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Hot Topics in Sexually Transmitted Infections and Associated Conditions

(Published November 2013)

Human Papillomavirus

  • Key facts about infection
    • There are > 100 types of HPV, of which > 40 can cause genital infection and are sexually transmitted.9
    • Within 2 years, about 90 percent of HPV infections are cleared by the immune system, although viral DNA may persist for prolonged periods, with risk of later reactivation. The remaining 10 percent of infections with high-risk types that persist are strongly linked to a high risk of a precancer diagnosis.50,51
    • HPV infection is ubiquitous; nearly all sexually active men and women will be infected with at least one type of HPV at some point in their lives.52
    • Of low-risk HPV types, two (HPV 6 and HPV 11) cause 90 percent of external genital and anal warts, with low-grade cervical lesions.53
    • High-risk types, such as HPV 16, HPV 18, and several others, are associated with cervical, anorectal, vulvovaginal, and penile cancers and may be cofactors in oropharyngeal, skin, and other cancers.9
    • The most prevalent high-risk types are HPV 16 and HPV 18; together they cause 60 to 70 percent of cervical and anal cancers. HPV 16 causes some pharyngeal cancers. 54
  • Prevention
Table 12: Comparison of HPV Vaccines5566
  Quadrivalent (Gardasil™) Bivalent (Cervarix™)
Targeted HPV types 6, 11, 16, 18

16, 18

HPV-related diseases potentially prevented

Cervical cancer

External genital warts

Cervical cancer

Indication Females ages 926 years for prevention of cervical cancer, cervical cancer precursors, vaginal and vulvar cancer precursors, and anogenital warts related to the four HPV types targeted by the vaccine.

Information is not yet available.

Dosing and administration Intramuscular injection of three separate 0.5-mL doses at 0, 2, and 6 months.

Intramuscular injection of three separate 0.5-mL doses at 0, 1,and 6 months.

Efficacy

Among young women (ages 1626 years) who previously had not been exposed to any of the four HPV types in the vaccine:

  • 98% efficacy in preventing CIN2/3 caused by the targeted HPV types
  • 100% efficacy in preventing vulvar and vaginal precancers caused by the targeted HPV types
  • 99% efficacy in preventing genital warts caused by the targeted HPV types

In men (ages 16 to 26 years) not previously exposed to the four HPV types in the vaccine, there was 90% vaccine efficacy in preventing genital warts and 75% efficacy in preventing anal precancers.

Among young women (ages 1525 years) who previously had not been exposed to either of the two HPV types in the vaccine:

  • 100% efficacy in preventing CIN3+ caused by the targeted HPV types
Most common adverse events Syncope (fainting), injection site pain and redness, dizziness, nausea, headache. Itchiness at the injection site and mild or moderate fever have also been reported.
To reduce fainting, prescribing information recommends that patients remain seated for 15 minutes after vaccination.

Syncope (fainting), injection site pain and redness, dizziness, nausea, headache.
To reduce fainting, prescribing information recommends that patients remain seated for 15 minutes after vaccination.

Systemic adverse events

Rates of serious adverse events similar between placebo and treated groups in clinical trials; vaccine-related serious adverse events occurred in 0.1% of more than 29,000 female and male participants.
Since 2006, 6% of all reports described serious adverse events. No current evidence suggests that the HPV vaccine caused the adverse events.

Low rates of events in more than 30,000 females in clinical trials.
Rates of serious adverse events similar between placebo and treated groups in clinical trials; no subject withdrawals due to serious adverse events.

    • The primary indication for males is prevention of penile and anal cancer.
    • Immunization of men contributes to protection of women and male partners, although this is not a formal indication for immunization.
    • Brief education about HPV and the vaccine can increase acceptance rates.67
    • Male latex condoms reduce but do not completely eliminate transmission; even with consistent condom use, most sexually active men and women can expect to acquire one or more anogenital HPV infections.68
  • Screening and diagnosis
    • HPV tests
        • Available tests detect viral nucleic acid (DNA or RNA) or capsid protein.
        • Tests are FDA approved for women only, for testing of cervical and vaginal specimens.
          • Age > 30 years undergo­ing cervical cancer screening
          • Age > 21 years with ASC-US result on Pap test (Note: HPV reflex testing for ASC-US is optional for women ages 21 to 24 years)
        • HPV testing is not recommended for women ≤ 20 years of age, as a general test for STIs, or to determine HPV status before vaccination.69

Table 13: FDA-Cleared Tests for High-Risk HPV

Test Manufacturer Genotyping
Aptima HPV Hologic If requested, subtyping for 16/18 and/or 45 can be added
Cervista HPV High-Risk Hologic If requested, Cervista HPV 16/18 can be added
Cobas HPV Roche Includes subtyping for 16 and 18
Hybrid Capture II High-Risk HPV Qiagen Subtyping cannot be added
        • Clinicians should know which tests are available at the laboratories from which they obtain HPV testing and should understand the process for ordering genotyping when needed.
    • Cytology
        • Screening guidelines are available for specific guidance on the use of Pap tests, colposcopy, and cervical biopsy and the management of abnormal cytology results (see the algorithms at www.asccp.org/Portals/9/docs/Algorithms%207.30.13.pdf)
        • Important recent changes to screening recommendations:70
          • HPV testing is no longer recommended in women 21 to 24 years old due to the high prevalence of HPV infection and because management is based solely on cytology or histology, regardless of HPV test result.
          • The recommended age for an initial Pap test is 21, regardless of sexual history and timing of sexual debut; this change will avoid the attendant harm of overtreatment of abnormal cytology related to HPV infection in young women.
          • The recommended frequency of Pap testing is every three years as long as results are normal.
          • Alternatively, women ages 30 to 65 may be screened with cytology combined with HPV (co-testing) every five years.
          • Women with certain risk factors may need more frequent screening or to continue screening beyond age 65.
          • See guidance for specific details (www.asccp.org/Portals/9/docs/Algorithms%207.30.13.pdf).
    • Evaluation for genital warts
        • Visual examination, sometimes aided by a hand-held magnifier, usually is sufficient for reliable diagnosis by experienced clinicians.
        • Acetic acid (35 percent) to highlight HPV-infected tissues (acetowhitening) is nonspecific, insensitive, and generally not recommended.
  • Treatment and management
    • HPV vaccines are among the most biologically effective of all vaccines, with nearly 100 percent efficacy in preventing infection with the types included in the vaccine; they have no effect on established infection and no role in therapy.
    • Treatment is not recommended for.9
        • Subclinical genital HPV infection whether diagnosed by colposcopy, acetic acid application, or laboratory tests for HPV DNA
        • Mild cytological or histological findings on Pap smear (ASC-US, LSIL) or cervical biopsy (CIN1)
    • For management of cervical cytology abnormalities, see the following:
    • For management of genital warts, see the following available treatments:

Table 14: Available Treatments for Genital Warts*9

Medication Comments
Patient applied (prescription)
Podofilox 0.5% solution or gel Patient should apply to visible warts twice a day for 3 days, followed by 4 days of no therapy; cycle can be repeated for up to four cycles if needed. Safety during pregnancy has not yet been established.
Imiquimod 5% cream Patient should apply once daily at bedtime, three times a week for up to 16 weeks. Treated area should be washed with soap and water 6 to 10 hours after application.
May weaken condoms and diaphragms. Safety during pregnancy has not yet been established.
Sinecatechins 15% ointment Patient should apply three times daily for no longer than 16 weeks. When medication is on the skin, the patient should avoid sexual contact. May weaken condoms and diaphragms. Safety during pregnancy has not yet been established.
Provider administered (clinic based)
Cryotherapy with liquid nitrogen or cryoprobe Repeat applications every 1 to 2 weeks. Adequate training required, as over- and under-treatment can lead to complications or low efficacy.
Podophyllin resin 10% to 25% in compound tincture of benzoin Apply to each wart and allow to dry before any contact with clothing; can be repeated weekly, if necessary. Application should be limited to < 0.5 mL of podophyllin or an area of < 10 cm2 of warts per session. Area treated should not contain any open lesions or wounds. Instruct the patient to thoroughly wash area 1 to 4 hours after application to reduce local irritation. Safety during pregnancy has not yet been established.
Bichloroacetic acid (BCA) 80% to 90% Apply a small amount only to the warts and allow area to dry before the patient sits or stands. If needed for pain, BCA can be neutralized with soap or sodium bicarbonate. Can be repeated weekly, if necessary.
Trichloroacetic acid (TCA) 80% to 90% Same comments as for BCA, plus
TCA has a low viscosity and can spread rapidly to surrounding areas if applied excessively.
Surgical removal with tangential scissor excision, tangential shave excision, curettage, or electrosurgery For patients with a large number or area of warts. This usually eliminates warts in one visit but requires sub­stantial training, additional equipment, and longer office visit than other modalities.

* For specific guidance regarding the use of these therapies or for treatment of vaginal, cervical, anal, or urethral meatus lesions, see CDC guidelines.

        • Treatment choice should be based on the prefer­ence of the patient, available resources, and the experience of the provider with the different treatment regimens.
        • Research has not shown any treatment to be superior to the others, and more than one type of treatment may be required to eradicate warts.9