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Guideline Summary
Guideline Title
Genital warts. In: Sexually transmitted diseases treatment guidelines, 2010.
Bibliographic Source(s)
Centers for Disease Control and Prevention (CDC). Genital warts. In: Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17;59(RR-12):70-4.
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Centers for Disease Control and Prevention. Human papillomavirus infection. Sexually transmitted diseases treatment guidelines. MMWR Recomm Rep 2006 Aug 4;55(RR-11):62-7.

Scope

Disease/Condition(s)
  • Human papillomavirus (HPV) infection
  • Genital warts
Guideline Category
Counseling
Diagnosis
Management
Treatment
Clinical Specialty
Family Practice
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Preventive Medicine
Surgery
Urology
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Health Care Providers
Managed Care Organizations
Nurses
Physician Assistants
Physicians
Public Health Departments
Guideline Objective(s)
  • To update the Sexually Transmitted Diseases Treatment Guidelines 2006
  • To assist physicians and other health-care providers in preventing and treating sexually transmitted diseases (STDs)
Target Population

Patients with human papillomavirus (HPV) infection and genital warts

Interventions and Practices Considered

Diagnosis

  1. Visual inspection
  2. Confirmation by biopsy if indicated

Note: Deoxyribonucleic acid (DNA) testing and acetic acid application were considered but not routinely recommended.

Treatment

Patient-Applied

  1. Podofilox 0.5% solution or gel
  2. Imiquimod 5% cream
  3. Sinecatechins 15% ointment

Provider-Administered

  1. Cryotherapy with liquid nitrogen or cryoprobe
  2. Podophyllin resin 10%-25% in a compound tincture of benzoin
  3. Trichloroacetic acid (TCA) or bichloroacetic acid (BCA) 80%-90%
  4. Surgical removal either by tangential scissor excision, tangential shave excision, curettage or electrosurgery

Alternative Regimens

  1. Intralesional interferon
  2. Photodynamic therapy
  3. Topical cidofovir

Special Considerations

  1. Management of warts during pregnancy or Cesarean delivery, if indicated
  2. Management of patients with concomitant human immunodeficiency virus (HIV) infection
  3. Management of patients with squamous cell carcinoma in situ

Management

  1. Patient education and counseling about human papillomavirus (HPV) infection and genital warts, including HPV diagnosis and treatment, prevention of HPV transmission, information on two available HPV vaccines, treatment of genital warts, male condom use
  2. Specialist consultation and referral, as indicated
  3. Follow-up evaluation
Major Outcomes Considered
  • Microbiologic cure
  • Presence of signs and symptoms
  • Occurrence of sequelae
  • Rate of transmission

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Not stated

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Subjective Review
Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Beginning in 2008, Centers for Disease Control and Prevention (CDC) staff members and public- and private-sector experts knowledgeable in the field of sexually transmitted diseases (STDs) systematically reviewed literature using an evidence-based approach (e.g., published abstracts and peer-reviewed journal articles), focusing on the common STDs and information that had become available since publication of the 2006 Guidelines for Treatment of Sexually Transmitted Diseases. CDC staff members and STD experts developed background papers and tables of evidence that summarized the type of study (e.g., randomized controlled trial or case series), study population and setting, treatments or other interventions, outcome measures assessed, reported findings, and weaknesses and biases in study design and analysis. CDC staff then developed a draft document on the basis of this evidence-based review.

Methods Used to Formulate the Recommendations
Expert Consensus (Consensus Development Conference)
Description of Methods Used to Formulate the Recommendations

Centers for Disease Control and Prevention (CDC) staff members and invited consultants (including public- and private-sector professionals knowledgeable in the treatment of patients with sexually transmitted diseases [STDs]) assembled in Atlanta, Georgia, in April 2009 for a meeting where all evidence from the literature reviews pertaining to STD management was discussed.

Specifically, participants identified key questions regarding STD treatment that emerged from the literature reviews and discussed the information available to answer those questions. Discussion focused on four principal outcomes of STD therapy for each individual disease: 1) treatment of infection based on microbiologic eradication, 2) alleviation of signs and symptoms 3) prevention of sequelae, and 4) prevention of transmission. Cost-effectiveness and other advantages (e.g., single-dose formulations and directly observed therapy [DOT]) of specific regimens also were discussed. The consultants then assessed whether the questions identified were relevant, ranked them in order of priority, and answered the questions using the available evidence. In addition, the consultants evaluated the quality of evidence supporting the answers on the basis of the number, type, and quality of the studies.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation

Not stated

Recommendations

Major Recommendations

Note from the National Guideline Clearinghouse (NGC) and the Centers for Disease Control and Prevention (CDC): When more than one therapeutic regimen is recommended, the sequence is alphabetized unless the choices for therapy are prioritized based on efficacy, convenience, or cost. For sexually transmitted diseases (STDs) with more than one recommended regimen, almost all regimens have similar efficacy and similar rates of intolerance or toxicity unless otherwise specified.

Of genital warts, 90% are caused by human papillomavirus (HPV) 6 or 11. HPV types 6 or 11 are commonly found before, or at the time of, detection of genital warts. HPV types 16, 18, 31, 33, and 35 are found occasionally in visible genital warts (usually as coinfections with HPV 6 or 11) and can be associated with foci of high-grade intraepithelial neoplasia, particularly in persons who are infected with HIV infection. In addition to warts on genital areas, HPV types 6 and 11 have been associated with conjunctival, nasal, oral, and laryngeal warts.

Genital warts are usually asymptomatic, but depending on the size and anatomic location, they can be painful or pruritic. Genital warts are usually flat, papular, or pedunculated growths on the genital mucosa. Genital warts occur commonly at certain anatomic sites, including around the introitus in women, under the foreskin of the uncircumcised penis, and on the shaft of the circumcised penis. Genital warts can also occur at multiple sites in the anogenital epithelium or within the anogenital tract (e.g., cervix, vagina, urethra, perineum, perianal skin, and scrotum). Intra-anal warts are observed predominantly in persons who have had receptive anal intercourse, but they can also occur in men and women who do not have a history of anal sexual contact.

Diagnosis of genital warts is usually clinical, made by visual inspection. Genital warts can be confirmed by biopsy, which might be indicated if 1) the diagnosis is uncertain; 2) the lesions do not respond to standard therapy; 3) the disease worsens during therapy; 4) the lesion is atypical; 5) the patient has comprised immunity; or 6) the warts are pigmented, indurated, fixed, bleeding, or ulcerated. The use of HPV deoxyribonucleic acid (DNA) testing for genital wart diagnosis is not recommended, because test results would not alter clinical management of the condition.

The application of 3%-5% acetic acid, which causes skin color to turn white, has been used by some providers to detect HPV-infected genital mucosa. However, acetic acid application is not a specific test for HPV infection. Therefore, the routine use of this procedure for screening to detect mucosal changes attributed to HPV infection is not recommended.

Treatment

The primary reason for treating genital warts is the amelioration of symptoms (including relieving cosmetic concerns) and ultimately, removal of the warts. In most patients, treatment can induce wart-free periods. If left untreated, visible genital warts can resolve on their own, remain unchanged, or increase in size or number. Available therapies for genital warts likely reduce, but probably do not eradicate, HPV infectivity. Whether the reduction in HPV viral DNA resulting from treatment reduces future transmission remains unclear. No evidence indicates that the presence of genital warts or their treatment is associated with the development of cervical cancer.

Regimens

Treatment of genital warts should be guided by the preference of the patient, the available resources, and the experience of the health-care provider. No definitive evidence suggests that any of the available treatments are superior to any other and no single treatment is ideal for all patients or all warts. The use of locally developed and monitored treatment algorithms has been associated with improved clinical outcomes and should be encouraged. Because of uncertainty regarding the effect of treatment on future transmission of HPV and the possibility of spontaneous resolution, an acceptable alternative for some persons is to forego treatment and wait for spontaneous resolution.

Factors that influence selection of treatment include wart size, wart number, anatomic site of the wart, wart morphology, patient preference, cost of treatment, convenience, adverse effects, and provider experience. Factors that might affect response to therapy include the presence of immunosuppression and compliance with therapy, which can consist of either a single treatment or complete course of treatment. In general, warts located on moist surfaces or in intertriginous areas respond best to topical treatment. The treatment modality should be changed if a patient has not improved substantially after a complete course of treatment or if side effects are severe. Most genital warts respond within 3 months of therapy. The response to treatment and any side effects should be evaluated throughout the course of therapy.

Complications occur rarely when treatment is administered properly. Patients should be warned that persistent hypopigmentation or hyperpigmentation occurs commonly with ablative modalities and has also been described with immune modulating therapies (imiquimod). Depressed or hypertrophic scars are uncommon but can occur, especially if the patient has had insufficient time to heal between treatments. Rarely, treatment can result in disabling chronic pain syndromes (e.g., vulvodynia and hyperesthesia of the treatment site) or, in the case of anal warts, painful defecation or fistulas. A limited number of case reports of severe systemic effects from treatment with podophyllin resin and interferon have been documented.

Treatment regimens are classified into patient-applied and provider-applied modalities. Patient-applied modalities are preferred by some patients because they can be administered in the privacy of the patient's home. To ensure that patient-applied modalities are effective, patients must comply with the treatment regimen and must be capable of identifying and reaching all genital warts. Follow-up visits are not required for persons using patient-applied therapy. However, follow-up visits after several weeks of therapy enable providers to answer any questions patients might have about the use of the medication and any side effects they have experienced; follow-up visits also facilitate the assessment of a patient's response to treatment.

Recommended Regimens for External Genital Warts

Patient-Applied

  • Podofilox 0.5% solution or gel

    OR

  • Imiquimod 5% cream

    OR

  • Sinecatechins 15% ointment

Provider-Administered

  • Cryotherapy with liquid nitrogen or cryoprobe. Repeat applications every 1-2 weeks.

    OR

  • Podophyllin resin 10%-25% in a compound tincture of benzoin

    OR

  • Trichloroacetic acid (TCA) or Bichloroacetic acid (BCA) 80%-90%

    OR

  • Surgical removal either by tangential scissor excision, tangential shave excision, curettage, or electrosurgery

Podofilox is an antimitotic drug that destroys warts, is relatively inexpensive, easy to use, safe, and self-applied. Podofilox solution should be applied with a cotton swab, or podofilox gel with a finger, to visible genital warts twice a day for 3 days, followed by 4 days of no therapy. This cycle can be repeated, as necessary, for up to four cycles. The total wart area treated should not exceed 10 cm2, and the total volume of podofilox should be limited to 0.5 mL per day. If possible, the health-care provider should apply the initial treatment to demonstrate the proper application technique and identify which warts should be treated. Mild to moderate pain or local irritation might develop after treatment. The safety of podofilox during pregnancy has not been established.

Imiquimod is a topically active immune enhancer that stimulates production of interferon and other cytokines. Imiquimod cream should be applied once daily at bedtime, three times a week for up to 16 weeks. The treatment area should be washed with soap and water 6 to 10 hours after the application. Local inflammatory reactions, including redness, irritation, induration, ulceration/erosions, and vesicles, are common with the use of imiquimod, and hypopigmentation has also been described. Imiquimod might weaken condoms and vaginal diaphragms. The safety of imiquimod during pregnancy has not been established.

Sinecatechin ointment, a green-tea extract with an active product (catechins), should be applied three times daily (0.5-cm strand of ointment to each wart) using a finger to ensure coverage with a thin layer of ointment until complete clearance of warts. This product should not be continued for longer than 16 weeks. The medication should not be washed off after use. Sexual (i.e., genital, anal, or oral) contact should be avoided while the ointment is on the skin. The most common side effects of sinecatechins 15% are erythema, pruritus/burning, pain, ulceration, edema, induration, and vesicular rash. This medication may weaken condoms and diaphragms. No clinical data are available regarding the efficacy or safety of sinecatechins compared with other available anogenital wart treatment modalities. The medication is not recommended for HIV-infected persons, immunocompromised persons, or persons with clinical genital herpes because the safety and efficacy of therapy in these settings has not been established. The safety of sinecatechins during pregnancy also is unknown.

Cryotherapy destroys warts by thermal-induced cytolysis. Health-care providers must be trained on the proper use of this therapy because over- and undertreatment might result in complications or low efficacy. Pain after application of the liquid nitrogen, followed by necrosis and sometimes blistering, is common. Local anesthesia (topical or injected) might facilitate therapy if warts are present in many areas or if the area of warts is large.

Podophyllin resin 10%–25% should be applied to each wart and allowed to air-dry before the treated area comes into contact with clothing; overapplication or failure to air dry can result in local irritation caused by spread of the compound to adjacent areas. The treatment can be repeated weekly, if necessary. To avoid the possibility of complications associated with systemic absorption and toxicity, two guidelines should be followed: 1) application should be limited to <0.5 mL of podophyllin or an area of <10 cm2 of warts per session and 2) the area to which treatment is administered should not contain any open lesions or wounds. The preparation should be thoroughly washed off 1–4 hours after application to reduce local irritation. The safety of podophyllin during pregnancy has not been established. Podophyllin resin preparations differ in the concentration of active components and contaminants. The shelf life and stability of podophyllin preparations are unknown.

Both TCA and BCA are caustic agents that destroy warts by chemical coagulation of proteins. Although these preparations are widely used, they have not been investigated thoroughly. TCA solutions have a low viscosity comparable with that of water and can spread rapidly if applied excessively; therefore, they can damage adjacent tissues. A small amount should be applied only to the warts and allowed to dry before the patient sits or stands, at which time a white frosting develops. If pain is intense, the acid can be neutralized with soap or sodium bicarbonate. If an excess amount of acid is applied, the treated area should be powdered with talc, sodium bicarbonate (i.e., baking soda), or liquid soap preparations to remove unreacted acid. This treatment can be repeated weekly, if necessary.

Surgical therapy has the advantage of usually eliminating warts at a single visit. However, such therapy requires substantial clinical training, additional equipment, and a longer office visit. After local anesthesia is applied, the visible genital warts can be physically destroyed by electrocautery, in which case no additional hemostasis is required. Care must be taken to control the depth of electrocautery to prevent scarring. Alternatively, the warts can be removed either by tangential excision with a pair of fine scissors or a scalpel, by laser, or by curettage. Because the majority of warts are exophytic, this procedure can be accomplished with a resulting wound that only extends into the upper dermis. Hemostasis can be achieved with an electrocautery unit or a chemical styptic (e.g., an aluminum chloride solution). Suturing is neither required nor indicated in the majority of cases if surgical removal is performed properly. Surgical therapy is most beneficial for patients who have a large number or area of genital warts. Both carbon dioxide laser and surgery might be useful in the management of extensive warts or intraurethral warts, particularly for those patients who have not responded to other treatments.

Because all available treatments have shortcomings, some clinics employ combination therapy (simultaneous use of two or more modalities on the same wart at the same time). Data are limited regarding the efficacy or risk of complications associated with use of such combinations.

Alternative Regimens

Alternative regimens include treatment options that might be associated with more side effects and/or less data on efficacy. Alternative regimens include intralesional interferon, photodynamic therapy, and topical cidofovir.

Recommended Regimens for Cervical Warts

  • For women who have exophytic cervical warts, a biopsy evaluation to exclude high-grade squamous intraepithelial lesion (SIL) must be performed before treatment is initiated. Management of exophytic cervical warts should include consultation with a specialist.

Recommended Regimens for Vaginal Warts

  • Cryotherapy with liquid nitrogen. The use of a cryoprobe in the vagina is not recommended because of the risk for vaginal perforation and fistula formation.

    OR

  • TCA or BCA 80%-90% applied to warts. A small amount should be applied only to warts and allowed to dry, at which time a white frosting develops. If an excess amount of acid is applied, the treated area should be powdered with talc, sodium bicarbonate, or liquid soap preparations to remove unreacted acid. This treatment can be repeated weekly, if necessary.

Recommended Regimens for Urethral Meatus Warts

  • Cryotherapy with liquid nitrogen

    OR

  • Podophyllin 10%-25% in compound tincture of benzoin. The treatment area and adjacent normal skin must be dry before contact with podophyllin. This treatment can be repeated weekly, if necessary. The safety of podophyllin during pregnancy has not been established. Data are limited on the use of podofilox and imiquimod for treatment of distal meatal warts.

Recommended Regimens for Anal Warts

  • Cryotherapy with liquid nitrogen

    OR

  • TCA or BCA 80%-90% applied to warts. A small amount should be applied only to warts and allowed to dry, at which time a white frosting develops. If an excess amount of acid is applied, the treated area should be powdered with talc, sodium bicarbonate, or liquid soap preparations to remove unreacted acid. This treatment can be repeated weekly, if necessary.

    OR

  • Surgical removal

Intra-anal warts should be managed in consultation with a specialist. Many persons with warts on the anal mucosa also have warts on the rectal mucosa, so persons with anal and/or intra-anal warts might benefit from an inspection of the rectal mucosa by digital examination, standard anoscopy, or high-resolution anoscopy.

Counseling

The following key counseling messages should be conveyed to all patients diagnosed with HPV infection:

  • Genital HPV infection is very common. Many types of HPV are passed on through genital contact, most often during vaginal and anal sexual contact. HPV can also be spread by oral sexual contact.
  • Most sexually active adults will get HPV at some point in their lives, though most will never know it because HPV infection usually has no signs or symptoms.
  • In most cases, HPV infection clears spontaneously, without causing any health problems. Nevertheless, some infections do progress to genital warts, precancers, and cancers.
  • The types of HPV that cause genital warts are different from the types that can cause anogenital cancers.
  • Within an ongoing sexual relationship, both partners are usually infected at the time one person is diagnosed with HPV infection, even though signs of infection might not be apparent.
  • A diagnosis of HPV in one sex partner is not indicative of sexual infidelity in the other partner.
  • Treatments are available for the conditions caused by HPV (e.g., genital warts), but not for the virus itself.
  • HPV does not affect a woman's fertility or ability to carry a pregnancy to term.
  • Correct and consistent male condom use might lower the chances of giving or getting genital HPV, but such use is not fully protective, because HPV can infect areas that are not covered by a condom.
  • Sexually active persons can lower their chances of getting HPV by limiting their number of partners. However, HPV is common and often goes unrecognized; persons with only one lifetime sex partner can have the infection. For this reason, the only definitive method to avoid giving and getting HPV infection and genital warts is to abstain from sexual activity.
  • Tests for HPV are now available to help providers screen for cervical cancer in certain women. These tests are not useful for screening adolescent females for cervical cancer, nor are they useful for screening for other HPV-related cancers or genital warts in men or women. HPV tests should not be used to screen:
    • Men
    • Partners of women with HPV
    • Adolescent females
    • For health conditions other than cervical cancer
  • Two HPV vaccines are available, both of which offer protection against the HPV types that cause 70% of cervical cancers (i.e., types 16 and 18); the quadrivalent vaccine (Gardasil) also protects against the types that cause 90% of genital warts (i.e., types 6 and 11). These vaccines are most effective when all doses are administered before sexual contact. Either vaccine is recommended for 11- and 12-year-old girls and for females aged 13–26 years who did not receive or complete the vaccine series when they were younger. The quadrivalent HPV vaccine can be used in males aged 9–26 years to prevent genital warts.

The following are specific counseling messages for those persons diagnosed with genital warts and their partners:

  • Genital warts are not life threatening. If left untreated, genital warts might go away, stay the same, or grow in size or number. Except in very rare and unusual cases, genital warts will not turn into cancer.
  • It is difficult to determine how or when a person became infected with HPV; genital warts can be transmitted to others even when no visible signs of warts are present, even after warts are treated.
  • It is not known how long a person remains contagious after warts are treated. It is also unclear whether informing subsequent sex partners about a past diagnosis of genital warts is beneficial to the health of those partners.
  • Genital warts commonly recur after treatment, especially in the first 3 months.
  • Women should get regular Papanicolaou (Pap) tests as recommended, regardless of vaccination or genital wart history. Women with genital warts do not need to get Pap tests more often than recommended.
  • HPV testing is unnecessary in sexual partners of persons with genital warts.
  • If one sex partner has genital warts, both sex partners benefit from getting screened for other STDs.
  • Persons with genital warts should inform current sex partner(s) because the warts can be transmitted to other partners. In addition, they should refrain from sexual activity until the warts are gone or removed.
  • Correct and consistent male condom use can lower the chances of giving or getting genital warts, but such use is not fully protective because HPV can infect areas that are not covered by a condom.
  • The Gardasil vaccine, which has been approved for use in males and females aged 9–26 years, protects against the HPV types that cause 90% of genital warts (i.e., types 6 and 11).

Special Considerations

Pregnancy

Imiquimod, sinecatechins, podophyllin, and podofilox should not be used during pregnancy. Genital warts can proliferate and become friable during pregnancy. Although removal of warts during pregnancy can be considered, resolution might be incomplete or poor until pregnancy is complete. Rarely, HPV types 6 and 11 can cause respiratory papillomatosis in infants and children, although the route of transmission (i.e., transplacental, perinatal, or postnatal) is not completely understood. Whether cesarean section prevents respiratory papillomatosis in infants and children also is unclear; therefore, cesarean delivery should not be performed solely to prevent transmission of HPV infection to the newborn. Cesarean delivery is indicated for women with genital warts if the pelvic outlet is obstructed or if vaginal delivery would result in excessive bleeding. Pregnant women with genital warts should be counseled concerning the low risk for warts on the larynx (recurrent respiratory papillomatosis) in their infants or children.

HIV Infection

Persons who are HIV-infected are more likely to develop genital warts then persons who are not HIV-infected; moreover, lesions are more recalcitrant to treatment due to depressed cell-mediated immunity. No data suggest that treatment modalities for external genital warts should be different for HIV-infected persons. However, persons who are immunosuppressed because of HIV or other reasons might have larger or more numerous warts, might not respond as well as immunocompetent persons to therapy for genital warts, and might have more frequent recurrences after treatment. Squamous cell carcinomas arising in or resembling genital warts might occur more frequently among immunosuppressed persons, therefore, requiring biopsy for confirmation of diagnosis for suspicious cases. Because of the increased incidence of anal cancer in HIV-infected men who have sex with men (MSM), screening for anal intraepithelial neoplasia by cytology can be considered. However, evidence is limited concerning the natural history of anal intraepithelial neoplasias, the reliability of screening methods, the safety and response to treatments, and the programmatic considerations that would support this screening approach.

Squamous Cell Carcinoma in Situ

Patients in whom squamous cell carcinoma in situ of the genitalia is diagnosed should be referred to a specialist for treatment. Ablative modalities usually are effective, but careful follow-up is essential for patient management.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is not specifically stated for each recommendation.

Throughout this guideline document, the evidence used as the basis for specific recommendations is discussed briefly. More comprehensive, annotated discussions of such evidence will appear in background papers that will be published in a supplement issue of the journal Clinical Infectious Diseases.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate diagnosis, treatment, and management of patients with human papillomavirus (HPV) infection, including external genital warts, vaginal warts, urethral meatus warts, anal warts, oral warts, and subclinical genital HPV infection without exophytic warts

Potential Harms
  • Complications rarely occur when treatment is administered properly. Patients should be warned that persistent hypopigmentation or hyperpigmentation occur commonly with ablative modalities and has also been described with immune modulating therapies (imiquimod).

    Depressed or hypertrophic scars are uncommon but can occur, especially if the patient has had insufficient time to heal between treatments. Rarely, treatment can result in disabling chronic pain syndromes (e.g., vulvodynia or hyperesthesia of the treatment site) or, in the case of rectal warts, painful defecation or fistulas. A limited number of case reports of severe systemic effects from treatment with podophyllin resin and interferon have been documented.

  • Mild to moderate pain or local irritation might develop after treatment with podofilox. The safety of podofilox during pregnancy has not been established.
  • Local inflammatory reactions, including redness, irritation, induration, ulceration/erosions, and vesicles, are common with the use of imiquimod, and hypopigmentation has also been described. Imiquimod might weaken condoms and vaginal diaphragms. The safety of imiquimod during pregnancy has not been established.
  • The most common side effects of sinecatechins 15% are erythema, pruritus/burning, pain, ulceration, edema, induration, and vesicular rash. This medication may weaken condoms and diaphragms. No clinical data are available regarding the efficacy or safety of sinecatechins compared with other available anogenital wart treatment modalities. The medication is not recommended for HIV-infected persons, immunocompromised persons, or persons with clinical genital herpes because the safety and efficacy of therapy in these settings has not been established. The safety of sinecatechins during pregnancy also is unknown.
  • With cryotherapy, pain after application of the liquid nitrogen, followed by necrosis and sometimes blistering, is common.
  • Over-application or failure to air-dry podophyllin resin can result in local irritation caused by spread of the compound to adjacent areas. The safety of podophyllin during pregnancy has not been established.
  • Trichloroacetic acid (TCA) solutions have low viscosity comparable with that of water and can spread rapidly if applied excessively; therefore, they can damage adjacent tissue.

Contraindications

Contraindications

Imiquimod, sinecatechins, podophyllin, and podofilox should not be used during pregnancy.

Qualifying Statements

Qualifying Statements

These recommendations should be regarded as a source of clinical guidance and not prescriptive standards; health-care providers should always consider the clinical circumstances of each person in the context of local disease prevalence. The recommendations are applicable to various patient-care settings, including family planning clinics, private physicians' offices, managed care organizations, and other primary-care facilities. These guidelines focus on the treatment and counseling of individual patients and do not address other community services and interventions that are essential in sexually transmitted disease (STD)/human immunodeficiency virus (HIV) prevention efforts.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Mobile Device Resources
Resources
Slide Presentation
Staff Training/Competency Material
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Centers for Disease Control and Prevention (CDC). Genital warts. In: Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17;59(RR-12):70-4.
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
1993 (revised 2010 Dec 17)
Guideline Developer(s)
Centers for Disease Control and Prevention - Federal Government Agency [U.S.]
Source(s) of Funding

United States Government

Guideline Committee

Not stated

Composition of Group That Authored the Guideline

Chairperson: Kimberly A. Workowski, MD, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), CDC and Emory University, Atlanta, Georgia

Presenters: Heidi Bauer, MD, California Sexually Transmitted Disease Control Branch, Oakland, California; Laura Bachman, MD, Wake Forest University; Gale Burstein, MD, MPH, Erie County Department of Health; Linda Eckert, MD, University of Washington; William M. Geisler, MD, University of Alabama, Birmingham, Alabama; Khalil Ghanem, MD, Johns Hopkins University; Matt Golden, MD, MPH, University of Washington; Linda Gorgos, MD, New Mexico Department of Health; Margaret Hammerschlag, MD, State University of New York, Downstate Medical Center, Brooklyn, New York; Lisa Hollier, MD, University of Texas at Houston; Peter Leone, MD, University of North Carolina School of Medicine, Chapel Hill, North Carolina; Jeanne Marrazzo, MD, University of Washington, Seattle, Washington; Kenneth Hugh Mayer, MD, Brown University Medical School, Providence, Rhode Island; Paul Nyirjesy, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania; Anne Rompalo, MD, Johns Hopkins School of Medicine, Baltimore, Maryland; Pablo Sanchez, MD, University of Texas Southwestern Medical Center, Dallas, Texas; Bradley Stoner, MD, PhD, Washington University, St. Louis, Missouri; Anna Wald, MD, University of Washington, Seattle, Washington; George Wendel, MD, University of Texas Southwestern Medical School, Dallas, Texas; Harold C. Wiesenfeld, MD, University of Pittsburgh, Pittsburgh, Pennsylvania

Moderators: Willard Cates, Jr., MD, MPH, Family Health International, Durham, North Carolina; King K. Holmes, MD, PhD, University of Washington, Seattle, Washington; David Martin, MD, Louisiana State University Medical Center, New Orleans, Louisiana

Rapporteurs: Hunter Handsfield, MD, University of Washington, Seattle, Washington; William McCormack, MD, State University of New York Health Science Center, Brooklyn, New York; William M. Geisler, MD, University of Alabama, Birmingham, Alabama

Consultants: N. Franklin Adkinson, MD, Johns Hopkins University; William Andrews, MD, PhD, University of Alabama, Birmingham; Michael Augenbraun, MD, State University of New York Health Science Center, Brooklyn, New York; Bryon Batteiger, MD, University of Indiana; Gail Bolan, MD, California Department of Health, Oakland, California; Bruce Coles, DO, New York Department of Health; Carolyn Deal, PhD, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; J. Dennis Fortenberry, MD, Indiana University School of Medicine, Indianapolis, Indiana; Edward Hook, III, MD, University of Alabama, Birmingham, Alabama; Jane R. Schwebke, MD, University of Alabama, Birmingham, Alabama; Joann Schulte, DO, National Institutes of Health, Bethesda, Maryland; David Soper, MD, Medical University of South Carolina, Charleston, South Carolina; Lawrence Stanberry, MD, PhD, University of Texas Medical Branch, Galveston, Texas; Bruce Trigg, MD, New Mexico Department of Health; Yolanda Wimberly, MD, Morehouse School of Medicine; Jonathan M. Zenilman, MD, Johns Hopkins Bayview Medical Center, Baltimore, Maryland

Liaison Participants: Kaytura Aaron, MD, HRSA; Laura Bachman, MD, HIV Association of America; Lynn Barclay, MD, American Social Health Association; Margaret J. Blythe, MD, American Academy of Pediatrics; Carolyn D. Deal, PhD, National Institutes of Health; Jordon Dimitrakov, MD, PhD, American Urological Association; Mark FitzGerald, MD, British Association for Sexual Health and HIV, Southampton, United Kingdom; Dennis Fortenberry, MD, Society of Adolescent Medicine; Edward W. Hook, III, MD, Infectious Disease Society of America; Noreen Jack, MD, Pan American Health Association; Peter Kerndt, MD, National Coalition of STD Directors; Jeanne Marrazzo, MD, American Sexually Transmitted Diseases Association; Francis J. Ndowa, MD, World Health Organization, Geneva, Switzerland; Michael Parkinson, MD, American College of Preventative Medicine; Jeffrey Piepert, MD, American College of Obstetrics and Gynecology; Patricia Reams, MD, National Commission on Correctional Health Care; Bisan Salhi, MD, American College of Emergency Physicians; Karen Shea, MSN, Planned Parenthood Federation of America; David Soper, MD, Infectious Diseases Society for Obstetrics and Gynecology; Bradley Stoner, MD, PhD, CDC STD Prevention Training Centers; Amy Swann, Association of Reproductive Health Professionals; Litjen Tan, PhD, American Medical Association; Tom Wong, MD, Public Health Agency of Canada, Ottawa, Ontario, Canada

CDC, Division of Sexually Transmitted Disease Prevention Treatment Guidelines 2010 Project Coordinator: Kimberly A. Workowski, MD, NCHHSTP, CDC and Emory University, Atlanta, GA

Project Manager: Richard Voigt, NCHHSTP, CDC, Atlanta, Georgia

NCHHSTP/CDC Presenters: Deblina Datta, MD; Eileen Dunne, MD; Matthew Hogben, PhD; Scott Holmberg, MD; Emily Koumans, MD; Lori Newman, MD

CDC Consultants: Sevgi O. Aral, PhD; Ronald Ballard, PhD; Bernard Branson, MD; John Brooks, MD, MPH; John Douglas, MD; Alison Friedman; Dale Hu, MD; Peter Kilmarx, MD; John Papp, PhD; Phil Spradling, MD

Support Staff: Brenda Kelley, Valerie Barner, and Deborah McElroy, NCHHSTP, CDC, Atlanta, Georgia

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Centers for Disease Control and Prevention. Human papillomavirus infection. Sexually transmitted diseases treatment guidelines. MMWR Recomm Rep 2006 Aug 4;55(RR-11):62-7.

Guideline Availability

Electronic copies: Available from the Centers for Disease Control and Prevention (CDC) Web site External Web Site Policy.

Print copies: Available from the Centers for Disease Control and Prevention, MMWR, Atlanta, GA 30333. Additional copies can be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325; (202) 783-3238.

Availability of Companion Documents

The following are available:

  • The Centers for Disease Control and Prevention (CDC) sexually transmitted diseases (STD) treatment guidelines, 2010. eBook for iPad, iPhone, and iPod Touch. Available from the CDC Web site External Web Site Policy.
  • 2010 STD treatment guidelines webinar: an overview by CDC and the National Network of STD/HIV Prevention Training Centers (NNPTC), including continuing medical education (CME) activity. Available from the CDC Web site External Web Site Policy. Slides from the webinar are also available from the CDC Web site External Web Site Policy.
  • Sexually transmitted diseases treatment guidelines, 2010. Pod cast. Available from the CDC Web site External Web Site Policy.
Patient Resources

None available

NGC Status

This summary was completed by ECRI on September 5, 2002. This summary was updated by ECRI on October 13, 2006 and September 13, 2011.

Copyright Statement

No copyright restrictions apply.

Disclaimer

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The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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