Intra-anal use of imiquimod: what is the clinical evidence?

2019 ◽  
Vol 30 (10) ◽  
pp. 1018-1024
Author(s):  
Ioannis D Gkegkes ◽  
Christos Iavazzo ◽  
Apostolos P Stamatiadis
Keyword(s):  
Human Papillomavirus ◽  
Adverse Effects ◽  
Clinical Evidence ◽  
Complete Healing ◽  
Burning Sensation ◽  
High Grade ◽  
Imiquimod Cream ◽  
Off Label ◽  
Anal Lesions ◽  
Intraepithelial Lesions

Imiquimod has been demonstrated to be rather effective in patients with anal as well as perianal high-grade squamous intraepithelial lesions (HSILs). Nevertheless, until now the intra-anal use of imiquimod has been considered off-label. The aim of this study is to review the clinical evidence related to the intra-anal use of imiquimod in the treatment of human papillomavirus-related anal lesions. A systematic search in PubMed and Scopus was performed. In total, 422 patients were included. The most common referred comorbidity was HIV infection (281 patients, 66.6%). The principal clinical entities, which were treated with intra-anal imiquimod, were HSILs. The most frequent formulation was self-applied imiquimod cream. In the HSIL group, there was complete healing in 74 patients (35%) and partial in 44 patients (20.9%), while in the wart group, there was complete healing in 128 patients (67%). Recurrence of HSIL was present in 19 patients (15%), while in cases with warts recurrence was present in 38 patients (19.8%). The most common adverse events were pain, itching, and burning sensation. In conclusion, the adverse effects associated with the intra-anal use of imiquimod seem to be minor. The present clinical evidence suggests that imiquimod may be proposed as effective, safe, and relatively well tolerated treatment.

Prognostic markers of high-grade squamous intraepithelial lesions: the role of p16INK4aand high-risk human papillomavirus

2007 ◽  
Vol 86 (1) ◽  
pp. 94-98 ◽  
Author(s):  
José Eleutério Jr ◽  
Paulo César Giraldo ◽  
Ana Katherine Gonçalves ◽  
Diane Isabelle Magno Cavalcante ◽  
Francisco Valdeci de Almeida Ferreira ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Prognostic Markers ◽  
High Grade ◽  
Squamous Intraepithelial Lesions ◽  
Intraepithelial Lesions

Human Papillomavirus Vaccination Prior to Loop Electroexcision Procedure Does Not Prevent Recurrent Cervical High-grade Squamous Intraepithelial Lesions in Women Living With Human Immunodeficiency Virus: A Randomized, Double-blind, Placebo-controlled Trial

2020 ◽  
Author(s):  
Cynthia Firnhaber ◽  
Avril Swarts ◽  
Vuyokazi Jezile ◽  
Masango Mulongo ◽  
Bridgette Goeieman ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Immunodeficiency Virus ◽  
Human Papillomavirus ◽  
Hpv Vaccination ◽  
High Grade ◽  
Double Blind ◽  
Women Living With Hiv ◽  
Immunodeficiency Virus ◽  
Living With Hiv ◽  
Intraepithelial Lesions

Abstract Background Women living with human immunodeficiency virus (HIV), especially in sub-Saharan Africa, are at high risk for cervical high-grade squamous intraepithelial lesions (HSIL) and cervical cancer. These women have high HSIL recurrence rates after loop electroexcision procedure (LEEP). Retrospective studies suggest that human papillomavirus (HPV) vaccination improves response to treatment of cervical HSIL. Methods We performed a double-blind, randomized clinical trial enrolling 180 women living with HIV in Johannesburg, South Africa, diagnosed with cervical HSIL by colposcopic biopsy. Women received quadrivalent HPV vaccine or placebo (1:1) at entry, week 4, and week 26. LEEP was performed at week 4. Colposcopic-directed biopsies and cervical cytology were performed at weeks 26 and 52. The primary endpoint, cervical HSIL by histology or cytology at either week 26 or 52, was compared between arms using χ 2 analysis. Results Participant characteristics included median age of 39 years and median CD4 count 489 cells/μL, and 94% had HIV suppression. One hundred seventy-four women completed the vaccine/placebo series and had evaluable results at week 26 or 52. The proportion experiencing the primary endpoint was similar in the vaccine and placebo groups (53% vs 45%; relative risk, 1.18 [95% confidence interval, .87–1.6]; P = .29). HSIL recurrence was associated with a LEEP biopsy result of HSIL and detection of HSIL at the margins of the LEEP sample. Conclusions This study did not support HPV vaccination to prevent recurrent HSIL after LEEP in women living with HIV. Recurrent HSIL was high despite virologic suppression. Improved treatments are needed for HSIL to reduce the burden of cervical cancer among women living with HIV.

scholarly journals Cervical Microbiome and Response to a Human Papillomavirus Therapeutic Vaccine for Treating High-Grade Cervical Squamous Intraepithelial Lesion

2019 ◽  
Vol 18 ◽  
pp. 153473541989306 ◽  
Author(s):  
Rahul Ravilla ◽  
Hannah N. Coleman ◽  
Cheryl-Emiliane Chow ◽  
Luisa Chan ◽  
Barbara J. Fuhrman ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Phase I ◽  
Therapeutic Vaccine ◽  
High Grade ◽  
T Helper ◽  
Squamous Intraepithelial Lesions ◽  
Hpv 16 ◽  
Intraepithelial Lesions ◽  
Helper Type

Human papillomavirus (HPV) infection is associated with the vast majority of cervical cancer cases as well as with other anogenital cancers. PepCan is an investigational HPV therapeutic vaccine for treating cervical high-grade squamous intraepithelial lesions. The present study was performed to test whether the cervical microbiome influences vaccine responses and to explore host factors as determinants of the cervical microbiome composition in women with biopsy-proven high-grade squamous intraepithelial lesions. In a recently completed Phase I clinical trial of PepCan, histological response rate of 45% (14 of 31 patients), a significant increase in circulating T-helper type 1 cells, and a significant decrease in HPV 16 viral load were reported. DNA, extracted from liquid cytology specimens collected before and after vaccinations, were amplified and then hybridized to a G4 PhyloChip assay to characterize the microbiome. We describe trends that certain bacterial taxa in the cervix may be enriched in non-responders in comparison to responders ( Padj = .052 for phylum Caldithrix and Padj = .059 for phylum Nitrospirae). There was no difference in bacterial diversity between the 2 groups. A permutational analysis of variance performed for various demographic and immune parameters showed significant clustering with microbiome beta diversity for race, HPV 16 status, peripheral T-helper type 1 cells, and HLA-B40 ( P = .001, .014, .037, and .024, respectively). Further analyses showed significant differences at the empirical Operational Taxonomic Unit level for race and HPV 16 status. As these results are from a small Phase I study, further studies are needed to examine the role of cervical microbiome in response to HPV therapeutic vaccines.

The performance of human papillomavirus biomarkers in predicting anal high-grade squamous intraepithelial lesions in gay and bisexual men

AIDS ◽  
2017 ◽  
Vol 31 (9) ◽  
pp. 1303-1311 ◽  
Author(s):  
Fengyi Jin ◽  
Jennifer M. Roberts ◽  
Andrew E. Grulich ◽  
Isobel M. Poynten ◽  
Dorothy A. Machalek ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Gay And Bisexual Men ◽  
High Grade ◽  
Bisexual Men ◽  
Squamous Intraepithelial Lesions ◽  
And Bisexual ◽  
Intraepithelial Lesions

scholarly journals The value of p16INK4a immunostaining for high-grade squamous intraepithelial lesions in human papillomavirus–negative patients

2020 ◽  
Author(s):  
Dai Zhang ◽  
Jie Song ◽  
Xiaosong Zhang ◽  
Hui Bi
Keyword(s):  
Human Papillomavirus ◽  
Predictive Value ◽  
Intraepithelial Neoplasia ◽  
Pathological Diagnosis ◽  
High Grade ◽  
Squamous Intraepithelial Lesions ◽  
P16 Ink4a ◽  
Objective Detection ◽  
High Risk Hpv ◽  
Intraepithelial Lesions

Abstract Background : This study aims to evaluate the value of p16 INK4a immunostaining for high-grade squamous intraepithelial lesions in human papillomavirus–negative patients in Beijing, China. Methods: In this study, we evaluated the value of p16 INK4a immunostaining, as well as cytology and colposcopy, for predicting high-grade squamous intraepithelial lesions (HSIL) in human papillomavirus (HPV)-negative patients by comparing the methods with the haematoxylin and eosin (H&E) staining pathological diagnosis of HPV-negative patients. Results: Of 122 patients negative for the high-risk HPV (HR-HPV) subtype, 26 (21.3%) underwent colposcopically directed multiple punch cervical biopsy with a H&E pathological diagnosis of HSIL and above (HSIL+), 11 patients (9.0%) had cervical intraepithelial neoplasia (CIN)2, nine patients (7.4%) had CIN3, and six patients (4.9%) had infiltrating carcinoma. Cytology, colposcopy, and p16 INK4a immunostaining had 52.4%, 38.5%, and 92.3% sensitivity, respectively, and 76.2%, 94.8%, and 99% specificity, respectively. The positive predictive value of cytology, colposcopy, and p16 INK4a immunostaining was 31.4%, 66.7%, and 96%, respectively, and the negative predictive value was 88.5%, 85.1%, and 97.9%, respectively. Compared with H&E staining, the kappa of cytology, colposcopy, and p16 INK4a immunostaining was 0.327, 0.323, and 0.926, respectively. Conclusion: Positive p16 INK4a immunostaining is very strongly consistent with an H&E diagnosis of CIN2+, and it can be used as an objective detection index for HSIL+ diagnosis of HPV-negative patients with CIN2+.

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