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A full 0.5-mL dose of inactivated influenza vaccine was as safe and effective as a was a half dose of 0.25 mL, with slightly higher immunogenicity, according to data from a randomized trial of nearly 2,000 children aged 6-35 months.

KatarzynaBialasiewicz/Thinkstock

Data from previous studies have suggested that a full dose of vaccine may be more immunogenic in young children compared with a half dose, and Sanofi Pasteur has submitted a supplemental Biologics License Application to the Food and Drug Administration to allow use of the full 0.5-mL dose in children as young as 6 months, Monica Mercer, MD, of Sanofi Pasteur, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Dr. Mercer presented findings from a phase IV randomized, observer-blinded study, in which the researchers assigned healthy children aged 6-35 months to receive Fluzone quadrivalent vaccine at a dose of 0.25 mL or 0.5 mL.

A total of 1,941 children (949 for the 0.25-mL dose and 992 for the 0.5-mL dose) were included in the safety analysis.

The most important safety outcome was to compare the rate of any fever, Dr. Mercer said at the meeting.

Overall, at 7 days after vaccination, the rate of fever was 11% for the half dose and 12% for the full dose, she said. The resulting difference of 0.84% met the criteria for noninferiority (less than 5%), she added.

In terms of safety, tenderness was the most frequently reported injection site reaction, noted in 47% of the half-dose group and 50% of the full-dose group. The rates of unsolicited adverse events were similar in both groups, the most common included diarrhea and cough, Dr. Mercer said.

No subjects in the full-dose group and three in the half-dose group discontinued the study because of adverse events. The only reported serious adverse event was one case of chronic urticaria in the half-dose group; no deaths were reported in either group.

As for efficacy, the full dose demonstrated noninferiority, compared with the half dose, against each of four strains: influenza A H1N1, influenza A H3N2, influenza B Victoria, and influenza B Yamagata. The geometric mean titers of the full and half doses for each of the four strains were, respectively, 310 and 214, 332 and 221, 348 and 261, and 349 and 243.

The potential action date for the supplemental Biologics License Application is January 2019, noted Dr. Mercer, who is employed by Sanofi Pasteur.

A full 0.5-mL dose of inactivated influenza vaccine was as safe and effective as a was a half dose of 0.25 mL, with slightly higher immunogenicity, according to data from a randomized trial of nearly 2,000 children aged 6-35 months.

KatarzynaBialasiewicz/Thinkstock

Data from previous studies have suggested that a full dose of vaccine may be more immunogenic in young children compared with a half dose, and Sanofi Pasteur has submitted a supplemental Biologics License Application to the Food and Drug Administration to allow use of the full 0.5-mL dose in children as young as 6 months, Monica Mercer, MD, of Sanofi Pasteur, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Dr. Mercer presented findings from a phase IV randomized, observer-blinded study, in which the researchers assigned healthy children aged 6-35 months to receive Fluzone quadrivalent vaccine at a dose of 0.25 mL or 0.5 mL.

A total of 1,941 children (949 for the 0.25-mL dose and 992 for the 0.5-mL dose) were included in the safety analysis.

The most important safety outcome was to compare the rate of any fever, Dr. Mercer said at the meeting.

Overall, at 7 days after vaccination, the rate of fever was 11% for the half dose and 12% for the full dose, she said. The resulting difference of 0.84% met the criteria for noninferiority (less than 5%), she added.

In terms of safety, tenderness was the most frequently reported injection site reaction, noted in 47% of the half-dose group and 50% of the full-dose group. The rates of unsolicited adverse events were similar in both groups, the most common included diarrhea and cough, Dr. Mercer said.

No subjects in the full-dose group and three in the half-dose group discontinued the study because of adverse events. The only reported serious adverse event was one case of chronic urticaria in the half-dose group; no deaths were reported in either group.

As for efficacy, the full dose demonstrated noninferiority, compared with the half dose, against each of four strains: influenza A H1N1, influenza A H3N2, influenza B Victoria, and influenza B Yamagata. The geometric mean titers of the full and half doses for each of the four strains were, respectively, 310 and 214, 332 and 221, 348 and 261, and 349 and 243.

The potential action date for the supplemental Biologics License Application is January 2019, noted Dr. Mercer, who is employed by Sanofi Pasteur.

A full 0.5-mL dose of inactivated influenza vaccine was as safe and effective as a was a half dose of 0.25 mL, with slightly higher immunogenicity, according to data from a randomized trial of nearly 2,000 children aged 6-35 months.

KatarzynaBialasiewicz/Thinkstock

Data from previous studies have suggested that a full dose of vaccine may be more immunogenic in young children compared with a half dose, and Sanofi Pasteur has submitted a supplemental Biologics License Application to the Food and Drug Administration to allow use of the full 0.5-mL dose in children as young as 6 months, Monica Mercer, MD, of Sanofi Pasteur, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Dr. Mercer presented findings from a phase IV randomized, observer-blinded study, in which the researchers assigned healthy children aged 6-35 months to receive Fluzone quadrivalent vaccine at a dose of 0.25 mL or 0.5 mL.

A total of 1,941 children (949 for the 0.25-mL dose and 992 for the 0.5-mL dose) were included in the safety analysis.

The most important safety outcome was to compare the rate of any fever, Dr. Mercer said at the meeting.

Overall, at 7 days after vaccination, the rate of fever was 11% for the half dose and 12% for the full dose, she said. The resulting difference of 0.84% met the criteria for noninferiority (less than 5%), she added.

In terms of safety, tenderness was the most frequently reported injection site reaction, noted in 47% of the half-dose group and 50% of the full-dose group. The rates of unsolicited adverse events were similar in both groups, the most common included diarrhea and cough, Dr. Mercer said.

No subjects in the full-dose group and three in the half-dose group discontinued the study because of adverse events. The only reported serious adverse event was one case of chronic urticaria in the half-dose group; no deaths were reported in either group.

As for efficacy, the full dose demonstrated noninferiority, compared with the half dose, against each of four strains: influenza A H1N1, influenza A H3N2, influenza B Victoria, and influenza B Yamagata. The geometric mean titers of the full and half doses for each of the four strains were, respectively, 310 and 214, 332 and 221, 348 and 261, and 349 and 243.

The potential action date for the supplemental Biologics License Application is January 2019, noted Dr. Mercer, who is employed by Sanofi Pasteur.

A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Piotr Marcinski/Thinkstock

To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.

He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).

The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.

Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.

“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.

The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.

Dr. Thompson had no financial conflicts to disclose.

A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Piotr Marcinski/Thinkstock

To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.

He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).

The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.

Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.

“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.

The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.

Dr. Thompson had no financial conflicts to disclose.

A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Piotr Marcinski/Thinkstock

To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.

He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).

The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.

Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.

“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.

The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.

Dr. Thompson had no financial conflicts to disclose.

The Elizabeth Dole Center of Excellence for Veteran and Caregiver Research, the first of its kind, recognizes Senator Dole for her national leadership and advocacy on behalf of the nation’s 5.5 million military and veteran caregivers.

Managed by the Office of Health Services, the center will “serve as the model for excellence” for peer-reviewed research on innovation, training, evaluation, implementation, and dissemination of best practices in supporting caregivers of veterans.

The team of VA investigators will be led by Dr. Luci Leykum of the South Texas Veterans Health Care System. Collaborating sites and leaders include Dr. Stuti Dang of the Miami VA Health Care System, Dr. Mary Jo Pugh of the VA Salt Lake City Health Care System, and Dr. Ranak Trivedi of the VA Palo Alto Health Care System.

The Elizabeth Dole Center of Excellence for Veteran and Caregiver Research, the first of its kind, recognizes Senator Dole for her national leadership and advocacy on behalf of the nation’s 5.5 million military and veteran caregivers.

Managed by the Office of Health Services, the center will “serve as the model for excellence” for peer-reviewed research on innovation, training, evaluation, implementation, and dissemination of best practices in supporting caregivers of veterans.

The team of VA investigators will be led by Dr. Luci Leykum of the South Texas Veterans Health Care System. Collaborating sites and leaders include Dr. Stuti Dang of the Miami VA Health Care System, Dr. Mary Jo Pugh of the VA Salt Lake City Health Care System, and Dr. Ranak Trivedi of the VA Palo Alto Health Care System.

The Elizabeth Dole Center of Excellence for Veteran and Caregiver Research, the first of its kind, recognizes Senator Dole for her national leadership and advocacy on behalf of the nation’s 5.5 million military and veteran caregivers.

Managed by the Office of Health Services, the center will “serve as the model for excellence” for peer-reviewed research on innovation, training, evaluation, implementation, and dissemination of best practices in supporting caregivers of veterans.

The team of VA investigators will be led by Dr. Luci Leykum of the South Texas Veterans Health Care System. Collaborating sites and leaders include Dr. Stuti Dang of the Miami VA Health Care System, Dr. Mary Jo Pugh of the VA Salt Lake City Health Care System, and Dr. Ranak Trivedi of the VA Palo Alto Health Care System.

The recent rise in pertussis rates may have peaked, but the experts are responding by reinstating a working group.

The new working group for pertussis was announced at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The ACIP’s new group, led by Fiona Havers, MD, of the CDC, heard data on the currently available pertussis vaccines and solicited ideas from ACIP members about what other data they would like before the February meeting.

One question on the agenda is whether the current recommendation that nonpregnant adults receive a single lifetime dose of Tdap and then tetanus-diphtheria (Td) boosters every 10 years be expanded to allow either Tdap or Td as the booster. Reasons for considering the change include possible changes in the circulating pertussis strain, improved diagnosis and reporting, and the waning of protection under the current guidelines, as well as the potential economic impact, Dr. Havers said.

This change could make booster administration easier for many physicians who do not routinely stock Td, some committee members noted. In addition, the Food and Drug Administration has approved a label change for one Tdap manufacturer to remove “single use” language.

In a study presented by David P. Greenberg, MD, associate vice president of Sanofi Pasteur, seroprotection rates to tetanus and diphtheria were similar in a comparison between groups of adults aged 18 years and older, receiving either Tdap (Adacel) or Td as a booster. “Seroprotection was greater than 99% in both groups,” he said.

Pain was the most common injection site reaction in both groups, rates of serious adverse events were similarly low (0.8% and 0.3%, respectively), and no deaths occurred in patients given either vaccine.

The postvaccination antipertussis geometric mean concentrations were noninferior in the Tdap group, compared with the Td group, Dr. Greenberg said.

A phase III open label study presented by Leonard Silverstein, MD, of GlaxoSmithKline also showed similar seroprotection rates for adults revaccinated with Tdap after an initial vaccination with either of two different Tdap vaccines.

Also at the February meeting, the committee will address whether any vaccine that contained Td should be allowed for use as tetanus prophylaxis in the setting of wound management, said Dr. Havers.

The committee members expressed interest in more information on several topics including pregnancy and pertussis, whether manufacturers could discuss vaccines in the pipeline, data on responses to multiple doses and if there is a point of diminishing returns, and whether some states are covering Tdap for adults.

The committee members had no financial conflicts to disclose.

The recent rise in pertussis rates may have peaked, but the experts are responding by reinstating a working group.

The new working group for pertussis was announced at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The ACIP’s new group, led by Fiona Havers, MD, of the CDC, heard data on the currently available pertussis vaccines and solicited ideas from ACIP members about what other data they would like before the February meeting.

One question on the agenda is whether the current recommendation that nonpregnant adults receive a single lifetime dose of Tdap and then tetanus-diphtheria (Td) boosters every 10 years be expanded to allow either Tdap or Td as the booster. Reasons for considering the change include possible changes in the circulating pertussis strain, improved diagnosis and reporting, and the waning of protection under the current guidelines, as well as the potential economic impact, Dr. Havers said.

This change could make booster administration easier for many physicians who do not routinely stock Td, some committee members noted. In addition, the Food and Drug Administration has approved a label change for one Tdap manufacturer to remove “single use” language.

In a study presented by David P. Greenberg, MD, associate vice president of Sanofi Pasteur, seroprotection rates to tetanus and diphtheria were similar in a comparison between groups of adults aged 18 years and older, receiving either Tdap (Adacel) or Td as a booster. “Seroprotection was greater than 99% in both groups,” he said.

Pain was the most common injection site reaction in both groups, rates of serious adverse events were similarly low (0.8% and 0.3%, respectively), and no deaths occurred in patients given either vaccine.

The postvaccination antipertussis geometric mean concentrations were noninferior in the Tdap group, compared with the Td group, Dr. Greenberg said.

A phase III open label study presented by Leonard Silverstein, MD, of GlaxoSmithKline also showed similar seroprotection rates for adults revaccinated with Tdap after an initial vaccination with either of two different Tdap vaccines.

Also at the February meeting, the committee will address whether any vaccine that contained Td should be allowed for use as tetanus prophylaxis in the setting of wound management, said Dr. Havers.

The committee members expressed interest in more information on several topics including pregnancy and pertussis, whether manufacturers could discuss vaccines in the pipeline, data on responses to multiple doses and if there is a point of diminishing returns, and whether some states are covering Tdap for adults.

The committee members had no financial conflicts to disclose.

The recent rise in pertussis rates may have peaked, but the experts are responding by reinstating a working group.

The new working group for pertussis was announced at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The ACIP’s new group, led by Fiona Havers, MD, of the CDC, heard data on the currently available pertussis vaccines and solicited ideas from ACIP members about what other data they would like before the February meeting.

One question on the agenda is whether the current recommendation that nonpregnant adults receive a single lifetime dose of Tdap and then tetanus-diphtheria (Td) boosters every 10 years be expanded to allow either Tdap or Td as the booster. Reasons for considering the change include possible changes in the circulating pertussis strain, improved diagnosis and reporting, and the waning of protection under the current guidelines, as well as the potential economic impact, Dr. Havers said.

This change could make booster administration easier for many physicians who do not routinely stock Td, some committee members noted. In addition, the Food and Drug Administration has approved a label change for one Tdap manufacturer to remove “single use” language.

In a study presented by David P. Greenberg, MD, associate vice president of Sanofi Pasteur, seroprotection rates to tetanus and diphtheria were similar in a comparison between groups of adults aged 18 years and older, receiving either Tdap (Adacel) or Td as a booster. “Seroprotection was greater than 99% in both groups,” he said.

Pain was the most common injection site reaction in both groups, rates of serious adverse events were similarly low (0.8% and 0.3%, respectively), and no deaths occurred in patients given either vaccine.

The postvaccination antipertussis geometric mean concentrations were noninferior in the Tdap group, compared with the Td group, Dr. Greenberg said.

A phase III open label study presented by Leonard Silverstein, MD, of GlaxoSmithKline also showed similar seroprotection rates for adults revaccinated with Tdap after an initial vaccination with either of two different Tdap vaccines.

Also at the February meeting, the committee will address whether any vaccine that contained Td should be allowed for use as tetanus prophylaxis in the setting of wound management, said Dr. Havers.

The committee members expressed interest in more information on several topics including pregnancy and pertussis, whether manufacturers could discuss vaccines in the pipeline, data on responses to multiple doses and if there is a point of diminishing returns, and whether some states are covering Tdap for adults.

The committee members had no financial conflicts to disclose.

Coffee drinking has been linked to the reduced risk of fibrosis progression, liver cirrhosis, and hepatocellular carcinoma in some patients, including those with hepatitis C virus (HCV) infection, but the results of studies in patients with hepatitis B virus (HBV) infection have been inconsistent. Given the “global impact of HBV infection and the wide consumption of coffee,” researchers from Tzu Chi University in Taiwan, wanted to find out more.

They analyzed data from 328 patients with chronic HBV infection who were enrolled in a population-based gastroesophageal reflux disease study. Of those, 155 patients also entered into a 5-year follow-up study. 

Among the patients with chronic HBV, 137 did not drink coffee. Of the 191 who did, 61 drank it on < 4 days a week, and 130 drank it ≥ 4 days.

Initially, the researchers observed an inverse association between coffee drinking and serum aspartate aminotransferase (AST) levels, as well as predicting indices of liver fibrosis in patients with HBV infection. Patients who drank ≥ 4 cups of coffee per day had a 70% decrease of serum AST, a 70% decrease of the AST to platelet ratio index, and a 70% decrease of fibrosis-4 index values. 

Those findings indicated that coffee might have a “generally beneficial” effect on liver inflammation and fibrosis progression in patients with chronic liver disease, the researchers say. However, at the end of the 5-year follow-up, the incidences of liver cirrhosis complications and changes of serum predicting indices of liver fibrosis were comparable between HBV coffee drinkers and nondrinkers. That indicated, the researchers believe, that the beneficial effect “seems to be outweighed” in patients with chronic HBV infection.

The researchers suggest that the protective effects of coffee consumption on liver inflammation and insulin resistance may not be able to surpass the direct carcinogenic effect of HBV, and even the HBV virus replication.

Coffee drinking has been linked to the reduced risk of fibrosis progression, liver cirrhosis, and hepatocellular carcinoma in some patients, including those with hepatitis C virus (HCV) infection, but the results of studies in patients with hepatitis B virus (HBV) infection have been inconsistent. Given the “global impact of HBV infection and the wide consumption of coffee,” researchers from Tzu Chi University in Taiwan, wanted to find out more.

They analyzed data from 328 patients with chronic HBV infection who were enrolled in a population-based gastroesophageal reflux disease study. Of those, 155 patients also entered into a 5-year follow-up study. 

Among the patients with chronic HBV, 137 did not drink coffee. Of the 191 who did, 61 drank it on < 4 days a week, and 130 drank it ≥ 4 days.

Initially, the researchers observed an inverse association between coffee drinking and serum aspartate aminotransferase (AST) levels, as well as predicting indices of liver fibrosis in patients with HBV infection. Patients who drank ≥ 4 cups of coffee per day had a 70% decrease of serum AST, a 70% decrease of the AST to platelet ratio index, and a 70% decrease of fibrosis-4 index values. 

Those findings indicated that coffee might have a “generally beneficial” effect on liver inflammation and fibrosis progression in patients with chronic liver disease, the researchers say. However, at the end of the 5-year follow-up, the incidences of liver cirrhosis complications and changes of serum predicting indices of liver fibrosis were comparable between HBV coffee drinkers and nondrinkers. That indicated, the researchers believe, that the beneficial effect “seems to be outweighed” in patients with chronic HBV infection.

The researchers suggest that the protective effects of coffee consumption on liver inflammation and insulin resistance may not be able to surpass the direct carcinogenic effect of HBV, and even the HBV virus replication.

Coffee drinking has been linked to the reduced risk of fibrosis progression, liver cirrhosis, and hepatocellular carcinoma in some patients, including those with hepatitis C virus (HCV) infection, but the results of studies in patients with hepatitis B virus (HBV) infection have been inconsistent. Given the “global impact of HBV infection and the wide consumption of coffee,” researchers from Tzu Chi University in Taiwan, wanted to find out more.

They analyzed data from 328 patients with chronic HBV infection who were enrolled in a population-based gastroesophageal reflux disease study. Of those, 155 patients also entered into a 5-year follow-up study. 

Among the patients with chronic HBV, 137 did not drink coffee. Of the 191 who did, 61 drank it on < 4 days a week, and 130 drank it ≥ 4 days.

Initially, the researchers observed an inverse association between coffee drinking and serum aspartate aminotransferase (AST) levels, as well as predicting indices of liver fibrosis in patients with HBV infection. Patients who drank ≥ 4 cups of coffee per day had a 70% decrease of serum AST, a 70% decrease of the AST to platelet ratio index, and a 70% decrease of fibrosis-4 index values. 

Those findings indicated that coffee might have a “generally beneficial” effect on liver inflammation and fibrosis progression in patients with chronic liver disease, the researchers say. However, at the end of the 5-year follow-up, the incidences of liver cirrhosis complications and changes of serum predicting indices of liver fibrosis were comparable between HBV coffee drinkers and nondrinkers. That indicated, the researchers believe, that the beneficial effect “seems to be outweighed” in patients with chronic HBV infection.

The researchers suggest that the protective effects of coffee consumption on liver inflammation and insulin resistance may not be able to surpass the direct carcinogenic effect of HBV, and even the HBV virus replication.

The Food and Drug Administration has cleared Xyrem (sodium oxybate) oral solution to treat cataplexy and excessive daytime sleepiness in patients ages 7-17 with narcolepsy.

The central nervous system depressant previously had been approved to treat cataplexy in adults with narcolepsy.

The current approval was granted by the FDA under a Priority Review designation. Xyrem also received the FDA’s Orphan Drug designation, which is intended to encourage the development of drugs for rare diseases.

The agency noted in a press release, however, that the drug would continue to be available only through risk evaluation mitigation strategy (REMS) programs because of “the risk of serious outcomes resulting from inappropriate prescribing, misuse, abuse and diversion.” Xyrem either alone or in combination with other CNS depressants may be associated with reactions including seizure, respiratory depression, decreases in the level of consciousness, coma, and death, the FDA said.

The most common adverse reactions in pediatric patients were enuresis, nausea, headache, vomiting, weight decrease, decreased appetite, and dizziness.

For more information on prescribing Xyrem for pediatric patients, see the revised labeling information on the FDA website.

rpizzi@mdedge.com

The Food and Drug Administration has cleared Xyrem (sodium oxybate) oral solution to treat cataplexy and excessive daytime sleepiness in patients ages 7-17 with narcolepsy.

The central nervous system depressant previously had been approved to treat cataplexy in adults with narcolepsy.

The current approval was granted by the FDA under a Priority Review designation. Xyrem also received the FDA’s Orphan Drug designation, which is intended to encourage the development of drugs for rare diseases.

The agency noted in a press release, however, that the drug would continue to be available only through risk evaluation mitigation strategy (REMS) programs because of “the risk of serious outcomes resulting from inappropriate prescribing, misuse, abuse and diversion.” Xyrem either alone or in combination with other CNS depressants may be associated with reactions including seizure, respiratory depression, decreases in the level of consciousness, coma, and death, the FDA said.

The most common adverse reactions in pediatric patients were enuresis, nausea, headache, vomiting, weight decrease, decreased appetite, and dizziness.

For more information on prescribing Xyrem for pediatric patients, see the revised labeling information on the FDA website.

rpizzi@mdedge.com

The Food and Drug Administration has cleared Xyrem (sodium oxybate) oral solution to treat cataplexy and excessive daytime sleepiness in patients ages 7-17 with narcolepsy.

The central nervous system depressant previously had been approved to treat cataplexy in adults with narcolepsy.

The current approval was granted by the FDA under a Priority Review designation. Xyrem also received the FDA’s Orphan Drug designation, which is intended to encourage the development of drugs for rare diseases.

The agency noted in a press release, however, that the drug would continue to be available only through risk evaluation mitigation strategy (REMS) programs because of “the risk of serious outcomes resulting from inappropriate prescribing, misuse, abuse and diversion.” Xyrem either alone or in combination with other CNS depressants may be associated with reactions including seizure, respiratory depression, decreases in the level of consciousness, coma, and death, the FDA said.

The most common adverse reactions in pediatric patients were enuresis, nausea, headache, vomiting, weight decrease, decreased appetite, and dizziness.

For more information on prescribing Xyrem for pediatric patients, see the revised labeling information on the FDA website.

rpizzi@mdedge.com

The antipsychotic medications haloperidol and ziprasidone are no better than placebo in altering the duration of delirium in patients in intensive care, new research has found.

copyright Andrei Malov/Thinkstock

In a paper published in the New England Journal of Medicine, researchers reported the results of a randomized, double-blind, placebo-controlled trial in 566 patients with acute respiratory failure or shock and hypoactive or hyperactive delirium. Participants were randomized either to a maximum of 20 mg IV haloperidol daily, maximum 40 mg ziprasidone daily, or placebo.

At the end of the 14-day intervention period, the placebo group had a median of 8.5 days alive without delirium or coma, the haloperidol group had a median of 7.9 days, and the ziprasidone group had a median of 8.7 days. The difference between groups was not statistically significant.

There were also no significant differences between the three groups in the secondary end point of duration of delirium and coma, 30-day and 90-day survival, time to freedom from mechanical ventilation, ICU discharge, ICU readmission, or hospital discharge.

Timothy D. Girard, MD, from the department of critical care at the University of Pittsburgh, and his coauthors wrote that their findings echoed those of two previous placebo-controlled trials in smaller numbers of ICU patients.

“One possible reason that we found no evidence that the use of haloperidol or ziprasidone resulted in a fewer days with delirium or coma than placebo is that the mechanism of brain dysfunction that is considered to be targeted by antipsychotic medications – increased dopamine signaling – may not play a major role in the pathogenesis of delirium during critical illness,” they wrote.

“In the current trial, approximately 90% of the patients received one or more doses of sedatives or analgesics, and the doses of sedatives and offtrial antipsychotic medications and the durations of exposures to those agents were similar in all trial groups,” the authors added.

Most of the patients in the trial had hypotensive delirium, which made it difficult to assess the effects of antipsychotics on hypertensive delirium.

The authors also commented that the patients enrolled were a mixed group, so their findings did not rule out the possibility that certain subgroups of patients – such as nonintubated patients with hyperactive delirium, those with alcohol withdrawal, or with other delirium phenotypes – may still benefit from antipsychotics.

Patients treated with ziprasidone were more likely to experience prolongation of the corrected QT interval. Two patients in the haloperidol group developed torsades de pointes but neither had received haloperidol in the 4 days preceding the onset of the arrhythmia.

One patient in each group – including the placebo group – experienced extrapyramidal symptoms and had treatment withheld. One patient in the haloperidol group also had the trial drug withheld because of suspected neuroleptic malignant syndrome, but this was later ruled out, and one patient had haloperidol withheld because of dystonia.

The dose of haloperidol used in the study was considered high, the authors said, but they left open the possibility that even higher doses might help. However, they also noted that doses of 25 mg and above were known to have adverse effects on cognition, which is why they chose the 20-mg dosage.

The study was supported by the National Institutes of Health and the Department of Veterans Affairs Geriatric Research Education and Clinical Center. Most authors declared support from the NIH or VA during the course of the study. Four authors also reported fees and grants from private industry outside the context of the study.

SOURCE: Girard TD et al. N Engl J Med.2018 Oct 22. doi: 10.1056/NEJMoa1808217.

The antipsychotic medications haloperidol and ziprasidone are no better than placebo in altering the duration of delirium in patients in intensive care, new research has found.

copyright Andrei Malov/Thinkstock

In a paper published in the New England Journal of Medicine, researchers reported the results of a randomized, double-blind, placebo-controlled trial in 566 patients with acute respiratory failure or shock and hypoactive or hyperactive delirium. Participants were randomized either to a maximum of 20 mg IV haloperidol daily, maximum 40 mg ziprasidone daily, or placebo.

At the end of the 14-day intervention period, the placebo group had a median of 8.5 days alive without delirium or coma, the haloperidol group had a median of 7.9 days, and the ziprasidone group had a median of 8.7 days. The difference between groups was not statistically significant.

There were also no significant differences between the three groups in the secondary end point of duration of delirium and coma, 30-day and 90-day survival, time to freedom from mechanical ventilation, ICU discharge, ICU readmission, or hospital discharge.

Timothy D. Girard, MD, from the department of critical care at the University of Pittsburgh, and his coauthors wrote that their findings echoed those of two previous placebo-controlled trials in smaller numbers of ICU patients.

“One possible reason that we found no evidence that the use of haloperidol or ziprasidone resulted in a fewer days with delirium or coma than placebo is that the mechanism of brain dysfunction that is considered to be targeted by antipsychotic medications – increased dopamine signaling – may not play a major role in the pathogenesis of delirium during critical illness,” they wrote.

“In the current trial, approximately 90% of the patients received one or more doses of sedatives or analgesics, and the doses of sedatives and offtrial antipsychotic medications and the durations of exposures to those agents were similar in all trial groups,” the authors added.

Most of the patients in the trial had hypotensive delirium, which made it difficult to assess the effects of antipsychotics on hypertensive delirium.

The authors also commented that the patients enrolled were a mixed group, so their findings did not rule out the possibility that certain subgroups of patients – such as nonintubated patients with hyperactive delirium, those with alcohol withdrawal, or with other delirium phenotypes – may still benefit from antipsychotics.

Patients treated with ziprasidone were more likely to experience prolongation of the corrected QT interval. Two patients in the haloperidol group developed torsades de pointes but neither had received haloperidol in the 4 days preceding the onset of the arrhythmia.

One patient in each group – including the placebo group – experienced extrapyramidal symptoms and had treatment withheld. One patient in the haloperidol group also had the trial drug withheld because of suspected neuroleptic malignant syndrome, but this was later ruled out, and one patient had haloperidol withheld because of dystonia.

The dose of haloperidol used in the study was considered high, the authors said, but they left open the possibility that even higher doses might help. However, they also noted that doses of 25 mg and above were known to have adverse effects on cognition, which is why they chose the 20-mg dosage.

The study was supported by the National Institutes of Health and the Department of Veterans Affairs Geriatric Research Education and Clinical Center. Most authors declared support from the NIH or VA during the course of the study. Four authors also reported fees and grants from private industry outside the context of the study.

SOURCE: Girard TD et al. N Engl J Med.2018 Oct 22. doi: 10.1056/NEJMoa1808217.

The antipsychotic medications haloperidol and ziprasidone are no better than placebo in altering the duration of delirium in patients in intensive care, new research has found.

copyright Andrei Malov/Thinkstock

In a paper published in the New England Journal of Medicine, researchers reported the results of a randomized, double-blind, placebo-controlled trial in 566 patients with acute respiratory failure or shock and hypoactive or hyperactive delirium. Participants were randomized either to a maximum of 20 mg IV haloperidol daily, maximum 40 mg ziprasidone daily, or placebo.

At the end of the 14-day intervention period, the placebo group had a median of 8.5 days alive without delirium or coma, the haloperidol group had a median of 7.9 days, and the ziprasidone group had a median of 8.7 days. The difference between groups was not statistically significant.

There were also no significant differences between the three groups in the secondary end point of duration of delirium and coma, 30-day and 90-day survival, time to freedom from mechanical ventilation, ICU discharge, ICU readmission, or hospital discharge.

Timothy D. Girard, MD, from the department of critical care at the University of Pittsburgh, and his coauthors wrote that their findings echoed those of two previous placebo-controlled trials in smaller numbers of ICU patients.

“One possible reason that we found no evidence that the use of haloperidol or ziprasidone resulted in a fewer days with delirium or coma than placebo is that the mechanism of brain dysfunction that is considered to be targeted by antipsychotic medications – increased dopamine signaling – may not play a major role in the pathogenesis of delirium during critical illness,” they wrote.

“In the current trial, approximately 90% of the patients received one or more doses of sedatives or analgesics, and the doses of sedatives and offtrial antipsychotic medications and the durations of exposures to those agents were similar in all trial groups,” the authors added.

Most of the patients in the trial had hypotensive delirium, which made it difficult to assess the effects of antipsychotics on hypertensive delirium.

The authors also commented that the patients enrolled were a mixed group, so their findings did not rule out the possibility that certain subgroups of patients – such as nonintubated patients with hyperactive delirium, those with alcohol withdrawal, or with other delirium phenotypes – may still benefit from antipsychotics.

Patients treated with ziprasidone were more likely to experience prolongation of the corrected QT interval. Two patients in the haloperidol group developed torsades de pointes but neither had received haloperidol in the 4 days preceding the onset of the arrhythmia.

One patient in each group – including the placebo group – experienced extrapyramidal symptoms and had treatment withheld. One patient in the haloperidol group also had the trial drug withheld because of suspected neuroleptic malignant syndrome, but this was later ruled out, and one patient had haloperidol withheld because of dystonia.

The dose of haloperidol used in the study was considered high, the authors said, but they left open the possibility that even higher doses might help. However, they also noted that doses of 25 mg and above were known to have adverse effects on cognition, which is why they chose the 20-mg dosage.

The study was supported by the National Institutes of Health and the Department of Veterans Affairs Geriatric Research Education and Clinical Center. Most authors declared support from the NIH or VA during the course of the study. Four authors also reported fees and grants from private industry outside the context of the study.

SOURCE: Girard TD et al. N Engl J Med.2018 Oct 22. doi: 10.1056/NEJMoa1808217.

Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R), which is used to treat several types of aggressive non-Hodgkin lymphomas, is associated with high rates of line-associated complications, a new study suggests.

MrArifnajafov/CC-BY-3.0

These findings, published in Clinical Lymphoma, Myeloma & Leukemia, confirm other recent findings that DA-EPOCH-R has a significantly greater rate of complications, compared with that of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy.

The authors note that the use of DA-EPOCH-R is based on data from early phase trials, as well as retrospective data, that support its use as induction chemotherapy in high-grade B-cell lymphoma with MYC, BCL2, and/or BCL6 translocations. But currently, there are no data published from randomized trials that support the use of upfront DA-EPOCH-R therapy.

DA-EPOCH-R is an infusion-based therapy that requires a central venous catheter.

In their study, Rachel J. David, MD, of Wilmot Cancer Institute, Rochester, N.Y., and her colleagues conducted a retrospective study that included all patients treated with DA-EPOCH-R at their institution between March 2011 and July 2016, and also included a concurrent cohort of patients with diffuse large B-cell lymphoma (DLBCL) who were treated with R-CHOP. The goal was to identify the rates and predictors of line-associated complications linked with the use of DA-EPOCH-R therapy in this population.

The patient cohort comprised 43 patients who received DA-EPOCH-R and 44 patients who received RCHOP.

Patients in the DA-EPOCH-R cohort experienced a significantly higher rate of complications (P =.03), compared with the R-CHOP group.

In the DA-EPOCH-R cohort, 17 patients (39.5%) reported at least one LAC, which included venous thromboembolism, chemotherapy extravasation, and line-associated infection, during the study period. Grade 3 toxicity was observed in 41% of these patients.

In contrast, eight patients (18.2%) in the R-CHOP arm experienced at least one complication, with five of the eight patients experiencing grade 3-4 toxicity.

In a univariate analysis, body mass index of 35 kg/m² and the use of a peripherally inserted central catheter line were both significantly associated with a higher risk of venous thromboembolism (P = .04 and P = .02, respectively).

“For patients undergoing treatment with DA-EPOCH-R in whom the use of [central venous catheters] cannot be avoided, the morbidity of [line-associated complications] should be factored in by the clinician when determining upfront treatment,” the researchers wrote.

They reported having no conflicts of interest.
 

SOURCE: David RJ et al. Clin Lymphoma Myeloma Leuk. 2018 Aug 29. doi: 10.1016/j.clml.2018.08.014.

Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R), which is used to treat several types of aggressive non-Hodgkin lymphomas, is associated with high rates of line-associated complications, a new study suggests.

MrArifnajafov/CC-BY-3.0

These findings, published in Clinical Lymphoma, Myeloma & Leukemia, confirm other recent findings that DA-EPOCH-R has a significantly greater rate of complications, compared with that of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy.

The authors note that the use of DA-EPOCH-R is based on data from early phase trials, as well as retrospective data, that support its use as induction chemotherapy in high-grade B-cell lymphoma with MYC, BCL2, and/or BCL6 translocations. But currently, there are no data published from randomized trials that support the use of upfront DA-EPOCH-R therapy.

DA-EPOCH-R is an infusion-based therapy that requires a central venous catheter.

In their study, Rachel J. David, MD, of Wilmot Cancer Institute, Rochester, N.Y., and her colleagues conducted a retrospective study that included all patients treated with DA-EPOCH-R at their institution between March 2011 and July 2016, and also included a concurrent cohort of patients with diffuse large B-cell lymphoma (DLBCL) who were treated with R-CHOP. The goal was to identify the rates and predictors of line-associated complications linked with the use of DA-EPOCH-R therapy in this population.

The patient cohort comprised 43 patients who received DA-EPOCH-R and 44 patients who received RCHOP.

Patients in the DA-EPOCH-R cohort experienced a significantly higher rate of complications (P =.03), compared with the R-CHOP group.

In the DA-EPOCH-R cohort, 17 patients (39.5%) reported at least one LAC, which included venous thromboembolism, chemotherapy extravasation, and line-associated infection, during the study period. Grade 3 toxicity was observed in 41% of these patients.

In contrast, eight patients (18.2%) in the R-CHOP arm experienced at least one complication, with five of the eight patients experiencing grade 3-4 toxicity.

In a univariate analysis, body mass index of 35 kg/m² and the use of a peripherally inserted central catheter line were both significantly associated with a higher risk of venous thromboembolism (P = .04 and P = .02, respectively).

“For patients undergoing treatment with DA-EPOCH-R in whom the use of [central venous catheters] cannot be avoided, the morbidity of [line-associated complications] should be factored in by the clinician when determining upfront treatment,” the researchers wrote.

They reported having no conflicts of interest.
 

SOURCE: David RJ et al. Clin Lymphoma Myeloma Leuk. 2018 Aug 29. doi: 10.1016/j.clml.2018.08.014.

Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R), which is used to treat several types of aggressive non-Hodgkin lymphomas, is associated with high rates of line-associated complications, a new study suggests.

MrArifnajafov/CC-BY-3.0

These findings, published in Clinical Lymphoma, Myeloma & Leukemia, confirm other recent findings that DA-EPOCH-R has a significantly greater rate of complications, compared with that of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy.

The authors note that the use of DA-EPOCH-R is based on data from early phase trials, as well as retrospective data, that support its use as induction chemotherapy in high-grade B-cell lymphoma with MYC, BCL2, and/or BCL6 translocations. But currently, there are no data published from randomized trials that support the use of upfront DA-EPOCH-R therapy.

DA-EPOCH-R is an infusion-based therapy that requires a central venous catheter.

In their study, Rachel J. David, MD, of Wilmot Cancer Institute, Rochester, N.Y., and her colleagues conducted a retrospective study that included all patients treated with DA-EPOCH-R at their institution between March 2011 and July 2016, and also included a concurrent cohort of patients with diffuse large B-cell lymphoma (DLBCL) who were treated with R-CHOP. The goal was to identify the rates and predictors of line-associated complications linked with the use of DA-EPOCH-R therapy in this population.

The patient cohort comprised 43 patients who received DA-EPOCH-R and 44 patients who received RCHOP.

Patients in the DA-EPOCH-R cohort experienced a significantly higher rate of complications (P =.03), compared with the R-CHOP group.

In the DA-EPOCH-R cohort, 17 patients (39.5%) reported at least one LAC, which included venous thromboembolism, chemotherapy extravasation, and line-associated infection, during the study period. Grade 3 toxicity was observed in 41% of these patients.

In contrast, eight patients (18.2%) in the R-CHOP arm experienced at least one complication, with five of the eight patients experiencing grade 3-4 toxicity.

In a univariate analysis, body mass index of 35 kg/m² and the use of a peripherally inserted central catheter line were both significantly associated with a higher risk of venous thromboembolism (P = .04 and P = .02, respectively).

“For patients undergoing treatment with DA-EPOCH-R in whom the use of [central venous catheters] cannot be avoided, the morbidity of [line-associated complications] should be factored in by the clinician when determining upfront treatment,” the researchers wrote.

They reported having no conflicts of interest.
 

SOURCE: David RJ et al. Clin Lymphoma Myeloma Leuk. 2018 Aug 29. doi: 10.1016/j.clml.2018.08.014.

The Food and Drug Administration has cleared Abbott Laboratories’ next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The Influenza A & B 2 assay can detect and differentiate influenza A and B in 13 minutes, with a call-out of positive results at 5 minutes. It can be stored at room temperature, simplifying storage and ordering. The Strep A 2 assay detects group A streptococcus bacterial nucleic acid in 6 minutes, with a call-out of positive results at 2 minutes. Both will be the fastest tests currently on the market in their respective fields, according to a corporate press release.

The assays will be available in a variety of inpatient and outpatient settings, particularly in locations where patients commonly access health care services, such as EDs, physician offices, walk-in clinics, and urgent care centers. This will allow health care providers to make a fast, informed diagnosis and provide appropriate treatment within the span of a single patient visit.

“The ability to obtain early call outs for positive test results with molecular accuracy in as little as 5 minutes for influenza and 2 minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care. Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, N.Y., said in the press release.

Find the full press release on the Abbott Laboratories website.

lfranki@mdedge.com

The Food and Drug Administration has cleared Abbott Laboratories’ next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The Influenza A & B 2 assay can detect and differentiate influenza A and B in 13 minutes, with a call-out of positive results at 5 minutes. It can be stored at room temperature, simplifying storage and ordering. The Strep A 2 assay detects group A streptococcus bacterial nucleic acid in 6 minutes, with a call-out of positive results at 2 minutes. Both will be the fastest tests currently on the market in their respective fields, according to a corporate press release.

The assays will be available in a variety of inpatient and outpatient settings, particularly in locations where patients commonly access health care services, such as EDs, physician offices, walk-in clinics, and urgent care centers. This will allow health care providers to make a fast, informed diagnosis and provide appropriate treatment within the span of a single patient visit.

“The ability to obtain early call outs for positive test results with molecular accuracy in as little as 5 minutes for influenza and 2 minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care. Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, N.Y., said in the press release.

Find the full press release on the Abbott Laboratories website.

lfranki@mdedge.com

The Food and Drug Administration has cleared Abbott Laboratories’ next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The Influenza A & B 2 assay can detect and differentiate influenza A and B in 13 minutes, with a call-out of positive results at 5 minutes. It can be stored at room temperature, simplifying storage and ordering. The Strep A 2 assay detects group A streptococcus bacterial nucleic acid in 6 minutes, with a call-out of positive results at 2 minutes. Both will be the fastest tests currently on the market in their respective fields, according to a corporate press release.

The assays will be available in a variety of inpatient and outpatient settings, particularly in locations where patients commonly access health care services, such as EDs, physician offices, walk-in clinics, and urgent care centers. This will allow health care providers to make a fast, informed diagnosis and provide appropriate treatment within the span of a single patient visit.

“The ability to obtain early call outs for positive test results with molecular accuracy in as little as 5 minutes for influenza and 2 minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care. Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, N.Y., said in the press release.

Find the full press release on the Abbott Laboratories website.

lfranki@mdedge.com

Bortezomib in combination with rituximab plus chemotherapy significantly improved overall survival in transplant-ineligible patients with newly diagnosed mantle cell lymphoma (MCL), compared with standard treatment, according to final results from the international, phase 3 LYM-3002 trial.

Courtesy Wikimedia Commons/Nephron/Creative Commons

After a median follow-up period of 82.0 months, median overall survival was 90.7 months among participants who were given first-line bortezomib in addition to rituximab plus cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus 55.7 months in the control arm, where patients were given rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), for a hazard ratio of 0.66 (95% confidence interval, 0.51-0.85; P = .001).

Tadeusz Robak, MD, of the Medical University of Lodz in Poland, and his colleagues also reported that patients in the bortezomib arm experienced two novel adverse effects, which were different from findings reported in the primary analysis. Each case was classified as grade 4; there was one case of gastric cancer and one case of lung adenocarcinoma.

The findings were reported in the Lancet Oncology.

Among 268 patients in the follow-up analysis set, the median age was 66 years and 31% were classified as high risk based on the MCL-specific International Prognostic Index (MIPI). For those considered high risk, no significant difference was noted when comparing the two groups on the basis of overall survival.

“When analyzed according to MIPI risk category, VR-CAP was associated with significantly improved overall survival, compared with R-CHOP in the low-risk and intermediate-risk categories, but not in the high-risk category,” the investigators wrote.

The authors acknowledged a key limitation of the study was that rituximab was not given as a maintenance therapy since it was not considered standard of care at the time of study initiation.

Moving forward, Dr. Robak and his colleagues recommended that bortezomib be investigated in combination with newer targeted therapies in order to establish best practice for treating MCL.

The study was sponsored by Janssen Pharmaceuticals. The authors reported financial ties to Janssen, Celgene, Ipsen Biopharmaceuticals, Johnson & Johnson, Novartis, and others.

SOURCE: Robak T et al. Lancet Oncol. 2018 Oct 19. doi: 10.1016/S1470-2045(18)30685-5.

Bortezomib in combination with rituximab plus chemotherapy significantly improved overall survival in transplant-ineligible patients with newly diagnosed mantle cell lymphoma (MCL), compared with standard treatment, according to final results from the international, phase 3 LYM-3002 trial.

Courtesy Wikimedia Commons/Nephron/Creative Commons

After a median follow-up period of 82.0 months, median overall survival was 90.7 months among participants who were given first-line bortezomib in addition to rituximab plus cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus 55.7 months in the control arm, where patients were given rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), for a hazard ratio of 0.66 (95% confidence interval, 0.51-0.85; P = .001).

Tadeusz Robak, MD, of the Medical University of Lodz in Poland, and his colleagues also reported that patients in the bortezomib arm experienced two novel adverse effects, which were different from findings reported in the primary analysis. Each case was classified as grade 4; there was one case of gastric cancer and one case of lung adenocarcinoma.

The findings were reported in the Lancet Oncology.

Among 268 patients in the follow-up analysis set, the median age was 66 years and 31% were classified as high risk based on the MCL-specific International Prognostic Index (MIPI). For those considered high risk, no significant difference was noted when comparing the two groups on the basis of overall survival.

“When analyzed according to MIPI risk category, VR-CAP was associated with significantly improved overall survival, compared with R-CHOP in the low-risk and intermediate-risk categories, but not in the high-risk category,” the investigators wrote.

The authors acknowledged a key limitation of the study was that rituximab was not given as a maintenance therapy since it was not considered standard of care at the time of study initiation.

Moving forward, Dr. Robak and his colleagues recommended that bortezomib be investigated in combination with newer targeted therapies in order to establish best practice for treating MCL.

The study was sponsored by Janssen Pharmaceuticals. The authors reported financial ties to Janssen, Celgene, Ipsen Biopharmaceuticals, Johnson & Johnson, Novartis, and others.

SOURCE: Robak T et al. Lancet Oncol. 2018 Oct 19. doi: 10.1016/S1470-2045(18)30685-5.

Bortezomib in combination with rituximab plus chemotherapy significantly improved overall survival in transplant-ineligible patients with newly diagnosed mantle cell lymphoma (MCL), compared with standard treatment, according to final results from the international, phase 3 LYM-3002 trial.

Courtesy Wikimedia Commons/Nephron/Creative Commons

After a median follow-up period of 82.0 months, median overall survival was 90.7 months among participants who were given first-line bortezomib in addition to rituximab plus cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus 55.7 months in the control arm, where patients were given rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), for a hazard ratio of 0.66 (95% confidence interval, 0.51-0.85; P = .001).

Tadeusz Robak, MD, of the Medical University of Lodz in Poland, and his colleagues also reported that patients in the bortezomib arm experienced two novel adverse effects, which were different from findings reported in the primary analysis. Each case was classified as grade 4; there was one case of gastric cancer and one case of lung adenocarcinoma.

The findings were reported in the Lancet Oncology.

Among 268 patients in the follow-up analysis set, the median age was 66 years and 31% were classified as high risk based on the MCL-specific International Prognostic Index (MIPI). For those considered high risk, no significant difference was noted when comparing the two groups on the basis of overall survival.

“When analyzed according to MIPI risk category, VR-CAP was associated with significantly improved overall survival, compared with R-CHOP in the low-risk and intermediate-risk categories, but not in the high-risk category,” the investigators wrote.

The authors acknowledged a key limitation of the study was that rituximab was not given as a maintenance therapy since it was not considered standard of care at the time of study initiation.

Moving forward, Dr. Robak and his colleagues recommended that bortezomib be investigated in combination with newer targeted therapies in order to establish best practice for treating MCL.

The study was sponsored by Janssen Pharmaceuticals. The authors reported financial ties to Janssen, Celgene, Ipsen Biopharmaceuticals, Johnson & Johnson, Novartis, and others.

SOURCE: Robak T et al. Lancet Oncol. 2018 Oct 19. doi: 10.1016/S1470-2045(18)30685-5.