Division of Infectious Diseases, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Dis Colon Rectum. 2018 Mar;61(3):298-305. doi: 10.1097/DCR.0000000000000991.
Imiquimod can be used to treat internal anal high-grade squamous intraepithelial lesions. In HIV-1-infected individuals there is a theoretical concern for increased HIV replication in anorectal tissue secondary to imiquimod-induced mucosal inflammation.
The purpose of this study was to assess local virologic, immunologic, and pathologic effects of imiquimod treatment in HIV-infected individuals.
This was a pilot study at a single academic center.
The study was conducted at the University of Pittsburgh Anal Dysplasia Clinic.
HIV-1-infected individuals with biopsy-confirmed internal anal high-grade squamous intraepithelial lesions were included.
Imiquimod cream was prescribed for intra-anal use 3 times per week for 9 weeks.
Anal human papillomavirus typing, anal and rectal tissue HIV-1 RNA and DNA quantification, cytokine gene expression, and anal histology were measured.
Nine evaluable participants (1 participant was lost to follow-up) were all white men with a median age of 46 years (interquartile range = 12 y) and a median CD4 T-cell count of 480 cells per cubic millimeter (interquartile range = 835). All were taking antiretroviral therapy, and 7 of 9 had HIV-1 RNA <50 copies per milliliter. The median dose of imiquimod used was 27.0 (interquartile range = 3.5), and there was a median of 11 days (interquartile range = 10 d) from last dose to assessment. There was no progression to cancer, no significant change in the number of human papillomavirus types detected, and no significant change in quantifiable cytokines/HIV-1 RNA or DNA levels in anal or rectal tissue. Seven (35%) of 20 high-grade lesions resolved to low-grade squamous intraepithelial lesions.
The study was limited by the small number of participants and variable time to final assessment.
Intra-anal imiquimod showed no evidence of immune activation or increase in HIV-1 viral replication in anal and rectal tissue and confirmed efficacy for intra-anal high-grade squamous intraepithelial lesion treatment morbidity. See Video Abstract at http://links.lww.com/DCR/A498.
咪喹莫特可用于治疗内部肛门高级别鳞状上皮内病变。在 HIV-1 感染者中，由于咪喹莫特诱导的黏膜炎症，肛门直肠组织中 HIV 复制增加存在理论上的担忧。
本研究旨在评估咪喹莫特治疗 HIV 感染者的局部病毒学、免疫学和病理学影响。
这是一家学术中心的试点研究。
本研究在匹兹堡肛门发育不良诊所进行。
经活检证实患有内部肛门高级别鳞状上皮内病变的 HIV-1 感染者。
咪喹莫特乳膏处方为每周 3 次，用于肛门内治疗，共 9 周。
肛门人乳头瘤病毒分型、肛门和直肠组织 HIV-1 RNA 和 DNA 定量、细胞因子基因表达和肛门组织学。
9 名可评估参与者（1 名参与者失访）均为白人男性，中位年龄为 46 岁（四分位距 = 12 岁），中位 CD4 T 细胞计数为 480 个/立方毫米（四分位距 = 835 个）。所有人均接受抗逆转录病毒治疗，9 人中 7 人的 HIV-1 RNA<50 拷贝/毫升。咪喹莫特的中位剂量为 27.0（四分位距 = 3.5），末次剂量至评估的中位时间为 11 天（四分位距 = 10 天）。未进展为癌症，检测到的人乳头瘤病毒类型数量无显著变化，肛门和直肠组织中可定量的细胞因子/HIV-1 RNA 或 DNA 水平也无显著变化。20 例高级别病变中有 7 例（35%）转为低级别鳞状上皮内病变。
该研究受到参与者数量少和最终评估时间不同的限制。
肛门内咪喹莫特治疗未显示出免疫激活或肛门直肠组织中 HIV-1 病毒复制增加的证据，证实了其治疗肛门内高级别鳞状上皮内病变的疗效和安全性。观看视频摘要请访问 http://links.lww.com/DCR/A498。
