FDA committee advises status quo for blood supply Zika testing

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Wed, 03/20/2019 - 15:43

Most members of a Food and Drug Administration advisory committee considered that data support maintaining current testing protocols for Zika virus in the blood donor pool. However, committee discussion entertained the idea of revisiting testing strategies after another year or 2 of Zika virus epidemiological data are available.

In its last guidance regarding Zika virus testing, issued in July 2018, the FDA recommended that either minipool nucleic acid testing (MP NAT) or individual donor (ID) NAT be used to screen for Zika virus. Current guidance still requires conversion to all-ID NAT “when certain threshold conditions are met that indicate an increased risk of suspected mosquito-borne transmission in a defined geographic collection area.”

In the first of three separate votes, 11 of 15 voting members of the FDA’s Blood Products Advisory Committee (BPAC) answered in the affirmative to the question of whether available data support continuing the status quo for Zika testing. Committee members then were asked to weigh whether current data support scaling back to a regional testing strategy targeting at-risk areas. Here, six committee members answered in the affirmative, and nine in the negative.

Just one committee member, F. Blaine Hollinger, MD, voted in favor of the third option, elimination of all Zika virus testing without reintroducing donor screening for risk factors in risk-free areas pending another outbreak in the United States. Dr. Hollinger is a professor of virology and microbiology at Baylor College of Medicine, Houston.

The committee as whole wasn’t swayed by a line of questioning put forward by chairman Richard Kaufman, MD. “I will be the devil’s advocate a little bit: We learned that there have been zero confirmed positives from blood donors for the past year. Would anyone be comfortable with just stopping screening of donors?” asked Dr. Kaufman, medical director of the adult transfusion service at Brigham and Women’s Hospital, Boston.

A wide-ranging morning of presentations put data regarding historical trends and current global Zika hot spots in front of the committee. Current upticks in infection rates in northwest Mexico and in some states in India were areas of concern, given North American travel patterns, noted speaker Marc Fisher, MD, of the Center for Disease Control and Prevention’s Arboviral Disease Branch (Fort Collins, Colo.) “We’re going to see sporadic outbreaks; it’s hard to predict the future,” he said. “The new outbreak in India raises concerns.”

Briefing information from the FDA explained that Zika virus local transmission peaked in the United States in late summer of 2016. More than 5,000 cases were reported in the United States and over 36,000 in Puerto Rico. This has plummeted to 220 in 2018, with about two-thirds of these cases occurring in the territories, mostly (97%) from Puerto Rico across all 3 years.

Zika viremic blood donors dropped by an order of magnitude yearly, totaling 363 in 2016, 38 in 2017, and just 3 in 2018. Of the 363 detected in 2016, 96% came from Puerto Rico or Florida, noted Dr. Fisher.

The number of suspected and confirmed cases in the Americas overall has also dropped from over 650,000 in 2016 to under 30,000 in 2018, with most cases in 2018 being suspected rather than laboratory confirmed. In contrast to testing conducted in North America, few cases in much of Central and South America were laboratory confirmed.

Asymptomatic infections have occurred in blood donors, said the FDA, with 1.8% of blood donations in Puerto Rico testing positive for Zika virus during the peak of the outbreak. Transmission by transfusion is thought to have occurred in Brazil.

Although Zika virus infections have plummeted in the United States and worldwide, prevalence and rates of local transmission are unpredictable, said the FDA, which pointed to sporadic increases in autochthonous transmission of viruses such as dengue and chikungunya that are carried by the same mosquito vector as Zika.

Some of the committee’s discussion centered around finding a way to carve out protection for those most harmed by Zika virus – pregnant women and their fetuses. Martin Schreiber, MD, professor of surgery at Oregon Health and Sciences University, Portland, proposed a point-of-care testing strategy in which only blood destined for pregnant women would be tested for Zika virus. Dr. Schreiber, a trauma surgeon, put forward the rationale that Zika virus causes harm almost exclusively to fetuses, except for rare cases of Guillain-Barré syndrome.

In response, Dr. Kaufman pointed out that with rare exceptions for some bacterial testing, all testing is done from samples taken at the point of donation. The supply chain for donor blood is not set up to accommodate point-of-care testing, he said.

Answering questions about another targeted strategy – maintaining a separate, Zika-tested supply of blood for pregnant women – Susan Stramer, PhD, vice president of scientific affairs for the American Red Cross, said, “Most hospitals do not want, and are very adamant against, carrying a dual inventory.”

Ultimately, the committee’s discussion swung toward the realization that it may be too soon after the recent spike in U.S. Zika cases to plot the best course for ongoing testing strategies. “We are at the tail end of a waning epidemic. ... I think it would probably be a pretty easy question for the committee and for the agency if we actually had some way of having a crystal ball and knowing that the current trend was likely to continue,” said Roger Lewis, MD, PhD, professor at the University of California, Los Angeles, and chair of the department of emergency medicine at Harbor-UCLA Medical Center.

“I think that is not the question,” he went on. “I think the question is, What is the optimal strategy if we have no idea if that tail is going to continue in this current trend. ... And that maybe the committee ought to be thinking about what is the right strategy for the next 2 years – with an underlying assumption that this is a question that can be brought back as we learn more about how this disease behaves.”

The FDA usually follows the recommendations of its advisory committees.

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Most members of a Food and Drug Administration advisory committee considered that data support maintaining current testing protocols for Zika virus in the blood donor pool. However, committee discussion entertained the idea of revisiting testing strategies after another year or 2 of Zika virus epidemiological data are available.

In its last guidance regarding Zika virus testing, issued in July 2018, the FDA recommended that either minipool nucleic acid testing (MP NAT) or individual donor (ID) NAT be used to screen for Zika virus. Current guidance still requires conversion to all-ID NAT “when certain threshold conditions are met that indicate an increased risk of suspected mosquito-borne transmission in a defined geographic collection area.”

In the first of three separate votes, 11 of 15 voting members of the FDA’s Blood Products Advisory Committee (BPAC) answered in the affirmative to the question of whether available data support continuing the status quo for Zika testing. Committee members then were asked to weigh whether current data support scaling back to a regional testing strategy targeting at-risk areas. Here, six committee members answered in the affirmative, and nine in the negative.

Just one committee member, F. Blaine Hollinger, MD, voted in favor of the third option, elimination of all Zika virus testing without reintroducing donor screening for risk factors in risk-free areas pending another outbreak in the United States. Dr. Hollinger is a professor of virology and microbiology at Baylor College of Medicine, Houston.

The committee as whole wasn’t swayed by a line of questioning put forward by chairman Richard Kaufman, MD. “I will be the devil’s advocate a little bit: We learned that there have been zero confirmed positives from blood donors for the past year. Would anyone be comfortable with just stopping screening of donors?” asked Dr. Kaufman, medical director of the adult transfusion service at Brigham and Women’s Hospital, Boston.

A wide-ranging morning of presentations put data regarding historical trends and current global Zika hot spots in front of the committee. Current upticks in infection rates in northwest Mexico and in some states in India were areas of concern, given North American travel patterns, noted speaker Marc Fisher, MD, of the Center for Disease Control and Prevention’s Arboviral Disease Branch (Fort Collins, Colo.) “We’re going to see sporadic outbreaks; it’s hard to predict the future,” he said. “The new outbreak in India raises concerns.”

Briefing information from the FDA explained that Zika virus local transmission peaked in the United States in late summer of 2016. More than 5,000 cases were reported in the United States and over 36,000 in Puerto Rico. This has plummeted to 220 in 2018, with about two-thirds of these cases occurring in the territories, mostly (97%) from Puerto Rico across all 3 years.

Zika viremic blood donors dropped by an order of magnitude yearly, totaling 363 in 2016, 38 in 2017, and just 3 in 2018. Of the 363 detected in 2016, 96% came from Puerto Rico or Florida, noted Dr. Fisher.

The number of suspected and confirmed cases in the Americas overall has also dropped from over 650,000 in 2016 to under 30,000 in 2018, with most cases in 2018 being suspected rather than laboratory confirmed. In contrast to testing conducted in North America, few cases in much of Central and South America were laboratory confirmed.

Asymptomatic infections have occurred in blood donors, said the FDA, with 1.8% of blood donations in Puerto Rico testing positive for Zika virus during the peak of the outbreak. Transmission by transfusion is thought to have occurred in Brazil.

Although Zika virus infections have plummeted in the United States and worldwide, prevalence and rates of local transmission are unpredictable, said the FDA, which pointed to sporadic increases in autochthonous transmission of viruses such as dengue and chikungunya that are carried by the same mosquito vector as Zika.

Some of the committee’s discussion centered around finding a way to carve out protection for those most harmed by Zika virus – pregnant women and their fetuses. Martin Schreiber, MD, professor of surgery at Oregon Health and Sciences University, Portland, proposed a point-of-care testing strategy in which only blood destined for pregnant women would be tested for Zika virus. Dr. Schreiber, a trauma surgeon, put forward the rationale that Zika virus causes harm almost exclusively to fetuses, except for rare cases of Guillain-Barré syndrome.

In response, Dr. Kaufman pointed out that with rare exceptions for some bacterial testing, all testing is done from samples taken at the point of donation. The supply chain for donor blood is not set up to accommodate point-of-care testing, he said.

Answering questions about another targeted strategy – maintaining a separate, Zika-tested supply of blood for pregnant women – Susan Stramer, PhD, vice president of scientific affairs for the American Red Cross, said, “Most hospitals do not want, and are very adamant against, carrying a dual inventory.”

Ultimately, the committee’s discussion swung toward the realization that it may be too soon after the recent spike in U.S. Zika cases to plot the best course for ongoing testing strategies. “We are at the tail end of a waning epidemic. ... I think it would probably be a pretty easy question for the committee and for the agency if we actually had some way of having a crystal ball and knowing that the current trend was likely to continue,” said Roger Lewis, MD, PhD, professor at the University of California, Los Angeles, and chair of the department of emergency medicine at Harbor-UCLA Medical Center.

“I think that is not the question,” he went on. “I think the question is, What is the optimal strategy if we have no idea if that tail is going to continue in this current trend. ... And that maybe the committee ought to be thinking about what is the right strategy for the next 2 years – with an underlying assumption that this is a question that can be brought back as we learn more about how this disease behaves.”

The FDA usually follows the recommendations of its advisory committees.

Most members of a Food and Drug Administration advisory committee considered that data support maintaining current testing protocols for Zika virus in the blood donor pool. However, committee discussion entertained the idea of revisiting testing strategies after another year or 2 of Zika virus epidemiological data are available.

In its last guidance regarding Zika virus testing, issued in July 2018, the FDA recommended that either minipool nucleic acid testing (MP NAT) or individual donor (ID) NAT be used to screen for Zika virus. Current guidance still requires conversion to all-ID NAT “when certain threshold conditions are met that indicate an increased risk of suspected mosquito-borne transmission in a defined geographic collection area.”

In the first of three separate votes, 11 of 15 voting members of the FDA’s Blood Products Advisory Committee (BPAC) answered in the affirmative to the question of whether available data support continuing the status quo for Zika testing. Committee members then were asked to weigh whether current data support scaling back to a regional testing strategy targeting at-risk areas. Here, six committee members answered in the affirmative, and nine in the negative.

Just one committee member, F. Blaine Hollinger, MD, voted in favor of the third option, elimination of all Zika virus testing without reintroducing donor screening for risk factors in risk-free areas pending another outbreak in the United States. Dr. Hollinger is a professor of virology and microbiology at Baylor College of Medicine, Houston.

The committee as whole wasn’t swayed by a line of questioning put forward by chairman Richard Kaufman, MD. “I will be the devil’s advocate a little bit: We learned that there have been zero confirmed positives from blood donors for the past year. Would anyone be comfortable with just stopping screening of donors?” asked Dr. Kaufman, medical director of the adult transfusion service at Brigham and Women’s Hospital, Boston.

A wide-ranging morning of presentations put data regarding historical trends and current global Zika hot spots in front of the committee. Current upticks in infection rates in northwest Mexico and in some states in India were areas of concern, given North American travel patterns, noted speaker Marc Fisher, MD, of the Center for Disease Control and Prevention’s Arboviral Disease Branch (Fort Collins, Colo.) “We’re going to see sporadic outbreaks; it’s hard to predict the future,” he said. “The new outbreak in India raises concerns.”

Briefing information from the FDA explained that Zika virus local transmission peaked in the United States in late summer of 2016. More than 5,000 cases were reported in the United States and over 36,000 in Puerto Rico. This has plummeted to 220 in 2018, with about two-thirds of these cases occurring in the territories, mostly (97%) from Puerto Rico across all 3 years.

Zika viremic blood donors dropped by an order of magnitude yearly, totaling 363 in 2016, 38 in 2017, and just 3 in 2018. Of the 363 detected in 2016, 96% came from Puerto Rico or Florida, noted Dr. Fisher.

The number of suspected and confirmed cases in the Americas overall has also dropped from over 650,000 in 2016 to under 30,000 in 2018, with most cases in 2018 being suspected rather than laboratory confirmed. In contrast to testing conducted in North America, few cases in much of Central and South America were laboratory confirmed.

Asymptomatic infections have occurred in blood donors, said the FDA, with 1.8% of blood donations in Puerto Rico testing positive for Zika virus during the peak of the outbreak. Transmission by transfusion is thought to have occurred in Brazil.

Although Zika virus infections have plummeted in the United States and worldwide, prevalence and rates of local transmission are unpredictable, said the FDA, which pointed to sporadic increases in autochthonous transmission of viruses such as dengue and chikungunya that are carried by the same mosquito vector as Zika.

Some of the committee’s discussion centered around finding a way to carve out protection for those most harmed by Zika virus – pregnant women and their fetuses. Martin Schreiber, MD, professor of surgery at Oregon Health and Sciences University, Portland, proposed a point-of-care testing strategy in which only blood destined for pregnant women would be tested for Zika virus. Dr. Schreiber, a trauma surgeon, put forward the rationale that Zika virus causes harm almost exclusively to fetuses, except for rare cases of Guillain-Barré syndrome.

In response, Dr. Kaufman pointed out that with rare exceptions for some bacterial testing, all testing is done from samples taken at the point of donation. The supply chain for donor blood is not set up to accommodate point-of-care testing, he said.

Answering questions about another targeted strategy – maintaining a separate, Zika-tested supply of blood for pregnant women – Susan Stramer, PhD, vice president of scientific affairs for the American Red Cross, said, “Most hospitals do not want, and are very adamant against, carrying a dual inventory.”

Ultimately, the committee’s discussion swung toward the realization that it may be too soon after the recent spike in U.S. Zika cases to plot the best course for ongoing testing strategies. “We are at the tail end of a waning epidemic. ... I think it would probably be a pretty easy question for the committee and for the agency if we actually had some way of having a crystal ball and knowing that the current trend was likely to continue,” said Roger Lewis, MD, PhD, professor at the University of California, Los Angeles, and chair of the department of emergency medicine at Harbor-UCLA Medical Center.

“I think that is not the question,” he went on. “I think the question is, What is the optimal strategy if we have no idea if that tail is going to continue in this current trend. ... And that maybe the committee ought to be thinking about what is the right strategy for the next 2 years – with an underlying assumption that this is a question that can be brought back as we learn more about how this disease behaves.”

The FDA usually follows the recommendations of its advisory committees.

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CDC exhorts more testing and treatment of HIV

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Tue, 03/19/2019 - 11:14

 

Approximately 80% of HIV infections in the United States in 2016 were spread by almost 40% of infected individuals who did not know their status or were not receiving care, according to data from the Centers for Disease Control and Prevention.

Courtesy CDC

However, leadership at the Department of Health & Human Services has developed a “bold but completely achievable” plan to reduce HIV infections within the next decade, Vice Adm. Jerome M. Adams, MD, the U.S. surgeon general, said in a teleconference to announce the results of a new Vital Signs report on the impact of undiagnosed and untreated HIV.  

In the early release Vital Signs from Morbidity and Mortality Weekly Report, Li Zihao, PhD, and his colleagues at the CDC used a model to estimate rates of HIV transmission in 2016 based on data from the National HIV Behavioral Surveillance on needle-sharing behavior and sexual behaviors. The overall transmission rate was 3.5/100,000 person-years. Of these transmissions, 73.0% were from men who have sex with men, 9.7% from intravenous drug users, and 12% from heterosexuals.

The percentages of transmissions for those who were acutely ill with HIV but unaware, not acutely ill but unaware, aware of HIV infection but not treated, receiving care but not virally suppressed, and receiving care and virally suppressed were 4.0%, 33.6%, 42.6%, 19.8%, and 0%, respectively, the researchers said.

The study “emphasizes the impact that HIV resources could have,” by showing the importance of identifying infected individuals early and using the tools now available to treat them before they can transmit the disease, Jonathan Mermin, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said during the conference.

“Today’s treatment regimens are simpler than those prescribed in the past, sometimes requiring only single-tablet formulations, with fewer side effects; most persons with HIV infection can achieve viral suppression within 6 months of initiating treatment,” the researchers wrote.

In the wake of the findings and at the start of the CDC’s 2019 National HIV Prevention Conference, the CDC proposed a federal initiative, Ending the HIV Epidemic: A Plan for America.”

The goal is to reduce the incidence of new HIV infections by at least 90% over the next decade, starting with a focus on parts of the country with the highest disease burden, according to the CDC.

“Today’s Vital Signs report illustrates how a goal that once seemed impossible is now within our reach.” Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, said during the conference. “If we increase access to testing and treatment for people with HIV, we could prevent a lion’s share of infections,” he said.

The plan involves working to identify individuals at risk, treating those who test positive as quickly as possible, and keeping them in care. Updated information on the CDC website provides more details for clinicians on how to have conversations about HIV with patients, the latest information about antiretroviral therapy, and details about prevention for partners including post- and pre-exposure prophylaxis (PEP and PreP), and condoms.

Eugene McCray, MD, director of the CDC’s Division of HIV/AIDS Prevention, emphasized that the CDC recommends HIV testing for all individuals aged 13-64 years at least once in their lives. He added that everyone who tests positive should seek medical care, that everyone with HIV deserves support to combat stigma, and that those at risk should be empowered to take advantage of proven effective prevention strategies.

Clinicians can access the updated CDC page on caring for HIV patients here.

SOURCE: Li Z et al. MMWR Morb Mortal Wkly Rep. 2019 March 18. doi: org/10.15585/mmwr.mm6811e1.

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Approximately 80% of HIV infections in the United States in 2016 were spread by almost 40% of infected individuals who did not know their status or were not receiving care, according to data from the Centers for Disease Control and Prevention.

Courtesy CDC

However, leadership at the Department of Health & Human Services has developed a “bold but completely achievable” plan to reduce HIV infections within the next decade, Vice Adm. Jerome M. Adams, MD, the U.S. surgeon general, said in a teleconference to announce the results of a new Vital Signs report on the impact of undiagnosed and untreated HIV.  

In the early release Vital Signs from Morbidity and Mortality Weekly Report, Li Zihao, PhD, and his colleagues at the CDC used a model to estimate rates of HIV transmission in 2016 based on data from the National HIV Behavioral Surveillance on needle-sharing behavior and sexual behaviors. The overall transmission rate was 3.5/100,000 person-years. Of these transmissions, 73.0% were from men who have sex with men, 9.7% from intravenous drug users, and 12% from heterosexuals.

The percentages of transmissions for those who were acutely ill with HIV but unaware, not acutely ill but unaware, aware of HIV infection but not treated, receiving care but not virally suppressed, and receiving care and virally suppressed were 4.0%, 33.6%, 42.6%, 19.8%, and 0%, respectively, the researchers said.

The study “emphasizes the impact that HIV resources could have,” by showing the importance of identifying infected individuals early and using the tools now available to treat them before they can transmit the disease, Jonathan Mermin, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said during the conference.

“Today’s treatment regimens are simpler than those prescribed in the past, sometimes requiring only single-tablet formulations, with fewer side effects; most persons with HIV infection can achieve viral suppression within 6 months of initiating treatment,” the researchers wrote.

In the wake of the findings and at the start of the CDC’s 2019 National HIV Prevention Conference, the CDC proposed a federal initiative, Ending the HIV Epidemic: A Plan for America.”

The goal is to reduce the incidence of new HIV infections by at least 90% over the next decade, starting with a focus on parts of the country with the highest disease burden, according to the CDC.

“Today’s Vital Signs report illustrates how a goal that once seemed impossible is now within our reach.” Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, said during the conference. “If we increase access to testing and treatment for people with HIV, we could prevent a lion’s share of infections,” he said.

The plan involves working to identify individuals at risk, treating those who test positive as quickly as possible, and keeping them in care. Updated information on the CDC website provides more details for clinicians on how to have conversations about HIV with patients, the latest information about antiretroviral therapy, and details about prevention for partners including post- and pre-exposure prophylaxis (PEP and PreP), and condoms.

Eugene McCray, MD, director of the CDC’s Division of HIV/AIDS Prevention, emphasized that the CDC recommends HIV testing for all individuals aged 13-64 years at least once in their lives. He added that everyone who tests positive should seek medical care, that everyone with HIV deserves support to combat stigma, and that those at risk should be empowered to take advantage of proven effective prevention strategies.

Clinicians can access the updated CDC page on caring for HIV patients here.

SOURCE: Li Z et al. MMWR Morb Mortal Wkly Rep. 2019 March 18. doi: org/10.15585/mmwr.mm6811e1.

 

Approximately 80% of HIV infections in the United States in 2016 were spread by almost 40% of infected individuals who did not know their status or were not receiving care, according to data from the Centers for Disease Control and Prevention.

Courtesy CDC

However, leadership at the Department of Health & Human Services has developed a “bold but completely achievable” plan to reduce HIV infections within the next decade, Vice Adm. Jerome M. Adams, MD, the U.S. surgeon general, said in a teleconference to announce the results of a new Vital Signs report on the impact of undiagnosed and untreated HIV.  

In the early release Vital Signs from Morbidity and Mortality Weekly Report, Li Zihao, PhD, and his colleagues at the CDC used a model to estimate rates of HIV transmission in 2016 based on data from the National HIV Behavioral Surveillance on needle-sharing behavior and sexual behaviors. The overall transmission rate was 3.5/100,000 person-years. Of these transmissions, 73.0% were from men who have sex with men, 9.7% from intravenous drug users, and 12% from heterosexuals.

The percentages of transmissions for those who were acutely ill with HIV but unaware, not acutely ill but unaware, aware of HIV infection but not treated, receiving care but not virally suppressed, and receiving care and virally suppressed were 4.0%, 33.6%, 42.6%, 19.8%, and 0%, respectively, the researchers said.

The study “emphasizes the impact that HIV resources could have,” by showing the importance of identifying infected individuals early and using the tools now available to treat them before they can transmit the disease, Jonathan Mermin, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said during the conference.

“Today’s treatment regimens are simpler than those prescribed in the past, sometimes requiring only single-tablet formulations, with fewer side effects; most persons with HIV infection can achieve viral suppression within 6 months of initiating treatment,” the researchers wrote.

In the wake of the findings and at the start of the CDC’s 2019 National HIV Prevention Conference, the CDC proposed a federal initiative, Ending the HIV Epidemic: A Plan for America.”

The goal is to reduce the incidence of new HIV infections by at least 90% over the next decade, starting with a focus on parts of the country with the highest disease burden, according to the CDC.

“Today’s Vital Signs report illustrates how a goal that once seemed impossible is now within our reach.” Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, said during the conference. “If we increase access to testing and treatment for people with HIV, we could prevent a lion’s share of infections,” he said.

The plan involves working to identify individuals at risk, treating those who test positive as quickly as possible, and keeping them in care. Updated information on the CDC website provides more details for clinicians on how to have conversations about HIV with patients, the latest information about antiretroviral therapy, and details about prevention for partners including post- and pre-exposure prophylaxis (PEP and PreP), and condoms.

Eugene McCray, MD, director of the CDC’s Division of HIV/AIDS Prevention, emphasized that the CDC recommends HIV testing for all individuals aged 13-64 years at least once in their lives. He added that everyone who tests positive should seek medical care, that everyone with HIV deserves support to combat stigma, and that those at risk should be empowered to take advantage of proven effective prevention strategies.

Clinicians can access the updated CDC page on caring for HIV patients here.

SOURCE: Li Z et al. MMWR Morb Mortal Wkly Rep. 2019 March 18. doi: org/10.15585/mmwr.mm6811e1.

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Measles cases confirmed in three more states

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Thu, 03/28/2019 - 14:28

 

Forty more cases and three more states were added to the measles count in the last week, bringing the U.S. total to 268 cases in 15 states so far in 2019, according to the Centers for Disease Control and Prevention.

Arizona, Michigan, and Missouri reported their first confirmed cases of the year, joining California (one outbreak), Colorado, Connecticut, Georgia, Illinois (one outbreak), Kentucky, New Hampshire, New Jersey, New York (two outbreaks), Oregon, Texas (one outbreak), and Washington (one outbreak), the CDC reported March 18.

Brooklyn, N.Y., has become the epicenter of measles activity since mid-February, and with 25 of the 40 new cases occurring there, the borough has now led the nation for four consecutive weeks. There have been 157 confirmed cases in Brooklyn and one in Queens since the outbreak began in October of 2018, the New York City Department of Health and Mental Hygiene reported.

Michigan’s first case of measles is travel related and involved an individual visiting from Israel following a stay in New York, the Michigan Department of Health and Human Services and Oakland County Health Division announced March 13.

In Arizona, the state department of health services and the Pima County Public Health Department announced that a 12-month-old infant from Pima County has been diagnosed with measles after traveling to Asia.

A single case of measles, contracted while the person was traveling out of state, has been reported in Jefferson County, Mo., and is being managed by the county health department, according to St. Louis Public Radio.

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Forty more cases and three more states were added to the measles count in the last week, bringing the U.S. total to 268 cases in 15 states so far in 2019, according to the Centers for Disease Control and Prevention.

Arizona, Michigan, and Missouri reported their first confirmed cases of the year, joining California (one outbreak), Colorado, Connecticut, Georgia, Illinois (one outbreak), Kentucky, New Hampshire, New Jersey, New York (two outbreaks), Oregon, Texas (one outbreak), and Washington (one outbreak), the CDC reported March 18.

Brooklyn, N.Y., has become the epicenter of measles activity since mid-February, and with 25 of the 40 new cases occurring there, the borough has now led the nation for four consecutive weeks. There have been 157 confirmed cases in Brooklyn and one in Queens since the outbreak began in October of 2018, the New York City Department of Health and Mental Hygiene reported.

Michigan’s first case of measles is travel related and involved an individual visiting from Israel following a stay in New York, the Michigan Department of Health and Human Services and Oakland County Health Division announced March 13.

In Arizona, the state department of health services and the Pima County Public Health Department announced that a 12-month-old infant from Pima County has been diagnosed with measles after traveling to Asia.

A single case of measles, contracted while the person was traveling out of state, has been reported in Jefferson County, Mo., and is being managed by the county health department, according to St. Louis Public Radio.

 

Forty more cases and three more states were added to the measles count in the last week, bringing the U.S. total to 268 cases in 15 states so far in 2019, according to the Centers for Disease Control and Prevention.

Arizona, Michigan, and Missouri reported their first confirmed cases of the year, joining California (one outbreak), Colorado, Connecticut, Georgia, Illinois (one outbreak), Kentucky, New Hampshire, New Jersey, New York (two outbreaks), Oregon, Texas (one outbreak), and Washington (one outbreak), the CDC reported March 18.

Brooklyn, N.Y., has become the epicenter of measles activity since mid-February, and with 25 of the 40 new cases occurring there, the borough has now led the nation for four consecutive weeks. There have been 157 confirmed cases in Brooklyn and one in Queens since the outbreak began in October of 2018, the New York City Department of Health and Mental Hygiene reported.

Michigan’s first case of measles is travel related and involved an individual visiting from Israel following a stay in New York, the Michigan Department of Health and Human Services and Oakland County Health Division announced March 13.

In Arizona, the state department of health services and the Pima County Public Health Department announced that a 12-month-old infant from Pima County has been diagnosed with measles after traveling to Asia.

A single case of measles, contracted while the person was traveling out of state, has been reported in Jefferson County, Mo., and is being managed by the county health department, according to St. Louis Public Radio.

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Repeat VTE risk heightened in HIV patients

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Mon, 03/18/2019 - 13:13

 

– HIV infection is associated with increased risk of recurrent venous thromboembolism, especially within 1 year of the initial episode. The finding, presented during a poster session at the Conference on Retroviruses & Opportunistic Infections, follows up on an earlier study that found that first-time VTE risk also is higher among HIV-positive individuals than in the general population.

Jim Kling/MDedge News
Dr. Peter Reiss

The conclusion about first-time VTE risk, published earlier this year in Lancet HIV, came from a comparison between the ATHENA (AIDS Therapy Evaluation in the Netherlands) cohort and European population-level of studies of VTE. It found a crude incidence of 2.33 VTE events per 1,000 person-years In HIV patients, with heightened odds when CD4 cell counts were below 200 cells/mcL (adjusted hazard ratio, 3.40).

The new work represents a follow-up and compared results from ATHENA (153 patients with HIV and first VTE) and the Dutch MEGA cohort (4,005 patients without HIV, with first VTE), which includes the general population. Overall, 26% of patients in the ATHENA cohort experienced a second VTE event, compared with 16% of the general population. At 1 year after anticoagulation withdrawal, HIV-positive individuals were at 67% increased risk (HR, 1.67). At 6-years after withdrawal, the relationship was not statistically significant (HR, 1.22).

Researchers also found that CD4 cell-count recovery was associated with lowered risk, with every 100 cell-count increase between initial VTE diagnosis and anticoagulant withdrawal linked to a 20% reduction in risk (HR, 0.80).

“The clinical question is: If it’s true you have an increased risk of recurrence, should you be continuing anticoagulant therapy longer in people with HIV? This poster doesn’t answer that question and you probably need a randomized, controlled trial to look at that,” Peter Reiss, MD, professor of medicine at Amsterdam University Medical Center, said in an interview during the conference.

In the absence of a clear answer, it’s sensible for clinicians to be aware of the potential increased risk, much as clinicians have internalized the increased risk of atherosclerotic vascular disease in HIV patients. “I think the publication [in Lancet HIV] as well as this poster suggest that on the venous side of things there may also be an accentuated risk,” said Dr. Reiss.

Heidi Crane, MD, a professor of medicine at the University of Washington, Seattle, presented a poster examining the underlying factors that may predispose HIV patients to first-time VTE events. Her team performed an adjudicated review of VTE cases among HIV patients at six institutions and found that the risk factors appeared to be distinct from those seen in the general population.

The traditional long plane ride was less common in this population, while factors such as injected drug use and pneumonia were more common. The VTE events occurred at a median age of 49 years; 30% of the patients had a detectable viral load. “We’re seeing a little more (VTE) than you might expect, and in a younger population than you might have guessed,” said Dr. Crane in an interview.

The most frequent predisposing risk factors were recent hospitalization (40%), infection (40%), or immobilization/bed rest (24%) within the past 90 days, and injectable drug use (22%). “It’s not just the traditional risk factors. Some HIV-specific risk factors are driving this,” said Dr. Crane.

She also aims to learn more about the specifics of risk factors, such as catheter-associated thromboses. The team is working to increase the sample size in order to parse out the relationships with specific outcomes.

In the meantime, the data further characterize the health challenges facing people living with HIV. “This is another example demonstrating that comorbid conditions among patients with HIV that are often considered age related occur at much younger ages in our population,” said Dr. Crane.

SOURCE: Rokx C et al. CROI 2019, Abstract 636; and Tenforde MW et al. CROI 2019, Abstract 637.

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– HIV infection is associated with increased risk of recurrent venous thromboembolism, especially within 1 year of the initial episode. The finding, presented during a poster session at the Conference on Retroviruses & Opportunistic Infections, follows up on an earlier study that found that first-time VTE risk also is higher among HIV-positive individuals than in the general population.

Jim Kling/MDedge News
Dr. Peter Reiss

The conclusion about first-time VTE risk, published earlier this year in Lancet HIV, came from a comparison between the ATHENA (AIDS Therapy Evaluation in the Netherlands) cohort and European population-level of studies of VTE. It found a crude incidence of 2.33 VTE events per 1,000 person-years In HIV patients, with heightened odds when CD4 cell counts were below 200 cells/mcL (adjusted hazard ratio, 3.40).

The new work represents a follow-up and compared results from ATHENA (153 patients with HIV and first VTE) and the Dutch MEGA cohort (4,005 patients without HIV, with first VTE), which includes the general population. Overall, 26% of patients in the ATHENA cohort experienced a second VTE event, compared with 16% of the general population. At 1 year after anticoagulation withdrawal, HIV-positive individuals were at 67% increased risk (HR, 1.67). At 6-years after withdrawal, the relationship was not statistically significant (HR, 1.22).

Researchers also found that CD4 cell-count recovery was associated with lowered risk, with every 100 cell-count increase between initial VTE diagnosis and anticoagulant withdrawal linked to a 20% reduction in risk (HR, 0.80).

“The clinical question is: If it’s true you have an increased risk of recurrence, should you be continuing anticoagulant therapy longer in people with HIV? This poster doesn’t answer that question and you probably need a randomized, controlled trial to look at that,” Peter Reiss, MD, professor of medicine at Amsterdam University Medical Center, said in an interview during the conference.

In the absence of a clear answer, it’s sensible for clinicians to be aware of the potential increased risk, much as clinicians have internalized the increased risk of atherosclerotic vascular disease in HIV patients. “I think the publication [in Lancet HIV] as well as this poster suggest that on the venous side of things there may also be an accentuated risk,” said Dr. Reiss.

Heidi Crane, MD, a professor of medicine at the University of Washington, Seattle, presented a poster examining the underlying factors that may predispose HIV patients to first-time VTE events. Her team performed an adjudicated review of VTE cases among HIV patients at six institutions and found that the risk factors appeared to be distinct from those seen in the general population.

The traditional long plane ride was less common in this population, while factors such as injected drug use and pneumonia were more common. The VTE events occurred at a median age of 49 years; 30% of the patients had a detectable viral load. “We’re seeing a little more (VTE) than you might expect, and in a younger population than you might have guessed,” said Dr. Crane in an interview.

The most frequent predisposing risk factors were recent hospitalization (40%), infection (40%), or immobilization/bed rest (24%) within the past 90 days, and injectable drug use (22%). “It’s not just the traditional risk factors. Some HIV-specific risk factors are driving this,” said Dr. Crane.

She also aims to learn more about the specifics of risk factors, such as catheter-associated thromboses. The team is working to increase the sample size in order to parse out the relationships with specific outcomes.

In the meantime, the data further characterize the health challenges facing people living with HIV. “This is another example demonstrating that comorbid conditions among patients with HIV that are often considered age related occur at much younger ages in our population,” said Dr. Crane.

SOURCE: Rokx C et al. CROI 2019, Abstract 636; and Tenforde MW et al. CROI 2019, Abstract 637.

.

 

– HIV infection is associated with increased risk of recurrent venous thromboembolism, especially within 1 year of the initial episode. The finding, presented during a poster session at the Conference on Retroviruses & Opportunistic Infections, follows up on an earlier study that found that first-time VTE risk also is higher among HIV-positive individuals than in the general population.

Jim Kling/MDedge News
Dr. Peter Reiss

The conclusion about first-time VTE risk, published earlier this year in Lancet HIV, came from a comparison between the ATHENA (AIDS Therapy Evaluation in the Netherlands) cohort and European population-level of studies of VTE. It found a crude incidence of 2.33 VTE events per 1,000 person-years In HIV patients, with heightened odds when CD4 cell counts were below 200 cells/mcL (adjusted hazard ratio, 3.40).

The new work represents a follow-up and compared results from ATHENA (153 patients with HIV and first VTE) and the Dutch MEGA cohort (4,005 patients without HIV, with first VTE), which includes the general population. Overall, 26% of patients in the ATHENA cohort experienced a second VTE event, compared with 16% of the general population. At 1 year after anticoagulation withdrawal, HIV-positive individuals were at 67% increased risk (HR, 1.67). At 6-years after withdrawal, the relationship was not statistically significant (HR, 1.22).

Researchers also found that CD4 cell-count recovery was associated with lowered risk, with every 100 cell-count increase between initial VTE diagnosis and anticoagulant withdrawal linked to a 20% reduction in risk (HR, 0.80).

“The clinical question is: If it’s true you have an increased risk of recurrence, should you be continuing anticoagulant therapy longer in people with HIV? This poster doesn’t answer that question and you probably need a randomized, controlled trial to look at that,” Peter Reiss, MD, professor of medicine at Amsterdam University Medical Center, said in an interview during the conference.

In the absence of a clear answer, it’s sensible for clinicians to be aware of the potential increased risk, much as clinicians have internalized the increased risk of atherosclerotic vascular disease in HIV patients. “I think the publication [in Lancet HIV] as well as this poster suggest that on the venous side of things there may also be an accentuated risk,” said Dr. Reiss.

Heidi Crane, MD, a professor of medicine at the University of Washington, Seattle, presented a poster examining the underlying factors that may predispose HIV patients to first-time VTE events. Her team performed an adjudicated review of VTE cases among HIV patients at six institutions and found that the risk factors appeared to be distinct from those seen in the general population.

The traditional long plane ride was less common in this population, while factors such as injected drug use and pneumonia were more common. The VTE events occurred at a median age of 49 years; 30% of the patients had a detectable viral load. “We’re seeing a little more (VTE) than you might expect, and in a younger population than you might have guessed,” said Dr. Crane in an interview.

The most frequent predisposing risk factors were recent hospitalization (40%), infection (40%), or immobilization/bed rest (24%) within the past 90 days, and injectable drug use (22%). “It’s not just the traditional risk factors. Some HIV-specific risk factors are driving this,” said Dr. Crane.

She also aims to learn more about the specifics of risk factors, such as catheter-associated thromboses. The team is working to increase the sample size in order to parse out the relationships with specific outcomes.

In the meantime, the data further characterize the health challenges facing people living with HIV. “This is another example demonstrating that comorbid conditions among patients with HIV that are often considered age related occur at much younger ages in our population,” said Dr. Crane.

SOURCE: Rokx C et al. CROI 2019, Abstract 636; and Tenforde MW et al. CROI 2019, Abstract 637.

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Flu activity levels down, but outpatient visits highest since 1998-99

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Thu, 03/28/2019 - 14:29

 

Influenza activity measures declined for a third consecutive week, but levels are higher than usual at this point in the flu season, according to the Centers for Disease Control and Prevention.

For the week ending March 9, an estimated 4.5% of outpatient visits were for influenza-like illness (ILI), which was down from 4.6% the previous week, the CDC’s influenza division reported March 15, but that is higher than the comparable week for any year since 1998-1999. During last year’s very severe flu season, the outpatient visit rate was just under 3.2% for the week ending March 10.


Although the number of states at level 10 on the CDC’s 1-10 scale remained at 21, the activity map actually looks more red than last week since Rhode Island and West Virgina were replaced by the much larger states of Iowa and Washington. The number of states in the high range (8-10), did go down from 32 to 30, data from the CDC’s Outpatient ILI Surveillance Network show.

ILI-related deaths among children were down considerably, with four reported during the week ending March 9, compared with nine the week before. Of those four deaths, only one occurred during the most recent reporting week, the CDC said.

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Influenza activity measures declined for a third consecutive week, but levels are higher than usual at this point in the flu season, according to the Centers for Disease Control and Prevention.

For the week ending March 9, an estimated 4.5% of outpatient visits were for influenza-like illness (ILI), which was down from 4.6% the previous week, the CDC’s influenza division reported March 15, but that is higher than the comparable week for any year since 1998-1999. During last year’s very severe flu season, the outpatient visit rate was just under 3.2% for the week ending March 10.


Although the number of states at level 10 on the CDC’s 1-10 scale remained at 21, the activity map actually looks more red than last week since Rhode Island and West Virgina were replaced by the much larger states of Iowa and Washington. The number of states in the high range (8-10), did go down from 32 to 30, data from the CDC’s Outpatient ILI Surveillance Network show.

ILI-related deaths among children were down considerably, with four reported during the week ending March 9, compared with nine the week before. Of those four deaths, only one occurred during the most recent reporting week, the CDC said.

 

Influenza activity measures declined for a third consecutive week, but levels are higher than usual at this point in the flu season, according to the Centers for Disease Control and Prevention.

For the week ending March 9, an estimated 4.5% of outpatient visits were for influenza-like illness (ILI), which was down from 4.6% the previous week, the CDC’s influenza division reported March 15, but that is higher than the comparable week for any year since 1998-1999. During last year’s very severe flu season, the outpatient visit rate was just under 3.2% for the week ending March 10.


Although the number of states at level 10 on the CDC’s 1-10 scale remained at 21, the activity map actually looks more red than last week since Rhode Island and West Virgina were replaced by the much larger states of Iowa and Washington. The number of states in the high range (8-10), did go down from 32 to 30, data from the CDC’s Outpatient ILI Surveillance Network show.

ILI-related deaths among children were down considerably, with four reported during the week ending March 9, compared with nine the week before. Of those four deaths, only one occurred during the most recent reporting week, the CDC said.

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Very early ART may benefit infants with HIV

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Thu, 03/28/2019 - 11:11

 

– Antiretroviral therapy (ART) in the earliest weeks of life is associated with reduced time to suppression, according to a new study. Each week that treatment was delayed, patients had a 35% reduction in odds of achieving earlier viral load (VL) suppression.

damircudic/E+

Previous research had already shown that patients treated in the first year of life have better outcomes, including shortened time to viral suppression, and a lower reservoir size. Those studies looked at median age of ART start by month, and a review of the literature revealed that no research had been done on the first month.

The research was presented at the Conference on Retroviruses & Opportunistic Infections by Sara Domínguez Rodríguez, biostatistician and data manager in the pediatric infectious disease service at Hospital 12 Octubre, Madrid.

The researchers retrospectively analyzed 44 patients who were treated in the first 28 days of life, who had uninterrupted ART for at least 2 years, and who had VL measured at least twice during follow-up. Among these, 25 patients received ART in the first week, 19 in weeks 2-4. Patients treated prophylactically with AZT + 3TC (lamivudine) + NVP (nevirapine) any time in the first 15 days of life were considered treated at day 1.

Five of the patients were from the United Kingdom, 23 from Spain, 3 from Italy, and 13 from Thailand. Fifty-seven percent were girls; 35% were preterm. Patients treated in the first week had a higher log10 HIV viral load at ART initiation (P = .02). There was no significant difference between the two groups with respect to CD4 count at ART initiation.

The time to suppression was not significantly different between the two groups, nor was the percentage of patients suppressed at various time points. Patients treated in the first week had reached suppression more often at 3 months and 6 months, but neither result reached statistical significance.

The small sample size of the study produced a challenge, and that led the team to consider suppression time and age as continuous variables. That revealed a curve that favored treatment in the first week of life: Each week of delay reduced the probability of achieving early viral suppression by 35% (hazard ratio, 0.65; 95% confidence interval, 0.46-0.92). “This means that if you delay the age at ART in terms of weeks, the probability of achieving suppression (over) time decreases, and this effect is particularly seen in the first year of follow-up,” Dr. Domínguez Rodríguez said in an interview.

Some might have concerns that treating children too early could have adverse effects. This study, though small, showed promising results. “You might think if you treat very early, maybe the child will not tolerate the medicine or keep on with the treatment, and we saw no difference. So that supports treating early,” senior author Pablo Rojo Conejo, PhD, an infectious disease specialist at Hospital 12 de Octubre, said in an interview.

Others in attendance found the results encouraging. “It’s very good news to see that early starting impacts the life of these children,” Filipe de Barros Perini, MD, head of care and treatment of the HIV program at the Brazilian Ministry of Health, said in an interview.

SOURCE: Domínguez Rodríguez S et al. CROI 2019, Abstract 44.

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– Antiretroviral therapy (ART) in the earliest weeks of life is associated with reduced time to suppression, according to a new study. Each week that treatment was delayed, patients had a 35% reduction in odds of achieving earlier viral load (VL) suppression.

damircudic/E+

Previous research had already shown that patients treated in the first year of life have better outcomes, including shortened time to viral suppression, and a lower reservoir size. Those studies looked at median age of ART start by month, and a review of the literature revealed that no research had been done on the first month.

The research was presented at the Conference on Retroviruses & Opportunistic Infections by Sara Domínguez Rodríguez, biostatistician and data manager in the pediatric infectious disease service at Hospital 12 Octubre, Madrid.

The researchers retrospectively analyzed 44 patients who were treated in the first 28 days of life, who had uninterrupted ART for at least 2 years, and who had VL measured at least twice during follow-up. Among these, 25 patients received ART in the first week, 19 in weeks 2-4. Patients treated prophylactically with AZT + 3TC (lamivudine) + NVP (nevirapine) any time in the first 15 days of life were considered treated at day 1.

Five of the patients were from the United Kingdom, 23 from Spain, 3 from Italy, and 13 from Thailand. Fifty-seven percent were girls; 35% were preterm. Patients treated in the first week had a higher log10 HIV viral load at ART initiation (P = .02). There was no significant difference between the two groups with respect to CD4 count at ART initiation.

The time to suppression was not significantly different between the two groups, nor was the percentage of patients suppressed at various time points. Patients treated in the first week had reached suppression more often at 3 months and 6 months, but neither result reached statistical significance.

The small sample size of the study produced a challenge, and that led the team to consider suppression time and age as continuous variables. That revealed a curve that favored treatment in the first week of life: Each week of delay reduced the probability of achieving early viral suppression by 35% (hazard ratio, 0.65; 95% confidence interval, 0.46-0.92). “This means that if you delay the age at ART in terms of weeks, the probability of achieving suppression (over) time decreases, and this effect is particularly seen in the first year of follow-up,” Dr. Domínguez Rodríguez said in an interview.

Some might have concerns that treating children too early could have adverse effects. This study, though small, showed promising results. “You might think if you treat very early, maybe the child will not tolerate the medicine or keep on with the treatment, and we saw no difference. So that supports treating early,” senior author Pablo Rojo Conejo, PhD, an infectious disease specialist at Hospital 12 de Octubre, said in an interview.

Others in attendance found the results encouraging. “It’s very good news to see that early starting impacts the life of these children,” Filipe de Barros Perini, MD, head of care and treatment of the HIV program at the Brazilian Ministry of Health, said in an interview.

SOURCE: Domínguez Rodríguez S et al. CROI 2019, Abstract 44.

 

– Antiretroviral therapy (ART) in the earliest weeks of life is associated with reduced time to suppression, according to a new study. Each week that treatment was delayed, patients had a 35% reduction in odds of achieving earlier viral load (VL) suppression.

damircudic/E+

Previous research had already shown that patients treated in the first year of life have better outcomes, including shortened time to viral suppression, and a lower reservoir size. Those studies looked at median age of ART start by month, and a review of the literature revealed that no research had been done on the first month.

The research was presented at the Conference on Retroviruses & Opportunistic Infections by Sara Domínguez Rodríguez, biostatistician and data manager in the pediatric infectious disease service at Hospital 12 Octubre, Madrid.

The researchers retrospectively analyzed 44 patients who were treated in the first 28 days of life, who had uninterrupted ART for at least 2 years, and who had VL measured at least twice during follow-up. Among these, 25 patients received ART in the first week, 19 in weeks 2-4. Patients treated prophylactically with AZT + 3TC (lamivudine) + NVP (nevirapine) any time in the first 15 days of life were considered treated at day 1.

Five of the patients were from the United Kingdom, 23 from Spain, 3 from Italy, and 13 from Thailand. Fifty-seven percent were girls; 35% were preterm. Patients treated in the first week had a higher log10 HIV viral load at ART initiation (P = .02). There was no significant difference between the two groups with respect to CD4 count at ART initiation.

The time to suppression was not significantly different between the two groups, nor was the percentage of patients suppressed at various time points. Patients treated in the first week had reached suppression more often at 3 months and 6 months, but neither result reached statistical significance.

The small sample size of the study produced a challenge, and that led the team to consider suppression time and age as continuous variables. That revealed a curve that favored treatment in the first week of life: Each week of delay reduced the probability of achieving early viral suppression by 35% (hazard ratio, 0.65; 95% confidence interval, 0.46-0.92). “This means that if you delay the age at ART in terms of weeks, the probability of achieving suppression (over) time decreases, and this effect is particularly seen in the first year of follow-up,” Dr. Domínguez Rodríguez said in an interview.

Some might have concerns that treating children too early could have adverse effects. This study, though small, showed promising results. “You might think if you treat very early, maybe the child will not tolerate the medicine or keep on with the treatment, and we saw no difference. So that supports treating early,” senior author Pablo Rojo Conejo, PhD, an infectious disease specialist at Hospital 12 de Octubre, said in an interview.

Others in attendance found the results encouraging. “It’s very good news to see that early starting impacts the life of these children,” Filipe de Barros Perini, MD, head of care and treatment of the HIV program at the Brazilian Ministry of Health, said in an interview.

SOURCE: Domínguez Rodríguez S et al. CROI 2019, Abstract 44.

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For now, HIV cure is worse than infection

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Fri, 03/15/2019 - 10:20

 

– The most important thing to know about the apparent HIV cure widely reported in the press recently is that the treatment was worse than the infection, according to John Mellors, MD, chief of the division of infectious diseases at the University of Pittsburgh.

M. Alexander Otto/MDedge News
Dr. John Mellors

Dr. Mellors moderated a presentation at the Conference on Retroviruses and Opportunistic Infections about what the cure involved.

An HIV-positive man with advanced Hodgkin’s lymphoma had an allogeneic bone marrow transplant in 2016 after failing first-line chemotherapy and multiple salvage regimens. His donor was homozygous for a gene mutation that prevents HIV from entering new cells. The transplant took; the man’s hematopoietic system was replaced by one with the anti-HIV mutation; and there’s been no trace of active virus in his system since. He’s been off of antiretrovirals for a year and a half. The cancer hasn’t returned.

He’s been dubbed the “London patient.” He joins the “Berlin patient” as the second person who appears to have been freed of infection following a stem cell transplant with the anti-HIV mutation. The Berlin patient recently identified himself as Timothy Ray Brown; he was in the audience at CROI and was applauded for coming forward and sharing his story.

Mr. Brown received a transplant for acute myeloid leukemia and has been off antiretrovirals now for about a decade with no evidence of viral rebound.

M. Alexander Otto/MDedge News
Dr. Ravindra Gupta

Although it didn’t get much attention at CROI, there was a poster of a similar approach seeming to work in a third patient, also with leukemia. It’s been tried – but failed – in two others: one patient died of their lymphoma and the transplant failed in the other, said lead investigator on the London patient case, Ravindra Gupta, MD, a professor in the division of infection & immunity at University College London.

Dr. Mellors pointed out that “the two people who have been cured had lethal malignancies that were unresponsive to conventional therapy and had the extreme measure of an allogeneic bone marrow transplant. Allogeneic bone marrow transplant is not a walk in the park. It has a mortality of 10%-25%, which is completely unacceptable” when “patients feel great on one pill a day” for HIV remission and pretty much have a normal life span.

The transplant reactivated both cytomegalovirus and Epstein Barr virus in the London patient, and he developed graft-versus-host colitis. He survived all three complications.

The take-home message is that “these cases are inspirational. The work ahead is to find out how to deliver the same results with less-extreme measures,” Dr. Mellors said.

The donors for both the London and Berlin patients were homozygous for a delta 32 deletion in the receptor most commonly used by HIV-1 to enter host cells, CCR5. Cells that carry the mutation don’t express the receptor, preventing infection. The mutation prevalence is about 1% among Europeans.

Of the two failed cases, the person who died of lymphoma had a strain of HIV-1 that used a different receptor – CXCR4 – so it’s doubtful the transplant would have worked even if he had survived his cancer.

The London patient wasn’t what’s called an “elite controller,” one of those rare people who suppress HIV without antiretrovirals. His viral loads bounced right back when we was taken off them prior to transplant.

He’s not interested in an active sex life at the moment, Dr. Gupta said, but he might be soon, so Dr. Gupta plans a discussion with him in the near future. Although the London patient could well be immune to HIV that uses the CCR5 receptor, he might not be immune to CXCR4 virus, and he might still be able to produce infectious CCR5 particles. Time will tell.

There was no industry funding for the work. Dr. Gupta is a consultant for ViiV Healthcare and a speaker for Gilead.

SOURCE: Gupta RK et al. CROI 2019, Abstract 29.

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– The most important thing to know about the apparent HIV cure widely reported in the press recently is that the treatment was worse than the infection, according to John Mellors, MD, chief of the division of infectious diseases at the University of Pittsburgh.

M. Alexander Otto/MDedge News
Dr. John Mellors

Dr. Mellors moderated a presentation at the Conference on Retroviruses and Opportunistic Infections about what the cure involved.

An HIV-positive man with advanced Hodgkin’s lymphoma had an allogeneic bone marrow transplant in 2016 after failing first-line chemotherapy and multiple salvage regimens. His donor was homozygous for a gene mutation that prevents HIV from entering new cells. The transplant took; the man’s hematopoietic system was replaced by one with the anti-HIV mutation; and there’s been no trace of active virus in his system since. He’s been off of antiretrovirals for a year and a half. The cancer hasn’t returned.

He’s been dubbed the “London patient.” He joins the “Berlin patient” as the second person who appears to have been freed of infection following a stem cell transplant with the anti-HIV mutation. The Berlin patient recently identified himself as Timothy Ray Brown; he was in the audience at CROI and was applauded for coming forward and sharing his story.

Mr. Brown received a transplant for acute myeloid leukemia and has been off antiretrovirals now for about a decade with no evidence of viral rebound.

M. Alexander Otto/MDedge News
Dr. Ravindra Gupta

Although it didn’t get much attention at CROI, there was a poster of a similar approach seeming to work in a third patient, also with leukemia. It’s been tried – but failed – in two others: one patient died of their lymphoma and the transplant failed in the other, said lead investigator on the London patient case, Ravindra Gupta, MD, a professor in the division of infection & immunity at University College London.

Dr. Mellors pointed out that “the two people who have been cured had lethal malignancies that were unresponsive to conventional therapy and had the extreme measure of an allogeneic bone marrow transplant. Allogeneic bone marrow transplant is not a walk in the park. It has a mortality of 10%-25%, which is completely unacceptable” when “patients feel great on one pill a day” for HIV remission and pretty much have a normal life span.

The transplant reactivated both cytomegalovirus and Epstein Barr virus in the London patient, and he developed graft-versus-host colitis. He survived all three complications.

The take-home message is that “these cases are inspirational. The work ahead is to find out how to deliver the same results with less-extreme measures,” Dr. Mellors said.

The donors for both the London and Berlin patients were homozygous for a delta 32 deletion in the receptor most commonly used by HIV-1 to enter host cells, CCR5. Cells that carry the mutation don’t express the receptor, preventing infection. The mutation prevalence is about 1% among Europeans.

Of the two failed cases, the person who died of lymphoma had a strain of HIV-1 that used a different receptor – CXCR4 – so it’s doubtful the transplant would have worked even if he had survived his cancer.

The London patient wasn’t what’s called an “elite controller,” one of those rare people who suppress HIV without antiretrovirals. His viral loads bounced right back when we was taken off them prior to transplant.

He’s not interested in an active sex life at the moment, Dr. Gupta said, but he might be soon, so Dr. Gupta plans a discussion with him in the near future. Although the London patient could well be immune to HIV that uses the CCR5 receptor, he might not be immune to CXCR4 virus, and he might still be able to produce infectious CCR5 particles. Time will tell.

There was no industry funding for the work. Dr. Gupta is a consultant for ViiV Healthcare and a speaker for Gilead.

SOURCE: Gupta RK et al. CROI 2019, Abstract 29.

 

– The most important thing to know about the apparent HIV cure widely reported in the press recently is that the treatment was worse than the infection, according to John Mellors, MD, chief of the division of infectious diseases at the University of Pittsburgh.

M. Alexander Otto/MDedge News
Dr. John Mellors

Dr. Mellors moderated a presentation at the Conference on Retroviruses and Opportunistic Infections about what the cure involved.

An HIV-positive man with advanced Hodgkin’s lymphoma had an allogeneic bone marrow transplant in 2016 after failing first-line chemotherapy and multiple salvage regimens. His donor was homozygous for a gene mutation that prevents HIV from entering new cells. The transplant took; the man’s hematopoietic system was replaced by one with the anti-HIV mutation; and there’s been no trace of active virus in his system since. He’s been off of antiretrovirals for a year and a half. The cancer hasn’t returned.

He’s been dubbed the “London patient.” He joins the “Berlin patient” as the second person who appears to have been freed of infection following a stem cell transplant with the anti-HIV mutation. The Berlin patient recently identified himself as Timothy Ray Brown; he was in the audience at CROI and was applauded for coming forward and sharing his story.

Mr. Brown received a transplant for acute myeloid leukemia and has been off antiretrovirals now for about a decade with no evidence of viral rebound.

M. Alexander Otto/MDedge News
Dr. Ravindra Gupta

Although it didn’t get much attention at CROI, there was a poster of a similar approach seeming to work in a third patient, also with leukemia. It’s been tried – but failed – in two others: one patient died of their lymphoma and the transplant failed in the other, said lead investigator on the London patient case, Ravindra Gupta, MD, a professor in the division of infection & immunity at University College London.

Dr. Mellors pointed out that “the two people who have been cured had lethal malignancies that were unresponsive to conventional therapy and had the extreme measure of an allogeneic bone marrow transplant. Allogeneic bone marrow transplant is not a walk in the park. It has a mortality of 10%-25%, which is completely unacceptable” when “patients feel great on one pill a day” for HIV remission and pretty much have a normal life span.

The transplant reactivated both cytomegalovirus and Epstein Barr virus in the London patient, and he developed graft-versus-host colitis. He survived all three complications.

The take-home message is that “these cases are inspirational. The work ahead is to find out how to deliver the same results with less-extreme measures,” Dr. Mellors said.

The donors for both the London and Berlin patients were homozygous for a delta 32 deletion in the receptor most commonly used by HIV-1 to enter host cells, CCR5. Cells that carry the mutation don’t express the receptor, preventing infection. The mutation prevalence is about 1% among Europeans.

Of the two failed cases, the person who died of lymphoma had a strain of HIV-1 that used a different receptor – CXCR4 – so it’s doubtful the transplant would have worked even if he had survived his cancer.

The London patient wasn’t what’s called an “elite controller,” one of those rare people who suppress HIV without antiretrovirals. His viral loads bounced right back when we was taken off them prior to transplant.

He’s not interested in an active sex life at the moment, Dr. Gupta said, but he might be soon, so Dr. Gupta plans a discussion with him in the near future. Although the London patient could well be immune to HIV that uses the CCR5 receptor, he might not be immune to CXCR4 virus, and he might still be able to produce infectious CCR5 particles. Time will tell.

There was no industry funding for the work. Dr. Gupta is a consultant for ViiV Healthcare and a speaker for Gilead.

SOURCE: Gupta RK et al. CROI 2019, Abstract 29.

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New cantharidin formulation alleviates molluscum contagiosum in pivotal trials

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Thu, 03/14/2019 - 13:58

A novel, standardized preparation of topical cantharidin effectively cleared lesions in patients with molluscum contagiosum, compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.

VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.

No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.

VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.

To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.

The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.


In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.

At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.

The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.

Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.

SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.

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A novel, standardized preparation of topical cantharidin effectively cleared lesions in patients with molluscum contagiosum, compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.

VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.

No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.

VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.

To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.

The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.


In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.

At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.

The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.

Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.

SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.

A novel, standardized preparation of topical cantharidin effectively cleared lesions in patients with molluscum contagiosum, compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.

VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.

No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.

VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.

To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.

The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.


In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.

At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.

The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.

Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.

SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.

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Key clinical point: VP-102 is an effective treatment for molluscum contagiosum.

Major finding: In two studies, 46% and 54% of actively treated patients had complete resolution, compared with 13% and 18% of controls, respectively.

Study details: Two phase 3, randomized, double-blind, placebo-controlled trials of 528 patients with molluscum contagiosum.

Disclosures: Verrica Pharmaceuticals sponsored the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica Pharmaceuticals.Source: Eichenfield L et al. AAD 19, Abstract 11251.

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Hospital-onset sepsis twice as lethal as community-onset disease

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Tue, 03/19/2019 - 08:52

 

– Patients who develop sepsis in the hospital appear to be in greater risk for mortality than those who bring it with them, a new study suggests. Patients with hospital-onset sepsis were twice as likely to die as those infected in the outside world.

MDedge News/Randy Dotinga
Dr. Chanu Rhee

“There could be some differences in quality of care that explains the difference in mortality,” said study lead author Chanu Rhee, MD, assistant professor of population medicine at Harvard Medical School, Boston, in a presentation about the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

In an interview, Dr. Rhee said researchers launched the study to gain a greater understanding of the epidemiology of sepsis in the hospital. They relied on a new Centers for Disease Control and Prevention definition of sepsis that is “enhancing the consistency of surveillance across hospitals and allowing more precise differentiation between hospital-onset versus community-onset sepsis.”

The study authors retrospectively tracked more than 2.2 million patients who were treated at 136 U.S. hospitals from 2009 to 2015. In general, hospital-onset sepsis was defined as patients who had a blood culture, initial antibiotic therapy, and organ dysfunction on their third day in the hospital or later.*

Of the patients, 83,600 had community-onset sepsis and 11,500 had hospital-onset sepsis. Those with sepsis were more likely to be men and have comorbidities such as cancer, congestive heart failure, diabetes, and renal disease.

Patients with hospital-onset sepsis had longer median lengths of stay (19 days) than the community-onset group (8 days) and the no-sepsis group (4 days). The hospital-onset group also had a greater likelihood of ICU admission (61%) than the community-onset (44%) and no-sepsis (9%) groups.

About 34% of those with hospital-onset sepsis died, compared with 17% of the community-onset group and 2% of the patients who didn’t have sepsis. After adjustment, those with hospital-onset sepsis were still more likely to have died (odds ratio, 2.1; 95% confidence interval, 2.0-2.2).

“Other studies have suggested that there may be delays in the recognition and care of patients who develop sepsis in the hospital as opposed to presenting to the hospital with sepsis,” Dr. Rhee said. “It is also possible that hospital-onset sepsis tends to be caused by organisms that are more virulent and resistant to antibiotics.”

Overall, he said, “our findings underscore the importance of targeting hospital-onset sepsis with surveillance, prevention, and quality improvement efforts.”

The study was funded by the CDC and the Agency for Healthcare Research and Quality. The authors reported no relevant disclosures.

SOURCE: Rhee C et al. CCC48, Abstract 29.

*Correction, 3/19/19: An earlier version of this article misstated the definition of sepsis.

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– Patients who develop sepsis in the hospital appear to be in greater risk for mortality than those who bring it with them, a new study suggests. Patients with hospital-onset sepsis were twice as likely to die as those infected in the outside world.

MDedge News/Randy Dotinga
Dr. Chanu Rhee

“There could be some differences in quality of care that explains the difference in mortality,” said study lead author Chanu Rhee, MD, assistant professor of population medicine at Harvard Medical School, Boston, in a presentation about the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

In an interview, Dr. Rhee said researchers launched the study to gain a greater understanding of the epidemiology of sepsis in the hospital. They relied on a new Centers for Disease Control and Prevention definition of sepsis that is “enhancing the consistency of surveillance across hospitals and allowing more precise differentiation between hospital-onset versus community-onset sepsis.”

The study authors retrospectively tracked more than 2.2 million patients who were treated at 136 U.S. hospitals from 2009 to 2015. In general, hospital-onset sepsis was defined as patients who had a blood culture, initial antibiotic therapy, and organ dysfunction on their third day in the hospital or later.*

Of the patients, 83,600 had community-onset sepsis and 11,500 had hospital-onset sepsis. Those with sepsis were more likely to be men and have comorbidities such as cancer, congestive heart failure, diabetes, and renal disease.

Patients with hospital-onset sepsis had longer median lengths of stay (19 days) than the community-onset group (8 days) and the no-sepsis group (4 days). The hospital-onset group also had a greater likelihood of ICU admission (61%) than the community-onset (44%) and no-sepsis (9%) groups.

About 34% of those with hospital-onset sepsis died, compared with 17% of the community-onset group and 2% of the patients who didn’t have sepsis. After adjustment, those with hospital-onset sepsis were still more likely to have died (odds ratio, 2.1; 95% confidence interval, 2.0-2.2).

“Other studies have suggested that there may be delays in the recognition and care of patients who develop sepsis in the hospital as opposed to presenting to the hospital with sepsis,” Dr. Rhee said. “It is also possible that hospital-onset sepsis tends to be caused by organisms that are more virulent and resistant to antibiotics.”

Overall, he said, “our findings underscore the importance of targeting hospital-onset sepsis with surveillance, prevention, and quality improvement efforts.”

The study was funded by the CDC and the Agency for Healthcare Research and Quality. The authors reported no relevant disclosures.

SOURCE: Rhee C et al. CCC48, Abstract 29.

*Correction, 3/19/19: An earlier version of this article misstated the definition of sepsis.

 

– Patients who develop sepsis in the hospital appear to be in greater risk for mortality than those who bring it with them, a new study suggests. Patients with hospital-onset sepsis were twice as likely to die as those infected in the outside world.

MDedge News/Randy Dotinga
Dr. Chanu Rhee

“There could be some differences in quality of care that explains the difference in mortality,” said study lead author Chanu Rhee, MD, assistant professor of population medicine at Harvard Medical School, Boston, in a presentation about the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

In an interview, Dr. Rhee said researchers launched the study to gain a greater understanding of the epidemiology of sepsis in the hospital. They relied on a new Centers for Disease Control and Prevention definition of sepsis that is “enhancing the consistency of surveillance across hospitals and allowing more precise differentiation between hospital-onset versus community-onset sepsis.”

The study authors retrospectively tracked more than 2.2 million patients who were treated at 136 U.S. hospitals from 2009 to 2015. In general, hospital-onset sepsis was defined as patients who had a blood culture, initial antibiotic therapy, and organ dysfunction on their third day in the hospital or later.*

Of the patients, 83,600 had community-onset sepsis and 11,500 had hospital-onset sepsis. Those with sepsis were more likely to be men and have comorbidities such as cancer, congestive heart failure, diabetes, and renal disease.

Patients with hospital-onset sepsis had longer median lengths of stay (19 days) than the community-onset group (8 days) and the no-sepsis group (4 days). The hospital-onset group also had a greater likelihood of ICU admission (61%) than the community-onset (44%) and no-sepsis (9%) groups.

About 34% of those with hospital-onset sepsis died, compared with 17% of the community-onset group and 2% of the patients who didn’t have sepsis. After adjustment, those with hospital-onset sepsis were still more likely to have died (odds ratio, 2.1; 95% confidence interval, 2.0-2.2).

“Other studies have suggested that there may be delays in the recognition and care of patients who develop sepsis in the hospital as opposed to presenting to the hospital with sepsis,” Dr. Rhee said. “It is also possible that hospital-onset sepsis tends to be caused by organisms that are more virulent and resistant to antibiotics.”

Overall, he said, “our findings underscore the importance of targeting hospital-onset sepsis with surveillance, prevention, and quality improvement efforts.”

The study was funded by the CDC and the Agency for Healthcare Research and Quality. The authors reported no relevant disclosures.

SOURCE: Rhee C et al. CCC48, Abstract 29.

*Correction, 3/19/19: An earlier version of this article misstated the definition of sepsis.

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ICYMI: Noninferior tuberculosis prevention in HIV has shorter duration

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Thu, 03/14/2019 - 11:33

The primary endpoint – first case of tuberculosis or death from tuberculosis or unknown cause among patients with HIV – was reported in 2% of both arms in the open-label, phase 3, noninferiority trial BRIEF TB (NCT01404312).

iLexx/Thinkstock

In the New England Journal of Medicine (2019 Mar 14;380[11]:1001-11), 3,000 patients with HIV were randomized to receive either 1 month of rifapentine/isoniazid or 9 months of isoniazid monotherapy for prevention of tuberculosis. Although safety was also similar between arms, the completion rate was significantly higher in the combination treatment arm, compared with the monotherapy arm (97% vs. 90%; P less than .001).

We covered this story at the annual Conference on Retroviruses & Opportunistic Infections. See our coverage at the link below.

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The primary endpoint – first case of tuberculosis or death from tuberculosis or unknown cause among patients with HIV – was reported in 2% of both arms in the open-label, phase 3, noninferiority trial BRIEF TB (NCT01404312).

iLexx/Thinkstock

In the New England Journal of Medicine (2019 Mar 14;380[11]:1001-11), 3,000 patients with HIV were randomized to receive either 1 month of rifapentine/isoniazid or 9 months of isoniazid monotherapy for prevention of tuberculosis. Although safety was also similar between arms, the completion rate was significantly higher in the combination treatment arm, compared with the monotherapy arm (97% vs. 90%; P less than .001).

We covered this story at the annual Conference on Retroviruses & Opportunistic Infections. See our coverage at the link below.

The primary endpoint – first case of tuberculosis or death from tuberculosis or unknown cause among patients with HIV – was reported in 2% of both arms in the open-label, phase 3, noninferiority trial BRIEF TB (NCT01404312).

iLexx/Thinkstock

In the New England Journal of Medicine (2019 Mar 14;380[11]:1001-11), 3,000 patients with HIV were randomized to receive either 1 month of rifapentine/isoniazid or 9 months of isoniazid monotherapy for prevention of tuberculosis. Although safety was also similar between arms, the completion rate was significantly higher in the combination treatment arm, compared with the monotherapy arm (97% vs. 90%; P less than .001).

We covered this story at the annual Conference on Retroviruses & Opportunistic Infections. See our coverage at the link below.

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