The role of polymerase chain reaction of high-risk human papilloma virus in the screening of high-grade squamous intraepithelial lesions in the anal mucosa of human immunodeficiency virus-positive males having sex with males.

To evaluate the advantages of cytology and PCR of high-risk human papilloma virus (PCR HR-HPV) infection in biopsy-derived diagnosis of high-grade squamous intraepithelial lesions (HSIL = AIN2/AIN3) in HIV-positive men having sex with men (MSM).This is a single-centered study conducted between May 2010 and May 2014 in patients (n = 201, mean age 37 years) recruited from our outpatient clinic. Samples of anal canal mucosa were taken into liquid medium for PCR HPV analysis and for cytology. Anoscopy was performed for histology evaluation.Anoscopy showed 33.8% were normal, 47.8% low-grade squamous intraepithelial lesions (LSIL), and 18.4% HSIL; 80.2% had HR-HPV. PCR of HR-HPV had greater sensitivity than did cytology (88.8% vs. 75.7%) in HSIL screening, with similar positive (PPV) and negative predictive value (NPV) of 20.3 vs. 22.9 and 89.7 vs. 88.1, respectively. Combining both tests increased the sensitivity and NPV of HSIL diagnosis to 100%. Correlation of cytology vs. histology was, generally, very low and PCR of HR-HPV vs. histology was non-existent (<0.2) or low (<0.4). Area under the receiver operating characteristics (AUROC) curve analysis of cytology and PCR HR-HPV for the diagnosis of HSIL was poor (<0.6). Multivariate regression analysis showed protective factors against HSIL were: viral suppression (OR: 0.312; 95%CI: 0.099-0.984), and/or syphilis infection (OR: 0.193; 95%CI: 0.045-0.827). HSIL risk was associated with HPV-68 genotype (OR: 20.1; 95%CI: 2.04-197.82).When cytology and PCR HR-HPV findings are normal, the diagnosis of pre-malignant HSIL can be reliably ruled-out in HIV suppression with treatment protects against the appearance of HSIL [corrected]

ROC curve of HR-HPV-negative and normal cytology <i>vs</i>. normal histology.

<p>ROC curve of HR-HPV-negative and normal cytology <i>vs</i>. normal histology.</p

Outcomes of PCR of HPV, cytology and histology.

<p>LSIL: low-grade squamous intraepithelial lesion; HSIL: high-grade squamous intraepithelial lesion; ASCUS: abnormality of uncertain significance; HPV: human papilloma virus; HR-HPV: high risk HPV; LR-HPV: low risk HPV; AIN: anal intraepithelial neoplasia.</p><p>Outcomes of PCR of HPV, cytology and histology.</p

General description of the patient study sample.

<p>HCV: hepatitis C virus infection; HBV: hepatitis B virus infection; EXIVDA: ex-intravenous drug abuser; STD: sexually transmitted disease; VL: HIV viral load; IQR: interquartile range; SD: standard deviation</p><p>General description of the patient study sample.</p

Risk factors associated with the appearance of HSIL in anoscopy.

<p>MSM HIV-positive: men who have sex with men and are HIV-positive; LTI: latent tuberculosis infection; HCV: hepatitis C virus; HBV: hepatitis B virus; HPV: human papilloma virus; EXIVDA: ex-intravenous drug abuser; VL: HIV viral load; HR-HPV: high-risk HPV; LR-HPV: low-risk HPV</p><p>Results of univariate analyses.</p

Correlations between cytology and PCR of HR-HPV of anal mucosa and histology.

<p>HR-HPV: high risk-human papilloma virus; HSIL: high-grade squamous intraepithelial lesions.</p><p>Correlations between cytology and PCR of HR-HPV of anal mucosa and histology.</p

Comparison of anal cytology and PCR of HR-HPV in HSIL (AIN2/3) diagnosis.

<p>Sen: sensitivity; Spe: specificity; PPV: positive predictive value; NPV: negative predictive value; HR-HPV: high-risk human papilloma virus; LR+: positive likelihood ratio; LR-: negative likelihood ratio; CI: confidence interval; HSIL: high-grade squamous intraepithelial lesions</p><p>Comparison of anal cytology and PCR of HR-HPV in HSIL (AIN2/3) diagnosis.</p