Genital Warts-Standard Treatment Guidelines

Introduction

Genital warts are single or multiple soft, painless, flat, papular, or pedunculated growths which appear around the anus, vulvovaginal area, penis, urethra and perineum. May also appear as keratinized papules. Common sites are

• Women: around the introitus


• Men: under the foreskin, on the shaft


• Both: On the anogenital epithelium, within the anogenital tract.

Ministry of Health and Family Welfare, Government of India has issued the Standard Treatment Guidelines for Genital Warts.
Following are the major recommendations :

Causative organism

• Caused by Human Papilloma virus (HPV) Type 6 or 11 (90% cases).


• HPV types 16, 18, 31, 33, and 35 found occasionally and associated with high-grade intraepithelial neoplasia.

Symptoms

• Usually asymptomatic.


• Depending on the size and anatomic location, can be painful or pruritic.

INCIDENCE OF THE CONDITION IN OUR COUNTRY

Epidemiological studies show genital warts to be the most common sexually transmitted diseases. The population-based incidence of genital warts is estimated to be 106-160 cases per 100,000 population in the west, with the highest incidence rates in young adults aged 15-25 years. Genital warts affect approximately 30 million individuals worldwide. The case load in India is estimated to be above 3 million (only extrapolated data, no well defined population based statistics available).

DIFFERENTIAL DIAGNOSIS

• Condyloma lata (syphilis)


• Molluscum contagiosum


• Bowenoid papulosis


• Lichen planus and nitidus


• Pearly penile papules


• Seborrhoeic keratoses


• Fordyce’s spots

PREVENTION AND COUNSELING

General measures as applicable to all patients with suspected STIs

• Educate and counsel patient and sex partner(s) regarding RTIs/STIs, genital cancers, safer sex practices and importance of taking complete treatment.


• Treat partner(s) for the suspected organisms.


• Advise sexual abstinence during the course of treatment to minimize transmission.


• Promote the use of barrier contraception like condoms, educate about correct and consistent use.


• Refer for voluntary counseling and testing for HIV, Syphilis and Hepatitis B.


• Consider immunization against Hepatitis B.


• Schedule return visit after 7 days to ensure treatment compliance as well as to see reports of tests done.


• If symptoms persist, assess whether it is due to treatment failure or reinfection and advise prompt referral.

Key counseling messages to be conveyed to all patients diagnosed with HPV infection

• Genital HPV infection is very common and can also be spread by oral- sexual contact.


• It usually has no signs or symptoms.


• Mostly, clears spontaneously. Some infections do progress to genital precancers, and cancers.


• The types of HPV causing genital warts are different from the ones causing anogenital cancers.


• Treatments are available for the conditions caused by HPV but not for the virus itself.


• Warts do not affect a woman’s fertility or ability to carry a pregnancy to term.


• Correct and consistent male condom use lowers the chances of giving or getting genital HPV does not protect fully.


• To lower the chances of getting infection, limit the number of partners. HPV vaccines.

Two types which offer protection against the HPV types 16 and 18 that cause 70% of cervical cancers.

• Cervarix: bivalent vaccine against Type 16 and 18 (0.5 ml IM at 0,1 and 6 mths).


• Gardasil: quadrivalent vaccine which also protects against the types 6 and 11. Three doses (0.5 ml IM at 0,2 and 6 months) Most effective when all three doses have been administered before any sexual contact.

OPTIMAL DIAGNOSTIC CRITERIA, INVESTIGATIONS, TREATMENT & REFERRAL CRITERIA

Situation 1: At Secondary Hospital/ Non-Metro situation: Optimal Standards of Treatment in Situations where technology and resources are limited

Clinical Diagnosis

• Presumptive Diagnosis based on clinical examination (inspection).


• History of exposure followed by signs and symptoms is contributory towards diagnosis.

On examination, genital warts can be

• Single or multiple.


• Soft or verrucous.


• Asymptomatic, may be painful occasionally.

Investigations

• Aceto-white test: Application of 3%–5% acetic acid, which causes HPV-infected genital mucosa to turn white in color.


• Biopsy: might be indicated if

• the diagnosis is uncertain


• the lesions do not respond to standard therapy


• the disease worsens during therapy


• the lesion is atypical


• the patient has comprised immunity


• the warts are pigmented, indurated, fixed, bleeding, or ulcerated.


• The lesion shows a high risk of atypia

• HPV DNA testing: Not recommended on a routine basis as test results would not alter clinical management of the condition.

Treatment

• Should be guided by the preference of the patient, available resources, and the experience of the health-care provider.


• No definitive evidence that any of the available treatments are superior to any other


• No single treatment is ideal for all patients or all warts.


• Spontaneous resolution of lesions may also occur.

Recommended regimens: (NACO recommended)

I. Penile and Perianal warts (external warts)
20% Podophyllin in compound tincture of benzoin

II. Cervical warts

• Podophyllin is contraindicated.


• Biopsy of warts to rule out malignant change.


• Cryo cauterization is the treatment of choice.


• Cervical cytology should be periodically done in the sexual partner(s) of men with genital warts.

• 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.

Alternate Regimens for External Genital Warts

Self applied

• Imiquimod 5% cream

Provider administered

• Cryotherapy: repeat application every 1-2 weeks


• Trichhloroaceitic acid: weekly applications


• Surgical removal: scissor excision, curettage, electrosurgery, radiosurgery

Alternate Regimens for Cervical Warts

• Management of exophytic cervical warts should include consultation with a specialist

Special situations

1. Vaginal Warts

• Cryo-cuaterisation


• TCA or BCA 80%–90% applied to warts.

2. Urethral Meatus Warts

• Cryotherapy with liquid nitrogen


• Podophyllin 10%–25% in compound tincture of benzoin.


• Imiquimod use

3. Anal Warts

• Cryotherapy with liquid nitrogen


• TCA or BCA 80%–90% applied to warts.


• Surgical removal


• Intra-anal warts should be managed in consultation with a surgical specialist for digital examination, standard anoscopy, or high-resolution anoscopy.

Alternative Regimens

• intralesional interferon


• photodynamic therapy


• topical cidofovir.

Special Considerations

Pregnancy

• Imiquimod, podophyllin not to be used


• genital warts can proliferate and become friable


• Removal of warts during pregnancy can be considered, though resolution might be incomplete or poor until pregnancy is complete.


• Cesarean delivery for women with genital warts is indicated if

• pelvic outlet is obstructed


• Vaginal delivery would result in excessive bleeding.


• HPV types 6 and 11 can rarely cause respiratory papillomatosis in infants and children. Whether cesarean section can prevent this is unclear, hence this is not an absolute indication for caesarean delivery.

HIV Infection

• more likely to develop genital warts


• Lesions are more recalcitrant to treatment


• Same treatment regimes to be followed, however, might not respond as well and might have more frequent recurrences after treatment


• Squamous cell carcinomas arising in or resembling genital warts are more frequent, hence biopsy for confirmation of diagnosis in suspicious cases.


• Screening for anal intraepithelial neoplasia by cytology recommended in HIV-infected MSM.

Squamous Cell Carcinoma in Situ

• Referred to a specialist for treatment


• Ablative modalities usually are effective


• Careful follow-up is essential

Referral to specialists

Cervical Intraepithelial neoplasia
Invasive cervical squamous cell carcinoma
Penile Intraepithelial Neoplasia
Anal intraepithelial neoplasia or carcinoma

Situation 2: At Super Specialty Facility in Metro location where higher-end technology is available

Clinical Diagnosis
Same as above

Investigations
Same as above

Treatment
Same as above

Guidelines by The Ministry of Health and Family Welfare :