News

Sandoz has decided not to pursue U.S. approval for its rituximab product (GP2013), a proposed biosimilar of Rituxan.

Sandoz, a division of Novartis, was seeking Food and Drug Administration approval of GP2013 for all the same indications as the reference product – B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.

GP2013 already is approved in the European Union and elsewhere.

The FDA had accepted the biologics license application (BLA) for GP2013 in September 2017. In May 2018, the agency issued a complete response letter saying it could not approve GP2013. The agency also requested additional information to complement the BLA submission.

At the time of the complete response letter, Sandoz said it was still committed to bringing GP2013 to the U.S. market.

“We appreciate the important conversations with the FDA, which have provided specific requirements for our potential U.S. biosimilar rituximab but believe the patient and marketplace needs in the U.S. will be satisfied before we can generate the data required,” Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said in a statement.

“We are disappointed to have to make this decision and stand behind the safety, efficacy, and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand, and Australia.”

The BLA for GP2013 was supported, in part, by results from the ASSIST-FL trial, in which researchers compared GP2013 with the reference product (Lancet Haematol. 2017 Aug;4[8]:e350-61).

The phase 3 trial included adults with previously untreated, advanced-stage follicular lymphoma. Patients received eight cycles of cyclophosphamide, vincristine, and prednisone with either GP2013 or reference rituximab. Responders then received GP2013 or rituximab monotherapy as maintenance for up to 2 years.

At a median follow-up of 11.6 months, the overall response rate was 87% in the GP2013 arm and 88% in the rituximab arm.

jensmith@mdedge.com

Sandoz has decided not to pursue U.S. approval for its rituximab product (GP2013), a proposed biosimilar of Rituxan.

Sandoz, a division of Novartis, was seeking Food and Drug Administration approval of GP2013 for all the same indications as the reference product – B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.

GP2013 already is approved in the European Union and elsewhere.

The FDA had accepted the biologics license application (BLA) for GP2013 in September 2017. In May 2018, the agency issued a complete response letter saying it could not approve GP2013. The agency also requested additional information to complement the BLA submission.

At the time of the complete response letter, Sandoz said it was still committed to bringing GP2013 to the U.S. market.

“We appreciate the important conversations with the FDA, which have provided specific requirements for our potential U.S. biosimilar rituximab but believe the patient and marketplace needs in the U.S. will be satisfied before we can generate the data required,” Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said in a statement.

“We are disappointed to have to make this decision and stand behind the safety, efficacy, and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand, and Australia.”

The BLA for GP2013 was supported, in part, by results from the ASSIST-FL trial, in which researchers compared GP2013 with the reference product (Lancet Haematol. 2017 Aug;4[8]:e350-61).

The phase 3 trial included adults with previously untreated, advanced-stage follicular lymphoma. Patients received eight cycles of cyclophosphamide, vincristine, and prednisone with either GP2013 or reference rituximab. Responders then received GP2013 or rituximab monotherapy as maintenance for up to 2 years.

At a median follow-up of 11.6 months, the overall response rate was 87% in the GP2013 arm and 88% in the rituximab arm.

jensmith@mdedge.com

Sandoz has decided not to pursue U.S. approval for its rituximab product (GP2013), a proposed biosimilar of Rituxan.

Sandoz, a division of Novartis, was seeking Food and Drug Administration approval of GP2013 for all the same indications as the reference product – B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.

GP2013 already is approved in the European Union and elsewhere.

The FDA had accepted the biologics license application (BLA) for GP2013 in September 2017. In May 2018, the agency issued a complete response letter saying it could not approve GP2013. The agency also requested additional information to complement the BLA submission.

At the time of the complete response letter, Sandoz said it was still committed to bringing GP2013 to the U.S. market.

“We appreciate the important conversations with the FDA, which have provided specific requirements for our potential U.S. biosimilar rituximab but believe the patient and marketplace needs in the U.S. will be satisfied before we can generate the data required,” Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said in a statement.

“We are disappointed to have to make this decision and stand behind the safety, efficacy, and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand, and Australia.”

The BLA for GP2013 was supported, in part, by results from the ASSIST-FL trial, in which researchers compared GP2013 with the reference product (Lancet Haematol. 2017 Aug;4[8]:e350-61).

The phase 3 trial included adults with previously untreated, advanced-stage follicular lymphoma. Patients received eight cycles of cyclophosphamide, vincristine, and prednisone with either GP2013 or reference rituximab. Responders then received GP2013 or rituximab monotherapy as maintenance for up to 2 years.

At a median follow-up of 11.6 months, the overall response rate was 87% in the GP2013 arm and 88% in the rituximab arm.

jensmith@mdedge.com

WASHINGTON, DC—The Drug Enforcement Administration (DEA) has reclassified Epidiolex, an oral cannabidiol (CBD) solution, from Schedule I to Schedule V, the lowest category of scheduled substances. The FDA approved Epidiolex earlier this year for the adjunctive treatment of seizures in patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome aged 2 and older. The DEA’s action paves the way for the manufacturer, GW Pharmaceuticals, to begin marketing Epidiolex, which is expected to be available in the United States this fall.

The DEA’s final rescheduling order is limited to drugs approved by the FDA that contain cannabis-derived CBD and no more than 0.1% tetrahydrocannabinol (THC). In practice, this means that the rescheduling currently applies only to Epidiolex, since this is the only formulation of CBD that has received FDA approval.

A Low Potential for Abuse

“We are pleased that the DEA has placed Epidiolex in the lowest restriction schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said GW Pharmaceutical’s Chief Executive Officer Justin Gover in a statement.

During the FDA advisory committee meeting for the approval of Epidiolex to treat LGS and Dravet syndrome, the FDA and GW Pharmaceuticals concluded that the potential to abuse CBD was low, since it does not contain THC, the primary psychoactive component of cannabis.

All other marijuana products are currently classified as Schedule I, along with illegal substances such as heroin and cocaine.

An Established Medical Use

Epidiolex had received fast track and rare pediatric designations from the FDA for LGS and Dravet syndrome; the approval was based on three pivotal randomized, double-blind, placebo-controlled clinical trials. The drug met its primary end point of reduced seizure frequency in all trials when added to standard of care for patients with drug-resistant LGS and those with Dravet syndrome.

Safety evaluations assessed data from 1,756 patients and found that the 20 deaths seen during the study period were not clearly linked to Epidiolex and may be expected for children with severe seizure disorders.

In supplementary information accompanying the order, the DEA’s Acting Administrator Uttam Dhillon noted that the FDA’s approval of Epidiolex means that “it has a currently accepted medical use in treatment for purposes of the Controlled Substances Act [CSA]. Accordingly, Epidiolex no longer meets the criteria for placement in Schedule I of the CSA.” Schedule I drugs do not have a currently accepted medical use.

Schedule V drugs, according to the DEA, are defined as “drugs with lower potential for abuse than Schedule IV and [that] consist of preparations containing limited quantities of certain narcotics.” Other Schedule V drugs include cough medicine with less than 200 mg of codeine or per 100 mL, antidiarrheal medications, pregabalin, and the antiepileptic drugs brivaracetam and lacosamide. “Schedule V drugs represent the least potential for abuse,” according to the DEA.

Initial dosing recommendations for Epidiolex are to titrate to a dose of 10 mg/kg/day. Dose adjustments to 20 mg/kg/day are permissible, depending on clinical response and tolerability. The manufacturer has submitted a marketing agreement to the European Medicines Agency and has received orphan drug designation for Epidiolex in the treatment of tuberous sclerosis complex.

—Kari Oakes

WASHINGTON, DC—The Drug Enforcement Administration (DEA) has reclassified Epidiolex, an oral cannabidiol (CBD) solution, from Schedule I to Schedule V, the lowest category of scheduled substances. The FDA approved Epidiolex earlier this year for the adjunctive treatment of seizures in patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome aged 2 and older. The DEA’s action paves the way for the manufacturer, GW Pharmaceuticals, to begin marketing Epidiolex, which is expected to be available in the United States this fall.

The DEA’s final rescheduling order is limited to drugs approved by the FDA that contain cannabis-derived CBD and no more than 0.1% tetrahydrocannabinol (THC). In practice, this means that the rescheduling currently applies only to Epidiolex, since this is the only formulation of CBD that has received FDA approval.

A Low Potential for Abuse

“We are pleased that the DEA has placed Epidiolex in the lowest restriction schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said GW Pharmaceutical’s Chief Executive Officer Justin Gover in a statement.

During the FDA advisory committee meeting for the approval of Epidiolex to treat LGS and Dravet syndrome, the FDA and GW Pharmaceuticals concluded that the potential to abuse CBD was low, since it does not contain THC, the primary psychoactive component of cannabis.

All other marijuana products are currently classified as Schedule I, along with illegal substances such as heroin and cocaine.

An Established Medical Use

Epidiolex had received fast track and rare pediatric designations from the FDA for LGS and Dravet syndrome; the approval was based on three pivotal randomized, double-blind, placebo-controlled clinical trials. The drug met its primary end point of reduced seizure frequency in all trials when added to standard of care for patients with drug-resistant LGS and those with Dravet syndrome.

Safety evaluations assessed data from 1,756 patients and found that the 20 deaths seen during the study period were not clearly linked to Epidiolex and may be expected for children with severe seizure disorders.

In supplementary information accompanying the order, the DEA’s Acting Administrator Uttam Dhillon noted that the FDA’s approval of Epidiolex means that “it has a currently accepted medical use in treatment for purposes of the Controlled Substances Act [CSA]. Accordingly, Epidiolex no longer meets the criteria for placement in Schedule I of the CSA.” Schedule I drugs do not have a currently accepted medical use.

Schedule V drugs, according to the DEA, are defined as “drugs with lower potential for abuse than Schedule IV and [that] consist of preparations containing limited quantities of certain narcotics.” Other Schedule V drugs include cough medicine with less than 200 mg of codeine or per 100 mL, antidiarrheal medications, pregabalin, and the antiepileptic drugs brivaracetam and lacosamide. “Schedule V drugs represent the least potential for abuse,” according to the DEA.

Initial dosing recommendations for Epidiolex are to titrate to a dose of 10 mg/kg/day. Dose adjustments to 20 mg/kg/day are permissible, depending on clinical response and tolerability. The manufacturer has submitted a marketing agreement to the European Medicines Agency and has received orphan drug designation for Epidiolex in the treatment of tuberous sclerosis complex.

—Kari Oakes

WASHINGTON, DC—The Drug Enforcement Administration (DEA) has reclassified Epidiolex, an oral cannabidiol (CBD) solution, from Schedule I to Schedule V, the lowest category of scheduled substances. The FDA approved Epidiolex earlier this year for the adjunctive treatment of seizures in patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome aged 2 and older. The DEA’s action paves the way for the manufacturer, GW Pharmaceuticals, to begin marketing Epidiolex, which is expected to be available in the United States this fall.

The DEA’s final rescheduling order is limited to drugs approved by the FDA that contain cannabis-derived CBD and no more than 0.1% tetrahydrocannabinol (THC). In practice, this means that the rescheduling currently applies only to Epidiolex, since this is the only formulation of CBD that has received FDA approval.

A Low Potential for Abuse

“We are pleased that the DEA has placed Epidiolex in the lowest restriction schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said GW Pharmaceutical’s Chief Executive Officer Justin Gover in a statement.

During the FDA advisory committee meeting for the approval of Epidiolex to treat LGS and Dravet syndrome, the FDA and GW Pharmaceuticals concluded that the potential to abuse CBD was low, since it does not contain THC, the primary psychoactive component of cannabis.

All other marijuana products are currently classified as Schedule I, along with illegal substances such as heroin and cocaine.

An Established Medical Use

Epidiolex had received fast track and rare pediatric designations from the FDA for LGS and Dravet syndrome; the approval was based on three pivotal randomized, double-blind, placebo-controlled clinical trials. The drug met its primary end point of reduced seizure frequency in all trials when added to standard of care for patients with drug-resistant LGS and those with Dravet syndrome.

Safety evaluations assessed data from 1,756 patients and found that the 20 deaths seen during the study period were not clearly linked to Epidiolex and may be expected for children with severe seizure disorders.

In supplementary information accompanying the order, the DEA’s Acting Administrator Uttam Dhillon noted that the FDA’s approval of Epidiolex means that “it has a currently accepted medical use in treatment for purposes of the Controlled Substances Act [CSA]. Accordingly, Epidiolex no longer meets the criteria for placement in Schedule I of the CSA.” Schedule I drugs do not have a currently accepted medical use.

Schedule V drugs, according to the DEA, are defined as “drugs with lower potential for abuse than Schedule IV and [that] consist of preparations containing limited quantities of certain narcotics.” Other Schedule V drugs include cough medicine with less than 200 mg of codeine or per 100 mL, antidiarrheal medications, pregabalin, and the antiepileptic drugs brivaracetam and lacosamide. “Schedule V drugs represent the least potential for abuse,” according to the DEA.

Initial dosing recommendations for Epidiolex are to titrate to a dose of 10 mg/kg/day. Dose adjustments to 20 mg/kg/day are permissible, depending on clinical response and tolerability. The manufacturer has submitted a marketing agreement to the European Medicines Agency and has received orphan drug designation for Epidiolex in the treatment of tuberous sclerosis complex.

—Kari Oakes

SAN DIEGO – Emergency care–sensitive conditions – those for which timely access to high-quality emergency care impact morbidity and mortality—account for 14% of all ED visits, results from a large analysis of national data showed.

Doug Brunk/MDedge News

In previously published work, an eight-member expert panel identified 51 condition groups as emergency care–sensitive conditions (ECSCs), including asthma, cardiac arrest, cerebral infarction, and pneumonia. The purpose of the current study, published in Annals of Emergency Medicine and presented by Anita Vashi, MD, MPH, at the annual meeting of the American College of Emergency Physicians, was to provide the first national estimates of acute care utilization and the demographic characteristics of adults experiencing ECSCs, compare ECSC and non-ECSC ED visits, and assess patient- and hospital-level characteristics predictive of an ECSC-related ED visit.

Using the Nationwide Emergency Department Sample data set, Dr. Vashi, a physician investigator at the Center for Innovation to Implementation at the VA Palo Alto Health Care System, and her colleagues retrospectively evaluated all ED visits for patients aged 18 years and older from 2009 to 2014. The researchers used summary statistics to compare population characteristics across groups and multivariable logistic regression models to assess the odds of an ECSC-related ED visit with patient- and hospital-level characteristics.

Of the 622,725,542 estimated ED visits evaluated during the study period, 86,577,041 (14%) were ECSCs. Among these ECSC visits, 58% of patients were admitted for an average length of 3.2 days and an average charge of $2,240. The most frequent ECSC-related visits were for pneumonia (9%), chronic obstructive pulmonary disease (9%), asthma (7%), heart failure (7%), and sepsis (5%), but varied by age group.

Dr. Vashi and her colleagues found that ECSCs were more common among older adults, males, those who reside in low-income areas, those who reside in the South, and among metropolitan-based hospitals and nontrauma center hospitals. ECSCs also accounted for about 45% of all inpatient admissions.

Multivariate logistic regression analysis revealed that the odds of having an ECSC-related visit was highest among patients aged 65 years and older (odds ratio, 3.84), those on Medicare (OR, 1.37), those who resided in rural counties (OR, 1.21), and those who reside in the Western portion of the United States (OR, 1.11). Significant hospital-related factors related to ECSC visits included trauma centers (OR, 1.09), nonteaching hospitals (OR, 1.04), and EDs located in the wealthiest counties (OR, 1.02).

The researchers also found that 40% of patients who made ECSC-related ED visits were treated and discharged back to the community. “There is evidence of regional variability, suggesting the need for future research,” said Dr. Vashi, who also holds a faculty position in the department of emergency medicine at Stanford (Calif.) University. “We found no consistent relationship between insurance, income, and ED use for ECSC-related conditions. This suggests that ECSCs are not significantly influenced by socioeconomic factor and can serve as a reliable marker for acuity.”

The next steps in this research area, she added, are to create condition-specific measures related to morbidity, mortality, and posthospital events, as well as to analyze regional and hospital variations including correlation across conditions, and to compare performance across conditions and hospitals.

Dr. Vashi reported having no financial disclosures.

dbrunk@mdedge.com

Source: Vashi A et al. Ann Emerg Med. 2018 Oct;72;4:S38. doi. 10.1016/j.annemergmed.2018.08.091.




 

SAN DIEGO – Emergency care–sensitive conditions – those for which timely access to high-quality emergency care impact morbidity and mortality—account for 14% of all ED visits, results from a large analysis of national data showed.

Doug Brunk/MDedge News

In previously published work, an eight-member expert panel identified 51 condition groups as emergency care–sensitive conditions (ECSCs), including asthma, cardiac arrest, cerebral infarction, and pneumonia. The purpose of the current study, published in Annals of Emergency Medicine and presented by Anita Vashi, MD, MPH, at the annual meeting of the American College of Emergency Physicians, was to provide the first national estimates of acute care utilization and the demographic characteristics of adults experiencing ECSCs, compare ECSC and non-ECSC ED visits, and assess patient- and hospital-level characteristics predictive of an ECSC-related ED visit.

Using the Nationwide Emergency Department Sample data set, Dr. Vashi, a physician investigator at the Center for Innovation to Implementation at the VA Palo Alto Health Care System, and her colleagues retrospectively evaluated all ED visits for patients aged 18 years and older from 2009 to 2014. The researchers used summary statistics to compare population characteristics across groups and multivariable logistic regression models to assess the odds of an ECSC-related ED visit with patient- and hospital-level characteristics.

Of the 622,725,542 estimated ED visits evaluated during the study period, 86,577,041 (14%) were ECSCs. Among these ECSC visits, 58% of patients were admitted for an average length of 3.2 days and an average charge of $2,240. The most frequent ECSC-related visits were for pneumonia (9%), chronic obstructive pulmonary disease (9%), asthma (7%), heart failure (7%), and sepsis (5%), but varied by age group.

Dr. Vashi and her colleagues found that ECSCs were more common among older adults, males, those who reside in low-income areas, those who reside in the South, and among metropolitan-based hospitals and nontrauma center hospitals. ECSCs also accounted for about 45% of all inpatient admissions.

Multivariate logistic regression analysis revealed that the odds of having an ECSC-related visit was highest among patients aged 65 years and older (odds ratio, 3.84), those on Medicare (OR, 1.37), those who resided in rural counties (OR, 1.21), and those who reside in the Western portion of the United States (OR, 1.11). Significant hospital-related factors related to ECSC visits included trauma centers (OR, 1.09), nonteaching hospitals (OR, 1.04), and EDs located in the wealthiest counties (OR, 1.02).

The researchers also found that 40% of patients who made ECSC-related ED visits were treated and discharged back to the community. “There is evidence of regional variability, suggesting the need for future research,” said Dr. Vashi, who also holds a faculty position in the department of emergency medicine at Stanford (Calif.) University. “We found no consistent relationship between insurance, income, and ED use for ECSC-related conditions. This suggests that ECSCs are not significantly influenced by socioeconomic factor and can serve as a reliable marker for acuity.”

The next steps in this research area, she added, are to create condition-specific measures related to morbidity, mortality, and posthospital events, as well as to analyze regional and hospital variations including correlation across conditions, and to compare performance across conditions and hospitals.

Dr. Vashi reported having no financial disclosures.

dbrunk@mdedge.com

Source: Vashi A et al. Ann Emerg Med. 2018 Oct;72;4:S38. doi. 10.1016/j.annemergmed.2018.08.091.




 

SAN DIEGO – Emergency care–sensitive conditions – those for which timely access to high-quality emergency care impact morbidity and mortality—account for 14% of all ED visits, results from a large analysis of national data showed.

Doug Brunk/MDedge News

In previously published work, an eight-member expert panel identified 51 condition groups as emergency care–sensitive conditions (ECSCs), including asthma, cardiac arrest, cerebral infarction, and pneumonia. The purpose of the current study, published in Annals of Emergency Medicine and presented by Anita Vashi, MD, MPH, at the annual meeting of the American College of Emergency Physicians, was to provide the first national estimates of acute care utilization and the demographic characteristics of adults experiencing ECSCs, compare ECSC and non-ECSC ED visits, and assess patient- and hospital-level characteristics predictive of an ECSC-related ED visit.

Using the Nationwide Emergency Department Sample data set, Dr. Vashi, a physician investigator at the Center for Innovation to Implementation at the VA Palo Alto Health Care System, and her colleagues retrospectively evaluated all ED visits for patients aged 18 years and older from 2009 to 2014. The researchers used summary statistics to compare population characteristics across groups and multivariable logistic regression models to assess the odds of an ECSC-related ED visit with patient- and hospital-level characteristics.

Of the 622,725,542 estimated ED visits evaluated during the study period, 86,577,041 (14%) were ECSCs. Among these ECSC visits, 58% of patients were admitted for an average length of 3.2 days and an average charge of $2,240. The most frequent ECSC-related visits were for pneumonia (9%), chronic obstructive pulmonary disease (9%), asthma (7%), heart failure (7%), and sepsis (5%), but varied by age group.

Dr. Vashi and her colleagues found that ECSCs were more common among older adults, males, those who reside in low-income areas, those who reside in the South, and among metropolitan-based hospitals and nontrauma center hospitals. ECSCs also accounted for about 45% of all inpatient admissions.

Multivariate logistic regression analysis revealed that the odds of having an ECSC-related visit was highest among patients aged 65 years and older (odds ratio, 3.84), those on Medicare (OR, 1.37), those who resided in rural counties (OR, 1.21), and those who reside in the Western portion of the United States (OR, 1.11). Significant hospital-related factors related to ECSC visits included trauma centers (OR, 1.09), nonteaching hospitals (OR, 1.04), and EDs located in the wealthiest counties (OR, 1.02).

The researchers also found that 40% of patients who made ECSC-related ED visits were treated and discharged back to the community. “There is evidence of regional variability, suggesting the need for future research,” said Dr. Vashi, who also holds a faculty position in the department of emergency medicine at Stanford (Calif.) University. “We found no consistent relationship between insurance, income, and ED use for ECSC-related conditions. This suggests that ECSCs are not significantly influenced by socioeconomic factor and can serve as a reliable marker for acuity.”

The next steps in this research area, she added, are to create condition-specific measures related to morbidity, mortality, and posthospital events, as well as to analyze regional and hospital variations including correlation across conditions, and to compare performance across conditions and hospitals.

Dr. Vashi reported having no financial disclosures.

dbrunk@mdedge.com

Source: Vashi A et al. Ann Emerg Med. 2018 Oct;72;4:S38. doi. 10.1016/j.annemergmed.2018.08.091.




 

SAN ANTONIO – Opioids do not mix well with sleep, interfering with breathing and increasing the risk of central sleep apnea, explained Anita Rajagopal, MD, a pulmonologist in private practice in Indianapolis.

“The chronic respiratory suppressant effects of opioids are well described,” Dr. Rajagopal told attendees at the annual meeting of the American College of Chest Physicians. “The most characteristic signs of chronic opioid effects are irregular central apneas, ataxic breathing, Biot’s respiration and hypoxemia, mainly during NREM sleep.”

Dr. Rajagopal reviewed the research on the effects of opioid use, primarily for therapeutic use, during sleep, especially highlighting the adverse respiratory effects.

In one small study of 24 patients, ages 18-75, who were taking long-term opioids for chronic pain, 46% had severe sleep-disordered breathing, defined as an apnea-hypopnea index greater than 30/hour (J Clin Sleep Med. 2014 Aug 15;10[8]:847-52).

When compared to sleep clinic patients referred for sleep disordered breathing, the participants taking opioids had a higher frequency of central apneas and a lower arousal index. Further, the researchers found that “morphine equivalent doses correlated with the severity of sleep-disordered breathing.”

In another study, a systematic review from 2015, researchers sought to characterize the clinical features of sleep-disordered breathing associated with chronic opioid therapy (Anesth Analg. 2015 Jun;120[6]:1273-85). They identified eight studies with 560 patients, about a quarter of whom (24%) had central sleep apnea.

Once again, “The morphine equivalent daily dose was strongly associated with the severity of the sleep disordered breathing, predominantly central sleep apnea, with a morphine equivalent daily dose of more than 200 mg being a threshold of particular concern,” the researchers reported.

Patients receiving methadone therapy for heroin addiction are not spared the respiratory risks of opioids during sleep. Dr. Rajagopal shared research revealing that patients receiving methadone treatment for at least two months had a blunted hypercapnic respiratory response and increased hypoxemic ventilatory response, changes related to respiratory rate but not tidal volume.

“All mu-opioid receptor agonists can cause complex and potentially lethal effects on respiration during sleep,” Dr. Rajagopal said as she shared evidence from a 2007 study that compared breathing patterns during sleep between 60 patients taking chronic opioids and 60 matched patients not taking opioids (J Clin Sleep Med. 2007 Aug 15;3[5]:455-61).

That study found chronic opioid use to be associated with increased central apneas and reduced arterial oxygen saturation during wakefulness and NREM sleep. Again, a dose-response relationship emerged between morphine dose equivalent and the apnea-hypopnea, obstructive apnea, hypopnea and central apnea indices (P less than .001).

Patients who took opioids long-term were also more likely to have ataxic or irregular breathing during NREM sleep, compared with patients not taking opioids.

In yet another meta-analysis and systematic review she related, researchers found across 803 patients in seven studies that long-term opioids users had a modestly increased risk for central sleep apnea but no similar increased risk for obstructive sleep apnea (J Clin Sleep Med. 2016 Apr 15;12[4]:617-25).

“REM and slow-wave sleep are decreased across all categories of opioid use — intravenous morphine, oral morphine, or methadone and heroin,” she said.

Since some patients are still going to need opioids, such as methadone therapy for those recovering from opioid use disorder, it’s important to understand appropriate effective treatments for central sleep apnea.

“CPAP [continuous positive airway pressure] is generally ineffective for opioid-induced sleep apnea and may augment central events,” Dr. Rajagopal explained, but adaptive servo ventilation (ASV) is effective for opioid-induced central apneas.

In one study of 20 patients receiving opioid therapy and referred for obstructive apnea, for example, the participants were diagnosed instead with central sleep apnea (J Clin Sleep Med. 2014 Jun 15;10[6]:637-43). The 16 patients who received CPAP continued to show central sleep apnea, with an AHI of 34 events/hour and central-apnea index (CAI) of 20 events/hour. Even after a four-week break before restarting CPAP, patients’ apnea did not resolve.

After receiving ASV, however, the average AHI dropped to 11 events/hour and CAI dropped to 0 events/hour. Those changes were accompanied by improvements in oxygen saturation, with the oxyhemoglobin saturation nadir increasing from 83% to 90%.

Similarly, a prospective multi-center observational trial assessed 27 patients with central apnea after they used ASV at home for three months (Chest. 2015 Dec;148[6]:1454-1461). The participants began with an average AHI of 55 and CAI of 23 at baseline. CPAP dropped these values only to an AHI of 33 and CAI of 10, but treatment with ASV dropped them to an AHI of 4 and CAI of 0 (P less than .001).

SAN ANTONIO – Opioids do not mix well with sleep, interfering with breathing and increasing the risk of central sleep apnea, explained Anita Rajagopal, MD, a pulmonologist in private practice in Indianapolis.

“The chronic respiratory suppressant effects of opioids are well described,” Dr. Rajagopal told attendees at the annual meeting of the American College of Chest Physicians. “The most characteristic signs of chronic opioid effects are irregular central apneas, ataxic breathing, Biot’s respiration and hypoxemia, mainly during NREM sleep.”

Dr. Rajagopal reviewed the research on the effects of opioid use, primarily for therapeutic use, during sleep, especially highlighting the adverse respiratory effects.

In one small study of 24 patients, ages 18-75, who were taking long-term opioids for chronic pain, 46% had severe sleep-disordered breathing, defined as an apnea-hypopnea index greater than 30/hour (J Clin Sleep Med. 2014 Aug 15;10[8]:847-52).

When compared to sleep clinic patients referred for sleep disordered breathing, the participants taking opioids had a higher frequency of central apneas and a lower arousal index. Further, the researchers found that “morphine equivalent doses correlated with the severity of sleep-disordered breathing.”

In another study, a systematic review from 2015, researchers sought to characterize the clinical features of sleep-disordered breathing associated with chronic opioid therapy (Anesth Analg. 2015 Jun;120[6]:1273-85). They identified eight studies with 560 patients, about a quarter of whom (24%) had central sleep apnea.

Once again, “The morphine equivalent daily dose was strongly associated with the severity of the sleep disordered breathing, predominantly central sleep apnea, with a morphine equivalent daily dose of more than 200 mg being a threshold of particular concern,” the researchers reported.

Patients receiving methadone therapy for heroin addiction are not spared the respiratory risks of opioids during sleep. Dr. Rajagopal shared research revealing that patients receiving methadone treatment for at least two months had a blunted hypercapnic respiratory response and increased hypoxemic ventilatory response, changes related to respiratory rate but not tidal volume.

“All mu-opioid receptor agonists can cause complex and potentially lethal effects on respiration during sleep,” Dr. Rajagopal said as she shared evidence from a 2007 study that compared breathing patterns during sleep between 60 patients taking chronic opioids and 60 matched patients not taking opioids (J Clin Sleep Med. 2007 Aug 15;3[5]:455-61).

That study found chronic opioid use to be associated with increased central apneas and reduced arterial oxygen saturation during wakefulness and NREM sleep. Again, a dose-response relationship emerged between morphine dose equivalent and the apnea-hypopnea, obstructive apnea, hypopnea and central apnea indices (P less than .001).

Patients who took opioids long-term were also more likely to have ataxic or irregular breathing during NREM sleep, compared with patients not taking opioids.

In yet another meta-analysis and systematic review she related, researchers found across 803 patients in seven studies that long-term opioids users had a modestly increased risk for central sleep apnea but no similar increased risk for obstructive sleep apnea (J Clin Sleep Med. 2016 Apr 15;12[4]:617-25).

“REM and slow-wave sleep are decreased across all categories of opioid use — intravenous morphine, oral morphine, or methadone and heroin,” she said.

Since some patients are still going to need opioids, such as methadone therapy for those recovering from opioid use disorder, it’s important to understand appropriate effective treatments for central sleep apnea.

“CPAP [continuous positive airway pressure] is generally ineffective for opioid-induced sleep apnea and may augment central events,” Dr. Rajagopal explained, but adaptive servo ventilation (ASV) is effective for opioid-induced central apneas.

In one study of 20 patients receiving opioid therapy and referred for obstructive apnea, for example, the participants were diagnosed instead with central sleep apnea (J Clin Sleep Med. 2014 Jun 15;10[6]:637-43). The 16 patients who received CPAP continued to show central sleep apnea, with an AHI of 34 events/hour and central-apnea index (CAI) of 20 events/hour. Even after a four-week break before restarting CPAP, patients’ apnea did not resolve.

After receiving ASV, however, the average AHI dropped to 11 events/hour and CAI dropped to 0 events/hour. Those changes were accompanied by improvements in oxygen saturation, with the oxyhemoglobin saturation nadir increasing from 83% to 90%.

Similarly, a prospective multi-center observational trial assessed 27 patients with central apnea after they used ASV at home for three months (Chest. 2015 Dec;148[6]:1454-1461). The participants began with an average AHI of 55 and CAI of 23 at baseline. CPAP dropped these values only to an AHI of 33 and CAI of 10, but treatment with ASV dropped them to an AHI of 4 and CAI of 0 (P less than .001).

SAN ANTONIO – Opioids do not mix well with sleep, interfering with breathing and increasing the risk of central sleep apnea, explained Anita Rajagopal, MD, a pulmonologist in private practice in Indianapolis.

“The chronic respiratory suppressant effects of opioids are well described,” Dr. Rajagopal told attendees at the annual meeting of the American College of Chest Physicians. “The most characteristic signs of chronic opioid effects are irregular central apneas, ataxic breathing, Biot’s respiration and hypoxemia, mainly during NREM sleep.”

Dr. Rajagopal reviewed the research on the effects of opioid use, primarily for therapeutic use, during sleep, especially highlighting the adverse respiratory effects.

In one small study of 24 patients, ages 18-75, who were taking long-term opioids for chronic pain, 46% had severe sleep-disordered breathing, defined as an apnea-hypopnea index greater than 30/hour (J Clin Sleep Med. 2014 Aug 15;10[8]:847-52).

When compared to sleep clinic patients referred for sleep disordered breathing, the participants taking opioids had a higher frequency of central apneas and a lower arousal index. Further, the researchers found that “morphine equivalent doses correlated with the severity of sleep-disordered breathing.”

In another study, a systematic review from 2015, researchers sought to characterize the clinical features of sleep-disordered breathing associated with chronic opioid therapy (Anesth Analg. 2015 Jun;120[6]:1273-85). They identified eight studies with 560 patients, about a quarter of whom (24%) had central sleep apnea.

Once again, “The morphine equivalent daily dose was strongly associated with the severity of the sleep disordered breathing, predominantly central sleep apnea, with a morphine equivalent daily dose of more than 200 mg being a threshold of particular concern,” the researchers reported.

Patients receiving methadone therapy for heroin addiction are not spared the respiratory risks of opioids during sleep. Dr. Rajagopal shared research revealing that patients receiving methadone treatment for at least two months had a blunted hypercapnic respiratory response and increased hypoxemic ventilatory response, changes related to respiratory rate but not tidal volume.

“All mu-opioid receptor agonists can cause complex and potentially lethal effects on respiration during sleep,” Dr. Rajagopal said as she shared evidence from a 2007 study that compared breathing patterns during sleep between 60 patients taking chronic opioids and 60 matched patients not taking opioids (J Clin Sleep Med. 2007 Aug 15;3[5]:455-61).

That study found chronic opioid use to be associated with increased central apneas and reduced arterial oxygen saturation during wakefulness and NREM sleep. Again, a dose-response relationship emerged between morphine dose equivalent and the apnea-hypopnea, obstructive apnea, hypopnea and central apnea indices (P less than .001).

Patients who took opioids long-term were also more likely to have ataxic or irregular breathing during NREM sleep, compared with patients not taking opioids.

In yet another meta-analysis and systematic review she related, researchers found across 803 patients in seven studies that long-term opioids users had a modestly increased risk for central sleep apnea but no similar increased risk for obstructive sleep apnea (J Clin Sleep Med. 2016 Apr 15;12[4]:617-25).

“REM and slow-wave sleep are decreased across all categories of opioid use — intravenous morphine, oral morphine, or methadone and heroin,” she said.

Since some patients are still going to need opioids, such as methadone therapy for those recovering from opioid use disorder, it’s important to understand appropriate effective treatments for central sleep apnea.

“CPAP [continuous positive airway pressure] is generally ineffective for opioid-induced sleep apnea and may augment central events,” Dr. Rajagopal explained, but adaptive servo ventilation (ASV) is effective for opioid-induced central apneas.

In one study of 20 patients receiving opioid therapy and referred for obstructive apnea, for example, the participants were diagnosed instead with central sleep apnea (J Clin Sleep Med. 2014 Jun 15;10[6]:637-43). The 16 patients who received CPAP continued to show central sleep apnea, with an AHI of 34 events/hour and central-apnea index (CAI) of 20 events/hour. Even after a four-week break before restarting CPAP, patients’ apnea did not resolve.

After receiving ASV, however, the average AHI dropped to 11 events/hour and CAI dropped to 0 events/hour. Those changes were accompanied by improvements in oxygen saturation, with the oxyhemoglobin saturation nadir increasing from 83% to 90%.

Similarly, a prospective multi-center observational trial assessed 27 patients with central apnea after they used ASV at home for three months (Chest. 2015 Dec;148[6]:1454-1461). The participants began with an average AHI of 55 and CAI of 23 at baseline. CPAP dropped these values only to an AHI of 33 and CAI of 10, but treatment with ASV dropped them to an AHI of 4 and CAI of 0 (P less than .001).

A retrospective study has revealed new potential risk factors for chemotherapy-induced febrile neutropenia in patients with solid tumors and non-Hodgkin lymphoma (NHL).

Researchers found the timing and duration of corticosteroid use were both associated with febrile neutropenia. The team also observed “marginal” associations between febrile neutropenia and certain dermatologic and mucosal conditions, as well as the use of intravenous antibiotics before chemotherapy.

However, there was no association found between oral antibiotic use and febrile neutropenia or between radiation therapy and febrile neutropenia.

Chun Rebecca Chao, PhD, of the Kaiser Permanente Southern California in Pasadena, and her colleagues reported these findings in the Journal of the National Comprehensive Cancer Network.

“Febrile neutropenia is life threatening and often requires hospitalization,” Dr. Chao said in a statement. “Furthermore, [febrile neutropenia] can lead to chemotherapy dose delay and dose reduction, which, in turn, negatively impacts antitumor efficacy. However, it can be prevented if high-risk individuals are identified and treated prophylactically.”

With this in mind, Dr. Chao and her colleagues set out to identify novel risk factors for febrile neutropenia by analyzing 15,971 patients who were treated with myelosuppressive chemotherapy at Kaiser Permanente Southern California between 2000 and 2009.

Patients had been diagnosed with NHL (n = 1,617) or breast (n = 6,323), lung (n = 3,584), colorectal (n = 3,062), ovarian (n = 924), or gastric (n = 461) cancers. In all, 4.3% of patients developed febrile neutropenia during their first cycle of chemotherapy.

The researchers found that corticosteroid use was associated with an increased risk of febrile neutropenia in a propensity score–adjusted (PSA) model. The hazard ratio was 1.53 (95% confidence interval, 1.17-1.98; P less than .01) for patients who received corticosteroids.

A longer duration of corticosteroid use was associated with a greater risk of febrile neutropenia. The adjusted HR, compared with no corticosteroid use, was 1.78 for corticosteroid treatment lasting less than 15 days and rose to 2.86 for treatment lasting 45-90 days.

“One way to reduce the incidence rate for [febrile neutropenia] could be to schedule prior corticosteroid use and subsequent chemotherapy with at least 2 weeks between them, given the magnitude of the risk increase and prevalence of this risk factor,” Dr. Chao said.

The researchers found a “marginally” increased risk of febrile neutropenia in patients with certain dermatologic conditions (dermatitis, psoriasis, pruritus) and mucosal conditions (gastritis, stomatitis, mucositis). In the PSA model, the HR was 1.40 (95% CI, 0.98-1.93; P = 0.05) for patients with these conditions.

Intravenous antibiotic use was also found to be marginally associated with an increased risk of febrile neutropenia in a restricted analysis covering patients treated in 2008 and 2009. In the PSA model, the HR was 1.35 (95% CI, 0.97-1.87; P = .08).

There was no association found between febrile neutropenia and oral antibiotic use in the restricted analysis. In the PSA model, the HR was 1.07 (95% CI, 0.77-1.48; P = .70) for patients who received oral antibiotics.

Dr. Chao and her colleagues wrote that these results suggest intravenous antibiotics may have a more profound impact than oral antibiotics on the balance of bacterial flora and other immune functions. Another possible explanation is that patients who received intravenous antibiotics were generally sicker and more prone to severe infection than patients who received oral antibiotics.

The researchers also found no association between febrile neutropenia and prior surgery, prior radiation therapy, and concurrent radiation therapy in the PSA model.

The study was funded by Amgen. Three of the authors reported being employees and stockholders of Amgen.

jensmith@mdedge.com

SOURCE: Chao CR et al. J Natl Compr Canc Netw. 2018;16(10):1201-8.

A retrospective study has revealed new potential risk factors for chemotherapy-induced febrile neutropenia in patients with solid tumors and non-Hodgkin lymphoma (NHL).

Researchers found the timing and duration of corticosteroid use were both associated with febrile neutropenia. The team also observed “marginal” associations between febrile neutropenia and certain dermatologic and mucosal conditions, as well as the use of intravenous antibiotics before chemotherapy.

However, there was no association found between oral antibiotic use and febrile neutropenia or between radiation therapy and febrile neutropenia.

Chun Rebecca Chao, PhD, of the Kaiser Permanente Southern California in Pasadena, and her colleagues reported these findings in the Journal of the National Comprehensive Cancer Network.

“Febrile neutropenia is life threatening and often requires hospitalization,” Dr. Chao said in a statement. “Furthermore, [febrile neutropenia] can lead to chemotherapy dose delay and dose reduction, which, in turn, negatively impacts antitumor efficacy. However, it can be prevented if high-risk individuals are identified and treated prophylactically.”

With this in mind, Dr. Chao and her colleagues set out to identify novel risk factors for febrile neutropenia by analyzing 15,971 patients who were treated with myelosuppressive chemotherapy at Kaiser Permanente Southern California between 2000 and 2009.

Patients had been diagnosed with NHL (n = 1,617) or breast (n = 6,323), lung (n = 3,584), colorectal (n = 3,062), ovarian (n = 924), or gastric (n = 461) cancers. In all, 4.3% of patients developed febrile neutropenia during their first cycle of chemotherapy.

The researchers found that corticosteroid use was associated with an increased risk of febrile neutropenia in a propensity score–adjusted (PSA) model. The hazard ratio was 1.53 (95% confidence interval, 1.17-1.98; P less than .01) for patients who received corticosteroids.

A longer duration of corticosteroid use was associated with a greater risk of febrile neutropenia. The adjusted HR, compared with no corticosteroid use, was 1.78 for corticosteroid treatment lasting less than 15 days and rose to 2.86 for treatment lasting 45-90 days.

“One way to reduce the incidence rate for [febrile neutropenia] could be to schedule prior corticosteroid use and subsequent chemotherapy with at least 2 weeks between them, given the magnitude of the risk increase and prevalence of this risk factor,” Dr. Chao said.

The researchers found a “marginally” increased risk of febrile neutropenia in patients with certain dermatologic conditions (dermatitis, psoriasis, pruritus) and mucosal conditions (gastritis, stomatitis, mucositis). In the PSA model, the HR was 1.40 (95% CI, 0.98-1.93; P = 0.05) for patients with these conditions.

Intravenous antibiotic use was also found to be marginally associated with an increased risk of febrile neutropenia in a restricted analysis covering patients treated in 2008 and 2009. In the PSA model, the HR was 1.35 (95% CI, 0.97-1.87; P = .08).

There was no association found between febrile neutropenia and oral antibiotic use in the restricted analysis. In the PSA model, the HR was 1.07 (95% CI, 0.77-1.48; P = .70) for patients who received oral antibiotics.

Dr. Chao and her colleagues wrote that these results suggest intravenous antibiotics may have a more profound impact than oral antibiotics on the balance of bacterial flora and other immune functions. Another possible explanation is that patients who received intravenous antibiotics were generally sicker and more prone to severe infection than patients who received oral antibiotics.

The researchers also found no association between febrile neutropenia and prior surgery, prior radiation therapy, and concurrent radiation therapy in the PSA model.

The study was funded by Amgen. Three of the authors reported being employees and stockholders of Amgen.

jensmith@mdedge.com

SOURCE: Chao CR et al. J Natl Compr Canc Netw. 2018;16(10):1201-8.

A retrospective study has revealed new potential risk factors for chemotherapy-induced febrile neutropenia in patients with solid tumors and non-Hodgkin lymphoma (NHL).

Researchers found the timing and duration of corticosteroid use were both associated with febrile neutropenia. The team also observed “marginal” associations between febrile neutropenia and certain dermatologic and mucosal conditions, as well as the use of intravenous antibiotics before chemotherapy.

However, there was no association found between oral antibiotic use and febrile neutropenia or between radiation therapy and febrile neutropenia.

Chun Rebecca Chao, PhD, of the Kaiser Permanente Southern California in Pasadena, and her colleagues reported these findings in the Journal of the National Comprehensive Cancer Network.

“Febrile neutropenia is life threatening and often requires hospitalization,” Dr. Chao said in a statement. “Furthermore, [febrile neutropenia] can lead to chemotherapy dose delay and dose reduction, which, in turn, negatively impacts antitumor efficacy. However, it can be prevented if high-risk individuals are identified and treated prophylactically.”

With this in mind, Dr. Chao and her colleagues set out to identify novel risk factors for febrile neutropenia by analyzing 15,971 patients who were treated with myelosuppressive chemotherapy at Kaiser Permanente Southern California between 2000 and 2009.

Patients had been diagnosed with NHL (n = 1,617) or breast (n = 6,323), lung (n = 3,584), colorectal (n = 3,062), ovarian (n = 924), or gastric (n = 461) cancers. In all, 4.3% of patients developed febrile neutropenia during their first cycle of chemotherapy.

The researchers found that corticosteroid use was associated with an increased risk of febrile neutropenia in a propensity score–adjusted (PSA) model. The hazard ratio was 1.53 (95% confidence interval, 1.17-1.98; P less than .01) for patients who received corticosteroids.

A longer duration of corticosteroid use was associated with a greater risk of febrile neutropenia. The adjusted HR, compared with no corticosteroid use, was 1.78 for corticosteroid treatment lasting less than 15 days and rose to 2.86 for treatment lasting 45-90 days.

“One way to reduce the incidence rate for [febrile neutropenia] could be to schedule prior corticosteroid use and subsequent chemotherapy with at least 2 weeks between them, given the magnitude of the risk increase and prevalence of this risk factor,” Dr. Chao said.

The researchers found a “marginally” increased risk of febrile neutropenia in patients with certain dermatologic conditions (dermatitis, psoriasis, pruritus) and mucosal conditions (gastritis, stomatitis, mucositis). In the PSA model, the HR was 1.40 (95% CI, 0.98-1.93; P = 0.05) for patients with these conditions.

Intravenous antibiotic use was also found to be marginally associated with an increased risk of febrile neutropenia in a restricted analysis covering patients treated in 2008 and 2009. In the PSA model, the HR was 1.35 (95% CI, 0.97-1.87; P = .08).

There was no association found between febrile neutropenia and oral antibiotic use in the restricted analysis. In the PSA model, the HR was 1.07 (95% CI, 0.77-1.48; P = .70) for patients who received oral antibiotics.

Dr. Chao and her colleagues wrote that these results suggest intravenous antibiotics may have a more profound impact than oral antibiotics on the balance of bacterial flora and other immune functions. Another possible explanation is that patients who received intravenous antibiotics were generally sicker and more prone to severe infection than patients who received oral antibiotics.

The researchers also found no association between febrile neutropenia and prior surgery, prior radiation therapy, and concurrent radiation therapy in the PSA model.

The study was funded by Amgen. Three of the authors reported being employees and stockholders of Amgen.

jensmith@mdedge.com

SOURCE: Chao CR et al. J Natl Compr Canc Netw. 2018;16(10):1201-8.

People living with HIV who inject drugs often encounter multiple obstacles, both personal and system related, to beginning and adhering to treatment. But NIH researchers found that an “integrated and flexible intervention” not only helped patients overcome those barriers, but also cut deaths by 50%.

The study, HPTN 074, took place in Indonesia, Ukraine, and Vietnam—3 countries with HIV epidemics driven by injection drug use. Researchers enrolled 502 adults with HIV who inject drugs, and 806 adults without HIV, who inject drugs with them (their injection partners). At ≥ 1 injection partner of every person in the study enrolled. The HIV participants were assigned either the national standard of care for HIV infection and drug use, or the standard of care plus the intervention designed to facilitate treatment. The participants were followed for 1 to 2 years.

In the intervention group, participants were referred to local health care providers for anti-HIV therapy. They were also each assigned a systems navigator, who helped the patient identify and overcome structural barriers to starting and staying in care, such as unfamiliarity with how to enroll in medical care, or difficulty keeping appointments. Psychosocial counselors helped each participant overcome their unique psychological obstacles, such as lack of interest in therapy or fear of stigma.

At the end of the study, 15% of participants with HIV who received standard care had died, compared with 7% of the intervention patients. About 26% of deaths among HIV participants were “clearly” HIV related; 3% were due to drug overdose. Among the 42% of patients who died of unknown cause, 24% had weak immune systems.

The intervention had a “remarkably positive impact” on the participants, said Protocol Chair William Miller, MD, PhD. After 1 year, 41% of the intervention group had undetectable levels of HIV, compared with 24% of the standard-care group. Moreover, 72% of the intervention group were still in treatment, compared with 43% of the standard-care group. Similarly, 41% of intervention patients were in treatment for substance use, compared with 25% of standard-care patients.

The study is designed to be scalable to other settings. Investigators have offered the intervention to all the study participants living with HIV. They will be followed for a second year to find out whether the positive impact is sustained.

Source:

National Institutes of Health.  Novel intervention halves rate of death among people living with HIV who inject drugs. https://www.nih.gov/news-events/news-releases/novel-intervention-halves-rate-death-among-people-living-hiv-who-inject-drugs. Published August 31,2018. Accessed October 25, 2018.

People living with HIV who inject drugs often encounter multiple obstacles, both personal and system related, to beginning and adhering to treatment. But NIH researchers found that an “integrated and flexible intervention” not only helped patients overcome those barriers, but also cut deaths by 50%.

The study, HPTN 074, took place in Indonesia, Ukraine, and Vietnam—3 countries with HIV epidemics driven by injection drug use. Researchers enrolled 502 adults with HIV who inject drugs, and 806 adults without HIV, who inject drugs with them (their injection partners). At ≥ 1 injection partner of every person in the study enrolled. The HIV participants were assigned either the national standard of care for HIV infection and drug use, or the standard of care plus the intervention designed to facilitate treatment. The participants were followed for 1 to 2 years.

In the intervention group, participants were referred to local health care providers for anti-HIV therapy. They were also each assigned a systems navigator, who helped the patient identify and overcome structural barriers to starting and staying in care, such as unfamiliarity with how to enroll in medical care, or difficulty keeping appointments. Psychosocial counselors helped each participant overcome their unique psychological obstacles, such as lack of interest in therapy or fear of stigma.

At the end of the study, 15% of participants with HIV who received standard care had died, compared with 7% of the intervention patients. About 26% of deaths among HIV participants were “clearly” HIV related; 3% were due to drug overdose. Among the 42% of patients who died of unknown cause, 24% had weak immune systems.

The intervention had a “remarkably positive impact” on the participants, said Protocol Chair William Miller, MD, PhD. After 1 year, 41% of the intervention group had undetectable levels of HIV, compared with 24% of the standard-care group. Moreover, 72% of the intervention group were still in treatment, compared with 43% of the standard-care group. Similarly, 41% of intervention patients were in treatment for substance use, compared with 25% of standard-care patients.

The study is designed to be scalable to other settings. Investigators have offered the intervention to all the study participants living with HIV. They will be followed for a second year to find out whether the positive impact is sustained.

Source:

National Institutes of Health.  Novel intervention halves rate of death among people living with HIV who inject drugs. https://www.nih.gov/news-events/news-releases/novel-intervention-halves-rate-death-among-people-living-hiv-who-inject-drugs. Published August 31,2018. Accessed October 25, 2018.

People living with HIV who inject drugs often encounter multiple obstacles, both personal and system related, to beginning and adhering to treatment. But NIH researchers found that an “integrated and flexible intervention” not only helped patients overcome those barriers, but also cut deaths by 50%.

The study, HPTN 074, took place in Indonesia, Ukraine, and Vietnam—3 countries with HIV epidemics driven by injection drug use. Researchers enrolled 502 adults with HIV who inject drugs, and 806 adults without HIV, who inject drugs with them (their injection partners). At ≥ 1 injection partner of every person in the study enrolled. The HIV participants were assigned either the national standard of care for HIV infection and drug use, or the standard of care plus the intervention designed to facilitate treatment. The participants were followed for 1 to 2 years.

In the intervention group, participants were referred to local health care providers for anti-HIV therapy. They were also each assigned a systems navigator, who helped the patient identify and overcome structural barriers to starting and staying in care, such as unfamiliarity with how to enroll in medical care, or difficulty keeping appointments. Psychosocial counselors helped each participant overcome their unique psychological obstacles, such as lack of interest in therapy or fear of stigma.

At the end of the study, 15% of participants with HIV who received standard care had died, compared with 7% of the intervention patients. About 26% of deaths among HIV participants were “clearly” HIV related; 3% were due to drug overdose. Among the 42% of patients who died of unknown cause, 24% had weak immune systems.

The intervention had a “remarkably positive impact” on the participants, said Protocol Chair William Miller, MD, PhD. After 1 year, 41% of the intervention group had undetectable levels of HIV, compared with 24% of the standard-care group. Moreover, 72% of the intervention group were still in treatment, compared with 43% of the standard-care group. Similarly, 41% of intervention patients were in treatment for substance use, compared with 25% of standard-care patients.

The study is designed to be scalable to other settings. Investigators have offered the intervention to all the study participants living with HIV. They will be followed for a second year to find out whether the positive impact is sustained.

Source:

National Institutes of Health.  Novel intervention halves rate of death among people living with HIV who inject drugs. https://www.nih.gov/news-events/news-releases/novel-intervention-halves-rate-death-among-people-living-hiv-who-inject-drugs. Published August 31,2018. Accessed October 25, 2018.

A macrophage-activating immune checkpoint inhibitor, combined with rituximab therapy, was safe and produced durable complete responses in patients with relapsed or refractory non-Hodgkin lymphoma, according to results of a phase 1b study.

Courtesy Stanford Medicine

Mainly low-grade toxic effects were seen on treatment with Hu5F9-G4 (5F9) and rituximab, which induced responses in more than half of patients, of which more than one-third were complete responses, the study investigators reported.

Most of the responses were ongoing at the time of data cutoff, suggesting durable responses with the combination of rituximab and 5F9 – a humanized monoclonal antibody that blocks CD47, an antiphagocytic or “do not eat me” signal overexpressed by most cancers, Ranjana Advani, MD, of Stanford (Calif.) University, and her coauthors wrote.

“The macrophage-mediated activity of 5F9 plus rituximab may serve as an effective new immunotherapy for stimulating the innate immune system,” Dr. Advani and her colleagues reported in the New England Journal of Medicine.

The study included 22 patients, including 15 with diffuse large B-cell lymphoma (DLBCL) and 7 with follicular lymphoma, who had received a median of four prior therapies. Almost all of the non-Hodgkin lymphomas (21, or 95%) were refractory to rituximab.

All patients received intravenous 5F9 starting with a priming dose of 1 mg/kg followed by weekly maintenance doses of 10-30 mg/kg in three dose-escalation cohorts, given until disease progression or lack of clinical benefit. Intravenous rituximab at 375 mg/m² weekly was started on the second week of the first cycle, and then monthly for cycles 2 through 6.

“Substantial antitumor activity” was seen with this chemotherapy-free regimen in a group of heavily pretreated, largely rituximab-refractory patients, Dr. Advani and her coauthors wrote in their report.

The objective response rate was 50%, including a 36% complete response rate in the intent-to-treat analysis. For DLBCL, the rates of objective and complete responses were 40% and 33%, while for follicular lymphoma, they were 71% and 43%.

The median duration of response was not reached in either disease cohort with a median follow-up of 6.2 months for DLBCL and 8.1 months for follicular lymphoma. Of the 11 patients who responded, 10 (91%) were still in response at the time of data cutoff. “Longer follow-up is needed,” the investigators wrote.

Most adverse events were seen within the first few weeks of treatment and mainly included anemia and infusion-related reactions. The anemia was an expected, on-target effect of 5F9 because of selective clearance of older red cells, which was predictable, transient, and mitigated by the maintenance dosing strategy employed in this phase 1b trial.

“As red cells age, they lose CD47 expression and gain expression of prophagocytic signals, leading to homeostatic clearance,” they wrote.

The activity of 5F9 and rituximab is “synergistic” based on the results of previous, preclinical investigations in models of lymphoma, Dr. Advani and her coauthors added.

A phase 2 trial of 5F9 plus rituximab in relapsed or refractory B-cell non-Hodgkin lymphoma is ongoing, according to their report.

The study was supported by Forty Seven and the Leukemia & Lymphoma Society. Dr. Advani reported disclosures related to Forty Seven, Bristol-Myers Squibb, Pharmacyclics, Seattle Genetics, and Roche/Genentech, among others.

SOURCE: Advani R et al. N Engl J Med. 2018;379:1711-21.

A macrophage-activating immune checkpoint inhibitor, combined with rituximab therapy, was safe and produced durable complete responses in patients with relapsed or refractory non-Hodgkin lymphoma, according to results of a phase 1b study.

Courtesy Stanford Medicine

Mainly low-grade toxic effects were seen on treatment with Hu5F9-G4 (5F9) and rituximab, which induced responses in more than half of patients, of which more than one-third were complete responses, the study investigators reported.

Most of the responses were ongoing at the time of data cutoff, suggesting durable responses with the combination of rituximab and 5F9 – a humanized monoclonal antibody that blocks CD47, an antiphagocytic or “do not eat me” signal overexpressed by most cancers, Ranjana Advani, MD, of Stanford (Calif.) University, and her coauthors wrote.

“The macrophage-mediated activity of 5F9 plus rituximab may serve as an effective new immunotherapy for stimulating the innate immune system,” Dr. Advani and her colleagues reported in the New England Journal of Medicine.

The study included 22 patients, including 15 with diffuse large B-cell lymphoma (DLBCL) and 7 with follicular lymphoma, who had received a median of four prior therapies. Almost all of the non-Hodgkin lymphomas (21, or 95%) were refractory to rituximab.

All patients received intravenous 5F9 starting with a priming dose of 1 mg/kg followed by weekly maintenance doses of 10-30 mg/kg in three dose-escalation cohorts, given until disease progression or lack of clinical benefit. Intravenous rituximab at 375 mg/m² weekly was started on the second week of the first cycle, and then monthly for cycles 2 through 6.

“Substantial antitumor activity” was seen with this chemotherapy-free regimen in a group of heavily pretreated, largely rituximab-refractory patients, Dr. Advani and her coauthors wrote in their report.

The objective response rate was 50%, including a 36% complete response rate in the intent-to-treat analysis. For DLBCL, the rates of objective and complete responses were 40% and 33%, while for follicular lymphoma, they were 71% and 43%.

The median duration of response was not reached in either disease cohort with a median follow-up of 6.2 months for DLBCL and 8.1 months for follicular lymphoma. Of the 11 patients who responded, 10 (91%) were still in response at the time of data cutoff. “Longer follow-up is needed,” the investigators wrote.

Most adverse events were seen within the first few weeks of treatment and mainly included anemia and infusion-related reactions. The anemia was an expected, on-target effect of 5F9 because of selective clearance of older red cells, which was predictable, transient, and mitigated by the maintenance dosing strategy employed in this phase 1b trial.

“As red cells age, they lose CD47 expression and gain expression of prophagocytic signals, leading to homeostatic clearance,” they wrote.

The activity of 5F9 and rituximab is “synergistic” based on the results of previous, preclinical investigations in models of lymphoma, Dr. Advani and her coauthors added.

A phase 2 trial of 5F9 plus rituximab in relapsed or refractory B-cell non-Hodgkin lymphoma is ongoing, according to their report.

The study was supported by Forty Seven and the Leukemia & Lymphoma Society. Dr. Advani reported disclosures related to Forty Seven, Bristol-Myers Squibb, Pharmacyclics, Seattle Genetics, and Roche/Genentech, among others.

SOURCE: Advani R et al. N Engl J Med. 2018;379:1711-21.

A macrophage-activating immune checkpoint inhibitor, combined with rituximab therapy, was safe and produced durable complete responses in patients with relapsed or refractory non-Hodgkin lymphoma, according to results of a phase 1b study.

Courtesy Stanford Medicine

Mainly low-grade toxic effects were seen on treatment with Hu5F9-G4 (5F9) and rituximab, which induced responses in more than half of patients, of which more than one-third were complete responses, the study investigators reported.

Most of the responses were ongoing at the time of data cutoff, suggesting durable responses with the combination of rituximab and 5F9 – a humanized monoclonal antibody that blocks CD47, an antiphagocytic or “do not eat me” signal overexpressed by most cancers, Ranjana Advani, MD, of Stanford (Calif.) University, and her coauthors wrote.

“The macrophage-mediated activity of 5F9 plus rituximab may serve as an effective new immunotherapy for stimulating the innate immune system,” Dr. Advani and her colleagues reported in the New England Journal of Medicine.

The study included 22 patients, including 15 with diffuse large B-cell lymphoma (DLBCL) and 7 with follicular lymphoma, who had received a median of four prior therapies. Almost all of the non-Hodgkin lymphomas (21, or 95%) were refractory to rituximab.

All patients received intravenous 5F9 starting with a priming dose of 1 mg/kg followed by weekly maintenance doses of 10-30 mg/kg in three dose-escalation cohorts, given until disease progression or lack of clinical benefit. Intravenous rituximab at 375 mg/m² weekly was started on the second week of the first cycle, and then monthly for cycles 2 through 6.

“Substantial antitumor activity” was seen with this chemotherapy-free regimen in a group of heavily pretreated, largely rituximab-refractory patients, Dr. Advani and her coauthors wrote in their report.

The objective response rate was 50%, including a 36% complete response rate in the intent-to-treat analysis. For DLBCL, the rates of objective and complete responses were 40% and 33%, while for follicular lymphoma, they were 71% and 43%.

The median duration of response was not reached in either disease cohort with a median follow-up of 6.2 months for DLBCL and 8.1 months for follicular lymphoma. Of the 11 patients who responded, 10 (91%) were still in response at the time of data cutoff. “Longer follow-up is needed,” the investigators wrote.

Most adverse events were seen within the first few weeks of treatment and mainly included anemia and infusion-related reactions. The anemia was an expected, on-target effect of 5F9 because of selective clearance of older red cells, which was predictable, transient, and mitigated by the maintenance dosing strategy employed in this phase 1b trial.

“As red cells age, they lose CD47 expression and gain expression of prophagocytic signals, leading to homeostatic clearance,” they wrote.

The activity of 5F9 and rituximab is “synergistic” based on the results of previous, preclinical investigations in models of lymphoma, Dr. Advani and her coauthors added.

A phase 2 trial of 5F9 plus rituximab in relapsed or refractory B-cell non-Hodgkin lymphoma is ongoing, according to their report.

The study was supported by Forty Seven and the Leukemia & Lymphoma Society. Dr. Advani reported disclosures related to Forty Seven, Bristol-Myers Squibb, Pharmacyclics, Seattle Genetics, and Roche/Genentech, among others.

SOURCE: Advani R et al. N Engl J Med. 2018;379:1711-21.

The NIH has chosen 13 researchers for the inaugural class of the Distinguished Scholars Program (DSP), launched earlier this year to build diversity within the NIH Intramural Research Program. “Nurturing diversity in the NIH Intramural Research Program is paramount to upholding our mission,” said NIH Director Francis Collins, MD, PhD. Research has shown that a “diversity of perspectives” is vital to the improved quality and number of discoveries, he adds.

The DSP aims to facilitate hiring and career progression of tenure-track investigators who have demonstrated commitment to promoting diversity and inclusion in the biomedical research workforce, according to the NIH. The DSP is unique in its focus on early-stage investigators, says Hannah A. Valantine, MD, NIH Chief Officer for Scientific Workforce Diversity. She says that is the “major point where we lose underrepresented groups from scientific careers.” 

Dr. Collins says the DSP can serve as a model for universities to prevent the attrition of underrepresented groups, including women, blacks, Hispanics or Latinos, American Indians and Alaska Natives, Native Hawaiians and other Pacific Islanders, individuals with disabilities, and individuals from disadvantaged backgrounds.

The pilot program will fund 3 cohorts of up to 15 scholars each. Nominees are chosen for their scientific excellence and commitment to diversity and inclusion, shown through participation in activities, such as mentoring programs.

Scholars will receive 4 years of research support of up to $2.35 million from the DSP; their nominating institute or center will continue to fund their research throughout their tenure track. Each scholar also will be mentored by a highly experienced NIH senior investigator and receive professional leadership training, workshops on management skills, and networking opportunities with NIH leadership.  

Source:

NIH selects first scholars in pioneering program to enhance diversity within inhouse research program [news release].  Bethesda, MD: National Institutes of Health; October 23, 2018. https://www.nih.gov/news-events/news-releases/nih-selects-first-scholars-pioneering-program-enhance-diversity-within-house-research-program . Accessed October 31, 2018.

The NIH has chosen 13 researchers for the inaugural class of the Distinguished Scholars Program (DSP), launched earlier this year to build diversity within the NIH Intramural Research Program. “Nurturing diversity in the NIH Intramural Research Program is paramount to upholding our mission,” said NIH Director Francis Collins, MD, PhD. Research has shown that a “diversity of perspectives” is vital to the improved quality and number of discoveries, he adds.

The DSP aims to facilitate hiring and career progression of tenure-track investigators who have demonstrated commitment to promoting diversity and inclusion in the biomedical research workforce, according to the NIH. The DSP is unique in its focus on early-stage investigators, says Hannah A. Valantine, MD, NIH Chief Officer for Scientific Workforce Diversity. She says that is the “major point where we lose underrepresented groups from scientific careers.” 

Dr. Collins says the DSP can serve as a model for universities to prevent the attrition of underrepresented groups, including women, blacks, Hispanics or Latinos, American Indians and Alaska Natives, Native Hawaiians and other Pacific Islanders, individuals with disabilities, and individuals from disadvantaged backgrounds.

The pilot program will fund 3 cohorts of up to 15 scholars each. Nominees are chosen for their scientific excellence and commitment to diversity and inclusion, shown through participation in activities, such as mentoring programs.

Scholars will receive 4 years of research support of up to $2.35 million from the DSP; their nominating institute or center will continue to fund their research throughout their tenure track. Each scholar also will be mentored by a highly experienced NIH senior investigator and receive professional leadership training, workshops on management skills, and networking opportunities with NIH leadership.  

Source:

NIH selects first scholars in pioneering program to enhance diversity within inhouse research program [news release].  Bethesda, MD: National Institutes of Health; October 23, 2018. https://www.nih.gov/news-events/news-releases/nih-selects-first-scholars-pioneering-program-enhance-diversity-within-house-research-program . Accessed October 31, 2018.

The NIH has chosen 13 researchers for the inaugural class of the Distinguished Scholars Program (DSP), launched earlier this year to build diversity within the NIH Intramural Research Program. “Nurturing diversity in the NIH Intramural Research Program is paramount to upholding our mission,” said NIH Director Francis Collins, MD, PhD. Research has shown that a “diversity of perspectives” is vital to the improved quality and number of discoveries, he adds.

The DSP aims to facilitate hiring and career progression of tenure-track investigators who have demonstrated commitment to promoting diversity and inclusion in the biomedical research workforce, according to the NIH. The DSP is unique in its focus on early-stage investigators, says Hannah A. Valantine, MD, NIH Chief Officer for Scientific Workforce Diversity. She says that is the “major point where we lose underrepresented groups from scientific careers.” 

Dr. Collins says the DSP can serve as a model for universities to prevent the attrition of underrepresented groups, including women, blacks, Hispanics or Latinos, American Indians and Alaska Natives, Native Hawaiians and other Pacific Islanders, individuals with disabilities, and individuals from disadvantaged backgrounds.

The pilot program will fund 3 cohorts of up to 15 scholars each. Nominees are chosen for their scientific excellence and commitment to diversity and inclusion, shown through participation in activities, such as mentoring programs.

Scholars will receive 4 years of research support of up to $2.35 million from the DSP; their nominating institute or center will continue to fund their research throughout their tenure track. Each scholar also will be mentored by a highly experienced NIH senior investigator and receive professional leadership training, workshops on management skills, and networking opportunities with NIH leadership.  

Source:

NIH selects first scholars in pioneering program to enhance diversity within inhouse research program [news release].  Bethesda, MD: National Institutes of Health; October 23, 2018. https://www.nih.gov/news-events/news-releases/nih-selects-first-scholars-pioneering-program-enhance-diversity-within-house-research-program . Accessed October 31, 2018.

In a “significant modernization effort,” the VA has removed nearly 8 million paper files from 60 locations in under 22 months. The files are scanned into the electronic claims process system, which means faster claims decisions, the VA says.

According to the VA, it is a milestone in a years-long project to improve the veteran experience and streamline claims processes. The project began in 2013 when the VA began removing paper records from its regional offices to save space and money. It then expanded in 2016 when the VA launched the File Bank Extraction initiative, which removed more than 1.7 million paper claims files. In 2017, the agency began extracting 6.1 million paper records held in the Records Control Division (RCD) in St. Louis.

The records are temporarily stored in a secure facility certified by the National Archives and Records Administration, where they are inventoried, prioritized, and sent to VA vendors for scanning into the VA’s Veterans Benefits Management System.

The VA is negotiating to return the RCD’s leased warehouse space to the General Services Administration, estimating the move will save roughly $1.8 million per year.

Source:
VA achieves major milestone in effort to modernize claims processing [news release]. Washington, DC: U.S. Department of Veteran Affairs Office of Public Affairs and Media Relations; October 23,2018.  https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5131. Accessed October 31, 2018.

In a “significant modernization effort,” the VA has removed nearly 8 million paper files from 60 locations in under 22 months. The files are scanned into the electronic claims process system, which means faster claims decisions, the VA says.

According to the VA, it is a milestone in a years-long project to improve the veteran experience and streamline claims processes. The project began in 2013 when the VA began removing paper records from its regional offices to save space and money. It then expanded in 2016 when the VA launched the File Bank Extraction initiative, which removed more than 1.7 million paper claims files. In 2017, the agency began extracting 6.1 million paper records held in the Records Control Division (RCD) in St. Louis.

The records are temporarily stored in a secure facility certified by the National Archives and Records Administration, where they are inventoried, prioritized, and sent to VA vendors for scanning into the VA’s Veterans Benefits Management System.

The VA is negotiating to return the RCD’s leased warehouse space to the General Services Administration, estimating the move will save roughly $1.8 million per year.

Source:
VA achieves major milestone in effort to modernize claims processing [news release]. Washington, DC: U.S. Department of Veteran Affairs Office of Public Affairs and Media Relations; October 23,2018.  https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5131. Accessed October 31, 2018.

In a “significant modernization effort,” the VA has removed nearly 8 million paper files from 60 locations in under 22 months. The files are scanned into the electronic claims process system, which means faster claims decisions, the VA says.

According to the VA, it is a milestone in a years-long project to improve the veteran experience and streamline claims processes. The project began in 2013 when the VA began removing paper records from its regional offices to save space and money. It then expanded in 2016 when the VA launched the File Bank Extraction initiative, which removed more than 1.7 million paper claims files. In 2017, the agency began extracting 6.1 million paper records held in the Records Control Division (RCD) in St. Louis.

The records are temporarily stored in a secure facility certified by the National Archives and Records Administration, where they are inventoried, prioritized, and sent to VA vendors for scanning into the VA’s Veterans Benefits Management System.

The VA is negotiating to return the RCD’s leased warehouse space to the General Services Administration, estimating the move will save roughly $1.8 million per year.

Source:
VA achieves major milestone in effort to modernize claims processing [news release]. Washington, DC: U.S. Department of Veteran Affairs Office of Public Affairs and Media Relations; October 23,2018.  https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5131. Accessed October 31, 2018.

Compatible electronic health record (EHR) systems at the US Department of Veterans Affairs (VA) and US Department of Defense (DoD) will ensure quality health care as service members transition to veterans, according to Defense Secretary James Mattis. The VA signed a contract with Cerner Corp last May to replace the 40-year-old Veterans Integrated System Technology Architecture (VistA) records system over the next 10 years with the new Cerner systems, which is in the pilot phase at DoD.

Mattis and VA Secretary Robert Wilkie signed a joint statement reinforcing the departments’ commitment to ensuring a successful transition from a legacy patient-data system to a modernized one. The statement represents “tangible evidence of our commitment to change how we deliver veteran-focused, provider-friendly care,” Wilkie said.

Both departments say the new EHR will be fully interoperable. Among the benefits: The collaboration will ensure that the VA understands the challenges encountered as DoD deploys Military Health System Genesis, its EHR system, the DoD says. It also will allow the VA to apply lessons learned to anticipate and mitigate known issues and assess prospective efficiencies to help deploy faster.

 “The EHR will give health care providers a full picture of patient medical history, driving better clinical outcomes,” Wilkie said. “It will also help us identify veterans proactively who are at higher risk for issues, such as opioid addiction and suicide, so health care providers can intervene earlier and save lives.”

Compatible electronic health record (EHR) systems at the US Department of Veterans Affairs (VA) and US Department of Defense (DoD) will ensure quality health care as service members transition to veterans, according to Defense Secretary James Mattis. The VA signed a contract with Cerner Corp last May to replace the 40-year-old Veterans Integrated System Technology Architecture (VistA) records system over the next 10 years with the new Cerner systems, which is in the pilot phase at DoD.

Mattis and VA Secretary Robert Wilkie signed a joint statement reinforcing the departments’ commitment to ensuring a successful transition from a legacy patient-data system to a modernized one. The statement represents “tangible evidence of our commitment to change how we deliver veteran-focused, provider-friendly care,” Wilkie said.

Both departments say the new EHR will be fully interoperable. Among the benefits: The collaboration will ensure that the VA understands the challenges encountered as DoD deploys Military Health System Genesis, its EHR system, the DoD says. It also will allow the VA to apply lessons learned to anticipate and mitigate known issues and assess prospective efficiencies to help deploy faster.

 “The EHR will give health care providers a full picture of patient medical history, driving better clinical outcomes,” Wilkie said. “It will also help us identify veterans proactively who are at higher risk for issues, such as opioid addiction and suicide, so health care providers can intervene earlier and save lives.”

Compatible electronic health record (EHR) systems at the US Department of Veterans Affairs (VA) and US Department of Defense (DoD) will ensure quality health care as service members transition to veterans, according to Defense Secretary James Mattis. The VA signed a contract with Cerner Corp last May to replace the 40-year-old Veterans Integrated System Technology Architecture (VistA) records system over the next 10 years with the new Cerner systems, which is in the pilot phase at DoD.

Mattis and VA Secretary Robert Wilkie signed a joint statement reinforcing the departments’ commitment to ensuring a successful transition from a legacy patient-data system to a modernized one. The statement represents “tangible evidence of our commitment to change how we deliver veteran-focused, provider-friendly care,” Wilkie said.

Both departments say the new EHR will be fully interoperable. Among the benefits: The collaboration will ensure that the VA understands the challenges encountered as DoD deploys Military Health System Genesis, its EHR system, the DoD says. It also will allow the VA to apply lessons learned to anticipate and mitigate known issues and assess prospective efficiencies to help deploy faster.

 “The EHR will give health care providers a full picture of patient medical history, driving better clinical outcomes,” Wilkie said. “It will also help us identify veterans proactively who are at higher risk for issues, such as opioid addiction and suicide, so health care providers can intervene earlier and save lives.”