IDSA News - July/August 2012
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CDC No Longer Recommends Cefixime as First-Line Treatment for Gonorrhea

Change is due to drug-resistance and critical to preserving last treatment option

The Centers for Disease Control and Prevention (CDC) issued updated treatment guidelines for gonorrhea in the Aug. 10 Morbidity and Mortality Weekly Report (MMWR), no longer recommending the oral antibiotic cefixime as a first-line treatment option for gonorrhea because of laboratory data showing that Neisseria gonorrhoeae is becoming resistant to the drug.

Based on data from CDC’s Gonococcal Isolate Surveillance Project, CDC now recommends combination therapy with ceftriaxone 250 mg intramuscularly and either azithromycin 1 g orally as a single dose or doxycycline 100 mg orally twice daily for seven days as the most reliably effective treatment for uncomplicated gonorrhea. CDC no longer recommends cefixime at any dose as a first-line regimen for treatment of gonococcal infections. If cefixime is used as an alternative agent, then the patient should return in one week for a test-of-cure at the site of infection, the new guidelines say.

CDC is urging clinicians to follow the new treatment guidelines, monitor for suspected cases of treatment failure, and report such cases to state or local health departments. Clinicians should also ensure that the patient’s sex partners from the preceding 60 days are evaluated promptly with culture and treated as indicated.

The new recommendation is viewed as critical to preserving the last available treatment option for gonorrhea. As cefixime becomes less effective, continued use of the oral drug might hasten the development of resistance to ceftriaxone, a safe, well-tolerated, injectable cephalosporin and the last antimicrobial that is known to be highly effective against gonorrhea. “It’s only a matter of time until gonorrhea develops resistance to this last remaining cure,” said Kevin Fenton, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, in a press release. “Changing how we treat infections now may buy the time needed to develop new treatment options.”

In some ways, gonorrhea has always been a "canary in the coal mine," because "it picks up resistance very easily," said IDSA Board member Carlos del Rio, MD, FIDSA, an author of the new CDC treatment guidelines, in an interview with USA Today. “Researchers and pharmaceutical companies must prioritize research to identify or develop new, effective drugs or drug combinations,” said Gail Bolan, MD, director of CDC’s Division of STD Prevention, in CDC’s press release.

Although public health officials and ID clinicians agree on the need for new antibiotics, "The pharmaceutical industry has very little incentive to do the research and development for an antibiotic that you take for five to 10 days, compared to something like a cholesterol drug, that you take for the rest of your life,” Dr. del Rio noted. In an interview with Bloomberg Business Week, Robert Guidos, IDSA’s vice president for public policy and government relations, called for options such as a research and development tax credit, or strengthening partnerships between public health officials and private industry.

Reminder: Registration, Reporting Requirements for Clinical Trials Investigators

Investigators and others who conduct clinical trials may be subject to mandatory registration of trials and reporting of results at clinicaltrials.gov, requirements that were instituted in 2007. The Food and Drug Administration (FDA) has recently determined that many academic and individual investigators are not familiar with these requirements and has asked for IDSA’s help in disseminating the information.

If you conduct clinical trials, please review FDA’s announcement (PDF) to see if you are subject to the registration and reporting requirements. Additionally, there is information in the announcement about changes to informed consent documents for trials initiated on or after March 7, 2012.

Drug Approvals, Recalls, Adverse Events Update

IDSA offers two email services to help members stay informed of updates from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Content includes a range of topics, including new drug approvals and warnings. Recent alerts have included:

IDSA members can sign up for these services online. (To subscribe, check the appropriate boxes to receive CDC’s Health Alert Network (HAN) messages and/or alerts from FDA, and provide your email address and name where indicated.)

Is Your Facility Experiencing Antibiotic Shortages?

IDSA members are urged to report drug shortages directly to FDA and to copy IDSA staff at schang@idsociety.org.

U.S. Pledges to Release Blueprint for “AIDS-Free Generation”

Secretary of State Hillary Clinton pledged that the U.S. government will release—by Dec. 1—an “AIDS-Free Generation Blueprint” detailing its plans to bring an end to the AIDS pandemic, during a speech at the AIDS 2012 conference in Washington, D.C., in July. See Science Speaks, the blog of the Center for Global Health Policy, for more.

More from the blog:

Haitian Prison Highlights TB Challenges Despite Improved Diagnostics

Haiti’s National Penitentiary underscores that improved diagnostics for tuberculosis (TB) address only the beginning of the TB challenges in prisons. Read more about an AIDS 2012 networking zone focused on prisoner issues in Science Speaks, the Center for Global Health Policy’s blog.

More from the blog:

Q&A: Global Fund General Manager Gabriel Jaramillo

Gabriel Jaramillo, general manager of the Global Fund to Fight AIDS, Tuberculosis and Malaria, spoke with Science Speaks at AIDS 2012 about preparing the Global Fund for the next decade and the need for transformation.

More from the blog:

HIV Treatment as Prevention Among Drug Users

Of the nearly 16 million injection drug users worldwide, approximately 3 million are living with HIV. An AIDS 2012 session explored the potential of antiretroviral therapy as prevention among this important marginalized population. For more details, see Science Speaks, the blog of the Center for Global Health Policy.

More from the blog:

FDA Takes Steps Towards More Judicious Antimicrobial Use in Animals

In July, IDSA commended the Food and Drug Administration (FDA) for taking critical steps towards more appropriate antimicrobial use in food animals and suggested ways to strengthen FDA's actions regarding judicious use of medically-important antimicrobials in food-producing animals, new animal drug products administered in feed and drinking water of food-producing animals, and the Veterinary Feed Directive proposed rule. Read IDSA’s full comments (PDF) online.

IDSA Applauds Finalized Guidelines for HCV Screening

The Society supports age-based hepatitis C virus (HCV) screening guidelines released earlier this month by the Centers for Disease Control and Prevention (CDC). In a letter, IDSA noted that CDC’s recommendation of a one-time HCV screening for all Americans born during the period 1945 to 1965 will create an opportunity to effectively approach this patient population, identify those who are infected with chronic hepatitis C, and link them to care, evaluation, and treatment. Read the full letter (PDF) online.

IDSA Comments on Upcoming HHS Antibiotic Incentives Study

IDSA recently provided additional information to the Department of Health and Human Services (HHS) to help guide the upcoming HHS study on antibiotic incentives and antimicrobial stewardship. The Food and Drug Administration (FDA) Safety and Innovation Act, passed by Congress in June, calls for HHS to undertake the study. IDSA’s full letter (PDF) to HHS Secretary Kathleen Sebelius is available online.

Check Out “My IDSA” for Latest Member News

Find the latest membership news on “My IDSA” on the IDSA website, including:

  • a reminder about voting for the IDSA and HIVMA Boards of Directors
  • the 2012 Medical Scholars Program recipients
  • members newly elected as fellows of IDSA
  • new IDSA members

Are you a member on the move? Do you know someone who is? Contact Stephanie Cox at scox@idsociety.org so that we can announce it to our membership.

CID Seeks Applicants for Assistant Deputy Editor Position

The editors of Clinical Infectious Diseases (CID) are seeking applicants for the position of Assistant Deputy Editor.

The responsibilities for the position are:

  • For the Editor, assist with evaluating authors’ responses to reviewers’ comments and changes made in revisions. For some articles, work with the assigned Associate Editor to review the authors’ revisions. Make recommendations for final decision or for additional reviews or revisions if required.
  • For the Deputy Editor, pre-review all brief reports and non-major articles to decide whether they should be sent for peer review, pre-reviewed by an Associate Editor, or refused without review. When sent to Associate Editor, make final decision with guidance from the Associate Editor.
  • Review News Section and press releases, along with Editor and Deputy Editor.
  • Participate with Editor and Deputy Editor on policy decisions and dealing with crisis situations.

Your name would appear on the masthead as Assistant Deputy Editor. You will be invited to attend all CID Associate Editor Meetings (twice yearly) and Editorial Advisory Board meetings (which coincide with the annual IDSA meeting). An annual salary is payable from IDSA.

If you are interested in being considered for this position and the terms outlined above, please send—by Sept. 10, 2012—a curriculum vitae and include in your letter information about any prior experience with journal publishing. Please email materials to CID Editor-in-Chief Sherwood L. Gorbach, MD, FIDSA, at Sherwood.gorbach@tufts.edu and copy Managing Editor Carlos M. Terra at carlos.terra@tufts.edu.

Updated IDSA Lyme Disease Online Course Offers CME Credit

IDSA’s recently updated online case study course is designed to help you and your practice prepare for the clinical assessment, treatment, and prevention of Lyme disease. Using cases written by expert faculty members, participants will be better able to:

The course, which was developed in partnership with the Centers for Disease Control and Prevention, is intended for clinicians with patients who are either at risk for, or are being treated for, Lyme disease. The audience includes physicians and other health care professionals.

Each case is accredited for .25 CME credits. To receive CME credit, you must complete at least four of the six cases, score 70 percent correct or higher on the post-test, and complete the evaluation. A letter of completion is also available for non-physicians.

Learn more and register for the course at lymecourse.idsociety.org

IDWeek 2012: See you in San Diego!

There’s still time to register for this year’s must-attend event for infectious diseases and other health professionals—IDWeek 2012, Oct. 17-21, in San Diego. Learn more about the first-ever joint meeting of IDSA, HIVMA, SHEA, and PIDS.

There’s still time to register for this year’s must-attend event for infectious diseases and other health professionals—IDWeek 2012, Oct. 17-21, in San Diego. Learn more about the first-ever joint meeting of IDSA, the HIV Medicine Association (HIVMA), the Society for Healthcare Epidemiology of America (SHEA), and the Pediatric Infectious Diseases Society (PIDS) at www.idweek.org.

The comprehensive program features the latest science and a diverse range of bench-to-bedside advances to help IDSA members who want to meet their educational needs, stay current, apply state-of-the-art science to clinical care, and excel in their own careers. For a complete listing of current speakers and topics, check out the interactive program planner.

A complete list of keynote speakers and bios is available online. Keynote speakers include:

 

Special Opening Plenary Session
Martin J. Blaser, MD, FIDSA, New York University School of Medicine
The Menace of Antibiotics

Special Opening Plenary Session
Robert Massie, M DIV, DBA, JFK School of Government, Harvard University
A Song in the Night: Reflections on Surviving Hemophilia, HIV, and Hepatitis C

Maxwell Finland Lecture
George H. McCracken, Jr., MD, FIDSA, University of Texas Southwestern
Progression of Clinical Research: A Personal Experience

Edward H. Kass Lecture
Elaine Larson, PhD, RN, FIDSA, FSHEA, Columbia University School of Nursing
Infection Prevention and Social Change

SHEA Lectureship
William A. Rutala, PhD, MPH, FSHEA, University of North Carolina School of Medicine
Safer Healthcare Environments for Infection Prevention

John F. Enders Lecture
David L. Thomas, MD, MPH, FIDSA, Johns Hopkins University School of Medicine
Hepatitis C: Drugs, Diversity, and Opportunity

Joseph E. Smadel Lecture
Diane V. Havlir, MD, FIDSA, University of California, San Francisco
Ending AIDS—View of a Scientific Realist

Several premeeting sessions are available to help you get even more out of IDWeek, including a session on Tuesday afternoon featuring IDSA’s maintenance of certification modules—one on general ID and the other on HIV—and a session on Wednesday morning on hepatitis C virus treatment options and opportunities for the ID practice. Space is limited, so act now to add a workshop to your registration.

Be sure to stay for Sunday morning’s Closing Plenary Session, focused on the reemergence of vaccine preventable diseases, featuring Janet A. Englund, MD, FIDSA, of Seattle Children’s Research Institute; Walter Orenstein, MD, FIDSA, of Emory University; and Michael N. Oxman, MD, FIDSA, of the VA Medical Center in San Diego.

If you haven’t already, register for IDWeek now to take advantage of the best deals on registration and housing. The regular registration deadline is Friday, Sept. 14, 2012. After this date higher on-site registration rates apply. We look forward to seeing you in San Diego!

H3N2v Information for Clinicians

Following recent developments with influenza virus transmission in the U.S., IDSA recently emailed members a synopsis with links to scientifically sound resources with additional information. 

Following recent developments with influenza virus transmission in the U.S., IDSA President Thomas G. Slama, MD, FIDSA; Andrew Pavia, MD, FIDSA, chair of the Pandemic Influenza Task Force; and Marguerite A. Neill, MD, FIDSA, chair of the Rapid Communications Work Group, emailed IDSA members a synopsis with links to scientifically sound resources with additional information on Aug. 14. The message is also available online. IDSA will provide additional updates as developments warrant.

Members can also sign up for the Health Alert Network (HAN) Service, an IDSA service that forwards HAN messages from the Centers for Disease Control and Prevention about outbreaks, bioemergencies, and other timely events. It is intended for members who do not receive these messages from other sources. To subscribe, simply click here. (Log-in required)

A Look Back at the AIDS 2012 Conference

The 2012 International AIDS Conference, held in July in Washington, D.C., featured important new science, key policy discussions, and an array of related events hosted by HIVMA and the IDSA/HIVMA Center for Global Health Policy. 

The 2012 International AIDS Conference, held in July in Washington, D.C., featured important new science, discussions about the promise of an “AIDS-free generation,” and an array of special events, public forums, and symposia hosted by the HIV Medicine Association (HIVMA) and the Center for Global Health Policy. HIVMA was one of two local scientific partners for the conference, along with the National Institutes of Health. See the latest issue of HIVMA enews for highlights from the conference and HIVMA’s activities.

IDSA Journal Club

July-August 2012
This month, studies investigating: vaccination for herpes zoster in immunosuppressed older patients; management of severe, left-sided infective endocarditis; safety and efficacy of pandemic influenza A(H1N1) vaccination; and persistence of non-gonococcal urethritis.

In this feature, a panel of IDSA members identifies and critiques important new studies in the current literature that have a significant impact on the practice of infectious diseases medicine.

Click here for the previous edition of Journal Club. For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, in each issue of Clinical Infectious Diseases.


Vaccination for Herpes Zoster in Immunosuppressed Older Patients
Reviewed by George R. Thompson III, MD

The development of a live attenuated herpes zoster (HZ) vaccine has significantly reduced the incidence of HZ in immunocompetent patients. However, vaccination is currently contraindicated in those who are immunosuppressed secondary to concerns regarding the safety and effectiveness of a live viral vaccine in this population.

In the July 4 issue of The Journal of the American Medical Association, researchers performed a retrospective cohort analysis using Medicare beneficiaries diagnosed with an autoimmune disease (ankylosing spondylitis, inflammatory bowel disease, psoriatric arthritis/psoriasis or rheumatoid arthritis) to examine the possible association between receipt of the zoster vaccine and HZ incidence in the short-term (<42 days after vaccination) and long term (median of two years of follow-up).

Six hundred and thirty-three patients received immunosuppressive medications (TNF-α blockers, non-TNF biologics, DMARDS, and oral/or glucocorticoids) within 42 days of vaccination. There were no patients in this group who developed varicella, HZ, or meningitis/encephalitis. The adjusted hazard ratio for the vaccine was 0.61 at a median of two years of follow-up—findings suggesting vaccination is associated with a decreased risk of HZ.

These results suggest live-zoster vaccination may not be associated with increased risk of HZ shortly after vaccination in patients treated with immunosuppressive medications. The generalizability of these results to other immunosuppressed populations remains in question and further study in these groups will be needed. However, the authors’ results do call into question current recommendations that HZ vaccination is contraindicated in patients receiving immunosuppressive medications.

(Zhang et al. JAMA. 2012;208(1):43-49.)

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Management of Severe, Left-sided Infective Endocarditis: The Scales Tip Toward Early Surgery?
Reviewed by Kathryn E. Stephenson, MD, MPH

Left-sided, native-valve infective endocarditis is challenging to manage when it is complicated by severe valve disease and large vegetations. Early surgery may lead to a decrease in systemic embolism or progression to heart failure. There is concern, however, that surgery in the setting of active infection may have unacceptable adverse effects.

In the June 28 issue of the New England Journal of Medicine, investigators reported on a randomized clinical trial comparing early surgery versus conventional treatment for left-sided infective endocarditis complicated by severe valve disease and large vegetations. Seventy-six patients were enrolled from 2006-2011 at two medical centers in Korea. Patients were diagnosed with endocarditis according to the modified Duke criteria and were excluded from the study if they had absolute indications or contraindications to surgery.

In an intention-to-treat analysis, the authors report that patients who received conventional treatment were significantly more likely to die in the hospital or have an embolic event than patients who received early surgery (23 percent vs. 3 percent of patients, respectively; P=0.03). At six weeks, the rate of embolism was 21 percent in the conventional-treatment group compared to 0 percent in the surgery group (P=0.005). There was also no increase in operative mortality or recurrence of endocarditis in the surgery group. Interestingly, 77 percent of patients in the conventional-treatment group underwent surgery anyway because of worsened cardiac disease.

The authors conclude that early surgery is superior to conventional therapy for severe left-sided, native-valve endocarditis, primarily because surgery reduces the risk of systemic embolism. The strength of the study is its randomized design, though the number of patients enrolled was small. Also, viridans streptococci were the predominant pathogens isolated and the results may not be generalizable to other organisms. Nevertheless, this study suggests that all patients with severe, left-sided, native-valve endocarditis should be referred to medical centers with cardiac surgical experience.

(Kang et al. N Engl J Med. 2012;366:2466-73.)

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Safety and Efficacy of Pandemic Influenza A(H1N1) Vaccination
Reviewed by Jason Weinberg, MD

Vaccination against pandemic influenza A(H1H1) is safe in pregnant women and in young HIV-1-infected individuals, according to recent reports in The Journal of the American Medical Association (JAMA) and The Journal of Infectious Diseases (JID).

Morbidity and mortality associated with both seasonal and pandemic influenza infection is increased in pregnancy. Pregnant women were prioritized for vaccination during the recent pandemic, but fetal safety associated with vaccination during pregnancy against pandemic influenza A(H1N1) has been incompletely defined. In an observational cohort study in the July 11 issue of JAMA, the authors assessed adverse fetal outcomes in 6,989 infants whose mothers were exposed to an adjuvant-containing influenza A(H1N1)pdm09 vaccine during pregnancy. Using a propensity score matching approach to compare vaccine-exposed and vaccine-unexposed infants, the investigators demonstrated that there was no significant increase in the prevalence of major birth defects, risk of preterm birth, or risk of low birth weight.

Influenza infection can also be more severe in HIV-1-infected individuals. However, antibody responses to seasonal influenza vaccine are less robust in the setting of HIV infection. To determine whether vaccination against pandemic influenza A(H1N1) was safe and effective in young HIV-1-infected patients, investigators in a study in the Aug. 1 edition of JID conducted an uncontrolled trial in which 55 patients aged 4 to 24 years who were perinatally infected with HIV-1 received two doses of a high-dose (30 μg), adjuvant-free monovalent vaccine. Very few adverse events were observed following vaccination. Seroresponse [≥ four-fold rise in hemagglutinin inhibition (HAI) titers] was noted in between 79.6 percent and 84.8 percent of patients depending on age, and seroprotection (HAI titers ≥ 40) was detected in between 79.6 percent and 85.1 percent of patients. In general, these responses were less robust than in previous studies with HIV-uninfected children.

Vaccination against pandemic influenza A(H1N1) is not without risk. In a separate study in the July 11 issue of JAMA, administration of an adjuvant-containing monovalent vaccine was associated with a small increased risk of Guillain-Barré syndrome. Longer-term safety data in infants whose mothers were vaccinated during pregnancy is still needed. Likewise, additional data confirming the safety and efficacy of vaccination in patients with greater immunocompromise due to HIV infection will be helpful. Collectively, however, these recent reports suggest that vaccination against pandemic influenza A(H1N1) is likely to be safe in these at-risk populations.

(Pasternak et al. JAMA 2012; 308(2):165-174; De Wals et al. JAMA 2012; 308(2):175-181; Flynn et al. J Infect Dis 2012; 206:421-30.)

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Persistence of Non-gonococcal Urethritis: Common and Dependent on Organism and Antibiotic Treatment
Reviewed by Jonathan Li, MD

Non-gonococcal urethritis (NGU) is the most common cause of urethritis in men in the United States. A multicenter randomized controlled study conducted in four sexually transmitted disease clinics and published last year evaluated optimal treatment. This trial randomized 305 heterosexual men to treatment with doxycycline or azithromycin alone or each in conjunction with tinidazole. The results showed no significant clinical benefit from tinidazole and overall similar clinical cure rates between azithromycin and doxycycline. A follow-up analysis published in the Aug. 1 issue of The Journal of Infectious Diseases evaluated the persistence of NGU after treatment.

Among the 293 evaluable participants, 44 percent were found to have Chlamydia trachomatis, 31 percent had Mycoplasma genitalium, 13 percent had Trichomonas vaginalis, and 28 percent had none of the three organisms detected. Persistence rates differed by organism and treatment regimen. Four weeks after the initial treatment, Chlamydia trachomatis persisted in 12 percent of participants, and Mycoplasma genitalium persisted in 44 percent. Chlamydia trachomatis was more likely to be detected at follow-up after treatment with azithromycin than after treatment with doxycycline (23 percent vs. 5 percent, P=0.01). In contrast, persistence of Mycoplasma genitalium was more common in those treated with doxycycline compared to those treated with azithromycin (68 percent vs. 33 percent, P=0.001). Persistent detection of organisms was significantly associated with the presence of urethral discharge and elevated inflammatory cells on urethral smear.

Current Centers for Disease Control and Prevention guidelines recommend either azithromycin or doxycycline for the empiric treatment of non-gonococcal urethritis. These data suggest that doxycycline may be preferred when Chlamydia trachomatis infection has been confirmed. However, azithromycin is likely to remain popular for empiric treatment given its simplicity of dosing (including ease of directly observed therapy) as well as the overall comparable efficacy with doxycycline in the primary analysis of the trial.

(Seña et al. Clin Infect Dis. 2011; 52:163-70.)

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For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, in each issue of Clinical Infectious Diseases:

Aug. 15

  • Hot Spring Hazard–Microsporidial Keratitis
  • Can Linezolid be Safely Used in Patients Receiving Serotonergic Drugs?

Aug. 1

  • Tropheryma whipplei Endocarditis
  • Aneurysms, Vascular Grafts, and Q Fever

July 15

  • Hot-Foot Syndrome
  • Nocardia Resistant to Trimethoprim-Sulfamethoxazole? Maybe Not
  • Vancomycin in Real Life

July 1

  • Mechanism of Action of Amphotericin B: Another Dogma Falls
  • Treatment of Infections Due to Methicillin-Susceptible Staphylococcus aureus (MSSA): Cephalosporins Versus Semisynthetic Penicillins