New Drug Reviews
Sinecatechins (Veregen) for External Genital and Perianal Warts
Am Fam Physician. 2009 Dec 15;80(12):1447-1454.
Sinecatechins (Veregen) 15% ointment is the first botanical drug product approved by the U.S. Food and Drug Administration (FDA) for the treatment of external genital and perianal warts.1 Sinecatechins is derived from green tea leaves; the mechanism of action is not yet known.1
0.5-cm strand of ointment applied to each wart three times per day until complete clearance, up to 16 weeks
*— Average wholesale cost based on Red Book. Montvale, N.J.: Medical Economics Data; 2008.
Serious adverse effects of sinecatechins that led to interruption or discontinuation of therapy in 5 percent of patients included application site reactions, phimosis, inguinal lymphade-nitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulceration, erosions in the urethral meatus, and superinfection of warts and ulcers.1 Sinecatechins is FDA pregnancy category C (podofilox [Condylox] and imiquimod [Aldara] are also category C).1–4 It has not been studied in pregnant women, and whether it is excreted in breast milk is unknown.1
Sinecatechins causes side effects similar to those of podofilox or imiquimod, with rates between 5 and 18 percent.1 The most common were application site reactions (e.g., erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration).1–4 If these reactions occur, treatment may need to be discontinued or stopped temporarily, with the option of restarting after the reaction subsides.5,6 Sinecatechins should not be used in conjunction with other skin products or on broken skin.1 There are no known drug interactions or contraindications.1
Currently available treatment options for genital and perianal warts include cryotherapy, podophyllum resin, trichloroacetic acid, surgical removal, or patient-applied therapy with podofilox 0.5% topical solution or gel and imiquimod 5% cream.2–4,7,8 After 16 weeks of treatment on average, sinecatechins causes complete clearance of warts in 53 to 58 percent of patients, compared with a clearance rate of 33 to 37 percent with placebo cream.5,6 This effectiveness appears to be greater than that demonstrated with imiquimod and podofilox,9 although no studies have directly compared sinecatechins with these products. Recurrence of warts will affect 5.9 to 6.5 percent of patients using sine-catechins; those using imiquimod and podofilox may have higher rates of recurrence.5,6,9 No research has determined whether topical treatments eradicate the strains of human papillomavirus that cause genital warts (i.e., types 6 and 11). However, these strains have not been associated with the development of cervical cancer.7
The cost of sinecatechins is $251 for a 15-g tube. In comparison, eight weeks of treatment with Aldara is $551 for 24 single-use packets (0.25 g per packet). Generic podofilox is available in a 3.5-mL solution for $106; Condylox is available as a 0.5% solution for $130 or a 0.5% gel (3.5-g tube) for $283.
Sinecatechins is applied three times per day for up to 16 weeks, which is more frequent than other patient-applied treatments. In general, sinecatechins does not need to be washed off following application; however, because it may weaken condoms or diaphragms, patients are advised to avoid sexual contact while the medication is applied or to wash off the medication before engaging in sexual activity. It can be refrigerated or, in cool climates, stored at room temperature up to 77°F (25°C).1
Sinecatechins offers no clear advantage with regard to safety and tolerability. Indirect comparisons with other treatments suggest that sinecatechins may be more effective, with fewer recurrences of warts following successful treatment, but direct comparisons are lacking. Depending on the length of treatment and size of application area, sinecate-chins may be as expensive as current therapies available for the treatment of external genital and perianal warts, although it does offer the option of patient-applied therapy.
1. Veregen (sinecatechins) [prescribing information]. Melville, NY: PharmaDerm; 2008 http://www.veregen.com/veregenrx/pdf/VER051_Promo_PI.pdf. Accessed June 15, 2009.
2. Aldara (imiquimod) 5% cream [prescribing information]. Bristol, Tenn.: Graceway Pharmaceuticals; 2009http://www.aldara.com/ie/pdfs/aldara_ppi.pdf. Accessed June 15, 2009.
3. Condylox (podofilox) 0.5% gel [prescribing information]. Corona, Calif.: Watson Pharmaceuticals, Inc.; 2007 http://pi.watson.com/data_stream.asp?product_group=1219&p=pi&language=E. Accessed June 15, 2009.
4. Condylox (podofilox) 0.5% topical solution [prescribing information]. Corona, Calif.: Watson Pharmaceuticals, Inc. http://pi.watson.com/data_stream.asp?product_group=1220&p=pi&language=E. Accessed June 15, 2009.
5. Tatti S, Swinehart JM, Thielert C, Tawfik H, Mescheder A, Beutner KR. Sinecatechins, a defined green tea extract, in the treatment of external anogenital warts: a randomized controlled trial. Obstet Gynecol. 2008;111(6):1371–1379.
6. Stockfleth E, Beti H, Orasan R, et al. Topical Polyphenon E in the treatment of external genital and perianal warts: a randomized controlled trial. Br J Dermatol. 2008;158(6):1329–1338.
7. Workowski KA, Berman SM, for the Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006 [published correction appears in MMWR Recomm Rep. 2006;55(36):997]. MMWR Recomm Rep. 2006;55(RR-11):1–94.
8. Buck HW Jr. Warts (genital). Clinical Evidence [online], 2009 http://clinicalevidence.bmj.com/ceweb/conditions/seh/1602/1602.jsp. Accessed June 15, 2009.
9. Beutner KR, Wiley DJ, Douglas JM, et al. Genital warts and their treatment. Clin Infect Dis. 1999;28(suppl 1):S37–S56.
STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.
The series coordinator for AFP is Allen F. Shaugh-nessy, PharmD, Tufts University Family Medicine Residency Program at Cambridge Health Alliance, Malden, Mass.
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