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Indian Journal of Sexually Transmitted Diseases and AIDS logoLink to Indian Journal of Sexually Transmitted Diseases and AIDS
. 2016 Jan-Jun;37(1):101–104.

Treatment of genital wart

Pinki A Narsinghani 1,✉, Dimpal Patel 1, Yogesh Marfatia 1
PMCID: PMC4857674
Indian J Sex Transm Dis AIDS. 2016 Jan-Jun;37(1):101–104.

A randomized trial of immunotherapy for persistent genital warts

Jardine D, Lu J, Pang J, Palmer C, Tu Q, Chuah J, et al. Hum Vaccin Immunother 2012;8:623-9.

Aim: To determine whether immunotherapy with HPV6 L1 virus-like particles (VLPs) without adjuvant (VLP immunotherapy) reduces recurrence of genital warts following destructive therapy. Methods: A randomized placebo-controlled blinded study of treatment of recurrent genital warts amenable to destructive therapy, conducted independently in Australia and China. Patients received conventional destructive therapy of all evident warts together with intramuscular administration of 1 µg, 5 µg, or 25 µg of VLP immunotherapy, or of placebo immunotherapy (0.9% NaCl), as immunotherapy at week 0 and week 4. The primary outcome, assessed at week 8, was a recurrence of visible warts. Results: Of 33 protocol compliant Brisbane recipients of placebo immunotherapy, 11 were disease-free at 2 months, and a further nine demonstrated reduction of >50% in total wart area. Wart area reduction following destructive treatment correlated with prior duration of disease. Among 102 protocol compliant Brisbane recipients of VLP immunotherapy, disease reduction was significantly greater than among the placebo immunotherapy (50% ± standard error of the mean [SEM] 7%) recipients for subjects receiving 5 µg or 25 µg of VLP immunotherapy/dose (71% ± SEM 7%) but not for those receiving 1 µg VLP immunotherapy/dose (42 ± 7%). Of 52 protocol compliant placebo immunotherapy recipients in Wenzhou, 37 were disease-free at 2 months, and a further eight had >50% disease reduction. Prior disease duration was much shorter in Wenzhou subject (8.1 ± 1.1 month) than in Brisbane subjects (53.7 ± 5.5 mo). No significant reduction in mean wart area was observed for the 168 Wenzhou protocol compliant subjects who also received VLP immunotherapy. Conclusions: This study confirms the findings in a previous open-label trial that administration of VLP immunotherapy may assist in clearance of recurrent genital warts in patients for whom destructive therapy is unsuccessful and that unsuccessful destructive therapy is more common with increasing prior disease duration.

Indian J Sex Transm Dis AIDS. 2016 Jan-Jun;37(1):101–104.

Warts (Genital)

Buck HW Jr. BMJ Clin Evid 2010;2010. pii: 1602.

Introduction: External genital warts (EGWs) are sexually transmitted benign epidermal growths caused by the human papillomavirus (HPV), on the anogenital areas of both females and males. About 50% to 60% of sexually active women aged 18 to 49 years have been exposed to HPV infection, but only 10% to 15% will have genital warts. Methods and Outcomes: A systematic review and aimed to answer the following clinical questions: What are the effects of treatments for external genital warts? What are the effects of interventions to prevent transmission of external genital warts? We searched: Medline, Embase, The Cochrane Library, and other important databases up to December 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organizations such as the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency. Results: We found 55 systematic reviews, randomized controlled trials, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. Conclusions: In this systematic review, we present information relating to the effectiveness and safety of the following interventions: Bi- and trichloroacetic acid; condoms; cryotherapy; electrosurgery; imiquimod; intralesional, topical, or systemic interferons; laser surgery; podophyllin; podophyllotoxin; surgical excision; and vaccines.

Indian J Sex Transm Dis AIDS. 2016 Jan-Jun;37(1):101–104.

Key points

Warts are more common in people with impaired immune systems, but, in people with adequate immune function, about one-third may resolve spontaneously. Some lesions, particularly those that are pigmented, should be biopsied to rule out severe dysplasia or melanoma; but EGWs rarely, if ever, progress to cancer. Imiquimod 1% and 5% creams increase clearance of warts compared with placebo in patients without HIV, but we do not know if they are effective in people with HIV. Imiquimod, 5% cream, may be more likely to clear warts, but it increases local irritation compared with imiquimod 1% cream. Topical interferon increases wart clearance at 4 weeks compared with placebo. Topical interferon is preferred to systemic interferon, which has not been shown consistently to be effective, is expensive to use, and is associated with severe adverse effects. We do not know if intralesional interferon is effective, although it is time-consuming, and expensive to use. Podophyllotoxin is more effective than placebo and probably as effective as podophyllin in clearing genital warts and it may be easier to use. Podophyllin may contain mutagenic compounds, and its formulation is unstandardized, so podophyllotoxin is the preferred treatment, despite the risk of local burning and bleeding. There is consensus that bi-and trichloroacetic acid and cryotherapy are effective treatments for EGWs, although we found no studies comparing them with placebo. Surgical (scissor) excision and electrosurgery may be effective at clearing genital warts, but we do not know whether laser surgery is also effective. Quadrivalent vaccine is effective in preventing infection and disease by HPV in young women. Less-complete data indicate that this is likely to be true for older ages. The vaccine is also licensed for use in males in many of the countries in which it is available.

Indian J Sex Transm Dis AIDS. 2016 Jan-Jun;37(1):101–104.

An open-label phase ii pilot study investigating the optimal duration of imiquimod 5% cream for the treatment of external genital warts in women

Garland SM, Waddell R, Mindel A, Denham IM, McCloskey JC. Int J STD AIDS 2006;17:448-52.

Our objective was to determine the optimal duration of treatment with imiquimod for external genital warts over 4, 8, 12, or 16 weeks. A total of 120 women with a history of genital warts for a median of 3–6 months and prior alternative treatments in 73% were evaluated for total clearance rates. There was no statistically significant difference in complete clearance rates after 16-week follow-up across treatment groups: Four weeks (40.0%), 8 weeks (48.4%), 12 weeks (39.3%), and 16 weeks (51.6%). Imiquimod was well tolerated, and in those treated for 4 weeks, there was a lower incidence of local skin reactions such as erythema and erosion, and no incidences of pain. These preliminary results suggest that a 4-week treatment course of imiquimod applied thrice weekly for women with external genital warts may provide a reasonable approach with comparable efficacy and compliance, and minimal adverse events, drug costs, and clinic visits.

Indian J Sex Transm Dis AIDS. 2016 Jan-Jun;37(1):101–104.

Topical podophyllin and podophyllotoxin for treatments of genital warts: A comparative study

Kar PK, Rajagopal R, PS Murthy. Indian J Dermatol 2003;48:146-50.

The efficacy of podophllin and podophyllotoxin was compared in the treatment of genital warts in 72 men. Thirty-five men in Group A were treated with 20% podophyllin in tincture benzoin compound at weekly intervals while 37 men in Group B were advised to apply 0.5% podophyllotoxin solution twice a day for three consecutive days every week. The study period was for 6 weeks with a follow-up to 6 months. Majority of men, 40 (55.5%) were aged below 30 years. Thirty-four (47.2%) were unmarried. Fifty-six (77.7%) had heterosexual contact with commercial sex workers. The mean duration of genital warts was 4.8 months in Group A and 5.7 months in Group B. The mean number of treatment cycles was 4.8 in podophyllin group and 4.6 in podophyllotoxin group. After 6 weeks, 29 (82.8%) men of podophyllin group and 33 (89.1%) of podophyllotoxin group were completely cured. At the end of 6 months follow-up, 8 (28.5%) men in Group A and 11 (32.3%) in Group B showed some evidence of recurrence of warts. Both podophyllin and podophyllotoxin were equally effective in the treatment of genital warts. However, podophyllotoxin has the advantage that it can be prescribed as a domiciliary treatment.

Indian J Sex Transm Dis AIDS. 2016 Jan-Jun;37(1):101–104.

Imiquimod for the treatment of genital warts: A quantitative systematic review

Moore RA, Edwards JE, Hopwood J, Hicks D. BMC Infect Dis 2001;1:3.

Objective: To review published randomized controlled trials to assess the benefit and harm of imiquimod in the treatment of external genital warts. Methods: Medline (1966-December 2000), Cochrane Library (Issue 3, 2000) and PubMed (December 15, 2000), review articles and reference lists: Included studies had to be randomized trials of imiquimod, to be full published papers, and to have a comparison group. Quality of trial reporting was assessed. Relative benefit and number needed to treat were calculated for the main outcomes of wart clearance at the end of therapy, of at least 50% reduction in wart area, and of complete clearance at the end of treatment and no recurrence of warts during a follow-up period, as well as for adverse effect withdrawal or lack of efficacy withdrawal. Results: There were six trials, all with quality scores of 3 (out of 5) or greater. In five trials with HIV-negative patients, complete clearance of warts at the end of treatment occurred in 51% of patients treated with imiquimod 2% or 5% cream and 6% of placebo-treated patients. The number needed to treat was 2.2 (95% confidence interval 2.0–2.6). In four trials at least 50% wart area reduction occurred with 72% of patients treated with imiquimod 5% cream and 20% of placebo-treated patients. The number needed to treat was 1.9 (1.7–2.2). In three trials complete clearance of warts at the end of treatment plus no recurrence occurred in 37% of patients treated with imiquimod 5% cream and 4% of those treated with placebo. The number needed to treat was 3.0 (2.5–3.8). Adverse event withdrawal was rare and no more likely with imiquimod than with placebo. Imiquimod was not effective in one trial in HIV-positive patients. Conclusion: The evidence base for imiquimod in treating genital warts is of high quality and the necessary size from which to draw useful conclusions. Imiquimod is effective in home application, though not in patients with HIV infection with the evidence presently available.

Indian J Sex Transm Dis AIDS. 2016 Jan-Jun;37(1):101–104.

Treatment of genital warts with an immune-response modifier (imiquimod)

Beutner KR, Spruance SL, Hougham AJ, Fox TL, Owens ML, Douglas JM Jr. J Am Acad Dermatol 1998;38(2 Pt 1):230-9.

Background: Genital warts are a common sexually transmitted disease caused by human papillomavirus. Imiquimod is a novel immune-response modifier capable of inducing a variety of cytokines, including interferon alfa, tumor necrosis factor-alfa, as well as interleukins 1, 6, and 8. In animal models imiquimod has demonstrated antiviral, antitumor, and adjuvant activity. In vitro, imiquimod has no antiviral or antitumor activity. Objective: The purpose was to determine the safety and efficacy of topical imiquimod for the treatment of external genital warts. Methods: This prospective double-blind, placebo-controlled, parallel design clinical trial was performed in three outpatient centers, a public health clinic, a university-based clinic, and private practice. One hundred eight patients with external genital warts (predominantly white men) were entered into the trial. Fifty-one patients were randomly selected to receive 5% imiquimod cream; 57 patients were randomly chosen to receive placebo cream. Study medication was applied 3 times weekly for up to 8 weeks. Patients whose warts cleared completely were observed for up to 10 weeks to determine recurrence rates. Results: In the intent-to-treat analysis, the warts of 37% (19 of 51) of the imiquimod-treated patients and 0% (0 of 57) of the placebo group cleared completely (P< 0.001). In addition, many patients experienced a partial response. A reduction in baseline wart area of 80% or more was observed in 62% of imiquimod-treated patients (28 of 45) and 4% of the placebo group (2 of 50) (P< 0.001); a 50% reduction or more in wart area was noted in 76% of imiquimod-treated patients (34 of 45) and 8% of placebo recipients (4 of 50) (P< 0.001). Of imiquimod-treated patients whose warts cleared completely and who finished the 10-week follow-up period, 19% (3 of 16) experienced recurrences of warts. Imiquimod-treated patients experienced a significantly greater number of local inflammatory reactions than the placebo group. Symptoms and signs associated with the local inflammatory reactions included itching (54.2%), erythema (33.3%), burning (31.3%), irritation (16.7%), tenderness (12.5%), ulceration (10.4%), erosion (10.4%), and pain (8.3%). There were no differences in systemic reactions or laboratory abnormalities between treatment groups. Conclusion: Topical 5% imiquimod cream appears to have a significant therapeutic effect in the treatment of external genital warts.

Acknowledgments

The help extended by all the staff at ART Centre, Dr. R. P. Government Medical College, Kangra, Tanda, Himachal Pradesh, India is gratefully acknowledged.

Articles from Indian Journal of Sexually Transmitted Diseases and AIDS are provided here courtesy of Wolters Kluwer -- Medknow Publications

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