Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain.
Infectious Diseases Unit, Alicante University General Hospital, Alicante, Spain.
PeerJ. 2023 Aug 23;11:e15878. doi: 10.7717/peerj.15878. eCollection 2023.
The incidence of high-grade anal intraepithelial lesions (HSILs) has increased in recent years among men who have sex with men with human immunodeficiency virus (HIV). This work evaluated the validity of the human papilloma virus viral load (HPV-VL) versus cytological and qualitative HPV results to detect HSILs.
From May 2017 to January 2020, 93 men who have sex with men and HIV were included in an anal cancer screening program from the Infectious Diseases Unit at a tertiary-care hospital in Alicante (Spain). The gold-standard for the screening of anal HSILs is the anal biopsy using high-resolution anoscopy. The diagnostic methods compared against gold-standard were HPV-16-VL, HPV-18-VL, and HPV-16-18-VL co-testing, anal cytology, and qualitative HPV detection. The receiver operating characteristic (ROC) curve and cut-off points for HPV-VL were calculated. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen's Kappa coefficient () were also calculated.
The mean patient age was 44.6 ± 9.5 years. All of them received antiretroviral treatment, 96.8% had an HIV viral load of <50 copies/mL and 17.2% had a previous diagnosis of AIDS. The diagnosis of the anal biopsies were: 19.4% ( = 18) HSIL, 29.1% ( = 27) LSIL, and 51.6% ( = 48) negative. An HPV-16-VL >6.2 copies/cell was detected in the HSIL biopsy samples ( = 0.007), showing a sensitivity of 100% and a specificity of 46.2%. HPV-18-VL and HPV16-18-VL co-testing showed a sensitivity of 75% and 76.9% and a specificity of 72.7% and 61.3%, respectively. The highest PPV was 50% obtained with the cytology and HPV-18-VL. The HPV-16-VL showed a NPV of 100%, followed by 88.9% in the HPV-18-VL and 87% in the abnormal cytology. Cohen's Kappa coefficient were: HPV-18-VL ( = 0.412), abnormal cytology ( = 0.353) and HPV-16-VL ( = 0.338).
HPV-VL testing improved the detection sensitivity but not the specificity for HSIL biopsies compared to anal cytology and the qualitative detection of HPV. In men who have sex with men and HIV the HPV-VL could be an useful tool for diagnosis of HSILs in anal cancer screening programs. Further studies will be needed to evaluate the clinical implications of HPV-VL in these programs.
近年来，人类免疫缺陷病毒（HIV）阳性的男男性行为者中高级别肛门上皮内瘤变（HSILs）的发病率有所增加。本研究评估了 HPV 病毒载量（HPV-VL）与细胞学和定性 HPV 结果检测 HSILs 的有效性。
2017 年 5 月至 2020 年 1 月，93 名男男性行为者和 HIV 阳性者参加了位于西班牙阿利坎特的一家三级保健医院传染病科的肛门癌筛查计划。HSIL 肛门活检是筛查肛门 HSIL 的金标准。与金标准相比，我们比较了 HPV-16-VL、HPV-18-VL 和 HPV-16-18-VL 联合检测、肛门细胞学和定性 HPV 检测。计算了 HPV-VL 的受试者工作特征（ROC）曲线和截断点。还计算了 HPV-VL 的敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）和 Cohen's Kappa 系数（κ）。
患者的平均年龄为 44.6±9.5 岁。他们都接受了抗逆转录病毒治疗，96.8%的 HIV 病毒载量<50 拷贝/mL，17.2%的人以前被诊断为艾滋病。肛门活检的诊断结果为：19.4%（18 例）HSIL、29.1%（27 例）LSIL 和 51.6%（48 例）阴性。在 HSIL 活检样本中检测到 HPV-16-VL >6.2 拷贝/细胞（P=0.007），其敏感性为 100%，特异性为 46.2%。HPV-18-VL 和 HPV16-18-VL 联合检测的敏感性分别为 75%和 76.9%，特异性分别为 72.7%和 61.3%。细胞学和 HPV-18-VL 联合检测的最高 PPV 为 50%。HPV-16-VL 的 NPV 为 100%，其次是 HPV-18-VL 的 88.9%和异常细胞学的 87%。Cohen's Kappa 系数分别为：HPV-18-VL（κ=0.412）、异常细胞学（κ=0.353）和 HPV-16-VL（κ=0.338）。
与肛门细胞学和 HPV 定性检测相比，HPV-VL 检测提高了 HSIL 活检的检测敏感性，但特异性无改善。在男男性行为者和 HIV 阳性者中，HPV-VL 可作为肛门癌筛查计划中 HSIL 诊断的有用工具。需要进一步研究来评估 HPV-VL 在这些计划中的临床意义。
