IDSA News - February 2016
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Update on Antimicrobial Susceptibility Testing from the Clinical and Laboratory Standards Institute (CLSI)
by, Melvin P. Weinstein, MD
Professor of Medicine & Pathology
Chief, Division of Infectious Diseases, Allergy & Immunology
Vice Chair for Clinical Affairs, Department of Medicine
Co-Director, Microbiology Laboratory
Robert Wood Johnson University Hospital
Clinicians depend heavily on information from the clinical microbiology laboratory for treatment of their seriously ill patients. The clinical importance of antimicrobial susceptibility test results demands that testing be performed under optimal conditions and that laboratories have the capability to provide results for the newest antimicrobial agents. The CLSI Subcommittee on Antimicrobial Susceptibility Testing provides laboratories and clinicians with annual updates. Several recent and important changes within CLSI are noteworthy for the Infectious Diseases community.
First, CLSI has now made several pivotal documents available free of charge on the CLSI Website in a non-downloadable format. This includes the crucial M100S Document (Performance Standards for Antimicrobial Susceptibility Testing) which contains the most current information for antibiotic selection and interpretation of susceptibility test results for the most common bacterial pathogens. Several notable additions and changes in the new edition of M100S include:
• Ceftolozane-tazobactam breakpoints for Enterobacteriaceae and viridans streptococci
• Clarifications for testing cefazolin against Enterobacteriaceae
• Oritavancin MIC criteria for S. aureus, vancomycin-susceptible E. faecalis, beta-haemolytic streptococci, and viridans streptococci
• Televancin MIC and disk criteria for S. aureus, vancomycin-susceptible E. faecalis, and viridans streptococci
• Tedizolid MIC criteria for S. aureus, vancomycin-susceptible E. faecalis, S. pyogenes, S. agalactiae, and S. anginosus group
The antifungal documents which contain interpretive criteria for yeasts (M27/M44S) and molds (M38/M51S) as well as the epidemiologic cutoff values for fungi (M57S) will also be available free of charge pending their revision/publication (anticipated November, 2016). These documents can be accessed via the CLSI Home Page at http://clsi.org/m100/
Second, owing to concerns of potential conflict of interest and after careful consideration, employees of the pharmaceutical industry or individuals who derive significant portions of their income from the pharmaceutical industry may no longer serve as chairholder, vice-chairholder or voting members of the CLSI Subcommittees. However, they are still permitted to serve on scientific working groups and to attend Subcommittee meetings. The adoption of this policy reflects an attempt to create the optimal balance between ensuring that CLSI attracts, retains, and benefits from leading experts participating in the standards development consensus process while ensuring that potential conflicts have been appropriately disclosed and do not influence the standard setting process.
For ID physicians who are not familiar with CLSI, it is a voluntary, non-profit, consensus guidelines and standards organization that has provided guidance for clinical laboratory testing for nearly 50 years. For many years, IDSA has had a representative to CLSI who serves as a voting member on the AST Subcommittee (most recently, Melvin P. Weinstein, MD). In addition, the CLSI Subcommittees on Antimicrobial Susceptibility Testing (AST) are led by IDSA members (Antibacterial Subcommittee Chair and Vice-Chair: Jean B. Patel, PhD and Melvin P. Weinstein, MD, respectively, and Antifungal Subcommittee Chair and Vice-Chair: Barbara D. Alexander, MD and Gary W. Procop, MD, respectively). The committees include ID physicians, clinical microbiologists, and PharmD’s from academia, government, and the diagnostics industry. CLSI welcomes volunteers
. If you are interested in becoming involved, please email Ms. Tracy Dooley (email@example.com) or one of the Chairs or Vice-Chairs mentioned above.
Avoid 2017 Medicare EHR Incentive Program Payment Penalties
The Medicare Electronic Health Records (EHR) Incentive Program
requires eligible professionals and hospitals to demonstrate meaningful use of certified EHR technology by attesting to a set of objectives and measures determined by the Center for Medicare and Medicaid Services (CMS). Clinicians who do not comply with the program are subject to negative payment adjustments, which began in 2015.
For clinicians who cannot satisfactorily meet the EHR Incentive Program’s requirements due to hardships that are out of their control, CMS makes available a streamlined application they may submit to claim hardships that hinder satisfactory reporting and avoid payment adjustments.. The new hardship exception application also allows group practices with multiple providers to submit a single application. The hardship exception application has the following hardship categories that clinicians may claim to avoid payment,
- Insufficient Internet Connectivity
- Extreme and Uncontrollable Circumstances
- Practice or Hospital Closure
- Severe Financial Distress
- EHR Certification/Vendor Issues
Lack of Control over the Availability of Certified EHR Technology
- Lack of Face-to-Face Patient Interaction
Furthermore, in agreement with the American Medical Association’s (AMA) recommendations (PDF)
, IDSA is encouraging all physicians who are eligible to participate for the Medicare EHR Incentive Program to apply for hardship exemption under the “EHR Certification/Vendor Issues” (option 2.2.d in the application). Due to the delay in publication of Medicare EHR Incentive Program regulations, this category will broadly apply to all physicians and CMS has stated that they will refrain from auditing physicians who apply under option 2.2d – EHR Certification/Vendor Issues.
The deadline for hardship exception applications is March 15, 2016.
How to Avoid Physicians Quality Reporting System (PQRS) Payment Penalties in 2018
The reporting period for the 2016 Physician Quality Reporting System (PQRS) program has begun and it is imperative for IDSA patient care members to report on relevant measures during this calendar year to avoid a payment penalty in 2018 on all Medicare Part B payments. Given that the overwhelming volume of ID patient care is delivered in the inpatient setting, IDSA has developed specific guidance on what relevant measures might be reasonable for ID specialists to report in order to avoid a payment penalty. Please see the Guidance for Reporting 2016 PQRS (PDF) located in the ID-Specific PQRS Resources section of IDSA’s website for more information.
Federal Budgets: What Lies Ahead in Funding for HIV/ID Priorities
Significant Increases for IDSA Priorities Included in Fiscal Year 2016 Funding Law
President Obama signed a spending bill for FY 2016 in mid-December that included new resources for several IDSA priorities. The new law provides roughly $379 million in new funding to combat antimicrobial resistance including:
- $160 million in new funding for the Centers for Disease Control and Prevention (CDC) Antibiotic Resistance Solutions Initiative
- $100 million increase for National Institute of Allergy and Infectious Diseases (NIAID) AR activities
- $97 million increase for Biomedical Advanced Research and Development Authority (BARDA) AR efforts
- $10 million increase for Agency for Healthcare Research and Quality (AHRQ) AR efforts
- $8.7 million increase for Food and Drug Administration (FDA) AR efforts
- $3 million increase for CDC’s National Healthcare Safety Network
Congress also increased funding for the CDC’s Section 317 Immunizations Program, which the administration proposed cutting – citing decreased need because of the Affordable Care Act requirements for increased immunization coverage in health plans. Funding was also maintained at current levels for the programs of the CDC National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.
Domestic HIV Funding Mostly Fared Well, Global ID Fell Flat
On the whole, domestic HIV/AIDS programs did fairly well, whereas global health funding languished
. In a major policy victory, Congress allowed federal funding to support syringe access programs, including program personnel, infrastructure, and other critical services, except for the purchase of syringes. In terms of domestic HIV priorities:
- The law provides $2.3 billion for Ryan White HIV/AIDS Programs, which is $4 million more than the FY2015 enacted level. Part C gets a $4 million increase, and most other parts are flat funded, with Senate-proposed cuts to Special Programs of National Significance (SPNS) and the Minority AIDS Initiative (MAI) restored -- also, the final law did not consolidate Part D into Part C.
- In the Veteran’s Affairs section, the treatment of hepatitis C within the VA system is funded at no less than $1.5 billion in fiscal year 2016, which is $810 million above the President's request.
- AHRQ is funded at $334M – a $29.7M cut below the FY15 enacted level.
- The HHS Teen Pregnancy Prevention program is flat funded at $101 million, but funding for abstinence-only-until-marriage programs is doubled from $5 million to $10 million.
- In the Foreign Operations section, the law flat funds PEPFAR at $4.3 billion, provides $1.35 billion for the Global Fund and $330 million for USAID HIV/AIDS programs. Fortunately, the law does NOT include a House policy rider codifying the “Global Gag Rule,” which prohibits non-governmental organizations (NGOs) receiving federal funds from providing women information about the full range of health services.
HIV research advocates remain concerned that none of the $2 billion FY 2016 increase for the National Institutes of Health (NIH) will be allocated to HIV research, despite the Administration’s request for a $100 million increase for HIV research in its FY 2016 budget proposal. HIVMA helped organize two letters sent to Administration officials: a community organizational sign-on letter
as well as an individual sign-on letter
Throughout the FY 2016 appropriations process, IDSA and HIVMA members sent hundreds of letters supporting priority programs to their members of Congress through the IDSA/HIVMA Action Center
. Those efforts magnified efforts by IDSA and HIVMA staff, including dozens of meetings with congressional offices, congressional testimony, and partnering with other health groups to highlight the importance of federal HIV/ID programs.
Advocacy for Federal Funding Begins Anew
Without pausing after the recent approval of the FY 2016 spending bill, IDSA and HIVMA’s advocacy efforts are underway for the next fiscal year budget. President Obama will release his last budget request to Congress on February 9. His Fiscal Year (FY) 2017 budget request is expected to carry forward priorities important to the infectious diseases community, such as continued investment in combating antimicrobial resistance.
FY 2017 begins on October 1, just a few weeks before the 2016 presidential and congressional elections. Leaders in Congress have expressed a desire to complete spending bills ahead of the elections. However, politically sensitive votes such as these typically stall during an election year. The work of funding the government may be somewhat easier given that a bipartisan budget framework was developed last fall. The agreement relieved much of sequestration for Fiscal Years 2016-2017 and paved the way for a final FY 2016 spending bill that provided investments championed by IDSA, HIVMA and other health groups, outlined above.
Once again, IDSA and HIVMA will call on members and other stakeholder groups to join in advocacy for funding of agencies such as the CDC, NIH, and the Health Resources and Services Administration.
Efforts Continue on Pyrimethamine Pricing Issues
In response to difficulties in obtaining pyrimethamine, the primary drug used to treat toxoplasmosis, IDSA in conjunction with HIVMA and the Pediatric Infectious Diseases Society created a new online resource
with information for obtaining the drug through a compound pharmacy or through Turing Pharmaceutical’s Daraprim Direct Program. The societies also continue to monitor member challenges obtaining the medication for patients through the Daraprim Access Blog
. If you have experienced difficulty obtaining pyrimethamine for a patient or for your institution, please let us know by reporting publicly through the blog or by emailing HIVMA
In related news, the U.S. House of Representatives’ Full Committee on Oversight and Government Reform held a hearing on February 4 on Developments in the Prescription Drug Market: Oversight
that included witnesses from the Food and Drug Administration, Turing Pharmaceuticals LLC and Valeant Pharmaceuticals International, Inc. IDSA
sent letters to the Committee in advance of the hearing and issued a statement
. During the hearing, Representative Elijah Cummings, ranking member of the committee, acknowledged IDSA and HIVMA and thanked the organizations for their input to the committee.
IDSA Pushes for Antibiotics and Diagnostics R&D Incentives on Capitol Hill
A recent Capitol Hill briefing hosted by IDSA provided clinician, industry, and patient perspectives on antimicrobial resistance and the need for new incentives for research and development for new antibiotics, antifungals and rapid diagnostics. The event featured presentations from IDSA Past President, Barbara Murray, MD, FIDSA, and Christine Ginocchio, MD, of bioMérieux. House sponsors of the Reinventing Antibiotic and Diagnostic Innovation (READI) Act
, Reps. Charles Boustany (R-LA), a former surgeon, and Mike Thompson (D-CA) also addressed attendees. Additionally, Dr. Murray met with key congressional staffers to encourage support for the bill.
Roughly 150 IDSA members joined the effort by emailing their representatives in support of the READI Act, which would create a tax credit to support clinical trials of new drugs and diagnostics that target serious or life-threatening infections and address an unmet medical need. You can still support passage of the READI Act by taking 3 minutes on the IDSA Action Center
to complete the latest action alert.
Physician-Scientist Diversity: IDSA Weighs in with NIH
Increasing the numbers of underrepresented minorities was a recommendation made by the 2014 National Institutes of Health (NIH) physician-scientist workforce report, to which IDSA, PIDS, and HIVMA responded in a joint letter that expressed support for the overall effort and offered specific recommendations to improve areas of concern. Recently, NIH issued a request for information on strategies to enhance diversity in the physician-scientist workforce. IDSA responded to this request and in its letter enthusiastically supported efforts to increase underrepresented minorities in the physician-scientist workforce, and highlighted the need for strong NIH support for mentorship to trainees during the vulnerable transition to independent investigators.
IDSA Expresses Concerns Over Limited Data on Antibiotic Use in Agriculture
The U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) have been working together to develop strategies for improving antimicrobial use data collection in food-animal production. Better information on the use of antimicrobial drugs in food animals could help public health officials and scientists to better understand and interpret trends and local variations in antimicrobial resistance.
IDSA recently submitted a comment letter
outlining the Society’s concerns with the current limitations facing data collection on the farm, where antibiotics are used the most often and in the largest quantities. The Society also recommended that the FDA publish monthly sales data for each drug class, as well as state or regional data on antimicrobial sales rather than the national aggregate it currently publishes. Finally, IDSA encouraged improvements to the National Animal Health Monitoring System (NAHMS) reporting of on-farm antimicrobial use.
When the 46th Union World Conference on Lung Health convened Dec. 2-6 in Cape Town, South Africa, the IDSA Center for Global Health Policy Science Speaks
blog was there, providing live coverage of:
in shorter TB treatment regimens;
faced by health workers in high TB burden settings;
Science Speaks looked back at events that dominated the global health landscape last year, and how they will shape responses in the year ahead in the blog’s annual Top 10 stories in HIV, TB and more
IDSA Center for Global Health Policy Releases Report from Mozambique
Staff of the IDSA Center for Global Health Policy carried out the Center’s fifth congressional study tour last August, bringing three United States Senate staff members to Mozambique to examine the continuing impacts of HIV and tuberculosis epidemics there, and to witness effective responses to those diseases.
The group visited US-funded programs supporting research, treatment, prevention and health system strengthening. They witnessed how a country with multiple health and resource challenges is making strides through collaborative efforts including in programs supported by Friends in Global Health and ICAP at Columbia University.
- Integrated services for HIV and TB in the rural Zambezia province
- Comprehensive approaches to women’s health challenges in the capital city
- Capacity building and civil society outreach accompanied by expanded health service access
IDSA, HIVMA Programs Give Medical Students a First-hand Look at ID, HIV
Applications Due: February 15
"The funding was integral in completing the formal statistical analysis of the data, as it allowed me to travel to San Diego to present the results at IDWeek 2015."
- Leila Kutob, 2015 Medical Scholar
IDSA Medical Scholars Program
An important part of IDSA's mission is to promote the subspecialty of infectious diseases by attracting the best and brightest medical students to the field. To further this goal, the IDSA Education and Research Foundation offers scholarships of up to $2,000 to medical students with mentorship by an IDSA member or fellow.
Students in any year of medical school are eligible for this award. The scholarship activity must focus on pediatric or adult infectious diseases and may involve either clinical or research activities.
IDSA members and fellows are encouraged to identify and solicit interested students and to serve as mentors.
To learn more or apply for the program, please visit:
Support for the Medical Scholars Program comes from IDSA member donations. To find out more about other Foundation programs please visit www.idsafoundation.org
HIVMA Medical Students Program
First-, second-, and third-year medical students may apply for the new HIVMA Medical Student Program, which will award grants for up to three years to medical students to complete an HIV-related project.
Students and mentors have flexibility in designing the project to complement their schools' curriculum and training. Awardees will receive free HIVMA/IDSA membership, and a $3,500 stipend per year for up to three years. The program provides an additional $1,000 for mentors and institutions per year to support incidental expenses including supplies and conference registration.
The deadline to apply for both programs is February 15.
IDWeek YouTube Channel Promotes the Specialty of ID
IDSA and HIVMA partnered during IDWeek to produce video interviews with IDSA and HIVMA members discussing opportunities in ID and hot topics covered at the conference. Now available on the IDWeek YouTube Channel, the interviews were conducted by Natasha Chida, MD, an infectious diseases fellow at Johns Hopkins University, and Sonali Advani, MD, an infectious diseases fellow at the University of Alabama at Birmingham. Both are members of the newly created IDSA Fellows Committee. The purpose of the short videos is both to promote IDWeek and ID as a specialty.
Members on the Move
William Schaffner, MD, FIDSA, professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine, was awarded the John P. McGovern Compleat Physician Award by the Harris County Medical Society (HCMS), and the Houston Academy of Medicine (HAM), the scientific and charitable organization of HCMS physicians. The award recognizes physicians who exemplify medical excellence, humane and ethical care, commitment to medical humanities and writing, research, and harmony between the academic and medical practitioner.
Sonya Shin, MD, associate professor of Medicine at Harvard Medical School, associate physician in the Divisions of Global Health Equity and Infectious Diseases at Brigham and Women’s Hospital, and infectious diseases physician at Gallup Indian Medical Center, received the Richard and Hinda Rosenthal Award from the American College of Physicians. The award is given to a physician-scientist, clinician, or scientific group whose recent innovative work is making a notable contribution to improve clinical care in the field of internal medicine.
IDSA welcomes the following new members:
Alserehi, Haleema, MD
Alsomali, Afrah, MD
Amini, Rosie, PharmD
Balagopal, Ashwin, MD
Bigabwa, Serge, MD, PhD
Blow, Benjamin, MD
Britto, Johnson, MD
DelaCruz, Jennifer, MD
Dharmapalan, Dhanya, MD
Grevera, Gregory, FNP, MSN
Hublikar, Siddharth, MBBS, MPH
Kennedy, Adam, PhD
Khuon, Daliya, MD, MS
Kiser, Jennifer, PharmD
Kulkarni, Pramod, MD, MBBS, MRCP
Lee, Dong, MD
Lin, Jessica, MD
Mungin, Barbara, PhD
Palese, Peter, PhD
Patarca, Roberto, MD, PhD
Perlin, David, PhD
Pradhan, Sagun, MD
Ravenna, Valerie, PharmD
Reale, Virginia, MSc
Samuel, George, MD, MSc
Wilson, Ira, MD
Adefisayo, Aderonke, MD
Aldea, Ana, DO
Ali, Mohammad, MD
Alkabab, Yosra, MBBS
Barocas, Joshua, MD
Basein, Tinzar, MD
Bukhari, Abdullah, MBBS
Chow, Robert, MD
Daniels, Heather, DO
Dave, Ankur, DO
Diaz, Mark Anthony, MD
Galindo, Sandra, MD
Goyal, Dheeraj, MD, MPH
Jagger, Brett, MD, PhD
Johnson, Tamara, MD
Kilgore Rodriguez, Richard, MD
Krishna, Vidya, MD
Loftus, Michael, MBBS
Markou, Theodore, MD
Masadeh, Maen, MBBS
Maude, Rapeephan, MD
McCauley, Melanie, MD
Mugwanya, Kenneth, MBBS, MS
Nagaro, Kristin, DO
Porto, Maura, DO
Ramoutar, Virin, MBBS
Reynoso, David, MD, PhD
Robinette, Eric, MD
Saffie, Medina, MD
Salazar, Jaime, MD
Schaffzin, Joshua, MD, PhD
Shcherbinina, Natalia, MD
Thet, Andrea, MD
Tsuha, Sanefumi, MD
Urich, Ryan, MD
Varma, Gotam, DO
Villanueva, Hiram, MD
Vohra, Rahat, MD
Yendewa, George, MD
Akpoji, Ukwen, PharmD
Baumann, Thomas, PharmD
Brasg, Ian, MD
Chodos, David, MD
Dishner, Emma, MD
Gonzalez, Natasha, PharmD
Hatlen, Timothy, MD
Lane, Alison, MD
O'Broin, Cathal, MB, BCh
Orlinski, Halle, PharmD
Otto, William, MD
Rahman, Farah, DO
Saenz, Jessica, MD
Tiyouh, Melissa, MD
Turvey, Shannon, MD
Willis, Courtney, PharmD
Kim, Hye Jin
Amphlett, Alexander, MD, MSc
Armstrong, Neal, DPM
Barchus, Andrew, NP
Bhattacharyya, Rishi, MD
Biskup, Toni, MD, MPA
Breaux, Melissa, MSN, NP
Brielmaier, Benjamin, PharmD
Bruss, Lauren, PA-C
Chawla, Parvinder, MD
Hanrahan, Colleen, MS, PhD
Herdrich, Monica, MSN
Kohlman, Krystal, PA-C
Martin, Maria, PhD
Merlin, Toby, MD
Pathan, Kaiser, MD
Powell, Scott, MS
Pulmano, Kimberly, PharmD
Roy-Ghanta, Sumita, MD
Skeen, Venus, NP
Syed, Muneebuddin, MD
Stewardship: Putting ID at the Helm, and Giving You the Tools You Need
IDSA has a clear strategic objective: To position ID
specialists as the leaders of antimicrobial stewardship programs across the
health care system. Several initiatives are well-underway to promote the
benefits of ID leadership in stewardship programs, and a host of resources is
available to help you develop and lead an ASP in your health care setting.
Whether or not you work in a hospital setting, the anticipated CMS requirement
for ASPs in acute care settings is important to the field and will very likely
impact your work.
Much has been said about the strategic priorities of
IDSA, but it has become clear that we need to do a better job of sharing our
efforts and the progress we are making with IDSA members. So, in this letter, I
will highlight the work we are doing to prepare for the anticipated Centers for
Medicare and Medicaid Services (CMS) regulation requiring antimicrobial
stewardship programs (ASPs) in acute care hospitals as directed in the National
Action Plan for Combatting Antibiotic-Resistant Bacteria (CARB). Whether or
not you work in a hospital setting, this change is important to the field and
will very likely impact your work.
I should begin by reiterating that IDSA
has a clear strategic objective: To
position ID specialists as the leaders of antimicrobial stewardship programs
across the health care system. Several
initiatives are well-underway to promote the benefits of ID leadership in
stewardship programs, and a host of resources is available to help you develop
and lead an ASP in your health care setting.
Under the leadership of our Clinical
Affairs Committee, IDSA has been actively contributing to the discussion of
ASPs on the national level, including commenting
CMS Proposed Rule requiring stewardship in long-term care facilities, providing input
Joint Commission’s Proposed Standard for
stewardship, and participating in the National Quality Forum’s effort to establish ASP quality measures.
IDSA will also provide comment on the CMS Proposed Rule requiring stewardship
in acute care hospitals, which is expected this year.
In addition, IDSA has provided comment to
the Presidential Advisory Council on CARB regarding surveillance and data
collection needs, and is developing a white paper regarding the value of ID led
stewardship to be presented to hospital leadership as well as policymakers. Our
Standards and Practice Guidelines Committee is hard at work developing new
stewardship guidelines that are to be published this year, and the IDWeek
Program Committee has several sessions focused on stewardship in development
The time to start preparing for this
regulation is now, and there are several resources to assist you including:
AS resources within IDSA’s The Value of ID Toolkit
including an ASP Policy and Procedure template that includes suggested language
describing procedures, personnel composition, interventions, surveillance and
more (member login required).
These lists serve to provide a glimpse of
the depth and breadth of the commitment IDSA is making to ID-led stewardship.
We have received input from several members who have shared their thoughts on
additional activities that would make such programs under the leadership of ID
specialists most effective and others that would assist our members in
developing successful ASPs. We welcome that input. Please let us hear from you as well
Zika Virus: IDSA Weighs In
On Feb. 1, the World Health Organization (WHO) declared Zika virus to be an international public health emergency, which now invests WHO with enhanced authority to focus high-level attention and mobilize resources internationally. IDSA is monitoring the outbreak, relaying guidance to clinicians, and providing input to the media and policymakers.
On Feb. 1, the World Health Organization (WHO) declared
Zika virus to be an international public health emergency, which now invests WHO with enhanced authority to focus high-level attention and mobilize resources internationally. IDSA is monitoring the outbreak, relaying guidance to clinicians, and providing input to the media and policymakers.
The first local transmission of the mosquito-borne Zika virus in the Western Hemisphere was reported by WHO last spring with locally acquired cases identified in Brazil. As of Feb. 1, according to the U.S. Centers for Disease Control and Prevention (CDC), at least 25 countries or territories in the Americas
have reported local transmission of the virus. Prior to last spring, Zika had been reported in Africa, Asia and islands in the Pacific. While local transmission has not been documented in the United States, infections have been reported in travelers returning to the United States from infected areas, and the CDC expects the number of these cases to increase.
Guidance for Clinicians
The following guidance has been distributed to IDSA members who subscribe to our CDC Alerts service:
CDC also sponsored a Clinician Outreach and Communication Activity (COCA) call on January 26 to provide guidance on Zika virus. Slides and transcript are available online
Alerts on Zika virus can be found on the IDSA website
and new information will be added as it becomes available.
The CDC also has developed a micro site
on Zika virus with the latest developments on affected areas, travel notices and important information for health care providers.
Informing the Public, Policymakers
IDSA spokespeople have fielded numerous media requests on Zika virus, helping to reassure the public about what’s currently known about the disease, including CDC’s recommended precautions for pregnant women, and stressing the importance of preventing mosquito bites
The House of Representatives committee that oversees health policy is reportedly planning a congressional hearing on the Zika virus to discuss steps that federal agencies can take to better confront the disease. IDSA plans to weigh in, stressing the need for funding for public health capacity at local and international levels, support for research and development of medical countermeasures, enhanced health system preparedness for infectious diseases, and improvements to the global health infrastructure.
IDSA is also making the case that Zika virus is just one more example of the continuing need to attract the best and brightest medical students to the field of infectious diseases.
IDSA’s Center for Global Health Policy’s blog—Science Speaks
—has expanded its coverage to include the Zika virus.
Sign Up for IDSA’s CDC/FDA Alerts
IDSA offers two email services to help members stay informed of updates from FDA and CDC. Content includes a range of topics, including drug warnings, recalls, and outbreak investigations. To subscribe, please click here
(member log-in required). Other recent (non-Zika) alerts include:
IDSA Names Robert T. “Chip” Schooley Next Editor of CID
The Infectious Diseases Society of America (IDSA) has named Robert T. “Chip” Schooley, MD, FIDSA, to be editor-in-chief of the Society’s prestigious peer-reviewed journal Clinical Infectious Diseases (CID). Dr. Schooley’s term will begin in January 2017, upon the retirement of the journal’s current editor-in-chief, Sherwood Gorbach, MD, FIDSA, who has led the journal with distinction since 2000. Ferric C. Fang, MD, will serve as CID’s next deputy editor-in-chief.
The Infectious Diseases Society of America (IDSA) has named Robert T. “Chip” Schooley, MD, FIDSA, to be editor-in-chief of the Society’s prestigious peer-reviewed journal Clinical Infectious Diseases (CID). Dr. Schooley’s term will begin in January 2017, upon the retirement of the journal’s current editor-in-chief, Sherwood Gorbach, MD, FIDSA, who has led the journal with distinction since 2000. Ferric C. Fang, MD, will serve as CID’s next deputy editor-in-chief.
Published since 1979, CID is a leading journal in the field of infectious diseases with a broad international readership. The journal publishes articles on a variety of subjects of interest to practitioners and researchers. Topics range from clinical descriptions of infections, public health, microbiology, and immunology to the prevention of infection, the evaluation of current and novel treatments, and the promotion of optimal practices for diagnosis and treatment.
Dr. Schooley was selected as editor-in-chief after a comprehensive search that generated numerous applications from highly qualified candidates. Currently, he serves as professor and head of the Division of Infectious Diseases of the University of California, San Diego (UCSD). He has served as an associate editor of CID for the past decade.
Dr. Schooley’s initial training in medicine was at the Johns Hopkins Hospital, followed by sequential infectious disease fellowships at the National Institute of Allergy and Infectious Diseases (NIAID) and at the Massachusetts General Hospital (MGH), where he joined the faculty of Harvard Medical School. In 1990, he became chief of the Division of Infectious Diseases at the University of Colorado, where he developed an integrated HIV research and clinical care program. Dr. Schooley led the NIAID’s AIDS Clinical Trials Group (ACTG) from 1995 through 2002, during which time the ACTG played a central role in the development of contemporary HIV management. He was the founding chair of the Conference on Retroviruses and Opportunistic Infections (CROI) and continues to play a central role in guiding this meeting. After stepping down from ACTG, Dr. Schooley refocused his research interests on extending antiretroviral therapy to resource-limited sessions and on the emerging area of hepatitis C virus (HCV) drug discovery and development. He served as a founding member of the American Association for the Study of Liver Disease/IDSA HCV Treatment Guidance Panel.
Dr. Schooley’s laboratory at UCSD conducts studies in HCV drug discovery, P. falciparum interactions with HIV, influenza and novel point of care diagnostics development. He is an active clinician and serves as an ID consultant on the Inpatient Infectious Disease services of the UCSD Medical Center and as an attending physician on the Internal Medicine Service. He also has an outpatient practice in which he provides care to HCV infected patients.
“We are fortunate to have identified such a distinguished physician as Dr. Schooley to provide editorial leadership and continue the legacy of the many renowned physicians who have served in this capacity,” said Louis D. Saravolatz, MD, FIDSA, chair of the IDSA Publications Committee and CID Editor Search Work Group.
As incoming editor-in-chief, Dr. Schooley inherits an extremely strong journal. CID’s current impact factor is 8.886 and it ranks 2 out of 78 journals in the infectious diseases category for the 10th consecutive year. “CID outstrips competitors because of its emphasis on fair, transparent and rapid review and careful selection of novel material of relevance to those with interest in clinical and translational topics in infectious diseases and public health,” said Dr. Schooley. His goals for CID include anticipating new areas of science, recognizing the global importance of the field, embracing new publication technologies and novel media, and supporting the clinical missions of the ID specialty.
Dr. Schooley is currently establishing his editorial team and has already named Dr. Fang to be CID’s deputy editor-in-chief. Dr. Fang received his undergraduate and medical education at Harvard, and obtained postgraduate training in internal medicine and infectious diseases at UCSD. He has worked as an academic clinician-scientist-educator at the University of Colorado (1992-2001) and the University of Washington (2001-present), where he currently holds an appointment as Professor of Laboratory Medicine, Microbiology and Medicine.
“Ferric’s experience as an infectious diseases clinician, clinical microbiologist, educator, researcher and journal editor-in-chief have provided him with excellent preparation to take on this new role at CID,” said Dr. Schooley.
While in Colorado, Dr. Fang directed the Clinical Microbiology Laboratory at the university hospital, where he developed a strong appreciation for the importance of diagnostic microbiology in ID practice. At UW, his primary clinical responsibility has been to direct the Clinical Microbiology Laboratory at Harborview Medical Center. Meeting thrice-weekly with the ID consult team and reviewing culture and clinical data for every patient coming through the hospital has provided him with an unusually broad clinical perspective, which is directly relevant to CID. His research has focused on bacterial pathogenesis and the molecular diagnosis of infections, and his research laboratory has made fundamental contributions concerning the role of nitric oxide in host defense, the pathogenesis of Salmonella and staphylococcal infections, the evolution of bacterial transcriptional regulatory networks, and the development of novel molecular diagnostic methods for conditions such as Clostridium difficile colitis. Dr. Fang is the founding Director of the UW Interdisciplinary Training Program in Bacterial Pathogenesis. He recently was appointed to a task force of the Clinical Laboratory Standards Institute (CLSI) charged with updating antimicrobial susceptibility guidelines to incorporate emerging molecular technologies.
Dr. Fang has served as editor-in-chief of the American Society for Microbiology journal Infection and Immunity since 2007 and his term will end in 2017. He has been a member of the IDSA since starting his fellowship in 1987, has been an invited speaker at numerous IDSA meetings, has served as a reviewer for CID and The Journal of Infectious Diseases, and has served on the IDSA Standards and Practice Guidelines Committee.
“With wise stewardship, CID is well positioned to continue its role as the preeminent journal in the field,” said Dr. Fang. “It is a great honor to be named part of the CID team.”
Nominate Your Colleague for an IDSA or HIVMA Award
and the IDSA Education and Research Foundation (ERF) are now accepting
nominations for the 2016 Society Awards and the HIVMA Awards, which honor outstanding achievement
and up-and-coming leaders in the field. Award recipients will be honored at IDWeek
in New Orleans, Oct. 26-30.
Few fields of medicine have as many inspiring colleagues as ID and HIV. IDSA, HIVMA and the IDSA Education and Research Foundation (ERF) are now accepting nominations for the 2016 Society Awards
and the HIVMA Awards
, which honor outstanding achievement and up-and-coming leaders in the field. Award recipients will be honored at ID
Week in New Orleans, Oct. 26-30.
IDSA Awards: Deadline April 1
- Alexander Fleming Award for Lifetime Achievement
- Oswald Avery Award for Early Achievement
- Clinical Teacher Award
- Walter E. Stamm Mentor Award
- Society Citation
- Watanakunakorn Clinician Award
Complete details about the awards, including how to submit nominations, are available on the IDSA website
. For more information, please email firstname.lastname@example.org
or call (703) 299-0200.
HIVMA Awards: Deadline May 1
HIVMA recognizes two members each year for outstanding achievements with the Clinical Educator
and the HIVMA Research
awards. Each awardee receives a $1,500 honorarium in addition to travel support to attend the ceremony. More information on these awards and how to nominate your colleagues is available on the HIVMA website
IDSA Journal Club
Meant to Heal, but also Conferring Risk for C. difficile; Is the Joint
Involved? Staphylococcus aureus Bacteremia among Patients with Joint
Prostheses; Isavuconazole: A New Alternative for the Treatment of Invasive
Aspergillosis; A Pan-Hepatitis C Medication with Excellent Safety and Efficacy.
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.
- Antibiotics: Meant to Heal, but also Conferring Risk for C. difficile
- Is the Joint Involved? Staphylococcus aureus Bacteremia among Patients with Joint Prostheses
- Isavuconazole: A New Alternative for the Treatment of Invasive Aspergillosis
- A Pan-Hepatitis C Medication with Excellent Safety and Efficacy
Antibiotics: Meant to Heal, but also Conferring Risk for C. difficile
Reviewed by Terri Stillwell, MD
Despite multidisciplinary efforts, health care-associated C. difficile
infections (HA-CDI) continue to cause significant morbidity and mortality. While it is well known that antibiotic exposure increases risk of HA-CDI, a recent Infection Control and Hospital Epidemiology article
took the analysis of antibiotic exposure a step further, looking at antibiotic use in both inpatient and outpatient settings.
This retrospective cohort study included all patients older than 18, with an inpatient admission from January 2011 through December 2012, comparing those with incident HA-CDI to non-HA-CDI patients. Data regarding all antibiotics, inpatient and outpatient, within three months prior to admission were gathered. The authors separated antibiotics into 27 categories on the inpatient review and 10 categories in the outpatient review, allowing for a more in-depth look at the impact of specific antibiotic classes.
Approximately 400,000 patients were admitted at least once during the study period; 2,638 had incident HA-CDI, 0.7 percent of the study population, equivalent to a rate of 14.98/10,000 patient days. Outpatient fluoroquinolone and lincosamide use was associated with increased risk of HA-CDI, while outpatient macrolide use seemed protective. Nearly all inpatient antibiotic classes exhibited an association with HA-CDI, except first-generation cephalosporins and tetracyclines, which appeared to reduce HA-CDI risk. Interestingly, inpatient metronidazole and PO vancomycin was also associated with increased risk of HA-CDI, which the authors hypothesized may be due to empiric treatment with delay in testing versus the potential that, like other antibiotic classes, these antibiotics too disrupt gut flora in colonized, but otherwise uninfected, patients, ultimately leading to disease.
Authors of another recent article
, in The Journal of Infectious Diseases
, aimed to explore that very question by assessing the impact of metronidazole and vancomycin on gut microbiota in mice, which were treated with three days of metronidazole, vancomycin, or both. The mice were then challenged with C. difficile
. Mice with no antibiotic pre-treatment did not exhibit colonization/infection with C. difficile. Those treated with metronidazole showed presence of C. difficile spores, but at decreasing levels; baseline colonization was restored within two weeks. Those receiving vancomycin were found to be heavily colonized, but nearly all had undetectable spore levels near the end of the study. However, those receiving metronidazole plus vancomycin had severe gut disruption, with nearly 80 percent having continued C. difficile growth at three weeks post antibiotic cessation.
Metronidazole caused minor shifts in commensals, returning to pre-treatment flora in one to two weeks, while vancomycin and metronidazole plus vancomycin created more significant changes. Finally, the authors also challenged mice with vancomycin-resistant Enterococcus (VRE), carbapenem-resistant K. pneumoniae, and E. coli. Those treated with metronidazole exhibited these bacteria early, with quick return to baseline; those receiving vancomycin were susceptible throughout the study period, with the exception of VRE. The authors extrapolated that treatment with these antibiotics could potentially create susceptibility to nosocomial infections by resistant organisms.
Antibiotics, though intended to benefit our patients, continue to place them at harm, increasing their risk for HA-CDI. Even those antibiotics meant to treat C. difficile can cause disruption in the gut microbiota, lending susceptibility to C. difficile infection itself, as well as potential for infections by resistant organisms, showing that empiric therapy carries its own inherent risks.
Is the Joint Involved? Staphylococcus aureus Bacteremia among Patients with Joint Prostheses
Reviewed by Michael T. Melia, MD
When caring for patients with Staphylococcus aureus bacteremia, infectious diseases physicians are often asked whether previously placed joint prostheses are foci of hematogenously spread infection. Identifying variables that can distinguish patients for whom diagnostic testing for prosthetic joint infection (PJI) is warranted from those for whom watchful waiting might be pursued may advance patient care.
A recent article
in the American Journal of Medicine
provides data that helps facilitate decision-making. The authors retrospectively identified 97 patients with S. aureus
bacteremia who had previously undergone 166 joint knee, hip, shoulder, and/or elbow arthroplasties. Twelve of these patients had only primary or indeterminate PJI, leaving a study population comprising 85 patients with 143 arthroplasties. Fifty (59 percent) of these patients had no PJI and 35 (41 percent) had a hematogenous PJI in at least one arthroplasty. All but one PJI manifested at least one clinical feature suggestive of infection. Joint pain (97 percent) was most commonly present, with other features including periarticular swelling or effusion (62 percent) and periarticular warmth (46 percent).
The study also found increased odds of PJI among patients with community-acquired S. aureus bacteremia as compared with nosocomial infection (odds ratio [OR] 21.39; 95 percent confidence interval [CI] 2.92-infinity; P = .001); no patient with nosocomial S. aureus bacteremia developed PJI. The presence of three or more arthroplasties was associated with increased odds of hematogenous PJI as compared with one or two arthroplasties (OR 8.55; 95 percent CI 1.44-95.71; P = .012). Previously revised joints were more likely to develop hematogenous PJI, and knees were more likely than hips to get infected.
PJIs are common among patients with S. aureus bacteremia and previous joint arthroplasty. Nearly all patients with PJI in this setting manifest with at least one sign or symptom consistent with PJI, suggesting that patients without such signs or symptoms might forego further evaluation for possible occult PJI.
Isavuconazole: A New Alternative for the Treatment of Invasive Aspergillosis
Reviewed by Sheila Mitsuma, MD
Isavuconazonium sulfate was approved for treatment of invasive aspergillosis and invasive mucormycosis in the U.S. in March 2015. This approval was based on a randomized-controlled, phase III trial of 527 adults with invasive mold disease recently published
in The Lancet
Diagnostic classification was based on definitions from the 2008 EEORTC/MSG Consensus Group. Patients with hepatic or moderate-severe renal dysfunction were excluded. Block randomization was used to stratify patients by active malignant disease at baseline, allogenic hematopoietic stem cell transplantation, and geographic region. Trial participants were randomized to receive either:
- isavuconazonium sulfate 372 mg intravenously (IV) three times daily for two days, then IV or orally once daily; or
- voriconazole 6 mg/kg IV twice daily for one day, then 4 mg/kg IV twice daily for one day, then 4 mg/kg twice daily or 200 mg orally twice daily.
In the intention-to-treat analysis, no significant difference in 42-day all-cause mortality (the primary endpoint) was found, with 19 percent vs. 20 percent mortality (95 percent confidence interval [CI], -7.8 percent to 5.7 percent) in the isavuconazole vs. voriconazole groups. Similar mortality rates were found among the subset of patients with proven or probably invasive aspergillosis (82 percent of the total study population). Noninferiority, defined as the upper limit of 95 percent CI for a treatment difference ≤ 10 percent, was also met for 84-day all-cause mortality and clinical, mycologic, and radiographic response (the secondary endpoints, along with safety and tolerability).
While overall adverse events did not differ between groups, drug-related adverse events were reported in fewer patients receiving isavuconazole when compared to voriconazole (42 percent vs. 60 percent, p<0.001). Specifically, there were fewer dermatologic reactions, visual abnormalities, and reports of hepatic dysfunction in the isavuconazole group.
In sum, isavuconazole appears to be a promising new alternative for the treatment of invasive aspergillosis, with potentially fewer side effects than voriconazole. However, drug monitoring was not performed in this study, which is not reflective of clinical practice and raises the possibility that a portion of the voriconazole cohort was underdosed. It is also unclear whether these results can be extrapolated to the treatment of non-Aspergillus molds such as mucormycosis, which comprised 5 percent or less of the study cohort. Finally, the clinical response rate in both groups was low (62 percent for isavuconazole vs. 60 percent for voriconazole) highlighting the need for further drug research and development.
A Pan-Hepatitis C Medication with Excellent Safety and Efficacy
Reviewed by George R. Thompson III, MD
The advent of new hepatitis C virus (HCV) medications that directly interfere with HCV replication has revolutionized treatment. There are now regimens of direct-acting agents available for most patients. However, multiple variables impact the selection of an appropriate treatment regimen.
The results of four studies evaluating once daily sofosbuvir (a NS5B inhibitor) and velpatasvir (a new NS5A inhibitor with activity against all HCV genotypes) in the treatment of HCV were recently published in three articles in the New England Journal of Medicine. In two of these studies, ASTRAL-1 and ASTRAL-2, a sustained virologic response 12 weeks after the end of therapy was observed in 97 percent and 100 percent of patients with HCV genotypes 1a, 1b, 2, 4, 5, and 6. Efficacy was also demonstrated in those previously failing treatment and in those with compensated cirrhosis.
The ASTRAL-3 study focused on those with HCV genotype 3, a genotype associated with more rapid disease progression and lower rates of response to treatment. A sustained virologic response 12 weeks after end of therapy was seen in 95 percent of patients (and was superior to patients treated with 24 weeks of sofosbuvir-ribavirin).
The ASTRAL-4 study evaluated outcomes in patients with HCV infection and decompensated cirrhosis, a group with no ribavirin-free regimen currently available. In this study, treatment with sofosbuvir-velpatasvir with or without ribavirin for 12 weeks and with sofosbuvir-velpatasvir for 24 weeks resulted in high rates of sustained virology response (83 percent, 94 percent, and 86 percent, respectively).
Collectively in these studies, few serious adverse events, high study-completion rates, and rates of sustained virologic response superior to selected study comparators were seen. The presence of NS5A resistance-associated variants was also not a factor in treatment outcomes, although additional study in this area is needed.
Back to Top
For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, FIDSA, in each issue of Clinical Infectious Diseases:
- MRSA Susceptible to Augmentin? mecC Is Not Your Mother's mecA
- Case Vignette: A Patient With Severe Immunodeficiency Associated With a GATA2 Mutation
- Coccidioidal Meningitis: Diagnosis by Antigen Detection
- When Tuberculous Lymphadenitis Appears to Worsen During Treatment in Non-HIV-Infected Patients
- Imaging of Prosthetic Valve Endocarditis and Infected Intracardiac Devices
- Influenza (and Other Viruses) Causing Parotitis
- Treatment of Infections due to Mycobacterium abscessus: Where Do We Go From Here?
- Shedding Vaccine-Derived Poliovirus for Almost 3 Decades!
- Case Vignette: Acute Hepatitis due to a Fruit Fly Endosymbiont