Bianca Nogrady

The overall rate of cholecystectomy after weight loss surgery is low, but it is more likely to occur among patients who experience excessive weight loss following their procedure and those who undergo laparoscopic Roux-en-Y gastric bypass.

Analysis of prospective data from 1,398 patients undergoing bariatric surgery showed an overall cholecystectomy rate of 7.8% over a median follow-up of 49 months, with the frequency higher in the first 6 months, according to data published in Surgery for Obesity and Related Diseases.

Cholecystectomy rates were significantly higher among individuals who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB), compared with those who received a laparoscopic adjustable gastric band (LAGB) or laparoscopic sleeve gastrectomy (LSG) (10.6% vs. 2.9% vs. 3.5%, P = .001).

"Although the LRYGB was the procedure associated with the highest rate of cholecystectomy, the present study found that this relationship was due to the superior %EWL [percent excess weight loss] associated with this procedure, compared with the LAGB and LSG procedures," wrote the late Dr. Victor B. Tsirline of Northwestern Memorial Hospital, and his colleagues.

Patients who lost more than a quarter of their weight within 3 months of surgery showed significantly higher rates of cholecystectomy, and there was a 25% increase in cholecystectomy per 10% of excess weight loss within the first 3 months after weight loss surgery, although this association was only significant among patients treated with gastric bypass (Surg. Obes. Relat. Dis. 2014;10:313-21).

There were statistically significant differences in cholecystectomy rates performed by the three surgeons involved, although again, this was only in patients who had undergone gastric bypass, and researchers said this could be partly attributed to the fact that one surgeon saw a greater proportion of revision patients.

Researchers also noted an interaction with race, as black patients had significantly lower rates of cholecystectomy, compared with white patients (2.2% vs. 8.9%, P = .0001), and Native American patients showed the highest rates of all (65%).

This study found no difference in cholecystectomy rates between patients taking ursodiol and those who weren’t.

Rapid weight loss after bariatric surgery is associated with an increased risk of gallstones, and routine cholecystectomy at the time of bariatric surgery has been the subject of considerable debate.

Those in favor argue that it prevents the morbidity of symptomatic cholelithiasis and avoids the risk of duct stones which can be difficult to treat after gastric bypass.

However opponents say routine cholecystectomy would prolong hospital stays, lengthen operating times, and potentially increase complication rates, when the use of ursodiol after weight loss surgery has been shown to decrease the frequency of gallstones.

"The findings of the present study indicate that a conservative approach to cholecystectomy, rather than prophylactic cholecystectomy, is warranted, because only 7.8% of patients developed symptomatic gallbladder disease within 4 years on average," researchers wrote.

"Furthermore, there are technical advantages of delayed cholecystectomy that stem from reduced intra-abdominal fat content and decreased liver size secondary to weight loss."

There were no conflicts of interest declared.

The overall rate of cholecystectomy after weight loss surgery is low, but it is more likely to occur among patients who experience excessive weight loss following their procedure and those who undergo laparoscopic Roux-en-Y gastric bypass.

Analysis of prospective data from 1,398 patients undergoing bariatric surgery showed an overall cholecystectomy rate of 7.8% over a median follow-up of 49 months, with the frequency higher in the first 6 months, according to data published in Surgery for Obesity and Related Diseases.

Cholecystectomy rates were significantly higher among individuals who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB), compared with those who received a laparoscopic adjustable gastric band (LAGB) or laparoscopic sleeve gastrectomy (LSG) (10.6% vs. 2.9% vs. 3.5%, P = .001).

"Although the LRYGB was the procedure associated with the highest rate of cholecystectomy, the present study found that this relationship was due to the superior %EWL [percent excess weight loss] associated with this procedure, compared with the LAGB and LSG procedures," wrote the late Dr. Victor B. Tsirline of Northwestern Memorial Hospital, and his colleagues.

Patients who lost more than a quarter of their weight within 3 months of surgery showed significantly higher rates of cholecystectomy, and there was a 25% increase in cholecystectomy per 10% of excess weight loss within the first 3 months after weight loss surgery, although this association was only significant among patients treated with gastric bypass (Surg. Obes. Relat. Dis. 2014;10:313-21).

There were statistically significant differences in cholecystectomy rates performed by the three surgeons involved, although again, this was only in patients who had undergone gastric bypass, and researchers said this could be partly attributed to the fact that one surgeon saw a greater proportion of revision patients.

Researchers also noted an interaction with race, as black patients had significantly lower rates of cholecystectomy, compared with white patients (2.2% vs. 8.9%, P = .0001), and Native American patients showed the highest rates of all (65%).

This study found no difference in cholecystectomy rates between patients taking ursodiol and those who weren’t.

Rapid weight loss after bariatric surgery is associated with an increased risk of gallstones, and routine cholecystectomy at the time of bariatric surgery has been the subject of considerable debate.

Those in favor argue that it prevents the morbidity of symptomatic cholelithiasis and avoids the risk of duct stones which can be difficult to treat after gastric bypass.

However opponents say routine cholecystectomy would prolong hospital stays, lengthen operating times, and potentially increase complication rates, when the use of ursodiol after weight loss surgery has been shown to decrease the frequency of gallstones.

"The findings of the present study indicate that a conservative approach to cholecystectomy, rather than prophylactic cholecystectomy, is warranted, because only 7.8% of patients developed symptomatic gallbladder disease within 4 years on average," researchers wrote.

"Furthermore, there are technical advantages of delayed cholecystectomy that stem from reduced intra-abdominal fat content and decreased liver size secondary to weight loss."

There were no conflicts of interest declared.

The overall rate of cholecystectomy after weight loss surgery is low, but it is more likely to occur among patients who experience excessive weight loss following their procedure and those who undergo laparoscopic Roux-en-Y gastric bypass.

Analysis of prospective data from 1,398 patients undergoing bariatric surgery showed an overall cholecystectomy rate of 7.8% over a median follow-up of 49 months, with the frequency higher in the first 6 months, according to data published in Surgery for Obesity and Related Diseases.

Cholecystectomy rates were significantly higher among individuals who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB), compared with those who received a laparoscopic adjustable gastric band (LAGB) or laparoscopic sleeve gastrectomy (LSG) (10.6% vs. 2.9% vs. 3.5%, P = .001).

"Although the LRYGB was the procedure associated with the highest rate of cholecystectomy, the present study found that this relationship was due to the superior %EWL [percent excess weight loss] associated with this procedure, compared with the LAGB and LSG procedures," wrote the late Dr. Victor B. Tsirline of Northwestern Memorial Hospital, and his colleagues.

Patients who lost more than a quarter of their weight within 3 months of surgery showed significantly higher rates of cholecystectomy, and there was a 25% increase in cholecystectomy per 10% of excess weight loss within the first 3 months after weight loss surgery, although this association was only significant among patients treated with gastric bypass (Surg. Obes. Relat. Dis. 2014;10:313-21).

There were statistically significant differences in cholecystectomy rates performed by the three surgeons involved, although again, this was only in patients who had undergone gastric bypass, and researchers said this could be partly attributed to the fact that one surgeon saw a greater proportion of revision patients.

Researchers also noted an interaction with race, as black patients had significantly lower rates of cholecystectomy, compared with white patients (2.2% vs. 8.9%, P = .0001), and Native American patients showed the highest rates of all (65%).

This study found no difference in cholecystectomy rates between patients taking ursodiol and those who weren’t.

Rapid weight loss after bariatric surgery is associated with an increased risk of gallstones, and routine cholecystectomy at the time of bariatric surgery has been the subject of considerable debate.

Those in favor argue that it prevents the morbidity of symptomatic cholelithiasis and avoids the risk of duct stones which can be difficult to treat after gastric bypass.

However opponents say routine cholecystectomy would prolong hospital stays, lengthen operating times, and potentially increase complication rates, when the use of ursodiol after weight loss surgery has been shown to decrease the frequency of gallstones.

"The findings of the present study indicate that a conservative approach to cholecystectomy, rather than prophylactic cholecystectomy, is warranted, because only 7.8% of patients developed symptomatic gallbladder disease within 4 years on average," researchers wrote.

"Furthermore, there are technical advantages of delayed cholecystectomy that stem from reduced intra-abdominal fat content and decreased liver size secondary to weight loss."

There were no conflicts of interest declared.

Clarithromycin use is linked to a significant increase in the risk of cardiac death, compared with penicillin, particularly among women, according to findings from a large Danish cohort study, which also found that roxithromycin carried no such increased risk.

Analysis of registry data from more than 5 million Danish adults prescribed 7-day courses of clarithromycin (n = 160,297), roxithromycin (n = 588,988), or penicillin V (n = 4,355,309) showed an overall 76% increase in the risk of cardiac death associated with clarithromycin. The risk was increased nearly threefold in women (adjusted rate ratio, 2.83), and it was a nonsignificant 4% higher in men, reported Henrik Svanström and his colleagues from the Statens Serum Institut, Copenhagen.

© bbbrrn/Thinkstockphotos.com

The researchers found no effect of age or concomitant use of cytochrome P450 3A inhibiting drugs on the risk of cardiac death. However, the study could not rule out confounding by lifestyle and health factors such as smoking and body mass index, they said in their report, which was published online Aug. 19 in BMJ (2014;349:g4930 [doi: 10.1136/bmj.g4930]).

"In absolute terms, 37 (95% confidence interval, 4-90) excess cardiac deaths occurred per 1 million treatment courses associated with current use of clarithromycin, compared with current penicillin V use in this study," the investigators wrote.

Mr. Svanström and his associates declared that they had no financial conflicts of interest relevant to this research.

Clarithromycin use is linked to a significant increase in the risk of cardiac death, compared with penicillin, particularly among women, according to findings from a large Danish cohort study, which also found that roxithromycin carried no such increased risk.

Analysis of registry data from more than 5 million Danish adults prescribed 7-day courses of clarithromycin (n = 160,297), roxithromycin (n = 588,988), or penicillin V (n = 4,355,309) showed an overall 76% increase in the risk of cardiac death associated with clarithromycin. The risk was increased nearly threefold in women (adjusted rate ratio, 2.83), and it was a nonsignificant 4% higher in men, reported Henrik Svanström and his colleagues from the Statens Serum Institut, Copenhagen.

© bbbrrn/Thinkstockphotos.com

The researchers found no effect of age or concomitant use of cytochrome P450 3A inhibiting drugs on the risk of cardiac death. However, the study could not rule out confounding by lifestyle and health factors such as smoking and body mass index, they said in their report, which was published online Aug. 19 in BMJ (2014;349:g4930 [doi: 10.1136/bmj.g4930]).

"In absolute terms, 37 (95% confidence interval, 4-90) excess cardiac deaths occurred per 1 million treatment courses associated with current use of clarithromycin, compared with current penicillin V use in this study," the investigators wrote.

Mr. Svanström and his associates declared that they had no financial conflicts of interest relevant to this research.

Clarithromycin use is linked to a significant increase in the risk of cardiac death, compared with penicillin, particularly among women, according to findings from a large Danish cohort study, which also found that roxithromycin carried no such increased risk.

Analysis of registry data from more than 5 million Danish adults prescribed 7-day courses of clarithromycin (n = 160,297), roxithromycin (n = 588,988), or penicillin V (n = 4,355,309) showed an overall 76% increase in the risk of cardiac death associated with clarithromycin. The risk was increased nearly threefold in women (adjusted rate ratio, 2.83), and it was a nonsignificant 4% higher in men, reported Henrik Svanström and his colleagues from the Statens Serum Institut, Copenhagen.

© bbbrrn/Thinkstockphotos.com

The researchers found no effect of age or concomitant use of cytochrome P450 3A inhibiting drugs on the risk of cardiac death. However, the study could not rule out confounding by lifestyle and health factors such as smoking and body mass index, they said in their report, which was published online Aug. 19 in BMJ (2014;349:g4930 [doi: 10.1136/bmj.g4930]).

"In absolute terms, 37 (95% confidence interval, 4-90) excess cardiac deaths occurred per 1 million treatment courses associated with current use of clarithromycin, compared with current penicillin V use in this study," the investigators wrote.

Mr. Svanström and his associates declared that they had no financial conflicts of interest relevant to this research.

MELBOURNE – Widespread availability of automated external defibrillators is far more likely than screening to prevent sudden cardiac deaths on the sports field, and has the added benefit of also preventing deaths off the sports field, said Dr. N.A. Mark Estes, professor of medicine at Tufts University, Boston.

He said there were significant knowledge gaps around the sensitivity, specificity, and predictive accuracy of screening for sudden cardiac death in athletes, and existing screening guidelines were the subject of great criticism.

"Each one of these deaths is tragic, and everyone understandably reacts in a fashion where they want to do something to prevent it," Dr. Estes, also director of the cardiac arrhythmia center at Tufts, said at the World Congress of Cardiology.

Bianca Nogrady/Frontline Medical News

"The notion has arisen that in Italy they have an effective screening program that can identify athletes at risk of sudden cardiac death, so we should be able to do it in the United States."

There are, however, significant differences between Italy and the United States, which made it unlikely that the success of the Italian screening efforts could be replicated here, he said.

"The Italians have specialized centers that are regional, they have highly skilled physicians, they have a demographic that’s completely different with a very homogeneous population base and a condition called ARVC [arrhythmogenic right ventricular cardiomyopathy] that you can effectively screen for with ECG and echocardiography."

Guidelines from the American College of Cardiology/American Heart Association currently recommend a 2-4 yearly history and physical examination for young athletes but, unlike Italy, they do not include an ECG.

The other challenge with screening is that, despite the extensive media coverage given to athletes’ deaths on the field, the condition is very rare, claiming around 150 lives each year on the sports field and 4,000 deaths off of it.

Dr. Estes said screening might result in significant numbers of athletes being excluded from the sports field even though we don’t know if restricting athletes from sport does in fact have an impact.

Instead, he argued in favor of greater availability of automated external defibrillators (AEDs) in public places and particularly recreation sites, with evidence showing survival rates above 75% for sudden cardiac death in participating high schools and colleges.

"We need to recognize that the effectiveness of the AED on the athletic field is extremely high, and we do have a way of preventing sudden death even though we can’t predict it, and the benefits for society go well beyond the athletic field," Dr. Estes said in an interview.

"If you look at the evidence, it tells us that screening hasn’t worked in the United States; it is epidemiologically and statistically highly improbable that it would ever work; so let’s put our money into something that’s going to have some proven benefits in a cost-effective fashion."

Commenting on the presentation, Dr. David Prior of St. Vincent’s Hospital, Melbourne, said he was supportive of the idea of secondary rather than primary prevention of sudden cardiac arrest.

"There is certainly ongoing debate, and there are no really good randomized, controlled trials comparing screening to no screening, and I don’t think anyone is either brave enough or has pockets deep enough, because it would be a huge trial because the event rate is so low," Dr. Prior said at the meeting, which was sponsored by the World Heart Federation.

Dr. Prior said screening was a fairly blunt tool, whereas the data suggested that AEDs were effective.

Dr. Estes disclosed consultancies with Medtronic, Boston Scientific, and St. Jude Medical.

MELBOURNE – Widespread availability of automated external defibrillators is far more likely than screening to prevent sudden cardiac deaths on the sports field, and has the added benefit of also preventing deaths off the sports field, said Dr. N.A. Mark Estes, professor of medicine at Tufts University, Boston.

He said there were significant knowledge gaps around the sensitivity, specificity, and predictive accuracy of screening for sudden cardiac death in athletes, and existing screening guidelines were the subject of great criticism.

"Each one of these deaths is tragic, and everyone understandably reacts in a fashion where they want to do something to prevent it," Dr. Estes, also director of the cardiac arrhythmia center at Tufts, said at the World Congress of Cardiology.

Bianca Nogrady/Frontline Medical News

"The notion has arisen that in Italy they have an effective screening program that can identify athletes at risk of sudden cardiac death, so we should be able to do it in the United States."

There are, however, significant differences between Italy and the United States, which made it unlikely that the success of the Italian screening efforts could be replicated here, he said.

"The Italians have specialized centers that are regional, they have highly skilled physicians, they have a demographic that’s completely different with a very homogeneous population base and a condition called ARVC [arrhythmogenic right ventricular cardiomyopathy] that you can effectively screen for with ECG and echocardiography."

Guidelines from the American College of Cardiology/American Heart Association currently recommend a 2-4 yearly history and physical examination for young athletes but, unlike Italy, they do not include an ECG.

The other challenge with screening is that, despite the extensive media coverage given to athletes’ deaths on the field, the condition is very rare, claiming around 150 lives each year on the sports field and 4,000 deaths off of it.

Dr. Estes said screening might result in significant numbers of athletes being excluded from the sports field even though we don’t know if restricting athletes from sport does in fact have an impact.

Instead, he argued in favor of greater availability of automated external defibrillators (AEDs) in public places and particularly recreation sites, with evidence showing survival rates above 75% for sudden cardiac death in participating high schools and colleges.

"We need to recognize that the effectiveness of the AED on the athletic field is extremely high, and we do have a way of preventing sudden death even though we can’t predict it, and the benefits for society go well beyond the athletic field," Dr. Estes said in an interview.

"If you look at the evidence, it tells us that screening hasn’t worked in the United States; it is epidemiologically and statistically highly improbable that it would ever work; so let’s put our money into something that’s going to have some proven benefits in a cost-effective fashion."

Commenting on the presentation, Dr. David Prior of St. Vincent’s Hospital, Melbourne, said he was supportive of the idea of secondary rather than primary prevention of sudden cardiac arrest.

"There is certainly ongoing debate, and there are no really good randomized, controlled trials comparing screening to no screening, and I don’t think anyone is either brave enough or has pockets deep enough, because it would be a huge trial because the event rate is so low," Dr. Prior said at the meeting, which was sponsored by the World Heart Federation.

Dr. Prior said screening was a fairly blunt tool, whereas the data suggested that AEDs were effective.

Dr. Estes disclosed consultancies with Medtronic, Boston Scientific, and St. Jude Medical.

MELBOURNE – Widespread availability of automated external defibrillators is far more likely than screening to prevent sudden cardiac deaths on the sports field, and has the added benefit of also preventing deaths off the sports field, said Dr. N.A. Mark Estes, professor of medicine at Tufts University, Boston.

He said there were significant knowledge gaps around the sensitivity, specificity, and predictive accuracy of screening for sudden cardiac death in athletes, and existing screening guidelines were the subject of great criticism.

"Each one of these deaths is tragic, and everyone understandably reacts in a fashion where they want to do something to prevent it," Dr. Estes, also director of the cardiac arrhythmia center at Tufts, said at the World Congress of Cardiology.

Bianca Nogrady/Frontline Medical News

"The notion has arisen that in Italy they have an effective screening program that can identify athletes at risk of sudden cardiac death, so we should be able to do it in the United States."

There are, however, significant differences between Italy and the United States, which made it unlikely that the success of the Italian screening efforts could be replicated here, he said.

"The Italians have specialized centers that are regional, they have highly skilled physicians, they have a demographic that’s completely different with a very homogeneous population base and a condition called ARVC [arrhythmogenic right ventricular cardiomyopathy] that you can effectively screen for with ECG and echocardiography."

Guidelines from the American College of Cardiology/American Heart Association currently recommend a 2-4 yearly history and physical examination for young athletes but, unlike Italy, they do not include an ECG.

The other challenge with screening is that, despite the extensive media coverage given to athletes’ deaths on the field, the condition is very rare, claiming around 150 lives each year on the sports field and 4,000 deaths off of it.

Dr. Estes said screening might result in significant numbers of athletes being excluded from the sports field even though we don’t know if restricting athletes from sport does in fact have an impact.

Instead, he argued in favor of greater availability of automated external defibrillators (AEDs) in public places and particularly recreation sites, with evidence showing survival rates above 75% for sudden cardiac death in participating high schools and colleges.

"We need to recognize that the effectiveness of the AED on the athletic field is extremely high, and we do have a way of preventing sudden death even though we can’t predict it, and the benefits for society go well beyond the athletic field," Dr. Estes said in an interview.

"If you look at the evidence, it tells us that screening hasn’t worked in the United States; it is epidemiologically and statistically highly improbable that it would ever work; so let’s put our money into something that’s going to have some proven benefits in a cost-effective fashion."

Commenting on the presentation, Dr. David Prior of St. Vincent’s Hospital, Melbourne, said he was supportive of the idea of secondary rather than primary prevention of sudden cardiac arrest.

"There is certainly ongoing debate, and there are no really good randomized, controlled trials comparing screening to no screening, and I don’t think anyone is either brave enough or has pockets deep enough, because it would be a huge trial because the event rate is so low," Dr. Prior said at the meeting, which was sponsored by the World Heart Federation.

Dr. Prior said screening was a fairly blunt tool, whereas the data suggested that AEDs were effective.

Dr. Estes disclosed consultancies with Medtronic, Boston Scientific, and St. Jude Medical.

MELBOURNE – Elevated total cholesterol and low-density lipoprotein cholesterol levels in patients with coronary heart disease were significantly associated with an increased risk of chronic kidney disease, according to a retrospective analysis of data from two large, randomized, controlled trials.

Data presented at the World Congress of Cardiology 2014 showed total cholesterol levels above 240 mg/dL were associated with a significant 78% increase in the risk of chronic kidney disease, while LDL cholesterol greater than 190 mg/dL was associated with a 72% increase in risk.

Elevated non–high-density lipoprotein cholesterol levels and the ratio of total cholesterol to HDL cholesterol were both associated with elevated risk of chronic kidney disease, but reduced HDL cholesterol and the ratio of apolipoprotein B/apolipoprotein A did not significantly affect risk.

Dyslipidemia is present in around 60% of patients with chronic kidney disease, noted presenter Dr. Prakash Deedwania, professor of medicine at the University of California, San Francisco. Previous studies in patients with coronary heart disease and chronic kidney disease also have shown that statins have a renoprotective effect.

However, Dr. Deedwania said there has been little exploration of the impact of baseline lipid parameters on renal function.

"We have found that there is a significant increase in not only the prevalence but also the morbidity and mortality in people with chronic kidney disease with coronary events and other cardiovascular events," Dr. Deedwania said in an interview.

Using data from the Treating to New Targets (TNT) study and Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) study, in which patients were treated with either atorvastatin or simvastatin, researchers were able to examine the relationship between baseline lipoprotein parameters and kidney function in a combined cohort of more than 19,000 patients with coronary heart disease.

"That showed very good relationship between total cholesterol and LDL cholesterol with progressive decline in renal function, which then helped me explain what I had observed earlier in terms of improvement in kidney function in early-stage patients with statins," Dr. Deedwania said at the meeting, which was sponsored by the World Heart Federation.

The relationship between lipoprotein parameters and chronic kidney disease persisted even after adjustment for age, body mass index, smoking status, diabetes history and status, hypertension, and treatment assignment.

The study defined chronic kidney disease as an estimated glomerular filtration rate below 60 mL/min per 1.73 m². However, Dr. Deedwania said no patients achieved stage 4 kidney disease, and all eGFR measurements fell between 45 and 60 mL/min per 1.73 m².

The analysis used a relatively early definition of kidney disease as the outcome of interest, observed session chair Dr. Vlado Perkovic, professor of medicine at the University of Sydney (Australia).

Dr. Deedwania later said he believed the key was to focus on early-stage interventions rather than waiting until the disease progressed and suggested some interventional trials had failed to achieve an effect because they were done in more advanced patients.

The researchers declared a range of speakers fees, consultancies, and honoraria from the pharmaceutical industry; two of the authors were employees of Pfizer.

MELBOURNE – Elevated total cholesterol and low-density lipoprotein cholesterol levels in patients with coronary heart disease were significantly associated with an increased risk of chronic kidney disease, according to a retrospective analysis of data from two large, randomized, controlled trials.

Data presented at the World Congress of Cardiology 2014 showed total cholesterol levels above 240 mg/dL were associated with a significant 78% increase in the risk of chronic kidney disease, while LDL cholesterol greater than 190 mg/dL was associated with a 72% increase in risk.

Elevated non–high-density lipoprotein cholesterol levels and the ratio of total cholesterol to HDL cholesterol were both associated with elevated risk of chronic kidney disease, but reduced HDL cholesterol and the ratio of apolipoprotein B/apolipoprotein A did not significantly affect risk.

Dyslipidemia is present in around 60% of patients with chronic kidney disease, noted presenter Dr. Prakash Deedwania, professor of medicine at the University of California, San Francisco. Previous studies in patients with coronary heart disease and chronic kidney disease also have shown that statins have a renoprotective effect.

However, Dr. Deedwania said there has been little exploration of the impact of baseline lipid parameters on renal function.

"We have found that there is a significant increase in not only the prevalence but also the morbidity and mortality in people with chronic kidney disease with coronary events and other cardiovascular events," Dr. Deedwania said in an interview.

Using data from the Treating to New Targets (TNT) study and Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) study, in which patients were treated with either atorvastatin or simvastatin, researchers were able to examine the relationship between baseline lipoprotein parameters and kidney function in a combined cohort of more than 19,000 patients with coronary heart disease.

"That showed very good relationship between total cholesterol and LDL cholesterol with progressive decline in renal function, which then helped me explain what I had observed earlier in terms of improvement in kidney function in early-stage patients with statins," Dr. Deedwania said at the meeting, which was sponsored by the World Heart Federation.

The relationship between lipoprotein parameters and chronic kidney disease persisted even after adjustment for age, body mass index, smoking status, diabetes history and status, hypertension, and treatment assignment.

The study defined chronic kidney disease as an estimated glomerular filtration rate below 60 mL/min per 1.73 m². However, Dr. Deedwania said no patients achieved stage 4 kidney disease, and all eGFR measurements fell between 45 and 60 mL/min per 1.73 m².

The analysis used a relatively early definition of kidney disease as the outcome of interest, observed session chair Dr. Vlado Perkovic, professor of medicine at the University of Sydney (Australia).

Dr. Deedwania later said he believed the key was to focus on early-stage interventions rather than waiting until the disease progressed and suggested some interventional trials had failed to achieve an effect because they were done in more advanced patients.

The researchers declared a range of speakers fees, consultancies, and honoraria from the pharmaceutical industry; two of the authors were employees of Pfizer.

MELBOURNE – Elevated total cholesterol and low-density lipoprotein cholesterol levels in patients with coronary heart disease were significantly associated with an increased risk of chronic kidney disease, according to a retrospective analysis of data from two large, randomized, controlled trials.

Data presented at the World Congress of Cardiology 2014 showed total cholesterol levels above 240 mg/dL were associated with a significant 78% increase in the risk of chronic kidney disease, while LDL cholesterol greater than 190 mg/dL was associated with a 72% increase in risk.

Elevated non–high-density lipoprotein cholesterol levels and the ratio of total cholesterol to HDL cholesterol were both associated with elevated risk of chronic kidney disease, but reduced HDL cholesterol and the ratio of apolipoprotein B/apolipoprotein A did not significantly affect risk.

Dyslipidemia is present in around 60% of patients with chronic kidney disease, noted presenter Dr. Prakash Deedwania, professor of medicine at the University of California, San Francisco. Previous studies in patients with coronary heart disease and chronic kidney disease also have shown that statins have a renoprotective effect.

However, Dr. Deedwania said there has been little exploration of the impact of baseline lipid parameters on renal function.

"We have found that there is a significant increase in not only the prevalence but also the morbidity and mortality in people with chronic kidney disease with coronary events and other cardiovascular events," Dr. Deedwania said in an interview.

Using data from the Treating to New Targets (TNT) study and Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) study, in which patients were treated with either atorvastatin or simvastatin, researchers were able to examine the relationship between baseline lipoprotein parameters and kidney function in a combined cohort of more than 19,000 patients with coronary heart disease.

"That showed very good relationship between total cholesterol and LDL cholesterol with progressive decline in renal function, which then helped me explain what I had observed earlier in terms of improvement in kidney function in early-stage patients with statins," Dr. Deedwania said at the meeting, which was sponsored by the World Heart Federation.

The relationship between lipoprotein parameters and chronic kidney disease persisted even after adjustment for age, body mass index, smoking status, diabetes history and status, hypertension, and treatment assignment.

The study defined chronic kidney disease as an estimated glomerular filtration rate below 60 mL/min per 1.73 m². However, Dr. Deedwania said no patients achieved stage 4 kidney disease, and all eGFR measurements fell between 45 and 60 mL/min per 1.73 m².

The analysis used a relatively early definition of kidney disease as the outcome of interest, observed session chair Dr. Vlado Perkovic, professor of medicine at the University of Sydney (Australia).

Dr. Deedwania later said he believed the key was to focus on early-stage interventions rather than waiting until the disease progressed and suggested some interventional trials had failed to achieve an effect because they were done in more advanced patients.

The researchers declared a range of speakers fees, consultancies, and honoraria from the pharmaceutical industry; two of the authors were employees of Pfizer.

Fever, infection with organisms other than Escherichia coli, elevated C-reactive protein, and an abnormal ultrasonographic finding are significant predictors of a higher risk of renal scarring among children and adolescents with a first episode of urinary tract infection, a meta-analysis has found.

Urinary tract infection (UTI) is the most common serious bacterial infection in children, and studies have shown that in 10%-15% of cases it leads to renal scarring (Pediatrics 2010;126:1084-91). If the renal scarring is considerable and results in a reduction in kidney function, it may be associated with hypertension, preeclampsia, and end-stage renal disease in adult life, studies have found (J. Hypertens. 2000;18:485-91; Pediatr. Nephrol. 1996;10:139-42).

The analysis of patient data from 1,280 individuals in nine cohort studies also showed a polymorphonuclear cell count of greater than 60% nearly doubled the risk while the presence of grades IV-V vesicoureteral reflux was associated with a 22-fold increase in the likelihood of renal scarring, defined as presence of photopenia on a technetium Tc 99m succimer renal scan.

"Although our data confirm the importance of high-grade VUR’ [vesicoureteral reflux] as a risk factor for renal scarring, they do not resolve the difficult question of how to identify this important but small subgroup of children without subjecting all children to a VCUG [voiding cystourethrogram]," reported Dr. Nader Shaikh of the Children’s Hospital of Pittsburgh, and his colleagues in a paper published online in the Aug. 4 issue of JAMA Pediatrics.

Researchers used the data to generate a predictive model using the three variables of temperature, ultrasonographic findings, and etiologic organism, whereby children with a score of two or more had twice the baseline risk of scarring (JAMA Pediatrics 2014, Aug. 4 [doi:10.1001/jamapediatrics.2014.637]).

The investigators found that 78.3% of patients are at low or intermediate risk of renal scarring from their first diagnosed UTI. They have normal renal ultrasound findings and only one of two other findings: a temperature of at least 39° C or an organism other than E. coli. Children with all three of the findings have twice the risk of renal scarring and constitute 21.7% of patients. The latter group merit close clinical follow-up and possibly a technetium Tc 99m succimer renal scan. "But the potential merits of obtaining a late scan clearly need to be explored in future prospective studies before the scan can be recommended," Dr. Nader Shaikh of the Children’s Hospital of Pittsburgh, and his colleagues wrote.

In an accompanying editorial, Dr. Kenneth B. Roberts of the University of North Carolina, Chapel Hill, said the findings shift the focus from vesicoureteral reflux to renal scarring, and confirm the value of renal-bladder ultrasonogram as a predictor of renal damage.

"High fever and organisms other than E. coli are also predictors, but notably, adding a VCUG and serum inflammatory markers to the evaluation contributes very little," Dr. Roberts wrote (JAMA Pediatrics 2014, Aug. 4 [doi:10.1001/jamapediatrics.2014.1329]).

No conflicts of interest were reported for the study or editorial.

[email protected]

Fever, infection with organisms other than Escherichia coli, elevated C-reactive protein, and an abnormal ultrasonographic finding are significant predictors of a higher risk of renal scarring among children and adolescents with a first episode of urinary tract infection, a meta-analysis has found.

Urinary tract infection (UTI) is the most common serious bacterial infection in children, and studies have shown that in 10%-15% of cases it leads to renal scarring (Pediatrics 2010;126:1084-91). If the renal scarring is considerable and results in a reduction in kidney function, it may be associated with hypertension, preeclampsia, and end-stage renal disease in adult life, studies have found (J. Hypertens. 2000;18:485-91; Pediatr. Nephrol. 1996;10:139-42).

The analysis of patient data from 1,280 individuals in nine cohort studies also showed a polymorphonuclear cell count of greater than 60% nearly doubled the risk while the presence of grades IV-V vesicoureteral reflux was associated with a 22-fold increase in the likelihood of renal scarring, defined as presence of photopenia on a technetium Tc 99m succimer renal scan.

"Although our data confirm the importance of high-grade VUR’ [vesicoureteral reflux] as a risk factor for renal scarring, they do not resolve the difficult question of how to identify this important but small subgroup of children without subjecting all children to a VCUG [voiding cystourethrogram]," reported Dr. Nader Shaikh of the Children’s Hospital of Pittsburgh, and his colleagues in a paper published online in the Aug. 4 issue of JAMA Pediatrics.

Researchers used the data to generate a predictive model using the three variables of temperature, ultrasonographic findings, and etiologic organism, whereby children with a score of two or more had twice the baseline risk of scarring (JAMA Pediatrics 2014, Aug. 4 [doi:10.1001/jamapediatrics.2014.637]).

The investigators found that 78.3% of patients are at low or intermediate risk of renal scarring from their first diagnosed UTI. They have normal renal ultrasound findings and only one of two other findings: a temperature of at least 39° C or an organism other than E. coli. Children with all three of the findings have twice the risk of renal scarring and constitute 21.7% of patients. The latter group merit close clinical follow-up and possibly a technetium Tc 99m succimer renal scan. "But the potential merits of obtaining a late scan clearly need to be explored in future prospective studies before the scan can be recommended," Dr. Nader Shaikh of the Children’s Hospital of Pittsburgh, and his colleagues wrote.

In an accompanying editorial, Dr. Kenneth B. Roberts of the University of North Carolina, Chapel Hill, said the findings shift the focus from vesicoureteral reflux to renal scarring, and confirm the value of renal-bladder ultrasonogram as a predictor of renal damage.

"High fever and organisms other than E. coli are also predictors, but notably, adding a VCUG and serum inflammatory markers to the evaluation contributes very little," Dr. Roberts wrote (JAMA Pediatrics 2014, Aug. 4 [doi:10.1001/jamapediatrics.2014.1329]).

No conflicts of interest were reported for the study or editorial.

[email protected]

Fever, infection with organisms other than Escherichia coli, elevated C-reactive protein, and an abnormal ultrasonographic finding are significant predictors of a higher risk of renal scarring among children and adolescents with a first episode of urinary tract infection, a meta-analysis has found.

Urinary tract infection (UTI) is the most common serious bacterial infection in children, and studies have shown that in 10%-15% of cases it leads to renal scarring (Pediatrics 2010;126:1084-91). If the renal scarring is considerable and results in a reduction in kidney function, it may be associated with hypertension, preeclampsia, and end-stage renal disease in adult life, studies have found (J. Hypertens. 2000;18:485-91; Pediatr. Nephrol. 1996;10:139-42).

The analysis of patient data from 1,280 individuals in nine cohort studies also showed a polymorphonuclear cell count of greater than 60% nearly doubled the risk while the presence of grades IV-V vesicoureteral reflux was associated with a 22-fold increase in the likelihood of renal scarring, defined as presence of photopenia on a technetium Tc 99m succimer renal scan.

"Although our data confirm the importance of high-grade VUR’ [vesicoureteral reflux] as a risk factor for renal scarring, they do not resolve the difficult question of how to identify this important but small subgroup of children without subjecting all children to a VCUG [voiding cystourethrogram]," reported Dr. Nader Shaikh of the Children’s Hospital of Pittsburgh, and his colleagues in a paper published online in the Aug. 4 issue of JAMA Pediatrics.

Researchers used the data to generate a predictive model using the three variables of temperature, ultrasonographic findings, and etiologic organism, whereby children with a score of two or more had twice the baseline risk of scarring (JAMA Pediatrics 2014, Aug. 4 [doi:10.1001/jamapediatrics.2014.637]).

The investigators found that 78.3% of patients are at low or intermediate risk of renal scarring from their first diagnosed UTI. They have normal renal ultrasound findings and only one of two other findings: a temperature of at least 39° C or an organism other than E. coli. Children with all three of the findings have twice the risk of renal scarring and constitute 21.7% of patients. The latter group merit close clinical follow-up and possibly a technetium Tc 99m succimer renal scan. "But the potential merits of obtaining a late scan clearly need to be explored in future prospective studies before the scan can be recommended," Dr. Nader Shaikh of the Children’s Hospital of Pittsburgh, and his colleagues wrote.

In an accompanying editorial, Dr. Kenneth B. Roberts of the University of North Carolina, Chapel Hill, said the findings shift the focus from vesicoureteral reflux to renal scarring, and confirm the value of renal-bladder ultrasonogram as a predictor of renal damage.

"High fever and organisms other than E. coli are also predictors, but notably, adding a VCUG and serum inflammatory markers to the evaluation contributes very little," Dr. Roberts wrote (JAMA Pediatrics 2014, Aug. 4 [doi:10.1001/jamapediatrics.2014.1329]).

No conflicts of interest were reported for the study or editorial.

[email protected]

MELBOURNE – One-third of HIV-positive children treated with antiretroviral therapy before 3 months of age will become HIV antibody–negative, but still be HIV positive, according to data presented at the 20th International AIDS Conference.

Presenter Louise Kuhn, Ph.D., professor of epidemiology at the Mailman School of Public Health at Columbia University, N.Y., said these perinatally infected children were likely to encounter clinical confusion in their later life because of their antibody-negative status.

Dr. Kuhn and her colleagues found around 30% of children who began antiretroviral therapy (ART) before 3 months of age had undetectable HIV antibodies when tested between 3-6 years of age using a standard enzyme-linked immunosorbent assay (ELISA).

The frequency of antibody-negative status decreased with increasing age of ART initiation – overall, 16% of children who began treatment before 6 months of age had low or no HIV antibodies, but there were no antibody-negative children among those who began treatment after 6 months of age.

The retrospective study initially enrolled 104 HIV-infected children aged 3-6 years from Johannesburg, South Africa, who were under 15 months of age when they started ART but were now virally suppressed with a viral load below 50 copies/mL. Researchers later added another 122 children who had begun treatment before 6 months of age.

Dr. Kuhn said standard HIV antibody tests are usually considered diagnostic, however, it was not previously expected that some individuals would revert to being antibody negative.

"In the pediatric field, there have been anecdotal reports of treated children known to be HIV infected but who have lost their HIV-positive status over time, including the Mississippi baby, as well as several other well-treated children who started therapy early," Dr Kuhn said at the conference.

The phenomenon is likely to cause some confusion in the clinical setting, for example when it comes to disclosure or children wanting to be retested, and the clinical significance of HIV antibody–negative status is unclear.

"One doesn’t want to by any means be telling the parents that their child is now negative and they can stop treatment, so I think addressing that confusion potentially might be a bigger problem going forward," Dr. Kuhn said in an interview.

"It’s about the health care workers being really educated and attuned to the subtleties of this, which I think we’re only beginning to appreciate as HIV turns out to be more complicated than we hoped," she said.

Dr. Kuhn said the standard practice of testing children 4-6 weeks after birth may be too late because by the time treatment is usually initiated, they are already around 3 months old.

"I was trying to make that point that we’re too late with what we’re doing currently, they’ve got to shift it earlier," she said.

"We’re learning more and more about what’s going on with early treatment, and so it’s opening up a whole area of research that we really need to look at in more detail in terms of what is happening with neonatal immune development, which may be related to HIV control," she concluded.

There were no disclosures.

MELBOURNE – One-third of HIV-positive children treated with antiretroviral therapy before 3 months of age will become HIV antibody–negative, but still be HIV positive, according to data presented at the 20th International AIDS Conference.

Presenter Louise Kuhn, Ph.D., professor of epidemiology at the Mailman School of Public Health at Columbia University, N.Y., said these perinatally infected children were likely to encounter clinical confusion in their later life because of their antibody-negative status.

Dr. Kuhn and her colleagues found around 30% of children who began antiretroviral therapy (ART) before 3 months of age had undetectable HIV antibodies when tested between 3-6 years of age using a standard enzyme-linked immunosorbent assay (ELISA).

The frequency of antibody-negative status decreased with increasing age of ART initiation – overall, 16% of children who began treatment before 6 months of age had low or no HIV antibodies, but there were no antibody-negative children among those who began treatment after 6 months of age.

The retrospective study initially enrolled 104 HIV-infected children aged 3-6 years from Johannesburg, South Africa, who were under 15 months of age when they started ART but were now virally suppressed with a viral load below 50 copies/mL. Researchers later added another 122 children who had begun treatment before 6 months of age.

Dr. Kuhn said standard HIV antibody tests are usually considered diagnostic, however, it was not previously expected that some individuals would revert to being antibody negative.

"In the pediatric field, there have been anecdotal reports of treated children known to be HIV infected but who have lost their HIV-positive status over time, including the Mississippi baby, as well as several other well-treated children who started therapy early," Dr Kuhn said at the conference.

The phenomenon is likely to cause some confusion in the clinical setting, for example when it comes to disclosure or children wanting to be retested, and the clinical significance of HIV antibody–negative status is unclear.

"One doesn’t want to by any means be telling the parents that their child is now negative and they can stop treatment, so I think addressing that confusion potentially might be a bigger problem going forward," Dr. Kuhn said in an interview.

"It’s about the health care workers being really educated and attuned to the subtleties of this, which I think we’re only beginning to appreciate as HIV turns out to be more complicated than we hoped," she said.

Dr. Kuhn said the standard practice of testing children 4-6 weeks after birth may be too late because by the time treatment is usually initiated, they are already around 3 months old.

"I was trying to make that point that we’re too late with what we’re doing currently, they’ve got to shift it earlier," she said.

"We’re learning more and more about what’s going on with early treatment, and so it’s opening up a whole area of research that we really need to look at in more detail in terms of what is happening with neonatal immune development, which may be related to HIV control," she concluded.

There were no disclosures.

MELBOURNE – One-third of HIV-positive children treated with antiretroviral therapy before 3 months of age will become HIV antibody–negative, but still be HIV positive, according to data presented at the 20th International AIDS Conference.

Presenter Louise Kuhn, Ph.D., professor of epidemiology at the Mailman School of Public Health at Columbia University, N.Y., said these perinatally infected children were likely to encounter clinical confusion in their later life because of their antibody-negative status.

Dr. Kuhn and her colleagues found around 30% of children who began antiretroviral therapy (ART) before 3 months of age had undetectable HIV antibodies when tested between 3-6 years of age using a standard enzyme-linked immunosorbent assay (ELISA).

The frequency of antibody-negative status decreased with increasing age of ART initiation – overall, 16% of children who began treatment before 6 months of age had low or no HIV antibodies, but there were no antibody-negative children among those who began treatment after 6 months of age.

The retrospective study initially enrolled 104 HIV-infected children aged 3-6 years from Johannesburg, South Africa, who were under 15 months of age when they started ART but were now virally suppressed with a viral load below 50 copies/mL. Researchers later added another 122 children who had begun treatment before 6 months of age.

Dr. Kuhn said standard HIV antibody tests are usually considered diagnostic, however, it was not previously expected that some individuals would revert to being antibody negative.

"In the pediatric field, there have been anecdotal reports of treated children known to be HIV infected but who have lost their HIV-positive status over time, including the Mississippi baby, as well as several other well-treated children who started therapy early," Dr Kuhn said at the conference.

The phenomenon is likely to cause some confusion in the clinical setting, for example when it comes to disclosure or children wanting to be retested, and the clinical significance of HIV antibody–negative status is unclear.

"One doesn’t want to by any means be telling the parents that their child is now negative and they can stop treatment, so I think addressing that confusion potentially might be a bigger problem going forward," Dr. Kuhn said in an interview.

"It’s about the health care workers being really educated and attuned to the subtleties of this, which I think we’re only beginning to appreciate as HIV turns out to be more complicated than we hoped," she said.

Dr. Kuhn said the standard practice of testing children 4-6 weeks after birth may be too late because by the time treatment is usually initiated, they are already around 3 months old.

"I was trying to make that point that we’re too late with what we’re doing currently, they’ve got to shift it earlier," she said.

"We’re learning more and more about what’s going on with early treatment, and so it’s opening up a whole area of research that we really need to look at in more detail in terms of what is happening with neonatal immune development, which may be related to HIV control," she concluded.

There were no disclosures.

MELBOURNE – One-third of HIV-positive children treated with antiretroviral therapy before 3 months of age will become HIV antibody–negative, but still be HIV positive, according to data presented at the 20th International AIDS Conference.

Presenter Louise Kuhn, Ph.D., professor of epidemiology at the Mailman School of Public Health at Columbia University, N.Y., said these perinatally infected children were likely to encounter clinical confusion in their later life because of their antibody-negative status.

Bianca Nogrady/Frontline Medical News

Dr. Kuhn and her colleagues found around 30% of children who began antiretroviral therapy (ART) before 3 months of age had undetectable HIV antibodies when tested between 3-6 years of age using a standard enzyme-linked immunosorbent assay (ELISA).

The frequency of antibody-negative status decreased with increasing age of ART initiation – overall, 16% of children who began treatment before 6 months of age had low or no HIV antibodies, but there were no antibody-negative children among those who began treatment after 6 months of age.

The retrospective study initially enrolled 104 HIV-infected children aged 3-6 years from Johannesburg, South Africa, who were under 15 months of age when they started ART but were now virally suppressed with a viral load below 50 copies/mL. Researchers later added another 122 children who had begun treatment before 6 months of age.

Dr. Kuhn said standard HIV antibody tests are usually considered diagnostic, however, it was not previously expected that some individuals would revert to being antibody negative.

"In the pediatric field, there have been anecdotal reports of treated children known to be HIV infected but who have lost their HIV-positive status over time, including the Mississippi baby, as well as several other well-treated children who started therapy early," Dr Kuhn said at the conference.

The phenomenon is likely to cause some confusion in the clinical setting, for example when it comes to disclosure or children wanting to be retested, and the clinical significance of HIV antibody–negative status is unclear.

"One doesn’t want to by any means be telling the parents that their child is now negative and they can stop treatment, so I think addressing that confusion potentially might be a bigger problem going forward," Dr. Kuhn said in an interview.

"It’s about the health care workers being really educated and attuned to the subtleties of this, which I think we’re only beginning to appreciate as HIV turns out to be more complicated than we hoped," she said.

Dr. Kuhn said the standard practice of testing children 4-6 weeks after birth may be too late because by the time treatment is usually initiated, they are already around 3 months old.

"I was trying to make that point that we’re too late with what we’re doing currently, they’ve got to shift it earlier," she said.

"We’re learning more and more about what’s going on with early treatment, and so it’s opening up a whole area of research that we really need to look at in more detail in terms of what is happening with neonatal immune development, which may be related to HIV control," she concluded.

There were no disclosures.

MELBOURNE – One-third of HIV-positive children treated with antiretroviral therapy before 3 months of age will become HIV antibody–negative, but still be HIV positive, according to data presented at the 20th International AIDS Conference.

Presenter Louise Kuhn, Ph.D., professor of epidemiology at the Mailman School of Public Health at Columbia University, N.Y., said these perinatally infected children were likely to encounter clinical confusion in their later life because of their antibody-negative status.

Bianca Nogrady/Frontline Medical News

Dr. Kuhn and her colleagues found around 30% of children who began antiretroviral therapy (ART) before 3 months of age had undetectable HIV antibodies when tested between 3-6 years of age using a standard enzyme-linked immunosorbent assay (ELISA).

The frequency of antibody-negative status decreased with increasing age of ART initiation – overall, 16% of children who began treatment before 6 months of age had low or no HIV antibodies, but there were no antibody-negative children among those who began treatment after 6 months of age.

The retrospective study initially enrolled 104 HIV-infected children aged 3-6 years from Johannesburg, South Africa, who were under 15 months of age when they started ART but were now virally suppressed with a viral load below 50 copies/mL. Researchers later added another 122 children who had begun treatment before 6 months of age.

Dr. Kuhn said standard HIV antibody tests are usually considered diagnostic, however, it was not previously expected that some individuals would revert to being antibody negative.

"In the pediatric field, there have been anecdotal reports of treated children known to be HIV infected but who have lost their HIV-positive status over time, including the Mississippi baby, as well as several other well-treated children who started therapy early," Dr Kuhn said at the conference.

The phenomenon is likely to cause some confusion in the clinical setting, for example when it comes to disclosure or children wanting to be retested, and the clinical significance of HIV antibody–negative status is unclear.

"One doesn’t want to by any means be telling the parents that their child is now negative and they can stop treatment, so I think addressing that confusion potentially might be a bigger problem going forward," Dr. Kuhn said in an interview.

"It’s about the health care workers being really educated and attuned to the subtleties of this, which I think we’re only beginning to appreciate as HIV turns out to be more complicated than we hoped," she said.

Dr. Kuhn said the standard practice of testing children 4-6 weeks after birth may be too late because by the time treatment is usually initiated, they are already around 3 months old.

"I was trying to make that point that we’re too late with what we’re doing currently, they’ve got to shift it earlier," she said.

"We’re learning more and more about what’s going on with early treatment, and so it’s opening up a whole area of research that we really need to look at in more detail in terms of what is happening with neonatal immune development, which may be related to HIV control," she concluded.

There were no disclosures.

MELBOURNE – One-third of HIV-positive children treated with antiretroviral therapy before 3 months of age will become HIV antibody–negative, but still be HIV positive, according to data presented at the 20th International AIDS Conference.

Presenter Louise Kuhn, Ph.D., professor of epidemiology at the Mailman School of Public Health at Columbia University, N.Y., said these perinatally infected children were likely to encounter clinical confusion in their later life because of their antibody-negative status.

Bianca Nogrady/Frontline Medical News

Dr. Kuhn and her colleagues found around 30% of children who began antiretroviral therapy (ART) before 3 months of age had undetectable HIV antibodies when tested between 3-6 years of age using a standard enzyme-linked immunosorbent assay (ELISA).

The frequency of antibody-negative status decreased with increasing age of ART initiation – overall, 16% of children who began treatment before 6 months of age had low or no HIV antibodies, but there were no antibody-negative children among those who began treatment after 6 months of age.

The retrospective study initially enrolled 104 HIV-infected children aged 3-6 years from Johannesburg, South Africa, who were under 15 months of age when they started ART but were now virally suppressed with a viral load below 50 copies/mL. Researchers later added another 122 children who had begun treatment before 6 months of age.

Dr. Kuhn said standard HIV antibody tests are usually considered diagnostic, however, it was not previously expected that some individuals would revert to being antibody negative.

"In the pediatric field, there have been anecdotal reports of treated children known to be HIV infected but who have lost their HIV-positive status over time, including the Mississippi baby, as well as several other well-treated children who started therapy early," Dr Kuhn said at the conference.

The phenomenon is likely to cause some confusion in the clinical setting, for example when it comes to disclosure or children wanting to be retested, and the clinical significance of HIV antibody–negative status is unclear.

"One doesn’t want to by any means be telling the parents that their child is now negative and they can stop treatment, so I think addressing that confusion potentially might be a bigger problem going forward," Dr. Kuhn said in an interview.

"It’s about the health care workers being really educated and attuned to the subtleties of this, which I think we’re only beginning to appreciate as HIV turns out to be more complicated than we hoped," she said.

Dr. Kuhn said the standard practice of testing children 4-6 weeks after birth may be too late because by the time treatment is usually initiated, they are already around 3 months old.

"I was trying to make that point that we’re too late with what we’re doing currently, they’ve got to shift it earlier," she said.

"We’re learning more and more about what’s going on with early treatment, and so it’s opening up a whole area of research that we really need to look at in more detail in terms of what is happening with neonatal immune development, which may be related to HIV control," she concluded.

There were no disclosures.

Acetaminophen taken regularly or as required was no better than placebo in improving time to recovery in patients with acute low back pain, Australian research shows.

A randomized, placebo-controlled, double-dummy study in 1,643 patients presenting with acute low back pain found the median time to recovery was 17 days, both in patients assigned to 665 mg acetaminophen three times daily and in those told to take acetaminophen as required, and was 16 days in the placebo group.

After 12 weeks, similar numbers of patients in each group had achieved sustained recovery: 84.7% of participants taking regular acetaminophen, 82.8% of patients taking acetaminophen as required, and 84.3% of the placebo group.

©Rocky89/thinkstockphotos.com

"The clinical implications of PACE [Paracetamol for Low-Back Pain Study] require careful consideration of the efficacy of paracetamol [acetaminophen] with respect to the safe use of medicines for low back pain," the study authors wrote in the Lancet (2014 July 24 [doi:10.1016/ S0140-6736(14)60805-9]).

Acetaminophen traditionally has been recommended over anti-inflammatory medication because the side effect profile is safer, noted study coauthor Chung-Wei Christine Lin, Ph.D. However, the recommendation for its use in low back pain has come from indirect evidence in other pain conditions.

"Our advice to patients should be that for back pain, the prognosis is mostly good, most people recover reasonably well, they should stay active, and they should avoid bed rest," said Dr. Lin of the George Institute for Global Health, University of Sydney. "Beyond that, the emphasis on taking pain relief should probably be reduced, because taking pain relief doesn’t really do much beyond placebo."

A previous Cochrane review examining the use of anti-inflammatories for short-term pain relief found only a small effect, Dr. Lin noted, and other direct comparisons between anti-inflammatories and acetaminophen have shown no differences in effects.

"Patients should weigh the benefits of taking medicine for a small amount pain relief against the potential side effects and discuss this with their doctor or pharmacist" she cautioned.

The National Health and Medical Research Council of Australia and GlaxoSmithKline funded the study. Dr. Lin had no relevant financial disclosures.

Acetaminophen taken regularly or as required was no better than placebo in improving time to recovery in patients with acute low back pain, Australian research shows.

A randomized, placebo-controlled, double-dummy study in 1,643 patients presenting with acute low back pain found the median time to recovery was 17 days, both in patients assigned to 665 mg acetaminophen three times daily and in those told to take acetaminophen as required, and was 16 days in the placebo group.

After 12 weeks, similar numbers of patients in each group had achieved sustained recovery: 84.7% of participants taking regular acetaminophen, 82.8% of patients taking acetaminophen as required, and 84.3% of the placebo group.

©Rocky89/thinkstockphotos.com

"The clinical implications of PACE [Paracetamol for Low-Back Pain Study] require careful consideration of the efficacy of paracetamol [acetaminophen] with respect to the safe use of medicines for low back pain," the study authors wrote in the Lancet (2014 July 24 [doi:10.1016/ S0140-6736(14)60805-9]).

Acetaminophen traditionally has been recommended over anti-inflammatory medication because the side effect profile is safer, noted study coauthor Chung-Wei Christine Lin, Ph.D. However, the recommendation for its use in low back pain has come from indirect evidence in other pain conditions.

"Our advice to patients should be that for back pain, the prognosis is mostly good, most people recover reasonably well, they should stay active, and they should avoid bed rest," said Dr. Lin of the George Institute for Global Health, University of Sydney. "Beyond that, the emphasis on taking pain relief should probably be reduced, because taking pain relief doesn’t really do much beyond placebo."

A previous Cochrane review examining the use of anti-inflammatories for short-term pain relief found only a small effect, Dr. Lin noted, and other direct comparisons between anti-inflammatories and acetaminophen have shown no differences in effects.

"Patients should weigh the benefits of taking medicine for a small amount pain relief against the potential side effects and discuss this with their doctor or pharmacist" she cautioned.

The National Health and Medical Research Council of Australia and GlaxoSmithKline funded the study. Dr. Lin had no relevant financial disclosures.

Acetaminophen taken regularly or as required was no better than placebo in improving time to recovery in patients with acute low back pain, Australian research shows.

A randomized, placebo-controlled, double-dummy study in 1,643 patients presenting with acute low back pain found the median time to recovery was 17 days, both in patients assigned to 665 mg acetaminophen three times daily and in those told to take acetaminophen as required, and was 16 days in the placebo group.

After 12 weeks, similar numbers of patients in each group had achieved sustained recovery: 84.7% of participants taking regular acetaminophen, 82.8% of patients taking acetaminophen as required, and 84.3% of the placebo group.

©Rocky89/thinkstockphotos.com

"The clinical implications of PACE [Paracetamol for Low-Back Pain Study] require careful consideration of the efficacy of paracetamol [acetaminophen] with respect to the safe use of medicines for low back pain," the study authors wrote in the Lancet (2014 July 24 [doi:10.1016/ S0140-6736(14)60805-9]).

Acetaminophen traditionally has been recommended over anti-inflammatory medication because the side effect profile is safer, noted study coauthor Chung-Wei Christine Lin, Ph.D. However, the recommendation for its use in low back pain has come from indirect evidence in other pain conditions.

"Our advice to patients should be that for back pain, the prognosis is mostly good, most people recover reasonably well, they should stay active, and they should avoid bed rest," said Dr. Lin of the George Institute for Global Health, University of Sydney. "Beyond that, the emphasis on taking pain relief should probably be reduced, because taking pain relief doesn’t really do much beyond placebo."

A previous Cochrane review examining the use of anti-inflammatories for short-term pain relief found only a small effect, Dr. Lin noted, and other direct comparisons between anti-inflammatories and acetaminophen have shown no differences in effects.

"Patients should weigh the benefits of taking medicine for a small amount pain relief against the potential side effects and discuss this with their doctor or pharmacist" she cautioned.

The National Health and Medical Research Council of Australia and GlaxoSmithKline funded the study. Dr. Lin had no relevant financial disclosures.

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the posttest. 

Tuberculosis, HIV, and malaria incidence and mortality have all declined significantly since the formulation of Millennium Development Goal 6 in 2000, which focused global attention on these three diseases and made them a priority.

Analysis of data from the Global Burden of Disease Study 2013 showed that annual deaths from tuberculosis among HIV-negative individuals decreased 1.4% from 1.8 million in 1990 to 1.3 million in 2013, while the global incidence of malaria appears to have peaked at 232 million in 2003 and since dropped 29% to 165 million new cases in 2013.

The study was published July 21 in JAMA coincident with the start of the 20th International AIDS Conference in Melbourne.Interventions such as prevention of mother-to-child transmission, and antiretroviral therapy (ART), have seen HIV deaths fall from 1.7 million in 2005 to 1.3 million in 2013 – a decline of 3.1% – representing 19.1 million life-years saved, mostly in developing countries, according to data published online July 22 in the Lancet.

However the prevalence of HIV-positive individuals has risen to 29.2 million in 2013, having increased at a rate of 1.2% per year since 2000 (Lancet 2014 July 22 [doi: 10.1016/ S0140-6736(14)60844-8]).

"There is substantial variation both in levels and trends for all three diseases across countries," wrote Dr. Christopher J. L. Murray, the director of the Institute for Health Metrics and Evaluation and professor of global health at the University of Washington, Seattle, and his associates.

"HIV and malaria incidence and death are concentrated in sub-Saharan Africa, whereas tuberculosis burden is more widespread but most pronounced in south and southeast Asia."

The authors pointed out that their estimates of the number of people living with HIV were 18.7% smaller and estimates for HIV mortality were 14.5% smaller than UNAIDS’s estimates for 2012.

"Revisions of the global epidemiology of HIV of this magnitude – in view of the weakness of direct measurement of incidence and death – should not be surprising," the authors wrote.

They suggested that the differences between their figures and those from UNAIDS could be partly attributed to their significantly lower estimates of mortality from concentrated epidemics such as those in Panama, Colombia, and Russia.

The Global Burden of Disease Study also selected epidemic curves for large generalized epidemics that were consistent with prevalence data, all-cause mortality, and data on survival with and without ART, which the authors said had shifted median survival up.

"For example, in southern Africa, median survival off ART for the age-group 25-34 years increased from 10.5 years to 11.5 years."

Similarly, the authors noted significant differences between their estimates and those from the World Health Organization in the prevalence of tuberculosis, commenting that in general they estimated higher mortality, lower prevalence and incidence, and a smaller fraction of tuberculosis related to HIV infection.

The study showed that HIV infections in children have declined by 62.4% since their peak in 2002; however, the authors said the continued 1.7 million new infections in adults each year were a stark reminder that the Millennium Development Goal’s work was far from done.

"The focus of the global health community on action to reduce HIV/AIDS, tuberculosis, and malaria, enshrined in MDG6 [Millennium Development Goal 6], was not only appropriate in 2000 at the Millennium Declaration, but is increasingly relevant now in view of the slow but important progress that disease control strategies have yielded, particularly since 2005.

"Much remains to be done, however: although evidence now exists that the implementation of known interventions is beginning to have an effect, it is probably less than is widely believed, or hoped."

In an accompanying editorial, Dr. Rifat Atun, professor of global health systems and director of the global health systems cluster at Harvard University’s School of Public Health, Boston, called for a revolution in the reporting of global health data, with new standards to make data, methods, and models available for all, enabling greater transparency, scrutiny, and accountability in global health research.

Describing the paper as "a bold and welcome action" in its efforts to clarify the reasons for differences in estimates between the global burden of disease data, and data from UNAIDS and WHO, Dr. Atun said that global health studies should strive for rigor of data, methods, and results.

"By providing detailed information on key data sources, key adjustments to data, modeling strategies, and uncertainty analyses, Murray and colleagues have pushed the boundaries of reporting in global health to levels expected of other disciplines and areas of health research – an important step in the right direction," Dr. Atun wrote.

The Global Burden of Disease Study is funded by the Bill & Melinda Gates Foundation. Some authors declared consultancies, lecture fees, honoraria, and grants from public funding sources and private industry. The editorial author declared no conflicts of interest.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the posttest. 

Tuberculosis, HIV, and malaria incidence and mortality have all declined significantly since the formulation of Millennium Development Goal 6 in 2000, which focused global attention on these three diseases and made them a priority.

Analysis of data from the Global Burden of Disease Study 2013 showed that annual deaths from tuberculosis among HIV-negative individuals decreased 1.4% from 1.8 million in 1990 to 1.3 million in 2013, while the global incidence of malaria appears to have peaked at 232 million in 2003 and since dropped 29% to 165 million new cases in 2013.

The study was published July 21 in JAMA coincident with the start of the 20th International AIDS Conference in Melbourne.Interventions such as prevention of mother-to-child transmission, and antiretroviral therapy (ART), have seen HIV deaths fall from 1.7 million in 2005 to 1.3 million in 2013 – a decline of 3.1% – representing 19.1 million life-years saved, mostly in developing countries, according to data published online July 22 in the Lancet.

However the prevalence of HIV-positive individuals has risen to 29.2 million in 2013, having increased at a rate of 1.2% per year since 2000 (Lancet 2014 July 22 [doi: 10.1016/ S0140-6736(14)60844-8]).

"There is substantial variation both in levels and trends for all three diseases across countries," wrote Dr. Christopher J. L. Murray, the director of the Institute for Health Metrics and Evaluation and professor of global health at the University of Washington, Seattle, and his associates.

"HIV and malaria incidence and death are concentrated in sub-Saharan Africa, whereas tuberculosis burden is more widespread but most pronounced in south and southeast Asia."

The authors pointed out that their estimates of the number of people living with HIV were 18.7% smaller and estimates for HIV mortality were 14.5% smaller than UNAIDS’s estimates for 2012.

"Revisions of the global epidemiology of HIV of this magnitude – in view of the weakness of direct measurement of incidence and death – should not be surprising," the authors wrote.

They suggested that the differences between their figures and those from UNAIDS could be partly attributed to their significantly lower estimates of mortality from concentrated epidemics such as those in Panama, Colombia, and Russia.

The Global Burden of Disease Study also selected epidemic curves for large generalized epidemics that were consistent with prevalence data, all-cause mortality, and data on survival with and without ART, which the authors said had shifted median survival up.

"For example, in southern Africa, median survival off ART for the age-group 25-34 years increased from 10.5 years to 11.5 years."

Similarly, the authors noted significant differences between their estimates and those from the World Health Organization in the prevalence of tuberculosis, commenting that in general they estimated higher mortality, lower prevalence and incidence, and a smaller fraction of tuberculosis related to HIV infection.

The study showed that HIV infections in children have declined by 62.4% since their peak in 2002; however, the authors said the continued 1.7 million new infections in adults each year were a stark reminder that the Millennium Development Goal’s work was far from done.

"The focus of the global health community on action to reduce HIV/AIDS, tuberculosis, and malaria, enshrined in MDG6 [Millennium Development Goal 6], was not only appropriate in 2000 at the Millennium Declaration, but is increasingly relevant now in view of the slow but important progress that disease control strategies have yielded, particularly since 2005.

"Much remains to be done, however: although evidence now exists that the implementation of known interventions is beginning to have an effect, it is probably less than is widely believed, or hoped."

In an accompanying editorial, Dr. Rifat Atun, professor of global health systems and director of the global health systems cluster at Harvard University’s School of Public Health, Boston, called for a revolution in the reporting of global health data, with new standards to make data, methods, and models available for all, enabling greater transparency, scrutiny, and accountability in global health research.

Describing the paper as "a bold and welcome action" in its efforts to clarify the reasons for differences in estimates between the global burden of disease data, and data from UNAIDS and WHO, Dr. Atun said that global health studies should strive for rigor of data, methods, and results.

"By providing detailed information on key data sources, key adjustments to data, modeling strategies, and uncertainty analyses, Murray and colleagues have pushed the boundaries of reporting in global health to levels expected of other disciplines and areas of health research – an important step in the right direction," Dr. Atun wrote.

The Global Burden of Disease Study is funded by the Bill & Melinda Gates Foundation. Some authors declared consultancies, lecture fees, honoraria, and grants from public funding sources and private industry. The editorial author declared no conflicts of interest.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the posttest. 

Tuberculosis, HIV, and malaria incidence and mortality have all declined significantly since the formulation of Millennium Development Goal 6 in 2000, which focused global attention on these three diseases and made them a priority.

Analysis of data from the Global Burden of Disease Study 2013 showed that annual deaths from tuberculosis among HIV-negative individuals decreased 1.4% from 1.8 million in 1990 to 1.3 million in 2013, while the global incidence of malaria appears to have peaked at 232 million in 2003 and since dropped 29% to 165 million new cases in 2013.

The study was published July 21 in JAMA coincident with the start of the 20th International AIDS Conference in Melbourne.Interventions such as prevention of mother-to-child transmission, and antiretroviral therapy (ART), have seen HIV deaths fall from 1.7 million in 2005 to 1.3 million in 2013 – a decline of 3.1% – representing 19.1 million life-years saved, mostly in developing countries, according to data published online July 22 in the Lancet.

However the prevalence of HIV-positive individuals has risen to 29.2 million in 2013, having increased at a rate of 1.2% per year since 2000 (Lancet 2014 July 22 [doi: 10.1016/ S0140-6736(14)60844-8]).

"There is substantial variation both in levels and trends for all three diseases across countries," wrote Dr. Christopher J. L. Murray, the director of the Institute for Health Metrics and Evaluation and professor of global health at the University of Washington, Seattle, and his associates.

"HIV and malaria incidence and death are concentrated in sub-Saharan Africa, whereas tuberculosis burden is more widespread but most pronounced in south and southeast Asia."

The authors pointed out that their estimates of the number of people living with HIV were 18.7% smaller and estimates for HIV mortality were 14.5% smaller than UNAIDS’s estimates for 2012.

"Revisions of the global epidemiology of HIV of this magnitude – in view of the weakness of direct measurement of incidence and death – should not be surprising," the authors wrote.

They suggested that the differences between their figures and those from UNAIDS could be partly attributed to their significantly lower estimates of mortality from concentrated epidemics such as those in Panama, Colombia, and Russia.

The Global Burden of Disease Study also selected epidemic curves for large generalized epidemics that were consistent with prevalence data, all-cause mortality, and data on survival with and without ART, which the authors said had shifted median survival up.

"For example, in southern Africa, median survival off ART for the age-group 25-34 years increased from 10.5 years to 11.5 years."

Similarly, the authors noted significant differences between their estimates and those from the World Health Organization in the prevalence of tuberculosis, commenting that in general they estimated higher mortality, lower prevalence and incidence, and a smaller fraction of tuberculosis related to HIV infection.

The study showed that HIV infections in children have declined by 62.4% since their peak in 2002; however, the authors said the continued 1.7 million new infections in adults each year were a stark reminder that the Millennium Development Goal’s work was far from done.

"The focus of the global health community on action to reduce HIV/AIDS, tuberculosis, and malaria, enshrined in MDG6 [Millennium Development Goal 6], was not only appropriate in 2000 at the Millennium Declaration, but is increasingly relevant now in view of the slow but important progress that disease control strategies have yielded, particularly since 2005.

"Much remains to be done, however: although evidence now exists that the implementation of known interventions is beginning to have an effect, it is probably less than is widely believed, or hoped."

In an accompanying editorial, Dr. Rifat Atun, professor of global health systems and director of the global health systems cluster at Harvard University’s School of Public Health, Boston, called for a revolution in the reporting of global health data, with new standards to make data, methods, and models available for all, enabling greater transparency, scrutiny, and accountability in global health research.

Describing the paper as "a bold and welcome action" in its efforts to clarify the reasons for differences in estimates between the global burden of disease data, and data from UNAIDS and WHO, Dr. Atun said that global health studies should strive for rigor of data, methods, and results.

"By providing detailed information on key data sources, key adjustments to data, modeling strategies, and uncertainty analyses, Murray and colleagues have pushed the boundaries of reporting in global health to levels expected of other disciplines and areas of health research – an important step in the right direction," Dr. Atun wrote.

The Global Burden of Disease Study is funded by the Bill & Melinda Gates Foundation. Some authors declared consultancies, lecture fees, honoraria, and grants from public funding sources and private industry. The editorial author declared no conflicts of interest.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

MELBOURNE – A regimen of ABT-450 coformulated with ritonavir, ombitasvir, and dasabuvir, plus ribavirin, resulted in high rates of sustained virologic response in hepatitis C patients co-infected with HIV. Further, the treatment approach did not have a negative effect on HIV viral load.

Data from the open-label study, presented at the 20th International AIDS Conference, showed that nearly 94% of patients treated with the three-dose (3D) interferon-free regimen plus ribavirin for 12 weeks had a sustained virologic response at 4 weeks after treatment cessation. Nearly 97% of those treated for 24 weeks achieved a sustained virologic response at 4 weeks after treatment cessation.

Biance Nogrady/Frontline Medical News

The TURQUOISE-I study assessed the 3D plus ribavirin regimen in 63 patients with hepatitis C genotype 1 infection plus HIV-1 infection. The treatment group included treatment-naive patients and patients previously treated with interferon.

Dr. Mark S. Sulkowski, who presented the data, said earlier phase III studies of the 3D regimen, both with and without ribavirin, showed greater than 96% sustained virologic response rates in HCV-1–infected patients treated for 12 weeks, and 92%-96% response rates in patients with cirrhosis treated for 12-24 weeks.

"Drug interactions with hepatitis C and HIV regimens are the foremost question when approaching treatment in this group," Dr. Sulkowski, professor of medicine at Johns Hopkins University, Baltimore, told conference attendees.

Virologic failure occurred in two patients. Both had previously not responded to treatment and had compensated cirrhosis, and both also had resistance-associated HCV variants that had not been present at baseline.

The majority of adverse events were mild. The most common was fatigue, affecting 58% of patients in the 12-week arm and 37% in the 24-week arm. Other adverse events included insomnia, nausea, and headache. No patients discontinued therapy because of adverse events.

Researchers also observed grade 3 elevations in total bilirubin levels in more than 35% of patients in the 12-week arm of the study and nearly 19% of patients in the 24-week arm. Most of the grade 3 elevations occurred in patients receiving the antiretroviral atazanavir for their HIV infections.

Dr. Sulkowski said side effects and drug interactions associated with interferon therapy have largely accounted for problems in treating patients co-infected with HIV and hepatitis C.

The emerging data suggest the interferon-free regimen "works just as well in HIV-positive patients as in HIV-negative patients, so the barriers really come down to potential interactions with antiretroviral drugs," Dr. Sulkowski said in an interview.

"We now believe that HIV in and of itself is not a factor in predicting success with interferon-free regimens," he said.

Dr. Sulkowski said the Food and Drug Administration is considering applications for the 3D regimen, with and without ribavirin, with a decision expected in the fall.

Dr. Sulkowski declared grant support, consultancies, and advisory board positions with several companies, including study sponsor AbbVie.

MELBOURNE – A regimen of ABT-450 coformulated with ritonavir, ombitasvir, and dasabuvir, plus ribavirin, resulted in high rates of sustained virologic response in hepatitis C patients co-infected with HIV. Further, the treatment approach did not have a negative effect on HIV viral load.

Data from the open-label study, presented at the 20th International AIDS Conference, showed that nearly 94% of patients treated with the three-dose (3D) interferon-free regimen plus ribavirin for 12 weeks had a sustained virologic response at 4 weeks after treatment cessation. Nearly 97% of those treated for 24 weeks achieved a sustained virologic response at 4 weeks after treatment cessation.

Biance Nogrady/Frontline Medical News

The TURQUOISE-I study assessed the 3D plus ribavirin regimen in 63 patients with hepatitis C genotype 1 infection plus HIV-1 infection. The treatment group included treatment-naive patients and patients previously treated with interferon.

Dr. Mark S. Sulkowski, who presented the data, said earlier phase III studies of the 3D regimen, both with and without ribavirin, showed greater than 96% sustained virologic response rates in HCV-1–infected patients treated for 12 weeks, and 92%-96% response rates in patients with cirrhosis treated for 12-24 weeks.

"Drug interactions with hepatitis C and HIV regimens are the foremost question when approaching treatment in this group," Dr. Sulkowski, professor of medicine at Johns Hopkins University, Baltimore, told conference attendees.

Virologic failure occurred in two patients. Both had previously not responded to treatment and had compensated cirrhosis, and both also had resistance-associated HCV variants that had not been present at baseline.

The majority of adverse events were mild. The most common was fatigue, affecting 58% of patients in the 12-week arm and 37% in the 24-week arm. Other adverse events included insomnia, nausea, and headache. No patients discontinued therapy because of adverse events.

Researchers also observed grade 3 elevations in total bilirubin levels in more than 35% of patients in the 12-week arm of the study and nearly 19% of patients in the 24-week arm. Most of the grade 3 elevations occurred in patients receiving the antiretroviral atazanavir for their HIV infections.

Dr. Sulkowski said side effects and drug interactions associated with interferon therapy have largely accounted for problems in treating patients co-infected with HIV and hepatitis C.

The emerging data suggest the interferon-free regimen "works just as well in HIV-positive patients as in HIV-negative patients, so the barriers really come down to potential interactions with antiretroviral drugs," Dr. Sulkowski said in an interview.

"We now believe that HIV in and of itself is not a factor in predicting success with interferon-free regimens," he said.

Dr. Sulkowski said the Food and Drug Administration is considering applications for the 3D regimen, with and without ribavirin, with a decision expected in the fall.

Dr. Sulkowski declared grant support, consultancies, and advisory board positions with several companies, including study sponsor AbbVie.

MELBOURNE – A regimen of ABT-450 coformulated with ritonavir, ombitasvir, and dasabuvir, plus ribavirin, resulted in high rates of sustained virologic response in hepatitis C patients co-infected with HIV. Further, the treatment approach did not have a negative effect on HIV viral load.

Data from the open-label study, presented at the 20th International AIDS Conference, showed that nearly 94% of patients treated with the three-dose (3D) interferon-free regimen plus ribavirin for 12 weeks had a sustained virologic response at 4 weeks after treatment cessation. Nearly 97% of those treated for 24 weeks achieved a sustained virologic response at 4 weeks after treatment cessation.

Biance Nogrady/Frontline Medical News

The TURQUOISE-I study assessed the 3D plus ribavirin regimen in 63 patients with hepatitis C genotype 1 infection plus HIV-1 infection. The treatment group included treatment-naive patients and patients previously treated with interferon.

Dr. Mark S. Sulkowski, who presented the data, said earlier phase III studies of the 3D regimen, both with and without ribavirin, showed greater than 96% sustained virologic response rates in HCV-1–infected patients treated for 12 weeks, and 92%-96% response rates in patients with cirrhosis treated for 12-24 weeks.

"Drug interactions with hepatitis C and HIV regimens are the foremost question when approaching treatment in this group," Dr. Sulkowski, professor of medicine at Johns Hopkins University, Baltimore, told conference attendees.

Virologic failure occurred in two patients. Both had previously not responded to treatment and had compensated cirrhosis, and both also had resistance-associated HCV variants that had not been present at baseline.

The majority of adverse events were mild. The most common was fatigue, affecting 58% of patients in the 12-week arm and 37% in the 24-week arm. Other adverse events included insomnia, nausea, and headache. No patients discontinued therapy because of adverse events.

Researchers also observed grade 3 elevations in total bilirubin levels in more than 35% of patients in the 12-week arm of the study and nearly 19% of patients in the 24-week arm. Most of the grade 3 elevations occurred in patients receiving the antiretroviral atazanavir for their HIV infections.

Dr. Sulkowski said side effects and drug interactions associated with interferon therapy have largely accounted for problems in treating patients co-infected with HIV and hepatitis C.

The emerging data suggest the interferon-free regimen "works just as well in HIV-positive patients as in HIV-negative patients, so the barriers really come down to potential interactions with antiretroviral drugs," Dr. Sulkowski said in an interview.

"We now believe that HIV in and of itself is not a factor in predicting success with interferon-free regimens," he said.

Dr. Sulkowski said the Food and Drug Administration is considering applications for the 3D regimen, with and without ribavirin, with a decision expected in the fall.

Dr. Sulkowski declared grant support, consultancies, and advisory board positions with several companies, including study sponsor AbbVie.