IDSA News - January 1, 2008
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Adult and Adolescent HIV Treatment Guidelines Updated

The Department of Health and Human Services has released a new version of the “Guidelines for the Use of Antiretroviral Agents in HIV-1-infected Adults and Adolescents.”  The update includes new information on:

  • lab tests to run for newly diagnosed patients during their initial clinic visit
  • updated recommendations on when to start treatment
  • management of treatment-experienced patients, including suggestions on prescribing the recently FDA-approved drugs, Maraviroc and Raltegravir

Changes to the guidelines are summarized at the beginning of the guidelines and are highlighted in yellow throughout the text and tables.

The updated guidelines are available on the NIH AIDS info Web site.  

IDSA Publishes Updated Guidelines on Aspergillus

New IDSA guidelines on the treatment of Aspergillus have been published in the February 1 issue of Clinical Infectious Diseases, now available online.

The new guidelines replace the previous practice guidelines that were published in 2000. The objective of the new guidelines is to summarize the current evidence for treatment of three different forms of aspergillosis, including invasive, chronic (and saprophytic), and allergic. They also introduce major new anti-fungal agents, including extended spectrum triazoles (such as voriconazole and posaconazole) and echinocandins, a new drug class with anti-Aspergillus activity. 

Similar to the previous practice guidelines, the new set places emphasis on early diagnosis, treatment, and prevention of the different forms of invasive aspergillosis, which include invasive pulmonary, sinus, disseminated and several types of single-organ.

Early detection is vital since aspergillus species have emerged as an important cause of life-threatening infections in patients with compromised immune systems, particularly those with prolonged neutropenia, advanced HIV infection, or those who have undergone allogeneic hematopoietic stem cell or lung transplantation.

As part of its emphasis on the importance of early diagnosis and therapy, the guidelines consider the role of galactomannan and beta-glucan as surrogate markers for early diagnosis, as well as the use of therapeutic drug monitoring (especially for triazoles) and potential for drug toxicity in patients with progressive infection.

Since 2000, new clinical data has been published to support the updated treatment recommendations for Aspergillus, including:

  • A global comparative clinical trial establishing voriconazole as the recommended primary therapy of invasive aspergillosis in most patients
  • A comparison of data establishing the efficacy and safety of liposomal amphotericin B as an alternative agent in some patients
  • Echinocandins being used as salvage therapy
  • Posaconazole prophylaxis being used for prevention of invasive aspergillosis in high-risk patients

In the absence of a well-controlled prospective clinical trial, routine administration of combination therapy is not recommended, but in the setting of salvage therapy, an additional anti-fungal agent might be added to current therapy.  Combination anti-fungal drugs from different classes other than the initial regimen may also be used.  It was also concluded that because of poorer outcomes and increased toxicity, the role of amphotericin B deoxycholate is reduced to resource-limited settings where other agents are not available.

CDC Releases Updated Immunization Schedule

Expanded recommendations for nasal spray influenza and meningococcal vaccines have been released in the 2008 Childhood and Adolescent Immunization Schedules from the Centers for Disease Control and Prevention (CDC).

The updated schedule approves the use of live attenuated influenza vaccine for children as young as 2 years old who do not have a history of asthma or wheezing. The previous recommendations limited its use to children at least five years old. 

Those who should receive the meningococcal conjugate vaccine include children and adolescents 11 years old and older, college freshmen who live in dorms, and military recruits. Children between 2 and 10 years of age with terminal complement deficiencies,  anatomic or functional asplenia or other high-risk conditions also should receive the meningococcal conjugate vaccine. CDC modified its earlier recommendations, which called for immunizing children 11 to 12 years of age, adolescents entering high school, and others at high risk.

CDC also recommends administering pneumococcal conjugate vaccine (PCV4) to healthy children 24 to 59 months of age. Children with underlying medical conditions should receive the pneumococcal polysaccharide vaccine (PPV).

The updated immunization schedule is available online.

ACIP recommended these updates at its October 2007 meeting. For more from that meeting, see the November issue of IDSA News.

Drug Approvals, Shortages, Recalls, Adverse Events

IDSA offers a members-only service that e-mails ID-related messages from the Food and Drug Administration on label changes, adverse events, newly approved drugs and other safety information on FDA-approved drugs and biologics.  Recent alerts included:

To sign up for this service IDSA members can visit: http://www.idsociety.org/Content.aspx?id=4250.

EIN Reports Problems with Vancomycin Levels

Several members of IDSA’s Emerging Infections Network have observed patients with blood levels of vancomycin that were unusually low for the dose they were given.

A member in California posted the initial observation to the network. “I thought it was just a fluke until, unprompted, my associate mentioned she seemed to be encountering the same thing,” the member noted. “Has anyone else run in to this? Is there a problem with some of the vanco?”

Members in Florida, Iowa, and New Jersey had similar experiences. “We reported this to our pharmacy,” the New Jersey member wrote, “and they determined potential lack of uniformity [in] how the vanco is being mixed (vials sent to floors, nurses drawing it up), so they are mixing it in our pharmacy now. If that does not solve the problem then there could very well be a problem with the product.”

The Texas member also had problems, and wondered “if the generic vancomycin we are using is actually in the vials at the stated concentration. “Human error may be responsible some of the time.” For example, the member noted one instance when a test of the residual fluid in the IV bag showed the vancomycin had not been added. The phenomenon seems random, though: “Sometimes we will go 3 to 4 weeks without any odd values, and then they go all over the place,” both high and low.

A member in Singapore said “an occasional patient” had unexpectedly low vancomycin levels, but added, “I suspect it has more to do with renal clearance than the vancomycin.” A member in Oregon also “chalked it up to individual variation in metabolism.”

A member in Minnesota asked, “Might erroneous lab values or interfering substances be part of the ‘problem?’” Others suggested mechanical issues. “We had a problem some time ago with the programmable pumps not delivering the complete infusion of vancomycin,” a Missouri member wrote. “This often occurred on the evening/night dose when the nurses did not want to turn on the light to wake up the patient, and did not realize that the infusion was incomplete.”

“This is one reason I always order a peak with my trough,” commented a member in Illinois. “The confirmation helps.”

Several members also noted anecdotally an increase in “red man syndrome.”

A North Carolina member suggested those who have observed problems report them to the Food and Drug Administration’s MedWatch program at http://www.fda.gov/medwatch/. “I have used Medwatch to report adverse events,” the member said.  “It is a simple process.”

“Also, it would be appropriate to report this concern to the manufacturer of your particular generic vancomycin preparation,” the member added.

In the IDSA Journals

Promising Results of EBV Vaccine Trial

A vaccine against Epstein-Barr virus (EBV) reduced the incidence of infective mononucleosis in a Phase II trial in Belgium. Ten percent of the control group developed symptomatic infections, compared to 2 percent of those receiving the vaccine. (Sokal et al., J Infect Dis. 2007;196:1749–1753.) 

Panton-Valentine Leukocidin Production by MRSA

Because most community-acquired strains of methicillin-resistant Staphylococcus aureus (MRSA) causing necrotizing infection carry the genes for Panton-Valentine leukocidin, it has been theorized that this toxin plays an important role in the severity of the infection. A total of 31 strains of community-associated S. aureus obtained from patients with severe infections were analyzed; 29 of them produced Panton-Valentine leukocidin. The quantity of Panton-Valentine leukocidin produced in vitro did not correlate with the severity of infection. Thus, Panton-Valentine leukocidin may not be a key determinant of the severity of infection. (Hamilton et al., Clin Infect Dis. 2007;45:1550–1558.)  

Prenatal HIV screening in Alberta, Canada

In Alberta, Canada, all pregnant women are tested for HIV infection unless they specifically decline. In this study, anonymous serum samples obtained from women who had opted out of HIV testing were tested for the presence of HIV, demographic characteristics, and HIV seroprevalence. The results were compared with  those patients who agreed to HIV testing. Those individuals who opted out of HIV testing were older and had higher gravidity and parity. They were 3.3 times more likely to be HIV positive than were women who agreed to be tested. The proportion of women who opted out of HIV testing decreased over the course of the study, from 4.3 percent in 2002 to 3.6 percent in 2004. (Plitt et al., Clin Infect Dis. 2007;45:1640–1643.)


The December 1 issues of The Journal of Infectious Diseases (JID) and Clinical Infectious Diseases (CID) joined more than 230 journals from 37 countries in publishing articles on the theme of global poverty and human development. The articles were published online in October as part of an initiative led by the Council of Science Editors. JID and CID articles included:

Lopinavir-ritonavir therapy reduces HIV levels in CSF

Combination antiretroviral therapy may fail to completely suppress HIV replication in the brain, which can lead to HIV-associated neurocognitive disorders. This study tested whether treatment with lopinavir-ritonavir reduced HIV RNA levels in CSF when used by itself. Use of the two drugs alone for 3 weeks reduced HIV RNA levels in CSF by at least 10-fold in most individuals. By week 24 of the study, HIV RNA levels were below quantitation in CSF and plasma for all subjects. (Letendre et al., Clin Infect Dis. 2007;45:1511–1517.)

Maternal Intermittent Preventive Treatment of Malaria—How Often?

A study looking at malaria prevention for HIV-positive pregnant women in Zambia found that two doses of sulfadoxine-pyrimethamine given in the last two trimesters was just as effective  as monthly treatment during this period. (Hamer et al., J Infect Dis. 2007;196:1585–1594.) However, a companion study found 15 percent of mothers scheduled to receive two doses in fact received only one, and these women had significantly poorer outcomes. The authors recommend monthly treatment to ensure mothers receive at least two doses. (Gill et al., J Infect Dis. 2007;196:1577–1584.)  

JID also featured a supplement titled, “The Realities of Antiretroviral Therapy Rollout: Challenges to Successful Programmatic Implementation,” dealing with issues in southern Africa and including articles on HIV and tuberculosis coinfection and program integration, improving access to antiretrovirals and perspectives from front-line caregivers.

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.

December 1:

  • Halfway to 2015—But Less than Halfway to the Millennium Targets
  • Breast-Feeding and HIV Transmission
  • Predictable but Unintended Consequences: Dams and Malaria
  • Human Papillomavirus (HPV) and Cervical Cancer in Lesser Resourced Countries
  • Hepatitis B Virus (HBV) Control in China

 December 15:

  • Can We Prevent Linezolid-associated Anemia and Thrombocytopenia?
  • Projecting Bacteria into Space
  • Not All Transmissible Diseases Are Infectious—The Devil Knows

Outbreaks and Bioemergencies

IDSA offers a members-only service that forwards Health Alert Network messages from the Centers for Disease Control and Prevention about outbreaks, bioemergencies and other timely events.  It is intended for members who rely on IDSA for the latest news updates.  The following report was issued on December 29, 2007.

IDSA members can sign up for this service online.

Developing a Research Agenda for HIV and Aging

Leading researchers in the fields of geriatrics and HIV met in late October to discuss the interface of HIV,  the aging process and areas needing more research to successfully treat the growing population of older adults living with HIV/AIDS.

Attendees also included representatives from the National Institute on Aging and the National Institute of Allergy and Infectious Diseases. Both agencies will play a critical role in implementing the research agenda developed at the conference.

The Association of Specialty Professors (ASP), HIVMA, and IDSA co-sponsored the workshop, which took place in Arlington, Virginia. Workshop presentations covered topics ranging from metabolic and co-morbidity implications of HIV and aging, to drug treatment and adherence issues for older adults with HIV/AIDS.

The workshop was funded by the John A. Hartford Foundation as part of an ASP Project "Integrating Geriatrics into the Specialties of Internal Medicine: Moving Forward from Awareness to Action."

First Annual IDSA Fellows’ In-Training Exam June 3 and 4

IDSA launches the first annual In-Training Exam (ITE) for fellows in infectious diseases fellowship programs on June 3 and 4.  The purpose of this exam is to assist fellowship programs in meeting Accreditation Council for Graduate Medical Education (ACGME) requirements; it is also designed to evaluate fellows’ knowledge of infectious diseases.

Fellowship programs must register by February 8 to participate in this year’s exam.  Fellows will take the exam at their home institutions.  Information regarding registration, along with a registration form, was sent to all training program directors via mail and email.

On March 3, online registration will open for training program directors to register their fellows to participate in the upcoming exam.  Registration will be open until April 15.  IDSA will be contacting all programs with registration instructions in late February.  The registration fee for each fellow is $200 and each program may register as many fellows as they choose. Fellows from U.S.-based institutions are eligible. 

New competency requirements instituted by the ACGME in 2005 specifically require each competency to be measured by at least two methods: a subjective evaluation by attending physicians and an objective examination, such as the In-Training Exam.

In addition to providing a method for ID knowledge evaluation, the ID ITE will serve several additional purposes:

  • Identifying ID fellows at risk of failing the ID ABIM exam while they are enrolled in fellowship training with time for additional programmatic and self-directed learning
  • Targeting didactics within a given program on areas where the fellows as a group are weak
  • Providing national performance measurements with which fellows can compare their scores.

IDSA is currently working on a webpage that will house detailed information regarding the In-Training Exam.  In the meantime, please contact Rachel Shnekendorf, rshnekendorf@idsociety.org with any questions.

New Resources for State and Regional Societies

IDSA has developed new online resources for local ID societies. In addition to general information about State and Regional Societies (S&RS) composition and procedures, the new site provides contact information for affiliated local ID societieseligibility requirements for Affiliated State and Regional Societiesan S&RS meetings calendar, and S&RS advocacy efforts.

For more information, please contact 
Jason Scull, program officer for clinical affairs, at (703) 299-5146.

CDC Finds Low Rates of Adult Immunization

 

 

 

 

 

 

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Anne Schuchat, MD, FIDSA, director of CDC's National Center for Immunization and Respiratory Diseases, speaking at an NFID news conference on Jan. 22 in Washington, DC.

New data released by the Centers for Disease Control and Prevention (CDC) shows low rates of immunization among adults, leaving many at risk for illness and death associated with preventable infectious diseases.

CDC’s National Immunization Survey found only 2.1 percent of adults 18 to 64 years old have received the tetanus-diphtheria-whooping cough vaccine. Immunization to prevent shingles among people 60 and older was only 1.9 percent, while immunization against human papillomavirus (HPV) among women 18 to 26 was around 10 percent. More commonly known vaccines, including influenza and pneumococcal, fell well below the 90 percent national target rates recommended for elderly patients. The data was released at a Jan. 23 news conference. 

Results of a new national survey by the National Foundation for Infectious Diseases (NFID) were also released during the press conference. According to the results, adults cannot name more than one or two vaccine-preventable adult diseases.

Half of the adults surveyed also said they were not concerned about whether another adult member of their families gets a vaccine-preventable disease.

Every year tens of thousands of adults die and hundreds of thousands are hospitalized because they are not properly vaccinated. CDC estimates the cost of this health care burden to be about $10 billion annually. The costs aren’t surprising, since there are more than 1 million shingles cases annually and the number is only expected to grow, according to CDC. More than 6 million new HPV infections occur annually and nearly 10,000 cases of cervical cancer. Pertussis incidences have also risen significantly since their all-time low in 1976. 

Adult immunization is a top priority for IDSA. The Society published principles to strengthen U.S. adult and adolescent immunization coverage in the June 15, 2007 issue of Clinical Infectious Diseases.

The IDSA policy principles include:

IDSA Advocacy Update

New IDSA Policy Report on Antimicrobial Resistance

The latest report in the Society’s campaign to improve the pipeline of antimicrobials was announced during a key meeting of federal policymakers and infectious diseases experts in December 2007.

In the report, published in the January 15 issue of Clinical Infectious Diseases, IDSA outlines a three-pronged strategy to address the growing antimicrobial resistance problem, including new incentives for increased research and development of new antimicrobial tools, ending non-therapeutic antimicrobial use in animals, and better federal coordination, surveillance, data collection, and research on resistance. (A news release on the report is available online.)

The December meeting was held to update the 2001 federal Public Health Action Plan to Combat Antimicrobial Resistance. An updated action plan is expected this fall. 

CAP Clinical Trials and FDA

In January, IDSA co-sponsored a workshop with the Food and Drug Administration (FDA) to help establish what standards new drugs against community-acquired pneumonia (CAP) should have to meet in order to receive FDA approval. The Society has criticized FDA for failing to provide clear guidance on clinical trial design for new drugs against CAP. The lack of guidance has frustrated some drug makers’ efforts to study potential products, while other companies have stayed on the sidelines.

The workshop program and the federal register notice about the workshop are available online.

 In other recent advocacy news, IDSA has: 

New Law Requires Free Access to NIH-funded Research

A change in federal policy will require all published research funded by the National Institutes of Health (NIH) to be available free to the public within one year. Authors publishing in IDSA journals will not notice any changes, however, since The Journal of Infectious Diseases (JID) and Clinical Infectious Diseases (CID) already comply with the policy.

The new policy stems from a provision in the omnibus spending bill Congress passed late last year. Starting April 7, scientists who receive NIH grants will be required to submit a final copy of their research paper to the National Library of Medicine’s PubMed Central. The intention is to ensure that the public has open access to taxpayer-sponsored research.

Currently, the program is voluntary. However, so far only about 5 percent of scientists participate.

All articles published in JID and CID already are available 12 months after publication at no additional cost, so no changes will be necessary. Everett Connor, publishing operations director at IDSA’s publisher, University of Chicago Press (UCP), added, “Both IDSA and the Press recognize the necessity of broad availability for medical research and have maintained an open access policy for some years prior to the recent inclusion of NIH policy in the omnibus spending bill.” The editors of both journals select several articles of particular interest to be available for free immediately upon publication. Also, all practice guidelines are freely available upon publication, he added.

NIH will now have to work to provide direction on how to implement the legislation to make sure everyone understands the policy and how to correctly follow it once it comes into effect. IDSA will continue to follow any updates on this policy.

More information on the NIH policy is available at http://publicaccess.nih.gov/.

Members on the Move

John G. Bartlett, M.D., FIDSA, and Sherwood Gorbach, M.D., FIDSA, will receive the Anaerobe Society of the Americas’ Lifetime Achievement Award during Anaerobe 2008 to be held June 24 to 27 in Long Beach, CA.  . 
Dr. Bartlett is chief of the division of infectious diseases at Johns Hopkins University School of Medicine in Baltimore, MD. Dr. Gorbach is currently editor-in-chief of Clinical Infectious Diseases and professor of public health and medicine at Tufts University School of Medicine in Boston.

IDSA Members Appointed to the National Biodefense Science Board

IDSA members Ruth Berkelman, M.D., FIDSA, Andrew Pavia, M.D., FIDSA, and Patrick Scannon, M.D., Ph.D., were appointed to the National Biodefense Science Board. The mission of the Board is to advise the Secretary of Health and Human Services on issues surrounding naturally occurring infectious diseases and chemical, biological, radiological, and nuclear agents. 

The Board was recently established under the 2006 Pandemic and All-Hazards Preparedness Act. As a result of the Board's first meeting, held in December in Washington, D.C., four working subcommittees were formed to look at pandemic influenza research (chaired by Dr. Pavia), the U.S. government’s advanced development portfolio of chemical, biological, nuclear, and radiological countermeasures (chaired by Dr. Scannon), disaster medicine, and gaps in the medical countermeasure marketplace.

Welcome, New IDSA Members!

Members

Akimov, Sergey, MD
Andrews, Janet I., MD
Apostolakos, Diane, MD, MS
Beenhouwer, David O., MD
Bilbisi, Montaser A., MD
Braun, Daniel K., MD, PhD
Brewer, Susan, MD
Burton, Mary J., MD
Cardona, Lyssette, MD
Clark, Brychan M., MD
Cronin, Jason D., MD
Da Eira, Margareth, MD
Diazgranados, Carlos A., MD
Doron, Shira, MD
Eason, Jane V., MD
Erhardt, William A., MD
Esolen, Lisa M., MD
Frankel, Renee, MD
Ghanem, Ghazi, MD
Greenberg, David, MD
Hennessy, Thomas W., MD
Higgs, Elizabeth S., MD
Jaffri, Anwer A., MD
Johnson, Andrew S., MD
Kudo, Makoto, MD
Kumar, Ritu A., MD
Nalmas, Sandhya, MD
Nusair, Ahmad, MD
Owaisi, Anjum S., MD
Owens, Robert C., PharmD
Perlroth, Joshua D., MD
Persaud, Deborah, MD
Pile, James, MD
Sanchez, Phillip L., MD
Schrager, Harry M., MD
Sidhwa, Kamo, MD
Sohail, Muhammad R., MD
Sun, Wellington, MD
Sutter, Deena, MD
Ticehurst, John R., MD
Toney, John F., MD
Torres, Jaime R., MD
Van Dort, Martin B., MD
Wu, Henry M., MD

Associate Members

Corretge, Silvia
Edwards, Leslie
El-Khatib, Walid F., MD, PhD
Faris, Jeffery A., PharmD
Hindman, Jason, PharmD
Hmoud, Jareer
King, Todd, PA-C
Kopacz, Joanna
Poznansky, Mark, MD, PhD
Soltz, Belinda, PA-C
Varma, Marianne, G
Vasquez, Emily, PA-C
Weiksner, Lizanne, PA-C

Members-In-Training

Atnafu, Gedion, MD
Desikan, Sunitha, MD
Lavoie, Myriam, MD
Marchesani, Diane M., MD
Oka, Hideaki, MD
Shan, Shaheena, MD
Sharma, Vibha, MD
Spicer, Kevin B., MD
Thompson, George, MD
Webster, Duncan, MD
Williams, John, MD, DTM&H
Syed, Ather, MD, MBBS
Zilioli, Gina, MD

WHO Promotes Community Health Workers for HIV/AIDS Care

With developing countries facing a critical shortage of medical professionals, which compounds epidemics of HIV/AIDS and other diseases, the World Health Organization (WHO) released guidelines to increase the role of less specialized community health workers. The guidelines’ goal is to assist countries seeking to make greater use of community health workers without sacrificing quality of care.

At a conference this month in Addis Ababa, Ethiopia, WHO released guidelines on shifting health care tasks down the specialization pyramid to free up time for skilled professionals to focus on aspects of HIV care requiring more training.

According to WHO, 36 countries in Africa and more than 20 others around the world have severe shortages of health workers. Training new doctors and nurses takes many years, but community health workers can be ready in a matter of months.

Although efforts to increase access to HIV/AIDS care are driving the task-shifting movement, WHO hopes task shifting also will strengthen health care systems as a whole by improving access to primary care.

A WHO brochure provides an introduction to task shifting.