High-Risk Human Papillomavirus Prevalence and Genotypes Distribution: Baseline Findings from Cervical Cancer Screening with Alinity m among Women in Bulgaria

Background: Persistent high-risk human papillomavirus HPV (HR-HPV) infection is the most significant risk factor for epithelial cell changes, the development of high-grade squamous cell lesions, and the progression to cervical cancer. This study aimed to provide epidemiological data and assess the prevalence and genotype distribution of HR-HPV. Methods: Liquid-based cytology (LBC) samples from 190 Bulgarian women were simultaneously tested to identify HR-HPV genotypes and perform cytological analysis. HPV detection and genotyping were performed using the clinically validated Alinity m HR-HPV assay. This test provides detailed information on HPV16, HPV18, and HPV45 and categorizes the remaining 11 HR-HPV genotypes. Results: HR-HPV infection was detected in 16.8% of the women screened, with mean age of 38.2 (±9.8) years. Infection with HPV16 was seen in 5.3%, HPV18 positivity was 2.2% and genotype HPV45 was found in 1.0%. Abnormalities in LBC cytology were observed in 18.9% of women. HR-HPV positivity in normal cytology samples was 5.2% and 63.9% in abnormal smears. Conclusion: At present, there is a notable absence of official data concerning the substantial impact of HPV in Bulgaria. Presented baseline findings establish a foundational understanding of the prevalence and genotype distribution of HR-HPV within selected segments of the Bulgarian population.