Imiquimod 5% cream for external genital or perianal warts in human immunodeficiency virus-positive patients treated with highly active antiretroviral therapy: an open-label, noncomparative study.
BACKGROUND
Human immunodeficiency virus (HIV)+ patients have an increased risk of anogenital warts. High-risk (HR) human papillomaviruses (HPVs), especially types 16 and 18, are major risk factors for precancerous and cancerous lesions of the anogenital tract, while low-risk (LR) HPVs are associated with benign lesions. Cure of genital warts with ablative techniques, surgical excision, podophyllotoxin or trichloroacetic acid is frequently difficult. Treatment with imiquimod cream showed a total clearance of external genital or perianal warts in about 50% of immunocompetent subjects. However, total clearance was reduced in HIV+ subjects not treated with highly active antiretroviral therapy (HAART).


OBJECTIVE
To assess clinically and by monitoring HPV content the efficacy of 5% topical imiquimod to treat anogenital warts in HIV+ subjects with at least partially restored immune functions.


METHODS
Fifty HIV+ patients successfully treated with HAART (total CD4+ cells > or = 200 cells mm(-3) and plasma HIV RNA load < 10(4) copies mL(-1)) with anogenital warts were included. Imiquimod 5% cream was applied on external genital or perianal warts three times weekly for up to 16 weeks. Warts were tested at entry and after treatment for human LR- and HR-HPV DNA.


RESULTS
Total wart clearance was observed in 16 of 50 (32%) patients at week 16. At enrolment, HPV DNA was present in more than 90% of lesions with a majority of lesions co-infected by HR- and LR-HPV. At study end, the HPV load decreased or became undetectable in 40% of cases studied.


CONCLUSIONS
Imiquimod 5% cream did not show safety concerns and is suitable for use in HIV+ subjects with anogenital warts and successful HAART treatment.
Saiag
P
P
Service de Dermatologie & Unité de Recherches EA4339 Skin, Environment, Cancer, Université Versailles St-Quentin, APHP, Hôpital Ambroise Paré, 92104 Boulogne, France. philippe.saiag@apr.aphp.fr
Bauhofer
A
A
Bouscarat
F
F
Aquilina
C
C
Ortonne
J P
JP
Dupin
N
N
Mougin
C
C
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000821:virology; D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active; D001004:Anus Diseases / Q000188:drug therapy* / Q000821:virology; D003218:Condylomata Acuminata / Q000188:drug therapy* / Q000821:virology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077271:Imiquimod; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000188:drug therapy* / Q000821:virology; D016896:Treatment Outcome; D055815:Young Adult
D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000077271:Imiquimod