IDSA News - March 2015
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Public Comment Period for IDSA/AAN/ACR Lyme Guideline Project Plan Closes April 9
IDSA, the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR) are requesting input on a project plan that lays the ground work for new Lyme disease guidelines.
The 30-day open public comment period on the Lyme Disease Project Plan is from March 9 to April 9. The project plan will be available on the IDSA website between these two dates. During the public comment period, anyone may comment on any aspect of the plan. All comments must be submitted through this link.
For more information, visit the IDSA website.
FDA Approves New Drugs, Cresemba and Avycaz
The U.S. Food and Drug Administration recently approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections. Cresemba belongs to a class of drugs called azole antifungal agents, which target the cell wall of a fungus.
A new antibacterial drug, Avycaz (ceftazidime-avibactam), was also recently approved by the FDA to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
IDSA offers two email services to help members stay informed of new drug approvals and similar updates from the FDA and Centers for Disease Control and Prevention (CDC). Content includes a range of topics, including drug warnings, recalls, and outbreak investigations. Recent alerts have included:
Product Removal/Foodborne Illness Outbreak Investigation Advisory (March 18, 2015)
CDC and Partners Investigate Newly Discovered Virus (February 20, 2015)
FDA Approves a Second Vaccine to Prevent Serogroup B Meningococcal Disease (January 23, 2015)
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.
NIH Training Opportunity: Biosafety Officer in High-Containment Facility
The National Biosafety and Biocontainment Training Program (NBBTP) is a partnership between the Division of Occupational Health and Safety and the National Institute of Allergy and Infectious Diseases that provides a training opportunity for those interested in a career as a biosafety officer in a high-containment facility.
The two-year program, based at the National Institutes of Health campus in Bethesda, will train fellows to work in high-containment research environments by providing the knowledge and skills necessary to meet the scientific, regulatory, biocontainment, biosafety, engineering, communications, management, and public relations challenges associated with working in these facilities.
Information on the fellowship, along with eligibility, can be found on the NBBTP website. Application packages are due July 6, 2015, and fellowships begin January 5, 2016. Interested candidates can apply online.
IDSA Joins the “Choosing Wisely” Campaign to Cut Back on Unnecessary Medical Care
IDSA has joined the growing list of health care organizations lending their voices to the ABIM Foundation’s Choosing Wisely campaign, aimed at promoting conversations between health care providers and patients that will lead to care that is supported by evidence, not duplicative of tests or procedures already received, free from harm, and truly necessary.
In partnership with this campaign, IDSA has released a list of “Five Things Physicians and Patients Should Question” developed by the Society’s Quality Improvement Committee. The list, aimed at health care providers, includes:
1. Don’t treat asymptomatic bacteruria with antibiotics.
2. Avoid prescribing antibiotics for upper respiratory infections.
3. Don’t use antibiotic therapy for stasis dermatitis of lower extremities.
4. Avoid testing for a Clostridium difficile infection in the absence of diarrhea.
5. Avoid prophylactic antibiotics for the treatment of mitral valve prolapse.
To learn more about the ABIM Foundation’s campaign, including lists aimed at health care professionals and consumers, visit www.choosingwisely.org.
New Forum for Contracting and Negotiations Information Exchange
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 in the Manage Your Practice section of the IDSA website.
IDSA Advances Priorities in 21st Century Cures Legislation
The U.S. House of Representatives is considering a wide-reaching 21st Century Cures initiative that provides a platform for IDSA to advocate for effective public policy on antimicrobial resistance, vaccines, ID research, and other priorities. The nearly 400-page draft bill reflects recommendations collected over the past year from multiple organizations, including IDSA.
The draft bill contains multiple promising provisions aimed at stimulating antibiotic research and development (R&D), including Limited Population Antibacterial Drug (LPAD) approval pathway, creation of a public private partnership similar to the European Union’s Innovative Medicines Initiative, improved reimbursement for antibiotics, and a provision to speed the Food and Drug Administration (FDA) process for updating susceptibility breakpoints. The proposed legislation also includes provisions aimed at speeding FDA review of urgently needed new diagnostic tests, and IDSA is seeking inclusion of additional provisions aimed at ID diagnostics.
The Cures draft also contains several provisions related to vaccines. IDSA expressed support for provisions that would direct the FDA to issue final guidance to facilitate the use of accelerated and expedited pathways for the development and licensure of urgently needed vaccines, expand National Institutes of Health (NIH) vaccine R&D programs, and require prompt updates to Medicare upon issuance of recommendations from the Advisory Committee on Immunization Practices (ACIP). IDSA also recommended that the bill require coverage for all ACIP-recommended vaccines through both Medicare Part B and D to ensure comprehensive coverage of these vaccines for all seniors. IDSA also expressed concern for provisions that would micromanage the ACIP process and require CDC to meet with any vaccine manufacturer within 90 days of a request without providing CDC any additional resources to support such activities.
The draft bill contains multiple IDSA-supported provisions pertaining to research, including use of a single institutional review board for multi-site studies, improving access to clinical data registries, and requiring entities that receive NIH funding to release their findings to the public. Congressional staff also indicated to IDSA their intention to add a provision to the bill to make it easier for federal employees to attend scientific conferences, and IDSA highlighted the importance of such participation.
The draft bill contains some provisions that are causing concern among many medical and scientific societies as well as patient groups. Many advocates believe these provisions would allow for inappropriate congressional micromanaging of NIH through such means as establishing term limits for institute directors, requiring detailed strategic plans, and statutorily mandating the percentage of funds to be spent on basic research. IDSA urged that Congress maintain NIH’s authority to be guided by science and not micromanaged by politicians.
For more information, you can view IDSA’s detailed comment letter here. IDSA will continue advocating for ID priorities in 21st Century Cures, which is expected to proceed in the House later this year. The Senate recently launched a similar initiative, and IDSA provided the leading Senators with detailed recommendations.
HIVMA Receives CAEAR Coalition Partnership Award
Congratulations to HIVMA, recipient of the 14th Annual Communities Advocating Emergency AIDS Relief (CAEAR) Coalition Partnership Award. CAEAR is a national membership organization that advocates for federal policy, legislation, regulations, and appropriations to meet the care, treatment, support and prevention needs of people living with HIV/AIDS and the organizations that serve them, focusing on health care reform and the evolving role of the Ryan White Program. HIVMA was recognized by the CAEAR Coalition for its continued work in advocating for the Ryan White Care Program and supporting the work of HIV/AIDS care providers.
HIVMA Board Member Dr. Sally Hodder advocating for HIV programs with Senator Cory Booker (NJ)
New Statement on Criminalization of HIV and other Communicable Diseases
HIVMA and IDSA have released a new policy statement on the criminalization of HIV, sexually transmitted infections (STIs) and other communicable diseases opposing legal statutes that undermine public health by criminalizing the transmission of infectious diseases.
According to the Centers for Disease Control and Prevention (CDC), 33 states have enacted a total of 67 HIV-specific criminalization laws. Twenty-four states have general STI/communicable disease laws; 21 have STI/communicable disease misdemeanor laws, and nine have STI/communicable disease felony laws. These laws discourage individuals from being screened and receiving treatment and fuel stigma. IDSA and HIVMA urge state policymakers to modernize existing criminalization laws and to direct resources to evidenced-based prevention interventions that can significantly reduce the impact of infectious diseases.
ID Funding Highlighted on Capitol Hill
President Obama’s budget request for Fiscal Year 2016 is now under consideration in Congress. House and Senate spending panels are holding hearings with federal agency heads and receiving input from outside stakeholders.
For FY 2016, President Obama proposed modest increases to agencies important to the infectious diseases community, including the Centers for Disease Control and Prevention (CDC, +1.6 percent), National Institutes of Health (NIH, +3.3 percent), and Food and Drug Administration (+5.7 percent). The president’s request to double funding for the CDC viral hepatitis program as well as to nearly double support for antimicrobial resistance programs across the government has initially drawn positive attention on the Hill. Most global infectious disease programs were slated for flat funding, with global tuberculosis programs again singled out for a 17 percent cut in funding.
During a March 3 hearing of NIH leaders in the House subcommittee that has oversight of much of health spending, antimicrobial resistance was mentioned as a top research priority by leaders of the subcommittee as well as by NIH Director Francis Collins, MD, and National Institute of Allergy and Infectious Diseases Director Anthony Fauci, MD, FIDSA. Despite this agreement, many on the panel noted that sequestration poses a challenge to new spending proposals. House and Senate leaders are separately looking at ideas to provide at least short-term relief from sequestration. Absent an agreement, sequestration will result in a reduction to the overall federal budget for FY 2016, largely preventing agency increases.
IDSA staff and members have been active on Capitol Hill in support of ID priorities in the budget. IDSA is leading efforts to build support among other organizations for increased funding to address antimicrobial resistance, including coordinating a recent letter and leading groups of stakeholders in meetings with key congressional offices.
If you have not already done so, please join the IDSA advocacy effort by taking 3 minutes to send a message to your representative and senators through the IDSA Action Center.
Laboratory Developed Tests: Regulation Should Keep Pace With ID Patient Needs
IDSA submitted comments to the Food and Drug Administration (FDA) in response to its draft guidance to regulate laboratory developed tests (LDTs), diagnostic devices intended for clinical use that are designed, manufactured, and used within a single laboratory. IDSA agrees that oversight of LDTs may be appropriate; however, the Society expressed concern that some elements of the regulations could limit patient access to ID testing and provided specific recommendations to address these key issues.
Diagnostic Task Force member Gregory A. Storch, MD, FIDSA, served on a panel discussion at an FDA public workshop on the regulations, while IDSA staff provided public comments on the regulations.
IDSA also drafted a response to several questions posed by the House Energy and Commerce Committee about the proposed LDT regulation as well as incentives for diagnostic development. IDSA stressed the importance of infectious disease diagnostics in patient care, and the need for flexible regulations to allow innovative test development to keep pace with evolving and emerging infectious diseases.
IDSA Responds to NIH on Proposed Regulatory Process for Multi-Site Research Trials
IDSA submitted comments to the National Institutes of Health (NIH) in response to its proposed draft policy to streamline the regulatory process of multi-site clinical trials while maintaining research participant protections. The policy would require all domestic NIH-funded multi-site trials to use a single institutional review board (IRB). IDSA applauded the draft policy but also noted key questions for NIH to consider as it moves forward with finalizing the policy.
NIAID Launches ClinRegs Website on International Clinical Research Regulations
The National Institute of Allergy and Infectious Diseases (NIAID) recently launched ClinRegs, a website that enables users to explore clinical research regulations within a country and compare requirements across countries. The ClinRegs website has the potential to be a useful resource for those involved in planning and implementing international clinical trials.
Key topic areas covered on the website include clinical trial lifecycle, competent authority oversight, ethics committee oversight, informed consent, investigational products, specimens, and sponsorship. Regulatory information is summarized in English and organized by country and topic.
ClinRegs currently includes information for Brazil, China, India, Kenya, Liberia, Malawi, Peru, Sierra Leone, South Africa, Tanzania, Thailand, Uganda, the United Kingdom, and the United States. The ClinRegs team plans to further expand its country list in alignment with NIAID research priorities, including Guinea, Mali, Mexico, and Vietnam. To access the ClinRegs site, go to clinregs.niaid.nih.gov.
Science Speaks: Coverage of CROI 2015
Science Speaks, IDSA’s blog on global health issues, was on the scene with on-site coverage of the 2015 Conference on Retroviruses and Opportunistic Infections (CROI). Posts included:
In addition, if you are interested in where influential legislators stand on public health and science, see the Science Speaks series on the 114th Congress.
Science Speaks is the official blog of IDSA’s Center for Global Health Policy.
ABIM MOC Changes
The American Board of Internal Medicine (ABIM) last month announced immediate changes to the existing Maintenance of Certification (MOC) program, including the suspension of the Practice Assessment, Patient Voice and Patient Safety requirements and a change in the language used to report a diplomate’s MOC status on the ABIM website. By the end of the year, ABIM will also recognize most forms of Accreditation Council on Continuing Medical Education (ACCME)-approved Continuing Medical Education, in an effort to allow for new and more flexible ways to demonstrate self-assessment of medical knowledge. Additional details are outlined in the ABIM announcement.
Free IDSA Hepatitis C MOC Module
The IDSA Hepatitis C Maintenance of Certification (MOC) Module is now free to first 500 who register. The module provides clinicians caring for hepatitis C infected patients with up-to-date information on epidemiology, virology, pathogenesis, laboratory testing and monitoring of therapy, antiretroviral therapy; HIV/HCV coinfection; complications of HCV and therapies; drug toxicity and side effects.
Please contact Kathy Matikonis, email@example.com, for access to the Hepatitis C MOC Module. If you have not previously utilized an IDSA MOC Module, you must also register to create an account in our Learning Management System. If you have already purchased this module in 2015, IDSA will provide a refund.
This opportunity is made available through a grant from the Agency for Healthcare Research and Quality (AHRQ), a division of the U.S. Department of Health and Human Services.
IDSA to Offer Infection Control MOC Pre-Meeting Workshop at SHEA Spring Meeting
If you’re headed to the Spring Meeting of the Society for Healthcare Epidemiology of America (SHEA) in Orlando, don’t miss the IDSA Infection Control Maintenance of Certification (MOC) Pre-Meeting Workshop. The interactive workshop is an opportunity to earn 11 American Board of Internal Medicine (ABIM) MOC points toward recertification. Participants may earn a maximum of 2.0 AMA PRA Category 1 Credit(s) ™. See ABIM MOC Changes article for status of requirements.
Date: Wednesday, May 13
Time: 3 – 5:30 p.m.
Location: Disney's Contemporary Resort
Cost: $150 for IDSA members ($200 for non-members)
This workshop is co-organized with SHEA.
Register for the workshop through Conference Registration. Select the workshop under the "Registration Type."
OFID is Now Indexed in PMC
Open Forum Infectious Diseases (OFID), IDSA’s new open access journal, is now indexed in PMC (formerly PubMed Central).
IDSA launched the journal in 2014 in partnership with Oxford University Press to offer the rapid publication of clinical, translational, and basic research for all aspects of infectious diseases, with a focus on studies that have the potential to improve patient care. OFID also features timely podcast interviews with experts in the field. The journal is fully peer-reviewed and freely accessible to all readers.
As an open access journal, OFID relies primarily on author fees to support publication, but IDSA and HIVMA members receive a discount on these author fees. OFID also offers a special peer-review track for Fellows of IDSA (FIDSAs) to facilitate quicker manuscript decisions and faster publication.
To submit your manuscript, read the Instructions for Authors and submit online.
To read timely updates from OFID, sign up for the journal’s free electronic table of contents (e-TOC) alerts at http://oxford.ly/OFIDalerts.
Apply Now for IDSA Fellow Advancement
Applications are now being accepted through April 1 for advancement to IDSA Fellow (FIDSA). IDSA Fellowship honors members who have achieved professional excellence and provided significant service to the profession. IDSA Fellows are recognized by their peers as leaders in the field, either nationally or locally, in their communities and in their hospitals. It is an honored rank that the Society reserves for its highest achievers.
The advancement to Fellow application is available online. Each application must be accompanied by two letters of nomination by current IDSA Fellows.
If you have any questions about the Fellows advancement process, please contact Member Services at firstname.lastname@example.org or (703) 299-0200.
IDSA Begins Search for CID Editor-in-Chief
Following the announcement that 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, the search has begun for his replacement.
IDSA has appointed a Search Task Force to review applications and nominations, which are now 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:
1. Academic and Publishing Record
2. Editorial Experience and Management Style
3. 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
The HHS Panel on Antiretroviral Guidelines for Adults and Adolescents, a working group of the Office of AIDS Research Council, added several new scientific members to the Panel who will begin a four-year term starting in April 2015. Each of the new additions is a member of HIVMA:
- Roger Bedimo, MD (University of Texas Southwestern, Dallas, TX)
- Charles Hicks, MD (University of California-San Diego, San Diego, CA)
- Susan Swindells, MD (University of Nebraska, Omaha, NE)
- Melanie Thompson, MD (AIDS Research Consortium of Atlanta, Atlanta, GA)
Arredondo, H David, MD
Choi, Mary, MD, MPH
DiNatale, Michael, PharmD
Harvey, Pierre, MD
Moore, Tim, PharmD
Nimboor, Kavita, MD
O'Donnell, Jill, PharmD
Ogunpitan, Adedayo, PharmD
Pawlowski, John, PhD, RPh
Rao, Sonia, PharmD
Ruto, Carolyne, PharmD
Spott, Sarah, NP
Ugurcan, Dogac, MD
Hugentobler, Emmanuelle, MD
Kallianpur, Asha, MD, MPH
Katsolis, Jennifer, DO
Klein, Nicole, MD
Krishnan Natesan, Suganthini, MD
Lesser, Cammie, MD, PhD
Meister, Fred, PharmD
Menon, Mahesh, MBBS
Podany, Anthony, PharmD
Schmitz, Jonathan, MD, PhD
Sood, Geetika, MD
Abubaker, Ahmed, MBBS
Albuerne, Marisol, MD
Auffant Caraballo, Karina, MD
Carlucci, James, MD
Dioverti Prono, Maria, MD
Fernandes, Ingrid, MD
Gozenput, Pavel, MD
Harris, Rebecca, MD
Hauck, Christopher, MD
Hijano, Diego, MD
Lopez-Vazquez, Manuel, MD
Masud, Shazia, MBBS
Mayer Arispe, Erick, MD, MS
Navarro, Aldo, MD
Partridge, Elizabeth, MD, MPH
Rapaka, Rekha, MD, PhD
Stang, Alexandra, MD
Thoendel, Matthew, MD, PhD
Wood, James, MD
Anderson, Anthony, PharmD
Asundi, Archana, MD
Calix, Juan, MD, PhD
Gautam, Samir, MD, PhD
O'Neil, Conar, MD
Tlamsa, Aileen, MD
Egnatios, Jeremy, MD
Slayton, Eric, MPH, PharmD
Surdel, Matthew, MD, PhD
Regaining Ground on Measles Eradication: The Role of the ID Specialist
While the causes are multi-faceted, the public’s misunderstanding of the safety of vaccines is undoubtedly a major contributor. As leaders in infectious diseases, we should raise our voice and lend our assistance to counter false and misleading information. The ongoing measles outbreak presents a stark reminder of the pre-vaccine era. It is up to all of us to ensure that children continue to enjoy protection against measles and other scourges of the past.
Merely a decade ago, measles was thought to be eliminated from this country. Today, we find ourselves in the midst of an outbreak with nearly 200 cases in 17 states. The cause of the outbreak has been much discussed and debated with even comedians and politicians weighing in. While the causes are multi-faceted, the public’s misunderstanding of the safety of vaccines is undoubtedly a major contributor. Our role as leaders in infectious disease is to send a strong, clear message not only about the safety of vaccines, but of the importance of universal vaccination in order to protect the most vulnerable, including those who cannot be vaccinated for medical reasons.
A recent study in Pediatrics found that more than 70 percent of pediatricians have agreed to parents’ requests to delay vaccinations, even though most believe that straying from the recommended immunization schedule puts children at risk. If even our colleagues in the medical community are feeling pressure to veer from the recommended vaccine schedule, it’s clear that as infectious diseases specialists, we must continue our efforts to spread scientifically sound information to members of the public. Parents are bombarded with information about vaccination from multiple sources including friends, the internet and social media. Some of the information is correct, but much of it is not, and unfortunately, we continue to see the spread of misinformation from studies that have been debunked and refuted over and again.
IDSA supports universal immunization of children, adolescents, and adults, on a schedule in accordance with recommendations and standards established by the Centers for Disease Control and Prevention. Further, IDSA strongly encourages states to enact and enforce laws requiring children to be fully immunized as a requirement for school or day care, with exemptions allowed only for validated medical contraindications. Most states currently allow religious and personal belief exemptions; in those states, physician counselling on the safety and efficacy of vaccines is the most important tool to encourage vaccine uptake.
I encourage you to communicate with your colleagues in pediatrics and primary care about the importance of ensuring that parents make an informed choice based on the best medical and scientific evidence. As leaders in infectious diseases, we should raise our voice and lend our assistance to counter false and misleading information. The ongoing measles outbreak presents a stark reminder of the pre-vaccine era. It is up to all of us to ensure that children continue to enjoy protection against measles and other scourges of the past. It would be a tragedy to let unsubstantiated fear trump the continued promise of one of medicine’s most powerful tools to protect the lives and health of our children.
Clinicians: Here’s How to Avoid a Payment Penalty in 2017
Recent changes to the Physician Quality Reporting System (PQRS) have important implications for IDSA members in clinical practice. IDSA has provided specific guidance on what relevant measures might be reasonable for ID specialists to report in order to avoid a payment penalty.
Recent changes to the Physician Quality Reporting System (PQRS) have important implications for IDSA members in clinical practice. It is imperative to report on relevant measures during this calendar year to avoid a payment penalty in 2017 on all Medicare Part B payments. Given that the overwhelming volume of ID patient care is delivered in the inpatient setting, IDSA has provided specific guidance on what relevant measures might be reasonable for ID specialists to report in order to avoid a payment penalty. Please see the Manage Your Practice section of IDSA’s website for more information.
IDWeek Advance Registration Now Open for IDSA Members
2015 member registration opened Tuesday,
March 17. Register early to take advantage of discounts and hotel
Catch a sneak peek of the schedule and session
titles slated for October 7-11 in San Diego by viewing the PDF Program Primer*.
IDWeek 2015 member registration opened Tuesday, March 17. Register early to take advantage of discounts and hotel selections.
Catch a sneak peek of the schedule and session titles slated for October 7-11 in San Diego by viewing the PDF Program Primer*.
Premeeting workshops start on Tuesday, October 6. The Special Opening Plenary, "Ebola: Survivorship, the Science, Global Response, and the West African Perspective," on Wednesday will feature:
- Ian Crozier, MD, Physician and Ebola Survivor
- Pardis Sabeti, MD, DPhil, Computational Geneticist and Associate Professor, Harvard University, Boston, MA
- Tolbert Nyenswah, Esq, LLB, MPH, Assistant Minister of Health, Liberia
Be sure to stay through Sunday for the Closing Plenary, which will cover Pandemic Influenza:
- Adolfo Garcia-Sastre, PhD, Director, Global Health and Emerging Pathogens Institute, Mount Sinai, New York, NY: Pathogenesis of Influenza
- Daniel B. Jernigan, MD, MPH, Deputy Director, Influenza Division, Centers for Disease Control and Prevention, Atlanta,GA: Circulation of Seasonal and Emergent Strains of Influenza—Preparing for a Pandemic
- Nicole Lurie, MD, MSPH, (invited) Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC: Pandemic Preparations
Sunday will also feature four mini-symposia on Antimicrobial Stewardship Intervention, Hepatitis C, Herpes, and Foodborne Diseases.
IDWeek, known for its innovative and engaging faculty, offers 42 CME credits as well as CPE opportunities.
For important dates and additional information, visit the IDWeek website.
Make sure your IDSA membership is up-to-date so you can take advantage of member discounts and advance registration.
*The Program Primer session titles and speakers are tentative and subject to change.
IDSA Journal Club
Screening for Incident Hepatitis C in Persons with HIV: A Call for Action; Combination Therapy for Invasive Aspergillosis: Better Than Monotherapy?; Antibiotics for Travelers’ Diarrhea Increase Risk of Colonization by ESBL-Producing Enterobacteriaceae; Thrice-Weekly Therapy for Nodular-Bronchiectatic Pulmonary MAC; Kicking the Can Down the Road: Delayed Infection and Antibiotic Prophylaxis for Transplant Recipients
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.
Screening for Incident Hepatitis C in Persons with HIV: A Call for ActionAround one-third of individuals with HIV infection in the United States are also infected with hepatitis C, with high rates of coinfection in injection drug users and rising incidence in men who have sex with men (MSM). Timely diagnosis of hepatitis C permits effective counseling, prevention efforts, and informed treatment decisions. So, how well are we meeting the need for screening in this high-risk population?
Reviewed by Brian R. Wood, MD
In a recent article in Clinical Infectious Diseases, investigators examined hepatitis C screening rates in 17,090 HIV-seropositive adults between 2000 and 2011 in a retrospective cohort study. Most (85 percent) received screening at entry into care; however, only about half (55.6 percent) of the 9,077 individuals who screened negative at baseline ever received repeat testing. Even those with ongoing risk or elevated transaminases were not uniformly retested. Of participants with first-time alanine aminotransferase (ALT) elevations >100 IU/L or >400 IU/L, only 26.7 percent and 20.3 percent, respectively, were tested within 12 months. The authors astutely call for concrete guidelines on screening for incident hepatitis C in the United States, as have been developed elsewhere.
Two recent analyses examined potential new methods that could arm providers with additional tools for hepatitis C screening and diagnosis. The first, a small, single-center study from the United Kingdom described in Clinical Infectious Diseases, found hepatitis C core antigen, which is not an approved assay in the United States, to be a sensitive and specific marker of acute hepatitis C in HIV-infected persons with abnormal ALT. This test could provide a cost-effective and rapid means (results generally available the same day) for detecting incident hepatitis C, especially where RT-PCR is not available.
Another study, also reported in Clinical Infectious Diseases, evaluated antibody dynamics in 63 HIV-seropositive MSM with acute hepatitis C in the Netherlands, most of whom received early treatment. Median time to seroconversion was 74 days and only 59 percent seroconverted by three months after infection. Notably, reinfection rates in this cohort were high (18 of 63 participants became reinfected, including one individual who became reinfected three times). Investigators noted a significant decrease in hepatitis C antibody reactivity following viral clearance, and a significant subsequent increase upon reinfection, even though only 44 percent of reinfection cases had elevated ALT. This provocative article confirms that MSM are at high risk for hepatitis C reinfection and reinforces the need for ongoing monitoring, perhaps using antibody reactivity levels.
Together, these studies highlight the challenge of diagnosing incident hepatitis C infection and the responsibility that ID providers have in ensuring that HIV-infected individuals at risk are routinely tested, as well as in propagating this best practice to other HIV primary care practitioners. The findings also underscore the need to develop and disseminate specific guidelines for incident hepatitis C screening in high-risk individuals and to consider novel approaches to testing.
(Freiman et al. Clin Infect Dis. 2014;59(12):1686-1693, Vanhommerig et al. Clin Infect Dis. 2014;59(12):1678-1685, and Cresswell et al. Clin Infect Dis. 2015;60(2):263-266.)
Combination Therapy for Invasive Aspergillosis: Better Than Monotherapy?
While voriconazole is now considered the drug of choice for the primary treatment of invasive aspergillosis (IA), it is still not clear whether combination with an echinocandin agent would be beneficial.
Reviewed by Zeina Kanafani, MD, MS
A recent article in the Annals of Internal Medicine describes a randomized double blind study comparing voriconazole monotherapy to combination therapy with voriconazole and anidulafungin in patients with suspected or documented IA in the setting of hematologic malignancy or hematopoietic stem cell transplantation. All patients received voriconazole for six weeks (intravenously during the first week at 6 mg/kg every 12 hours on day one then 4 mg/kg every 12 hours, with possible switching to oral formulation afterwards at 300 mg every 12 hours). In addition, patients were randomized to receive either intravenous anidulafungin at 200 mg on day one, then 100 mg every 24 hours, or placebo every 24 hours for two to four weeks.
The primary end point (all cause-mortality at six weeks in the modified intent-to-treat population) was achieved in 19.5 percent of patients in the combination therapy arm compared to 27.8 percent in the monotherapy arm (p=0.087). Mortality at 12 weeks was 29.3 percent with combination therapy and 39.4 percent with voriconazole monotherapy (p=0.077). A low Karnofsky score, low platelet count, and high serum galactomannan antigen index at baseline were the only independent risk factors for mortality at six weeks.
In addition, a post hoc analysis was performed in patients where the diagnosis of IA was made based on radiographic abnormalities and galactomannan antigen positivity in serum or bronchoalveolar lavage. Combination therapy in this subgroup was associated with an all-cause mortality rate of 15.7 percent versus 27.3 percent with monotherapy (p=0.037). Combination therapy was safe and well tolerated in the majority of patients.
The study suggests that treatment with voriconazole/anidulafungin for IA may be associated with improved outcomes compared to voriconazole alone, although the difference did not reach statistical significance. The exact benefit of combination therapy is yet to be determined in further trials.
(Marr et al. Ann Intern Med. 2015;162(2):81-9.)
Antibiotics for Travelers’ Diarrhea Increase Risk of Colonization by ESBL-Producing Enterobacteriaceae
Reviewed by Manie Beheshti, MD
Rising rates of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) globally pose significant risks of increased morbidity and mortality. Travelers’ diarrhea, use of antibiotics, and travel to areas with high prevalence have previously been identified as risk factors for colonization with ESBL-PEs. In a recent study published in Clinical Infectious Diseases, investigators studied these travelers’ risks of colonization in the largest inquiry on the matter to date.
Utilizing a questionnaire, 430 Finns traveling outside of Scandinavia were evaluated for travelers’ diarrhea and antibiotic use directed at travelers’ diarrhea. In addition, stool samples were analyzed before and after travel to assess for colonization by ESBL-PE. Overall, 21 percent of travelers became colonized by ESBL-PE during travel. Travelers’ diarrhea, use of antibiotics, and travel destination were identified as notable risk factors accounting for rates as high as 80 percent in those traveling to South Asia. Of interest, use of antimalarials alone, including doxycycline, was not identified as a risk factor.
Rates of colonization with ESBL-PE were as follows:
|No Antibiotics for TD
|Antibiotics for TD|
|No Travelers’ Diarrhea (TD)
|TD in South Asia
This study highlights travelers’ diarrhea and antimicrobials as independent risk factors for acquisition of ESBL-PE. Noting the complexities in the management of travelers’ diarrhea, the authors contend that efforts should focus on measures to avoid travelers’ diarrhea and to limit the use of antibiotics. Perhaps the most reasonable first step would be to eliminate use of antibiotics for mild to moderate travelers’ diarrhea, which resolves spontaneously.
(Kantele et al. Clin Infect Dis. 2015; published online January 21, 2015, doi:10.1093/cid/ciu957)
Thrice-Weekly Therapy for Nodular-Bronchiectatic Pulmonary MAC
Reviewed by Michael T. Melia, MD
Treatment of pulmonary Mycobacterium avium complex (MAC) infection is complicated by the need for long-term antimicrobial therapy and attendant risks of medication side effects and intolerance. Treatment modifications associated with enhanced medication tolerability may be associated with greater response rates owing to a greater likelihood of completing therapy.
In a recent issue of the American Journal of Respiratory and Critical Care Medicine, investigators retrospectively reviewed 217 treatment-naïve patients with nodular-bronchiectatic, macrolide-susceptible pulmonary MAC infection (NB-MAC) treated at a single center in Seoul, Korea. Ninety-nine patients were treated with daily macrolide (88 percent clarithromycin) + rifamycin (96 percent rifampin) + ethambutol; 61 percent received thrice-weekly (TIW) streptomycin for three months. Owing to a protocol change, as of January 2011 patients with NB-MAC were treated with thrice-weekly macrolide (97 percent azithromycin) + rifampin + ethambutol without an aminoglycoside. More TIW cohort patients were treated with azithromycin because it was approved for nontuberculous mycobacterial infection treatment in Korea in 2011.
Inter-group demographic data were similar, although more daily therapy patients had diabetes (11 percent vs. 3 percent). Forty-three percent of patients were acid-fast bacilli smear-positive at baseline. Daily therapy patients were treated longer (24.3 vs. 16.6 months).
Between-group treatment outcomes were similar; there were no differences in rates of symptom improvement (75-82 percent), radiographic (high-resolution chest computed tomography) improvement (68-73 percent), sputum culture conversion (67-76 percent), or time to sputum culture conversion. More daily therapy patients required a medication change (46 percent vs. 21 percent); this was driven almost entirely by different rates of ethambutol discontinuation (24 percent vs. 1 percent). There were no differences in emergence of macrolide resistance during treatment.
While the 2007 American Thoracic Society (ATS)/IDSA guidelines recommend TIW therapy for patients with NB-MAC, relatively few data support this recommendation, and heterogeneous populations were studied to produce those data. Although long-term patient follow-up was lacking in the present study, it provides compelling data supporting TIW treatment for treatment-naïve patients with NB-MAC.
(Jeong et al. Am J Respir Crit Care Med. 2015;191(1):96-103.)
Kicking the Can Down the Road: Delayed Infection and Antibiotic Prophylaxis for Transplant Recipients
Reviewed by Nirav Patel, MD
Pneumocystis jirovecii pneumonia (PCP) frequently develops in the immunocompromised patient. Although the risk has been mitigated with prophylaxis, there is no clear consensus on the duration or the risk factors that predispose infection in the modern era of widespread use of PCP prophylaxis. A study in the January 2015 issue of the American Journal of Transplantation attempts to answer these questions.
This retrospective case-control study included 1,895 adult transplant recipients (kidney, liver, and heart). All patients received six months of prophylactic antibiotics against PCP. Thirty-three patients met study inclusion criteria for diagnosis of PCP: 23 kidney recipients, five liver recipients, and five heart recipients. These cases were matched to two control patients who had negative bronchoalveolar lavage PCR testing for Pneumocystis jirovecii.
Notably, the incidence of PCP post-transplantation could be divided into three periods. Within one year of transplantation, only one case of PCP was diagnosed. During the second year, 11 patients were diagnosed, while 21 patients developed PCP between the third year and the 16th year post-transplantation, at a rate of about 1.6 cases per year.
Further, in multivariate analysis, age ≥ 65 (odds ratio [OR] 3.7, confidence interval [CI] 1.3-10.4, p=0.012), cytomegalovirus viremia (OR 5.2, CI 1.8-14.7, P=0.002), and total lymphocyte count <750/mm3 in the 50 days before PCP diagnosis (OR 3.9, CI 1.4-10.7, p=0.009) were all significant risk factors. Based on the analysis, PCP prophylaxis initiated 180 days prior to diagnosis of infection would benefit 70 percent of patients meeting all three criteria.
This study quantifies what many clinicians note in practice: Prophylaxis works, but what happens after stopping? The authors note that the “new” highest risk period is the second year post-transplantation. By identifying specific risk factors, clinicians can better target prophylaxis to those who would most benefit and reduce the unnecessary use in patients at lower risk.
(Iriart et al. Am J Transplant. 2015;15(1):190-9.)
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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: March 15
• Does Ceftriaxone Therapy Eliminate Viable Borrelia burgdorferi?
• Norovirus and Interferon
• Chagas Disease in Texas
• Risk of Active Tuberculosis–Exposed Contacts
• Trimethoprim-Sulfamethoxazole: Be Careful!
• Case Vignette: Blastomycosis Acquired in India
• Bartonella Bacteremia in Veterinary Workers
• Injectional Anthrax: A Look Back
• Case Vignette: Cerebral and Meningeal Chagas Disease
• Aspergillus terreus Infection
• “You Dirty Rat … ” —Jimmy Cagney
• Peripheral Neuropathy—Another Adverse Effect of Fluoroquinolone Therapy