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AIDS:
doi: 10.1097/QAD.0b013e32835a9b16
Clinical Science

Safety and efficacy of topical cidofovir to treat high-grade perianal and vulvar intraepithelial neoplasia in HIV-positive men and women

Stier, Elizabeth A.a; Goldstone, Stephen E.b; Einstein, Mark H.c; Jay, Naomid; Berry, John M.d; Wilkin, Timothye; Lee, Jeannette Y.f; Darragh, Teresa M.g; Da Costa, Mariad; Panther, Lorih; Aboulafia, Davidi; Palefsky, Joel M.d

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Abstract

Objective: To evaluate the safety and efficacy of topical cidofovir for treatment of high-grade squamous perianal intraepithelial neoplasia (PAIN) and vulvar intraepithelial neoplasia (VIN) lesions in HIV-positive individuals.

Design: Phase IIa prospective multicenter trial conducted at eight clinical sites through the AIDS Malignancy Consortium.

Methods: HIV-positive patients with biopsy-proven high-grade PAIN that was at least 3 cm2 were enrolled. PAIN biopsy specimens were assessed for human papillomavirus (HPV) using PCR and type-specific HPV probing. Participants applied 1% topical cidofovir to PAIN and VIN (if present) for six 2-week cycles. Results were designated as complete response (CR), partial response (PR) (>50% reduction in size), stable disease, or progressive disease (PD).

Results: Twenty-four men and nine women (eight with high-grade VIN as well) were enrolled. Mean age was 44 years and mean CD4+ cell count was 412 cells/μl. HPV DNA (most commonly HPV16) was detected in all pretreatment study specimens. Twenty six (79%) participants completed treatment per protocol: CR, five (15%); PR, 12 (36%), stable disease, seven (21%); PD, two (6%) (one with a superficially invasive cancer and one with new area of high-grade PAIN). Treatment was well tolerated with most common adverse events being mild to moderate affecting lesional skin: pain/burning/irritation (25 patients) and ulceration (13 patients).

Conclusion: Topical cidofovir had 51% efficacy in the short-term treatment of high-grade PAIN and VIN with acceptable toxicity in HIV-positive individuals. Randomized control studies with more prolonged treatment courses and longer follow-up to assess the durability of the response are needed.

© 2013 Lippincott Williams & Wilkins, Inc.

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