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Guideline Summary
Guideline Title
Human papillomavirus (HPV) infection. In: Sexually transmitted diseases treatment guidelines, 2010.
Bibliographic Source(s)
Centers for Disease Control and Prevention (CDC). Human papillomavirus (HPV) infection. In: Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17;59(RR-12):69-70.
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

Guideline Category
Diagnosis
Management
Prevention
Clinical Specialty
Family Practice
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Preventive Medicine
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

Interventions and Practices Considered

Diagnosis

Human papillomavirus (HPV) tests to detect viral nucleic acid or capsid protein

Prevention

  1. Bivalent vaccine (Cervarix)
  2. Quadrivalent vaccine (Gardasil)
  3. Routine cervical cancer screening
Major Outcomes Considered
  • Rate of asymptomatic genital human papillomavirus (HPV) infection
  • 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.

More than 100 types of human papillomavirus (HPV) exist, more than 40 of which can infect the genital area. Most HPV infections are asymptomatic, unrecognized, or subclinical. Oncogenic, or high-risk HPV types (e.g., HPV types 16 and 18), are the cause of cervical cancers. These HPV types are also associated with other anogenital cancers in men and women, including penile, vulvar, vaginal, and anal cancer, as well as a subset of oropharyngeal cancers. Nononcogenic, or low-risk HPV types (e.g., HPV types 6 and 11), are the cause of genital warts and recurrent respiratory papillomatosis. Asymptomatic genital HPV infection is common and usually self-limited; it is estimated that more than 50% of sexually active persons become infected at least once in their lifetime. Persistent oncogenic HPV infection is the strongest risk factor for development of precancers and cancers.

HPV Tests

HPV tests are available for women aged >30 years undergoing cervical cancer screening. These tests should not be used for men, for women <20 years of age, or as a general test for STDs. These HPV tests detect viral nucleic acid (i.e., deoxyribonucleic acid [DNA] or ribonucleic acid [RNA]) or capsid protein. Four tests have been approved by the U.S. Food and Drug Administration (FDA) for use in the United States: the HC II High-Risk HPV test (Qiagen), HC II Low-Risk HPV test (Qiagen), Cervista HPV 16/18 test, and Cervista HPV High-Risk test (Hologics).

Treatment

Treatment is directed to the macroscopic (i.e., genital warts) or pathologic (i.e., precancerous) lesions caused by infection. Subclinical genital HPV infection typically clears spontaneously, and therefore specific antiviral therapy is not recommended to eradicate HPV infection. In the absence of lesions, treatment is not recommended for subclinical genital HPV infection whether it is diagnosed by colposcopy, acetic acid application, or by laboratory tests for HPV DNA. Treatment also is not recommended for cervical intraepithelial neoplasia 1 (CIN1).

Prevention

Two HPV vaccines are licensed in the United States: a bivalent vaccine (Cervarix) containing HPV types 16 and 18 and a quadrivalent vaccine (Gardasil) vaccine containing HPV types 6, 11, 16, and 18. Both vaccines offer protection against the HPV types that cause 70% of cervical cancers (i.e., types 16 and 18), and the quadrivalent HPV vaccine also protects against the types that cause 90% of genital warts (i.e., types 6 and 11). Either vaccine can be administered to girls aged 11–12 years and can be administered to those as young as 9 years of age; girls and women ages 13–26 years who have not started or completed the vaccine series also should receive the vaccine. HPV vaccine is indicated for girls in this age group, because benefit is greatest if it is administered before the onset of sexual activity. The quadrivalent (Gardasil) HPV vaccine can also be used in males aged 9–26 years to prevent genital warts. Administering the vaccine to boys before the onset of sexual activity is optimal. Both HPV vaccines are administered as a 3-dose series of intramuscular (IM) injections over a 6-month period, with the second and third doses given 1–2 and then 6 months after the first dose. Ideally, the same vaccine product should be used for the entire 3-dose series. HPV vaccine is available for eligible children and adolescents aged <19 years through the Vaccines for Children (VFC) program (available by calling CDC INFO [800-232-4636]).

Women who have received HPV vaccine should continue routine cervical cancer screening because 30% of cervical cancers are caused by HPV types other than 16 or 18. In the United States, the vaccines are not licensed or recommended for use in women >26 years of age. No published data are available on the effectiveness, programmatic requirements, or cost-effectiveness of administering the HPV vaccine in STD clinic settings.

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 prevention, diagnosis, and management of patients with human papillomavirus (HPV) infection

Potential Harms

Not stated

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
Staying Healthy
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Centers for Disease Control and Prevention (CDC). Human papillomavirus (HPV) infection. In: Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17;59(RR-12):69-70.
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

NGC Disclaimer

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

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