Promising Results From Anti-HIV Combination Treatment

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Wed, 11/21/2018 - 05:39
Researchers theorize that combining multiple antibodies that target distinct regions of HIV would both suppress the virus and prevent resistance.

Reliable treatment with broadly neutralizing antibodies—bNAbs—could change the future for people living with HIV. But studies have found that infusions of a single bNAb did not suppress HIV because some patients developed resistance.

Rockefeller University researchers, however, theorized that combining multiple antibodies that target distinct regions of HIV would both suppress the virus and prevent resistance. So in an NIH-supported pilot study, researhcers recruited 15 volunteers whose HIV was suppressed with antiretroviral treatment (ART) and who were sensitive to 3BNC117 and 10-1074, both potent bNAbs.

Participants received infusions of both bNAbs, stopped taking ART 2 days later, and received additional infusions 3 and 6 weeks later.

Of the 11 people who completed the study, 9 maintained viral suppression without ART for an average of 15 weeks, until the amount of bNAbs in their bodies fell below protective levels. In 2 of the 9, virus was controlled through the end of the 30-week follow-up period. The remaining 2 participants were found to harbor HIV resistant to at least 1 bNAb and experienced viral rebound before 12 weeks after stopping ART.

The researchers are enrolling people with HIV in a larger study to determine an optimal regimen of bNAbs.

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Researchers theorize that combining multiple antibodies that target distinct regions of HIV would both suppress the virus and prevent resistance.
Researchers theorize that combining multiple antibodies that target distinct regions of HIV would both suppress the virus and prevent resistance.

Reliable treatment with broadly neutralizing antibodies—bNAbs—could change the future for people living with HIV. But studies have found that infusions of a single bNAb did not suppress HIV because some patients developed resistance.

Rockefeller University researchers, however, theorized that combining multiple antibodies that target distinct regions of HIV would both suppress the virus and prevent resistance. So in an NIH-supported pilot study, researhcers recruited 15 volunteers whose HIV was suppressed with antiretroviral treatment (ART) and who were sensitive to 3BNC117 and 10-1074, both potent bNAbs.

Participants received infusions of both bNAbs, stopped taking ART 2 days later, and received additional infusions 3 and 6 weeks later.

Of the 11 people who completed the study, 9 maintained viral suppression without ART for an average of 15 weeks, until the amount of bNAbs in their bodies fell below protective levels. In 2 of the 9, virus was controlled through the end of the 30-week follow-up period. The remaining 2 participants were found to harbor HIV resistant to at least 1 bNAb and experienced viral rebound before 12 weeks after stopping ART.

The researchers are enrolling people with HIV in a larger study to determine an optimal regimen of bNAbs.

Reliable treatment with broadly neutralizing antibodies—bNAbs—could change the future for people living with HIV. But studies have found that infusions of a single bNAb did not suppress HIV because some patients developed resistance.

Rockefeller University researchers, however, theorized that combining multiple antibodies that target distinct regions of HIV would both suppress the virus and prevent resistance. So in an NIH-supported pilot study, researhcers recruited 15 volunteers whose HIV was suppressed with antiretroviral treatment (ART) and who were sensitive to 3BNC117 and 10-1074, both potent bNAbs.

Participants received infusions of both bNAbs, stopped taking ART 2 days later, and received additional infusions 3 and 6 weeks later.

Of the 11 people who completed the study, 9 maintained viral suppression without ART for an average of 15 weeks, until the amount of bNAbs in their bodies fell below protective levels. In 2 of the 9, virus was controlled through the end of the 30-week follow-up period. The remaining 2 participants were found to harbor HIV resistant to at least 1 bNAb and experienced viral rebound before 12 weeks after stopping ART.

The researchers are enrolling people with HIV in a larger study to determine an optimal regimen of bNAbs.

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Naloxone in the Workplace

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Mon, 11/19/2018 - 05:17
An increase of overdose deaths within the workplace calls to question the ethics of providing naloxone at work.

According to 2017 data from the CDC’s National Center for Health Statistics, on average 115 Americans die every day from an opioid overdose—and it is happening more often at work. Between 2013 and 2016, the Bureau of Labor Statistics finds overdose deaths at work from nonmedical use of drugs and alcohol increased by at least 38% annually.

Naloxone can be one of the first-aid tools of today’s workplace. To help employers decide whether to supply naloxone at work, NIOSH has released a new fact sheet that outlines questions to consider. Using Naloxone to Reverse Opioid Overdose in the Workplace: Information for Employers and Workers gives an overview of opioids and naloxone, a checklist to determine whether a naloxone program is appropriate, and information about how to implement and maintain a program.

The fact sheet is available at www.cdc.gov/niosh/docs/2019-101/.  

 

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An increase of overdose deaths within the workplace calls to question the ethics of providing naloxone at work.
An increase of overdose deaths within the workplace calls to question the ethics of providing naloxone at work.

According to 2017 data from the CDC’s National Center for Health Statistics, on average 115 Americans die every day from an opioid overdose—and it is happening more often at work. Between 2013 and 2016, the Bureau of Labor Statistics finds overdose deaths at work from nonmedical use of drugs and alcohol increased by at least 38% annually.

Naloxone can be one of the first-aid tools of today’s workplace. To help employers decide whether to supply naloxone at work, NIOSH has released a new fact sheet that outlines questions to consider. Using Naloxone to Reverse Opioid Overdose in the Workplace: Information for Employers and Workers gives an overview of opioids and naloxone, a checklist to determine whether a naloxone program is appropriate, and information about how to implement and maintain a program.

The fact sheet is available at www.cdc.gov/niosh/docs/2019-101/.  

 

According to 2017 data from the CDC’s National Center for Health Statistics, on average 115 Americans die every day from an opioid overdose—and it is happening more often at work. Between 2013 and 2016, the Bureau of Labor Statistics finds overdose deaths at work from nonmedical use of drugs and alcohol increased by at least 38% annually.

Naloxone can be one of the first-aid tools of today’s workplace. To help employers decide whether to supply naloxone at work, NIOSH has released a new fact sheet that outlines questions to consider. Using Naloxone to Reverse Opioid Overdose in the Workplace: Information for Employers and Workers gives an overview of opioids and naloxone, a checklist to determine whether a naloxone program is appropriate, and information about how to implement and maintain a program.

The fact sheet is available at www.cdc.gov/niosh/docs/2019-101/.  

 

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Congenital Syphilis Is on the Rise

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Fri, 11/16/2018 - 05:13
Recent CDC report shows an exponential increase of syphilis cases in pregnant women and suggests methods to reduce the rate of spread.

Diagnoses of primary and secondary syphilis, the most infectious stages of the disease, jumped 76% from 2013 to 2017. And reported cases of congenital syphilis—passed from mother to infant during pregnancy—rose 44% between 2016 and 2017, from 16 cases to 23 cases per 100,000 live births, according to the CDC’s annual Sexually Transmitted Disease Surveillance Report. Those data highlight the need for better prenatal care that includes syphilis testing at the first visit and follow-up testing for women at high risk of the infection, the CDC says. Syphilis can cause miscarriage, newborn death, and severe lifelong physical and mental health problems.

The 918 cases reported in 2017 represent the highest number of recorded cases in 20 years. Cases were reported in 37 states, primarily western and southern states. The report notes that the surge in cases parallels similar increases in syphilis among women of reproductive age and outpaces national increases in sexually transmitted dieseases (STDs) overall.

Syphilis during pregnancy is easily cured with the right antibiotics. Left untreated, a pregnant woman with syphilis has as much as an 80% chance of passing it to the baby.

Early testing, prompt treatment, and follow-up are key. Recent CDC research found that 1 in 3 women who gave birth to a baby with syphilis in 2016 had in fact been tested during pregnancy but either acquired syphilis after that test or was not treated in time to cure the infection in the fetus.

“Too many women are falling through the cracks of the system,” said Gail Bolan, MD, director of the CDC’s Division of STD Prevention. The CDC recommends that all pregnant women be treated for syphilis at the first prenatal visit. But for many women, 1 test may not be enough. Woman at high risk, or those who live in high-prevalence areas, should be tested again early in the third trimester and at delivery.

“To protect every baby,” Bolan says, “we have to start by protecting every mother.”

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Recent CDC report shows an exponential increase of syphilis cases in pregnant women and suggests methods to reduce the rate of spread.
Recent CDC report shows an exponential increase of syphilis cases in pregnant women and suggests methods to reduce the rate of spread.

Diagnoses of primary and secondary syphilis, the most infectious stages of the disease, jumped 76% from 2013 to 2017. And reported cases of congenital syphilis—passed from mother to infant during pregnancy—rose 44% between 2016 and 2017, from 16 cases to 23 cases per 100,000 live births, according to the CDC’s annual Sexually Transmitted Disease Surveillance Report. Those data highlight the need for better prenatal care that includes syphilis testing at the first visit and follow-up testing for women at high risk of the infection, the CDC says. Syphilis can cause miscarriage, newborn death, and severe lifelong physical and mental health problems.

The 918 cases reported in 2017 represent the highest number of recorded cases in 20 years. Cases were reported in 37 states, primarily western and southern states. The report notes that the surge in cases parallels similar increases in syphilis among women of reproductive age and outpaces national increases in sexually transmitted dieseases (STDs) overall.

Syphilis during pregnancy is easily cured with the right antibiotics. Left untreated, a pregnant woman with syphilis has as much as an 80% chance of passing it to the baby.

Early testing, prompt treatment, and follow-up are key. Recent CDC research found that 1 in 3 women who gave birth to a baby with syphilis in 2016 had in fact been tested during pregnancy but either acquired syphilis after that test or was not treated in time to cure the infection in the fetus.

“Too many women are falling through the cracks of the system,” said Gail Bolan, MD, director of the CDC’s Division of STD Prevention. The CDC recommends that all pregnant women be treated for syphilis at the first prenatal visit. But for many women, 1 test may not be enough. Woman at high risk, or those who live in high-prevalence areas, should be tested again early in the third trimester and at delivery.

“To protect every baby,” Bolan says, “we have to start by protecting every mother.”

Diagnoses of primary and secondary syphilis, the most infectious stages of the disease, jumped 76% from 2013 to 2017. And reported cases of congenital syphilis—passed from mother to infant during pregnancy—rose 44% between 2016 and 2017, from 16 cases to 23 cases per 100,000 live births, according to the CDC’s annual Sexually Transmitted Disease Surveillance Report. Those data highlight the need for better prenatal care that includes syphilis testing at the first visit and follow-up testing for women at high risk of the infection, the CDC says. Syphilis can cause miscarriage, newborn death, and severe lifelong physical and mental health problems.

The 918 cases reported in 2017 represent the highest number of recorded cases in 20 years. Cases were reported in 37 states, primarily western and southern states. The report notes that the surge in cases parallels similar increases in syphilis among women of reproductive age and outpaces national increases in sexually transmitted dieseases (STDs) overall.

Syphilis during pregnancy is easily cured with the right antibiotics. Left untreated, a pregnant woman with syphilis has as much as an 80% chance of passing it to the baby.

Early testing, prompt treatment, and follow-up are key. Recent CDC research found that 1 in 3 women who gave birth to a baby with syphilis in 2016 had in fact been tested during pregnancy but either acquired syphilis after that test or was not treated in time to cure the infection in the fetus.

“Too many women are falling through the cracks of the system,” said Gail Bolan, MD, director of the CDC’s Division of STD Prevention. The CDC recommends that all pregnant women be treated for syphilis at the first prenatal visit. But for many women, 1 test may not be enough. Woman at high risk, or those who live in high-prevalence areas, should be tested again early in the third trimester and at delivery.

“To protect every baby,” Bolan says, “we have to start by protecting every mother.”

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Are Doctors Willing to PrEP Young Patients?

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A survey of health care providers found a willingness to prescribe pre-exposure prophylaxis for HIV, but concerns over adherence.

In 2015, young people aged 13 to 24 years—disproportionately young men and boys—accounted for 23% of new HIV infections. Pre-exposure prophylaxis (PrEP) can prevent HIV, and has been found safe and effective for young people, but are health care providers who treat adolescents willing to prescribe it?

Researchers from University of California, San Francisco say internal medicine and infectious disease providers have expressed concerns about adherence, development of resistant HIV strains, higher risk sexual behavior, cost, toxicity, and lack of evidence. Data are lacking, though, among youth providers. To find out how aware those clinicians are about PrEP, and how willing they are to prescribe it, the researchers conducted an online survey of members of the Society of Adolescent Health and Medicine.

Almost all of the 162 respondents had heard of PrEP, and agreed that it prevents HIV. Of the respondents, 57 (35%) had prescribed PrEP. Although 73% said they had treated few to no young patients with HIV, 65% were willing to prescribe PrEP to adolescents (aged 13-17 years) and young adults. Only 30 providers said they would refer adolescents and 25 would refer young adults.

Among the providers who would refer or were not willing to prescribe to adolescents, 35 (67%) would prescribe PrEP if it were FDA-approved for adolescents.

Willingness to prescribe was associated with the provider having enough knowledge to safely provide PrEP to adolescents and a belief that adolescents would adhere to a daily medication regimen. Some also said they would prefer to know that they could ensure confidentiality.

The researchers say their findings highlight potential opportunities to reduce HIV incidence among young people by shaping educational and implementation tools to improve provider self-efficacy and youth adherence. 

 

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A survey of health care providers found a willingness to prescribe pre-exposure prophylaxis for HIV, but concerns over adherence.
A survey of health care providers found a willingness to prescribe pre-exposure prophylaxis for HIV, but concerns over adherence.

In 2015, young people aged 13 to 24 years—disproportionately young men and boys—accounted for 23% of new HIV infections. Pre-exposure prophylaxis (PrEP) can prevent HIV, and has been found safe and effective for young people, but are health care providers who treat adolescents willing to prescribe it?

Researchers from University of California, San Francisco say internal medicine and infectious disease providers have expressed concerns about adherence, development of resistant HIV strains, higher risk sexual behavior, cost, toxicity, and lack of evidence. Data are lacking, though, among youth providers. To find out how aware those clinicians are about PrEP, and how willing they are to prescribe it, the researchers conducted an online survey of members of the Society of Adolescent Health and Medicine.

Almost all of the 162 respondents had heard of PrEP, and agreed that it prevents HIV. Of the respondents, 57 (35%) had prescribed PrEP. Although 73% said they had treated few to no young patients with HIV, 65% were willing to prescribe PrEP to adolescents (aged 13-17 years) and young adults. Only 30 providers said they would refer adolescents and 25 would refer young adults.

Among the providers who would refer or were not willing to prescribe to adolescents, 35 (67%) would prescribe PrEP if it were FDA-approved for adolescents.

Willingness to prescribe was associated with the provider having enough knowledge to safely provide PrEP to adolescents and a belief that adolescents would adhere to a daily medication regimen. Some also said they would prefer to know that they could ensure confidentiality.

The researchers say their findings highlight potential opportunities to reduce HIV incidence among young people by shaping educational and implementation tools to improve provider self-efficacy and youth adherence. 

 

In 2015, young people aged 13 to 24 years—disproportionately young men and boys—accounted for 23% of new HIV infections. Pre-exposure prophylaxis (PrEP) can prevent HIV, and has been found safe and effective for young people, but are health care providers who treat adolescents willing to prescribe it?

Researchers from University of California, San Francisco say internal medicine and infectious disease providers have expressed concerns about adherence, development of resistant HIV strains, higher risk sexual behavior, cost, toxicity, and lack of evidence. Data are lacking, though, among youth providers. To find out how aware those clinicians are about PrEP, and how willing they are to prescribe it, the researchers conducted an online survey of members of the Society of Adolescent Health and Medicine.

Almost all of the 162 respondents had heard of PrEP, and agreed that it prevents HIV. Of the respondents, 57 (35%) had prescribed PrEP. Although 73% said they had treated few to no young patients with HIV, 65% were willing to prescribe PrEP to adolescents (aged 13-17 years) and young adults. Only 30 providers said they would refer adolescents and 25 would refer young adults.

Among the providers who would refer or were not willing to prescribe to adolescents, 35 (67%) would prescribe PrEP if it were FDA-approved for adolescents.

Willingness to prescribe was associated with the provider having enough knowledge to safely provide PrEP to adolescents and a belief that adolescents would adhere to a daily medication regimen. Some also said they would prefer to know that they could ensure confidentiality.

The researchers say their findings highlight potential opportunities to reduce HIV incidence among young people by shaping educational and implementation tools to improve provider self-efficacy and youth adherence. 

 

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Investigation Into New Antimalarial Drug Begins

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Wed, 11/14/2018 - 05:11
Phase 1 trial of a modified chloroquine aims to reduce malaria rates in in sub-Saharan Africa.

In 2016, a staggering 216 million people developed malaria, and 445,000 died—primarily children in sub-Saharan Africa. But a new first-in-human study sponsored by the National Institute of Allergy and Infectious Disease may help reduce the numbers of future victims.

Enrollment has begun in a phase I trial to test the safety of DM1157, an investigational modified form of chloroquine. Many strains of Plasmodium falciparum are now resistant to chloroquine. In fact, the parasites can expel the drug before it can affect them. Like chloroquine, DM1157 interferes with the parasite’s metabolism, but it also inhibits the parasite’s ability to expel the drug.

The study will enroll up to 104 healthy volunteers aged 18-45 years. One group will fast overnight and then receive either a single dose of the experimental drug at 1 of 7 dosage levels or a placebo. A second group also will fast and receive 1 dose at 1 of 4 dosage levels and repeat the routine for 2 more consecutive days. A third group will be given either a single 300-mg dose or placebo after eating a high-fat meal.

The study is expected to be completed by June 2019.

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Phase 1 trial of a modified chloroquine aims to reduce malaria rates in in sub-Saharan Africa.
Phase 1 trial of a modified chloroquine aims to reduce malaria rates in in sub-Saharan Africa.

In 2016, a staggering 216 million people developed malaria, and 445,000 died—primarily children in sub-Saharan Africa. But a new first-in-human study sponsored by the National Institute of Allergy and Infectious Disease may help reduce the numbers of future victims.

Enrollment has begun in a phase I trial to test the safety of DM1157, an investigational modified form of chloroquine. Many strains of Plasmodium falciparum are now resistant to chloroquine. In fact, the parasites can expel the drug before it can affect them. Like chloroquine, DM1157 interferes with the parasite’s metabolism, but it also inhibits the parasite’s ability to expel the drug.

The study will enroll up to 104 healthy volunteers aged 18-45 years. One group will fast overnight and then receive either a single dose of the experimental drug at 1 of 7 dosage levels or a placebo. A second group also will fast and receive 1 dose at 1 of 4 dosage levels and repeat the routine for 2 more consecutive days. A third group will be given either a single 300-mg dose or placebo after eating a high-fat meal.

The study is expected to be completed by June 2019.

In 2016, a staggering 216 million people developed malaria, and 445,000 died—primarily children in sub-Saharan Africa. But a new first-in-human study sponsored by the National Institute of Allergy and Infectious Disease may help reduce the numbers of future victims.

Enrollment has begun in a phase I trial to test the safety of DM1157, an investigational modified form of chloroquine. Many strains of Plasmodium falciparum are now resistant to chloroquine. In fact, the parasites can expel the drug before it can affect them. Like chloroquine, DM1157 interferes with the parasite’s metabolism, but it also inhibits the parasite’s ability to expel the drug.

The study will enroll up to 104 healthy volunteers aged 18-45 years. One group will fast overnight and then receive either a single dose of the experimental drug at 1 of 7 dosage levels or a placebo. A second group also will fast and receive 1 dose at 1 of 4 dosage levels and repeat the routine for 2 more consecutive days. A third group will be given either a single 300-mg dose or placebo after eating a high-fat meal.

The study is expected to be completed by June 2019.

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Can Probiotics Beat MRSA?

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Could a simple probiotic regimen wipe out MRSA infection in hospitals?

An unexpected finding in a study by National Institute of Health (NIH) researchers suggests that a “good” bacterium commonly found in probiotic digestive supplements works against Staphylococcus aureus (S aureus).

The researchers recruited 200 volunteers in Thailand for the study. They speculated that Thais would not be as affected by food sterilization or antibiotics as people in highly developed urban areas. The researchers analyzed fecal samples from each participant for bacteria correlated with the absence of S aureus. They found 101 samples positive for bacillus, primarily Bacillus subtilis (B subtilis), which is often mixed with other bacteria in probiotic products. The researchers then sampled for S aureus and found 25 positive gut samples and 26 positive nose samples. Strikingly, the researchers say, they found no S aureus in any of the samples that contained bacillus.

Using chromatography and mass spectrometry, the study team identified fengycins—a class of lipopeptides—as the specific bacillus substance that inhibited the S aureus sensing system. Other tests showed that fengycins had the same effect on several different strains of S aureus, including high-risk USA300 methicillin-resistant S aureus  (MRSA).

To further validate their findings, the researchers colonized the gut of mice with S aureus and fed them B subtilis spores. Probiotic bacillus given every 2 days eliminated S aureus. The same test using bacillus where fengycin production had been removed had no effect: S aureus grew as expected.

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Could a simple probiotic regimen wipe out MRSA infection in hospitals?
Could a simple probiotic regimen wipe out MRSA infection in hospitals?

An unexpected finding in a study by National Institute of Health (NIH) researchers suggests that a “good” bacterium commonly found in probiotic digestive supplements works against Staphylococcus aureus (S aureus).

The researchers recruited 200 volunteers in Thailand for the study. They speculated that Thais would not be as affected by food sterilization or antibiotics as people in highly developed urban areas. The researchers analyzed fecal samples from each participant for bacteria correlated with the absence of S aureus. They found 101 samples positive for bacillus, primarily Bacillus subtilis (B subtilis), which is often mixed with other bacteria in probiotic products. The researchers then sampled for S aureus and found 25 positive gut samples and 26 positive nose samples. Strikingly, the researchers say, they found no S aureus in any of the samples that contained bacillus.

Using chromatography and mass spectrometry, the study team identified fengycins—a class of lipopeptides—as the specific bacillus substance that inhibited the S aureus sensing system. Other tests showed that fengycins had the same effect on several different strains of S aureus, including high-risk USA300 methicillin-resistant S aureus  (MRSA).

To further validate their findings, the researchers colonized the gut of mice with S aureus and fed them B subtilis spores. Probiotic bacillus given every 2 days eliminated S aureus. The same test using bacillus where fengycin production had been removed had no effect: S aureus grew as expected.

An unexpected finding in a study by National Institute of Health (NIH) researchers suggests that a “good” bacterium commonly found in probiotic digestive supplements works against Staphylococcus aureus (S aureus).

The researchers recruited 200 volunteers in Thailand for the study. They speculated that Thais would not be as affected by food sterilization or antibiotics as people in highly developed urban areas. The researchers analyzed fecal samples from each participant for bacteria correlated with the absence of S aureus. They found 101 samples positive for bacillus, primarily Bacillus subtilis (B subtilis), which is often mixed with other bacteria in probiotic products. The researchers then sampled for S aureus and found 25 positive gut samples and 26 positive nose samples. Strikingly, the researchers say, they found no S aureus in any of the samples that contained bacillus.

Using chromatography and mass spectrometry, the study team identified fengycins—a class of lipopeptides—as the specific bacillus substance that inhibited the S aureus sensing system. Other tests showed that fengycins had the same effect on several different strains of S aureus, including high-risk USA300 methicillin-resistant S aureus  (MRSA).

To further validate their findings, the researchers colonized the gut of mice with S aureus and fed them B subtilis spores. Probiotic bacillus given every 2 days eliminated S aureus. The same test using bacillus where fengycin production had been removed had no effect: S aureus grew as expected.

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What’s the Impact of Osteoporosis in Multiple Myeloma?

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The researchers examined the relationship between the Fracture Risk Assessment Tool and the risk of death in women.

Osteoporosis is common among patients with multiple myeloma (MM), in part because both largely affect older adults. And more than half of MM patients will have MM skeletal-related events, which are painful, and can lead to complications (such as spinal cord compression) and death.

But how does pre-existing bone disease contribute to clinical outcomes in MM? Osteoporosis is a “silent condition” and very little is known about its role in MM, say researchers from The Ohio State University in Columbus and University of Massachusetts in Worcester. The standard diagnostic evaluation for MM does not include dual-energy x-ray absorptiometry, therefore assessments of underlying osteoporosis are not routine. Moreover, it is a challenge to distinguish osteoporotic fragility fractures from pathologic MM-induced fractures. Skeletal surveys underestimate bone involvement by about 40%, the researchers note, and are even less specific for distinguishing myeloma-related secondary osteoporosis from primary osteoporosis.

The researchers examined the relationship between the Fracture Risk Assessment Tool (FRAX) and the risk of death in women who developed MM. They analyzed data from 161,808 women in the Women’s Health Initiative (WHI). Of those, 409 developed MM; 362 had no history of cancer.

At baseline, 98 (27%) women had high FRAX scores, and 264 (73%) had low scores. The median follow-up period was 10.5 years from enrollment and 7.2 years from the time of MM diagnosis. Of the patients with MM, 226 died during the follow-up period, including 71 with high FRAX scores and 155 with low scores. MM mortality was higher among women with high FRAX scores: 72%, vs 59% of those with low scores. Poor bone health was associated with greater MM mortality but was not related to delay in time to diagnosis.

During the evaluation, 57 fractures were reported, 65% before MM diagnosis. Fewer than half of the women had a first fracture after diagnosis. The probability of fracture was similar among the women, regardless of FRAX score. Not surprisingly, older women with lower BMI were most at risk.

The WHI does not include information on staging, chemotherapy, or use of bisphosphonates. Therefore, the impact of bisphosphonates could not be determined in this study. The researchers also did not know how many patients might have had pre-existing monoclonal gammopathy of undetermined significance, a disorder in about 3% of the aging population that progresses to MM in 1% per year.

Source:
Rosko AE, Hade EM, Li W, et al. Clin Lymphoma Myeloma Leuk. 2018;18(9):597-602.

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The researchers examined the relationship between the Fracture Risk Assessment Tool and the risk of death in women.
The researchers examined the relationship between the Fracture Risk Assessment Tool and the risk of death in women.

Osteoporosis is common among patients with multiple myeloma (MM), in part because both largely affect older adults. And more than half of MM patients will have MM skeletal-related events, which are painful, and can lead to complications (such as spinal cord compression) and death.

But how does pre-existing bone disease contribute to clinical outcomes in MM? Osteoporosis is a “silent condition” and very little is known about its role in MM, say researchers from The Ohio State University in Columbus and University of Massachusetts in Worcester. The standard diagnostic evaluation for MM does not include dual-energy x-ray absorptiometry, therefore assessments of underlying osteoporosis are not routine. Moreover, it is a challenge to distinguish osteoporotic fragility fractures from pathologic MM-induced fractures. Skeletal surveys underestimate bone involvement by about 40%, the researchers note, and are even less specific for distinguishing myeloma-related secondary osteoporosis from primary osteoporosis.

The researchers examined the relationship between the Fracture Risk Assessment Tool (FRAX) and the risk of death in women who developed MM. They analyzed data from 161,808 women in the Women’s Health Initiative (WHI). Of those, 409 developed MM; 362 had no history of cancer.

At baseline, 98 (27%) women had high FRAX scores, and 264 (73%) had low scores. The median follow-up period was 10.5 years from enrollment and 7.2 years from the time of MM diagnosis. Of the patients with MM, 226 died during the follow-up period, including 71 with high FRAX scores and 155 with low scores. MM mortality was higher among women with high FRAX scores: 72%, vs 59% of those with low scores. Poor bone health was associated with greater MM mortality but was not related to delay in time to diagnosis.

During the evaluation, 57 fractures were reported, 65% before MM diagnosis. Fewer than half of the women had a first fracture after diagnosis. The probability of fracture was similar among the women, regardless of FRAX score. Not surprisingly, older women with lower BMI were most at risk.

The WHI does not include information on staging, chemotherapy, or use of bisphosphonates. Therefore, the impact of bisphosphonates could not be determined in this study. The researchers also did not know how many patients might have had pre-existing monoclonal gammopathy of undetermined significance, a disorder in about 3% of the aging population that progresses to MM in 1% per year.

Source:
Rosko AE, Hade EM, Li W, et al. Clin Lymphoma Myeloma Leuk. 2018;18(9):597-602.

Osteoporosis is common among patients with multiple myeloma (MM), in part because both largely affect older adults. And more than half of MM patients will have MM skeletal-related events, which are painful, and can lead to complications (such as spinal cord compression) and death.

But how does pre-existing bone disease contribute to clinical outcomes in MM? Osteoporosis is a “silent condition” and very little is known about its role in MM, say researchers from The Ohio State University in Columbus and University of Massachusetts in Worcester. The standard diagnostic evaluation for MM does not include dual-energy x-ray absorptiometry, therefore assessments of underlying osteoporosis are not routine. Moreover, it is a challenge to distinguish osteoporotic fragility fractures from pathologic MM-induced fractures. Skeletal surveys underestimate bone involvement by about 40%, the researchers note, and are even less specific for distinguishing myeloma-related secondary osteoporosis from primary osteoporosis.

The researchers examined the relationship between the Fracture Risk Assessment Tool (FRAX) and the risk of death in women who developed MM. They analyzed data from 161,808 women in the Women’s Health Initiative (WHI). Of those, 409 developed MM; 362 had no history of cancer.

At baseline, 98 (27%) women had high FRAX scores, and 264 (73%) had low scores. The median follow-up period was 10.5 years from enrollment and 7.2 years from the time of MM diagnosis. Of the patients with MM, 226 died during the follow-up period, including 71 with high FRAX scores and 155 with low scores. MM mortality was higher among women with high FRAX scores: 72%, vs 59% of those with low scores. Poor bone health was associated with greater MM mortality but was not related to delay in time to diagnosis.

During the evaluation, 57 fractures were reported, 65% before MM diagnosis. Fewer than half of the women had a first fracture after diagnosis. The probability of fracture was similar among the women, regardless of FRAX score. Not surprisingly, older women with lower BMI were most at risk.

The WHI does not include information on staging, chemotherapy, or use of bisphosphonates. Therefore, the impact of bisphosphonates could not be determined in this study. The researchers also did not know how many patients might have had pre-existing monoclonal gammopathy of undetermined significance, a disorder in about 3% of the aging population that progresses to MM in 1% per year.

Source:
Rosko AE, Hade EM, Li W, et al. Clin Lymphoma Myeloma Leuk. 2018;18(9):597-602.

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Gastric Banding vs Metformin

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NIH study looks into the efficacy of gastric banding in stabilizing prediabetes over metformin.

Gastric banding was just as successful as metformin alone in stabilizing prediabetes or new-onset type 2 diabetes in the Beta Cell Restoration through Fat Mitigation study (BetaFat), an NIH-supported study.

The study is part of the Restoring Insulin Secretion (RISE) study, a set of 3 clinical trials designed to find ways to reverse or slow the loss of insulin production and release in people at risk for type 2 diabetes.

In this study, 44 patients were randomly assigned to have a gastric banding procedure, and 44 were taking metformin. After 2 years, people in the gastric banding group had lost an average of 23 lb , vs 4 lb in the metformin group. Insulin sensitivity improved similarly in both groups, as did function of insulin-producing cells. Both groups showed small improvements in blood glucose levels.

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NIH study looks into the efficacy of gastric banding in stabilizing prediabetes over metformin.
NIH study looks into the efficacy of gastric banding in stabilizing prediabetes over metformin.

Gastric banding was just as successful as metformin alone in stabilizing prediabetes or new-onset type 2 diabetes in the Beta Cell Restoration through Fat Mitigation study (BetaFat), an NIH-supported study.

The study is part of the Restoring Insulin Secretion (RISE) study, a set of 3 clinical trials designed to find ways to reverse or slow the loss of insulin production and release in people at risk for type 2 diabetes.

In this study, 44 patients were randomly assigned to have a gastric banding procedure, and 44 were taking metformin. After 2 years, people in the gastric banding group had lost an average of 23 lb , vs 4 lb in the metformin group. Insulin sensitivity improved similarly in both groups, as did function of insulin-producing cells. Both groups showed small improvements in blood glucose levels.

Gastric banding was just as successful as metformin alone in stabilizing prediabetes or new-onset type 2 diabetes in the Beta Cell Restoration through Fat Mitigation study (BetaFat), an NIH-supported study.

The study is part of the Restoring Insulin Secretion (RISE) study, a set of 3 clinical trials designed to find ways to reverse or slow the loss of insulin production and release in people at risk for type 2 diabetes.

In this study, 44 patients were randomly assigned to have a gastric banding procedure, and 44 were taking metformin. After 2 years, people in the gastric banding group had lost an average of 23 lb , vs 4 lb in the metformin group. Insulin sensitivity improved similarly in both groups, as did function of insulin-producing cells. Both groups showed small improvements in blood glucose levels.

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Testing the Limits of Low-Dose Aspirin

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Does taking low-dose aspirin daily have an effect on cardiovascular event risk?

Unless someone has already had a heart attack or other cardiovascular event, daily low-dose aspirin does not prolong healthy independent living, according to the ASPirin in Reducing Events in the Elderly (ASPREE) trial.

The study began in 2010, enrolling 19,114 adults aged ≥ 65 years. The participants were treated with 100 mg/d of aspirin or placebo and followed for an average of 4.7 years. Of participants randomly assigned aspirin, 90.3% were still alive at the end of the treatment without persistent physical disability or dementia, as were 90.5% of those on placebo. Rates of dementia were almost identical in both groups. Major cardiovascular events were similar: 448 in the aspirin group and 474 in the placebo group.

The aspirin group had a slightly higher risk of death (5.9% vs 5.2%). The researchers advise interpreting this cautiously: Most of the deaths were due to cancer. A small increase in new cases of cancer was reported for the aspirin group but may have been due to chance. Heart disease accounted for 19% of deaths and major bleeding for 5%. People taking aspirin were more likely to have significant bleeding (3.8% vs 2.7%).

The researchers emphasize that, study findings notwithstanding, older adults should follow their physician’s advice about daily aspirin use. The new findings do not apply to people with an indication for aspirin, including stroke, heart attack, or other cardiovascular disease.

 

 

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Does taking low-dose aspirin daily have an effect on cardiovascular event risk?
Does taking low-dose aspirin daily have an effect on cardiovascular event risk?

Unless someone has already had a heart attack or other cardiovascular event, daily low-dose aspirin does not prolong healthy independent living, according to the ASPirin in Reducing Events in the Elderly (ASPREE) trial.

The study began in 2010, enrolling 19,114 adults aged ≥ 65 years. The participants were treated with 100 mg/d of aspirin or placebo and followed for an average of 4.7 years. Of participants randomly assigned aspirin, 90.3% were still alive at the end of the treatment without persistent physical disability or dementia, as were 90.5% of those on placebo. Rates of dementia were almost identical in both groups. Major cardiovascular events were similar: 448 in the aspirin group and 474 in the placebo group.

The aspirin group had a slightly higher risk of death (5.9% vs 5.2%). The researchers advise interpreting this cautiously: Most of the deaths were due to cancer. A small increase in new cases of cancer was reported for the aspirin group but may have been due to chance. Heart disease accounted for 19% of deaths and major bleeding for 5%. People taking aspirin were more likely to have significant bleeding (3.8% vs 2.7%).

The researchers emphasize that, study findings notwithstanding, older adults should follow their physician’s advice about daily aspirin use. The new findings do not apply to people with an indication for aspirin, including stroke, heart attack, or other cardiovascular disease.

 

 

Unless someone has already had a heart attack or other cardiovascular event, daily low-dose aspirin does not prolong healthy independent living, according to the ASPirin in Reducing Events in the Elderly (ASPREE) trial.

The study began in 2010, enrolling 19,114 adults aged ≥ 65 years. The participants were treated with 100 mg/d of aspirin or placebo and followed for an average of 4.7 years. Of participants randomly assigned aspirin, 90.3% were still alive at the end of the treatment without persistent physical disability or dementia, as were 90.5% of those on placebo. Rates of dementia were almost identical in both groups. Major cardiovascular events were similar: 448 in the aspirin group and 474 in the placebo group.

The aspirin group had a slightly higher risk of death (5.9% vs 5.2%). The researchers advise interpreting this cautiously: Most of the deaths were due to cancer. A small increase in new cases of cancer was reported for the aspirin group but may have been due to chance. Heart disease accounted for 19% of deaths and major bleeding for 5%. People taking aspirin were more likely to have significant bleeding (3.8% vs 2.7%).

The researchers emphasize that, study findings notwithstanding, older adults should follow their physician’s advice about daily aspirin use. The new findings do not apply to people with an indication for aspirin, including stroke, heart attack, or other cardiovascular disease.

 

 

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‘Flexible’ Intervention Helps Patients Overcome Barriers to HIV Treatment

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Researchers find that an “integrated and flexible intervention” helped patients overcome personal and system related barriers.

People living with HIV who inject drugs often encounter multiple obstacles, both personal and system related, to beginning and adhering to treatment. But NIH researchers found that an “integrated and flexible intervention” not only helped patients overcome those barriers, but also cut deaths by 50%.

The study, HPTN 074, took place in Indonesia, Ukraine, and Vietnam—3 countries with HIV epidemics driven by injection drug use. Researchers enrolled 502 adults with HIV who inject drugs, and 806 adults without HIV, who inject drugs with them (their injection partners). At ≥ 1 injection partner of every person in the study enrolled. The HIV participants were assigned either the national standard of care for HIV infection and drug use, or the standard of care plus the intervention designed to facilitate treatment. The participants were followed for 1 to 2 years.

In the intervention group, participants were referred to local health care providers for anti-HIV therapy. They were also each assigned a systems navigator, who helped the patient identify and overcome structural barriers to starting and staying in care, such as unfamiliarity with how to enroll in medical care, or difficulty keeping appointments. Psychosocial counselors helped each participant overcome their unique psychological obstacles, such as lack of interest in therapy or fear of stigma.

At the end of the study, 15% of participants with HIV who received standard care had died, compared with 7% of the intervention patients. About 26% of deaths among HIV participants were “clearly” HIV related; 3% were due to drug overdose. Among the 42% of patients who died of unknown cause, 24% had weak immune systems.

The intervention had a “remarkably positive impact” on the participants, said Protocol Chair William Miller, MD, PhD. After 1 year, 41% of the intervention group had undetectable levels of HIV, compared with 24% of the standard-care group. Moreover, 72% of the intervention group were still in treatment, compared with 43% of the standard-care group. Similarly, 41% of intervention patients were in treatment for substance use, compared with 25% of standard-care patients.

The study is designed to be scalable to other settings. Investigators have offered the intervention to all the study participants living with HIV. They will be followed for a second year to find out whether the positive impact is sustained.

 

Source:

National Institutes of Health.  Novel intervention halves rate of death among people living with HIV who inject drugs. https://www.nih.gov/news-events/news-releases/novel-intervention-halves-rate-death-among-people-living-hiv-who-inject-drugs. Published August 31,2018. Accessed October 25, 2018.

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Researchers find that an “integrated and flexible intervention” helped patients overcome personal and system related barriers.
Researchers find that an “integrated and flexible intervention” helped patients overcome personal and system related barriers.

People living with HIV who inject drugs often encounter multiple obstacles, both personal and system related, to beginning and adhering to treatment. But NIH researchers found that an “integrated and flexible intervention” not only helped patients overcome those barriers, but also cut deaths by 50%.

The study, HPTN 074, took place in Indonesia, Ukraine, and Vietnam—3 countries with HIV epidemics driven by injection drug use. Researchers enrolled 502 adults with HIV who inject drugs, and 806 adults without HIV, who inject drugs with them (their injection partners). At ≥ 1 injection partner of every person in the study enrolled. The HIV participants were assigned either the national standard of care for HIV infection and drug use, or the standard of care plus the intervention designed to facilitate treatment. The participants were followed for 1 to 2 years.

In the intervention group, participants were referred to local health care providers for anti-HIV therapy. They were also each assigned a systems navigator, who helped the patient identify and overcome structural barriers to starting and staying in care, such as unfamiliarity with how to enroll in medical care, or difficulty keeping appointments. Psychosocial counselors helped each participant overcome their unique psychological obstacles, such as lack of interest in therapy or fear of stigma.

At the end of the study, 15% of participants with HIV who received standard care had died, compared with 7% of the intervention patients. About 26% of deaths among HIV participants were “clearly” HIV related; 3% were due to drug overdose. Among the 42% of patients who died of unknown cause, 24% had weak immune systems.

The intervention had a “remarkably positive impact” on the participants, said Protocol Chair William Miller, MD, PhD. After 1 year, 41% of the intervention group had undetectable levels of HIV, compared with 24% of the standard-care group. Moreover, 72% of the intervention group were still in treatment, compared with 43% of the standard-care group. Similarly, 41% of intervention patients were in treatment for substance use, compared with 25% of standard-care patients.

The study is designed to be scalable to other settings. Investigators have offered the intervention to all the study participants living with HIV. They will be followed for a second year to find out whether the positive impact is sustained.

 

Source:

National Institutes of Health.  Novel intervention halves rate of death among people living with HIV who inject drugs. https://www.nih.gov/news-events/news-releases/novel-intervention-halves-rate-death-among-people-living-hiv-who-inject-drugs. Published August 31,2018. Accessed October 25, 2018.

People living with HIV who inject drugs often encounter multiple obstacles, both personal and system related, to beginning and adhering to treatment. But NIH researchers found that an “integrated and flexible intervention” not only helped patients overcome those barriers, but also cut deaths by 50%.

The study, HPTN 074, took place in Indonesia, Ukraine, and Vietnam—3 countries with HIV epidemics driven by injection drug use. Researchers enrolled 502 adults with HIV who inject drugs, and 806 adults without HIV, who inject drugs with them (their injection partners). At ≥ 1 injection partner of every person in the study enrolled. The HIV participants were assigned either the national standard of care for HIV infection and drug use, or the standard of care plus the intervention designed to facilitate treatment. The participants were followed for 1 to 2 years.

In the intervention group, participants were referred to local health care providers for anti-HIV therapy. They were also each assigned a systems navigator, who helped the patient identify and overcome structural barriers to starting and staying in care, such as unfamiliarity with how to enroll in medical care, or difficulty keeping appointments. Psychosocial counselors helped each participant overcome their unique psychological obstacles, such as lack of interest in therapy or fear of stigma.

At the end of the study, 15% of participants with HIV who received standard care had died, compared with 7% of the intervention patients. About 26% of deaths among HIV participants were “clearly” HIV related; 3% were due to drug overdose. Among the 42% of patients who died of unknown cause, 24% had weak immune systems.

The intervention had a “remarkably positive impact” on the participants, said Protocol Chair William Miller, MD, PhD. After 1 year, 41% of the intervention group had undetectable levels of HIV, compared with 24% of the standard-care group. Moreover, 72% of the intervention group were still in treatment, compared with 43% of the standard-care group. Similarly, 41% of intervention patients were in treatment for substance use, compared with 25% of standard-care patients.

The study is designed to be scalable to other settings. Investigators have offered the intervention to all the study participants living with HIV. They will be followed for a second year to find out whether the positive impact is sustained.

 

Source:

National Institutes of Health.  Novel intervention halves rate of death among people living with HIV who inject drugs. https://www.nih.gov/news-events/news-releases/novel-intervention-halves-rate-death-among-people-living-hiv-who-inject-drugs. Published August 31,2018. Accessed October 25, 2018.

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