Clinical and economic implications of adding HPV tests to the routine cytology follow-up and management of patients with histologically defined cervical intraepithelial neoplasia grade 1.

Abstract

The objective of this study was to evaluate the clinical and economic implications of adding human papillomavirus (HPV) testing to the follow-up and management protocol of women with a histological diagnosis of low-grade cervical intraepithelial neoplasia (CIN1). The study cohort consisted of 314 women with histological diagnosis of CIN1 and who met the inclusion criteria. They were followed-up by pap smears and samples for HPV tests that were obtained and analyzed on the first visit after referral. HPV assessment was carried out later. Colposcopy and biopsies were performed when there were two consecutive abnormal pap results or positive HPV tests. Women with any degree of CIN underwent cone biopsies. The positive predictive value (PPV) of low-grade squamous intraepithelial lesion and high-grade squamous epithelial lesion to identify high-grade lesions (CIN2-3) were 48.9 and 95%, respectively. The PPV of low-risk HPV type for CIN1 and that of high-risk HPV type for CIN2-3 were both 97%. Of the 314 study participants, 68 (21.6%) patients were positive for HPV analysis, and 67 of these (98.5%) had either CIN1 or CIN2-3 on the cone biopsy, with an overall PPV of 95%. The cost effectiveness ratio was $1457 per additional case detected by the "HPV approach." Testing for the presence of high-risk HPV types is both clinically and economically more beneficial than cytology in the follow-up and management of patients with a diagnosis of CIN 1 because of its better sensitivity, specificity, and PPV reports.