Abstract
Objectives People living with HIV/AIDS (PLWHA) have an increased incidence of anal squamous cell carcinoma. Since high-risk human papillomavirus (hrHPV) is the primary cause, hrHPV DNA testing may play an important role in anal cancer screening. This study aims to determine the negative predictive value (NPV) of hrHPV testing in PLWHA as well as factors that may lead to false-negative results. Methods Anal swabs were collected for cytology and Cobas® 4800 HPV test for 14 hrHPV types. Patients underwent concomitant high-resolution anoscopy (HRA) examination and biopsy. High-grade squamous intraepithelial lesions (HSIL, synonymous with anal intraepithelial neoplasia AIN2 and 3) detected in Cobas-negative patients were genotyped for 22 HPV types using BioPerfectus Multiplex Real-time PCR. Results 156 PLWHA tested negative for hrHPV on anal swab samples (i.e., Cobas-negative). HRA-guided biopsy detected HSIL/AIN3 in 13 patients (8%, NPV 92%), HSIL/AIN2 in 5 patients (3%), low-grade squamous intraepithelial lesions in 82 (LSIL, 53%), or benign findings in 56 (36%). No cancer was found. The HSIL group was similar to the LSIL/benign group regarding age, gender, race/ethnicity, clinical HIV parameters, cytological diagnoses, history of receptive anal sex, and smoking (p ≥ 0.02). Genotyping HSIL tissue derived from Cobas-negative patients revealed hrHPV (n=7), possibly carcinogenic HPV53, 67, 73, 82 (n=12), or absence of hrHPV (n=4). Conclusions In this series, anal hrHPV DNA testing offered 92% NPV for PLWHA; in other words, a 8% risk of occult precancer remains for those who test hrHPV negative on anal swab samples.
Highlights
Human papillomavirus- (HPV) associated anal cancer has been on the rise with a projected incidence of 8,300 new cases and 1,280 deaths in the United States in 2019 [1]
Four lesions were negative for any of the 22 HPV types included in the BioPerfectus Multiplex Real Time (BMRT) assay. In this retrospective study, using biopsy-proven anal HSIL/ AIN3 as an endpoint, we found that the high-risk HPV (hrHPV) DNA test had a Negative predictive value (NPV) of 92% for people living withHIV/AIDS (PLWHA) undergoing anal cancer screening at our clinic. us, there is a low, but nonnegligible, risk (8%) of occult HSIL/AIN3 for subjects who test negative for hrHPV on anal swab
During the same study period, a total of 1,140 PLWHA had anorectal cytology and HPV contesting at our clinic
Summary
Human papillomavirus- (HPV) associated anal cancer has been on the rise with a projected incidence of 8,300 new cases and 1,280 deaths in the United States in 2019 [1]. In the case of cervical cancer screening, both exfoliative cytology and high-risk HPV (hrHPV) testing have proven largely successful [7]. Given the significant overlap between cervical and anal HPV carcinogenesis, it is reasonable to expect that both methods will be effective in anal cancer screening [8]. As a result of the high prevalence of HPV-associated lesions and spectrum of different HPV types reported among HIV-infected MSM, anal cytology and hrHPV testing both demonstrate high sensitivity (81% and 95%, respectively) but low specificity (53% and 24%) [9]. Anal cytology is further hampered by substantial interobserver variability among cytopathologists, underscoring its deficiency as a sole screening test for anal cancer [10]
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