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Measuring high-value care practices
Because health care in the United States is extremely expensive, it’s driving an increased focus on high-value care (HVC), said Carolyn D. Sy, MD. And, she added, while hospitalists and other physicians are the ones responsible for translating HVC from formalized settings (lectures, modules, etc.) to the bedside, there are few instruments designed to measure the success of HVC practices.
So Dr. Sy, director of the University of Washington Medical Center Hospital Medicine Service in Seattle and her colleagues developed an HVC Rounding Tool, which allows users to empirically assess the discussion of HVC topics at the bedside. They divided 10 HVC topics into three domains (quality, cost, patient values) to create an observational tool and tested its validity.
“It addresses an important educational gap in translating HVC from theoretical knowledge to bedside practice,” she said.
The tool is designed to capture multidisciplinary participation: involvement from faculty, fellows or trainees, nurses, pharmacists, families, and other members of the health care team.
It has multidisciplinary benefits too. “The HVC Rounding Tool provides an opportunity for faculty development through peer observation and feedback on the integration and role modeling of HVC at the bedside,” Dr. Sy said. “It also is an instrument to help assess the educational efficacy of formal HVC curriculum and translation into bedside practice. Lastly, it is a tool that could be used to measure the relationship between HVC behaviors and actual patient outcomes, such as length of stay, readmissions, and cost of hospitalization – a feature with increasing importance given our move towards value-based health care.”
Reference
1. Sy CD et al. The development and validation of a high-value care rounding tool using the Delphi method. J Hosp Med. 2017;12(suppl 2). Accessed Oct 10, 2017.
Because health care in the United States is extremely expensive, it’s driving an increased focus on high-value care (HVC), said Carolyn D. Sy, MD. And, she added, while hospitalists and other physicians are the ones responsible for translating HVC from formalized settings (lectures, modules, etc.) to the bedside, there are few instruments designed to measure the success of HVC practices.
So Dr. Sy, director of the University of Washington Medical Center Hospital Medicine Service in Seattle and her colleagues developed an HVC Rounding Tool, which allows users to empirically assess the discussion of HVC topics at the bedside. They divided 10 HVC topics into three domains (quality, cost, patient values) to create an observational tool and tested its validity.
“It addresses an important educational gap in translating HVC from theoretical knowledge to bedside practice,” she said.
The tool is designed to capture multidisciplinary participation: involvement from faculty, fellows or trainees, nurses, pharmacists, families, and other members of the health care team.
It has multidisciplinary benefits too. “The HVC Rounding Tool provides an opportunity for faculty development through peer observation and feedback on the integration and role modeling of HVC at the bedside,” Dr. Sy said. “It also is an instrument to help assess the educational efficacy of formal HVC curriculum and translation into bedside practice. Lastly, it is a tool that could be used to measure the relationship between HVC behaviors and actual patient outcomes, such as length of stay, readmissions, and cost of hospitalization – a feature with increasing importance given our move towards value-based health care.”
Reference
1. Sy CD et al. The development and validation of a high-value care rounding tool using the Delphi method. J Hosp Med. 2017;12(suppl 2). Accessed Oct 10, 2017.
Because health care in the United States is extremely expensive, it’s driving an increased focus on high-value care (HVC), said Carolyn D. Sy, MD. And, she added, while hospitalists and other physicians are the ones responsible for translating HVC from formalized settings (lectures, modules, etc.) to the bedside, there are few instruments designed to measure the success of HVC practices.
So Dr. Sy, director of the University of Washington Medical Center Hospital Medicine Service in Seattle and her colleagues developed an HVC Rounding Tool, which allows users to empirically assess the discussion of HVC topics at the bedside. They divided 10 HVC topics into three domains (quality, cost, patient values) to create an observational tool and tested its validity.
“It addresses an important educational gap in translating HVC from theoretical knowledge to bedside practice,” she said.
The tool is designed to capture multidisciplinary participation: involvement from faculty, fellows or trainees, nurses, pharmacists, families, and other members of the health care team.
It has multidisciplinary benefits too. “The HVC Rounding Tool provides an opportunity for faculty development through peer observation and feedback on the integration and role modeling of HVC at the bedside,” Dr. Sy said. “It also is an instrument to help assess the educational efficacy of formal HVC curriculum and translation into bedside practice. Lastly, it is a tool that could be used to measure the relationship between HVC behaviors and actual patient outcomes, such as length of stay, readmissions, and cost of hospitalization – a feature with increasing importance given our move towards value-based health care.”
Reference
1. Sy CD et al. The development and validation of a high-value care rounding tool using the Delphi method. J Hosp Med. 2017;12(suppl 2). Accessed Oct 10, 2017.
Hidden costs
By the time you reach age 55, 18% of your pediatrician colleagues – or you yourself – will have been sued for malpractice. As many as 64% of your brother and sister obstetrician-gynecologists will have suffered the same fate. These numbers come from a pool of recent data released by the American Medical Association that suggest that nearly half of physicians in this country will be sued for malpractice by age 55 years.
I have read the AMA’s press release and the two studies several times and didn’t see a single reference to the emotional toll taken on the health care providers who have been sued. Of course, although it is easy to imagine that the human cost of a malpractice suit is probably high, it is not one of those figures that the number crunchers can find in their data sets and spreadsheets.
Although a case that goes to trial is unusual (7%), most cases like ours are won by defendants (87.5%). That number was of little or no reassurance to me and my codefendants. Every waking hour during the 7 years that it took our case to play out was darkened by the threat to my professional career. Every trip to the mailbox was an exercise in courage. Would there be another piece of voluminous communication to remind me of the terrible reality?
Thanks to my wife and a lawyer who was always concerned about how I was doing emotionally, my story had a happy ending. I survived with my solo practice and my marriage intact. But I know that others have not been as lucky. Chemical dependency, divorce, poor productivity, and early retirement are just part of the underreported collateral damage that can come in the wake of a malpractice case, even one that is resolved with a relatively small financial cost.
Beyond the emotional cost, there is the staggering expense of defensive medicine. It has been going on for so long that many physicians practicing today don’t realize they are practicing defensive medicine because that’s the way they have been taught by several generations of gun-shy mentors.
And, of course, the risk-averse mentality is one of the drivers of the tsunami of computerization that threatens to drown our health care delivery system. The fallacious legal argument that if it wasn’t documented, it didn’t happen, has resulted in a glut of computer-enhanced “documentation” that even the most casual observer realizes isn’t worth the electrons it takes to light up the pixels on a computer screen.
Even if we ignore their incalculable emotional costs, malpractice suits and the litigious climate in which we practice are eating away at our health care delivery system. I certainly don’t have the answers to rein in the costs. I only can recommend that you practice the best medicine you know how, and do it in a manner that demonstrates you care about the patient. And hope you have good lawyer who cares about you more than his fee.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
By the time you reach age 55, 18% of your pediatrician colleagues – or you yourself – will have been sued for malpractice. As many as 64% of your brother and sister obstetrician-gynecologists will have suffered the same fate. These numbers come from a pool of recent data released by the American Medical Association that suggest that nearly half of physicians in this country will be sued for malpractice by age 55 years.
I have read the AMA’s press release and the two studies several times and didn’t see a single reference to the emotional toll taken on the health care providers who have been sued. Of course, although it is easy to imagine that the human cost of a malpractice suit is probably high, it is not one of those figures that the number crunchers can find in their data sets and spreadsheets.
Although a case that goes to trial is unusual (7%), most cases like ours are won by defendants (87.5%). That number was of little or no reassurance to me and my codefendants. Every waking hour during the 7 years that it took our case to play out was darkened by the threat to my professional career. Every trip to the mailbox was an exercise in courage. Would there be another piece of voluminous communication to remind me of the terrible reality?
Thanks to my wife and a lawyer who was always concerned about how I was doing emotionally, my story had a happy ending. I survived with my solo practice and my marriage intact. But I know that others have not been as lucky. Chemical dependency, divorce, poor productivity, and early retirement are just part of the underreported collateral damage that can come in the wake of a malpractice case, even one that is resolved with a relatively small financial cost.
Beyond the emotional cost, there is the staggering expense of defensive medicine. It has been going on for so long that many physicians practicing today don’t realize they are practicing defensive medicine because that’s the way they have been taught by several generations of gun-shy mentors.
And, of course, the risk-averse mentality is one of the drivers of the tsunami of computerization that threatens to drown our health care delivery system. The fallacious legal argument that if it wasn’t documented, it didn’t happen, has resulted in a glut of computer-enhanced “documentation” that even the most casual observer realizes isn’t worth the electrons it takes to light up the pixels on a computer screen.
Even if we ignore their incalculable emotional costs, malpractice suits and the litigious climate in which we practice are eating away at our health care delivery system. I certainly don’t have the answers to rein in the costs. I only can recommend that you practice the best medicine you know how, and do it in a manner that demonstrates you care about the patient. And hope you have good lawyer who cares about you more than his fee.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
By the time you reach age 55, 18% of your pediatrician colleagues – or you yourself – will have been sued for malpractice. As many as 64% of your brother and sister obstetrician-gynecologists will have suffered the same fate. These numbers come from a pool of recent data released by the American Medical Association that suggest that nearly half of physicians in this country will be sued for malpractice by age 55 years.
I have read the AMA’s press release and the two studies several times and didn’t see a single reference to the emotional toll taken on the health care providers who have been sued. Of course, although it is easy to imagine that the human cost of a malpractice suit is probably high, it is not one of those figures that the number crunchers can find in their data sets and spreadsheets.
Although a case that goes to trial is unusual (7%), most cases like ours are won by defendants (87.5%). That number was of little or no reassurance to me and my codefendants. Every waking hour during the 7 years that it took our case to play out was darkened by the threat to my professional career. Every trip to the mailbox was an exercise in courage. Would there be another piece of voluminous communication to remind me of the terrible reality?
Thanks to my wife and a lawyer who was always concerned about how I was doing emotionally, my story had a happy ending. I survived with my solo practice and my marriage intact. But I know that others have not been as lucky. Chemical dependency, divorce, poor productivity, and early retirement are just part of the underreported collateral damage that can come in the wake of a malpractice case, even one that is resolved with a relatively small financial cost.
Beyond the emotional cost, there is the staggering expense of defensive medicine. It has been going on for so long that many physicians practicing today don’t realize they are practicing defensive medicine because that’s the way they have been taught by several generations of gun-shy mentors.
And, of course, the risk-averse mentality is one of the drivers of the tsunami of computerization that threatens to drown our health care delivery system. The fallacious legal argument that if it wasn’t documented, it didn’t happen, has resulted in a glut of computer-enhanced “documentation” that even the most casual observer realizes isn’t worth the electrons it takes to light up the pixels on a computer screen.
Even if we ignore their incalculable emotional costs, malpractice suits and the litigious climate in which we practice are eating away at our health care delivery system. I certainly don’t have the answers to rein in the costs. I only can recommend that you practice the best medicine you know how, and do it in a manner that demonstrates you care about the patient. And hope you have good lawyer who cares about you more than his fee.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
ACC Day 2: Late-Breaking Clinical Trial highlights
Of the late-breaking clinical trials to be presented on Sunday, March 11, at the annual meeting of the American College of Cardiology in Orlando, the meeting’s vice chair, Andrew Kates, MD, highlighted two in a press briefing: ARTEMIS and MOMENTUM 3.
ARTEMIS
The investigators of this unique trial sought to determine whether reducing patients’ cost burden for their medication would improve adherence and, in turn, improve patient outcomes.
Specifically, ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) evaluated whether eliminating copayments for patients after acute MI could optimize antiplatelet therapy selection and long-term adherence, as well as patient outcomes and overall cost of care following acute MI.
Dr. Kates, professor of medicine, Washington University, St. Louis, said ARTEMIS would go far in answering the question, “If costs are lowered, are guidelines followed?”
Tracy Wang, MD, of Duke University, Durham, N.C., will present the results on Sunday in a joint Late-Breaking Clinical Trial session with JAMA, being held at 8 a.m.-9 a.m. in the Main Tent (Hall C).
MOMENTUM 3
Last year, HeartMate 3, a fully magnetically levitated centrifugal-flow circulatory pump, showed better outcomes at 6 months than did HEARTMATE 2, an axial-flow pump, in the primary results of MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3).
Most impressive was the complete elimination of pump thrombosis in the patients with the smaller HeartMate 3 device. On Sunday, the 2-year results will reveal whether longer-term use of the novel technology will carry similar benefits, Dr. Kates said.
MOMENTUM 3 will be presented at the third Late-Breaking Clinical Trials session, at 10:45-11:45 a.m., in the Main Tent (Hall C) by Mandeep R. Mehra, MD, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center of Brigham and Women’s Hospital, both in Boston.
Of the late-breaking clinical trials to be presented on Sunday, March 11, at the annual meeting of the American College of Cardiology in Orlando, the meeting’s vice chair, Andrew Kates, MD, highlighted two in a press briefing: ARTEMIS and MOMENTUM 3.
ARTEMIS
The investigators of this unique trial sought to determine whether reducing patients’ cost burden for their medication would improve adherence and, in turn, improve patient outcomes.
Specifically, ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) evaluated whether eliminating copayments for patients after acute MI could optimize antiplatelet therapy selection and long-term adherence, as well as patient outcomes and overall cost of care following acute MI.
Dr. Kates, professor of medicine, Washington University, St. Louis, said ARTEMIS would go far in answering the question, “If costs are lowered, are guidelines followed?”
Tracy Wang, MD, of Duke University, Durham, N.C., will present the results on Sunday in a joint Late-Breaking Clinical Trial session with JAMA, being held at 8 a.m.-9 a.m. in the Main Tent (Hall C).
MOMENTUM 3
Last year, HeartMate 3, a fully magnetically levitated centrifugal-flow circulatory pump, showed better outcomes at 6 months than did HEARTMATE 2, an axial-flow pump, in the primary results of MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3).
Most impressive was the complete elimination of pump thrombosis in the patients with the smaller HeartMate 3 device. On Sunday, the 2-year results will reveal whether longer-term use of the novel technology will carry similar benefits, Dr. Kates said.
MOMENTUM 3 will be presented at the third Late-Breaking Clinical Trials session, at 10:45-11:45 a.m., in the Main Tent (Hall C) by Mandeep R. Mehra, MD, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center of Brigham and Women’s Hospital, both in Boston.
Of the late-breaking clinical trials to be presented on Sunday, March 11, at the annual meeting of the American College of Cardiology in Orlando, the meeting’s vice chair, Andrew Kates, MD, highlighted two in a press briefing: ARTEMIS and MOMENTUM 3.
ARTEMIS
The investigators of this unique trial sought to determine whether reducing patients’ cost burden for their medication would improve adherence and, in turn, improve patient outcomes.
Specifically, ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) evaluated whether eliminating copayments for patients after acute MI could optimize antiplatelet therapy selection and long-term adherence, as well as patient outcomes and overall cost of care following acute MI.
Dr. Kates, professor of medicine, Washington University, St. Louis, said ARTEMIS would go far in answering the question, “If costs are lowered, are guidelines followed?”
Tracy Wang, MD, of Duke University, Durham, N.C., will present the results on Sunday in a joint Late-Breaking Clinical Trial session with JAMA, being held at 8 a.m.-9 a.m. in the Main Tent (Hall C).
MOMENTUM 3
Last year, HeartMate 3, a fully magnetically levitated centrifugal-flow circulatory pump, showed better outcomes at 6 months than did HEARTMATE 2, an axial-flow pump, in the primary results of MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3).
Most impressive was the complete elimination of pump thrombosis in the patients with the smaller HeartMate 3 device. On Sunday, the 2-year results will reveal whether longer-term use of the novel technology will carry similar benefits, Dr. Kates said.
MOMENTUM 3 will be presented at the third Late-Breaking Clinical Trials session, at 10:45-11:45 a.m., in the Main Tent (Hall C) by Mandeep R. Mehra, MD, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center of Brigham and Women’s Hospital, both in Boston.
‘Clean and sober’ ex-prisoners have better HIV suppression
BOSTON – Prisoners living with HIV who have drug- or alcohol-abuse disorders and are given extended-release naltrexone prior to release are significantly more likely to have improved viral suppression at 6 months, compared with fellow HIV+ prisoners who do not, investigators in two parallel clinical trials reported.
“A medication that can be used for reduction of alcohol and opiate use could also help stabilize patients coming out of prison and jail, and help maintain or achieve viral suppression,” said Sandra Springer, MD, from Yale University, New Haven, Conn.
“The United States incarcerates more individuals than any other country in the world, and our prevalence rates in prison of HIV are three times greater, and if we’re trying to achieve the 90-90-90 goals in 2 years, we have to pay special attention to this population that has significant substance-use disorders, in particular opiate- and alcohol-use disorders,” she said at a briefing following her presentation of the data in an oral abstract session.
Dr. Springer and her colleagues had shown in a previous study that, although 59% of HIV-positive prisoners treated with ART while incarcerated attained viral suppression, the percentage who retained suppression dropped to 18% just 3 months after they were released. The investigators also found that relapse to drug and alcohol use occurs quickly after release, and that relapses are associated with loss of viral suppression.
In the studies reported at CROI 2018, Dr. Springer and her colleagues evaluated the effects of treatment with XR-NTX on HIV viral suppression among HIV-positive prisoners and jail detainees with either opioid-use disorders (NEW HOPE study) or alcohol-use disorders (INSPIRE study) after they are released to the community.
Both studies were double-blind, placebo-controlled, randomized trials. Detainees were recruited, enrolled, and randomized while imprisoned to receive either placebo or XR-NTX in six monthly injections, with the first performed in prison, and the subsequent five injections performed in the community.
The participants were all HIV-seropositive prisoners aged 18 years or older returning to communities in Connecticut and western Massachusetts who met DSM-IV criteria for either alcohol- or opioid-use disorder.
The investigators found that among opioid users in NEW HOPE, viral suppression levels (fewer than 50 copies/mL) improved from 37.9% at baseline to 60.6% at 6 months among 66 individuals who received XR-NTX (P = .002). In contrast, viral suppression among 27 placebo users dropped from 55.6% at baseline to 40.7%, although this decline was not statistically significant.
In multivariate analysis controlling for treatment arm, cocaine-use disorder, homelessness, or number of injections received, the only significant predictor for viral suppression at 6 months was XR-NTX vs. placebo (odds ratio, 2.90; P = .043). There were no serious adverse events in this study.
Among those with alcohol-use disorders in the INSPIRE study, the changes in viral suppression were similar to those in the NEW HOPE study, improving from 31% at baseline to 56.7% at 6 months among 67 participants in the XR-NTX arm (P = .001), compared with a decline from 42% to 30.3% among 33 participants in the placebo arm, although again this difference was not significant.
In the INSPIRE study, significant predictors of viral suppression at 6 months included naltrexone XR (OR, 4.54; P = .009), three or more injections (OR, 6.34; P = .001), white vs. black or Hispanic (OR, 5.37; P = .040), and alcohol improvement score, a composite measure of drinking parameters (OR, 1.43; P =.033).
Dr. Springer said in the briefing that inclusion criteria in the studies were broad enough to allow overlap between alcohol-use and drug-use disorders,
She emphasized that persons living with HIV who have drug- or alcohol-use disorders and are being released from incarcerations should be strongly considered for antiopioid and/or antialcohol pharmacotherapy in addition to ART.
The study was supported by National Institutes of Health grants, and by Alkermes, which supplied XR-NTX and placebo to investigators. Dr. Springer disclosed research grants from the National Institute on Drug Abuse.
SOURCE: Springer S et al. CROI Abstract 96
BOSTON – Prisoners living with HIV who have drug- or alcohol-abuse disorders and are given extended-release naltrexone prior to release are significantly more likely to have improved viral suppression at 6 months, compared with fellow HIV+ prisoners who do not, investigators in two parallel clinical trials reported.
“A medication that can be used for reduction of alcohol and opiate use could also help stabilize patients coming out of prison and jail, and help maintain or achieve viral suppression,” said Sandra Springer, MD, from Yale University, New Haven, Conn.
“The United States incarcerates more individuals than any other country in the world, and our prevalence rates in prison of HIV are three times greater, and if we’re trying to achieve the 90-90-90 goals in 2 years, we have to pay special attention to this population that has significant substance-use disorders, in particular opiate- and alcohol-use disorders,” she said at a briefing following her presentation of the data in an oral abstract session.
Dr. Springer and her colleagues had shown in a previous study that, although 59% of HIV-positive prisoners treated with ART while incarcerated attained viral suppression, the percentage who retained suppression dropped to 18% just 3 months after they were released. The investigators also found that relapse to drug and alcohol use occurs quickly after release, and that relapses are associated with loss of viral suppression.
In the studies reported at CROI 2018, Dr. Springer and her colleagues evaluated the effects of treatment with XR-NTX on HIV viral suppression among HIV-positive prisoners and jail detainees with either opioid-use disorders (NEW HOPE study) or alcohol-use disorders (INSPIRE study) after they are released to the community.
Both studies were double-blind, placebo-controlled, randomized trials. Detainees were recruited, enrolled, and randomized while imprisoned to receive either placebo or XR-NTX in six monthly injections, with the first performed in prison, and the subsequent five injections performed in the community.
The participants were all HIV-seropositive prisoners aged 18 years or older returning to communities in Connecticut and western Massachusetts who met DSM-IV criteria for either alcohol- or opioid-use disorder.
The investigators found that among opioid users in NEW HOPE, viral suppression levels (fewer than 50 copies/mL) improved from 37.9% at baseline to 60.6% at 6 months among 66 individuals who received XR-NTX (P = .002). In contrast, viral suppression among 27 placebo users dropped from 55.6% at baseline to 40.7%, although this decline was not statistically significant.
In multivariate analysis controlling for treatment arm, cocaine-use disorder, homelessness, or number of injections received, the only significant predictor for viral suppression at 6 months was XR-NTX vs. placebo (odds ratio, 2.90; P = .043). There were no serious adverse events in this study.
Among those with alcohol-use disorders in the INSPIRE study, the changes in viral suppression were similar to those in the NEW HOPE study, improving from 31% at baseline to 56.7% at 6 months among 67 participants in the XR-NTX arm (P = .001), compared with a decline from 42% to 30.3% among 33 participants in the placebo arm, although again this difference was not significant.
In the INSPIRE study, significant predictors of viral suppression at 6 months included naltrexone XR (OR, 4.54; P = .009), three or more injections (OR, 6.34; P = .001), white vs. black or Hispanic (OR, 5.37; P = .040), and alcohol improvement score, a composite measure of drinking parameters (OR, 1.43; P =.033).
Dr. Springer said in the briefing that inclusion criteria in the studies were broad enough to allow overlap between alcohol-use and drug-use disorders,
She emphasized that persons living with HIV who have drug- or alcohol-use disorders and are being released from incarcerations should be strongly considered for antiopioid and/or antialcohol pharmacotherapy in addition to ART.
The study was supported by National Institutes of Health grants, and by Alkermes, which supplied XR-NTX and placebo to investigators. Dr. Springer disclosed research grants from the National Institute on Drug Abuse.
SOURCE: Springer S et al. CROI Abstract 96
BOSTON – Prisoners living with HIV who have drug- or alcohol-abuse disorders and are given extended-release naltrexone prior to release are significantly more likely to have improved viral suppression at 6 months, compared with fellow HIV+ prisoners who do not, investigators in two parallel clinical trials reported.
“A medication that can be used for reduction of alcohol and opiate use could also help stabilize patients coming out of prison and jail, and help maintain or achieve viral suppression,” said Sandra Springer, MD, from Yale University, New Haven, Conn.
“The United States incarcerates more individuals than any other country in the world, and our prevalence rates in prison of HIV are three times greater, and if we’re trying to achieve the 90-90-90 goals in 2 years, we have to pay special attention to this population that has significant substance-use disorders, in particular opiate- and alcohol-use disorders,” she said at a briefing following her presentation of the data in an oral abstract session.
Dr. Springer and her colleagues had shown in a previous study that, although 59% of HIV-positive prisoners treated with ART while incarcerated attained viral suppression, the percentage who retained suppression dropped to 18% just 3 months after they were released. The investigators also found that relapse to drug and alcohol use occurs quickly after release, and that relapses are associated with loss of viral suppression.
In the studies reported at CROI 2018, Dr. Springer and her colleagues evaluated the effects of treatment with XR-NTX on HIV viral suppression among HIV-positive prisoners and jail detainees with either opioid-use disorders (NEW HOPE study) or alcohol-use disorders (INSPIRE study) after they are released to the community.
Both studies were double-blind, placebo-controlled, randomized trials. Detainees were recruited, enrolled, and randomized while imprisoned to receive either placebo or XR-NTX in six monthly injections, with the first performed in prison, and the subsequent five injections performed in the community.
The participants were all HIV-seropositive prisoners aged 18 years or older returning to communities in Connecticut and western Massachusetts who met DSM-IV criteria for either alcohol- or opioid-use disorder.
The investigators found that among opioid users in NEW HOPE, viral suppression levels (fewer than 50 copies/mL) improved from 37.9% at baseline to 60.6% at 6 months among 66 individuals who received XR-NTX (P = .002). In contrast, viral suppression among 27 placebo users dropped from 55.6% at baseline to 40.7%, although this decline was not statistically significant.
In multivariate analysis controlling for treatment arm, cocaine-use disorder, homelessness, or number of injections received, the only significant predictor for viral suppression at 6 months was XR-NTX vs. placebo (odds ratio, 2.90; P = .043). There were no serious adverse events in this study.
Among those with alcohol-use disorders in the INSPIRE study, the changes in viral suppression were similar to those in the NEW HOPE study, improving from 31% at baseline to 56.7% at 6 months among 67 participants in the XR-NTX arm (P = .001), compared with a decline from 42% to 30.3% among 33 participants in the placebo arm, although again this difference was not significant.
In the INSPIRE study, significant predictors of viral suppression at 6 months included naltrexone XR (OR, 4.54; P = .009), three or more injections (OR, 6.34; P = .001), white vs. black or Hispanic (OR, 5.37; P = .040), and alcohol improvement score, a composite measure of drinking parameters (OR, 1.43; P =.033).
Dr. Springer said in the briefing that inclusion criteria in the studies were broad enough to allow overlap between alcohol-use and drug-use disorders,
She emphasized that persons living with HIV who have drug- or alcohol-use disorders and are being released from incarcerations should be strongly considered for antiopioid and/or antialcohol pharmacotherapy in addition to ART.
The study was supported by National Institutes of Health grants, and by Alkermes, which supplied XR-NTX and placebo to investigators. Dr. Springer disclosed research grants from the National Institute on Drug Abuse.
SOURCE: Springer S et al. CROI Abstract 96
REPORTING FROM CROI
Key clinical point: Among the HIV-positive prison population, drug and alcohol use are predictors for lower viral suppression rates.
Major finding: Viral suppression levels at 6 months were significantly higher among HIV+ drug or alcohol abusers treated with monthly naltrexone extended release.
Data source: Prospective, double-blind randomized trials in 93 HIV+ prisoners with opioid-use disorder (NEW HOPE) and 100 with alcohol-use disorder (INSPIRE).
Disclosures: The study was supported by National Institutes of Health grants, and by Alkermes, which supplied XR-NTX and placebo to investigators. Dr. Springer disclosed research grants from the National Institute on Drug Abuse.
Source: Springer S et al. CROI, Abstract 96.
MDedge Daily News: High deductibles harm breast cancer care
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
How high deductibles could harm breast cancer care, CMS pushes back on Arkansas’s proposed Medicaid rollback, opioid deaths spill into the nation’s emergency departments, and why opioids aren’t the better choice for chronic pain.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
How high deductibles could harm breast cancer care, CMS pushes back on Arkansas’s proposed Medicaid rollback, opioid deaths spill into the nation’s emergency departments, and why opioids aren’t the better choice for chronic pain.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
How high deductibles could harm breast cancer care, CMS pushes back on Arkansas’s proposed Medicaid rollback, opioid deaths spill into the nation’s emergency departments, and why opioids aren’t the better choice for chronic pain.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
Researchers question validity of NCCN guidelines
New research suggests guidelines from the National Comprehensive Cancer Network (NCCN) may sometimes be supported by low-quality evidence or no evidence at all.
Researchers compared NCCN recommendations for cancer drugs to US cancer drug approvals over a 5-year period.
Thirty-nine percent of NCCN’s treatment recommendations did not coincide with uses approved by the US Food and Drug Administration (FDA).
For most of these recommendations (84%), NCCN did not provide supporting data from randomized, phase 3 trials.
For 36% of the recommendations, NCCN gave no supporting evidence.
Vinay Prasad, MD, of Oregon Health & Science University in Portland, Oregon, and his colleagues reported these findings in The BMJ.
Dr Prasad and his colleagues compared FDA approvals of cancer drugs between 2011 and 2015 with NCCN recommendations as of March 25, 2016.
When NCCN made recommendations beyond FDA approvals, the researchers evaluated the evidence used to support those recommendations.
Forty-seven new cancer drugs were approved by the FDA for 69 indications between 2011 and 2015. NCCN recommended the 47 drugs for 113 indications, including the 69 FDA-approved indications.
So 39% (n=44) of NCCN’s recommendations were not approved by the FDA, and NCCN gave the following evidence to support these recommendations:
- No evidence—36% (n=16)
- Phase 2 trial without randomization—30% (n=13)
- Randomized, phase 3 trial—16% (n=7)
- Phase 2 trial with randomization—7% (n=3)
- Case report or series of less than 5 patients—5% (n=2)
- Book chapter or review article—2% (n=1)
- Phase 1 trial—2% (n=1)
- Ongoing trial—2% (n=1).
Dr Prasad and his colleagues did point out that not all FDA approvals are supported by randomized, phase 3 trials.
And when the team followed-up 21 months after their initial analysis, they found that 6 of the 44 (14%) additional recommendations by NCCN had received FDA approval.
The researchers also noted that they did not search for independent evidence to support NCCN recommendations beyond the references NCCN provided. So some of the recommendations may have had more or better supporting evidence than what was provided.
Still, the team said these results suggest NCCN “frequently” makes recommendations that go beyond FDA approvals and “often fails to cite evidence or relies on low levels of evidence.” Therefore, NCCN should cite all evidence used to formulate its recommendations.
NCCN argues that it does provide ample evidence to support the recommendations in its guidelines.
“The NCCN guidelines contain more than 24,500 references to inform users of the evidence used in making its decisions,” said Robert W. Carlson, MD, chief executive officer of NCCN.
“These data are supplemented by the analysis of the available evidence by expert clinician researchers and patient advocates who evaluate each recommendation and come to consensus. Each recommendation is labeled with a Category of Evidence, and the vast majority of those for systemic therapies are accompanied by Evidence Blocks, which outline, on 1-5 scales, the efficacy, safety, quality of the evidence, consistency of the evidence, and affordability of the treatment.”
New research suggests guidelines from the National Comprehensive Cancer Network (NCCN) may sometimes be supported by low-quality evidence or no evidence at all.
Researchers compared NCCN recommendations for cancer drugs to US cancer drug approvals over a 5-year period.
Thirty-nine percent of NCCN’s treatment recommendations did not coincide with uses approved by the US Food and Drug Administration (FDA).
For most of these recommendations (84%), NCCN did not provide supporting data from randomized, phase 3 trials.
For 36% of the recommendations, NCCN gave no supporting evidence.
Vinay Prasad, MD, of Oregon Health & Science University in Portland, Oregon, and his colleagues reported these findings in The BMJ.
Dr Prasad and his colleagues compared FDA approvals of cancer drugs between 2011 and 2015 with NCCN recommendations as of March 25, 2016.
When NCCN made recommendations beyond FDA approvals, the researchers evaluated the evidence used to support those recommendations.
Forty-seven new cancer drugs were approved by the FDA for 69 indications between 2011 and 2015. NCCN recommended the 47 drugs for 113 indications, including the 69 FDA-approved indications.
So 39% (n=44) of NCCN’s recommendations were not approved by the FDA, and NCCN gave the following evidence to support these recommendations:
- No evidence—36% (n=16)
- Phase 2 trial without randomization—30% (n=13)
- Randomized, phase 3 trial—16% (n=7)
- Phase 2 trial with randomization—7% (n=3)
- Case report or series of less than 5 patients—5% (n=2)
- Book chapter or review article—2% (n=1)
- Phase 1 trial—2% (n=1)
- Ongoing trial—2% (n=1).
Dr Prasad and his colleagues did point out that not all FDA approvals are supported by randomized, phase 3 trials.
And when the team followed-up 21 months after their initial analysis, they found that 6 of the 44 (14%) additional recommendations by NCCN had received FDA approval.
The researchers also noted that they did not search for independent evidence to support NCCN recommendations beyond the references NCCN provided. So some of the recommendations may have had more or better supporting evidence than what was provided.
Still, the team said these results suggest NCCN “frequently” makes recommendations that go beyond FDA approvals and “often fails to cite evidence or relies on low levels of evidence.” Therefore, NCCN should cite all evidence used to formulate its recommendations.
NCCN argues that it does provide ample evidence to support the recommendations in its guidelines.
“The NCCN guidelines contain more than 24,500 references to inform users of the evidence used in making its decisions,” said Robert W. Carlson, MD, chief executive officer of NCCN.
“These data are supplemented by the analysis of the available evidence by expert clinician researchers and patient advocates who evaluate each recommendation and come to consensus. Each recommendation is labeled with a Category of Evidence, and the vast majority of those for systemic therapies are accompanied by Evidence Blocks, which outline, on 1-5 scales, the efficacy, safety, quality of the evidence, consistency of the evidence, and affordability of the treatment.”
New research suggests guidelines from the National Comprehensive Cancer Network (NCCN) may sometimes be supported by low-quality evidence or no evidence at all.
Researchers compared NCCN recommendations for cancer drugs to US cancer drug approvals over a 5-year period.
Thirty-nine percent of NCCN’s treatment recommendations did not coincide with uses approved by the US Food and Drug Administration (FDA).
For most of these recommendations (84%), NCCN did not provide supporting data from randomized, phase 3 trials.
For 36% of the recommendations, NCCN gave no supporting evidence.
Vinay Prasad, MD, of Oregon Health & Science University in Portland, Oregon, and his colleagues reported these findings in The BMJ.
Dr Prasad and his colleagues compared FDA approvals of cancer drugs between 2011 and 2015 with NCCN recommendations as of March 25, 2016.
When NCCN made recommendations beyond FDA approvals, the researchers evaluated the evidence used to support those recommendations.
Forty-seven new cancer drugs were approved by the FDA for 69 indications between 2011 and 2015. NCCN recommended the 47 drugs for 113 indications, including the 69 FDA-approved indications.
So 39% (n=44) of NCCN’s recommendations were not approved by the FDA, and NCCN gave the following evidence to support these recommendations:
- No evidence—36% (n=16)
- Phase 2 trial without randomization—30% (n=13)
- Randomized, phase 3 trial—16% (n=7)
- Phase 2 trial with randomization—7% (n=3)
- Case report or series of less than 5 patients—5% (n=2)
- Book chapter or review article—2% (n=1)
- Phase 1 trial—2% (n=1)
- Ongoing trial—2% (n=1).
Dr Prasad and his colleagues did point out that not all FDA approvals are supported by randomized, phase 3 trials.
And when the team followed-up 21 months after their initial analysis, they found that 6 of the 44 (14%) additional recommendations by NCCN had received FDA approval.
The researchers also noted that they did not search for independent evidence to support NCCN recommendations beyond the references NCCN provided. So some of the recommendations may have had more or better supporting evidence than what was provided.
Still, the team said these results suggest NCCN “frequently” makes recommendations that go beyond FDA approvals and “often fails to cite evidence or relies on low levels of evidence.” Therefore, NCCN should cite all evidence used to formulate its recommendations.
NCCN argues that it does provide ample evidence to support the recommendations in its guidelines.
“The NCCN guidelines contain more than 24,500 references to inform users of the evidence used in making its decisions,” said Robert W. Carlson, MD, chief executive officer of NCCN.
“These data are supplemented by the analysis of the available evidence by expert clinician researchers and patient advocates who evaluate each recommendation and come to consensus. Each recommendation is labeled with a Category of Evidence, and the vast majority of those for systemic therapies are accompanied by Evidence Blocks, which outline, on 1-5 scales, the efficacy, safety, quality of the evidence, consistency of the evidence, and affordability of the treatment.”
FDA approves first donor screening tests for Babesia
The US Food and Drug Administration (FDA) has approved the first tests to screen blood donors for Babesia parasites.
The Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA) is approved for the detection of antibodies to Babesia microti in plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT) is approved for the detection of Babesia microti DNA in whole blood samples.
These tests are intended to be used on samples from volunteer donors of whole blood and blood components as well as living organ and tissue donors.
The tests are not intended for use in the diagnosis of babesiosis infections.
The approval of the Imugen Babesia microti AFIA and NAT tests was granted to Oxford Immunotec, Inc. Both assays are in-house tests that can only be performed at the Norwood, Massachusetts facility.
The applications for the tests were granted priority review. The FDA aims to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA grants priority review to applications for products expected to significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.
“While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“Today’s actions represent the first approvals of Babesia detection tests for use in screening donors of whole blood and blood components, and other living donors.”
About babesiosis
Babesiosis is caused by Babesia parasites that are transmitted by Ixodes scapularis ticks, also known as blacklegged or deer ticks. Babesia microti is the main species of parasite that causes infection in the US.
There are about 1000 to 2000 cases of babesiosis reported in the US each year, with the majority reported from states in the Northeast and upper Midwest.
Most people infected with Babesia microti do not have symptoms and are never diagnosed. Some people develop flu-like symptoms, such as fever, headache, and body aches.
For certain people, especially those with a weak immune system, babesiosis can be a severe, life-threatening disease. And although blood-borne transmission of babesiosis is thought to be uncommon, it is the most frequently reported transfusion-transmitted parasitic infection in the US.
At present, there is no FDA guidance for the testing of donor samples for Babesia. However, the FDA is planning to issue a draft guidance later this year that will include recommendations for reducing the risk of transfusion-transmitted babesiosis.
The US Food and Drug Administration (FDA) has approved the first tests to screen blood donors for Babesia parasites.
The Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA) is approved for the detection of antibodies to Babesia microti in plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT) is approved for the detection of Babesia microti DNA in whole blood samples.
These tests are intended to be used on samples from volunteer donors of whole blood and blood components as well as living organ and tissue donors.
The tests are not intended for use in the diagnosis of babesiosis infections.
The approval of the Imugen Babesia microti AFIA and NAT tests was granted to Oxford Immunotec, Inc. Both assays are in-house tests that can only be performed at the Norwood, Massachusetts facility.
The applications for the tests were granted priority review. The FDA aims to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA grants priority review to applications for products expected to significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.
“While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“Today’s actions represent the first approvals of Babesia detection tests for use in screening donors of whole blood and blood components, and other living donors.”
About babesiosis
Babesiosis is caused by Babesia parasites that are transmitted by Ixodes scapularis ticks, also known as blacklegged or deer ticks. Babesia microti is the main species of parasite that causes infection in the US.
There are about 1000 to 2000 cases of babesiosis reported in the US each year, with the majority reported from states in the Northeast and upper Midwest.
Most people infected with Babesia microti do not have symptoms and are never diagnosed. Some people develop flu-like symptoms, such as fever, headache, and body aches.
For certain people, especially those with a weak immune system, babesiosis can be a severe, life-threatening disease. And although blood-borne transmission of babesiosis is thought to be uncommon, it is the most frequently reported transfusion-transmitted parasitic infection in the US.
At present, there is no FDA guidance for the testing of donor samples for Babesia. However, the FDA is planning to issue a draft guidance later this year that will include recommendations for reducing the risk of transfusion-transmitted babesiosis.
The US Food and Drug Administration (FDA) has approved the first tests to screen blood donors for Babesia parasites.
The Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA) is approved for the detection of antibodies to Babesia microti in plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT) is approved for the detection of Babesia microti DNA in whole blood samples.
These tests are intended to be used on samples from volunteer donors of whole blood and blood components as well as living organ and tissue donors.
The tests are not intended for use in the diagnosis of babesiosis infections.
The approval of the Imugen Babesia microti AFIA and NAT tests was granted to Oxford Immunotec, Inc. Both assays are in-house tests that can only be performed at the Norwood, Massachusetts facility.
The applications for the tests were granted priority review. The FDA aims to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA grants priority review to applications for products expected to significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.
“While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“Today’s actions represent the first approvals of Babesia detection tests for use in screening donors of whole blood and blood components, and other living donors.”
About babesiosis
Babesiosis is caused by Babesia parasites that are transmitted by Ixodes scapularis ticks, also known as blacklegged or deer ticks. Babesia microti is the main species of parasite that causes infection in the US.
There are about 1000 to 2000 cases of babesiosis reported in the US each year, with the majority reported from states in the Northeast and upper Midwest.
Most people infected with Babesia microti do not have symptoms and are never diagnosed. Some people develop flu-like symptoms, such as fever, headache, and body aches.
For certain people, especially those with a weak immune system, babesiosis can be a severe, life-threatening disease. And although blood-borne transmission of babesiosis is thought to be uncommon, it is the most frequently reported transfusion-transmitted parasitic infection in the US.
At present, there is no FDA guidance for the testing of donor samples for Babesia. However, the FDA is planning to issue a draft guidance later this year that will include recommendations for reducing the risk of transfusion-transmitted babesiosis.
Drug nets orphan designation for beta-thalassemia
The US Food and Drug Administration (FDA) has granted orphan drug designation to PTG-300, a subcutaneous injectable hepcidin mimetic, for the treatment of beta-thalassemia.
Protagonist Therapeutics, the company developing PTG-300, recently completed a phase 1 trial of the drug.
In this study, healthy volunteers treated with PTG-300 achieved dose-related and sustained reductions in serum iron levels.
In addition, PTG-300 was considered well tolerated, producing no serious adverse events or dose-limiting toxicities.
Protagonist Therapeutics intends to initiate a global clinical trial of PTG-300 in patients with beta-thalassemia following upcoming meetings with the FDA and European Medicines Agency.
“Beta-thalassemia is a rare genetic blood disorder that is characterized by impaired red blood cell production that can result in life-threatening chronic anemia, usually requiring regular and life-long blood transfusions for survival,” said David Y. Liu, PhD, chief scientific officer and head of research and development at Protagonist Therapeutics.
“Over time, these transfusions can lead to excessive iron levels in the body, which can be toxic and consequently lead to end-stage damage to vital organs such as the liver and the heart. As a hepcidin mimetic, PTG-300 is designed to help reduce these excessive iron levels, and, thereby, it may lead to improvements in anemia and decreased need for blood transfusions and chelation therapy.”
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted orphan drug designation to PTG-300, a subcutaneous injectable hepcidin mimetic, for the treatment of beta-thalassemia.
Protagonist Therapeutics, the company developing PTG-300, recently completed a phase 1 trial of the drug.
In this study, healthy volunteers treated with PTG-300 achieved dose-related and sustained reductions in serum iron levels.
In addition, PTG-300 was considered well tolerated, producing no serious adverse events or dose-limiting toxicities.
Protagonist Therapeutics intends to initiate a global clinical trial of PTG-300 in patients with beta-thalassemia following upcoming meetings with the FDA and European Medicines Agency.
“Beta-thalassemia is a rare genetic blood disorder that is characterized by impaired red blood cell production that can result in life-threatening chronic anemia, usually requiring regular and life-long blood transfusions for survival,” said David Y. Liu, PhD, chief scientific officer and head of research and development at Protagonist Therapeutics.
“Over time, these transfusions can lead to excessive iron levels in the body, which can be toxic and consequently lead to end-stage damage to vital organs such as the liver and the heart. As a hepcidin mimetic, PTG-300 is designed to help reduce these excessive iron levels, and, thereby, it may lead to improvements in anemia and decreased need for blood transfusions and chelation therapy.”
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted orphan drug designation to PTG-300, a subcutaneous injectable hepcidin mimetic, for the treatment of beta-thalassemia.
Protagonist Therapeutics, the company developing PTG-300, recently completed a phase 1 trial of the drug.
In this study, healthy volunteers treated with PTG-300 achieved dose-related and sustained reductions in serum iron levels.
In addition, PTG-300 was considered well tolerated, producing no serious adverse events or dose-limiting toxicities.
Protagonist Therapeutics intends to initiate a global clinical trial of PTG-300 in patients with beta-thalassemia following upcoming meetings with the FDA and European Medicines Agency.
“Beta-thalassemia is a rare genetic blood disorder that is characterized by impaired red blood cell production that can result in life-threatening chronic anemia, usually requiring regular and life-long blood transfusions for survival,” said David Y. Liu, PhD, chief scientific officer and head of research and development at Protagonist Therapeutics.
“Over time, these transfusions can lead to excessive iron levels in the body, which can be toxic and consequently lead to end-stage damage to vital organs such as the liver and the heart. As a hepcidin mimetic, PTG-300 is designed to help reduce these excessive iron levels, and, thereby, it may lead to improvements in anemia and decreased need for blood transfusions and chelation therapy.”
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
FDA approves label update for nivolumab
The US Food and Drug Administration (FDA) has updated the label for nivolumab (Opdivo®) to include new dosing and administration information.
Nivolumab can now be given at 480 mg infused every 4 weeks for most approved indications, in addition to the previously approved dosing schedule of 240 mg every 2 weeks.
The FDA also approved a shorter 30-minute infusion across all approved indications of nivolumab.
The 480 mg dose option can be used for nearly all approved indications of nivolumab. The exceptions are patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer.
Nivolumab is FDA-approved for the following indications:
- To treat adults with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplant (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT.
- As monotherapy for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma as well as BRAF V600 wild-type unresectable or metastatic melanoma.
- In combination with ipilimumab for the treatment of patients with unresectable or metastatic melanoma.
- To treat patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab.
- For patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
- To treat patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
- For patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
- To treat adult and pediatric (12 years and older) patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
- For patients with hepatocellular carcinoma who have been previously treated with sorafenib.
- For the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
The US Food and Drug Administration (FDA) has updated the label for nivolumab (Opdivo®) to include new dosing and administration information.
Nivolumab can now be given at 480 mg infused every 4 weeks for most approved indications, in addition to the previously approved dosing schedule of 240 mg every 2 weeks.
The FDA also approved a shorter 30-minute infusion across all approved indications of nivolumab.
The 480 mg dose option can be used for nearly all approved indications of nivolumab. The exceptions are patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer.
Nivolumab is FDA-approved for the following indications:
- To treat adults with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplant (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT.
- As monotherapy for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma as well as BRAF V600 wild-type unresectable or metastatic melanoma.
- In combination with ipilimumab for the treatment of patients with unresectable or metastatic melanoma.
- To treat patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab.
- For patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
- To treat patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
- For patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
- To treat adult and pediatric (12 years and older) patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
- For patients with hepatocellular carcinoma who have been previously treated with sorafenib.
- For the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
The US Food and Drug Administration (FDA) has updated the label for nivolumab (Opdivo®) to include new dosing and administration information.
Nivolumab can now be given at 480 mg infused every 4 weeks for most approved indications, in addition to the previously approved dosing schedule of 240 mg every 2 weeks.
The FDA also approved a shorter 30-minute infusion across all approved indications of nivolumab.
The 480 mg dose option can be used for nearly all approved indications of nivolumab. The exceptions are patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer.
Nivolumab is FDA-approved for the following indications:
- To treat adults with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplant (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT.
- As monotherapy for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma as well as BRAF V600 wild-type unresectable or metastatic melanoma.
- In combination with ipilimumab for the treatment of patients with unresectable or metastatic melanoma.
- To treat patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab.
- For patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
- To treat patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
- For patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
- To treat adult and pediatric (12 years and older) patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
- For patients with hepatocellular carcinoma who have been previously treated with sorafenib.
- For the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
Dark mole on face
The physician suspected that this was a benign blue nevus because it had a regular border and was uniformly dark in color. He also recognized that melanoma is very rare at age 19. That said, it is hard to ignore a changing mole that is so black in color.
The patient wanted it removed, so a 5-mm punch biopsy was performed. (See the Watch and Learn video on punch biopsy.)
When the punch core was removed, the physician noted that the pigment was visible in the deep dermis (as expected with a blue nevus). A single suture was placed, and the patient was scheduled for follow-up in one week. The pathology report came back as a blue nevus, which is completely benign.
While many blue nevi actually appear blue because of the Tyndall effect causing the dark melanin in the deep dermis to create a blue coloration, some will appear black (as was seen in this case). On the follow-up visit, the suture was removed and the incision was healing well. The patient was reassured that this was a benign mole and was happy with the cosmetic result.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M, Usatine R. Benign nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:945-952.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.
The physician suspected that this was a benign blue nevus because it had a regular border and was uniformly dark in color. He also recognized that melanoma is very rare at age 19. That said, it is hard to ignore a changing mole that is so black in color.
The patient wanted it removed, so a 5-mm punch biopsy was performed. (See the Watch and Learn video on punch biopsy.)
When the punch core was removed, the physician noted that the pigment was visible in the deep dermis (as expected with a blue nevus). A single suture was placed, and the patient was scheduled for follow-up in one week. The pathology report came back as a blue nevus, which is completely benign.
While many blue nevi actually appear blue because of the Tyndall effect causing the dark melanin in the deep dermis to create a blue coloration, some will appear black (as was seen in this case). On the follow-up visit, the suture was removed and the incision was healing well. The patient was reassured that this was a benign mole and was happy with the cosmetic result.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M, Usatine R. Benign nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:945-952.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.
The physician suspected that this was a benign blue nevus because it had a regular border and was uniformly dark in color. He also recognized that melanoma is very rare at age 19. That said, it is hard to ignore a changing mole that is so black in color.
The patient wanted it removed, so a 5-mm punch biopsy was performed. (See the Watch and Learn video on punch biopsy.)
When the punch core was removed, the physician noted that the pigment was visible in the deep dermis (as expected with a blue nevus). A single suture was placed, and the patient was scheduled for follow-up in one week. The pathology report came back as a blue nevus, which is completely benign.
While many blue nevi actually appear blue because of the Tyndall effect causing the dark melanin in the deep dermis to create a blue coloration, some will appear black (as was seen in this case). On the follow-up visit, the suture was removed and the incision was healing well. The patient was reassured that this was a benign mole and was happy with the cosmetic result.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M, Usatine R. Benign nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:945-952.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.
