Demonstrating a Statistically Significant Association Between Anal High-Grade Squamous Intraepithelial Lesion and Positive OncoE6 Anal Test in Men Who Have Sex With Men and Are Living With HIV.

OBJECTIVES: The aim of the study is to determine whether a positive OncoE6 Anal Test result has statistically significant higher odds of being associated with high-grade squamous intraepithelial lesion (HSIL) and to calculate sensitivity and specificity of this test for predicting HSIL in adult men who have sex with men and are living with HIV (MSMLWH). MATERIALS AND METHODS: Men living with HIV 18 years or older having ≥atypical squamous cells of undetermined significance-grade anal cytology results were eligible to enroll in this cross-sectional study. Anal samples were collected just before the high-resolution anoscopy procedure. OncoE6 Anal Test results were compared with histology, the reference standard. Sensitivity, specificity, and odds ratio were calculated using HSIL as the threshold. RESULTS: Two hundred seventy-seven consented MSMLWH were enrolled between June 2017 and January 2022. Of these, 219 (79.1%) had biopsies obtained and histology performed; 81 of 219 participants (37%) had 1 or more biopsies with HSIL results while the remaining 138 of 219 (63%) had only low-grade squamous intraepithelial lesion or were negative for dysplasia. Anal samples from 7 participants (8.6%, 7/81) with HSIL and 3 (2.2%, 3/138) with low-grade squamous intraepithelial lesion had positive OncoE6 Anal Test results. Odds of having HSIL were 4.26 times higher among participants testing positive for HPV16/HPV18 E6 oncoprotein(s) (OR = 4.26, 95% CI = 1.07-16.95, p = .04). The OncoE6 Anal Test demonstrated excellent specificity, 97.83% (93.78-99.55), but poor sensitivity, 8.64% (3.55-17.0). CONCLUSIONS: In this highest-risk population for anal cancer, one could combine the OncoE6 Anal Test, having excellent specificity, with the anal Pap test, having higher sensitivity. Patients found having both an abnormal anal Pap and positive OncoE6 Anal Test result could be triaged for rapid scheduling of their high-resolution anoscopy.

The Risk of Anal Carcinoma After Anogenital Warts in Adults Living With HIV.

Importance: In the US, incidence of and mortality due to anal carcinoma are rising faster than for most other cancers. Identifying populations who have a higher risk of developing anal cancers is critical to target preventive interventions. Objective: To assess the risk of developing anal carcinoma in adults living with HIV who have a history of anogenital warts. Design, Setting, and Participants: This longitudinal cohort study included adults living with HIV from 14 clinics in Washington, DC, and at least 18 months of follow-up. Data were collected from January 1, 2011, to March 31, 2017, and analyzed from June 1, 2019, to October 31, 2020. Exposures: Development of warts in the anal or genital region identified by diagnosis codes. Main Outcomes and Measures: Individuals with anal carcinoma were identified by diagnosis codes or anal biopsy results. Results: A total of 6515 participants were enrolled (4720 male [72.4%] at birth; mean [SD] age, 49.9 [12.7] years), and 383 (5.9%) developed anogenital warts during the study period. Patients who were diagnosed with anogenital warts were more likely to subsequently develop anal carcinoma (17 of 383 [4.4%]) compared with participants without a history of anogenital warts (17 of 6132 [0.3%]) (P < .001). After adjusting for covariates, the odds of developing anal carcinoma were 12.79 (95% CI, 6.19-26.45; P < .001) times higher in individuals with a history of anogenital warts compared with individuals without a history of anogenital warts. Conclusions and Relevance: These findings suggest that adults living with HIV who have a history of anogenital warts have a substantially increased risk of developing anal carcinoma. Clinicians should counsel individuals living with HIV who have anogenital warts on this risk.