Influenza

Influenza activity dropped slightly in South Carolina, but remained high enough to make it the nation’s hot spot during week 9 of the 2015-2016 U.S. flu season, the Centers for Disease Control and Prevention reported Dec. 18.

The activity of influenza-like illness (ILI) in South Carolina went from level 9 down to level 8 for the week ending Dec. 12 (week 9), but that kept it in the “high” range, according to the CDC report.

The rest of the United States saw a slight increase in activity, with 15 states at level 2 or higher, compared with 13 the week before. New Jersey had the next-highest level of activity after South Carolina, rising from level 5 last week to level 6, which moved it into the “moderate” range.

Minnesota had the largest increase in ILI activity from the previous week, going from level 1 to level 4, and other states with increased activity were Alabama, Colorado, Georgia, Illinois, Nevada, Tennessee, and Virginia. States besides South Carolina with decreased activity were Arizona, Hawaii, Louisiana, Mississippi, and Texas, the CDC data show.

The proportion of outpatient visits nationwide for ILI – defined as a temperature of 100° F or greater and cough and/or sore throat – was 1.9%, continuing to stay below the national baseline of 2.1%, the CDC said.

Outside of the fifty states, Guam reported widespread activity, Puerto Rico reported “moderate” (level 7) activity, and the District of Columbia and the U.S. Virgin Islands reported sporadic activity, the CDC noted.

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Influenza activity dropped slightly in South Carolina, but remained high enough to make it the nation’s hot spot during week 9 of the 2015-2016 U.S. flu season, the Centers for Disease Control and Prevention reported Dec. 18.

The activity of influenza-like illness (ILI) in South Carolina went from level 9 down to level 8 for the week ending Dec. 12 (week 9), but that kept it in the “high” range, according to the CDC report.

The rest of the United States saw a slight increase in activity, with 15 states at level 2 or higher, compared with 13 the week before. New Jersey had the next-highest level of activity after South Carolina, rising from level 5 last week to level 6, which moved it into the “moderate” range.

Minnesota had the largest increase in ILI activity from the previous week, going from level 1 to level 4, and other states with increased activity were Alabama, Colorado, Georgia, Illinois, Nevada, Tennessee, and Virginia. States besides South Carolina with decreased activity were Arizona, Hawaii, Louisiana, Mississippi, and Texas, the CDC data show.

The proportion of outpatient visits nationwide for ILI – defined as a temperature of 100° F or greater and cough and/or sore throat – was 1.9%, continuing to stay below the national baseline of 2.1%, the CDC said.

Outside of the fifty states, Guam reported widespread activity, Puerto Rico reported “moderate” (level 7) activity, and the District of Columbia and the U.S. Virgin Islands reported sporadic activity, the CDC noted.

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Influenza activity dropped slightly in South Carolina, but remained high enough to make it the nation’s hot spot during week 9 of the 2015-2016 U.S. flu season, the Centers for Disease Control and Prevention reported Dec. 18.

The activity of influenza-like illness (ILI) in South Carolina went from level 9 down to level 8 for the week ending Dec. 12 (week 9), but that kept it in the “high” range, according to the CDC report.

The rest of the United States saw a slight increase in activity, with 15 states at level 2 or higher, compared with 13 the week before. New Jersey had the next-highest level of activity after South Carolina, rising from level 5 last week to level 6, which moved it into the “moderate” range.

Minnesota had the largest increase in ILI activity from the previous week, going from level 1 to level 4, and other states with increased activity were Alabama, Colorado, Georgia, Illinois, Nevada, Tennessee, and Virginia. States besides South Carolina with decreased activity were Arizona, Hawaii, Louisiana, Mississippi, and Texas, the CDC data show.

The proportion of outpatient visits nationwide for ILI – defined as a temperature of 100° F or greater and cough and/or sore throat – was 1.9%, continuing to stay below the national baseline of 2.1%, the CDC said.

Outside of the fifty states, Guam reported widespread activity, Puerto Rico reported “moderate” (level 7) activity, and the District of Columbia and the U.S. Virgin Islands reported sporadic activity, the CDC noted.

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SAN ANTONIO – Hospitalization for an infection within the first year following diagnosis of primary nonmetastatic breast cancer is a red flag for increased risk of subsequent development of distant metastases or breast cancer–related death, Judith S. Brand, Ph.D., reported at the San Antonio Breast Cancer Symposium.

This increased risk for future adverse breast cancer outcomes was statistically significant and clinically meaningful for women hospitalized for respiratory tract or skin infections or sepsis. Those are the patients for whom particularly close monitoring for recurrence of breast cancer is warranted in the next 5 years, said Dr. Brand of the Karolinska Institute, Stockholm.

In contrast, hospitalization for a gastrointestinal or urinary tract infection didn’t achieve significance as an independent predictor of increased risk of adverse breast cancer outcomes.

Dr. Brand presented a prospective population-based study of 8,338 women diagnosed with stage I-III breast cancer in the Stockholm area during 2001-2008. During a median 4.9 years of follow-up after diagnosis, 720 women had an infection-related hospitalization, with the great majority of these events occurring during the first year.

The incidence of hospitalization for sepsis among breast cancer patients in their first year post diagnosis was 14-fold greater than in the general Swedish female population matched for age and year. Respiratory infections resulting in hospitalization were fourfold more frequent than in the general population, skin infections were eightfold more common, and GI infections were twice as common.

Infection-related hospitalizations had a strong and independent association with breast cancer mortality during follow-up, as seen in a multivariate analysis adjusted for age at diagnosis, comorbid conditions, infectious disease history, type of breast cancer therapy, and tumor characteristics including size, grade, hormone receptor status, and lymph node involvement.

Moreover, the risk of developing distant metastases was 50%-78% greater in breast cancer patients hospitalized for respiratory infection, sepsis, or skin infection, compared with breast cancer patients who didn’t have an infection-related hospitalization.

“We think the sepsis results are the most interesting findings,” Dr. Brand said in an interview. “Sepsis could be an expression of an immunosuppressed state. And sepsis itself can induce immunosuppression for a long time, which could trigger tumor growth. Animal studies have shown that in postseptic mice, tumor grows faster.”

Infection-related hospitalizations didn’t increase the future risk of locoregional recurrences.

Independent predictors of infection-related hospitalization included older age, comorbidities, markers indicative of greater tumor aggressiveness, and treatment with chemotherapy or axillary radiotherapy.

“This shows that the risk of infection-related hospitalizations is not only due to immunosuppression caused by chemotherapy, but that the characteristics of the tumor itself play a role, as do patient characteristics. This is the first epidemiologic study to show with very extensive data that all three elements contribute to the risk,” Dr. Brand said.

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SAN ANTONIO – Hospitalization for an infection within the first year following diagnosis of primary nonmetastatic breast cancer is a red flag for increased risk of subsequent development of distant metastases or breast cancer–related death, Judith S. Brand, Ph.D., reported at the San Antonio Breast Cancer Symposium.

This increased risk for future adverse breast cancer outcomes was statistically significant and clinically meaningful for women hospitalized for respiratory tract or skin infections or sepsis. Those are the patients for whom particularly close monitoring for recurrence of breast cancer is warranted in the next 5 years, said Dr. Brand of the Karolinska Institute, Stockholm.

In contrast, hospitalization for a gastrointestinal or urinary tract infection didn’t achieve significance as an independent predictor of increased risk of adverse breast cancer outcomes.

Dr. Brand presented a prospective population-based study of 8,338 women diagnosed with stage I-III breast cancer in the Stockholm area during 2001-2008. During a median 4.9 years of follow-up after diagnosis, 720 women had an infection-related hospitalization, with the great majority of these events occurring during the first year.

The incidence of hospitalization for sepsis among breast cancer patients in their first year post diagnosis was 14-fold greater than in the general Swedish female population matched for age and year. Respiratory infections resulting in hospitalization were fourfold more frequent than in the general population, skin infections were eightfold more common, and GI infections were twice as common.

Infection-related hospitalizations had a strong and independent association with breast cancer mortality during follow-up, as seen in a multivariate analysis adjusted for age at diagnosis, comorbid conditions, infectious disease history, type of breast cancer therapy, and tumor characteristics including size, grade, hormone receptor status, and lymph node involvement.

Moreover, the risk of developing distant metastases was 50%-78% greater in breast cancer patients hospitalized for respiratory infection, sepsis, or skin infection, compared with breast cancer patients who didn’t have an infection-related hospitalization.

“We think the sepsis results are the most interesting findings,” Dr. Brand said in an interview. “Sepsis could be an expression of an immunosuppressed state. And sepsis itself can induce immunosuppression for a long time, which could trigger tumor growth. Animal studies have shown that in postseptic mice, tumor grows faster.”

Infection-related hospitalizations didn’t increase the future risk of locoregional recurrences.

Independent predictors of infection-related hospitalization included older age, comorbidities, markers indicative of greater tumor aggressiveness, and treatment with chemotherapy or axillary radiotherapy.

“This shows that the risk of infection-related hospitalizations is not only due to immunosuppression caused by chemotherapy, but that the characteristics of the tumor itself play a role, as do patient characteristics. This is the first epidemiologic study to show with very extensive data that all three elements contribute to the risk,” Dr. Brand said.

[email protected]

SAN ANTONIO – Hospitalization for an infection within the first year following diagnosis of primary nonmetastatic breast cancer is a red flag for increased risk of subsequent development of distant metastases or breast cancer–related death, Judith S. Brand, Ph.D., reported at the San Antonio Breast Cancer Symposium.

This increased risk for future adverse breast cancer outcomes was statistically significant and clinically meaningful for women hospitalized for respiratory tract or skin infections or sepsis. Those are the patients for whom particularly close monitoring for recurrence of breast cancer is warranted in the next 5 years, said Dr. Brand of the Karolinska Institute, Stockholm.

In contrast, hospitalization for a gastrointestinal or urinary tract infection didn’t achieve significance as an independent predictor of increased risk of adverse breast cancer outcomes.

Dr. Brand presented a prospective population-based study of 8,338 women diagnosed with stage I-III breast cancer in the Stockholm area during 2001-2008. During a median 4.9 years of follow-up after diagnosis, 720 women had an infection-related hospitalization, with the great majority of these events occurring during the first year.

The incidence of hospitalization for sepsis among breast cancer patients in their first year post diagnosis was 14-fold greater than in the general Swedish female population matched for age and year. Respiratory infections resulting in hospitalization were fourfold more frequent than in the general population, skin infections were eightfold more common, and GI infections were twice as common.

Infection-related hospitalizations had a strong and independent association with breast cancer mortality during follow-up, as seen in a multivariate analysis adjusted for age at diagnosis, comorbid conditions, infectious disease history, type of breast cancer therapy, and tumor characteristics including size, grade, hormone receptor status, and lymph node involvement.

Moreover, the risk of developing distant metastases was 50%-78% greater in breast cancer patients hospitalized for respiratory infection, sepsis, or skin infection, compared with breast cancer patients who didn’t have an infection-related hospitalization.

“We think the sepsis results are the most interesting findings,” Dr. Brand said in an interview. “Sepsis could be an expression of an immunosuppressed state. And sepsis itself can induce immunosuppression for a long time, which could trigger tumor growth. Animal studies have shown that in postseptic mice, tumor grows faster.”

Infection-related hospitalizations didn’t increase the future risk of locoregional recurrences.

Independent predictors of infection-related hospitalization included older age, comorbidities, markers indicative of greater tumor aggressiveness, and treatment with chemotherapy or axillary radiotherapy.

“This shows that the risk of infection-related hospitalizations is not only due to immunosuppression caused by chemotherapy, but that the characteristics of the tumor itself play a role, as do patient characteristics. This is the first epidemiologic study to show with very extensive data that all three elements contribute to the risk,” Dr. Brand said.

[email protected]

South Carolina officially became the first state to reach a “high” level of influenza activity during the 2015-2016 flu season, the Centers for Disease Control and Prevention reported Dec. 11.

Activity of influenza-like illness (ILI) in the state was at level 9 on a scale of 1-10 for the week ending Dec. 5, 2015. For the country as a whole, however, activity was down a bit, with 13 states at level 2 or higher, compared with 20 states the week before. Among those with reduced ILI activity was Oklahoma, which went from level 6 for the week ending Nov. 28 to level 3 for the week ending Dec. 5, according to the CDC report.

For the week, 1.8% of patient visits reported to the U.S. Outpatient Influenza-like Illness Surveillance Network were for ILI, which is below the national baseline of 2.1%. This measure peaked at almost 6% during last year’s flu season, with that high coming at the end of Dec. 2014. The pattern was similar for the 2013-2014 season, with a peak of about 4.5% during the same week at the end of December, the report showed.

There was one influenza-related pediatric death for the week ending Dec. 5, bringing the total to three that have been reported for the season, the CDC said.

[email protected]

South Carolina officially became the first state to reach a “high” level of influenza activity during the 2015-2016 flu season, the Centers for Disease Control and Prevention reported Dec. 11.

Activity of influenza-like illness (ILI) in the state was at level 9 on a scale of 1-10 for the week ending Dec. 5, 2015. For the country as a whole, however, activity was down a bit, with 13 states at level 2 or higher, compared with 20 states the week before. Among those with reduced ILI activity was Oklahoma, which went from level 6 for the week ending Nov. 28 to level 3 for the week ending Dec. 5, according to the CDC report.

For the week, 1.8% of patient visits reported to the U.S. Outpatient Influenza-like Illness Surveillance Network were for ILI, which is below the national baseline of 2.1%. This measure peaked at almost 6% during last year’s flu season, with that high coming at the end of Dec. 2014. The pattern was similar for the 2013-2014 season, with a peak of about 4.5% during the same week at the end of December, the report showed.

There was one influenza-related pediatric death for the week ending Dec. 5, bringing the total to three that have been reported for the season, the CDC said.

[email protected]

South Carolina officially became the first state to reach a “high” level of influenza activity during the 2015-2016 flu season, the Centers for Disease Control and Prevention reported Dec. 11.

Activity of influenza-like illness (ILI) in the state was at level 9 on a scale of 1-10 for the week ending Dec. 5, 2015. For the country as a whole, however, activity was down a bit, with 13 states at level 2 or higher, compared with 20 states the week before. Among those with reduced ILI activity was Oklahoma, which went from level 6 for the week ending Nov. 28 to level 3 for the week ending Dec. 5, according to the CDC report.

For the week, 1.8% of patient visits reported to the U.S. Outpatient Influenza-like Illness Surveillance Network were for ILI, which is below the national baseline of 2.1%. This measure peaked at almost 6% during last year’s flu season, with that high coming at the end of Dec. 2014. The pattern was similar for the 2013-2014 season, with a peak of about 4.5% during the same week at the end of December, the report showed.

There was one influenza-related pediatric death for the week ending Dec. 5, bringing the total to three that have been reported for the season, the CDC said.

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Two U.S. states experienced “moderate” activity of influenza-like illness for the week ending Nov. 28, 2015 – week 7 of the 2015-2016 flu season – the Centers for Disease Control and Prevention reported Dec. 4.

South Carolina had the highest (level 7) activity for the week, with Oklahoma joined by Puerto Rico at level 6. New Jersey was at the highest level (level 5) of “low” activity, while Arizona, Mississippi, and Virginia were a notch lower (level 4) but still in the “low” zone. All told, 20 states had flu activity of level 2 or higher, according to the CDC.

There were no influenza-associated pediatric deaths reported during the week, with two such deaths reported for the 2015-2016 season so far. For week 7 nationwide, 1.9% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network were the result of influenza-like illness – defined as a temperature of 100° F or greater and cough and/or sore throat – which is below the national baseline of 2.1%, the CDC said.

During week 7, 1.5% of the 11,288 specimens tested were positive for influenza, with 60% positive for influenza A and 40% positive for influenza B. For the season overall, 1.2% of the 102,675 specimens tested have been positive, with a 61/39 split for influenza A and B, the CDC noted.

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Two U.S. states experienced “moderate” activity of influenza-like illness for the week ending Nov. 28, 2015 – week 7 of the 2015-2016 flu season – the Centers for Disease Control and Prevention reported Dec. 4.

South Carolina had the highest (level 7) activity for the week, with Oklahoma joined by Puerto Rico at level 6. New Jersey was at the highest level (level 5) of “low” activity, while Arizona, Mississippi, and Virginia were a notch lower (level 4) but still in the “low” zone. All told, 20 states had flu activity of level 2 or higher, according to the CDC.

There were no influenza-associated pediatric deaths reported during the week, with two such deaths reported for the 2015-2016 season so far. For week 7 nationwide, 1.9% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network were the result of influenza-like illness – defined as a temperature of 100° F or greater and cough and/or sore throat – which is below the national baseline of 2.1%, the CDC said.

During week 7, 1.5% of the 11,288 specimens tested were positive for influenza, with 60% positive for influenza A and 40% positive for influenza B. For the season overall, 1.2% of the 102,675 specimens tested have been positive, with a 61/39 split for influenza A and B, the CDC noted.

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Two U.S. states experienced “moderate” activity of influenza-like illness for the week ending Nov. 28, 2015 – week 7 of the 2015-2016 flu season – the Centers for Disease Control and Prevention reported Dec. 4.

South Carolina had the highest (level 7) activity for the week, with Oklahoma joined by Puerto Rico at level 6. New Jersey was at the highest level (level 5) of “low” activity, while Arizona, Mississippi, and Virginia were a notch lower (level 4) but still in the “low” zone. All told, 20 states had flu activity of level 2 or higher, according to the CDC.

There were no influenza-associated pediatric deaths reported during the week, with two such deaths reported for the 2015-2016 season so far. For week 7 nationwide, 1.9% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network were the result of influenza-like illness – defined as a temperature of 100° F or greater and cough and/or sore throat – which is below the national baseline of 2.1%, the CDC said.

During week 7, 1.5% of the 11,288 specimens tested were positive for influenza, with 60% positive for influenza A and 40% positive for influenza B. For the season overall, 1.2% of the 102,675 specimens tested have been positive, with a 61/39 split for influenza A and B, the CDC noted.

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In a study with implications for the development of new influenza vaccine strategies, researchers discovered that – among patients who received the 2009 H1N1 influenza vaccine – individuals with low levels of H1N1-specific antibodies prior to vaccination produced a more broadly protective immune response against the influenza virus than patients with high levels of H1N1-specific antibodies prior to vaccination.

A research team led by Patrick C. Wilson, Ph.D., of the Knapp Center for Lupus and Immunology Research at the University of Chicago, studied the B cell response in patients who received the pandemic 2009 H1N1 vaccine 2 years in a row and had varied histories of influenza exposure. All patients were 18 years or older, healthy, and had not received the yearly influenza vaccine prior to participating in the study. The researchers compared the patients’ “vaccine-induced plasmablast response upon first vaccination with the pandemic H1N1 strain in 2009-2010” with the patients’ plasmablast response upon revaccination with this same strain in 2010-2011 or 2011-2012. Each of the 21 study participants provided the researchers with at least four H1N1-specific plasmablasts.

CDC/Cynthia Goldsmith

The researchers “analyzed the immunoglobulin regions, strain specificity, and functional properties of the antibodies produced by this plasmablast population at the single-cell level across multiple years,” which allowed them to directly evaluate the effect of immune memory on the specificity of the current response to the virus.

Among the study’s findings was that “only individuals with low preexisting serological levels of pandemic H1N1 specific antibodies generated a broadly neutralizing plasmablast response directed toward the [hemagglutinin] stalk,” which is part of the hemagglutinin protein located on the surface of the influenza virus.

“[W]e demonstrate that the immune subdominance of the [hemagglutinin] stalk is a function of both the poor accessibility to the broadly protective epitopes and the inherent polyreactivity of the antibodies that can bind. We conclude that immunological memory profoundly shapes the viral epitopes targeted upon exposure with divergent influenza strains and determines the likelihood of generating a broadly protective response,” said Dr. Wilson and his coauthors. The authors reported no conflicts of interest.

Read the full study in Science Translational Medicine (doi: 10.1126/scitranslmed.aad0522).

[email protected]

In a study with implications for the development of new influenza vaccine strategies, researchers discovered that – among patients who received the 2009 H1N1 influenza vaccine – individuals with low levels of H1N1-specific antibodies prior to vaccination produced a more broadly protective immune response against the influenza virus than patients with high levels of H1N1-specific antibodies prior to vaccination.

A research team led by Patrick C. Wilson, Ph.D., of the Knapp Center for Lupus and Immunology Research at the University of Chicago, studied the B cell response in patients who received the pandemic 2009 H1N1 vaccine 2 years in a row and had varied histories of influenza exposure. All patients were 18 years or older, healthy, and had not received the yearly influenza vaccine prior to participating in the study. The researchers compared the patients’ “vaccine-induced plasmablast response upon first vaccination with the pandemic H1N1 strain in 2009-2010” with the patients’ plasmablast response upon revaccination with this same strain in 2010-2011 or 2011-2012. Each of the 21 study participants provided the researchers with at least four H1N1-specific plasmablasts.

CDC/Cynthia Goldsmith

The researchers “analyzed the immunoglobulin regions, strain specificity, and functional properties of the antibodies produced by this plasmablast population at the single-cell level across multiple years,” which allowed them to directly evaluate the effect of immune memory on the specificity of the current response to the virus.

Among the study’s findings was that “only individuals with low preexisting serological levels of pandemic H1N1 specific antibodies generated a broadly neutralizing plasmablast response directed toward the [hemagglutinin] stalk,” which is part of the hemagglutinin protein located on the surface of the influenza virus.

“[W]e demonstrate that the immune subdominance of the [hemagglutinin] stalk is a function of both the poor accessibility to the broadly protective epitopes and the inherent polyreactivity of the antibodies that can bind. We conclude that immunological memory profoundly shapes the viral epitopes targeted upon exposure with divergent influenza strains and determines the likelihood of generating a broadly protective response,” said Dr. Wilson and his coauthors. The authors reported no conflicts of interest.

Read the full study in Science Translational Medicine (doi: 10.1126/scitranslmed.aad0522).

[email protected]

In a study with implications for the development of new influenza vaccine strategies, researchers discovered that – among patients who received the 2009 H1N1 influenza vaccine – individuals with low levels of H1N1-specific antibodies prior to vaccination produced a more broadly protective immune response against the influenza virus than patients with high levels of H1N1-specific antibodies prior to vaccination.

A research team led by Patrick C. Wilson, Ph.D., of the Knapp Center for Lupus and Immunology Research at the University of Chicago, studied the B cell response in patients who received the pandemic 2009 H1N1 vaccine 2 years in a row and had varied histories of influenza exposure. All patients were 18 years or older, healthy, and had not received the yearly influenza vaccine prior to participating in the study. The researchers compared the patients’ “vaccine-induced plasmablast response upon first vaccination with the pandemic H1N1 strain in 2009-2010” with the patients’ plasmablast response upon revaccination with this same strain in 2010-2011 or 2011-2012. Each of the 21 study participants provided the researchers with at least four H1N1-specific plasmablasts.

CDC/Cynthia Goldsmith

The researchers “analyzed the immunoglobulin regions, strain specificity, and functional properties of the antibodies produced by this plasmablast population at the single-cell level across multiple years,” which allowed them to directly evaluate the effect of immune memory on the specificity of the current response to the virus.

Among the study’s findings was that “only individuals with low preexisting serological levels of pandemic H1N1 specific antibodies generated a broadly neutralizing plasmablast response directed toward the [hemagglutinin] stalk,” which is part of the hemagglutinin protein located on the surface of the influenza virus.

“[W]e demonstrate that the immune subdominance of the [hemagglutinin] stalk is a function of both the poor accessibility to the broadly protective epitopes and the inherent polyreactivity of the antibodies that can bind. We conclude that immunological memory profoundly shapes the viral epitopes targeted upon exposure with divergent influenza strains and determines the likelihood of generating a broadly protective response,” said Dr. Wilson and his coauthors. The authors reported no conflicts of interest.

Read the full study in Science Translational Medicine (doi: 10.1126/scitranslmed.aad0522).

[email protected]

Activity of influenza-like illness (ILI) “increased slightly in the United States” during week 5 of the 2015-2016 influenza season, the Centers for Disease Control and Prevention reported Nov. 20.

Thirteen states were above level-1 activity as of Nov. 14, 2015, compared with seven the week before. South Carolina jumped all the way up to “moderate” activity (level 6) and Missouri and Oklahoma moved into the low-activity category (level 4). Oregon remained at a still-minimal level 3, while Arizona, Georgia, Illinois, Louisiana, Maine, Mississippi, Texas, Utah, and Virginia are at level 2, according to the CDC.

The first influenza-associated pediatric death was reported this week, although it actually occurred during week 4 (the week ending Nov. 7), the CDC said. There has been an average of 143 flu-associated pediatric deaths over the last three flu seasons.

ILI is defined as fever (temperature of 100° F or greater) and cough and/or sore throat. Activity level within a state is the proportion of outpatient visits to health care providers for influenza-like illness.

That proportion for the United States overall was 1.6%, which is up from last week’s 1.4% but still below the national baseline of 2.1%, the CDC said.

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Activity of influenza-like illness (ILI) “increased slightly in the United States” during week 5 of the 2015-2016 influenza season, the Centers for Disease Control and Prevention reported Nov. 20.

Thirteen states were above level-1 activity as of Nov. 14, 2015, compared with seven the week before. South Carolina jumped all the way up to “moderate” activity (level 6) and Missouri and Oklahoma moved into the low-activity category (level 4). Oregon remained at a still-minimal level 3, while Arizona, Georgia, Illinois, Louisiana, Maine, Mississippi, Texas, Utah, and Virginia are at level 2, according to the CDC.

The first influenza-associated pediatric death was reported this week, although it actually occurred during week 4 (the week ending Nov. 7), the CDC said. There has been an average of 143 flu-associated pediatric deaths over the last three flu seasons.

ILI is defined as fever (temperature of 100° F or greater) and cough and/or sore throat. Activity level within a state is the proportion of outpatient visits to health care providers for influenza-like illness.

That proportion for the United States overall was 1.6%, which is up from last week’s 1.4% but still below the national baseline of 2.1%, the CDC said.

[email protected]

Activity of influenza-like illness (ILI) “increased slightly in the United States” during week 5 of the 2015-2016 influenza season, the Centers for Disease Control and Prevention reported Nov. 20.

Thirteen states were above level-1 activity as of Nov. 14, 2015, compared with seven the week before. South Carolina jumped all the way up to “moderate” activity (level 6) and Missouri and Oklahoma moved into the low-activity category (level 4). Oregon remained at a still-minimal level 3, while Arizona, Georgia, Illinois, Louisiana, Maine, Mississippi, Texas, Utah, and Virginia are at level 2, according to the CDC.

The first influenza-associated pediatric death was reported this week, although it actually occurred during week 4 (the week ending Nov. 7), the CDC said. There has been an average of 143 flu-associated pediatric deaths over the last three flu seasons.

ILI is defined as fever (temperature of 100° F or greater) and cough and/or sore throat. Activity level within a state is the proportion of outpatient visits to health care providers for influenza-like illness.

That proportion for the United States overall was 1.6%, which is up from last week’s 1.4% but still below the national baseline of 2.1%, the CDC said.

[email protected]

A prime-boost flu vaccination strategy proved effective in children and adolescents in an open-label phase III trial conducted by the vaccine manufacturer and reported online in the Pediatric Infectious Disease Journal.

This proof-of-concept result suggests that at the outbreak of the next flu pandemic, immediate priming with two doses of a subtype-matched flu vaccine, followed by boosting once a strain-matched vaccine becomes available, will offer the pediatric population better protection than simply waiting for adequate quantities of the strain-matched vaccine to be developed and marketed.

© mik38 - Fotolia.com

It is impossible to predict which specific viral strain will cause the next flu pandemic, but H5N1 is considered a likely candidate virus, “to the extent that vaccine manufacturers and regulatory authorities are actively developing H5N1 vaccines” for all age groups, said Dr. Patricia Izurieta of GlaxoSmithKline Vaccines, Belgium, and her associates.

Waiting for a pandemic to begin and then producing strain-specific vaccines could take as long as 6 months, and even then supplies probably would be limited. Experts have theorized that preemptive “priming” with already stockpiled H5N1 vaccines immediately after a pandemic begins may provide broad cross-protection that could mitigate the intensity of the subsequent pandemic, potentially reducing morbidity, mortality, and viral transmission.

To test this theory, Dr. Izurieta and her associates mimicked a potential flu pandemic by priming children and adolescents with two doses of an H5N1-AS03 vaccine, giving a booster dose of a specific H5N1 strain at 6 months, and assessing antibody response to all the vaccinations through 12 months. (Assessing actual vaccine efficacy was impossible because it would be unethical to determine this by exposing children to a flu virus.)

A total of 520 participants at a single medical center in the Philippines who were aged 3-18 years (mean age, 9 years) were assigned to two intervention groups and two control groups. Approximately half of these children and adolescents received the intervention – two priming doses of A/Indonesia/05/2005/H5N1-AS03B vaccine – while the control subjects received a single dose of hepatitis A vaccine. At day 182, half of the primed and half of the unprimed participants then received a booster dose of A/turkey/Turkey/01/2005-H5N1-As03B, while the remainder received the hepatitis A vaccine.

Compared with no priming, priming afforded superior seroconversion and putative seroprotection against the second, specific strain of H5N1. This robust protective effect was seen within 10 days after vaccination, occurred across all ages, and persisted through 12 months of follow-up, the investigators said (Ped Infect Dis J. 2015 Nov 6. [doi: 10.1097/INF.0000000000000968]).

Adverse events within 7 days of the priming vaccinations developed in 68%-76% of the intervention group, compared with only 37%-64% of the control group. Adverse events within 7 days of the booster vaccinations developed in 69% of the intervention group, compared with only 40% of the control group. The most common adverse events were upper respiratory tract infection (20% vs 14%), nasopharyngitis (4% vs 3%), and rhinitis (3% in both study groups). The most serious adverse events affected two children and were classified as grade 3.

The study results suggest that a prime-boost strategy can induce broad and long-lasting immunity and could be effectively employed in this age group in the prepandemic setting, Dr. Izurieta and her associates reported.

This trial was funded by GlaxoSmithKline, which also was involved in the design and conduct of the study, the data analysis, and the writing and publishing of the report. Dr. Izurieta and two of her associates are employed by GSK.

A prime-boost flu vaccination strategy proved effective in children and adolescents in an open-label phase III trial conducted by the vaccine manufacturer and reported online in the Pediatric Infectious Disease Journal.

This proof-of-concept result suggests that at the outbreak of the next flu pandemic, immediate priming with two doses of a subtype-matched flu vaccine, followed by boosting once a strain-matched vaccine becomes available, will offer the pediatric population better protection than simply waiting for adequate quantities of the strain-matched vaccine to be developed and marketed.

© mik38 - Fotolia.com

It is impossible to predict which specific viral strain will cause the next flu pandemic, but H5N1 is considered a likely candidate virus, “to the extent that vaccine manufacturers and regulatory authorities are actively developing H5N1 vaccines” for all age groups, said Dr. Patricia Izurieta of GlaxoSmithKline Vaccines, Belgium, and her associates.

Waiting for a pandemic to begin and then producing strain-specific vaccines could take as long as 6 months, and even then supplies probably would be limited. Experts have theorized that preemptive “priming” with already stockpiled H5N1 vaccines immediately after a pandemic begins may provide broad cross-protection that could mitigate the intensity of the subsequent pandemic, potentially reducing morbidity, mortality, and viral transmission.

To test this theory, Dr. Izurieta and her associates mimicked a potential flu pandemic by priming children and adolescents with two doses of an H5N1-AS03 vaccine, giving a booster dose of a specific H5N1 strain at 6 months, and assessing antibody response to all the vaccinations through 12 months. (Assessing actual vaccine efficacy was impossible because it would be unethical to determine this by exposing children to a flu virus.)

A total of 520 participants at a single medical center in the Philippines who were aged 3-18 years (mean age, 9 years) were assigned to two intervention groups and two control groups. Approximately half of these children and adolescents received the intervention – two priming doses of A/Indonesia/05/2005/H5N1-AS03B vaccine – while the control subjects received a single dose of hepatitis A vaccine. At day 182, half of the primed and half of the unprimed participants then received a booster dose of A/turkey/Turkey/01/2005-H5N1-As03B, while the remainder received the hepatitis A vaccine.

Compared with no priming, priming afforded superior seroconversion and putative seroprotection against the second, specific strain of H5N1. This robust protective effect was seen within 10 days after vaccination, occurred across all ages, and persisted through 12 months of follow-up, the investigators said (Ped Infect Dis J. 2015 Nov 6. [doi: 10.1097/INF.0000000000000968]).

Adverse events within 7 days of the priming vaccinations developed in 68%-76% of the intervention group, compared with only 37%-64% of the control group. Adverse events within 7 days of the booster vaccinations developed in 69% of the intervention group, compared with only 40% of the control group. The most common adverse events were upper respiratory tract infection (20% vs 14%), nasopharyngitis (4% vs 3%), and rhinitis (3% in both study groups). The most serious adverse events affected two children and were classified as grade 3.

The study results suggest that a prime-boost strategy can induce broad and long-lasting immunity and could be effectively employed in this age group in the prepandemic setting, Dr. Izurieta and her associates reported.

This trial was funded by GlaxoSmithKline, which also was involved in the design and conduct of the study, the data analysis, and the writing and publishing of the report. Dr. Izurieta and two of her associates are employed by GSK.

A prime-boost flu vaccination strategy proved effective in children and adolescents in an open-label phase III trial conducted by the vaccine manufacturer and reported online in the Pediatric Infectious Disease Journal.

This proof-of-concept result suggests that at the outbreak of the next flu pandemic, immediate priming with two doses of a subtype-matched flu vaccine, followed by boosting once a strain-matched vaccine becomes available, will offer the pediatric population better protection than simply waiting for adequate quantities of the strain-matched vaccine to be developed and marketed.

© mik38 - Fotolia.com

It is impossible to predict which specific viral strain will cause the next flu pandemic, but H5N1 is considered a likely candidate virus, “to the extent that vaccine manufacturers and regulatory authorities are actively developing H5N1 vaccines” for all age groups, said Dr. Patricia Izurieta of GlaxoSmithKline Vaccines, Belgium, and her associates.

Waiting for a pandemic to begin and then producing strain-specific vaccines could take as long as 6 months, and even then supplies probably would be limited. Experts have theorized that preemptive “priming” with already stockpiled H5N1 vaccines immediately after a pandemic begins may provide broad cross-protection that could mitigate the intensity of the subsequent pandemic, potentially reducing morbidity, mortality, and viral transmission.

To test this theory, Dr. Izurieta and her associates mimicked a potential flu pandemic by priming children and adolescents with two doses of an H5N1-AS03 vaccine, giving a booster dose of a specific H5N1 strain at 6 months, and assessing antibody response to all the vaccinations through 12 months. (Assessing actual vaccine efficacy was impossible because it would be unethical to determine this by exposing children to a flu virus.)

A total of 520 participants at a single medical center in the Philippines who were aged 3-18 years (mean age, 9 years) were assigned to two intervention groups and two control groups. Approximately half of these children and adolescents received the intervention – two priming doses of A/Indonesia/05/2005/H5N1-AS03B vaccine – while the control subjects received a single dose of hepatitis A vaccine. At day 182, half of the primed and half of the unprimed participants then received a booster dose of A/turkey/Turkey/01/2005-H5N1-As03B, while the remainder received the hepatitis A vaccine.

Compared with no priming, priming afforded superior seroconversion and putative seroprotection against the second, specific strain of H5N1. This robust protective effect was seen within 10 days after vaccination, occurred across all ages, and persisted through 12 months of follow-up, the investigators said (Ped Infect Dis J. 2015 Nov 6. [doi: 10.1097/INF.0000000000000968]).

Adverse events within 7 days of the priming vaccinations developed in 68%-76% of the intervention group, compared with only 37%-64% of the control group. Adverse events within 7 days of the booster vaccinations developed in 69% of the intervention group, compared with only 40% of the control group. The most common adverse events were upper respiratory tract infection (20% vs 14%), nasopharyngitis (4% vs 3%), and rhinitis (3% in both study groups). The most serious adverse events affected two children and were classified as grade 3.

The study results suggest that a prime-boost strategy can induce broad and long-lasting immunity and could be effectively employed in this age group in the prepandemic setting, Dr. Izurieta and her associates reported.

This trial was funded by GlaxoSmithKline, which also was involved in the design and conduct of the study, the data analysis, and the writing and publishing of the report. Dr. Izurieta and two of her associates are employed by GSK.

Four weeks into the 2015-2016 flu season, activity levels of influenza-like illness (ILI) are minimal in all 50 states, the Centers for Disease Control and Prevention reported Nov. 13.

Seven states – Georgia, Hawaii, Illinois, Minnesota, Nevada, Utah, and Virginia – had level 2 activity for the week ending Nov. 7, 2015, which, although still minimal, was higher than the level 1 activity in the other 43 states. There was a moderate level of influenza-like illness activity (level 7) in Puerto Rico, which was up from level 6 the week before, and there were insufficient data to determine flu activity in the District of Columbia, according to the CDC.

ILI is defined as fever (temperature of 100° F or greater) and cough and/or sore throat. Activity level within a state is the proportion of outpatient visits to health care providers for influenza-like illness.

For the country overall, the proportion of outpatient visits for ILI was 1.4%, which is below the national baseline of 2.1% for week 4 of the flu season, the CDC noted.

[email protected]

Four weeks into the 2015-2016 flu season, activity levels of influenza-like illness (ILI) are minimal in all 50 states, the Centers for Disease Control and Prevention reported Nov. 13.

Seven states – Georgia, Hawaii, Illinois, Minnesota, Nevada, Utah, and Virginia – had level 2 activity for the week ending Nov. 7, 2015, which, although still minimal, was higher than the level 1 activity in the other 43 states. There was a moderate level of influenza-like illness activity (level 7) in Puerto Rico, which was up from level 6 the week before, and there were insufficient data to determine flu activity in the District of Columbia, according to the CDC.

ILI is defined as fever (temperature of 100° F or greater) and cough and/or sore throat. Activity level within a state is the proportion of outpatient visits to health care providers for influenza-like illness.

For the country overall, the proportion of outpatient visits for ILI was 1.4%, which is below the national baseline of 2.1% for week 4 of the flu season, the CDC noted.

[email protected]

Four weeks into the 2015-2016 flu season, activity levels of influenza-like illness (ILI) are minimal in all 50 states, the Centers for Disease Control and Prevention reported Nov. 13.

Seven states – Georgia, Hawaii, Illinois, Minnesota, Nevada, Utah, and Virginia – had level 2 activity for the week ending Nov. 7, 2015, which, although still minimal, was higher than the level 1 activity in the other 43 states. There was a moderate level of influenza-like illness activity (level 7) in Puerto Rico, which was up from level 6 the week before, and there were insufficient data to determine flu activity in the District of Columbia, according to the CDC.

ILI is defined as fever (temperature of 100° F or greater) and cough and/or sore throat. Activity level within a state is the proportion of outpatient visits to health care providers for influenza-like illness.

For the country overall, the proportion of outpatient visits for ILI was 1.4%, which is below the national baseline of 2.1% for week 4 of the flu season, the CDC noted.

[email protected]

MONTREAL – A new, next-generation macrolide, solithromycin, showed safety and efficacy as a once-daily oral agent that was noninferior to the comparator oral antibiotic, the fluoroquinolone moxifloxacin, in a phase III trial.

Macrolide resistance among strains of Streptococcus pneumoniae that cause many U.S. cases of severe community-acquired pneumonia has become common, complicating treatment of this common infection with a macrolide, Dr. Carlos M. Barrera explained at the annual meeting of the American College of Chest Physicians.

Mitchel L. Zoler/Frontline Medical News

The SOLITAIRE-ORAL (Efficacy and Safety Study of Oral Solithromycin [CEM-101] Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia) trial enrolled 860 patients with moderate to moderately severe community-acquired pneumonia.

About half of the patients enrolled in the trial underwent microbiologic assessment of their infecting pathogen, and about 40% of cases in each treatment arm had infections caused by S. pneumoniae. In this subgroup, the 5-day regimen of solithromycin tested in the study succeeded in clearing the infection in 89% of patients, comparable to the 83% success rate achieved with a 7-day course of moxifloxacin (Avelox), said Dr. Barrera, a pulmonologist who practices in Miami.

The study’s primary endpoint for Food and Drug Administration approval of solithromycin was early clinical response, defined as an improvement in at least two listed symptoms at 72 hours after onset of treatment. That endpoint occurred in 78% of patients enrolled in each of the two arms of the study.

The data make solithromycin look like a promising way to once again have a macrolide available for empiric oral treatment of more severe community-acquired pneumonia, pending full peer review of the data, commented Dr. Muthiah P. Muthiah, a pulmonologist at the University of Tennessee Health Science Center in Memphis.

“A couple of decades ago, you could comfortably treat a patient with severe community-acquired pneumonia with a macrolide, but you can’t do that anymore,” Dr. Muthiah said in an interview.

If the newly reported data on oral solithromycin hold up under further review, it would mean that solithromycin was as effective as a potent quinolone, which remains an effective monotherapy for community-acquired pneumonia in patients who do not require treatment in an intensive care unit, Dr. Muthiah noted.

A companion study, SOLITAIRE-IV, is a phase III pivotal trial assessing the safety and efficacy of solithromycin when begun intravenously for treating community-acquired pneumonia, followed by a switch to oral dosing, in comparison with intravenous followed by oral treatment with moxifloxacin.

Once those data are fully collected and analyzed, the company will submit the information from both trials to the FDA, said Dr. David Oldach, chief medical officer for Cempra.

Results from the intravenous trial, reported in a preliminary way by Cempra Oct. 16 in a press release, showed that the solithromycin treatment regimen tested in SOLITAIRE-IV met its noninferiority targets, compared with moxifloxacin. The safety results, however, showed that solithromycin produced a higher number of patients with a liver-enzyme elevation, compared with patients treated with moxifloxacin.

In SOLITAIRE-IV, Cempra reported that grade 3 increase in levels of alanine transaminase (ALT) occurred in 8% of patients on solithromycin and in 3% of patients on moxifloxacin. Grade 4 increases in ALT occurred in less than 1% of patients in both treatment arms.

In the current, orally administered trial, grade 3 ALT increases occurred in 5% of patients treated with solithromycin and in 2% of patients treated with moxifloxacin, Dr. Barrera reported. Grade 4 ALT increases occurred in 0.5% of patients treated with solithromycin and in 1.2% of those treated with moxifloxacin. No patients in either arm developed an elevation of both ALT and bilirubin, and the ALT increases seen were reversible and asymptomatic, Dr. Barrera said.

By other assessments, the safety profiles of solithromycin and moxifloxacin were similar: 7% of patients on solithromycin and 6% on moxifloxacin had a serious adverse event, and 4% of patients in each study arm discontinued treatment because of an adverse event.

SOLITAIRE-ORAL was sponsored by Cempra, the company developing solithromycin. Dr. Barrera has received research funding from Cempra. Dr. Muthiah had no disclosures.

[email protected] 


On Twitter @mitchelzoler

MONTREAL – A new, next-generation macrolide, solithromycin, showed safety and efficacy as a once-daily oral agent that was noninferior to the comparator oral antibiotic, the fluoroquinolone moxifloxacin, in a phase III trial.

Macrolide resistance among strains of Streptococcus pneumoniae that cause many U.S. cases of severe community-acquired pneumonia has become common, complicating treatment of this common infection with a macrolide, Dr. Carlos M. Barrera explained at the annual meeting of the American College of Chest Physicians.

Mitchel L. Zoler/Frontline Medical News

The SOLITAIRE-ORAL (Efficacy and Safety Study of Oral Solithromycin [CEM-101] Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia) trial enrolled 860 patients with moderate to moderately severe community-acquired pneumonia.

About half of the patients enrolled in the trial underwent microbiologic assessment of their infecting pathogen, and about 40% of cases in each treatment arm had infections caused by S. pneumoniae. In this subgroup, the 5-day regimen of solithromycin tested in the study succeeded in clearing the infection in 89% of patients, comparable to the 83% success rate achieved with a 7-day course of moxifloxacin (Avelox), said Dr. Barrera, a pulmonologist who practices in Miami.

The study’s primary endpoint for Food and Drug Administration approval of solithromycin was early clinical response, defined as an improvement in at least two listed symptoms at 72 hours after onset of treatment. That endpoint occurred in 78% of patients enrolled in each of the two arms of the study.

The data make solithromycin look like a promising way to once again have a macrolide available for empiric oral treatment of more severe community-acquired pneumonia, pending full peer review of the data, commented Dr. Muthiah P. Muthiah, a pulmonologist at the University of Tennessee Health Science Center in Memphis.

“A couple of decades ago, you could comfortably treat a patient with severe community-acquired pneumonia with a macrolide, but you can’t do that anymore,” Dr. Muthiah said in an interview.

If the newly reported data on oral solithromycin hold up under further review, it would mean that solithromycin was as effective as a potent quinolone, which remains an effective monotherapy for community-acquired pneumonia in patients who do not require treatment in an intensive care unit, Dr. Muthiah noted.

A companion study, SOLITAIRE-IV, is a phase III pivotal trial assessing the safety and efficacy of solithromycin when begun intravenously for treating community-acquired pneumonia, followed by a switch to oral dosing, in comparison with intravenous followed by oral treatment with moxifloxacin.

Once those data are fully collected and analyzed, the company will submit the information from both trials to the FDA, said Dr. David Oldach, chief medical officer for Cempra.

Results from the intravenous trial, reported in a preliminary way by Cempra Oct. 16 in a press release, showed that the solithromycin treatment regimen tested in SOLITAIRE-IV met its noninferiority targets, compared with moxifloxacin. The safety results, however, showed that solithromycin produced a higher number of patients with a liver-enzyme elevation, compared with patients treated with moxifloxacin.

In SOLITAIRE-IV, Cempra reported that grade 3 increase in levels of alanine transaminase (ALT) occurred in 8% of patients on solithromycin and in 3% of patients on moxifloxacin. Grade 4 increases in ALT occurred in less than 1% of patients in both treatment arms.

In the current, orally administered trial, grade 3 ALT increases occurred in 5% of patients treated with solithromycin and in 2% of patients treated with moxifloxacin, Dr. Barrera reported. Grade 4 ALT increases occurred in 0.5% of patients treated with solithromycin and in 1.2% of those treated with moxifloxacin. No patients in either arm developed an elevation of both ALT and bilirubin, and the ALT increases seen were reversible and asymptomatic, Dr. Barrera said.

By other assessments, the safety profiles of solithromycin and moxifloxacin were similar: 7% of patients on solithromycin and 6% on moxifloxacin had a serious adverse event, and 4% of patients in each study arm discontinued treatment because of an adverse event.

SOLITAIRE-ORAL was sponsored by Cempra, the company developing solithromycin. Dr. Barrera has received research funding from Cempra. Dr. Muthiah had no disclosures.

[email protected] 


On Twitter @mitchelzoler

MONTREAL – A new, next-generation macrolide, solithromycin, showed safety and efficacy as a once-daily oral agent that was noninferior to the comparator oral antibiotic, the fluoroquinolone moxifloxacin, in a phase III trial.

Macrolide resistance among strains of Streptococcus pneumoniae that cause many U.S. cases of severe community-acquired pneumonia has become common, complicating treatment of this common infection with a macrolide, Dr. Carlos M. Barrera explained at the annual meeting of the American College of Chest Physicians.

Mitchel L. Zoler/Frontline Medical News

The SOLITAIRE-ORAL (Efficacy and Safety Study of Oral Solithromycin [CEM-101] Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia) trial enrolled 860 patients with moderate to moderately severe community-acquired pneumonia.

About half of the patients enrolled in the trial underwent microbiologic assessment of their infecting pathogen, and about 40% of cases in each treatment arm had infections caused by S. pneumoniae. In this subgroup, the 5-day regimen of solithromycin tested in the study succeeded in clearing the infection in 89% of patients, comparable to the 83% success rate achieved with a 7-day course of moxifloxacin (Avelox), said Dr. Barrera, a pulmonologist who practices in Miami.

The study’s primary endpoint for Food and Drug Administration approval of solithromycin was early clinical response, defined as an improvement in at least two listed symptoms at 72 hours after onset of treatment. That endpoint occurred in 78% of patients enrolled in each of the two arms of the study.

The data make solithromycin look like a promising way to once again have a macrolide available for empiric oral treatment of more severe community-acquired pneumonia, pending full peer review of the data, commented Dr. Muthiah P. Muthiah, a pulmonologist at the University of Tennessee Health Science Center in Memphis.

“A couple of decades ago, you could comfortably treat a patient with severe community-acquired pneumonia with a macrolide, but you can’t do that anymore,” Dr. Muthiah said in an interview.

If the newly reported data on oral solithromycin hold up under further review, it would mean that solithromycin was as effective as a potent quinolone, which remains an effective monotherapy for community-acquired pneumonia in patients who do not require treatment in an intensive care unit, Dr. Muthiah noted.

A companion study, SOLITAIRE-IV, is a phase III pivotal trial assessing the safety and efficacy of solithromycin when begun intravenously for treating community-acquired pneumonia, followed by a switch to oral dosing, in comparison with intravenous followed by oral treatment with moxifloxacin.

Once those data are fully collected and analyzed, the company will submit the information from both trials to the FDA, said Dr. David Oldach, chief medical officer for Cempra.

Results from the intravenous trial, reported in a preliminary way by Cempra Oct. 16 in a press release, showed that the solithromycin treatment regimen tested in SOLITAIRE-IV met its noninferiority targets, compared with moxifloxacin. The safety results, however, showed that solithromycin produced a higher number of patients with a liver-enzyme elevation, compared with patients treated with moxifloxacin.

In SOLITAIRE-IV, Cempra reported that grade 3 increase in levels of alanine transaminase (ALT) occurred in 8% of patients on solithromycin and in 3% of patients on moxifloxacin. Grade 4 increases in ALT occurred in less than 1% of patients in both treatment arms.

In the current, orally administered trial, grade 3 ALT increases occurred in 5% of patients treated with solithromycin and in 2% of patients treated with moxifloxacin, Dr. Barrera reported. Grade 4 ALT increases occurred in 0.5% of patients treated with solithromycin and in 1.2% of those treated with moxifloxacin. No patients in either arm developed an elevation of both ALT and bilirubin, and the ALT increases seen were reversible and asymptomatic, Dr. Barrera said.

By other assessments, the safety profiles of solithromycin and moxifloxacin were similar: 7% of patients on solithromycin and 6% on moxifloxacin had a serious adverse event, and 4% of patients in each study arm discontinued treatment because of an adverse event.

SOLITAIRE-ORAL was sponsored by Cempra, the company developing solithromycin. Dr. Barrera has received research funding from Cempra. Dr. Muthiah had no disclosures.

[email protected] 


On Twitter @mitchelzoler

A 35-year-old woman with asthma presents for a follow-up visit in October. You recommend that she receive the influenza vaccine. She tells you that she cannot take the influenza vaccine because she is allergic to eggs.

What do you recommend?

A. Give her the influenza vaccine.

B. Give her an oseltamivir prescription, and have her start it if any flu-like symptoms appear.

C. Give her the nasal influenza vaccine.

D. Give her the cell-based influenza vaccine.

The clinic I work in asks all patients if they have allergy to eggs before giving the influenza vaccine. If the patient replies yes, then the vaccine is not given and the physician is consulted.

For many years, allergy to egg was considered a contraindication to receiving the influenza vaccine. This contraindication was based on the fear that administering a vaccine that was grown in eggs and could contain egg protein might cause anaphylaxis in patients with immunoglobulin E antibodies against egg proteins.

Fortunately, there is a good evidence base that shows that administering influenza vaccine to patients with egg allergy is safe.

This is extremely important information, because it is estimated that there are about 200,000-300,000 hospitalizations annually because of influenza. For the 2012-2013 influenza season, the CDC estimated that the flu vaccine prevented 6.6 million cases of influenza, 3.2 million doctor visits, and 79,000 hospitalizations. There were 170 pediatric deaths from the flu during the 2012-2013 influenza season (MMWR Morb Mortal Wkly Rep. 2013 Dec 13;62[49]:997-1000). The need for widespread vaccination is great, and decreasing the number of people unable to receive the vaccine is an important goal.

Raquel Camacho Gómez/Thinkstock

There are many studies in children and adults that show that those with egg allergy can be safely vaccinated with influenza vaccine. Dr. John M. James and colleagues reported a study of mostly children with egg allergy confirmed with skin testing (average age of the study group was 3 years) receiving influenza vaccine (J Pediatr. 1998 Nov;133[5]:624-8). A total of 83 patients with egg allergy received the vaccine (including 27 patients with a history of anaphylaxis or severe reactions after egg ingestion). No patients suffered severe reactions with the vaccine, with only four patients having mild, self-limited symptoms.

In another study, Dr. Anne Des Roches and colleagues performed a prospective, cohort study recruiting and vaccinating egg-allergic patients with trivalent inactivated influenza vaccine between 2010 and 2012 (J Allergy Clin Immunol. 2012 Nov;130[5]:1213-1216.e1). In the second year of the study, the focus was on recruiting patients with a history of anaphylaxis or severe cardiopulmonary symptoms upon egg ingestion. In addition, a retrospective study of all egg-allergic patients who had received an influenza vaccine between 2007 and 2010 was included.

A total of 457 doses of vaccine were administered to 367 patients with egg allergy, of whom 132 had a history of severe allergy. No patients developed anaphylaxis, and 13 patients developed mild allergiclike symptoms in the 24 hours after vaccination.

In an authoritative review on the subject of influenza vaccination in egg-allergic patients, Dr. John Kelso reported on 28 studies with a total of 4,315 patients with egg allergy, including 656 with history of anaphylaxis with egg ingestion (Expert Rev Vaccines. 2014 Aug;13[8]:1049-57). None of these patients developed a serious reaction when they received influenza vaccine.

Dr. Des Roches and colleagues reported on a prospective, cohort study in which 68 children with previous egg allergy received intranasal live attenuated influenza vaccine (J Allergy Clin Immunol Pract. 2015 Jan-Feb;3[1]:138-9). No patients had anaphylaxis or a severe allergic reaction. There were more adverse reactions in the patients with egg (7 patients) than in the control group (1 patient), but these were mild and nonspecific (abdominal pain, nasal congestion, headache, and cough).

The 2012 adverse reactions to vaccines practice parameter update recommended that patients with egg allergy should receive influenza vaccinations (trivalent influenza vaccine), because the risks of vaccinating are outweighed by the risks of not vaccinating (J Allergy Clin Immunol. 2012 Jul;130[1]:25-43).

A subsequent recommendation takes this a step further, recommending that all patients with egg allergy of any severity should receive inactivated influenza vaccine annually, using any age-approved brand (Ann Allergy Asthma Immunol. 2013 Oct;111[4]:301-2). In addition, there are no special waiting periods after vaccination of egg allergic patients beyond what is standard practice for any vaccine.

I think that we have plenty of evidence now to immunize all patients who report egg allergy, and to do so in the primary care setting.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 35-year-old woman with asthma presents for a follow-up visit in October. You recommend that she receive the influenza vaccine. She tells you that she cannot take the influenza vaccine because she is allergic to eggs.

What do you recommend?

A. Give her the influenza vaccine.

B. Give her an oseltamivir prescription, and have her start it if any flu-like symptoms appear.

C. Give her the nasal influenza vaccine.

D. Give her the cell-based influenza vaccine.

The clinic I work in asks all patients if they have allergy to eggs before giving the influenza vaccine. If the patient replies yes, then the vaccine is not given and the physician is consulted.

For many years, allergy to egg was considered a contraindication to receiving the influenza vaccine. This contraindication was based on the fear that administering a vaccine that was grown in eggs and could contain egg protein might cause anaphylaxis in patients with immunoglobulin E antibodies against egg proteins.

Fortunately, there is a good evidence base that shows that administering influenza vaccine to patients with egg allergy is safe.

This is extremely important information, because it is estimated that there are about 200,000-300,000 hospitalizations annually because of influenza. For the 2012-2013 influenza season, the CDC estimated that the flu vaccine prevented 6.6 million cases of influenza, 3.2 million doctor visits, and 79,000 hospitalizations. There were 170 pediatric deaths from the flu during the 2012-2013 influenza season (MMWR Morb Mortal Wkly Rep. 2013 Dec 13;62[49]:997-1000). The need for widespread vaccination is great, and decreasing the number of people unable to receive the vaccine is an important goal.

Raquel Camacho Gómez/Thinkstock

There are many studies in children and adults that show that those with egg allergy can be safely vaccinated with influenza vaccine. Dr. John M. James and colleagues reported a study of mostly children with egg allergy confirmed with skin testing (average age of the study group was 3 years) receiving influenza vaccine (J Pediatr. 1998 Nov;133[5]:624-8). A total of 83 patients with egg allergy received the vaccine (including 27 patients with a history of anaphylaxis or severe reactions after egg ingestion). No patients suffered severe reactions with the vaccine, with only four patients having mild, self-limited symptoms.

In another study, Dr. Anne Des Roches and colleagues performed a prospective, cohort study recruiting and vaccinating egg-allergic patients with trivalent inactivated influenza vaccine between 2010 and 2012 (J Allergy Clin Immunol. 2012 Nov;130[5]:1213-1216.e1). In the second year of the study, the focus was on recruiting patients with a history of anaphylaxis or severe cardiopulmonary symptoms upon egg ingestion. In addition, a retrospective study of all egg-allergic patients who had received an influenza vaccine between 2007 and 2010 was included.

A total of 457 doses of vaccine were administered to 367 patients with egg allergy, of whom 132 had a history of severe allergy. No patients developed anaphylaxis, and 13 patients developed mild allergiclike symptoms in the 24 hours after vaccination.

In an authoritative review on the subject of influenza vaccination in egg-allergic patients, Dr. John Kelso reported on 28 studies with a total of 4,315 patients with egg allergy, including 656 with history of anaphylaxis with egg ingestion (Expert Rev Vaccines. 2014 Aug;13[8]:1049-57). None of these patients developed a serious reaction when they received influenza vaccine.

Dr. Des Roches and colleagues reported on a prospective, cohort study in which 68 children with previous egg allergy received intranasal live attenuated influenza vaccine (J Allergy Clin Immunol Pract. 2015 Jan-Feb;3[1]:138-9). No patients had anaphylaxis or a severe allergic reaction. There were more adverse reactions in the patients with egg (7 patients) than in the control group (1 patient), but these were mild and nonspecific (abdominal pain, nasal congestion, headache, and cough).

The 2012 adverse reactions to vaccines practice parameter update recommended that patients with egg allergy should receive influenza vaccinations (trivalent influenza vaccine), because the risks of vaccinating are outweighed by the risks of not vaccinating (J Allergy Clin Immunol. 2012 Jul;130[1]:25-43).

A subsequent recommendation takes this a step further, recommending that all patients with egg allergy of any severity should receive inactivated influenza vaccine annually, using any age-approved brand (Ann Allergy Asthma Immunol. 2013 Oct;111[4]:301-2). In addition, there are no special waiting periods after vaccination of egg allergic patients beyond what is standard practice for any vaccine.

I think that we have plenty of evidence now to immunize all patients who report egg allergy, and to do so in the primary care setting.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 35-year-old woman with asthma presents for a follow-up visit in October. You recommend that she receive the influenza vaccine. She tells you that she cannot take the influenza vaccine because she is allergic to eggs.

What do you recommend?

A. Give her the influenza vaccine.

B. Give her an oseltamivir prescription, and have her start it if any flu-like symptoms appear.

C. Give her the nasal influenza vaccine.

D. Give her the cell-based influenza vaccine.

The clinic I work in asks all patients if they have allergy to eggs before giving the influenza vaccine. If the patient replies yes, then the vaccine is not given and the physician is consulted.

For many years, allergy to egg was considered a contraindication to receiving the influenza vaccine. This contraindication was based on the fear that administering a vaccine that was grown in eggs and could contain egg protein might cause anaphylaxis in patients with immunoglobulin E antibodies against egg proteins.

Fortunately, there is a good evidence base that shows that administering influenza vaccine to patients with egg allergy is safe.

This is extremely important information, because it is estimated that there are about 200,000-300,000 hospitalizations annually because of influenza. For the 2012-2013 influenza season, the CDC estimated that the flu vaccine prevented 6.6 million cases of influenza, 3.2 million doctor visits, and 79,000 hospitalizations. There were 170 pediatric deaths from the flu during the 2012-2013 influenza season (MMWR Morb Mortal Wkly Rep. 2013 Dec 13;62[49]:997-1000). The need for widespread vaccination is great, and decreasing the number of people unable to receive the vaccine is an important goal.

Raquel Camacho Gómez/Thinkstock

There are many studies in children and adults that show that those with egg allergy can be safely vaccinated with influenza vaccine. Dr. John M. James and colleagues reported a study of mostly children with egg allergy confirmed with skin testing (average age of the study group was 3 years) receiving influenza vaccine (J Pediatr. 1998 Nov;133[5]:624-8). A total of 83 patients with egg allergy received the vaccine (including 27 patients with a history of anaphylaxis or severe reactions after egg ingestion). No patients suffered severe reactions with the vaccine, with only four patients having mild, self-limited symptoms.

In another study, Dr. Anne Des Roches and colleagues performed a prospective, cohort study recruiting and vaccinating egg-allergic patients with trivalent inactivated influenza vaccine between 2010 and 2012 (J Allergy Clin Immunol. 2012 Nov;130[5]:1213-1216.e1). In the second year of the study, the focus was on recruiting patients with a history of anaphylaxis or severe cardiopulmonary symptoms upon egg ingestion. In addition, a retrospective study of all egg-allergic patients who had received an influenza vaccine between 2007 and 2010 was included.

A total of 457 doses of vaccine were administered to 367 patients with egg allergy, of whom 132 had a history of severe allergy. No patients developed anaphylaxis, and 13 patients developed mild allergiclike symptoms in the 24 hours after vaccination.

In an authoritative review on the subject of influenza vaccination in egg-allergic patients, Dr. John Kelso reported on 28 studies with a total of 4,315 patients with egg allergy, including 656 with history of anaphylaxis with egg ingestion (Expert Rev Vaccines. 2014 Aug;13[8]:1049-57). None of these patients developed a serious reaction when they received influenza vaccine.

Dr. Des Roches and colleagues reported on a prospective, cohort study in which 68 children with previous egg allergy received intranasal live attenuated influenza vaccine (J Allergy Clin Immunol Pract. 2015 Jan-Feb;3[1]:138-9). No patients had anaphylaxis or a severe allergic reaction. There were more adverse reactions in the patients with egg (7 patients) than in the control group (1 patient), but these were mild and nonspecific (abdominal pain, nasal congestion, headache, and cough).

The 2012 adverse reactions to vaccines practice parameter update recommended that patients with egg allergy should receive influenza vaccinations (trivalent influenza vaccine), because the risks of vaccinating are outweighed by the risks of not vaccinating (J Allergy Clin Immunol. 2012 Jul;130[1]:25-43).

A subsequent recommendation takes this a step further, recommending that all patients with egg allergy of any severity should receive inactivated influenza vaccine annually, using any age-approved brand (Ann Allergy Asthma Immunol. 2013 Oct;111[4]:301-2). In addition, there are no special waiting periods after vaccination of egg allergic patients beyond what is standard practice for any vaccine.

I think that we have plenty of evidence now to immunize all patients who report egg allergy, and to do so in the primary care setting.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].