From the Journals

The United States multi-society task force on colorectal cancer (CRC) has updated its 2014 guidance for optimizing the adequacy of bowel preparation for colonoscopy.

The latest consensus recommendations emphasize the importance of verbal and written patient education, refine diet restrictions, update optimal purgative regimens, and advise tracking bowel prep adequacy rates at both the individual endoscopist and unit levels.

“Colorectal cancer remains the second most common cause of cancer death in the United States, and colonoscopy is considered the gold standard for evaluating the colon, including assessing causes of colon-related signs or symptoms and the detection of precancerous lesions. It is well recognized that the adequacy of bowel preparation is essential for optimal colonoscopy performance,” the task force wrote.

 

Choice of Prep, Dosing and Timing, and Dietary Restrictions 

When choosing bowel preparation regimens, the task force recommends considering the individual’s medical history, medications, and, when available, the adequacy of bowel preparation reported from prior colonoscopies. Other considerations include patient preference, associated additional costs to the patient, and ease in obtaining and consuming any purgatives or adjuncts.

In terms of timing and dose, the task force now “suggests that lower-volume bowel preparation regimens, such as those that rely on only 2 liters of fluid compared to the traditional 4L, are acceptable options for individuals considered unlikely to have an inadequate bowel preparation. This assumes that the purgative is taken in a split-dose fashion (half the evening prior to colonoscopy and half the morning of the colonoscopy),” co–lead author Brian C. Jacobson, MD, MPH, AGAF, with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.

The task force also states that a same-day bowel preparation regimen for afternoon, but not morning, colonoscopy is a “reasonable alternative to the now-common split-dose regimen,” Jacobson said.

The group did not find one bowel preparation purgative to be better than others, although table 7 in the document details characteristics of commonly used prep regimens including their side effects and contraindications.

Recommendations regarding dietary modifications depend upon the patient’s risk for inadequate bowel prep. For patients at low risk for inadequate bowel prep, the task force recommends limiting dietary restrictions to the day before a colonoscopy, relying on either clear liquids or low-fiber/low-residue diets for the early and midday meals. Table 5 in the document provides a list of low-residue foods and sample meals.

The task force also suggests the adjunctive use of oral simethicone (≥ 320 mg) to bowel prep as a way to potentially improve visualization, although they acknowledge that further research is needed.

How might these updated consensus recommendations change current clinical practice? 

Jacobson said: “Some physicians may try to identify individuals who will do just as well with a more patient-friendly, easily tolerated bowel preparation regimen, including less stringent dietary restrictions leading up to colonoscopy.” 

He noted that the task force prefers the term “guidance” to “guidelines.”

 

New Quality Benchmark 

The task force recommends documenting bowel prep quality in the endoscopy report after all washing and suctioning have been completed using reliably understood descriptors that communicate the adequacy of the preparation.

They recommend the term “adequate bowel preparation” be used to indicate that standard screening or surveillance intervals can be assigned based on the findings of the colonoscopy.

Additionally, the task force recommends that endoscopy units and individual endoscopists track and aim for ≥ 90% adequacy rates in bowel preparation — up from the 85% benchmark contained in the prior recommendations.

Jacobson told this news organization it’s “currently unknown” how many individual endoscopists and endoscopy units track and meet the 90% benchmark at present.

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who wasn’t on the task force, said endoscopy units and providers “need to be accountable and should be tracking this quality metric.”

Johnson noted that bowel prep inadequacy has “intrinsic costs,” impacting lesion detection, CRC incidence, and patient outcomes. Inadequate prep leads to “increased risk for morbidity, mortality, longer appointment and wait times for rescheduling, and negative connotations that may deter patients from returning.”

 

Brian Sullivan, MD, MHS, assistant professor of medicine, division of gastroenterology, Duke University School of Medicine, Durham, North Carolina, who wasn’t on the task force, said the recommendation to target a 90% or higher bowel preparation adequacy rate is “appreciated.”

“This benchmark encourages practices to standardize measurement, tracking, and reporting of preparation quality at both the individual and unit levels. Specifically, it should motivate providers to critically evaluate their interpretation of preparation quality and ensure adequate cleansing before making determinations,” Sullivan said in an interview.

“At the unit level, this metric can identify whether there are opportunities for quality improvement, such as by implementing evidence-based initiatives (provided in the guidance) to enhance outpatient preparation processes,” Sullivan noted.

The task force emphasized that the majority of consensus recommendations focus on individuals at average risk for inadequate bowel prep. Patients at high risk for inadequate bowel prep (eg, diabetes, constipation, opioid use) should receive tailored instructions, including a more extended dietary prep and high-volume purgatives.

 

‘Timely and Important’ Updates

Sullivan said the updated consensus recommendations on optimizing bowel preparation quality for colonoscopy are both “timely and important.” 

“Clear guidance facilitates dissemination and adoption, promoting flexible yet evidence-based approaches that enhance patient and provider satisfaction while potentially improving CRC prevention outcomes. For instance, surveys reveal that some practices still do not utilize split-dose bowel preparation, which is proven to improve preparation quality, particularly for the right-side of the colon. This gap underscores the need for standardized guidance to ensure high-quality colonoscopy and effective CRC screening,” Sullivan said.

He also noted that the inclusion of lower-volume bowel prep regimens and less intensive dietary modifications for selected patients is a “welcome update.”

“These options can improve patient adherence and satisfaction, which are critical not only for the quality of the index exam but also for ensuring patients return for future screenings, thereby supporting long-term CRC prevention efforts,” Sullivan said.

The task force includes representatives from the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy.

The consensus document was published online in the three societies’ respective scientific journals — Gastroenterology, the American Journal of Gastroenterology, and Gastrointestinal Endsocopy.

This research had no financial support. Jacobson is a consultant for Curis and Guardant Health. Sullivan had no disclosures. Johnson is an adviser to ISOThrive and a past president of the American College of Gastroenterology.

A version of this article first appeared on Medscape.com.

The United States multi-society task force on colorectal cancer (CRC) has updated its 2014 guidance for optimizing the adequacy of bowel preparation for colonoscopy.

The latest consensus recommendations emphasize the importance of verbal and written patient education, refine diet restrictions, update optimal purgative regimens, and advise tracking bowel prep adequacy rates at both the individual endoscopist and unit levels.

“Colorectal cancer remains the second most common cause of cancer death in the United States, and colonoscopy is considered the gold standard for evaluating the colon, including assessing causes of colon-related signs or symptoms and the detection of precancerous lesions. It is well recognized that the adequacy of bowel preparation is essential for optimal colonoscopy performance,” the task force wrote.

 

Choice of Prep, Dosing and Timing, and Dietary Restrictions 

When choosing bowel preparation regimens, the task force recommends considering the individual’s medical history, medications, and, when available, the adequacy of bowel preparation reported from prior colonoscopies. Other considerations include patient preference, associated additional costs to the patient, and ease in obtaining and consuming any purgatives or adjuncts.

In terms of timing and dose, the task force now “suggests that lower-volume bowel preparation regimens, such as those that rely on only 2 liters of fluid compared to the traditional 4L, are acceptable options for individuals considered unlikely to have an inadequate bowel preparation. This assumes that the purgative is taken in a split-dose fashion (half the evening prior to colonoscopy and half the morning of the colonoscopy),” co–lead author Brian C. Jacobson, MD, MPH, AGAF, with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.

The task force also states that a same-day bowel preparation regimen for afternoon, but not morning, colonoscopy is a “reasonable alternative to the now-common split-dose regimen,” Jacobson said.

The group did not find one bowel preparation purgative to be better than others, although table 7 in the document details characteristics of commonly used prep regimens including their side effects and contraindications.

Recommendations regarding dietary modifications depend upon the patient’s risk for inadequate bowel prep. For patients at low risk for inadequate bowel prep, the task force recommends limiting dietary restrictions to the day before a colonoscopy, relying on either clear liquids or low-fiber/low-residue diets for the early and midday meals. Table 5 in the document provides a list of low-residue foods and sample meals.

The task force also suggests the adjunctive use of oral simethicone (≥ 320 mg) to bowel prep as a way to potentially improve visualization, although they acknowledge that further research is needed.

How might these updated consensus recommendations change current clinical practice? 

Jacobson said: “Some physicians may try to identify individuals who will do just as well with a more patient-friendly, easily tolerated bowel preparation regimen, including less stringent dietary restrictions leading up to colonoscopy.” 

He noted that the task force prefers the term “guidance” to “guidelines.”

 

New Quality Benchmark 

The task force recommends documenting bowel prep quality in the endoscopy report after all washing and suctioning have been completed using reliably understood descriptors that communicate the adequacy of the preparation.

They recommend the term “adequate bowel preparation” be used to indicate that standard screening or surveillance intervals can be assigned based on the findings of the colonoscopy.

Additionally, the task force recommends that endoscopy units and individual endoscopists track and aim for ≥ 90% adequacy rates in bowel preparation — up from the 85% benchmark contained in the prior recommendations.

Jacobson told this news organization it’s “currently unknown” how many individual endoscopists and endoscopy units track and meet the 90% benchmark at present.

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who wasn’t on the task force, said endoscopy units and providers “need to be accountable and should be tracking this quality metric.”

Johnson noted that bowel prep inadequacy has “intrinsic costs,” impacting lesion detection, CRC incidence, and patient outcomes. Inadequate prep leads to “increased risk for morbidity, mortality, longer appointment and wait times for rescheduling, and negative connotations that may deter patients from returning.”

 

Brian Sullivan, MD, MHS, assistant professor of medicine, division of gastroenterology, Duke University School of Medicine, Durham, North Carolina, who wasn’t on the task force, said the recommendation to target a 90% or higher bowel preparation adequacy rate is “appreciated.”

“This benchmark encourages practices to standardize measurement, tracking, and reporting of preparation quality at both the individual and unit levels. Specifically, it should motivate providers to critically evaluate their interpretation of preparation quality and ensure adequate cleansing before making determinations,” Sullivan said in an interview.

“At the unit level, this metric can identify whether there are opportunities for quality improvement, such as by implementing evidence-based initiatives (provided in the guidance) to enhance outpatient preparation processes,” Sullivan noted.

The task force emphasized that the majority of consensus recommendations focus on individuals at average risk for inadequate bowel prep. Patients at high risk for inadequate bowel prep (eg, diabetes, constipation, opioid use) should receive tailored instructions, including a more extended dietary prep and high-volume purgatives.

 

‘Timely and Important’ Updates

Sullivan said the updated consensus recommendations on optimizing bowel preparation quality for colonoscopy are both “timely and important.” 

“Clear guidance facilitates dissemination and adoption, promoting flexible yet evidence-based approaches that enhance patient and provider satisfaction while potentially improving CRC prevention outcomes. For instance, surveys reveal that some practices still do not utilize split-dose bowel preparation, which is proven to improve preparation quality, particularly for the right-side of the colon. This gap underscores the need for standardized guidance to ensure high-quality colonoscopy and effective CRC screening,” Sullivan said.

He also noted that the inclusion of lower-volume bowel prep regimens and less intensive dietary modifications for selected patients is a “welcome update.”

“These options can improve patient adherence and satisfaction, which are critical not only for the quality of the index exam but also for ensuring patients return for future screenings, thereby supporting long-term CRC prevention efforts,” Sullivan said.

The task force includes representatives from the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy.

The consensus document was published online in the three societies’ respective scientific journals — Gastroenterology, the American Journal of Gastroenterology, and Gastrointestinal Endsocopy.

This research had no financial support. Jacobson is a consultant for Curis and Guardant Health. Sullivan had no disclosures. Johnson is an adviser to ISOThrive and a past president of the American College of Gastroenterology.

A version of this article first appeared on Medscape.com.

The United States multi-society task force on colorectal cancer (CRC) has updated its 2014 guidance for optimizing the adequacy of bowel preparation for colonoscopy.

The latest consensus recommendations emphasize the importance of verbal and written patient education, refine diet restrictions, update optimal purgative regimens, and advise tracking bowel prep adequacy rates at both the individual endoscopist and unit levels.

“Colorectal cancer remains the second most common cause of cancer death in the United States, and colonoscopy is considered the gold standard for evaluating the colon, including assessing causes of colon-related signs or symptoms and the detection of precancerous lesions. It is well recognized that the adequacy of bowel preparation is essential for optimal colonoscopy performance,” the task force wrote.

 

Choice of Prep, Dosing and Timing, and Dietary Restrictions 

When choosing bowel preparation regimens, the task force recommends considering the individual’s medical history, medications, and, when available, the adequacy of bowel preparation reported from prior colonoscopies. Other considerations include patient preference, associated additional costs to the patient, and ease in obtaining and consuming any purgatives or adjuncts.

In terms of timing and dose, the task force now “suggests that lower-volume bowel preparation regimens, such as those that rely on only 2 liters of fluid compared to the traditional 4L, are acceptable options for individuals considered unlikely to have an inadequate bowel preparation. This assumes that the purgative is taken in a split-dose fashion (half the evening prior to colonoscopy and half the morning of the colonoscopy),” co–lead author Brian C. Jacobson, MD, MPH, AGAF, with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.

The task force also states that a same-day bowel preparation regimen for afternoon, but not morning, colonoscopy is a “reasonable alternative to the now-common split-dose regimen,” Jacobson said.

The group did not find one bowel preparation purgative to be better than others, although table 7 in the document details characteristics of commonly used prep regimens including their side effects and contraindications.

Recommendations regarding dietary modifications depend upon the patient’s risk for inadequate bowel prep. For patients at low risk for inadequate bowel prep, the task force recommends limiting dietary restrictions to the day before a colonoscopy, relying on either clear liquids or low-fiber/low-residue diets for the early and midday meals. Table 5 in the document provides a list of low-residue foods and sample meals.

The task force also suggests the adjunctive use of oral simethicone (≥ 320 mg) to bowel prep as a way to potentially improve visualization, although they acknowledge that further research is needed.

How might these updated consensus recommendations change current clinical practice? 

Jacobson said: “Some physicians may try to identify individuals who will do just as well with a more patient-friendly, easily tolerated bowel preparation regimen, including less stringent dietary restrictions leading up to colonoscopy.” 

He noted that the task force prefers the term “guidance” to “guidelines.”

 

New Quality Benchmark 

The task force recommends documenting bowel prep quality in the endoscopy report after all washing and suctioning have been completed using reliably understood descriptors that communicate the adequacy of the preparation.

They recommend the term “adequate bowel preparation” be used to indicate that standard screening or surveillance intervals can be assigned based on the findings of the colonoscopy.

Additionally, the task force recommends that endoscopy units and individual endoscopists track and aim for ≥ 90% adequacy rates in bowel preparation — up from the 85% benchmark contained in the prior recommendations.

Jacobson told this news organization it’s “currently unknown” how many individual endoscopists and endoscopy units track and meet the 90% benchmark at present.

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who wasn’t on the task force, said endoscopy units and providers “need to be accountable and should be tracking this quality metric.”

Johnson noted that bowel prep inadequacy has “intrinsic costs,” impacting lesion detection, CRC incidence, and patient outcomes. Inadequate prep leads to “increased risk for morbidity, mortality, longer appointment and wait times for rescheduling, and negative connotations that may deter patients from returning.”

 

Brian Sullivan, MD, MHS, assistant professor of medicine, division of gastroenterology, Duke University School of Medicine, Durham, North Carolina, who wasn’t on the task force, said the recommendation to target a 90% or higher bowel preparation adequacy rate is “appreciated.”

“This benchmark encourages practices to standardize measurement, tracking, and reporting of preparation quality at both the individual and unit levels. Specifically, it should motivate providers to critically evaluate their interpretation of preparation quality and ensure adequate cleansing before making determinations,” Sullivan said in an interview.

“At the unit level, this metric can identify whether there are opportunities for quality improvement, such as by implementing evidence-based initiatives (provided in the guidance) to enhance outpatient preparation processes,” Sullivan noted.

The task force emphasized that the majority of consensus recommendations focus on individuals at average risk for inadequate bowel prep. Patients at high risk for inadequate bowel prep (eg, diabetes, constipation, opioid use) should receive tailored instructions, including a more extended dietary prep and high-volume purgatives.

 

‘Timely and Important’ Updates

Sullivan said the updated consensus recommendations on optimizing bowel preparation quality for colonoscopy are both “timely and important.” 

“Clear guidance facilitates dissemination and adoption, promoting flexible yet evidence-based approaches that enhance patient and provider satisfaction while potentially improving CRC prevention outcomes. For instance, surveys reveal that some practices still do not utilize split-dose bowel preparation, which is proven to improve preparation quality, particularly for the right-side of the colon. This gap underscores the need for standardized guidance to ensure high-quality colonoscopy and effective CRC screening,” Sullivan said.

He also noted that the inclusion of lower-volume bowel prep regimens and less intensive dietary modifications for selected patients is a “welcome update.”

“These options can improve patient adherence and satisfaction, which are critical not only for the quality of the index exam but also for ensuring patients return for future screenings, thereby supporting long-term CRC prevention efforts,” Sullivan said.

The task force includes representatives from the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy.

The consensus document was published online in the three societies’ respective scientific journals — Gastroenterology, the American Journal of Gastroenterology, and Gastrointestinal Endsocopy.

This research had no financial support. Jacobson is a consultant for Curis and Guardant Health. Sullivan had no disclosures. Johnson is an adviser to ISOThrive and a past president of the American College of Gastroenterology.

A version of this article first appeared on Medscape.com.

Despite universal hepatitis C virus (HCV) screening recommendations issued in 2020, HCV screening rates remain suboptimal among US women, a new analysis showed. 

“We found that screening rates were higher and rose more steeply in pregnant individuals compared to nonpregnant reproductive age females after this guidance.” However overall, HCV screening in women still remained low by the end of 2022, authors Roshni Singh, MD, and Rachel Epstein, MD, MSc, with the section of infectious diseases, Boston Medical Center, noted in an email to this news organization.

The study was published online in JAMA.

The researchers leveraged TriNetX LIVE electronic health record data to compare HCV screening rates from 68 US healthcare organizations covering more than 115 million patients.

Using a multiple-group interrupted time series analysis, they compared HCV screening rates for pregnant and nonpregnant women for each 6-month period before (January 2014 to December 2019) and after (July 2020 to December 2022) the 2020 guidelines. January to June 2020 was considered a washout period to account for the COVID-19 pandemic peak and guideline dissemination.

For the entire 9-year study period (2014-2022), a total of 79,231 incident HCV tests occurred among pregnant women and 678,951 occurred among nonpregnant women. 

In the 6 months before the guidance, HCV screening per 1000 person-years increased from 52 to 117 tests among pregnant women and 16 to 24 tests among nonpregnant women.

In the 6 months after the guidance, screening per 1000 person-years increased from 141 to 253 among pregnant women and from 29 to 37 among nonpregnant women.

Yet by the end of 2022, only 38.7% of women with a pregnancy and 8.7% of nonpregnant women were ever tested for the HCV.

 

How to Boost HCV Screening

These results suggest that “innovative strategies are needed to improve HCV diagnosis and treatment,” the authors wrote. 

“Several interventions have been demonstrated to be effective in increasing screening in general, including electronic medical record alerts for opt-out testing, routine test offer by nonclinician office staff, offering testing in nontraditional spaces, including substance use treatment programs, harm reduction centers, STI clinics, and mobile health units,” Singh and Epstein told this news organization.

“A key step is educating primary care providers in addition to addiction medicine and emergency medicine clinicians about the updated guidelines as they interface with a large number of at-risk individuals,” they said. And the most important measure is creating clear work flows that respond to positive results to link people to treatment and cure. 

“Clinicians need to feel empowered that their work screening a patient can make a meaningful difference in both the patient’s life and in helping end this epidemic,” the two researchers explained. 

Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America, who wasn’t involved in the study, told this news organization that the low HCV screening rates are not surprising. 

“We tend not to do well with screening. It’s not necessarily anybody’s fault, but patients don’t necessarily want to be screened. Sometimes physicians are very busy. Sometimes screening is not the most important thing for them to do. Sometimes there are processes in place that fall through,” said Glatt, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau, Oceanside, New York. 

“We tend to do a better job of screening in pregnant than nonpregnant women because pregnancy is a focus and there is 9 months that you can be following-up, so there is more opportunity. A healthy nonpregnant woman may not see her doctor for another year,” Glatt noted. 

“I think that many physicians are very good at screening for hepatitis C in patients that are clearly at risk,” he added. “We’re not so good at screening for people” that don’t have a clear risk but do “have risk factors.”

The study had no commercial funding. Singh, Epstein, and Glatt had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Despite universal hepatitis C virus (HCV) screening recommendations issued in 2020, HCV screening rates remain suboptimal among US women, a new analysis showed. 

“We found that screening rates were higher and rose more steeply in pregnant individuals compared to nonpregnant reproductive age females after this guidance.” However overall, HCV screening in women still remained low by the end of 2022, authors Roshni Singh, MD, and Rachel Epstein, MD, MSc, with the section of infectious diseases, Boston Medical Center, noted in an email to this news organization.

The study was published online in JAMA.

The researchers leveraged TriNetX LIVE electronic health record data to compare HCV screening rates from 68 US healthcare organizations covering more than 115 million patients.

Using a multiple-group interrupted time series analysis, they compared HCV screening rates for pregnant and nonpregnant women for each 6-month period before (January 2014 to December 2019) and after (July 2020 to December 2022) the 2020 guidelines. January to June 2020 was considered a washout period to account for the COVID-19 pandemic peak and guideline dissemination.

For the entire 9-year study period (2014-2022), a total of 79,231 incident HCV tests occurred among pregnant women and 678,951 occurred among nonpregnant women. 

In the 6 months before the guidance, HCV screening per 1000 person-years increased from 52 to 117 tests among pregnant women and 16 to 24 tests among nonpregnant women.

In the 6 months after the guidance, screening per 1000 person-years increased from 141 to 253 among pregnant women and from 29 to 37 among nonpregnant women.

Yet by the end of 2022, only 38.7% of women with a pregnancy and 8.7% of nonpregnant women were ever tested for the HCV.

 

How to Boost HCV Screening

These results suggest that “innovative strategies are needed to improve HCV diagnosis and treatment,” the authors wrote. 

“Several interventions have been demonstrated to be effective in increasing screening in general, including electronic medical record alerts for opt-out testing, routine test offer by nonclinician office staff, offering testing in nontraditional spaces, including substance use treatment programs, harm reduction centers, STI clinics, and mobile health units,” Singh and Epstein told this news organization.

“A key step is educating primary care providers in addition to addiction medicine and emergency medicine clinicians about the updated guidelines as they interface with a large number of at-risk individuals,” they said. And the most important measure is creating clear work flows that respond to positive results to link people to treatment and cure. 

“Clinicians need to feel empowered that their work screening a patient can make a meaningful difference in both the patient’s life and in helping end this epidemic,” the two researchers explained. 

Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America, who wasn’t involved in the study, told this news organization that the low HCV screening rates are not surprising. 

“We tend not to do well with screening. It’s not necessarily anybody’s fault, but patients don’t necessarily want to be screened. Sometimes physicians are very busy. Sometimes screening is not the most important thing for them to do. Sometimes there are processes in place that fall through,” said Glatt, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau, Oceanside, New York. 

“We tend to do a better job of screening in pregnant than nonpregnant women because pregnancy is a focus and there is 9 months that you can be following-up, so there is more opportunity. A healthy nonpregnant woman may not see her doctor for another year,” Glatt noted. 

“I think that many physicians are very good at screening for hepatitis C in patients that are clearly at risk,” he added. “We’re not so good at screening for people” that don’t have a clear risk but do “have risk factors.”

The study had no commercial funding. Singh, Epstein, and Glatt had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Despite universal hepatitis C virus (HCV) screening recommendations issued in 2020, HCV screening rates remain suboptimal among US women, a new analysis showed. 

“We found that screening rates were higher and rose more steeply in pregnant individuals compared to nonpregnant reproductive age females after this guidance.” However overall, HCV screening in women still remained low by the end of 2022, authors Roshni Singh, MD, and Rachel Epstein, MD, MSc, with the section of infectious diseases, Boston Medical Center, noted in an email to this news organization.

The study was published online in JAMA.

The researchers leveraged TriNetX LIVE electronic health record data to compare HCV screening rates from 68 US healthcare organizations covering more than 115 million patients.

Using a multiple-group interrupted time series analysis, they compared HCV screening rates for pregnant and nonpregnant women for each 6-month period before (January 2014 to December 2019) and after (July 2020 to December 2022) the 2020 guidelines. January to June 2020 was considered a washout period to account for the COVID-19 pandemic peak and guideline dissemination.

For the entire 9-year study period (2014-2022), a total of 79,231 incident HCV tests occurred among pregnant women and 678,951 occurred among nonpregnant women. 

In the 6 months before the guidance, HCV screening per 1000 person-years increased from 52 to 117 tests among pregnant women and 16 to 24 tests among nonpregnant women.

In the 6 months after the guidance, screening per 1000 person-years increased from 141 to 253 among pregnant women and from 29 to 37 among nonpregnant women.

Yet by the end of 2022, only 38.7% of women with a pregnancy and 8.7% of nonpregnant women were ever tested for the HCV.

 

How to Boost HCV Screening

These results suggest that “innovative strategies are needed to improve HCV diagnosis and treatment,” the authors wrote. 

“Several interventions have been demonstrated to be effective in increasing screening in general, including electronic medical record alerts for opt-out testing, routine test offer by nonclinician office staff, offering testing in nontraditional spaces, including substance use treatment programs, harm reduction centers, STI clinics, and mobile health units,” Singh and Epstein told this news organization.

“A key step is educating primary care providers in addition to addiction medicine and emergency medicine clinicians about the updated guidelines as they interface with a large number of at-risk individuals,” they said. And the most important measure is creating clear work flows that respond to positive results to link people to treatment and cure. 

“Clinicians need to feel empowered that their work screening a patient can make a meaningful difference in both the patient’s life and in helping end this epidemic,” the two researchers explained. 

Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America, who wasn’t involved in the study, told this news organization that the low HCV screening rates are not surprising. 

“We tend not to do well with screening. It’s not necessarily anybody’s fault, but patients don’t necessarily want to be screened. Sometimes physicians are very busy. Sometimes screening is not the most important thing for them to do. Sometimes there are processes in place that fall through,” said Glatt, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau, Oceanside, New York. 

“We tend to do a better job of screening in pregnant than nonpregnant women because pregnancy is a focus and there is 9 months that you can be following-up, so there is more opportunity. A healthy nonpregnant woman may not see her doctor for another year,” Glatt noted. 

“I think that many physicians are very good at screening for hepatitis C in patients that are clearly at risk,” he added. “We’re not so good at screening for people” that don’t have a clear risk but do “have risk factors.”

The study had no commercial funding. Singh, Epstein, and Glatt had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are associated with retained gastric contents and aborted procedures among patients undergoing upper endoscopy, according to a meta-analysis of more than 80,000 patients.

Safety profiles, however, were comparable across groups, suggesting that prolonged fasting may be a sufficient management strategy, instead of withholding GLP-1RAs, lead author Antonio Facciorusso, MD, PhD, of the University of Foggia, Italy, and colleagues reported.

“The impact of GLP-1RAs on slowing gastric motility has raised concerns in patients undergoing endoscopic procedures, particularly upper endoscopies,” the investigators wrote in Clinical Gastroenterology and Hepatology. “This is due to the perceived risk of aspiration of retained gastric contents in sedated patients and the decreased visibility of the gastric mucosa, which can reduce the diagnostic yield of the examination.”

The American Society of Anesthesiologists (ASA) recommends withholding GLP-1RAs before procedures or surgery, whereas AGA suggests an individualized approach, citing limited supporting data. 

A previous meta-analysis reported that GLP-1RAs mildly delayed gastric emptying, but clinical relevance remained unclear. 

The present meta-analysis aimed to clarify this uncertainty by analyzing 13 retrospective studies that involved 84,065 patients undergoing upper endoscopy. Outcomes were compared among GLP-1RA users vs non-users, including rates of retained gastric contents, aborted procedures, and adverse events. 

Patients on GLP-1RAs had significantly higher rates of retained gastric contents than non-users (odds ratio [OR], 5.56), a finding that held steady (OR, 4.20) after adjusting for age, sex, diabetes, body mass index, and other therapies. 

GLP-1RAs were also associated with an increased likelihood of aborted procedures (OR, 5.13; 1% vs. 0.3%) and a higher need for repeat endoscopies (OR, 2.19; 1% vs 2%); however, Facciorusso and colleagues noted that these events, in absolute terms, were relatively uncommon.

“The rate of aborted and repeat procedures in the included studies was low,” the investigators wrote. “This meant that only for every 110 patients undergoing upper endoscopy while in GLP-1RA therapy would we observe an aborted procedure and only for every 120 patients would we need to repeat the procedure.”

The overall safety profile of GLP-1RAs in the context of upper endoscopy remained largely reassuring, they added. Specifically, rates of bronchial aspiration were not significantly different between users and non-users. What’s more, no single study reported a statistically significant increase in major complications, including pulmonary adverse events, among GLP-1RA users. 

According to Facciorusso and colleagues, these findings suggest that retained gastric contents do not appear to substantially heighten the risk of serious harm, though further prospective studies are needed.

“Our comprehensive analysis indicates that, while the use of GLP-1RA results in higher rates of [retained gastric contents], the actual clinical impact appears to be limited,” they wrote. “Therefore, there is no strong evidence to support the routine discontinuation of the drug before upper endoscopy procedures.”

Instead, they supported the AGA task force’s recommendation for an individualized approach, and not withholding GLP-1RAs unnecessarily, calling this “the best compromise.”

“Prolonging the duration of fasting for solids could represent the optimal approach in these patients, although this strategy requires further evaluation,” the investigators concluded.

The investigators disclosed no conflicts of interest.







 

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are associated with retained gastric contents and aborted procedures among patients undergoing upper endoscopy, according to a meta-analysis of more than 80,000 patients.

Safety profiles, however, were comparable across groups, suggesting that prolonged fasting may be a sufficient management strategy, instead of withholding GLP-1RAs, lead author Antonio Facciorusso, MD, PhD, of the University of Foggia, Italy, and colleagues reported.

“The impact of GLP-1RAs on slowing gastric motility has raised concerns in patients undergoing endoscopic procedures, particularly upper endoscopies,” the investigators wrote in Clinical Gastroenterology and Hepatology. “This is due to the perceived risk of aspiration of retained gastric contents in sedated patients and the decreased visibility of the gastric mucosa, which can reduce the diagnostic yield of the examination.”

The American Society of Anesthesiologists (ASA) recommends withholding GLP-1RAs before procedures or surgery, whereas AGA suggests an individualized approach, citing limited supporting data. 

A previous meta-analysis reported that GLP-1RAs mildly delayed gastric emptying, but clinical relevance remained unclear. 

The present meta-analysis aimed to clarify this uncertainty by analyzing 13 retrospective studies that involved 84,065 patients undergoing upper endoscopy. Outcomes were compared among GLP-1RA users vs non-users, including rates of retained gastric contents, aborted procedures, and adverse events. 

Patients on GLP-1RAs had significantly higher rates of retained gastric contents than non-users (odds ratio [OR], 5.56), a finding that held steady (OR, 4.20) after adjusting for age, sex, diabetes, body mass index, and other therapies. 

GLP-1RAs were also associated with an increased likelihood of aborted procedures (OR, 5.13; 1% vs. 0.3%) and a higher need for repeat endoscopies (OR, 2.19; 1% vs 2%); however, Facciorusso and colleagues noted that these events, in absolute terms, were relatively uncommon.

“The rate of aborted and repeat procedures in the included studies was low,” the investigators wrote. “This meant that only for every 110 patients undergoing upper endoscopy while in GLP-1RA therapy would we observe an aborted procedure and only for every 120 patients would we need to repeat the procedure.”

The overall safety profile of GLP-1RAs in the context of upper endoscopy remained largely reassuring, they added. Specifically, rates of bronchial aspiration were not significantly different between users and non-users. What’s more, no single study reported a statistically significant increase in major complications, including pulmonary adverse events, among GLP-1RA users. 

According to Facciorusso and colleagues, these findings suggest that retained gastric contents do not appear to substantially heighten the risk of serious harm, though further prospective studies are needed.

“Our comprehensive analysis indicates that, while the use of GLP-1RA results in higher rates of [retained gastric contents], the actual clinical impact appears to be limited,” they wrote. “Therefore, there is no strong evidence to support the routine discontinuation of the drug before upper endoscopy procedures.”

Instead, they supported the AGA task force’s recommendation for an individualized approach, and not withholding GLP-1RAs unnecessarily, calling this “the best compromise.”

“Prolonging the duration of fasting for solids could represent the optimal approach in these patients, although this strategy requires further evaluation,” the investigators concluded.

The investigators disclosed no conflicts of interest.







 

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are associated with retained gastric contents and aborted procedures among patients undergoing upper endoscopy, according to a meta-analysis of more than 80,000 patients.

Safety profiles, however, were comparable across groups, suggesting that prolonged fasting may be a sufficient management strategy, instead of withholding GLP-1RAs, lead author Antonio Facciorusso, MD, PhD, of the University of Foggia, Italy, and colleagues reported.

“The impact of GLP-1RAs on slowing gastric motility has raised concerns in patients undergoing endoscopic procedures, particularly upper endoscopies,” the investigators wrote in Clinical Gastroenterology and Hepatology. “This is due to the perceived risk of aspiration of retained gastric contents in sedated patients and the decreased visibility of the gastric mucosa, which can reduce the diagnostic yield of the examination.”

The American Society of Anesthesiologists (ASA) recommends withholding GLP-1RAs before procedures or surgery, whereas AGA suggests an individualized approach, citing limited supporting data. 

A previous meta-analysis reported that GLP-1RAs mildly delayed gastric emptying, but clinical relevance remained unclear. 

The present meta-analysis aimed to clarify this uncertainty by analyzing 13 retrospective studies that involved 84,065 patients undergoing upper endoscopy. Outcomes were compared among GLP-1RA users vs non-users, including rates of retained gastric contents, aborted procedures, and adverse events. 

Patients on GLP-1RAs had significantly higher rates of retained gastric contents than non-users (odds ratio [OR], 5.56), a finding that held steady (OR, 4.20) after adjusting for age, sex, diabetes, body mass index, and other therapies. 

GLP-1RAs were also associated with an increased likelihood of aborted procedures (OR, 5.13; 1% vs. 0.3%) and a higher need for repeat endoscopies (OR, 2.19; 1% vs 2%); however, Facciorusso and colleagues noted that these events, in absolute terms, were relatively uncommon.

“The rate of aborted and repeat procedures in the included studies was low,” the investigators wrote. “This meant that only for every 110 patients undergoing upper endoscopy while in GLP-1RA therapy would we observe an aborted procedure and only for every 120 patients would we need to repeat the procedure.”

The overall safety profile of GLP-1RAs in the context of upper endoscopy remained largely reassuring, they added. Specifically, rates of bronchial aspiration were not significantly different between users and non-users. What’s more, no single study reported a statistically significant increase in major complications, including pulmonary adverse events, among GLP-1RA users. 

According to Facciorusso and colleagues, these findings suggest that retained gastric contents do not appear to substantially heighten the risk of serious harm, though further prospective studies are needed.

“Our comprehensive analysis indicates that, while the use of GLP-1RA results in higher rates of [retained gastric contents], the actual clinical impact appears to be limited,” they wrote. “Therefore, there is no strong evidence to support the routine discontinuation of the drug before upper endoscopy procedures.”

Instead, they supported the AGA task force’s recommendation for an individualized approach, and not withholding GLP-1RAs unnecessarily, calling this “the best compromise.”

“Prolonging the duration of fasting for solids could represent the optimal approach in these patients, although this strategy requires further evaluation,” the investigators concluded.

The investigators disclosed no conflicts of interest.







 

Placing two cystic duct stents instead of one during endoscopic transpapillary gallbladder drainage (ETGBD) is associated with a lower rate of unplanned reintervention, according to a retrospective multicenter study.

These findings suggest that endoscopists should prioritize dual stent placement when feasible, and consider adding a second stent in patients who previously received a single stent, James D. Haddad, MD, of the University of Texas Southwestern, Dallas, and colleagues reported.

 

The American Gastroenterological Association (AGA) has recognized the role of endoscopic drainage in managing acute cholecystitis in high-risk patients, but specific guidance on optimal technique and follow-up remains unclear, the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

“Despite accumulating data and increased interest in this technique, clear guidance on the ideal strategy for ETGBD is lacking,” Dr. Haddad and colleagues wrote. “For example, the optimal size, number, and follow-up of cystic duct stents for patients undergoing ETGBD has not been well established.”

To address this knowledge gap, the investigators analyzed data from 75 patients at five academic medical centers who had undergone ETGBD between June 2013 and October 2022. Patients were divided into two groups based on whether they received one or two cystic duct stents. 

The primary outcome was clinical success, defined as symptom resolution without requiring another drainage procedure. Secondary outcomes included technical success (defined as successful stent placement), along with rates of adverse events and unplanned reinterventions. 

Out of the 75 patients, 59 received a single stent, while 16 received dual stents. The median follow-up time was 407 days overall, with a longer follow-up in the single-stent group (433 days), compared with the double-stent group (118 days).

Clinical success was reported in 81.3% of cases, which technical success was achieved in 88.2% of cases. 

Patients who received two stents had significantly lower rates of unplanned reintervention, compared with those who received a single stent (0% vs 25.4%; P = .02). The median time to unplanned reintervention in the single-stent group was 210 days.

Use of a 7 French stent was strongly associated with placement of two stents (odd ratio [OR], 15.5; P = .01). Similarly, patients with a prior percutaneous cholecystostomy tube were significantly more likely to have two stents placed (OR, 10.8; P = .001).

Adverse event rates were uncommon and not statistically different between groups, with an overall rate of 6.7%. Post-endoscopic retrograde cholangiopancreatography pancreatitis was the most common adverse event, occurring in two patients in the single-stent group and one patient in the double-stent group. There were no reported cases of cystic duct or gallbladder perforation.

“In conclusion,” the investigators wrote, “ETGBD with dual transpapillary gallbladder stenting is associated with a lower rate of unplanned reinterventions, compared with that with single stenting, and has a low rate of adverse events. Endoscopists performing ETGBD should consider planned exchange of solitary transpapillary gallbladder stents or interval ERCP for reattempted placement of a second stent if placement of two stents is not possible at the index ERCP.”

The investigators disclosed relationships with Boston Scientific, Motus GI, and ConMed.







 

Placing two cystic duct stents instead of one during endoscopic transpapillary gallbladder drainage (ETGBD) is associated with a lower rate of unplanned reintervention, according to a retrospective multicenter study.

These findings suggest that endoscopists should prioritize dual stent placement when feasible, and consider adding a second stent in patients who previously received a single stent, James D. Haddad, MD, of the University of Texas Southwestern, Dallas, and colleagues reported.

 

The American Gastroenterological Association (AGA) has recognized the role of endoscopic drainage in managing acute cholecystitis in high-risk patients, but specific guidance on optimal technique and follow-up remains unclear, the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

“Despite accumulating data and increased interest in this technique, clear guidance on the ideal strategy for ETGBD is lacking,” Dr. Haddad and colleagues wrote. “For example, the optimal size, number, and follow-up of cystic duct stents for patients undergoing ETGBD has not been well established.”

To address this knowledge gap, the investigators analyzed data from 75 patients at five academic medical centers who had undergone ETGBD between June 2013 and October 2022. Patients were divided into two groups based on whether they received one or two cystic duct stents. 

The primary outcome was clinical success, defined as symptom resolution without requiring another drainage procedure. Secondary outcomes included technical success (defined as successful stent placement), along with rates of adverse events and unplanned reinterventions. 

Out of the 75 patients, 59 received a single stent, while 16 received dual stents. The median follow-up time was 407 days overall, with a longer follow-up in the single-stent group (433 days), compared with the double-stent group (118 days).

Clinical success was reported in 81.3% of cases, which technical success was achieved in 88.2% of cases. 

Patients who received two stents had significantly lower rates of unplanned reintervention, compared with those who received a single stent (0% vs 25.4%; P = .02). The median time to unplanned reintervention in the single-stent group was 210 days.

Use of a 7 French stent was strongly associated with placement of two stents (odd ratio [OR], 15.5; P = .01). Similarly, patients with a prior percutaneous cholecystostomy tube were significantly more likely to have two stents placed (OR, 10.8; P = .001).

Adverse event rates were uncommon and not statistically different between groups, with an overall rate of 6.7%. Post-endoscopic retrograde cholangiopancreatography pancreatitis was the most common adverse event, occurring in two patients in the single-stent group and one patient in the double-stent group. There were no reported cases of cystic duct or gallbladder perforation.

“In conclusion,” the investigators wrote, “ETGBD with dual transpapillary gallbladder stenting is associated with a lower rate of unplanned reinterventions, compared with that with single stenting, and has a low rate of adverse events. Endoscopists performing ETGBD should consider planned exchange of solitary transpapillary gallbladder stents or interval ERCP for reattempted placement of a second stent if placement of two stents is not possible at the index ERCP.”

The investigators disclosed relationships with Boston Scientific, Motus GI, and ConMed.







 

Placing two cystic duct stents instead of one during endoscopic transpapillary gallbladder drainage (ETGBD) is associated with a lower rate of unplanned reintervention, according to a retrospective multicenter study.

These findings suggest that endoscopists should prioritize dual stent placement when feasible, and consider adding a second stent in patients who previously received a single stent, James D. Haddad, MD, of the University of Texas Southwestern, Dallas, and colleagues reported.

 

The American Gastroenterological Association (AGA) has recognized the role of endoscopic drainage in managing acute cholecystitis in high-risk patients, but specific guidance on optimal technique and follow-up remains unclear, the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

“Despite accumulating data and increased interest in this technique, clear guidance on the ideal strategy for ETGBD is lacking,” Dr. Haddad and colleagues wrote. “For example, the optimal size, number, and follow-up of cystic duct stents for patients undergoing ETGBD has not been well established.”

To address this knowledge gap, the investigators analyzed data from 75 patients at five academic medical centers who had undergone ETGBD between June 2013 and October 2022. Patients were divided into two groups based on whether they received one or two cystic duct stents. 

The primary outcome was clinical success, defined as symptom resolution without requiring another drainage procedure. Secondary outcomes included technical success (defined as successful stent placement), along with rates of adverse events and unplanned reinterventions. 

Out of the 75 patients, 59 received a single stent, while 16 received dual stents. The median follow-up time was 407 days overall, with a longer follow-up in the single-stent group (433 days), compared with the double-stent group (118 days).

Clinical success was reported in 81.3% of cases, which technical success was achieved in 88.2% of cases. 

Patients who received two stents had significantly lower rates of unplanned reintervention, compared with those who received a single stent (0% vs 25.4%; P = .02). The median time to unplanned reintervention in the single-stent group was 210 days.

Use of a 7 French stent was strongly associated with placement of two stents (odd ratio [OR], 15.5; P = .01). Similarly, patients with a prior percutaneous cholecystostomy tube were significantly more likely to have two stents placed (OR, 10.8; P = .001).

Adverse event rates were uncommon and not statistically different between groups, with an overall rate of 6.7%. Post-endoscopic retrograde cholangiopancreatography pancreatitis was the most common adverse event, occurring in two patients in the single-stent group and one patient in the double-stent group. There were no reported cases of cystic duct or gallbladder perforation.

“In conclusion,” the investigators wrote, “ETGBD with dual transpapillary gallbladder stenting is associated with a lower rate of unplanned reinterventions, compared with that with single stenting, and has a low rate of adverse events. Endoscopists performing ETGBD should consider planned exchange of solitary transpapillary gallbladder stents or interval ERCP for reattempted placement of a second stent if placement of two stents is not possible at the index ERCP.”

The investigators disclosed relationships with Boston Scientific, Motus GI, and ConMed.







 

Circulating blood proteins could enable early identification of Crohn’s disease (CD) years before clinical signs, according to investigators.

The 29-protein biosignature, which was validated across multiple independent cohorts, could potentially open doors to new preclinical interventions, lead author Olle Grännö, MD, of Örebro University in Sweden, and colleagues reported. 

“Predictive biomarkers of future clinical onset of active inflammatory bowel disease could detect the disease during ‘a window of opportunity’ when the immune dysregulation is potentially reversible,” the investigators wrote in Gastroenterology.

Preclinical biomarker screening has proven effective in other immune-mediated diseases, such as type 1 diabetes, where risk stratification using autoantibodies enabled early intervention that delayed disease onset, they noted. 

Previous studies suggested similar potential for inflammatory bowel disease (IBD) via predictive autoantibodies and serum proteins, although the accuracy of these markers was not validated in external cohorts. The present study aimed to fill this validation gap.

First, the investigators measured 178 plasma proteins in blood samples taken from 312 individuals before they were diagnosed with IBD. Using machine learning, Dr. Grännö and colleagues compared these findings with blood-matched controls who remained free of IBD through follow-up. This process revealed the 29-protein signature. 

In the same discovery cohort, the panel of 29 proteins differentiated preclinical CD cases from controls with an area under the curve (AUC) of 0.85. The signature was then validated in an independent preclinical cohort of CD patients, with an AUC of 0.87. 

While accuracy increased in proximity to clinical disease onset, the model was still highly predictive up to 16 years before CD diagnosis, at which time the AUC was 0.82. The panel showed perfect performance among newly diagnosed CD patients, with an AUC of 1.0, supporting clinical relevance.

Predictive power was statistically significant but less compelling among individuals with preclinical ulcerative colitis (UC). In this IBD subgroup, AUC for identification and validation cohorts was 0.77 and 0.67, respectively, while newly diagnosed patients had an AUC of 0.95.

“In preclinical samples, downregulated (but not upregulated) proteins related to gut barrier integrity and macrophage functionality correlated with time to diagnosis of CD,” Dr. Grännö and colleagues wrote. “Contrarily, all proteins associated with preclinical UC were upregulated, and only one protein marker correlated with the time to diagnosis.”

These findings suggest that disruptions in gut barrier integrity and macrophage function precede clinical CD onset, they explained, potentially serving as an early signal of inflammation-driven intestinal damage. In contrast, the preclinical UC signature primarily involved upregulated inflammatory markers.

Dr. Grännö and colleagues also examined the influence of genetic and environmental factors by comparing preclinical IBD signatures in unrelated and related twin pairs. 

The CD biosignature had an AUC of 0.89 when comparing individuals with preclinical CD to matched external (unrelated) healthy twins. Predictive ability dropped significantly (AUC = 0.58) when comparing CD cases to their own healthy twin siblings, suggesting that genetic and shared environmental factors have a “predominant influence” on protein dysregulation. 

In contrast, AUC among unrelated vs related twin controls was more similar for UC, at 0.76 and 0.64, respectively, indicating “a limited impact” of genetic and environmental factors on the protein signature.

Altogether, this study reinforces the concept of a long preclinical phase in CD, and highlights the potential for early detection and intervention, according to the investigators.

“The long preclinical period in CD endorses the adoption of early preventive strategies (e.g., diet alterations and medication) to potentially attenuate disease progression and improve the natural history of CD,” they concluded.

This study was funded by the Swedish Research Council, the Swedish Foundation for Strategic Research, the Örebro University Hospital Research Foundation, and others. The investigators disclosed relationships with Pfizer, Janssen, AbbVie, and others.

Circulating blood proteins could enable early identification of Crohn’s disease (CD) years before clinical signs, according to investigators.

The 29-protein biosignature, which was validated across multiple independent cohorts, could potentially open doors to new preclinical interventions, lead author Olle Grännö, MD, of Örebro University in Sweden, and colleagues reported. 

“Predictive biomarkers of future clinical onset of active inflammatory bowel disease could detect the disease during ‘a window of opportunity’ when the immune dysregulation is potentially reversible,” the investigators wrote in Gastroenterology.

Preclinical biomarker screening has proven effective in other immune-mediated diseases, such as type 1 diabetes, where risk stratification using autoantibodies enabled early intervention that delayed disease onset, they noted. 

Previous studies suggested similar potential for inflammatory bowel disease (IBD) via predictive autoantibodies and serum proteins, although the accuracy of these markers was not validated in external cohorts. The present study aimed to fill this validation gap.

First, the investigators measured 178 plasma proteins in blood samples taken from 312 individuals before they were diagnosed with IBD. Using machine learning, Dr. Grännö and colleagues compared these findings with blood-matched controls who remained free of IBD through follow-up. This process revealed the 29-protein signature. 

In the same discovery cohort, the panel of 29 proteins differentiated preclinical CD cases from controls with an area under the curve (AUC) of 0.85. The signature was then validated in an independent preclinical cohort of CD patients, with an AUC of 0.87. 

While accuracy increased in proximity to clinical disease onset, the model was still highly predictive up to 16 years before CD diagnosis, at which time the AUC was 0.82. The panel showed perfect performance among newly diagnosed CD patients, with an AUC of 1.0, supporting clinical relevance.

Predictive power was statistically significant but less compelling among individuals with preclinical ulcerative colitis (UC). In this IBD subgroup, AUC for identification and validation cohorts was 0.77 and 0.67, respectively, while newly diagnosed patients had an AUC of 0.95.

“In preclinical samples, downregulated (but not upregulated) proteins related to gut barrier integrity and macrophage functionality correlated with time to diagnosis of CD,” Dr. Grännö and colleagues wrote. “Contrarily, all proteins associated with preclinical UC were upregulated, and only one protein marker correlated with the time to diagnosis.”

These findings suggest that disruptions in gut barrier integrity and macrophage function precede clinical CD onset, they explained, potentially serving as an early signal of inflammation-driven intestinal damage. In contrast, the preclinical UC signature primarily involved upregulated inflammatory markers.

Dr. Grännö and colleagues also examined the influence of genetic and environmental factors by comparing preclinical IBD signatures in unrelated and related twin pairs. 

The CD biosignature had an AUC of 0.89 when comparing individuals with preclinical CD to matched external (unrelated) healthy twins. Predictive ability dropped significantly (AUC = 0.58) when comparing CD cases to their own healthy twin siblings, suggesting that genetic and shared environmental factors have a “predominant influence” on protein dysregulation. 

In contrast, AUC among unrelated vs related twin controls was more similar for UC, at 0.76 and 0.64, respectively, indicating “a limited impact” of genetic and environmental factors on the protein signature.

Altogether, this study reinforces the concept of a long preclinical phase in CD, and highlights the potential for early detection and intervention, according to the investigators.

“The long preclinical period in CD endorses the adoption of early preventive strategies (e.g., diet alterations and medication) to potentially attenuate disease progression and improve the natural history of CD,” they concluded.

This study was funded by the Swedish Research Council, the Swedish Foundation for Strategic Research, the Örebro University Hospital Research Foundation, and others. The investigators disclosed relationships with Pfizer, Janssen, AbbVie, and others.

Circulating blood proteins could enable early identification of Crohn’s disease (CD) years before clinical signs, according to investigators.

The 29-protein biosignature, which was validated across multiple independent cohorts, could potentially open doors to new preclinical interventions, lead author Olle Grännö, MD, of Örebro University in Sweden, and colleagues reported. 

“Predictive biomarkers of future clinical onset of active inflammatory bowel disease could detect the disease during ‘a window of opportunity’ when the immune dysregulation is potentially reversible,” the investigators wrote in Gastroenterology.

Preclinical biomarker screening has proven effective in other immune-mediated diseases, such as type 1 diabetes, where risk stratification using autoantibodies enabled early intervention that delayed disease onset, they noted. 

Previous studies suggested similar potential for inflammatory bowel disease (IBD) via predictive autoantibodies and serum proteins, although the accuracy of these markers was not validated in external cohorts. The present study aimed to fill this validation gap.

First, the investigators measured 178 plasma proteins in blood samples taken from 312 individuals before they were diagnosed with IBD. Using machine learning, Dr. Grännö and colleagues compared these findings with blood-matched controls who remained free of IBD through follow-up. This process revealed the 29-protein signature. 

In the same discovery cohort, the panel of 29 proteins differentiated preclinical CD cases from controls with an area under the curve (AUC) of 0.85. The signature was then validated in an independent preclinical cohort of CD patients, with an AUC of 0.87. 

While accuracy increased in proximity to clinical disease onset, the model was still highly predictive up to 16 years before CD diagnosis, at which time the AUC was 0.82. The panel showed perfect performance among newly diagnosed CD patients, with an AUC of 1.0, supporting clinical relevance.

Predictive power was statistically significant but less compelling among individuals with preclinical ulcerative colitis (UC). In this IBD subgroup, AUC for identification and validation cohorts was 0.77 and 0.67, respectively, while newly diagnosed patients had an AUC of 0.95.

“In preclinical samples, downregulated (but not upregulated) proteins related to gut barrier integrity and macrophage functionality correlated with time to diagnosis of CD,” Dr. Grännö and colleagues wrote. “Contrarily, all proteins associated with preclinical UC were upregulated, and only one protein marker correlated with the time to diagnosis.”

These findings suggest that disruptions in gut barrier integrity and macrophage function precede clinical CD onset, they explained, potentially serving as an early signal of inflammation-driven intestinal damage. In contrast, the preclinical UC signature primarily involved upregulated inflammatory markers.

Dr. Grännö and colleagues also examined the influence of genetic and environmental factors by comparing preclinical IBD signatures in unrelated and related twin pairs. 

The CD biosignature had an AUC of 0.89 when comparing individuals with preclinical CD to matched external (unrelated) healthy twins. Predictive ability dropped significantly (AUC = 0.58) when comparing CD cases to their own healthy twin siblings, suggesting that genetic and shared environmental factors have a “predominant influence” on protein dysregulation. 

In contrast, AUC among unrelated vs related twin controls was more similar for UC, at 0.76 and 0.64, respectively, indicating “a limited impact” of genetic and environmental factors on the protein signature.

Altogether, this study reinforces the concept of a long preclinical phase in CD, and highlights the potential for early detection and intervention, according to the investigators.

“The long preclinical period in CD endorses the adoption of early preventive strategies (e.g., diet alterations and medication) to potentially attenuate disease progression and improve the natural history of CD,” they concluded.

This study was funded by the Swedish Research Council, the Swedish Foundation for Strategic Research, the Örebro University Hospital Research Foundation, and others. The investigators disclosed relationships with Pfizer, Janssen, AbbVie, and others.

Perioperative optimization of nutrition leads to lower risks, better outcomes, and improved quality of life for adult patients undergoing metabolic and bariatric surgery, according to an updated clinical practice statement from the Obesity Medicine Association (OMA).

The update offers guidance on how to manage metabolic and bariatric surgery patients’ nutrition, from preoperative nutritional assessments through identification and treatment of the most common nutritional problems associated with bariatric procedures.

“The main takeaway really is that obesity is a complex and chronic disease. It requires the same model of care as diabetes or other chronic conditions,” said Rutuja Patel, DO, senior author and an obesity medicine specialist at Northwestern Medicine Regional Medical Group in Winfield, Illinois.

The development of an interdisciplinary team of medical providers with evidence-based nutrition knowledge and consistent information improves the quality of nutrition care provided to bariatric surgery patients, the authors wrote.

“Collaborative multidisciplinary care that takes into consideration the whole patient in a biopsychosocial way and uses multiple modalities — including medical, behavioral, nutritional, and others — leads to the best outcomes in these complex patients,” Patel said.

The updated statement, published online in Obesity Pillars, offers a variety of tools and checklists to aid clinicians, especially those who may not have access to a multidisciplinary team or dietitian knowledgeable about bariatric nutrition.

It is a follow-up to the OMA’s 2022 clinical practice statement, which provided an overview of bariatric surgery, gastrointestinal hormones, and the microbiome in patients with obesity.

 

Presurgical Guidance

The new guidance lays out the various components of preoperative nutrition screenings, among which is a medication review to determine if the patient is taking drugs that may affect weight and calorie intake. These include antihypertensives, diabetes agents, hormonal contraceptives, antidepressants, migraine medications, and antipsychotics.

In taking a patient’s history, clinicians should ask about major events associated with weight changes, such as medication changes, illness, pregnancy, divorce, stressful employment, food insecurity, and periods of disordered eating.

The fundamental approach to conducting a nutrition assessment is an understanding of the role that various sections of the gastrointestinal tract play in micronutrient absorption, the authors wrote. As an educational tool, the update includes a diagram that indicates the areas of the stomach, duodenum, jejunum, and ileum that may be altered by bariatric surgery and how they factor into micronutrient absorption.

“It makes it easier to see why certain surgical procedures are more likely to cause certain deficiencies,” Patel said.

 

Postsurgery Patient Management

Post surgery, clinicians should monitor patients for other problems that could affect nutrient absorption, including food intolerances, drug-nutrient interactions, and increased gastrointestinal transit time.

Patel and coauthors discussed the pros and cons of multivitamin mineral supplement formulations as well as specific vitamin and mineral recommendations for patients undergoing certain metabolic or bariatric surgery procedures. They included three supplemental cases in the appendix to illustrate supplementation recommendations and long-term maintenance suggestions.

“It’s important to remember that most of these deficiencies present without many clinical symptoms, so it becomes essential to screen for them and repeat as needed,” Patel said.

The update also tackles postoperative nutritional assessments and diet progression. No evidence supports following one postsurgical diet progression protocol over another, but they generally proceed from a clear liquid diet to foods with normal textures, the authors noted. Clinicians should adapt them according to the procedure type, they added.

In addition, clinicians must troubleshoot any nutrition-related concerns, including constipation, dehydration, nausea, heartburn, and fatigue, for up to a year after surgery, they wrote.

Metabolic and bariatric surgery patients should be evaluated annually at a minimum, if not more frequently, to gauge nutritional health, the authors wrote. Treating obesity as a disease involves more than weight loss — instead, it’s about improving the quality of life of patients through procedures, medications, and lifestyle modifications, they added.

 

Track New Developments

With ongoing changes in the field of metabolic and bariatric surgery, it’s helpful for clinicians to remain updated about new approaches across various disciplines linked to obesity management and treatment, said Christina Poa-Li, MD, a surgeon at Huntington Health Medical Center, affiliated with Cedars-Sinai Health System, in Pasadena, California, who was not involved in developing the updated practice statement.

“For example, the rapidly growing prescription of anti-obesity medications and their use in both preoperative and postoperative surgical patients drastically affect their nutrition,” she said. “Providers of various backgrounds and specialties will benefit from the most updated guidance on evaluating patient nutrition.”

Clinicians should consider expanding their patient population to include those with metabolic dysfunction–associated steatohepatitis or metabolic dysfunction–associated steatotic liver disease, Poa-Li said.

“These patient subpopulations may not have been considered for bariatric surgery or even referral to a bariatric surgeon for consultation previously,” she said. “It is important to increase awareness among clinicians of the potential benefits for metabolic and bariatric surgery for these patients.”

The report didn’t receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Patel and Poa-Li reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Perioperative optimization of nutrition leads to lower risks, better outcomes, and improved quality of life for adult patients undergoing metabolic and bariatric surgery, according to an updated clinical practice statement from the Obesity Medicine Association (OMA).

The update offers guidance on how to manage metabolic and bariatric surgery patients’ nutrition, from preoperative nutritional assessments through identification and treatment of the most common nutritional problems associated with bariatric procedures.

“The main takeaway really is that obesity is a complex and chronic disease. It requires the same model of care as diabetes or other chronic conditions,” said Rutuja Patel, DO, senior author and an obesity medicine specialist at Northwestern Medicine Regional Medical Group in Winfield, Illinois.

The development of an interdisciplinary team of medical providers with evidence-based nutrition knowledge and consistent information improves the quality of nutrition care provided to bariatric surgery patients, the authors wrote.

“Collaborative multidisciplinary care that takes into consideration the whole patient in a biopsychosocial way and uses multiple modalities — including medical, behavioral, nutritional, and others — leads to the best outcomes in these complex patients,” Patel said.

The updated statement, published online in Obesity Pillars, offers a variety of tools and checklists to aid clinicians, especially those who may not have access to a multidisciplinary team or dietitian knowledgeable about bariatric nutrition.

It is a follow-up to the OMA’s 2022 clinical practice statement, which provided an overview of bariatric surgery, gastrointestinal hormones, and the microbiome in patients with obesity.

 

Presurgical Guidance

The new guidance lays out the various components of preoperative nutrition screenings, among which is a medication review to determine if the patient is taking drugs that may affect weight and calorie intake. These include antihypertensives, diabetes agents, hormonal contraceptives, antidepressants, migraine medications, and antipsychotics.

In taking a patient’s history, clinicians should ask about major events associated with weight changes, such as medication changes, illness, pregnancy, divorce, stressful employment, food insecurity, and periods of disordered eating.

The fundamental approach to conducting a nutrition assessment is an understanding of the role that various sections of the gastrointestinal tract play in micronutrient absorption, the authors wrote. As an educational tool, the update includes a diagram that indicates the areas of the stomach, duodenum, jejunum, and ileum that may be altered by bariatric surgery and how they factor into micronutrient absorption.

“It makes it easier to see why certain surgical procedures are more likely to cause certain deficiencies,” Patel said.

 

Postsurgery Patient Management

Post surgery, clinicians should monitor patients for other problems that could affect nutrient absorption, including food intolerances, drug-nutrient interactions, and increased gastrointestinal transit time.

Patel and coauthors discussed the pros and cons of multivitamin mineral supplement formulations as well as specific vitamin and mineral recommendations for patients undergoing certain metabolic or bariatric surgery procedures. They included three supplemental cases in the appendix to illustrate supplementation recommendations and long-term maintenance suggestions.

“It’s important to remember that most of these deficiencies present without many clinical symptoms, so it becomes essential to screen for them and repeat as needed,” Patel said.

The update also tackles postoperative nutritional assessments and diet progression. No evidence supports following one postsurgical diet progression protocol over another, but they generally proceed from a clear liquid diet to foods with normal textures, the authors noted. Clinicians should adapt them according to the procedure type, they added.

In addition, clinicians must troubleshoot any nutrition-related concerns, including constipation, dehydration, nausea, heartburn, and fatigue, for up to a year after surgery, they wrote.

Metabolic and bariatric surgery patients should be evaluated annually at a minimum, if not more frequently, to gauge nutritional health, the authors wrote. Treating obesity as a disease involves more than weight loss — instead, it’s about improving the quality of life of patients through procedures, medications, and lifestyle modifications, they added.

 

Track New Developments

With ongoing changes in the field of metabolic and bariatric surgery, it’s helpful for clinicians to remain updated about new approaches across various disciplines linked to obesity management and treatment, said Christina Poa-Li, MD, a surgeon at Huntington Health Medical Center, affiliated with Cedars-Sinai Health System, in Pasadena, California, who was not involved in developing the updated practice statement.

“For example, the rapidly growing prescription of anti-obesity medications and their use in both preoperative and postoperative surgical patients drastically affect their nutrition,” she said. “Providers of various backgrounds and specialties will benefit from the most updated guidance on evaluating patient nutrition.”

Clinicians should consider expanding their patient population to include those with metabolic dysfunction–associated steatohepatitis or metabolic dysfunction–associated steatotic liver disease, Poa-Li said.

“These patient subpopulations may not have been considered for bariatric surgery or even referral to a bariatric surgeon for consultation previously,” she said. “It is important to increase awareness among clinicians of the potential benefits for metabolic and bariatric surgery for these patients.”

The report didn’t receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Patel and Poa-Li reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Perioperative optimization of nutrition leads to lower risks, better outcomes, and improved quality of life for adult patients undergoing metabolic and bariatric surgery, according to an updated clinical practice statement from the Obesity Medicine Association (OMA).

The update offers guidance on how to manage metabolic and bariatric surgery patients’ nutrition, from preoperative nutritional assessments through identification and treatment of the most common nutritional problems associated with bariatric procedures.

“The main takeaway really is that obesity is a complex and chronic disease. It requires the same model of care as diabetes or other chronic conditions,” said Rutuja Patel, DO, senior author and an obesity medicine specialist at Northwestern Medicine Regional Medical Group in Winfield, Illinois.

The development of an interdisciplinary team of medical providers with evidence-based nutrition knowledge and consistent information improves the quality of nutrition care provided to bariatric surgery patients, the authors wrote.

“Collaborative multidisciplinary care that takes into consideration the whole patient in a biopsychosocial way and uses multiple modalities — including medical, behavioral, nutritional, and others — leads to the best outcomes in these complex patients,” Patel said.

The updated statement, published online in Obesity Pillars, offers a variety of tools and checklists to aid clinicians, especially those who may not have access to a multidisciplinary team or dietitian knowledgeable about bariatric nutrition.

It is a follow-up to the OMA’s 2022 clinical practice statement, which provided an overview of bariatric surgery, gastrointestinal hormones, and the microbiome in patients with obesity.

 

Presurgical Guidance

The new guidance lays out the various components of preoperative nutrition screenings, among which is a medication review to determine if the patient is taking drugs that may affect weight and calorie intake. These include antihypertensives, diabetes agents, hormonal contraceptives, antidepressants, migraine medications, and antipsychotics.

In taking a patient’s history, clinicians should ask about major events associated with weight changes, such as medication changes, illness, pregnancy, divorce, stressful employment, food insecurity, and periods of disordered eating.

The fundamental approach to conducting a nutrition assessment is an understanding of the role that various sections of the gastrointestinal tract play in micronutrient absorption, the authors wrote. As an educational tool, the update includes a diagram that indicates the areas of the stomach, duodenum, jejunum, and ileum that may be altered by bariatric surgery and how they factor into micronutrient absorption.

“It makes it easier to see why certain surgical procedures are more likely to cause certain deficiencies,” Patel said.

 

Postsurgery Patient Management

Post surgery, clinicians should monitor patients for other problems that could affect nutrient absorption, including food intolerances, drug-nutrient interactions, and increased gastrointestinal transit time.

Patel and coauthors discussed the pros and cons of multivitamin mineral supplement formulations as well as specific vitamin and mineral recommendations for patients undergoing certain metabolic or bariatric surgery procedures. They included three supplemental cases in the appendix to illustrate supplementation recommendations and long-term maintenance suggestions.

“It’s important to remember that most of these deficiencies present without many clinical symptoms, so it becomes essential to screen for them and repeat as needed,” Patel said.

The update also tackles postoperative nutritional assessments and diet progression. No evidence supports following one postsurgical diet progression protocol over another, but they generally proceed from a clear liquid diet to foods with normal textures, the authors noted. Clinicians should adapt them according to the procedure type, they added.

In addition, clinicians must troubleshoot any nutrition-related concerns, including constipation, dehydration, nausea, heartburn, and fatigue, for up to a year after surgery, they wrote.

Metabolic and bariatric surgery patients should be evaluated annually at a minimum, if not more frequently, to gauge nutritional health, the authors wrote. Treating obesity as a disease involves more than weight loss — instead, it’s about improving the quality of life of patients through procedures, medications, and lifestyle modifications, they added.

 

Track New Developments

With ongoing changes in the field of metabolic and bariatric surgery, it’s helpful for clinicians to remain updated about new approaches across various disciplines linked to obesity management and treatment, said Christina Poa-Li, MD, a surgeon at Huntington Health Medical Center, affiliated with Cedars-Sinai Health System, in Pasadena, California, who was not involved in developing the updated practice statement.

“For example, the rapidly growing prescription of anti-obesity medications and their use in both preoperative and postoperative surgical patients drastically affect their nutrition,” she said. “Providers of various backgrounds and specialties will benefit from the most updated guidance on evaluating patient nutrition.”

Clinicians should consider expanding their patient population to include those with metabolic dysfunction–associated steatohepatitis or metabolic dysfunction–associated steatotic liver disease, Poa-Li said.

“These patient subpopulations may not have been considered for bariatric surgery or even referral to a bariatric surgeon for consultation previously,” she said. “It is important to increase awareness among clinicians of the potential benefits for metabolic and bariatric surgery for these patients.”

The report didn’t receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Patel and Poa-Li reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Among patients with obesity and compensated cirrhosis, bariatric surgery may significantly lower the risk of developing serious liver disease complications, according to a recent study by Cleveland Clinic researchers.

Compared with patients who received medical therapy alone, those who underwent bariatric surgery had a 72% lower risk of developing serious complications of liver disease and an 80% lower risk for progression to decompensated cirrhosis.

The results could have major implications for patients with metabolic dysfunction–associated steatohepatitis (MASH), particularly given that about 20% of patients with MASH progress to cirrhosis, the researchers said.

 

“Currently, lifestyle intervention is the only therapeutic recommendation for compensated MASH-related cirrhosis,” said Steven Nissen, MD, the senior author and chief academic officer of the Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Ohio.

“However, lifestyle changes alone rarely provide the weight loss and metabolic changes needed to reduce the risk of liver complications in this patient population,” he said. “This study shows that bariatric surgery is an effective treatment that can influence the trajectory of cirrhosis progression in select patients.”

The study was published online in Nature Medicine.

 

Significantly Reduced Risks

As part of the Surgical Procedures Eliminate Compensated Cirrhosis in Advancing Long-Term (SPECCIAL) observational study, Nissen and colleagues compared the long-term effects of metabolic surgery and medical treatment in patients with obesity and compensated, biopsy-proven MASH-related cirrhosis. They looked for six major adverse liver outcomes (MALO): ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, liver transplantation, and all-cause mortality.

Among nearly 37,000 patients who underwent liver biopsy at the Cleveland Clinic Health System between 1995 and 2020, the research team identified 168 patients (69.6% women) with MASH-related cirrhosis, Child-Pugh class A, and model for end-stage liver disease scores ≤ 10. Among those, 62 underwent metabolic surgery (37 Roux-en-Y gastric bypass and 25 sleeve gastrectomy) and 106 had nonsurgical treatment.

After overlap weighting, the groups had balanced baseline characteristics, including mean body mass index of 42.7, Fibrosis-4 score of 2.1, albumin of 4.1 g/dL, bilirubin of 0.6 mg/dL, and Elixhauser comorbidity index of 9. In each group, 84.5% had type 2 diabetes and 79.1% had Ishak fibrosis stage 6.

Overall, the 15-year cumulative incidence of MALO was 20.9% in the surgical group and 46.4% in the nonsurgical group (adjusted hazard ratio [aHR], 0.28; P = .003), with MALO occurring in 10 surgical patients and 42 nonsurgical patients.

Assuming a causal effect, the number needed to treat with metabolic surgery to avoid one incidence of MALO over a 15-year timespan was 4.5. 

The 15-year incidence of MALO was similar between surgical methods, with 20.1% for Roux-en-Y gastric bypass and 19.9% for sleeve gastrectomy.

In addition, the 15-year cumulative incidence of progression to decompensated cirrhosis was 15.6% in the surgical group and 30.7% in the nonsurgical group (aHR, 0.2; P = .01), with decompensation occurring in four surgical patients and 33 nonsurgical patients.

At 15 years, patients in the surgical group lost 31.6 kg or about 26.6% of their weight, and those in the nonsurgical group lost 10.7 kg or 9.8%.

Among patients with type 2 diabetes at baseline, metabolic surgery was associated with a reduction in hemoglobin A1c levels, as well as diabetes remission for some patients.

 

Potential to Fill an Unmet Need

Previous studies have indicated that bariatric surgery can effectively treat noncirrhotic MASH and lead to histologic resolution of MASH. In a 2021 study, Nissen and colleagues found bariatric surgery was associated with a lower risk for MALO and major adverse cardiovascular events in patients with biopsy-proven MASH without cirrhosis. Now, Nissen said, the SPECCIAL study indicates surgery may be a good option for MASH-related cirrhosis as well.

The study authors also noted that similar findings are theoretically possible from medical therapies, given the emergence of a new generation of anti-obesity medications. In this study, 16.8% of the surgical group and 14.3% of the nonsurgical group took semaglutide or tirzepatide at some point during the follow-up period.

“Patients with MASH-related cirrhosis have extremely limited treatment options,” said Sobia Laique, MD, study coauthor and a transplant hepatologist at the Cleveland Clinic who specializes in MASH-related cirrhosis. She cofounded the Cleveland Clinic’s task force on metabolic dysfunction–associated steatotic liver disease (MASLD) to improve screening, management, and patient outcomes for MASLD and related comorbidities.

“No therapeutic interventions have demonstrated efficacy in mitigating the risk of severe liver complications for these patients,” she said. “This underscores a critical unmet need for the development of effective therapies specifically targeting patients with compensated MASH-related cirrhosis.”

No funding was reported for this study. Several authors reported receiving grant funding, consultant fees, and advisory roles for various pharmaceutical companies.

A version of this article appeared on Medscape.com.

Among patients with obesity and compensated cirrhosis, bariatric surgery may significantly lower the risk of developing serious liver disease complications, according to a recent study by Cleveland Clinic researchers.

Compared with patients who received medical therapy alone, those who underwent bariatric surgery had a 72% lower risk of developing serious complications of liver disease and an 80% lower risk for progression to decompensated cirrhosis.

The results could have major implications for patients with metabolic dysfunction–associated steatohepatitis (MASH), particularly given that about 20% of patients with MASH progress to cirrhosis, the researchers said.

 

“Currently, lifestyle intervention is the only therapeutic recommendation for compensated MASH-related cirrhosis,” said Steven Nissen, MD, the senior author and chief academic officer of the Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Ohio.

“However, lifestyle changes alone rarely provide the weight loss and metabolic changes needed to reduce the risk of liver complications in this patient population,” he said. “This study shows that bariatric surgery is an effective treatment that can influence the trajectory of cirrhosis progression in select patients.”

The study was published online in Nature Medicine.

 

Significantly Reduced Risks

As part of the Surgical Procedures Eliminate Compensated Cirrhosis in Advancing Long-Term (SPECCIAL) observational study, Nissen and colleagues compared the long-term effects of metabolic surgery and medical treatment in patients with obesity and compensated, biopsy-proven MASH-related cirrhosis. They looked for six major adverse liver outcomes (MALO): ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, liver transplantation, and all-cause mortality.

Among nearly 37,000 patients who underwent liver biopsy at the Cleveland Clinic Health System between 1995 and 2020, the research team identified 168 patients (69.6% women) with MASH-related cirrhosis, Child-Pugh class A, and model for end-stage liver disease scores ≤ 10. Among those, 62 underwent metabolic surgery (37 Roux-en-Y gastric bypass and 25 sleeve gastrectomy) and 106 had nonsurgical treatment.

After overlap weighting, the groups had balanced baseline characteristics, including mean body mass index of 42.7, Fibrosis-4 score of 2.1, albumin of 4.1 g/dL, bilirubin of 0.6 mg/dL, and Elixhauser comorbidity index of 9. In each group, 84.5% had type 2 diabetes and 79.1% had Ishak fibrosis stage 6.

Overall, the 15-year cumulative incidence of MALO was 20.9% in the surgical group and 46.4% in the nonsurgical group (adjusted hazard ratio [aHR], 0.28; P = .003), with MALO occurring in 10 surgical patients and 42 nonsurgical patients.

Assuming a causal effect, the number needed to treat with metabolic surgery to avoid one incidence of MALO over a 15-year timespan was 4.5. 

The 15-year incidence of MALO was similar between surgical methods, with 20.1% for Roux-en-Y gastric bypass and 19.9% for sleeve gastrectomy.

In addition, the 15-year cumulative incidence of progression to decompensated cirrhosis was 15.6% in the surgical group and 30.7% in the nonsurgical group (aHR, 0.2; P = .01), with decompensation occurring in four surgical patients and 33 nonsurgical patients.

At 15 years, patients in the surgical group lost 31.6 kg or about 26.6% of their weight, and those in the nonsurgical group lost 10.7 kg or 9.8%.

Among patients with type 2 diabetes at baseline, metabolic surgery was associated with a reduction in hemoglobin A1c levels, as well as diabetes remission for some patients.

 

Potential to Fill an Unmet Need

Previous studies have indicated that bariatric surgery can effectively treat noncirrhotic MASH and lead to histologic resolution of MASH. In a 2021 study, Nissen and colleagues found bariatric surgery was associated with a lower risk for MALO and major adverse cardiovascular events in patients with biopsy-proven MASH without cirrhosis. Now, Nissen said, the SPECCIAL study indicates surgery may be a good option for MASH-related cirrhosis as well.

The study authors also noted that similar findings are theoretically possible from medical therapies, given the emergence of a new generation of anti-obesity medications. In this study, 16.8% of the surgical group and 14.3% of the nonsurgical group took semaglutide or tirzepatide at some point during the follow-up period.

“Patients with MASH-related cirrhosis have extremely limited treatment options,” said Sobia Laique, MD, study coauthor and a transplant hepatologist at the Cleveland Clinic who specializes in MASH-related cirrhosis. She cofounded the Cleveland Clinic’s task force on metabolic dysfunction–associated steatotic liver disease (MASLD) to improve screening, management, and patient outcomes for MASLD and related comorbidities.

“No therapeutic interventions have demonstrated efficacy in mitigating the risk of severe liver complications for these patients,” she said. “This underscores a critical unmet need for the development of effective therapies specifically targeting patients with compensated MASH-related cirrhosis.”

No funding was reported for this study. Several authors reported receiving grant funding, consultant fees, and advisory roles for various pharmaceutical companies.

A version of this article appeared on Medscape.com.

Among patients with obesity and compensated cirrhosis, bariatric surgery may significantly lower the risk of developing serious liver disease complications, according to a recent study by Cleveland Clinic researchers.

Compared with patients who received medical therapy alone, those who underwent bariatric surgery had a 72% lower risk of developing serious complications of liver disease and an 80% lower risk for progression to decompensated cirrhosis.

The results could have major implications for patients with metabolic dysfunction–associated steatohepatitis (MASH), particularly given that about 20% of patients with MASH progress to cirrhosis, the researchers said.

 

“Currently, lifestyle intervention is the only therapeutic recommendation for compensated MASH-related cirrhosis,” said Steven Nissen, MD, the senior author and chief academic officer of the Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Ohio.

“However, lifestyle changes alone rarely provide the weight loss and metabolic changes needed to reduce the risk of liver complications in this patient population,” he said. “This study shows that bariatric surgery is an effective treatment that can influence the trajectory of cirrhosis progression in select patients.”

The study was published online in Nature Medicine.

 

Significantly Reduced Risks

As part of the Surgical Procedures Eliminate Compensated Cirrhosis in Advancing Long-Term (SPECCIAL) observational study, Nissen and colleagues compared the long-term effects of metabolic surgery and medical treatment in patients with obesity and compensated, biopsy-proven MASH-related cirrhosis. They looked for six major adverse liver outcomes (MALO): ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, liver transplantation, and all-cause mortality.

Among nearly 37,000 patients who underwent liver biopsy at the Cleveland Clinic Health System between 1995 and 2020, the research team identified 168 patients (69.6% women) with MASH-related cirrhosis, Child-Pugh class A, and model for end-stage liver disease scores ≤ 10. Among those, 62 underwent metabolic surgery (37 Roux-en-Y gastric bypass and 25 sleeve gastrectomy) and 106 had nonsurgical treatment.

After overlap weighting, the groups had balanced baseline characteristics, including mean body mass index of 42.7, Fibrosis-4 score of 2.1, albumin of 4.1 g/dL, bilirubin of 0.6 mg/dL, and Elixhauser comorbidity index of 9. In each group, 84.5% had type 2 diabetes and 79.1% had Ishak fibrosis stage 6.

Overall, the 15-year cumulative incidence of MALO was 20.9% in the surgical group and 46.4% in the nonsurgical group (adjusted hazard ratio [aHR], 0.28; P = .003), with MALO occurring in 10 surgical patients and 42 nonsurgical patients.

Assuming a causal effect, the number needed to treat with metabolic surgery to avoid one incidence of MALO over a 15-year timespan was 4.5. 

The 15-year incidence of MALO was similar between surgical methods, with 20.1% for Roux-en-Y gastric bypass and 19.9% for sleeve gastrectomy.

In addition, the 15-year cumulative incidence of progression to decompensated cirrhosis was 15.6% in the surgical group and 30.7% in the nonsurgical group (aHR, 0.2; P = .01), with decompensation occurring in four surgical patients and 33 nonsurgical patients.

At 15 years, patients in the surgical group lost 31.6 kg or about 26.6% of their weight, and those in the nonsurgical group lost 10.7 kg or 9.8%.

Among patients with type 2 diabetes at baseline, metabolic surgery was associated with a reduction in hemoglobin A1c levels, as well as diabetes remission for some patients.

 

Potential to Fill an Unmet Need

Previous studies have indicated that bariatric surgery can effectively treat noncirrhotic MASH and lead to histologic resolution of MASH. In a 2021 study, Nissen and colleagues found bariatric surgery was associated with a lower risk for MALO and major adverse cardiovascular events in patients with biopsy-proven MASH without cirrhosis. Now, Nissen said, the SPECCIAL study indicates surgery may be a good option for MASH-related cirrhosis as well.

The study authors also noted that similar findings are theoretically possible from medical therapies, given the emergence of a new generation of anti-obesity medications. In this study, 16.8% of the surgical group and 14.3% of the nonsurgical group took semaglutide or tirzepatide at some point during the follow-up period.

“Patients with MASH-related cirrhosis have extremely limited treatment options,” said Sobia Laique, MD, study coauthor and a transplant hepatologist at the Cleveland Clinic who specializes in MASH-related cirrhosis. She cofounded the Cleveland Clinic’s task force on metabolic dysfunction–associated steatotic liver disease (MASLD) to improve screening, management, and patient outcomes for MASLD and related comorbidities.

“No therapeutic interventions have demonstrated efficacy in mitigating the risk of severe liver complications for these patients,” she said. “This underscores a critical unmet need for the development of effective therapies specifically targeting patients with compensated MASH-related cirrhosis.”

No funding was reported for this study. Several authors reported receiving grant funding, consultant fees, and advisory roles for various pharmaceutical companies.

A version of this article appeared on Medscape.com.

The American Gastroenterological Association (AGA) has released an updated clinical practice guideline on the prevention of hepatitis B virus reactivation (HBVr) in at-risk persons. The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.

Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.

With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.

 

“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”

Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”

 

Main Recommendations

AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.

The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.

1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).

2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.

Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.

3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.

4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.

It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.

 

Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment

The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.

In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.

 

A ‘Useful Clinical Tool’

Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”

In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.

She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.

“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.

Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.

 

The Future

According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.

Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.

The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.

AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.

The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.

A version of this article appeared on Medscape.com.

The American Gastroenterological Association (AGA) has released an updated clinical practice guideline on the prevention of hepatitis B virus reactivation (HBVr) in at-risk persons. The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.

Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.

With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.

 

“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”

Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”

 

Main Recommendations

AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.

The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.

1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).

2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.

Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.

3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.

4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.

It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.

 

Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment

The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.

In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.

 

A ‘Useful Clinical Tool’

Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”

In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.

She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.

“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.

Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.

 

The Future

According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.

Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.

The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.

AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.

The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.

A version of this article appeared on Medscape.com.

The American Gastroenterological Association (AGA) has released an updated clinical practice guideline on the prevention of hepatitis B virus reactivation (HBVr) in at-risk persons. The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.

Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.

With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.

 

“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”

Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”

 

Main Recommendations

AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.

The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.

1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).

2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.

Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.

3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.

4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.

It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.

 

Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment

The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.

In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.

 

A ‘Useful Clinical Tool’

Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”

In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.

She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.

“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.

Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.

 

The Future

According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.

Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.

The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.

AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.

The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.

A version of this article appeared on Medscape.com.

At least 250,000 US hospitalized patients a year require enteral support using an artificial pathway into the gastrointestinal (GI) tract to deliver nutrition or medication. In light of this, AGA has issued a clinical practice update to improve the practice of endoscopic enteral access.

Covering indications, placement techniques, and management, the comprehensive document is a response to the increasing use of enteral access devices in chronic GI conditions. The update, published in Gastroenterology, addresses patient factors complicating placement decision-making such as thrombocytopenia, use of dual antiplatelet therapy, or performance of percutaneous access in the setting of cirrhosis.

 

“We provide clinical recommendations in these various scenarios understanding that the final decision-making is in the hands of the provider and care team,” said first author Dejan Micic, MD, a gastroenterologist and associate professor at University of Chicago Medical Center in Illinois at the time of the update (since relocated to Loyola University Medical Center in Chicago). “We hope this can serve a day-to-day purpose for clinical gastroenterologists and can be referenced as they encounter individuals with or needing an enteral access device.”

Traditionally, enteral access was reserved for patients with severe malnutrition or those unable to maintain oral intake. Recent recommendations emphasize early nutritional intervention including prehabilitation before major surgery, adjunctive therapy for oncology patients, and in specific inflammatory conditions such as Crohn’s disease. “These shifts recognize the role of enteral nutrition not only in preventing malnutrition but also as a therapeutic strategy,” Micic said in an interview.

There is, however, variability in the use of devices including the selection of appropriate units, technical aspects of placement, and subsequent management. “Such variability can lead to complications, suboptimal patient outcomes, and inefficiencies in care delivery,” Micic said.

He added that enteral access has been historically underemphasized in GI endoscopic training. “While procedural skill in placing devices such as percutaneous endoscopic gastrostomy, or PEG, tubes is often taught, a comprehensive understanding of the broader clinical context — such as proper patient selection, prevention of complications, and postplacement care — is not always thoroughly covered.”

The current update aims to bridge knowledge gaps with evidence-based-guidance. “It also underscores the importance of interdisciplinary collaboration with dietitians, nurses, and care givers to achieve the best outcomes for patients,” Micic said.

 

Commenting on the update but not involved with creating it, Shirley C. Paski, MD, MS, a gastroenterologist at the Cleveland Clinic, Ohio, called it timely, adding: “As GI training is becoming more subspecialized and interventional radiology has been able to provide enteral access, gastroenterology training in enteral access has declined to where some fellows are graduating with limited enteral access experience.”

Yet malnutrition remains a common consequence when GI disease is severe, chronic, or refractory to treatment, or in the setting of postsurgical anatomy, she added. “Enteral nutrition is increasingly being considered a therapeutic or adjunct treatment in some cases of Crohn’s disease or small intestinal bacterial overgrowth. Gastroenterologists need the endoscopic skill to secure enteral access tubes, particularly in more challenging anatomy.”

 

Also commenting on the document but not involved in it, Steven Shamah, MD, director of Endoscopy at Northwell Lenox Hill Hospital in New York City, said: “This should serve as a concise review for any general hospitalist or gastroenterologist to understand what we have and when we should offer the proper feeding tube options.” He stressed, however, that all gastroenterologists should be trained in the placing of all of tube options.

“The axiom ‘If the gut works, we should use it’ is something that I was taught when I was a medical student and it still holds true,” Shamah continued. “There’s been a jump in interventional procedures to assure continuity of the GI tract even in progressive malignancy. So there’s a rise in moving away from intravenous nutrition and a rise in tube-delivered enteral nutrition.” Options for reducing reflux and aspiration will likely take on more importance, he said.

 

Tubing Options

According to Micic and colleagues, recent data suggest a favorable safety profile of enteral feeding tubes placed endoscopically compared with surgical or radiologic placement. The illustrated AGA document outlines such approaches as synthetic flexible tubes placed into the stomach or small bowel via the oral (orogastric and oroenteral) or nasal routes (nasogastric [NG] and nasojejunal [NJ]) and percutaneous tubes accessing the stomach. The choice of tube, access point, delivery site, and feeding method varies with indication, expected duration of use, and patient anatomy, the authors stressed.

The update notes that NG and NJ tubes can be used immediately after confirmation of placement, most often with abdominal radiography. PEG tubes can be used immediately for medications and after 4 hours for tube feedings. A multidisciplinary team approach after placement provides improved patient care. “Dietitians assist with formula choice, volume, free water needs, and delivery method, and nurses and advanced practice clinicians assist with tube site assessment and troubleshooting,” the authors wrote.

Complications can occur but should be infrequent, Micic said. “Frankly, most complications can be predicted based on the duration of use and prevented with appropriate monitoring.” Common complications include tube dislodgement, clogging, site infections, buried bumper syndrome, and aspiration. “Minimizing these risks requires a thorough understanding of patient-specific factors, careful technique during placement, and ongoing monitoring after the device is in use,” he added.

Paski said the update aligns with established guidelines for enteral access but also offers suggestions to mitigate the risk of tube placement in patients in whom placement has traditionally been more challenging. “This is a helpful addition to the literature because if enteral access cannot be obtained in a patient unable to meet their needs orally, total paternal nutrition is the next and much more invasive step for nutrition support.”

She called the practice update a concise, comprehensive reference for trainees and experienced gastroenterologists to optimize placement conditions and reduce complication risk, noting that training in nutrition is suboptimal in many GI fellowships.

Becoming familiar with common and advanced enteral access techniques is within the armamentarium of all practicing gastroenterologists, the authors stated. Because malnutrition affects nearly all GI disorders, “understanding common routes of enteral access and the basic principles of nutrition support promotes the initiation of optimal enteral nutrition, mitigating the impact of malnutrition, and improving prognosis for patients at nutritional risk,” they wrote.

Micic served on the advisory board for Ironwood Pharmaceuticals and is on the speaker’s bureau for Takeda Pharmaceuticals. One coauthor served as a consultant for Merit Medical, Circa Scientific, and Aspero Medical. Paski and Shamah had disclosed no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

At least 250,000 US hospitalized patients a year require enteral support using an artificial pathway into the gastrointestinal (GI) tract to deliver nutrition or medication. In light of this, AGA has issued a clinical practice update to improve the practice of endoscopic enteral access.

Covering indications, placement techniques, and management, the comprehensive document is a response to the increasing use of enteral access devices in chronic GI conditions. The update, published in Gastroenterology, addresses patient factors complicating placement decision-making such as thrombocytopenia, use of dual antiplatelet therapy, or performance of percutaneous access in the setting of cirrhosis.

 

“We provide clinical recommendations in these various scenarios understanding that the final decision-making is in the hands of the provider and care team,” said first author Dejan Micic, MD, a gastroenterologist and associate professor at University of Chicago Medical Center in Illinois at the time of the update (since relocated to Loyola University Medical Center in Chicago). “We hope this can serve a day-to-day purpose for clinical gastroenterologists and can be referenced as they encounter individuals with or needing an enteral access device.”

Traditionally, enteral access was reserved for patients with severe malnutrition or those unable to maintain oral intake. Recent recommendations emphasize early nutritional intervention including prehabilitation before major surgery, adjunctive therapy for oncology patients, and in specific inflammatory conditions such as Crohn’s disease. “These shifts recognize the role of enteral nutrition not only in preventing malnutrition but also as a therapeutic strategy,” Micic said in an interview.

There is, however, variability in the use of devices including the selection of appropriate units, technical aspects of placement, and subsequent management. “Such variability can lead to complications, suboptimal patient outcomes, and inefficiencies in care delivery,” Micic said.

He added that enteral access has been historically underemphasized in GI endoscopic training. “While procedural skill in placing devices such as percutaneous endoscopic gastrostomy, or PEG, tubes is often taught, a comprehensive understanding of the broader clinical context — such as proper patient selection, prevention of complications, and postplacement care — is not always thoroughly covered.”

The current update aims to bridge knowledge gaps with evidence-based-guidance. “It also underscores the importance of interdisciplinary collaboration with dietitians, nurses, and care givers to achieve the best outcomes for patients,” Micic said.

 

Commenting on the update but not involved with creating it, Shirley C. Paski, MD, MS, a gastroenterologist at the Cleveland Clinic, Ohio, called it timely, adding: “As GI training is becoming more subspecialized and interventional radiology has been able to provide enteral access, gastroenterology training in enteral access has declined to where some fellows are graduating with limited enteral access experience.”

Yet malnutrition remains a common consequence when GI disease is severe, chronic, or refractory to treatment, or in the setting of postsurgical anatomy, she added. “Enteral nutrition is increasingly being considered a therapeutic or adjunct treatment in some cases of Crohn’s disease or small intestinal bacterial overgrowth. Gastroenterologists need the endoscopic skill to secure enteral access tubes, particularly in more challenging anatomy.”

 

Also commenting on the document but not involved in it, Steven Shamah, MD, director of Endoscopy at Northwell Lenox Hill Hospital in New York City, said: “This should serve as a concise review for any general hospitalist or gastroenterologist to understand what we have and when we should offer the proper feeding tube options.” He stressed, however, that all gastroenterologists should be trained in the placing of all of tube options.

“The axiom ‘If the gut works, we should use it’ is something that I was taught when I was a medical student and it still holds true,” Shamah continued. “There’s been a jump in interventional procedures to assure continuity of the GI tract even in progressive malignancy. So there’s a rise in moving away from intravenous nutrition and a rise in tube-delivered enteral nutrition.” Options for reducing reflux and aspiration will likely take on more importance, he said.

 

Tubing Options

According to Micic and colleagues, recent data suggest a favorable safety profile of enteral feeding tubes placed endoscopically compared with surgical or radiologic placement. The illustrated AGA document outlines such approaches as synthetic flexible tubes placed into the stomach or small bowel via the oral (orogastric and oroenteral) or nasal routes (nasogastric [NG] and nasojejunal [NJ]) and percutaneous tubes accessing the stomach. The choice of tube, access point, delivery site, and feeding method varies with indication, expected duration of use, and patient anatomy, the authors stressed.

The update notes that NG and NJ tubes can be used immediately after confirmation of placement, most often with abdominal radiography. PEG tubes can be used immediately for medications and after 4 hours for tube feedings. A multidisciplinary team approach after placement provides improved patient care. “Dietitians assist with formula choice, volume, free water needs, and delivery method, and nurses and advanced practice clinicians assist with tube site assessment and troubleshooting,” the authors wrote.

Complications can occur but should be infrequent, Micic said. “Frankly, most complications can be predicted based on the duration of use and prevented with appropriate monitoring.” Common complications include tube dislodgement, clogging, site infections, buried bumper syndrome, and aspiration. “Minimizing these risks requires a thorough understanding of patient-specific factors, careful technique during placement, and ongoing monitoring after the device is in use,” he added.

Paski said the update aligns with established guidelines for enteral access but also offers suggestions to mitigate the risk of tube placement in patients in whom placement has traditionally been more challenging. “This is a helpful addition to the literature because if enteral access cannot be obtained in a patient unable to meet their needs orally, total paternal nutrition is the next and much more invasive step for nutrition support.”

She called the practice update a concise, comprehensive reference for trainees and experienced gastroenterologists to optimize placement conditions and reduce complication risk, noting that training in nutrition is suboptimal in many GI fellowships.

Becoming familiar with common and advanced enteral access techniques is within the armamentarium of all practicing gastroenterologists, the authors stated. Because malnutrition affects nearly all GI disorders, “understanding common routes of enteral access and the basic principles of nutrition support promotes the initiation of optimal enteral nutrition, mitigating the impact of malnutrition, and improving prognosis for patients at nutritional risk,” they wrote.

Micic served on the advisory board for Ironwood Pharmaceuticals and is on the speaker’s bureau for Takeda Pharmaceuticals. One coauthor served as a consultant for Merit Medical, Circa Scientific, and Aspero Medical. Paski and Shamah had disclosed no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

At least 250,000 US hospitalized patients a year require enteral support using an artificial pathway into the gastrointestinal (GI) tract to deliver nutrition or medication. In light of this, AGA has issued a clinical practice update to improve the practice of endoscopic enteral access.

Covering indications, placement techniques, and management, the comprehensive document is a response to the increasing use of enteral access devices in chronic GI conditions. The update, published in Gastroenterology, addresses patient factors complicating placement decision-making such as thrombocytopenia, use of dual antiplatelet therapy, or performance of percutaneous access in the setting of cirrhosis.

 

“We provide clinical recommendations in these various scenarios understanding that the final decision-making is in the hands of the provider and care team,” said first author Dejan Micic, MD, a gastroenterologist and associate professor at University of Chicago Medical Center in Illinois at the time of the update (since relocated to Loyola University Medical Center in Chicago). “We hope this can serve a day-to-day purpose for clinical gastroenterologists and can be referenced as they encounter individuals with or needing an enteral access device.”

Traditionally, enteral access was reserved for patients with severe malnutrition or those unable to maintain oral intake. Recent recommendations emphasize early nutritional intervention including prehabilitation before major surgery, adjunctive therapy for oncology patients, and in specific inflammatory conditions such as Crohn’s disease. “These shifts recognize the role of enteral nutrition not only in preventing malnutrition but also as a therapeutic strategy,” Micic said in an interview.

There is, however, variability in the use of devices including the selection of appropriate units, technical aspects of placement, and subsequent management. “Such variability can lead to complications, suboptimal patient outcomes, and inefficiencies in care delivery,” Micic said.

He added that enteral access has been historically underemphasized in GI endoscopic training. “While procedural skill in placing devices such as percutaneous endoscopic gastrostomy, or PEG, tubes is often taught, a comprehensive understanding of the broader clinical context — such as proper patient selection, prevention of complications, and postplacement care — is not always thoroughly covered.”

The current update aims to bridge knowledge gaps with evidence-based-guidance. “It also underscores the importance of interdisciplinary collaboration with dietitians, nurses, and care givers to achieve the best outcomes for patients,” Micic said.

 

Commenting on the update but not involved with creating it, Shirley C. Paski, MD, MS, a gastroenterologist at the Cleveland Clinic, Ohio, called it timely, adding: “As GI training is becoming more subspecialized and interventional radiology has been able to provide enteral access, gastroenterology training in enteral access has declined to where some fellows are graduating with limited enteral access experience.”

Yet malnutrition remains a common consequence when GI disease is severe, chronic, or refractory to treatment, or in the setting of postsurgical anatomy, she added. “Enteral nutrition is increasingly being considered a therapeutic or adjunct treatment in some cases of Crohn’s disease or small intestinal bacterial overgrowth. Gastroenterologists need the endoscopic skill to secure enteral access tubes, particularly in more challenging anatomy.”

 

Also commenting on the document but not involved in it, Steven Shamah, MD, director of Endoscopy at Northwell Lenox Hill Hospital in New York City, said: “This should serve as a concise review for any general hospitalist or gastroenterologist to understand what we have and when we should offer the proper feeding tube options.” He stressed, however, that all gastroenterologists should be trained in the placing of all of tube options.

“The axiom ‘If the gut works, we should use it’ is something that I was taught when I was a medical student and it still holds true,” Shamah continued. “There’s been a jump in interventional procedures to assure continuity of the GI tract even in progressive malignancy. So there’s a rise in moving away from intravenous nutrition and a rise in tube-delivered enteral nutrition.” Options for reducing reflux and aspiration will likely take on more importance, he said.

 

Tubing Options

According to Micic and colleagues, recent data suggest a favorable safety profile of enteral feeding tubes placed endoscopically compared with surgical or radiologic placement. The illustrated AGA document outlines such approaches as synthetic flexible tubes placed into the stomach or small bowel via the oral (orogastric and oroenteral) or nasal routes (nasogastric [NG] and nasojejunal [NJ]) and percutaneous tubes accessing the stomach. The choice of tube, access point, delivery site, and feeding method varies with indication, expected duration of use, and patient anatomy, the authors stressed.

The update notes that NG and NJ tubes can be used immediately after confirmation of placement, most often with abdominal radiography. PEG tubes can be used immediately for medications and after 4 hours for tube feedings. A multidisciplinary team approach after placement provides improved patient care. “Dietitians assist with formula choice, volume, free water needs, and delivery method, and nurses and advanced practice clinicians assist with tube site assessment and troubleshooting,” the authors wrote.

Complications can occur but should be infrequent, Micic said. “Frankly, most complications can be predicted based on the duration of use and prevented with appropriate monitoring.” Common complications include tube dislodgement, clogging, site infections, buried bumper syndrome, and aspiration. “Minimizing these risks requires a thorough understanding of patient-specific factors, careful technique during placement, and ongoing monitoring after the device is in use,” he added.

Paski said the update aligns with established guidelines for enteral access but also offers suggestions to mitigate the risk of tube placement in patients in whom placement has traditionally been more challenging. “This is a helpful addition to the literature because if enteral access cannot be obtained in a patient unable to meet their needs orally, total paternal nutrition is the next and much more invasive step for nutrition support.”

She called the practice update a concise, comprehensive reference for trainees and experienced gastroenterologists to optimize placement conditions and reduce complication risk, noting that training in nutrition is suboptimal in many GI fellowships.

Becoming familiar with common and advanced enteral access techniques is within the armamentarium of all practicing gastroenterologists, the authors stated. Because malnutrition affects nearly all GI disorders, “understanding common routes of enteral access and the basic principles of nutrition support promotes the initiation of optimal enteral nutrition, mitigating the impact of malnutrition, and improving prognosis for patients at nutritional risk,” they wrote.

Micic served on the advisory board for Ironwood Pharmaceuticals and is on the speaker’s bureau for Takeda Pharmaceuticals. One coauthor served as a consultant for Merit Medical, Circa Scientific, and Aspero Medical. Paski and Shamah had disclosed no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.