Examine genital wart treatment options
Examine genital wart treatment options
Does your treatment approach for genital warts (condyloma acuminata) include at least one patient-applied therapy in addition to your provider-administered options? While no one treatment is superior to the other when it comes to the removal of symptomatic warts, the Atlanta-based Centers for Disease Control and Prevention (CDC) recommends the availability of at least one patient-applied option for genital warts in addition to provider-administered therapies.1
Providers need a selection of weapons in their arsenal against external genital warts, which are caused by several of the many types of human papilloma virus (HPV), the most common sexually transmitted disease in the United States.2 Visible genital warts are usually caused by HPV types 6 or 11. Depending on their size, genital warts can be painful, friable, and/or pruritic.
HPV infection is a chronic condition, even when it is asymptomatic. No therapy has been shown to eradicate the virus.
Make the diagnosis
According to the CDC, genital warts may present as single or multiple growths or bumps that appear in the genital area, sometimes forming a cauliflowerlike shape. The warts usually appear as soft, moist, pink or red swellings. The shapes may be raised or flat, in single or multiple growths, and vary in size from small to large. Look for the warts on the vulva, in or around the vagina or anus, on the cervix, and on the penis, scrotum, groin, or thigh.
When choosing the proper therapeutic approach, consider the size, location, and number of warts; changes in the warts; patient preference; cost of treatment; convenience; adverse effects; and your own experience with the treatments, advises the CDC.
If you administer the therapy, provider options include cryotherapy; podophyllin application; TCA (trichloroacetic acid) or BCA (bichloroacetic acid) application; or surgical removal via scissors, shaving excision, curette, or electrocautery. Other provider-administered treatments include laser surgery or intralesional interferon.
Look at patient options
When it comes to patient-applied options, two therapies are available in the United States: imiquimod (Aldara Cream, 3M Pharmaceuticals, St. Paul, MN) and podofilox (Condylox Gel, Oclassen Pharmaceuticals, a division of Watson Labs, Corona, CA). Both therapies were approved by the U.S. Food and Drug Administration in 1997. (Contraceptive Technology Update reported on the two options in its April 1998 article, "New tests, treatments aid in fight against HPV," p. 48.)
Imiquimod is the first in a new class of drugs called immune response modifiers, which demonstrate in vivo antiviral and antitumor activity. Other treatments work by destroying the wart tissue, but imiquimod actually boosts the immune system to fight HPV. The drug also is being examined for other uses such as treatment of actinic keratosis and superficial basal cell carcinoma, according to Deneen Law, 3M market development manager.
A just-published international open-label study is the first to investigate the efficacy of a topical therapy for external genital warts in a large group of patients.3 A total of 114 clinics across Europe, Canada, Latin America, Australia, and South Africa participated in the trial. The study reports that the efficacy of Aldara in 943 male and female patients of different ethnic backgrounds was similar to that in previous randomized, vehicle-controlled studies.4
Patients whose warts decreased in size but did not totally clear in the initial 16 weeks of therapy (191; 20%), were offered the option to apply Aldara for up to an additional 16 weeks. This resulted in total clearance in 33% of these patients. Patients whose warts cleared with imiquimod therapy tended to remain clear, researchers report.
The fact that fewer than 10% of the study participants required re-treatment in the three months after their warts cleared poses a considerable advantage over other available therapies, says lead author Suzanne Garland, MD, associate professor in the department of microbiology and infectious diseases at the Royal Women’s and Royal Children’s Hospitals in Victoria, Australia.
New therapy eyed
European researchers are studying another potential topical treatment for genital warts. The first clinical Phase III trial for Polyphenon E was completed in October 2001 by its developer MediGene AG, a German biopharmaceutical company with headquarters in Martinsried, Munich, and a subsidiary, MediGene in San Diego. A second Phase III trial is being prepared, according to company officials.
Applied as cream or ointment, the drug’s active ingredients include polyphenols that inhibit the infectious properties of HPV. While results of the first trial have not yet been published, the company reports positive results from the multicenter clinical trial. A total of 272 patients in 30 centers in Europe participated in the randomized, double-blinded and placebo-controlled trial. Two formulations of the drug, a cream and an ointment, were tested for their efficacy for the topical treatment of external genital warts.
References
1. Centers for Disease Control and Prevention. 1998 guidelines for treatment of sexually transmitted diseases. MMWR 1998; 47:89.
2. American Social Health Association and the Kaiser Family Foundation. Sexually Transmitted Diseases in America: How Many Cases and at What Cost? Menlo Park, CA: Kaiser Family Foundation; 1998.
3. Garland SM, Sellors JW, Wikstrom A, et al. Imiquimod 5% cream is a safe and effective self-applied treatment for anogenital warts — results of an open-label, multicentre Phase IIIB trial. Int J STD AIDS 2001; 12:722-729.
4. Beutner KR, Spruance SL, Hougham AJ, et al. Treatment of genital warts with an immune-response modifier (imiquimod). J Am Acad Dermatol 1998; 38:230-239.
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