IDSA News - Nov./Dec. 2009
Vol. 19 No. 11
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From the President: IDSA Priorities for the Year Ahead
As my term as IDSA president begins, I want to introduce several important priorities the Society will be focusing on in the year ahead. As this brief list indicates, IDSA continues its strong commitment to serve the needs of a diverse membership with a broad policy agenda.
As my term as IDSA president begins, I want to introduce several important priorities the Society will be focusing on in the year ahead. As this brief list indicates, IDSA continues its strong commitment to serve the needs of a diverse membership with a broad policy agenda, incorporating the needs of both scientists and researchers in the academic setting and practicing ID clinicians who are on the front-line providing direct patient care.
Not surprisingly, IDSA will continue to play an important role in the response to the 2009 H1N1 influenza pandemic. As we have already seen, H1N1 has created one of the most challenging influenza seasons in memory, and IDSA will make sure the perspectives of ID clinicians and scientists are heard by key policymakers regarding how to best protect the public and health care workers (HCWs).
In a recent example, IDSA joined with the Society for Healthcare Epidemiology of America (SHEA) and the Association for Professionals in Infection Control and Epidemiology (APIC) in November to urge the Obama administration to update current federal guidance for the use of personal protective equipment by HCWs (see related article). IDSA and our colleagues at SHEA and APIC believe this guidance, which calls for HCWs in close contact with influenza patients to wear N-95 respirators rather than surgical masks, does not reflect the best available science and could limit the availability of already scarce respirators for situations where they are truly needed.
Demonstrating the value that ID specialists add to our nation’s health care system, both in patient care and non-patient care activities, is another important priority for IDSA. Despite strong opposition from IDSA and virtually all internal medicine subspecialties, the Centers for Medicare and Medicaid Services recently finalized a rule that will eliminate payments for inpatient and outpatient consultation codes, starting in January 2010 (see related article).
This development underscores our specialty’s need to develop evidence to support what we strongly believe to be true: ID specialists improve outcomes for patients and often reduce health care costs. As the nation’s health care reform process progresses, the Society will continue to pursue this important goal, in addition to providing IDSA members with additional guidance on billing and coding.
Shortly after the 47th Annual Meeting of IDSA in Philadelphia, there was welcome news in another area very important to the Society—addressing the growing threat of antimicrobial resistance. In early November, President Barack Obama and Swedish Prime Minister Fredrik Reinfeldt, representing the European Union presidency, agreed to establish a transatlantic task force to address this global health problem (see related article). IDSA looks forward to working with this group to help ensure that experts from the medical, scientific, and public health fields are involved in this critical effort. Specific to the antibacterial drug pipeline problem, IDSA has already weighed in strongly in a letter to both political leaders.
Additionally, IDSA will continue to engage lawmakers and federal agencies through its three work groups on resistance, the Antimicrobial Availability Task Force, the Research on Resistance Work Group, and the Antimicrobial Resistance Work Group. This includes pushing for passage of the Strategies to Address Antimicrobial Resistance Act, which IDSA took a lead role in crafting (see previous IDSA News article). Drug resistance in general remains a pressing problem, as even this challenging influenza season has shown us, with increased concerns about resistance to antiviral medications.
Of course, the HIV Medicine Association (HIVMA) will continue to play an important role by promoting quality in HIV care and advocating for polices that ensure a science-based, comprehensive and human response to the AIDS pandemic. In addition, the Center for Global Health Policy, a project of IDSA and HIVMA, will remain an important voice in promoting the effective, evidence-based use of U.S. funding for addressing the global HIV/AIDS and TB epidemics.
This is not a complete list of IDSA priorities—for instance, the Society will also continue to press for appropriate funding for the government agencies that patients, ID physicians, and scientists rely on, including the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), to name just two. But I believe the important examples described above demonstrate the Society’s commitment to its diverse membership, a commitment that will remain unchanged under my presidency. I look forward to serving you.
IDSA Calls for Global Commitment to Create 10 New Antibiotics by 2020
10 X ’20 Initiative Follows Creation of U.S. and EU Task Force to Address Antimicrobial Resistance
To address the urgent and growing global threat of antimicrobial resistance, IDSA in November called on U.S. and European Union (EU) leaders to commit to developing 10 new antibiotics by 2020, known as the 10 X '20 Initiative.
To address the urgent and growing global threat of antimicrobial resistance, IDSA in November called on U.S. and European Union (EU) leaders to commit to developing 10 new antibiotics by 2020, known as the 10 X ’20 Initiative. In a letter to President Barack Obama and Swedish Prime Minister Fredrik Reinfeldt, acting on behalf of the EU Presidency, the Society highlighted the critical importance of reaching this goal, which would represent a significant step toward safeguarding the health and well-being of patients around the world.
“We must succeed in creating a stable research infrastructure for antibiotic development, otherwise physicians around the world will be left without the tools they need to effectively treat patients,” IDSA President Richard Whitley, MD, FIDSA, said in a press release.
IDSA’s call followed an agreement, signed by the two leaders during a Nov. 2-3 summit in Washington, to create a joint U.S./EU transatlantic task force to encourage global research and development of new antibiotics and address antimicrobial resistance. The task force will begin its work by identifying and agreeing on several issues, including the appropriate use of antimicrobial drugs in medical and veterinary communities, prevention of both health care- and community-associated drug-resistant infections, and strategies for improving the antimicrobial drug pipeline.
In its letter, the Society called on the two governments to create a specialized antibacterial drug pipeline work group, which would be responsible for identifying strategies to motivate antibiotic drug development. IDSA also urged that the U.S. and EU activities be carried out at the highest levels of both governments, within the White House—possibly in connection with the President’s Advisory Council on Science and Technology—and the European Commission.
In addition, IDSA has reached out to more than 100 international infectious diseases and microbiology societies around the world, requesting their support for the important global commitment to develop 10 new antibacterial drugs within 10 years.
IDSA also joined with the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the Pew Health Group, an arm of The Pew Charitable Trusts, in welcoming the establishment of the U.S./EU task force. In a joint press release, the organizations called for experts from the scientific, medical, and public health communities to be included as the initiative moves forward. The task force follows two recent European reports, similar to IDSA’s 2004 “Bad Bugs, No Drugs” report, that outline the growing problem of antibiotic resistance in Europe and highlight possible strategies to stimulate new drug development, including financial and other incentives (see related IDSA News article).
For more information about the task force and IDSA’s 10 X ’20 Initiative, see this column written by Robert J. Guidos, JD, IDSA’s vice president of public policy and government relations, for the Center for Global Development’s November newsletter. To learn more about IDSA’s efforts to address antimicrobial resistance, see IDSA’s website.
Medicare in 2010: No More Payment for Consultation Codes; Possible Cuts Looming
Several changes are in store for Medicare in 2010. The biggest disappointment for ID physicians is the elimination of payments for inpatient and outpatient consultation codes, despite vigorous opposition from IDSA and other specialty societies.
Several changes are in store for Medicare in 2010—so many, in fact, that the Centers for Medicare and Medicaid Services (CMS) has extended the deadline for physicians to determine whether to participate in Medicare to Jan. 31, 2010.
To help IDSA members make that decision, IDSA has partnered with the American Medical Association (AMA) to develop a brief overview of the options. For more information, click here.
The biggest disappointment for ID physicians is the elimination of payments for inpatient (99251-99255) and outpatient (99241-99245) consultation codes, effective Jan. 1, despite vigorous opposition from IDSA and other specialty societies. CMS will allow physicians to bill initial inpatient consultative visits using the hospital admission codes (99221-99223), and follow-up care will continue to be billed using the subsequent hospital visit codes (99231-99233). The financial impact on an individual physician will vary, depending on his or her service mix.
Fortunately, Medicare will also increase the values for some Evaluation and Management (E&M) service codes, and ID physicians could also benefit from other, unrelated provisions in the Medicare fee schedule. Click here to see how the inpatient and outpatient consultation codes could be “cross-walked” to other E&M services.
Looming in the background, though, are potential, across-the-board physician payment cuts of 21 percent that will take effect Jan. 1 unless Congress acts. Congress forestalled previously planned cuts in 2008 and 2009, and physician groups are cautiously optimistic that these cuts also will be prevented, but maybe not before the new year. IDSA, AMA, and other medical societies are backing legislation that would permanently fix the Medicare physician payment problem as part of health reform. The measure passed the House of Representatives on Nov. 19, but Senate passage is less certain, given concerns about the price tag. See IDSA’s online Physician Payment Toolkit to learn how you can support this effort.
In addition, AMA in November adopted a resolution introduced by IDSA and 10 other medical associations that opposes efforts to eliminate payments for inpatient and outpatient consultation codes by either public or private payers. The AMA resolution also supports legislation to overturn the recent CMS action. IDSA also recently wrote a letter to Health and Human Services Secretary Kathleen Sebelius strongly opposing the CMS decision and urging a delay.
IDSA continues to monitor Medicare payment issues, and is developing new billing and coding resources for IDSA members, particularly related to consultations. Check the Billing and Coding Resources page of the IDSA website in late December. (You must be logged in to access this page.)
IDSA Journal Club
This month: hepatitis B vaccine and long-term immunogenicity, prophylactic paracetamol following childhood vaccinations, treating hyperlipidemia in patients on protease inhibitors: rosuvastatin versus pravastatin, the Thai HIV vaccine trial, preventing neonatal sepsis with lactoferrin, and a human gammaretrovirus and the pathogenesis of chronic fatigue syndrome.
In this feature, a panel of IDSA members identifies and critiques important new infectious diseases studies in the current literature that have a significant impact on the practice of infectious diseases medicine.
Good News and Not So Good News: Hepatitis B Vaccine Associated with Long-Term Immunogenicity, But Prophylactic Paracetamol Following Childhood Vaccinations May Diminish Immunogenicity
Reviewed by Khalil Ghanem, MD, PhD
Booster doses following hepatitis B vaccination are not needed even more than two decades after primary immunization. The encouraging results come from a study published in the Nov. 1 issue of The Journal of Infectious Diseases.
Among 493 Alaska Native adults and children who received the primary doses of hepatitis B vaccine in 1981, 60 percent still had antibody levels ≥10 mIU/mL (protective level) 22 years later. Among those who had lower or undetectable levels of antibody, 81 percent responded to a booster dose, suggesting that immunological memory was preserved. In addition, none of the vaccinated patients, even those with undetectable antibodies, were found to be infected with hepatitis B. These data highlight two important points: Immunity to hepatitis B vaccine is long-lived, and antibody concentrations may not be the best indicator of long-term protection, as other immune mechanisms, such as cellular immunity, may be important in mediating continued protection.
In another vaccination related study, prophylactic paracetamol, also known as acetaminophen, given to children for 24 hours after immunizations decreased post-vaccination febrile episodes but also significantly decreased antibody titers to the vaccine. The findings were published in the Oct. 17 issue of The Lancet.
Four hundred and fifty nine infants (mean age 12 weeks) were randomized to receive either placebo or three doses of prophylactic paracetamol following primary and booster immunizations (a 10-valent pneumococcal non-typeable H. influenzae conjugate vaccine, DTPa-HBV-IPV/Hib and rotavirus vaccines) in this open label study. Although severe febrile reactions were uncommon in both groups, children receiving paracetamol were approximately 50 percent less likely to experience fevers greater or equal to 38 ̊C. However, there was a significant reduction in mean antibody titers in infants receiving paracetamol in response to several of the vaccines, including pneumococcal conjugate, Hib, diphtheria, and tetanus.
The big question is whether this study should change clinical practice. Although paracetamol use decreased febrile reactions and pain, serious reactions were exceedingly rare in both groups, suggesting that, short of minimizing mild discomfort, paracetamol use was of limited clinical benefit. However, the long-term implications of reduced antibody titers are not clear. The authors’ conclusion appears reasonable: Prophylactic paracetamol administration in infants should not be routinely recommended without careful weighing of the potential risks and benefits. Whether these findings are applicable to older children and adults is unknown.
(McMahon et al. J Infect Dis 2009;200:1390–1396 and Prymula et al. Lancet 2009;374:1339-1350)
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Treating Hyperlipidemia in Patients on Protease Inhibitors (PIs): Rosuvastatin Versus Pravastatin
Reviewed by Kathryn E. Stephenson, MD, MPH
A recent study from the journal AIDS sheds some light on a common clinical question: What is the best way to lower cholesterol in HIV patients taking antiretroviral regimens that include boosted protease inhibitors (PIs)? Statins are the most effective drugs to treat hyperlipidemia, but many are metabolized by the CYP3AF enzyme, which is inhibited by PIs, particularly ritonavir. Pravastatin does not use CYP3AF and is thus widely used for these patients. However, it is not the most effective statin, especially when compared with rosuvastatin, which also does not use CYP3AF.
In this French study, published online ahead of print, patients with HIV-1 and dyslipidemia (LDL > 158 mg/dL) were randomized to receive either pravastatin or rosuvastatin in a multicenter, open-label trial. All patients were required to be on a stable antiretroviral regimen containing a boosted PI. Over a two-year period, 88 patients were enrolled at 21 centers. Both groups were balanced in terms of type of PI therapy and baseline lipid levels.
After 45 days of statin therapy, pravastatin lowered LDL levels by a median of 19 percent compared with 37 percent in the rosuvastatin group (P<0.001). Pravastatin also lowered triglyceride levels by a median of 7 percent compared with 19 percent in the rosuvastatin group (P=0.035). Trough plasma concentrations of both statins were within expected ranges, and there were no significant differences in lab parameters or adverse events in the two groups.
These results indicate that rosuvastatin is more effective than pravastatin, and just as safe, in reducing LDL and triglyceride levels in patients with HIV on antiretroviral regimens containing a boosted PI. The primary weakness of this study is that the data is not tied to clinical endpoints, such as cardiovascular events or mortality.
(Aslangul et al. AIDS 2009:23: (ahead of print))
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The Thai HIV Vaccine Trial: A Possible Milestone, but More Research Is Needed
Reviewed by Jonathan Li, MD
For the first time, a group of researchers has found a significant, though modest, protective effect afforded by an HIV vaccine. The findings of their study, published online in the New England Journal of Medicine on Oct. 20, also suggest there is more work to be done before an effective vaccine can be developed for widespread use.
Investigators enrolled 16,402 healthy Thai adults between the ages of 18 and 30 years old in a multicenter randomized controlled trial. Patients in the experimental arm first received four priming injections of a recombinant canarypox vector vaccine (ALVAC-HIV) followed by two booster does of a recombinant glycoprotein 120 subunit vaccine (AIDSVAX B/E). The study was designed to evaluate two co-primary endpoints: the prevention of HIV infection and the effect of the vaccine on post-infection viral load.
In the modified intention-to-treat analysis (the primary analysis criteria), the vaccine had a significant 31.2 percent efficacy in preventing new HIV infections. In the vaccine arm, 51 of 8,197 individuals became infected as compared to 74 of 8,198 individuals who received placebo (P=0.04). Analysis of the data by the intention-to-treat and per protocol analysis found vaccine efficacy rates of 26.4 percent and 26.2 percent, respectively. However, these effects were not statistically significant. Individuals were enrolled in this study regardless of their risk of acquiring HIV, and the majority were low risk (47.5 percent) or moderate risk (28.4 percent). Surprisingly, the vaccine efficacy was found predominantly in those at low or medium risk of infection. There was no significant effect of the vaccine on post-infection viral load.
While there has been some controversy about the most appropriate methodology to analyze the data, this trial does seem to show a likely modest benefit from the vaccine. However, there is still a long way to go before such a vaccine is ready for routine use to prevent infection. As the accompanying editorial notes, the most important contribution of this trial may lie in the opportunity to further our understanding of the immune response necessary to prevent HIV infection. The lessons learned from this trial will be crucial in the development of the next generation of HIV vaccines.
(Rerks-Ngarm et al. N Engl J Med 2009;Oct. 20 and Dolin R. N Engl J Med 2009;Oct 20)
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Preventing Neonatal Sepsis With Lactoferrin Supplementation
Reviewed by Jason Weinberg, MD
Supplementing infant feedings with bovine lactoferrin (BLF), a component of milk that has antimicrobial and immunomodulatory capabilities, reduces the incidence of late-onset sepsis in very low birth weight premature infants, according to a study in the Oct. 7 issue of the Journal of the American Medical Association.
Infants were enrolled in a multicenter, double-blind, randomized, placebo-controlled trial in which feedings were supplemented with BLF alone or in combination with the probiotic Lactobacillus rhamnosus GG (LGG). The incidence of late-onset sepsis was reduced from 17.3 percent in the placebo group to 5.9 percent in infants receiving BLF and to 4.6 percent in infants receiving BLF and LGG. The milk component alone provided protection against gram-positive but not gram-negative bacteria. The use of BLF had no effect on fungal colonization but did provide protection against invasive fungal infection.
Subgroup analyses showed that the overall protective effect of supplementation was significant for the smallest (less than 1,000 g) and most premature (less than 27 weeks gestation) infants, possibly because these infants received proportionately more BLF for longer periods of time. Infection-related mortality was decreased in both treatment groups, while necrotizing enterocolitis occurred less frequently and only in infants receiving both BLF and LGG.
Sepsis remains a substantial cause of morbidity and mortality in premature infants. The promising and robust results of this study should encourage further research on the use of BLF in these premature infants at risk for infection, exploring mechanisms underlying the milk component’s effects and other issues, such as optimal dose and duration of treatment.
(Manzoni et al. JAMA 2009; 302(13):1421-1428)
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A Human Gammaretrovirus and the Pathogenesis of Chronic Fatigue Syndrome (CFS)
Reviewed by George R. Thompson III, MD
Researchers identified xenotropic murine leukemia virus-related virus (XMRV), a human gammaretrovirus, in two-thirds of patients in a chronic fatigue syndrome (CFS) cohort, although it remains unclear what causal role, if any, the virus may play. The findings and an accompanying editorial were published in the Oct. 23 issue of Science.
XMRV had previously been detected in nearly a quarter of all prostate cancer biopsies, and prior reports of alterations in RNase L, an antiviral enzyme, in both prostate cancer and CFS led the authors to speculate that XMRV may be a contributing factor in the pathogenesis of CFS.
Using a national tissue repository, which contains samples from well-characterized cohorts of CFS patients, the investigators assayed samples for the presence of XMRV. The virus was detected in 68 of 101 CFS patients (67 percent), compared with only 8 of 218 healthy controls (3.7 percent). Further laboratory investigation revealed latent infection in B and T lymphocytes, and preparations from these cells were infectious and could be transmitted to other cell lines. CFS patients also exhibited an antibody response to XMRV more frequently than healthy controls. Immune dysfunction is a known feature of CFS, and the authors suggest that infectious XMRV in lymphocytes may be responsible.
It remains to be seen if XMRV infection is causal in the pathogenesis of CFS or merely a “passenger virus” in CFS patients who have dysregulated immunity from other causes. XMRV may be more frequent in the same geographic region as the studied CFS cohort, and viral transmission, prevalence, and distribution remain largely unknown. The frequency of infection in healthy controls is relatively high, suggesting many people worldwide are potentially infected with a virus whose pathogenic potential is largely unknown. Clearly, more research is needed to study XMRV and to potentially develop effective diagnostic and treatment strategies.
(Lombardi et al. Science 2009;326:585-589 and Coffin et al. Science 2009;326:530-531)
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Updates on H1N1 and Seasonal Influenza
In the midst of a challenging influenza season, clinicians and researchers shared information about the current understanding of—and response to—the novel 2009 H1N1 strain, as well as findings related to seasonal influenza, during a series of presentations at the 47th Annual Meeting of IDSA.
Sylvie Briand, MD, MPH, PhD, acting director of the Global Influenza Programme of the World Health Organization (WHO), reported that H1N1 manifests in a wide spectrum of infection from cases without symptoms to fatal disease. “Most people develop self-limited upper respiratory illness,” she said, but groups at higher risk for severe disease include pregnant women; individuals with chronic respiratory and cardiovascular diseases; people with diabetes; and those who are immunosuppressed.
Bacterial co-infection, namely with pneumococcus and Staphylococcus aureus, is more frequently reported than initially recognized, especially in severe rapidly progressing disease, Dr. Briand said during an H1N1 symposium. “Timely antiviral treatment has gained evidence in reducing severe illness and death,” she said.
Antivirals should be used, ideally early, and at any stage of active disease when ongoing viral replication is observed, she said. However, due to reports of resistance developing to oseltamivir, chemoprophylaxis against influenza has not been recommended.
Strikingly, researchers have observed, very elderly individuals appear to be resistant to the latest H1N1 strain, and James E. Crowe Jr., MD, FIDSA, professor of pediatrics, microbiology, and immunology at Vanderbilt University Medical Center in Nashville, Tenn., thinks he knows why.
Antibodies induced by the devastating 1918 influenza pandemic are still found in potent levels among people in their 90s and even those older than 100 years, he said. “The 2009 H1N1 hemaglutinin possesses what are essentially some of the 1918 hemaglutinin antigenic sites, thus facilitating cross-reactive immunity of elderly antibodies to both the early 20th century flu viruses and the 2009 pandemic virus.”
In the United States, Stephen Redd, MD, director of the Influenza Coordination Unit at the Centers for Disease Control (CDC), outlined the pillars of attack against influenza – either seasonal or H1N1 – which are based on enhanced surveillance, vaccination, state and local support, medical care and countermeasures, community mitigation measures, and communication though the media. He also noted the Food and Drug Administration’s (FDA) decision in October to allow for the emergency use of the investigational intravenous antiviral paramivir for the treatment of influenza.
The current response to H1N1 has been marked by a lesser than expected supply of vaccine, at least initially. But even when vaccine is available, motivating people to get immunized against influenza is not always easy, said Bruce G. Gellin, MD, MPH, deputy assistant secretary for health and director of the National Vaccine Program Office at the U.S. Department of Health and Human Services. While polling suggests worries about catching influenza have increased, from 39 percent of respondents expressing such concerns in August 2009 to 51 percent in October 2009, Dr. Gellin said health care professionals still have to deal with those who avoid influenza vaccination.
The government’s goal is “to vaccinate as many persons as quickly as possible,” Dr. Gellin said. “During initial limited availability, the goal is to target those at higher risk for influenza-related complications and infections.” He also noted recommendations encouraging local flexibility and decision-making for expanding the target to larger population groups.
While H1N1 may currently be generating more attention, seasonal influenza remains a concern and “causes a substantial disease burden,” said Kathleen Neuzil, MD, PhD, an associate professor of medicine at the University of Washington, in a symposium on seasonal influenza.” She noted that vaccination rates for influenza remain low for a number of reasons, including public perception that influenza isn’t a serious disease. Efforts are being made to improve production of vaccines to make them easier to produce and more effective, she said.
One problem with seasonal influenza appears to be resistance to M2 inhibitors and/or neuraminidase inhibitor oseltamivir, said Larisa Gubareva, MD, PhD, with the influenza division at CDC’s National Center for Immunization and Respiratory Diseases. To combat seasonal influenza, researchers will need to develop new antivirals and combinations of antiviral medications. “We also need enhanced surveillance and improved methods for drug resistance monitoring,” she said. In addition, Dr. Gubareva cited a need to determine the clinical relevance of laboratory-detected resistance of antiviral medications.
Audio and synchronized speaker slides from sessions at the 2009 IDSA Annual Meeting are available for purchase online.
Understanding Opposition and Barriers to Vaccination
Today’s anti-vaccine movement had its impetus in one event in the early 1980s, according to immunization advocate Paul Offit, MD: a television show that aired in Washington, D.C., in 1982 called “DPT Vaccine Roulette.” Dr. Offit, chief of infectious diseases and director of the Vaccine Education Center at Children’s Hospital in Philadelphia, shared this conclusion during a presentation at the opening plenary session of the 47th Annual Meeting of IDSA, one of several sessions that addressed immunization issues.
Based on the belief that their children had suffered permanent harm from the pertussis vaccine, Dr. Offit said, a small group of advocates, featured in that program, “were ultimately able to gather a grassroots group of parents who were very media savvy, who were politically connected. Any time a new vaccine was introduced from that point, they were very good about getting media access.”
The movement that followed has contributed to outbreaks of pertussis in 2006, measles in 2008, and recent deaths from Haemophilus influenzae, all of which occurred in undervaccinated groups, Dr. Offit suggested. But after 25 years of attacks on science, the pendulum may be swinging back, he said, as people pay more attention to protecting their children through vaccination rather than withholding their children from vaccination because of unproven claims.
Obstacles to vaccination, however, come not only come from parents – usually well-educated, and upper middle-class – but sometimes from physicians as well, said Marietta Vazquez, MD, assistant professor of pediatrics at Yale University School of Medicine in New Haven, Conn., and an oral abstract session presenter. In a matched case-control study, researchers found that vaccinating pregnant mothers against influenza reduced the risk of hospitalization of their infants within six months of birth.
As part of the study, researchers also interviewed parents to determine their risk factors for influenza. “When we asked pregnant women about why they didn’t get [influenza] vaccinations,” Dr. Vazquez said, “what we found, in large strokes, was that obstetricians do not offer influenza vaccine.”
William Schaffner, MD, FIDSA, professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn., and chair of IDSA’s Immunization Work Group, has observed the same phenomenon. “We find that obstetricians are not used to vaccinating,” Dr. Schaffner said. “Their office staff doesn’t know how to order the vaccine. They are uncomfortable with billing procedures and all that paraphernalia: how you keep the vaccine safe, what’s the temperature of the refrigerator.”
In a “Meet the Professor” discussion at the meeting, Dr. Offit noted that his hospital’s vaccine education program was developed, in part, in response to a doctor who questioned vaccination. “When we created our vaccination center, we wanted to educate young parents through doctors,” he said, “but we also wanted to educate young doctors at the same time.”
The reason some in both groups are not compelled by vaccination may be the same, Dr. Offit suggested: “They don’t see those diseases, didn’t grow up with those diseases, and for them, it has become a matter of faith.”
During a symposium on controversies in infection control, Thomas R. Talbot, MD, MPH, assistant professor of medicine and preventive medicine at Vanderbilt University, gave a review of states’ vaccination requirements for school entry. All 50 states have medical exemptions for parents to opt out of such requirements for their children, Dr. Talbot said, while 48 states have religious exemptions, and 21 have philosophical/personal belief exemptions.
In a review of state vaccination laws, Dr. Talbot noted that declination rates in those states that allowed personal belief exemptions from school-entry requirements rose from 0.99 percent in 1999 to 2.54 percent in 2004. In contrast, those states allowing only medical and religious exemptions noted no increase in declination rate (1.0 percent for both years).
In the case of influenza, reluctance among some physicians and other health care workers (HCWs) to support immunization—and the risk that these workers will spread influenza to patients—are two of the reasons that many hospitals and health systems are implementing mandatory influenza vaccination programs for HCWs—a move supported by IDSA (see related IDSA News story).
“Health care worker influenza vaccination has been recommended for several decades, but voluntary programs overall have not been effective at markedly improving rates,” Dr. Talbot said. “Mandating does increase vaccination rates. The argument regarding patient safety must be pushed.”
A poster presentation, meanwhile, shared the results of a survey at a large children’s hospital that helps shed light on how one institution’s physicians, nurses, and allied HCWs feel about influenza immunization. The survey found that physicians were more likely than the other two worker groups to favor mandatory vaccination against influenza for HCWs, said Mary Anne Jackson, MD, FIDSA, chief of the section of infectious diseases at Children’s Mercy Hospital & Clinics and professor of pediatrics at the University of Missouri in Kansas City School of Medicine. Nurses were the next most likely group to support such policies, followed by allied HCWs.
Even among doctors, myths and misperceptions about influenza vaccination persisted, the survey found. These included the mistaken belief that a person who is not showing influenza symptoms could not transmit influenza to patients, Dr. Jackson said. These knowledge gaps were more common among nurses and allied HCWs than among doctors.
The survey also examined workers’ attitudes about vaccinating their children against influenza and other diseases. “Most of the health care workers who had children had immunized them, but not against influenza,” Dr. Jackson said. According to the survey results, allied health care workers believed that it should be up to the parent to decide which vaccine a child should receive.
Audio and synchronized speaker slides from sessions at the 2009 IDSA Annual Meeting are available for purchase online.
Preventing HIV Infection, Managing Drug Interactions
Current or proposed clinical trials involving more than 20,000 volunteers around the world will soon help answer important questions about the use of pre-exposure prophylaxis (PrEP) to prevent sexual HIV transmission. That was the message of Myron S. Cohen, MD, FIDSA, professor of medicine, microbiology, and public health at the University of North Carolina at Chapel Hill, during the “State of the Art in HIV Treatment” symposium at the 47th Annual Meeting of IDSA in Philadelphia. Encouraging results in animal studies to date have led to great interest in this approach and its potential to slow the HIV/AIDS pandemic.
One of the research efforts, the Global iPrEx study, is an ongoing Phase III trial determining whether the use of a single daily antiretroviral pill, emtricitabine/tenofovir disoproxil fumarate, can prevent HIV infection among a population of approximately 2,400 adult men who have sex with men. The trial includes sites in the United States, Peru, Ecuador, Brazil, South Africa, and Thailand.
Other studies are examining the use of topical antiretroviral gels to prevent infection in women. A Phase IIb trial of a tenofovir gel in South Africa, involving 980 women, has been ongoing since 2007, Dr. Cohen said, and results are expected in 2010. Another strategy currently in Phase I and II trials uses a vaginal ring impregnated with an antiviral agent, dapivirine, allowing the drug to be delivered over as many as 30 days, potentially offering extended protection from HIV infection and the possibility of combining birth control drugs in the same device.
Dr. Cohen also discussed the use of antiretrovirals to prevent infection post-exposure and the concept of using of HIV treatment of infected individuals as a preventive tool, in addition to aggressive “test and treat” efforts at the community level. Antiretroviral agents will be used as part of prevention efforts, he predicted, but precisely how, for whom, and with what degree of benefit are questions that remain to be answered by further research. “These are the unknowns that will be resolved in the next five years,” Dr. Cohen added.
Drug Interactions and Antiretrovirals
For clinicians managing patient treatment with antiretroviral drugs, the interaction of these agents with other medications can pose challenges. Another symposium presenter, Adriana Andrade, MD, MPH, assistant professor at Johns Hopkins University in Baltimore, offered several management strategies, such as taking a full medication history, including leftover medications a patient may still have in the medicine cabinet. “The only way to stay ahead in the drug interaction game is to know what your patients are taking,” Dr. Andrade said.
Some interactions are predictable and hard to miss—the interaction between protease inhibitors and statins, for example—but others can be more unexpected, Dr. Andrade noted, such as interactions between atazanavir/ritonavir and tenofovir. While it’s impossible to memorize every possible drug interaction, it can be helpful to remember metabolic inducers or inhibitors, simplify by remembering broad drug classes, and look up specific interactions if you are planning to use an inducer or inhibitor.
It’s also important to keep an eye on the literature each month for new information about possible interactions, Dr. Andrade said. A stepwise approach can also involve a thorough patient medication history, the use of pocket reference guides, and consulting drug information resources online, such as the AIDSinfo website at the U.S. Department of Health and Human Services. IDSA also offers a service that forwards ID-related messages from the Food and Drug Administration (FDA) on adverse events and other safety information on FDA-approved drugs and biologics. To subscribe, click here.
Audio and synchronized speaker slides from this session and others at the 2009 IDSA Annual Meeting are available for purchase online.
Self Tests for HIV May Be Possible, Opt-Out Testing Has Lifesaving Potential
With more than 200,000 people in the United States living with HIV and not knowing it, the expanded use of HIV testing can connect people with the care they need earlier, when treatment is most effective. Two presenters at the 47th Annual Meeting of IDSA in Philadelphia shared findings highlighting this theme, including the possibility of having people perform their own HIV tests.
In one study, presented during an oral abstract session, investigators asked adult patients in an emergency room setting whether they would be willing to test themselves for HIV, using either an oral fluid or a finger stick test, while waiting for the lab results of an HIV test administered by a health care worker (HCW). Of the 440 patients who were approached, 402 agreed to do so. The self-test results were 99.5 percent accurate when compared with results of the tests performed by HCWs. More than 90 percent of the patients who tested themselves said they would definitely or probably recommend self-testing to a friend.
The findings suggest that an over-the-counter home test for HIV may be possible, said Charlotte A. Gaydos, MS, MPH, DrPH, FIDSA, one of the study’s authors and a professor of medicine at Johns Hopkins University in Baltimore. However, more research will be needed to examine how individuals might react to a positive result from such a test, including seeking a confirmatory positive test and HIV care, Dr. Gaydos noted.
An analysis using computer modeling, meanwhile, suggests that changes in state laws governing HIV testing could save thousands of lives by encouraging earlier diagnosis and treatment. Presented at an oral abstract session, the study quantified anticipated gains in life expectancy if states that currently require opt-out HIV testing, in which patients must provide explicit consent to be tested, instead passed opt-in testing laws, which allow automatic testing unless a patient refuses. More than 600,000 life years could be saved during the lifetime of the current U.S. population if all states adopted opt-in testing, according to the study’s projections, which used data from the U.S. Centers for Disease Control and Prevention (CDC).
“We believe opt-in consent laws are an outdated legacy of the early HIV epidemic, during which informed consent was prioritized over case detection because no treatment was available,” said Michael D. April, DPhil, MSc, a medical student at Harvard Medical School in Boston and an author of the study. He urged legislators in opt-in states to consider the study’s results and revise their consent laws to promote opt-out testing to help diagnose individuals sooner and connect them with care and treatment.
Audio and synchronized speaker slides from sessions at the 2009 IDSA Annual Meeting are available for purchase online.
Powerful Film Chronicles Early Days of AIDS Pandemic
There was a point when AIDS activist Cleve Jones of San Francisco retired to a small hamlet on the Russian River in northern California and waited to die.
Today, Jones is alive and well. He survived the dark days of the AIDS pandemic in the late 1980s and early 1990s thanks to combination antiretroviral therapy. But those dark days haunt him still: “There are times when I am going to bed to sleep and suddenly it comes back to me with such clarity that I feel that I am falling backwards off a cliff. Those faces start to come back again and it’s just unbearable.” He tears up. “I have to stop.”
Jones is one of the voices that AIDS expert Paul Volberding, MD, FIDSA professor of medicine at the University of California, San Francisco, included in his documentary film, “Life Before the Lifeboat: San Francisco’s Courageous Response to the AIDS Outbreak.” A packed audience at the 47th Annual Meeting of IDSA was treated to the premiere showing of the film, presented by Dr. Volberding as part of the Edward H. Kass Lecture. The moving film and Dr. Volberding were accorded a minute-long standing ovation by an audience that included many people who dabbed away tears themselves as they cheered the film.
“I thought that in doing this lecture I would interview a few of the voices that are still with us to get a sense of what it seemed like to them when they were at the front lines of the epidemic,” Dr. Volberding said. Instead of bringing the people with him to Philadelphia, he raised funds and made a documentary that was shot in San Francisco.
In the film, Dr. Volberding elicits comments from activists such as Jones, physicians, health department administrators, politicians, nurses, and others who reacted to the epidemic, sometimes changing hospital rules to offer compassion when compassion was the only commodity available to patients before advances in antiretroviral therapy.
“The patients were exactly our age,” he said. “They had gone to the same schools; they listened to the same music; they went to the same restaurants. They were really us. It added to the commitment of all of us, but it added to the stress as well.”
During the film, a reporter interviews Dr. Volberding, who says his goal is to turn HIV/AIDS infection from a rapid, heart-wrenching death into a chronic disorder, a goal achieved for many patients due to advances in treatment.
“There were so many people that were part of the early response to AIDS—many of whom are no longer with us,” Dr. Volberding said, including AIDS pioneer Merle A. Sande, MD, FIDSA and a past president of IDSA, who passed away in 2007. “Before we lose many more of those voices and memories, I thought it was important to preserve history in the words of those who lived it—day to day—during the onset of the AIDS epidemic.”
To tell the story, Dr. Volberding collaborated with film director and producer Shipra Shukla of Kathaka Films. Shukla features Dr. Volberding with many of the AIDS pioneers of the early ’80s and tells their stories through reflective conversations. The documentary incorporates photos, footage, and journal entries of those who died of AIDS, chronicling and preserving San Francisco’s history. Among others, the film includes conversations with Mervyn Silverman, former head of San Francisco’s Department of Public Health, and Ambassador Eric Goosby, MD, the State Department’s Global AIDS Coordinator.
Audio and synchronized speaker slides from sessions at the 2009 IDSA Annual Meeting are available for purchase online.
Gram-Negative Resistance Grows at Frightening Pace
Although we are not yet in a “post antibiotic era,” untreatable gram-negative resistant infections are occurring with greater frequency, emphasizing the need for quick action to control these pathogens. Arjun Srinivasan, MD, an epidemiologist with the U.S. Centers for Disease Control and Prevention (CDC), shared this perspective during a symposium outlining the growing problem at the 47th Annual Meeting of IDSA in Philadelphia.
Data from a recent CDC analysis underscored the threat and showed a continuing increase in resistance among gram-negative strains to antimicrobials in four classes (beta-lactams, quinolones, aminoglycosides, and carbapenems) compared to previous data. At the symposium, Dr. Srinivasan presented parts of this analysis, which was based on data collected through CDC’s National Health Safety Network from more than 400 hospitals in 45 U.S. states from January 2006 to January 2009.
The analysis included four infection types: ventilator-associated pneumonias, central-line associated bloodstream infections, catheter-associated urinary tract infections, and surgical site infections.
Among the findings, 30 percent of Acinetobacter baumannii isolates reported to the network tested resistant to all agents in all four drug classes, an increase from approximately 16 percent of isolates reported in 2004. “We now stand at a place where a third of all the acineobacter isolates causing these health care-associated infections, at least in our data, are resistant to all the frontline therapies,” Dr. Srinivasan said.
A poster presentation described a similar trend involving an older and infrequently used class of antibiotics, polymyxins, that recently more clinicians have come to rely on for treating gram-negative resistant bacteria. The research found a 50 percent increase in resistance to polymyxin B over a two-year period among three gram-negative bacteria species at a New York hospital. In addition, 75 percent of the organisms studied were resistant to at least three classes of antibiotics, while 30 percent were resistant to five or more classes, reported Jason Kessler, MD, clinical fellow in the division of infectious diseases at Columbia University in New York.
In his presentation, Dr. Srinivasan noted that gram-negative resistant infections are not limited to certain parts of the country or specific types of facilities: Four-class resistant acineobacter isolates, for instance, came from 23 different states, while isolates resistant to drugs in three of the classes were reported in 28 states.
The emerging trend of increasing resistance to carbapanem shown by Klebsiella pneumoniae is particularly frightening, Dr. Srinivasan said. In CDC’s analysis, 10 percent of K. pneumoniae isolates, reported from 11 states, showed carbapanem resistance, compared with less than 1 percent of reported klebsiella isolates in 2000. The increase helps demonstrate the epidemiology of KPC-producing organisms, Dr. Srinivasan added, including their ability to disseminate very quickly, within individual hospitals and throughout the country.
The troubling statistics highlight the need for action to address gram-negative resistant pathogens, including broad and aggressive use of infection control measures, Dr. Srinivasan concluded, in addition to raising awareness among the public and policymakers about the growing problem.
Several speakers echoed these concerns at a press conference and highlighted IDSA’s efforts to address the threat of drug-resistance on several fronts, including antimicrobial stewardship, infection control, and stimulating the development of new antimicrobial agents. “Antibiotic development is dying, and we’re running out of drugs,” said Brad Spellberg, MD, FIDSA, a member of IDSA’s Antimicrobial Availability Task Force and an associate professor of medicine at the University of California-Los Angeles. “We have organisms that are already resistant to every antibiotic we can throw at them. It’s already being seen.”
A recent article and accompanying editorial in the Journal of the American Medical Association underscore the growing problem. In an international study, researchers found that infections, including those caused by drug-resistant gram-negative organisms, are common in intensive care units worldwide and associated with increased risk of hospital death.
To address the urgent threat of antimicrobial resistance around the world, IDSA in November called on U.S. and European Union leaders to commit to developing 10 new antibiotics by 2020, known as the 10 X ’20 Initiative (see related IDSA News story). The new initiative follows an agreement by U.S. and European political leaders to establish a transatlantic taskforce to help address the global crisis posed by resistance. For more information about the Society’s efforts to address antimicrobial resistance, see IDSA’s website.
Audio and synchronized speaker slides from sessions at the 2009 IDSA Annual Meeting are available for purchase online.
Increased Resistance Complicates UTI and SSTI Treatment
The growth of antibiotic resistance continues to complicate the treatment of common community-acquired infections, including urinary tract infections (UTIs) and skin and soft tissue infections (SSTIs), according to presenters at a symposium during the 47th Annual Meeting of IDSA.
While several regimens are currently available for the empiric treatment of acute uncomplicated cystitis (AUC), many clinicians are likely to use a fluoroquinolone, such as ciprofloxacin, because it is well tolerated and highly effective, said Thomas M. Hooton, MD, FIDSA, professor of clinical medicine at the University of Miami. But increasing rates of fluorquinolone resistance, reported in several U.S. and European studies, have highlighted the need for antimicrobial stewardship to preserve these drugs while they are still effective in treating UTIs, which affect at least 60 percent of adult women at some point in their lifetime.
Updated IDSA guidelines for the diagnosis and management of uncomplicated UTIs, currently in draft form, will likely stress that there is no single best agent to treat acute cystitis but will emphasize the need to limit the use of fluorquinolones, Dr. Hooton said. The guidelines will also likely suggest that clinicians consider effectiveness, antimicrobial resistance, potential for “collateral damage,” adverse effects, and specific patient factors, such as allergy history, in empiric treatment decisions.
Another presenter, Donald E. Low, MD, microbiologist-in-chief at Mount Sinai Hospital in Toronto, addressed resistance levels for SSTI methicillin-resistant Staphylococcus aureus (MRSA) infections, and at what point these levels in a community should change therapy recommendations. Although surgical drainage may be sufficient for patients with uncomplicated SSTIs, appropriate therapy is associated with better outcomes in those with complicated infections.
While acknowledging the lack of guidance on the subject, Dr. Low suggested that rates of MRSA as a cause of complicated SSTIs in a community greater than 10 percent warrant a change in empirical therapy.
Even with appropriate treatment recommendations in place, however, educating physicians and other health care workers on the front lines remains a challenge. A recently published retrospective analysis of community-acquired and health care-associated USA300 MRSA infections in a Detroit hospital found that approximately 36 percent of patients with these infections were empirically treated with a drug inactive against USA300. “The message is obviously not getting out there to front-line physicians in centers where this is a major problem,” Dr. Low said.
The USA300 strain is also posing clinical challenges in other situations, as shown in a poster presentation at the meeting. The research found that patients admitted to the hospital with community-acquired invasive pneumonia caused by USA300 were at higher risk of early complications —but not of death—than patients with invasive pneumonia due to the USA100 strain. Fernanda Lessa, a medical epidemiologist with the Centers for Disease Control and Prevention (CDC), said the increased virulence caused by USA300 in otherwise healthy patients was a concern, along with the strain’s increasing movement from the community to the health care setting.Audio and synchronized speaker slides from sessions at the 2009 IDSA Annual Meeting are available for purchase online.
Using Electronic Tools and Health Records in ID
A “Meet the Professor” session at the 47th Annual Meeting of IDSA offered a practical approach to health information technology from two presenters who use some of these electronic tools on a daily basis in their infectious diseases practices.
Using online or e-mailed versions of journal tables of contents, keeping PDFs of journal articles rather than print copies, and using searchable drug interaction databases were among the ways to use electronic tools highlighted by Steven D. Burdette, MD, associate professor of internal medicine at Wright State University in Dayton, Ohio. He also urged caution when looking up recommendations, treatment guidelines, and other medical information on the web. “You’ve just got to be very careful when you do your searches what the source of the information is,” said Dr. Burdette.
Steven K. Schmitt, MD, FIDSA, a staff physician in the Department of Infectious Diseases at Cleveland Clinic, shared advice for how to select an electronic health record (EHR) system. Multiple forces are driving the greater use of these systems, Dr. Schmitt noted, including inefficiencies and duplication, illegibility of orders and notes, concerns over medication errors, record portability, and communication and billing issues, in addition to external forces, such as quality improvement initiatives and pay-for-performance measures.
The American Academy of Family Physicians offers an online reference that includes a list of common functions to help practices organize their priorities before writing requests for proposals for an EHR system. Later in the selection process, other steps can help guide the decision. These include viewing demonstrations from vendors; ranking vendors in terms of cost, function, and service; and checking references. Visiting other sites currently using the same systems can help as well. “There’s nothing like seeing it in action,” Dr. Schmitt said.
The work doesn’t stop once you choose an EHR system. You will need time to refine new work flows, get buy-in from staff, and customize the system for your particular practice or institution, Dr. Schmitt said, in addition to setting aside time for staff training. Additional computers and software, support and maintenance personnel, and extra space are other possible needs.
While EHR systems offer benefits, there can be unintended consequences, including the distraction they sometimes create in the doctor-patient relationship. The additional typing, pointing, and clicking can reduce eye contact between patient and doctor, Dr. Schmitt noted. He also advised clinicians to avoid the tendency to cut and paste information, which can perpetuate incorrect information in records, highlighting the need to verify and update data.
In addition, electronic systems can also push some functions traditionally performed by ancillary staff to the physician, potentially adding time to the workday without additional compensation. “It’s very easy to become an army of one with your computer and your mobile device,” Dr. Schmitt said.
Regulations are another factor driving greater use of electronic tools. Federal legislation passed in 2009 includes financial incentives to implement EHR systems for physicians who treat Medicare patients. For more information, visit the U.S. Department of Health and Human Services website. More information about how to integrate health information technology into your practice, including an EHR comparison tool developed by the American College of Physicians, is available at www.idsociety.org/healthit.htm. (You must be logged in to access this page.)
Audio and synchronized speaker slides from sessions at the 2009 IDSA Annual Meeting are available for purchase online.
New TB Drugs on the Horizon, But TB and HIV/AIDS Challenges Remain
The medical landscape for diagnosing and treating tuberculosis (TB) could change dramatically in the coming years, with new tests and better drugs paving an easier path for TB treatment and care, according to William Burman, MD, a TB specialist and a professor of medicine at the University of Colorado in Denver, who spoke at the 47th Annual Meeting of IDSA.
“We could have new TB drugs approved by 2011,” said Dr. Burman, a member of the Center for Global Health Policy’s Scientific Advisory Committee. Two drugs currently in the pipeline look particularly promising for TB treatment because they work in new ways and appear to be very potent. Those drugs and other research developments have the potential to “revolutionize the treatment of multidrug-resistant tuberculosis,” Dr. Burman said. “We can start to see the outlines of major improvement for TB treatment for patients,” with shorter and possibly safer therapy, too.
But the scope of the TB threat is still grave, he said, with 9 million new TB cases a year and more than 1 million deaths. “The message is that this is a time of great need,” Dr. Burman said. “It’s also a time of great opportunity.”
At a symposium on HIV and TB, Richard Chaisson, MD, professor of medicine, epidemiology, and international health at Johns Hopkins University in Baltimore, detailed the “deadly synergy” between HIV/AIDS and TB, noting that TB incidence doubles in the first year following HIV seroconversion and that TB is associated with an increased risk of death in HIV-positive patients. Dr. Chaisson said better intensified case finding for TB is critical, along with better TB prevention and treatment strategies.
Another presenter, Gerald Friedland, MD, professor of medicine and epidemiology at Yale University in New Haven, Conn., described the current threat of drug-resistant TB. He said the extent of multidrug-resistant and extensively-drug resistant TB is unknown because of poor diagnostic capabilities, and he highlighted the need to provide community-based treatment of drug-resistant TB to reduce transmission and reduce high rates of mortality.
In a symposium on HIV in the developing world, Eric Goosby, MD, the U.S. global AIDS coordinator, described efforts to transform PEPFAR, the U.S. President’s Emergency Plan for AIDS Relief, from an emergency response initiative to one that focuses on building sustainability and country ownership. Dr. Goosby also outlined the administration’s focus on strengthening health systems and how HIV/AIDS fits into the plans for a new six-year $63 billion Global Health Initiative. The economic crisis made robust scale up of PEPFAR funding “impossible,” said Dr. Goosby, who spoke of the need to engage key U.S. allies for a more collaborative international effort against global AIDS.
Two other HIV/AIDS experts said the gains made in the last decade against this deadly pandemic are tenuous, and developing countries could all too easily lose ground if leadership and resources wane. “We’ve progressed from a situation of calamitous magnitude to one that’s extremely serious,” said Mark Cotton, MD, a professor of medicine at Stellenbosch University in South Africa. “And that progress is very fragile.”
Dr. Cotton, a pediatrician, detailed the difficulties of treating HIV in infants and children. Many South African physicians and nurses are afraid to do it, he said, because of the complexities of diagnosis and the lack of appropriate drug formulations for children. Some key antiretroviral drugs are not well tolerated by children due to their bad taste combined with an inability to substitute due to a lack of alternatives. Researchers need to focus urgent attention on developing new drugs and easier formulations for children, he said.
Another South African HIV specialist, Quarraisha Abdool Karim, MD, with the Centre for the AIDS Programme of Research in South Africa, discussed the difficulties in HIV prevention efforts, particularly among women. She said there is no magic bullet, and physicians must rely on combination strategies to curb the pandemic.
Audio and synchronized speaker slides from sessions at the 2009 IDSA Annual Meeting are available for purchase online.
A Special Thanks to all the supporters of the 47th Annual Meeting of IDSA
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EIN Update: Intestinal Complications, Oseltamivir, and H1N1
The Emerging Infections Network (EIN) is a forum for infectious diseases consultants and public health officials to report information on clinical phenomena and epidemiological issues with public health significance. Any diagnostic or therapeutic recommendations and all opinions presented are those of the individual contributor. They do not necessarily represent the views of EIN, IDSA (EIN’s sponsor), or the Centers for Disease Control and Prevention (CDC), which funds the EIN. The reader assumes all risks in using this information.
As this challenging influenza season continues, EIN members are asking about intestinal complications possibly related to novel H1N1 influenza and the effects of oseltamivir. Starting a recent discussion, a member from Ohio shared the case of a 5-year-old child who recently died after being hospitalized with a PCR-confirmed case of H1N1.
“My understanding is the child had improved to the point that discharge was considered,” the member wrote. “He then rapidly deteriorated and died. [A] post-mortem exam found 700 mL of dark brown fluid in the abdominal cavity. It seems difficult to believe the processes are unrelated, but I find nothing in the literature about an association.” Other details from the autopsy were not yet available, the member reported.
A respondent from Texas described a 4-year-old who tested positive for influenza at an outside hospital using a rapid test, was started on oseltamivir, and “presented to us with very severe colitis on day four of [oseltamivir]. He was in DIC [disseminated intravascular coagulation] and ultimately required surgery and colostomy due to necrosis of [the] bowel. We did a full workup and never isolated any bacterial or viral pathogen.”
Other EIN members shared related cases, including a respondent from Washington state, who described a 55-year-old man who tested positive for H1N1 but had no prior medical problems. The patient had sudden onset of malaise, diarrhea, and confusion. On admission, “he had a severe lactic acidosis and was found to have a severely ischemic colon requiring partial colectomy,” the member wrote.
A respondent from New York told of a 32-week-old infant born to a mother with fulminant and lethal H1N1. The infant developed a perforation requiring colostomy. “The mother was treated with oseltamivir, the infant was not,” the member wrote. “Despite the presumed high level viremia in the mother at the time of the infant's emergent birth, we never detected influenza from the newborn. The perforation was thought to be secondary to the intrauterine hypoxemia during the time the mother could not be effectively oxygenated/ventilated.”
A final case was shared by a member from San Diego: a 55-year-old women with confirmed H1N1 who died after three weeks. While on extracorporeal membrane oxygenation (ECMO), the patient deteriorated suddenly “with abdominal distention and elevated lactic acid of 6.3. The patient was on oseltamivir and had just received one dose of peramivir.” A chest X-ray at that time did not show air under the diaphragm, but did show pneumopericardium and pneumomediastinum. A postmortem analysis was not done.
The reports of intestinal perforation in children with H1N1 who had received oseltamivir suggest a need for more investigation, a California respondent wrote. The member suggested submitting a report to MedWatch, the Food and Drug Administration’s (FDA) safety information and adverse event reporting program. (To report an adverse event to MedWatch, visit this website or call 1-800-332-1088.)
Distinguishing between hemorrhagic colitis and ischemic colitis is important, a member from Maryland responded, noting the possibility that H1N1 “may be associated with ischemic colitis—it seems to be associated with pulmonary embolism.” The member cited a July 2009 MMWR Dispatch reporting that five out of 10 H1N1 patients in a Michigan intensive care unit had pulmonary embolism.
Oseltamivir, meanwhile, may be associated with hemorrhagic colitis and a mild coagulopathy, the member continued, citing a 2009 article in Cardiology on the influence of the antiviral on the risk of stroke after influenza infection. A member from Texas posted another reference, a 2007 Journal of Infection and Chemotherapy article describing acute hemorrhagic colitis associated with oral administration of oseltamivir for influenza.
In a separate discussion, an EIN member from Pennsylvania raised a question about the expanded use of oseltamivir: “Now that we are using unprecedented quantities of this drug, has anyone noted any associations between oseltamivir and hepatocellular injury?”
The member was aware of two adults in the past few months with unexplained increases in aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) that began after hospitalization with influenza-like illness (ILI), although neither was confirmed via rapid testing to have influenza. “In both cases, enzymes increased after admission/initiation of oseltamivir and improved after medication stopped/illness subsided,” the member wrote. “One patient had a history of liver transplantation; however, her lab abnormalities resolved too quickly to prompt a liver biopsy.”
A respondent from Washington state noted a similar association of ILI with abnormal liver enzymes in his area. “I am not sure if it relates to [oseltamivir] or the underlying ILI/H1N1 influenza,” he wrote. A 2006 commentary from the American Journal of Pathology discusses systemic viral infections and collateral liver damage, the member added.
In light of the current H1N1 pandemic, IDSA convened a group of influenza experts to address a number of clinical questions about the clinical management and antiviral treatment of patients with H1N1 influenza. This group is developing a Frequently Asked Questions document that will be available soon on the IDSA website.
E-mail the Emerging Infections Network.
The Emerging Infections Network (EIN) is a provider-based sentinel network designed to help the public-health community detect trends in emerging infectious diseases.
A joint project of IDSA and the Pediatric Infectious Diseases Society (PIDS) with funding from the Centers for Disease Control and Prevention (CDC), EIN tracks emerging infectious diseases and keeps the public-health community up to date with new disease trends, difficult cases, and other issues affecting members’ clinical practices. The Network provides a great opportunity for members to share knowledge quickly across large geographical distances. Both IDSA and PIDS members are eligible to join. Click here for more information or to join EIN.
Drug Approvals, Recalls, Adverse Events Update
IDSA offers two e-mail services to help members stay informed of updates from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Content normally includes a range of topics, including new drug approvals and warnings. Recent alerts have included:
IDSA members can sign up for these services online. (You must be logged in to have access to this link.)
Is Your Facility Experiencing Antibiotic Shortages?
Report these to FDA and IDSA.
Medicare Disburses Incentive Payments for 2008 PQRI
New ID Measures and Reporting Options Also Available for 2010
The Centers for Medicare and Medicaid Services (CMS) recently announced that over 85,000 physicians and other providers who reported on accountability measures through the 2008 Physician Quality Reporting Initiative (PQRI) received incentive payments totaling more than $92 million. If you reported on these measures, click here for instructions on how to obtain your 2008 PQRI feedback reports.
For 2010, several new accountability measures and reporting options will be added to the PQRI. These include four additional HIV/AIDS measures and measures group reporting options for both the HIV/AIDS and hepatitis C measures. These changes should enhance the ability of infectious diseases physicians to earn a 2 percent incentive payment under Medicare beginning next year.
Next year, Medicare will still not allow claims-based reporting of the HIV/AIDS measures—individual HIV/AIDS measures and the proposed measures group must be reported through a PQRI-qualified registry. However, given that Medicare is likely to transition away from claims-based reporting over the next few years, it is probably preferable to report through a registry.
To view the requirements for reporting and a full list of ID related measures, click here. For more information on the PQRI program, visit www.cms.hhs.gov/pqri.
Deadline for Identity Theft Policies Extended to June 1, 2010
Physician practices now have until June 1, 2010 to set up policies to protect against patients’ identity theft under a new Federal Trade Commission (FTC) rule. The rule was originally scheduled to go into effect May 1, 2009 (see the April issue of IDSA News), but the deadline has been extended several times to give creditors (including physicians) and financial institutions more time to develop and implement written identity theft prevention programs. Click here for an explanation of the rule and a sample compliance policy.
New Medicare Resource Answers H1N1 Vaccine Billing Questions
Medicare recently released a new educational resource for providers with billing questions related to the novel H1N1 influenza vaccine. The Medicare fee-for-service question-and-answer document is available here.
Global Center Releases Issue Brief on Broad Benefits of HIV/AIDS Response
The Center for Global Health Policy, working in conjunction with amfAR, The Foundation for AIDS Research, has published a new issue brief documenting how the international response to the HIV/AIDS pandemic has transformed global health financing and programming. The new report—titled “Smart Investments in AIDS and Global Health: Building on What Works” and released the week of World AIDS Day, Dec. 1—details how the rollout of HIV/AIDS treatment and prevention programs has begun to change the trajectory of the pandemic and has yielded significant benefits beyond HIV/AIDS, creating new health care infrastructure and catalyzing policy changes across the developing world.
The report comes amid signs that the U.S. government is considering a slowdown in the scale-up of global AIDS funding, a move that would have adverse impacts on both the response to HIV/AIDS and broader efforts to advance global health. The report says that policymakers now have an opportunity to leverage the success of the AIDS response by using accelerated scale-up of HIV/AIDS prevention and treatment as a platform on which to build broader and more sustainable health care capacity in low- and middle-income countries.
Read more about the Center’s new issue brief and other global health news at the Center for Global Health Policy’s blog, sciencespeaks.wordpress.com.
IDSA Joins Stop TB Partnership’s TB/HIV Working Group
The Stop TB Partnership has made IDSA an organizational member of its TB/HIV working group, a reflection of IDSA’s increasingly visible work on these twin global health threats.
Housed within the World Health Organization (WHO), the Stop TB Partnership was formed more than a decade ago as a network of international organizations, donors, and governmental and non-governmental groups—all committed to eliminating the deadly scourge of TB. The partnership has seven working groups to focus energy and attention on specific challenges in fighting TB, including drug-resistant TB, new TB drugs, and expansion of the Directly Observed Therapy Short-Course (DOTS) treatment strategy.
IDSA’s membership in the TB/HIV working group will provide a new way to advocate for improvements in policies and programs designed to combat these two epidemics, which have formed a deadly synergy that threatens to unravel gains in treating HIV. Christine Lubinski, IDSA vice president for global health, will serve as IDSA’s representative on the TB/HIV working group.
In ratifying a proposal to accept IDSA, the partnership noted IDSA’s recent work on co-infection through its Center for Global Health Policy. In particular, the partnership drew attention to the Global Center’s call for a presidential initiative on TB and for a comprehensive strategy to combat HIV/TB co-infection, as detailed in its issue brief, “Deadly Duo: The Synergy Between HIV/AIDS & Tuberculosis.” For more information about the Stop TB Partnership, visit this website.
IDSA, Other Experts Urge White House to Modify H1N1 Guidance for Health Care Workers
IDSA joined the Society for Healthcare Epidemiology of America (SHEA) and the Association for Professionals in Infection Control and Epidemiology (APIC) in November in urging the Obama administration to update current federal guidance concerning the use of personal protective equipment (PPE) by health care workers (HCWs) in treating suspected or confirmed cases of 2009 H1N1 influenza.
In a letter to the White House, the three groups also urged the administration to issue an immediate moratorium on the Occupational Safety and Health Administration’s (OSHA) enforcement of the current requirements. As expected, OSHA on Nov. 20 released a compliance directive, which lays out OSHA enforcement procedures that follow current recommendations from the Centers for Disease Control and Prevention (CDC).
CDC's recommendations, issued in October as interim guidance, state that workers in close contact with influenza patients should wear N-95 respirators, rather than standard surgical masks. However, CDC noted that N-95s are just one part of a comprehensive approach, and that when in short supply, respirators should be reserved for high-risk situations, such as aerosol-generating procedures.
IDSA and the other infection control experts contend that the current guidance does not reflect the best available scientific evidence, citing two recent studies demonstrating that N-95s do not offer better protection than surgical masks. In the first study (Loeb, et al. JAMA. 2009;302(17):1865-1871.), no significant difference in influenza acquisition was observed in nurses in Toronto assigned to wear N-95 respirators or surgical masks.
The second study, a re-evaluation of a study performed in China (MacIntyre, et al.), was presented at the 47th Annual Meeting of IDSA last month in Philadelphia. Investigators from Australia presented a new analysis of their data, made at the request of peer reviewers who had asked that the control group of unprotected workers be dropped, because those workers had not been randomly assigned to not wear protection. The result was that there was no longer a statistical difference between those who wore N-95s and those who wore surgical masks. Dr. MacIntyre asserts that the study results still indicate a real difference in levels of protection, but IDSA and SHEA leaders believe the re-analysis undermines that conclusion. To listen to the IDSA abstract oral presentation, click here.
“During a time of a national emergency, health care professionals need clear, practical, and evidence-based guidance from the government,” said IDSA President Richard Whitley, MD, FIDSA. “The current guidance is not supported by the best-available science and only serves to create skepticism toward federal public and occupational health decision-making.”
SHEA President Mark Rupp, MD, called the current requirements “deeply flawed” and expressed concern over the “potential for considerable untoward consequences”—such as limiting the availability of the already scarce respirators in situations where they are truly warranted.
The groups maintain that other strategies—among them, immunization—would provide better protection for HCWs (see related story). Although the groups support continued research on the route of H1N1 transmission and means of prevention, their letter to the White House says that “until and unless such evidence exists, the current federal PPE guidance and OSHA requirements remain deeply flawed with considerable consequences.”
As of Dec. 3, the groups have received no response from the administration.
Welcome, New IDSA Members!
Babady, Ngolela, PhD
Bao, Xiaoyong, PhD
Besser, Mitchell, MD
Goren, Ronald, MD
Hayajneh, Wail, MD
Kato, Tetsuro, MD
Morrissey, Richard, MD
Pai, Hyunjoo, MD, PhD
Pasyar, Neda, MD
Sherer, Clark, MD
Yeh, Wendy, MD
Anastasio, Patrick, DO
Apewokin, Senu, MD
Armas-Kolostroubis, Laura, MD
Brinkman, Kees, MD, PhD
Bucher, Kasey, PharmD
Byleen, Sarah, PharmD
Coit, Henry, MD
Corbett, Michael, MD
Cox, Diethra, MD
De Jesus, Loreta, MD
Febles, Arelis, MD
Gutierrez-Rodriguez, Raul, MD
Hawkins, Myra, PharmD
Herigon, Joshua, MPH
Hill, Jessica, PharmD
Hong, Young Jin, MD, PhD
Kizilbash, Quratulain, MD
Kumar, Dinesh, MD
Madhav, Nita, MSPH
Rocha, Jaime, MD
Sheddan, Gavin, MBBS
Silva, Isabel, MD
Sorabjee, Jehangir, MD, DTM&H, MBBS, MRCP
Torno, Larissa, MD
Wali, Ghasan, MD
Bunce, Paul, MD
Campbell, Omobolaji, MD
Campfield, Brian, MD
Chea, Anucheat, MD
Desai, Balaji, MD
Diaz-Cardenas, Melina, MD
Durand, Christine, MD
Geevarghese, Bessey, DO
Mousselli, Hosam, MD
Narastmhan, Aarthi, MD
Nevitt Goncalves, Tracy, MSc, PhD
Rosen, Seth, MD
Said, Maria, MD
Seal, Paula, MD, MPH
Schmucker, Robyn, MD
Thurlow, Caroline, MD
Yi, Jumi, MD
How to Claim CME/CPE Credit from the IDSA Annual Meeting
If you attended the 47th Annual Meeting of IDSA, you can claim continuing medical education (CME) credit and continuing pharmacy education (CPE) credit through the Annual Meeting website by clicking the “Claim CME/CPE” link. To log in, use your first and last name and the ZIP code you used to register for the meeting. For non-U.S. residents, enter your country name in place of the ZIP code. Please note that IDSA is not providing CME/CPE credit for sessions with faculty who are employed by commercial interests.
Use Your Member Discount at the ID/HIV Career Center
Starting Jan. 1, IDSA members will receive a 30 percent discount when posting a physician position with the ID/HIV Career Center, the official online career center of IDSA and the HIV Medicine Association (HIVMA). The site is your link to first-rate job listings and job seekers in ID and HIV medicine, including academic/research, general, and pediatric. More information on the Career Center pricing structure can be found at this website.
New Clinical Practice Guideline Pocketcards Now Available
New pocket-sized quick reference guides featuring IDSA and HIVMA clinical practice guidelines, including those for immunization and the primary care management of HIV-infected patients, are now available. These 4-by-7-inch reference tools feature essential diagnostic and treatment recommendations in a brief, easy-to-use format. Pocketcards for aspergillosis, candidiasis, and community-acquired pneumonia (CAP) guidelines are also available.
IDSA and HIVMA members are eligible for a 20 percent discount when purchasing the Pocketcards. Click here to select and order individual cards. When placing your order, be sure to enter DCIDSA09 in the “Discount” field on the Shopping Cart page. Electronic versions of the Pocketcards are also available for viewing on the website.