IDSA News - June 2015
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FDA Cautions About Dose Confusion and Medication Errors for Antibacterial Drug Zerbaxa
The U.S. Food and Drug Administration (FDA) issued a warning last month about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vial and carton labeling. To prevent future medication errors, the strength on the drug labeling has been revised to reflect the sum of the two active ingredients. Zerbaxa is used to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen. Click here for an FDA Drug Safety Podcast on these cautions (MP3 - 1.8MB).
IDSA offers two email services to help members stay informed of updates from FDA and the Centers for Disease Control and Prevention (CDC). Content includes a range of topics, including drug warnings, recalls, and outbreak investigations. Recent alerts have included:
Updated Information and Guidelines for Evaluation of Patients for MERS-CoV Infection ( CDC Alert 06/12/2015)
Bird Infections with Highly Pathogenic Avian Influenza A (H5N2), (H5N8), and (H5N1) Viruses: Recommendations for Human Health Investigations and Response (CDC Alert 6/2/15)
Lassa Fever Confirmed in Death of U.S. Traveler Returning from Liberia (CDC Alert 5/26/15)
Outbreak of Recent HIV and HCV Infections Among Persons Who Inject Drugs (CDC Alert 4/24/15)
IDSA members can sign up for these services online. (To subscribe, check the appropriate boxes to receive CDC’s Health Alert Network [HAN] messages and/or alerts from FDA, and provide your email address and name where indicated.)
Is Your Facility Experiencing Antibiotic Shortages?
IDSA members are urged to report drug shortages directly to FDA and to copy IDSA staff at firstname.lastname@example.org.
Foundation to Develop Database of C. difficile Providers
The Peggy Lillis Foundation (PLF) is the leading national organization focused on raising awareness of and advocating for people with Clostridium difficile infections. Christian and Liam Lillis founded PLF in 2012 after losing their mother, Peggy, to C. difficile associated disease. As part of its mission, the organization is launching a new website, which will house an online database of C. diff providers. PLF wants to create the most robust database possible for patients and caregivers seeking diagnosis and treatment for this dangerous infection. To be included, please fill out PLF’s survey.
So Long SGR! What’s Next, and How Will MACRA Affect You?
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), signed into law in April, not only repealed the Medicare sustainable growth rate (SGR) formula, it also contained other provisions that will impact how physicians deliver care.
Medicare payment rates will be stableThe bill also provides for positive payment updates of 0.5 percent, starting July 1 this year and then on Jan. 1 annually through 2019.
MACRA prevented an impending physician payment cut under the SGR and increased the Medicare conversion factor, part of the formula for calculating physician payments. As a result, Medicare physician pay this year will be 27 percent greater than under SGR.
Quality reporting programs will be consolidated
Medicare's current quality reporting programs will be simplified into one merit-based incentive payment system, referred to as "MIPS." This means the current penalties under the Physician Quality Reporting System (PQRS), meaningful use electronic health record (EHR) program, and the value-based payment modifier will expire at the end of 2018 and will be replaced with the MIPS. Performance under the MIPS will be based upon four categories—quality, resource use, meaningful use, and clinical practice improvement activities. The MIPS also would build and improve upon current quality measures and concepts in existing programs.
Physicians will be encouraged to report quality measures through certified EHR technology or qualified clinical data registries. Participation in a qualified clinical data registry would also count as a clinical practice improvement activity. Alternative payment models will be rewarded--physicians who participate in qualified alternative payment models will receive a 5 percent bonus starting in 2019. These physicians also will be exempt from participating in MIPS. Technical support will be provided to help smaller practices participate in alternative payment models.
Physicians will have liability protections.
The bill contains a provision similar to the Standard of Care Protection Act that will protect physicians by preventing quality program standards and measures (such as PQRS or MIPS) from being used as a standard or duty of care in medical liability cases.
Learn more about how MACRA will impact physicians on the American Medical Association's new Web page on Medicare physician payment reform, including fact sheets on the impact of MACRA in each state.
CMS to Host Physician Compare Informational WebinarDuring this session, CMS will answer questions about Physician Compare and public reporting, but the agency is requesting that participants submit their questions in advance of the webinar. All questions must be received by 5 p.m. Eastern time June 15.
The Centers for Medicare & Medicaid Services (CMS) will host a webinar to discuss the Physician Compare program from 1-2 p.m. ET on June 23.
To register or submit a question, send an email to PhysicianCompare@Westat.com. Please use the subject line "Physician Compare Virtual Office Hour" and include your name, organization, telephone number and email address. For more information, visit CMS's Physician Compare Initiative Web page.
CMS Proposes Changes to Meaningful Use Program; ONC Updates HIT Certification Criteria
The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule on the Electronic Healthcare Record (EHR) Meaningful Use Program Stage 3. Concurrently, the Office of the National Coordinator for Health Information Technology (ONC) released a proposed rule updating certification requirements for health IT (HIT) platforms that are used in federal programs like Meaningful Use. In a comment letter to CMS, IDSA continued to advocate for less stringent reporting requirements for eligible providers and for more flexibility in the adoption of healthcare information technology. The Society also stressed the importance of including incentives for providers to use Immunization Information Systems (IIS) to ensure that adults as well as children are receiving recommended vaccines and to adhere to state case-reporting protocol to detect possible outbreaks as early as possible. In a separate comment letter to ONC, IDSA applauded the addition of the Antibiotic Use and Resistance module capabilities, which will encourage healthcare facilities to report resistance and use data through the National Healthcare Safety Network. The Society also applauded the inclusion of required capabilities for bidirectional reporting to the IIS.
IDSA Offers Discussion Board, Other Resources on Contract Negotiations
To provide IDSA members a platform to discuss matters regarding contracts, contract negotiations, and other topics related to ID specialist compensation, IDSA has developed the IDSA Contracting and Negotiations Discussion Board (member login required). Through this discussion board members can connect with colleagues and share information about compensation for the myriad of clinical services rendered.
Additionally, the Value of ID Specialists’ Toolkit (member login required) provides valuable resources for contract negotiations such as the IDSA guide to co-management agreements for antimicrobial stewardship, infection control and prevention services, gain-sharing contract template, and various media to raise awareness on the value of the ID specialists.
These and other helpful resources for clinicians can be found on the IDSA website.
IDSA Members Urge Increased NIH Funding on Capitol Hill
IDSA Research Committee Chair Ebbing Lautenbach, MD, FIDSA, and committee members Kami Kim, MD, FIDSA; Mark Mulligan, MD, FIDSA; and Julie Parsonnet, MD, FIDSA, met with over 20 congressional offices earlier this month, primarily to support funding increases for the National Institutes of Health (NIH).
Efforts like these by IDSA members greatly enhance the Society’s advocacy efforts. IDSA members can provide unique expertise and perspective on how federal policies, such as NIH funding, directly impact individual states and congressional districts. Such meetings have helped strengthened IDSA’s relationships with key Members of Congress, secured congressional champions for key IDSA initiatives, and helped advance IDSA policy priorities.
If you’re planning a trip Washington, DC, IDSA can help you connect with congressional offices from your state. IDSA staff would schedule your meetings, supply you with background information and talking points, join you in your meetings, and follow up with congressional staff. For more information, contact IDSA’s Director of Government Relations, Jonathan Nurse at email@example.com.
Even if you can’t come to DC, you can still support IDSA’s advocacy efforts. Take 3 minutes to echo the Research Committee members’ messages about NIH funding through IDSA’s online action alert.
Help HIVMA Advocate for HIV Funding and Syringe Exchange
HIVMA Board members took to Capitol Hill last month to advocate for robust funding for HIV/AIDS programs, including HIV research at the National Institutes of Health, and to urge Congress to lift the ban on the use of federal funding for syringe exchange programs.
Weigh in with your congressional representatives to urge them to support federal funding for syringe exchange programs. Read the IDSA and HIVMA Policy Statement on Syringe Access and Paraphernalia Laws.
HIVMA Board Members Melanie Thompson, MD; Jeanne Keruly, MS, CRNP;
and Natella Rakhmanina, MD, PhD outside the Rayburn House Office Building
HOPE Act Springs Forward
Implementation of the HIV Organ Policy Equity (HOPE) Act is moving forward thanks to a Department of Health and Human Services final rule issued last month. Previous federal regulations prevented organ donation from individuals known to be infected with HIV. Once fully implemented, the HOPE Act will allow organs from people with HIV to be transplanted into other individuals with HIV.HIVMA has been a leader in making this important step in equitable access to life-saving transplants possible, from issuing a policy statement in 2011 calling for a repeal of the federal ban on organ donations from people with HIV, to working with partners to get the law passed in 2013, to advocating for swift and effective implementation since enactment. Read the final rule, with background, here.
Weigh in on FDA Proposed Changes to Blood Donor Deferral Policy
The Food and Drug Administration (FDA) has released a proposed guidance document for revising the blood donor deferral criteria, lifting the lifetime ban on blood donations by men who have sex with men. However, the new guidance excludes men who have had sex with men within a year from donating blood, and continues an indefinite exclusion for people who inject drugs and commercial sex workers.
HIVMA issued a statement recognizing the proposed criteria as a first step but calling for further evidence-based reforms. HIVMA recommends that blood donor screening procedures be revised to ask all potential donors to exclude themselves if within the previous six months they have tested positive for HIV, engaged in unprotected sex with a partner with HIV or unknown HIV status, or used a syringe not prescribed by a physician.
You can weigh in on the guidance during the 60-day comment period here by searching for "Docket No. 2015-11690." The deadline to comment is July 14.
Societies Provide Comments to NIH on Improving Impact and Sustainability of Biomedical Research
IDSA, along with HIVMA and the Pediatric Infectious Diseases Society (PIDS), jointly commented on an National Institutes of Health request for information on ways to optimize funding policies or other strategies that improve the impact and sustainability of biomedical research. The societies listed areas of concern in administrative burden, workforce sustainability, and prioritization of research funding, and offered specific recommendations to improve them.
Science Speaks: Global HIV, TB and Ebola Research and Responses
May was a month of breaking news and developments in global HIV, tuberculosis and Ebola research and responses. Science Speaks, the official blog of the Center for Global Health Policy, covered them with:
Stay tuned: Science Speaks will provide live coverage of the 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, where additional news on START and other pivotal research will be featured.
- Reporting on the launch of the first clinical trial to test an all-oral treatment regimen for extensively drug resistant tuberculosis;
- A review of World Health Organization Director General Margaret Chan’s call for improved emergency health preparedness in wake of the agency’s delayed Ebola response;
- Analysis on the ramifications of findings from the National Institute of Allergy and Infectious Disease-sponsored START trial, which saw illness rates among people living with HIV more than double with delayed antiretroviral treatment initiation.
IDSA Foundation Joins the Combined Federal Campaign
The IDSA Education and Research Foundation
is now part of the Combined Federal Campaign (CFC), which is the
world’s largest annual workplace charity campaign. Inclusion in the
National/International Combined Federal Campaign Charity List will
increase visibility of the Foundation, particularly with federal
employees, and provide the opportunity to participate in CFC events at
Federal agencies. The Foundation’s designated CFC number is 97049.
If you’re a federal employee, look for the IDSA Foundation when
making your annual donations. Anyone can donate to the IDSA Foundation
at any time via the Foundation’s website.
Donations support a wide range of programs to develop careers, promote
research, and disseminate knowledge about infectious diseases.
Courses in Antimicrobial Stewardship
Primer on Healthcare Epidemiology, Infection Control & Antimicrobial Stewardship: Online CourseThe Society for Healthcare Epidemiology of America (SHEA) has recently released its Primer on Healthcare Epidemiology, Infection Control & Antimicrobial Stewardship: Online Course, endorsed by IDSA and the Pediatric Infectious Diseases Society (PIDS). The course meets the requirements for ID fellows for course work in healthcare epidemiology and infection prevention as outlined by the American Board for Internal Medicine (ABIM). Other physicians and healthcare practitioners can earn CME credits.
The course’s 12 online modules use interactive case-based scenarios on the following topics:
IDSA members receive a discount on the course registration fees.
- Pathogen transmission: Diarrheal illness, airborne infections, and respiratory viral illness
- Implementing antimicrobial stewardship
- Outbreak management in the healthcare setting
- Approach to control of bioterrorism agents
- Advanced occupational health management
- Prevention and management of multidrug resistant organisms including: methicillin-resistant Staphylococcus aureus, carbapenem-resistant Enterobacteriaceae, vancomycin-resistant Enterococci, extended-spectrum β-lactamase–producing Escherichia coli, and C. difficile
- Device-associated infections including: catheter-associated bloodstream infection, catheter-associated urinary tract infection, and ventilator-associated pneumonia
- Surgical site infections: Impact, frequency, and risk factors
IDAC Course in Antimicrobial Stewardship
The Infectious Disease Association of California (IDAC), in association with the California Department of Public Health, is offering Practical Antimicrobial Stewardship: Implementation and Expansion in Healthcare Facilities on Saturday, July 18, 2015 at the Hilton Hotel in Irvine, CA. This CME activity is designed to assist health care facilities in implementing and improving their own Antimicrobial Stewardship Programs (ASP).For info: http://idac.org/upcoming.php
For brochure: http://idac.org/brochures/2015Summer.pdf
Updated Lyme Disease Case Study Course
An updated and reaccredited version of IDSA’s Lyme Disease Case Study Course is now available online. The course focuses on how to evaluate and diagnose Lyme disease, and utilize effective therapy. Those who have already completed the course cannot earn CME again.
Reminder: CID Editor-in-Chief Search is On!
As previously announced, Sherwood Gorbach, MD, FIDSA, will be retiring from his post as Editor-in-Chief of IDSA’s journal Clinical Infectious Diseases (CID) in December 2016, and IDSA is engaged in a search for his replacement.
Applications and nominations are being accepted through July 15, 2015. Short-listed candidates will be interviewed during IDWeek in San Diego in October and a successor will be announced in January 2016. The new Editor-in-Chief will officially take office on January 1, 2017 for a 5-year term. If you wish to apply, please send a CV and a 2-4 page statement of qualifications and why you are interested in the position, your availability to devote considerable time and energy to the journal, and information to address the following criteria:
- Academic and Publishing Record
- Editorial Experience and Management Style
- Vision for the Journal’s Future
For more information, including a description of CID’s current workload, editorial structure, and peer-review process, please contact:
Vice President, Communications, IDSA
Members on the Move
IDSA Past President, John Bartlett, MD, FIDSA, received the 4th C. Everett Koop Public Health Leadership Award at the 2015 National Summit on HCV and HIV Diagnosis, Prevention and Access to Care for his work in HIV. The award was presented by IDSA staff member Christine Lubinski of the Center for Global Health Policy, Lynda Dee (AIDS Action Baltimore) and Laura Cheever, MD, ScM (HRSA/JHU). Dr. Bartlett has been at the forefront of fighting the AIDS epidemic since the early 1980s, starting an AIDS clinic at Hopkins in 1983, being the first to direct clinical trials in Baltimore of new treatments that prevent HIV from replicating, and being the co-chair and one of the founding members of the national committee that drafted the first and all subsequent treatment guidelines for HIV-infected patients.
Arturo Casadevall, MD, FIDSA, member of IDSA’s Research Committee, was awarded a Johns Hopkins University Bloomberg Distinguished Professorship. This program brings together world-class faculty members whose excellence in research, teaching and service will be centered on interdisciplinary scholarship. Together they will lend their outlook to public health, medicine, nursing, engineering, and the sciences, and work toward finding solutions to today's global problems.
Jeffrey Duchin, MD, FIDSA, chair of IDSA’s public health committee, has been named County Health Officer of Seattle & King County. Dr. Duchin is a nationally recognized leader in public health and a longtime leader in the Seattle & King County Public Health Department as chief of the Communicable Disease Epidemiology and Immunization Section.
Kevin High, MD, MS, FIDSA, professor and chair of Internal Medicine and Infectious Diseases, has been named Executive Vice President, Health System Affairs of Wake Forest Baptist Health. Dr. High joined Wake Forest’s School of Medicine as faculty in 1993 and has earned national recognition in the field of infectious diseases. He has also served as the IDSA Education Committee chair and was involved in other IDSA educational initiatives including IDSA’s Annual Meeting and IDWeek.
Trini A. Mathew, MD, FIDSA, member of IDSA’s Public Health Committee, will assume a new position as hospital epidemiologist and ID physician at Conemaugh Memorial Medical Center in Johnstown, PA as of July 1. Dr. Mathew previously worked in the Division of Infectious Diseases at the University of Connecticut Health Center.
Daniel McQuillen, MD, FIDSA, president of the Massachusetts Infectious Diseases Society (MIDS), recently received the Kenneth Kaplan Clinician Award by the MIDS, awarded to one outstanding ID clinician each year. Dr. McQuillen is senior staff physician at the Lahey Hospital and Medical Center in Burlington, MA.
Bruce Polsky, MD, MACP, FIDSA, will be joining Winthrop University Hospital in Mineola, NY as Chairman of the department of medicine. Dr. Polsky previously served as an infectious diseases specialist with Mt. Sinai St. Luke’s-Roosevelt, where he chaired the Department of Medicine since 2014.
MEMBERSAshbaugh, Cameron, MD
Hung, Ivan F.N., MD
Kizy, Anne, PhD
McTigue, Sean, MD
Naji Alasil, Saad Mushbah, PhD
Price, Jennifer, MD, PhD
Trible, Ronald, MD, PhD
MEMBERS-IN-TRAINING/FELLOWSAaron, Justin, MD
Akande, Olaide, MBBS
Almaghlouth, Nouf, MBBS, MPH
Aravindakshan, Nisha, MD
Bizanjo, Mahwash, MBBS
Choi, Woo Jeong, MD
Gohel, Swati, MD
Jenks, Jeffrey, MD, MPH
John, Amrita, MBBS
Macsesic, Nenad, MD
Majumdar, Anjali, MD
McCluskey, Suzanne, MD
Medaris, Leigh, MD
Meylan, Sylvain, MD, PhD
Sarfaraz, Samreen, MRCP
Schaefer, Sarah, MD
Spier, Addie, MD
Syed, Beenish, MBBS
Taramona-Espinoza, Claudia, MD
Zucker, Jason, MD
RESIDENTSBercholc Urinowsky, Irina Jeanette, MD
Gross Duarte, Fernanda, MD
Guzman, Johnny, MS
Hassouna, Habiba, MD
Ruh, Christine, PharmD
Suthar, Mitesh, MD
Yasmin, Mohamad, MD
ASSOCIATESCleghorn, Farley, MD, MPH
Fadlallah, Hasan, DMD
Galang, Mari, MSN, NP, RN
Girio-Herrera, Leonardo, DO
Mcnabb, Paul, MD
Nadipuram, Santhosh, MD
Olugbosi, Morounfolu, MD
Phillips, Michael, MD
Richards, Jennifer, PhD
Srikantiah, Padmini, MD, MPH
Vaidiyanathan, Sabanayagam, MBBS
Wijaya, Limin, MD
Yoshimatsu, Shoji, MD, PhD
DECEASEDGwen Stephens, MD
Concerned About Changes to the ABIM MOC Program? IDSA is Working for You
Several concerns have been raised by IDSA members regarding the administrative burdens, costs, and the need for flexibility in how points are earned within the MOC program. Thanks to a long-standing working relationship that staff and leadership has had with ABIM, we have shared these concerns and are beginning to see several significant changes.
IDSA has been working to address your concerns regarding the American Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) program. There were several issues raised by IDSA members, along with members of other internal medicine subspecialty societies, regarding the administrative burdens, costs, and the need for flexibility in how points are earned within the MOC program.
Earlier this year, ABIM announced the following changes:
- Suspend the Practice Assessment (Part 4), Patient Voice, and Patient Safety requirements for at least two years.
- Change the language used to publicly report a Diplomate’s MOC status on the ABIM website from “meeting MOC requirements” to “participating in MOC.”
- Update the Internal Medicine MOC exam to focus on making the exam more reflective of what physicians in practice are doing; these changes will be incorporated beginning fall 2015.
- Promise to keep MOC enrollment fees at or below 2014 levels through at least 2017.
- Pledge, by the end of this year, new and more flexible ways for physicians to demonstrate self-assessment of medical knowledge through recognition of most forms of continuing medical education approved by the Accreditation Council for Continuing Medical Education (ACCME).
For the past seven years, IDSA staff have served on the ABIM Liaison Committee on Certification and Recertification (LCCR), a group that meets biannually to discuss issues related to MOC, receive updates from ABIM, and share best practices among specialty societies. This involvement has allowed IDSA not only to maintain a dialogue with ABIM, but also to voice concerns raised by the IDSA membership.
More recently, ABIM hosted a series of meetings to address the modifications to the MOC program. IDSA Board member Thomas Fekete, MD, FIDSA, and IDSA staff attended a meeting in March to discuss with ABIM what “keeping-up” means to physicians. Dr. Fekete subsequently attended an internal medicine summit, coordinated by ABIM in April, to further discuss the evolution of the MOC program.
In addition to changing the MOC program, ABIM is making changes in its governance structure and attempting to engage the physician community. IDSA member Jeanne Marrazzo, MD, FIDSA, recently was named as the first chair of the ABIM Council and chair of the Infectious Diseases Subspecialty Board.
We still have a number of issues of concern related to the MOC program. IDSA is fully committed to continue to work with ABIM on behalf of our members to ensure that your concerns are addressed. As new information becomes available, we will share it with you as quickly as possible. Thanks for your input, and please continue to provide further input as this process evolves.
For more information regarding the MOC changes, please visit the following:
ABIM MOC FAQ page
IDSA MOC resources
ACP MOC resources
Big Advances in Antibiotic Stewardship and R&D Policies
IDSA President Stephen Calderwood, MD, FIDSA, and IDSA staff were on hand at the recent White House Forum on Antimicrobial Stewardship to make the case for the role of ID specialists in stewardship programs, and to emphasize the need for new diagnostics and new drug development. The Society made a series of commitments to lead advocacy efforts in support of stewardship.
White House Forum on Antibiotic StewardshipFederal officials announced a number of new policies and plans to promote antimicrobial stewardship at the first-ever White House Forum on Antibiotic Stewardship on June 2. IDSA was on hand to make the case for the role of ID specialists in stewardship programs, and to emphasize the need for new diagnostics and new drug development. The Society made a series of commitments to lead advocacy efforts in support of stewardship.
IDSA President Stephen Calderwood, MD, FIDSA, and IDSA staff represented the Society at the forum, which featured Secretary of Health and Human Services Sylvia Burwell, Secretary of Agriculture Tom Vilsack, and representatives from about 150 stakeholders from both the human health and agricultural settings. In her opening remarks, Secretary Burwell quoted IDSA Antimicrobial Resistance Committee member Brad Spellberg, MD, FIDSA, remarking on the importance of stewardship, and highlighted the story of Addie Rerecich, a young patient who suffered from a multidrug resistant infection and whose family has worked with IDSA to raise awareness about the issue.
Federal officials at the forum discussed upcoming policies to provide preference in federal purchasing for meat produced using responsible antibiotic use, to provide regulations for the establishment of stewardship programs in hospitals and long-term care (LTC) facilities, to increase the number of facilities reporting antibiotic use and resistance data through CDC’s National Healthcare Safety Network (NHSN), to improve data collection regarding antibiotic use in agricultural settings, and to stimulate the development of new rapid diagnostics.
For the bulk of the meeting, participants were split into breakout sessions on human and agricultural topics related to stewardship. IDSA participants were assigned to sessions that focused on inpatient stewardship, outpatient stewardship, stewardship in LTC facilities, and tools needed for stewardship. Dr. Calderwood spoke on the final panel and highlighted ID physicians as critical leaders of stewardship programs and also discussed the need to stimulate the research, development and appropriate use of rapid diagnostics. Lastly, he noted that while stewardship is critical, we will continue to need new antibiotics.
House Committee Passes Bill on Antibiotic Incentives and MoreThe House Energy and Commerce Committee voted unanimously last month to advance the 21st Century Cures Act, H.R. 6. As previously reported, this bill contains several key IDSA priorities, including the limited population antibacterial drug (LPAD) approval pathway, funding increases for the National Institutes of Health (NIH), and quicker Food and Drug Administration (FDA) review of diagnostic tests and other medical devices that do not have sufficient alternatives. The bill is expected to be approved by the full House of Representatives this year, possibly as early as this month.
In response to IDSA action alerts, IDSA members have sent thousands of emails to their members of Congress in support of LPAD, increased NIH funding, and diagnostics incentives. This input from expert constituents—IDSA members in the individual states and districts of members of Congress—has been instrumental in advancing these policies in Congress.
MERS: The Emergence Continues -- Learn the Latest at IDWeek
In the past month alone, MERS has rapidly spread with the latest outbreaks occurring in China and South Korea. John Watson, MD, MSc, a medical epidemiologist actively involved in the MERS-CoV control activities at the Centers for Disease Control and Prevention, will offer insight at IDWeek 2015.
IDWeek has covered the developments of the Middle East Respiratory Syndrome (MERS) since the disease’s initial emergence in September 2012 and will continue to do so this year.
IDWeek 2013’s Opening Plenary Panel discusses the MERS-CoV Outbreak featuring
Ziad Memish, MD, FACP, FIDSA, FSHEA, Deputy Minister
for Public Health in the Kingdom of Saudi Arabia.
John Watson, MD, MSc, a medical epidemiologist actively involved in the MERS-CoV control activities at the Centers for Disease Control and Prevention, will offer insight at IDWeek 2015 to be held October 7-11 in San Diego. He will discuss the latest information concerning the epidemiology, clinical manifestations, and treatments for the disease. In the past month alone, MERS has rapidly spread with the latest outbreaks occurring in China and South Korea. Approximately 1,244 cases have been reported in a total of 25 countries with a mortality rate of 30% to 40%, according to the World Health Organization. As a fairly new disease to humans, there are no vaccines and no cures – its pathogenic potential and mode of transmission are still unknown.
Register now to attend this invigorating symposium taking place on Thursday, October 8.
For further session information, view the interactive program.
Discounted Early Registration
Late Breaker Abstract Deadline
August 6 at 5 p.m. EDT
Thank You From IDSA
Thank you to those who took the time to respond to our survey on member needs. The information you provided will be invaluable in guiding the upcoming Board of Directors’ strategic planning session later this month. Look for updates on that planning process in future editions of IDSA News.
Thank you to those who took the time to respond to our survey on member needs. The information you provided will be invaluable in guiding the upcoming Board of Directors’ strategic planning session later this month. Look for updates on that planning process in future editions of IDSA News.
Studies reviewed in this edition of Journal Club: Treatment of Symptomatic Congenital CMV: Is Six Months Better Than Six Weeks?; A New Tenofovir Formulation: Fewer Renal and Bone Effects?
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, FIDSA, in each issue of Clinical Infectious Diseases.
Treatment of Symptomatic Congenital CMV: Is Six Months Better Than Six Weeks?
Reviewed by Terri Stillwell, MD
Cytomegalovirus (CMV) is the most common cause of congenital viral infection. Many neonates with congenital CMV are asymptomatic, with only about 10 percent exhibiting symptoms at birth. However, despite being asymptomatic, some infected neonates can go on to develop hearing loss. Additionally, those that are symptomatic at birth can have progression of existing symptoms or development of additional complications later in life.
Previous studies have found that, for symptomatic neonates with central nervous system (CNS) involvement treated within the first month of life, six weeks of antiviral therapy led to improved hearing and neurologic outcomes. A recent New England Journal of Medicine article goes a step further, evaluating the benefit of six months of treatment in comparison to six weeks of treatment.
From June 2008 through May 2011, investigators randomized 96 infants with symptomatic congenital CMV infection to one of two arms: 47 received six weeks of valganciclovir plus four and a half months of placebo; 49 received six months of valganciclovir. The study’s primary endpoint evaluated change in “best-ear” hearing at six months. Secondary end points included change in hearing and neurologic outcomes at 12 and 24 months; medication side effects were also assessed.
While the change in six-month best-ear hearing was the same for both treatment groups, significant differences were seen when assessing the secondary endpoints. When adjusting for baseline CNS involvement, total-ear hearing at 12 months was more likely maintained or improved in those treated with six months of valganciclovir. Also, with CNS-adjusted results, those treated with six months of valganciclovir had significantly higher scores on neurologic testing at 24 months. No significant medication side effects were seen between the two groups.
This study suggests that six months of valganciclovir in symptomatic congenital CMV infection has a positive effect on long-term outcomes. Additional studies are needed to determine if comparable benefit can be achieved in asymptomatic infections.
(Kimberlin et al. N Engl J Med. 2015;372:933-943.)
A New Tenofovir Formulation: Fewer Renal and Bone Effects?
Tenofovir disoproxil fumarate is included in four of the five regimens currently recommended for HIV-infected patients naïve to antiretroviral therapy. Although highly potent, safe, and widely used, tenofovir disoproxil fumarate causes nephrotoxicity (including proximal tubular injury) in a small but significant number of patients, and has also been linked to decreases in bone mineral density.
Reviewed by George R. Thompson III, MD
Tenofovir disoproxil fumarate is metabolized to tenofovir and thereafter metabolized in cells to tenofovir-diphosphate (the active drug). High plasma levels of tenofovir have been associated with the toxicities mentioned above, and thus a novel tenofovir prodrug, tenofovir alafenamide, was developed. This formulation results in four times higher intracellular concentrations allowing for much lower doses to be administered, potentially reducing side-effects.
In a recent article published online in The Lancet, researchers reported the results of two phase 3, double-blind comparative trials of tenofovir alafenamide versus tenofovir disoproxil fumarate (both coformulated with elvitegravir, cobicistat, and emtricitabine). The findings showed similar antiviral activity of both formulations with a significant reduced effect of tenofovir alafenamide compared to tenofovir disoproxil fumarate on patient glomerular filtration rate (p<0.0001), tubular proteinuria (p<0.0001), and bone mineral density (p<0.0001).
The high rate of virologic success in these trials, with a concurrent reduction in both renal and bone effects observed in patients treated with tenofovir alafenamide, suggests this may become the preferred formulation.
(Sax et al. Lancet. published online: April 15, 2015.)
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: June 15
Ebola in West Africa: Getting Ready for What Comes Next -- Measles and More
- Optimal Treatment of Uncomplicated Malaria due to Chloroquine-Resistant Plasmodium falciparum in Returned Travelers
- Case Vignette: Legionella Infection of an Infant Born in a Bath
- Case Vignette: Toscana Encephalitis in a U.S. Traveler to Italy
- Staphylococcus aureus Bacteremia and Endovascular Device Infection
- The “Fat City” Sewage Microbiome
- Case Vignette: African Histoplasmosis in India
- Case Vignette: Cerebral Chagas in a Transplant Recipient