ACP leaders explain why they value telehealth

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More than half of physicians surveyed work in a practice that has implemented at least one technology required to engage in telehealth, according to the recently announced results of a questionnaire by the American College of Physicians.

The survey participants included 233 members of the ACP, who provided their responses between October 2018 and January 2019. ACP President Ana Maria Lopez, MD, as well as Tabassum Salam, MD, vice president for medical education, announced the survey’s results at a press briefing at the annual meeting of the American College of Physicians.

Dr. Lopez and Dr. Salam highlighted some of the findings and expressed their enthusiasm about the recent increases in the use of telemedicine in a video interview. They also explained how telehealth benefits patients and the barriers to more widespread use of telemedicine.

Dr. Lopez and Dr. Salam did not disclose any relevant conflicts of interest.

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More than half of physicians surveyed work in a practice that has implemented at least one technology required to engage in telehealth, according to the recently announced results of a questionnaire by the American College of Physicians.

The survey participants included 233 members of the ACP, who provided their responses between October 2018 and January 2019. ACP President Ana Maria Lopez, MD, as well as Tabassum Salam, MD, vice president for medical education, announced the survey’s results at a press briefing at the annual meeting of the American College of Physicians.

Dr. Lopez and Dr. Salam highlighted some of the findings and expressed their enthusiasm about the recent increases in the use of telemedicine in a video interview. They also explained how telehealth benefits patients and the barriers to more widespread use of telemedicine.

Dr. Lopez and Dr. Salam did not disclose any relevant conflicts of interest.

More than half of physicians surveyed work in a practice that has implemented at least one technology required to engage in telehealth, according to the recently announced results of a questionnaire by the American College of Physicians.

The survey participants included 233 members of the ACP, who provided their responses between October 2018 and January 2019. ACP President Ana Maria Lopez, MD, as well as Tabassum Salam, MD, vice president for medical education, announced the survey’s results at a press briefing at the annual meeting of the American College of Physicians.

Dr. Lopez and Dr. Salam highlighted some of the findings and expressed their enthusiasm about the recent increases in the use of telemedicine in a video interview. They also explained how telehealth benefits patients and the barriers to more widespread use of telemedicine.

Dr. Lopez and Dr. Salam did not disclose any relevant conflicts of interest.

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REPORTING FROM INTERNAL MEDICINE 2019

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Gilteritinib prolonged survival in FLT3-mutated AML

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– The FLT3 inhibitor gilteritinib (Xospata) significantly prolonged overall survival, compared with salvage chemotherapy, in patients with FLT3-mutated relapsed/refractory acute myeloid leukemia, Alexander E. Perl, MD, from the Abramson Cancer Center at the University of Pennsylvania in Philadelphia reported at the 2019 annual meeting of the American Association for Cancer Research (AACR).

In a video interview, Dr. Perl discussed the results of the ADMIRAL global phase 3 randomized trial and described the current state of therapy for patients with relapsed/refractory AML bearing FLT3 mutations. Up to 70% of patients with acute myeloid leukemia will experience a relapse, and up to 40% may have disease that is resistant to induction chemotherapy. Survival for these patients is generally poor.

In particular, patients with acute myeloid leukemia and FLT3-activating mutations are at increased risk for early relapse and poor overall survival.

The ADMIRAL trial is funded by Astellas Pharma. Dr. Perl disclosed advisory board participation, consulting fees, and institutional support from Astellas and others.

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– The FLT3 inhibitor gilteritinib (Xospata) significantly prolonged overall survival, compared with salvage chemotherapy, in patients with FLT3-mutated relapsed/refractory acute myeloid leukemia, Alexander E. Perl, MD, from the Abramson Cancer Center at the University of Pennsylvania in Philadelphia reported at the 2019 annual meeting of the American Association for Cancer Research (AACR).

In a video interview, Dr. Perl discussed the results of the ADMIRAL global phase 3 randomized trial and described the current state of therapy for patients with relapsed/refractory AML bearing FLT3 mutations. Up to 70% of patients with acute myeloid leukemia will experience a relapse, and up to 40% may have disease that is resistant to induction chemotherapy. Survival for these patients is generally poor.

In particular, patients with acute myeloid leukemia and FLT3-activating mutations are at increased risk for early relapse and poor overall survival.

The ADMIRAL trial is funded by Astellas Pharma. Dr. Perl disclosed advisory board participation, consulting fees, and institutional support from Astellas and others.

– The FLT3 inhibitor gilteritinib (Xospata) significantly prolonged overall survival, compared with salvage chemotherapy, in patients with FLT3-mutated relapsed/refractory acute myeloid leukemia, Alexander E. Perl, MD, from the Abramson Cancer Center at the University of Pennsylvania in Philadelphia reported at the 2019 annual meeting of the American Association for Cancer Research (AACR).

In a video interview, Dr. Perl discussed the results of the ADMIRAL global phase 3 randomized trial and described the current state of therapy for patients with relapsed/refractory AML bearing FLT3 mutations. Up to 70% of patients with acute myeloid leukemia will experience a relapse, and up to 40% may have disease that is resistant to induction chemotherapy. Survival for these patients is generally poor.

In particular, patients with acute myeloid leukemia and FLT3-activating mutations are at increased risk for early relapse and poor overall survival.

The ADMIRAL trial is funded by Astellas Pharma. Dr. Perl disclosed advisory board participation, consulting fees, and institutional support from Astellas and others.

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REPORTING FROM AACR 2019

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Highlights from the ‘Updates in ACS’ session (VIDEO)

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Hospital Medicine 2019 attendees outlined their key takeaways from the Updates in Acute Coronary Syndrome session, presented by Jeffrey Trost, MD, of Johns Hopkins University, Baltimore.

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Dr. Trost’s discussion focused on the relationship between dual antiplatelet therapy, in-stent thrombosis, and in-stent restenosis. He also explored the diagnostic role of fractional flow reserve, and he outlined effective approaches to PCSK9 inhibitor use.

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Hospital Medicine 2019 attendees outlined their key takeaways from the Updates in Acute Coronary Syndrome session, presented by Jeffrey Trost, MD, of Johns Hopkins University, Baltimore.

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Dr. Trost’s discussion focused on the relationship between dual antiplatelet therapy, in-stent thrombosis, and in-stent restenosis. He also explored the diagnostic role of fractional flow reserve, and he outlined effective approaches to PCSK9 inhibitor use.

 

Hospital Medicine 2019 attendees outlined their key takeaways from the Updates in Acute Coronary Syndrome session, presented by Jeffrey Trost, MD, of Johns Hopkins University, Baltimore.

Vidyard Video

Dr. Trost’s discussion focused on the relationship between dual antiplatelet therapy, in-stent thrombosis, and in-stent restenosis. He also explored the diagnostic role of fractional flow reserve, and he outlined effective approaches to PCSK9 inhibitor use.

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Leveraging consumer technology in gastroenterology practice

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SAN FRANCISCO – Dr. Michael Docktor, a pediatric gastroenterologist at Boston Hospital, described myriad digital tools that physicians – especially gastroenterologists – as well as patients are now using. Some tools may be implemented to track stool output or diet for diseases like irritable bowel syndrome or Crohn’s disease, he said in an interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

There are patient-facing applications that provide data that can be used by both patients and their physicians to better understand the disease. These data can help in diagnosis and management and give the GI doctor a “window into the 99% of the time that they aren’t with the patient.” Other apps can build a timeline of the disease that can help the patient get a better understanding of their disease and learn to distinguish a flare from a bad day with poor food choices. Dr. Docktor described the AGA Tech Summit as a place to try out new ideas and work with like-minded doctors.

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SAN FRANCISCO – Dr. Michael Docktor, a pediatric gastroenterologist at Boston Hospital, described myriad digital tools that physicians – especially gastroenterologists – as well as patients are now using. Some tools may be implemented to track stool output or diet for diseases like irritable bowel syndrome or Crohn’s disease, he said in an interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

There are patient-facing applications that provide data that can be used by both patients and their physicians to better understand the disease. These data can help in diagnosis and management and give the GI doctor a “window into the 99% of the time that they aren’t with the patient.” Other apps can build a timeline of the disease that can help the patient get a better understanding of their disease and learn to distinguish a flare from a bad day with poor food choices. Dr. Docktor described the AGA Tech Summit as a place to try out new ideas and work with like-minded doctors.

SAN FRANCISCO – Dr. Michael Docktor, a pediatric gastroenterologist at Boston Hospital, described myriad digital tools that physicians – especially gastroenterologists – as well as patients are now using. Some tools may be implemented to track stool output or diet for diseases like irritable bowel syndrome or Crohn’s disease, he said in an interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

There are patient-facing applications that provide data that can be used by both patients and their physicians to better understand the disease. These data can help in diagnosis and management and give the GI doctor a “window into the 99% of the time that they aren’t with the patient.” Other apps can build a timeline of the disease that can help the patient get a better understanding of their disease and learn to distinguish a flare from a bad day with poor food choices. Dr. Docktor described the AGA Tech Summit as a place to try out new ideas and work with like-minded doctors.

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REPORTING FROM 2019 AGA TECH SUMMIT

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Obeticholic acid reversed NASH liver fibrosis in phase 3 trial

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Daily treatment of patients with nonalcoholic steatohepatitis with obeticholic acid led to a near doubling of patients who had fibrosis regression in a phase 3 trial with 931 patients, making obeticholic acid the first agent proven to improve the course of this disease.

“There is no doubt that with these data we have changed the treatment” of nonalcoholic steatohepatitis (NASH), Zobair M. Younossi, MD, of Inova Fairfax Medical Campus in Falls Church, Va., said at the meeting sponsored by the European Association for the Study of the Liver. “We are at a watershed moment” in NASH treatment, Dr. Younossi added in a video interview.

Until now “we have had no effective treatments for NASH. This is the first success in a phase 3 trial; obeticholic acid looks very promising,” commented Philip N. Newsome, PhD, professor of experimental hepatology at the University of Birmingham (England).

Obeticholic acid (OCA), an agonist of the farnesoid X receptor, already has Food and Drug Administration marketing approval for the indication of primary biliary cholangitis, a much rarer disease than NASH.

Mitchel L. Zoler/MDedge News
Dr. Philip Newsome

The REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment) trial has so far enrolled 931 patients at about 350 sites in 20 countries, including the United States, and followed them during 18 months of treatment, the prespecified time for an interim analysis. The study enrolled adults with biopsy-proven NASH and generally focused on patients with either stage 2 or 3 liver fibrosis and a nonalcoholic fatty liver disease activity score of at least 4. Enrolled patients averaged about 55 years old, slightly more than half the enrolled patients had type 2 diabetes, and more than half had stage 3 fibrosis.

 

 


The study design included two coprimary endpoints, and specified that a statistically significant finding for either outcome meant a positive trial result, but the design also prespecified that the benefit would need to meet a stringent definition of statistical significance, compared with placebo patients, with a P value of no more than .01. REGENERATE tested two different OCA dosages, 10 mg or 25 mg, once daily. The results showed a trend for benefit from the smaller dosage, but these effects did not achieve statistical significance.

For the primary endpoint of regression of liver fibrosis by at least one stage with no worsening of NASH the intention-to-treat analysis showed after 18 months a 13% rate with placebo, a 21% rate with the 10-mg dosage, and a 23% rate with the 25-mg dosage, a statistically significant improvement over placebo for the higher dosage.

The second primary endpoint was resolution of NASH without worsening liver fibrosis, which occurred in 8% of placebo patients, 11% of patients on 10 mg OCA/day and 12% of those on 25 mg/day. The differences between each of the active groups and the controls were not statistically significant for this endpoint.

Among the 931 enrolled patients 668 (72%) actually received treatment fully consistent with the study protocol, and among these per-protocol patients the benefit from 25 mg/day OCA was even more striking: a 28% rate of fibrosis regression, compared with 13% in the control patients. Regression by at least two fibrotic stages occurred in 5% of placebo patients and 13% of those on 25 mg/day OCA. Many treated patients also showed normalizations of liver enzyme levels.



Adverse events on OCA were mostly mild or moderate, with similar rates of serious adverse events in the OCA groups and in control patients. The most common adverse effect on OCA treatment was pruritus, a previously described effect, reported by 51% of patients on the 25 mg/day dosage and by 19% of control patients.

REGENERATE will continue until a goal level of endpoint events occur, and may eventually enroll as many as 2,400 patients and extend for a few more years. By then, Dr. Younossi said, he hopes that an analysis will be possible of “harder” endpoints than fibrosis, such as development of cirrhosis. He noted, however, that the FDA has designated fibrosis regression as a valid surrogate endpoint for assessing treatment efficacy for NASH.

Already on the U.S. market, a single 10-mg OCA pill currently retails for almost $230; a 25-mg formulation is not currently marketed. Dr. Younossi said that subsequent studies will assess the cost-effectiveness of OCA treatment for NASH. He also hopes that further study of patient characteristics will identify which NASH patients are most likely to respond to OCA. Eventually, OCA may be part of a multidrug strategy for treating this disease, Dr. Younossi said.

REGENERATE was sponsored by Intercept, the company that markets obeticholic acid (Ocaliva). Dr. Younossi is a consultant to and has received research funding from Intercept. He has also been a consultant to Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Novartis, Novo Nordisk, Quest, Siemens, Terns Pharmaceutical, and Viking Therapeutics. Dr. Newsome has been a consultant or speaker for Intercept as well as Boehringer Ingelheim, Dignity Sciences, Johnson & Johnson, Novo Nordisk, and Shire, and he has received research funding from Pharmaxis and Boehringer Ingelheim.

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Daily treatment of patients with nonalcoholic steatohepatitis with obeticholic acid led to a near doubling of patients who had fibrosis regression in a phase 3 trial with 931 patients, making obeticholic acid the first agent proven to improve the course of this disease.

“There is no doubt that with these data we have changed the treatment” of nonalcoholic steatohepatitis (NASH), Zobair M. Younossi, MD, of Inova Fairfax Medical Campus in Falls Church, Va., said at the meeting sponsored by the European Association for the Study of the Liver. “We are at a watershed moment” in NASH treatment, Dr. Younossi added in a video interview.

Until now “we have had no effective treatments for NASH. This is the first success in a phase 3 trial; obeticholic acid looks very promising,” commented Philip N. Newsome, PhD, professor of experimental hepatology at the University of Birmingham (England).

Obeticholic acid (OCA), an agonist of the farnesoid X receptor, already has Food and Drug Administration marketing approval for the indication of primary biliary cholangitis, a much rarer disease than NASH.

Mitchel L. Zoler/MDedge News
Dr. Philip Newsome

The REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment) trial has so far enrolled 931 patients at about 350 sites in 20 countries, including the United States, and followed them during 18 months of treatment, the prespecified time for an interim analysis. The study enrolled adults with biopsy-proven NASH and generally focused on patients with either stage 2 or 3 liver fibrosis and a nonalcoholic fatty liver disease activity score of at least 4. Enrolled patients averaged about 55 years old, slightly more than half the enrolled patients had type 2 diabetes, and more than half had stage 3 fibrosis.

 

 


The study design included two coprimary endpoints, and specified that a statistically significant finding for either outcome meant a positive trial result, but the design also prespecified that the benefit would need to meet a stringent definition of statistical significance, compared with placebo patients, with a P value of no more than .01. REGENERATE tested two different OCA dosages, 10 mg or 25 mg, once daily. The results showed a trend for benefit from the smaller dosage, but these effects did not achieve statistical significance.

For the primary endpoint of regression of liver fibrosis by at least one stage with no worsening of NASH the intention-to-treat analysis showed after 18 months a 13% rate with placebo, a 21% rate with the 10-mg dosage, and a 23% rate with the 25-mg dosage, a statistically significant improvement over placebo for the higher dosage.

The second primary endpoint was resolution of NASH without worsening liver fibrosis, which occurred in 8% of placebo patients, 11% of patients on 10 mg OCA/day and 12% of those on 25 mg/day. The differences between each of the active groups and the controls were not statistically significant for this endpoint.

Among the 931 enrolled patients 668 (72%) actually received treatment fully consistent with the study protocol, and among these per-protocol patients the benefit from 25 mg/day OCA was even more striking: a 28% rate of fibrosis regression, compared with 13% in the control patients. Regression by at least two fibrotic stages occurred in 5% of placebo patients and 13% of those on 25 mg/day OCA. Many treated patients also showed normalizations of liver enzyme levels.



Adverse events on OCA were mostly mild or moderate, with similar rates of serious adverse events in the OCA groups and in control patients. The most common adverse effect on OCA treatment was pruritus, a previously described effect, reported by 51% of patients on the 25 mg/day dosage and by 19% of control patients.

REGENERATE will continue until a goal level of endpoint events occur, and may eventually enroll as many as 2,400 patients and extend for a few more years. By then, Dr. Younossi said, he hopes that an analysis will be possible of “harder” endpoints than fibrosis, such as development of cirrhosis. He noted, however, that the FDA has designated fibrosis regression as a valid surrogate endpoint for assessing treatment efficacy for NASH.

Already on the U.S. market, a single 10-mg OCA pill currently retails for almost $230; a 25-mg formulation is not currently marketed. Dr. Younossi said that subsequent studies will assess the cost-effectiveness of OCA treatment for NASH. He also hopes that further study of patient characteristics will identify which NASH patients are most likely to respond to OCA. Eventually, OCA may be part of a multidrug strategy for treating this disease, Dr. Younossi said.

REGENERATE was sponsored by Intercept, the company that markets obeticholic acid (Ocaliva). Dr. Younossi is a consultant to and has received research funding from Intercept. He has also been a consultant to Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Novartis, Novo Nordisk, Quest, Siemens, Terns Pharmaceutical, and Viking Therapeutics. Dr. Newsome has been a consultant or speaker for Intercept as well as Boehringer Ingelheim, Dignity Sciences, Johnson & Johnson, Novo Nordisk, and Shire, and he has received research funding from Pharmaxis and Boehringer Ingelheim.

Daily treatment of patients with nonalcoholic steatohepatitis with obeticholic acid led to a near doubling of patients who had fibrosis regression in a phase 3 trial with 931 patients, making obeticholic acid the first agent proven to improve the course of this disease.

“There is no doubt that with these data we have changed the treatment” of nonalcoholic steatohepatitis (NASH), Zobair M. Younossi, MD, of Inova Fairfax Medical Campus in Falls Church, Va., said at the meeting sponsored by the European Association for the Study of the Liver. “We are at a watershed moment” in NASH treatment, Dr. Younossi added in a video interview.

Until now “we have had no effective treatments for NASH. This is the first success in a phase 3 trial; obeticholic acid looks very promising,” commented Philip N. Newsome, PhD, professor of experimental hepatology at the University of Birmingham (England).

Obeticholic acid (OCA), an agonist of the farnesoid X receptor, already has Food and Drug Administration marketing approval for the indication of primary biliary cholangitis, a much rarer disease than NASH.

Mitchel L. Zoler/MDedge News
Dr. Philip Newsome

The REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment) trial has so far enrolled 931 patients at about 350 sites in 20 countries, including the United States, and followed them during 18 months of treatment, the prespecified time for an interim analysis. The study enrolled adults with biopsy-proven NASH and generally focused on patients with either stage 2 or 3 liver fibrosis and a nonalcoholic fatty liver disease activity score of at least 4. Enrolled patients averaged about 55 years old, slightly more than half the enrolled patients had type 2 diabetes, and more than half had stage 3 fibrosis.

 

 


The study design included two coprimary endpoints, and specified that a statistically significant finding for either outcome meant a positive trial result, but the design also prespecified that the benefit would need to meet a stringent definition of statistical significance, compared with placebo patients, with a P value of no more than .01. REGENERATE tested two different OCA dosages, 10 mg or 25 mg, once daily. The results showed a trend for benefit from the smaller dosage, but these effects did not achieve statistical significance.

For the primary endpoint of regression of liver fibrosis by at least one stage with no worsening of NASH the intention-to-treat analysis showed after 18 months a 13% rate with placebo, a 21% rate with the 10-mg dosage, and a 23% rate with the 25-mg dosage, a statistically significant improvement over placebo for the higher dosage.

The second primary endpoint was resolution of NASH without worsening liver fibrosis, which occurred in 8% of placebo patients, 11% of patients on 10 mg OCA/day and 12% of those on 25 mg/day. The differences between each of the active groups and the controls were not statistically significant for this endpoint.

Among the 931 enrolled patients 668 (72%) actually received treatment fully consistent with the study protocol, and among these per-protocol patients the benefit from 25 mg/day OCA was even more striking: a 28% rate of fibrosis regression, compared with 13% in the control patients. Regression by at least two fibrotic stages occurred in 5% of placebo patients and 13% of those on 25 mg/day OCA. Many treated patients also showed normalizations of liver enzyme levels.



Adverse events on OCA were mostly mild or moderate, with similar rates of serious adverse events in the OCA groups and in control patients. The most common adverse effect on OCA treatment was pruritus, a previously described effect, reported by 51% of patients on the 25 mg/day dosage and by 19% of control patients.

REGENERATE will continue until a goal level of endpoint events occur, and may eventually enroll as many as 2,400 patients and extend for a few more years. By then, Dr. Younossi said, he hopes that an analysis will be possible of “harder” endpoints than fibrosis, such as development of cirrhosis. He noted, however, that the FDA has designated fibrosis regression as a valid surrogate endpoint for assessing treatment efficacy for NASH.

Already on the U.S. market, a single 10-mg OCA pill currently retails for almost $230; a 25-mg formulation is not currently marketed. Dr. Younossi said that subsequent studies will assess the cost-effectiveness of OCA treatment for NASH. He also hopes that further study of patient characteristics will identify which NASH patients are most likely to respond to OCA. Eventually, OCA may be part of a multidrug strategy for treating this disease, Dr. Younossi said.

REGENERATE was sponsored by Intercept, the company that markets obeticholic acid (Ocaliva). Dr. Younossi is a consultant to and has received research funding from Intercept. He has also been a consultant to Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Novartis, Novo Nordisk, Quest, Siemens, Terns Pharmaceutical, and Viking Therapeutics. Dr. Newsome has been a consultant or speaker for Intercept as well as Boehringer Ingelheim, Dignity Sciences, Johnson & Johnson, Novo Nordisk, and Shire, and he has received research funding from Pharmaxis and Boehringer Ingelheim.

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ACP launches program to better implement QI projects

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The American College of Physicians has launched a program – ACP Advance – to help organizations better implement quality improvement (QI) projects .

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The program includes 12 months of virtual coaching for a cost, and free online module training, according to Daisy Smith, MD, FACP, who spoke at a press conference at the annual meeting of the American College of Physicians.

Dr. Smith, the ACP’s vice president of clinical programs, discussed additional aspects of ACP Advance with Selam Wubu, director of the ACP’s Center for Quality, in a video interview.

“We launched ACP Advance to engage physicians and their teams [and] empower them to engage and implement quality improvement that results in meaningful improvement for them and their patients,” Ms. Wubu said.

Dr. Smith and Ms. Wubu have no relevant disclosures.

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The American College of Physicians has launched a program – ACP Advance – to help organizations better implement quality improvement (QI) projects .

Vidyard Video

The program includes 12 months of virtual coaching for a cost, and free online module training, according to Daisy Smith, MD, FACP, who spoke at a press conference at the annual meeting of the American College of Physicians.

Dr. Smith, the ACP’s vice president of clinical programs, discussed additional aspects of ACP Advance with Selam Wubu, director of the ACP’s Center for Quality, in a video interview.

“We launched ACP Advance to engage physicians and their teams [and] empower them to engage and implement quality improvement that results in meaningful improvement for them and their patients,” Ms. Wubu said.

Dr. Smith and Ms. Wubu have no relevant disclosures.

 

The American College of Physicians has launched a program – ACP Advance – to help organizations better implement quality improvement (QI) projects .

Vidyard Video

The program includes 12 months of virtual coaching for a cost, and free online module training, according to Daisy Smith, MD, FACP, who spoke at a press conference at the annual meeting of the American College of Physicians.

Dr. Smith, the ACP’s vice president of clinical programs, discussed additional aspects of ACP Advance with Selam Wubu, director of the ACP’s Center for Quality, in a video interview.

“We launched ACP Advance to engage physicians and their teams [and] empower them to engage and implement quality improvement that results in meaningful improvement for them and their patients,” Ms. Wubu said.

Dr. Smith and Ms. Wubu have no relevant disclosures.

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REPORTING FROM INTERNAL MEDICINE 2019

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Interventional endoscopic ultrasonography is hitting its stride

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SAN FRANCISCO – Interventional endoscopic ultrasonography (EUS) recently has brought transluminal stent placement to problems like walled off pancreatic necroses, Joo Ha Hwang, MD, PhD, professor of medicine at Stanford (Calif.) University, said in an interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. He sees EUS taking over surgical territory beyond the usual biopsies in the gastrointestinal and biliary tracts and soon moving into tumor treatment in these areas. The field is “rapidly expanding,” he said, and the value of these minimally invasive procedures means that the field will soon need to train more interventional endoscopists.

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SAN FRANCISCO – Interventional endoscopic ultrasonography (EUS) recently has brought transluminal stent placement to problems like walled off pancreatic necroses, Joo Ha Hwang, MD, PhD, professor of medicine at Stanford (Calif.) University, said in an interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. He sees EUS taking over surgical territory beyond the usual biopsies in the gastrointestinal and biliary tracts and soon moving into tumor treatment in these areas. The field is “rapidly expanding,” he said, and the value of these minimally invasive procedures means that the field will soon need to train more interventional endoscopists.

Vidyard Video

SAN FRANCISCO – Interventional endoscopic ultrasonography (EUS) recently has brought transluminal stent placement to problems like walled off pancreatic necroses, Joo Ha Hwang, MD, PhD, professor of medicine at Stanford (Calif.) University, said in an interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. He sees EUS taking over surgical territory beyond the usual biopsies in the gastrointestinal and biliary tracts and soon moving into tumor treatment in these areas. The field is “rapidly expanding,” he said, and the value of these minimally invasive procedures means that the field will soon need to train more interventional endoscopists.

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REPORTING FROM 2019 AGA TECH SUMMIT

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– Several studies featured during a press briefing at the annual meeting of the American Association for Cancer Research highlight the types of “transformative strategies” currently being developed and implemented, according to Louis Weiner, MD.

“Had this been the AACR [meeting] 20 years ago ... each one of them would have been a main plenary presentation and would have been the talk of the meeting,” Dr. Weiner, director of the Georgetown Lombardi Cancer Center at Georgetown University, Washington, and press briefing moderator, said of the findings.

While they are well accepted as being high quality presentations of great value, they don’t cause the same amount of stir, he said, adding: “I wouldn’t say we’re jaded, but we’ve come to the point where we almost expect great results at these meetings, and isn’t that wonderful?”



In this video interview he discussed the findings of two of the studies, including the phase 2 UNITY-NHL study and a preclinical Lynch syndrome mouse model used to develop a potential cancer preventive vaccine.

The Lynch syndrome data “suggest the strong possibility that we might be able to immunize people and combine that treatment with standard nonsteroidal anti-inflammatory agents such as naproxen to delay or reduce the impact of Lynch syndrome.”

“This set of findings ... opens the door to investigators in many different areas of cancer research to explore whether or not there are common frameshift mutations that might create novel neoantigens that we can go after with vaccines – be they for therapeutic benefit or for prevention,” he said.



The UNITY-NHL study, which showed that umbralisib is active and well tolerated as single-agent therapy in patients with relapsed or refractory marginal zone lymphoma, suggests “it’s quite possible that [the phosphoinositide 3-kinase delta inhibitor] is going to become a very important element in the treatment of patients with marginal zone lymphomas, and obviously it can be then used in earlier stages of diseases since it’s well tolerated, and it may well have useful activity in other B-cell malignancies,” he said.

Dr. Weiner reported having no relevant disclosures.

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– Several studies featured during a press briefing at the annual meeting of the American Association for Cancer Research highlight the types of “transformative strategies” currently being developed and implemented, according to Louis Weiner, MD.

“Had this been the AACR [meeting] 20 years ago ... each one of them would have been a main plenary presentation and would have been the talk of the meeting,” Dr. Weiner, director of the Georgetown Lombardi Cancer Center at Georgetown University, Washington, and press briefing moderator, said of the findings.

While they are well accepted as being high quality presentations of great value, they don’t cause the same amount of stir, he said, adding: “I wouldn’t say we’re jaded, but we’ve come to the point where we almost expect great results at these meetings, and isn’t that wonderful?”



In this video interview he discussed the findings of two of the studies, including the phase 2 UNITY-NHL study and a preclinical Lynch syndrome mouse model used to develop a potential cancer preventive vaccine.

The Lynch syndrome data “suggest the strong possibility that we might be able to immunize people and combine that treatment with standard nonsteroidal anti-inflammatory agents such as naproxen to delay or reduce the impact of Lynch syndrome.”

“This set of findings ... opens the door to investigators in many different areas of cancer research to explore whether or not there are common frameshift mutations that might create novel neoantigens that we can go after with vaccines – be they for therapeutic benefit or for prevention,” he said.



The UNITY-NHL study, which showed that umbralisib is active and well tolerated as single-agent therapy in patients with relapsed or refractory marginal zone lymphoma, suggests “it’s quite possible that [the phosphoinositide 3-kinase delta inhibitor] is going to become a very important element in the treatment of patients with marginal zone lymphomas, and obviously it can be then used in earlier stages of diseases since it’s well tolerated, and it may well have useful activity in other B-cell malignancies,” he said.

Dr. Weiner reported having no relevant disclosures.

– Several studies featured during a press briefing at the annual meeting of the American Association for Cancer Research highlight the types of “transformative strategies” currently being developed and implemented, according to Louis Weiner, MD.

“Had this been the AACR [meeting] 20 years ago ... each one of them would have been a main plenary presentation and would have been the talk of the meeting,” Dr. Weiner, director of the Georgetown Lombardi Cancer Center at Georgetown University, Washington, and press briefing moderator, said of the findings.

While they are well accepted as being high quality presentations of great value, they don’t cause the same amount of stir, he said, adding: “I wouldn’t say we’re jaded, but we’ve come to the point where we almost expect great results at these meetings, and isn’t that wonderful?”



In this video interview he discussed the findings of two of the studies, including the phase 2 UNITY-NHL study and a preclinical Lynch syndrome mouse model used to develop a potential cancer preventive vaccine.

The Lynch syndrome data “suggest the strong possibility that we might be able to immunize people and combine that treatment with standard nonsteroidal anti-inflammatory agents such as naproxen to delay or reduce the impact of Lynch syndrome.”

“This set of findings ... opens the door to investigators in many different areas of cancer research to explore whether or not there are common frameshift mutations that might create novel neoantigens that we can go after with vaccines – be they for therapeutic benefit or for prevention,” he said.



The UNITY-NHL study, which showed that umbralisib is active and well tolerated as single-agent therapy in patients with relapsed or refractory marginal zone lymphoma, suggests “it’s quite possible that [the phosphoinositide 3-kinase delta inhibitor] is going to become a very important element in the treatment of patients with marginal zone lymphomas, and obviously it can be then used in earlier stages of diseases since it’s well tolerated, and it may well have useful activity in other B-cell malignancies,” he said.

Dr. Weiner reported having no relevant disclosures.

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Artificial intelligence and machine learning in gastroenterology

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SAN FRANCISCO – Artificial intelligence (AI) is using computer technology to solve particular kinds of medical problems, Sushovan Guha, MD, PhD, AGAF, chair, division of gastroenterology, University of Arizona, Phoenix, said in an interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Vidyard Video

Computers are good at doing many processes in a short period of time and executing repetitive tasks with no errors, whereas humans tend to introduce errors after many repetitions. Using algorithms by which physicians assess and diagnose colonic lesions, computer software can learn the criteria that diagnose adenomas and assist in the process of diagnosis, Dr. Guha said.

Computers are also ideal for managing and analyzing large amounts of data – this ability has so far been used to personalize cancer treatment – and is now being used to suggest the best treatment and predict remission in patients with inflammatory bowel disease. AI can use anatomical data combined with endoscopy to predict GI bleeding so that physicians can target therapy. Dr. Guha predicts that there will be an “explosion” of applications of AI in gastroenterology in the next 5-10 years.

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SAN FRANCISCO – Artificial intelligence (AI) is using computer technology to solve particular kinds of medical problems, Sushovan Guha, MD, PhD, AGAF, chair, division of gastroenterology, University of Arizona, Phoenix, said in an interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Vidyard Video

Computers are good at doing many processes in a short period of time and executing repetitive tasks with no errors, whereas humans tend to introduce errors after many repetitions. Using algorithms by which physicians assess and diagnose colonic lesions, computer software can learn the criteria that diagnose adenomas and assist in the process of diagnosis, Dr. Guha said.

Computers are also ideal for managing and analyzing large amounts of data – this ability has so far been used to personalize cancer treatment – and is now being used to suggest the best treatment and predict remission in patients with inflammatory bowel disease. AI can use anatomical data combined with endoscopy to predict GI bleeding so that physicians can target therapy. Dr. Guha predicts that there will be an “explosion” of applications of AI in gastroenterology in the next 5-10 years.

SAN FRANCISCO – Artificial intelligence (AI) is using computer technology to solve particular kinds of medical problems, Sushovan Guha, MD, PhD, AGAF, chair, division of gastroenterology, University of Arizona, Phoenix, said in an interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Vidyard Video

Computers are good at doing many processes in a short period of time and executing repetitive tasks with no errors, whereas humans tend to introduce errors after many repetitions. Using algorithms by which physicians assess and diagnose colonic lesions, computer software can learn the criteria that diagnose adenomas and assist in the process of diagnosis, Dr. Guha said.

Computers are also ideal for managing and analyzing large amounts of data – this ability has so far been used to personalize cancer treatment – and is now being used to suggest the best treatment and predict remission in patients with inflammatory bowel disease. AI can use anatomical data combined with endoscopy to predict GI bleeding so that physicians can target therapy. Dr. Guha predicts that there will be an “explosion” of applications of AI in gastroenterology in the next 5-10 years.

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Research coalition issues plan for curing hepatitis B virus

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An international coalition of hepatitis B virus researchers, patients, and health organizations have released a comprehensive plan for developing a cure for this infection. They hope either to have a cure or to have made substantial progress toward this goal over the next 10 years.

Treatments already are on the market that effectively inhibit hepatitis B replication in infected patients (and an effective preventive vaccine also exists). Still, these treatments are not curative, and for the vast majority of patients treatment must continue indefinitely, while their risk for liver cancer and their virally induced immune system abnormalities remain, Peter A. Revill, PhD, said during a press briefing that introduced a strategy for hepatitis B virus (HBV) cure development from the International Coalition to Eliminate HBV. Concurrently with the briefing session, the strategy appeared in an article published online (Lancet Gastroenterol Hepatol. 2019 Apr 10. doi: 10.1016/s2468-1253(19)30119-0).

The way forward will likely be a “two-pronged approach or restoring immune responses and targeting the virus,” Dr. Revill, head of molecular virology at the Doherty Institute in Melbourne, said in a video interview.

Mitchel L. Zoler/MDedge News
Dr. Anna S. Lok

The new strategy recognizes the huge challenge of devising a treatment that produces a total cure that includes elimination of all traces of viral DNA from patients and for the immediate future focuses on the goal of functional cure. The term functional cure means a sustained period without detectable HBV surface antigen or HBV DNA in a patient’s serum, as well as suppressed virus release. Another feature of a functional cure would be a halt to progression of liver disease, replaced by liver regeneration, said Anna S. Lok, MD, professor of medicine and director of clinical hepatology at the University of Michigan, Ann Arbor, and a member of the strategy-writing group. She and her colleagues who wrote the strategy foresee the need for drug combinations with agents that can hit multiple viral targets as well as agents that restore normal immune function.

 

 



Mitchel L. Zoler/MDedge News
Dr. Fabien Zoulim

Several novel drug classes aimed at new viral targets, such as capsid inhibitors, are in various stages of clinical development, said Fabien Zoulim, MD, head of the gastroenterology and hepatology service at the Red Cross Hospital in Lyon, France, and another member of the writing panel. “We have many drug candidates” that use novel approaches to further restrict viral growth, roughly 50 agents in phase 1 and 2 studies, he said during the press briefing, held during the meeting sponsored by the European Association for the Study of the Liver. The other, immunologic aspect of the two-part cure strategy – restoring the “exhausted” HBV-specific T-cell population and stimulating production of neutralizing antibody to HBV – remains hypothetical right now, however. “It’s a concept that needs development,” Dr. Zoulim said.



A reason members of the coalition are optimistic about eventual prospects for a cure is that currently about 1% of patients on HBV antiviral treatments have a functional cure after relatively brief treatment, and the percentage of cured patients plateaus at about 10% among those who remain on current HBV antiviral drugs for several years. In addition, a substantial fraction of patients spontaneously resolve their HBV infection without any treatment. Experts estimate that more than 1 billion people worldwide have been infected by HBV and then later had their infection clear “naturally,” said Dr. Revill. But the mechanism by which this happens is currently a mystery. “We don’t know how or why” so many infected people are “cured” naturally, Dr. Revill admitted, but it gives him and his colleagues hope that the numbers can expand once more and better treatments for HBV infection are available.

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An international coalition of hepatitis B virus researchers, patients, and health organizations have released a comprehensive plan for developing a cure for this infection. They hope either to have a cure or to have made substantial progress toward this goal over the next 10 years.

Treatments already are on the market that effectively inhibit hepatitis B replication in infected patients (and an effective preventive vaccine also exists). Still, these treatments are not curative, and for the vast majority of patients treatment must continue indefinitely, while their risk for liver cancer and their virally induced immune system abnormalities remain, Peter A. Revill, PhD, said during a press briefing that introduced a strategy for hepatitis B virus (HBV) cure development from the International Coalition to Eliminate HBV. Concurrently with the briefing session, the strategy appeared in an article published online (Lancet Gastroenterol Hepatol. 2019 Apr 10. doi: 10.1016/s2468-1253(19)30119-0).

The way forward will likely be a “two-pronged approach or restoring immune responses and targeting the virus,” Dr. Revill, head of molecular virology at the Doherty Institute in Melbourne, said in a video interview.

Mitchel L. Zoler/MDedge News
Dr. Anna S. Lok

The new strategy recognizes the huge challenge of devising a treatment that produces a total cure that includes elimination of all traces of viral DNA from patients and for the immediate future focuses on the goal of functional cure. The term functional cure means a sustained period without detectable HBV surface antigen or HBV DNA in a patient’s serum, as well as suppressed virus release. Another feature of a functional cure would be a halt to progression of liver disease, replaced by liver regeneration, said Anna S. Lok, MD, professor of medicine and director of clinical hepatology at the University of Michigan, Ann Arbor, and a member of the strategy-writing group. She and her colleagues who wrote the strategy foresee the need for drug combinations with agents that can hit multiple viral targets as well as agents that restore normal immune function.

 

 



Mitchel L. Zoler/MDedge News
Dr. Fabien Zoulim

Several novel drug classes aimed at new viral targets, such as capsid inhibitors, are in various stages of clinical development, said Fabien Zoulim, MD, head of the gastroenterology and hepatology service at the Red Cross Hospital in Lyon, France, and another member of the writing panel. “We have many drug candidates” that use novel approaches to further restrict viral growth, roughly 50 agents in phase 1 and 2 studies, he said during the press briefing, held during the meeting sponsored by the European Association for the Study of the Liver. The other, immunologic aspect of the two-part cure strategy – restoring the “exhausted” HBV-specific T-cell population and stimulating production of neutralizing antibody to HBV – remains hypothetical right now, however. “It’s a concept that needs development,” Dr. Zoulim said.



A reason members of the coalition are optimistic about eventual prospects for a cure is that currently about 1% of patients on HBV antiviral treatments have a functional cure after relatively brief treatment, and the percentage of cured patients plateaus at about 10% among those who remain on current HBV antiviral drugs for several years. In addition, a substantial fraction of patients spontaneously resolve their HBV infection without any treatment. Experts estimate that more than 1 billion people worldwide have been infected by HBV and then later had their infection clear “naturally,” said Dr. Revill. But the mechanism by which this happens is currently a mystery. “We don’t know how or why” so many infected people are “cured” naturally, Dr. Revill admitted, but it gives him and his colleagues hope that the numbers can expand once more and better treatments for HBV infection are available.

An international coalition of hepatitis B virus researchers, patients, and health organizations have released a comprehensive plan for developing a cure for this infection. They hope either to have a cure or to have made substantial progress toward this goal over the next 10 years.

Treatments already are on the market that effectively inhibit hepatitis B replication in infected patients (and an effective preventive vaccine also exists). Still, these treatments are not curative, and for the vast majority of patients treatment must continue indefinitely, while their risk for liver cancer and their virally induced immune system abnormalities remain, Peter A. Revill, PhD, said during a press briefing that introduced a strategy for hepatitis B virus (HBV) cure development from the International Coalition to Eliminate HBV. Concurrently with the briefing session, the strategy appeared in an article published online (Lancet Gastroenterol Hepatol. 2019 Apr 10. doi: 10.1016/s2468-1253(19)30119-0).

The way forward will likely be a “two-pronged approach or restoring immune responses and targeting the virus,” Dr. Revill, head of molecular virology at the Doherty Institute in Melbourne, said in a video interview.

Mitchel L. Zoler/MDedge News
Dr. Anna S. Lok

The new strategy recognizes the huge challenge of devising a treatment that produces a total cure that includes elimination of all traces of viral DNA from patients and for the immediate future focuses on the goal of functional cure. The term functional cure means a sustained period without detectable HBV surface antigen or HBV DNA in a patient’s serum, as well as suppressed virus release. Another feature of a functional cure would be a halt to progression of liver disease, replaced by liver regeneration, said Anna S. Lok, MD, professor of medicine and director of clinical hepatology at the University of Michigan, Ann Arbor, and a member of the strategy-writing group. She and her colleagues who wrote the strategy foresee the need for drug combinations with agents that can hit multiple viral targets as well as agents that restore normal immune function.

 

 



Mitchel L. Zoler/MDedge News
Dr. Fabien Zoulim

Several novel drug classes aimed at new viral targets, such as capsid inhibitors, are in various stages of clinical development, said Fabien Zoulim, MD, head of the gastroenterology and hepatology service at the Red Cross Hospital in Lyon, France, and another member of the writing panel. “We have many drug candidates” that use novel approaches to further restrict viral growth, roughly 50 agents in phase 1 and 2 studies, he said during the press briefing, held during the meeting sponsored by the European Association for the Study of the Liver. The other, immunologic aspect of the two-part cure strategy – restoring the “exhausted” HBV-specific T-cell population and stimulating production of neutralizing antibody to HBV – remains hypothetical right now, however. “It’s a concept that needs development,” Dr. Zoulim said.



A reason members of the coalition are optimistic about eventual prospects for a cure is that currently about 1% of patients on HBV antiviral treatments have a functional cure after relatively brief treatment, and the percentage of cured patients plateaus at about 10% among those who remain on current HBV antiviral drugs for several years. In addition, a substantial fraction of patients spontaneously resolve their HBV infection without any treatment. Experts estimate that more than 1 billion people worldwide have been infected by HBV and then later had their infection clear “naturally,” said Dr. Revill. But the mechanism by which this happens is currently a mystery. “We don’t know how or why” so many infected people are “cured” naturally, Dr. Revill admitted, but it gives him and his colleagues hope that the numbers can expand once more and better treatments for HBV infection are available.

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