. HPV genotypes 16 and 18 cause 70% of cervical cancer cases as well as an even higher proportion of other cancers associated with HPV infection, such as cancer of the vulva, vagina, penis, anus, and oropharynx [8,9,10]

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