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Recent studies of microbiota offer insights into digestive disease management
LAS VEGAS – Recent studies of human microbiota are yielding new insights that could improve the diagnosis, evaluation, and treatment of digestive diseases, according to Eamonn M. Quigley, MD.
There are “many possibilities” for new therapeutics that focus on the assemblage of bacteria and other microorganisms present in the human body, said Dr. Quigley, director of the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist.
The role of the microbiota has already been well established, for example, in cases of Helicobacter pylori infection and Clostridium difficile–associated disease. “They’re the classics,” Dr. Quigley told attendees. “They’re the templates for studies in other diseases.”
Dr. Quigley shared results of one recent treatment-related study that he said could have important implications for sepsis prevention in infants. The randomized trial showed that administration of a particular synbiotic – a probiotic plus a prebiotic substance – may have reduced sepsis incidence among infants in rural India.
The study comprised 4,556 infants with no signs of sepsis who were given an oral synbiotic preparation of Lactobacillus plantarum plus fructooligosaccharide. The composite outcome of sepsis and death was reduced in the treatment arm of the study (risk ratio, 0.60; 95% confidence interval, 0.48-0.74).
Based on that outcome, investigators said in their report that the preparation could prevent a “large proportion” of neonatal sepsis in developing countries.
“This is a very dramatic result for a very simple and cheap intervention in a high-risk population,” Dr. Quigley said in his presentation at the meeting.
He also provided a short list of studies showing “exciting recent data” regarding the predictive role of microbiota.
In one such study, investigators showed that the oral microbiota associated with colorectal cancer is distinctive, raising the possibility that analyzing microbiota could help identify patients at risk for development of colon cancer or offer an alternative cancer screening method.
In other studies, Dr. Quigley said, microbiota have been associated with response to metformin, and to the immune checkpoint inhibitors that have become important in the treatment of cancers.
In addition, microbiota have been associated with predicting response to low fermentable, oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diets in irritable bowel syndrome patients, and predicting metabolic response to high-fiber diets, he added.
Diagnostics is another area where microbiota could soon become important: “In diseases like [inflammatory bowel disease and irritable bowel syndrome] where we have a very heterogeneous population, looking at the microbiota might allow us to define new disease categories,” Dr. Quigley said.
Despite the promise, much research is still needed to confirm many of the findings of experimental studies.
“I think it’s clear that the microbiota is important in health and disease,” Dr. Quigley said. “However, host/microbiome interactions in [humans] are complex and far from completely understood, and unfortunately, some of the elegant work in animal models has not quite translated into man.”
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Quigley reported disclosures related to Alimentary Health, Almirall, Biocodex, 4D Pharma, Menarini, Pharmasierra, Salix, Synergy, and Vibrant.
LAS VEGAS – Recent studies of human microbiota are yielding new insights that could improve the diagnosis, evaluation, and treatment of digestive diseases, according to Eamonn M. Quigley, MD.
There are “many possibilities” for new therapeutics that focus on the assemblage of bacteria and other microorganisms present in the human body, said Dr. Quigley, director of the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist.
The role of the microbiota has already been well established, for example, in cases of Helicobacter pylori infection and Clostridium difficile–associated disease. “They’re the classics,” Dr. Quigley told attendees. “They’re the templates for studies in other diseases.”
Dr. Quigley shared results of one recent treatment-related study that he said could have important implications for sepsis prevention in infants. The randomized trial showed that administration of a particular synbiotic – a probiotic plus a prebiotic substance – may have reduced sepsis incidence among infants in rural India.
The study comprised 4,556 infants with no signs of sepsis who were given an oral synbiotic preparation of Lactobacillus plantarum plus fructooligosaccharide. The composite outcome of sepsis and death was reduced in the treatment arm of the study (risk ratio, 0.60; 95% confidence interval, 0.48-0.74).
Based on that outcome, investigators said in their report that the preparation could prevent a “large proportion” of neonatal sepsis in developing countries.
“This is a very dramatic result for a very simple and cheap intervention in a high-risk population,” Dr. Quigley said in his presentation at the meeting.
He also provided a short list of studies showing “exciting recent data” regarding the predictive role of microbiota.
In one such study, investigators showed that the oral microbiota associated with colorectal cancer is distinctive, raising the possibility that analyzing microbiota could help identify patients at risk for development of colon cancer or offer an alternative cancer screening method.
In other studies, Dr. Quigley said, microbiota have been associated with response to metformin, and to the immune checkpoint inhibitors that have become important in the treatment of cancers.
In addition, microbiota have been associated with predicting response to low fermentable, oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diets in irritable bowel syndrome patients, and predicting metabolic response to high-fiber diets, he added.
Diagnostics is another area where microbiota could soon become important: “In diseases like [inflammatory bowel disease and irritable bowel syndrome] where we have a very heterogeneous population, looking at the microbiota might allow us to define new disease categories,” Dr. Quigley said.
Despite the promise, much research is still needed to confirm many of the findings of experimental studies.
“I think it’s clear that the microbiota is important in health and disease,” Dr. Quigley said. “However, host/microbiome interactions in [humans] are complex and far from completely understood, and unfortunately, some of the elegant work in animal models has not quite translated into man.”
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Quigley reported disclosures related to Alimentary Health, Almirall, Biocodex, 4D Pharma, Menarini, Pharmasierra, Salix, Synergy, and Vibrant.
LAS VEGAS – Recent studies of human microbiota are yielding new insights that could improve the diagnosis, evaluation, and treatment of digestive diseases, according to Eamonn M. Quigley, MD.
There are “many possibilities” for new therapeutics that focus on the assemblage of bacteria and other microorganisms present in the human body, said Dr. Quigley, director of the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist.
The role of the microbiota has already been well established, for example, in cases of Helicobacter pylori infection and Clostridium difficile–associated disease. “They’re the classics,” Dr. Quigley told attendees. “They’re the templates for studies in other diseases.”
Dr. Quigley shared results of one recent treatment-related study that he said could have important implications for sepsis prevention in infants. The randomized trial showed that administration of a particular synbiotic – a probiotic plus a prebiotic substance – may have reduced sepsis incidence among infants in rural India.
The study comprised 4,556 infants with no signs of sepsis who were given an oral synbiotic preparation of Lactobacillus plantarum plus fructooligosaccharide. The composite outcome of sepsis and death was reduced in the treatment arm of the study (risk ratio, 0.60; 95% confidence interval, 0.48-0.74).
Based on that outcome, investigators said in their report that the preparation could prevent a “large proportion” of neonatal sepsis in developing countries.
“This is a very dramatic result for a very simple and cheap intervention in a high-risk population,” Dr. Quigley said in his presentation at the meeting.
He also provided a short list of studies showing “exciting recent data” regarding the predictive role of microbiota.
In one such study, investigators showed that the oral microbiota associated with colorectal cancer is distinctive, raising the possibility that analyzing microbiota could help identify patients at risk for development of colon cancer or offer an alternative cancer screening method.
In other studies, Dr. Quigley said, microbiota have been associated with response to metformin, and to the immune checkpoint inhibitors that have become important in the treatment of cancers.
In addition, microbiota have been associated with predicting response to low fermentable, oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diets in irritable bowel syndrome patients, and predicting metabolic response to high-fiber diets, he added.
Diagnostics is another area where microbiota could soon become important: “In diseases like [inflammatory bowel disease and irritable bowel syndrome] where we have a very heterogeneous population, looking at the microbiota might allow us to define new disease categories,” Dr. Quigley said.
Despite the promise, much research is still needed to confirm many of the findings of experimental studies.
“I think it’s clear that the microbiota is important in health and disease,” Dr. Quigley said. “However, host/microbiome interactions in [humans] are complex and far from completely understood, and unfortunately, some of the elegant work in animal models has not quite translated into man.”
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Quigley reported disclosures related to Alimentary Health, Almirall, Biocodex, 4D Pharma, Menarini, Pharmasierra, Salix, Synergy, and Vibrant.
REPORTING FROM PERSPECTIVES IN DIGESTIVE DISEASES
Celiac disease: Can biopsy be avoided?
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
Biopsy, already a tarnished standard because of issues such as interpretation, according to Dr. Murray, is being challenged in studies that examine alternate ways of making the diagnosis.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
AGA offers celiac disease information for your patients in the GI Patient Center at http://ow.ly/VwJ130jN7Sx.
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
Biopsy, already a tarnished standard because of issues such as interpretation, according to Dr. Murray, is being challenged in studies that examine alternate ways of making the diagnosis.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
AGA offers celiac disease information for your patients in the GI Patient Center at http://ow.ly/VwJ130jN7Sx.
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
Biopsy, already a tarnished standard because of issues such as interpretation, according to Dr. Murray, is being challenged in studies that examine alternate ways of making the diagnosis.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
AGA offers celiac disease information for your patients in the GI Patient Center at http://ow.ly/VwJ130jN7Sx.
Hepatic adenoma assessment: Wait longer to avoid overtreatment?
LAS VEGAS – For women with larger hepatic adenomas, current guidelines suggest reassessment at 6 months after oral contraceptive withdrawal to determine whether resection is warranted.
However, emerging data show reassessing at that time point may lead to overtreatment, according to Laura M. Kulik, MD, professor of medicine (gastroenterology and hepatology), radiology and surgery (organ transplantation), Northwestern University, Chicago.
“There’s been some controversy that 6 months may be too short,” Dr. Kulik said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
Unlike other benign liver lesions, hepatic adenomas can hemorrhage and transform to hepatocellular carcinoma. Current guidelines from the European Association for the Study of the Liver state that larger lesions (i.e., 5 cm or greater on baseline imaging) are associated with a higher risk of complications. According to one systematic review cited in the document, almost all cases of hemorrhage or spontaneous rupture occur in lesions 5 cm or larger.
Oral contraceptive use has been associated with a 30- to 40-fold increase in hepatic adenoma incidence, according to the guidelines.
All men with hepatic adenomas should undergo resection or curative treatment, the guidelines say, since they have a significantly higher risk of hepatocellular carcinoma.
By contrast, women with hepatic adenomas larger than 5 cm should discontinue oral contraceptives – which may lead to tumor regression in some cases – and should be reassessed 6 months later with contrast-enhanced MRI; if the lesion is still greater than 5 cm at that time, they should be considered for resection or curative treatment, the guidelines say.
However, authors of a retrospective cohort study have challenged that advice, suggesting that a 6-month follow-up may not always be long enough to see adequate tumor regression (HPB 2017 Apr;19[Suppl 1]:S3).
In the study, researchers from Erasmus MC University Medical Center, Rotterdam, the Netherlands, reviewed records for patients who were diagnosed with a hepatic adenoma of at least 5 cm and followed for at least 6 months after oral contraceptives were stopped.
Of that group, 104 underwent surgical treatment for a lesion larger than 5 cm, while the remaining 86 were conservatively treated.
The researchers found that in the conservatively treated group, 61 lesions (71%) regressed below the 5-cm cutoff after a median of 85 weeks (95% confidence interval, 52-110 weeks), with larger lesions taking significantly longer to regress.
Based on those findings, the investigators said the 6-month cutoff may lead to overtreatment, and that for some patients with particularly large tumors, it may be justified to wait up to 24 months.
“The study does suggest that, potentially, 6 months may be too short,” Dr. Kulik told attendees at the meeting. “They do caution that beta-catenin mutated adenomas should probably be removed without waiting longer because of the risk of developing cancer.”
Dr. Kulik reported disclosures related to Bayer, BMS, BTG, and Eisai. Global Academy and this news organization are owned by the same parent company.
LAS VEGAS – For women with larger hepatic adenomas, current guidelines suggest reassessment at 6 months after oral contraceptive withdrawal to determine whether resection is warranted.
However, emerging data show reassessing at that time point may lead to overtreatment, according to Laura M. Kulik, MD, professor of medicine (gastroenterology and hepatology), radiology and surgery (organ transplantation), Northwestern University, Chicago.
“There’s been some controversy that 6 months may be too short,” Dr. Kulik said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
Unlike other benign liver lesions, hepatic adenomas can hemorrhage and transform to hepatocellular carcinoma. Current guidelines from the European Association for the Study of the Liver state that larger lesions (i.e., 5 cm or greater on baseline imaging) are associated with a higher risk of complications. According to one systematic review cited in the document, almost all cases of hemorrhage or spontaneous rupture occur in lesions 5 cm or larger.
Oral contraceptive use has been associated with a 30- to 40-fold increase in hepatic adenoma incidence, according to the guidelines.
All men with hepatic adenomas should undergo resection or curative treatment, the guidelines say, since they have a significantly higher risk of hepatocellular carcinoma.
By contrast, women with hepatic adenomas larger than 5 cm should discontinue oral contraceptives – which may lead to tumor regression in some cases – and should be reassessed 6 months later with contrast-enhanced MRI; if the lesion is still greater than 5 cm at that time, they should be considered for resection or curative treatment, the guidelines say.
However, authors of a retrospective cohort study have challenged that advice, suggesting that a 6-month follow-up may not always be long enough to see adequate tumor regression (HPB 2017 Apr;19[Suppl 1]:S3).
In the study, researchers from Erasmus MC University Medical Center, Rotterdam, the Netherlands, reviewed records for patients who were diagnosed with a hepatic adenoma of at least 5 cm and followed for at least 6 months after oral contraceptives were stopped.
Of that group, 104 underwent surgical treatment for a lesion larger than 5 cm, while the remaining 86 were conservatively treated.
The researchers found that in the conservatively treated group, 61 lesions (71%) regressed below the 5-cm cutoff after a median of 85 weeks (95% confidence interval, 52-110 weeks), with larger lesions taking significantly longer to regress.
Based on those findings, the investigators said the 6-month cutoff may lead to overtreatment, and that for some patients with particularly large tumors, it may be justified to wait up to 24 months.
“The study does suggest that, potentially, 6 months may be too short,” Dr. Kulik told attendees at the meeting. “They do caution that beta-catenin mutated adenomas should probably be removed without waiting longer because of the risk of developing cancer.”
Dr. Kulik reported disclosures related to Bayer, BMS, BTG, and Eisai. Global Academy and this news organization are owned by the same parent company.
LAS VEGAS – For women with larger hepatic adenomas, current guidelines suggest reassessment at 6 months after oral contraceptive withdrawal to determine whether resection is warranted.
However, emerging data show reassessing at that time point may lead to overtreatment, according to Laura M. Kulik, MD, professor of medicine (gastroenterology and hepatology), radiology and surgery (organ transplantation), Northwestern University, Chicago.
“There’s been some controversy that 6 months may be too short,” Dr. Kulik said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
Unlike other benign liver lesions, hepatic adenomas can hemorrhage and transform to hepatocellular carcinoma. Current guidelines from the European Association for the Study of the Liver state that larger lesions (i.e., 5 cm or greater on baseline imaging) are associated with a higher risk of complications. According to one systematic review cited in the document, almost all cases of hemorrhage or spontaneous rupture occur in lesions 5 cm or larger.
Oral contraceptive use has been associated with a 30- to 40-fold increase in hepatic adenoma incidence, according to the guidelines.
All men with hepatic adenomas should undergo resection or curative treatment, the guidelines say, since they have a significantly higher risk of hepatocellular carcinoma.
By contrast, women with hepatic adenomas larger than 5 cm should discontinue oral contraceptives – which may lead to tumor regression in some cases – and should be reassessed 6 months later with contrast-enhanced MRI; if the lesion is still greater than 5 cm at that time, they should be considered for resection or curative treatment, the guidelines say.
However, authors of a retrospective cohort study have challenged that advice, suggesting that a 6-month follow-up may not always be long enough to see adequate tumor regression (HPB 2017 Apr;19[Suppl 1]:S3).
In the study, researchers from Erasmus MC University Medical Center, Rotterdam, the Netherlands, reviewed records for patients who were diagnosed with a hepatic adenoma of at least 5 cm and followed for at least 6 months after oral contraceptives were stopped.
Of that group, 104 underwent surgical treatment for a lesion larger than 5 cm, while the remaining 86 were conservatively treated.
The researchers found that in the conservatively treated group, 61 lesions (71%) regressed below the 5-cm cutoff after a median of 85 weeks (95% confidence interval, 52-110 weeks), with larger lesions taking significantly longer to regress.
Based on those findings, the investigators said the 6-month cutoff may lead to overtreatment, and that for some patients with particularly large tumors, it may be justified to wait up to 24 months.
“The study does suggest that, potentially, 6 months may be too short,” Dr. Kulik told attendees at the meeting. “They do caution that beta-catenin mutated adenomas should probably be removed without waiting longer because of the risk of developing cancer.”
Dr. Kulik reported disclosures related to Bayer, BMS, BTG, and Eisai. Global Academy and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
Constipation on opioids? Follow these three steps to ID the true cause
LAS VEGAS – To appropriately manage patients on opioids who develop constipation, one of the most important distinctions to make is whether the condition was caused by the pain treatment or was just exacerbated by it, according to Darren M. Brenner, MD.
Because of the rampant use of opioids, the answer to that question is increasingly relevant to clinical practice, said Dr. Brenner, associate professor of medicine (gastroenterology and hepatology) and surgery at Northwestern University, Chicago.
Dr. Brenner described a concise algorithm (Curr Gastroenterol Rep. 2017 Mar;19[3]:12) for discerning these patient groups; he codeveloped the algorithm with meeting cochair Brooks D. Cash, MD, chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston.
Step 1 in the algorithm is simply to ask patients whether they are constipated. “You should ask all of your patients who are on opioids if they have this problem,” Dr. Brenner said. “A significant percentage of individuals using opioids will develop constipation.”
According to the results of studies that Dr. Brenner summarized, up to 80% of patients taking opioids for chronic, noncancer pain will develop opioid-induced constipation, and more than 90% of opioid-taking patients with advanced illness will need laxatives.
Given this prevalence, clinicians might want to be skeptical when patients on opioids reply “no” when asked whether they are constipated.
“From my own clinical experience, you will miss a third of your population that has constipation,” Dr. Brenner said, noting that some patients will instead think of their condition in terms of incomplete evacuation or decreased stool frequency.
Step 2 of the algorithm, therefore, is to assess for signs and symptoms of functional constipation in all patients, regardless of whether they report the condition.
The recently published Rome IV diagnostic criteria included a new category for opioid-induced constipation. According to the new definition, opioid-induced constipation must include new or worsening symptoms, such as fewer than three solid bowel movements per week, and straining, blockage sensation, or manual maneuvers on at least 25% of bowel movements, among other symptoms listed in the report.
If patients do have constipation meeting these criteria, then step 3 of the algorithm is to determine whether the symptoms were present prior to taking opioids.
If onset of constipation is related to the start of opioid treatment, options may include prescribing peripherally acting mu-opioid receptor antagonists (PAMORAs). By contrast, onset unrelated to the start of opioids, also known as opioid-exacerbated constipation, may require treatment according to the underlying cause. For example, slow-transit constipation may respond to laxatives, while evacuation disorders may be treated with surgery, biofeedback, or physical therapy.
The hardest group to identify, according to Dr. Brenner, is individuals whose symptoms were so minor that they didn’t even realize they had constipation symptoms prior to opioids.
Because treatment protocols for opioid-induced and opioid-exacerbated constipation are so different, “we must tease these people out,” Dr. Brenner said.
Global Academy and this news organization are owned by the same parent company.
Dr. Brenner reported disclosures related to Allergan, Daiichi Sankyo, Ironwood Pharmaceuticals, Prius Medical, Salix Pharmaceuticals, Synergy Pharmaceuticals, Shionogi, and others.
LAS VEGAS – To appropriately manage patients on opioids who develop constipation, one of the most important distinctions to make is whether the condition was caused by the pain treatment or was just exacerbated by it, according to Darren M. Brenner, MD.
Because of the rampant use of opioids, the answer to that question is increasingly relevant to clinical practice, said Dr. Brenner, associate professor of medicine (gastroenterology and hepatology) and surgery at Northwestern University, Chicago.
Dr. Brenner described a concise algorithm (Curr Gastroenterol Rep. 2017 Mar;19[3]:12) for discerning these patient groups; he codeveloped the algorithm with meeting cochair Brooks D. Cash, MD, chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston.
Step 1 in the algorithm is simply to ask patients whether they are constipated. “You should ask all of your patients who are on opioids if they have this problem,” Dr. Brenner said. “A significant percentage of individuals using opioids will develop constipation.”
According to the results of studies that Dr. Brenner summarized, up to 80% of patients taking opioids for chronic, noncancer pain will develop opioid-induced constipation, and more than 90% of opioid-taking patients with advanced illness will need laxatives.
Given this prevalence, clinicians might want to be skeptical when patients on opioids reply “no” when asked whether they are constipated.
“From my own clinical experience, you will miss a third of your population that has constipation,” Dr. Brenner said, noting that some patients will instead think of their condition in terms of incomplete evacuation or decreased stool frequency.
Step 2 of the algorithm, therefore, is to assess for signs and symptoms of functional constipation in all patients, regardless of whether they report the condition.
The recently published Rome IV diagnostic criteria included a new category for opioid-induced constipation. According to the new definition, opioid-induced constipation must include new or worsening symptoms, such as fewer than three solid bowel movements per week, and straining, blockage sensation, or manual maneuvers on at least 25% of bowel movements, among other symptoms listed in the report.
If patients do have constipation meeting these criteria, then step 3 of the algorithm is to determine whether the symptoms were present prior to taking opioids.
If onset of constipation is related to the start of opioid treatment, options may include prescribing peripherally acting mu-opioid receptor antagonists (PAMORAs). By contrast, onset unrelated to the start of opioids, also known as opioid-exacerbated constipation, may require treatment according to the underlying cause. For example, slow-transit constipation may respond to laxatives, while evacuation disorders may be treated with surgery, biofeedback, or physical therapy.
The hardest group to identify, according to Dr. Brenner, is individuals whose symptoms were so minor that they didn’t even realize they had constipation symptoms prior to opioids.
Because treatment protocols for opioid-induced and opioid-exacerbated constipation are so different, “we must tease these people out,” Dr. Brenner said.
Global Academy and this news organization are owned by the same parent company.
Dr. Brenner reported disclosures related to Allergan, Daiichi Sankyo, Ironwood Pharmaceuticals, Prius Medical, Salix Pharmaceuticals, Synergy Pharmaceuticals, Shionogi, and others.
LAS VEGAS – To appropriately manage patients on opioids who develop constipation, one of the most important distinctions to make is whether the condition was caused by the pain treatment or was just exacerbated by it, according to Darren M. Brenner, MD.
Because of the rampant use of opioids, the answer to that question is increasingly relevant to clinical practice, said Dr. Brenner, associate professor of medicine (gastroenterology and hepatology) and surgery at Northwestern University, Chicago.
Dr. Brenner described a concise algorithm (Curr Gastroenterol Rep. 2017 Mar;19[3]:12) for discerning these patient groups; he codeveloped the algorithm with meeting cochair Brooks D. Cash, MD, chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston.
Step 1 in the algorithm is simply to ask patients whether they are constipated. “You should ask all of your patients who are on opioids if they have this problem,” Dr. Brenner said. “A significant percentage of individuals using opioids will develop constipation.”
According to the results of studies that Dr. Brenner summarized, up to 80% of patients taking opioids for chronic, noncancer pain will develop opioid-induced constipation, and more than 90% of opioid-taking patients with advanced illness will need laxatives.
Given this prevalence, clinicians might want to be skeptical when patients on opioids reply “no” when asked whether they are constipated.
“From my own clinical experience, you will miss a third of your population that has constipation,” Dr. Brenner said, noting that some patients will instead think of their condition in terms of incomplete evacuation or decreased stool frequency.
Step 2 of the algorithm, therefore, is to assess for signs and symptoms of functional constipation in all patients, regardless of whether they report the condition.
The recently published Rome IV diagnostic criteria included a new category for opioid-induced constipation. According to the new definition, opioid-induced constipation must include new or worsening symptoms, such as fewer than three solid bowel movements per week, and straining, blockage sensation, or manual maneuvers on at least 25% of bowel movements, among other symptoms listed in the report.
If patients do have constipation meeting these criteria, then step 3 of the algorithm is to determine whether the symptoms were present prior to taking opioids.
If onset of constipation is related to the start of opioid treatment, options may include prescribing peripherally acting mu-opioid receptor antagonists (PAMORAs). By contrast, onset unrelated to the start of opioids, also known as opioid-exacerbated constipation, may require treatment according to the underlying cause. For example, slow-transit constipation may respond to laxatives, while evacuation disorders may be treated with surgery, biofeedback, or physical therapy.
The hardest group to identify, according to Dr. Brenner, is individuals whose symptoms were so minor that they didn’t even realize they had constipation symptoms prior to opioids.
Because treatment protocols for opioid-induced and opioid-exacerbated constipation are so different, “we must tease these people out,” Dr. Brenner said.
Global Academy and this news organization are owned by the same parent company.
Dr. Brenner reported disclosures related to Allergan, Daiichi Sankyo, Ironwood Pharmaceuticals, Prius Medical, Salix Pharmaceuticals, Synergy Pharmaceuticals, Shionogi, and others.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
Celiac disease: Can biopsy be avoided?
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.
Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.
Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
LAS VEGAS – It may be only a matter of time before the “gold standard” small biopsy is no longer considered mandatory to make a diagnosis of celiac disease in adults, according to Joseph A. Murray, MD, consultant in the division of gastroenterology and hepatology and department of immunology, Mayo Clinic, Rochester, Minn.
“Right now, none of the adult societies support biopsy avoidance, but I predict that it will come to be,” Dr. Murray said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
In one recently reported study, investigators at Royal Derby Hospital, England, suggested that clinicians could make a reliable diagnosis of celiac disease by looking at serum IgA-tissue transglutaminase antibody levels.
Those investigators retrospectively analyzed an unselected series of 270 adult patients and found that an IgA-tissue transglutaminase antibody cut-off of 45 U/mL, or 8 times the upper limit of normal, had a positive predictive value of 100%.
Biopsy avoidance remains controversial, however. In a published letter to the editor commenting on the Derby study, authors took issue with some of the statistical analysis and remarked that the study included some patients with Marsh 1 histology.
“Studies suggest that the majority of seropositive patients with Marsh 1 histology do not progress to develop villous atrophy while on a gluten-containing diet, raising the question whether all of them are truly celiac,” they wrote.
The first society to endorse skipping the biopsy was the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
In guidelines for the diagnosis of celiac disease, that group said a celiac diagnosis could be made based on symptoms, antibodies, and HLA in children with symptoms suggestive of the disease and high antibody levels (IgA anti-tissue transglutaminase type 2 antibody titers greater than 10 times the upper limit of normal).
“The data [are] now pretty good to support that approach in symptomatic children,” Dr. Murray said. “If we apply these to adult patients, it’s not bad, actually, partly because our biopsies aren’t perfect.”
However, not all adult gastroenterology specialists agreed with the recommendations of the pediatric society. Guidelines from the British Society of Gastroenterology have stated that serology cannot replace biopsy, which “remains essential” for celiac disease diagnosis.
Global Academy and this news organization are owned by the same parent company.
Dr. Murray reported disclosures related to Ardent Mills, DBV Technologies, Evelo, GlaxoSmithKline, Johnson & Johnson, Immunogenix, Innovate, National Center for Complementary and Integrative Health, Takeda, Torax Medical, and UCB.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
Endoscopic therapy for Barrett’s: highly effective, but not perfect
LAS VEGAS – While endoscopic therapy of Barrett’s esophagus is often successful, the risk of recurrence after complete ablation remains considerable, according to Prateek Sharma, MD, of the department of medicine in the division of gastroenterology and hepatology at the University of Kansas, Kansas City.
“This is not perfect therapy,” Dr. Sharma said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
The risk of recurrence for intestinal metaplasia was 7.1% per patient-year, authors of that study found. The risk of dysplastic Barrett’s esophagus was 1.3% per patient-year in the meta-analysis, while the risk of high-grade dysplasia or esophageal adenocarcinoma was 0.8%.
Because of these risks, patients should be followed up regularly with careful examination and biopsies to ensure there is no recurrent intestinal metaplasia, dysplasia, or adenocarcinoma, Dr. Sharma told attendees at the meeting.
“If it comes back, you can still treat it endoscopically,” he continued, “but you have to be aware of the situation, and inform the patient that it can be curative, but at the same time it’s not a 100% success story in all situations.”
When patients do develop early cancers or high-grade lesions, the latest evidence suggests endoscopic therapy is effective and helps avoid esophagectomy in the majority of patients.
“It used to be esophagectomy for all,” Dr. Sharma said. “Now the paradigm has switched, and it is endoscopic therapy for all.”
That paradigm shift is supported in part by a German study showing excellent long-term results in 1,000 consecutive patients receiving endoscopic treatment of mucosal adenocarcinoma of the esophagus.
In that study, nearly all of the patients (963, or 96.3%) had a complete response, with 12 patients undergoing surgery because of failure of endoscopic therapy. Fifteen patients (1.5%) had major complications that were nonetheless managed conservatively, according to investigators. Although new lesions or recurrences were seen in 140 patients (14.5%) over 5 years of follow-up, 115 patients had successful endoscopic retreatment. Based on these data, the investigators calculated a 10-year survival rate of 75%.
On the basis of these findings, investigators said endoscopic therapy should be considered the standard of care for patients with mucosal adenocarcinoma of the esophagus.
“That’s the paradigm shift that I was talking about – now, we are sending less than 4% of our patients for surgery for this condition,” Dr. Sharma said at the meeting.
Global Academy and this news organization are owned by the same parent company.
Dr. Sharma reported disclosures related to Medtronics, National Institutes of Health, and US Endoscopy.
LAS VEGAS – While endoscopic therapy of Barrett’s esophagus is often successful, the risk of recurrence after complete ablation remains considerable, according to Prateek Sharma, MD, of the department of medicine in the division of gastroenterology and hepatology at the University of Kansas, Kansas City.
“This is not perfect therapy,” Dr. Sharma said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
The risk of recurrence for intestinal metaplasia was 7.1% per patient-year, authors of that study found. The risk of dysplastic Barrett’s esophagus was 1.3% per patient-year in the meta-analysis, while the risk of high-grade dysplasia or esophageal adenocarcinoma was 0.8%.
Because of these risks, patients should be followed up regularly with careful examination and biopsies to ensure there is no recurrent intestinal metaplasia, dysplasia, or adenocarcinoma, Dr. Sharma told attendees at the meeting.
“If it comes back, you can still treat it endoscopically,” he continued, “but you have to be aware of the situation, and inform the patient that it can be curative, but at the same time it’s not a 100% success story in all situations.”
When patients do develop early cancers or high-grade lesions, the latest evidence suggests endoscopic therapy is effective and helps avoid esophagectomy in the majority of patients.
“It used to be esophagectomy for all,” Dr. Sharma said. “Now the paradigm has switched, and it is endoscopic therapy for all.”
That paradigm shift is supported in part by a German study showing excellent long-term results in 1,000 consecutive patients receiving endoscopic treatment of mucosal adenocarcinoma of the esophagus.
In that study, nearly all of the patients (963, or 96.3%) had a complete response, with 12 patients undergoing surgery because of failure of endoscopic therapy. Fifteen patients (1.5%) had major complications that were nonetheless managed conservatively, according to investigators. Although new lesions or recurrences were seen in 140 patients (14.5%) over 5 years of follow-up, 115 patients had successful endoscopic retreatment. Based on these data, the investigators calculated a 10-year survival rate of 75%.
On the basis of these findings, investigators said endoscopic therapy should be considered the standard of care for patients with mucosal adenocarcinoma of the esophagus.
“That’s the paradigm shift that I was talking about – now, we are sending less than 4% of our patients for surgery for this condition,” Dr. Sharma said at the meeting.
Global Academy and this news organization are owned by the same parent company.
Dr. Sharma reported disclosures related to Medtronics, National Institutes of Health, and US Endoscopy.
LAS VEGAS – While endoscopic therapy of Barrett’s esophagus is often successful, the risk of recurrence after complete ablation remains considerable, according to Prateek Sharma, MD, of the department of medicine in the division of gastroenterology and hepatology at the University of Kansas, Kansas City.
“This is not perfect therapy,” Dr. Sharma said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
The risk of recurrence for intestinal metaplasia was 7.1% per patient-year, authors of that study found. The risk of dysplastic Barrett’s esophagus was 1.3% per patient-year in the meta-analysis, while the risk of high-grade dysplasia or esophageal adenocarcinoma was 0.8%.
Because of these risks, patients should be followed up regularly with careful examination and biopsies to ensure there is no recurrent intestinal metaplasia, dysplasia, or adenocarcinoma, Dr. Sharma told attendees at the meeting.
“If it comes back, you can still treat it endoscopically,” he continued, “but you have to be aware of the situation, and inform the patient that it can be curative, but at the same time it’s not a 100% success story in all situations.”
When patients do develop early cancers or high-grade lesions, the latest evidence suggests endoscopic therapy is effective and helps avoid esophagectomy in the majority of patients.
“It used to be esophagectomy for all,” Dr. Sharma said. “Now the paradigm has switched, and it is endoscopic therapy for all.”
That paradigm shift is supported in part by a German study showing excellent long-term results in 1,000 consecutive patients receiving endoscopic treatment of mucosal adenocarcinoma of the esophagus.
In that study, nearly all of the patients (963, or 96.3%) had a complete response, with 12 patients undergoing surgery because of failure of endoscopic therapy. Fifteen patients (1.5%) had major complications that were nonetheless managed conservatively, according to investigators. Although new lesions or recurrences were seen in 140 patients (14.5%) over 5 years of follow-up, 115 patients had successful endoscopic retreatment. Based on these data, the investigators calculated a 10-year survival rate of 75%.
On the basis of these findings, investigators said endoscopic therapy should be considered the standard of care for patients with mucosal adenocarcinoma of the esophagus.
“That’s the paradigm shift that I was talking about – now, we are sending less than 4% of our patients for surgery for this condition,” Dr. Sharma said at the meeting.
Global Academy and this news organization are owned by the same parent company.
Dr. Sharma reported disclosures related to Medtronics, National Institutes of Health, and US Endoscopy.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
New options emerge for primary biliary cholangitis
LAS VEGAS – Evidence is mounting for several adjuvant treatments that may be appropriate for patients with primary biliary cholangitis who are not responding to first-line ursodeoxycholic acid (UDCA), according to Cynthia Levy, MD.
Given these new potential treatment options, it’s important for clinicians to assess biochemical response to first-line UDCA, said Dr. Levy, assistant director for the Schiff Center for Liver Diseases at the University of Miami.
“Up until recently, we didn’t have anything to offer to nonresponders,” Dr. Levy said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education. “Now we know at 1 year, we need to restratify to evaluate the need for adjuvant therapy.”
Many UDCA-treated patients will not respond to that first-line treatment, putting them at risk for progression to hepatocellular carcinoma and end-stage liver disease, according to Dr. Levy.
Obeticholic acid, a farnesoid X receptor agonist, is now a Food and Drug Administration–approved option for these patients, while fibrates and budesonide have recent data supporting their use and are available off-label, she added.
The conditional FDA approval for obeticholic acid, granted in May 2016, is for treatment as monotherapy in patients who do not tolerate UDCA or in combination with UDCA for patients who had had incomplete responses to that treatment for at least a year. Improvement in survival without liver transplantation has not yet been demonstrated for this agent, though studies are ongoing, Dr. Levy noted.
In the meantime, research is progressing with the peroxisome proliferator-activated receptor alpha (PPAR-alpha) agonists fenofibrate and bezafibrate.
In the BEZURSO study, presented at the 2017 EASL Congress, 100 patients with incomplete response to UDCA were randomized to bezafibrate plus UDCA or placebo plus UDCA for 2 years. The primary endpoint, normalization of liver function tests at 2 years, was achieved in 30% of the bezafibrate group and 0% of the placebo group. In addition, 67% of the bezafibrate-treated patients had alkaline phosphatase normalization, compared with 0% in the placebo group.
Bezafibrate was also associated with significant reductions in fatigue and itching, as well as surrogate liver fibrosis markers, according to investigators. The serious adverse event rate was similar between groups, as was the rate of end-stage liver complications, which was 4% for each arm.
Fenofibrate was studied in a small 20-patient, open-label, phase 2 study by Dr. Levy and her colleagues. “Alkaline phosphatase significantly improved fairly early when the drug was started,” she said. Treatment was for 48 weeks, and once the drug was discontinued, there was a rebound in alkaline phosphatase levels.
Seladelpar is another PPAR agonist far along in the pipeline, according to Dr. Levy. This selective PPAR-delta agonist demonstrated significant improvements in alkaline phosphatase and other measures in a 12-week trial that included 75 patients with primary biliary cholangitis and incomplete response to UDCA.
While fenofibrate and bezafibrate can be used off-label for primary biliary cholangitis, Dr. Levy said, fenofibrate labeling indicates that it is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cholangitis.
According to Dr. Levy, that contraindication is based on experience with clofibrate, a first-generation fibrate that was associated with increased risk of gallstone formation. “If you choose to use fenofibrate, this is off-label use, and you need to warn your patients,” she told attendees at the meeting.
Two other agents under investigation in primary biliary cholangitis that have shown some promising results recently, according to Dr. Levy, include budesonide and an engineered variant of the human hormone FGF19 known as NGM282.
Global Academy and this news organization are owned by the same parent company.
Dr. Levy reported disclosures related to CymaBay Therapeutics, Enanta Pharmaceuticals, Genfit, GenKyoTex, Gilead Sciences, GlaxoSmithKline, Intercept Pharmaceuticals, NGM Biopharmaceuticals, and Novartis.
LAS VEGAS – Evidence is mounting for several adjuvant treatments that may be appropriate for patients with primary biliary cholangitis who are not responding to first-line ursodeoxycholic acid (UDCA), according to Cynthia Levy, MD.
Given these new potential treatment options, it’s important for clinicians to assess biochemical response to first-line UDCA, said Dr. Levy, assistant director for the Schiff Center for Liver Diseases at the University of Miami.
“Up until recently, we didn’t have anything to offer to nonresponders,” Dr. Levy said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education. “Now we know at 1 year, we need to restratify to evaluate the need for adjuvant therapy.”
Many UDCA-treated patients will not respond to that first-line treatment, putting them at risk for progression to hepatocellular carcinoma and end-stage liver disease, according to Dr. Levy.
Obeticholic acid, a farnesoid X receptor agonist, is now a Food and Drug Administration–approved option for these patients, while fibrates and budesonide have recent data supporting their use and are available off-label, she added.
The conditional FDA approval for obeticholic acid, granted in May 2016, is for treatment as monotherapy in patients who do not tolerate UDCA or in combination with UDCA for patients who had had incomplete responses to that treatment for at least a year. Improvement in survival without liver transplantation has not yet been demonstrated for this agent, though studies are ongoing, Dr. Levy noted.
In the meantime, research is progressing with the peroxisome proliferator-activated receptor alpha (PPAR-alpha) agonists fenofibrate and bezafibrate.
In the BEZURSO study, presented at the 2017 EASL Congress, 100 patients with incomplete response to UDCA were randomized to bezafibrate plus UDCA or placebo plus UDCA for 2 years. The primary endpoint, normalization of liver function tests at 2 years, was achieved in 30% of the bezafibrate group and 0% of the placebo group. In addition, 67% of the bezafibrate-treated patients had alkaline phosphatase normalization, compared with 0% in the placebo group.
Bezafibrate was also associated with significant reductions in fatigue and itching, as well as surrogate liver fibrosis markers, according to investigators. The serious adverse event rate was similar between groups, as was the rate of end-stage liver complications, which was 4% for each arm.
Fenofibrate was studied in a small 20-patient, open-label, phase 2 study by Dr. Levy and her colleagues. “Alkaline phosphatase significantly improved fairly early when the drug was started,” she said. Treatment was for 48 weeks, and once the drug was discontinued, there was a rebound in alkaline phosphatase levels.
Seladelpar is another PPAR agonist far along in the pipeline, according to Dr. Levy. This selective PPAR-delta agonist demonstrated significant improvements in alkaline phosphatase and other measures in a 12-week trial that included 75 patients with primary biliary cholangitis and incomplete response to UDCA.
While fenofibrate and bezafibrate can be used off-label for primary biliary cholangitis, Dr. Levy said, fenofibrate labeling indicates that it is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cholangitis.
According to Dr. Levy, that contraindication is based on experience with clofibrate, a first-generation fibrate that was associated with increased risk of gallstone formation. “If you choose to use fenofibrate, this is off-label use, and you need to warn your patients,” she told attendees at the meeting.
Two other agents under investigation in primary biliary cholangitis that have shown some promising results recently, according to Dr. Levy, include budesonide and an engineered variant of the human hormone FGF19 known as NGM282.
Global Academy and this news organization are owned by the same parent company.
Dr. Levy reported disclosures related to CymaBay Therapeutics, Enanta Pharmaceuticals, Genfit, GenKyoTex, Gilead Sciences, GlaxoSmithKline, Intercept Pharmaceuticals, NGM Biopharmaceuticals, and Novartis.
LAS VEGAS – Evidence is mounting for several adjuvant treatments that may be appropriate for patients with primary biliary cholangitis who are not responding to first-line ursodeoxycholic acid (UDCA), according to Cynthia Levy, MD.
Given these new potential treatment options, it’s important for clinicians to assess biochemical response to first-line UDCA, said Dr. Levy, assistant director for the Schiff Center for Liver Diseases at the University of Miami.
“Up until recently, we didn’t have anything to offer to nonresponders,” Dr. Levy said at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education. “Now we know at 1 year, we need to restratify to evaluate the need for adjuvant therapy.”
Many UDCA-treated patients will not respond to that first-line treatment, putting them at risk for progression to hepatocellular carcinoma and end-stage liver disease, according to Dr. Levy.
Obeticholic acid, a farnesoid X receptor agonist, is now a Food and Drug Administration–approved option for these patients, while fibrates and budesonide have recent data supporting their use and are available off-label, she added.
The conditional FDA approval for obeticholic acid, granted in May 2016, is for treatment as monotherapy in patients who do not tolerate UDCA or in combination with UDCA for patients who had had incomplete responses to that treatment for at least a year. Improvement in survival without liver transplantation has not yet been demonstrated for this agent, though studies are ongoing, Dr. Levy noted.
In the meantime, research is progressing with the peroxisome proliferator-activated receptor alpha (PPAR-alpha) agonists fenofibrate and bezafibrate.
In the BEZURSO study, presented at the 2017 EASL Congress, 100 patients with incomplete response to UDCA were randomized to bezafibrate plus UDCA or placebo plus UDCA for 2 years. The primary endpoint, normalization of liver function tests at 2 years, was achieved in 30% of the bezafibrate group and 0% of the placebo group. In addition, 67% of the bezafibrate-treated patients had alkaline phosphatase normalization, compared with 0% in the placebo group.
Bezafibrate was also associated with significant reductions in fatigue and itching, as well as surrogate liver fibrosis markers, according to investigators. The serious adverse event rate was similar between groups, as was the rate of end-stage liver complications, which was 4% for each arm.
Fenofibrate was studied in a small 20-patient, open-label, phase 2 study by Dr. Levy and her colleagues. “Alkaline phosphatase significantly improved fairly early when the drug was started,” she said. Treatment was for 48 weeks, and once the drug was discontinued, there was a rebound in alkaline phosphatase levels.
Seladelpar is another PPAR agonist far along in the pipeline, according to Dr. Levy. This selective PPAR-delta agonist demonstrated significant improvements in alkaline phosphatase and other measures in a 12-week trial that included 75 patients with primary biliary cholangitis and incomplete response to UDCA.
While fenofibrate and bezafibrate can be used off-label for primary biliary cholangitis, Dr. Levy said, fenofibrate labeling indicates that it is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cholangitis.
According to Dr. Levy, that contraindication is based on experience with clofibrate, a first-generation fibrate that was associated with increased risk of gallstone formation. “If you choose to use fenofibrate, this is off-label use, and you need to warn your patients,” she told attendees at the meeting.
Two other agents under investigation in primary biliary cholangitis that have shown some promising results recently, according to Dr. Levy, include budesonide and an engineered variant of the human hormone FGF19 known as NGM282.
Global Academy and this news organization are owned by the same parent company.
Dr. Levy reported disclosures related to CymaBay Therapeutics, Enanta Pharmaceuticals, Genfit, GenKyoTex, Gilead Sciences, GlaxoSmithKline, Intercept Pharmaceuticals, NGM Biopharmaceuticals, and Novartis.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
Use these two questions to simplify H. pylori treatment choice
Recent clinical guidelines have expanded not only the pool of patients who should be tested for Helicobacter pylori infection, but also the number of first-line treatment strategies clinicians should consider.
The American College of Gastroenterology guidelines from 2007 recommended just two treatments: clarithromycin-based triple therapy or bismuth-based quadruple therapy.
The 2017 update to ACG guidelines adds five additional recommended treatment possibilities, not all of which have been well studied in U.S. clinical practice, Colin W. Howden, MD, AGAF, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are a variety of options, and unfortunately for us as practitioners, antibiotic sensitivity testing is not routinely or easily available in contemporary U.S. practice,” said Dr. Howden, professor of medicine–gastroenterology at the University of Tennessee Health Sciences Center, Memphis.
Dr. Howden, a coauthor of the latest ACG guidelines, said asking two pointed questions outlined in the document can help simplify the treatment decision:
- Is there a penicillin allergy?
- Has there been previous macrolide exposure?
“The ideal situation is that the patient is not penicillin allergic, and they’ve never had a macrolide before,” Dr. Howden said. In that case, bismuth-based quadruple therapy would be an appropriate choice.
“Bismuth quadruple therapy is never the wrong answer,” he added.
Clarithromycin-based triple therapy might be considered, according to Dr. Howden, if the local rate of resistance to H. pylori is known to be low.
Bismuth-based quadruple therapy consists of a proton pump inhibitor (PPI) or H2 blocker, bismuth, tetracycline, and metronidazole for 10-14 days, while clarithromycin triple therapy consists of a PPI, clarithromycin, and amoxicillin or metronidazole for 10-14 days.
Several other options recently added to the guidelines have been tried in this scenario, he noted, including concomitant therapy, which consists of a PPI, clarithromycin, amoxicillin, and metronidazole for 10-14 days.
If there has been previous macrolide use but the patient is not penicillin allergic, bismuth quadruple therapy is again recommended, Dr. Howden said, and an additional approach might be the introduction of a levofloxacin-based regimen, as outlined in the guidelines.
Conversely, if there has been no previous macrolide use but the patient is confirmed to be penicillin allergic, the current guideline-recommended options are limited to bismuth quadruple therapy, or clarithromycin triple therapy with metronidazole instead of amoxicillin, Dr. Howden said at the meeting.
Finally, for penicillin-allergic patients with previous macrolide use, recommended options are whittled down to just bismuth-based quadruple therapy. “Again, it’s never the wrong answer,” Dr. Howden said.
Global Academy and this news organization are owned by the same parent company.
Dr. Howden reported disclosures related to Horizon, Otsuka, Allergan, Aralaez, EndoStim, Ironwood, Pfizer, and SynteractHCR.
Recent clinical guidelines have expanded not only the pool of patients who should be tested for Helicobacter pylori infection, but also the number of first-line treatment strategies clinicians should consider.
The American College of Gastroenterology guidelines from 2007 recommended just two treatments: clarithromycin-based triple therapy or bismuth-based quadruple therapy.
The 2017 update to ACG guidelines adds five additional recommended treatment possibilities, not all of which have been well studied in U.S. clinical practice, Colin W. Howden, MD, AGAF, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are a variety of options, and unfortunately for us as practitioners, antibiotic sensitivity testing is not routinely or easily available in contemporary U.S. practice,” said Dr. Howden, professor of medicine–gastroenterology at the University of Tennessee Health Sciences Center, Memphis.
Dr. Howden, a coauthor of the latest ACG guidelines, said asking two pointed questions outlined in the document can help simplify the treatment decision:
- Is there a penicillin allergy?
- Has there been previous macrolide exposure?
“The ideal situation is that the patient is not penicillin allergic, and they’ve never had a macrolide before,” Dr. Howden said. In that case, bismuth-based quadruple therapy would be an appropriate choice.
“Bismuth quadruple therapy is never the wrong answer,” he added.
Clarithromycin-based triple therapy might be considered, according to Dr. Howden, if the local rate of resistance to H. pylori is known to be low.
Bismuth-based quadruple therapy consists of a proton pump inhibitor (PPI) or H2 blocker, bismuth, tetracycline, and metronidazole for 10-14 days, while clarithromycin triple therapy consists of a PPI, clarithromycin, and amoxicillin or metronidazole for 10-14 days.
Several other options recently added to the guidelines have been tried in this scenario, he noted, including concomitant therapy, which consists of a PPI, clarithromycin, amoxicillin, and metronidazole for 10-14 days.
If there has been previous macrolide use but the patient is not penicillin allergic, bismuth quadruple therapy is again recommended, Dr. Howden said, and an additional approach might be the introduction of a levofloxacin-based regimen, as outlined in the guidelines.
Conversely, if there has been no previous macrolide use but the patient is confirmed to be penicillin allergic, the current guideline-recommended options are limited to bismuth quadruple therapy, or clarithromycin triple therapy with metronidazole instead of amoxicillin, Dr. Howden said at the meeting.
Finally, for penicillin-allergic patients with previous macrolide use, recommended options are whittled down to just bismuth-based quadruple therapy. “Again, it’s never the wrong answer,” Dr. Howden said.
Global Academy and this news organization are owned by the same parent company.
Dr. Howden reported disclosures related to Horizon, Otsuka, Allergan, Aralaez, EndoStim, Ironwood, Pfizer, and SynteractHCR.
Recent clinical guidelines have expanded not only the pool of patients who should be tested for Helicobacter pylori infection, but also the number of first-line treatment strategies clinicians should consider.
The American College of Gastroenterology guidelines from 2007 recommended just two treatments: clarithromycin-based triple therapy or bismuth-based quadruple therapy.
The 2017 update to ACG guidelines adds five additional recommended treatment possibilities, not all of which have been well studied in U.S. clinical practice, Colin W. Howden, MD, AGAF, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are a variety of options, and unfortunately for us as practitioners, antibiotic sensitivity testing is not routinely or easily available in contemporary U.S. practice,” said Dr. Howden, professor of medicine–gastroenterology at the University of Tennessee Health Sciences Center, Memphis.
Dr. Howden, a coauthor of the latest ACG guidelines, said asking two pointed questions outlined in the document can help simplify the treatment decision:
- Is there a penicillin allergy?
- Has there been previous macrolide exposure?
“The ideal situation is that the patient is not penicillin allergic, and they’ve never had a macrolide before,” Dr. Howden said. In that case, bismuth-based quadruple therapy would be an appropriate choice.
“Bismuth quadruple therapy is never the wrong answer,” he added.
Clarithromycin-based triple therapy might be considered, according to Dr. Howden, if the local rate of resistance to H. pylori is known to be low.
Bismuth-based quadruple therapy consists of a proton pump inhibitor (PPI) or H2 blocker, bismuth, tetracycline, and metronidazole for 10-14 days, while clarithromycin triple therapy consists of a PPI, clarithromycin, and amoxicillin or metronidazole for 10-14 days.
Several other options recently added to the guidelines have been tried in this scenario, he noted, including concomitant therapy, which consists of a PPI, clarithromycin, amoxicillin, and metronidazole for 10-14 days.
If there has been previous macrolide use but the patient is not penicillin allergic, bismuth quadruple therapy is again recommended, Dr. Howden said, and an additional approach might be the introduction of a levofloxacin-based regimen, as outlined in the guidelines.
Conversely, if there has been no previous macrolide use but the patient is confirmed to be penicillin allergic, the current guideline-recommended options are limited to bismuth quadruple therapy, or clarithromycin triple therapy with metronidazole instead of amoxicillin, Dr. Howden said at the meeting.
Finally, for penicillin-allergic patients with previous macrolide use, recommended options are whittled down to just bismuth-based quadruple therapy. “Again, it’s never the wrong answer,” Dr. Howden said.
Global Academy and this news organization are owned by the same parent company.
Dr. Howden reported disclosures related to Horizon, Otsuka, Allergan, Aralaez, EndoStim, Ironwood, Pfizer, and SynteractHCR.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
Hep B therapy: Indefinite or FINITE for e-negative patients?
LAS VEGAS – Current guidelines recommend indefinite continuation of antiviral therapy in chronic hepatitis B patients who are hepatitis B e-antigen (HBeAg)-negative. But emerging data suggest that this may not always be the case.
“It’s very provocative data, though not at the guideline level,” W. Ray Kim, MD, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are patients who really have begged to go off treatment because they are sick of taking the medication for year after year after year,” said Dr. Kim, professor of medicine, gastroenterology and hepatology, Stanford (Calif.) University.
In light of new data, taking them off medication might be “something to consider” in noncirrhotic patients if they are completely suppressed, have normal ALT, and have a low level of quantitative hepatitis B surface antigen (HBsAg), Dr. Kim told attendees.
The most current Association for the Advancement of the Study of Liver Diseases guidelines state that unless there is a competing rationale, antiviral therapy should be continued indefinitely for noncirrhotic adults with HBeAg‐negative immune‐active chronic hepatitis B.
They do also say that treatment discontinuation “may be considered” for individuals with proven loss of HBsAg. “However, there is currently insufficient evidence to definitively guide treatment decisions for such persons,” the guidelines say.
Evidence has emerged since those guideline statements were written. Most recently, German investigators published results of the FINITE study showing some long-term responses after stopping tenofovir disoproxil fumarate (TDF) in noncirrhotic, HBeAg-negative patients.
In that prospective, controlled study, 62% of patients who stopped TDF therapy (n = 13) stayed off therapy to week 144 of treatment follow-up. Four of the patients achieved HBsAg loss, and median HBsAg change was –0.59log10IU/mL vs. 0.21log10IU/mL in patients who stayed on TDF therapy.
Investigators said that result demonstrated the potential of stopping long-term TDF treatment and seeing either HBsAg loss or sustained virologic response.
Before that, a retrospective study from investigators in Taiwan showed that age plus level of HBsAg were associated with HBV relapse after entecavir treatment in HBeAg-negative patients. According to investigators, those results suggested HBsAg levels could be used to guide timing of entecavir cessation.
If antiviral therapy is stopped in an HBeAg-negative patient, that patient should be monitored every 3 month for a year for recurrent viremia, ALT flares, and hepatic decompensation, Dr. Kim said at the meeting.
Even before stopping, “there are a number of factors to consider, including biological relapse, flare, hepatic decompensation,” he said.
On the other hand, there is the burden of continued therapy, financial concerns of continuing treatment due not only to medication costs but also long-term monitoring, as well as patient and provider preference, he noted in his presentation.
Global Academy and this news organization are owned by the same parent company.
Dr. Kim reported serving as a consultant to Gilead.
LAS VEGAS – Current guidelines recommend indefinite continuation of antiviral therapy in chronic hepatitis B patients who are hepatitis B e-antigen (HBeAg)-negative. But emerging data suggest that this may not always be the case.
“It’s very provocative data, though not at the guideline level,” W. Ray Kim, MD, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are patients who really have begged to go off treatment because they are sick of taking the medication for year after year after year,” said Dr. Kim, professor of medicine, gastroenterology and hepatology, Stanford (Calif.) University.
In light of new data, taking them off medication might be “something to consider” in noncirrhotic patients if they are completely suppressed, have normal ALT, and have a low level of quantitative hepatitis B surface antigen (HBsAg), Dr. Kim told attendees.
The most current Association for the Advancement of the Study of Liver Diseases guidelines state that unless there is a competing rationale, antiviral therapy should be continued indefinitely for noncirrhotic adults with HBeAg‐negative immune‐active chronic hepatitis B.
They do also say that treatment discontinuation “may be considered” for individuals with proven loss of HBsAg. “However, there is currently insufficient evidence to definitively guide treatment decisions for such persons,” the guidelines say.
Evidence has emerged since those guideline statements were written. Most recently, German investigators published results of the FINITE study showing some long-term responses after stopping tenofovir disoproxil fumarate (TDF) in noncirrhotic, HBeAg-negative patients.
In that prospective, controlled study, 62% of patients who stopped TDF therapy (n = 13) stayed off therapy to week 144 of treatment follow-up. Four of the patients achieved HBsAg loss, and median HBsAg change was –0.59log10IU/mL vs. 0.21log10IU/mL in patients who stayed on TDF therapy.
Investigators said that result demonstrated the potential of stopping long-term TDF treatment and seeing either HBsAg loss or sustained virologic response.
Before that, a retrospective study from investigators in Taiwan showed that age plus level of HBsAg were associated with HBV relapse after entecavir treatment in HBeAg-negative patients. According to investigators, those results suggested HBsAg levels could be used to guide timing of entecavir cessation.
If antiviral therapy is stopped in an HBeAg-negative patient, that patient should be monitored every 3 month for a year for recurrent viremia, ALT flares, and hepatic decompensation, Dr. Kim said at the meeting.
Even before stopping, “there are a number of factors to consider, including biological relapse, flare, hepatic decompensation,” he said.
On the other hand, there is the burden of continued therapy, financial concerns of continuing treatment due not only to medication costs but also long-term monitoring, as well as patient and provider preference, he noted in his presentation.
Global Academy and this news organization are owned by the same parent company.
Dr. Kim reported serving as a consultant to Gilead.
LAS VEGAS – Current guidelines recommend indefinite continuation of antiviral therapy in chronic hepatitis B patients who are hepatitis B e-antigen (HBeAg)-negative. But emerging data suggest that this may not always be the case.
“It’s very provocative data, though not at the guideline level,” W. Ray Kim, MD, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are patients who really have begged to go off treatment because they are sick of taking the medication for year after year after year,” said Dr. Kim, professor of medicine, gastroenterology and hepatology, Stanford (Calif.) University.
In light of new data, taking them off medication might be “something to consider” in noncirrhotic patients if they are completely suppressed, have normal ALT, and have a low level of quantitative hepatitis B surface antigen (HBsAg), Dr. Kim told attendees.
The most current Association for the Advancement of the Study of Liver Diseases guidelines state that unless there is a competing rationale, antiviral therapy should be continued indefinitely for noncirrhotic adults with HBeAg‐negative immune‐active chronic hepatitis B.
They do also say that treatment discontinuation “may be considered” for individuals with proven loss of HBsAg. “However, there is currently insufficient evidence to definitively guide treatment decisions for such persons,” the guidelines say.
Evidence has emerged since those guideline statements were written. Most recently, German investigators published results of the FINITE study showing some long-term responses after stopping tenofovir disoproxil fumarate (TDF) in noncirrhotic, HBeAg-negative patients.
In that prospective, controlled study, 62% of patients who stopped TDF therapy (n = 13) stayed off therapy to week 144 of treatment follow-up. Four of the patients achieved HBsAg loss, and median HBsAg change was –0.59log10IU/mL vs. 0.21log10IU/mL in patients who stayed on TDF therapy.
Investigators said that result demonstrated the potential of stopping long-term TDF treatment and seeing either HBsAg loss or sustained virologic response.
Before that, a retrospective study from investigators in Taiwan showed that age plus level of HBsAg were associated with HBV relapse after entecavir treatment in HBeAg-negative patients. According to investigators, those results suggested HBsAg levels could be used to guide timing of entecavir cessation.
If antiviral therapy is stopped in an HBeAg-negative patient, that patient should be monitored every 3 month for a year for recurrent viremia, ALT flares, and hepatic decompensation, Dr. Kim said at the meeting.
Even before stopping, “there are a number of factors to consider, including biological relapse, flare, hepatic decompensation,” he said.
On the other hand, there is the burden of continued therapy, financial concerns of continuing treatment due not only to medication costs but also long-term monitoring, as well as patient and provider preference, he noted in his presentation.
Global Academy and this news organization are owned by the same parent company.
Dr. Kim reported serving as a consultant to Gilead.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES