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IOM calls for pay for end-of-life planning
Physicians should be compensated for counseling patients on end-of-life planning, according to recommendations from the Institute of Medicine, and the health care delivery and payment system should be realigned to encourage and financially reward higher-quality, more comprehensive, more efficient, and more humane care for those with serious illnesses.
“Individuals should have time with their doctors to talk about end-of-life issues, and clinicians should receive the training and financial incentives for such discussions,” said David Walker, the former comptroller general of the United States, who was the cochair of the IOM committee that created the report published Sept. 17.
Dying in America calls on health care providers, payers, policy makers, and the American public to have a more open discourse about death and dying.
End-of-life care was caught up in a political firestorm in 2009 when the Obama administration proposed to pay for advanced care conversations under the Affordable Care Act, Dr. Harvey Fineberg, former IOM president, noted in a video message at a briefing to release the report. Such efforts were construed as “death panels,” and the administration withdrew its proposal within days of it going into effect in 2011, said Dr. Fineberg, who is now at the University of California, San Francisco.
“The controversy on this topic and the political desire to avoid it do not alter the fact that every person will face the end of life one day, and many have had hard experience with the final days of a parent, a spouse, a child, a sibling, another relative, or a dear friend,” Dr. Fineberg said.
The report focuses on three areas: what individuals and their families can do to take more control over their own life and their health care throughout their life; what clinicians and other professionals can do; and what policy makers and payers need to do to try to effectuate change. The 21-member IOM committee spent 2 years developing the consensus report, Mr. Walker said.
“For most people, death does not come suddenly,” said Dr. Philip Pizzo, committee cochair. “Instead, dying is a result of one or more diseases that must be managed carefully and compassionately over weeks, months, or even years, through many ups and downs,” said Dr. Pizzo of Stanford (Calif.) University.
The committee made five broad recommendations:
• Comprehensive care for patients with advanced, serious illness who are nearing the end of life should be covered by public and private payers.
• Evidence-based standards for clinician-patient communication and advanced care planning should be developed by professional societies; such standards should be used as measures for payment, licensing, and credentialing.
• Standardized training and requirements should be developed and implemented.
• Care standards should seek to avoid unnecessary emergency department or acute care services; care should be coordinated across settings and providers by using tools such as interoperable electronic health records and physician orders for life-sustaining treatment programs.
• Fact-based information on end-of-life care planning should be developed and disseminated broadly through public health and other governmental agencies, community-based organizations, and faith-based organizations, as well as through health care providers and payers.
More needs to be done to educate physicians, other health care providers, and patients about the differences between hospice care and palliative care, and the potential they have for improving quality of life and reducing potentially unnecessary – and costly – medical services, according to the committee report.
Dr. Pizzo noted that many physicians, when asked in surveys, have said that they would personally prefer less-aggressive care at the end of life, and if possible, having the patient receive care at home. Yet, when it comes to their patients, they tend to pull out the stops.
He said that was being driven by a lack of understanding of patients’ individual needs and preferences, and by what he and the committee called the “perverse incentives” of the health care system.
The system rewards more care, not less, and acute care more so than palliative or supportive care, Mr. Walker noted. “Our current system is broken. It does not result in the honoring of individual preferences as much as it should.”
The IOM report was financed by an anonymous donor, Dr. Fineberg said.
The donor made money available for the IOM to continue for at least a year, disseminating the findings and encouraging adoption of its recommendations, Mr. Walker said.
On Twitter @aliciaault
This recommendation for end-of-life discussions is long overdue. Physicians have been providing these services for years, and it is appropriate that they be encouraged to provide such care both in and out of the hospital. The impact can be significant for this time-consuming and emotion-consuming practice. Referrals to palliative care will likely increase, as will patient satisfaction scores. Use of hospital resources and their cost are likely to decrease as patients and their families request that nonessential treatment be decreased or stopped. Only good can come from this, once the process has been fully developed by the CMS.
This recommendation for end-of-life discussions is long overdue. Physicians have been providing these services for years, and it is appropriate that they be encouraged to provide such care both in and out of the hospital. The impact can be significant for this time-consuming and emotion-consuming practice. Referrals to palliative care will likely increase, as will patient satisfaction scores. Use of hospital resources and their cost are likely to decrease as patients and their families request that nonessential treatment be decreased or stopped. Only good can come from this, once the process has been fully developed by the CMS.
This recommendation for end-of-life discussions is long overdue. Physicians have been providing these services for years, and it is appropriate that they be encouraged to provide such care both in and out of the hospital. The impact can be significant for this time-consuming and emotion-consuming practice. Referrals to palliative care will likely increase, as will patient satisfaction scores. Use of hospital resources and their cost are likely to decrease as patients and their families request that nonessential treatment be decreased or stopped. Only good can come from this, once the process has been fully developed by the CMS.
Physicians should be compensated for counseling patients on end-of-life planning, according to recommendations from the Institute of Medicine, and the health care delivery and payment system should be realigned to encourage and financially reward higher-quality, more comprehensive, more efficient, and more humane care for those with serious illnesses.
“Individuals should have time with their doctors to talk about end-of-life issues, and clinicians should receive the training and financial incentives for such discussions,” said David Walker, the former comptroller general of the United States, who was the cochair of the IOM committee that created the report published Sept. 17.
Dying in America calls on health care providers, payers, policy makers, and the American public to have a more open discourse about death and dying.
End-of-life care was caught up in a political firestorm in 2009 when the Obama administration proposed to pay for advanced care conversations under the Affordable Care Act, Dr. Harvey Fineberg, former IOM president, noted in a video message at a briefing to release the report. Such efforts were construed as “death panels,” and the administration withdrew its proposal within days of it going into effect in 2011, said Dr. Fineberg, who is now at the University of California, San Francisco.
“The controversy on this topic and the political desire to avoid it do not alter the fact that every person will face the end of life one day, and many have had hard experience with the final days of a parent, a spouse, a child, a sibling, another relative, or a dear friend,” Dr. Fineberg said.
The report focuses on three areas: what individuals and their families can do to take more control over their own life and their health care throughout their life; what clinicians and other professionals can do; and what policy makers and payers need to do to try to effectuate change. The 21-member IOM committee spent 2 years developing the consensus report, Mr. Walker said.
“For most people, death does not come suddenly,” said Dr. Philip Pizzo, committee cochair. “Instead, dying is a result of one or more diseases that must be managed carefully and compassionately over weeks, months, or even years, through many ups and downs,” said Dr. Pizzo of Stanford (Calif.) University.
The committee made five broad recommendations:
• Comprehensive care for patients with advanced, serious illness who are nearing the end of life should be covered by public and private payers.
• Evidence-based standards for clinician-patient communication and advanced care planning should be developed by professional societies; such standards should be used as measures for payment, licensing, and credentialing.
• Standardized training and requirements should be developed and implemented.
• Care standards should seek to avoid unnecessary emergency department or acute care services; care should be coordinated across settings and providers by using tools such as interoperable electronic health records and physician orders for life-sustaining treatment programs.
• Fact-based information on end-of-life care planning should be developed and disseminated broadly through public health and other governmental agencies, community-based organizations, and faith-based organizations, as well as through health care providers and payers.
More needs to be done to educate physicians, other health care providers, and patients about the differences between hospice care and palliative care, and the potential they have for improving quality of life and reducing potentially unnecessary – and costly – medical services, according to the committee report.
Dr. Pizzo noted that many physicians, when asked in surveys, have said that they would personally prefer less-aggressive care at the end of life, and if possible, having the patient receive care at home. Yet, when it comes to their patients, they tend to pull out the stops.
He said that was being driven by a lack of understanding of patients’ individual needs and preferences, and by what he and the committee called the “perverse incentives” of the health care system.
The system rewards more care, not less, and acute care more so than palliative or supportive care, Mr. Walker noted. “Our current system is broken. It does not result in the honoring of individual preferences as much as it should.”
The IOM report was financed by an anonymous donor, Dr. Fineberg said.
The donor made money available for the IOM to continue for at least a year, disseminating the findings and encouraging adoption of its recommendations, Mr. Walker said.
On Twitter @aliciaault
Physicians should be compensated for counseling patients on end-of-life planning, according to recommendations from the Institute of Medicine, and the health care delivery and payment system should be realigned to encourage and financially reward higher-quality, more comprehensive, more efficient, and more humane care for those with serious illnesses.
“Individuals should have time with their doctors to talk about end-of-life issues, and clinicians should receive the training and financial incentives for such discussions,” said David Walker, the former comptroller general of the United States, who was the cochair of the IOM committee that created the report published Sept. 17.
Dying in America calls on health care providers, payers, policy makers, and the American public to have a more open discourse about death and dying.
End-of-life care was caught up in a political firestorm in 2009 when the Obama administration proposed to pay for advanced care conversations under the Affordable Care Act, Dr. Harvey Fineberg, former IOM president, noted in a video message at a briefing to release the report. Such efforts were construed as “death panels,” and the administration withdrew its proposal within days of it going into effect in 2011, said Dr. Fineberg, who is now at the University of California, San Francisco.
“The controversy on this topic and the political desire to avoid it do not alter the fact that every person will face the end of life one day, and many have had hard experience with the final days of a parent, a spouse, a child, a sibling, another relative, or a dear friend,” Dr. Fineberg said.
The report focuses on three areas: what individuals and their families can do to take more control over their own life and their health care throughout their life; what clinicians and other professionals can do; and what policy makers and payers need to do to try to effectuate change. The 21-member IOM committee spent 2 years developing the consensus report, Mr. Walker said.
“For most people, death does not come suddenly,” said Dr. Philip Pizzo, committee cochair. “Instead, dying is a result of one or more diseases that must be managed carefully and compassionately over weeks, months, or even years, through many ups and downs,” said Dr. Pizzo of Stanford (Calif.) University.
The committee made five broad recommendations:
• Comprehensive care for patients with advanced, serious illness who are nearing the end of life should be covered by public and private payers.
• Evidence-based standards for clinician-patient communication and advanced care planning should be developed by professional societies; such standards should be used as measures for payment, licensing, and credentialing.
• Standardized training and requirements should be developed and implemented.
• Care standards should seek to avoid unnecessary emergency department or acute care services; care should be coordinated across settings and providers by using tools such as interoperable electronic health records and physician orders for life-sustaining treatment programs.
• Fact-based information on end-of-life care planning should be developed and disseminated broadly through public health and other governmental agencies, community-based organizations, and faith-based organizations, as well as through health care providers and payers.
More needs to be done to educate physicians, other health care providers, and patients about the differences between hospice care and palliative care, and the potential they have for improving quality of life and reducing potentially unnecessary – and costly – medical services, according to the committee report.
Dr. Pizzo noted that many physicians, when asked in surveys, have said that they would personally prefer less-aggressive care at the end of life, and if possible, having the patient receive care at home. Yet, when it comes to their patients, they tend to pull out the stops.
He said that was being driven by a lack of understanding of patients’ individual needs and preferences, and by what he and the committee called the “perverse incentives” of the health care system.
The system rewards more care, not less, and acute care more so than palliative or supportive care, Mr. Walker noted. “Our current system is broken. It does not result in the honoring of individual preferences as much as it should.”
The IOM report was financed by an anonymous donor, Dr. Fineberg said.
The donor made money available for the IOM to continue for at least a year, disseminating the findings and encouraging adoption of its recommendations, Mr. Walker said.
On Twitter @aliciaault
Senate OKs sunscreen bill
The Senate unanimously approved a bill designed to speed up Food and Drug Administration approval of sunscreen ingredients, adding to the likelihood that the legislation will become law.
The full Senate took quick action on Sept. 17, the same day that the Health, Education, Labor & Pensions (HELP) Committee unanimously voted 12-0 in favor of the Sunscreen Innovation Act (S.2141).
“We have a number of ingredients for sunscreens that have languished at the FDA for years – as long as a decade,” Sen. Johnny Isakson (R-Ga.), a cosponsor of the bill, said at the HELP hearing. “This doesn’t mean Congress makes the decision,” he said, adding that, instead, the law does establish time frames for review.
The legislation “is also about holding the FDA accountable to timelines and reforming the process,” said Sen. Lamar Alexander (R-Tenn.).
The bill would require the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more congressional oversight.
At a recent FDA advisory committee hearing on sunscreen ingredient safety, Dr. Theresa Michele, an FDA official, said that eight ingredients were awaiting approval through what was supposed to be an expedited process. These are the same ingredients that have been under review for 10 years or more. The agency has responded to manufacturers of five of the eight, telling them that so far, there’s not enough data to determine whether they can be marketed, said Dr. Michele.
The Senate joins the House in calling on the FDA to move those approvals along. The full House approved companion legislation (H.R.4250) in late July.
The legislation is supported by the American Academy of Dermatology and by consumer advocates and manufacturers, including the Public Access to SunScreens (PASS) Coalition.
“Congress’s commitment to addressing the skin cancer epidemic in the United States was clearly demonstrated in tonight’s Senate passage of the Sunscreen Innovation Act,” said Michael Werner, PASS Coalition Policy Adviser, in a statement after the vote. “We now call on the House and Senate to swiftly reconcile the differences in their bills and enact final legislation,” Werner said.
Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a statement that if the bill became law, it would add more predictability to FDA reviews.
“The Senate took a critical step yesterday to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer,” he said.
Tim Turnham, executive director of the Melanoma Research Foundation, said in a statement that some of the ingredients under FDA review have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.
“Americans are limited in their choices for compounds that block UV radiation because of the long-standing bureaucratic gridlock at the FDA that prevents new agents from being approved,” said Mr. Turnham.
The House and Senate have to reconcile the two versions of the bill, and then the legislation will have to be approved again by both bodies before being sent to the White House for final approval.
On Twitter @aliciaault
The Senate unanimously approved a bill designed to speed up Food and Drug Administration approval of sunscreen ingredients, adding to the likelihood that the legislation will become law.
The full Senate took quick action on Sept. 17, the same day that the Health, Education, Labor & Pensions (HELP) Committee unanimously voted 12-0 in favor of the Sunscreen Innovation Act (S.2141).
“We have a number of ingredients for sunscreens that have languished at the FDA for years – as long as a decade,” Sen. Johnny Isakson (R-Ga.), a cosponsor of the bill, said at the HELP hearing. “This doesn’t mean Congress makes the decision,” he said, adding that, instead, the law does establish time frames for review.
The legislation “is also about holding the FDA accountable to timelines and reforming the process,” said Sen. Lamar Alexander (R-Tenn.).
The bill would require the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more congressional oversight.
At a recent FDA advisory committee hearing on sunscreen ingredient safety, Dr. Theresa Michele, an FDA official, said that eight ingredients were awaiting approval through what was supposed to be an expedited process. These are the same ingredients that have been under review for 10 years or more. The agency has responded to manufacturers of five of the eight, telling them that so far, there’s not enough data to determine whether they can be marketed, said Dr. Michele.
The Senate joins the House in calling on the FDA to move those approvals along. The full House approved companion legislation (H.R.4250) in late July.
The legislation is supported by the American Academy of Dermatology and by consumer advocates and manufacturers, including the Public Access to SunScreens (PASS) Coalition.
“Congress’s commitment to addressing the skin cancer epidemic in the United States was clearly demonstrated in tonight’s Senate passage of the Sunscreen Innovation Act,” said Michael Werner, PASS Coalition Policy Adviser, in a statement after the vote. “We now call on the House and Senate to swiftly reconcile the differences in their bills and enact final legislation,” Werner said.
Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a statement that if the bill became law, it would add more predictability to FDA reviews.
“The Senate took a critical step yesterday to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer,” he said.
Tim Turnham, executive director of the Melanoma Research Foundation, said in a statement that some of the ingredients under FDA review have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.
“Americans are limited in their choices for compounds that block UV radiation because of the long-standing bureaucratic gridlock at the FDA that prevents new agents from being approved,” said Mr. Turnham.
The House and Senate have to reconcile the two versions of the bill, and then the legislation will have to be approved again by both bodies before being sent to the White House for final approval.
On Twitter @aliciaault
The Senate unanimously approved a bill designed to speed up Food and Drug Administration approval of sunscreen ingredients, adding to the likelihood that the legislation will become law.
The full Senate took quick action on Sept. 17, the same day that the Health, Education, Labor & Pensions (HELP) Committee unanimously voted 12-0 in favor of the Sunscreen Innovation Act (S.2141).
“We have a number of ingredients for sunscreens that have languished at the FDA for years – as long as a decade,” Sen. Johnny Isakson (R-Ga.), a cosponsor of the bill, said at the HELP hearing. “This doesn’t mean Congress makes the decision,” he said, adding that, instead, the law does establish time frames for review.
The legislation “is also about holding the FDA accountable to timelines and reforming the process,” said Sen. Lamar Alexander (R-Tenn.).
The bill would require the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more congressional oversight.
At a recent FDA advisory committee hearing on sunscreen ingredient safety, Dr. Theresa Michele, an FDA official, said that eight ingredients were awaiting approval through what was supposed to be an expedited process. These are the same ingredients that have been under review for 10 years or more. The agency has responded to manufacturers of five of the eight, telling them that so far, there’s not enough data to determine whether they can be marketed, said Dr. Michele.
The Senate joins the House in calling on the FDA to move those approvals along. The full House approved companion legislation (H.R.4250) in late July.
The legislation is supported by the American Academy of Dermatology and by consumer advocates and manufacturers, including the Public Access to SunScreens (PASS) Coalition.
“Congress’s commitment to addressing the skin cancer epidemic in the United States was clearly demonstrated in tonight’s Senate passage of the Sunscreen Innovation Act,” said Michael Werner, PASS Coalition Policy Adviser, in a statement after the vote. “We now call on the House and Senate to swiftly reconcile the differences in their bills and enact final legislation,” Werner said.
Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a statement that if the bill became law, it would add more predictability to FDA reviews.
“The Senate took a critical step yesterday to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer,” he said.
Tim Turnham, executive director of the Melanoma Research Foundation, said in a statement that some of the ingredients under FDA review have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.
“Americans are limited in their choices for compounds that block UV radiation because of the long-standing bureaucratic gridlock at the FDA that prevents new agents from being approved,” said Mr. Turnham.
The House and Senate have to reconcile the two versions of the bill, and then the legislation will have to be approved again by both bodies before being sent to the White House for final approval.
On Twitter @aliciaault
Emory’s Ebola Experience Held Logistical Surprises
WASHINGTON – When two Ebola-infected patients were airlifted to Emory University Hospital in Atlanta in early August, dedicated staffers were prepared to care for the patients. But those staffers had to act quickly to deal with unanticipated challenges that came from regulators and some of the hospital’s contractors, who initially refused to dispose of the mountains of medical waste generated by the patients and the clinicians who cared for them, according to Dr. Aneesh Mehta.
Dr. Mehta, associate chief of Emory’s infectious disease service, was one of the primary attending physicians for Nancy Writebol and Dr. Kent Brantly, who recovered from their Ebola infections and were discharged from Emory’s isolation unit on Aug. 19 and Aug. 21.
The lessons learned from caring for these initial patients are now being applied to Emory’s latest Ebola-infected patient, who arrived at the facility from West Africa on Sept. 9, said Dr. Mehta, who spoke on the logistics, successes, and challenges of caring for Ebola-infected patients at Emory at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The local civil authorities asked that the Emory unit not introduce any untreated patient waste into the municipal waste stream. The staff disinfected with bleach or detergents all of the patients’ liquid wastes for more than 5 minutes before flushing them down the toilet.
And there was plenty of other potentially hazardous and infectious material that had to be addressed. At the peak of the patients’ illness, up to 40 bags a day of medical waste were being produced, said Dr. Mehta.
Initially, the hospital’s waste management contractor refused to pick up the medical waste for several days. To manage the situation temporarily, the Emory staff "went to Home Depot and bought up every large trash can and sealed canister that we could get," said Dr. Mehta. The filled cans were kept in a containment room until the hospital completed negotiations with the contractor to pick up the waste.
Even the commercial courier company that the hospital had always used to transport infectious and potentially lethal samples to the labs at the Centers for Disease Control and Prevention "suddenly said ‘no,’ " Dr. Mehta said. "If the label said ‘CDC’ on it, they refused to touch it."
Even some Emory staffers who had previously handled and packed dangerous samples for shipping refused to come to the isolation unit’s lab, said Dr. Mehta. The hospital’s safety officers had to train some of the dedicated Ebola staff to pack samples appropriately for shipping.
But even as the hospital dealt with these issues and the growing media circus, the Ebola staff stayed focused, Dr. Mehta said. "It was very chaotic outside, but very calm in the hospital and with our team."
The hospital spent a lot of time on communications – with the public, with staff, and with other patients in the hospital and their families. Emory held twice-daily town halls with staff to give information and answer questions, and also sent regular e-mail updates about the Ebola patients. Every inpatient and new admission was given a letter explaining why Emory had taken the patients, and physician and administrative leaders rounded throughout the hospital to answer questions.
Emory already had a "serious communicable diseases" unit, which it created in 2002 as a place to receive any CDC workers who might be exposed to pathogens on the job. The six-room unit has a patient room on each end, with a private bathroom in each, a staff dressing area, and an anteroom that was used as a staging area for nurses.
After the decision to accept the Ebola-infected patients, a new point-of-care lab facility was built in less than 72 hours in an adjoining office space, said Dr. Mehta. Having this kind of dedicated unit was not absolutely necessary, but it allowed the staff to more conveniently perform chemistry, hematology, blood gas, urinalysis, coagulation, and malaria tests and get immediate results. Having a dedicated lab space also limited the exposure fears of staff elsewhere in the hospital.
To prevent transmission of the virus, the unit followed the CDC’s recommendations, which included keeping a detailed log of anyone who entered and exited a patient room, using disposable equipment whenever possible, and using personal protective equipment that included gloves, fluid-resistant or impermeable gowns, and goggles or face shields. Initially, the Emory caregivers had leg and foot coverings because the patients had vomited blood before arriving, and one of the patients had fulminant diarrhea, up to four liters per day, said Dr. Mehta.
Because the disease can be transmitted from protective gear, all staff had a refresher course on appropriate use of the gear, everyone was observed by another team member when putting on or taking off the gear, and reminders about appropriate use of the gear were placed on the walls of the unit and in the changing area.
The clinical care team met every day to review plans and protocols and to answer staff questions. Twice daily, all personnel had to enter into an online registry their body temperatures and any symptoms. Dr. Mehta told the ICAAC audience that he had just completed his 21-day observation period.
The patient care itself was far from clear cut, as there is no proven treatment and Emory officials initially were not clear on the availability of any experimental therapy, said Dr. Mehta. The CDC helped to monitor the patients’ viral load, and both patients had marked electrolyte imbalances, including hypokalemia, hypocalcemia, and hyponatremia, as well as severe nutritional deficiencies. Both required significant potassium replacement.
Both patients received a three-dose course of Zmapp, which consists of three monoclonal antibodies and is under development by Mapp Biopharmaceutical. While in Africa, Dr. Brantly also had received a transfusion of plasma from a patient who was recovering from the Ebola virus.
High-level, one-on-one nursing care also was noted as a significant factor in patient recovery, said Dr. Mehta.
"It’s hard to derive a lot of meaningful data from the care of those two patients," Dr. Mehta said. It’s not clear yet which of these factors – Zmapp, the transfusion, the supportive care, or the combination – was responsible for the patients’ recovery.
Emory will publish its experiences in Ebola care, but "the real front line is in West Africa," Dr. Mehta added.
On Twitter @aliciaault
WASHINGTON – When two Ebola-infected patients were airlifted to Emory University Hospital in Atlanta in early August, dedicated staffers were prepared to care for the patients. But those staffers had to act quickly to deal with unanticipated challenges that came from regulators and some of the hospital’s contractors, who initially refused to dispose of the mountains of medical waste generated by the patients and the clinicians who cared for them, according to Dr. Aneesh Mehta.
Dr. Mehta, associate chief of Emory’s infectious disease service, was one of the primary attending physicians for Nancy Writebol and Dr. Kent Brantly, who recovered from their Ebola infections and were discharged from Emory’s isolation unit on Aug. 19 and Aug. 21.
The lessons learned from caring for these initial patients are now being applied to Emory’s latest Ebola-infected patient, who arrived at the facility from West Africa on Sept. 9, said Dr. Mehta, who spoke on the logistics, successes, and challenges of caring for Ebola-infected patients at Emory at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The local civil authorities asked that the Emory unit not introduce any untreated patient waste into the municipal waste stream. The staff disinfected with bleach or detergents all of the patients’ liquid wastes for more than 5 minutes before flushing them down the toilet.
And there was plenty of other potentially hazardous and infectious material that had to be addressed. At the peak of the patients’ illness, up to 40 bags a day of medical waste were being produced, said Dr. Mehta.
Initially, the hospital’s waste management contractor refused to pick up the medical waste for several days. To manage the situation temporarily, the Emory staff "went to Home Depot and bought up every large trash can and sealed canister that we could get," said Dr. Mehta. The filled cans were kept in a containment room until the hospital completed negotiations with the contractor to pick up the waste.
Even the commercial courier company that the hospital had always used to transport infectious and potentially lethal samples to the labs at the Centers for Disease Control and Prevention "suddenly said ‘no,’ " Dr. Mehta said. "If the label said ‘CDC’ on it, they refused to touch it."
Even some Emory staffers who had previously handled and packed dangerous samples for shipping refused to come to the isolation unit’s lab, said Dr. Mehta. The hospital’s safety officers had to train some of the dedicated Ebola staff to pack samples appropriately for shipping.
But even as the hospital dealt with these issues and the growing media circus, the Ebola staff stayed focused, Dr. Mehta said. "It was very chaotic outside, but very calm in the hospital and with our team."
The hospital spent a lot of time on communications – with the public, with staff, and with other patients in the hospital and their families. Emory held twice-daily town halls with staff to give information and answer questions, and also sent regular e-mail updates about the Ebola patients. Every inpatient and new admission was given a letter explaining why Emory had taken the patients, and physician and administrative leaders rounded throughout the hospital to answer questions.
Emory already had a "serious communicable diseases" unit, which it created in 2002 as a place to receive any CDC workers who might be exposed to pathogens on the job. The six-room unit has a patient room on each end, with a private bathroom in each, a staff dressing area, and an anteroom that was used as a staging area for nurses.
After the decision to accept the Ebola-infected patients, a new point-of-care lab facility was built in less than 72 hours in an adjoining office space, said Dr. Mehta. Having this kind of dedicated unit was not absolutely necessary, but it allowed the staff to more conveniently perform chemistry, hematology, blood gas, urinalysis, coagulation, and malaria tests and get immediate results. Having a dedicated lab space also limited the exposure fears of staff elsewhere in the hospital.
To prevent transmission of the virus, the unit followed the CDC’s recommendations, which included keeping a detailed log of anyone who entered and exited a patient room, using disposable equipment whenever possible, and using personal protective equipment that included gloves, fluid-resistant or impermeable gowns, and goggles or face shields. Initially, the Emory caregivers had leg and foot coverings because the patients had vomited blood before arriving, and one of the patients had fulminant diarrhea, up to four liters per day, said Dr. Mehta.
Because the disease can be transmitted from protective gear, all staff had a refresher course on appropriate use of the gear, everyone was observed by another team member when putting on or taking off the gear, and reminders about appropriate use of the gear were placed on the walls of the unit and in the changing area.
The clinical care team met every day to review plans and protocols and to answer staff questions. Twice daily, all personnel had to enter into an online registry their body temperatures and any symptoms. Dr. Mehta told the ICAAC audience that he had just completed his 21-day observation period.
The patient care itself was far from clear cut, as there is no proven treatment and Emory officials initially were not clear on the availability of any experimental therapy, said Dr. Mehta. The CDC helped to monitor the patients’ viral load, and both patients had marked electrolyte imbalances, including hypokalemia, hypocalcemia, and hyponatremia, as well as severe nutritional deficiencies. Both required significant potassium replacement.
Both patients received a three-dose course of Zmapp, which consists of three monoclonal antibodies and is under development by Mapp Biopharmaceutical. While in Africa, Dr. Brantly also had received a transfusion of plasma from a patient who was recovering from the Ebola virus.
High-level, one-on-one nursing care also was noted as a significant factor in patient recovery, said Dr. Mehta.
"It’s hard to derive a lot of meaningful data from the care of those two patients," Dr. Mehta said. It’s not clear yet which of these factors – Zmapp, the transfusion, the supportive care, or the combination – was responsible for the patients’ recovery.
Emory will publish its experiences in Ebola care, but "the real front line is in West Africa," Dr. Mehta added.
On Twitter @aliciaault
WASHINGTON – When two Ebola-infected patients were airlifted to Emory University Hospital in Atlanta in early August, dedicated staffers were prepared to care for the patients. But those staffers had to act quickly to deal with unanticipated challenges that came from regulators and some of the hospital’s contractors, who initially refused to dispose of the mountains of medical waste generated by the patients and the clinicians who cared for them, according to Dr. Aneesh Mehta.
Dr. Mehta, associate chief of Emory’s infectious disease service, was one of the primary attending physicians for Nancy Writebol and Dr. Kent Brantly, who recovered from their Ebola infections and were discharged from Emory’s isolation unit on Aug. 19 and Aug. 21.
The lessons learned from caring for these initial patients are now being applied to Emory’s latest Ebola-infected patient, who arrived at the facility from West Africa on Sept. 9, said Dr. Mehta, who spoke on the logistics, successes, and challenges of caring for Ebola-infected patients at Emory at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The local civil authorities asked that the Emory unit not introduce any untreated patient waste into the municipal waste stream. The staff disinfected with bleach or detergents all of the patients’ liquid wastes for more than 5 minutes before flushing them down the toilet.
And there was plenty of other potentially hazardous and infectious material that had to be addressed. At the peak of the patients’ illness, up to 40 bags a day of medical waste were being produced, said Dr. Mehta.
Initially, the hospital’s waste management contractor refused to pick up the medical waste for several days. To manage the situation temporarily, the Emory staff "went to Home Depot and bought up every large trash can and sealed canister that we could get," said Dr. Mehta. The filled cans were kept in a containment room until the hospital completed negotiations with the contractor to pick up the waste.
Even the commercial courier company that the hospital had always used to transport infectious and potentially lethal samples to the labs at the Centers for Disease Control and Prevention "suddenly said ‘no,’ " Dr. Mehta said. "If the label said ‘CDC’ on it, they refused to touch it."
Even some Emory staffers who had previously handled and packed dangerous samples for shipping refused to come to the isolation unit’s lab, said Dr. Mehta. The hospital’s safety officers had to train some of the dedicated Ebola staff to pack samples appropriately for shipping.
But even as the hospital dealt with these issues and the growing media circus, the Ebola staff stayed focused, Dr. Mehta said. "It was very chaotic outside, but very calm in the hospital and with our team."
The hospital spent a lot of time on communications – with the public, with staff, and with other patients in the hospital and their families. Emory held twice-daily town halls with staff to give information and answer questions, and also sent regular e-mail updates about the Ebola patients. Every inpatient and new admission was given a letter explaining why Emory had taken the patients, and physician and administrative leaders rounded throughout the hospital to answer questions.
Emory already had a "serious communicable diseases" unit, which it created in 2002 as a place to receive any CDC workers who might be exposed to pathogens on the job. The six-room unit has a patient room on each end, with a private bathroom in each, a staff dressing area, and an anteroom that was used as a staging area for nurses.
After the decision to accept the Ebola-infected patients, a new point-of-care lab facility was built in less than 72 hours in an adjoining office space, said Dr. Mehta. Having this kind of dedicated unit was not absolutely necessary, but it allowed the staff to more conveniently perform chemistry, hematology, blood gas, urinalysis, coagulation, and malaria tests and get immediate results. Having a dedicated lab space also limited the exposure fears of staff elsewhere in the hospital.
To prevent transmission of the virus, the unit followed the CDC’s recommendations, which included keeping a detailed log of anyone who entered and exited a patient room, using disposable equipment whenever possible, and using personal protective equipment that included gloves, fluid-resistant or impermeable gowns, and goggles or face shields. Initially, the Emory caregivers had leg and foot coverings because the patients had vomited blood before arriving, and one of the patients had fulminant diarrhea, up to four liters per day, said Dr. Mehta.
Because the disease can be transmitted from protective gear, all staff had a refresher course on appropriate use of the gear, everyone was observed by another team member when putting on or taking off the gear, and reminders about appropriate use of the gear were placed on the walls of the unit and in the changing area.
The clinical care team met every day to review plans and protocols and to answer staff questions. Twice daily, all personnel had to enter into an online registry their body temperatures and any symptoms. Dr. Mehta told the ICAAC audience that he had just completed his 21-day observation period.
The patient care itself was far from clear cut, as there is no proven treatment and Emory officials initially were not clear on the availability of any experimental therapy, said Dr. Mehta. The CDC helped to monitor the patients’ viral load, and both patients had marked electrolyte imbalances, including hypokalemia, hypocalcemia, and hyponatremia, as well as severe nutritional deficiencies. Both required significant potassium replacement.
Both patients received a three-dose course of Zmapp, which consists of three monoclonal antibodies and is under development by Mapp Biopharmaceutical. While in Africa, Dr. Brantly also had received a transfusion of plasma from a patient who was recovering from the Ebola virus.
High-level, one-on-one nursing care also was noted as a significant factor in patient recovery, said Dr. Mehta.
"It’s hard to derive a lot of meaningful data from the care of those two patients," Dr. Mehta said. It’s not clear yet which of these factors – Zmapp, the transfusion, the supportive care, or the combination – was responsible for the patients’ recovery.
Emory will publish its experiences in Ebola care, but "the real front line is in West Africa," Dr. Mehta added.
On Twitter @aliciaault
FDA panel backs diabetes drug for weight loss indication
A diabetes drug is now poised to become a weight loss therapeutic, even in patients without the condition, after a panel of Food and Drug Administration advisers recommended approval of liraglutide for weight management.
The glucagon-like peptide-1 receptor agonist, to be marketed as Saxenda by Novo Nordisk, has been on the market since 2010 for treatment of type 2 diabetes under the brand name Victoza. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 that Saxenda is safe and effective and should be approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of at least 30 kg/m2, or 27 kg/m2 with at least one weight-related comorbidity.
Liraglutide is marketed at a lower dose for diabetes – a 1.8-mg, once-daily dose that’s delivered subcutaneously through a pen-like device – than that proposed for weight management, which would be a 3-mg dose delivered the same way.
The vote to approve came despite the fact that even the lower dose of liraglutide currently carries a boxed warning about the potential for medullary thyroid (C-cell) tumors, and includes warnings and precautions about the potential for pancreatitis, serious hypoglycemia, renal impairment, and hypersensitivity. There also have been significant adverse events in clinical trials and reported to the FDA since the drug has been on the market, including nausea and vomiting and increases in heart rate.
In the phase III studies of Saxenda – which included more than 3,000 patients who took the drug – there were 48 cancers detected, including 7 C-cell thyroid tumors and 14 breast neoplasms.
The panel discussed at length whether the 3-mg dose may trigger more tumors or spur a greater incidence of other side effects, especially since the anticipated wider use may expose even more patients to the drug’s downsides.
Fourteen of the committee members put aside their concerns and voted for approval, but it was not cut-and-dried for all of them.
“For me it was more of a difficult decision rendering an opinion on the risk-benefit ratio,” said Dr. Kenneth Burman, acting chairperson of the committee.
He said he was not completely convinced that the risk for medullary thyroid tumors was minimal. Dr. Burman, director of the endocrine section at the Washington Hospital Center, also said that he was concerned that there was no real guidance on how long a patient should take liraglutide for weight management, especially if the effect plateaued as it did in trials, or was reversed.
Medullary tumors are rare in the general population, and though rare in the phase III clinical trials in 3-mg liraglutide, the data still suggested the possibility of an increased risk, said FDA reviewers. There was also a small excess risk of breast cancers in those trials, which suggested a potential signal, said Christian Hampp, Ph.D., a reviewer from the epidemiology division at the FDA’s Center for Drug Evaluation and Research.
However, Dr. Julie Golden, a medical officer in the FDA’s division of metabolism and endocrinology products, noted that there’s little evidence to suggest that liraglutide has a role in promoting breast cancer.
Panelist Barbara Hansen, Ph.D., agreed that there seemed to be little biological plausibility. “I’m happy with the amount of risk that has been identified,” said Dr. Hansen, professor of internal medicine, University of South Florida College of Medicine, Tampa. “I don’t see a signal there,” she said.
The majority of the committee agreed that liraglutide was effective for weight loss and met the FDA criteria, which was a 5% difference in mean weight loss between the drug and placebo; or at least 35% of patients on therapy losing at least 5% of their baseline weight and double the number on placebo who lost that much; and, improvement in cardiometabolic parameters.
More than 5,000 patients were enrolled in the four phase III trials; over 3,000 took the 3-mg dose of liraglutide. All patients were required to have a stable body weight and to have failed previous dietary intervention. Once in the study, they were told to reduce caloric intake by 500 kcal a day and to maintain or add at least 150 minutes week of physical activity.
The mean age was 47 years, and most participants were women. The mean BMI was 38 kg/m2.
In the largest trial, 3,731 patients were studied for 56 weeks, and were stratified by the presence or absence of prediabetes. Of patients taking liraglutide, 64% lost at least 5% of their body weight and 33% lost at least 10%, compared with 27% and 10% of the placebo patients, respectively. There were no significant differences in these endpoints between patients with prediabetes and those without.
Results were similar across the three other phase III studies, though not as pronounced. In addition, Novo Nordisk said that weight loss began to plateau for many patients at 34 weeks. Although liraglutide also helped reduce hypertension, blood lipids, blood glucose, and waist circumference, there were still signs that it might have some adverse cardiovascular effects.
Many panel members said they’d like to see more specific study of cardiovascular outcomes in patients taking a 3-mg dose.
Earlier this week, the FDA approved a combination drug, Contrave (naltrexone and bupropion) for weight management. If approved, Saxenda would be the fourth weight management drug on the U.S. market, after Contrave, the phentermine/topiramate combo Qsymia, and lorcaserin (Belviq).
The FDA is not bound by its advisory panels’ advice, but usually follows their recommendations.
On Twitter @aliciaault
A diabetes drug is now poised to become a weight loss therapeutic, even in patients without the condition, after a panel of Food and Drug Administration advisers recommended approval of liraglutide for weight management.
The glucagon-like peptide-1 receptor agonist, to be marketed as Saxenda by Novo Nordisk, has been on the market since 2010 for treatment of type 2 diabetes under the brand name Victoza. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 that Saxenda is safe and effective and should be approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of at least 30 kg/m2, or 27 kg/m2 with at least one weight-related comorbidity.
Liraglutide is marketed at a lower dose for diabetes – a 1.8-mg, once-daily dose that’s delivered subcutaneously through a pen-like device – than that proposed for weight management, which would be a 3-mg dose delivered the same way.
The vote to approve came despite the fact that even the lower dose of liraglutide currently carries a boxed warning about the potential for medullary thyroid (C-cell) tumors, and includes warnings and precautions about the potential for pancreatitis, serious hypoglycemia, renal impairment, and hypersensitivity. There also have been significant adverse events in clinical trials and reported to the FDA since the drug has been on the market, including nausea and vomiting and increases in heart rate.
In the phase III studies of Saxenda – which included more than 3,000 patients who took the drug – there were 48 cancers detected, including 7 C-cell thyroid tumors and 14 breast neoplasms.
The panel discussed at length whether the 3-mg dose may trigger more tumors or spur a greater incidence of other side effects, especially since the anticipated wider use may expose even more patients to the drug’s downsides.
Fourteen of the committee members put aside their concerns and voted for approval, but it was not cut-and-dried for all of them.
“For me it was more of a difficult decision rendering an opinion on the risk-benefit ratio,” said Dr. Kenneth Burman, acting chairperson of the committee.
He said he was not completely convinced that the risk for medullary thyroid tumors was minimal. Dr. Burman, director of the endocrine section at the Washington Hospital Center, also said that he was concerned that there was no real guidance on how long a patient should take liraglutide for weight management, especially if the effect plateaued as it did in trials, or was reversed.
Medullary tumors are rare in the general population, and though rare in the phase III clinical trials in 3-mg liraglutide, the data still suggested the possibility of an increased risk, said FDA reviewers. There was also a small excess risk of breast cancers in those trials, which suggested a potential signal, said Christian Hampp, Ph.D., a reviewer from the epidemiology division at the FDA’s Center for Drug Evaluation and Research.
However, Dr. Julie Golden, a medical officer in the FDA’s division of metabolism and endocrinology products, noted that there’s little evidence to suggest that liraglutide has a role in promoting breast cancer.
Panelist Barbara Hansen, Ph.D., agreed that there seemed to be little biological plausibility. “I’m happy with the amount of risk that has been identified,” said Dr. Hansen, professor of internal medicine, University of South Florida College of Medicine, Tampa. “I don’t see a signal there,” she said.
The majority of the committee agreed that liraglutide was effective for weight loss and met the FDA criteria, which was a 5% difference in mean weight loss between the drug and placebo; or at least 35% of patients on therapy losing at least 5% of their baseline weight and double the number on placebo who lost that much; and, improvement in cardiometabolic parameters.
More than 5,000 patients were enrolled in the four phase III trials; over 3,000 took the 3-mg dose of liraglutide. All patients were required to have a stable body weight and to have failed previous dietary intervention. Once in the study, they were told to reduce caloric intake by 500 kcal a day and to maintain or add at least 150 minutes week of physical activity.
The mean age was 47 years, and most participants were women. The mean BMI was 38 kg/m2.
In the largest trial, 3,731 patients were studied for 56 weeks, and were stratified by the presence or absence of prediabetes. Of patients taking liraglutide, 64% lost at least 5% of their body weight and 33% lost at least 10%, compared with 27% and 10% of the placebo patients, respectively. There were no significant differences in these endpoints between patients with prediabetes and those without.
Results were similar across the three other phase III studies, though not as pronounced. In addition, Novo Nordisk said that weight loss began to plateau for many patients at 34 weeks. Although liraglutide also helped reduce hypertension, blood lipids, blood glucose, and waist circumference, there were still signs that it might have some adverse cardiovascular effects.
Many panel members said they’d like to see more specific study of cardiovascular outcomes in patients taking a 3-mg dose.
Earlier this week, the FDA approved a combination drug, Contrave (naltrexone and bupropion) for weight management. If approved, Saxenda would be the fourth weight management drug on the U.S. market, after Contrave, the phentermine/topiramate combo Qsymia, and lorcaserin (Belviq).
The FDA is not bound by its advisory panels’ advice, but usually follows their recommendations.
On Twitter @aliciaault
A diabetes drug is now poised to become a weight loss therapeutic, even in patients without the condition, after a panel of Food and Drug Administration advisers recommended approval of liraglutide for weight management.
The glucagon-like peptide-1 receptor agonist, to be marketed as Saxenda by Novo Nordisk, has been on the market since 2010 for treatment of type 2 diabetes under the brand name Victoza. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 that Saxenda is safe and effective and should be approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of at least 30 kg/m2, or 27 kg/m2 with at least one weight-related comorbidity.
Liraglutide is marketed at a lower dose for diabetes – a 1.8-mg, once-daily dose that’s delivered subcutaneously through a pen-like device – than that proposed for weight management, which would be a 3-mg dose delivered the same way.
The vote to approve came despite the fact that even the lower dose of liraglutide currently carries a boxed warning about the potential for medullary thyroid (C-cell) tumors, and includes warnings and precautions about the potential for pancreatitis, serious hypoglycemia, renal impairment, and hypersensitivity. There also have been significant adverse events in clinical trials and reported to the FDA since the drug has been on the market, including nausea and vomiting and increases in heart rate.
In the phase III studies of Saxenda – which included more than 3,000 patients who took the drug – there were 48 cancers detected, including 7 C-cell thyroid tumors and 14 breast neoplasms.
The panel discussed at length whether the 3-mg dose may trigger more tumors or spur a greater incidence of other side effects, especially since the anticipated wider use may expose even more patients to the drug’s downsides.
Fourteen of the committee members put aside their concerns and voted for approval, but it was not cut-and-dried for all of them.
“For me it was more of a difficult decision rendering an opinion on the risk-benefit ratio,” said Dr. Kenneth Burman, acting chairperson of the committee.
He said he was not completely convinced that the risk for medullary thyroid tumors was minimal. Dr. Burman, director of the endocrine section at the Washington Hospital Center, also said that he was concerned that there was no real guidance on how long a patient should take liraglutide for weight management, especially if the effect plateaued as it did in trials, or was reversed.
Medullary tumors are rare in the general population, and though rare in the phase III clinical trials in 3-mg liraglutide, the data still suggested the possibility of an increased risk, said FDA reviewers. There was also a small excess risk of breast cancers in those trials, which suggested a potential signal, said Christian Hampp, Ph.D., a reviewer from the epidemiology division at the FDA’s Center for Drug Evaluation and Research.
However, Dr. Julie Golden, a medical officer in the FDA’s division of metabolism and endocrinology products, noted that there’s little evidence to suggest that liraglutide has a role in promoting breast cancer.
Panelist Barbara Hansen, Ph.D., agreed that there seemed to be little biological plausibility. “I’m happy with the amount of risk that has been identified,” said Dr. Hansen, professor of internal medicine, University of South Florida College of Medicine, Tampa. “I don’t see a signal there,” she said.
The majority of the committee agreed that liraglutide was effective for weight loss and met the FDA criteria, which was a 5% difference in mean weight loss between the drug and placebo; or at least 35% of patients on therapy losing at least 5% of their baseline weight and double the number on placebo who lost that much; and, improvement in cardiometabolic parameters.
More than 5,000 patients were enrolled in the four phase III trials; over 3,000 took the 3-mg dose of liraglutide. All patients were required to have a stable body weight and to have failed previous dietary intervention. Once in the study, they were told to reduce caloric intake by 500 kcal a day and to maintain or add at least 150 minutes week of physical activity.
The mean age was 47 years, and most participants were women. The mean BMI was 38 kg/m2.
In the largest trial, 3,731 patients were studied for 56 weeks, and were stratified by the presence or absence of prediabetes. Of patients taking liraglutide, 64% lost at least 5% of their body weight and 33% lost at least 10%, compared with 27% and 10% of the placebo patients, respectively. There were no significant differences in these endpoints between patients with prediabetes and those without.
Results were similar across the three other phase III studies, though not as pronounced. In addition, Novo Nordisk said that weight loss began to plateau for many patients at 34 weeks. Although liraglutide also helped reduce hypertension, blood lipids, blood glucose, and waist circumference, there were still signs that it might have some adverse cardiovascular effects.
Many panel members said they’d like to see more specific study of cardiovascular outcomes in patients taking a 3-mg dose.
Earlier this week, the FDA approved a combination drug, Contrave (naltrexone and bupropion) for weight management. If approved, Saxenda would be the fourth weight management drug on the U.S. market, after Contrave, the phentermine/topiramate combo Qsymia, and lorcaserin (Belviq).
The FDA is not bound by its advisory panels’ advice, but usually follows their recommendations.
On Twitter @aliciaault
AT AN FDA ADVISORY COMMITTEE MEETING
Microbiome-based Pill Holds Promise for Chronic C difficile
WASHINGTON – A rationally designed microbiome-based pill successfully eradicated recurrent Clostridium difficile infection in 29 of 30 patients in an early study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Preliminary data were presented at the 2014 James W. Freston Conference sponsored by the American Gastroenterological Association in August.
The patients in the phase I/II study were divided into two separate 15-patient cohorts and were given two different dose levels of the therapy, SER-109. The drug contains spores from gram-positive bacteria that are taken from stool and then purified to kill the vegetative bacteria, said David Cook, Ph.D., executive vice president and chief scientific officer of Cambridge, Mass.–based Seres Health.
The therapy appears to work by restoring the gut flora to a normal balance after having been disrupted by antibiotic treatment.
It is not the first attempt to encapsulate a fecal transplant; Dr. Thomas Louie of the University of Calgary (Alberta), presented data on his very effective formulation against C. difficile at the ID Week annual meeting in 2013.
In the current study, the first cohort received a mean dose of 1.5 × 109 spores and the second cohort received a dose of 1 × 108 spores. In the early studies, the number of pills given to achieve that dose varied. The aim is to contain the dose in a few tablets for a commercial product, Dr. Cook said.
All doses were given on 1 or 2 days at the study’s start; there was no need for additional doses.
Patients were as young as 22 years old and as old as 88 years, and all had three or more laboratory-confirmed C. difficile infections over the previous year. They had to have a life expectancy of 3 months or longer and be able to give informed consent. They were excluded if they had any immunosuppression, a history of irritable bowel disease, total colectomy, cirrhosis, a need for antibiotics within 6 weeks of baseline, prior fecal transplant, or if they were in intensive care. There were 10 women and five men in each cohort.
After patients stopped taking antibiotics, there was a washout period after which they took SER-109. Stool was collected on day four and at 1, 2, 4, 8, and 24 weeks. Efficacy was assessed at the 8-week time point.
In the first group, 13 of the 15 patients achieved the protocol-defined endpoint: absence of C. difficile over the 8 weeks.
The two patients who failed had self-limited, transient diarrhea with a positive C. difficile test, but neither required antibiotics and both recovered within 24 hours, so they were considered to not have recurrent C. difficile, said Dr. Cook. In the second cohort, 14 of the 15 patients were free of C. difficile at 8 weeks. The patient who failed had diarrhea and a positive C. difficile test, and the diarrhea did not resolve on its own. She required antibiotics to achieve remission.
There were no serious adverse events in the study.
The company hopes to eventually conduct a phase III study and seek Food and Drug Administration approval, but it is too early to say when that might occur, said Dr. Cook.
WASHINGTON – A rationally designed microbiome-based pill successfully eradicated recurrent Clostridium difficile infection in 29 of 30 patients in an early study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Preliminary data were presented at the 2014 James W. Freston Conference sponsored by the American Gastroenterological Association in August.
The patients in the phase I/II study were divided into two separate 15-patient cohorts and were given two different dose levels of the therapy, SER-109. The drug contains spores from gram-positive bacteria that are taken from stool and then purified to kill the vegetative bacteria, said David Cook, Ph.D., executive vice president and chief scientific officer of Cambridge, Mass.–based Seres Health.
The therapy appears to work by restoring the gut flora to a normal balance after having been disrupted by antibiotic treatment.
It is not the first attempt to encapsulate a fecal transplant; Dr. Thomas Louie of the University of Calgary (Alberta), presented data on his very effective formulation against C. difficile at the ID Week annual meeting in 2013.
In the current study, the first cohort received a mean dose of 1.5 × 109 spores and the second cohort received a dose of 1 × 108 spores. In the early studies, the number of pills given to achieve that dose varied. The aim is to contain the dose in a few tablets for a commercial product, Dr. Cook said.
All doses were given on 1 or 2 days at the study’s start; there was no need for additional doses.
Patients were as young as 22 years old and as old as 88 years, and all had three or more laboratory-confirmed C. difficile infections over the previous year. They had to have a life expectancy of 3 months or longer and be able to give informed consent. They were excluded if they had any immunosuppression, a history of irritable bowel disease, total colectomy, cirrhosis, a need for antibiotics within 6 weeks of baseline, prior fecal transplant, or if they were in intensive care. There were 10 women and five men in each cohort.
After patients stopped taking antibiotics, there was a washout period after which they took SER-109. Stool was collected on day four and at 1, 2, 4, 8, and 24 weeks. Efficacy was assessed at the 8-week time point.
In the first group, 13 of the 15 patients achieved the protocol-defined endpoint: absence of C. difficile over the 8 weeks.
The two patients who failed had self-limited, transient diarrhea with a positive C. difficile test, but neither required antibiotics and both recovered within 24 hours, so they were considered to not have recurrent C. difficile, said Dr. Cook. In the second cohort, 14 of the 15 patients were free of C. difficile at 8 weeks. The patient who failed had diarrhea and a positive C. difficile test, and the diarrhea did not resolve on its own. She required antibiotics to achieve remission.
There were no serious adverse events in the study.
The company hopes to eventually conduct a phase III study and seek Food and Drug Administration approval, but it is too early to say when that might occur, said Dr. Cook.
WASHINGTON – A rationally designed microbiome-based pill successfully eradicated recurrent Clostridium difficile infection in 29 of 30 patients in an early study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Preliminary data were presented at the 2014 James W. Freston Conference sponsored by the American Gastroenterological Association in August.
The patients in the phase I/II study were divided into two separate 15-patient cohorts and were given two different dose levels of the therapy, SER-109. The drug contains spores from gram-positive bacteria that are taken from stool and then purified to kill the vegetative bacteria, said David Cook, Ph.D., executive vice president and chief scientific officer of Cambridge, Mass.–based Seres Health.
The therapy appears to work by restoring the gut flora to a normal balance after having been disrupted by antibiotic treatment.
It is not the first attempt to encapsulate a fecal transplant; Dr. Thomas Louie of the University of Calgary (Alberta), presented data on his very effective formulation against C. difficile at the ID Week annual meeting in 2013.
In the current study, the first cohort received a mean dose of 1.5 × 109 spores and the second cohort received a dose of 1 × 108 spores. In the early studies, the number of pills given to achieve that dose varied. The aim is to contain the dose in a few tablets for a commercial product, Dr. Cook said.
All doses were given on 1 or 2 days at the study’s start; there was no need for additional doses.
Patients were as young as 22 years old and as old as 88 years, and all had three or more laboratory-confirmed C. difficile infections over the previous year. They had to have a life expectancy of 3 months or longer and be able to give informed consent. They were excluded if they had any immunosuppression, a history of irritable bowel disease, total colectomy, cirrhosis, a need for antibiotics within 6 weeks of baseline, prior fecal transplant, or if they were in intensive care. There were 10 women and five men in each cohort.
After patients stopped taking antibiotics, there was a washout period after which they took SER-109. Stool was collected on day four and at 1, 2, 4, 8, and 24 weeks. Efficacy was assessed at the 8-week time point.
In the first group, 13 of the 15 patients achieved the protocol-defined endpoint: absence of C. difficile over the 8 weeks.
The two patients who failed had self-limited, transient diarrhea with a positive C. difficile test, but neither required antibiotics and both recovered within 24 hours, so they were considered to not have recurrent C. difficile, said Dr. Cook. In the second cohort, 14 of the 15 patients were free of C. difficile at 8 weeks. The patient who failed had diarrhea and a positive C. difficile test, and the diarrhea did not resolve on its own. She required antibiotics to achieve remission.
There were no serious adverse events in the study.
The company hopes to eventually conduct a phase III study and seek Food and Drug Administration approval, but it is too early to say when that might occur, said Dr. Cook.
AT ICAAC 2014
Microbiome-based pill holds promise for chronic C. difficile
WASHINGTON – A rationally designed microbiome-based pill successfully eradicated recurrent Clostridium difficile infection in 29 of 30 patients in an early study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Preliminary data were presented at the 2014 James W. Freston Conference sponsored by the American Gastroenterological Association in August.
The patients in the phase I/II study were divided into two separate 15-patient cohorts and were given two different dose levels of the therapy, SER-109. The drug contains spores from gram-positive bacteria that are taken from stool and then purified to kill the vegetative bacteria, said David Cook, Ph.D., executive vice president and chief scientific officer of Cambridge, Mass.–based Seres Health.
The therapy appears to work by restoring the gut flora to a normal balance after having been disrupted by antibiotic treatment.
It is not the first attempt to encapsulate a fecal transplant; Dr. Thomas Louie of the University of Calgary (Alberta), presented data on his very effective formulation against C. difficile at the ID Week annual meeting in 2013.
In the current study, the first cohort received a mean dose of 1.5 × 109 spores and the second cohort received a dose of 1 × 108 spores. In the early studies, the number of pills given to achieve that dose varied. The aim is to contain the dose in a few tablets for a commercial product, Dr. Cook said.
All doses were given on 1 or 2 days at the study’s start; there was no need for additional doses.
Patients were as young as 22 years old and as old as 88 years, and all had three or more laboratory-confirmed C. difficile infections over the previous year. They had to have a life expectancy of 3 months or longer and be able to give informed consent. They were excluded if they had any immunosuppression, a history of irritable bowel disease, total colectomy, cirrhosis, a need for antibiotics within 6 weeks of baseline, prior fecal transplant, or if they were in intensive care. There were 10 women and five men in each cohort.
After patients stopped taking antibiotics, there was a washout period after which they took SER-109. Stool was collected on day four and at 1, 2, 4, 8, and 24 weeks. Efficacy was assessed at the 8-week time point.
In the first group, 13 of the 15 patients achieved the protocol-defined endpoint: absence of C. difficile over the 8 weeks.
The two patients who failed had self-limited, transient diarrhea with a positive C. difficile test, but neither required antibiotics and both recovered within 24 hours, so they were considered to not have recurrent C. difficile, said Dr. Cook. In the second cohort, 14 of the 15 patients were free of C. difficile at 8 weeks. The patient who failed had diarrhea and a positive C. difficile test, and the diarrhea did not resolve on its own. She required antibiotics to achieve remission.
There were no serious adverse events in the study.
The company hopes to eventually conduct a phase III study and seek Food and Drug Administration approval, but it is too early to say when that might occur, said Dr. Cook.
On Twitter @aliciaault
This story was updated on October 14.
The AGA hosted the annual James W. Freston conference in Chicago this August, and this year's topic was therapeutic innovations in microbiome research and technology, with a focus on fecal microbiota transplantation (FMT). There were more than 140 participants from 16 countries present to discuss evolving research and clinical approaches to FMT.
The 2-day meeting opened with lectures highlighting evolving knowledge about the human microbiome, and how quickly its composition can change with environmental exposures such as travel or diet. These were followed by additional presentations about FMT as a treatment for Clostridium difficile and inflammatory bowel disease, and intriguing work on the role of the gut microbiome in the metabolic syndrome. There were many productive discussions among the FMT enthusiasts, some of which are summarized in this issue of GI & Hepatology News. The final session of the meeting featured presentations about institutional review board regulation of trials involving FMT, and updates from the Food and Drug Administration.
It is clear that FMT is an effective treatment for recurrent C. diff., and may even be positioned as an earlier treatment option for some patients. The short-term safety of FMT in existing trials is reassuring, but there was general consensus at the meeting that we need further study of long-term outcomes of recipients. In the United States, the FDA has relaxed its stance on FMT for recurrent C. diff., but an investigational new drug application must be filed with the FDA for its use for any other purposes. Studies of FMT for inflammatory bowel diseases, irritable bowel syndrome, and other conditions are quite limited at this time, and it is clear that additional research is needed before we will understand the associations and potential causality related to the microbiome. In addition, there is a desperate need for further understanding of the complex ecology of the gut microbiome as well as what additional viruses, phages, and proteins may be transferred from a donor to recipient.
Patients have eagerly embraced FMT as a potential treatment for a variety of illnesses, but the evidence for safety and efficacy for any conditions beyond C. diff. is lacking. Therefore, many attendees at the conference emphasized the need for better education about the potential risks and the need for more study.
The Freston conference was a great success, and highlighted some of the important progress that has been made in understanding the human microbiome and its therapeutic potential, but also underscored the near-term research priorities and safety concerns.
Dr. David T. Rubin is Joseph B. Kirsner Professor of Medicine, section chief of gastroenterology, hepatology and nutrition, and codirector of the Digestive Diseases Center, University of Chicago. He was co-course director of the Freston conference with Dr. Stacy Kahn.
The AGA hosted the annual James W. Freston conference in Chicago this August, and this year's topic was therapeutic innovations in microbiome research and technology, with a focus on fecal microbiota transplantation (FMT). There were more than 140 participants from 16 countries present to discuss evolving research and clinical approaches to FMT.
The 2-day meeting opened with lectures highlighting evolving knowledge about the human microbiome, and how quickly its composition can change with environmental exposures such as travel or diet. These were followed by additional presentations about FMT as a treatment for Clostridium difficile and inflammatory bowel disease, and intriguing work on the role of the gut microbiome in the metabolic syndrome. There were many productive discussions among the FMT enthusiasts, some of which are summarized in this issue of GI & Hepatology News. The final session of the meeting featured presentations about institutional review board regulation of trials involving FMT, and updates from the Food and Drug Administration.
It is clear that FMT is an effective treatment for recurrent C. diff., and may even be positioned as an earlier treatment option for some patients. The short-term safety of FMT in existing trials is reassuring, but there was general consensus at the meeting that we need further study of long-term outcomes of recipients. In the United States, the FDA has relaxed its stance on FMT for recurrent C. diff., but an investigational new drug application must be filed with the FDA for its use for any other purposes. Studies of FMT for inflammatory bowel diseases, irritable bowel syndrome, and other conditions are quite limited at this time, and it is clear that additional research is needed before we will understand the associations and potential causality related to the microbiome. In addition, there is a desperate need for further understanding of the complex ecology of the gut microbiome as well as what additional viruses, phages, and proteins may be transferred from a donor to recipient.
Patients have eagerly embraced FMT as a potential treatment for a variety of illnesses, but the evidence for safety and efficacy for any conditions beyond C. diff. is lacking. Therefore, many attendees at the conference emphasized the need for better education about the potential risks and the need for more study.
The Freston conference was a great success, and highlighted some of the important progress that has been made in understanding the human microbiome and its therapeutic potential, but also underscored the near-term research priorities and safety concerns.
Dr. David T. Rubin is Joseph B. Kirsner Professor of Medicine, section chief of gastroenterology, hepatology and nutrition, and codirector of the Digestive Diseases Center, University of Chicago. He was co-course director of the Freston conference with Dr. Stacy Kahn.
The AGA hosted the annual James W. Freston conference in Chicago this August, and this year's topic was therapeutic innovations in microbiome research and technology, with a focus on fecal microbiota transplantation (FMT). There were more than 140 participants from 16 countries present to discuss evolving research and clinical approaches to FMT.
The 2-day meeting opened with lectures highlighting evolving knowledge about the human microbiome, and how quickly its composition can change with environmental exposures such as travel or diet. These were followed by additional presentations about FMT as a treatment for Clostridium difficile and inflammatory bowel disease, and intriguing work on the role of the gut microbiome in the metabolic syndrome. There were many productive discussions among the FMT enthusiasts, some of which are summarized in this issue of GI & Hepatology News. The final session of the meeting featured presentations about institutional review board regulation of trials involving FMT, and updates from the Food and Drug Administration.
It is clear that FMT is an effective treatment for recurrent C. diff., and may even be positioned as an earlier treatment option for some patients. The short-term safety of FMT in existing trials is reassuring, but there was general consensus at the meeting that we need further study of long-term outcomes of recipients. In the United States, the FDA has relaxed its stance on FMT for recurrent C. diff., but an investigational new drug application must be filed with the FDA for its use for any other purposes. Studies of FMT for inflammatory bowel diseases, irritable bowel syndrome, and other conditions are quite limited at this time, and it is clear that additional research is needed before we will understand the associations and potential causality related to the microbiome. In addition, there is a desperate need for further understanding of the complex ecology of the gut microbiome as well as what additional viruses, phages, and proteins may be transferred from a donor to recipient.
Patients have eagerly embraced FMT as a potential treatment for a variety of illnesses, but the evidence for safety and efficacy for any conditions beyond C. diff. is lacking. Therefore, many attendees at the conference emphasized the need for better education about the potential risks and the need for more study.
The Freston conference was a great success, and highlighted some of the important progress that has been made in understanding the human microbiome and its therapeutic potential, but also underscored the near-term research priorities and safety concerns.
Dr. David T. Rubin is Joseph B. Kirsner Professor of Medicine, section chief of gastroenterology, hepatology and nutrition, and codirector of the Digestive Diseases Center, University of Chicago. He was co-course director of the Freston conference with Dr. Stacy Kahn.
WASHINGTON – A rationally designed microbiome-based pill successfully eradicated recurrent Clostridium difficile infection in 29 of 30 patients in an early study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Preliminary data were presented at the 2014 James W. Freston Conference sponsored by the American Gastroenterological Association in August.
The patients in the phase I/II study were divided into two separate 15-patient cohorts and were given two different dose levels of the therapy, SER-109. The drug contains spores from gram-positive bacteria that are taken from stool and then purified to kill the vegetative bacteria, said David Cook, Ph.D., executive vice president and chief scientific officer of Cambridge, Mass.–based Seres Health.
The therapy appears to work by restoring the gut flora to a normal balance after having been disrupted by antibiotic treatment.
It is not the first attempt to encapsulate a fecal transplant; Dr. Thomas Louie of the University of Calgary (Alberta), presented data on his very effective formulation against C. difficile at the ID Week annual meeting in 2013.
In the current study, the first cohort received a mean dose of 1.5 × 109 spores and the second cohort received a dose of 1 × 108 spores. In the early studies, the number of pills given to achieve that dose varied. The aim is to contain the dose in a few tablets for a commercial product, Dr. Cook said.
All doses were given on 1 or 2 days at the study’s start; there was no need for additional doses.
Patients were as young as 22 years old and as old as 88 years, and all had three or more laboratory-confirmed C. difficile infections over the previous year. They had to have a life expectancy of 3 months or longer and be able to give informed consent. They were excluded if they had any immunosuppression, a history of irritable bowel disease, total colectomy, cirrhosis, a need for antibiotics within 6 weeks of baseline, prior fecal transplant, or if they were in intensive care. There were 10 women and five men in each cohort.
After patients stopped taking antibiotics, there was a washout period after which they took SER-109. Stool was collected on day four and at 1, 2, 4, 8, and 24 weeks. Efficacy was assessed at the 8-week time point.
In the first group, 13 of the 15 patients achieved the protocol-defined endpoint: absence of C. difficile over the 8 weeks.
The two patients who failed had self-limited, transient diarrhea with a positive C. difficile test, but neither required antibiotics and both recovered within 24 hours, so they were considered to not have recurrent C. difficile, said Dr. Cook. In the second cohort, 14 of the 15 patients were free of C. difficile at 8 weeks. The patient who failed had diarrhea and a positive C. difficile test, and the diarrhea did not resolve on its own. She required antibiotics to achieve remission.
There were no serious adverse events in the study.
The company hopes to eventually conduct a phase III study and seek Food and Drug Administration approval, but it is too early to say when that might occur, said Dr. Cook.
On Twitter @aliciaault
This story was updated on October 14.
WASHINGTON – A rationally designed microbiome-based pill successfully eradicated recurrent Clostridium difficile infection in 29 of 30 patients in an early study presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Preliminary data were presented at the 2014 James W. Freston Conference sponsored by the American Gastroenterological Association in August.
The patients in the phase I/II study were divided into two separate 15-patient cohorts and were given two different dose levels of the therapy, SER-109. The drug contains spores from gram-positive bacteria that are taken from stool and then purified to kill the vegetative bacteria, said David Cook, Ph.D., executive vice president and chief scientific officer of Cambridge, Mass.–based Seres Health.
The therapy appears to work by restoring the gut flora to a normal balance after having been disrupted by antibiotic treatment.
It is not the first attempt to encapsulate a fecal transplant; Dr. Thomas Louie of the University of Calgary (Alberta), presented data on his very effective formulation against C. difficile at the ID Week annual meeting in 2013.
In the current study, the first cohort received a mean dose of 1.5 × 109 spores and the second cohort received a dose of 1 × 108 spores. In the early studies, the number of pills given to achieve that dose varied. The aim is to contain the dose in a few tablets for a commercial product, Dr. Cook said.
All doses were given on 1 or 2 days at the study’s start; there was no need for additional doses.
Patients were as young as 22 years old and as old as 88 years, and all had three or more laboratory-confirmed C. difficile infections over the previous year. They had to have a life expectancy of 3 months or longer and be able to give informed consent. They were excluded if they had any immunosuppression, a history of irritable bowel disease, total colectomy, cirrhosis, a need for antibiotics within 6 weeks of baseline, prior fecal transplant, or if they were in intensive care. There were 10 women and five men in each cohort.
After patients stopped taking antibiotics, there was a washout period after which they took SER-109. Stool was collected on day four and at 1, 2, 4, 8, and 24 weeks. Efficacy was assessed at the 8-week time point.
In the first group, 13 of the 15 patients achieved the protocol-defined endpoint: absence of C. difficile over the 8 weeks.
The two patients who failed had self-limited, transient diarrhea with a positive C. difficile test, but neither required antibiotics and both recovered within 24 hours, so they were considered to not have recurrent C. difficile, said Dr. Cook. In the second cohort, 14 of the 15 patients were free of C. difficile at 8 weeks. The patient who failed had diarrhea and a positive C. difficile test, and the diarrhea did not resolve on its own. She required antibiotics to achieve remission.
There were no serious adverse events in the study.
The company hopes to eventually conduct a phase III study and seek Food and Drug Administration approval, but it is too early to say when that might occur, said Dr. Cook.
On Twitter @aliciaault
This story was updated on October 14.
AT ICAAC 2014
Key clinical point: A new oral medication might eventually replace fecal transplants.
Major finding: Recurrent Clostridium difficile infection was eradicated in 29 of 30 patients.
Data source: Open-label prospective study that assessed absence of C. difficile at 8 weeks post therapy.
Disclosures: The study was sponsored by Seres Health. Dr. Cook is a Seres employee.
MOC changes haven’t quieted uprising
The American Board of Internal Medicine is making several changes to its maintenance of certification requirements, but, so far, it is not enough to quell the still-growing tide of anger and resentment against the process.
The ABIM announced the changes just ahead of a July 15 "summit" with 26 specialty societies that receive certification through the organization, and outlined them in a detailed letter that was sent to internal medicine diplomates on July 28. That correspondence also responded in detail to a May 7 letter sent by the American College of Physicians (ACP) on behalf of 14 medical societies, enumerating their concerns about the process.
The American Gastroenterological Association, which attended the July 15 meeting, has a number of concerns about the administrative burden of maintenance of certification, the cost of the requirements, and implications for failing to complete a flawed process.
Dr. Lawrence S. Kim, AGAF, who’s in private practice in Denver, attended the meeting on behalf of the AGA. He noted that "gastroenterologists feel increasingly threatened by recent changes to the ABIM recertification process. We are all struggling to adapt to a brave new world of narrowing networks and ever-increasing public scrutiny. In this milieu, loss of board certification represents a true calamity to the professional lives of our physicians and in many cases, presents a truly existential threat to their livelihoods."
Recently, the AGA Governing Board discussed why the ABIM is in charge of saying what the requirements are for keeping certification in gastroenterology.
"It’s time to take charge of our profession and be proactive, setting the criteria for recertification in our specialty. To that end, AGA has joined with other societies to advocate for changes to the system. We have visited the ABIM to share concerns and push for changes to help GIs meet the requirements," said Dr. Suzanne Rose, AGA Governing Board Education Councillor.
Meanwhile, 3,000 or so physicians have signed on to a "Pledge of Non-Compliance" with the ABIM’s requirements. The pledge was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology at the Scripps Clinic, La Jolla, Calif., and colleagues who have formed Physicians for Certification Change, an anti-MOC organization. Dr. Teirstein also launched a petition drive in March to overhaul the MOC process. That petition had about 18,000 signees at press time.
There are several other organizations hoping to derail or significantly change the ABIM’s requirements, including the Association of American Physicians and Surgeons, Change Board Certification, and Docs4PatientCare. In addition, many of the 26 professional societies, including AGA, whose members are certified by the ABIM, have been very organized in presenting their discontent.
The ABIM understands the frustration, said Dr. Richard Baron, ABIM president and chief executive officer, in an interview. "One of the things that people have said is that we’re not listening," he said. That is one reason why the ABIM decided to hold what he called a "listening session" on July 15. "We’re a learning organization," he added, noting that the ABIM will "continue to evolve the program," based on the feedback it receives from individuals and from professional societies, among others.
Dr. Baron also acknowledges that by presenting an entirely new MOC process this year, "our timing was not propitious." The ABIM outlined pressures on physicians in the July 28 letter, counting among them "dealing with the Affordable Care Act," fulfilling meaningful use requirements, and responding to changes in payment and practice models, including team-based care.
The ABIM is making a handful of changes to address some of the concerns, including "broadening the kinds of educational activities that can count for self-assessment of knowledge," said Dr. Baron. That is, the ABIM will be broadening the continuing medical education that will count toward the self-assessment of medical knowledge portion of the MOC requirements. Physicians must earn 100 MOC points every 5 years. At least 20 points must be self-assessment of medical knowledge and at least 20 points must be self-evaluation of practice assessment. The remaining 60 points can be either type of MOC.
There have also been a huge number of complaints about the self-evaluation of practice assessment MOC, often referred to as practice improvement modules or PIM’s. There will be less direct data collection by the ABIM, and more of a focus "on improvement activities doctors may already be doing in their practice," Dr. Baron said.
But Dr. Kim noted that it might not be that simple. Existing EMR products do not have the capability to assess most subspecialty-specific measures. "We urge the ABIM to bring its influence to bear on the health IT industry, to develop standardized templates and reports," said Dr. Kim. Ideally, maintenance of certification practice assessments will harmonize with federal quality reporting programs.
Among other things, ABIM is also looking at changes to the secure exam and whether it needs to change how it describes on its website whether physicians are meeting MOC requirements (see related story on p. 5 for more details on ABIM changes).
However, many at the July meeting questioned whether the current exam truly reflects physicians’ clinical abilities. Pass rates for the recertification exam have steadily declined over recent years for many subspecialties. AGA has communicated this concern to ABIM on several occasions, helping to instigate the new changes to ABIM’s governance and operational structure.
"AGA wants a role in determining the components of recertification. We will ensure the requirements are a reflection of competent clinical practice," said Dr. Rose.
Despite the newly announced changes from ABIM, critics remain dissatisfied.
Dr. Ron Benbassat, an internist in Beverly Hills, Calif. and a founder of Change Board Certification, said, "No one is drinking the ABIM’s Koolaid." He added, "The momentum is increasing and I believe we’re reaching the tipping point. As to what form it will take – widespread noncompliance or political or legal, I don’t have the answer."
Dr. Teirstein was a bit more muted in his criticism. "They are certainly taking many good steps. But, the devil will be in the details." He, like many physicians, said that he still sees the ABIM’s fees as a big problem. "To reestablish credibility, ABIM will need to roll back its fee schedule," said Dr. Teirstein.
The ABIM charges $1,940 for a 10-year basic internal medicine certification, which includes a secure examination for each specialty the diplomate chooses to maintain, access to all ABIM self-evaluation products, and any CME credit a physician can claim through completion of an ABIM module. There are basically four requirements: MOC participants have to take a secure exam; they have to complete a module that contains knowledge and patient management questions; another module is on practice improvement; and, a third covers a survey of patient safety and satisfaction.
The fees vary for different practices within the field of internal medicine: $2,060 for a focused practice in hospital medicine for 10 years and $2,560 for any subspecialty – including gastroenterology – for the 10 years.
"Physicians are forced to spend unreasonable time and expense to collect this data," says Dr. Kim. "The time needed to fulfill new expanded MOC requirements should not come at the expense of time spent on patient care."
The ABIM said in its July 28 letter that extensive evidence does exist that the ABIM process works – with more than half of the studies coming from non-ABIM researchers – but that maybe it hasn’t done the best job of communicating that to diplomates. However, it does say it welcomes partnering on new projects "and a broader discussion of [sic] potential research agenda."
Many say that they are in favor of requiring lifelong learning, but that the ABIM has gone about it the wrong way. Dr. Steven Weinberger, chief executive of the ACP, said that his organization wants to see more customization of the secure board exam "so that it’s more relevant to a particular physician’s practice."
Many who attended the ABIM’s July 15 meeting said that they felt like the organization had heard their concerns. But they are still waiting to see what will happen next.
The changes already announced "are a very good start," said Dr. Weinberger, who said that the ACP hopes that the ABIM board might make more changes at its meeting in August.
Likewise, Dr. Eric Green, chair of the MOC Task Force at the Society of General Internal Medicine, said that the SGIM would continue to work in cooperation with the ABIM. The question is how much the ABIM will use the input from the subspecialty societies, he said.
Dr. Christopher White, professor and chairman of medicine at the Ochsner Clinical School, New Orleans, a founding member of Physicians for Certification Change, who has signed the pledge of noncompliance, is a bit more skeptical. "I think the ABIM is going to have to be a lot less arrogant," he said, calling for more accountability by the organization.
The American Board of Internal Medicine is making several changes to its maintenance of certification requirements, but, so far, it is not enough to quell the still-growing tide of anger and resentment against the process.
The ABIM announced the changes just ahead of a July 15 "summit" with 26 specialty societies that receive certification through the organization, and outlined them in a detailed letter that was sent to internal medicine diplomates on July 28. That correspondence also responded in detail to a May 7 letter sent by the American College of Physicians (ACP) on behalf of 14 medical societies, enumerating their concerns about the process.
The American Gastroenterological Association, which attended the July 15 meeting, has a number of concerns about the administrative burden of maintenance of certification, the cost of the requirements, and implications for failing to complete a flawed process.
Dr. Lawrence S. Kim, AGAF, who’s in private practice in Denver, attended the meeting on behalf of the AGA. He noted that "gastroenterologists feel increasingly threatened by recent changes to the ABIM recertification process. We are all struggling to adapt to a brave new world of narrowing networks and ever-increasing public scrutiny. In this milieu, loss of board certification represents a true calamity to the professional lives of our physicians and in many cases, presents a truly existential threat to their livelihoods."
Recently, the AGA Governing Board discussed why the ABIM is in charge of saying what the requirements are for keeping certification in gastroenterology.
"It’s time to take charge of our profession and be proactive, setting the criteria for recertification in our specialty. To that end, AGA has joined with other societies to advocate for changes to the system. We have visited the ABIM to share concerns and push for changes to help GIs meet the requirements," said Dr. Suzanne Rose, AGA Governing Board Education Councillor.
Meanwhile, 3,000 or so physicians have signed on to a "Pledge of Non-Compliance" with the ABIM’s requirements. The pledge was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology at the Scripps Clinic, La Jolla, Calif., and colleagues who have formed Physicians for Certification Change, an anti-MOC organization. Dr. Teirstein also launched a petition drive in March to overhaul the MOC process. That petition had about 18,000 signees at press time.
There are several other organizations hoping to derail or significantly change the ABIM’s requirements, including the Association of American Physicians and Surgeons, Change Board Certification, and Docs4PatientCare. In addition, many of the 26 professional societies, including AGA, whose members are certified by the ABIM, have been very organized in presenting their discontent.
The ABIM understands the frustration, said Dr. Richard Baron, ABIM president and chief executive officer, in an interview. "One of the things that people have said is that we’re not listening," he said. That is one reason why the ABIM decided to hold what he called a "listening session" on July 15. "We’re a learning organization," he added, noting that the ABIM will "continue to evolve the program," based on the feedback it receives from individuals and from professional societies, among others.
Dr. Baron also acknowledges that by presenting an entirely new MOC process this year, "our timing was not propitious." The ABIM outlined pressures on physicians in the July 28 letter, counting among them "dealing with the Affordable Care Act," fulfilling meaningful use requirements, and responding to changes in payment and practice models, including team-based care.
The ABIM is making a handful of changes to address some of the concerns, including "broadening the kinds of educational activities that can count for self-assessment of knowledge," said Dr. Baron. That is, the ABIM will be broadening the continuing medical education that will count toward the self-assessment of medical knowledge portion of the MOC requirements. Physicians must earn 100 MOC points every 5 years. At least 20 points must be self-assessment of medical knowledge and at least 20 points must be self-evaluation of practice assessment. The remaining 60 points can be either type of MOC.
There have also been a huge number of complaints about the self-evaluation of practice assessment MOC, often referred to as practice improvement modules or PIM’s. There will be less direct data collection by the ABIM, and more of a focus "on improvement activities doctors may already be doing in their practice," Dr. Baron said.
But Dr. Kim noted that it might not be that simple. Existing EMR products do not have the capability to assess most subspecialty-specific measures. "We urge the ABIM to bring its influence to bear on the health IT industry, to develop standardized templates and reports," said Dr. Kim. Ideally, maintenance of certification practice assessments will harmonize with federal quality reporting programs.
Among other things, ABIM is also looking at changes to the secure exam and whether it needs to change how it describes on its website whether physicians are meeting MOC requirements (see related story on p. 5 for more details on ABIM changes).
However, many at the July meeting questioned whether the current exam truly reflects physicians’ clinical abilities. Pass rates for the recertification exam have steadily declined over recent years for many subspecialties. AGA has communicated this concern to ABIM on several occasions, helping to instigate the new changes to ABIM’s governance and operational structure.
"AGA wants a role in determining the components of recertification. We will ensure the requirements are a reflection of competent clinical practice," said Dr. Rose.
Despite the newly announced changes from ABIM, critics remain dissatisfied.
Dr. Ron Benbassat, an internist in Beverly Hills, Calif. and a founder of Change Board Certification, said, "No one is drinking the ABIM’s Koolaid." He added, "The momentum is increasing and I believe we’re reaching the tipping point. As to what form it will take – widespread noncompliance or political or legal, I don’t have the answer."
Dr. Teirstein was a bit more muted in his criticism. "They are certainly taking many good steps. But, the devil will be in the details." He, like many physicians, said that he still sees the ABIM’s fees as a big problem. "To reestablish credibility, ABIM will need to roll back its fee schedule," said Dr. Teirstein.
The ABIM charges $1,940 for a 10-year basic internal medicine certification, which includes a secure examination for each specialty the diplomate chooses to maintain, access to all ABIM self-evaluation products, and any CME credit a physician can claim through completion of an ABIM module. There are basically four requirements: MOC participants have to take a secure exam; they have to complete a module that contains knowledge and patient management questions; another module is on practice improvement; and, a third covers a survey of patient safety and satisfaction.
The fees vary for different practices within the field of internal medicine: $2,060 for a focused practice in hospital medicine for 10 years and $2,560 for any subspecialty – including gastroenterology – for the 10 years.
"Physicians are forced to spend unreasonable time and expense to collect this data," says Dr. Kim. "The time needed to fulfill new expanded MOC requirements should not come at the expense of time spent on patient care."
The ABIM said in its July 28 letter that extensive evidence does exist that the ABIM process works – with more than half of the studies coming from non-ABIM researchers – but that maybe it hasn’t done the best job of communicating that to diplomates. However, it does say it welcomes partnering on new projects "and a broader discussion of [sic] potential research agenda."
Many say that they are in favor of requiring lifelong learning, but that the ABIM has gone about it the wrong way. Dr. Steven Weinberger, chief executive of the ACP, said that his organization wants to see more customization of the secure board exam "so that it’s more relevant to a particular physician’s practice."
Many who attended the ABIM’s July 15 meeting said that they felt like the organization had heard their concerns. But they are still waiting to see what will happen next.
The changes already announced "are a very good start," said Dr. Weinberger, who said that the ACP hopes that the ABIM board might make more changes at its meeting in August.
Likewise, Dr. Eric Green, chair of the MOC Task Force at the Society of General Internal Medicine, said that the SGIM would continue to work in cooperation with the ABIM. The question is how much the ABIM will use the input from the subspecialty societies, he said.
Dr. Christopher White, professor and chairman of medicine at the Ochsner Clinical School, New Orleans, a founding member of Physicians for Certification Change, who has signed the pledge of noncompliance, is a bit more skeptical. "I think the ABIM is going to have to be a lot less arrogant," he said, calling for more accountability by the organization.
The American Board of Internal Medicine is making several changes to its maintenance of certification requirements, but, so far, it is not enough to quell the still-growing tide of anger and resentment against the process.
The ABIM announced the changes just ahead of a July 15 "summit" with 26 specialty societies that receive certification through the organization, and outlined them in a detailed letter that was sent to internal medicine diplomates on July 28. That correspondence also responded in detail to a May 7 letter sent by the American College of Physicians (ACP) on behalf of 14 medical societies, enumerating their concerns about the process.
The American Gastroenterological Association, which attended the July 15 meeting, has a number of concerns about the administrative burden of maintenance of certification, the cost of the requirements, and implications for failing to complete a flawed process.
Dr. Lawrence S. Kim, AGAF, who’s in private practice in Denver, attended the meeting on behalf of the AGA. He noted that "gastroenterologists feel increasingly threatened by recent changes to the ABIM recertification process. We are all struggling to adapt to a brave new world of narrowing networks and ever-increasing public scrutiny. In this milieu, loss of board certification represents a true calamity to the professional lives of our physicians and in many cases, presents a truly existential threat to their livelihoods."
Recently, the AGA Governing Board discussed why the ABIM is in charge of saying what the requirements are for keeping certification in gastroenterology.
"It’s time to take charge of our profession and be proactive, setting the criteria for recertification in our specialty. To that end, AGA has joined with other societies to advocate for changes to the system. We have visited the ABIM to share concerns and push for changes to help GIs meet the requirements," said Dr. Suzanne Rose, AGA Governing Board Education Councillor.
Meanwhile, 3,000 or so physicians have signed on to a "Pledge of Non-Compliance" with the ABIM’s requirements. The pledge was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology at the Scripps Clinic, La Jolla, Calif., and colleagues who have formed Physicians for Certification Change, an anti-MOC organization. Dr. Teirstein also launched a petition drive in March to overhaul the MOC process. That petition had about 18,000 signees at press time.
There are several other organizations hoping to derail or significantly change the ABIM’s requirements, including the Association of American Physicians and Surgeons, Change Board Certification, and Docs4PatientCare. In addition, many of the 26 professional societies, including AGA, whose members are certified by the ABIM, have been very organized in presenting their discontent.
The ABIM understands the frustration, said Dr. Richard Baron, ABIM president and chief executive officer, in an interview. "One of the things that people have said is that we’re not listening," he said. That is one reason why the ABIM decided to hold what he called a "listening session" on July 15. "We’re a learning organization," he added, noting that the ABIM will "continue to evolve the program," based on the feedback it receives from individuals and from professional societies, among others.
Dr. Baron also acknowledges that by presenting an entirely new MOC process this year, "our timing was not propitious." The ABIM outlined pressures on physicians in the July 28 letter, counting among them "dealing with the Affordable Care Act," fulfilling meaningful use requirements, and responding to changes in payment and practice models, including team-based care.
The ABIM is making a handful of changes to address some of the concerns, including "broadening the kinds of educational activities that can count for self-assessment of knowledge," said Dr. Baron. That is, the ABIM will be broadening the continuing medical education that will count toward the self-assessment of medical knowledge portion of the MOC requirements. Physicians must earn 100 MOC points every 5 years. At least 20 points must be self-assessment of medical knowledge and at least 20 points must be self-evaluation of practice assessment. The remaining 60 points can be either type of MOC.
There have also been a huge number of complaints about the self-evaluation of practice assessment MOC, often referred to as practice improvement modules or PIM’s. There will be less direct data collection by the ABIM, and more of a focus "on improvement activities doctors may already be doing in their practice," Dr. Baron said.
But Dr. Kim noted that it might not be that simple. Existing EMR products do not have the capability to assess most subspecialty-specific measures. "We urge the ABIM to bring its influence to bear on the health IT industry, to develop standardized templates and reports," said Dr. Kim. Ideally, maintenance of certification practice assessments will harmonize with federal quality reporting programs.
Among other things, ABIM is also looking at changes to the secure exam and whether it needs to change how it describes on its website whether physicians are meeting MOC requirements (see related story on p. 5 for more details on ABIM changes).
However, many at the July meeting questioned whether the current exam truly reflects physicians’ clinical abilities. Pass rates for the recertification exam have steadily declined over recent years for many subspecialties. AGA has communicated this concern to ABIM on several occasions, helping to instigate the new changes to ABIM’s governance and operational structure.
"AGA wants a role in determining the components of recertification. We will ensure the requirements are a reflection of competent clinical practice," said Dr. Rose.
Despite the newly announced changes from ABIM, critics remain dissatisfied.
Dr. Ron Benbassat, an internist in Beverly Hills, Calif. and a founder of Change Board Certification, said, "No one is drinking the ABIM’s Koolaid." He added, "The momentum is increasing and I believe we’re reaching the tipping point. As to what form it will take – widespread noncompliance or political or legal, I don’t have the answer."
Dr. Teirstein was a bit more muted in his criticism. "They are certainly taking many good steps. But, the devil will be in the details." He, like many physicians, said that he still sees the ABIM’s fees as a big problem. "To reestablish credibility, ABIM will need to roll back its fee schedule," said Dr. Teirstein.
The ABIM charges $1,940 for a 10-year basic internal medicine certification, which includes a secure examination for each specialty the diplomate chooses to maintain, access to all ABIM self-evaluation products, and any CME credit a physician can claim through completion of an ABIM module. There are basically four requirements: MOC participants have to take a secure exam; they have to complete a module that contains knowledge and patient management questions; another module is on practice improvement; and, a third covers a survey of patient safety and satisfaction.
The fees vary for different practices within the field of internal medicine: $2,060 for a focused practice in hospital medicine for 10 years and $2,560 for any subspecialty – including gastroenterology – for the 10 years.
"Physicians are forced to spend unreasonable time and expense to collect this data," says Dr. Kim. "The time needed to fulfill new expanded MOC requirements should not come at the expense of time spent on patient care."
The ABIM said in its July 28 letter that extensive evidence does exist that the ABIM process works – with more than half of the studies coming from non-ABIM researchers – but that maybe it hasn’t done the best job of communicating that to diplomates. However, it does say it welcomes partnering on new projects "and a broader discussion of [sic] potential research agenda."
Many say that they are in favor of requiring lifelong learning, but that the ABIM has gone about it the wrong way. Dr. Steven Weinberger, chief executive of the ACP, said that his organization wants to see more customization of the secure board exam "so that it’s more relevant to a particular physician’s practice."
Many who attended the ABIM’s July 15 meeting said that they felt like the organization had heard their concerns. But they are still waiting to see what will happen next.
The changes already announced "are a very good start," said Dr. Weinberger, who said that the ACP hopes that the ABIM board might make more changes at its meeting in August.
Likewise, Dr. Eric Green, chair of the MOC Task Force at the Society of General Internal Medicine, said that the SGIM would continue to work in cooperation with the ABIM. The question is how much the ABIM will use the input from the subspecialty societies, he said.
Dr. Christopher White, professor and chairman of medicine at the Ochsner Clinical School, New Orleans, a founding member of Physicians for Certification Change, who has signed the pledge of noncompliance, is a bit more skeptical. "I think the ABIM is going to have to be a lot less arrogant," he said, calling for more accountability by the organization.
Emory’s Ebola experience held logistical surprises
WASHINGTON – When two Ebola-infected patients were airlifted to Emory University Hospital in Atlanta in early August, dedicated staffers were prepared to care for the patients. But those staffers had to act quickly to deal with unanticipated challenges that came from regulators and some of the hospital’s contractors, who initially refused to dispose of the mountains of medical waste generated by the patients and the clinicians who cared for them, according to Dr. Aneesh Mehta.
Dr. Mehta, associate chief of Emory’s infectious disease service, was one of the primary attending physicians for Nancy Writebol and Dr. Kent Brantly, who recovered from their Ebola infections and were discharged from Emory’s isolation unit on Aug. 19 and Aug. 21.
The lessons learned from caring for these initial patients are now being applied to Emory’s latest Ebola-infected patient, who arrived at the facility from West Africa on Sept. 9, said Dr. Mehta, who spoke on the logistics, successes, and challenges of caring for Ebola-infected patients at Emory at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The local civil authorities asked that the Emory unit not introduce any untreated patient waste into the municipal waste stream. The staff disinfected with bleach or detergents all of the patients’ liquid wastes for more than 5 minutes before flushing them down the toilet.
And there was plenty of other potentially hazardous and infectious material that had to be addressed. At the peak of the patients’ illness, up to 40 bags a day of medical waste were being produced, said Dr. Mehta.
Initially, the hospital’s waste management contractor refused to pick up the medical waste for several days. To manage the situation temporarily, the Emory staff "went to Home Depot and bought up every large trash can and sealed canister that we could get," said Dr. Mehta. The filled cans were kept in a containment room until the hospital completed negotiations with the contractor to pick up the waste.
Even the commercial courier company that the hospital had always used to transport infectious and potentially lethal samples to the labs at the Centers for Disease Control and Prevention "suddenly said ‘no,’ " Dr. Mehta said. "If the label said ‘CDC’ on it, they refused to touch it."
Even some Emory staffers who had previously handled and packed dangerous samples for shipping refused to come to the isolation unit’s lab, said Dr. Mehta. The hospital’s safety officers had to train some of the dedicated Ebola staff to pack samples appropriately for shipping.
But even as the hospital dealt with these issues and the growing media circus, the Ebola staff stayed focused, Dr. Mehta said. "It was very chaotic outside, but very calm in the hospital and with our team."
The hospital spent a lot of time on communications – with the public, with staff, and with other patients in the hospital and their families. Emory held twice-daily town halls with staff to give information and answer questions, and also sent regular e-mail updates about the Ebola patients. Every inpatient and new admission was given a letter explaining why Emory had taken the patients, and physician and administrative leaders rounded throughout the hospital to answer questions.
Emory already had a "serious communicable diseases" unit, which it created in 2002 as a place to receive any CDC workers who might be exposed to pathogens on the job. The six-room unit has a patient room on each end, with a private bathroom in each, a staff dressing area, and an anteroom that was used as a staging area for nurses.
After the decision to accept the Ebola-infected patients, a new point-of-care lab facility was built in less than 72 hours in an adjoining office space, said Dr. Mehta. Having this kind of dedicated unit was not absolutely necessary, but it allowed the staff to more conveniently perform chemistry, hematology, blood gas, urinalysis, coagulation, and malaria tests and get immediate results. Having a dedicated lab space also limited the exposure fears of staff elsewhere in the hospital.
To prevent transmission of the virus, the unit followed the CDC’s recommendations, which included keeping a detailed log of anyone who entered and exited a patient room, using disposable equipment whenever possible, and using personal protective equipment that included gloves, fluid-resistant or impermeable gowns, and goggles or face shields. Initially, the Emory caregivers had leg and foot coverings because the patients had vomited blood before arriving, and one of the patients had fulminant diarrhea, up to four liters per day, said Dr. Mehta.
Because the disease can be transmitted from protective gear, all staff had a refresher course on appropriate use of the gear, everyone was observed by another team member when putting on or taking off the gear, and reminders about appropriate use of the gear were placed on the walls of the unit and in the changing area.
The clinical care team met every day to review plans and protocols and to answer staff questions. Twice daily, all personnel had to enter into an online registry their body temperatures and any symptoms. Dr. Mehta told the ICAAC audience that he had just completed his 21-day observation period.
The patient care itself was far from clear cut, as there is no proven treatment and Emory officials initially were not clear on the availability of any experimental therapy, said Dr. Mehta. The CDC helped to monitor the patients’ viral load, and both patients had marked electrolyte imbalances, including hypokalemia, hypocalcemia, and hyponatremia, as well as severe nutritional deficiencies. Both required significant potassium replacement.
Both patients received a three-dose course of Zmapp, which consists of three monoclonal antibodies and is under development by Mapp Biopharmaceutical. While in Africa, Dr. Brantly also had received a transfusion of plasma from a patient who was recovering from the Ebola virus.
High-level, one-on-one nursing care also was noted as a significant factor in patient recovery, said Dr. Mehta.
"It’s hard to derive a lot of meaningful data from the care of those two patients," Dr. Mehta said. It’s not clear yet which of these factors – Zmapp, the transfusion, the supportive care, or the combination – was responsible for the patients’ recovery.
Emory will publish its experiences in Ebola care, but "the real front line is in West Africa," Dr. Mehta added.
On Twitter @aliciaault
WASHINGTON – When two Ebola-infected patients were airlifted to Emory University Hospital in Atlanta in early August, dedicated staffers were prepared to care for the patients. But those staffers had to act quickly to deal with unanticipated challenges that came from regulators and some of the hospital’s contractors, who initially refused to dispose of the mountains of medical waste generated by the patients and the clinicians who cared for them, according to Dr. Aneesh Mehta.
Dr. Mehta, associate chief of Emory’s infectious disease service, was one of the primary attending physicians for Nancy Writebol and Dr. Kent Brantly, who recovered from their Ebola infections and were discharged from Emory’s isolation unit on Aug. 19 and Aug. 21.
The lessons learned from caring for these initial patients are now being applied to Emory’s latest Ebola-infected patient, who arrived at the facility from West Africa on Sept. 9, said Dr. Mehta, who spoke on the logistics, successes, and challenges of caring for Ebola-infected patients at Emory at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The local civil authorities asked that the Emory unit not introduce any untreated patient waste into the municipal waste stream. The staff disinfected with bleach or detergents all of the patients’ liquid wastes for more than 5 minutes before flushing them down the toilet.
And there was plenty of other potentially hazardous and infectious material that had to be addressed. At the peak of the patients’ illness, up to 40 bags a day of medical waste were being produced, said Dr. Mehta.
Initially, the hospital’s waste management contractor refused to pick up the medical waste for several days. To manage the situation temporarily, the Emory staff "went to Home Depot and bought up every large trash can and sealed canister that we could get," said Dr. Mehta. The filled cans were kept in a containment room until the hospital completed negotiations with the contractor to pick up the waste.
Even the commercial courier company that the hospital had always used to transport infectious and potentially lethal samples to the labs at the Centers for Disease Control and Prevention "suddenly said ‘no,’ " Dr. Mehta said. "If the label said ‘CDC’ on it, they refused to touch it."
Even some Emory staffers who had previously handled and packed dangerous samples for shipping refused to come to the isolation unit’s lab, said Dr. Mehta. The hospital’s safety officers had to train some of the dedicated Ebola staff to pack samples appropriately for shipping.
But even as the hospital dealt with these issues and the growing media circus, the Ebola staff stayed focused, Dr. Mehta said. "It was very chaotic outside, but very calm in the hospital and with our team."
The hospital spent a lot of time on communications – with the public, with staff, and with other patients in the hospital and their families. Emory held twice-daily town halls with staff to give information and answer questions, and also sent regular e-mail updates about the Ebola patients. Every inpatient and new admission was given a letter explaining why Emory had taken the patients, and physician and administrative leaders rounded throughout the hospital to answer questions.
Emory already had a "serious communicable diseases" unit, which it created in 2002 as a place to receive any CDC workers who might be exposed to pathogens on the job. The six-room unit has a patient room on each end, with a private bathroom in each, a staff dressing area, and an anteroom that was used as a staging area for nurses.
After the decision to accept the Ebola-infected patients, a new point-of-care lab facility was built in less than 72 hours in an adjoining office space, said Dr. Mehta. Having this kind of dedicated unit was not absolutely necessary, but it allowed the staff to more conveniently perform chemistry, hematology, blood gas, urinalysis, coagulation, and malaria tests and get immediate results. Having a dedicated lab space also limited the exposure fears of staff elsewhere in the hospital.
To prevent transmission of the virus, the unit followed the CDC’s recommendations, which included keeping a detailed log of anyone who entered and exited a patient room, using disposable equipment whenever possible, and using personal protective equipment that included gloves, fluid-resistant or impermeable gowns, and goggles or face shields. Initially, the Emory caregivers had leg and foot coverings because the patients had vomited blood before arriving, and one of the patients had fulminant diarrhea, up to four liters per day, said Dr. Mehta.
Because the disease can be transmitted from protective gear, all staff had a refresher course on appropriate use of the gear, everyone was observed by another team member when putting on or taking off the gear, and reminders about appropriate use of the gear were placed on the walls of the unit and in the changing area.
The clinical care team met every day to review plans and protocols and to answer staff questions. Twice daily, all personnel had to enter into an online registry their body temperatures and any symptoms. Dr. Mehta told the ICAAC audience that he had just completed his 21-day observation period.
The patient care itself was far from clear cut, as there is no proven treatment and Emory officials initially were not clear on the availability of any experimental therapy, said Dr. Mehta. The CDC helped to monitor the patients’ viral load, and both patients had marked electrolyte imbalances, including hypokalemia, hypocalcemia, and hyponatremia, as well as severe nutritional deficiencies. Both required significant potassium replacement.
Both patients received a three-dose course of Zmapp, which consists of three monoclonal antibodies and is under development by Mapp Biopharmaceutical. While in Africa, Dr. Brantly also had received a transfusion of plasma from a patient who was recovering from the Ebola virus.
High-level, one-on-one nursing care also was noted as a significant factor in patient recovery, said Dr. Mehta.
"It’s hard to derive a lot of meaningful data from the care of those two patients," Dr. Mehta said. It’s not clear yet which of these factors – Zmapp, the transfusion, the supportive care, or the combination – was responsible for the patients’ recovery.
Emory will publish its experiences in Ebola care, but "the real front line is in West Africa," Dr. Mehta added.
On Twitter @aliciaault
WASHINGTON – When two Ebola-infected patients were airlifted to Emory University Hospital in Atlanta in early August, dedicated staffers were prepared to care for the patients. But those staffers had to act quickly to deal with unanticipated challenges that came from regulators and some of the hospital’s contractors, who initially refused to dispose of the mountains of medical waste generated by the patients and the clinicians who cared for them, according to Dr. Aneesh Mehta.
Dr. Mehta, associate chief of Emory’s infectious disease service, was one of the primary attending physicians for Nancy Writebol and Dr. Kent Brantly, who recovered from their Ebola infections and were discharged from Emory’s isolation unit on Aug. 19 and Aug. 21.
The lessons learned from caring for these initial patients are now being applied to Emory’s latest Ebola-infected patient, who arrived at the facility from West Africa on Sept. 9, said Dr. Mehta, who spoke on the logistics, successes, and challenges of caring for Ebola-infected patients at Emory at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The local civil authorities asked that the Emory unit not introduce any untreated patient waste into the municipal waste stream. The staff disinfected with bleach or detergents all of the patients’ liquid wastes for more than 5 minutes before flushing them down the toilet.
And there was plenty of other potentially hazardous and infectious material that had to be addressed. At the peak of the patients’ illness, up to 40 bags a day of medical waste were being produced, said Dr. Mehta.
Initially, the hospital’s waste management contractor refused to pick up the medical waste for several days. To manage the situation temporarily, the Emory staff "went to Home Depot and bought up every large trash can and sealed canister that we could get," said Dr. Mehta. The filled cans were kept in a containment room until the hospital completed negotiations with the contractor to pick up the waste.
Even the commercial courier company that the hospital had always used to transport infectious and potentially lethal samples to the labs at the Centers for Disease Control and Prevention "suddenly said ‘no,’ " Dr. Mehta said. "If the label said ‘CDC’ on it, they refused to touch it."
Even some Emory staffers who had previously handled and packed dangerous samples for shipping refused to come to the isolation unit’s lab, said Dr. Mehta. The hospital’s safety officers had to train some of the dedicated Ebola staff to pack samples appropriately for shipping.
But even as the hospital dealt with these issues and the growing media circus, the Ebola staff stayed focused, Dr. Mehta said. "It was very chaotic outside, but very calm in the hospital and with our team."
The hospital spent a lot of time on communications – with the public, with staff, and with other patients in the hospital and their families. Emory held twice-daily town halls with staff to give information and answer questions, and also sent regular e-mail updates about the Ebola patients. Every inpatient and new admission was given a letter explaining why Emory had taken the patients, and physician and administrative leaders rounded throughout the hospital to answer questions.
Emory already had a "serious communicable diseases" unit, which it created in 2002 as a place to receive any CDC workers who might be exposed to pathogens on the job. The six-room unit has a patient room on each end, with a private bathroom in each, a staff dressing area, and an anteroom that was used as a staging area for nurses.
After the decision to accept the Ebola-infected patients, a new point-of-care lab facility was built in less than 72 hours in an adjoining office space, said Dr. Mehta. Having this kind of dedicated unit was not absolutely necessary, but it allowed the staff to more conveniently perform chemistry, hematology, blood gas, urinalysis, coagulation, and malaria tests and get immediate results. Having a dedicated lab space also limited the exposure fears of staff elsewhere in the hospital.
To prevent transmission of the virus, the unit followed the CDC’s recommendations, which included keeping a detailed log of anyone who entered and exited a patient room, using disposable equipment whenever possible, and using personal protective equipment that included gloves, fluid-resistant or impermeable gowns, and goggles or face shields. Initially, the Emory caregivers had leg and foot coverings because the patients had vomited blood before arriving, and one of the patients had fulminant diarrhea, up to four liters per day, said Dr. Mehta.
Because the disease can be transmitted from protective gear, all staff had a refresher course on appropriate use of the gear, everyone was observed by another team member when putting on or taking off the gear, and reminders about appropriate use of the gear were placed on the walls of the unit and in the changing area.
The clinical care team met every day to review plans and protocols and to answer staff questions. Twice daily, all personnel had to enter into an online registry their body temperatures and any symptoms. Dr. Mehta told the ICAAC audience that he had just completed his 21-day observation period.
The patient care itself was far from clear cut, as there is no proven treatment and Emory officials initially were not clear on the availability of any experimental therapy, said Dr. Mehta. The CDC helped to monitor the patients’ viral load, and both patients had marked electrolyte imbalances, including hypokalemia, hypocalcemia, and hyponatremia, as well as severe nutritional deficiencies. Both required significant potassium replacement.
Both patients received a three-dose course of Zmapp, which consists of three monoclonal antibodies and is under development by Mapp Biopharmaceutical. While in Africa, Dr. Brantly also had received a transfusion of plasma from a patient who was recovering from the Ebola virus.
High-level, one-on-one nursing care also was noted as a significant factor in patient recovery, said Dr. Mehta.
"It’s hard to derive a lot of meaningful data from the care of those two patients," Dr. Mehta said. It’s not clear yet which of these factors – Zmapp, the transfusion, the supportive care, or the combination – was responsible for the patients’ recovery.
Emory will publish its experiences in Ebola care, but "the real front line is in West Africa," Dr. Mehta added.
On Twitter @aliciaault
AT ICAAC 2014
Risk of multidrug-resistant gram-negative infections rose 1% per day of hospitalization
WASHINGTON – With each day of hospitalization, the risk rises by 1% for contracting an infection with a gram-negative, multidrug-resistant organism, based on results from a single-hospital retrospective study.
While conventional wisdom holds that infection risk increases with duration of hospitalization, the study is the first to quantify the potential risk of contracting a multidrug-resistant infection based on length of stay. And while the results may not be applicable to all patients at all hospitals, the findings do give clinicians a sense of the risk posed by a prolonged stay, according to John A. Bosso, Pharm.D., a professor in the College of Pharmacy at the Medical University of South Carolina, Charleston.
Dr. Bosso and his colleagues focused on gram-negative organisms because a colleague had compiled data for 949 episodes of documented gram-negative infections that occurred between 1998 and 2011 at the university hospital. A statement issued at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy noted that the Centers for Disease Control and Prevention has estimated that on any given day, 1 in 25 hospitalized patients has at least one health care–associated infection, and about a third of these are caused by gram-negative bacteria.
The study defined drug-resistant organisms as those that did not respond to treatment with one or more agents in three or more antibiotic classes. The five classes of antibiotics used in the cases studied included aminoglycosides, penicillins, cephalosporins, fluoroquinolones, and folic acid inhibitors. The largest percentage of isolates (38%) was taken from patients with blood stream infections; 29% had pneumonia, 23% had surgical site infections, 6% had urinary tract infections, and 4% had other infections.
Of the 949 organisms reviewed, 251 (26%) were determined to be multidrug resistant.
Ultimately, the type of infection was found to be unrelated to whether a patient had a multidrug-resistant infection. Certain pathogens were more likely to be multidrug resistant. About 56% of Enterobacter isolates, for example, were multidrug resistant as compared with 20% of all other organisms. Alternatively, Pseudomonas isolates were 44% less likely than other isolates to be multidrug resistant.
Length of stay seemed to have the greatest impact on contracting multidrug-resistant strains of gram-negative organisms, with risk maximizing at 10 days of hospitalization. Each day of hospitalization increased the likelihood of multidrug resistance by 1%, Dr. Bosso said.
The researchers were unable to determine the proportion of patients who were already colonized with a multidrug-resistant strain at admission from those who acquired their infections while hospitalized, said Dr. Bosso.
Dr. Bosso reported no financial conflicts of interest.
On Twitter @aliciaault
WASHINGTON – With each day of hospitalization, the risk rises by 1% for contracting an infection with a gram-negative, multidrug-resistant organism, based on results from a single-hospital retrospective study.
While conventional wisdom holds that infection risk increases with duration of hospitalization, the study is the first to quantify the potential risk of contracting a multidrug-resistant infection based on length of stay. And while the results may not be applicable to all patients at all hospitals, the findings do give clinicians a sense of the risk posed by a prolonged stay, according to John A. Bosso, Pharm.D., a professor in the College of Pharmacy at the Medical University of South Carolina, Charleston.
Dr. Bosso and his colleagues focused on gram-negative organisms because a colleague had compiled data for 949 episodes of documented gram-negative infections that occurred between 1998 and 2011 at the university hospital. A statement issued at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy noted that the Centers for Disease Control and Prevention has estimated that on any given day, 1 in 25 hospitalized patients has at least one health care–associated infection, and about a third of these are caused by gram-negative bacteria.
The study defined drug-resistant organisms as those that did not respond to treatment with one or more agents in three or more antibiotic classes. The five classes of antibiotics used in the cases studied included aminoglycosides, penicillins, cephalosporins, fluoroquinolones, and folic acid inhibitors. The largest percentage of isolates (38%) was taken from patients with blood stream infections; 29% had pneumonia, 23% had surgical site infections, 6% had urinary tract infections, and 4% had other infections.
Of the 949 organisms reviewed, 251 (26%) were determined to be multidrug resistant.
Ultimately, the type of infection was found to be unrelated to whether a patient had a multidrug-resistant infection. Certain pathogens were more likely to be multidrug resistant. About 56% of Enterobacter isolates, for example, were multidrug resistant as compared with 20% of all other organisms. Alternatively, Pseudomonas isolates were 44% less likely than other isolates to be multidrug resistant.
Length of stay seemed to have the greatest impact on contracting multidrug-resistant strains of gram-negative organisms, with risk maximizing at 10 days of hospitalization. Each day of hospitalization increased the likelihood of multidrug resistance by 1%, Dr. Bosso said.
The researchers were unable to determine the proportion of patients who were already colonized with a multidrug-resistant strain at admission from those who acquired their infections while hospitalized, said Dr. Bosso.
Dr. Bosso reported no financial conflicts of interest.
On Twitter @aliciaault
WASHINGTON – With each day of hospitalization, the risk rises by 1% for contracting an infection with a gram-negative, multidrug-resistant organism, based on results from a single-hospital retrospective study.
While conventional wisdom holds that infection risk increases with duration of hospitalization, the study is the first to quantify the potential risk of contracting a multidrug-resistant infection based on length of stay. And while the results may not be applicable to all patients at all hospitals, the findings do give clinicians a sense of the risk posed by a prolonged stay, according to John A. Bosso, Pharm.D., a professor in the College of Pharmacy at the Medical University of South Carolina, Charleston.
Dr. Bosso and his colleagues focused on gram-negative organisms because a colleague had compiled data for 949 episodes of documented gram-negative infections that occurred between 1998 and 2011 at the university hospital. A statement issued at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy noted that the Centers for Disease Control and Prevention has estimated that on any given day, 1 in 25 hospitalized patients has at least one health care–associated infection, and about a third of these are caused by gram-negative bacteria.
The study defined drug-resistant organisms as those that did not respond to treatment with one or more agents in three or more antibiotic classes. The five classes of antibiotics used in the cases studied included aminoglycosides, penicillins, cephalosporins, fluoroquinolones, and folic acid inhibitors. The largest percentage of isolates (38%) was taken from patients with blood stream infections; 29% had pneumonia, 23% had surgical site infections, 6% had urinary tract infections, and 4% had other infections.
Of the 949 organisms reviewed, 251 (26%) were determined to be multidrug resistant.
Ultimately, the type of infection was found to be unrelated to whether a patient had a multidrug-resistant infection. Certain pathogens were more likely to be multidrug resistant. About 56% of Enterobacter isolates, for example, were multidrug resistant as compared with 20% of all other organisms. Alternatively, Pseudomonas isolates were 44% less likely than other isolates to be multidrug resistant.
Length of stay seemed to have the greatest impact on contracting multidrug-resistant strains of gram-negative organisms, with risk maximizing at 10 days of hospitalization. Each day of hospitalization increased the likelihood of multidrug resistance by 1%, Dr. Bosso said.
The researchers were unable to determine the proportion of patients who were already colonized with a multidrug-resistant strain at admission from those who acquired their infections while hospitalized, said Dr. Bosso.
Dr. Bosso reported no financial conflicts of interest.
On Twitter @aliciaault
AT ICAAC 2014
Key clinical point: Risk of multidrug-resistant gram-negative infections rise with length of stay.
Major finding: With each day of hospitalization, the risk of a multidrug resistant gram-negative infection rose by 1%.
Data source: A single-hospital review of 949 documented cases of gram-negative infections from 1998 to 2011.
Disclosures: The authors reported no financial conflicts.
TURQUOISE regimen active against HCV-HIV coinfection
WASHINGTON – Early studies show that a new, combined antiviral regimen seems to suppress hepatitis C viremia while keeping HIV viremia stable in coinfected patients.
Dr. Joseph Eron presented phase II data from 63 patients who were enrolled in TURQUOISE-I. A total of 94% (59/63) of patients achieved a sustained virologic response (SVR) 12 weeks after completing 12 weeks of therapy, and 61 of 63 patients achieved an SVR 4 weeks after completing 12 or 24 weeks of therapy, Dr. Eron reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The regimen included ABT-450 (an NS3-4A protease inhibitor that was identified by AbbVie and Enanta), which was combined with ritonavir and ombitasvir (another AbbVie drug, also known as ABT-267) into a single tablet, plus dasabuvir (ABT-333) and ribavirin. Ombitasvir is an NS5A inhibitor and dasabuvir is a non-nucleoside NS5B polymerase inhibitor.
To be included in TURQUOISE-I, patients have to be aged 18-70 years; be treatment naive or have previous pegylated interferon/ribavirin treatment experience; have hepatitis C virus (HCV) genotype 1 infection; have plasma HIV-1 RNA less than 40 copies/mL; and be taking a stable, qualifying HIV-1 antiretroviral therapy regimen, said Dr. Eron, a professor of medicine at the University of North Carolina, Chapel Hill.
Patients with cirrhosis are not excluded, but will not be enrolled if they have had prior therapy with direct-acting antivirals for HCV, or any current or past clinical evidence of liver decompensation.
All patients will be followed for 48 weeks after therapy is stopped. Thirty-one patients were given therapy for 12 weeks and then assessed for SVR at 12 weeks. Thirty-two patients were given therapy for 24 weeks and assessed 4 weeks later. Patients also were evaluated for end-of-treatment response, on-treatment virologic failure, and post-treatment HCV viral relapse.
At baseline, 59 patients in each arm were male, and 16 were African American. The mean age was 51 years. Six patients in each arm (19%) had cirrhosis. A high proportion in each arm (53/63 in the 12-week and 49/63 in the 24-week arm) had the interleukin-28B genotype, which is known to indicate a much harder-to-treat disease, Dr. Eron said.
At the end of treatment, only one patient in each arm was not responsive. Four weeks post therapy, 29 of 31 patients in the 12-week arm and 31 of 32 patients in the 24-week arm had an SVR.
Two patients had virologic failure. Both had been unresponsive to previous therapies, and both had the IL-28B genotype and resistance-associated variants at the time of failure.
No patient withdrew because of adverse events, but about 90% (57/63) experienced some side effect, with the most common being fatigue and insomnia. Six patients had to reduce their ribavirin dose because of a decline in hemoglobin levels, but they were still responsive to therapy. Five patients had a confirmed increase in HIV RNA higher than 40 copies/mL, but not above 200 copies/mL, said Dr. Eron. And all the patients remained suppressed on the same HIV regimen and without interrupting their HCV therapy, he said.
Soon, a cohort of patients on stable darunavir antiretroviral therapy will be enrolled and given the three-drug HCV regimen for 12 weeks. The full global TURQUOISE study will begin later in 2014, Dr. Eron said.
The study was sponsored by AbbVie. Dr. Eron received grant and research support from, and/or served as a consultant to, AbbVie, Bristol-Myers Squibb, and other companies. Other authors had numerous additional disclosures.
On Twitter @aliciaault
WASHINGTON – Early studies show that a new, combined antiviral regimen seems to suppress hepatitis C viremia while keeping HIV viremia stable in coinfected patients.
Dr. Joseph Eron presented phase II data from 63 patients who were enrolled in TURQUOISE-I. A total of 94% (59/63) of patients achieved a sustained virologic response (SVR) 12 weeks after completing 12 weeks of therapy, and 61 of 63 patients achieved an SVR 4 weeks after completing 12 or 24 weeks of therapy, Dr. Eron reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The regimen included ABT-450 (an NS3-4A protease inhibitor that was identified by AbbVie and Enanta), which was combined with ritonavir and ombitasvir (another AbbVie drug, also known as ABT-267) into a single tablet, plus dasabuvir (ABT-333) and ribavirin. Ombitasvir is an NS5A inhibitor and dasabuvir is a non-nucleoside NS5B polymerase inhibitor.
To be included in TURQUOISE-I, patients have to be aged 18-70 years; be treatment naive or have previous pegylated interferon/ribavirin treatment experience; have hepatitis C virus (HCV) genotype 1 infection; have plasma HIV-1 RNA less than 40 copies/mL; and be taking a stable, qualifying HIV-1 antiretroviral therapy regimen, said Dr. Eron, a professor of medicine at the University of North Carolina, Chapel Hill.
Patients with cirrhosis are not excluded, but will not be enrolled if they have had prior therapy with direct-acting antivirals for HCV, or any current or past clinical evidence of liver decompensation.
All patients will be followed for 48 weeks after therapy is stopped. Thirty-one patients were given therapy for 12 weeks and then assessed for SVR at 12 weeks. Thirty-two patients were given therapy for 24 weeks and assessed 4 weeks later. Patients also were evaluated for end-of-treatment response, on-treatment virologic failure, and post-treatment HCV viral relapse.
At baseline, 59 patients in each arm were male, and 16 were African American. The mean age was 51 years. Six patients in each arm (19%) had cirrhosis. A high proportion in each arm (53/63 in the 12-week and 49/63 in the 24-week arm) had the interleukin-28B genotype, which is known to indicate a much harder-to-treat disease, Dr. Eron said.
At the end of treatment, only one patient in each arm was not responsive. Four weeks post therapy, 29 of 31 patients in the 12-week arm and 31 of 32 patients in the 24-week arm had an SVR.
Two patients had virologic failure. Both had been unresponsive to previous therapies, and both had the IL-28B genotype and resistance-associated variants at the time of failure.
No patient withdrew because of adverse events, but about 90% (57/63) experienced some side effect, with the most common being fatigue and insomnia. Six patients had to reduce their ribavirin dose because of a decline in hemoglobin levels, but they were still responsive to therapy. Five patients had a confirmed increase in HIV RNA higher than 40 copies/mL, but not above 200 copies/mL, said Dr. Eron. And all the patients remained suppressed on the same HIV regimen and without interrupting their HCV therapy, he said.
Soon, a cohort of patients on stable darunavir antiretroviral therapy will be enrolled and given the three-drug HCV regimen for 12 weeks. The full global TURQUOISE study will begin later in 2014, Dr. Eron said.
The study was sponsored by AbbVie. Dr. Eron received grant and research support from, and/or served as a consultant to, AbbVie, Bristol-Myers Squibb, and other companies. Other authors had numerous additional disclosures.
On Twitter @aliciaault
WASHINGTON – Early studies show that a new, combined antiviral regimen seems to suppress hepatitis C viremia while keeping HIV viremia stable in coinfected patients.
Dr. Joseph Eron presented phase II data from 63 patients who were enrolled in TURQUOISE-I. A total of 94% (59/63) of patients achieved a sustained virologic response (SVR) 12 weeks after completing 12 weeks of therapy, and 61 of 63 patients achieved an SVR 4 weeks after completing 12 or 24 weeks of therapy, Dr. Eron reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The regimen included ABT-450 (an NS3-4A protease inhibitor that was identified by AbbVie and Enanta), which was combined with ritonavir and ombitasvir (another AbbVie drug, also known as ABT-267) into a single tablet, plus dasabuvir (ABT-333) and ribavirin. Ombitasvir is an NS5A inhibitor and dasabuvir is a non-nucleoside NS5B polymerase inhibitor.
To be included in TURQUOISE-I, patients have to be aged 18-70 years; be treatment naive or have previous pegylated interferon/ribavirin treatment experience; have hepatitis C virus (HCV) genotype 1 infection; have plasma HIV-1 RNA less than 40 copies/mL; and be taking a stable, qualifying HIV-1 antiretroviral therapy regimen, said Dr. Eron, a professor of medicine at the University of North Carolina, Chapel Hill.
Patients with cirrhosis are not excluded, but will not be enrolled if they have had prior therapy with direct-acting antivirals for HCV, or any current or past clinical evidence of liver decompensation.
All patients will be followed for 48 weeks after therapy is stopped. Thirty-one patients were given therapy for 12 weeks and then assessed for SVR at 12 weeks. Thirty-two patients were given therapy for 24 weeks and assessed 4 weeks later. Patients also were evaluated for end-of-treatment response, on-treatment virologic failure, and post-treatment HCV viral relapse.
At baseline, 59 patients in each arm were male, and 16 were African American. The mean age was 51 years. Six patients in each arm (19%) had cirrhosis. A high proportion in each arm (53/63 in the 12-week and 49/63 in the 24-week arm) had the interleukin-28B genotype, which is known to indicate a much harder-to-treat disease, Dr. Eron said.
At the end of treatment, only one patient in each arm was not responsive. Four weeks post therapy, 29 of 31 patients in the 12-week arm and 31 of 32 patients in the 24-week arm had an SVR.
Two patients had virologic failure. Both had been unresponsive to previous therapies, and both had the IL-28B genotype and resistance-associated variants at the time of failure.
No patient withdrew because of adverse events, but about 90% (57/63) experienced some side effect, with the most common being fatigue and insomnia. Six patients had to reduce their ribavirin dose because of a decline in hemoglobin levels, but they were still responsive to therapy. Five patients had a confirmed increase in HIV RNA higher than 40 copies/mL, but not above 200 copies/mL, said Dr. Eron. And all the patients remained suppressed on the same HIV regimen and without interrupting their HCV therapy, he said.
Soon, a cohort of patients on stable darunavir antiretroviral therapy will be enrolled and given the three-drug HCV regimen for 12 weeks. The full global TURQUOISE study will begin later in 2014, Dr. Eron said.
The study was sponsored by AbbVie. Dr. Eron received grant and research support from, and/or served as a consultant to, AbbVie, Bristol-Myers Squibb, and other companies. Other authors had numerous additional disclosures.
On Twitter @aliciaault
AT ICAAC 2014
Key clinical point: A new therapy is on the horizon for HCV-HIV coinfected patients that achieves high virologic response with few severe side effects.
Major finding: A three-drug regimen that includes ABT-450 and ombitasvir in one pill, plus dasabuvir and ribavirin, achieved high SVR in patients coinfected with HCV GT1 and HIV.
Data source: A 63-patient, two-arm, open-label prospective study.
Disclosures: The study was sponsored by AbbVie. Dr. Eron received grant and research support from, and/or served as a consultant to, AbbVie, Bristol-Myers Squibb, and other companies. Other authors had numerous additional disclosures.
