IDSA News - January 2014
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FDA Approves Simeprevir and Sofosbuvir for Chronic Hepatitis C
In recent weeks the U.S. Food and Drug Administration (FDA) has approved
sofosbuvir (Sovaldi) and simeprevir (Olysio) to treat chronic hepatitis C virus (HCV) infection. Sofosbuvir is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.
IDSA offers two email services to help members stay informed of new drug approvals and similar 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:
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.)
For more information about the new hepatitis drugs and evolving clinical recommendations from IDSA and liver disease experts, see www.HCVGuidelines.org
Is Your Facility Experiencing Antibiotic Shortages?
Congress Approves Partial Relief from Sequestration Funding Cuts
The House and Senate recently finalized federal funding levels for Fiscal Year 2014. The catch-all appropriations bill, known as the Consolidated Appropriations Act of 2014
, provides infectious disease programs some immediate relief from sequestration, as captured in this chart (PDF)
. Highlights from the bill include:
- $29.93 billion for the National Institutes of Health (increase of roughly $1 billion from FY2013)
- $4.36 billion for the National Institute of Allergy and Infectious Diseases (increase of roughly $127 million)
- $6.85 billion for the Centers for Disease Control and Prevention (increase of roughly $562 million)
- $30 million for the new Advanced Molecular Detection (AMD) initiative–for which IDSA led lobbying efforts
While the budget compromise is a step in the right direction, most public health line-items remain below their FY 2010 level. IDSA will continue to advocate for a reversal of the reductions to public health programs contained in the Budget Control Act of 2011.
IDSA Supports Diagnostics Bill Moving through House of Representatives
Congress is considering legislation that would increase patient access to important diagnostic testing services by helping to ensure appropriate reimbursement. IDSA members can help garner support for the bill by using IDSA’s Action Alert
to urge congressional Representatives to co-sponsor it.
In a letter to Rep. Peter Roskam (R- IL), IDSA President Barbara Murray, MD, FIDSA, expressed the Society’s support for the bill, known as the Diagnostic Innovation Testing and Knowledge Advancement Act, which he introduced last year.
Medicare’s appropriate valuation of diagnostic tests is needed to spur innovation and integration into clinical care. The letter explained that diagnostic tests help guide and improve patient care, and that their appropriate use can improve patient outcomes and reduce health care costs associated with suboptimal treatment. IDSA also expressed its strong support of a provision in the bill that would establish an independent advisory panel to provide expert input into rate setting and consideration of patient value and potential impact on health as criteria for use in a new payment setting process.
IDSA’s work on this legislation is one of several current efforts to promote improved diagnostics, a high priority for the Society. Last November, IDSA released “Better Tests, Better Care: Improved Diagnostics for Infectious Diseases,”
a special policy report in Clinical Infectious Diseases, which outlined specific recommendations to spur the development of new diagnostics and encourage their use in patient care and public health.
IDSA and PIDS Submit Comments to FDA on Proposed Drug Shortage Rule
IDSA and the Pediatric Infectious Diseases Society (PIDS) jointly submitted comments (PDF) on Dec. 23 in response to the Food and Drug Administration’s (FDA) proposed regulations aimed at preventing and mitigating drug shortages. In the comments, IDSA and PIDS expressed support for FDA’s general framework but reiterated concern that the underlying law is not strong enough to ensure improvement in manufacturing processes. The comments also reiterate previous calls for FDA cooperation in issuing clinical guidance for alternative therapies, and the creation of a clear mechanism to import drugs and biological products deemed medically necessary but unavailable in the U.S.
Congressional Briefing Highlights Barriers to Immunization for Older Adults
IDSA took part in a congressional briefing in December to inform policymakers about the value of increasing immunization rates among seniors and to highlight strategies for doing so. Despite their tremendous potential for prevention, vaccination rates in seniors fall far short of target rates recommended by the Centers for Disease Control and Prevention (CDC).
The briefing, which was co-sponsored with the Society for Healthcare Epidemiology of America (SHEA), the National Foundation for Infectious Diseases (NFID), and the Alliance for Aging Research, showcased the Alliance’s new Silver Book
(PDF) volume on vaccinations for older adults. Silver Book
is a series of publications featuring information on the chronic conditions that disproportionately affect older Americans. Jeffrey Duchin, MD, FIDSA, chair of IDSA’s Public Health Committee, presented
(PDF) on behalf of IDSA.
Dr. Duchin discussed recommended vaccines, coverage rates, disparities, and barriers. He also highlighted the need for legislative changes to Medicare coverage of immunizations. Preeti Malani, MD, presented on behalf of SHEA, and Keipp Talbot, MD, (also a member of IDSA’s Public Health Committee) represented NFID. The event, hosted by Rep. Alan Grayson (D-FL), was well-attended by staffers from various congressional offices.
IDSA, SHEA, PIDS Call for Mandatory Immunization of Health Care Personnel
IDSA, the Society for Healthcare Epidemiology of America (SHEA), and the Pediatric Infectious Diseases Society (PIDS) released a joint policy statement
(PDF) in December calling for mandatory, universal immunization of health care personnel as recommended by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP).
for health care personnel currently include vaccination against influenza, measles, pertussis (whooping cough), hepatitis B, varicella (chicken pox), and other vaccine-preventable diseases.
Some voluntary programs have been effective in boosting vaccination rates among health care personnel when combined with strong institutional leadership and robust educational campaigns, say the societies. However, for the vast majority of facilities, mandatory immunization programs are necessary to achieve target rates. The policy calls for documentation of immunity or receipt of recommended vaccinations as a condition of employment, unpaid service, or receipt of professional privileges.
“Immunization rates for ACIP-recommended vaccines remain low among health care personnel,” said Barbara Murray, MD, FIDSA, president of IDSA. “When voluntary programs fall short, we think vaccination should be a condition of employment for the protection of both patients and health care workers from illness and death associated with these diseases.”
Those who cannot be vaccinated due to medical contraindications or because of vaccine supply shortages may need to be reassigned away from direct patient care or take other infection control measures. “ACIP-recommended vaccines are proven to be safe, effective and cost-saving,” said Daniel Diekema, MD, president-elect of SHEA. “Although there may be exceptions made for individuals for whom vaccination is not appropriate or in circumstances when the vaccine is not available, these exceptions should be extremely rare.” Notably, the policy does not provide for exemptions based on personal belief or religion.
The societies have previously called for mandatory influenza vaccination for health care personnel. “This new statement adds to this by recognizing the significant threat that other pathogens pose for the health of patients and health care workers in the healthcare setting,” said David Kimberlin, MD, president of PIDS. The societies also support requiring health care employers to engage in comprehensive educational efforts to inform health care personnel about the benefits of immunization and the risks of not maintaining immunization.
See the full policy statement
(PDF) on mandatory vaccination of health care personnel.
HIVMA Welcomes HIV Policy Assessment Directive in Defense Bill
The HIV Medicine Association (HIVMA) joined numerous health and legal professionals in supporting a required report on the military’s HIV and hepatitis B policies that was included in the 2014 defense bill which Congress passed Dec. 20.
The FY2014 National Defense Authorization Act includes two provisions that have the potential to eliminate discriminatory policies around HIV and hepatitis B by compelling the Department of Defense to medically justify current policies. This is a significant step toward reform of HIV criminalization laws.
The provisions require the Secretary of Defense to prepare a report for Congress concerning members of the Armed Forces who have HIV or hepatitis B. The report is to include a description of policies "addressing the enlistment or commissioning of individuals with these conditions” as well as “retention policies, deployment policies, discharge policies and disciplinary policies regarding individuals with these conditions." The defense act specifies that the report must include an assessment of whether these policies "reflect an evidence-based, medically accurate understanding" of how these conditions are contracted and transmitted.
Michael Horberg, MD, FIDSA, an HIVMA Board member and former chair, hailed the defense bill’s HIV directive in a press release
(PDF) issued by the Positive Justice Project, a network of individuals and agencies representing people with HIV. “The notion that people with HIV cannot enlist and serve in any aspect of the military, or that their health status warrants special 'safe sex' orders or punishments for consensual sex, seems rooted in a 1980’s understanding of HIV, and flies in the face of national efforts to get people with HIV tested and into treatment.”
President Obama Mentions Vaccines and Drug Resistance in State of the Union
The Society praised the President for acknowledging the need for innovation to address drug-resistant bacteria, and urged him to work with Congress to pass the Antibiotic Development to Advance Patient Treatment Act and the Strategies to Address Antimicrobial Resistance Act.
New Resource Helps ID Specialists Prove Their Value
A new PowerPoint presentation has been added to the Value of the ID Specialists’ Toolkit to help IDSA members inform hospital administrators, payors, and others about the invaluable, cost-saving services ID clinicians provide. The presentation
(member login required) provides a high-level review of the evidence of the beneficial impact of ID intervention on patient outcomes and costs, as well as the objectives, methods, and limitations of the IDSA-Avalere study that was published in Clinical Infectious Diseases
. Presentations are available in PowerPoint with speaker notes, PDF with speaker notes, and PDF formats.
President Obama Signs Bill to Prevent Scheduled Medicare Cut
IDSA continues to advocate
(PDF) for a repeal of the SGR, and will keep members apprised of legislative action on this front.
The Center for Global Health Policy Examines the Impact of Drug Prices on Vulnerable Populations, and Other Newsworthy Events
The end of 2013 and the start of 2014 brought news and issues to follow in global health.
is a project of the IDSA-HIVMA Center for Global Health Policy. To subscribe to the blog, which covers HIV and TB news, click here
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Members on the Move
HIVMA Board of Directors member, Judith Aberg, MD, FIDSA, FACP, is now chief of the division of infectious diseases and professor of medicine at ICAHN School of Medicine at Mt. Sinai.
Beginning in February, Emily Shuman, MD, of the IDSA Public Health Committee will be assistant professor of internal medicine and associate hospital epidemiologist at the University of Michigan.
Several members of IDSA and HIVMA were selected by the National Institutes of Health to lead and conduct the research of five HIV/AIDS clinical trials networks: Daniel Kuritzkes, MD FIDSA; Wafaa El-Sadr, MD, MPH, FIDSA; Myron Cohen, MD, FIDSA; and Scott Hammer, MD, FIDSA.
Are you a member on the move? Do you know someone who is? Contact Jennifer Ford at firstname.lastname@example.org so that we can announce it to our membership.
Aguilar, Delta, MD
Almukhaini, Suad, MD
Cortas, Chadi, MD, MPH, MSc
Dhand, Abhay, MD
Eppy, Eppy, MD
Etheredge, Catherine, MA
Forest, Stephen, MPH
Gonzalez, Julio, MD
Grill, Marie, MD
Husney, Robert, MD
Kang, Key, MSc
Kang, Seung, MD
Krawitzky, Samantha, MD
lodha, Abhijit, MD
Mendel, Carl, MD
Merrick, Samuel, MD
Mmeje, Okeoma, MD, MPH
Nestor, Sean, RPh
Ogle, Michelle, MD
Patel, Parag, MD
Piracha, Nauman, MD
Rafeiner, Philippe, MD
Ramidi, Ganga Bhavani, MD
Romero, Luis, MD
Sedgwick, Jacqueline, MD, MPH
Sowunmi, Abimbola, MBBS
Sparks, Susan, PharmD
van der Hilst, Jeroen, MD,PhD
Weinberg, Amy, BSN, FNP, MSN, NP, RN
Yelverton, Dennis, PA-C
Bhalodi, Amira, PharmD
Bloom, Sharon, MD
Chu, Helen, MD
Falade-Nwulia, Oluwaseun, MBBS
Friedrich, Lawrence, PHARMD
Haley, Clinton, MD, MPH
Jacobs, Frederique, MD
Jain, Amita, MD
Jones, Joyce, MS
Konda, Sumitra, MD
Lipkin, W. Ian, MD
Malhotra, Hardeep, MD
Munoz, Rodrigo, MD
Nace, Heather, MD
Offner, Lenka, MD
Phillips, Elizabeth, MD
Pho, Mai, MD
Richard, Marie Paule, MD
Terriquez, Joel, MD
Zanni, Markella, MD
Arnold, Christopher, MD
Fiske, Lauren, MD
Pan, Samuel, MD
Patel, Ronak, MD
Simwale, Owen, PhD
Tartof, Sara, MPH, PhD
Acuna Villaorduna, Carlos, MD
Ahuja, Jasmine, MBBS
Al Saghbini, Samer, MD
Alaan, Kristina, MD
Alagesan, Murali, MD
Alharbi, Maher, MD
Alobida, Hussam, MBBS, MD
Baredhwan, Abdullah, MD
Beste, Jason, MD
Booher, Katelyn, DO
Burston, John, MBBS
Campbell, Wesley, MD
Chun Lin, Rone, MD
Corey, Anna, MD
Duchon, Jennifer, MD, MPH
Ebisu, Yosuke, MD
Fricchione, Marielle, MD
Garlic, Raquel, MD
Gibson, Alison, MD
Hameed, Nida, MD
Henson, Karl Evans, MD
Heywood Thornton, Amanda, MD
Khadka Kunwar, Erina, MBBS
Khirfan, Mohamed, MD
Klein, Corinne, MD
Lopes, Vinicius, MD
Lum Hon Wai, Lionel, MBBS, MRCP
Miller, David, MD, MPH
Mizusawa, Masako, MD
Osmanzai, Yama, MD
Petty, Lindsay, MD
Poeth, Kaitlin, MD
Prahl, Mary, MD
R, Madhumitha, MD
Richards, Julie, MD
Saleh, Rania, MD
Saraiya, Nimit, MD
Simeunovic, Gordana, MD
Tyner, Harmony, MD, MPH
Zailaie, Roaa, MBBS
In Memoriam: Martin C. McHenry, MD, MS, FIDSA (1932-2013)
Martin C. McHenry, MD, FIDSA, was a passionate practitioner of infectious diseases who mentored many IDSA leaders during his long career as an infectious diseases and internal medicine practitioner. His career was dedicated to patient care, education, and scholarship.
Dr. McHenry graduated from the University of Cincinnati College of Medicine and subsequently trained in infectious diseases at the Mayo Clinic. After three years as a staff physician in the Division of Infectious Diseases at the Henry Ford Hospital in Detroit, Dr. McHenry joined the staff of the Cleveland Clinic Foundation and served for 20 years there as the first chair of the Department of Infectious Diseases.
Dr. McHenry was known for his extensive clinical experience and encyclopedic knowledge of medical literature and his empathic and thorough bedside manner. His warm personality permeated his interactions with patients, colleagues, trainees, family, and friends. In 2000, Dr. McHenry was recognized with the IDSA Clinician Award.
Dr. McHenry was a fellow of IDSA and was active in many professional societies. He was a well-recognized authority in the field of bacterial infections and general clinical infectious disease. His seminal study of vertebral osteomyelitis was the product of many years of research and was influential in the development of IDSA’s upcoming vertebral osteomyelitis guidelines.
Dr. McHenry is survived by his wife, Patricia; children Michael, Christopher, Timothy, Jeffrey, Paul, Kevin, William, Monica, Martin C. Jr., and the late Mary Ann; fifteen grandchildren; and one great-grandchild.
Free Online Course on Antimicrobial Stewardship
Antimicrobial Stewardship: Optimization of Antibiotic Practices is a free online course offered by the Division of Infectious Diseases in the Department of Medicine at Stanford University and designed to provide a comprehensive, practical approach to antimicrobial use and stewardship with the aim of optimizing patient care and slowing the progression of microbial resistance. Course material is based on IDSA and SHEA Guidelines and offers six CME credits with a nominal CME processing fee. Learn more by visiting the course website
Changes to ABIM MOC Now In Effect
The American Board of Internal Medicine (ABIM) now requires more
frequent participation in Maintenance of Certification (MOC) for all
board certified physicians to aid them in keeping pace with changes in
the science of medicine and assessment. ABIM has launched a redesigned website
with a personalized Physician Portal that shows diplomates exactly what
they need to do over the next few years to continue to meet MOC
requirements. IDSA has developed six ABIM-approved MOC modules, including for hepatitis C and HIV in primary care
, where one can earn part-2 credit.
Open Forum Infectious Diseases Now Accepting Submissions
Manuscripts are now being accepted for the new peer-reviewed journal from IDSA and the HIV Medicine Association (HIVMA), Open Forum Infectious Diseases (OFID). Launching soon, OFID will provide a global forum for the rapid publication of clinical, translational, and basic research findings in a fully open access, online journal environment. Papers will be peer-reviewed and, if accepted for publication, indexed in PubMed Central. Editor-in-Chief Paul Sax, MD, FIDSA, recently explained what types of manuscripts he wants to publish in a blog post with publisher Oxford University Press. IDSA and HIVMA members will receive discounts on article processing charges. For more information, read the instructions to authors at http://oxford.ly/ofid_authors and submit online today at http://oxford.ly/ofid_submit.
Apply Now for the ID Research Careers Meeting
IDSA and the National Institute of Allergy and Infectious Diseases (NIAID) are pleased to co-sponsor the third annual ID Research Careers Meeting, an exciting program designed to help foster the next generation of infectious diseases physician scientists. The two-day meeting for ID fellows and medical students will take place from May 8 – 10, 2014 in Bethesda, MD. Lodging and travel costs will be provided for meeting participants. IDSA members are encouraged to identify and solicit interested fellows and medical students. All interested may apply but spaces are filling up quickly.
Participants will have the opportunity to hear from leading ID physician-scientists about frontiers in medical research, including keynote speaker, Dr. Anthony Fauci, NIAID Director. There will be presentations and discussions on the practical aspects of developing a successful career in research. Attendees will have the opportunity to present their own research in a poster session and visit the campus of the National Institutes of Health (NIH). In addition, our outstanding faculty will be available for both formal and informal interaction over the course of the meeting.
From the President: New Website Provides Clinicians with Timely Advice on HCV
HCVguidelines.org, a new website developed by IDSA and the American Association for the Study of Liver Disease (AASLD) in collaboration with the International Antiviral Society-USA (IAS-USA), offers evidence-based, consensus recommendations for the screening, treatment and management of patients with HCV.
As ID specialists, we strive to use the latest information and tools, including diagnostics and drug regimens, to provide the best care possible to our patients and to share our expertise with fellow health care providers. A new website launched this week provides the most up-to-date guidance on appropriate care for practitioners who treat patients infected with hepatitis C virus (HCV). HCVguidelines.org
, developed by IDSA and the American Association for the Study of Liver Disease (AASLD) in collaboration with the International Antiviral Society-USA (IAS-USA), offers evidence-based, consensus recommendations for the screening, treatment and management of patients with HCV.
This guidance, which is not available elsewhere, comes at a time when the field of treating the estimated 3-4 million Americans infected with HCV is rapidly changing. Recent changes in recommendations by the Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force regarding who should be tested for HCV are likely to increase the numbers of patients diagnosed with the infection and those who seek treatment. In addition, the latest generation of direct-acting antivirals has the potential to cure most patients with HCV; however, the rapid pace of drug development has left medical providers and insurance companies unsure of optimal treatments.
will be updated regularly to keep pace with improved diagnostic tools and new drug options as they meet Food and Drug Administration (FDA) approval. The panel of experts behind the site consists of 26 liver disease and/or infectious diseases specialists who base their recommendations on a rigorous review of data and includes IDSA co-chairs, Dr. Henry Masur and Dr. David Thomas, as well as a patient advocate. The panel will continue to provide updated recommendations as new research becomes available and new drugs are approved by FDA.
The guidance offered through HCVguidelines.org
comes at a time of great promise for patients living with HCV infection who will benefit from modern treatments that can result in a cure of their illness. This site is a great example of ID specialists working alongside other medical specialists to provide much needed insight into the most effective way of treating complex infectious diseases.
ADAPT Act Would Promote New Drug Development
You Can Help IDSA Strengthen Bill and Secure Passage
New bipartisan legislation supported by IDSA would advance drug development by establishing a new limited population antibacterial and antifungal drug approval pathway for drugs to treat serious or life-threatening infections where there exists an unmet medical need.
IDSA is making important progress in legislative efforts to promote antibiotic drug development. Reps. Phil Gingrey (R-VA) and Gene Green (D-TX) on Dec. 12 led a bipartisan effort to introduce the Antibiotic Development to Advance Patient Treatment (ADAPT) Act
IDSA worked closely with Reps. Green and Gingrey, who is a physician, to develop this legislation, which is an important successor to the GAIN Act
, introduced by Reps. Gingrey and Green, supported by IDSA, and signed into law in 2012.
The ADAPT Act would advance drug development by establishing a new limited population antibacterial and antifungal drug approval pathway for drugs to treat serious or life-threatening infections where there exists an unmet medical need. IDSA first put forward this concept in 2012, and the ADAPT Act is a result of IDSA’s persistent advocacy on this issue. In a letter
(PDF) to Reps. Gingrey and Green, IDSA President Barbara Murray, MD, FIDSA, expressed IDSA’s support of the legislation and highlighted one area in which the bill could be strengthened. IDSA’s Take Action
web page includes an action alert that makes it easy to email your congressional representatives and urge them to co-sponsor and strengthen the ADAPT Act.
The proposed legislation would speed patient access to important antibacterial and antifungal drugs by allowing them to be approved based upon smaller, more rapid clinical trials. It is often not feasible for these drugs to be developed using traditional, large clinical trials due to the limited numbers of patients in whom these infections currently occur.
Any drug approved under this new pathway would still need to meet the Food and Drug Administration’s (FDA) standards of evidence for safety and effectiveness for the limited indicated population. IDSA expressed to the sponsoring legislators the importance of communicating to the health care community the need to use these drugs prudently. Specifically, IDSA appreciates the bill’s current provisions aimed at this goal, but is also recommending that drugs approved under this new pathway be marked with a special logo to more clearly differentiate them from traditional antibiotics.
In a report
issued last April, IDSA identified only seven new drugs in development for the treatment of infections caused by multidrug-resistant Gram-negative bacilli, and none of these drugs addresses the complete set of needs associated with these infections. The ADAPT Act would help to address this need as well as the increasing antibiotic threats outlined in the Centers for Disease Control and Prevention (CDC) report
(PDF) issued in September 2013.
Additional co-sponsors of the legislation are: Reps. Marsha Blackburn (R-TN), G.K. Butterfield (D-NC), Eliot Engel (D-NY), Anna Eshoo (D-CA), Morgan Griffith (R-VA), John Shimkus (R-IL), and Ed Whitfield (R-KY).
Updated Guideline for Vaccination of Immunocompromised Host Now Available
IDSA’s updated guideline was developed in an effort to make it easier for clinicians to rapidly find vaccine recommendations for the immunocompromised patient population.
IDSA has updated its Guideline for the Vaccination of the Immunocompromised Host
in an effort to make it easier for clinicians to rapidly find vaccine recommendations for this patient population. The ultimate goal is to decrease morbidity and mortality from vaccine-preventable infections in immunocompromised patients.
The guideline recommends that primary care clinicians and subspecialty providers share responsibility for ensuring appropriate vaccination of these patients. Vaccination of children and adults with primary immunodeficiencies are discussed, as are patients with a secondary deficiency including HIV infection, cancer treatment, stem cell or solid organ transplant, asplenia, cochlear implant, CSF leak, and patients with chronic inflammatory diseases treated with immunosuppressive therapies. Vaccinations of immunocompetent contacts of patients who have defense abnormalities and travel-related vaccination are also addressed.
“The guideline provides ‘one-stop shopping’ for clinicians caring for children and adults with compromised immune systems and includes recommendations and evidence for most vaccinations, from influenza to chicken pox,” said Lorry G. Rubin, MD, FIDSA, lead author of the guideline. “Previously, the recommendations were difficult to retrieve because in most cases information had to be accessed individually by vaccine rather than by the category of patient disease.” Dr. Rubin is director of the Division of Pediatric Infectious Diseases at the Steven and Alexandra Cohen Children’s Medical Center of New York in New Hyde Park and professor of pediatrics at Hofstra North Shore-LIJ School of Medicine.
The vast majority of the recommendations contained in the guideline conform to recommendations of the Advisory Committee on Immunization Practices and the American Academy of Pediatrics. The guideline provides recommendations for most vaccines, including the appropriate use of varicella and zoster vaccines, in easy-reference tables.
Areas where future research is warranted are outlined, such as establishment of a registry of immunocompromised vaccine recipients and research regarding the efficacy and safety of zoster vaccine in these patient populations.
The evidence-based guideline was prepared by an international panel of pediatric and adult experts in infectious diseases, immunology, oncology, stem cell and solid organ transplant, gastroenterology, and rheumatology.
The full guideline is available online
and will also appear in the February 1 issue of Clinical Infectious Diseases
. Visit the practice guidelines
section of the IDSA website for additional guidelines and related resources.
IDSA Journal Club
This month’s studies investigating: Predicting Drug-Resistant Organisms in HCAP: Do We Always Need to Go Big?; Preventing Hepatic Decompensation in HIV-HCV Coinfected Individuals; Another Flu Shot Benefit: Meta-Analysis Suggests Reduction in Cardiovascular Events After Vaccination; Eradication of CRE Gastrointestinal Colonization with Oral Antibiotics; Is Amoxicillin Really Associated with Rash in Acute EBV Infection?
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.
Predicting Drug-Resistant Organisms in HCAP: Do We Always Need to Go Big?
Reviewed by Nirav Patel, MD
recommend that health care-associated pneumonia (HCAP) be treated with broad spectrum antibiotics to ensure adequate initial therapy. However, the risk of inappropriate therapy must be weighed against the risk of overuse of antibiotics. A multi-centered trial from Japan, described in the October 15 issue of the American Journal of Respiratory and Critical Care Medicine
, builds on prior single-center trials attempting to assess the specific risk factors for resistance for patients presenting with either community-acquired pneumonia (CAP) or HCAP.
This prospective study
collected data from 10 large hospitals, screening 1,742 patients and enrolling 1,413 subjects based on the CAP and HCAP definitions. Aggressive microbiologic evaluation identified the etiologic agent of pneumonia. Endpoints included identification of organisms with resistance to guideline recommended therapy for CAP: ceftriaxone, ampicillin-sulbactam, macrolides, and fluoroquinolones.
Not surprisingly, the HCAP group had higher rates of comorbidities and baseline laboratory abnormalities compared to the CAP group, with a higher mortality (likely driven by inappropriate initial antibiotics).
However, when drug resistance was assessed, the same risk factors were noted for both CAP and HCAP, all with an adjusted OR of ~2-2.5: hospitalization for ≥ two days in the last 90 days, immunosuppression, use of antibiotics within the prior 90 days, use of gastric acid suppression, tube feeding, and non-ambulatory status. In addition, three specific methicillin-resistant Staphylococcus aureus (MRSA) risks were also noted: chronic hemodialysis in the previous 30 days, prior MRSA colonization, and congestive heart failure. The sensitivity of ≥ three risk factors was 47.1 percent; specificity, 90.9 percent; positive predictive value, 49.6 percent; negative predictive value, 90 percent; and accuracy, 83.9 percent. The area under the receiver operating characteristic curve was 0.79, which compared favorably to the prior single centered studies.
Based on the results, a significant number of patients with HCAP could be safely treated with CAP antibiotics without compromising therapy. The authors note that the “type of pneumonia…may not determine the presence…of [drug-resistant pathogens].” Clearly, more specific risk factors are at play, including non-traditional risks such as gastric acid suppression. An accompanying editorial
provides a clear table and flowchart to help clinicians use the results in patient care. Before this approach can become the standard of care, however, a further validation study is needed.
Preventing Hepatic Decompensation in HIV-HCV Coinfected Individuals
Reviewed by Brian R. Wood, MD
Among HIV-infected individuals, hepatitis C virus (HCV) coinfection is common, and HIV accelerates progression to advanced liver disease. This has become a dominant driver of mortality in this population, making strategies to prevent hepatic deterioration of paramount importance. Two recent studies in Clinical Infectious Diseases emphasize the role of early treatment: One advocates early antiretroviral therapy (ART), and the other earlier treatment of HCV.
First, investigators from the United States examined early ART and liver disease outcomes in HIV-HCV coinfected men (median age 47, 61 percent black, 87 percent HCV genotype 1) enrolled in the Veterans Aging Cohort Study Virtual Cohort since 1996.
Participants contributed 46,444 person-years of follow-up. Those who started ART had a significantly lower rate of incident hepatic decompensation (HR 0.72, 95 percent CI 0.54-0.94). ART initiation decreased the likelihood of decompensation by 28-41 percent, on average. Strengths of this study
include the large sample size and the use of marginal structural models, which help eliminate bias for indication. The study is limited because it examined only male veterans and lacks solid data on drug and alcohol use. However, this analysis provides robust evidence for early ART in HIV-HCV coinfected patients and suggests that early ART should be strongly recommended for them.
In the second study
, investigators from Spain performed a retrospective cohort analysis to examine the risk of hepatic decompensation in 892 HIV-HCV coinfected individuals (median age 43, 87 percent male, 88 percent on ART at baseline, 59 percent HCV genotype 1) with stage 3 versus stage 4 fibrosis. The results show higher rates of hepatic decompensation in participants with stage 4 fibrosis as compared to stage 3, as measured by liver biopsy (P=0.023, mean follow-up 5.4 years) or transient elastography (P<0.0001, mean follow-up 2.1 years). However, the authors cite that the rate of decompensation with stage 3 fibrosis is clinically meaningful because decompensations occurred in this group, even within one to three years.
The authors conclude that patients with bridging fibrosis should be prioritized for treatment along with those who have cirrhosis. If resources allow, this seems wise. Otherwise, given the hastened course of liver disease in HIV-HCV coinfection, these individuals require close clinical follow-up and perhaps frequent reassessments of fibrosis. (This is feasible with transient elastography, a modality approved by the Food and Drug Administration earlier this year.)
Together, these studies underscore the importance of early ART and early HCV therapy in coinfected individuals; hopefully new antivirals on the horizon will make HCV treatment for all these patients a reality.
Another Flu Shot Benefit: Meta-Analysis Suggests Reduction in Cardiovascular Events After Vaccination
Reviewed by Manie Beheshti, MD
Data has previously linked vaccination against influenza with a reduction in vascular events, such as stroke and myocardial infarction. However, most of this data is based on observational studies and small randomized clinical trials.
In a recent issue of The Journal of the American Medical Association, investigators performed a comprehensive meta-analysis of all randomized clinical trials of the influenza vaccine that evaluated vascular events as efficacy or safety outcomes. This extensive search of Ovid MEDLINE, EMBASE, and the Cochrane databases dating back to 1946 selected adequate studies assessing vaccine vs. placebo. These studies accounted for approximately 6,700 patients (mean age, 67; 51 percent female; 32 percent with a history of coronary artery disease; mean follow-up time, 8 months).
Pooled results demonstrated a significant decrease in major cardiovascular events in those who received influenza vaccine vs. placebo or control (2.9 percent vs. 4.7 percent; RR: 0.64). The number needed to treat (NNT) to prevent one major adverse cardiovascular event was 58. This beneficial trend was even more pronounced in vaccinated patients with recent acute coronary syndromes (10.2 percent in the vaccinated group vs. 23 percent in the placebo or control group; RR 0.45; NNT: 8).
Although limited by its inherent design as a meta-analysis, this study
provides a thorough review of the available literature and demonstrates a significant reduction in cardiovascular events in those receiving the influenza vaccine. Further, the authors note their intent to go forward with a large randomized trial to better evaluate cardiovascular benefits in the vaccinated.
Since less than half of U.S. adults receive this universally and annually recommended vaccine, this study helps add important information about additional potential benefits linked to vaccination against influenza, particularly for high-risk patients.
Eradication of CRE Gastrointestinal Colonization with Oral Antibiotics
Reviewed by Zeina A. Kanafani, MD, MS
A recent study
in the American Journal of Infection Control
examined whether non-absorbable oral antibiotics may be useful in eradicating gastrointestinal colonization with carbapenem-resistant Enterobacteriaceae
Active surveillance for CRE was conducted through rectal swab cultures. Patients received gentamicin (GM) if their isolate was sensitive to GM but resistant to colistin (COL), or COL if their isolate was resistant to GM but sensitive to COL. If the isolate was sensitive to both drugs, patients were randomized to receive GM alone, COL alone, or a combination. Controls were colonized patients who did not receive treatment. Treatment was continued until eradication, but not exceeding 60 days.
Fifty patients were treated (26 with GM, 16 with COL, 8 with both), and 102 patients were controls. Spontaneous eradication occurred in 7 percent of controls after 140 days median follow-up. Eradication rates were 42 percent with GM, 50 percent with COL, and 37.5 percent with combination (median treatment 31, 54, and 45 days, respectively). Eradication rates in the treatment arms were not statistically different, but all were significantly higher than the spontaneous eradication rate in controls. There were no observed side effects with either antibiotic.
CRE-positive clinical cultures and administration of intravenous antibiotics were not different between treated patients and controls. Overall mortality was higher in controls (53 percent vs. 22 percent; p<0.001), although CRE-related mortality was similar. Patients with successful eradication (spontaneous or after treatment) had lower mortality than those with persistent colonization (17 percent vs. 49 percent; p=0.002).
Oral GM and COL appear to be safe and effective in eradicating CRE gastrointestinal colonization when optimal infection control measures have failed, based on the study’s results. Although higher overall mortality was observed in controls, the authors did not adjust for differences in baseline characteristics (higher age, frequency of hematologic malignancies, and bedridden patients among controls). Therefore, gastrointestinal decolonization is not strongly correlated with better clinical outcome, and has to be balanced against development of resistance with prolonged therapy.
Is Amoxicillin Really Associated with Rash in Acute EBV Infection?
Reviewed by Christopher J. Graber, MD, MPH, FIDSA
The notion that amoxicillin, when given during an episode of acute Epstein-Barr virus (EBV) infection (infectious mononucleosis), leads to a rash in 80-100 percent of patients has been a widely believed clinical pearl since a relationship between ampicillin and rash in acute EBV was described in three studies published in 1967. However, two new studies recently challenge this assumption.
The first study
, published in Pediatrics
, was a retrospective examination of 238 children presenting with serologically confirmed acute EBV infection hospitalized at two tertiary medical centers in Israel from 1999 to 2009, 173 of whom were treated with antibiotics and 65 of whom were not. Fifty-seven (32.9 percent) of the antibiotic-treated patients developed a rash, as compared with 15 (23.1 percent) of the patients that did not receive antibiotics (p=0.16). Antibiotic-attributable rash, in which rash developed after administration of the first dose of antibiotic and up to 48 hours after the treatment ended, was seen in only 41 (23.7 percent) of the 173 patients who received antibiotics, though amoxicillin was associated with the highest rate of overall (39.3 percent) and antibiotic-attributable (29.5 percent) rash.
The second study, described in a letter to the editor
published in Clinical Infectious Diseases
, retrospectively identified 184 patients (either inpatient or outpatient) with acute EBV infection from a regional hospital in France from 2008 to 2013, 34 of whom had rash and 150 of whom did not. Fourteen (41 percent) of the patients with rash received amoxicillin, as compared with 71 (47 percent) of those who did not have rash. Furthermore, 16 (47 percent) of the patients with rash received any penicillin derivative, as compared with 87 (58 percent) of those who did not have rash.
The first study was limited because it only included hospitalized patients, and both studies were limited by relatively small sample sizes. However, they nevertheless suggest that the relationship between amoxicillin and rash in the setting of acute EBV infection may not be as well-defined as previously thought and that receipt of amoxicillin may not necessarily alter the likelihood of patients with acute EBV infection developing a rash. The authors of the first paper suggest that chemical differences between ampicillin and amoxicillin may be responsible for the differences between the studies from the 1960s and now, but the 1960s papers were also limited by relatively small sample sizes.
For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, in each issue of Clinical Infectious Diseases:
- Updated European Guideline for Management of Clostridium difficile Infection
- Antibiotics for Low Back Pain?
- Occult Rifampin Resistance in Mycobacterium tuberculosis
- Autoimmune N-methyl-D-aspartate Receptor Encephalitis or Herpes Simplex Encephalitis?
- What Is the Linezolid Concentration?
- Administration of Antibiotic Therapy for 2 Days to Treat Possible Sepsis of Unknown Origin: A Pilot Study