IDSA News - December 2011/January 2012
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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. (You must be logged in to have access to this link. Once logged in, click on the “My Alerts” tab to subscribe to the alerts. 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.

Help Boost ID Participation in Physician Compensation Survey

Increase the accuracy of ID physicians’ compensation data by participating in the influential Medical Group Management Association’s (MGMA) 2012 Physician Compensation and Production Survey. Visit www6.mgma.com to complete the free survey by March 9. You do not need to be a member of MGMA, although you will be prompted to register if you are a non-MGMA member.

Please indicate you are an IDSA member in the comments box on the last page of the survey questionnaire. If completing the Microsoft Excel version on the survey (available for download online), the comments box is at the bottom of the “Medical Practice Information” sheet. 

Contact MGMA at (877) 275-6462, ext. 1895, or email survey@mgma.com, if you need any assistance. To see results from previous years’ surveys, visit IDSA’s website (login required).

Webinar: Billing and Coding Update for 2012

Learn about current procedural terminology (CPT) coding changes to evaluation and management (E&M) codes, tips for choosing the appropriate level of E&M code, and how to prepare for the 10th edition of the International Classification of Diseases (ICD-10) code sets during a free, one-hour IDSA-sponsored webinar with “Ask the Coder” expert Barb Pierce on Feb. 21 at 4 p.m. EST.

To sign up, email Andres Rodriguez, IDSA senior program officer for practice and payment policy, at arodriguez@idsociety.org. The webinar is open to IDSA and HIVMA members only.

Congress Should Repeal Flawed Physician Payment Formula

Physicians will face drastic payment cuts, limiting patient access to services, unless the flawed Medicare physician payment formula is addressed. IDSA joined the American Medical Association and more than 60 physician organizations in a January letter (PDF) to Congress urging action to address the formula. Visit IDSA’s Take Action website to send your own letter to Congress.

IDSA Comments on Medicare Conditions of Participation

Antimicrobial stewardship programs should be included in infection control requirements outlined in the Centers for Medicare and Medicaid Services’ proposed Conditions of Participation rule, IDSA urged in comments submitted in December 2011. Read the comments online (PDF).

Early HIV Treatment Study Named Breakthrough of the Year

The HIV Prevention Trials Network 052 (HPTN 052) study, led by Myron S. Cohen, MD, FIDSA, of the University of North Carolina (UNC) in Chapel Hill, has been named the 2011 Breakthrough of the Year by the journal Science. HPTN 052 evaluated whether antiretroviral drugs can prevent sexual transmission of HIV among couples in which one partner has HIV and the other does not. The research found that early treatment with antiretroviral therapy reduced sexual transmission of HIV in these couples by at least 96 percent. Time magazine also highlighted HIV treatment as prevention as one of the top 10 medical breakthroughs of 2011.

Dr. Cohen is associate vice chancellor for global health and the J. Herbert Bate Distinguished Professor of Medicine, Microbiology, and Immunology at UNC; public health director for the UNC Institute of Global Health; and infectious disease chief in the Division of Clinical Infectious Diseases. A member of HIVMA and the Center for Global Health Policy’s Scientific Advisory Committee, Dr. Cohen has also served on the IDSA Annual Meeting Program Committee.

PEPFAR Takes Hit, Military HIV Research Program Survives

Learn about 2012 funding for the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Walter Reed Amy Institute of Research Military HIV Research Program on the Science Speaks blog.

More recent news from Science Speaks:

Level of HIV in Blood Major Factor in Sexual Transmission

Check out Science Speaks, the blog of the Center for Global Health Policy, for coverage of a recent study in The Journal of Infectious Diseases on HIV infectivity.

More recent news from Science Speaks:

“Totally” Drug Resistant TB in India

Read more on Science Speaks about a report of drug-resistant tuberculosis cases in India from Clinical Infectious Diseases.

More recent news from Science Speaks:

FDA Limits Cephalosporin Use in Food Animals

A recent order issued by the Food and Drug Administration will limit certain uses of cephalosporins in food-producing animals, starting in April. The order prohibits extra-label or unapproved uses of these antibiotics in cattle, swine, chickens, and turkeys. Prohibiting these uses “is intended to reduce the risk of cephalosporin resistance in certain bacterial pathogens” and to preserve the effectiveness of these antibiotics for treating human diseases, FDA noted in a press release Jan. 4. For more information, see FDA’s online question-and-answer document.

IDSA joined several other organizations in a June 2011 letter (PDF) urging FDA to prohibit extra-label use of cephalosporin drugs in food-producing animals. For more on IDSA’s efforts to eliminate inappropriate uses of antibiotics in food animals and other aspects of agriculture, visit the IDSA website.

IDSA, PIDS, SHEA Urge Mandatory HCW Influenza Vaccination

IDSA joined the Pediatric Infectious Diseases Society and the Society for Healthcare Epidemiology of America in urging the National Vaccine Advisory Committee to strongly recommend mandatory influenza vaccination policies for all health care workers (HCWs). Submitted Jan. 13, the comments are online (PDF). 

Organ Transplant Guidelines Should Take Balanced Approach

Responding to proposed federal guidelines for reducing the risk of HIV and viral hepatitis transmission during organ transplantation, the HIV Medicine Association (HIVMA) and IDSA on Dec. 21 called for a more balanced approach to assessing donor risk that maintains patient safety while not reducing transplants. Read the full comments (PDF) to the Centers for Disease Control and Prevention.

IDSA Raises Alarm on Anti-Infective Drug Shortages

In a recent statement (PDF) to Congress, IDSA highlighted serious anti-infective shortages and their impact on patient care and public health, and offered strategies to address the problem. A review article and related commentary published in January in Clinical Infectious Diseases also underscored the threat to public health and patient safety posed by these shortages.

ID Funding Should Be Federal Budget Priority

In a December 2011 letter (PDF) to the Office of Management and Budget, IDSA and the HIV Medicine Association (HIVMA) urged the Obama administration to protect investments critical to the nation’s health as they prepare the president’s budget request for the 2013 fiscal year.

Check Out “My IDSA” for Latest Member News

Find the latest membership news on “My IDSA” on the IDSA website, including new IDSA members, updates on Martin J. Blaser, MD, FIDSA, and John S. Bradley, MD, FIDSA, and three members of the HIV Medicine Association (HIMVA) recently chosen for a federal antiretroviral guidelines panel. Log in with your user ID and password, and look under the “My Membership News” tab.

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.

Antimicrobial Resistance CME Activity Available Online

IDSA, the Society for Healthcare Epidemiology of America, the Centers for Disease Control and Prevention, and Medscape continue to offer a free CME activity, “Antimicrobial Resistance Across the Continuum of Care: Winning the War One Battle at a Time.” The 45-minute program, which has been renewed for another year, includes a roundtable discussion with antimicrobial resistance and stewardship experts and is intended for clinicians who regularly prescribe antibiotics.

To participate in this free CME activity, please visit www.medscape.org/viewprogram/31864.

Discount for IDSA Members on OUP Books

IDSA members can receive a 20 percent discount on most books published by Oxford University Press (OUP). Log in with your IDSA user ID and password, then follow the link under “My Membership News” to see the discounted prices on applicable titles on the OUP website.

From the President: IDSA Needs You, More Than Ever

The year ahead will be pivotal for the infectious diseases specialty. IDSA will need your help—this year more than ever—in sharing the important perspectives of ID and HIV specialists with Congress, federal, state, and local agencies, and your local hospitals and health care organizations on key issues.

The year ahead will be pivotal for the infectious diseases specialty. From federal funding for public health, prevention, ID-related research, and HIV/AIDS to physician payment issues, new models of delivering care and opportunities to spur antibiotic research and development, 2012 will be critical as policymakers make decisions in an increasingly challenging budget landscape.

IDSA will need your help—this year more than ever—in sharing the important perspectives of ID and HIV specialists with Congress, federal, state, and local agencies, and your local hospitals and health care organizations on key issues. If you have not participated in advocacy efforts before, now is a critical time to start. Visit IDSA’s “Take Action” webpage to communicate key messages with your representatives in Congress, and stay tuned for additional opportunities to get involved in 2012.

In the meantime, here are some key issues IDSA will be watching—and weighing in on: (For a recap of IDSA’s 2011 advocacy activities, see this round-up.)

  • Antimicrobial Resistance and Availability: After making good progress in 2011, we are hopeful that legislation addressing the decline in antimicrobial research and development will become law this year. An important bill, the Generating Antibiotics Incentives Now (GAIN) Act, has been introduced in the U.S. House and Senate. IDSA’s Antimicrobial Availability Task Force and related work groups will continue their important work as we engage Congress, federal agencies, and other stakeholders to build on efforts to spur the development of antibiotics and related diagnostics—and to address the need for antimicrobial stewardship. (Contact your lawmakers.)

  • Physician Payments: In late 2011, Congress froze Medicare physician payments for two months, temporarily postponing a 27-percent cut set to begin Jan. 1, 2012. Congress must act again by the end of February to prevent the payment cuts from going into effect in March. IDSA is working with other physician groups to urge lawmakers to change the flawed Sustainable Growth Rate (SGR) physician payment formula, used to calculate Medicare payments to physicians. If Congress fails to act, physicians will continue to face periodic payment cuts, limiting patient access to physician services. (Contact your lawmakers.)

  • Health Care Delivery: Starting this year, 32 health systems across the country will take part in the Medicare Shared-Savings Program, which allows Accountable Care Organizations (ACOs) to share in savings generated by providing more efficient, high quality care for Medicare patients. IDSA will be watching to see how these changes affect ID physicians and HIV medical providers working in different settings—and what resources physicians will need to navigate these changes. IDSA’s ongoing work to document the value of ID specialists will help illustrate the important role of our specialty in improving patient outcomes and lowering health care costs. The HIV Medicine Association (HIVMA) will continue to urge policymakers to build on the effective model of care developed under the Ryan White program.

  • Federal Funding: Funding will continue to be at risk for public health and prevention programs, ID and HIV-related research, HIV/AIDS treatment and prevention, and global health. Because Congress failed to enact $1.2 trillion in deficit reduction in 2011, federal programs and agencies face across-the-board cuts beginning in the 2013 fiscal year. IDSA, HIVMA, and the Center for Global Health Policy will urge lawmakers to protect investments in public health and research. (Contact your lawmakers.)

This is not a complete list, but it underscores what is at stake. IDSA and its partners will work to ensure the perspectives of ID and HIV specialists are heard this year. IDSA is viewed as a credible source on our issues, but it is essential that elected representatives hear directly from you, their constituents. We will only be successful if lawmakers and policymakers hear you echoing our messages. IDSA looks forward to working with you in 2012 to meet the challenges ahead.

NIAID Seeks Lead Investigators for Antibacterial Resistance Clinical Research Network

The leadership group of investigators will be responsible for designing, prioritizing, implementing, and managing the new network’s clinical research agenda, including soliciting research ideas from the community. Apply now.

The National Institute of Allergy and Infectious Diseases (NIAID) is seeking applications for a leadership group for a new clinical research network focused on antibacterial resistance. The leadership group of investigators will be responsible for designing, prioritizing, implementing, and managing the new network’s clinical research agenda, including soliciting research ideas from the community. See this IDSA email for more information.

Applications are due June 1, 2012 (letter of intent due May 1, 2012). Awards are expected to be made in 2013 and will consist of $10 million per year for seven years. The request for applications is online: grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-019.html. NIAID will also host an online informational session on March 5, 2012, 1-4 p.m. EST, available at videocast.nih.gov/summary.asp?live=10894.

EIN Update: Cases of M. abscessus Continue to Pose Treatment Challenges

EIN members recently reported several cases of Mycobacterium abscessus, highlighting the range of infections this organism causes as well as the difficulty in treating it.

The Emerging Infections Network (EIN) is a forum for infectious diseases consultants and public health officials to report information on clinical phenomena and epidemiological issues with public health significance. Any diagnostic or therapeutic recommendations and all opinions presented are those of the individual contributor. They do not necessarily represent the views of EIN, IDSA (EIN’s sponsor), or the Centers for Disease Control and Prevention (CDC), which funds EIN. The reader assumes all risks in using this information.

EIN members recently reported several cases of Mycobacterium abscessus, highlighting the range of infections this organism causes as well as the difficulty in treating it.

A member in California shared the case of a 17-year-old girl with cystic fibrosis and recent decline in lung function, who over the past year had three bronchoalveolar lavage (BAL) cultures that grew M. abscessus only. “Due to her declining function and only M. abscessus growing, we feel that she should receive treatment, which is where we’ve faced a hurdle,” the member wrote, given the patient’s drug reactions and resistance profile.

A respondent in Florida described a patient with persistent M. abscessus bacteraemia, who had been bacteremic for approximately eight weeks. “Thus far, he is on tigecycline/cefoxitin/imipenem and oral clarithromycin, the member wrote. The patient also has an inferior vena cava (IVC) filter and an implantable cardioverter defibrillator (ICD)/pacer, which several EIN respondents suggested may be the source of the infection.

A Pennsylvania EIN member described a 33-year-old man who cut his hand while swimming in an indoor pool and developed persistent cellulitis, which responded to intermittent courses of trimethoprim and sulfamethoxazole (TMP-SMX). A biopsy showed a ruptured epidermoid cyst and acute and chronic granulomatous inflammation, with no bone, joint, or tendon involvement.

Cultures grew M. abscessus/chelonae, and the patient was started on clarithromycin, doxycycline, and a combination of TMP-SMX, with “minimal improvement after three weeks,” the member wrote. “I have tentatively put him on a combination of clarithromycin and tigecycline. Any suggestions? Would anyone add clofazimine?”

Clofazimine does have in vitro activity, but there are no studies that demonstrate the effectiveness of clofazimine in the treatment of M. abscessus. Dosing and treatment duration are not currently defined. Clofazimine is not marketed in the U.S., but physicians can gain access to the drug for patients with nontuberculous mycobacterial (NTM) disease through the Food and Drug Administration. Application forms, a description of the application process, and an explanation for the medication’s limited distribution are available online.

Treating these infections is further complicated by the recent finding that M. abscessus actually consists of three distinct species (M. abscessus sensu stricto, M. massilinese, and M. bolleti), an EIN member in California noted. These frequently carry an erm gene, which is often inducible, meaning that “standard susceptibility testing often fails to detect macrolide/azalide resistance in the absence of a preincubation step or prolonged incubation (approximately 14 days),” the member continued.

This may account for the frequent failure of eradication of M. abscessus complex organisms in patients receiving clarithromycin or azithromycin as part of a two- or three-drug regimen. The EIN member shared several references:


E-mail the Emerging Infections Network.

The Emerging Infections Network (EIN) is a provider-based sentinel network designed to help the public health community detect trends in emerging infectious diseases.

A joint project of IDSA and the Pediatric Infectious Diseases Society (PIDS) with funding from the Centers for Disease Control and Prevention (CDC), EIN tracks emerging infectious diseases and keeps the public health community up to date with new disease trends, difficult cases, and other issues affecting members’ clinical practices. The Network provides a great opportunity for members to share knowledge quickly across large geographical distances. Both IDSA and PIDS members are eligible to join. Click here for more information or to join EIN.

IDSA Journal Club

December 2011/January 2012

This month: Studies investigating environmental factors that impact hepatitis C virus transmission; long-term follow-up of periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis syndrome patients; short-course combination therapy for latent tuberculosis; and weekly atovaquone-proguanil for malaria prevention.

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.


Environmental Factors that Impact HCV Transmission
Reviewed by Jonathan Li, MD

As many as 170 million people are infected with hepatitis C virus (HCV) worldwide, and HCV incidence in injection drug users (IDUs) may be as high as 40 infections per 100 person-years, according to estimates. Harm reduction strategies have significantly reduced rates of HIV infection among IDUs but have had a far smaller impact on HCV. In addition, a number of HCV outbreaks have been reported in health-care settings linked to either contaminated products or equipment. The high prevalence of HCV is thought to be due to the higher transmissibility of the virus and its durability in the environment. Two recent studies in The Journal of Infectious Diseases shed more light on environmental factors that may decrease HCV transmission.

In the first study, 620 pieces of used IDU equipment (needles, syringes, filters, cups, water, alcohol swabs, and cotton pads) were collected from a cohort of HCV infected individuals and a separate validation cohort of IDUs in the community with unknown HCV serostatus. Items were pooled in groups of 10 for HCV RNA testing. In both groups, HCV RNA was detected in more than 80 percent of pooled compress material (alcohol swabs and cotton pads) and in more than 30 percent of pooled syringe washes. In addition, HCV viral loads were much higher within the compress material than the syringes.

In the second study, researchers used a recently developed HCV cell culture system to test the ability of various disinfectants and environmental conditions in decreasing the infectivity of dried HCV. They found that in the presence of serum, infectious HCV could be reconstituted for up to five days after drying but could be inactivated by all six of the commercially available disinfectants that were tested. Finally, the authors found that heating dried HCV to ≥65oC in a spoon cooker (80-95 seconds using a tea light until small bubbles began appearing) was required to inactivate the virus.

These studies provide valuable insight into mechanisms of HCV transmission and also provide specific targets for prevention efforts, namely emphasizing the need to avoid sharing compression material (including alcohol swabs) and the prolonged heating of injected material. The effectiveness of commercially available disinfectants to inactivate HCV highlights the need to strictly adhere to hospital infection control measures to prevent transmission in the health-care setting.

(Thibault et al. J Infect Dis. 2011;204(12):1839-42 and Doerrbecker et al. J Infect Dis. 2011;204(12):1830-8.)

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Long-Term Follow-Up of PFAPA Patients
Reviewed by Jason B. Weinberg, MD

Long-term outcomes are good in patients with periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) syndrome, according to an article in the December 2011 issue of the Journal of Pediatrics.

Children with PFAPA are often evaluated in infectious diseases clinics because of the fevers, which are accompanied by other characteristic features and typically recur at regular intervals in the absence of documented infections. This study details up to 21 years of follow-up of a cohort of 94 patients with PFAPA that was assembled beginning in 1988 using strict diagnostic criteria.

Fever episodes ended at a median age of 9.2 years in the majority of 59 patients who could be surveyed. Episodes were shorter and less frequent in the nine patients who continued to have episodes of fever. Glucocorticoid therapy was deemed effective in 37 of 44 (84 percent) patients, while cimetidine was effective in six of 25 (24 percent) patients. Only 12 patients underwent tonsillectomy or adenotonsillectomy, but nine of these patients (75 percent) reported very effective results, with complete remission of episodes occurring in six patients at some point following surgery. Only three patients from the cohort ultimately received alternative diagnoses, none of which included infections.

Although the pathogenesis of PFAPA remains unclear, this valuable study helps to define its natural history. In doing so, it will help practitioners reassure patients with PFAPA and their families of the likelihood that the episodes spontaneously resolve as well as the patients’ very good long-term prognosis.

(Wurster et al. J Pediatr 2011; 159:958-64.)

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Short-Course Combination Therapy for Latent TB
Reviewed by Jason B. Weinberg, MD

Three months of therapy with rifapentine and isoniazid was as effective as nine months of isoniazid in preventing tuberculosis (TB), according to a study published in the Dec. 8, 2011 edition of The New England Journal of Medicine.

In an open-label, randomized, noninferiority trial, 8,053 subjects over 2 years of age who were at high risk for developing TB received either three months of once-weekly rifapentine and isoniazid or nine months of daily isoniazid. Treatment was given under direct observation for the combination group and self-administered for the isoniazid-only group. Combination therapy was noninferior to the isoniazid-only regimen in preventing tuberculosis, with cumulative proportions of subjects developing tuberculosis of 0.19 percent in the combination-therapy group and 0.43 percent in the isoniazid-only group. Subjects in the combination group were more likely to complete treatment than subjects receiving only isoniazid. Combination-therapy subjects were more likely to discontinue treatment due to an adverse event, although they were less likely to develop adverse events overall and hepatotoxicity in particular.

Treatment of latent TB is a mainstay of TB-control programs, but overall success is limited by poor compliance and side effects associated with long-term, daily medication regimens. This study was limited by the small number of patients in each group who developed TB. Additional data are needed to confirm efficacy and safety of the combined regimen in HIV-infected patients and children, who represented only a small proportion of the subjects in this study. However, the results of this study provide additional evidence that short-term combination regimens can be effective in preventing TB. 

(Sterling et al. N Engl J Med. 2011; 365:2155-66.)

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Weekly Atovaquone-Proguanil for Malaria Prevention
Reviewed by Kathryn E. Stephenson, MD, MPH

Malaria is the primary cause of febrile illness in returning travelers, but adherence to daily malaria chemoprophylaxis can be difficult for many patients. The use of weekly chemoprophylaxis with chloroquine or hydroxychloroquine is limited by widespread malaria resistance to these agents, and weekly mefloquine is associated with neuropsychiatric side effects. Thus, an additional weekly chemoprophylaxis regimen for prevention would greatly benefit the field of travel medicine.

A Jan. 15, 2012, report in Clinical Infectious Diseases describes a randomized, placebo-controlled, double-blind trial of once-weekly atovaquone-proguanil (A-P) for the prevention of Plasmodium falciparum using a human P. falciparum challenge model. Thirty volunteers were randomly assigned to receive either A-P 250/100 mg one day prior to malaria challenge, A-P 250/100 mg four days after challenge, A-P 250/100 mg seven days prior to challenge, A-P 500/200 mg seven days prior to challenge, or A-P 1000/400 mg seven days prior to challenge. All volunteers were exposed to P. falciparum sporozoites by having five infected mosquitoes feed on their forearms for five minutes. Infection was determined through serial microscopy and clinical monitoring.

After sporozoite challenge, three volunteers developed parasitemia: two volunteers who received A-P 250/100 seven days prior to challenge, and one who received A-P 1000/400 mg seven days prior to challenge. All volunteers who received A-P 250/100 four days after sporozoite exposure were protected from parasitemia. The authors conclude that a single dose of A-P provides significant chemoprophylaxis against P. falciparum challenge and argue that weekly dosing would likely be 100 percent effective.

Follow-up clinical trials involving more patients in the field are needed to establish efficacy of a weekly A-P regimen for the prevention of malaria. However, this study provides evidence that a few missed doses of A-P per week should not greatly impact prophylactic efficacy.

(Deye et al. Clin Infect Dis. 2012;54(2):232-239.)

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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:

January 15

  • Antibiotic Resistance—It’s Not All Our Fault
  • “Slingshotting” Through Biofilm
  • Daptomcin and Cationic Antimicrobial Peptides

January 1

  • Genomic Variability of Cytomegalovirus is Comparable to That Seen in HIV
  • DRACOnian Antivirals or the “Greatest Discovery Since Penicillin: A Cure for Everything—From Colds to HIV”
  • Controlling Dengue