H1N1 Can Cause Substantial Illness, Death in Transplant Recipients

Doctor's Guide
NEW YORK -- July 8, 2010 -- Influenza A(H1N1) caused substantial disease and death in solid organ transplant (SOT) recipients during 2009-2010. However, early treatment (within 48 hours) with antiviral therapy resulted in lower rates of hospitalization and reduced the number of admissions to intensive care by almost two-thirds.

Wherever possible, early antiviral treatment for symptomatic patients during future outbreaks along with preventive measures such as vaccination might offer protection for this high risk population, according to a study published online first and appearing in an upcoming print issue of The Lancet Infectious Diseases.

Transplant recipients infected with H1N1 are probably more likely to develop severe disease than the general population. Although many guidelines document the importance of influenza infection in organ transplantation, studies on the impact of influenza and the use of antiviral treatment in SOT patients are lacking. In addition, conflicting outcomes have been reported about the severity of disease resulting from influenza infection.

To provide more evidence on clinical outcomes in people who have had a SOT, Deepali Kumar, MD, University of Alberta, Edmonton, Alberta, and colleagues assessed 237 transplant recipients infected with H1N1 to identify factors leading to admission to hospital and intensive care unit (ICU), and other complications.

The researchers surveyed 154 adults and 83 children from 26 transplant centers in the US, Canada, and Europe who had received organ transplants (kidney, heart, lung, liver, and others) and had H1N1 between April and December 2009. Information on type of transplant, symptoms, diagnosis, and treatment were collected, and factors leading to pneumonia, admission to hospital, and ICU were calculated using statistical models.

Patients received their transplant a median 3.6 years before being infected with H1N1. Overall, 167 (71%) of 237 patients were admitted to hospital, 37 (16%) were sent to the ICU (of whom 21 needed mechanical ventilation), and 10(4%) died.

Importantly, findings showed that early antiviral treatment, primarily with oseltamivir, was linked with a reduced likelihood of ICU admission (7 of 90 patients treated within 48 hours vs 28 of 125 patients treated after 48 hours), admission to hospital, need for mechanical ventilation, and death.

The results confirmed previous research showing a high risk of pneumonia, with almost a third of patients in this study contracting pneumonia. Interestingly, children were less likely to present with pneumonia compared with adults (13 of 81 children vs 60 of 149 adults).

"Pandemic influenza A H1N1 resulted in a spectrum of illness ranging from mild and self-limiting to severe disease in recipients of solid-organ transplants…starting treatment with antiviral drugs early is important for reduction of morbidity and mortality in this highly susceptible population," the authors wrote. "For example, during periods of transmission, transplant patients presenting with signs and symptoms that are compatible with influenza should probably start empirical treatment with antiviral drugs before the diagnosis is confirmed."

"Almost a third of the patients in our cohort reported contact with an ill household member before their own illness," they continued. "In this setting, postexposure chemoprophylaxis might be an option…Vaccination of both transplant patients and their household contacts is probably an important preventive measure since vaccine responses might be suboptimum after transplantation."

SOURCE: The Lancet Infectious Diseases

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H1N1 Vaccine as Safe as Seasonal Vaccine, WHO Says

For anyone avoiding the H1N1 flu shot because of concerns about potential side effects this briefing from the World Health Organization is certainly great news. The WHO says that all data compiled to date indicate that pandemic vaccines match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years.

Read the full WHO briefing on the Safety of pandemic vaccines.

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Have you had your H1N1 flu shot?

After receiving the seasonal flu shot a couple of weeks ago I managed to get the H1N1 vaccine this week so I'm hopefully well protected against the flu for this year. I hope that all transplant recipients make an effort to get these shots. Medical specialists recommend that all immunosuppressed individuals receive the vaccines. People that have had solid organ transplants (such as lungs, kidneys or livers) have higher flu infection rates due to the immunosuppressant drugs they take. Lung transplant recipients such as I seem particularly at risk as the lungs are the primary site of flu infection.

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H1N1 Flu Challenges Heart and Lung Transplants

By Michael Smith, North American Correspondent, MedPage Today

The pandemic H1N1 flu poses special problems for people getting heart and lung transplants, according to an advisory from the International Society for Heart and Lung Transplantation.

The pandemic virus "highlights unique aspects of transplant care that will require heightened vigilance in coming months," according to Lara Danziger-Isakov, MD, of the Cleveland Clinic Children's Hospital, and colleagues.

"Aggressive diagnosis and early treatment" will need to be paired with active preventive measures to lessen the impact of the pandemic on the transplant population, she and colleagues wrote online in the Journal of Heart and Lung Transplantation.

Among the key elements:

• Transplant patients should get both the seasonal trivalent inactivated flu vaccine and the H1N1 vaccine as soon as possible.


• Avoid using live, attenuated seasonal trivalent vaccine (FluMist nasal spray) with transplant candidates and recipients, as well as their care providers.


• Both seasonal and flu vaccines can be given soon after transplant, but caregivers should be aware that vaccination soon after transplantation may only be partly protective.


• Potential donors should have nasopharyngeal and throat swabs for the H1N1 virus before the organs are harvested.


• The preferred test for all flu infections, including the pandemic virus, is real-time reverse transcriptase-polymerase chain reaction (rRT-PCR).


• A negative result on a rapid influenza detection assay does not exclude diagnosis of pandemic flu infection.

The turnaround time for rRT-PCR is up to 48 hours, plus travel time in some cases, the researchers said.

Especially when it comes to evaluating donors -- where time is of the essence -- the long turnaround is "a concern" and highlights the need for faster tests, they said.

Aside from vaccination, Danziger-Isakov and colleagues said, caregivers can also consider postexposure prophylaxis and prolonged seasonal prophylaxis, both with oseltamivir (Tamiflu).

In the case of prolonged prophylaxis, caregivers should be aware that oseltamivir resistance in the H1N1 flu is rare, but cases have been identified, many in immunocompromised patients.

If a potential donor dies of confirmed H1N1 flu, Danziger-Isakov and colleagues said, neither the lungs nor heart should be used for transplantation.

In some cases, a donor with confirmed H1N1 flu might die of another cause, they said. In those cases, the lungs should not be used, but the heart may be, at the discretion of the transplanting medical team.

The same is true for potential donors with suspect cases of the pandemic flu, they said.

On the other hand, both the lungs and heart of a donor with a history of the H1N1 flu who received at least five days of treatment can be used, they said.

Primary source: The Journal of Heart and Lung Transplantation
Source reference:
Danziger-Isakov LA, et al "The Novel 2009 H1N1 influenza virus pandemic: Unique considerations for programs in cardiothoracic transplantation" J Heart Lung Transpl 2009; DOI: 10.1016/j.healun.2009.10.001.

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Flu Vaccine Advised for Transplant Patients

Lung transplant recipients particularly at risk

Renal & Urology News

Patients who receive solid organ transplants (SOT) generally have higher influenza infection rates because of the immunosuppressant drugs they take to prevent organ rejection, Dr. De Serres noted. Lung transplant recipients seem particularly at risk as the lungs are the primary site of flu infection.

SAN FRANCISCO—As the nation prepares for influenza season, the susceptibility of immunosuppressed individuals, including transplant recipients, to the new H1N1 influenza strain (“swine flu”) and efficacy of the new H1N1 vaccines in these populations remain unclear. Nevertheless, a medical epidemiologist believes transplant recipients and other immunosuppressed individuals receive the new vaccines.

“I think if I were a renal transplant patient, I would get vaccinated before influenza strikes in my community,” said Gaston De Serres, MD, PhD, of Laval University in Quebec, Canada. “If I have flu-like symptoms during the time influenza is circulating in my community, I should go and consult early [with my physician], not late.”

At the 49th annual meeting here of the Interscience Conference on Antimicrobial Agents and Chemotherapy, Dr. De Serres spoke about the H1N1 vaccines approved by the FDA on September 15.

Over the next six months, more will be known about how safe and effective the H1N1 vaccines are in immunocompromised patients, he said. Based on preliminary data from adults participating in multiple clinical studies, the H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.

Ongoing clinical studies will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in non-thimerosal formulations. Patients with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

Patients who receive solid organ transplants (SOT) generally have higher influenza infection rates because of the immunosuppressant drugs they take to prevent organ rejection, Dr. De Serres noted. Lung transplant recipients seem particularly at risk as the lungs are the primary site of flu infection. Kidney transplant recipients can suffer organ rejection if they contract influenza. In theory, vaccination in these populations could also stimulate a T-cell response, leading to rejection. However, most studies suggest this does not occur.

Flu can cause organ rejection

“Seasonal influenza has been reported to cause rejection of the transplanted kidney, so preventing influenza in kidney transplant recipients is important,” said Ken Kunisaki, MD, Assistant Professor of Medicine at the University of Minnesota in Minneapolis. “While kidney transplant recipients may not have as good antibody responses to influenza vaccine as people without transplants, a substantial proportion still responds. Therefore, kidney transplant recipients should receive influenza vaccination, in accordance with guidelines from the American Society of Transplantation. Unfortunately, there are not enough data about swine flu in transplant recipients and its vaccine to make firm conclusions and recommendations at this time.”

With seasonal influenza, a key issue appears to be timing. The American Society of Transplantation recommends flu vaccination every year for all recipients of SOTs, beginning six months after transplantation. U.S. guidelines recommend lifelong annual vaccinations; European guidelines recommend individual patient assessment.

Estimates show that more than 327,000 people were receiving hemodialysis treatment in the United States at the end of 2006. Infections are the second leading cause of death in these patients, and lung infections such as influenza claim a higher proportion of lives among dialysis patients than the general population. An analysis of Medicare claims data showed that flu-vaccinated patients on dialysis had a substantially lower chance of hospitalization or death from any cause than unvaccinated patients.

Chemotherapy can produce acute and profound immunosuppression in cancer patients and studies suggest that 21%-33% of cancer patients may be infected with influenza when admitted to a hospital with respiratory symptoms during a flu epidemic. Again, timing of flu vaccination may be crucial in cancer patients. The response to flu vaccination might be best between chemotherapy cycles or more than 7 days before chemotherapy starts.

“Patients receiving chemotherapy for cancer appear to be at heightened risk for influenza-related complications,” Dr. Kunisaki said. “They also appear less likely to respond to influenza vaccine, but nevertheless, a fair proportion still responds. No formal guidelines exist for influenza vaccination of patients receiving chemotherapy, but the data suggest timing vaccination to either more than two weeks before receiving chemotherapy or between chemotherapy cycles.”

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Your generosity can save up to eight lives with heart, kidneys, liver, lungs, pancreas and small intestine transplants. One tissue donor can help up to 100 other people by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ transplant.

Swine flu and immunosuppression

The study reported here notes that people who have had solid organ transplants (such as lungs, kidneys or livers) also have higher flu infection rates due to the immunosuppressant drugs they take to prevent organ rejection. Lung transplant recipients are particularly prone to infection and kidney transplant recipients can suffer rejection if they contract flu. As a lung transplant recipient, I'm getting my flu shot as soon as it's available. Most immunosuppressed people can be safely vaccinated.

Nathional Health Service (NHS - Britain)

A review of research on how flu affects immunosuppressed people and the effects of vaccination on them has been published in The Lancet Infectious Diseases. The authors specifically looked at susceptibility in people with HIV/AIDS, cancer, those who have had a solid organ transplant or bone-marrow transplant and patients on haemodialysis or steroids.

Such groups are thought to be at higher risk of serious influenza-associated complications and as such are priority groups for immunisation.

However, treatments for immune dysfunction may also limit the effectiveness of vaccination and there may be complications from the vaccination itself in these groups. The evidence behind these issues is discussed in this review.

Key points from the review

• There is little research on using vaccination to prevent influenza in immunosuppressed people. This review found just one randomised clinical trial. This trial of HIV-infected patients found high vaccine effectiveness.


• The same immune dysfunction that can increase the risk and consequences of influenza infection might also compromise vaccine responses and effectiveness.


• Most immunosuppressed populations are at higher risk of influenza-associated complications, have a general trend toward impaired antibody responses but can be safely vaccinated.


• The priority for control of influenza is focused on generating effective antibody responses with vaccines. Progress is being made at increasing the scale, duration, and breadth of vaccine responses to the two main surface proteins H and N (haemagglutinin and neuraminidase) in both healthy and immuno-compromised populations.


• There are two main types of influenza vaccine and both are being developed for the new H1N1 swine flu virus. One involves inactivated vaccines that contain viruses grown in eggs (mostly) and then killed. The other involves live weakened H1N1 vaccines. The researchers say that previous concerns that these live attenuated vaccine would pose a risk to people that are immunocompromised have not been demonstrated by the studies in their review. Research into this area and into and other novel approaches to flu vaccine development are important. They ask that efficacy studies of attenuated vaccines in adults that are immunocompromised are also considered.

Where was the article published?

The research was carried out by Dr Ken M Kunisaki from the Minneapolis VA Medical Center and Edward N Janoff from the University of Colorado Denver School of Medicine.
The study was published in The Lancet Infectious Diseases. It was supported by grants from the National Institutes of Health and the Veterans Affairs Research Service.

What kind of study was this?

In this review, the researchers looked at the susceptibility of immunosuppressed people to the H1N1 swine flu virus, and the possible effectiveness and side effects of upcoming vaccines. Specifically, the authors looked at susceptibility in people with HIV/AIDS, cancer, those who have had a solid organ transplant, or bone-marrow transplant and patients on haemodialysis.

They say: “Although influenza vaccination is widely recommended for people that are immunosuppressed, the same immune dysfunction that can increase the risk and consequences of influenza infection might also compromise vaccine responses and effectiveness.”

The researchers aimed to investigate:

• the incidence and mortality rates of influenza infection among adults who are immuno-compromised,


• the risks and adverse effects of vaccination,


• the ability of a vaccine to get appropriate immune responses, and


• the clinical effectiveness of vaccination in these populations.

The researchers searched Medline through the years 1966-2009 for articles on adult influenza, its frequency, complications, and antibody or clinical responses to vaccination. The antibody responses were measured as the percentage of people with levels of antibody protective against H3N2, and the clinical responses were defined as the frequency of influenza reported during the total observation period. They also looked for policy recommendations and guidelines. Excess deaths and hospitalisations were also reported. They only included articles reporting outcomes related to inactivated vaccines, because live attenuated vaccines are not recommended in immuno-compromised groups because there is a theoretical possibility of causing the disease itself.

What was found?

The researchers discussed the following:

HIV/AIDS

Studies show that the numbers of HIV/AIDS patients admitted to hospital with flu has fallen substantially since the introduction of effective antiretroviral therapy. However, admissions are still higher than in the general population.

HIV/AIDS patients generally have lower antibody responses to vaccination, but several studies have shown that vaccination leads to fewer and less severe cases of flu in these patients. Larger randomised trials are needed to assess vaccination, particularly among those with more advanced disease as measured by low CD4+ cell counts.

Transplantation

People who have had solid organ transplants (such as lungs, kidneys or livers) also have higher flu infection rates due to the immunosuppressant drugs they take to prevent organ rejection. Lung transplant recipients are particularly prone to infection and kidney transplant recipients can suffer rejection if they contract flu. In theory, vaccination in these populations could also stimulate a T-cell response, leading to rejection, but the researchers say that most studies say this does not occur.

The intensive pre-transplantation regimens used in preparing people for bone marrow (haematopoetic stem cell) transplants leave patients deeply immunocompromised for up to several months after transplantation. A study on 10 patients’ response to vaccination showed that there was a complete lack of serological response within six months in all 10.

Malignancies and chemotherapy

Chemotherapy can produce major immunosuppression in people with cancer and one study shows that 21-33% of cancer patients contracted flu and were admitted to hospital with respiratory symptoms during one recent seasonal flu epidemic.

Timing of flu vaccination can be crucial in cancer patients. The response might be best between chemotherapy cycles, or more than seven days before chemotherapy starts.

Haemodialysis

Infections are the second leading cause of death in patients on dialysis, and lung infections such as flu are particularly serious. Vaccinated patients on dialysis have been shown to have a lower chance of hospital admission or death from any cause than unvaccinated patients.

Systemic corticosteroids

The authors also looked at people taking oral or inhaled steroids, saying that the evidence shows flu vaccination is both safe and often stimulates an immune response. However, the vaccine’s clinical effectiveness in reducing episodes of flu in people taking the drugs has not been well tested.

What were the researchers’ conclusions?

The researchers say that most immunosuppressed populations are at higher risk of influenza-associated complications. These people have impaired antibody responses to the vaccine (although data for this conclusion is mixed. For example, in some trials, HIV patients with low CD4+ counts developed only 30% of the antibody response of healthy controls, and in one trial of patients on chemotherapy, there was even less of a response. However, other studies have shown that patients who have had haemodialysis and transplant managed up to 80% protective titres.

They say that most immunosuppressed people can be safely vaccinated (although longitudinal data that follows up patients over time are largely lacking).

They also say that the small number of studies of cellular responses to influenza vaccination, in relatively small numbers of immunosuppressed individuals, showed impaired cellular responses among a few patients.

The researchers call for better trial data to inform vaccination recommendations based on the effectiveness and cost in these at-risk populations.

What does the NHS Knowledge Service make of this study?

This study has addressed an important question in vaccination research and one that has become topical with the spread of the new H1N1 swine flu virus. It is disappointing that there are so few high quality trials in this area and that the trials that exist are observational studies.

This means that the evidence presented may be prone to bias. Nevertheless, decisions on vaccination in high-risk groups need to be made on the balance of the evidence that exists. This review has presented a useful summary, which can guide practice.

Links to the science

See the NHS report

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FDA Approves Vaccine for 2009-2010 Seasonal Influenza

Although this seasonal flu vaccine will not protect against the H1N1 virus (swine flu), receiving the seasonal vaccine is still critical for those of us who are at risk due to being immuno suppressed as well as older people, young children and people with chronic medical conditions. It's expected that a vaccine for the H1N1 virus will be available later this fall.

For Immediate Release: July 20, 2009

The U.S. Food and Drug Administration today announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States.

The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009. The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus.

Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine. No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths.

“The approval of this year’s seasonal influenza vaccine is an example of the FDA’s important responsibility to assure timely availability of vaccine to help protect the health of the American public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

The six vaccine brand names and manufacturers are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur Inc.; and FluMist, MedImmune Vaccines Inc.

Each year, experts from the FDA, WHO, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of the FDA’s Vaccine and Related Products Advisory Committee, the FDA determines the three strains that manufacturers should include in their vaccines for the U.S. population. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against the disease.

The vaccine for the 2009-2010 seasonal influenza contains:

• an A/Brisbane/59/2007 (H1N1)-like virus


• an A/Brisbane/10/2007 (H3N2)-like virus


• a B/Brisbane/60/2008-like virus

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year. More than 200,000 are hospitalized from its complications and about 36,000 people die. Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications. Vaccination of these groups is critical.

Additionally, influenza immunization of health care personnel is important in protecting them and others from influenza.

For more information:

FDA Web Page on Influenza Vaccine Safety & Availability

FDA List of Strains Included in the 2009-2010 Influenza Vaccine

U.S. Centers for Disease Control and Prevention Web Page on Seasonal Influenza Resources for Health Professionals

U.S. Centers for Disease Control and Prevention Web Page with Key Fact About Seasonal Flu Vaccine

“You Have the Power to Save Lives – Sign Your Donor Card & Tell Your Loved Ones of Your Decision”

Register to be a donor in Ontario or Download Donor Cards from Trillium Gift of Life Network. NEW for Ontario: recycleMe.org - Learn The Ins & Outs Of Organ And Tissue Donation. Register Today! For other Canadian provinces click here

In the United States, be sure to find out how to register in your state at ShareYourLife.org or Download Donor Cards from OrganDonor.Gov

In Great Britain, register at NHS Organ Donor Register

In Australia, register at Australian Organ Donor Register

Your generosity can save up to eight lives with heart, kidneys, liver, lungs, pancreas and small intestine transplants. One tissue donor can help up to 100 other people by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes.

Protecting yourself against H1N1 Virus (Swine Flu)

Officials say that the next wave of H1N1 flu could arrive in September and governments worldwide are planning for a pandemic. No one knows for sure if it will continue to cause mostly mild illness or if it will strike with the vengeance of the 1918 Spanish flu, which hit with a mild form in the spring but returned in the fall to infect one-third of the world's population and contributed to the deaths of 50 million people.

Organ transplant recipients, who are immunosuppressed, need to be especially vigilant and use common sense to avoid infection, especially during the flu season.

Following the advice of experts, such as can be found at Flu.gov I plan to avoid large groups of people; wash my hands frequently with soap and water; avoid shaking hands; use a tissue when sneezing or coughing and place it in the trash. Our hands have poison on them and washing is a huge thing. I'll get a flu shot as soon as it's available and I've already had a pneumonia shot to protect against secondary infection.

I hope the epidemic doesn't come but I, for one, intend to protect myself. I hope you will also.

“You Have the Power to Save Lives – Sign Your Donor Card & Tell Your Loved Ones of Your Decision”

Register to be a donor in Ontario or Download Donor Cards from Trillium Gift of Life Network. NEW for Ontario: recycleMe.org - Learn The Ins & Outs Of Organ And Tissue Donation. Register Today! For other Canadian provinces click here

In the United States, be sure to find out how to register in your state at ShareYourLife.org or Download Donor Cards from OrganDonor.Gov

In Great Britain, register at NHS Organ Donor Register

In Australia, register at Australian Organ Donor Register

Your generosity can save up to eight lives with heart, kidneys, liver, lungs, pancreas and small intestine transplants. One tissue donor can help up to 100 other people by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes.