Liver Disease

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Identification of a case of acute hepatitis C virus (HCV) infection in a frequent blood donor without other risk factors should be considered a sentinel event and should prompt public health investigation, according to research published in Morbidity and Mortality Weekly Report, because this could indicate a possible health care–associated infection.

©vchal/Thinkstock

Negative media reports about the safety of the hepatitis B vaccine in China harmed perception of the vaccine’s safety among patients, according to a recent study. Although the reports were erroneous, the failure of public health departments to communicate effectively contributed to a rise in the number of parents refusing to vaccinate their children.

An experimental, highly specific and sensitive HCV core antigen enzyme immunoassay (HCV-Ags EIA) was found to have the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL. Investigators found that the HCV-Ags EIA reliably differentiated viremic HCV infection from resolved HCV infection, thus accomplishing screening and diagnosis of viremic HCV infection in one step.

Loss of confidence in the hepatitis B vaccine following disproved allegations that the vaccine caused multiple sclerosis persists in France, according to research published in Human Vaccines & Immunotherapeutics.

The approval of the direct-acting antiviral agents (DAAs) grazoprevir and elbasvir with an indication for all levels of kidney function and dialysis has altered the landscape for the treatment of hepatitis C virus in patients with chronic kidney disease, according to a review in Clinical Liver Disease. The authors say this is because other DAAs are either not approved for use in patients with advanced chronic kidney disease or no safety data are available for the dialysis population.

A study in the Journal of Viral Hepatitis found that insulin resistance was associated with an increased risk for loss of vaccine-acquired anti-HBs (hepatitis B surface antigen) in a large sample of a nondiabetic, general population, indicating a possible role of insulin resistance in vaccine-induced immunity.

Grazoprevir, a second-generation HCV NS3/4A protease inhibitor, combined with ribavirin was associated with a rapid and sustained suppression of HCV RNA in a randomized study. The authors said the results support further evaluation of grazoprevir-based treatment regimens.

HIV–HCV coinfected patients treated with a fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) showed significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation, according to a study in the Journal of Viral Hepatitis.

A Swedish study found that diabetes mellitus and cirrhosis are strong risk factors for hepatocellular carcinoma development after sustained virologic response (SVR) following treatment for chronic HCV has been achieved. However, the risk to develop hepatocellular carcinoma diminished significantly 2 years after SVR.

Chinese investigators said serum levels of platelet-derived growth factor (PDGF) decreased remarkably through fibrosis progression and could be used as a noninvasive biomarker for the assessment of fibrosis stage in patients with chronic hepatitis B virus (HBV).

A genome-wide association study of liver fibrosis progression in patients coinfected with HCV and HIV identified a new locus associated with fibrosis severity on chromosome 3p25. The authors said the results may help define new targets for drug development or new prognostic tests.

The RNA helicase DDX5 and E3 ligase Mex3b are important cellular targets for the design of novel, epigenetic therapies to combat HBV infection and poor-prognosis HBV-associated liver cancer, according to a study in Hepatology.

A Japanese study found that daclatasvir (DCV) and asunaprevir (ASV) dual therapy in hemodialysis patients infected with HCV is effective and safe with similar results, compared with patients with normal renal function.

A study evaluating the antiviral effect of ribavirin priming, and its influence on sustained virologic response after combination treatment, found that the lowest response pattern in HCV-infected patients was observed in prior nonresponder patients to pegylated interferon-alfa plus ribavirin combination therapy. The authors said this suggests that not only the individual interferon, but also the ribavirin sensitivity contributes significantly to the nonresponsive state.

A veterinary study provided evidence that hepatitis E virus is able to damage the blood-brain barrier and replicate in the brain and spinal cord.

An all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV genotype 4 subtypes in both treatment-naive and -experienced patients, including those with compensated cirrhosis, according to results of a recent study.

AGA Resource
Through the Hepatitis C Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for your patients.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Identification of a case of acute hepatitis C virus (HCV) infection in a frequent blood donor without other risk factors should be considered a sentinel event and should prompt public health investigation, according to research published in Morbidity and Mortality Weekly Report, because this could indicate a possible health care–associated infection.

©vchal/Thinkstock

Negative media reports about the safety of the hepatitis B vaccine in China harmed perception of the vaccine’s safety among patients, according to a recent study. Although the reports were erroneous, the failure of public health departments to communicate effectively contributed to a rise in the number of parents refusing to vaccinate their children.

An experimental, highly specific and sensitive HCV core antigen enzyme immunoassay (HCV-Ags EIA) was found to have the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL. Investigators found that the HCV-Ags EIA reliably differentiated viremic HCV infection from resolved HCV infection, thus accomplishing screening and diagnosis of viremic HCV infection in one step.

Loss of confidence in the hepatitis B vaccine following disproved allegations that the vaccine caused multiple sclerosis persists in France, according to research published in Human Vaccines & Immunotherapeutics.

The approval of the direct-acting antiviral agents (DAAs) grazoprevir and elbasvir with an indication for all levels of kidney function and dialysis has altered the landscape for the treatment of hepatitis C virus in patients with chronic kidney disease, according to a review in Clinical Liver Disease. The authors say this is because other DAAs are either not approved for use in patients with advanced chronic kidney disease or no safety data are available for the dialysis population.

A study in the Journal of Viral Hepatitis found that insulin resistance was associated with an increased risk for loss of vaccine-acquired anti-HBs (hepatitis B surface antigen) in a large sample of a nondiabetic, general population, indicating a possible role of insulin resistance in vaccine-induced immunity.

Grazoprevir, a second-generation HCV NS3/4A protease inhibitor, combined with ribavirin was associated with a rapid and sustained suppression of HCV RNA in a randomized study. The authors said the results support further evaluation of grazoprevir-based treatment regimens.

HIV–HCV coinfected patients treated with a fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) showed significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation, according to a study in the Journal of Viral Hepatitis.

A Swedish study found that diabetes mellitus and cirrhosis are strong risk factors for hepatocellular carcinoma development after sustained virologic response (SVR) following treatment for chronic HCV has been achieved. However, the risk to develop hepatocellular carcinoma diminished significantly 2 years after SVR.

Chinese investigators said serum levels of platelet-derived growth factor (PDGF) decreased remarkably through fibrosis progression and could be used as a noninvasive biomarker for the assessment of fibrosis stage in patients with chronic hepatitis B virus (HBV).

A genome-wide association study of liver fibrosis progression in patients coinfected with HCV and HIV identified a new locus associated with fibrosis severity on chromosome 3p25. The authors said the results may help define new targets for drug development or new prognostic tests.

The RNA helicase DDX5 and E3 ligase Mex3b are important cellular targets for the design of novel, epigenetic therapies to combat HBV infection and poor-prognosis HBV-associated liver cancer, according to a study in Hepatology.

A Japanese study found that daclatasvir (DCV) and asunaprevir (ASV) dual therapy in hemodialysis patients infected with HCV is effective and safe with similar results, compared with patients with normal renal function.

A study evaluating the antiviral effect of ribavirin priming, and its influence on sustained virologic response after combination treatment, found that the lowest response pattern in HCV-infected patients was observed in prior nonresponder patients to pegylated interferon-alfa plus ribavirin combination therapy. The authors said this suggests that not only the individual interferon, but also the ribavirin sensitivity contributes significantly to the nonresponsive state.

A veterinary study provided evidence that hepatitis E virus is able to damage the blood-brain barrier and replicate in the brain and spinal cord.

An all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV genotype 4 subtypes in both treatment-naive and -experienced patients, including those with compensated cirrhosis, according to results of a recent study.

AGA Resource
Through the Hepatitis C Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for your patients.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Identification of a case of acute hepatitis C virus (HCV) infection in a frequent blood donor without other risk factors should be considered a sentinel event and should prompt public health investigation, according to research published in Morbidity and Mortality Weekly Report, because this could indicate a possible health care–associated infection.

©vchal/Thinkstock

Negative media reports about the safety of the hepatitis B vaccine in China harmed perception of the vaccine’s safety among patients, according to a recent study. Although the reports were erroneous, the failure of public health departments to communicate effectively contributed to a rise in the number of parents refusing to vaccinate their children.

An experimental, highly specific and sensitive HCV core antigen enzyme immunoassay (HCV-Ags EIA) was found to have the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL. Investigators found that the HCV-Ags EIA reliably differentiated viremic HCV infection from resolved HCV infection, thus accomplishing screening and diagnosis of viremic HCV infection in one step.

Loss of confidence in the hepatitis B vaccine following disproved allegations that the vaccine caused multiple sclerosis persists in France, according to research published in Human Vaccines & Immunotherapeutics.

The approval of the direct-acting antiviral agents (DAAs) grazoprevir and elbasvir with an indication for all levels of kidney function and dialysis has altered the landscape for the treatment of hepatitis C virus in patients with chronic kidney disease, according to a review in Clinical Liver Disease. The authors say this is because other DAAs are either not approved for use in patients with advanced chronic kidney disease or no safety data are available for the dialysis population.

A study in the Journal of Viral Hepatitis found that insulin resistance was associated with an increased risk for loss of vaccine-acquired anti-HBs (hepatitis B surface antigen) in a large sample of a nondiabetic, general population, indicating a possible role of insulin resistance in vaccine-induced immunity.

Grazoprevir, a second-generation HCV NS3/4A protease inhibitor, combined with ribavirin was associated with a rapid and sustained suppression of HCV RNA in a randomized study. The authors said the results support further evaluation of grazoprevir-based treatment regimens.

HIV–HCV coinfected patients treated with a fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) showed significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation, according to a study in the Journal of Viral Hepatitis.

A Swedish study found that diabetes mellitus and cirrhosis are strong risk factors for hepatocellular carcinoma development after sustained virologic response (SVR) following treatment for chronic HCV has been achieved. However, the risk to develop hepatocellular carcinoma diminished significantly 2 years after SVR.

Chinese investigators said serum levels of platelet-derived growth factor (PDGF) decreased remarkably through fibrosis progression and could be used as a noninvasive biomarker for the assessment of fibrosis stage in patients with chronic hepatitis B virus (HBV).

A genome-wide association study of liver fibrosis progression in patients coinfected with HCV and HIV identified a new locus associated with fibrosis severity on chromosome 3p25. The authors said the results may help define new targets for drug development or new prognostic tests.

The RNA helicase DDX5 and E3 ligase Mex3b are important cellular targets for the design of novel, epigenetic therapies to combat HBV infection and poor-prognosis HBV-associated liver cancer, according to a study in Hepatology.

A Japanese study found that daclatasvir (DCV) and asunaprevir (ASV) dual therapy in hemodialysis patients infected with HCV is effective and safe with similar results, compared with patients with normal renal function.

A study evaluating the antiviral effect of ribavirin priming, and its influence on sustained virologic response after combination treatment, found that the lowest response pattern in HCV-infected patients was observed in prior nonresponder patients to pegylated interferon-alfa plus ribavirin combination therapy. The authors said this suggests that not only the individual interferon, but also the ribavirin sensitivity contributes significantly to the nonresponsive state.

A veterinary study provided evidence that hepatitis E virus is able to damage the blood-brain barrier and replicate in the brain and spinal cord.

An all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV genotype 4 subtypes in both treatment-naive and -experienced patients, including those with compensated cirrhosis, according to results of a recent study.

AGA Resource
Through the Hepatitis C Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for your patients.

[email protected]

On Twitter @richpizzi

Among patients with hepatitis C virus infection who were in compensated cirrhosis, sustained viral response was associated with significantly lower rates of liver decompensation, hepatocellular carcinoma, and liver-related death, even in the presence of clinically meaningful portal hypertension.

But patients in stage 2 cirrhosis were more likely than were stage 1 patients to develop liver decompensation and to die of hepatocellular carcinoma, regardless of SVR, said Dr. Vito Di Marco and his associates at the University of Palermo, Italy. “The available evidence, including our own, suggests that it is opportune to treat HCV as early as possible, in order to reduce progression to stages of cirrhosis in which a viral cure may be less likely lead to ultimate achievement of a major benefit,” they wrote. The report is in the July issue of Gastroenterology.

Clinically significant portal hypertension causes esophageal varices, a “landmark” indicator of stage 2 cirrhosis, the researchers noted. To parse the effects of SVR by cirrhosis stage, they followed all 444 HCV patients with compensated cirrhosis who were treated with pegylated interferon a2b and ribavirin at their tertiary liver centers between 2001 and 2009 (Gastroenterology 2016 March 31. doi: 10.1053/j.gastro.2016.03.036).

The cohort included 218 patients without esophageal varices (that is, patients in stage 1 cirrhosis) and 226 patients with esophageal varices (stage 2 cirrhosis), the researchers said. The groups were demographically similar at baseline, and had similar body mass indices and rates of comorbidities. Rates of SVR were 31% for patients in stage 1 cirrhosis and 18% for patients in stage 2 cirrhosis (P = .003).

Among stage 1 patients, achieving SVR was associated with a lower risk of liver decompensation (0% versus 7%; P = .009), a lower annual rate of hepatocellular carcinoma (0.7% versus 2.9%; P = .002), and a lower risk of liver-related death (3% versus 12%; P = .03). Stage 1 cirrhosis patients also were about 75% less likely to develop esophageal varices if they achieved SVR than if they did not (hazard ratio [HR], 0.23; 95% confidence interval [CI], 0.11 to 0.48; P less than .001).

Eradicating HCV infection also was associated with better clinical outcomes among patients in stage 2 cirrhosis, according to the investigators. For example, those who achieved SVR had a 0.9% annual rate of hepatocellular carcinoma, compared with 3.6% for those who did not (P = .002). And only 2% of stage 2 patients who achieved SVR died from hepatocellular carcinoma, compared to 18% of those who did not (P = .003).

But regardless of SVR, patients with stage 2 cirrhosis were nearly three times more likely to develop liver compensation (HR, 2.8; 95% CI, 1.73 to 4.59) and about 1.75 times more likely to die of liver-related causes (HR, 1.77; 95% CI, 1.12 to 2.80) compared with patients in stage 1 cirrhosis, the investigators emphasized. Also, achieving SVR did not prevent stage 2 patients from developing more esophageal varices (HR, 1.58; 95% CI, 0.33 to 1.03).

The researchers acknowledged several study limitations. “We have performed many comparisons with respect to multiple endpoints, which could have increased the likelihood of inference errors that can result from multiple comparisons,” they wrote. “Furthermore, we cannot exclude the lack of power as an explanation for some of our results.” In addition, pegylated interferon–based therapies have low rates of SVR, and the study was limited to patients who could tolerate the regimen, they added. Nonetheless, the results indicate that eradicating HCV is clinically beneficial even in advanced compensated cirrhosis, but that early treatment helps maximize these outcomes, they concluded. “Pegylated interferon–free direct-acting antiviral combo regimens will ultimately increase the rate of virological cure to almost universal effectiveness,” they added. “It remains to be assessed whether the effectiveness of these new regimens will be automatically translated into a universal clinical benefit.”

The Italian Ministry of Health funded the study. The investigators had no disclosures.

Among patients with hepatitis C virus infection who were in compensated cirrhosis, sustained viral response was associated with significantly lower rates of liver decompensation, hepatocellular carcinoma, and liver-related death, even in the presence of clinically meaningful portal hypertension.

But patients in stage 2 cirrhosis were more likely than were stage 1 patients to develop liver decompensation and to die of hepatocellular carcinoma, regardless of SVR, said Dr. Vito Di Marco and his associates at the University of Palermo, Italy. “The available evidence, including our own, suggests that it is opportune to treat HCV as early as possible, in order to reduce progression to stages of cirrhosis in which a viral cure may be less likely lead to ultimate achievement of a major benefit,” they wrote. The report is in the July issue of Gastroenterology.

Clinically significant portal hypertension causes esophageal varices, a “landmark” indicator of stage 2 cirrhosis, the researchers noted. To parse the effects of SVR by cirrhosis stage, they followed all 444 HCV patients with compensated cirrhosis who were treated with pegylated interferon a2b and ribavirin at their tertiary liver centers between 2001 and 2009 (Gastroenterology 2016 March 31. doi: 10.1053/j.gastro.2016.03.036).

The cohort included 218 patients without esophageal varices (that is, patients in stage 1 cirrhosis) and 226 patients with esophageal varices (stage 2 cirrhosis), the researchers said. The groups were demographically similar at baseline, and had similar body mass indices and rates of comorbidities. Rates of SVR were 31% for patients in stage 1 cirrhosis and 18% for patients in stage 2 cirrhosis (P = .003).

Among stage 1 patients, achieving SVR was associated with a lower risk of liver decompensation (0% versus 7%; P = .009), a lower annual rate of hepatocellular carcinoma (0.7% versus 2.9%; P = .002), and a lower risk of liver-related death (3% versus 12%; P = .03). Stage 1 cirrhosis patients also were about 75% less likely to develop esophageal varices if they achieved SVR than if they did not (hazard ratio [HR], 0.23; 95% confidence interval [CI], 0.11 to 0.48; P less than .001).

Eradicating HCV infection also was associated with better clinical outcomes among patients in stage 2 cirrhosis, according to the investigators. For example, those who achieved SVR had a 0.9% annual rate of hepatocellular carcinoma, compared with 3.6% for those who did not (P = .002). And only 2% of stage 2 patients who achieved SVR died from hepatocellular carcinoma, compared to 18% of those who did not (P = .003).

But regardless of SVR, patients with stage 2 cirrhosis were nearly three times more likely to develop liver compensation (HR, 2.8; 95% CI, 1.73 to 4.59) and about 1.75 times more likely to die of liver-related causes (HR, 1.77; 95% CI, 1.12 to 2.80) compared with patients in stage 1 cirrhosis, the investigators emphasized. Also, achieving SVR did not prevent stage 2 patients from developing more esophageal varices (HR, 1.58; 95% CI, 0.33 to 1.03).

The researchers acknowledged several study limitations. “We have performed many comparisons with respect to multiple endpoints, which could have increased the likelihood of inference errors that can result from multiple comparisons,” they wrote. “Furthermore, we cannot exclude the lack of power as an explanation for some of our results.” In addition, pegylated interferon–based therapies have low rates of SVR, and the study was limited to patients who could tolerate the regimen, they added. Nonetheless, the results indicate that eradicating HCV is clinically beneficial even in advanced compensated cirrhosis, but that early treatment helps maximize these outcomes, they concluded. “Pegylated interferon–free direct-acting antiviral combo regimens will ultimately increase the rate of virological cure to almost universal effectiveness,” they added. “It remains to be assessed whether the effectiveness of these new regimens will be automatically translated into a universal clinical benefit.”

The Italian Ministry of Health funded the study. The investigators had no disclosures.

Among patients with hepatitis C virus infection who were in compensated cirrhosis, sustained viral response was associated with significantly lower rates of liver decompensation, hepatocellular carcinoma, and liver-related death, even in the presence of clinically meaningful portal hypertension.

But patients in stage 2 cirrhosis were more likely than were stage 1 patients to develop liver decompensation and to die of hepatocellular carcinoma, regardless of SVR, said Dr. Vito Di Marco and his associates at the University of Palermo, Italy. “The available evidence, including our own, suggests that it is opportune to treat HCV as early as possible, in order to reduce progression to stages of cirrhosis in which a viral cure may be less likely lead to ultimate achievement of a major benefit,” they wrote. The report is in the July issue of Gastroenterology.

Clinically significant portal hypertension causes esophageal varices, a “landmark” indicator of stage 2 cirrhosis, the researchers noted. To parse the effects of SVR by cirrhosis stage, they followed all 444 HCV patients with compensated cirrhosis who were treated with pegylated interferon a2b and ribavirin at their tertiary liver centers between 2001 and 2009 (Gastroenterology 2016 March 31. doi: 10.1053/j.gastro.2016.03.036).

The cohort included 218 patients without esophageal varices (that is, patients in stage 1 cirrhosis) and 226 patients with esophageal varices (stage 2 cirrhosis), the researchers said. The groups were demographically similar at baseline, and had similar body mass indices and rates of comorbidities. Rates of SVR were 31% for patients in stage 1 cirrhosis and 18% for patients in stage 2 cirrhosis (P = .003).

Among stage 1 patients, achieving SVR was associated with a lower risk of liver decompensation (0% versus 7%; P = .009), a lower annual rate of hepatocellular carcinoma (0.7% versus 2.9%; P = .002), and a lower risk of liver-related death (3% versus 12%; P = .03). Stage 1 cirrhosis patients also were about 75% less likely to develop esophageal varices if they achieved SVR than if they did not (hazard ratio [HR], 0.23; 95% confidence interval [CI], 0.11 to 0.48; P less than .001).

Eradicating HCV infection also was associated with better clinical outcomes among patients in stage 2 cirrhosis, according to the investigators. For example, those who achieved SVR had a 0.9% annual rate of hepatocellular carcinoma, compared with 3.6% for those who did not (P = .002). And only 2% of stage 2 patients who achieved SVR died from hepatocellular carcinoma, compared to 18% of those who did not (P = .003).

But regardless of SVR, patients with stage 2 cirrhosis were nearly three times more likely to develop liver compensation (HR, 2.8; 95% CI, 1.73 to 4.59) and about 1.75 times more likely to die of liver-related causes (HR, 1.77; 95% CI, 1.12 to 2.80) compared with patients in stage 1 cirrhosis, the investigators emphasized. Also, achieving SVR did not prevent stage 2 patients from developing more esophageal varices (HR, 1.58; 95% CI, 0.33 to 1.03).

The researchers acknowledged several study limitations. “We have performed many comparisons with respect to multiple endpoints, which could have increased the likelihood of inference errors that can result from multiple comparisons,” they wrote. “Furthermore, we cannot exclude the lack of power as an explanation for some of our results.” In addition, pegylated interferon–based therapies have low rates of SVR, and the study was limited to patients who could tolerate the regimen, they added. Nonetheless, the results indicate that eradicating HCV is clinically beneficial even in advanced compensated cirrhosis, but that early treatment helps maximize these outcomes, they concluded. “Pegylated interferon–free direct-acting antiviral combo regimens will ultimately increase the rate of virological cure to almost universal effectiveness,” they added. “It remains to be assessed whether the effectiveness of these new regimens will be automatically translated into a universal clinical benefit.”

The Italian Ministry of Health funded the study. The investigators had no disclosures.

State Medicaid programs denied nearly half of requests to cover direct-acting antiviral drugs for patients with chronic hepatitis C virus (HCV) infection, according to a prospective study of beneficiaries in Delaware, Maryland, New Jersey, and Pennsylvania reported in the July issue of Clinical Gastroenterology and Hepatology.

In contrast, only 5% of Medicare patients and 10% of privately insured patients were denied coverage, said Dr. Vincent Lo Re III of the University of Pennsylvania, Philadelphia, together with his associates. “Notably, nearly one-quarter of Medicaid recipients with cirrhosis experienced treatment denial. Medicaid patients from these states also experienced a longer time to prescription fill than those with Medicare or commercial insurance,” the researchers said.

©roxanabalint/Thinkstock

Their study included 2,321 HCV patients prescribed a direct-acting antiviral regimen between November 1, 2014 and April 30, 2015. All prescriptions were submitted to a specialty pharmacy that serves HCV patients in Maryland, Pennsylvania, Delaware, and New Jersey, the investigators noted. They focused on “absolute denial,” meaning that the prescription was never filled because the insurer denied coverage, regardless of appeals. “Data are lacking on the incidence of absolute denial of direct-acting antiviral prescriptions and factors associated with this outcome,” the investigators said. “These data are important because absolute denial of HCV treatment by insurers might have adverse outcomes on patients and could harm patient-provider relationships” (Clin Gastroenterol Hepatol. 2016 Apr 5. doi: 10.1016/j.cgh.2016.03.040).

Source: American Gastroenterological Association

A total of 1,023 study patients were privately insured, 795 were enrolled in Medicare, and 503 were Medicaid patients, according to the researchers. In all, 377 patients (16%) received absolute denials, most often because of “insufficient information to assess medical need” (36% of denials) and “lack of medical necessity” (35%). Medicaid patients faced an absolute denial rate of 46% – significantly higher than rates for private insurers (10.5%) or Medicare (5%; P less than .001 for both comparisons). After adjusting for potential confounders, Medicaid patients were more than four times as likely to be denied coverage for direct-acting antivirals, compared with privately insured patients (relative risk, 4.1; 95% confidence interval, 3.4-5.1). Delaware’s Medicaid program had the highest rate of absolute denial (57%), followed by Pennsylvania (48%), Maryland (47%), and New Jersey (37%).

Medicaid programs even refused to cover direct-acting antiviral prescriptions for 25% of patients who had cirrhosis, compared with absolute denial rates of only 1% for Medicare and 3% of private insurers (P less than .001 for both comparisons), according to the researchers. The implications of these denials “remain unknown,” but lack of treatment increases the risk of end-stage liver disease, hepatocellular carcinoma, extrahepatic disease, HCV transmission, and “anxiety and stress about HCV disease progression, [which can] provoke distrust among patients of the health care system and their providers,” they added. “Clinicians then are challenged to explain the denial, and important opportunities for patient engagement, education, and cure could be irrevocably lost.”

Medicaid programs also initially denied about 25% of prescriptions before eventually approving them, despite the fact that “patients had complete prior authorization requests that should have contained the materials needed to justify approval,” said the investigators. Furthermore, denial letters usually did not specify the information that was needed, “making it difficult [for clinicians] to appeal the decision.” In contrast, only about 8% of privately insured patients and 13% of Medicare enrollees were initially denied coverage.

Prescriptions as a whole were more likely to be filled in the last 3 months of the study than earlier, perhaps because insurers are starting to relax their reimbursement criteria, said the investigators. Indeed, in October 2015, the American Association for the Study of Liver Diseases and the Infectious Disease Society of America stopped triaging groups of patients for direct-acting antiviral therapy, they noted.

The research was supported by the Penn Center for AIDS Research, which is funded by the National Institutes of Health. Dr. Lo Re received investigator-initiated research support from AstraZeneca. Five coinvestigators reported relationships with a number of pharmaceutical companies. Four coinvestigators reported employment by the study site, Burman’s Specialty Pharmacy. The other four coauthors had no disclosures.

State Medicaid programs denied nearly half of requests to cover direct-acting antiviral drugs for patients with chronic hepatitis C virus (HCV) infection, according to a prospective study of beneficiaries in Delaware, Maryland, New Jersey, and Pennsylvania reported in the July issue of Clinical Gastroenterology and Hepatology.

In contrast, only 5% of Medicare patients and 10% of privately insured patients were denied coverage, said Dr. Vincent Lo Re III of the University of Pennsylvania, Philadelphia, together with his associates. “Notably, nearly one-quarter of Medicaid recipients with cirrhosis experienced treatment denial. Medicaid patients from these states also experienced a longer time to prescription fill than those with Medicare or commercial insurance,” the researchers said.

©roxanabalint/Thinkstock

Their study included 2,321 HCV patients prescribed a direct-acting antiviral regimen between November 1, 2014 and April 30, 2015. All prescriptions were submitted to a specialty pharmacy that serves HCV patients in Maryland, Pennsylvania, Delaware, and New Jersey, the investigators noted. They focused on “absolute denial,” meaning that the prescription was never filled because the insurer denied coverage, regardless of appeals. “Data are lacking on the incidence of absolute denial of direct-acting antiviral prescriptions and factors associated with this outcome,” the investigators said. “These data are important because absolute denial of HCV treatment by insurers might have adverse outcomes on patients and could harm patient-provider relationships” (Clin Gastroenterol Hepatol. 2016 Apr 5. doi: 10.1016/j.cgh.2016.03.040).

Source: American Gastroenterological Association

A total of 1,023 study patients were privately insured, 795 were enrolled in Medicare, and 503 were Medicaid patients, according to the researchers. In all, 377 patients (16%) received absolute denials, most often because of “insufficient information to assess medical need” (36% of denials) and “lack of medical necessity” (35%). Medicaid patients faced an absolute denial rate of 46% – significantly higher than rates for private insurers (10.5%) or Medicare (5%; P less than .001 for both comparisons). After adjusting for potential confounders, Medicaid patients were more than four times as likely to be denied coverage for direct-acting antivirals, compared with privately insured patients (relative risk, 4.1; 95% confidence interval, 3.4-5.1). Delaware’s Medicaid program had the highest rate of absolute denial (57%), followed by Pennsylvania (48%), Maryland (47%), and New Jersey (37%).

Medicaid programs even refused to cover direct-acting antiviral prescriptions for 25% of patients who had cirrhosis, compared with absolute denial rates of only 1% for Medicare and 3% of private insurers (P less than .001 for both comparisons), according to the researchers. The implications of these denials “remain unknown,” but lack of treatment increases the risk of end-stage liver disease, hepatocellular carcinoma, extrahepatic disease, HCV transmission, and “anxiety and stress about HCV disease progression, [which can] provoke distrust among patients of the health care system and their providers,” they added. “Clinicians then are challenged to explain the denial, and important opportunities for patient engagement, education, and cure could be irrevocably lost.”

Medicaid programs also initially denied about 25% of prescriptions before eventually approving them, despite the fact that “patients had complete prior authorization requests that should have contained the materials needed to justify approval,” said the investigators. Furthermore, denial letters usually did not specify the information that was needed, “making it difficult [for clinicians] to appeal the decision.” In contrast, only about 8% of privately insured patients and 13% of Medicare enrollees were initially denied coverage.

Prescriptions as a whole were more likely to be filled in the last 3 months of the study than earlier, perhaps because insurers are starting to relax their reimbursement criteria, said the investigators. Indeed, in October 2015, the American Association for the Study of Liver Diseases and the Infectious Disease Society of America stopped triaging groups of patients for direct-acting antiviral therapy, they noted.

The research was supported by the Penn Center for AIDS Research, which is funded by the National Institutes of Health. Dr. Lo Re received investigator-initiated research support from AstraZeneca. Five coinvestigators reported relationships with a number of pharmaceutical companies. Four coinvestigators reported employment by the study site, Burman’s Specialty Pharmacy. The other four coauthors had no disclosures.

State Medicaid programs denied nearly half of requests to cover direct-acting antiviral drugs for patients with chronic hepatitis C virus (HCV) infection, according to a prospective study of beneficiaries in Delaware, Maryland, New Jersey, and Pennsylvania reported in the July issue of Clinical Gastroenterology and Hepatology.

In contrast, only 5% of Medicare patients and 10% of privately insured patients were denied coverage, said Dr. Vincent Lo Re III of the University of Pennsylvania, Philadelphia, together with his associates. “Notably, nearly one-quarter of Medicaid recipients with cirrhosis experienced treatment denial. Medicaid patients from these states also experienced a longer time to prescription fill than those with Medicare or commercial insurance,” the researchers said.

©roxanabalint/Thinkstock

Their study included 2,321 HCV patients prescribed a direct-acting antiviral regimen between November 1, 2014 and April 30, 2015. All prescriptions were submitted to a specialty pharmacy that serves HCV patients in Maryland, Pennsylvania, Delaware, and New Jersey, the investigators noted. They focused on “absolute denial,” meaning that the prescription was never filled because the insurer denied coverage, regardless of appeals. “Data are lacking on the incidence of absolute denial of direct-acting antiviral prescriptions and factors associated with this outcome,” the investigators said. “These data are important because absolute denial of HCV treatment by insurers might have adverse outcomes on patients and could harm patient-provider relationships” (Clin Gastroenterol Hepatol. 2016 Apr 5. doi: 10.1016/j.cgh.2016.03.040).

Source: American Gastroenterological Association

A total of 1,023 study patients were privately insured, 795 were enrolled in Medicare, and 503 were Medicaid patients, according to the researchers. In all, 377 patients (16%) received absolute denials, most often because of “insufficient information to assess medical need” (36% of denials) and “lack of medical necessity” (35%). Medicaid patients faced an absolute denial rate of 46% – significantly higher than rates for private insurers (10.5%) or Medicare (5%; P less than .001 for both comparisons). After adjusting for potential confounders, Medicaid patients were more than four times as likely to be denied coverage for direct-acting antivirals, compared with privately insured patients (relative risk, 4.1; 95% confidence interval, 3.4-5.1). Delaware’s Medicaid program had the highest rate of absolute denial (57%), followed by Pennsylvania (48%), Maryland (47%), and New Jersey (37%).

Medicaid programs even refused to cover direct-acting antiviral prescriptions for 25% of patients who had cirrhosis, compared with absolute denial rates of only 1% for Medicare and 3% of private insurers (P less than .001 for both comparisons), according to the researchers. The implications of these denials “remain unknown,” but lack of treatment increases the risk of end-stage liver disease, hepatocellular carcinoma, extrahepatic disease, HCV transmission, and “anxiety and stress about HCV disease progression, [which can] provoke distrust among patients of the health care system and their providers,” they added. “Clinicians then are challenged to explain the denial, and important opportunities for patient engagement, education, and cure could be irrevocably lost.”

Medicaid programs also initially denied about 25% of prescriptions before eventually approving them, despite the fact that “patients had complete prior authorization requests that should have contained the materials needed to justify approval,” said the investigators. Furthermore, denial letters usually did not specify the information that was needed, “making it difficult [for clinicians] to appeal the decision.” In contrast, only about 8% of privately insured patients and 13% of Medicare enrollees were initially denied coverage.

Prescriptions as a whole were more likely to be filled in the last 3 months of the study than earlier, perhaps because insurers are starting to relax their reimbursement criteria, said the investigators. Indeed, in October 2015, the American Association for the Study of Liver Diseases and the Infectious Disease Society of America stopped triaging groups of patients for direct-acting antiviral therapy, they noted.

The research was supported by the Penn Center for AIDS Research, which is funded by the National Institutes of Health. Dr. Lo Re received investigator-initiated research support from AstraZeneca. Five coinvestigators reported relationships with a number of pharmaceutical companies. Four coinvestigators reported employment by the study site, Burman’s Specialty Pharmacy. The other four coauthors had no disclosures.

Adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis can now be prescribed Epclusa. The Food and Drug Administration approved the fixed-dose combination tablet is the first treatment that controls genotypes 1-6 of HCV.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Epclusa, which contains sofosbuvir and velpatasvir, is manufactured by Gilead Sciences, located in Foster City, Calif. Before approval, the drug was evaluated for 12 weeks in three phase III clinical trials that included 1,558 patients diagnosed without cirrhosis and patients with compensated cirrhosis. Twelve weeks after finishing treatment, 95%-99% of patients who received Epclusa had no signs of infection. Epclusa cured the condition, which means no sign of the virus was detected in any of the patients’ blood. In addition, 267 patients were studied for the safety and efficacy of Epclusa, 87 of whom took Epclusa in combination with ribavirin for 12 weeks, and 94% of these patients had no virus detected in the blood 12 weeks after finishing treatment.

Side effects of Epclusa include headache and fatigue. Epclusa also carries a warning not to use with certain drugs that may reduce the effective amount of Epclusa.

[email protected]

Adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis can now be prescribed Epclusa. The Food and Drug Administration approved the fixed-dose combination tablet is the first treatment that controls genotypes 1-6 of HCV.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Epclusa, which contains sofosbuvir and velpatasvir, is manufactured by Gilead Sciences, located in Foster City, Calif. Before approval, the drug was evaluated for 12 weeks in three phase III clinical trials that included 1,558 patients diagnosed without cirrhosis and patients with compensated cirrhosis. Twelve weeks after finishing treatment, 95%-99% of patients who received Epclusa had no signs of infection. Epclusa cured the condition, which means no sign of the virus was detected in any of the patients’ blood. In addition, 267 patients were studied for the safety and efficacy of Epclusa, 87 of whom took Epclusa in combination with ribavirin for 12 weeks, and 94% of these patients had no virus detected in the blood 12 weeks after finishing treatment.

Side effects of Epclusa include headache and fatigue. Epclusa also carries a warning not to use with certain drugs that may reduce the effective amount of Epclusa.

[email protected]

Adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis can now be prescribed Epclusa. The Food and Drug Administration approved the fixed-dose combination tablet is the first treatment that controls genotypes 1-6 of HCV.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Epclusa, which contains sofosbuvir and velpatasvir, is manufactured by Gilead Sciences, located in Foster City, Calif. Before approval, the drug was evaluated for 12 weeks in three phase III clinical trials that included 1,558 patients diagnosed without cirrhosis and patients with compensated cirrhosis. Twelve weeks after finishing treatment, 95%-99% of patients who received Epclusa had no signs of infection. Epclusa cured the condition, which means no sign of the virus was detected in any of the patients’ blood. In addition, 267 patients were studied for the safety and efficacy of Epclusa, 87 of whom took Epclusa in combination with ribavirin for 12 weeks, and 94% of these patients had no virus detected in the blood 12 weeks after finishing treatment.

Side effects of Epclusa include headache and fatigue. Epclusa also carries a warning not to use with certain drugs that may reduce the effective amount of Epclusa.

[email protected]

A new study has identified a higher mortality rate among males with primary biliary cholangitis (PBC) and a lower sex ratio in disease prevalence than previously thought, according to findings published online in the journal Scientific Reports.

Investigators analyzed inpatient data from 2000 to 2009 for PBC patients in Denmark and in the Italian province of Lombardia. In the Lombardia cohort, 2,970 PBC patients were identified, with a female to male ratio of 2.3:1. In the Denmark population, 722 cases were identified, with a female to male ratio of 4.2:1, reported Dr. Ana Lleo from the Humanitas Clinical and Research Center in Rozzano, Italy, and her coauthors.

©Tashatuvango/Thinkstock

Among the Lombardia patients, survival at 1, 5, and 10 years was significantly higher for females (89%, 95% confidence interval, 88%-91%; 77%, 95% CI, 75%-78%; and 67%, 95% CI, 65%-70%, respectively) than for males (78%, 95% CI, 75%-80%; 55%, 95% CI, 52%-59%; and 47%, 95% CI, 43%-51%, respectively). Findings were similar in the Denmark cohort, with female patients having higher survival rates (survival at 1, 5, and 10 years of 90%, 87%-92%; 73%, 95% CI, 69%-77%; and 60%, 95% CI, 53%-67%, respectively) than males (72%, 95% CI, 63%-79%; 42%, 95% CI, 32%-51%; and 27%, 95% CI, 14%-43%, respectively), the authors reported.

The study findings question long-held beliefs on PBC, the authors said. Hepatologists should be aware that “male PBC patients have higher mortality than [do] their female counterparts, such that close clinical follow-up and checking adherence to therapy are strongly recommended,” Dr. Lleu and colleagues concluded.

Read the full article in Scientific Reports: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4872151.

[email protected]

A new study has identified a higher mortality rate among males with primary biliary cholangitis (PBC) and a lower sex ratio in disease prevalence than previously thought, according to findings published online in the journal Scientific Reports.

Investigators analyzed inpatient data from 2000 to 2009 for PBC patients in Denmark and in the Italian province of Lombardia. In the Lombardia cohort, 2,970 PBC patients were identified, with a female to male ratio of 2.3:1. In the Denmark population, 722 cases were identified, with a female to male ratio of 4.2:1, reported Dr. Ana Lleo from the Humanitas Clinical and Research Center in Rozzano, Italy, and her coauthors.

©Tashatuvango/Thinkstock

Among the Lombardia patients, survival at 1, 5, and 10 years was significantly higher for females (89%, 95% confidence interval, 88%-91%; 77%, 95% CI, 75%-78%; and 67%, 95% CI, 65%-70%, respectively) than for males (78%, 95% CI, 75%-80%; 55%, 95% CI, 52%-59%; and 47%, 95% CI, 43%-51%, respectively). Findings were similar in the Denmark cohort, with female patients having higher survival rates (survival at 1, 5, and 10 years of 90%, 87%-92%; 73%, 95% CI, 69%-77%; and 60%, 95% CI, 53%-67%, respectively) than males (72%, 95% CI, 63%-79%; 42%, 95% CI, 32%-51%; and 27%, 95% CI, 14%-43%, respectively), the authors reported.

The study findings question long-held beliefs on PBC, the authors said. Hepatologists should be aware that “male PBC patients have higher mortality than [do] their female counterparts, such that close clinical follow-up and checking adherence to therapy are strongly recommended,” Dr. Lleu and colleagues concluded.

Read the full article in Scientific Reports: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4872151.

[email protected]

A new study has identified a higher mortality rate among males with primary biliary cholangitis (PBC) and a lower sex ratio in disease prevalence than previously thought, according to findings published online in the journal Scientific Reports.

Investigators analyzed inpatient data from 2000 to 2009 for PBC patients in Denmark and in the Italian province of Lombardia. In the Lombardia cohort, 2,970 PBC patients were identified, with a female to male ratio of 2.3:1. In the Denmark population, 722 cases were identified, with a female to male ratio of 4.2:1, reported Dr. Ana Lleo from the Humanitas Clinical and Research Center in Rozzano, Italy, and her coauthors.

©Tashatuvango/Thinkstock

Among the Lombardia patients, survival at 1, 5, and 10 years was significantly higher for females (89%, 95% confidence interval, 88%-91%; 77%, 95% CI, 75%-78%; and 67%, 95% CI, 65%-70%, respectively) than for males (78%, 95% CI, 75%-80%; 55%, 95% CI, 52%-59%; and 47%, 95% CI, 43%-51%, respectively). Findings were similar in the Denmark cohort, with female patients having higher survival rates (survival at 1, 5, and 10 years of 90%, 87%-92%; 73%, 95% CI, 69%-77%; and 60%, 95% CI, 53%-67%, respectively) than males (72%, 95% CI, 63%-79%; 42%, 95% CI, 32%-51%; and 27%, 95% CI, 14%-43%, respectively), the authors reported.

The study findings question long-held beliefs on PBC, the authors said. Hepatologists should be aware that “male PBC patients have higher mortality than [do] their female counterparts, such that close clinical follow-up and checking adherence to therapy are strongly recommended,” Dr. Lleu and colleagues concluded.

Read the full article in Scientific Reports: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4872151.

[email protected]

Substituting a less-expensive hepatitis C core antigen test into the standard two-step process for diagnosing active hepatitis C virus (HCV) infection could streamline and cut the cost of HCV detection.

The standard two-step approach – detection of HCV antibodies followed by nucleic acid testing (NAT) as a marker for HCV viremia – may be improved by replacing NAT with the HCV core antigen (HCVcAg) test, according to the results of a study published in Annals of Internal Medicine.

Dr. J. Morgan Freiman, of the Boston Medical Center, and her colleagues conducted a systematic literature review to identify 44 case-control, cross-sectional, cohort, or randomized trials that compared any of five HCVcAg screening tests with a NAT reference standard.

The investigators performed a meta-analysis to assess the sensitivity (proportion of samples with a positive NAT and HCVcAg) and specificity (proportion of samples with a negative NAT and HCVcAg) associated with the five HCVcAg tests, as well as how they correlated with NAT-derived HCV RNA levels greater than 3,000 IU/mL.

The two best-performing HCVcAg tests of the five assessed were the Abbott ARCHITECT HCV Ag and the Ortho HCV Ag ELISA, based on their sensitivity (93.4%and 93.2%, respectively), specificity (98.8% and 99.2%, respectively), and positive (80.6 and 116.5, respectively) and negative (0.06 and 0.06, respectively) likelihood ratios.

Although limited data were available, the results of three quantitative studies showed that Abbott ARCHITECT HCVcAg was well correlated with HCV RNA levels greater than 3,000 IU/mL.

“This systematic review concludes that a well-performing HCVcAg test can achieve similar diagnostic accuracy to NAT for identification of active HCV infection when the viral load exceeds 3,000 IU/mL,” Dr. Freiman and her colleagues noted.

HCVcAg testing should be researched further as a potentially viable and less-expensive alternative to NAT, the investigators said, with the goal of simplifying detection at the point of care and increasing the rate of patient diagnosis (Ann Intern Med. 2016 Jun 21; doi: 10.7326/M16-0065).

The National Institutes of Health funded the study. Dr. White disclosed grant support from the funding source. Dr. Ongarello and Dr. Denkinger reported relationships with the Foundation for Innovative New Diagnostics. No additional authors reported conflicts of interest.

Substituting a less-expensive hepatitis C core antigen test into the standard two-step process for diagnosing active hepatitis C virus (HCV) infection could streamline and cut the cost of HCV detection.

The standard two-step approach – detection of HCV antibodies followed by nucleic acid testing (NAT) as a marker for HCV viremia – may be improved by replacing NAT with the HCV core antigen (HCVcAg) test, according to the results of a study published in Annals of Internal Medicine.

Dr. J. Morgan Freiman, of the Boston Medical Center, and her colleagues conducted a systematic literature review to identify 44 case-control, cross-sectional, cohort, or randomized trials that compared any of five HCVcAg screening tests with a NAT reference standard.

The investigators performed a meta-analysis to assess the sensitivity (proportion of samples with a positive NAT and HCVcAg) and specificity (proportion of samples with a negative NAT and HCVcAg) associated with the five HCVcAg tests, as well as how they correlated with NAT-derived HCV RNA levels greater than 3,000 IU/mL.

The two best-performing HCVcAg tests of the five assessed were the Abbott ARCHITECT HCV Ag and the Ortho HCV Ag ELISA, based on their sensitivity (93.4%and 93.2%, respectively), specificity (98.8% and 99.2%, respectively), and positive (80.6 and 116.5, respectively) and negative (0.06 and 0.06, respectively) likelihood ratios.

Although limited data were available, the results of three quantitative studies showed that Abbott ARCHITECT HCVcAg was well correlated with HCV RNA levels greater than 3,000 IU/mL.

“This systematic review concludes that a well-performing HCVcAg test can achieve similar diagnostic accuracy to NAT for identification of active HCV infection when the viral load exceeds 3,000 IU/mL,” Dr. Freiman and her colleagues noted.

HCVcAg testing should be researched further as a potentially viable and less-expensive alternative to NAT, the investigators said, with the goal of simplifying detection at the point of care and increasing the rate of patient diagnosis (Ann Intern Med. 2016 Jun 21; doi: 10.7326/M16-0065).

The National Institutes of Health funded the study. Dr. White disclosed grant support from the funding source. Dr. Ongarello and Dr. Denkinger reported relationships with the Foundation for Innovative New Diagnostics. No additional authors reported conflicts of interest.

Substituting a less-expensive hepatitis C core antigen test into the standard two-step process for diagnosing active hepatitis C virus (HCV) infection could streamline and cut the cost of HCV detection.

The standard two-step approach – detection of HCV antibodies followed by nucleic acid testing (NAT) as a marker for HCV viremia – may be improved by replacing NAT with the HCV core antigen (HCVcAg) test, according to the results of a study published in Annals of Internal Medicine.

Dr. J. Morgan Freiman, of the Boston Medical Center, and her colleagues conducted a systematic literature review to identify 44 case-control, cross-sectional, cohort, or randomized trials that compared any of five HCVcAg screening tests with a NAT reference standard.

The investigators performed a meta-analysis to assess the sensitivity (proportion of samples with a positive NAT and HCVcAg) and specificity (proportion of samples with a negative NAT and HCVcAg) associated with the five HCVcAg tests, as well as how they correlated with NAT-derived HCV RNA levels greater than 3,000 IU/mL.

The two best-performing HCVcAg tests of the five assessed were the Abbott ARCHITECT HCV Ag and the Ortho HCV Ag ELISA, based on their sensitivity (93.4%and 93.2%, respectively), specificity (98.8% and 99.2%, respectively), and positive (80.6 and 116.5, respectively) and negative (0.06 and 0.06, respectively) likelihood ratios.

Although limited data were available, the results of three quantitative studies showed that Abbott ARCHITECT HCVcAg was well correlated with HCV RNA levels greater than 3,000 IU/mL.

“This systematic review concludes that a well-performing HCVcAg test can achieve similar diagnostic accuracy to NAT for identification of active HCV infection when the viral load exceeds 3,000 IU/mL,” Dr. Freiman and her colleagues noted.

HCVcAg testing should be researched further as a potentially viable and less-expensive alternative to NAT, the investigators said, with the goal of simplifying detection at the point of care and increasing the rate of patient diagnosis (Ann Intern Med. 2016 Jun 21; doi: 10.7326/M16-0065).

The National Institutes of Health funded the study. Dr. White disclosed grant support from the funding source. Dr. Ongarello and Dr. Denkinger reported relationships with the Foundation for Innovative New Diagnostics. No additional authors reported conflicts of interest.

SAN DIEGO – Patients with hepatitis C virus (HCV) infections had distinct duodenal mucosal microbiomes and greater intestinal permeability, compared with healthy controls and patients with other chronic liver diseases, Dr. Ashok Raj reported.

The findings might one day lead to therapies that aim to restore or normalize the microbiomes of patients with HCV, Dr. Raj said in an interview at the annual Digestive Disease Week.

Amy Karon/Frontline Medical News

Chronic liver disease (CLD) has been linked to dysbiosis, or abnormal shifts of the microbiome. But most studies have focused on fecal specimens, and “recent evidence suggests that the mucosal microbiota differ from fecal microbiota,” said Dr. Raj, a gastroenterologist and hepatologist at Princess Alexandra Hospital in Brisbane, Australia, and a PhD candidate at the University of Queensland at Brisbane.

“The small-intestinal mucosal microbiota are of particular interest to us,” Dr. Raj explained. “Anatomically, all the blood from this region of the gut drains into the portal vein and flows directly to the liver. Because of small-intestinal permeability, either bacteria or their products could travel to the liver and contribute to disease. But very little is known about this microbiota in CLD.”

Therefore, Dr. Raj and his associates sequenced bacterial DNA from mucosal biopsies of the second part of the duodenum from 38 prospectively recruited endoscopy patients with CLD and 13 healthy controls. The researchers also evaluated dietary habits, intestinal permeability, hepatic stiffness based on transient elastography, and the presence of metabolic syndrome, as measured by the International Diabetes Federation/American Heart Association/National Heart, Lung, and Blood Institute 2009 Consensus criteria. The CLD group included 28 men and 10 women aged 36-82 years, including 16 patients with HCV, 10 patients with nonalcoholic fatty liver disease, 7 patients with fatty liver disease, 3 patients with autoimmune hepatitis, and 2 patients with hepatitis B virus infection. The controls were between 24 and 73 years old, and 70% were women.

Sequencing of bacteria DNA revealed significant differences between patients and controls, particularly among patients with HCV, Dr. Raj said. The HCV patients not only had significantly less microbial diversity (P less than .02), but the overall changes in their microbiota were significant enough for them to cluster separately from controls and from patients with other types of CLD (P less than .01 for both comparisons). Furthermore, HCV patients had significantly greater small-intestinal permeability (mean ± SD log lactulose to rhamnose ratio, 1.57 ± 0.27) than controls (1.21 ± 0.25; P less than .01) or patients with other CLDs (1.24 ± 0.39; P = .01).

“Additionally, for the HCV patients, dietary fat intake showed a moderately strong positive correlation with intestinal permeability,” Dr. Raj said (r = 0.58; P = .03). “These findings are in keeping with animal models, which have shown that dietary fat can change the microbiota and also increase intestinal permeability.” However, the multivariate analysis found no links between microbial characteristics and hepatic stiffness or metabolic syndrome – perhaps because most patients were “at the cirrhotic end of the spectrum, reflecting their indication for endoscopy,” or because “these relationships are subtler and require larger sample numbers,” he said.

“Patients with HCV may have a unique small-intestinal microbiome,” Dr. Raj concluded. “These patients had higher intestinal permeability, and it is possible that the microbiota have a part to play in that.” Exactly how microbiota and gut permeability contribute to disease remains unclear, but pathology in the small intestine could help explain some features of the HCV trajectory, such as extrahepatic manifestations or variations in disease progression, he added. “Future studies may lead to targeting the small-intestinal gut microbiome to modulate and even treat HCV.”

The study was funded by a postgraduate award from the government of Australia and by the Princess Alexandra Hospital Research Foundation. Dr. Raj had no disclosures.

SAN DIEGO – Patients with hepatitis C virus (HCV) infections had distinct duodenal mucosal microbiomes and greater intestinal permeability, compared with healthy controls and patients with other chronic liver diseases, Dr. Ashok Raj reported.

The findings might one day lead to therapies that aim to restore or normalize the microbiomes of patients with HCV, Dr. Raj said in an interview at the annual Digestive Disease Week.

Amy Karon/Frontline Medical News

Chronic liver disease (CLD) has been linked to dysbiosis, or abnormal shifts of the microbiome. But most studies have focused on fecal specimens, and “recent evidence suggests that the mucosal microbiota differ from fecal microbiota,” said Dr. Raj, a gastroenterologist and hepatologist at Princess Alexandra Hospital in Brisbane, Australia, and a PhD candidate at the University of Queensland at Brisbane.

“The small-intestinal mucosal microbiota are of particular interest to us,” Dr. Raj explained. “Anatomically, all the blood from this region of the gut drains into the portal vein and flows directly to the liver. Because of small-intestinal permeability, either bacteria or their products could travel to the liver and contribute to disease. But very little is known about this microbiota in CLD.”

Therefore, Dr. Raj and his associates sequenced bacterial DNA from mucosal biopsies of the second part of the duodenum from 38 prospectively recruited endoscopy patients with CLD and 13 healthy controls. The researchers also evaluated dietary habits, intestinal permeability, hepatic stiffness based on transient elastography, and the presence of metabolic syndrome, as measured by the International Diabetes Federation/American Heart Association/National Heart, Lung, and Blood Institute 2009 Consensus criteria. The CLD group included 28 men and 10 women aged 36-82 years, including 16 patients with HCV, 10 patients with nonalcoholic fatty liver disease, 7 patients with fatty liver disease, 3 patients with autoimmune hepatitis, and 2 patients with hepatitis B virus infection. The controls were between 24 and 73 years old, and 70% were women.

Sequencing of bacteria DNA revealed significant differences between patients and controls, particularly among patients with HCV, Dr. Raj said. The HCV patients not only had significantly less microbial diversity (P less than .02), but the overall changes in their microbiota were significant enough for them to cluster separately from controls and from patients with other types of CLD (P less than .01 for both comparisons). Furthermore, HCV patients had significantly greater small-intestinal permeability (mean ± SD log lactulose to rhamnose ratio, 1.57 ± 0.27) than controls (1.21 ± 0.25; P less than .01) or patients with other CLDs (1.24 ± 0.39; P = .01).

“Additionally, for the HCV patients, dietary fat intake showed a moderately strong positive correlation with intestinal permeability,” Dr. Raj said (r = 0.58; P = .03). “These findings are in keeping with animal models, which have shown that dietary fat can change the microbiota and also increase intestinal permeability.” However, the multivariate analysis found no links between microbial characteristics and hepatic stiffness or metabolic syndrome – perhaps because most patients were “at the cirrhotic end of the spectrum, reflecting their indication for endoscopy,” or because “these relationships are subtler and require larger sample numbers,” he said.

“Patients with HCV may have a unique small-intestinal microbiome,” Dr. Raj concluded. “These patients had higher intestinal permeability, and it is possible that the microbiota have a part to play in that.” Exactly how microbiota and gut permeability contribute to disease remains unclear, but pathology in the small intestine could help explain some features of the HCV trajectory, such as extrahepatic manifestations or variations in disease progression, he added. “Future studies may lead to targeting the small-intestinal gut microbiome to modulate and even treat HCV.”

The study was funded by a postgraduate award from the government of Australia and by the Princess Alexandra Hospital Research Foundation. Dr. Raj had no disclosures.

SAN DIEGO – Patients with hepatitis C virus (HCV) infections had distinct duodenal mucosal microbiomes and greater intestinal permeability, compared with healthy controls and patients with other chronic liver diseases, Dr. Ashok Raj reported.

The findings might one day lead to therapies that aim to restore or normalize the microbiomes of patients with HCV, Dr. Raj said in an interview at the annual Digestive Disease Week.

Amy Karon/Frontline Medical News

Chronic liver disease (CLD) has been linked to dysbiosis, or abnormal shifts of the microbiome. But most studies have focused on fecal specimens, and “recent evidence suggests that the mucosal microbiota differ from fecal microbiota,” said Dr. Raj, a gastroenterologist and hepatologist at Princess Alexandra Hospital in Brisbane, Australia, and a PhD candidate at the University of Queensland at Brisbane.

“The small-intestinal mucosal microbiota are of particular interest to us,” Dr. Raj explained. “Anatomically, all the blood from this region of the gut drains into the portal vein and flows directly to the liver. Because of small-intestinal permeability, either bacteria or their products could travel to the liver and contribute to disease. But very little is known about this microbiota in CLD.”

Therefore, Dr. Raj and his associates sequenced bacterial DNA from mucosal biopsies of the second part of the duodenum from 38 prospectively recruited endoscopy patients with CLD and 13 healthy controls. The researchers also evaluated dietary habits, intestinal permeability, hepatic stiffness based on transient elastography, and the presence of metabolic syndrome, as measured by the International Diabetes Federation/American Heart Association/National Heart, Lung, and Blood Institute 2009 Consensus criteria. The CLD group included 28 men and 10 women aged 36-82 years, including 16 patients with HCV, 10 patients with nonalcoholic fatty liver disease, 7 patients with fatty liver disease, 3 patients with autoimmune hepatitis, and 2 patients with hepatitis B virus infection. The controls were between 24 and 73 years old, and 70% were women.

Sequencing of bacteria DNA revealed significant differences between patients and controls, particularly among patients with HCV, Dr. Raj said. The HCV patients not only had significantly less microbial diversity (P less than .02), but the overall changes in their microbiota were significant enough for them to cluster separately from controls and from patients with other types of CLD (P less than .01 for both comparisons). Furthermore, HCV patients had significantly greater small-intestinal permeability (mean ± SD log lactulose to rhamnose ratio, 1.57 ± 0.27) than controls (1.21 ± 0.25; P less than .01) or patients with other CLDs (1.24 ± 0.39; P = .01).

“Additionally, for the HCV patients, dietary fat intake showed a moderately strong positive correlation with intestinal permeability,” Dr. Raj said (r = 0.58; P = .03). “These findings are in keeping with animal models, which have shown that dietary fat can change the microbiota and also increase intestinal permeability.” However, the multivariate analysis found no links between microbial characteristics and hepatic stiffness or metabolic syndrome – perhaps because most patients were “at the cirrhotic end of the spectrum, reflecting their indication for endoscopy,” or because “these relationships are subtler and require larger sample numbers,” he said.

“Patients with HCV may have a unique small-intestinal microbiome,” Dr. Raj concluded. “These patients had higher intestinal permeability, and it is possible that the microbiota have a part to play in that.” Exactly how microbiota and gut permeability contribute to disease remains unclear, but pathology in the small intestine could help explain some features of the HCV trajectory, such as extrahepatic manifestations or variations in disease progression, he added. “Future studies may lead to targeting the small-intestinal gut microbiome to modulate and even treat HCV.”

The study was funded by a postgraduate award from the government of Australia and by the Princess Alexandra Hospital Research Foundation. Dr. Raj had no disclosures.

A 12-week regimen achieved sustained viral response for 90% of patients with genotype 1 hepatitis C virus (HCV) infection and stage 4 or 5 chronic kidney disease (CKD), researchers reported in the April issue of Gastroenterology.

“The regimen is well tolerated, though ribavirin use may require a reduction or interruption to manage anemia,” said Dr. Paul Pockros at Scripps Clinic and Scripps Translational Science Institute in La Jolla, Calif., and his associates. The second phase of the study will evaluate the regimen in treatment-experienced CKD patients and those with compensated cirrhosis, they said.

©picsfive/Fotolia

The regimen contained ombitasvir, paritaprevir, ritonavir, and dasabuvir.

Between 8% and 44% of hemodialysis patients are HCV positive, and CKD is known to heighten the risk of HCV-associated cirrhosis, hepatocellular carcinoma, and liver-related death, the researchers noted. While sofosbuvir is cleared renally, ombitasvir, paritaprevir, ritonavir, and dasabuvir undergo hepatic metabolism and needed no dose adjustment in phase I studies of patients with mild, moderate, or severe renal impairment. To further investigate the safety and efficacy of these direct-acting antivirals in patients with severe kidney disease, the researchers performed a single-arm, open-label, multicenter study of 20 treatment-naive, noncirrhotic, HCV-infected adults with stage 4 CKD (estimated glomerular filtration rate, 15-30 mL/min per 1.73 m²) or stage 5 (eGFR, less than 15 mL/min per 1.73 m² or requiring hemodialysis). Patients received once-daily ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) plus dasabuvir (250 mg) for 12 weeks. The 13 patients with genotype 1a infections also received once-daily ribavirin (200 mg). Most patients were black men with stage 5 CKD, and 14 were on hemodialysis, the researchers said (Gastroenterology. 2016 Apr 16. doi: 10.1053/j.gastro.2016.02.078).

All 20 patients completed treatment, and 18 (90%) achieved sustained viral response (SVR) at posttreatment week 12 (SVR12; 95% confidence interval, 70%-97%). No patients developed hepatic decompensation, the researchers said. The most common adverse effects were anemia (45%), fatigue (35%), diarrhea (25%), and nausea (25%). Anemia developed only in patients receiving ribavirin and was more pronounced than in phase III studies of this regimen, the researchers said. Hemoglobin levels dropped an average of 1.38 plus or minus 1.54 g/dL among patients who received ribavirin, compared with 0.02 plus or minus 0.9 g/dL among patients who did not receive ribavirin. There was one case of grade 3 anemia related to incorrect dosing of ribavirin; the lowest measured hemoglobin level was 7.0 g/dL, which improved to more than 10 g/dL after stopping ribavirin and starting erythropoietin treatment. This patient also achieved SVR12. The other eight patients who developed anemia also stopped ribavirin, although three were able to resume it after their hemoglobin levels improved.

Of the two patients who did not achieve SVR12, one relapsed 4 weeks after treatment, and one died of cardiac arrest 14 days after treatment. The patient who died had a history of hypertension; his hemoglobin level was stable (9-11 g/dL) during the last 6 weeks of treatment, and was 10 g/dL at admission, suggesting that ribavirin-induced anemia did not cause the cardiac event, the investigators said.

“The results of this study are important for hepatologists, gastroenterologists, and infectious disease specialists who are accustomed to treating HCV-infected patients with DAA [direct-acting antiviral] therapy but who may not yet have seen sufficient data to initiate DAA therapy in patients with ESRD [end-stage renal disease],” the researchers concluded. “Nephrologists, who may not be accustomed to treating HCV, should also be aware that treatment options may now be available that can help prevent the end-stage sequelae of HCV. How treatment of HCV infection affects early or intermediate stages of CKD and how achievement of SVR impacts strategies for kidney transplantation in patients with ESRD require more study.”

AbbVie makes the regimen and sponsored the study. Dr. Pockros and six coinvestigators disclosed financial relationships with AbbVie and numerous other pharmaceutical companies. Seven coinvestigators reported being employed by AbbVie.

A 12-week regimen achieved sustained viral response for 90% of patients with genotype 1 hepatitis C virus (HCV) infection and stage 4 or 5 chronic kidney disease (CKD), researchers reported in the April issue of Gastroenterology.

“The regimen is well tolerated, though ribavirin use may require a reduction or interruption to manage anemia,” said Dr. Paul Pockros at Scripps Clinic and Scripps Translational Science Institute in La Jolla, Calif., and his associates. The second phase of the study will evaluate the regimen in treatment-experienced CKD patients and those with compensated cirrhosis, they said.

©picsfive/Fotolia

The regimen contained ombitasvir, paritaprevir, ritonavir, and dasabuvir.

Between 8% and 44% of hemodialysis patients are HCV positive, and CKD is known to heighten the risk of HCV-associated cirrhosis, hepatocellular carcinoma, and liver-related death, the researchers noted. While sofosbuvir is cleared renally, ombitasvir, paritaprevir, ritonavir, and dasabuvir undergo hepatic metabolism and needed no dose adjustment in phase I studies of patients with mild, moderate, or severe renal impairment. To further investigate the safety and efficacy of these direct-acting antivirals in patients with severe kidney disease, the researchers performed a single-arm, open-label, multicenter study of 20 treatment-naive, noncirrhotic, HCV-infected adults with stage 4 CKD (estimated glomerular filtration rate, 15-30 mL/min per 1.73 m²) or stage 5 (eGFR, less than 15 mL/min per 1.73 m² or requiring hemodialysis). Patients received once-daily ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) plus dasabuvir (250 mg) for 12 weeks. The 13 patients with genotype 1a infections also received once-daily ribavirin (200 mg). Most patients were black men with stage 5 CKD, and 14 were on hemodialysis, the researchers said (Gastroenterology. 2016 Apr 16. doi: 10.1053/j.gastro.2016.02.078).

All 20 patients completed treatment, and 18 (90%) achieved sustained viral response (SVR) at posttreatment week 12 (SVR12; 95% confidence interval, 70%-97%). No patients developed hepatic decompensation, the researchers said. The most common adverse effects were anemia (45%), fatigue (35%), diarrhea (25%), and nausea (25%). Anemia developed only in patients receiving ribavirin and was more pronounced than in phase III studies of this regimen, the researchers said. Hemoglobin levels dropped an average of 1.38 plus or minus 1.54 g/dL among patients who received ribavirin, compared with 0.02 plus or minus 0.9 g/dL among patients who did not receive ribavirin. There was one case of grade 3 anemia related to incorrect dosing of ribavirin; the lowest measured hemoglobin level was 7.0 g/dL, which improved to more than 10 g/dL after stopping ribavirin and starting erythropoietin treatment. This patient also achieved SVR12. The other eight patients who developed anemia also stopped ribavirin, although three were able to resume it after their hemoglobin levels improved.

Of the two patients who did not achieve SVR12, one relapsed 4 weeks after treatment, and one died of cardiac arrest 14 days after treatment. The patient who died had a history of hypertension; his hemoglobin level was stable (9-11 g/dL) during the last 6 weeks of treatment, and was 10 g/dL at admission, suggesting that ribavirin-induced anemia did not cause the cardiac event, the investigators said.

“The results of this study are important for hepatologists, gastroenterologists, and infectious disease specialists who are accustomed to treating HCV-infected patients with DAA [direct-acting antiviral] therapy but who may not yet have seen sufficient data to initiate DAA therapy in patients with ESRD [end-stage renal disease],” the researchers concluded. “Nephrologists, who may not be accustomed to treating HCV, should also be aware that treatment options may now be available that can help prevent the end-stage sequelae of HCV. How treatment of HCV infection affects early or intermediate stages of CKD and how achievement of SVR impacts strategies for kidney transplantation in patients with ESRD require more study.”

AbbVie makes the regimen and sponsored the study. Dr. Pockros and six coinvestigators disclosed financial relationships with AbbVie and numerous other pharmaceutical companies. Seven coinvestigators reported being employed by AbbVie.

A 12-week regimen achieved sustained viral response for 90% of patients with genotype 1 hepatitis C virus (HCV) infection and stage 4 or 5 chronic kidney disease (CKD), researchers reported in the April issue of Gastroenterology.

“The regimen is well tolerated, though ribavirin use may require a reduction or interruption to manage anemia,” said Dr. Paul Pockros at Scripps Clinic and Scripps Translational Science Institute in La Jolla, Calif., and his associates. The second phase of the study will evaluate the regimen in treatment-experienced CKD patients and those with compensated cirrhosis, they said.

©picsfive/Fotolia

The regimen contained ombitasvir, paritaprevir, ritonavir, and dasabuvir.

Between 8% and 44% of hemodialysis patients are HCV positive, and CKD is known to heighten the risk of HCV-associated cirrhosis, hepatocellular carcinoma, and liver-related death, the researchers noted. While sofosbuvir is cleared renally, ombitasvir, paritaprevir, ritonavir, and dasabuvir undergo hepatic metabolism and needed no dose adjustment in phase I studies of patients with mild, moderate, or severe renal impairment. To further investigate the safety and efficacy of these direct-acting antivirals in patients with severe kidney disease, the researchers performed a single-arm, open-label, multicenter study of 20 treatment-naive, noncirrhotic, HCV-infected adults with stage 4 CKD (estimated glomerular filtration rate, 15-30 mL/min per 1.73 m²) or stage 5 (eGFR, less than 15 mL/min per 1.73 m² or requiring hemodialysis). Patients received once-daily ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) plus dasabuvir (250 mg) for 12 weeks. The 13 patients with genotype 1a infections also received once-daily ribavirin (200 mg). Most patients were black men with stage 5 CKD, and 14 were on hemodialysis, the researchers said (Gastroenterology. 2016 Apr 16. doi: 10.1053/j.gastro.2016.02.078).

All 20 patients completed treatment, and 18 (90%) achieved sustained viral response (SVR) at posttreatment week 12 (SVR12; 95% confidence interval, 70%-97%). No patients developed hepatic decompensation, the researchers said. The most common adverse effects were anemia (45%), fatigue (35%), diarrhea (25%), and nausea (25%). Anemia developed only in patients receiving ribavirin and was more pronounced than in phase III studies of this regimen, the researchers said. Hemoglobin levels dropped an average of 1.38 plus or minus 1.54 g/dL among patients who received ribavirin, compared with 0.02 plus or minus 0.9 g/dL among patients who did not receive ribavirin. There was one case of grade 3 anemia related to incorrect dosing of ribavirin; the lowest measured hemoglobin level was 7.0 g/dL, which improved to more than 10 g/dL after stopping ribavirin and starting erythropoietin treatment. This patient also achieved SVR12. The other eight patients who developed anemia also stopped ribavirin, although three were able to resume it after their hemoglobin levels improved.

Of the two patients who did not achieve SVR12, one relapsed 4 weeks after treatment, and one died of cardiac arrest 14 days after treatment. The patient who died had a history of hypertension; his hemoglobin level was stable (9-11 g/dL) during the last 6 weeks of treatment, and was 10 g/dL at admission, suggesting that ribavirin-induced anemia did not cause the cardiac event, the investigators said.

“The results of this study are important for hepatologists, gastroenterologists, and infectious disease specialists who are accustomed to treating HCV-infected patients with DAA [direct-acting antiviral] therapy but who may not yet have seen sufficient data to initiate DAA therapy in patients with ESRD [end-stage renal disease],” the researchers concluded. “Nephrologists, who may not be accustomed to treating HCV, should also be aware that treatment options may now be available that can help prevent the end-stage sequelae of HCV. How treatment of HCV infection affects early or intermediate stages of CKD and how achievement of SVR impacts strategies for kidney transplantation in patients with ESRD require more study.”

AbbVie makes the regimen and sponsored the study. Dr. Pockros and six coinvestigators disclosed financial relationships with AbbVie and numerous other pharmaceutical companies. Seven coinvestigators reported being employed by AbbVie.

Black patients with hepatocellular carcinoma (HCC) have shorter survival and more adverse clinical features at diagnosis than do non-Hispanic whites and other races, according to a single-center review.

Blacks were at a 33% increased risk of death because of HCC, compared with non-Hispanic whites, and were diagnosed at a later stage with larger tumors. Thus, they were less likely to be eligible for curative transplantation, said Dr. Patricia D. Jones of the University of Miami, who presented her findings during a teleconference in advance of the annual Digestive Disease Week.

“We found that race was the strongest predictor of survival in a diverse sample of patients diagnosed with HCC,” said lead author Dr. Jones, who is also on the staff of the Sylvester Comprehensive Cancer Center at the university.

“Most research on racial disparity in medical illness comes from large retrospective databases such as SEER [Surveillance, Epidemiology, and End Results], which represents 28% of the U.S. population. Florida is excluded from the SEER database, but Florida has a diversity of patients as well as a diversity of practitioners. More than 50% of our study sample was born outside of the U.S.,” Dr. Jones explained.

The study included 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014.

Based on a review of patient records, median survival following a diagnosis of HCC was 301 days for black patients, compared with 534 days for non-Hispanic whites and 437 days for Hispanics.

An analysis showed that median tumor size in blacks was 5.2 cm, compared with 3.9 cm in whites. “This seems like a small difference, but tumor size greater than 5 cm excludes a patient from transplantation, which is curative,” she said. “Larger tumor size also suggests inadequate screening and lack of access to medical care.”

After adjustment for factors such as alcohol use, tobacco use, insurance, and age at diagnosis, non-Hispanic whites had a 25% reduced risk of death and Hispanics, a 21% reduced risk of death, compared with black patients. Black patients were also significantly more likely to have hepatitis B virus (HBV), compared with non-Hispanic whites (24.1% vs. 7%, respectively; P less than .01), which increases the risk of developing HCC.

“Hepatitis B virus can be prevented by vaccination. This may be an underlying issue in this population,” according to Dr. Jones.

Patients who were eligible for and went on to have a liver transplant had a 66% reduction in death, compared with those who did not. Only 11.9% of black patients had a liver transplant, compared with 33.3% of non-Hispanic whites. When adjusted for transplant, the survival gap between races was narrowed. Among transplant recipients, non-Hispanic whites had an 8% reduction in risk of death and Hispanics, a 7% reduction, compared with blacks.

Dr. Jones and her coinvestigators plan to conduct further research to explore risk factors for HCC among their diverse patient population and identify opportunities to maximize education and screening.

One limitation of this study, she said, is that some information may be missing in studies based on records, and the severity of underlying liver disease was not known.

“Because this is a single-center study, we have the ability to go back and get more detailed information to understand racial disparities. For example, we can continue to review the charts of these patients to determine medical conditions and comorbidities,” she said. “So far, the factors that have emerged are socioeconomic, related to access to care and insurance.”

Dr. Jones had no relevant financial disclosures.

Black patients with hepatocellular carcinoma (HCC) have shorter survival and more adverse clinical features at diagnosis than do non-Hispanic whites and other races, according to a single-center review.

Blacks were at a 33% increased risk of death because of HCC, compared with non-Hispanic whites, and were diagnosed at a later stage with larger tumors. Thus, they were less likely to be eligible for curative transplantation, said Dr. Patricia D. Jones of the University of Miami, who presented her findings during a teleconference in advance of the annual Digestive Disease Week.

“We found that race was the strongest predictor of survival in a diverse sample of patients diagnosed with HCC,” said lead author Dr. Jones, who is also on the staff of the Sylvester Comprehensive Cancer Center at the university.

“Most research on racial disparity in medical illness comes from large retrospective databases such as SEER [Surveillance, Epidemiology, and End Results], which represents 28% of the U.S. population. Florida is excluded from the SEER database, but Florida has a diversity of patients as well as a diversity of practitioners. More than 50% of our study sample was born outside of the U.S.,” Dr. Jones explained.

The study included 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014.

Based on a review of patient records, median survival following a diagnosis of HCC was 301 days for black patients, compared with 534 days for non-Hispanic whites and 437 days for Hispanics.

An analysis showed that median tumor size in blacks was 5.2 cm, compared with 3.9 cm in whites. “This seems like a small difference, but tumor size greater than 5 cm excludes a patient from transplantation, which is curative,” she said. “Larger tumor size also suggests inadequate screening and lack of access to medical care.”

After adjustment for factors such as alcohol use, tobacco use, insurance, and age at diagnosis, non-Hispanic whites had a 25% reduced risk of death and Hispanics, a 21% reduced risk of death, compared with black patients. Black patients were also significantly more likely to have hepatitis B virus (HBV), compared with non-Hispanic whites (24.1% vs. 7%, respectively; P less than .01), which increases the risk of developing HCC.

“Hepatitis B virus can be prevented by vaccination. This may be an underlying issue in this population,” according to Dr. Jones.

Patients who were eligible for and went on to have a liver transplant had a 66% reduction in death, compared with those who did not. Only 11.9% of black patients had a liver transplant, compared with 33.3% of non-Hispanic whites. When adjusted for transplant, the survival gap between races was narrowed. Among transplant recipients, non-Hispanic whites had an 8% reduction in risk of death and Hispanics, a 7% reduction, compared with blacks.

Dr. Jones and her coinvestigators plan to conduct further research to explore risk factors for HCC among their diverse patient population and identify opportunities to maximize education and screening.

One limitation of this study, she said, is that some information may be missing in studies based on records, and the severity of underlying liver disease was not known.

“Because this is a single-center study, we have the ability to go back and get more detailed information to understand racial disparities. For example, we can continue to review the charts of these patients to determine medical conditions and comorbidities,” she said. “So far, the factors that have emerged are socioeconomic, related to access to care and insurance.”

Dr. Jones had no relevant financial disclosures.

Black patients with hepatocellular carcinoma (HCC) have shorter survival and more adverse clinical features at diagnosis than do non-Hispanic whites and other races, according to a single-center review.

Blacks were at a 33% increased risk of death because of HCC, compared with non-Hispanic whites, and were diagnosed at a later stage with larger tumors. Thus, they were less likely to be eligible for curative transplantation, said Dr. Patricia D. Jones of the University of Miami, who presented her findings during a teleconference in advance of the annual Digestive Disease Week.

“We found that race was the strongest predictor of survival in a diverse sample of patients diagnosed with HCC,” said lead author Dr. Jones, who is also on the staff of the Sylvester Comprehensive Cancer Center at the university.

“Most research on racial disparity in medical illness comes from large retrospective databases such as SEER [Surveillance, Epidemiology, and End Results], which represents 28% of the U.S. population. Florida is excluded from the SEER database, but Florida has a diversity of patients as well as a diversity of practitioners. More than 50% of our study sample was born outside of the U.S.,” Dr. Jones explained.

The study included 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014.

Based on a review of patient records, median survival following a diagnosis of HCC was 301 days for black patients, compared with 534 days for non-Hispanic whites and 437 days for Hispanics.

An analysis showed that median tumor size in blacks was 5.2 cm, compared with 3.9 cm in whites. “This seems like a small difference, but tumor size greater than 5 cm excludes a patient from transplantation, which is curative,” she said. “Larger tumor size also suggests inadequate screening and lack of access to medical care.”

After adjustment for factors such as alcohol use, tobacco use, insurance, and age at diagnosis, non-Hispanic whites had a 25% reduced risk of death and Hispanics, a 21% reduced risk of death, compared with black patients. Black patients were also significantly more likely to have hepatitis B virus (HBV), compared with non-Hispanic whites (24.1% vs. 7%, respectively; P less than .01), which increases the risk of developing HCC.

“Hepatitis B virus can be prevented by vaccination. This may be an underlying issue in this population,” according to Dr. Jones.

Patients who were eligible for and went on to have a liver transplant had a 66% reduction in death, compared with those who did not. Only 11.9% of black patients had a liver transplant, compared with 33.3% of non-Hispanic whites. When adjusted for transplant, the survival gap between races was narrowed. Among transplant recipients, non-Hispanic whites had an 8% reduction in risk of death and Hispanics, a 7% reduction, compared with blacks.

Dr. Jones and her coinvestigators plan to conduct further research to explore risk factors for HCC among their diverse patient population and identify opportunities to maximize education and screening.

One limitation of this study, she said, is that some information may be missing in studies based on records, and the severity of underlying liver disease was not known.

“Because this is a single-center study, we have the ability to go back and get more detailed information to understand racial disparities. For example, we can continue to review the charts of these patients to determine medical conditions and comorbidities,” she said. “So far, the factors that have emerged are socioeconomic, related to access to care and insurance.”

Dr. Jones had no relevant financial disclosures.

SAN DIEGO – A retrospective study provides insight as to why some patients have a milder versus a more severe course of inflammatory bowel disease (IBD) after liver transplant for primary sclerosing cholangitis (PSC).

Recurrent PSC, prolonged use of steroids, and cancer development after liver transplant were associated with a milder course of IBD, but tacrolimus use was associated with increased IBD flare post transplant.

Alice Goodman/Frontline Medical News

“The course of IBD is highly variable after liver transplant for PSC. PSC is associated with IBD in 60% to 90% of patients, and IBD worsens in about 30% of PSC-IBD patients after transplant. We wanted to explore the risk factors for worsening IBD in this setting,” Dr. Mohamad Mouchli of the Mayo Clinic in Rochester, Minn., explained at the annual Digestive Disease Week.

For purposes of this study, progression of IBD was defined as the need for escalation of medical therapy, compared with before liver transplant, or need for colectomy for medically refractory IBD.

The study population included patients with PSC-IBD who underwent liver transplant for noncholangiocarcinoma indications at the Mayo Clinic from 1998 to 2012. Patients were followed through February 2015.

The investigators screened 373 patients: After exclusions for cancer, no IBD at transplant, and pretransplant colectomy, 151 patients with an intact colon were left and formed the basis of further analysis.

Median age at transplant was 46 years and two-thirds of the patients were male. Transplant-related variables included the following: 23% experienced allograft failure, 36% had recurrent PSC, 25.2% had CMV infection, 19.2% were retransplanted, 22.5% developed cancer after liver transplant, and 52.3% had acute cellular rejection.

Before transplant, 69 patients had quiescent IBD with no therapy and 62 were maintained on 5-aminosalicylates. Post transplant, despite transplant-related immunosuppression, 56 patients (37.1%) required escalation of therapy, 87 patients (57.6%) had a stable course, and 8 patients (5.3%) improved.

Risk of IBD progression at 1, 5, and 10 years was 4%, 18.5%, and 25.5%, respectively. Thirty-five patients underwent colectomy after transplant: the 1-, 5-, and 10-year risks of colectomy were 2%, 9.3%, and 17.2%, respectively. Fourteen percent of patients required anti–tumor necrosis factor therapy after transplant.

On multivariate analysis, tacrolimus exposure emerged as a risk factor for progression of IBD. Tacrolimus immunosuppression was twice as likely as cyclosporine-based immunosuppression to lead to IBD progression. By contrast, recurrent PSC, use of steroids for longer than 6 months, and cancer development after liver transplant were protective of IBD progression.

No association was found between progression of IBD and transplant-related infection or mismatch, immunosuppression with mycophenolate or azathioprine, or IBD-related factors such as pretransplant IBD status or empirical initiation of 5-aminosalicylates within 4 months of liver transplant. During the question-and-answer session following his presentation, Dr. Mouchli was asked whether these results justify prophylactic colectomy. He said that could be considered in patients with active IBD before transplant, but on a case-by-case basis.

SAN DIEGO – A retrospective study provides insight as to why some patients have a milder versus a more severe course of inflammatory bowel disease (IBD) after liver transplant for primary sclerosing cholangitis (PSC).

Recurrent PSC, prolonged use of steroids, and cancer development after liver transplant were associated with a milder course of IBD, but tacrolimus use was associated with increased IBD flare post transplant.

Alice Goodman/Frontline Medical News

“The course of IBD is highly variable after liver transplant for PSC. PSC is associated with IBD in 60% to 90% of patients, and IBD worsens in about 30% of PSC-IBD patients after transplant. We wanted to explore the risk factors for worsening IBD in this setting,” Dr. Mohamad Mouchli of the Mayo Clinic in Rochester, Minn., explained at the annual Digestive Disease Week.

For purposes of this study, progression of IBD was defined as the need for escalation of medical therapy, compared with before liver transplant, or need for colectomy for medically refractory IBD.

The study population included patients with PSC-IBD who underwent liver transplant for noncholangiocarcinoma indications at the Mayo Clinic from 1998 to 2012. Patients were followed through February 2015.

The investigators screened 373 patients: After exclusions for cancer, no IBD at transplant, and pretransplant colectomy, 151 patients with an intact colon were left and formed the basis of further analysis.

Median age at transplant was 46 years and two-thirds of the patients were male. Transplant-related variables included the following: 23% experienced allograft failure, 36% had recurrent PSC, 25.2% had CMV infection, 19.2% were retransplanted, 22.5% developed cancer after liver transplant, and 52.3% had acute cellular rejection.

Before transplant, 69 patients had quiescent IBD with no therapy and 62 were maintained on 5-aminosalicylates. Post transplant, despite transplant-related immunosuppression, 56 patients (37.1%) required escalation of therapy, 87 patients (57.6%) had a stable course, and 8 patients (5.3%) improved.

Risk of IBD progression at 1, 5, and 10 years was 4%, 18.5%, and 25.5%, respectively. Thirty-five patients underwent colectomy after transplant: the 1-, 5-, and 10-year risks of colectomy were 2%, 9.3%, and 17.2%, respectively. Fourteen percent of patients required anti–tumor necrosis factor therapy after transplant.

On multivariate analysis, tacrolimus exposure emerged as a risk factor for progression of IBD. Tacrolimus immunosuppression was twice as likely as cyclosporine-based immunosuppression to lead to IBD progression. By contrast, recurrent PSC, use of steroids for longer than 6 months, and cancer development after liver transplant were protective of IBD progression.

No association was found between progression of IBD and transplant-related infection or mismatch, immunosuppression with mycophenolate or azathioprine, or IBD-related factors such as pretransplant IBD status or empirical initiation of 5-aminosalicylates within 4 months of liver transplant. During the question-and-answer session following his presentation, Dr. Mouchli was asked whether these results justify prophylactic colectomy. He said that could be considered in patients with active IBD before transplant, but on a case-by-case basis.

SAN DIEGO – A retrospective study provides insight as to why some patients have a milder versus a more severe course of inflammatory bowel disease (IBD) after liver transplant for primary sclerosing cholangitis (PSC).

Recurrent PSC, prolonged use of steroids, and cancer development after liver transplant were associated with a milder course of IBD, but tacrolimus use was associated with increased IBD flare post transplant.

Alice Goodman/Frontline Medical News

“The course of IBD is highly variable after liver transplant for PSC. PSC is associated with IBD in 60% to 90% of patients, and IBD worsens in about 30% of PSC-IBD patients after transplant. We wanted to explore the risk factors for worsening IBD in this setting,” Dr. Mohamad Mouchli of the Mayo Clinic in Rochester, Minn., explained at the annual Digestive Disease Week.

For purposes of this study, progression of IBD was defined as the need for escalation of medical therapy, compared with before liver transplant, or need for colectomy for medically refractory IBD.

The study population included patients with PSC-IBD who underwent liver transplant for noncholangiocarcinoma indications at the Mayo Clinic from 1998 to 2012. Patients were followed through February 2015.

The investigators screened 373 patients: After exclusions for cancer, no IBD at transplant, and pretransplant colectomy, 151 patients with an intact colon were left and formed the basis of further analysis.

Median age at transplant was 46 years and two-thirds of the patients were male. Transplant-related variables included the following: 23% experienced allograft failure, 36% had recurrent PSC, 25.2% had CMV infection, 19.2% were retransplanted, 22.5% developed cancer after liver transplant, and 52.3% had acute cellular rejection.

Before transplant, 69 patients had quiescent IBD with no therapy and 62 were maintained on 5-aminosalicylates. Post transplant, despite transplant-related immunosuppression, 56 patients (37.1%) required escalation of therapy, 87 patients (57.6%) had a stable course, and 8 patients (5.3%) improved.

Risk of IBD progression at 1, 5, and 10 years was 4%, 18.5%, and 25.5%, respectively. Thirty-five patients underwent colectomy after transplant: the 1-, 5-, and 10-year risks of colectomy were 2%, 9.3%, and 17.2%, respectively. Fourteen percent of patients required anti–tumor necrosis factor therapy after transplant.

On multivariate analysis, tacrolimus exposure emerged as a risk factor for progression of IBD. Tacrolimus immunosuppression was twice as likely as cyclosporine-based immunosuppression to lead to IBD progression. By contrast, recurrent PSC, use of steroids for longer than 6 months, and cancer development after liver transplant were protective of IBD progression.

No association was found between progression of IBD and transplant-related infection or mismatch, immunosuppression with mycophenolate or azathioprine, or IBD-related factors such as pretransplant IBD status or empirical initiation of 5-aminosalicylates within 4 months of liver transplant. During the question-and-answer session following his presentation, Dr. Mouchli was asked whether these results justify prophylactic colectomy. He said that could be considered in patients with active IBD before transplant, but on a case-by-case basis.