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Spleen/liver stiffness ratio differentiates HCV, ALD
The spleen stiffness (SS) to liver stiffness (LS) ratio was significantly higher in patients with hepatitis C virus infection (HCV) than in patients with alcohol-related liver disease (ALD), according to the results of a multicenter prospective study. In addition, long-term outcome and complications differed dramatically between HCV and ALD. Variceal bleeding was the most common sign of decompensation and cause of death in patients with HCV, while jaundice was the most common sign of decompensation in patients with ALD.
Omar Elshaarawy, MSc, of the University of Heidelberg (Germany) and colleagues reported on their prospective study of 411 patients with HCV (220 patients) or ALD (191 patients) that were assessed for both LS and SS using the Fibroscan device. They also discussed their retrospective analysis of LS and spleen length (SL) from a separate, retrospective cohort of 449 patients (267 with HCV, 182 with ALD) for whom long-term data on decompensation/death were available.
The researchers found that SS was significantly higher in HCV patients, compared with those with ALD (42.0 vs. 32.6 kPa; P less than .0001), as was SL (15.6 vs. 11.9 cm, P less than .0001); this was despite a lower mean LS in HCV. As a result, the SS/LS ratio and the SL/LS ratio were both significantly higher in HCV (3.8 vs. 1.72 and 1.46 vs. 0.86, P less than .0001) through all fibrosis stages.
They also found that patients with ALD had higher LS values (30.5 vs. 21.3 kPa) and predominantly presented with jaundice (65.2%), with liver failure as the major cause of death (P less than .01). In contrast, in HCV, spleens were larger (17.6 vs. 12.1 cm) while variceal bleeding was the major cause of decompensation (73.2%) and death (P less than .001).
“We have demonstrated the disease-specific differences in SS/LS and SL/LS ratio between HCV and ALD. They underscore the role of the intrahepatic histological site of inflammation/fibrosis. We suggest that the SS/LS ratio could be used to confirm the disease etiology and predict disease-specific complications,” the researchers concluded.
The study was supported by the Dietmar Hopp Foundation. The authors reported they had no conflicts.
SOURCE: Elshaarawy O et al. J Hepatol Reports. 2019 Jun 20. doi: 10.1016/j.jhepr.2019.05.003.
The spleen stiffness (SS) to liver stiffness (LS) ratio was significantly higher in patients with hepatitis C virus infection (HCV) than in patients with alcohol-related liver disease (ALD), according to the results of a multicenter prospective study. In addition, long-term outcome and complications differed dramatically between HCV and ALD. Variceal bleeding was the most common sign of decompensation and cause of death in patients with HCV, while jaundice was the most common sign of decompensation in patients with ALD.
Omar Elshaarawy, MSc, of the University of Heidelberg (Germany) and colleagues reported on their prospective study of 411 patients with HCV (220 patients) or ALD (191 patients) that were assessed for both LS and SS using the Fibroscan device. They also discussed their retrospective analysis of LS and spleen length (SL) from a separate, retrospective cohort of 449 patients (267 with HCV, 182 with ALD) for whom long-term data on decompensation/death were available.
The researchers found that SS was significantly higher in HCV patients, compared with those with ALD (42.0 vs. 32.6 kPa; P less than .0001), as was SL (15.6 vs. 11.9 cm, P less than .0001); this was despite a lower mean LS in HCV. As a result, the SS/LS ratio and the SL/LS ratio were both significantly higher in HCV (3.8 vs. 1.72 and 1.46 vs. 0.86, P less than .0001) through all fibrosis stages.
They also found that patients with ALD had higher LS values (30.5 vs. 21.3 kPa) and predominantly presented with jaundice (65.2%), with liver failure as the major cause of death (P less than .01). In contrast, in HCV, spleens were larger (17.6 vs. 12.1 cm) while variceal bleeding was the major cause of decompensation (73.2%) and death (P less than .001).
“We have demonstrated the disease-specific differences in SS/LS and SL/LS ratio between HCV and ALD. They underscore the role of the intrahepatic histological site of inflammation/fibrosis. We suggest that the SS/LS ratio could be used to confirm the disease etiology and predict disease-specific complications,” the researchers concluded.
The study was supported by the Dietmar Hopp Foundation. The authors reported they had no conflicts.
SOURCE: Elshaarawy O et al. J Hepatol Reports. 2019 Jun 20. doi: 10.1016/j.jhepr.2019.05.003.
The spleen stiffness (SS) to liver stiffness (LS) ratio was significantly higher in patients with hepatitis C virus infection (HCV) than in patients with alcohol-related liver disease (ALD), according to the results of a multicenter prospective study. In addition, long-term outcome and complications differed dramatically between HCV and ALD. Variceal bleeding was the most common sign of decompensation and cause of death in patients with HCV, while jaundice was the most common sign of decompensation in patients with ALD.
Omar Elshaarawy, MSc, of the University of Heidelberg (Germany) and colleagues reported on their prospective study of 411 patients with HCV (220 patients) or ALD (191 patients) that were assessed for both LS and SS using the Fibroscan device. They also discussed their retrospective analysis of LS and spleen length (SL) from a separate, retrospective cohort of 449 patients (267 with HCV, 182 with ALD) for whom long-term data on decompensation/death were available.
The researchers found that SS was significantly higher in HCV patients, compared with those with ALD (42.0 vs. 32.6 kPa; P less than .0001), as was SL (15.6 vs. 11.9 cm, P less than .0001); this was despite a lower mean LS in HCV. As a result, the SS/LS ratio and the SL/LS ratio were both significantly higher in HCV (3.8 vs. 1.72 and 1.46 vs. 0.86, P less than .0001) through all fibrosis stages.
They also found that patients with ALD had higher LS values (30.5 vs. 21.3 kPa) and predominantly presented with jaundice (65.2%), with liver failure as the major cause of death (P less than .01). In contrast, in HCV, spleens were larger (17.6 vs. 12.1 cm) while variceal bleeding was the major cause of decompensation (73.2%) and death (P less than .001).
“We have demonstrated the disease-specific differences in SS/LS and SL/LS ratio between HCV and ALD. They underscore the role of the intrahepatic histological site of inflammation/fibrosis. We suggest that the SS/LS ratio could be used to confirm the disease etiology and predict disease-specific complications,” the researchers concluded.
The study was supported by the Dietmar Hopp Foundation. The authors reported they had no conflicts.
SOURCE: Elshaarawy O et al. J Hepatol Reports. 2019 Jun 20. doi: 10.1016/j.jhepr.2019.05.003.
FROM JHEP REPORTS
USPSTF updates, reaffirms recommendation for HBV screening in pregnant women
The according to task force member Douglas K. Owens, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System and other members of the task force.
The recommendation statement, published in JAMA, was based on an evidence report and systematic review also published in JAMA. In that review, two studies of fair quality were identified; one included 155,081 infants born to HBV-positive women identified for case management through the national Perinatal Hepatitis B Prevention Program from 1994 to 2008, and the other included 4,446 infants born in a large, regional health care organization in the United States between 1997 and 2010. In both, low rates of perinatal transmission were reported for those periods – between 0.5% and 1.9% – with the rate falling over time.
In the 2009 recommendation, the USPSTF found adequate evidence that serologic testing for hepatitis B surface antigen accurately identifies HBV infection, and that interventions were effective in preventing perinatal transmission. That recommendation has been reaffirmed in the current update, with HBV screening receiving a grade of A, which is the strongest the USPSTF offers.
In a related editorial, Neil S. Silverman, MD, of the Center for Fetal Medicine and Women’s Ultrasound in Los Angeles noted several improvements in maternal HBV therapy since the publication of the original 2009 recommendation, including maternal HBV-targeted antiviral therapy during pregnancy as an adjunct to neonatal immunoprophylaxis and the ability to refer women for chronic treatment of their HBV disease to prevent long-term infection complications. The task forces also noted that HBV screening of all pregnant women is mandated by law in 26 states.
One member of the task force reported receiving grants and/or personal fees from Healthwise, another member reported receiving personal fees from UpToDate; a third reported participating in the American Association for the Study of Liver Diseases’ Hepatitis B Guidance and Hepatitis B Systematic Review Group. The evidence and review study was funded by the Agency for Healthcare Research and Quality. Dr. Silverman reported no disclosures.
SOURCes: Owens DK et al. JAMA. 2019 Jul 23. doi: 10.1001/jama.2019.9365; Henderson JT et al. JAMA. 2019 Jul 23;32(4):360-2; Silverman NS. JAMA. 2019 Jul 23;32(4):312-14.
The according to task force member Douglas K. Owens, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System and other members of the task force.
The recommendation statement, published in JAMA, was based on an evidence report and systematic review also published in JAMA. In that review, two studies of fair quality were identified; one included 155,081 infants born to HBV-positive women identified for case management through the national Perinatal Hepatitis B Prevention Program from 1994 to 2008, and the other included 4,446 infants born in a large, regional health care organization in the United States between 1997 and 2010. In both, low rates of perinatal transmission were reported for those periods – between 0.5% and 1.9% – with the rate falling over time.
In the 2009 recommendation, the USPSTF found adequate evidence that serologic testing for hepatitis B surface antigen accurately identifies HBV infection, and that interventions were effective in preventing perinatal transmission. That recommendation has been reaffirmed in the current update, with HBV screening receiving a grade of A, which is the strongest the USPSTF offers.
In a related editorial, Neil S. Silverman, MD, of the Center for Fetal Medicine and Women’s Ultrasound in Los Angeles noted several improvements in maternal HBV therapy since the publication of the original 2009 recommendation, including maternal HBV-targeted antiviral therapy during pregnancy as an adjunct to neonatal immunoprophylaxis and the ability to refer women for chronic treatment of their HBV disease to prevent long-term infection complications. The task forces also noted that HBV screening of all pregnant women is mandated by law in 26 states.
One member of the task force reported receiving grants and/or personal fees from Healthwise, another member reported receiving personal fees from UpToDate; a third reported participating in the American Association for the Study of Liver Diseases’ Hepatitis B Guidance and Hepatitis B Systematic Review Group. The evidence and review study was funded by the Agency for Healthcare Research and Quality. Dr. Silverman reported no disclosures.
SOURCes: Owens DK et al. JAMA. 2019 Jul 23. doi: 10.1001/jama.2019.9365; Henderson JT et al. JAMA. 2019 Jul 23;32(4):360-2; Silverman NS. JAMA. 2019 Jul 23;32(4):312-14.
The according to task force member Douglas K. Owens, MD, of the Veterans Affairs Palo Alto (Calif.) Health Care System and other members of the task force.
The recommendation statement, published in JAMA, was based on an evidence report and systematic review also published in JAMA. In that review, two studies of fair quality were identified; one included 155,081 infants born to HBV-positive women identified for case management through the national Perinatal Hepatitis B Prevention Program from 1994 to 2008, and the other included 4,446 infants born in a large, regional health care organization in the United States between 1997 and 2010. In both, low rates of perinatal transmission were reported for those periods – between 0.5% and 1.9% – with the rate falling over time.
In the 2009 recommendation, the USPSTF found adequate evidence that serologic testing for hepatitis B surface antigen accurately identifies HBV infection, and that interventions were effective in preventing perinatal transmission. That recommendation has been reaffirmed in the current update, with HBV screening receiving a grade of A, which is the strongest the USPSTF offers.
In a related editorial, Neil S. Silverman, MD, of the Center for Fetal Medicine and Women’s Ultrasound in Los Angeles noted several improvements in maternal HBV therapy since the publication of the original 2009 recommendation, including maternal HBV-targeted antiviral therapy during pregnancy as an adjunct to neonatal immunoprophylaxis and the ability to refer women for chronic treatment of their HBV disease to prevent long-term infection complications. The task forces also noted that HBV screening of all pregnant women is mandated by law in 26 states.
One member of the task force reported receiving grants and/or personal fees from Healthwise, another member reported receiving personal fees from UpToDate; a third reported participating in the American Association for the Study of Liver Diseases’ Hepatitis B Guidance and Hepatitis B Systematic Review Group. The evidence and review study was funded by the Agency for Healthcare Research and Quality. Dr. Silverman reported no disclosures.
SOURCes: Owens DK et al. JAMA. 2019 Jul 23. doi: 10.1001/jama.2019.9365; Henderson JT et al. JAMA. 2019 Jul 23;32(4):360-2; Silverman NS. JAMA. 2019 Jul 23;32(4):312-14.
FROM JAMA
Small study suggests natural HCV clearance is caused by AR3-antibody response
Individuals who spontaneously cleared their primary hepatitis C virus (HCV) infection or reinfection had significantly more antibodies that recognized multiple HCV genotypes beyond the initial infection, compared with chronically infected individuals, according to a small molecular study of immortalized cultured B cells from patient.
In a study published in the Journal of Hepatology, Sabrina J. Merat of AIMM Therapeutics and colleagues classified patients into two groups based on the outcome of their HCV infection: individuals who became chronically infected (CHRs; n = 5) either after primary infection or after HCV reinfection and individuals who cleared one or more HCV infections and were HCV RNA negative at the end of follow-up (CLs; n = 8). The researchers considered that all CLs who cleared the infection were presumably re-exposed to HCV as they continued injecting drugs for a median of 5.9 years after primary infection. The median follow-up time of individuals after primary HCV infection was 17.5 years.
Although the frequency of total antibodies did not differ between the two groups, the antibodies from CHRs were mainly genotype specific and directed against the genotype of the ongoing infection. Antibodies from CLs showed a much broader reactivity than CHR-derived antibodies, with the absolute number of antibodies recognizing at least three or more genotypes was significantly higher in CLs than in CHRs (13 vs. 0, respectively; P = .03).
In addition, in order to determine which epitopes were being targeted in the CL patients, the researchers tested the antibodies secreted in the B-cell supernatant for binding to E2 alanine mutants in the four epitopes known to be recognized by broadly neutralizing HCV antibodies. They found that the majority of the cross-genotype antibodies (82/113; 73%) were specific for AR3 because they bound to the AR3-specific mutants.
“In chronically infected individuals, AR3-specific antibody responses may be too weak and/or may develop too late to prevent chronic infection. If confirmed, this means that a strong and broadly neutralizing antibody response should be established very early after infection in order to confer protection,” the researchers concluded.
This study was supported by the Virgo consortium, funded by the Dutch government. Sabrina Merat and several coauthors are employees of AIMM Therapeutics, as well as shareholders.
SOURCE: Merat SJ et al. J Hepatol 2019;71:14-24.
Individuals who spontaneously cleared their primary hepatitis C virus (HCV) infection or reinfection had significantly more antibodies that recognized multiple HCV genotypes beyond the initial infection, compared with chronically infected individuals, according to a small molecular study of immortalized cultured B cells from patient.
In a study published in the Journal of Hepatology, Sabrina J. Merat of AIMM Therapeutics and colleagues classified patients into two groups based on the outcome of their HCV infection: individuals who became chronically infected (CHRs; n = 5) either after primary infection or after HCV reinfection and individuals who cleared one or more HCV infections and were HCV RNA negative at the end of follow-up (CLs; n = 8). The researchers considered that all CLs who cleared the infection were presumably re-exposed to HCV as they continued injecting drugs for a median of 5.9 years after primary infection. The median follow-up time of individuals after primary HCV infection was 17.5 years.
Although the frequency of total antibodies did not differ between the two groups, the antibodies from CHRs were mainly genotype specific and directed against the genotype of the ongoing infection. Antibodies from CLs showed a much broader reactivity than CHR-derived antibodies, with the absolute number of antibodies recognizing at least three or more genotypes was significantly higher in CLs than in CHRs (13 vs. 0, respectively; P = .03).
In addition, in order to determine which epitopes were being targeted in the CL patients, the researchers tested the antibodies secreted in the B-cell supernatant for binding to E2 alanine mutants in the four epitopes known to be recognized by broadly neutralizing HCV antibodies. They found that the majority of the cross-genotype antibodies (82/113; 73%) were specific for AR3 because they bound to the AR3-specific mutants.
“In chronically infected individuals, AR3-specific antibody responses may be too weak and/or may develop too late to prevent chronic infection. If confirmed, this means that a strong and broadly neutralizing antibody response should be established very early after infection in order to confer protection,” the researchers concluded.
This study was supported by the Virgo consortium, funded by the Dutch government. Sabrina Merat and several coauthors are employees of AIMM Therapeutics, as well as shareholders.
SOURCE: Merat SJ et al. J Hepatol 2019;71:14-24.
Individuals who spontaneously cleared their primary hepatitis C virus (HCV) infection or reinfection had significantly more antibodies that recognized multiple HCV genotypes beyond the initial infection, compared with chronically infected individuals, according to a small molecular study of immortalized cultured B cells from patient.
In a study published in the Journal of Hepatology, Sabrina J. Merat of AIMM Therapeutics and colleagues classified patients into two groups based on the outcome of their HCV infection: individuals who became chronically infected (CHRs; n = 5) either after primary infection or after HCV reinfection and individuals who cleared one or more HCV infections and were HCV RNA negative at the end of follow-up (CLs; n = 8). The researchers considered that all CLs who cleared the infection were presumably re-exposed to HCV as they continued injecting drugs for a median of 5.9 years after primary infection. The median follow-up time of individuals after primary HCV infection was 17.5 years.
Although the frequency of total antibodies did not differ between the two groups, the antibodies from CHRs were mainly genotype specific and directed against the genotype of the ongoing infection. Antibodies from CLs showed a much broader reactivity than CHR-derived antibodies, with the absolute number of antibodies recognizing at least three or more genotypes was significantly higher in CLs than in CHRs (13 vs. 0, respectively; P = .03).
In addition, in order to determine which epitopes were being targeted in the CL patients, the researchers tested the antibodies secreted in the B-cell supernatant for binding to E2 alanine mutants in the four epitopes known to be recognized by broadly neutralizing HCV antibodies. They found that the majority of the cross-genotype antibodies (82/113; 73%) were specific for AR3 because they bound to the AR3-specific mutants.
“In chronically infected individuals, AR3-specific antibody responses may be too weak and/or may develop too late to prevent chronic infection. If confirmed, this means that a strong and broadly neutralizing antibody response should be established very early after infection in order to confer protection,” the researchers concluded.
This study was supported by the Virgo consortium, funded by the Dutch government. Sabrina Merat and several coauthors are employees of AIMM Therapeutics, as well as shareholders.
SOURCE: Merat SJ et al. J Hepatol 2019;71:14-24.
FROM THE JOURNAL OF HEPATOLOGY
HCC surveillance after anti-HCV therapy cost effective only for patients with cirrhosis
For patients with hepatitis C virus (HCV)–related cirrhosis (F4), but not those with advanced fibrosis (F3), hepatocellular carcinoma (HCC) surveillance after a sustained virologic response (SVR) is cost effective, according to investigators.
Current international guidelines call for HCC surveillance among all patients with advanced fibrosis (F3) or cirrhosis (F4) who have achieved SVR, but this is “very unlikely to be cost effective,” reported lead author Hooman Farhang Zangneh, MD, of Toronto General Hospital and colleagues. “HCV-related HCC rarely occurs in patients without cirrhosis,” the investigators explained in Clinical Gastroenterology and Hepatology. “With cirrhosis present, HCC incidence is 1.4% to 4.9% per year. If found early, options for curative therapy include radiofrequency ablation (RFA), surgical resection, and liver transplantation.”
The investigators developed a Markov model to determine which at-risk patients could undergo surveillance while remaining below willingness-to-pay thresholds. Specifically, cost-effectiveness was assessed for ultrasound screenings annually (every year) or biannually (twice a year) among patients with advanced fibrosis (F3) or compensated cirrhosis (F4) who were aged 50 years and had an SVR. Relevant data were drawn from expert opinions, medical literature, and Canada Life Tables. Various HCC incidence rates were tested, including a constant annual rate, rates based on type of antiviral treatment (direct-acting and interferon-based therapies), others based on stage of fibrosis, and another that increased with age. The model was validated by applying it to patients with F3 or F4 fibrosis who had not yet achieved an SVR. All monetary values were reported in 2015 Canadian dollars.
Representative of current guidelines, the investigators first tested costs when conducting surveillance among all patients with F3 or F4 fibrosis with an assumed constant HCC annual incidence rate of 0.5%. Biannual ultrasound surveillance after SVR caught more cases of HCC still in a curable stage (78%) than no surveillance (29%); however, false-positives were relatively common at 21.8% and 15.7% for biannual and annual surveillance, respectively. The investigators noted that in the real world, some of these false-positives are not detected by more advanced imaging, so patients go on to receive unnecessary RFA, which incurs additional costs. Partly for this reason, while biannual surveillance was more effective, it was also more expensive, with an incremental cost-effectiveness ratio (ICER) of $106,792 per quality-adjusted life-years (QALY), compared with $72,105 per QALY for annual surveillance.
Including only patients with F3 fibrosis after interferon-based therapy, using an HCC incidence of 0.23%, biannual and annual ICERs rose to $484,160 and $204,708 per QALY, respectively, both of which exceed standard willingness-to-pay thresholds. In comparison, annual and biannual ICERs were at most $55,850 and $42,305 per QALY, respectively, among patients with cirrhosis before interferon-induced SVR, using an HCC incidence rate of up to 1.39% per year.
“These results suggest that biannual (or annual) HCC surveillance is likely to be cost effective for patients with cirrhosis, but not for patients with F3 fibrosis before SVR,” the investigators wrote.
Costs for HCC surveillance among cirrhosis patients after direct-acting antiviral-induced SVR were still lower, at $43,229 and $34,307 per QALY, which were far lower than costs for patients with F3 fibrosis, which were $188,157 and $111,667 per QALY.
Focusing on the evident savings associated with surveillance of patients with cirrhosis, the investigators tested two diagnostic thresholds within this population with the aim of reducing costs further. They found that surveillance of patients with a pretreatment aspartate aminotransferase to platelet ratio index (APRI) greater than 2.0 (HCC incidence, 0.89%) was associated with biannual and annual ICERs of $48,729 and $37,806 per QALY, respectively, but when APRI was less than 2.0 (HCC incidence, 0.093%), surveillance was less effective and more expensive than no surveillance at all. A similar trend was found for an FIB-4 threshold of 3.25.
Employment of age-stratified risk of HCC also reduced costs of screening for patients with cirrhosis. With this strategy, ICER was $48,432 per QALY for biannual surveillance and $37,201 per QALY for annual surveillance.
“These data suggest that, if we assume HCC incidence increases with age, biannual or annual surveillance will be cost effective for the vast majority, if not all, patients with cirrhosis before SVR,” the investigators wrote.
“Our analysis suggests that HCC surveillance is very unlikely to be cost effective in patients with F3 fibrosis, whereas both annual and biannual modalities are likely to be cost effective at standard willingness-to-pay thresholds for patients with cirrhosis compared with no surveillance,” the investigators wrote.
“Additional long-term follow-up data are required to help identify patients at highest risk of HCC after SVR to tailor surveillance guidelines,” the investigators concluded.
The study was funded by the Toronto Centre for Liver Disease. The investigators declared no conflicts of interest.
This story was updated on 7/12/2019.
SOURCE: Zangneh et al. Clin Gastroenterol Hepatol. 2018 Dec 20. doi: 10.1016/j.cgh.2018.12.018.
For patients with hepatitis C virus (HCV)–related cirrhosis (F4), but not those with advanced fibrosis (F3), hepatocellular carcinoma (HCC) surveillance after a sustained virologic response (SVR) is cost effective, according to investigators.
Current international guidelines call for HCC surveillance among all patients with advanced fibrosis (F3) or cirrhosis (F4) who have achieved SVR, but this is “very unlikely to be cost effective,” reported lead author Hooman Farhang Zangneh, MD, of Toronto General Hospital and colleagues. “HCV-related HCC rarely occurs in patients without cirrhosis,” the investigators explained in Clinical Gastroenterology and Hepatology. “With cirrhosis present, HCC incidence is 1.4% to 4.9% per year. If found early, options for curative therapy include radiofrequency ablation (RFA), surgical resection, and liver transplantation.”
The investigators developed a Markov model to determine which at-risk patients could undergo surveillance while remaining below willingness-to-pay thresholds. Specifically, cost-effectiveness was assessed for ultrasound screenings annually (every year) or biannually (twice a year) among patients with advanced fibrosis (F3) or compensated cirrhosis (F4) who were aged 50 years and had an SVR. Relevant data were drawn from expert opinions, medical literature, and Canada Life Tables. Various HCC incidence rates were tested, including a constant annual rate, rates based on type of antiviral treatment (direct-acting and interferon-based therapies), others based on stage of fibrosis, and another that increased with age. The model was validated by applying it to patients with F3 or F4 fibrosis who had not yet achieved an SVR. All monetary values were reported in 2015 Canadian dollars.
Representative of current guidelines, the investigators first tested costs when conducting surveillance among all patients with F3 or F4 fibrosis with an assumed constant HCC annual incidence rate of 0.5%. Biannual ultrasound surveillance after SVR caught more cases of HCC still in a curable stage (78%) than no surveillance (29%); however, false-positives were relatively common at 21.8% and 15.7% for biannual and annual surveillance, respectively. The investigators noted that in the real world, some of these false-positives are not detected by more advanced imaging, so patients go on to receive unnecessary RFA, which incurs additional costs. Partly for this reason, while biannual surveillance was more effective, it was also more expensive, with an incremental cost-effectiveness ratio (ICER) of $106,792 per quality-adjusted life-years (QALY), compared with $72,105 per QALY for annual surveillance.
Including only patients with F3 fibrosis after interferon-based therapy, using an HCC incidence of 0.23%, biannual and annual ICERs rose to $484,160 and $204,708 per QALY, respectively, both of which exceed standard willingness-to-pay thresholds. In comparison, annual and biannual ICERs were at most $55,850 and $42,305 per QALY, respectively, among patients with cirrhosis before interferon-induced SVR, using an HCC incidence rate of up to 1.39% per year.
“These results suggest that biannual (or annual) HCC surveillance is likely to be cost effective for patients with cirrhosis, but not for patients with F3 fibrosis before SVR,” the investigators wrote.
Costs for HCC surveillance among cirrhosis patients after direct-acting antiviral-induced SVR were still lower, at $43,229 and $34,307 per QALY, which were far lower than costs for patients with F3 fibrosis, which were $188,157 and $111,667 per QALY.
Focusing on the evident savings associated with surveillance of patients with cirrhosis, the investigators tested two diagnostic thresholds within this population with the aim of reducing costs further. They found that surveillance of patients with a pretreatment aspartate aminotransferase to platelet ratio index (APRI) greater than 2.0 (HCC incidence, 0.89%) was associated with biannual and annual ICERs of $48,729 and $37,806 per QALY, respectively, but when APRI was less than 2.0 (HCC incidence, 0.093%), surveillance was less effective and more expensive than no surveillance at all. A similar trend was found for an FIB-4 threshold of 3.25.
Employment of age-stratified risk of HCC also reduced costs of screening for patients with cirrhosis. With this strategy, ICER was $48,432 per QALY for biannual surveillance and $37,201 per QALY for annual surveillance.
“These data suggest that, if we assume HCC incidence increases with age, biannual or annual surveillance will be cost effective for the vast majority, if not all, patients with cirrhosis before SVR,” the investigators wrote.
“Our analysis suggests that HCC surveillance is very unlikely to be cost effective in patients with F3 fibrosis, whereas both annual and biannual modalities are likely to be cost effective at standard willingness-to-pay thresholds for patients with cirrhosis compared with no surveillance,” the investigators wrote.
“Additional long-term follow-up data are required to help identify patients at highest risk of HCC after SVR to tailor surveillance guidelines,” the investigators concluded.
The study was funded by the Toronto Centre for Liver Disease. The investigators declared no conflicts of interest.
This story was updated on 7/12/2019.
SOURCE: Zangneh et al. Clin Gastroenterol Hepatol. 2018 Dec 20. doi: 10.1016/j.cgh.2018.12.018.
For patients with hepatitis C virus (HCV)–related cirrhosis (F4), but not those with advanced fibrosis (F3), hepatocellular carcinoma (HCC) surveillance after a sustained virologic response (SVR) is cost effective, according to investigators.
Current international guidelines call for HCC surveillance among all patients with advanced fibrosis (F3) or cirrhosis (F4) who have achieved SVR, but this is “very unlikely to be cost effective,” reported lead author Hooman Farhang Zangneh, MD, of Toronto General Hospital and colleagues. “HCV-related HCC rarely occurs in patients without cirrhosis,” the investigators explained in Clinical Gastroenterology and Hepatology. “With cirrhosis present, HCC incidence is 1.4% to 4.9% per year. If found early, options for curative therapy include radiofrequency ablation (RFA), surgical resection, and liver transplantation.”
The investigators developed a Markov model to determine which at-risk patients could undergo surveillance while remaining below willingness-to-pay thresholds. Specifically, cost-effectiveness was assessed for ultrasound screenings annually (every year) or biannually (twice a year) among patients with advanced fibrosis (F3) or compensated cirrhosis (F4) who were aged 50 years and had an SVR. Relevant data were drawn from expert opinions, medical literature, and Canada Life Tables. Various HCC incidence rates were tested, including a constant annual rate, rates based on type of antiviral treatment (direct-acting and interferon-based therapies), others based on stage of fibrosis, and another that increased with age. The model was validated by applying it to patients with F3 or F4 fibrosis who had not yet achieved an SVR. All monetary values were reported in 2015 Canadian dollars.
Representative of current guidelines, the investigators first tested costs when conducting surveillance among all patients with F3 or F4 fibrosis with an assumed constant HCC annual incidence rate of 0.5%. Biannual ultrasound surveillance after SVR caught more cases of HCC still in a curable stage (78%) than no surveillance (29%); however, false-positives were relatively common at 21.8% and 15.7% for biannual and annual surveillance, respectively. The investigators noted that in the real world, some of these false-positives are not detected by more advanced imaging, so patients go on to receive unnecessary RFA, which incurs additional costs. Partly for this reason, while biannual surveillance was more effective, it was also more expensive, with an incremental cost-effectiveness ratio (ICER) of $106,792 per quality-adjusted life-years (QALY), compared with $72,105 per QALY for annual surveillance.
Including only patients with F3 fibrosis after interferon-based therapy, using an HCC incidence of 0.23%, biannual and annual ICERs rose to $484,160 and $204,708 per QALY, respectively, both of which exceed standard willingness-to-pay thresholds. In comparison, annual and biannual ICERs were at most $55,850 and $42,305 per QALY, respectively, among patients with cirrhosis before interferon-induced SVR, using an HCC incidence rate of up to 1.39% per year.
“These results suggest that biannual (or annual) HCC surveillance is likely to be cost effective for patients with cirrhosis, but not for patients with F3 fibrosis before SVR,” the investigators wrote.
Costs for HCC surveillance among cirrhosis patients after direct-acting antiviral-induced SVR were still lower, at $43,229 and $34,307 per QALY, which were far lower than costs for patients with F3 fibrosis, which were $188,157 and $111,667 per QALY.
Focusing on the evident savings associated with surveillance of patients with cirrhosis, the investigators tested two diagnostic thresholds within this population with the aim of reducing costs further. They found that surveillance of patients with a pretreatment aspartate aminotransferase to platelet ratio index (APRI) greater than 2.0 (HCC incidence, 0.89%) was associated with biannual and annual ICERs of $48,729 and $37,806 per QALY, respectively, but when APRI was less than 2.0 (HCC incidence, 0.093%), surveillance was less effective and more expensive than no surveillance at all. A similar trend was found for an FIB-4 threshold of 3.25.
Employment of age-stratified risk of HCC also reduced costs of screening for patients with cirrhosis. With this strategy, ICER was $48,432 per QALY for biannual surveillance and $37,201 per QALY for annual surveillance.
“These data suggest that, if we assume HCC incidence increases with age, biannual or annual surveillance will be cost effective for the vast majority, if not all, patients with cirrhosis before SVR,” the investigators wrote.
“Our analysis suggests that HCC surveillance is very unlikely to be cost effective in patients with F3 fibrosis, whereas both annual and biannual modalities are likely to be cost effective at standard willingness-to-pay thresholds for patients with cirrhosis compared with no surveillance,” the investigators wrote.
“Additional long-term follow-up data are required to help identify patients at highest risk of HCC after SVR to tailor surveillance guidelines,” the investigators concluded.
The study was funded by the Toronto Centre for Liver Disease. The investigators declared no conflicts of interest.
This story was updated on 7/12/2019.
SOURCE: Zangneh et al. Clin Gastroenterol Hepatol. 2018 Dec 20. doi: 10.1016/j.cgh.2018.12.018.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Louisiana HCV program cuts costs – and hassles
Beginning July 15, physicians will no longer have to seek prior authorization or preauthorization to prescribe the authorized generic version of Epclusa (sofosbuvir/velpatasvir) to any Medicaid patient with hepatitis C. There will be no forms to file.
The change comes as part of a supplemental rebate agreement approved June 26 by CMS. That same day, Louisiana announced a deal with Asegua Therapeutics, a wholly owned subsidiary of Epclusa maker Gilead, that essentially caps the annual cost to the state for treating hepatitis C in incarcerated patients and Medicaid recipients.
State officials estimate about 39,000 Louisianans fit those criteria; the goal of the program is to cure at least 31,000 of them by the time the 5-year agreement expires.
“This new model has the potential to save many lives and improve the health of our citizens,” Louisiana Gov. John Bel Edwards (D) said in a statement. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this 5-year partnership. Ultimately our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort.”
The agreement was designed to change very little in terms of the mechanics of how Medicaid managed care organizations, which cover most of the state’s Medicaid population and handle coverage and claims. The biggest change is that, when a spending cap is reached, Asegua will rebate 100% excess costs to the state. Louisiana officials did not disclose what the annual financial caps were as part of the agreement.
“We really thought it was important to leave the system – as much as possible – intact because we think that is going to make us most successful,” Alex Billioux, MD, of the Louisiana Department of Health said in an interview. “We think it leverages existing patient relationships and existing [Medicaid managed care organization] care management responsibilities.”
He added that, by keeping current processes unchanged, “it takes what is an otherwise very complicated arrangement with the state and makes it a little simpler.”
Patients will see no change in terms of copayments for the approved generic topping out at $3 depending on income level as they would have prior to the agreement. The biggest difference for them is that “people who couldn’t be treated are now going to have access to those prescriptions,” Dr. Billioux said.
Some cautious optimism surrounds this kind of arrangement and the potential effect it can have on the affected population.
“Innovation geared to improve access to hepatitis C treatment is critical, particularly in areas like Louisiana where treatment rates for Medicaid patients have been very low,” Robert Brown, MD, member of the American Liver Foundation’s National Medical Advisory Committee and hepatologist at Weill Cornell Medical College, New York, said. “If we can enhance patient access to treatment, we know we will improve health outcomes. However, it is too early to tell if this innovation will be a success. At the end of the day, the number of additional patients cured will determine if this was the right approach.”
Beginning July 15, physicians will no longer have to seek prior authorization or preauthorization to prescribe the authorized generic version of Epclusa (sofosbuvir/velpatasvir) to any Medicaid patient with hepatitis C. There will be no forms to file.
The change comes as part of a supplemental rebate agreement approved June 26 by CMS. That same day, Louisiana announced a deal with Asegua Therapeutics, a wholly owned subsidiary of Epclusa maker Gilead, that essentially caps the annual cost to the state for treating hepatitis C in incarcerated patients and Medicaid recipients.
State officials estimate about 39,000 Louisianans fit those criteria; the goal of the program is to cure at least 31,000 of them by the time the 5-year agreement expires.
“This new model has the potential to save many lives and improve the health of our citizens,” Louisiana Gov. John Bel Edwards (D) said in a statement. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this 5-year partnership. Ultimately our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort.”
The agreement was designed to change very little in terms of the mechanics of how Medicaid managed care organizations, which cover most of the state’s Medicaid population and handle coverage and claims. The biggest change is that, when a spending cap is reached, Asegua will rebate 100% excess costs to the state. Louisiana officials did not disclose what the annual financial caps were as part of the agreement.
“We really thought it was important to leave the system – as much as possible – intact because we think that is going to make us most successful,” Alex Billioux, MD, of the Louisiana Department of Health said in an interview. “We think it leverages existing patient relationships and existing [Medicaid managed care organization] care management responsibilities.”
He added that, by keeping current processes unchanged, “it takes what is an otherwise very complicated arrangement with the state and makes it a little simpler.”
Patients will see no change in terms of copayments for the approved generic topping out at $3 depending on income level as they would have prior to the agreement. The biggest difference for them is that “people who couldn’t be treated are now going to have access to those prescriptions,” Dr. Billioux said.
Some cautious optimism surrounds this kind of arrangement and the potential effect it can have on the affected population.
“Innovation geared to improve access to hepatitis C treatment is critical, particularly in areas like Louisiana where treatment rates for Medicaid patients have been very low,” Robert Brown, MD, member of the American Liver Foundation’s National Medical Advisory Committee and hepatologist at Weill Cornell Medical College, New York, said. “If we can enhance patient access to treatment, we know we will improve health outcomes. However, it is too early to tell if this innovation will be a success. At the end of the day, the number of additional patients cured will determine if this was the right approach.”
Beginning July 15, physicians will no longer have to seek prior authorization or preauthorization to prescribe the authorized generic version of Epclusa (sofosbuvir/velpatasvir) to any Medicaid patient with hepatitis C. There will be no forms to file.
The change comes as part of a supplemental rebate agreement approved June 26 by CMS. That same day, Louisiana announced a deal with Asegua Therapeutics, a wholly owned subsidiary of Epclusa maker Gilead, that essentially caps the annual cost to the state for treating hepatitis C in incarcerated patients and Medicaid recipients.
State officials estimate about 39,000 Louisianans fit those criteria; the goal of the program is to cure at least 31,000 of them by the time the 5-year agreement expires.
“This new model has the potential to save many lives and improve the health of our citizens,” Louisiana Gov. John Bel Edwards (D) said in a statement. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this 5-year partnership. Ultimately our goal is to eliminate this disease in Louisiana, and we have taken a big step forward in that effort.”
The agreement was designed to change very little in terms of the mechanics of how Medicaid managed care organizations, which cover most of the state’s Medicaid population and handle coverage and claims. The biggest change is that, when a spending cap is reached, Asegua will rebate 100% excess costs to the state. Louisiana officials did not disclose what the annual financial caps were as part of the agreement.
“We really thought it was important to leave the system – as much as possible – intact because we think that is going to make us most successful,” Alex Billioux, MD, of the Louisiana Department of Health said in an interview. “We think it leverages existing patient relationships and existing [Medicaid managed care organization] care management responsibilities.”
He added that, by keeping current processes unchanged, “it takes what is an otherwise very complicated arrangement with the state and makes it a little simpler.”
Patients will see no change in terms of copayments for the approved generic topping out at $3 depending on income level as they would have prior to the agreement. The biggest difference for them is that “people who couldn’t be treated are now going to have access to those prescriptions,” Dr. Billioux said.
Some cautious optimism surrounds this kind of arrangement and the potential effect it can have on the affected population.
“Innovation geared to improve access to hepatitis C treatment is critical, particularly in areas like Louisiana where treatment rates for Medicaid patients have been very low,” Robert Brown, MD, member of the American Liver Foundation’s National Medical Advisory Committee and hepatologist at Weill Cornell Medical College, New York, said. “If we can enhance patient access to treatment, we know we will improve health outcomes. However, it is too early to tell if this innovation will be a success. At the end of the day, the number of additional patients cured will determine if this was the right approach.”
ACIP endorses catch-up hepatitis A vaccinations
The Centers for Disease Control and Prevention’s Committee on Immunization Practices voted unanimously in support of three recommendations for the use of hepatitis A vaccines.
The committee recommended catch-up vaccination at any age for all children aged 2-18 years who had not previously received hepatitis A vaccination, recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine, and approved updating the language in the full hepatitis A vaccine statement, “Prevention of Hepatitis A Virus Infection in The United States: Recommendations of The Advisory Committee on Immunization Practices.”
Catch-up vaccination will expand coverage to adolescents who might have missed it, and data show that the vaccine effectiveness is high, and the rates of adverse events are low in the child and adolescent population, said Noele Nelson, MD, of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, who presented the recommendations to the committee. “Recent outbreaks are occurring primarily among adults,” and many cases are among persons who use drugs or are homeless, she added.
Several committee members noted that the specific recommendations for catch-up in children and teens and for vaccination of HIV patients offer more opportunities for protection than risk-based recommendations. Catching up with vaccinating adolescents is “more effective than tracking down high-risk adults later in life,” noted Grace Lee, MD, of Lucile Packard Children’s Hospital at Stanford, Calif.
The committee also recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine. Data on persons with HIV show that approximately 60% have at least one risk factor for hepatitis A, such as men who have sex with men or individuals engaged in intravenous drug use, said Dr. Nelson. Data also show that individuals with HIV are at increased risk for complications if they get hepatitis A.
The committee’s approval of the full hepatitis A vaccine statement included one notable change – the removal of clotting factor disorders as a high-risk group. The risk has decreased over time based on improvements such as better screening of source plasma, and this group is now at no greater risk than the general population, according to work group chair Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn.
The ACIP members had no financial conflicts to disclose.
The Centers for Disease Control and Prevention’s Committee on Immunization Practices voted unanimously in support of three recommendations for the use of hepatitis A vaccines.
The committee recommended catch-up vaccination at any age for all children aged 2-18 years who had not previously received hepatitis A vaccination, recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine, and approved updating the language in the full hepatitis A vaccine statement, “Prevention of Hepatitis A Virus Infection in The United States: Recommendations of The Advisory Committee on Immunization Practices.”
Catch-up vaccination will expand coverage to adolescents who might have missed it, and data show that the vaccine effectiveness is high, and the rates of adverse events are low in the child and adolescent population, said Noele Nelson, MD, of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, who presented the recommendations to the committee. “Recent outbreaks are occurring primarily among adults,” and many cases are among persons who use drugs or are homeless, she added.
Several committee members noted that the specific recommendations for catch-up in children and teens and for vaccination of HIV patients offer more opportunities for protection than risk-based recommendations. Catching up with vaccinating adolescents is “more effective than tracking down high-risk adults later in life,” noted Grace Lee, MD, of Lucile Packard Children’s Hospital at Stanford, Calif.
The committee also recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine. Data on persons with HIV show that approximately 60% have at least one risk factor for hepatitis A, such as men who have sex with men or individuals engaged in intravenous drug use, said Dr. Nelson. Data also show that individuals with HIV are at increased risk for complications if they get hepatitis A.
The committee’s approval of the full hepatitis A vaccine statement included one notable change – the removal of clotting factor disorders as a high-risk group. The risk has decreased over time based on improvements such as better screening of source plasma, and this group is now at no greater risk than the general population, according to work group chair Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn.
The ACIP members had no financial conflicts to disclose.
The Centers for Disease Control and Prevention’s Committee on Immunization Practices voted unanimously in support of three recommendations for the use of hepatitis A vaccines.
The committee recommended catch-up vaccination at any age for all children aged 2-18 years who had not previously received hepatitis A vaccination, recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine, and approved updating the language in the full hepatitis A vaccine statement, “Prevention of Hepatitis A Virus Infection in The United States: Recommendations of The Advisory Committee on Immunization Practices.”
Catch-up vaccination will expand coverage to adolescents who might have missed it, and data show that the vaccine effectiveness is high, and the rates of adverse events are low in the child and adolescent population, said Noele Nelson, MD, of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, who presented the recommendations to the committee. “Recent outbreaks are occurring primarily among adults,” and many cases are among persons who use drugs or are homeless, she added.
Several committee members noted that the specific recommendations for catch-up in children and teens and for vaccination of HIV patients offer more opportunities for protection than risk-based recommendations. Catching up with vaccinating adolescents is “more effective than tracking down high-risk adults later in life,” noted Grace Lee, MD, of Lucile Packard Children’s Hospital at Stanford, Calif.
The committee also recommended that all persons with HIV aged 1 year and older should be vaccinated with the hepatitis A vaccine. Data on persons with HIV show that approximately 60% have at least one risk factor for hepatitis A, such as men who have sex with men or individuals engaged in intravenous drug use, said Dr. Nelson. Data also show that individuals with HIV are at increased risk for complications if they get hepatitis A.
The committee’s approval of the full hepatitis A vaccine statement included one notable change – the removal of clotting factor disorders as a high-risk group. The risk has decreased over time based on improvements such as better screening of source plasma, and this group is now at no greater risk than the general population, according to work group chair Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn.
The ACIP members had no financial conflicts to disclose.
REPORTING FROM AN ACIP MEETING
ACIP adds hexavalent vaccine to VFC program
The pediatric hexavalent vaccine (DTaP-[inactivated poliovirus] IPV-[hepatitis B] HepB-[Haemophilis influenzae type b] Hib) should be included as an option in the Vaccines for Children (VFC) program for the infant series at ages 2, 4, and 6 months, according to unanimous votes at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The addition of the vaccine to the VFC program required no motions on the part of the committee, but involved separate votes on each component of the vaccine.
Combination vaccination has been associated with increased coverage and more likely completion of the full infant vaccine series, said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases.
The new vaccine is being developed jointly by Sanofi and Merck, and has been approved by the Food and Drug Administration for use in children through age 4 years.
Dr. Oliver presented evidence that the safety profile of the combination vaccine is consistent with that of the component vaccines. In addition, “use of combination vaccines can reduce the number of injections patient receive and alleviate concern associated with the number of injections,” she said. However, “considerations should include provider assessment, patient preference, and the potential for adverse events.”
although it will not be available until 2021 in order to ensure sufficient supply, Dr. Oliver noted.
The combination vaccination work group considered whether the new vaccine should be preferentially recommended for American Indian and Alaskan Native populations, but they concluded that post–dose one immunogenicity data are needed before such a preferential recommendation can be made.
The ACIP members had no financial conflicts to disclose.
The pediatric hexavalent vaccine (DTaP-[inactivated poliovirus] IPV-[hepatitis B] HepB-[Haemophilis influenzae type b] Hib) should be included as an option in the Vaccines for Children (VFC) program for the infant series at ages 2, 4, and 6 months, according to unanimous votes at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The addition of the vaccine to the VFC program required no motions on the part of the committee, but involved separate votes on each component of the vaccine.
Combination vaccination has been associated with increased coverage and more likely completion of the full infant vaccine series, said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases.
The new vaccine is being developed jointly by Sanofi and Merck, and has been approved by the Food and Drug Administration for use in children through age 4 years.
Dr. Oliver presented evidence that the safety profile of the combination vaccine is consistent with that of the component vaccines. In addition, “use of combination vaccines can reduce the number of injections patient receive and alleviate concern associated with the number of injections,” she said. However, “considerations should include provider assessment, patient preference, and the potential for adverse events.”
although it will not be available until 2021 in order to ensure sufficient supply, Dr. Oliver noted.
The combination vaccination work group considered whether the new vaccine should be preferentially recommended for American Indian and Alaskan Native populations, but they concluded that post–dose one immunogenicity data are needed before such a preferential recommendation can be made.
The ACIP members had no financial conflicts to disclose.
The pediatric hexavalent vaccine (DTaP-[inactivated poliovirus] IPV-[hepatitis B] HepB-[Haemophilis influenzae type b] Hib) should be included as an option in the Vaccines for Children (VFC) program for the infant series at ages 2, 4, and 6 months, according to unanimous votes at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The addition of the vaccine to the VFC program required no motions on the part of the committee, but involved separate votes on each component of the vaccine.
Combination vaccination has been associated with increased coverage and more likely completion of the full infant vaccine series, said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases.
The new vaccine is being developed jointly by Sanofi and Merck, and has been approved by the Food and Drug Administration for use in children through age 4 years.
Dr. Oliver presented evidence that the safety profile of the combination vaccine is consistent with that of the component vaccines. In addition, “use of combination vaccines can reduce the number of injections patient receive and alleviate concern associated with the number of injections,” she said. However, “considerations should include provider assessment, patient preference, and the potential for adverse events.”
although it will not be available until 2021 in order to ensure sufficient supply, Dr. Oliver noted.
The combination vaccination work group considered whether the new vaccine should be preferentially recommended for American Indian and Alaskan Native populations, but they concluded that post–dose one immunogenicity data are needed before such a preferential recommendation can be made.
The ACIP members had no financial conflicts to disclose.
REPORTING FROM AN ACIP MEETING
Treatment for hepatitis C reduces risk of Parkinson’s disease
, according to a cohort study published online June 5 in JAMA Neurology. The results provide evidence that hepatitis C virus is a risk factor for Parkinson’s disease.
In the past several years, epidemiologic studies have suggested an association between hepatitis C virus infection and Parkinson’s disease. A study published in 2017, however, found no association between the two. In addition, these investigations did not consider antiviral therapy as a potential modifying factor.
Wey-Yil Lin, MD, a neurologist at Landseed International Hospital in Taoyuan, Taiwan, and colleagues examined claims data from the Taiwan National Health Insurance Research Database to identify the risk of incident Parkinson’s disease in patients with hepatitis C virus infection who received antiviral treatment, compared with those who did not receive treatment.
The investigators selected all patients with a new diagnosis of hepatitis C virus infection with or without hepatitis from January 1, 2003, to December 31, 2013. They excluded patients who were aged 20 years or younger; had Parkinson’s disease, dementia, or stroke; or had had major hepatic diseases on the index date. To ensure that treated patients had had an effective course of therapy, the researchers excluded patients who were lost to follow-up within 6 months of the index date, received antiviral therapy for fewer than 16 weeks, or developed Parkinson’s disease within 6 months of the index date.
The primary outcome was incident Parkinson’s disease. Dr. Lin and colleagues excluded participants with a diagnosis of stroke and dementia before the index date to reduce the possibility of enrolling participants with secondary and atypical parkinsonism.
To minimize the potential selection bias to which observational studies are subject, the investigators performed propensity score matching with sex, age, comorbidities, and medication as covariates. This method was intended to create treated and untreated cohorts with comparable characteristics.
Dr. Lin and colleagues included 188,152 patients in their analysis. After matching, each group included 39,936 participants. In the group that received antiviral treatment, 45.0% of participants were female, and mean age was 52.8 years. In the untreated group, 44.4% of participants were female, and mean age was 52.5 years.
The incidence density of Parkinson’s disease per 1,000 person-years was 1.00 in the treated group and 1.39 in the untreated group. The difference in risk of Parkinson’s disease between the treated and untreated groups was statistically significant at year 5 of follow-up (hazard ratio [HR], 0.75) and at the end of the cohort (HR, 0.71). The risk did not differ significantly at year 1 and year 3, however. A subgroup analysis found a greater benefit of antiviral therapy among patients who concurrently used dihydropyridine calcium channel blockers.
“To our knowledge, this is the first cohort study to investigate the association between antiviral therapy and risk of Parkinson’s disease in patients with chronic hepatitis C viral infection,” said Dr. Lin and colleagues. Although it is possible that interferon-based antiviral therapy directly protected against the development of Parkinson’s disease, the short time of exposure to the antiviral agent “makes protecting against Parkinson’s disease development in 5 years less likely,” they added.
Among the study limitations that the authors acknowledged was the lack of data about hepatic function profile, serum virologic response, viral genotype, and hepatitis C virus RNA-level. The database that the investigators used also lacked data about behavioral factors (e.g., smoking status, coffee consumption, and alcohol consumption) that may have affected the incidence of Parkinson’s disease in the cohort. Investigations with longer follow-up periods will be needed to provide clearer information, they concluded.
The authors reported no conflicts of interest. The study was funded by grants from Chang Gung Medical Research Fund and from Chang Gung Memorial Hospital.
SOURCE: Lin W-Y et al. JAMA Neurol. 2019 Jun 5. doi: 10.1001/jamaneurol.2019.1368.
The findings of Lin et al. suggest a potentially modifiable hepatologic risk factor for Parkinson’s disease, Adolfo Ramirez-Zamora, MD, associate professor of neurology; Christopher W. Hess, MD, assistant professor of neurology; and David R. Nelson, MD, senior vice president for health affairs, all at the University of Florida in Gainesville, wrote in an accompanying editorial. Hepatitis C virus infection might enter the brain through the microvasculature and might induce microglial and macrophage-related inflammatory changes (JAMA Neurol. 2019 June 5. doi: 10.1001/jamaneurol.2019.1377).
Lin et al. estimated high diagnostic accuracy for Parkinson’s disease in their study. Nevertheless, clinical, neuroimaging, and pathological confirmation was unavailable, which is a limitation of their investigation, said Dr. Ramirez-Zamora and colleagues. “The diagnosis of Parkinson’s disease in early stages can be challenging, as other related conditions can mimic Parkinson’s disease, including cirrhosis-related parkinsonism. Moreover, using record-linkage systems excludes patients who did not seek medical advice or those who were misdiagnosed by symptoms alone, which may also underestimate the prevalence of Parkinson’s disease. Using population-based studies would be a more accurate method.”
Because interferon, which was the antiviral therapy used in this study, greatly affects the immune system and has a modest rate of eradicating viral hepatitis C infection, future research should examine the association between Parkinson’s disease and patients who cleared the virus, as well as patients who did not, said Dr. Ramirez-Zamora and colleagues. Such research could shed light on potential mechanisms of treatment response. Lin et al. did not examine the newer direct-acting antiviral therapies for hepatitis C virus infection, which cure more than 90% of patients. Nor did they analyze other well established lifestyle and demographic risk factors for developing the disease. In addition, “the authors could not generalize the results to those aged 75 years or older because of the substantially smaller number of patients in this age group,” said Dr. Ramirez-Zamora and colleagues.
Still, “identification of potentially treatable Parkinson’s disease risk factors presents a unique opportunity for treatment. Additional studies with detailed viral analysis and exposure are needed, including in other geographic and ethnic distributions,” they concluded.
The findings of Lin et al. suggest a potentially modifiable hepatologic risk factor for Parkinson’s disease, Adolfo Ramirez-Zamora, MD, associate professor of neurology; Christopher W. Hess, MD, assistant professor of neurology; and David R. Nelson, MD, senior vice president for health affairs, all at the University of Florida in Gainesville, wrote in an accompanying editorial. Hepatitis C virus infection might enter the brain through the microvasculature and might induce microglial and macrophage-related inflammatory changes (JAMA Neurol. 2019 June 5. doi: 10.1001/jamaneurol.2019.1377).
Lin et al. estimated high diagnostic accuracy for Parkinson’s disease in their study. Nevertheless, clinical, neuroimaging, and pathological confirmation was unavailable, which is a limitation of their investigation, said Dr. Ramirez-Zamora and colleagues. “The diagnosis of Parkinson’s disease in early stages can be challenging, as other related conditions can mimic Parkinson’s disease, including cirrhosis-related parkinsonism. Moreover, using record-linkage systems excludes patients who did not seek medical advice or those who were misdiagnosed by symptoms alone, which may also underestimate the prevalence of Parkinson’s disease. Using population-based studies would be a more accurate method.”
Because interferon, which was the antiviral therapy used in this study, greatly affects the immune system and has a modest rate of eradicating viral hepatitis C infection, future research should examine the association between Parkinson’s disease and patients who cleared the virus, as well as patients who did not, said Dr. Ramirez-Zamora and colleagues. Such research could shed light on potential mechanisms of treatment response. Lin et al. did not examine the newer direct-acting antiviral therapies for hepatitis C virus infection, which cure more than 90% of patients. Nor did they analyze other well established lifestyle and demographic risk factors for developing the disease. In addition, “the authors could not generalize the results to those aged 75 years or older because of the substantially smaller number of patients in this age group,” said Dr. Ramirez-Zamora and colleagues.
Still, “identification of potentially treatable Parkinson’s disease risk factors presents a unique opportunity for treatment. Additional studies with detailed viral analysis and exposure are needed, including in other geographic and ethnic distributions,” they concluded.
The findings of Lin et al. suggest a potentially modifiable hepatologic risk factor for Parkinson’s disease, Adolfo Ramirez-Zamora, MD, associate professor of neurology; Christopher W. Hess, MD, assistant professor of neurology; and David R. Nelson, MD, senior vice president for health affairs, all at the University of Florida in Gainesville, wrote in an accompanying editorial. Hepatitis C virus infection might enter the brain through the microvasculature and might induce microglial and macrophage-related inflammatory changes (JAMA Neurol. 2019 June 5. doi: 10.1001/jamaneurol.2019.1377).
Lin et al. estimated high diagnostic accuracy for Parkinson’s disease in their study. Nevertheless, clinical, neuroimaging, and pathological confirmation was unavailable, which is a limitation of their investigation, said Dr. Ramirez-Zamora and colleagues. “The diagnosis of Parkinson’s disease in early stages can be challenging, as other related conditions can mimic Parkinson’s disease, including cirrhosis-related parkinsonism. Moreover, using record-linkage systems excludes patients who did not seek medical advice or those who were misdiagnosed by symptoms alone, which may also underestimate the prevalence of Parkinson’s disease. Using population-based studies would be a more accurate method.”
Because interferon, which was the antiviral therapy used in this study, greatly affects the immune system and has a modest rate of eradicating viral hepatitis C infection, future research should examine the association between Parkinson’s disease and patients who cleared the virus, as well as patients who did not, said Dr. Ramirez-Zamora and colleagues. Such research could shed light on potential mechanisms of treatment response. Lin et al. did not examine the newer direct-acting antiviral therapies for hepatitis C virus infection, which cure more than 90% of patients. Nor did they analyze other well established lifestyle and demographic risk factors for developing the disease. In addition, “the authors could not generalize the results to those aged 75 years or older because of the substantially smaller number of patients in this age group,” said Dr. Ramirez-Zamora and colleagues.
Still, “identification of potentially treatable Parkinson’s disease risk factors presents a unique opportunity for treatment. Additional studies with detailed viral analysis and exposure are needed, including in other geographic and ethnic distributions,” they concluded.
, according to a cohort study published online June 5 in JAMA Neurology. The results provide evidence that hepatitis C virus is a risk factor for Parkinson’s disease.
In the past several years, epidemiologic studies have suggested an association between hepatitis C virus infection and Parkinson’s disease. A study published in 2017, however, found no association between the two. In addition, these investigations did not consider antiviral therapy as a potential modifying factor.
Wey-Yil Lin, MD, a neurologist at Landseed International Hospital in Taoyuan, Taiwan, and colleagues examined claims data from the Taiwan National Health Insurance Research Database to identify the risk of incident Parkinson’s disease in patients with hepatitis C virus infection who received antiviral treatment, compared with those who did not receive treatment.
The investigators selected all patients with a new diagnosis of hepatitis C virus infection with or without hepatitis from January 1, 2003, to December 31, 2013. They excluded patients who were aged 20 years or younger; had Parkinson’s disease, dementia, or stroke; or had had major hepatic diseases on the index date. To ensure that treated patients had had an effective course of therapy, the researchers excluded patients who were lost to follow-up within 6 months of the index date, received antiviral therapy for fewer than 16 weeks, or developed Parkinson’s disease within 6 months of the index date.
The primary outcome was incident Parkinson’s disease. Dr. Lin and colleagues excluded participants with a diagnosis of stroke and dementia before the index date to reduce the possibility of enrolling participants with secondary and atypical parkinsonism.
To minimize the potential selection bias to which observational studies are subject, the investigators performed propensity score matching with sex, age, comorbidities, and medication as covariates. This method was intended to create treated and untreated cohorts with comparable characteristics.
Dr. Lin and colleagues included 188,152 patients in their analysis. After matching, each group included 39,936 participants. In the group that received antiviral treatment, 45.0% of participants were female, and mean age was 52.8 years. In the untreated group, 44.4% of participants were female, and mean age was 52.5 years.
The incidence density of Parkinson’s disease per 1,000 person-years was 1.00 in the treated group and 1.39 in the untreated group. The difference in risk of Parkinson’s disease between the treated and untreated groups was statistically significant at year 5 of follow-up (hazard ratio [HR], 0.75) and at the end of the cohort (HR, 0.71). The risk did not differ significantly at year 1 and year 3, however. A subgroup analysis found a greater benefit of antiviral therapy among patients who concurrently used dihydropyridine calcium channel blockers.
“To our knowledge, this is the first cohort study to investigate the association between antiviral therapy and risk of Parkinson’s disease in patients with chronic hepatitis C viral infection,” said Dr. Lin and colleagues. Although it is possible that interferon-based antiviral therapy directly protected against the development of Parkinson’s disease, the short time of exposure to the antiviral agent “makes protecting against Parkinson’s disease development in 5 years less likely,” they added.
Among the study limitations that the authors acknowledged was the lack of data about hepatic function profile, serum virologic response, viral genotype, and hepatitis C virus RNA-level. The database that the investigators used also lacked data about behavioral factors (e.g., smoking status, coffee consumption, and alcohol consumption) that may have affected the incidence of Parkinson’s disease in the cohort. Investigations with longer follow-up periods will be needed to provide clearer information, they concluded.
The authors reported no conflicts of interest. The study was funded by grants from Chang Gung Medical Research Fund and from Chang Gung Memorial Hospital.
SOURCE: Lin W-Y et al. JAMA Neurol. 2019 Jun 5. doi: 10.1001/jamaneurol.2019.1368.
, according to a cohort study published online June 5 in JAMA Neurology. The results provide evidence that hepatitis C virus is a risk factor for Parkinson’s disease.
In the past several years, epidemiologic studies have suggested an association between hepatitis C virus infection and Parkinson’s disease. A study published in 2017, however, found no association between the two. In addition, these investigations did not consider antiviral therapy as a potential modifying factor.
Wey-Yil Lin, MD, a neurologist at Landseed International Hospital in Taoyuan, Taiwan, and colleagues examined claims data from the Taiwan National Health Insurance Research Database to identify the risk of incident Parkinson’s disease in patients with hepatitis C virus infection who received antiviral treatment, compared with those who did not receive treatment.
The investigators selected all patients with a new diagnosis of hepatitis C virus infection with or without hepatitis from January 1, 2003, to December 31, 2013. They excluded patients who were aged 20 years or younger; had Parkinson’s disease, dementia, or stroke; or had had major hepatic diseases on the index date. To ensure that treated patients had had an effective course of therapy, the researchers excluded patients who were lost to follow-up within 6 months of the index date, received antiviral therapy for fewer than 16 weeks, or developed Parkinson’s disease within 6 months of the index date.
The primary outcome was incident Parkinson’s disease. Dr. Lin and colleagues excluded participants with a diagnosis of stroke and dementia before the index date to reduce the possibility of enrolling participants with secondary and atypical parkinsonism.
To minimize the potential selection bias to which observational studies are subject, the investigators performed propensity score matching with sex, age, comorbidities, and medication as covariates. This method was intended to create treated and untreated cohorts with comparable characteristics.
Dr. Lin and colleagues included 188,152 patients in their analysis. After matching, each group included 39,936 participants. In the group that received antiviral treatment, 45.0% of participants were female, and mean age was 52.8 years. In the untreated group, 44.4% of participants were female, and mean age was 52.5 years.
The incidence density of Parkinson’s disease per 1,000 person-years was 1.00 in the treated group and 1.39 in the untreated group. The difference in risk of Parkinson’s disease between the treated and untreated groups was statistically significant at year 5 of follow-up (hazard ratio [HR], 0.75) and at the end of the cohort (HR, 0.71). The risk did not differ significantly at year 1 and year 3, however. A subgroup analysis found a greater benefit of antiviral therapy among patients who concurrently used dihydropyridine calcium channel blockers.
“To our knowledge, this is the first cohort study to investigate the association between antiviral therapy and risk of Parkinson’s disease in patients with chronic hepatitis C viral infection,” said Dr. Lin and colleagues. Although it is possible that interferon-based antiviral therapy directly protected against the development of Parkinson’s disease, the short time of exposure to the antiviral agent “makes protecting against Parkinson’s disease development in 5 years less likely,” they added.
Among the study limitations that the authors acknowledged was the lack of data about hepatic function profile, serum virologic response, viral genotype, and hepatitis C virus RNA-level. The database that the investigators used also lacked data about behavioral factors (e.g., smoking status, coffee consumption, and alcohol consumption) that may have affected the incidence of Parkinson’s disease in the cohort. Investigations with longer follow-up periods will be needed to provide clearer information, they concluded.
The authors reported no conflicts of interest. The study was funded by grants from Chang Gung Medical Research Fund and from Chang Gung Memorial Hospital.
SOURCE: Lin W-Y et al. JAMA Neurol. 2019 Jun 5. doi: 10.1001/jamaneurol.2019.1368.
FROM JAMA NEUROLOGY
Despite HCV cure, liver cancer-associated genetic changes persist
A new study showed that liver tissue from hepatitis C virus (HCV)–infected humans with and without sustained virologic response found epigenetic and gene expression alterations associated with the risk for hepatocellular carcinoma (HCC), according to Nourdine Hamdane, PHD, of the Institut de Recherche sur les Maladies Virales et Hépatiques, Strasbourg, France, and colleagues.
The researchers analyzed liver tissue from 6 noninfected control patients, 18 patients with chronic HCV infection, 21 patients with cured chronic HCV, 4 patients with hepatitis B virus (HBV) infection, and 7 patients with nonalcoholic steatohepatitis (NASH), as well as 8 paired HCC samples with HCV-induced liver disease (Gastroenterology 2019;156:2313–29).
They found that several altered pathways related to carcinogenesis persisted after cure, including TNF-alpha signaling, inflammatory response, G2M checkpoint, epithelial–mesenchymal transition, and phosphoinositide 3-kinase, Akt, and mammalian target of rapamycin.
They also observed lower levels of H3K27ac mapping to genes related to oxidative phosphorylation pathways, providing evidence supporting a functional role for H3K27ac changes in establishing gene expression patterns that persist after cure and contribute to carcinogenesis, according to the authors.
“Our study exposes a previously undiscovered paradigm showing that chronic HCV infection induces H3K27ac modifications that are associated with HCC risk and that persist after HCV cure,” the authors wrote. “[This study] provides a unique opportunity to uncover novel biomarkers for HCC risk, that is, from plasma through the detection of epigenetic changes of histones bound to circulating DNA complexes. Furthermore, by uncovering virus-induced epigenetic changes as therapeutic targets, our findings offer novel perspectives for HCC prevention – a key unmet medical need,” the researchers concluded.
The authors declared that they had no conflicts.
SOURCE: Hamdane N, et al. 2019; Gastroenterology 156:2313–29.
A new study showed that liver tissue from hepatitis C virus (HCV)–infected humans with and without sustained virologic response found epigenetic and gene expression alterations associated with the risk for hepatocellular carcinoma (HCC), according to Nourdine Hamdane, PHD, of the Institut de Recherche sur les Maladies Virales et Hépatiques, Strasbourg, France, and colleagues.
The researchers analyzed liver tissue from 6 noninfected control patients, 18 patients with chronic HCV infection, 21 patients with cured chronic HCV, 4 patients with hepatitis B virus (HBV) infection, and 7 patients with nonalcoholic steatohepatitis (NASH), as well as 8 paired HCC samples with HCV-induced liver disease (Gastroenterology 2019;156:2313–29).
They found that several altered pathways related to carcinogenesis persisted after cure, including TNF-alpha signaling, inflammatory response, G2M checkpoint, epithelial–mesenchymal transition, and phosphoinositide 3-kinase, Akt, and mammalian target of rapamycin.
They also observed lower levels of H3K27ac mapping to genes related to oxidative phosphorylation pathways, providing evidence supporting a functional role for H3K27ac changes in establishing gene expression patterns that persist after cure and contribute to carcinogenesis, according to the authors.
“Our study exposes a previously undiscovered paradigm showing that chronic HCV infection induces H3K27ac modifications that are associated with HCC risk and that persist after HCV cure,” the authors wrote. “[This study] provides a unique opportunity to uncover novel biomarkers for HCC risk, that is, from plasma through the detection of epigenetic changes of histones bound to circulating DNA complexes. Furthermore, by uncovering virus-induced epigenetic changes as therapeutic targets, our findings offer novel perspectives for HCC prevention – a key unmet medical need,” the researchers concluded.
The authors declared that they had no conflicts.
SOURCE: Hamdane N, et al. 2019; Gastroenterology 156:2313–29.
A new study showed that liver tissue from hepatitis C virus (HCV)–infected humans with and without sustained virologic response found epigenetic and gene expression alterations associated with the risk for hepatocellular carcinoma (HCC), according to Nourdine Hamdane, PHD, of the Institut de Recherche sur les Maladies Virales et Hépatiques, Strasbourg, France, and colleagues.
The researchers analyzed liver tissue from 6 noninfected control patients, 18 patients with chronic HCV infection, 21 patients with cured chronic HCV, 4 patients with hepatitis B virus (HBV) infection, and 7 patients with nonalcoholic steatohepatitis (NASH), as well as 8 paired HCC samples with HCV-induced liver disease (Gastroenterology 2019;156:2313–29).
They found that several altered pathways related to carcinogenesis persisted after cure, including TNF-alpha signaling, inflammatory response, G2M checkpoint, epithelial–mesenchymal transition, and phosphoinositide 3-kinase, Akt, and mammalian target of rapamycin.
They also observed lower levels of H3K27ac mapping to genes related to oxidative phosphorylation pathways, providing evidence supporting a functional role for H3K27ac changes in establishing gene expression patterns that persist after cure and contribute to carcinogenesis, according to the authors.
“Our study exposes a previously undiscovered paradigm showing that chronic HCV infection induces H3K27ac modifications that are associated with HCC risk and that persist after HCV cure,” the authors wrote. “[This study] provides a unique opportunity to uncover novel biomarkers for HCC risk, that is, from plasma through the detection of epigenetic changes of histones bound to circulating DNA complexes. Furthermore, by uncovering virus-induced epigenetic changes as therapeutic targets, our findings offer novel perspectives for HCC prevention – a key unmet medical need,” the researchers concluded.
The authors declared that they had no conflicts.
SOURCE: Hamdane N, et al. 2019; Gastroenterology 156:2313–29.
FROM GASTROENTEROLOGY
Are ObGyns knowledgeable about the risk factors for hepatitis C virus in pregnancy?
The American College of Obstetricians and Gynecologists (ACOG) recommends risk-based screening for hepatitis C virus (HCV) infection during pregnancy.1 However, the prevalence of HCV among pregnant women in the United States is on the rise. From 2009 to 2014, HCV infection present at delivery increased 89%.2 In addition, the risk of an HCV-infected mother transmitting the infection to her baby is about 4% to 7% per pregnancy.3 Currently, the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases recommend universal HCV screening in pregnancy.4
Researchers at Tufts Medical Center in Boston, Massachusetts, a tertiary care center, presented survey findings on HCV screening among ObGyns at ACOG’s 2019 Annual Clinical and Scientific Meeting in Nashville, Tennessee.5 Katherine G. Koniares, MD, and colleagues sought to assess the opinions and clinical practices of ObGyns by emailing a 10-question electronic survey to providers. A total of 38 of 41 providers (93%) responded to the survey.
Survey results show lack of knowledge on risk factors
In response to the question, “Which pregnant patients do you believe should be screened for HCV,” 43.2% of providers stated “all pregnant women,” while 54.1% said “only pregnant women with risk factors for HCV.” A small percentage (2.7%) responded that they were not sure.
Providers also were asked which patients in their practice they screen for HCV. In response, 77.8% stated that they screen pregnant women for HCV based on risk factors, while 13.9% screen all pregnant patients for HCV; 8.3% do not screen for HCV.
When asked which risk factors providers use to screen patients for HCV, 42% to 85% said they screen for each indicated risk factor. Only 36% of providers, however, correctly identified all risk factors (for example, receiving blood products from donors who later tested positive for HCV; unexplained liver disease; and percutaneous/parenteral exposures in an unregulated setting, such as receiving tattoos outside a licensed parlor).
Further study needed on universal screening
The researchers assert that risk-based screening for HCV is not effective and that further research on universal HCV screening in pregnant patients is needed.
- American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 86: Viral hepatitis in pregnancy. Obstet Gynecol. 2007;110:941-956.
- Patrick SW, Bauer AM, Warren MD, et al. Hepatitis C virus infection among women giving birth—Tennessee and the United States, 2009-2014. MMWR Morbid Mortal Weekly Rep. 2017;66:470-473.
- Koneru A, Nelson N, Hariri S, et al. Increased hepatitis C virus (HCV) detection in women of childbearing age and potential risk for vertical transmission—United States and Kentucky, 2011-2014. MMWR Morbid Mortal Weekly Rep. 2016;65:705-710.
- American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA). Recommendations for testing, management, and treating, hepatitis C. HCV testing and linkage to care. https://www.hcvguidelines.org/.
- Koniares KG, Fadlallah H, Kolettis DS, et al. A survey of hepatitis C virus (HCV) screening in pregnancy among ObGyns at a tertiary care center. Poster presented at: American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting; May 3-6, 2019; Nashville, TN.
The American College of Obstetricians and Gynecologists (ACOG) recommends risk-based screening for hepatitis C virus (HCV) infection during pregnancy.1 However, the prevalence of HCV among pregnant women in the United States is on the rise. From 2009 to 2014, HCV infection present at delivery increased 89%.2 In addition, the risk of an HCV-infected mother transmitting the infection to her baby is about 4% to 7% per pregnancy.3 Currently, the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases recommend universal HCV screening in pregnancy.4
Researchers at Tufts Medical Center in Boston, Massachusetts, a tertiary care center, presented survey findings on HCV screening among ObGyns at ACOG’s 2019 Annual Clinical and Scientific Meeting in Nashville, Tennessee.5 Katherine G. Koniares, MD, and colleagues sought to assess the opinions and clinical practices of ObGyns by emailing a 10-question electronic survey to providers. A total of 38 of 41 providers (93%) responded to the survey.
Survey results show lack of knowledge on risk factors
In response to the question, “Which pregnant patients do you believe should be screened for HCV,” 43.2% of providers stated “all pregnant women,” while 54.1% said “only pregnant women with risk factors for HCV.” A small percentage (2.7%) responded that they were not sure.
Providers also were asked which patients in their practice they screen for HCV. In response, 77.8% stated that they screen pregnant women for HCV based on risk factors, while 13.9% screen all pregnant patients for HCV; 8.3% do not screen for HCV.
When asked which risk factors providers use to screen patients for HCV, 42% to 85% said they screen for each indicated risk factor. Only 36% of providers, however, correctly identified all risk factors (for example, receiving blood products from donors who later tested positive for HCV; unexplained liver disease; and percutaneous/parenteral exposures in an unregulated setting, such as receiving tattoos outside a licensed parlor).
Further study needed on universal screening
The researchers assert that risk-based screening for HCV is not effective and that further research on universal HCV screening in pregnant patients is needed.
The American College of Obstetricians and Gynecologists (ACOG) recommends risk-based screening for hepatitis C virus (HCV) infection during pregnancy.1 However, the prevalence of HCV among pregnant women in the United States is on the rise. From 2009 to 2014, HCV infection present at delivery increased 89%.2 In addition, the risk of an HCV-infected mother transmitting the infection to her baby is about 4% to 7% per pregnancy.3 Currently, the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases recommend universal HCV screening in pregnancy.4
Researchers at Tufts Medical Center in Boston, Massachusetts, a tertiary care center, presented survey findings on HCV screening among ObGyns at ACOG’s 2019 Annual Clinical and Scientific Meeting in Nashville, Tennessee.5 Katherine G. Koniares, MD, and colleagues sought to assess the opinions and clinical practices of ObGyns by emailing a 10-question electronic survey to providers. A total of 38 of 41 providers (93%) responded to the survey.
Survey results show lack of knowledge on risk factors
In response to the question, “Which pregnant patients do you believe should be screened for HCV,” 43.2% of providers stated “all pregnant women,” while 54.1% said “only pregnant women with risk factors for HCV.” A small percentage (2.7%) responded that they were not sure.
Providers also were asked which patients in their practice they screen for HCV. In response, 77.8% stated that they screen pregnant women for HCV based on risk factors, while 13.9% screen all pregnant patients for HCV; 8.3% do not screen for HCV.
When asked which risk factors providers use to screen patients for HCV, 42% to 85% said they screen for each indicated risk factor. Only 36% of providers, however, correctly identified all risk factors (for example, receiving blood products from donors who later tested positive for HCV; unexplained liver disease; and percutaneous/parenteral exposures in an unregulated setting, such as receiving tattoos outside a licensed parlor).
Further study needed on universal screening
The researchers assert that risk-based screening for HCV is not effective and that further research on universal HCV screening in pregnant patients is needed.
- American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 86: Viral hepatitis in pregnancy. Obstet Gynecol. 2007;110:941-956.
- Patrick SW, Bauer AM, Warren MD, et al. Hepatitis C virus infection among women giving birth—Tennessee and the United States, 2009-2014. MMWR Morbid Mortal Weekly Rep. 2017;66:470-473.
- Koneru A, Nelson N, Hariri S, et al. Increased hepatitis C virus (HCV) detection in women of childbearing age and potential risk for vertical transmission—United States and Kentucky, 2011-2014. MMWR Morbid Mortal Weekly Rep. 2016;65:705-710.
- American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA). Recommendations for testing, management, and treating, hepatitis C. HCV testing and linkage to care. https://www.hcvguidelines.org/.
- Koniares KG, Fadlallah H, Kolettis DS, et al. A survey of hepatitis C virus (HCV) screening in pregnancy among ObGyns at a tertiary care center. Poster presented at: American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting; May 3-6, 2019; Nashville, TN.
- American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 86: Viral hepatitis in pregnancy. Obstet Gynecol. 2007;110:941-956.
- Patrick SW, Bauer AM, Warren MD, et al. Hepatitis C virus infection among women giving birth—Tennessee and the United States, 2009-2014. MMWR Morbid Mortal Weekly Rep. 2017;66:470-473.
- Koneru A, Nelson N, Hariri S, et al. Increased hepatitis C virus (HCV) detection in women of childbearing age and potential risk for vertical transmission—United States and Kentucky, 2011-2014. MMWR Morbid Mortal Weekly Rep. 2016;65:705-710.
- American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA). Recommendations for testing, management, and treating, hepatitis C. HCV testing and linkage to care. https://www.hcvguidelines.org/.
- Koniares KG, Fadlallah H, Kolettis DS, et al. A survey of hepatitis C virus (HCV) screening in pregnancy among ObGyns at a tertiary care center. Poster presented at: American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting; May 3-6, 2019; Nashville, TN.