VIDEO: Recognizing the systemic impact of rosacea

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– At its core, “we understand that rosacea is an inflammatory disease,” Linda Stein Gold, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

As with psoriasis, she added, “we understand that rosacea might have some systemic implications.”

In fact, data suggest that cardiovascular disease is independently associated with rosacea after controlling for multiple variables, she noted. “So we now believe it’s important to get the inflammation under control, not just for the skin, but for the body as a whole,” Dr. Stein Gold, director of dermatology research, Henry Ford Health System, Detroit, said in a video interview.

She disclosed receiving research support, serving as a consultant, serving on the speakers bureau, and/or serving on the scientific advisory board for multiple pharmaceutical companies.

SDEF and this organization are owned by the same parent company.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– At its core, “we understand that rosacea is an inflammatory disease,” Linda Stein Gold, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

As with psoriasis, she added, “we understand that rosacea might have some systemic implications.”

In fact, data suggest that cardiovascular disease is independently associated with rosacea after controlling for multiple variables, she noted. “So we now believe it’s important to get the inflammation under control, not just for the skin, but for the body as a whole,” Dr. Stein Gold, director of dermatology research, Henry Ford Health System, Detroit, said in a video interview.

She disclosed receiving research support, serving as a consultant, serving on the speakers bureau, and/or serving on the scientific advisory board for multiple pharmaceutical companies.

SDEF and this organization are owned by the same parent company.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– At its core, “we understand that rosacea is an inflammatory disease,” Linda Stein Gold, MD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

As with psoriasis, she added, “we understand that rosacea might have some systemic implications.”

In fact, data suggest that cardiovascular disease is independently associated with rosacea after controlling for multiple variables, she noted. “So we now believe it’s important to get the inflammation under control, not just for the skin, but for the body as a whole,” Dr. Stein Gold, director of dermatology research, Henry Ford Health System, Detroit, said in a video interview.

She disclosed receiving research support, serving as a consultant, serving on the speakers bureau, and/or serving on the scientific advisory board for multiple pharmaceutical companies.

SDEF and this organization are owned by the same parent company.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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EXPERT ANALYSIS AT SDEF LAS VEGAS DERMATOLOGY SEMINAR

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PCR will improve diagnostic testing for dermatophytes, expert says

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– Until polymerase chain reaction (PCR) testing for diagnosing dermatophyte infections becomes available in the United States, the options remain the KOH test, periodic acid–Schiff (PAS) stain, and culture, Dr. Theodore Rosen said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

PCR testing is both the most sensitive and most specific method to diagnose dermatophyte infections and eventually will become the gold standard for diagnosing such infections, noted Dr. Rosen, professor of dermatology, Baylor College of Medicine, Houston. A commercial PCR kit to diagnose dermatophytes, manufactured by a Danish company, is available outside of the United States but currently is not approved in this country.

Dr. Theodore Rosen
A KOH test can take time and be difficult to interpret, he said. Referring to the mixed results with KOH, “sometimes you see fungus, and sometimes you don’t,” while “PAS positivity means there is fungus there that doesn’t belong.”

He listed several studies that compared these methods, including a retrospective trial that analyzed the reliability of different tests in verifying a clinical diagnosis of onychomycosis in 108 patients (J Am Podiatr Med Assoc. 2015 Nov;105[6]:503-8). When toenail clippings from the study participants were tested, PAS produced the most consistent positive results (60%, compared with 43.5% for KOH and 39.8% for culture). Compared with the KOH test, PAS also had a higher sensitivity (0.79 vs. 0.64) for confirming fungal infection.

Dr. Rosen said that PCR testing should become available in the United States in the future. “PCR is not only good because we know that the fungus is there, but it can be very specific,” he said. A small percentage of onychomycosis cases are due to Candida, most often affecting the fingernails of people who have their hands in water frequently, such as bartenders and housekeepers.

“And then there’s another small percentage that are due to nondermatophyte molds, the kind of things that are everywhere in the environment,” said Dr. Rosen. Describing the appearance of these types of cases, he said, “sometimes they look different … they’re darker. The nails are a little more heavily affected.”

Dr. Rosen listed several PCR studies, including one that compared PCR with conventional diagnostic methods in 107 nail specimens of patients with clinically suspected onychomycosis. The study found that PCR use increased the diagnosis of specimens positive for dermatophytes by almost 40%. PCR was positive in 72% of the specimens, compared with 57% of the fungal cultures. In addition, PCR detected dermatophytes in 39 specimens that cultures missed (Australas J Dermatol. 2013 May;54[2]:105-8).

SDEF and this news organization are owned by the same parent company.

Dr. Rosen disclosed being a paid participant on the scientific advisory boards for Anacor and Valeant.
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– Until polymerase chain reaction (PCR) testing for diagnosing dermatophyte infections becomes available in the United States, the options remain the KOH test, periodic acid–Schiff (PAS) stain, and culture, Dr. Theodore Rosen said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

PCR testing is both the most sensitive and most specific method to diagnose dermatophyte infections and eventually will become the gold standard for diagnosing such infections, noted Dr. Rosen, professor of dermatology, Baylor College of Medicine, Houston. A commercial PCR kit to diagnose dermatophytes, manufactured by a Danish company, is available outside of the United States but currently is not approved in this country.

Dr. Theodore Rosen
A KOH test can take time and be difficult to interpret, he said. Referring to the mixed results with KOH, “sometimes you see fungus, and sometimes you don’t,” while “PAS positivity means there is fungus there that doesn’t belong.”

He listed several studies that compared these methods, including a retrospective trial that analyzed the reliability of different tests in verifying a clinical diagnosis of onychomycosis in 108 patients (J Am Podiatr Med Assoc. 2015 Nov;105[6]:503-8). When toenail clippings from the study participants were tested, PAS produced the most consistent positive results (60%, compared with 43.5% for KOH and 39.8% for culture). Compared with the KOH test, PAS also had a higher sensitivity (0.79 vs. 0.64) for confirming fungal infection.

Dr. Rosen said that PCR testing should become available in the United States in the future. “PCR is not only good because we know that the fungus is there, but it can be very specific,” he said. A small percentage of onychomycosis cases are due to Candida, most often affecting the fingernails of people who have their hands in water frequently, such as bartenders and housekeepers.

“And then there’s another small percentage that are due to nondermatophyte molds, the kind of things that are everywhere in the environment,” said Dr. Rosen. Describing the appearance of these types of cases, he said, “sometimes they look different … they’re darker. The nails are a little more heavily affected.”

Dr. Rosen listed several PCR studies, including one that compared PCR with conventional diagnostic methods in 107 nail specimens of patients with clinically suspected onychomycosis. The study found that PCR use increased the diagnosis of specimens positive for dermatophytes by almost 40%. PCR was positive in 72% of the specimens, compared with 57% of the fungal cultures. In addition, PCR detected dermatophytes in 39 specimens that cultures missed (Australas J Dermatol. 2013 May;54[2]:105-8).

SDEF and this news organization are owned by the same parent company.

Dr. Rosen disclosed being a paid participant on the scientific advisory boards for Anacor and Valeant.

 

– Until polymerase chain reaction (PCR) testing for diagnosing dermatophyte infections becomes available in the United States, the options remain the KOH test, periodic acid–Schiff (PAS) stain, and culture, Dr. Theodore Rosen said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

PCR testing is both the most sensitive and most specific method to diagnose dermatophyte infections and eventually will become the gold standard for diagnosing such infections, noted Dr. Rosen, professor of dermatology, Baylor College of Medicine, Houston. A commercial PCR kit to diagnose dermatophytes, manufactured by a Danish company, is available outside of the United States but currently is not approved in this country.

Dr. Theodore Rosen
A KOH test can take time and be difficult to interpret, he said. Referring to the mixed results with KOH, “sometimes you see fungus, and sometimes you don’t,” while “PAS positivity means there is fungus there that doesn’t belong.”

He listed several studies that compared these methods, including a retrospective trial that analyzed the reliability of different tests in verifying a clinical diagnosis of onychomycosis in 108 patients (J Am Podiatr Med Assoc. 2015 Nov;105[6]:503-8). When toenail clippings from the study participants were tested, PAS produced the most consistent positive results (60%, compared with 43.5% for KOH and 39.8% for culture). Compared with the KOH test, PAS also had a higher sensitivity (0.79 vs. 0.64) for confirming fungal infection.

Dr. Rosen said that PCR testing should become available in the United States in the future. “PCR is not only good because we know that the fungus is there, but it can be very specific,” he said. A small percentage of onychomycosis cases are due to Candida, most often affecting the fingernails of people who have their hands in water frequently, such as bartenders and housekeepers.

“And then there’s another small percentage that are due to nondermatophyte molds, the kind of things that are everywhere in the environment,” said Dr. Rosen. Describing the appearance of these types of cases, he said, “sometimes they look different … they’re darker. The nails are a little more heavily affected.”

Dr. Rosen listed several PCR studies, including one that compared PCR with conventional diagnostic methods in 107 nail specimens of patients with clinically suspected onychomycosis. The study found that PCR use increased the diagnosis of specimens positive for dermatophytes by almost 40%. PCR was positive in 72% of the specimens, compared with 57% of the fungal cultures. In addition, PCR detected dermatophytes in 39 specimens that cultures missed (Australas J Dermatol. 2013 May;54[2]:105-8).

SDEF and this news organization are owned by the same parent company.

Dr. Rosen disclosed being a paid participant on the scientific advisory boards for Anacor and Valeant.
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EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR

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Cooling, occlusion, and antihistamines are among the options that optimize ALA-PDT results

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Treatment of a broad area, occluding extremities, and the use of antihistamines are among the measures that can help optimize the results of treating actinic keratoses (AKs) with topical photodynamic therapy (PDT) using aminolevulinic acid (ALA), according to Dr. Brian Berman.

Dr. Brian Berman
Histamines play a role in the topical response to ALA-PDT, which generally involves some edema and erythema, he noted. “The edema component is generated by mast cell degranulation and can be uncoupled using selective H1 antihistamines,” he said. However, the erythema response is not affected by H1 blockade, he added.

Dr. Berman’s recommendations for optimizing ALA-PDT to treat AKs include a shorter ALA incubation time; treatment of a broad area, not just the baseline visible AKs; occlusion of ALA for AKs on the arms and legs; increased skin temperature during ALA incubation; and moderate cooling during light exposure. To reduce pain, he recommended a very short ALA incubation time with a longer time of light exposure.

He referred to a 2004 study of 18 patients, which found that AK reductions were not significantly different at 1 month post treatment with ALA incubation times of 1, 2, or 3 hours (Arch Dermatol. 2004 Jan;140[1]:33-40). As for occlusion, a 2012 study found that AK clearance was significantly greater for extremities that were occluded during incubation in patients undergoing blue light ALA-PDT, compared with areas that were not occluded (J Drugs Dermatol. 2012 Dec;11[12]:1483-9).

Skin cooling can be useful in reducing patients’ pain, said Dr. Berman of the department of dermatology and cutaneous surgery, University of Miami. Data from a retrospective study showed that cooling pain relief, with an air-cooling device during treatment, resulted in lower PpIX photobleaching in AK lesions, compared with no cooling (J Photochem Photobiol B. 2011 Apr 4;103[1]:1-7). But cooling was associated with decreased efficacy of the PDT treatment in terms of complete AK response (68% for the cooling device group vs. 82% for controls without cooling), he said.

Increasing skin temperature has been shown to reduce AK lesions significantly, compared with no heat, Dr. Berman pointed out. “PpIX synthesis is temperature dependent,” he said. The median difference in AK lesion counts was significantly greater on a heated extremity side than a control side in an unpublished study, he noted.

Finally, when it comes to facial AKs, less may be more in terms of treatment time. In a split face study, a “painless PDT” protocol of 15 minutes of ALA incubation with 1 hour of blue light yielded a 52% reduction in AKs at 8 weeks post treatment, vs. a 44% reduction with a standard treatment of 75 minutes of ALA incubation with 16 minutes, 45 seconds of blue light, Dr. Berman said.

Dr. Berman disclosed relationships with multiple companies including Ferndale, LEO, Halscion, Sensus, Exeltis, Dermira, Celumigen, Sun, DUSA, Biofrontera, and Berg. He holds stock in Halscion, Dermira, Celumigen, and Berg.

SDEF and this news organization are owned by the same parent company.
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Treatment of a broad area, occluding extremities, and the use of antihistamines are among the measures that can help optimize the results of treating actinic keratoses (AKs) with topical photodynamic therapy (PDT) using aminolevulinic acid (ALA), according to Dr. Brian Berman.

Dr. Brian Berman
Histamines play a role in the topical response to ALA-PDT, which generally involves some edema and erythema, he noted. “The edema component is generated by mast cell degranulation and can be uncoupled using selective H1 antihistamines,” he said. However, the erythema response is not affected by H1 blockade, he added.

Dr. Berman’s recommendations for optimizing ALA-PDT to treat AKs include a shorter ALA incubation time; treatment of a broad area, not just the baseline visible AKs; occlusion of ALA for AKs on the arms and legs; increased skin temperature during ALA incubation; and moderate cooling during light exposure. To reduce pain, he recommended a very short ALA incubation time with a longer time of light exposure.

He referred to a 2004 study of 18 patients, which found that AK reductions were not significantly different at 1 month post treatment with ALA incubation times of 1, 2, or 3 hours (Arch Dermatol. 2004 Jan;140[1]:33-40). As for occlusion, a 2012 study found that AK clearance was significantly greater for extremities that were occluded during incubation in patients undergoing blue light ALA-PDT, compared with areas that were not occluded (J Drugs Dermatol. 2012 Dec;11[12]:1483-9).

Skin cooling can be useful in reducing patients’ pain, said Dr. Berman of the department of dermatology and cutaneous surgery, University of Miami. Data from a retrospective study showed that cooling pain relief, with an air-cooling device during treatment, resulted in lower PpIX photobleaching in AK lesions, compared with no cooling (J Photochem Photobiol B. 2011 Apr 4;103[1]:1-7). But cooling was associated with decreased efficacy of the PDT treatment in terms of complete AK response (68% for the cooling device group vs. 82% for controls without cooling), he said.

Increasing skin temperature has been shown to reduce AK lesions significantly, compared with no heat, Dr. Berman pointed out. “PpIX synthesis is temperature dependent,” he said. The median difference in AK lesion counts was significantly greater on a heated extremity side than a control side in an unpublished study, he noted.

Finally, when it comes to facial AKs, less may be more in terms of treatment time. In a split face study, a “painless PDT” protocol of 15 minutes of ALA incubation with 1 hour of blue light yielded a 52% reduction in AKs at 8 weeks post treatment, vs. a 44% reduction with a standard treatment of 75 minutes of ALA incubation with 16 minutes, 45 seconds of blue light, Dr. Berman said.

Dr. Berman disclosed relationships with multiple companies including Ferndale, LEO, Halscion, Sensus, Exeltis, Dermira, Celumigen, Sun, DUSA, Biofrontera, and Berg. He holds stock in Halscion, Dermira, Celumigen, and Berg.

SDEF and this news organization are owned by the same parent company.

 

Treatment of a broad area, occluding extremities, and the use of antihistamines are among the measures that can help optimize the results of treating actinic keratoses (AKs) with topical photodynamic therapy (PDT) using aminolevulinic acid (ALA), according to Dr. Brian Berman.

Dr. Brian Berman
Histamines play a role in the topical response to ALA-PDT, which generally involves some edema and erythema, he noted. “The edema component is generated by mast cell degranulation and can be uncoupled using selective H1 antihistamines,” he said. However, the erythema response is not affected by H1 blockade, he added.

Dr. Berman’s recommendations for optimizing ALA-PDT to treat AKs include a shorter ALA incubation time; treatment of a broad area, not just the baseline visible AKs; occlusion of ALA for AKs on the arms and legs; increased skin temperature during ALA incubation; and moderate cooling during light exposure. To reduce pain, he recommended a very short ALA incubation time with a longer time of light exposure.

He referred to a 2004 study of 18 patients, which found that AK reductions were not significantly different at 1 month post treatment with ALA incubation times of 1, 2, or 3 hours (Arch Dermatol. 2004 Jan;140[1]:33-40). As for occlusion, a 2012 study found that AK clearance was significantly greater for extremities that were occluded during incubation in patients undergoing blue light ALA-PDT, compared with areas that were not occluded (J Drugs Dermatol. 2012 Dec;11[12]:1483-9).

Skin cooling can be useful in reducing patients’ pain, said Dr. Berman of the department of dermatology and cutaneous surgery, University of Miami. Data from a retrospective study showed that cooling pain relief, with an air-cooling device during treatment, resulted in lower PpIX photobleaching in AK lesions, compared with no cooling (J Photochem Photobiol B. 2011 Apr 4;103[1]:1-7). But cooling was associated with decreased efficacy of the PDT treatment in terms of complete AK response (68% for the cooling device group vs. 82% for controls without cooling), he said.

Increasing skin temperature has been shown to reduce AK lesions significantly, compared with no heat, Dr. Berman pointed out. “PpIX synthesis is temperature dependent,” he said. The median difference in AK lesion counts was significantly greater on a heated extremity side than a control side in an unpublished study, he noted.

Finally, when it comes to facial AKs, less may be more in terms of treatment time. In a split face study, a “painless PDT” protocol of 15 minutes of ALA incubation with 1 hour of blue light yielded a 52% reduction in AKs at 8 weeks post treatment, vs. a 44% reduction with a standard treatment of 75 minutes of ALA incubation with 16 minutes, 45 seconds of blue light, Dr. Berman said.

Dr. Berman disclosed relationships with multiple companies including Ferndale, LEO, Halscion, Sensus, Exeltis, Dermira, Celumigen, Sun, DUSA, Biofrontera, and Berg. He holds stock in Halscion, Dermira, Celumigen, and Berg.

SDEF and this news organization are owned by the same parent company.
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EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR

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Prenatal triple ART arrests HIV transmission

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A triple-drug antiretroviral therapy given to HIV-infected pregnant women significantly reduced transmission of the disease to their newborns, but with greater risk of adverse outcomes for mothers and infants, a study showed.

The findings were based on data from three treatment regimens in approximately 3,500 women and infant sets. The three treatments were zidovudine plus intrapartum single-dose nevirapine with 6-14 days of tenofovir and emtricitabine post partum (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based antiretroviral therapy [ART]); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). All infants received nevirapine once daily, and infants of mothers coinfected with hepatitis B also received hepatitis B vaccination.

MattZ90/Thinkstock.com
The rate of disease transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8% in the zidovudine group). “However, both ART regimens were associated with higher rates of adverse events than zidovudine alone,” wrote Mary G. Fowler, MD, of Johns Hopkins University, Baltimore, and her colleagues (N Engl J Med. 2016;375:1726-37. doi: 10.1056/NEJMoa1511691).

The Promoting Maternal and Infant Survival Everywhere (PROMISE) trial included patients at 14 sites in seven countries (India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe). The current study presented findings from women with a CD4 count of at least 350 cells per cubic millimeter who were randomized at 14 weeks’ gestation to one of the three treatment regimens.

Maternal adverse events (grade 2 or higher) were significantly more common in the zidovudine-based ART group than in the zidovudine-only group (21.1% vs. 17.3%), as was the rate of grade 2 or higher abnormal blood chemical values (5.8% vs. 1.3%).

In addition, rates of abnormal blood chemical values grade 2 or higher were significantly more common in women treated with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%).

Low birth weight (less than 2,500 g) was significantly more likely for infants of mothers in the zidovudine-based ART group, compared with the zidovudine-only group (23.0% vs. 12.0%) and in the tenofovir-based ART group, compared with the zidovudine-only group (16.9% vs. 8.9%). Preterm delivery and early infant death rates were significantly more likely in the tenofovir-based ART group than in the zidovudine-based ART group. Overall, the rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART, the investigators reported.

The findings were limited by several factors, and the safest and most effective regimens have yet to be determined, the researchers said. “Our findings emphasize the need for continued research to assess ART in pregnancy to ensure safer pregnancies for HIV-infected women and healthier outcomes for their uninfected infants,” they wrote.

A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers, disclosed any financial conflicts.
 

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A triple-drug antiretroviral therapy given to HIV-infected pregnant women significantly reduced transmission of the disease to their newborns, but with greater risk of adverse outcomes for mothers and infants, a study showed.

The findings were based on data from three treatment regimens in approximately 3,500 women and infant sets. The three treatments were zidovudine plus intrapartum single-dose nevirapine with 6-14 days of tenofovir and emtricitabine post partum (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based antiretroviral therapy [ART]); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). All infants received nevirapine once daily, and infants of mothers coinfected with hepatitis B also received hepatitis B vaccination.

MattZ90/Thinkstock.com
The rate of disease transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8% in the zidovudine group). “However, both ART regimens were associated with higher rates of adverse events than zidovudine alone,” wrote Mary G. Fowler, MD, of Johns Hopkins University, Baltimore, and her colleagues (N Engl J Med. 2016;375:1726-37. doi: 10.1056/NEJMoa1511691).

The Promoting Maternal and Infant Survival Everywhere (PROMISE) trial included patients at 14 sites in seven countries (India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe). The current study presented findings from women with a CD4 count of at least 350 cells per cubic millimeter who were randomized at 14 weeks’ gestation to one of the three treatment regimens.

Maternal adverse events (grade 2 or higher) were significantly more common in the zidovudine-based ART group than in the zidovudine-only group (21.1% vs. 17.3%), as was the rate of grade 2 or higher abnormal blood chemical values (5.8% vs. 1.3%).

In addition, rates of abnormal blood chemical values grade 2 or higher were significantly more common in women treated with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%).

Low birth weight (less than 2,500 g) was significantly more likely for infants of mothers in the zidovudine-based ART group, compared with the zidovudine-only group (23.0% vs. 12.0%) and in the tenofovir-based ART group, compared with the zidovudine-only group (16.9% vs. 8.9%). Preterm delivery and early infant death rates were significantly more likely in the tenofovir-based ART group than in the zidovudine-based ART group. Overall, the rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART, the investigators reported.

The findings were limited by several factors, and the safest and most effective regimens have yet to be determined, the researchers said. “Our findings emphasize the need for continued research to assess ART in pregnancy to ensure safer pregnancies for HIV-infected women and healthier outcomes for their uninfected infants,” they wrote.

A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers, disclosed any financial conflicts.
 

A triple-drug antiretroviral therapy given to HIV-infected pregnant women significantly reduced transmission of the disease to their newborns, but with greater risk of adverse outcomes for mothers and infants, a study showed.

The findings were based on data from three treatment regimens in approximately 3,500 women and infant sets. The three treatments were zidovudine plus intrapartum single-dose nevirapine with 6-14 days of tenofovir and emtricitabine post partum (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based antiretroviral therapy [ART]); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). All infants received nevirapine once daily, and infants of mothers coinfected with hepatitis B also received hepatitis B vaccination.

MattZ90/Thinkstock.com
The rate of disease transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8% in the zidovudine group). “However, both ART regimens were associated with higher rates of adverse events than zidovudine alone,” wrote Mary G. Fowler, MD, of Johns Hopkins University, Baltimore, and her colleagues (N Engl J Med. 2016;375:1726-37. doi: 10.1056/NEJMoa1511691).

The Promoting Maternal and Infant Survival Everywhere (PROMISE) trial included patients at 14 sites in seven countries (India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe). The current study presented findings from women with a CD4 count of at least 350 cells per cubic millimeter who were randomized at 14 weeks’ gestation to one of the three treatment regimens.

Maternal adverse events (grade 2 or higher) were significantly more common in the zidovudine-based ART group than in the zidovudine-only group (21.1% vs. 17.3%), as was the rate of grade 2 or higher abnormal blood chemical values (5.8% vs. 1.3%).

In addition, rates of abnormal blood chemical values grade 2 or higher were significantly more common in women treated with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%).

Low birth weight (less than 2,500 g) was significantly more likely for infants of mothers in the zidovudine-based ART group, compared with the zidovudine-only group (23.0% vs. 12.0%) and in the tenofovir-based ART group, compared with the zidovudine-only group (16.9% vs. 8.9%). Preterm delivery and early infant death rates were significantly more likely in the tenofovir-based ART group than in the zidovudine-based ART group. Overall, the rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART, the investigators reported.

The findings were limited by several factors, and the safest and most effective regimens have yet to be determined, the researchers said. “Our findings emphasize the need for continued research to assess ART in pregnancy to ensure safer pregnancies for HIV-infected women and healthier outcomes for their uninfected infants,” they wrote.

A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers, disclosed any financial conflicts.
 

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FROM THE NEW ENGLAND JOURNAL OF MEDICINE

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Vitals

Key clinical point: Prenatal ART significantly lowered rates of early HIV transmission from HIV-infected pregnant women to their newborns, compared with zidovudine alone.

Major finding: The transmission rate for HIV was significantly lower in patients who underwent ART, compared with zidovudine alone (0.5% vs. 1.8%).

Data source: A randomized trial including 3,529 HIV-positive pregnant women at at least 14 weeks’ gestation.

Disclosures: A study coauthor reported receiving grant support from Gilead Sciences and ViiV Healthcare, and consulting fees from Janssen, paid directly to her institution. None of the other researchers disclosed any financial conflicts.
 

Mefloquine labeling falls short on adverse reaction recommendations

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The current labeling for the antimalarial mefloquine is inconsistent internationally with medication guides regarding certain adverse reactions, including depression and anxiety, according to a review of drug labels and medication guides from six English-speaking countries.

Neuropsychiatric reactions have been reported by 29% to 77% of mefloquine users at prophylactic doses of 250 mg per week, wrote Remington L. Nevin, MD, MPH, of Johns Hopkins University in Baltimore, and Aricia M. Byrd, an MD student at Trinity School of Medicine, Kingstown, St. Vincent and the Grenadines. “Neuropsychiatric adverse reactions may occur early during use – frequently within the first three doses – and may even occur after only a single dose,” the researchers said (Neurol Ther. 2016 Jun;5[1]:69-83).

In addition, data suggest that the neuropsychiatric adverse reactions, including nightmares and cognitive dysfunction, can last many years after the drug has been discontinued, and a black box warning was added to the U.S. label in 2013 to emphasize the potential long-term impact, Dr. Nevin and Ms. Byrd reported.

In this study, Dr. Nevin and Ms. Byrd compared prescribing information and patient safety guidance in the United States and five other English-speaking countries: the United Kingdom, Ireland, Australia, Canada, and New Zealand.

At the time of the study, mefloquine was licensed in all six countries, but the innovator product was withdrawn from the United States in 2011 and from Canada in 2013.

In addition to the United States, the United Kingdom and Ireland recommended discontinuing mefloquine at the onset of any general neurologic or psychiatric symptoms, the researchers noted.

All six countries were in complete agreement with corresponding medication guides and drug labeling that recommended discontinuing mefloquine or consulting a healthcare provider if adverse reactions occurred within four high level group terms (HLGTs): anxiety disorders and symptoms, changes in physical activity, depressed mood disorders and disturbances, and deliria (including confusion).

Three of the six countries (the United States, the United Kingdom, and Ireland) show partial agreement in medication guides and drug labeling recommendations to discontinue the drug or consult a healthcare provider in the instance of three other HLGTs: disturbances in thinking and perception, personality disorders and disturbances in behavior, and suicidal and self-injurious behaviors not elsewhere classified. The United Kingdom and Ireland also showed partial agreement in corresponding medication guides and drug labeling, drug discontinuation, or consulting a healthcare provider for the following adverse reactions: neuromuscular disorders, sleep disorders and disturbances, and peripheral neuropathies.

In the United States alone, medication guides and drug labeling corresponded in terms of drug discontinuation or healthcare provider consultation in cases of cranial nerve disorders, excluding neoplasms and neurologic disorders not elsewhere classified. For nine other areas of adverse reactions, medication guidelines recommended healthcare provider consultation, but no corresponding guidance was found on the drug labeling.

The review was limited by several factors, including the use of data from only six countries and the subjective interpretation of the language used in the drug labeling and medication guides, the researchers noted.

However, the results “suggest opportunities for physicians in these countries to improve patient counseling by specifically emphasizing the need to discontinue at the onset of these adverse reactions,” they said.

“The results of this analysis also suggest opportunities for international drug regulators to clarify language in future updates to remaining mefloquine drug labels and medication guides to better reflect national risk-benefit considerations for continued use of the drug,” they concluded.

Dr. Nevin disclosed that he has been retained as consultant and expert witness in legal cases involving antimalarial drug toxicity claims. Ms. Byrd had no financial conflicts to disclose.
 

Body

“The big picture is that it is critically important to fund research on mefloquine, because there has been relatively little postmarketing surveillance,” said Col. (Ret.) Elspeth Cameron Ritchie, MD, MPH, a forensic psychiatrist with expertise in military and veterans’ issues. Although the risk of neuropsychiatric side effects associated with mefloquine has been known, it has become more recognized in the past 15 years in the United States, she said.

“Dr. Nevin has really been a leader in this area for 10 years; he was a major force in putting the black box warning on this drug that led to the U.S. military dramatically decreasing their use of it,” Dr. Ritchie said.

Dr. Elspeth Cameron Ritchie
The U.S. Army no longer uses mefloquine to prevent malaria for soldiers, but it is still prescribed for volunteers in the Peace Corps, which means that clinicians in private practice should be aware of the potential long-term neuropsychiatric side effects, Dr. Ritchie noted. Data on susceptibility to the side effects of mefloquine are limited, but “we suspect some people are genetically susceptible,” she said.

As for further research, Dr. Ritchie said, “I think we need a good definition of mefloquine toxicity. We need to determine the best medication to treat the neuropsychiatric side effects and determine what part of the brain is affected.”

A systematic review of the side effects also is needed to help determine treatment, she added.
 

Dr. Ritchie retired from the U.S. Army in 2010 after serving for 24 years and holding many leadership positions, including chief of psychiatry. Currently, Dr. Ritchie is chief of mental health for the community-based outpatient clinics at the Washington VA Medical Center. She also serves as professor of psychiatry at the Uniformed Services University of the Health Sciences in Bethesda, Md., and at Georgetown University and Howard University, both in Washington. She had no relevant financial conflicts to disclose.

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“The big picture is that it is critically important to fund research on mefloquine, because there has been relatively little postmarketing surveillance,” said Col. (Ret.) Elspeth Cameron Ritchie, MD, MPH, a forensic psychiatrist with expertise in military and veterans’ issues. Although the risk of neuropsychiatric side effects associated with mefloquine has been known, it has become more recognized in the past 15 years in the United States, she said.

“Dr. Nevin has really been a leader in this area for 10 years; he was a major force in putting the black box warning on this drug that led to the U.S. military dramatically decreasing their use of it,” Dr. Ritchie said.

Dr. Elspeth Cameron Ritchie
The U.S. Army no longer uses mefloquine to prevent malaria for soldiers, but it is still prescribed for volunteers in the Peace Corps, which means that clinicians in private practice should be aware of the potential long-term neuropsychiatric side effects, Dr. Ritchie noted. Data on susceptibility to the side effects of mefloquine are limited, but “we suspect some people are genetically susceptible,” she said.

As for further research, Dr. Ritchie said, “I think we need a good definition of mefloquine toxicity. We need to determine the best medication to treat the neuropsychiatric side effects and determine what part of the brain is affected.”

A systematic review of the side effects also is needed to help determine treatment, she added.
 

Dr. Ritchie retired from the U.S. Army in 2010 after serving for 24 years and holding many leadership positions, including chief of psychiatry. Currently, Dr. Ritchie is chief of mental health for the community-based outpatient clinics at the Washington VA Medical Center. She also serves as professor of psychiatry at the Uniformed Services University of the Health Sciences in Bethesda, Md., and at Georgetown University and Howard University, both in Washington. She had no relevant financial conflicts to disclose.

Body

“The big picture is that it is critically important to fund research on mefloquine, because there has been relatively little postmarketing surveillance,” said Col. (Ret.) Elspeth Cameron Ritchie, MD, MPH, a forensic psychiatrist with expertise in military and veterans’ issues. Although the risk of neuropsychiatric side effects associated with mefloquine has been known, it has become more recognized in the past 15 years in the United States, she said.

“Dr. Nevin has really been a leader in this area for 10 years; he was a major force in putting the black box warning on this drug that led to the U.S. military dramatically decreasing their use of it,” Dr. Ritchie said.

Dr. Elspeth Cameron Ritchie
The U.S. Army no longer uses mefloquine to prevent malaria for soldiers, but it is still prescribed for volunteers in the Peace Corps, which means that clinicians in private practice should be aware of the potential long-term neuropsychiatric side effects, Dr. Ritchie noted. Data on susceptibility to the side effects of mefloquine are limited, but “we suspect some people are genetically susceptible,” she said.

As for further research, Dr. Ritchie said, “I think we need a good definition of mefloquine toxicity. We need to determine the best medication to treat the neuropsychiatric side effects and determine what part of the brain is affected.”

A systematic review of the side effects also is needed to help determine treatment, she added.
 

Dr. Ritchie retired from the U.S. Army in 2010 after serving for 24 years and holding many leadership positions, including chief of psychiatry. Currently, Dr. Ritchie is chief of mental health for the community-based outpatient clinics at the Washington VA Medical Center. She also serves as professor of psychiatry at the Uniformed Services University of the Health Sciences in Bethesda, Md., and at Georgetown University and Howard University, both in Washington. She had no relevant financial conflicts to disclose.

Title
Define toxicity to help find treatment solutions
Define toxicity to help find treatment solutions

The current labeling for the antimalarial mefloquine is inconsistent internationally with medication guides regarding certain adverse reactions, including depression and anxiety, according to a review of drug labels and medication guides from six English-speaking countries.

Neuropsychiatric reactions have been reported by 29% to 77% of mefloquine users at prophylactic doses of 250 mg per week, wrote Remington L. Nevin, MD, MPH, of Johns Hopkins University in Baltimore, and Aricia M. Byrd, an MD student at Trinity School of Medicine, Kingstown, St. Vincent and the Grenadines. “Neuropsychiatric adverse reactions may occur early during use – frequently within the first three doses – and may even occur after only a single dose,” the researchers said (Neurol Ther. 2016 Jun;5[1]:69-83).

In addition, data suggest that the neuropsychiatric adverse reactions, including nightmares and cognitive dysfunction, can last many years after the drug has been discontinued, and a black box warning was added to the U.S. label in 2013 to emphasize the potential long-term impact, Dr. Nevin and Ms. Byrd reported.

In this study, Dr. Nevin and Ms. Byrd compared prescribing information and patient safety guidance in the United States and five other English-speaking countries: the United Kingdom, Ireland, Australia, Canada, and New Zealand.

At the time of the study, mefloquine was licensed in all six countries, but the innovator product was withdrawn from the United States in 2011 and from Canada in 2013.

In addition to the United States, the United Kingdom and Ireland recommended discontinuing mefloquine at the onset of any general neurologic or psychiatric symptoms, the researchers noted.

All six countries were in complete agreement with corresponding medication guides and drug labeling that recommended discontinuing mefloquine or consulting a healthcare provider if adverse reactions occurred within four high level group terms (HLGTs): anxiety disorders and symptoms, changes in physical activity, depressed mood disorders and disturbances, and deliria (including confusion).

Three of the six countries (the United States, the United Kingdom, and Ireland) show partial agreement in medication guides and drug labeling recommendations to discontinue the drug or consult a healthcare provider in the instance of three other HLGTs: disturbances in thinking and perception, personality disorders and disturbances in behavior, and suicidal and self-injurious behaviors not elsewhere classified. The United Kingdom and Ireland also showed partial agreement in corresponding medication guides and drug labeling, drug discontinuation, or consulting a healthcare provider for the following adverse reactions: neuromuscular disorders, sleep disorders and disturbances, and peripheral neuropathies.

In the United States alone, medication guides and drug labeling corresponded in terms of drug discontinuation or healthcare provider consultation in cases of cranial nerve disorders, excluding neoplasms and neurologic disorders not elsewhere classified. For nine other areas of adverse reactions, medication guidelines recommended healthcare provider consultation, but no corresponding guidance was found on the drug labeling.

The review was limited by several factors, including the use of data from only six countries and the subjective interpretation of the language used in the drug labeling and medication guides, the researchers noted.

However, the results “suggest opportunities for physicians in these countries to improve patient counseling by specifically emphasizing the need to discontinue at the onset of these adverse reactions,” they said.

“The results of this analysis also suggest opportunities for international drug regulators to clarify language in future updates to remaining mefloquine drug labels and medication guides to better reflect national risk-benefit considerations for continued use of the drug,” they concluded.

Dr. Nevin disclosed that he has been retained as consultant and expert witness in legal cases involving antimalarial drug toxicity claims. Ms. Byrd had no financial conflicts to disclose.
 

The current labeling for the antimalarial mefloquine is inconsistent internationally with medication guides regarding certain adverse reactions, including depression and anxiety, according to a review of drug labels and medication guides from six English-speaking countries.

Neuropsychiatric reactions have been reported by 29% to 77% of mefloquine users at prophylactic doses of 250 mg per week, wrote Remington L. Nevin, MD, MPH, of Johns Hopkins University in Baltimore, and Aricia M. Byrd, an MD student at Trinity School of Medicine, Kingstown, St. Vincent and the Grenadines. “Neuropsychiatric adverse reactions may occur early during use – frequently within the first three doses – and may even occur after only a single dose,” the researchers said (Neurol Ther. 2016 Jun;5[1]:69-83).

In addition, data suggest that the neuropsychiatric adverse reactions, including nightmares and cognitive dysfunction, can last many years after the drug has been discontinued, and a black box warning was added to the U.S. label in 2013 to emphasize the potential long-term impact, Dr. Nevin and Ms. Byrd reported.

In this study, Dr. Nevin and Ms. Byrd compared prescribing information and patient safety guidance in the United States and five other English-speaking countries: the United Kingdom, Ireland, Australia, Canada, and New Zealand.

At the time of the study, mefloquine was licensed in all six countries, but the innovator product was withdrawn from the United States in 2011 and from Canada in 2013.

In addition to the United States, the United Kingdom and Ireland recommended discontinuing mefloquine at the onset of any general neurologic or psychiatric symptoms, the researchers noted.

All six countries were in complete agreement with corresponding medication guides and drug labeling that recommended discontinuing mefloquine or consulting a healthcare provider if adverse reactions occurred within four high level group terms (HLGTs): anxiety disorders and symptoms, changes in physical activity, depressed mood disorders and disturbances, and deliria (including confusion).

Three of the six countries (the United States, the United Kingdom, and Ireland) show partial agreement in medication guides and drug labeling recommendations to discontinue the drug or consult a healthcare provider in the instance of three other HLGTs: disturbances in thinking and perception, personality disorders and disturbances in behavior, and suicidal and self-injurious behaviors not elsewhere classified. The United Kingdom and Ireland also showed partial agreement in corresponding medication guides and drug labeling, drug discontinuation, or consulting a healthcare provider for the following adverse reactions: neuromuscular disorders, sleep disorders and disturbances, and peripheral neuropathies.

In the United States alone, medication guides and drug labeling corresponded in terms of drug discontinuation or healthcare provider consultation in cases of cranial nerve disorders, excluding neoplasms and neurologic disorders not elsewhere classified. For nine other areas of adverse reactions, medication guidelines recommended healthcare provider consultation, but no corresponding guidance was found on the drug labeling.

The review was limited by several factors, including the use of data from only six countries and the subjective interpretation of the language used in the drug labeling and medication guides, the researchers noted.

However, the results “suggest opportunities for physicians in these countries to improve patient counseling by specifically emphasizing the need to discontinue at the onset of these adverse reactions,” they said.

“The results of this analysis also suggest opportunities for international drug regulators to clarify language in future updates to remaining mefloquine drug labels and medication guides to better reflect national risk-benefit considerations for continued use of the drug,” they concluded.

Dr. Nevin disclosed that he has been retained as consultant and expert witness in legal cases involving antimalarial drug toxicity claims. Ms. Byrd had no financial conflicts to disclose.
 

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Key clinical point: Drug labeling and medication guides are inconsistent in some aspects of recommendations to discontinue use of the antimalarial drug mefloquine in cases of certain neuropsychiatric adverse reactions.

Major finding: All six countries were in complete agreement with corresponding medication guides and drug labeling that recommended discontinuing mefloquine or consulting a healthcare provider if adverse reactions occurred within four high level group terms (HLGTs): anxiety disorders and symptoms, changes in physical activity, depressed mood disorders and disturbances, and deliria (including confusion).

Data source: A review of drug labeling and medication guides in six countries: the United States, the United Kingdom, Ireland, Australia, Canada, and New Zealand.

Disclosures: Dr. Nevin disclosed that he has been retained as consultant and expert witness in legal cases involving antimalarial drug toxicity claims. Ms. Byrd had no financial conflicts to disclose.

Benefits of dental sealant programs for low-income children exceed costs

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The benefits of dental sealant programs for low-income children exceed the costs, according to researchers.

Cavities and fillings were approximately three times more likely among low-income children aged 7-11 years whose teeth were not treated with dental sealants, compared to those treated with sealants, based on data from the National Health and Nutrition Examination Survey (NHANES) from 2011-2014.

Overall, 43% of children and 39% of low-income children in the United States were treated at least once with dental sealant.

(c) robertprzybysz/ Thinkstock


Although sealant use in children increased overall from 31% to 44% in a comparison of 1999-2004 and 2011-2014 NHANES data, sealant use was less common among low-income children compared with high-income children (39% vs. 48%) in the 2011-2014 period after increases of 16% and 9%, respectively, during 2011-2014.

School-based programs to provide sealants could increase their use among low-income children, wrote Susan O. Griffin, PhD, of the Centers for Disease Control and Prevention in Atlanta, and her associates. The researchers reviewed data from 1,371 low-income children aged 6-11 years, and found that 60% (approximately 6.5 million children), had not been treated with dental sealants. “The systematic review of economic evaluations of school-based sealant programs (SBSP) conducted for the Task Force found that SBSP became cost-saving within 2 years of placing sealants,” the researchers noted.

The data were published in the CDC’s Morbidity and Mortality Weekly Report (MMWR 2016 Oct 21;65[41];1141-5).

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The benefits of dental sealant programs for low-income children exceed the costs, according to researchers.

Cavities and fillings were approximately three times more likely among low-income children aged 7-11 years whose teeth were not treated with dental sealants, compared to those treated with sealants, based on data from the National Health and Nutrition Examination Survey (NHANES) from 2011-2014.

Overall, 43% of children and 39% of low-income children in the United States were treated at least once with dental sealant.

(c) robertprzybysz/ Thinkstock


Although sealant use in children increased overall from 31% to 44% in a comparison of 1999-2004 and 2011-2014 NHANES data, sealant use was less common among low-income children compared with high-income children (39% vs. 48%) in the 2011-2014 period after increases of 16% and 9%, respectively, during 2011-2014.

School-based programs to provide sealants could increase their use among low-income children, wrote Susan O. Griffin, PhD, of the Centers for Disease Control and Prevention in Atlanta, and her associates. The researchers reviewed data from 1,371 low-income children aged 6-11 years, and found that 60% (approximately 6.5 million children), had not been treated with dental sealants. “The systematic review of economic evaluations of school-based sealant programs (SBSP) conducted for the Task Force found that SBSP became cost-saving within 2 years of placing sealants,” the researchers noted.

The data were published in the CDC’s Morbidity and Mortality Weekly Report (MMWR 2016 Oct 21;65[41];1141-5).

 

The benefits of dental sealant programs for low-income children exceed the costs, according to researchers.

Cavities and fillings were approximately three times more likely among low-income children aged 7-11 years whose teeth were not treated with dental sealants, compared to those treated with sealants, based on data from the National Health and Nutrition Examination Survey (NHANES) from 2011-2014.

Overall, 43% of children and 39% of low-income children in the United States were treated at least once with dental sealant.

(c) robertprzybysz/ Thinkstock


Although sealant use in children increased overall from 31% to 44% in a comparison of 1999-2004 and 2011-2014 NHANES data, sealant use was less common among low-income children compared with high-income children (39% vs. 48%) in the 2011-2014 period after increases of 16% and 9%, respectively, during 2011-2014.

School-based programs to provide sealants could increase their use among low-income children, wrote Susan O. Griffin, PhD, of the Centers for Disease Control and Prevention in Atlanta, and her associates. The researchers reviewed data from 1,371 low-income children aged 6-11 years, and found that 60% (approximately 6.5 million children), had not been treated with dental sealants. “The systematic review of economic evaluations of school-based sealant programs (SBSP) conducted for the Task Force found that SBSP became cost-saving within 2 years of placing sealants,” the researchers noted.

The data were published in the CDC’s Morbidity and Mortality Weekly Report (MMWR 2016 Oct 21;65[41];1141-5).

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U.S. HIV incidence dropped during past decade

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HIV incidence in the United States declined by approximately 26% since 2003, based on a study using a new and simple method of estimating the number of new cases.

“Previously, the number of newly diagnosed HIV cases in a year was used as a proxy measure for HIV incidence but has never been used as the sole data source to calculate HIV incidence, because HIV infection can remain asymptomatic for many years and newly reported cases represent both recent and long-standing infections,” wrote Qiang Xia, MD, of the New York City Department of Health and Mental Hygiene, and coauthors.

©grandeduc/Thinkstock
Overall, the estimated incidence of HIV decreased from approximately 52,721 in 2003 to 39,651 in 2010. Incidence of HIV dropped from 38,164 to 33,035 in men and from 13,557 to 6,616 in women during this time.

The researchers divided the period of study from 2002-2011 into 3-year intervals with overlaps, and estimated HIV incidence based on the assumption that all HIV infections would be diagnosed through testing or death and that HIV incidence and case findings were stable within each 3-year period. HIV incidence was then defined as the number of new HIV infections in a year, and the number of new diagnoses in the previous year, current year, and following year were used to calculate each current year.

The study was limited by several factors, including the accuracy of HIV case reporting and the stability of HIV case finding within the 3-year periods, the researchers wrote. However, the findings suggest that the “CDC may have overestimated HIV incidence and HIV incidence in the United States may have been declining since 2003,” the coauthors said. “We should consider all available methods, rather than relying on one, to provide more accurate estimates of HIV incidence to guide our intervention programs,” they added.

The researchers had no financial conflicts to disclose.

Find the full study in the Journal of Acquired Immune Deficiency Syndromes (JAIDS. 2016 Sep 19;138:e20154664. doi: 10.1097/QAI.0000000000001185).


 

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HIV incidence in the United States declined by approximately 26% since 2003, based on a study using a new and simple method of estimating the number of new cases.

“Previously, the number of newly diagnosed HIV cases in a year was used as a proxy measure for HIV incidence but has never been used as the sole data source to calculate HIV incidence, because HIV infection can remain asymptomatic for many years and newly reported cases represent both recent and long-standing infections,” wrote Qiang Xia, MD, of the New York City Department of Health and Mental Hygiene, and coauthors.

©grandeduc/Thinkstock
Overall, the estimated incidence of HIV decreased from approximately 52,721 in 2003 to 39,651 in 2010. Incidence of HIV dropped from 38,164 to 33,035 in men and from 13,557 to 6,616 in women during this time.

The researchers divided the period of study from 2002-2011 into 3-year intervals with overlaps, and estimated HIV incidence based on the assumption that all HIV infections would be diagnosed through testing or death and that HIV incidence and case findings were stable within each 3-year period. HIV incidence was then defined as the number of new HIV infections in a year, and the number of new diagnoses in the previous year, current year, and following year were used to calculate each current year.

The study was limited by several factors, including the accuracy of HIV case reporting and the stability of HIV case finding within the 3-year periods, the researchers wrote. However, the findings suggest that the “CDC may have overestimated HIV incidence and HIV incidence in the United States may have been declining since 2003,” the coauthors said. “We should consider all available methods, rather than relying on one, to provide more accurate estimates of HIV incidence to guide our intervention programs,” they added.

The researchers had no financial conflicts to disclose.

Find the full study in the Journal of Acquired Immune Deficiency Syndromes (JAIDS. 2016 Sep 19;138:e20154664. doi: 10.1097/QAI.0000000000001185).


 

 

HIV incidence in the United States declined by approximately 26% since 2003, based on a study using a new and simple method of estimating the number of new cases.

“Previously, the number of newly diagnosed HIV cases in a year was used as a proxy measure for HIV incidence but has never been used as the sole data source to calculate HIV incidence, because HIV infection can remain asymptomatic for many years and newly reported cases represent both recent and long-standing infections,” wrote Qiang Xia, MD, of the New York City Department of Health and Mental Hygiene, and coauthors.

©grandeduc/Thinkstock
Overall, the estimated incidence of HIV decreased from approximately 52,721 in 2003 to 39,651 in 2010. Incidence of HIV dropped from 38,164 to 33,035 in men and from 13,557 to 6,616 in women during this time.

The researchers divided the period of study from 2002-2011 into 3-year intervals with overlaps, and estimated HIV incidence based on the assumption that all HIV infections would be diagnosed through testing or death and that HIV incidence and case findings were stable within each 3-year period. HIV incidence was then defined as the number of new HIV infections in a year, and the number of new diagnoses in the previous year, current year, and following year were used to calculate each current year.

The study was limited by several factors, including the accuracy of HIV case reporting and the stability of HIV case finding within the 3-year periods, the researchers wrote. However, the findings suggest that the “CDC may have overestimated HIV incidence and HIV incidence in the United States may have been declining since 2003,” the coauthors said. “We should consider all available methods, rather than relying on one, to provide more accurate estimates of HIV incidence to guide our intervention programs,” they added.

The researchers had no financial conflicts to disclose.

Find the full study in the Journal of Acquired Immune Deficiency Syndromes (JAIDS. 2016 Sep 19;138:e20154664. doi: 10.1097/QAI.0000000000001185).


 

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FROM THE JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

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Perinatal problems raise adult OCD risk

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Adverse events during the perinatal period were independently associated with an increased risk of obsessive-compulsive disorder at age 40 years, based on data published Oct. 5 from a population-based cohort study of more than 2 million Swedish children.

Perinatal complications, including C-section delivery and preterm birth, have been linked to psychiatric disorders including schizophrenia, autism, and attention-deficit/hyperactivity disorder, but evidence of an impact of obsessive-compulsive disorders has not been well studied, reported Gustaf Brander of the Karolinska Institutet, Stockholm, and his colleagues.

The researchers reviewed data from 2,421,284 live singleton births in Sweden between Jan. 1, 1973, and Dec. 31, 1996. The overall prevalence of OCD was 1.3% at 40 years of age. Several perinatal factors were independently associated with an increased OCD risk: breech presentation, cesarean section delivery, gestational age of less than 32 weeks, maternal smoking during pregnancy, Apgar scores near the distress level, and both low and high birth weight (defined as 1,500-2,500 g and greater than 4,500 g, respectively).

“These findings contradict the widely held notion that, although mental disorders share genetic risk factors, the contribution of environmental risk factors is largely disorder specific,” with the exception of maternal smoking during pregnancy, the researchers wrote. In addition, the researchers found a dose-response relationship in which the risk for OCD increased with the greater number of perinatal adverse events.

“The findings are important for the understanding of the cause of OCD and will inform future studies of gene by environment interaction and epigenetics,” the researchers said. “If the finding is replication, the association between maternal smoking during pregnancy and OCD may emerge as an interesting disorder-specific risk factor for evaluation in future research,” they added.

Mr. Brander had no financial conflicts to disclose; several coauthors disclosed relationships with companies including Eli Lilly, Shire, and Medice.

Find the full study here: (JAMA Psychiatry. 2016 Oct 5. doi: 10.1001/jamapsychiatry.2016.2095).

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Adverse events during the perinatal period were independently associated with an increased risk of obsessive-compulsive disorder at age 40 years, based on data published Oct. 5 from a population-based cohort study of more than 2 million Swedish children.

Perinatal complications, including C-section delivery and preterm birth, have been linked to psychiatric disorders including schizophrenia, autism, and attention-deficit/hyperactivity disorder, but evidence of an impact of obsessive-compulsive disorders has not been well studied, reported Gustaf Brander of the Karolinska Institutet, Stockholm, and his colleagues.

The researchers reviewed data from 2,421,284 live singleton births in Sweden between Jan. 1, 1973, and Dec. 31, 1996. The overall prevalence of OCD was 1.3% at 40 years of age. Several perinatal factors were independently associated with an increased OCD risk: breech presentation, cesarean section delivery, gestational age of less than 32 weeks, maternal smoking during pregnancy, Apgar scores near the distress level, and both low and high birth weight (defined as 1,500-2,500 g and greater than 4,500 g, respectively).

“These findings contradict the widely held notion that, although mental disorders share genetic risk factors, the contribution of environmental risk factors is largely disorder specific,” with the exception of maternal smoking during pregnancy, the researchers wrote. In addition, the researchers found a dose-response relationship in which the risk for OCD increased with the greater number of perinatal adverse events.

“The findings are important for the understanding of the cause of OCD and will inform future studies of gene by environment interaction and epigenetics,” the researchers said. “If the finding is replication, the association between maternal smoking during pregnancy and OCD may emerge as an interesting disorder-specific risk factor for evaluation in future research,” they added.

Mr. Brander had no financial conflicts to disclose; several coauthors disclosed relationships with companies including Eli Lilly, Shire, and Medice.

Find the full study here: (JAMA Psychiatry. 2016 Oct 5. doi: 10.1001/jamapsychiatry.2016.2095).

 

Adverse events during the perinatal period were independently associated with an increased risk of obsessive-compulsive disorder at age 40 years, based on data published Oct. 5 from a population-based cohort study of more than 2 million Swedish children.

Perinatal complications, including C-section delivery and preterm birth, have been linked to psychiatric disorders including schizophrenia, autism, and attention-deficit/hyperactivity disorder, but evidence of an impact of obsessive-compulsive disorders has not been well studied, reported Gustaf Brander of the Karolinska Institutet, Stockholm, and his colleagues.

The researchers reviewed data from 2,421,284 live singleton births in Sweden between Jan. 1, 1973, and Dec. 31, 1996. The overall prevalence of OCD was 1.3% at 40 years of age. Several perinatal factors were independently associated with an increased OCD risk: breech presentation, cesarean section delivery, gestational age of less than 32 weeks, maternal smoking during pregnancy, Apgar scores near the distress level, and both low and high birth weight (defined as 1,500-2,500 g and greater than 4,500 g, respectively).

“These findings contradict the widely held notion that, although mental disorders share genetic risk factors, the contribution of environmental risk factors is largely disorder specific,” with the exception of maternal smoking during pregnancy, the researchers wrote. In addition, the researchers found a dose-response relationship in which the risk for OCD increased with the greater number of perinatal adverse events.

“The findings are important for the understanding of the cause of OCD and will inform future studies of gene by environment interaction and epigenetics,” the researchers said. “If the finding is replication, the association between maternal smoking during pregnancy and OCD may emerge as an interesting disorder-specific risk factor for evaluation in future research,” they added.

Mr. Brander had no financial conflicts to disclose; several coauthors disclosed relationships with companies including Eli Lilly, Shire, and Medice.

Find the full study here: (JAMA Psychiatry. 2016 Oct 5. doi: 10.1001/jamapsychiatry.2016.2095).

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Complementary medicine impedes children’s flu vaccination

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Children treated with complementary and alternative medicine (CAM) therapies were significantly less likely to receive the annual influenza vaccine than those who didn’t use alternative medicine, based on data from 9,000 children aged 4-17 years in the Child Complementary and Alternative Medicine File of the 2012 National Health Interview Survey.

“CAM has been implicated as lending support to antivaccine/vaccine-hesitant viewpoints via criticism of vaccination, public health, and conventional medicine from adults using CAM, as well as from CAM practitioners and practitioners-in-training,” wrote William K. Bleser, Ph.D., and his colleagues at Pennsylvania State University, University Park.

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Overall, flu vaccination rates in children who used alternative medicine services (AMS) or manipulative and body-based therapies (MBBT) were significantly lower than in children who never used these services (33% vs. 43% and 35% vs. 43%, respectively). In multivariate analysis, flu vaccination rates in the past 12 months were approximately 40% for children who had used any type of AMS or MBBT (adjusted odds ratio, 0.61), compared with approximately 25% for children who had never used these services (adjusted OR, 0.75).

No significant differences in vaccination rates were noted for children who had used three other categories of nonconventional care: biologically based therapies (such as herbal supplements), mind-body therapies (such as yoga), and multivitamins.

“There is an opportunity for U.S. public health, policy, and conventional medical professionals and educators to improve vaccine uptake and child health by better engaging both CAM and conventional medicine practitioners-in-training, parents of children using particular domains of CAM, and the CAM practitioners advising them,” the researchers said.

Find the full article in Pediatrics (2016. doi: 10.1542/peds.2015-4664).

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Children treated with complementary and alternative medicine (CAM) therapies were significantly less likely to receive the annual influenza vaccine than those who didn’t use alternative medicine, based on data from 9,000 children aged 4-17 years in the Child Complementary and Alternative Medicine File of the 2012 National Health Interview Survey.

“CAM has been implicated as lending support to antivaccine/vaccine-hesitant viewpoints via criticism of vaccination, public health, and conventional medicine from adults using CAM, as well as from CAM practitioners and practitioners-in-training,” wrote William K. Bleser, Ph.D., and his colleagues at Pennsylvania State University, University Park.

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Overall, flu vaccination rates in children who used alternative medicine services (AMS) or manipulative and body-based therapies (MBBT) were significantly lower than in children who never used these services (33% vs. 43% and 35% vs. 43%, respectively). In multivariate analysis, flu vaccination rates in the past 12 months were approximately 40% for children who had used any type of AMS or MBBT (adjusted odds ratio, 0.61), compared with approximately 25% for children who had never used these services (adjusted OR, 0.75).

No significant differences in vaccination rates were noted for children who had used three other categories of nonconventional care: biologically based therapies (such as herbal supplements), mind-body therapies (such as yoga), and multivitamins.

“There is an opportunity for U.S. public health, policy, and conventional medical professionals and educators to improve vaccine uptake and child health by better engaging both CAM and conventional medicine practitioners-in-training, parents of children using particular domains of CAM, and the CAM practitioners advising them,” the researchers said.

Find the full article in Pediatrics (2016. doi: 10.1542/peds.2015-4664).

 

Children treated with complementary and alternative medicine (CAM) therapies were significantly less likely to receive the annual influenza vaccine than those who didn’t use alternative medicine, based on data from 9,000 children aged 4-17 years in the Child Complementary and Alternative Medicine File of the 2012 National Health Interview Survey.

“CAM has been implicated as lending support to antivaccine/vaccine-hesitant viewpoints via criticism of vaccination, public health, and conventional medicine from adults using CAM, as well as from CAM practitioners and practitioners-in-training,” wrote William K. Bleser, Ph.D., and his colleagues at Pennsylvania State University, University Park.

CAP53/iStockphoto.com
Overall, flu vaccination rates in children who used alternative medicine services (AMS) or manipulative and body-based therapies (MBBT) were significantly lower than in children who never used these services (33% vs. 43% and 35% vs. 43%, respectively). In multivariate analysis, flu vaccination rates in the past 12 months were approximately 40% for children who had used any type of AMS or MBBT (adjusted odds ratio, 0.61), compared with approximately 25% for children who had never used these services (adjusted OR, 0.75).

No significant differences in vaccination rates were noted for children who had used three other categories of nonconventional care: biologically based therapies (such as herbal supplements), mind-body therapies (such as yoga), and multivitamins.

“There is an opportunity for U.S. public health, policy, and conventional medical professionals and educators to improve vaccine uptake and child health by better engaging both CAM and conventional medicine practitioners-in-training, parents of children using particular domains of CAM, and the CAM practitioners advising them,” the researchers said.

Find the full article in Pediatrics (2016. doi: 10.1542/peds.2015-4664).

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Targeted HCV patients improve on sofosbuvir/daclatasvir combination

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Targeted HCV patients improve on sofosbuvir/daclatasvir combination

A combination of sofosbuvir/daclatasvir yielded sustained virological responses at 12 weeks after the last treatment in 95% of hepatitis C virus–infected patients with genotype 1.

“Real-life results of the sofosbuvir + ribavirin or sofosbuvir + simeprevir combination have been extensively reported, but there are few data regarding the sofosbuvir + daclatasvir combination in genotype 1–infected patients,” wrote Stanislas Pol, MD, of Hôpital Cochin, Institut Pasteur, Paris, and his colleagues.

To assess the effectiveness of the combination, researchers reviewed data from 768 patients with HCV genotype 1 who began treatments of 400 mg/day sofosbuvir and 60 mg/day daclatasvir prior to Oct. 1, 2014 (J Hepatol. 2016. doi: 10.1016/j.jhep.2016.08.021). Patients were treated for 12 or 24 weeks, and the primary endpoint was sustained virological response 12 weeks after the last treatment (SVR12).

A total of 92% of patients treated for 12 weeks and 99% of patients treated for 24 weeks with the combination met the primary endpoint of SVR12, for an average of 95% overall. Treatment duration and the presence or absence of ribavirin had no significant impact on the treatment responses in noncirrhotic patients. However, the SVR12 rate was significantly higher among cirrhotic patients in the 24-week treatment group than in the 12-week group (95% vs. 88%).

One patient died from cerebral hemorrhage 6 weeks after beginning treatment, and the death was considered possibly related to the combination treatment; two deaths from septic shock and two deaths from end-stage liver disease were not considered treatment related. Other serious adverse events were reported in 10% of patients independent of treatment duration or use of ribavirin. The six serious adverse events possibly related to treatment included three cardiac disorders. The most common adverse events included insomnia, headache, and asthenia, reported in at least 10% of patients.

Only decompensated cirrhosis and a prothrombin time greater than 70% were independently associated with serious adverse events.

The study was limited by several factors, including its observational nature and relatively low number of patients treated with ribavirin in the 12-week group, the researchers noted. However, the results suggest that “in real life, the sofosbuvir + daclatasvir combination in difficult-to-treat patients with HCV genotype 1 infection was associated with a high rate of SVR12,” they said.

Inserm-ANRS supported the study. The researchers disclosed funding from government organizations and pharmaceutical companies including MSD, Janssen, Gilead, AbbVie, BMS, and Roche.

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A combination of sofosbuvir/daclatasvir yielded sustained virological responses at 12 weeks after the last treatment in 95% of hepatitis C virus–infected patients with genotype 1.

“Real-life results of the sofosbuvir + ribavirin or sofosbuvir + simeprevir combination have been extensively reported, but there are few data regarding the sofosbuvir + daclatasvir combination in genotype 1–infected patients,” wrote Stanislas Pol, MD, of Hôpital Cochin, Institut Pasteur, Paris, and his colleagues.

To assess the effectiveness of the combination, researchers reviewed data from 768 patients with HCV genotype 1 who began treatments of 400 mg/day sofosbuvir and 60 mg/day daclatasvir prior to Oct. 1, 2014 (J Hepatol. 2016. doi: 10.1016/j.jhep.2016.08.021). Patients were treated for 12 or 24 weeks, and the primary endpoint was sustained virological response 12 weeks after the last treatment (SVR12).

A total of 92% of patients treated for 12 weeks and 99% of patients treated for 24 weeks with the combination met the primary endpoint of SVR12, for an average of 95% overall. Treatment duration and the presence or absence of ribavirin had no significant impact on the treatment responses in noncirrhotic patients. However, the SVR12 rate was significantly higher among cirrhotic patients in the 24-week treatment group than in the 12-week group (95% vs. 88%).

One patient died from cerebral hemorrhage 6 weeks after beginning treatment, and the death was considered possibly related to the combination treatment; two deaths from septic shock and two deaths from end-stage liver disease were not considered treatment related. Other serious adverse events were reported in 10% of patients independent of treatment duration or use of ribavirin. The six serious adverse events possibly related to treatment included three cardiac disorders. The most common adverse events included insomnia, headache, and asthenia, reported in at least 10% of patients.

Only decompensated cirrhosis and a prothrombin time greater than 70% were independently associated with serious adverse events.

The study was limited by several factors, including its observational nature and relatively low number of patients treated with ribavirin in the 12-week group, the researchers noted. However, the results suggest that “in real life, the sofosbuvir + daclatasvir combination in difficult-to-treat patients with HCV genotype 1 infection was associated with a high rate of SVR12,” they said.

Inserm-ANRS supported the study. The researchers disclosed funding from government organizations and pharmaceutical companies including MSD, Janssen, Gilead, AbbVie, BMS, and Roche.

A combination of sofosbuvir/daclatasvir yielded sustained virological responses at 12 weeks after the last treatment in 95% of hepatitis C virus–infected patients with genotype 1.

“Real-life results of the sofosbuvir + ribavirin or sofosbuvir + simeprevir combination have been extensively reported, but there are few data regarding the sofosbuvir + daclatasvir combination in genotype 1–infected patients,” wrote Stanislas Pol, MD, of Hôpital Cochin, Institut Pasteur, Paris, and his colleagues.

To assess the effectiveness of the combination, researchers reviewed data from 768 patients with HCV genotype 1 who began treatments of 400 mg/day sofosbuvir and 60 mg/day daclatasvir prior to Oct. 1, 2014 (J Hepatol. 2016. doi: 10.1016/j.jhep.2016.08.021). Patients were treated for 12 or 24 weeks, and the primary endpoint was sustained virological response 12 weeks after the last treatment (SVR12).

A total of 92% of patients treated for 12 weeks and 99% of patients treated for 24 weeks with the combination met the primary endpoint of SVR12, for an average of 95% overall. Treatment duration and the presence or absence of ribavirin had no significant impact on the treatment responses in noncirrhotic patients. However, the SVR12 rate was significantly higher among cirrhotic patients in the 24-week treatment group than in the 12-week group (95% vs. 88%).

One patient died from cerebral hemorrhage 6 weeks after beginning treatment, and the death was considered possibly related to the combination treatment; two deaths from septic shock and two deaths from end-stage liver disease were not considered treatment related. Other serious adverse events were reported in 10% of patients independent of treatment duration or use of ribavirin. The six serious adverse events possibly related to treatment included three cardiac disorders. The most common adverse events included insomnia, headache, and asthenia, reported in at least 10% of patients.

Only decompensated cirrhosis and a prothrombin time greater than 70% were independently associated with serious adverse events.

The study was limited by several factors, including its observational nature and relatively low number of patients treated with ribavirin in the 12-week group, the researchers noted. However, the results suggest that “in real life, the sofosbuvir + daclatasvir combination in difficult-to-treat patients with HCV genotype 1 infection was associated with a high rate of SVR12,” they said.

Inserm-ANRS supported the study. The researchers disclosed funding from government organizations and pharmaceutical companies including MSD, Janssen, Gilead, AbbVie, BMS, and Roche.

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Targeted HCV patients improve on sofosbuvir/daclatasvir combination
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FROM THE JOURNAL OF HEPATOLOGY

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Alternative CME
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114661
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Key clinical point: A sofosbuvir/daclatasvir combination was effective in most patients with HCV genotype 1, independent of an addition of ribavirin.

Major finding: Sustained virological response at 12 weeks after the last treatment occurred in 95% of patients treated with a combination of sofosbuvir and daclatasvir.

Data source: A selection of 768 patients with a HCV genotype 1 who were part of a ongoing multicenter, observational cohort study.

Disclosures: Inserm-ANRS supported the study. The researchers disclosed funding from government organizations and pharmaceutical companies including MSD, Janssen, Gilead, AbbVie, BMS, and Roche.