Introduction

Vaccination against human papillomavirus (HPV) is recommended to prevent HPV infections and HPV-associated diseases, including cancers. Routine vaccination at age 11 or 12 years has been recommended by the Advisory Committee on Immunization Practices (ACIP) since 2006 for females and since 2011 for males (1,2). This report provides recommendations and guidance regarding use of HPV vaccines and updates ACIP HPV vaccination recommendations previously published in 2014 and 2015 (1,2). This report includes new recommendations for use of a 2-dose schedule for girls and boys who initiate the vaccination series at ages 9 through 14 years. Three doses remain recommended for persons who initiate the vaccination series at ages 15 through 26 years and for immunocompromised persons.

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Background

HPV infection causes cervical, vaginal, and vulvar cancers in women; penile cancers in men; and oropharyngeal and anal cancers as well as genital warts in both men and women (3). Three HPV vaccines are licensed for use in the United States. All are noninfectious. Quadrivalent and 9-valent HPV vaccines (4vHPV and 9vHPV, Gardasil and Gardasil 9, Merck and Co, Inc., Whitehouse Station, New Jersey) are licensed for use in females and males aged 9 through 26 years (1). Bivalent HPV vaccine (2vHPV, Cervarix, GlaxoSmithKline, Rixensart, Belgium) is licensed for use in females aged 9 through 25 years (1). As of late 2016, only 9vHPV is being distributed in the United States. The majority of all HPV-associated cancers are caused by HPV 16 or 18, types targeted by all three vaccines. In addition, 4vHPV targets HPV 6 and 11, types that cause genital warts. 9vHPV protects against these and five additional types: HPV 31, 33, 45, 52, and 58. All three vaccines have been approved for administration in a 3-dose series at intervals of 0, 1 or 2, and 6 months. In October 2016, after considering new clinical trial results (4), the Food and Drug Administration (FDA) also approved 9vHPV for use in a 2-dose series for girls and boys aged 9 through 14 years (5). In October 2016, ACIP recommended a 2-dose schedule for adolescents initiating HPV vaccination in this age range. This report provides recommendations for use of 2-dose and 3-dose schedules for HPV vaccination.

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Methods

During November 2015–October 2016, the ACIP HPV Vaccines Work Group held monthly telephone conferences to 1) review and evaluate the quality of the evidence assessing immunogenicity, efficacy, and postlicensure effectiveness of a 2-dose schedule; 2) consider benefits and harms of a 2-dose schedule; 3) weigh the variability in the values and preferences of patients and providers for a 2-dose schedule; and 4) examine health economic analyses. During teleconferences, summaries of findings were presented for Work Group discussion.

A systematic review was conducted to identify studies involving human subjects* that reported primary data on any important or critical health outcomes related to HPV vaccination† after 2 doses of 9vHPV, 4vHPV, or 2vHPV, administered at an interval of 0 and ≥6 months (±4 weeks) to persons aged 9 through 14 years. The review focused on this age group given available 2-dose trial data for 9vHPV (4). Immunogenicity outcomes of interest were seroconversion, geometric mean titers (GMTs), or antibody avidity. Studies were excluded if they lacked a comparison group in which efficacy of 3 doses of HPV vaccine against clinical endpoints was demonstrated in clinical trials (e.g., females aged 15 through 26 years).§ Evidence regarding a 3-dose schedule for HPV vaccine was reviewed previously (1,2).

Quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Detailed methods and GRADE tables can be found online (6). Other studies from the search and from the broader literature informed additional expert guidance that extended beyond the research question addressed formally via GRADE analysis (7). Evidence was reviewed by the Work Group, summarized, and publicly presented at the February and June 2016 ACIP meetings. CDC vaccine recommendations are developed using the GRADE framework (8). Proposed recommendations were presented, and after a public comment period, were approved unanimously¶ by the voting ACIP members at the October 2016 ACIP meeting.

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Summary of Key Findings

Immunogenicity. In the 9vHPV clinical trial that was the basis for FDA approval of a 2-dose series, participants were girls and boys aged 9 through 14 years, compared with young females aged 16 through 26 years (4). Among 1,377 participants, ≥97.9% seroconverted to all nine vaccine-preventable HPV types by 4 weeks after the last dose. For girls and boys who received 2 doses of 9vHPV 6 months apart (0, 6 month schedule) or 12 months apart (0, 12 month schedule), noninferiority criteria were met for seroconversion and GMTs. Furthermore, GMTs were significantly higher for all 9vHPV types among persons aged 9 through 14 years who received 2 doses compared with females aged 16–26 years who received 3 doses (0, 2, 6 month schedule). Six additional studies found similar results for 4vHPV and 2vHPV (6). Immunogenicity was found to be noninferior with 2 doses in persons aged 9 through 14 years compared with 3 doses in a group in which clinical efficacy was demonstrated (GRADE evidence type 3).

Efficacy and effectiveness. Although efficacy and postlicensure effectiveness studies were reviewed, none met the inclusion criteria detailed above. The prelicensure HPV vaccine efficacy trials were conducted with 3-dose series; post hoc analyses conducted with data from some of these trials found high efficacy against infection among vaccinees who received 2 doses and those who received 3 doses (9,10). A large study comparing 2 doses with 3 doses also suggested similar efficacy against infection (11). Postlicensure effectiveness studies have found lower effectiveness against various HPV-associated outcomes among vaccinees who received 2 doses compared with those who received 3 doses, but methodologic challenges with these studies limit interpretation of the findings.**

Duration of protection. Through 10 years of follow-up from clinical trials, no evidence of waning protection after a 3-dose series of HPV vaccine has been found (1). Because antibody kinetics are similar with 2-dose and 3-dose series, duration of protection is also expected to be long-lasting after a 2-dose series (12,13).

Health impact and cost-effectiveness modeling. Population-level effectiveness and cost-effectiveness of 2-dose and 3-dose schedules of 9vHPV in the United States have been modeled (14). Assuming both efficacy and duration of protection are similar with either schedule, a 2-dose series would be cost-saving and have similar population impact to a 3-dose series. Even if duration of protection is 20 years for a 2-dose series and lifelong for a 3-dose series, additional benefits of a 3-dose series would be relatively small, and a 2-dose series would be more cost-effective (14).

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Rationale

HPV vaccines are highly effective and safe, and a powerful prevention tool for reducing HPV infections and HPV-associated cancers (1,2). Based on the available immunogenicity evidence, a 2-dose schedule (0, 6–12 months) will have efficacy equivalent to a 3-dose schedule (0, 1–2, 6 months) if the HPV vaccination series is initiated before the 15th birthday (GRADE evidence type 3) (6). ACIP recommends a 2-dose schedule for HPV vaccination of girls and boys who initiate the vaccination series at ages 9 through 14 years (Category A recommendation).

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Recommendations

Routine and catch-up age groups. ACIP recommends routine HPV vaccination at age 11 or 12 years. Vaccination can be given starting at age 9 years. ACIP also recommends vaccination for females through age 26 years and for males through age 21 years who were not adequately vaccinated previously. Males aged 22 through 26 years may be vaccinated. (See also: Special populations, Medical conditions)

Dosing schedules. For persons initiating vaccination before their 15th birthday, the recommended immunization schedule is 2 doses of HPV vaccine. The second dose should be administered 6–12 months after the first dose (0, 6–12 month schedule)†† ( Table).

For persons initiating vaccination on or after their 15th birthday, the recommended immunization schedule is 3 doses of HPV vaccine. The second dose should be administered 1–2 months after the first dose, and the third dose should be administered 6 months after the first dose (0, 1–2, 6 month schedule)§§ (Table).

Persons vaccinated previously. Persons who initiated vaccination with 9vHPV, 4vHPV, or 2vHPV before their 15th birthday, and received 2 doses of any HPV vaccine at the recommended dosing schedule (0, 6–12 months), or 3 doses of any HPV vaccine at the recommended dosing schedule (0, 1–2, 6 months), are considered adequately vaccinated.

Persons who initiated vaccination with 9vHPV, 4vHPV, or 2vHPV on or after their 15th birthday, and received 3 doses of any HPV vaccine at the recommended dosing schedule, are considered adequately vaccinated.

9vHPV may be used to continue or complete a vaccination series started with 4vHPV or 2vHPV.

For persons who have been adequately vaccinated with 2vHPV or 4vHPV, there is no ACIP recommendation regarding additional vaccination with 9vHPV.

Interrupted schedules. If the vaccination schedule is interrupted, the series does not need to be restarted. The number of recommended doses is based on age at administration of the first dose.

Special populations. For children with a history of sexual abuse or assault, ACIP recommends routine HPV vaccination beginning at age 9 years.

For men who have sex with men,¶¶ ACIP recommends routine HPV vaccination as for all males, and vaccination through age 26 years for those who were not adequately vaccinated previously.

For transgender persons, ACIP recommends routine HPV vaccination as for all adolescents, and vaccination through age 26 years for those who were not adequately vaccinated previously.

Medical conditions. ACIP recommends vaccination with 3 doses of HPV vaccine (0, 1–2, 6 months) for females and males aged 9 through 26 years with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity,*** such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasms, transplantation, autoimmune disease, or immunosuppressive therapy, because immune response to vaccination might be attenuated (Table) (7).

Contraindications and precautions. Contraindications and precautions, including those related to pregnancy, are unchanged from previous recommendations (1,2). Adverse events occurring after administration of any vaccine should be reported to the Vaccine Adverse Event Reporting System (VAERS). Reports can be submitted to VAERS online, by fax, or by mail. Additional information about VAERS is available by telephone (1-800-822-7967) or online (https://vaers.hhs.gov ).

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Acknowledgments

Members of the Advisory Committee on Immunization Practices (ACIP) (member roster for July 2016–June 2017 is available online at https://www.cdc.gov/vaccines/acip/committee/members-archive.html); ACIP HPV Vaccines Work Group: Jorge E. Arana, MD, Atlanta, Georgia; Joseph Bocchini, MD, Shreveport, Louisiana; Harrell Chesson, PhD, Atlanta, Georgia; Tamera Coyne-Beasley, MD, Chapel Hill, North Carolina; C. Robinette Curtis, MD, Atlanta, Georgia; Carolyn D. Deal, PhD, Bethesda, Maryland; Shelley Deeks, MD, Toronto, Ontario, Canada; John Douglas, MD, Greenwood Village, Colorado; Linda Eckert, MD, Seattle, Washington; Sandra Adamson Fryhofer, MD, Atlanta, Georgia; Julianne Gee, MPH, Atlanta, Georgia; Bruce G. Gellin, MD, Washington, DC; Samuel Katz, MD, Durham, North Carolina; Alison Kempe, MD, Denver, Colorado (Chair); Aimée R. Kreimer, PhD, Bethesda, Maryland; Joohee Lee, MD, Silver Spring, Maryland; Lauri E. Markowitz, MD, Atlanta, Georgia (CDC Lead); Elissa Meites, MD, Atlanta, Georgia; Amy B. Middleman, MD, Oklahoma City, Oklahoma; Chris Nyquist, MD, Denver, Colorado; Sean O’Leary, MD, Aurora, Colorado; Sara E. Oliver, MD, Atlanta, Georgia; Cynthia Pellegrini, Washington, DC; Jeff Roberts, MD; Rockville, Maryland; José R. Romero, MD, Little Rock, Arkansas; Jeanne Santoli, MD, Atlanta, Georgia; Mona Saraiya, MD, Atlanta, Georgia; Debbie Saslow, PhD, Atlanta, Georgia; Margot Savoy, MD, Wilmington, Delaware; Shannon Stokley, DrPH, Atlanta, Georgia; Lakshmi Sukumaran, MD, Atlanta, Georgia; Elizabeth R. Unger, PhD, MD, Atlanta, Georgia; Patricia Whitley-Williams, MD, New Brunswick, New Jersey; Rodney Willoughby, MD, Wauwatosa, Wisconsin; JoEllen Wolicki, Atlanta, Georgia; Sixun Yang, MD, Rockville, Maryland; Jane Zucker, MD, New York, New York.

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Corresponding author: Elissa Meites, emeites@cdc.gov, 404-639-8253.

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1Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, CDC; 2HPV Vaccines Work Group, Advisory Committee on Immunization Practices, Atlanta, Georgia; 3Department of Pediatrics, University of Colorado Anschutz Medical Campus, Denver, Colorado.

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* No primary data on special populations or medical conditions, including immunocompromising conditions, were available for 2-dose intervals and age ranges specified.

† No primary data on other important and critical outcomes, including genital warts, precancers, oropharyngeal cancer, anal cancer, cervical cancer, vaginal/vulvar cancer, and penile cancer, were available for 2-dose intervals and age ranges specified.

§ Studies were excluded when 2-dose interval was not ≥5 months.

¶ Twelve votes to none, with one recusal.

** In studies conducted in the setting of a 3-dose HPV vaccine recommendation or policy, many 2-dose recipients received HPV vaccine doses at a 1–2 month interval; in addition, 2-dose recipients differed from 3-dose recipients in ways that suggested differences in HPV exposure.

†† In a 2-dose schedule of HPV vaccine, the minimum interval between the first and second doses is 5 months. If the second dose is administered after a shorter interval, a third dose should be administered a minimum of 12 weeks after the second dose and a minimum of 5 months after the first dose.

§§ In a 3-dose schedule of HPV vaccine, the minimum intervals are 4 weeks between the first and second doses, 12 weeks between the second and third doses, and 5 months between the first and third doses. If a vaccine dose is administered after a shorter interval, it should be readministered after another minimum interval has elapsed since the most recent dose.

¶¶ Including men who identify as gay or bisexual, or who intend to have sex with men.

*** The recommendation for a 3-dose schedule of HPV vaccine does not apply to children aged <15 years with asplenia, asthma, chronic granulomatous disease, chronic liver disease, chronic lung disease, chronic renal disease, central nervous system anatomic barrier defects (e.g., cochlear implant), complement deficiency, diabetes, heart disease, or sickle cell disease.

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References

1. Markowitz LE, Dunne EF, Saraiya M, et al. Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2014;63(No. RR-05). PubMed
2. Petrosky E, Bocchini JA , Hariri S, et al. . Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rep 2015;64:300–4. PubMed
3. Viens LJ, Henley SJ, Watson M, et al. Human papillomavirus-associated cancers—United States, 2008–2012. MMWR Morb Mortal Wkly Rep 2016;65:661–6. CrossRef  PubMed
4. Iversen O-E, Miranda MJ, Ulied A, et al. Immunogenicity of the 9-valent HPV vaccine using 2-dose regimens in girls and boys vs a 3-dose regimen in women. JAMA 2016;316:2411–21.CrossRef  PubMed
5. Food and Drug Administration. Prescribing information [package insert]. Gardasil 9 [human papillomavirus 9-valent vaccine, recombinant]. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2016. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM426457.pdf
6. CDC. Grading of Recommendations Assessment, Development and Evaluation (GRADE) of a 2-dose schedule for human papillomavirus (HPV) vaccination. Atlanta, GA: US Department of Health and Human Services, CDC; 2016. https://www.cdc.gov/vaccines/acip/recs/grade/hpv-2-dose.html
7. Rubin LG, Levin MJ, Ljungman P, et al. ; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014;58:e44–100. CrossRef  PubMed
8. Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ; ACIP Evidence Based Recommendations Work Group (EBRWG). Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine 2011;29:9171–6. CrossRef  PubMed
9. Kreimer AR, Struyf F, Del Rosario-Raymundo MR, et al. ; Costa Rica Vaccine Trial Study Group Authors; PATRICIA Study Group Authors; HPV PATRICIA Principal Investigators/Co-Principal Investigator Collaborators; GSK Vaccines Clinical Study Support Group. Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA Trials. Lancet Oncol 2015;16:775–86. CrossRef  PubMed
10. Kreimer AR, Rodriguez AC, Hildesheim A, et al. ; CVT Vaccine Group. Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine. J Natl Cancer Inst 2011;103:1444–51. CrossRef  PubMed
11. Sankaranarayanan R, Prabhu PR, Pawlita M, et al. ; Indian HPV Vaccine Study Group. Immunogenicity and HPV infection after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre prospective cohort study. Lancet Oncol 2016;17:67–77. CrossRef  PubMed
12. Romanowski B, Schwarz TF, Ferguson L, et al. Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a two-dose schedule in adolescent girls: five-year clinical data and modeling predictions from a randomized study. Hum Vaccin Immunother 2016;12:20–9. CrossRef  PubMed
13. Dobson SR, McNeil S, Dionne M, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA 2013;309:1793–802.CrossRef  PubMed
14. Laprise JF, Markowitz LE, Chesson HW, Drolet M, Brisson M. Comparison of 2-dose and 3-dose 9-valent human papillomavirus vaccine schedules in the United States: a cost-effectiveness analysis. J Infect Dis 2016;214:685–8. CrossRef  PubMed

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TABLE. Recommended number of doses and intervals for human papillomavirus (HPV) vaccine, by age at series initiation and medical conditions — United States, 2016

Population	Recommended number of HPV vaccine doses	Recommended interval between doses
Persons initiating HPV vaccination at ages 9 through 14 years,* except immunocompromised persons†	2	0, 6–12 months§
Persons initiating HPV vaccination at ages 15 through 26 years¶ and immunocompromised persons† initiating HPV vaccination at ages 9 through 26 years	3	0, 1–2, 6 months**

*ACIP recommends routine HPV vaccination for adolescents at age 11 or 12 years; vaccination may be given starting at age 9 years.
† Persons with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity (see also: Medical conditions)
§ In a 2-dose schedule of HPV vaccine, the minimum interval between the first and second doses is 5 months.
¶ For persons who were not adequately vaccinated previously, ACIP recommends vaccination for females through age 26 years and for males through age 21 years; males ages 22 through 26 years may be vaccinated. Vaccination is recommended for some persons aged 22 through 26 years; see Medical conditions and Special populations.
** In a 3-dose schedule of HPV vaccine, the minimum intervals are 4 weeks between the first and second doses, 12 weeks between the second and third doses, and 5 months between the first and third doses.

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Recommendations for use of vaccines in children, adolescents and adults are developed by the Advisory Committee on Immunization Practices (ACIP). ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to the Director of the Centers for Disease Control and Prevention (CDC) on use of vaccines and related agents for the control of vaccine-preventable diseases in the civilian population of the United States. Recommendations for use of vaccines in children and adolescents are harmonized to the greatest extent possible with recommendations made by the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the American College of Obstetricians and Gynecologists (ACOG). Recommendations for routine use of vaccines in adults are harmonized with recommendations of AAFP, ACOG, and the American College of Physicians (ACP). ACIP recommendations approved by the CDC Director become agency guidelines on the date published in the Morbidity and Mortality Weekly Report (MMWR). Additional information about ACIP is available at https://www.cdc.gov/vaccines/acip.

Suggested citation for this article: Meites E, Kempe A, Markowitz LE. Use of a 2-Dose Schedule for Human Papillomavirus Vaccination — Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2016;65:1405–1408. DOI: http://dx.doi.org/10.15585/mmwr.mm6549a5 .

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Plan to Join APAOG at the Southern Obstetric and Gynecologic  Seminar!

Stay tuned for more information about an APAOG meeting at the Southern Obstetric and Gynecologic Seminar. 

July 13, 2016 - July 16, 2016

Description:In its 62nd season, the Southern Obstetric and Gynecologic Seminar is a three day educational event designed to address relevant and timely topics in women’s health for the busy provider. Distinguished lecturers and leading experts in the field of obstetrics and gynecology will present clinical best-practices and care recommendations the provider can easily implement to improve patient care and outcomes. The content covered in this year’s conference was derived from assessing the information needs and educational gaps reported by Southern’s physician membership. Information will be delivered through a series of four lectures each day, case-studies, and question and answer sessions. 

Accompanying the academic portion of the annual meeting, Southern’s members value the opportunity to interact socially with longstanding and new members. This year Southern has moved the Seminar to the Biltmore Estate, Gerorge W. Vanderbilt's summer house. Make plans to attend Wednesday evening’s Welcome Reception in Cedric's Loft at the Biltmore and the Friday evening Membership Banquet in the Antler Hill Main Barn at the Biltmore. 

Book your overnight accommodations at the Village Hotel on the Biltmore Estate by clicking here or by calling(866) 779-6277 and identifying yourself as being part of the Southern Ob/Gyn Seminar room block. The cut-off date for reserving a room at the Village Hotel on the Biltmore Estate is May 29, 2016. 

As always, Annual Meeting registration fees are determined by your membership status. You may register and pay both your annual meeting fee and membership dues online by clicking the Registration tab. Should you prefer, you can click the pdf brochure icon and print a hard copy registration form to register or pay due via fax or mail. 

More information on Southern Obstetric and Gynecologic Seminar can be found here.

Location: Biltmore Estate, One Lodge Street, Asheville, NC

Faculty:

• Sarah Ellestad, MD
• Sean Esplin, MD
• Jeffrey Garris, MD
• Mahreen Hashmi, MD
• Hytham Imseis, MD
• Grover May, MD, FACOG
• Rebecca Usadi, MD
  

AAPA 
AAPA is looking for a PA member to serve as a medical liaison to the American Medical Association (AMA). As a medical liaison, you should be well-versed in AAPA's policy positions and strategic agenda, trends in healthcare, the U.S. political landscape, clinical issues, and policies and sensitivities of AMA and its constituencies. Be ready to assertively address issues with physicians and medical organizations, and secure physician support for PA issues. The deadline is Dec. 30 — so apply today!

AAPA

 
NCCPA no longer requires PAs to complete self-assessment CME and PI-CME to remain certified. Instead, PAs who complete these types of CME will be provided with an incentive for doing so. PAs will receive an additional 50 percent weighting for all self-assessment credits logged with NCCPA, and the first 20 PI-CME credits logged during every two-year cycle will now be doubled. This incentive will apply only to NCCPA's calculations regarding CME requirements. 

PAs should be aware that the additional weighting applies only to NCCPA certification. States that require CME for license renewal purposes do not apply any additional weighting for self-assessment or PI-CME. For state license purposes, PAs must report credits exactly as awarded on their CME certificates. 

PAs are encouraged to pay close attention to state licensing agency requirements for license renewal. For additional information, check the renewal requirements for your state licensing agency, the summary information for your state and AAPA's Certification Maintenance and CME FAQ.

AAPA's Learning Central

New, free CME you can complete by Dec. 31! Address the challenges of HPV vaccination with a video-based roundtable discussion (approved for AAPA Category 1 CME credit) coupled with an interactive, text-based case study (approved for AAPA Category 1 Self-Assessment CME credit). Activities outline barriers to HPV vaccination and provide strategies for successful HPV vaccination in the pediatric and/or adult clinic setting.

FDA approved bevacizumab (Avastin, Genentech) for patients with platinum-sensitive recurrent epithelial ovarian (psOC), fallopian tube or primary peritoneal cancer.

While Avastin was approved in 2014, this is the first new treatment option for women with psOC in the US in more than a decade. FDA approved Avastin either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone.

Related: Breast cancer biosimilar shows equivalency to brand

Patients are said to have a ‘platinum-sensitive’ form of the disease if a relapse occurs 6 months or longer following the last treatment with a platinum-based chemotherapy.

“With today’s approval of Avastin plus chemotherapy, women in the US with recurrent, platinum-sensitive ovarian cancer now have a treatment option that showed a survival difference of more than 5 months compared to chemotherapy alone in a clinical trial,” said Sandra Horning, MD, chief medical officer and head of global product development at Genentech.

Ovarian cancer causes more deaths annually in the United States than any other gynecologic cancer, said David Barley, CEO of the National Ovarian Cancer Coalition (NOCC).

FDA’s approval was based on results from 2 randomized, controlled phase 3 studies, GOG-0213 and OCEANS. The GOG-0213 study demonstrated that adding Avastin to chemotherapy showed an overall survival difference of 5 months compared to chemotherapy alone.

Related: Sharp price increases for cancer drugs

Both the GOG-0213 and OCEANS studies demonstrated a significant improvement in the time women lived without their disease getting worse (progression-free survival, PFS). The GOG-0213 study showed that women lived a median of 3.4 months longer without disease progression with the addition of Avastin to chemotherapy compared to chemotherapy alone. And the OCEANS study showed that Avastin in combination with chemotherapy significantly improved PFS compared to placebo plus chemotherapy (median PFS: 12.4 months vs. 8.4 months).

Overall survival, one of the secondary end points in the OCEANS study, was not significantly improved with the addition of Avastin to chemotherapy.

Adverse events in both studies were consistent with those seen in previous trials of Avastin across tumor types for approved indications, but also included fatigue, low white blood cell count with fever, low sodium level in the blood, pain in extremity, low platelet count, too much protein in the urine, high blood pressure and headache.

Source: http://formularyjournal.modernmedicine.com/formulary-journal/news/fda-approves-expansion-avastin-ovarian-cancer

On December 7, the Senate followed the House of Representatives and passed the 21st Century Cures Act by an overwhelming majority. The bipartisan bill will now be sent to President Obama who has said he will sign the measure into law. The legislation will accelerate Food and Drug Administration (FDA) approved treatments, therapies, and drugs by modernizing FDA regulations considered by Congress to unnecessarily delay the approval of new drugs and devices. Additionally, the legislation provides $4.8 billion to the National Institutes of Health which covers support for the president’s Precision Medicine Initiative to drive research on the effects of genetics, lifestyle, and environment on disease, as well as support for Vice President Biden’s “Cancer Moonshot” initiative and increased research to improve understanding of diseases affecting the brain, such as Alzheimer’s. The bill also provides $1 billion in grants to states to combat opioid addiction and addresses the country’s mental health crisis.

The role of PAs in mental healthcare is acknowledged for the first time in federal mental health policy through key mental health provisions of the soon-to-be law, such as:

• Inclusion of PAs as high-need providers in mental healthcare through a required mental health strategic plan;
• Including PAs who specialize in mental healthcare as members of advisory councils authorized by the Public Health Service Act;
• Adding PAs with experience in treating serious mental illnesses or serious emotional disturbances as potential committee members to a federal Interdepartmental Serious Mental Illness Coordinating Committee;
• Strengthening the mental and substance use disorders workforce by awarding grants to eligible entities to support training for PAs and other providers to offer integrated primary care, mental health, and substance use disorder treatment services in underserved areas; and
• Requiring the Department of Health and Human Services (HHS) to identify model programs and materials for training PAs and other healthcare providers on permitted uses and disclosures of health information when caring for patients with mental illnesses.

AAPA continues to seek clarification that PAs are also included in legislative provisions on peer review, mental and behavioral health education and training grants, the minority fellowship program, and increasing access to pediatric mental healthcare.

Mental health system reforms passed by the House in July through the Helping Families in Mental Health Crisis Act were also part of the bill's package. In addition to strengthening the mental health workforce, these provisions are intended to reform the nation’s mental health delivery system by establishing a new assistant secretary for mental health within the HHS; creating a system to award grants based on evidence-based mental health and substance use treatment policy; evaluating privacy law to improve mental health treatment through increased communication among providers, families, and patients; and improving care for children and adults with serious behavioral and mental illness.

AAPA worked closely with relevant House and Senate committees and members throughout the development of the mental health provisions in the bill, educating them on the interface of PAs in primary and other medical care with patients experiencing behavioral health issues, the increasing number of PAs who provide mental healthcare , and the valuable role of PAs in building the behavioral healthcare workforce.

- See more at: https://www.aapa.org/twocolumn.aspx?id=6442451789#sthash.AWSTJjxW.dpuf

By Lisa Rapaport

Age-related decline in women’s lung function may speed up during and after menopause, a recent study suggests.

Past research has shown that young women can boost their lung function through their mid-twenties by following a healthy lifestyle that includes getting plenty of aerobic exercise and avoiding cigarettes. After that, lung function declines gradually, and the process can be sped up when people smoke or carry excess fat around their midsection.

"Our study adds, that with increasing reproductive age slope of decline becomes steeper and the decline becomes faster, and it accelerates beyond the age-related expectations," said lead study author Kai Triebner, a researcher at the University of Bergen in Norway.

The good news for women is they can take steps to manage their respiratory health early in life to limit the potential for declines in lung function with menopause to lead to meaningful health problems, Triebner added by email.

"Generally speaking you cannot build up lung function again unless the loss was due to a medical condition, but you can manage the decline," Triebner added.

Women go through menopause when they stop menstruating, which typically happens between ages 45 and 55. As the ovaries curb production of the hormones estrogen and progesterone in the years leading up to menopause and afterwards, women can experience symptoms ranging from irregular periods and vaginal dryness to mood swings and insomnia.

For the current study, researchers examined data on 1,438 women who were followed for 20 years starting when they were between 25 and 48 years old.

None of the women had started going through menopause when they joined the study. By the end, they had either started or completed the process of going through menopause.

To assess shifts in lung function tied to menopause, researchers examined what's known as forced vital capacity (FVC), a measure of lung size, as well as forced expiratory volume (FEV1), or how much air can be pushed out of the lungs in one second.

Lung function decline was faster during the transition to menopause and sped up even further after menopause, compared to when women were still menstruating, researchers report in the American Journal of Respiratory and Critical Care Medicine.

For example, transitional women lost about 10 milliliters of forced vital lung capacity more per year than pre-menopausal women, and after menopause women lost a mean of 12 ml/year more.

For forced vital capacity, the decline after menopause was comparable to smoking 20 cigarettes a day for 10 years, the study found.

With forced expiratory volume, the decline after menopause was comparable to smoking 20 cigarettes a day for two years.

The more pronounced decline in forced vital capacity compared to forced expiratory volume suggests that menopause may be more likely to lead to what's known as restrictive breathing problems, such as sarcoidosis, that make it difficult to fully expand the lungs when inhaling, rather than breathing problems such as chronic obstructive pulmonary disorder (COPD) that make it difficult to exhale air from the lungs, the authors conclude.

The study is observational and doesn't prove menopause directly causes breathing problems, the authors note.

While the findings don't explain why lung function dropped for women after menopause, it's possible that hormonal changes during this time that are linked to systemic inflammation may also trigger lung function declines, the authors point out.

Hormonal changes are also implicated in osteoporosis, which shortens the height of the chest vertebrae and may, in turn, limit the amount of air a person can inhale.

Both before and after menopause, though, the rate of decline in lung function is slow, and may only be significant in women with lung disease, said Dr. David Jacoby, a researcher at Oregon Health and Science University in Portland who wasn't involved in the study.

"Someone with lungs damaged by smoking who has no symptoms at age 30 may have symptoms of her lung disease later in life as her lung function declines with age," Jacoby said by email. "The message, an obvious one, is to avoid smoking to avoid damaging your lungs, and if you have chronic lung disease, take your medications to keep your lung function as good as possible."

Source: http://www.reuters.com/article/us-health-menopause-lung-function-idUSKBN13V2IA

Frequent removal of pubic hair is associated with an increased risk for herpes, syphilis and human papillomavirus, doctors at the University of California, San Francisco, reported Monday in the journal Sexually Transmitted Infections.

People who have "mowed the lawn" at least once in their lifetimes were nearly twice as likely to say they had had at least one STD. And "extreme groomers" – those who remove all their pubic hair more than 11 times each year — were more than four times as likely to have had an infection. "High-frequency groomers," who just trim their hair a few times a month, fell between the two extremes. They were about three times more likely to have reported an STD.

"We were surprised at how big the effect was," says Benjamin Breyer, a urologist at the University of California, San Francisco, who led the study. "Right now, we have no way knowing if grooming causes the increase in risk for infections. All we can say is that they're correlated. But I probably would avoid an aggressive shave right before having sex."

In the study, Breyer and his team surveyed about 7,500 men and women between ages 18 and 65. They asked them about their grooming habits: How often do you shave or wax? Do you shave it all off or just give it a trim? And they asked about their sex lives: How many partners have you had? What STDs have you had?

About two-thirds of men and more than 80 percent of the women said they had done some manscaping or tended their lady garden at least once before. And a little more than 10 percent said they were "extreme groomers," who like to keep things completely hairless.

Infections that affect the skin, such as HPV and syphilis, were most strongly associated with aggressive grooming. But for other types of sexually transmitted infections, such as gonorrhea and lice, the link wasn't as clear. Lice actually cement their eggs to hair shafts. So if you remove all your hair, there's nowhere for the insects to breed.

"This is an excellent study," says Scott Butler, who studies STDs in college students at Georgia College & State University. "It's good for health care providers to be aware of this connection."

But there also are some big limitations to the study, Butler says. Although the analysis took into the number of sexual partners people said they had, it did not consider whether people were having safe sex or getting vaccinated for HPV. And the survey didn't ask people whether they were diagnosed with the STD before or after they started grooming.

That said, it makes sense biologically that shaving and waxing could make you more vulnerable to infections, says Jennifer Gunter, an OB-GYN at Kaiser Permanente Northern California who wasn't involved in the study.

"We know that shaving creates microtears and cuts," Gunter says. And if men and women are doing it right before sex, those wounds might not be healed, making it easier for viruses and bacteria to enter skin.

"Pubic hair is there for a reason," Gunter says. "It's a mechanical barrier, like your eyebrows. It traps bacteria and debris. And there could be health consequences to removing it."

Source: NPR.org

by Salynn Boyles 

This article is a collaboration between MedPage Today® and:

 

Action Points

Avoiding three key risk factors for heart failure between the ages of 45 and 55 lowered later-life heart failure risk by as much as 86%.

According to a study online in JACC: Heart Failure, men who reached the age of 45 without becoming obese or developing hypertension or diabetes lived an average of 10.6 years longer free of heart failure, while women who reached age 45 without any of the cardiovascular risk factors lived, on average, 14.9 years longer without heart failure.

The retrospective study is the first to quantify the impact of mid-life avoidance of heart failure risk factors with heart failure-free survival times later in life, and the researchers concluded that the new information may help clinicians better convey this to patients.

"Quantification of heart failure-free survival may be a novel, useful tool for risk communication to patients for the purpose of promoting cardiovascular health," wrote John Wilkins, MD, of Northwestern University Feinberg School of Medicine in Chicago, and colleagues.

The findings add to the understanding of how individual risk factors in middle age affect incident heart failure risk late in life, Wilkins told MedPage Today. "The effect size of primordial prevention is massive. Quantifying this risk really illustrates the importance of lifestyle interventions to prevent the onset of diabetes, hypertension, and obesity. Avoiding these risk factors can pay huge dividends in terms of reducing heart failure risk later in life."

When the researchers conducted a pooled, individual-level analysis sampling from communities across the United States, they found that at the ages of 45 and 55, respectively, 53.2% and 43.7% of participants had none of the three risk factors.

The sampling included data from four cohort trials: Framingham Heart, Framingham Offspring, Chicago Heart Association Detection Project in Industry, and the Atherosclerosis Risk in Communities studies.

Competing risk-adjusted Cox models, as well as a modified Kaplan-Meir estimator and Irwin's restricted mean were used to estimate the association between the absence of risk factors at mid-life and incident heart failure, heart failure-free survival, and overall survival.

For participants at age 45, with over 516,537 person-years of follow-up, 1,677 incident heart failure events occurred. At an index age of 55, during 502,252 person years of follow-up, 2,976 cases of incident heart failure were identified.

Diabetes was found to have a strong association with shorter heart failure-free survival: those without diabetes lived, on average, between 8.6 and 10.6 years longer without heart failure.

White and black participants without any of the three risk factors at age 45 lived, respectively, 12.4 and 12.9 years longer without heart failure, and similar trends were seen for the index age of 55.

"The benefits of risk factor avoidance and primordial prevention were consistent and substantial in black and white participants," the researchers wrote. "These data suggest that a public health strategy focused on primordial prevention of risk factors in blacks early on in the life course may reduce disparities in heart failure incidence and prevalence."

In an accompanying editorial, Thomas J. Wang, MD, director of the Division of Cardiovascular Medicine of Vanderbilt University and physician-in-chief of the Vanderbilt Heart and Vascular Institute in Nashville, Tenn., wrote that efforts to shift the focus in heart failure to prevention were bolstered by the introduction, more than a decade ago, of the American College of Cardiology and American Heart Association's two preclinical heart failure stages.

Stage A describes patients with major risk factors for heart failure such as diabetes and heart disease without myocardial infarction, and Stage B includes patients with structural heart disease but no overt symptoms of heart failure.

"The concept of heart failure-free survival adds another dimension to lifetime risk estimates by taking into account the timing of disease onset," Wang wrote. "Because healthy individuals live longer overall, they have more years exposed to the possibility of getting heart failure, which may increase lifetime risk estimates. However, when heart failure does occur in such individuals, it typically does so at a later age. The ability to enjoy more years free of disease is more important for many individuals than simply living longer."

Study limitations cited by the authors and Wang included the differing methods for ascertaining heart failure across the four studies and the inability to distinguish between heart failure with reduced ejection fraction, and heart failure with preserved ejection fraction.

But Wang noted that despite these limitations, the study findings highlight a new way to think about heart failure risk: "Such a perspective is particularly valuable when one considers another result embedded in the data: for almost all of the clinical subgroups, the interval between heart failure diagnosis and death was short (≤2 years)," he said. "Although advancing the care of patients with established heart failure remains an important objective, figuring out how to maximize the number of years free of disease is just as critical."

This research was funded in part by the National Heart, Lung, and Blood Institute and Northwestern University Feinberg School of Medicine.

The researchers reported having no relevant financial relationships with industry related to the study.

• Reviewed by F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner