Unintended pregnancies fewer with Mirena vs. copper IUD

Both IUDs are good choices
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Unintended pregnancies fewer with Mirena vs. copper IUD

HONOLULU – The risk of unintended pregnancy was 84% lower with use of levonorgestrel-releasing intrauterine devices than with copper intrauterine devices, according to an analysis of secondary outcomes in a prospective international cohort study of 61,448 women.

EURAS-IUD (the European Active Surveillance Study for Intrauterine Devices) reported its primary outcome in early 2014, showing very low and similar uterine perforation rates in women receiving either levonorgestrel-releasing IUDs or copper IUDs for the first time.

Among secondary outcomes, the levonorgestrel-releasing IUD (Mirena) was associated with a significantly lower risk of unintended pregnancy than were copper IUDs, after adjustment for the influence of age, body mass index, and parity, Dr. Klaas Heinemann Jr. and his associates reported at the annual meeting of the American Society for Reproductive Medicine.

The risk of ectopic pregnancy also was lower with the Mirena than with copper IUDs, showing a 74% decrease in the likelihood of ectopic pregnancy after adjustment for the effects of age, body mass index, and parity, said

Dr. Klaas Heinemann, Jr.

Dr. Heinemann of the Berlin Center for Epidemiology and Health Research.

Rates of unintended or ectopic pregnancies were very low in both groups.

Among the 43,078 women receiving the Mirena, follow-up information on 41,001 women aged 18-50 years provided data on 44,633 women-years of observation. Among the 18,370 women receiving copper IUDs, follow-up information on 17,323 women aged 18-50 years provided data on 17,703 women-years of observation.

The 26 contraceptive failures on the Mirena included 13 in women with unrecognized expulsion of the IUD and 1 with a dislocated IUD. The 92 contraceptive failures on copper IUDs included 16 women with unrecognized expulsion of the IUD and 26 with a dislocated IUD.

On the Pearl Index of contraception effectiveness (the number of unintended pregnancies divided by 100 women-years), the Mirena rated 0.06 and copper IUDs rated 0.52, Dr. Heinemann reported. Pregnancy incidence rates were less than 0.08/100 women-years with the Mirena and less than 0.56/100 women-years with copper IUDs.

The lower pregnancy rate with the Mirena was present in all age groups, he added.

Seven confirmed ectopic pregnancies in the Mirena group and 14 in the copper IUD group produced incidence rates of less than 0.05/100 women-years with the Mirena and less than 0.10/100 women-years with copper IUDs.

The 70% of women who received the Mirena tended to be older (mean age, 37 years) than those who got copper IUDs (mean age, 33 years). The women who got the Mirena also were less likely to have delivered a child within the prior year (20%) or to be breast-feeding at the time of insertion (9%), compared with women who got copper IUDs (29% and 15%, respectively).

The research was funded by Bayer, which markets Mirena. Dr. Heinemann is a former employee of Bayer Schering Pharma.

sboschert@frontlinemedcom.com


On Twitter @sherryboschert

References

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All contraceptives, particularly IUDs, are very effective. Keep in mind that this is one study that showed a difference between the two IUDs. I don’t think any other studies in the past, in the years that both IUDs have been on the market, have shown this type of phenomenon.

This study was sponsored by a pharmaceutical company. I think you have to take any industry-sponsored results with a grain of salt if they show major differences. My reading of this study is that there are differences, but the differences are much lower than any complications or problems with pregnancy in and of itself, without a contraceptive agent.

The way I would spin this for any prospective patient is that all IUDs, both the levonorgestrel-releasing IUD and the copper IUD, are great methods of contraception. Pregnancy rates are low overall and the risk of ectopic pregnancy is low.

The Pearl Index was below 1, which is good. The Pearl Index for the copper IUD was higher than reported in previous studies. That’s a little unusual.

It’s hard to take a lot from this study other than to say these are two very good methods of contraception. I’m awaiting the full paper before I would be too concerned about changing prescribing habits. If you are a Mirena prescriber, continue to be a Mirena prescriber. I don’t think there’s anything alarming here, although it’s a little surprising because it does go against what’s been shown in previous studies.

Dr. Michael A. Thomas is professor of ob.gyn. and chief of the division of reproductive endocrinology and infertility at the University of Cincinnati. He gave these remarks in an interview. Dr. Thomas has been an adviser to Teva Pharmaceutical Industries, which markets copper IUDs, and has participated in clinical trials that helped bring the Mirena IUD to market.

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All contraceptives, particularly IUDs, are very effective. Keep in mind that this is one study that showed a difference between the two IUDs. I don’t think any other studies in the past, in the years that both IUDs have been on the market, have shown this type of phenomenon.

This study was sponsored by a pharmaceutical company. I think you have to take any industry-sponsored results with a grain of salt if they show major differences. My reading of this study is that there are differences, but the differences are much lower than any complications or problems with pregnancy in and of itself, without a contraceptive agent.

The way I would spin this for any prospective patient is that all IUDs, both the levonorgestrel-releasing IUD and the copper IUD, are great methods of contraception. Pregnancy rates are low overall and the risk of ectopic pregnancy is low.

The Pearl Index was below 1, which is good. The Pearl Index for the copper IUD was higher than reported in previous studies. That’s a little unusual.

It’s hard to take a lot from this study other than to say these are two very good methods of contraception. I’m awaiting the full paper before I would be too concerned about changing prescribing habits. If you are a Mirena prescriber, continue to be a Mirena prescriber. I don’t think there’s anything alarming here, although it’s a little surprising because it does go against what’s been shown in previous studies.

Dr. Michael A. Thomas is professor of ob.gyn. and chief of the division of reproductive endocrinology and infertility at the University of Cincinnati. He gave these remarks in an interview. Dr. Thomas has been an adviser to Teva Pharmaceutical Industries, which markets copper IUDs, and has participated in clinical trials that helped bring the Mirena IUD to market.

Body

All contraceptives, particularly IUDs, are very effective. Keep in mind that this is one study that showed a difference between the two IUDs. I don’t think any other studies in the past, in the years that both IUDs have been on the market, have shown this type of phenomenon.

This study was sponsored by a pharmaceutical company. I think you have to take any industry-sponsored results with a grain of salt if they show major differences. My reading of this study is that there are differences, but the differences are much lower than any complications or problems with pregnancy in and of itself, without a contraceptive agent.

The way I would spin this for any prospective patient is that all IUDs, both the levonorgestrel-releasing IUD and the copper IUD, are great methods of contraception. Pregnancy rates are low overall and the risk of ectopic pregnancy is low.

The Pearl Index was below 1, which is good. The Pearl Index for the copper IUD was higher than reported in previous studies. That’s a little unusual.

It’s hard to take a lot from this study other than to say these are two very good methods of contraception. I’m awaiting the full paper before I would be too concerned about changing prescribing habits. If you are a Mirena prescriber, continue to be a Mirena prescriber. I don’t think there’s anything alarming here, although it’s a little surprising because it does go against what’s been shown in previous studies.

Dr. Michael A. Thomas is professor of ob.gyn. and chief of the division of reproductive endocrinology and infertility at the University of Cincinnati. He gave these remarks in an interview. Dr. Thomas has been an adviser to Teva Pharmaceutical Industries, which markets copper IUDs, and has participated in clinical trials that helped bring the Mirena IUD to market.

Title
Both IUDs are good choices
Both IUDs are good choices

HONOLULU – The risk of unintended pregnancy was 84% lower with use of levonorgestrel-releasing intrauterine devices than with copper intrauterine devices, according to an analysis of secondary outcomes in a prospective international cohort study of 61,448 women.

EURAS-IUD (the European Active Surveillance Study for Intrauterine Devices) reported its primary outcome in early 2014, showing very low and similar uterine perforation rates in women receiving either levonorgestrel-releasing IUDs or copper IUDs for the first time.

Among secondary outcomes, the levonorgestrel-releasing IUD (Mirena) was associated with a significantly lower risk of unintended pregnancy than were copper IUDs, after adjustment for the influence of age, body mass index, and parity, Dr. Klaas Heinemann Jr. and his associates reported at the annual meeting of the American Society for Reproductive Medicine.

The risk of ectopic pregnancy also was lower with the Mirena than with copper IUDs, showing a 74% decrease in the likelihood of ectopic pregnancy after adjustment for the effects of age, body mass index, and parity, said

Dr. Klaas Heinemann, Jr.

Dr. Heinemann of the Berlin Center for Epidemiology and Health Research.

Rates of unintended or ectopic pregnancies were very low in both groups.

Among the 43,078 women receiving the Mirena, follow-up information on 41,001 women aged 18-50 years provided data on 44,633 women-years of observation. Among the 18,370 women receiving copper IUDs, follow-up information on 17,323 women aged 18-50 years provided data on 17,703 women-years of observation.

The 26 contraceptive failures on the Mirena included 13 in women with unrecognized expulsion of the IUD and 1 with a dislocated IUD. The 92 contraceptive failures on copper IUDs included 16 women with unrecognized expulsion of the IUD and 26 with a dislocated IUD.

On the Pearl Index of contraception effectiveness (the number of unintended pregnancies divided by 100 women-years), the Mirena rated 0.06 and copper IUDs rated 0.52, Dr. Heinemann reported. Pregnancy incidence rates were less than 0.08/100 women-years with the Mirena and less than 0.56/100 women-years with copper IUDs.

The lower pregnancy rate with the Mirena was present in all age groups, he added.

Seven confirmed ectopic pregnancies in the Mirena group and 14 in the copper IUD group produced incidence rates of less than 0.05/100 women-years with the Mirena and less than 0.10/100 women-years with copper IUDs.

The 70% of women who received the Mirena tended to be older (mean age, 37 years) than those who got copper IUDs (mean age, 33 years). The women who got the Mirena also were less likely to have delivered a child within the prior year (20%) or to be breast-feeding at the time of insertion (9%), compared with women who got copper IUDs (29% and 15%, respectively).

The research was funded by Bayer, which markets Mirena. Dr. Heinemann is a former employee of Bayer Schering Pharma.

sboschert@frontlinemedcom.com


On Twitter @sherryboschert

HONOLULU – The risk of unintended pregnancy was 84% lower with use of levonorgestrel-releasing intrauterine devices than with copper intrauterine devices, according to an analysis of secondary outcomes in a prospective international cohort study of 61,448 women.

EURAS-IUD (the European Active Surveillance Study for Intrauterine Devices) reported its primary outcome in early 2014, showing very low and similar uterine perforation rates in women receiving either levonorgestrel-releasing IUDs or copper IUDs for the first time.

Among secondary outcomes, the levonorgestrel-releasing IUD (Mirena) was associated with a significantly lower risk of unintended pregnancy than were copper IUDs, after adjustment for the influence of age, body mass index, and parity, Dr. Klaas Heinemann Jr. and his associates reported at the annual meeting of the American Society for Reproductive Medicine.

The risk of ectopic pregnancy also was lower with the Mirena than with copper IUDs, showing a 74% decrease in the likelihood of ectopic pregnancy after adjustment for the effects of age, body mass index, and parity, said

Dr. Klaas Heinemann, Jr.

Dr. Heinemann of the Berlin Center for Epidemiology and Health Research.

Rates of unintended or ectopic pregnancies were very low in both groups.

Among the 43,078 women receiving the Mirena, follow-up information on 41,001 women aged 18-50 years provided data on 44,633 women-years of observation. Among the 18,370 women receiving copper IUDs, follow-up information on 17,323 women aged 18-50 years provided data on 17,703 women-years of observation.

The 26 contraceptive failures on the Mirena included 13 in women with unrecognized expulsion of the IUD and 1 with a dislocated IUD. The 92 contraceptive failures on copper IUDs included 16 women with unrecognized expulsion of the IUD and 26 with a dislocated IUD.

On the Pearl Index of contraception effectiveness (the number of unintended pregnancies divided by 100 women-years), the Mirena rated 0.06 and copper IUDs rated 0.52, Dr. Heinemann reported. Pregnancy incidence rates were less than 0.08/100 women-years with the Mirena and less than 0.56/100 women-years with copper IUDs.

The lower pregnancy rate with the Mirena was present in all age groups, he added.

Seven confirmed ectopic pregnancies in the Mirena group and 14 in the copper IUD group produced incidence rates of less than 0.05/100 women-years with the Mirena and less than 0.10/100 women-years with copper IUDs.

The 70% of women who received the Mirena tended to be older (mean age, 37 years) than those who got copper IUDs (mean age, 33 years). The women who got the Mirena also were less likely to have delivered a child within the prior year (20%) or to be breast-feeding at the time of insertion (9%), compared with women who got copper IUDs (29% and 15%, respectively).

The research was funded by Bayer, which markets Mirena. Dr. Heinemann is a former employee of Bayer Schering Pharma.

sboschert@frontlinemedcom.com


On Twitter @sherryboschert

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Key clinical point: The adjusted risk of unintended pregnancy was 84% lower with levonorgestrel-releasing IUDs than with copper IUDs.

Major finding: Pregnancy incidence rates were less than 0.08/100 women-years with the Mirena and less than 0.56/100 women-years with copper IUDs.

Data source: Secondary outcomes analysis in a prospective, multinational cohort study of 61,448 women receiving IUDs.

Disclosures: The research was funded by Bayer, which markets Mirena. Dr. Heinemann is a former employee of Bayer Schering Pharma.

Plurality main factor in adverse ART outcomes

Low rate of defects comforting
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Plurality main factor in adverse ART outcomes

HONOLULU – Modest increases in the risks of cardiac and noncardiac fetal defects in babies born from assisted reproductive technology are likely due to the increased likelihood of multiple births and not the procedures themselves, an analysis of 335,910 births suggests.

In a separate analysis, certain assisted reproductive technology methods were associated with higher or lower risks of adverse maternal and fetal outcomes, but plurality played a much bigger role in the risk of adverse outcomes.

“ART does not appear to be a major cause of birth defects; however, there are modest increases in both cardiac and noncardiac defects,” Kelly D. Getz, Ph.D., reported at the annual meeting of the American Society for Reproductive Medicine (ASRM). “The relationship between ART and birth defects is mediated through multiple birth,” a factor that may be more important for cardiac and for noncardiac defects.

Dr. Kelly D. Getz

“Plurality is the predominant ART treatment risk factor associated with excess morbidity for both mothers and infants,” Barbara Luke, Sc.D.said. “Other treatment factors had much less or no effect,” especially the semen source, assisted hatching, or the number of embryos transferred.

The two analyses, presented separately by Dr. Getz and Dr. Luke, were part of the Massachusetts Outcomes Study of Assisted Reproductive Technologies (ART), which linked data on births in Massachusetts between 2004 and 2008 in the Pregnancy to Early Life Longitudinal database with data from the Massachusetts Birth Defects Monitoring Program. Older age was significantly associated with the use of ART and outcomes, so the analyses adjusted for the influence of age.

A comparison of 324,148 births from spontaneous conception and 11,762 births from ART estimated prevalence ratios for patients with ART of 1.6 for any cardiac defect, septal defects, or atrial septal defects; 1.8 for ventricular septal defects; 2.1 for conotruncal and aortic arch; and 3.8 for tetralogy of Fallot.

The estimated prevalence ratios among patients with ART for noncardiac defects included 1.2 for any noncardiac defect, 1.3 for genitourinary defects, 1.5 for gastrointestinal or musculoskeletal defects, and 1.6 for hypospadias, said Dr. Getz of the Massachusetts Department of Public Health, Boston.

The prevalence of defects differed in singletons and multiples. For singletons, the prevalence of cardiac defects was 60 per 10,000 births after ART and 46/10,000 without ART. Among multiples, the prevalence of cardiac defects was 101/10,000 with ART and 91/10,000 without ART. The adjusted prevalence ratios for cardiac defects were higher in multiples with or without ART (2), compared with singletons with ART (1.1) or without ART (1, the reference group), but did not differ significantly within each subgroup based on whether or not ART was used.

Dr. Barbara Luke

Similarly, for noncardiac defects, the prevalence among singletons was 163/10,000 with ART and 133/10,000 without ART, and among multiples was 200/10,000 with ART and 179/10,000 without ART. The adjusted prevalence ratios were 1.4 for multiples with ART, 1.3 for multiples without ART, and 1.2 for singletons with ART.

A separate analysis in the study looked at maternal and fetal outcomes by various ART treatment factors, including autologous or donor oocytes, autologous or donor semen, the use or not of intracytoplasmic sperm injection or assisted zona hatching, fresh or thawed embryos, the number of embryos transferred, fetal heartbeats at 6 weeks of gestation, and plurality at birth.

Rates of adverse maternal outcomes were significantly higher in 2,422 twin pregnancies than in 6,526 singleton pregnancies, including pregnancy-induced hypertension in 25% and 13%, respectively, gestational diabetes in 10% and 8%, and a primary Cesarean section delivery in 78% and 40%, respectively, reported Dr. Luke.

Adverse fetal outcomes also were significantly more likely in twins than singletons, including preterm birth in 61% of twins and 12% of singletons, birth defects in 5% and 2%, respectively, and low birth weight in 48% and 8%. Fourteen percent of twins and 7% of singletons were small for gestational age.

Those risks were only slightly modified with adjustment for each ART treatment parameter, said Dr. Luke of Michigan State University, East Lansing, Mich.

Several ART treatment factors were associated with higher or lower risks of adverse outcomes, she added. Compared with outcomes from the use of autologous oocytes, the adjusted odds ratios with donor oocytes were 1.87 for pregnancy-induced hypertension and 1.87 and 1.43 for primary C-section and preterm birth. Using frozen rather than fresh embryos was associated with a 30% increased risk for pregnancy-induced hypertension, but also a 21% lower risk for low fetal birth weight and a 62% lower likelihood that the baby will be small for gestational age. Hearing two fetal heartbeats instead of one at 6 weeks was associated with a 49% increased risk of prematurity and a 57% increased risk of low birth weight. Hearing three or more heartbeats instead of one was associated with more than a doubling in risk for prematurity, low birth weight, or a small-for-gestational-age baby.

 

 

Massachusetts has the highest use of ART procedures per capita of any U.S. state and a higher rate of multiple births than many other states – nearly 5%, or nearly 8% for women aged 35 years or older.

The National Institutes of Health funded the studies. Dr. Getz reported having no financial disclosures. Dr. Luke has been a paid consultant for the Society for Assisted Reproductive Technology.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

References

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“While we need to better understand any relationship between birth defects and infertility, it is comforting to confirm that rates of birth defects remain low among those children conceived using assisted reproductive technologies,” Dr. Charles C. Coddington III said in a statement released by the ASRM.

Dr. Owen K. Davis commented in a separate statement from the ASRM, “There is much to learn from this rich data set. The first step to reducing these complications is to understand what factors may be contributing to them. Hopefully, this will allow us to better care for women based on the specifics of their infertility diagnosis.”

Dr. Charles C. Coddington III is president of the Society for Assisted Reproductive Technology and a professor of ob.gyn. at the Mayo Clinic, Rochester, Minn. Dr. Owen K. Davis is president-elect of the ASRM and a professor of ob.gyn. at Weill Cornell Medical College, N.Y. Their financial disclosures were not available.

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“While we need to better understand any relationship between birth defects and infertility, it is comforting to confirm that rates of birth defects remain low among those children conceived using assisted reproductive technologies,” Dr. Charles C. Coddington III said in a statement released by the ASRM.

Dr. Owen K. Davis commented in a separate statement from the ASRM, “There is much to learn from this rich data set. The first step to reducing these complications is to understand what factors may be contributing to them. Hopefully, this will allow us to better care for women based on the specifics of their infertility diagnosis.”

Dr. Charles C. Coddington III is president of the Society for Assisted Reproductive Technology and a professor of ob.gyn. at the Mayo Clinic, Rochester, Minn. Dr. Owen K. Davis is president-elect of the ASRM and a professor of ob.gyn. at Weill Cornell Medical College, N.Y. Their financial disclosures were not available.

Body

“While we need to better understand any relationship between birth defects and infertility, it is comforting to confirm that rates of birth defects remain low among those children conceived using assisted reproductive technologies,” Dr. Charles C. Coddington III said in a statement released by the ASRM.

Dr. Owen K. Davis commented in a separate statement from the ASRM, “There is much to learn from this rich data set. The first step to reducing these complications is to understand what factors may be contributing to them. Hopefully, this will allow us to better care for women based on the specifics of their infertility diagnosis.”

Dr. Charles C. Coddington III is president of the Society for Assisted Reproductive Technology and a professor of ob.gyn. at the Mayo Clinic, Rochester, Minn. Dr. Owen K. Davis is president-elect of the ASRM and a professor of ob.gyn. at Weill Cornell Medical College, N.Y. Their financial disclosures were not available.

Title
Low rate of defects comforting
Low rate of defects comforting

HONOLULU – Modest increases in the risks of cardiac and noncardiac fetal defects in babies born from assisted reproductive technology are likely due to the increased likelihood of multiple births and not the procedures themselves, an analysis of 335,910 births suggests.

In a separate analysis, certain assisted reproductive technology methods were associated with higher or lower risks of adverse maternal and fetal outcomes, but plurality played a much bigger role in the risk of adverse outcomes.

“ART does not appear to be a major cause of birth defects; however, there are modest increases in both cardiac and noncardiac defects,” Kelly D. Getz, Ph.D., reported at the annual meeting of the American Society for Reproductive Medicine (ASRM). “The relationship between ART and birth defects is mediated through multiple birth,” a factor that may be more important for cardiac and for noncardiac defects.

Dr. Kelly D. Getz

“Plurality is the predominant ART treatment risk factor associated with excess morbidity for both mothers and infants,” Barbara Luke, Sc.D.said. “Other treatment factors had much less or no effect,” especially the semen source, assisted hatching, or the number of embryos transferred.

The two analyses, presented separately by Dr. Getz and Dr. Luke, were part of the Massachusetts Outcomes Study of Assisted Reproductive Technologies (ART), which linked data on births in Massachusetts between 2004 and 2008 in the Pregnancy to Early Life Longitudinal database with data from the Massachusetts Birth Defects Monitoring Program. Older age was significantly associated with the use of ART and outcomes, so the analyses adjusted for the influence of age.

A comparison of 324,148 births from spontaneous conception and 11,762 births from ART estimated prevalence ratios for patients with ART of 1.6 for any cardiac defect, septal defects, or atrial septal defects; 1.8 for ventricular septal defects; 2.1 for conotruncal and aortic arch; and 3.8 for tetralogy of Fallot.

The estimated prevalence ratios among patients with ART for noncardiac defects included 1.2 for any noncardiac defect, 1.3 for genitourinary defects, 1.5 for gastrointestinal or musculoskeletal defects, and 1.6 for hypospadias, said Dr. Getz of the Massachusetts Department of Public Health, Boston.

The prevalence of defects differed in singletons and multiples. For singletons, the prevalence of cardiac defects was 60 per 10,000 births after ART and 46/10,000 without ART. Among multiples, the prevalence of cardiac defects was 101/10,000 with ART and 91/10,000 without ART. The adjusted prevalence ratios for cardiac defects were higher in multiples with or without ART (2), compared with singletons with ART (1.1) or without ART (1, the reference group), but did not differ significantly within each subgroup based on whether or not ART was used.

Dr. Barbara Luke

Similarly, for noncardiac defects, the prevalence among singletons was 163/10,000 with ART and 133/10,000 without ART, and among multiples was 200/10,000 with ART and 179/10,000 without ART. The adjusted prevalence ratios were 1.4 for multiples with ART, 1.3 for multiples without ART, and 1.2 for singletons with ART.

A separate analysis in the study looked at maternal and fetal outcomes by various ART treatment factors, including autologous or donor oocytes, autologous or donor semen, the use or not of intracytoplasmic sperm injection or assisted zona hatching, fresh or thawed embryos, the number of embryos transferred, fetal heartbeats at 6 weeks of gestation, and plurality at birth.

Rates of adverse maternal outcomes were significantly higher in 2,422 twin pregnancies than in 6,526 singleton pregnancies, including pregnancy-induced hypertension in 25% and 13%, respectively, gestational diabetes in 10% and 8%, and a primary Cesarean section delivery in 78% and 40%, respectively, reported Dr. Luke.

Adverse fetal outcomes also were significantly more likely in twins than singletons, including preterm birth in 61% of twins and 12% of singletons, birth defects in 5% and 2%, respectively, and low birth weight in 48% and 8%. Fourteen percent of twins and 7% of singletons were small for gestational age.

Those risks were only slightly modified with adjustment for each ART treatment parameter, said Dr. Luke of Michigan State University, East Lansing, Mich.

Several ART treatment factors were associated with higher or lower risks of adverse outcomes, she added. Compared with outcomes from the use of autologous oocytes, the adjusted odds ratios with donor oocytes were 1.87 for pregnancy-induced hypertension and 1.87 and 1.43 for primary C-section and preterm birth. Using frozen rather than fresh embryos was associated with a 30% increased risk for pregnancy-induced hypertension, but also a 21% lower risk for low fetal birth weight and a 62% lower likelihood that the baby will be small for gestational age. Hearing two fetal heartbeats instead of one at 6 weeks was associated with a 49% increased risk of prematurity and a 57% increased risk of low birth weight. Hearing three or more heartbeats instead of one was associated with more than a doubling in risk for prematurity, low birth weight, or a small-for-gestational-age baby.

 

 

Massachusetts has the highest use of ART procedures per capita of any U.S. state and a higher rate of multiple births than many other states – nearly 5%, or nearly 8% for women aged 35 years or older.

The National Institutes of Health funded the studies. Dr. Getz reported having no financial disclosures. Dr. Luke has been a paid consultant for the Society for Assisted Reproductive Technology.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

HONOLULU – Modest increases in the risks of cardiac and noncardiac fetal defects in babies born from assisted reproductive technology are likely due to the increased likelihood of multiple births and not the procedures themselves, an analysis of 335,910 births suggests.

In a separate analysis, certain assisted reproductive technology methods were associated with higher or lower risks of adverse maternal and fetal outcomes, but plurality played a much bigger role in the risk of adverse outcomes.

“ART does not appear to be a major cause of birth defects; however, there are modest increases in both cardiac and noncardiac defects,” Kelly D. Getz, Ph.D., reported at the annual meeting of the American Society for Reproductive Medicine (ASRM). “The relationship between ART and birth defects is mediated through multiple birth,” a factor that may be more important for cardiac and for noncardiac defects.

Dr. Kelly D. Getz

“Plurality is the predominant ART treatment risk factor associated with excess morbidity for both mothers and infants,” Barbara Luke, Sc.D.said. “Other treatment factors had much less or no effect,” especially the semen source, assisted hatching, or the number of embryos transferred.

The two analyses, presented separately by Dr. Getz and Dr. Luke, were part of the Massachusetts Outcomes Study of Assisted Reproductive Technologies (ART), which linked data on births in Massachusetts between 2004 and 2008 in the Pregnancy to Early Life Longitudinal database with data from the Massachusetts Birth Defects Monitoring Program. Older age was significantly associated with the use of ART and outcomes, so the analyses adjusted for the influence of age.

A comparison of 324,148 births from spontaneous conception and 11,762 births from ART estimated prevalence ratios for patients with ART of 1.6 for any cardiac defect, septal defects, or atrial septal defects; 1.8 for ventricular septal defects; 2.1 for conotruncal and aortic arch; and 3.8 for tetralogy of Fallot.

The estimated prevalence ratios among patients with ART for noncardiac defects included 1.2 for any noncardiac defect, 1.3 for genitourinary defects, 1.5 for gastrointestinal or musculoskeletal defects, and 1.6 for hypospadias, said Dr. Getz of the Massachusetts Department of Public Health, Boston.

The prevalence of defects differed in singletons and multiples. For singletons, the prevalence of cardiac defects was 60 per 10,000 births after ART and 46/10,000 without ART. Among multiples, the prevalence of cardiac defects was 101/10,000 with ART and 91/10,000 without ART. The adjusted prevalence ratios for cardiac defects were higher in multiples with or without ART (2), compared with singletons with ART (1.1) or without ART (1, the reference group), but did not differ significantly within each subgroup based on whether or not ART was used.

Dr. Barbara Luke

Similarly, for noncardiac defects, the prevalence among singletons was 163/10,000 with ART and 133/10,000 without ART, and among multiples was 200/10,000 with ART and 179/10,000 without ART. The adjusted prevalence ratios were 1.4 for multiples with ART, 1.3 for multiples without ART, and 1.2 for singletons with ART.

A separate analysis in the study looked at maternal and fetal outcomes by various ART treatment factors, including autologous or donor oocytes, autologous or donor semen, the use or not of intracytoplasmic sperm injection or assisted zona hatching, fresh or thawed embryos, the number of embryos transferred, fetal heartbeats at 6 weeks of gestation, and plurality at birth.

Rates of adverse maternal outcomes were significantly higher in 2,422 twin pregnancies than in 6,526 singleton pregnancies, including pregnancy-induced hypertension in 25% and 13%, respectively, gestational diabetes in 10% and 8%, and a primary Cesarean section delivery in 78% and 40%, respectively, reported Dr. Luke.

Adverse fetal outcomes also were significantly more likely in twins than singletons, including preterm birth in 61% of twins and 12% of singletons, birth defects in 5% and 2%, respectively, and low birth weight in 48% and 8%. Fourteen percent of twins and 7% of singletons were small for gestational age.

Those risks were only slightly modified with adjustment for each ART treatment parameter, said Dr. Luke of Michigan State University, East Lansing, Mich.

Several ART treatment factors were associated with higher or lower risks of adverse outcomes, she added. Compared with outcomes from the use of autologous oocytes, the adjusted odds ratios with donor oocytes were 1.87 for pregnancy-induced hypertension and 1.87 and 1.43 for primary C-section and preterm birth. Using frozen rather than fresh embryos was associated with a 30% increased risk for pregnancy-induced hypertension, but also a 21% lower risk for low fetal birth weight and a 62% lower likelihood that the baby will be small for gestational age. Hearing two fetal heartbeats instead of one at 6 weeks was associated with a 49% increased risk of prematurity and a 57% increased risk of low birth weight. Hearing three or more heartbeats instead of one was associated with more than a doubling in risk for prematurity, low birth weight, or a small-for-gestational-age baby.

 

 

Massachusetts has the highest use of ART procedures per capita of any U.S. state and a higher rate of multiple births than many other states – nearly 5%, or nearly 8% for women aged 35 years or older.

The National Institutes of Health funded the studies. Dr. Getz reported having no financial disclosures. Dr. Luke has been a paid consultant for the Society for Assisted Reproductive Technology.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Key clinical point: Higher rates of some adverse outcomes after ART appear to be due to multiple births, not ART itself.

Major finding: Adjusted odds ratios for cardiac defects were 2.0 for multiples with or without ART and 1.1 for singletons with ART, compared with singletons without ART.

Data source: Analyses of data on 335,910 births in the Massachusetts clinical and surveillance databases.

Disclosures: The National Institutes of Health funded the studies. Dr. Getz reported having no financial disclosures. Dr. Luke has been a paid consultant for the Society for Assisted Reproductive Technology.

Ectopic risk rises with more embryos transferred

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Ectopic risk rises with more embryos transferred

HONOLULU – The only means of modifying the risk of ectopic pregnancy in fresh nondonor cycles of assisted reproductive technology is to limit the number of embryos transferred, a retrospective cohort study of 553,577 clinical pregnancies found.

Among the 379,023 clinical pregnancies from fresh nondonor cycles, the risk of ectopic pregnancy increased by 33%-49% with the transfer of more than two embryos, compared with transferring one embryo, Dr. Kiran M. Perkins reported at the annual meeting of the American Society for Reproductive Medicine.

Dr. Kiran M. Perkins said fresh nondonor cycles were associated with the highest rate of ectopic pregnancy (2%).

The incidence of ectopic pregnancy in pregnancies from fresh nondonor cycles was 1.6% with the transfer of one embryo, 1.7% with the transfer of two embryos, 2.2% with the transfer of three embryos, and 2.5% with the transfer of four or more embryos, said Dr. Perkins of the Centers for Disease Control and Prevention.

The overall incidence of ectopic pregnancy in this cohort of 553,577 clinical pregnancies from assisted reproductive technology (ART) procedures was 1.7%, similar to the 2% incidence among the general U.S. population, she added. From January 2001 to the end of 2011, there was a significant downward trend in the incidence of ectopic pregnancy after ART procedures, from 2% in 2001 to 1.6% in 2011.

Most of the clinical pregnancies from ART occurred after fresh nondonor cycles (68%), followed by frozen-thawed nondonor cycles (15%), fresh donor cycles (12%), and frozen-thawed donor cycles (4%). (Percentages were rounded.)

Fresh nondonor cycles were associated with the highest rate of ectopic pregnancy (2%). Rates of ectopic pregnancy were 1.3% using frozen-thawed nondonor cycles, 1.2% using frozen-thawed donor cycles, and 1% using fresh donor cycles.

The study identified other risk factors for ectopic pregnancy after ART, but these were not things that clinicians could modify. The ectopic pregnancy risk after fresh nondonor cycles increased with age between the ages of 29 and 44 years, with an adjusted risk ratio of 21%-23%. The rates of ectopic pregnancy increased from 1.6% in women younger than 30 years to 1.9% for ages 30-34 years, 2.1% for ages 35-37 years, 2.2% for ages 38-40 years, and 2.4% for ages 41-43 years.

Women with a history of two or more ART cycles had a significantly increased incidence of ectopic pregnancy, compared with women with no prior ART cycles: 2.3% vs. 1.8%, Dr. Perkins reported.

Having one or more prior live births was protective, reducing the risk of ectopic pregnancy by 29% in women with one prior live birth and by 45% in women with two or more prior births, compared with nulliparous women. Ectopic pregnancy rates were 2.1% in women with no prior births, 1.7% in those with one prior live birth, and 1.4% in those with two or more previous births.

The 2.3% incidence of ectopic pregnancy in couples with tubal factor infertility was significantly higher than the 1.8% incidence in couples with male factor infertility.

Data for the study came from the National ART Surveillance System, which contains information on 95% of ART procedures in the United States.

Dr. Perkins reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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HONOLULU – The only means of modifying the risk of ectopic pregnancy in fresh nondonor cycles of assisted reproductive technology is to limit the number of embryos transferred, a retrospective cohort study of 553,577 clinical pregnancies found.

Among the 379,023 clinical pregnancies from fresh nondonor cycles, the risk of ectopic pregnancy increased by 33%-49% with the transfer of more than two embryos, compared with transferring one embryo, Dr. Kiran M. Perkins reported at the annual meeting of the American Society for Reproductive Medicine.

Dr. Kiran M. Perkins said fresh nondonor cycles were associated with the highest rate of ectopic pregnancy (2%).

The incidence of ectopic pregnancy in pregnancies from fresh nondonor cycles was 1.6% with the transfer of one embryo, 1.7% with the transfer of two embryos, 2.2% with the transfer of three embryos, and 2.5% with the transfer of four or more embryos, said Dr. Perkins of the Centers for Disease Control and Prevention.

The overall incidence of ectopic pregnancy in this cohort of 553,577 clinical pregnancies from assisted reproductive technology (ART) procedures was 1.7%, similar to the 2% incidence among the general U.S. population, she added. From January 2001 to the end of 2011, there was a significant downward trend in the incidence of ectopic pregnancy after ART procedures, from 2% in 2001 to 1.6% in 2011.

Most of the clinical pregnancies from ART occurred after fresh nondonor cycles (68%), followed by frozen-thawed nondonor cycles (15%), fresh donor cycles (12%), and frozen-thawed donor cycles (4%). (Percentages were rounded.)

Fresh nondonor cycles were associated with the highest rate of ectopic pregnancy (2%). Rates of ectopic pregnancy were 1.3% using frozen-thawed nondonor cycles, 1.2% using frozen-thawed donor cycles, and 1% using fresh donor cycles.

The study identified other risk factors for ectopic pregnancy after ART, but these were not things that clinicians could modify. The ectopic pregnancy risk after fresh nondonor cycles increased with age between the ages of 29 and 44 years, with an adjusted risk ratio of 21%-23%. The rates of ectopic pregnancy increased from 1.6% in women younger than 30 years to 1.9% for ages 30-34 years, 2.1% for ages 35-37 years, 2.2% for ages 38-40 years, and 2.4% for ages 41-43 years.

Women with a history of two or more ART cycles had a significantly increased incidence of ectopic pregnancy, compared with women with no prior ART cycles: 2.3% vs. 1.8%, Dr. Perkins reported.

Having one or more prior live births was protective, reducing the risk of ectopic pregnancy by 29% in women with one prior live birth and by 45% in women with two or more prior births, compared with nulliparous women. Ectopic pregnancy rates were 2.1% in women with no prior births, 1.7% in those with one prior live birth, and 1.4% in those with two or more previous births.

The 2.3% incidence of ectopic pregnancy in couples with tubal factor infertility was significantly higher than the 1.8% incidence in couples with male factor infertility.

Data for the study came from the National ART Surveillance System, which contains information on 95% of ART procedures in the United States.

Dr. Perkins reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

HONOLULU – The only means of modifying the risk of ectopic pregnancy in fresh nondonor cycles of assisted reproductive technology is to limit the number of embryos transferred, a retrospective cohort study of 553,577 clinical pregnancies found.

Among the 379,023 clinical pregnancies from fresh nondonor cycles, the risk of ectopic pregnancy increased by 33%-49% with the transfer of more than two embryos, compared with transferring one embryo, Dr. Kiran M. Perkins reported at the annual meeting of the American Society for Reproductive Medicine.

Dr. Kiran M. Perkins said fresh nondonor cycles were associated with the highest rate of ectopic pregnancy (2%).

The incidence of ectopic pregnancy in pregnancies from fresh nondonor cycles was 1.6% with the transfer of one embryo, 1.7% with the transfer of two embryos, 2.2% with the transfer of three embryos, and 2.5% with the transfer of four or more embryos, said Dr. Perkins of the Centers for Disease Control and Prevention.

The overall incidence of ectopic pregnancy in this cohort of 553,577 clinical pregnancies from assisted reproductive technology (ART) procedures was 1.7%, similar to the 2% incidence among the general U.S. population, she added. From January 2001 to the end of 2011, there was a significant downward trend in the incidence of ectopic pregnancy after ART procedures, from 2% in 2001 to 1.6% in 2011.

Most of the clinical pregnancies from ART occurred after fresh nondonor cycles (68%), followed by frozen-thawed nondonor cycles (15%), fresh donor cycles (12%), and frozen-thawed donor cycles (4%). (Percentages were rounded.)

Fresh nondonor cycles were associated with the highest rate of ectopic pregnancy (2%). Rates of ectopic pregnancy were 1.3% using frozen-thawed nondonor cycles, 1.2% using frozen-thawed donor cycles, and 1% using fresh donor cycles.

The study identified other risk factors for ectopic pregnancy after ART, but these were not things that clinicians could modify. The ectopic pregnancy risk after fresh nondonor cycles increased with age between the ages of 29 and 44 years, with an adjusted risk ratio of 21%-23%. The rates of ectopic pregnancy increased from 1.6% in women younger than 30 years to 1.9% for ages 30-34 years, 2.1% for ages 35-37 years, 2.2% for ages 38-40 years, and 2.4% for ages 41-43 years.

Women with a history of two or more ART cycles had a significantly increased incidence of ectopic pregnancy, compared with women with no prior ART cycles: 2.3% vs. 1.8%, Dr. Perkins reported.

Having one or more prior live births was protective, reducing the risk of ectopic pregnancy by 29% in women with one prior live birth and by 45% in women with two or more prior births, compared with nulliparous women. Ectopic pregnancy rates were 2.1% in women with no prior births, 1.7% in those with one prior live birth, and 1.4% in those with two or more previous births.

The 2.3% incidence of ectopic pregnancy in couples with tubal factor infertility was significantly higher than the 1.8% incidence in couples with male factor infertility.

Data for the study came from the National ART Surveillance System, which contains information on 95% of ART procedures in the United States.

Dr. Perkins reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Most weight-loss apps are losers

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Introducing overweight patients to one of the most popular weight-loss apps didn’t help them shed pounds in a prospective, randomized, controlled trial with 212 patients in primary care clinics.

The two-clinic study screened 633 patients with a body mass index of at least 25 kg/m2, most of whom did not own a smartphone (421) or were not interested in losing weight (135), with 86 patients declining the study for other reasons. The remaining 212 patients were randomized to 6 months of usual care or usual care plus the free MyFitnessPal app. Research assistants helped patients download the app during a regular clinic visit, showed them an instructional video developed by MyFitnessPal, and followed up a week later with a phone call to assist patients with any technical problems with the app.

Dr. Brian Y. Laing

Not much weight was lost in the following 6 months. The app group lost a mean of 0.03 kg and the control group gained a mean of 0.3 kg, a 0.3-kg difference between groups that was not statistically significant, Dr. Brian Y. Laing and his associates reported (Ann. Intern. Med. 2014 Nov. 18 [doi:10.7326/M13-3005]). Among the 158 patients with 6-month measurements, 13 of 71 in the app group lost 2.7 kg or more (18%), as did 14 of 87 in the control group (16%).

The groups also did not differ significantly in changes in systolic blood pressure, with the app group losing a mean of 0.3 mm Hg and the control group gaining a mean of 1.5 mm Hg, reported Dr. Laing, now of the Los Angeles County Department of Health Services.

Patients in the app group seldom bothered to open it after the first month, with open rates dropping from 94 patients in the first month (97%) to 34 patients in the sixth month (35%). The ones who stopped using it complained in a survey that the app was “tedious,” or said they were too busy or stressed to use it, or dropped it for other reasons.

There were a few hopeful signs, however, Dr. Laing said in an interview. A few patients continued using the app at least 30 times in month 6. The app group was more likely to report using a “personal calorie goal” significantly more often than the control group – a mean of 2 days per week, compared with a quarter-day per week, respectively. And perhaps outcomes might have been better if physicians instead of research assistants had introduced patients to the app and followed up, he speculated.

Success may depend more on the patient’s readiness for change than on the app itself. “There was a subset of patients who used the app a lot and appeared to lose more weight, but on average, there wasn’t a significant difference between the groups. I think what it tells us is the app still can be a very powerful tool for patients who are truly motivated to track calories, but not for everyone,” said Dr. Laing, who works on operational issues for the county and practices part-time as a family physician in a county clinic.

Dr. Laing still recommends MyFitnessPal to overweight patients if they answer his questions by saying they’re interested in losing weight and enjoy using a smartphone. But he adds a warning: If you want the app to work, “you’ll have to put some time into this” and spend 5 minutes or so entering calories at each meal.

“I’m a primary care physician. One thing we struggle with is the 10- to 15-minute visit. I think about how we can help patients lead healthy lives when they’re not in front of us except for 10 minutes twice a year,” he said. For the right patients, apps could help, he believes.

Dr. Laing was one of the investigators in a previous study that evaluated the quality of 23 of the top-rated free health and fitness apps. The apps seldom employed evidence-based theories of behavior change, they found. The mean behavioral theory score was 8 out of 100, and the mean persuasive technology score on the Fogg Behavioral Model was 2 out of a possible 6. The top-scoring app on both scales was Lose It! (Am. J. Prev. Med. 2013;45:583-9).

A separate study by other investigators rated 62 apps for the prevention of pediatric obesity and found that the apps were likely to incorporate expert-recommended behaviors such as eating five servings of fruit or vegetables per day (94%) but few adhered to expert-recommended strategies such as self-monitoring diet and physical activity (21%). Approximately half the apps addressed physical activity and consumption of fruit or vegetables and only 2% of apps addressed the child’s amount of screen time or the importance of family meals together, among other important behaviors (Child. Obes. 2014;10:132-44).

 

 

The company Weight Watchers funded a randomized study of 292 participants in the company’s programs that found they lost more weight by attending its in-person meetings than by using its app or online tools (Am. J. Med. 2013;126:1143e19-1143.324).

Dr. Laing reported having no financial disclosures. MyFitnessPal shared users’ log-on data with investigators for the study.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Introducing overweight patients to one of the most popular weight-loss apps didn’t help them shed pounds in a prospective, randomized, controlled trial with 212 patients in primary care clinics.

The two-clinic study screened 633 patients with a body mass index of at least 25 kg/m2, most of whom did not own a smartphone (421) or were not interested in losing weight (135), with 86 patients declining the study for other reasons. The remaining 212 patients were randomized to 6 months of usual care or usual care plus the free MyFitnessPal app. Research assistants helped patients download the app during a regular clinic visit, showed them an instructional video developed by MyFitnessPal, and followed up a week later with a phone call to assist patients with any technical problems with the app.

Dr. Brian Y. Laing

Not much weight was lost in the following 6 months. The app group lost a mean of 0.03 kg and the control group gained a mean of 0.3 kg, a 0.3-kg difference between groups that was not statistically significant, Dr. Brian Y. Laing and his associates reported (Ann. Intern. Med. 2014 Nov. 18 [doi:10.7326/M13-3005]). Among the 158 patients with 6-month measurements, 13 of 71 in the app group lost 2.7 kg or more (18%), as did 14 of 87 in the control group (16%).

The groups also did not differ significantly in changes in systolic blood pressure, with the app group losing a mean of 0.3 mm Hg and the control group gaining a mean of 1.5 mm Hg, reported Dr. Laing, now of the Los Angeles County Department of Health Services.

Patients in the app group seldom bothered to open it after the first month, with open rates dropping from 94 patients in the first month (97%) to 34 patients in the sixth month (35%). The ones who stopped using it complained in a survey that the app was “tedious,” or said they were too busy or stressed to use it, or dropped it for other reasons.

There were a few hopeful signs, however, Dr. Laing said in an interview. A few patients continued using the app at least 30 times in month 6. The app group was more likely to report using a “personal calorie goal” significantly more often than the control group – a mean of 2 days per week, compared with a quarter-day per week, respectively. And perhaps outcomes might have been better if physicians instead of research assistants had introduced patients to the app and followed up, he speculated.

Success may depend more on the patient’s readiness for change than on the app itself. “There was a subset of patients who used the app a lot and appeared to lose more weight, but on average, there wasn’t a significant difference between the groups. I think what it tells us is the app still can be a very powerful tool for patients who are truly motivated to track calories, but not for everyone,” said Dr. Laing, who works on operational issues for the county and practices part-time as a family physician in a county clinic.

Dr. Laing still recommends MyFitnessPal to overweight patients if they answer his questions by saying they’re interested in losing weight and enjoy using a smartphone. But he adds a warning: If you want the app to work, “you’ll have to put some time into this” and spend 5 minutes or so entering calories at each meal.

“I’m a primary care physician. One thing we struggle with is the 10- to 15-minute visit. I think about how we can help patients lead healthy lives when they’re not in front of us except for 10 minutes twice a year,” he said. For the right patients, apps could help, he believes.

Dr. Laing was one of the investigators in a previous study that evaluated the quality of 23 of the top-rated free health and fitness apps. The apps seldom employed evidence-based theories of behavior change, they found. The mean behavioral theory score was 8 out of 100, and the mean persuasive technology score on the Fogg Behavioral Model was 2 out of a possible 6. The top-scoring app on both scales was Lose It! (Am. J. Prev. Med. 2013;45:583-9).

A separate study by other investigators rated 62 apps for the prevention of pediatric obesity and found that the apps were likely to incorporate expert-recommended behaviors such as eating five servings of fruit or vegetables per day (94%) but few adhered to expert-recommended strategies such as self-monitoring diet and physical activity (21%). Approximately half the apps addressed physical activity and consumption of fruit or vegetables and only 2% of apps addressed the child’s amount of screen time or the importance of family meals together, among other important behaviors (Child. Obes. 2014;10:132-44).

 

 

The company Weight Watchers funded a randomized study of 292 participants in the company’s programs that found they lost more weight by attending its in-person meetings than by using its app or online tools (Am. J. Med. 2013;126:1143e19-1143.324).

Dr. Laing reported having no financial disclosures. MyFitnessPal shared users’ log-on data with investigators for the study.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Introducing overweight patients to one of the most popular weight-loss apps didn’t help them shed pounds in a prospective, randomized, controlled trial with 212 patients in primary care clinics.

The two-clinic study screened 633 patients with a body mass index of at least 25 kg/m2, most of whom did not own a smartphone (421) or were not interested in losing weight (135), with 86 patients declining the study for other reasons. The remaining 212 patients were randomized to 6 months of usual care or usual care plus the free MyFitnessPal app. Research assistants helped patients download the app during a regular clinic visit, showed them an instructional video developed by MyFitnessPal, and followed up a week later with a phone call to assist patients with any technical problems with the app.

Dr. Brian Y. Laing

Not much weight was lost in the following 6 months. The app group lost a mean of 0.03 kg and the control group gained a mean of 0.3 kg, a 0.3-kg difference between groups that was not statistically significant, Dr. Brian Y. Laing and his associates reported (Ann. Intern. Med. 2014 Nov. 18 [doi:10.7326/M13-3005]). Among the 158 patients with 6-month measurements, 13 of 71 in the app group lost 2.7 kg or more (18%), as did 14 of 87 in the control group (16%).

The groups also did not differ significantly in changes in systolic blood pressure, with the app group losing a mean of 0.3 mm Hg and the control group gaining a mean of 1.5 mm Hg, reported Dr. Laing, now of the Los Angeles County Department of Health Services.

Patients in the app group seldom bothered to open it after the first month, with open rates dropping from 94 patients in the first month (97%) to 34 patients in the sixth month (35%). The ones who stopped using it complained in a survey that the app was “tedious,” or said they were too busy or stressed to use it, or dropped it for other reasons.

There were a few hopeful signs, however, Dr. Laing said in an interview. A few patients continued using the app at least 30 times in month 6. The app group was more likely to report using a “personal calorie goal” significantly more often than the control group – a mean of 2 days per week, compared with a quarter-day per week, respectively. And perhaps outcomes might have been better if physicians instead of research assistants had introduced patients to the app and followed up, he speculated.

Success may depend more on the patient’s readiness for change than on the app itself. “There was a subset of patients who used the app a lot and appeared to lose more weight, but on average, there wasn’t a significant difference between the groups. I think what it tells us is the app still can be a very powerful tool for patients who are truly motivated to track calories, but not for everyone,” said Dr. Laing, who works on operational issues for the county and practices part-time as a family physician in a county clinic.

Dr. Laing still recommends MyFitnessPal to overweight patients if they answer his questions by saying they’re interested in losing weight and enjoy using a smartphone. But he adds a warning: If you want the app to work, “you’ll have to put some time into this” and spend 5 minutes or so entering calories at each meal.

“I’m a primary care physician. One thing we struggle with is the 10- to 15-minute visit. I think about how we can help patients lead healthy lives when they’re not in front of us except for 10 minutes twice a year,” he said. For the right patients, apps could help, he believes.

Dr. Laing was one of the investigators in a previous study that evaluated the quality of 23 of the top-rated free health and fitness apps. The apps seldom employed evidence-based theories of behavior change, they found. The mean behavioral theory score was 8 out of 100, and the mean persuasive technology score on the Fogg Behavioral Model was 2 out of a possible 6. The top-scoring app on both scales was Lose It! (Am. J. Prev. Med. 2013;45:583-9).

A separate study by other investigators rated 62 apps for the prevention of pediatric obesity and found that the apps were likely to incorporate expert-recommended behaviors such as eating five servings of fruit or vegetables per day (94%) but few adhered to expert-recommended strategies such as self-monitoring diet and physical activity (21%). Approximately half the apps addressed physical activity and consumption of fruit or vegetables and only 2% of apps addressed the child’s amount of screen time or the importance of family meals together, among other important behaviors (Child. Obes. 2014;10:132-44).

 

 

The company Weight Watchers funded a randomized study of 292 participants in the company’s programs that found they lost more weight by attending its in-person meetings than by using its app or online tools (Am. J. Med. 2013;126:1143e19-1143.324).

Dr. Laing reported having no financial disclosures. MyFitnessPal shared users’ log-on data with investigators for the study.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Trusted sources developing apps

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Every month sees new apps launched by established medical organizations. Although these apps don’t have data to confirm their usefulness, at least they come from known and trusted sources. Here’s a roundup of some of the latest. You decide whether or not they’re worth a try.

The Centers for Disease Control and Prevention (CDC) makes it easier for clinicians to find recommended immunization schedules for adults and children through its free CDC Vaccine Schedules app. Look up contraindications to vaccination or catch-up schedules for children and adolescents, or search recommendations for adults based on the presence of diabetes, HIV, pregnancy, or other conditions, among other features.

Courtesy CDC/Douglas Jordan, M.A.
Immunization schedules and more for adults and children can be had through the CDC Vaccine Schedules app.

The free Spot a Stroke FAST app from the American Heart Association and American Stroke Association can help patients and family members identify the signs and symptoms of stroke in order to get timely help. Named after the mnemonic FAST (Face, Arm, Speech, Time), the app includes the ability to phone 911, with a time stamp showing when the call was made, features that may help clinicians in management decisions.

The American College of Cardiology’s free Guideline Clinical App includes three recently updated practice guidelines in its first iteration, on the management of heart failure, assessment of cardiovascular risk, and the treatment of blood cholesterol.

Clinical pearls for emergency medicine developed by the University of Maryland are available in the university’s free app UMEM Pearls.

The U.S. Substance Abuse and Mental Health Services Administration’s free KnowBullying app guides parents and educators on how to start easy, meaningful conversations with children about preventing or responding to bullying. Parents and caregivers who spend at least 15 minutes a day talking with a child can help build a strong relationship that can help prevent bullying, the group says.

The CDC’s free Heads Up app can help parents and caregivers spot the signs and symptoms of a concussion and learn what to do if you think a child or adolescent may have a concussion or other serious brain injury. Bonus: It also offers information on picking the right helmet for specific activities.

While we’re on the topic of pediatrics – the American Academy of Pediatrics (AAP) offers a slew of apps for physicians and parents. One of the most recent is the free AAP Journals app, which received an overall positive but mixed review on iMedicalApps.com.

Residents in the states of Washington or Minnesota can use Planned Parenthood’s free Planned Parenthood Care app in a pilot program that lets them connect with clinicians via video to get birth control methods sent through the mail – contraceptive pills, patches, or rings. The video visit costs $45.

Women who are pregnant or nursing and want to eat fish may like the free Fish4Health app from Purdue University that provides information on the benefits and safety of various fish species and helps them track their intake of healthy fats and mercury.

The European Society of Human Reproduction and Embryology offers its members a free app and/or web-based guidelines on the “Management of Women with Endometriosis.” The app summarizes the 83 recommendations in the guidelines and offers a decision-aid on six key issues in endometriosis.

Among a bevy of apps from the American Red Cross, the recent free Blood Donor app streamlines the process of donating blood, offers rewards to donors from participating retailers, and includes social media features that help promote giving blood.

Is there a new app that you think we should highlight? Let us know.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Every month sees new apps launched by established medical organizations. Although these apps don’t have data to confirm their usefulness, at least they come from known and trusted sources. Here’s a roundup of some of the latest. You decide whether or not they’re worth a try.

The Centers for Disease Control and Prevention (CDC) makes it easier for clinicians to find recommended immunization schedules for adults and children through its free CDC Vaccine Schedules app. Look up contraindications to vaccination or catch-up schedules for children and adolescents, or search recommendations for adults based on the presence of diabetes, HIV, pregnancy, or other conditions, among other features.

Courtesy CDC/Douglas Jordan, M.A.
Immunization schedules and more for adults and children can be had through the CDC Vaccine Schedules app.

The free Spot a Stroke FAST app from the American Heart Association and American Stroke Association can help patients and family members identify the signs and symptoms of stroke in order to get timely help. Named after the mnemonic FAST (Face, Arm, Speech, Time), the app includes the ability to phone 911, with a time stamp showing when the call was made, features that may help clinicians in management decisions.

The American College of Cardiology’s free Guideline Clinical App includes three recently updated practice guidelines in its first iteration, on the management of heart failure, assessment of cardiovascular risk, and the treatment of blood cholesterol.

Clinical pearls for emergency medicine developed by the University of Maryland are available in the university’s free app UMEM Pearls.

The U.S. Substance Abuse and Mental Health Services Administration’s free KnowBullying app guides parents and educators on how to start easy, meaningful conversations with children about preventing or responding to bullying. Parents and caregivers who spend at least 15 minutes a day talking with a child can help build a strong relationship that can help prevent bullying, the group says.

The CDC’s free Heads Up app can help parents and caregivers spot the signs and symptoms of a concussion and learn what to do if you think a child or adolescent may have a concussion or other serious brain injury. Bonus: It also offers information on picking the right helmet for specific activities.

While we’re on the topic of pediatrics – the American Academy of Pediatrics (AAP) offers a slew of apps for physicians and parents. One of the most recent is the free AAP Journals app, which received an overall positive but mixed review on iMedicalApps.com.

Residents in the states of Washington or Minnesota can use Planned Parenthood’s free Planned Parenthood Care app in a pilot program that lets them connect with clinicians via video to get birth control methods sent through the mail – contraceptive pills, patches, or rings. The video visit costs $45.

Women who are pregnant or nursing and want to eat fish may like the free Fish4Health app from Purdue University that provides information on the benefits and safety of various fish species and helps them track their intake of healthy fats and mercury.

The European Society of Human Reproduction and Embryology offers its members a free app and/or web-based guidelines on the “Management of Women with Endometriosis.” The app summarizes the 83 recommendations in the guidelines and offers a decision-aid on six key issues in endometriosis.

Among a bevy of apps from the American Red Cross, the recent free Blood Donor app streamlines the process of donating blood, offers rewards to donors from participating retailers, and includes social media features that help promote giving blood.

Is there a new app that you think we should highlight? Let us know.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Every month sees new apps launched by established medical organizations. Although these apps don’t have data to confirm their usefulness, at least they come from known and trusted sources. Here’s a roundup of some of the latest. You decide whether or not they’re worth a try.

The Centers for Disease Control and Prevention (CDC) makes it easier for clinicians to find recommended immunization schedules for adults and children through its free CDC Vaccine Schedules app. Look up contraindications to vaccination or catch-up schedules for children and adolescents, or search recommendations for adults based on the presence of diabetes, HIV, pregnancy, or other conditions, among other features.

Courtesy CDC/Douglas Jordan, M.A.
Immunization schedules and more for adults and children can be had through the CDC Vaccine Schedules app.

The free Spot a Stroke FAST app from the American Heart Association and American Stroke Association can help patients and family members identify the signs and symptoms of stroke in order to get timely help. Named after the mnemonic FAST (Face, Arm, Speech, Time), the app includes the ability to phone 911, with a time stamp showing when the call was made, features that may help clinicians in management decisions.

The American College of Cardiology’s free Guideline Clinical App includes three recently updated practice guidelines in its first iteration, on the management of heart failure, assessment of cardiovascular risk, and the treatment of blood cholesterol.

Clinical pearls for emergency medicine developed by the University of Maryland are available in the university’s free app UMEM Pearls.

The U.S. Substance Abuse and Mental Health Services Administration’s free KnowBullying app guides parents and educators on how to start easy, meaningful conversations with children about preventing or responding to bullying. Parents and caregivers who spend at least 15 minutes a day talking with a child can help build a strong relationship that can help prevent bullying, the group says.

The CDC’s free Heads Up app can help parents and caregivers spot the signs and symptoms of a concussion and learn what to do if you think a child or adolescent may have a concussion or other serious brain injury. Bonus: It also offers information on picking the right helmet for specific activities.

While we’re on the topic of pediatrics – the American Academy of Pediatrics (AAP) offers a slew of apps for physicians and parents. One of the most recent is the free AAP Journals app, which received an overall positive but mixed review on iMedicalApps.com.

Residents in the states of Washington or Minnesota can use Planned Parenthood’s free Planned Parenthood Care app in a pilot program that lets them connect with clinicians via video to get birth control methods sent through the mail – contraceptive pills, patches, or rings. The video visit costs $45.

Women who are pregnant or nursing and want to eat fish may like the free Fish4Health app from Purdue University that provides information on the benefits and safety of various fish species and helps them track their intake of healthy fats and mercury.

The European Society of Human Reproduction and Embryology offers its members a free app and/or web-based guidelines on the “Management of Women with Endometriosis.” The app summarizes the 83 recommendations in the guidelines and offers a decision-aid on six key issues in endometriosis.

Among a bevy of apps from the American Red Cross, the recent free Blood Donor app streamlines the process of donating blood, offers rewards to donors from participating retailers, and includes social media features that help promote giving blood.

Is there a new app that you think we should highlight? Let us know.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Direct-acting Antivirals Treat Recurrent HCV After Transplant

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BOSTON – Treating recurrent hepatitis C infection after liver transplantation using sofosbuvir-containing regimens produced a sustained virologic response 4 weeks later in 60%-90% of 237 patients, depending on genotype and the presence of cirrhosis.

Investigators analyzed data on 245 posttransplant patients with hepatitis C (HCV) collected from 38 academic medical centers and 15 community medical centers in North America and Europe participating in the prospective, longitudinal, observational HCV-Target study. Of the 227 patients who started treatment, 69% completed treatment, 3% discontinued treatment prematurely, and 28% are undergoing treatment.

Among the 68 patients with HCV genotype 1 and a known virologic outcome who were treated with sofosbuvir and simeprevir with or without ribavirin, 61 (90%) achieved a sustained virologic response for 4 weeks (SVR4).

Response rates in that group varied, however, depending on whether patients had cirrhosis (SVR4 in 32 of 37, 86%) or no cirrhosis (SVR4 in 29 of 31, 94%). Results also varied in that group by genotype, with SVR4 in 30 of 36 patients with genotype 1a infection (83%) and SVR4 in 18 of 19 patients with genotype 1b (95%), Dr. Robert S. Brown Jr. and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

“This is the regimen that probably holds the highest interest,” Dr. Brown said, because most of the patients in the study were genotype 1, and most genotype 1 patients received sofosbuvir and simeprevir with or without ribavirin.

A total of 10 of 12 patients with HCV genotype 1 infection who were treated with sofosbuvir plus pegylated interferon and ribavirin achieved SVR4 (83%).

A total of 9 of 10 patients with HCV genotype 2 infection who had complete data and who received sofosbuvir plus ribavirin achieved SVR4 (90%), reported Dr. Brown, the Frank Cardile Professor of Medicine and Pediatrics (in Surgery) at Columbia University, New York, and director of the Center for Liver Disease and Transplantation at New York-Presbyterian Hospital/Columbia University Medical Center.

Three of five patients with genotype 3 infection and complete data who received sofosbuvir plus ribavirin achieved SVR4 (60%), and one patient with genotype 3 achieved SVR4 after treatment with sofosbuvir, pegylated interferon, and ribavirin.

Next page: Adverse events >>

 

 

Adverse events were reported by 82% of patients, with rates ranging from 77% to 92% in different treatment groups. “The majority of these were mild and manageable,” Dr. Brown noted. The overall rate of serious adverse events was 8%, ranging from 0% to 21% in different treatment groups, though some of those cases were unlikely to be related to treatment, he added.

In general, interferon-free regimens had low rates of serious adverse events, Dr. Brown said. No patients developed acute liver graft rejection.

“Hepatitis C following liver transplant does remain a problem in 2014, because reinfection is universal and therapeutic options, at least to date, have been limited,” he said. The study’s real-world data supplement encouraging results from small, controlled trials of newer anti-HCV agents in posttransplant patients.

Most of the patients in the study were treated for recurrent HCV “well after” transplantation, Dr. Brown said. “The optimal treatment regimen and the duration of therapy still remain to be determined.”

Treatment regimens in the HCV-Target study are selected by physicians according to the local standard of care.

The study was too small to do a multivariate analysis of predictive factors for SVR4, Dr. Brown commented.

The HCV-Target study was funded by AbbVie, Bristol Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Kadmon, Janssen, Merck, and Vertex. Dr. Brown reported financial associations with AbbVie, Genentech, Gilead, Janssen, Merck, Salix, Vertex, and Vital Therapies.

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BOSTON – Treating recurrent hepatitis C infection after liver transplantation using sofosbuvir-containing regimens produced a sustained virologic response 4 weeks later in 60%-90% of 237 patients, depending on genotype and the presence of cirrhosis.

Investigators analyzed data on 245 posttransplant patients with hepatitis C (HCV) collected from 38 academic medical centers and 15 community medical centers in North America and Europe participating in the prospective, longitudinal, observational HCV-Target study. Of the 227 patients who started treatment, 69% completed treatment, 3% discontinued treatment prematurely, and 28% are undergoing treatment.

Among the 68 patients with HCV genotype 1 and a known virologic outcome who were treated with sofosbuvir and simeprevir with or without ribavirin, 61 (90%) achieved a sustained virologic response for 4 weeks (SVR4).

Response rates in that group varied, however, depending on whether patients had cirrhosis (SVR4 in 32 of 37, 86%) or no cirrhosis (SVR4 in 29 of 31, 94%). Results also varied in that group by genotype, with SVR4 in 30 of 36 patients with genotype 1a infection (83%) and SVR4 in 18 of 19 patients with genotype 1b (95%), Dr. Robert S. Brown Jr. and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

“This is the regimen that probably holds the highest interest,” Dr. Brown said, because most of the patients in the study were genotype 1, and most genotype 1 patients received sofosbuvir and simeprevir with or without ribavirin.

A total of 10 of 12 patients with HCV genotype 1 infection who were treated with sofosbuvir plus pegylated interferon and ribavirin achieved SVR4 (83%).

A total of 9 of 10 patients with HCV genotype 2 infection who had complete data and who received sofosbuvir plus ribavirin achieved SVR4 (90%), reported Dr. Brown, the Frank Cardile Professor of Medicine and Pediatrics (in Surgery) at Columbia University, New York, and director of the Center for Liver Disease and Transplantation at New York-Presbyterian Hospital/Columbia University Medical Center.

Three of five patients with genotype 3 infection and complete data who received sofosbuvir plus ribavirin achieved SVR4 (60%), and one patient with genotype 3 achieved SVR4 after treatment with sofosbuvir, pegylated interferon, and ribavirin.

Next page: Adverse events >>

 

 

Adverse events were reported by 82% of patients, with rates ranging from 77% to 92% in different treatment groups. “The majority of these were mild and manageable,” Dr. Brown noted. The overall rate of serious adverse events was 8%, ranging from 0% to 21% in different treatment groups, though some of those cases were unlikely to be related to treatment, he added.

In general, interferon-free regimens had low rates of serious adverse events, Dr. Brown said. No patients developed acute liver graft rejection.

“Hepatitis C following liver transplant does remain a problem in 2014, because reinfection is universal and therapeutic options, at least to date, have been limited,” he said. The study’s real-world data supplement encouraging results from small, controlled trials of newer anti-HCV agents in posttransplant patients.

Most of the patients in the study were treated for recurrent HCV “well after” transplantation, Dr. Brown said. “The optimal treatment regimen and the duration of therapy still remain to be determined.”

Treatment regimens in the HCV-Target study are selected by physicians according to the local standard of care.

The study was too small to do a multivariate analysis of predictive factors for SVR4, Dr. Brown commented.

The HCV-Target study was funded by AbbVie, Bristol Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Kadmon, Janssen, Merck, and Vertex. Dr. Brown reported financial associations with AbbVie, Genentech, Gilead, Janssen, Merck, Salix, Vertex, and Vital Therapies.

BOSTON – Treating recurrent hepatitis C infection after liver transplantation using sofosbuvir-containing regimens produced a sustained virologic response 4 weeks later in 60%-90% of 237 patients, depending on genotype and the presence of cirrhosis.

Investigators analyzed data on 245 posttransplant patients with hepatitis C (HCV) collected from 38 academic medical centers and 15 community medical centers in North America and Europe participating in the prospective, longitudinal, observational HCV-Target study. Of the 227 patients who started treatment, 69% completed treatment, 3% discontinued treatment prematurely, and 28% are undergoing treatment.

Among the 68 patients with HCV genotype 1 and a known virologic outcome who were treated with sofosbuvir and simeprevir with or without ribavirin, 61 (90%) achieved a sustained virologic response for 4 weeks (SVR4).

Response rates in that group varied, however, depending on whether patients had cirrhosis (SVR4 in 32 of 37, 86%) or no cirrhosis (SVR4 in 29 of 31, 94%). Results also varied in that group by genotype, with SVR4 in 30 of 36 patients with genotype 1a infection (83%) and SVR4 in 18 of 19 patients with genotype 1b (95%), Dr. Robert S. Brown Jr. and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

“This is the regimen that probably holds the highest interest,” Dr. Brown said, because most of the patients in the study were genotype 1, and most genotype 1 patients received sofosbuvir and simeprevir with or without ribavirin.

A total of 10 of 12 patients with HCV genotype 1 infection who were treated with sofosbuvir plus pegylated interferon and ribavirin achieved SVR4 (83%).

A total of 9 of 10 patients with HCV genotype 2 infection who had complete data and who received sofosbuvir plus ribavirin achieved SVR4 (90%), reported Dr. Brown, the Frank Cardile Professor of Medicine and Pediatrics (in Surgery) at Columbia University, New York, and director of the Center for Liver Disease and Transplantation at New York-Presbyterian Hospital/Columbia University Medical Center.

Three of five patients with genotype 3 infection and complete data who received sofosbuvir plus ribavirin achieved SVR4 (60%), and one patient with genotype 3 achieved SVR4 after treatment with sofosbuvir, pegylated interferon, and ribavirin.

Next page: Adverse events >>

 

 

Adverse events were reported by 82% of patients, with rates ranging from 77% to 92% in different treatment groups. “The majority of these were mild and manageable,” Dr. Brown noted. The overall rate of serious adverse events was 8%, ranging from 0% to 21% in different treatment groups, though some of those cases were unlikely to be related to treatment, he added.

In general, interferon-free regimens had low rates of serious adverse events, Dr. Brown said. No patients developed acute liver graft rejection.

“Hepatitis C following liver transplant does remain a problem in 2014, because reinfection is universal and therapeutic options, at least to date, have been limited,” he said. The study’s real-world data supplement encouraging results from small, controlled trials of newer anti-HCV agents in posttransplant patients.

Most of the patients in the study were treated for recurrent HCV “well after” transplantation, Dr. Brown said. “The optimal treatment regimen and the duration of therapy still remain to be determined.”

Treatment regimens in the HCV-Target study are selected by physicians according to the local standard of care.

The study was too small to do a multivariate analysis of predictive factors for SVR4, Dr. Brown commented.

The HCV-Target study was funded by AbbVie, Bristol Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Kadmon, Janssen, Merck, and Vertex. Dr. Brown reported financial associations with AbbVie, Genentech, Gilead, Janssen, Merck, Salix, Vertex, and Vital Therapies.

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Direct-acting antivirals treat recurrent HCV after transplant

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BOSTON – Treating recurrent hepatitis C infection after liver transplantation using sofosbuvir-containing regimens produced a sustained virologic response 4 weeks later in 60%-90% of 237 patients, depending on genotype and the presence of cirrhosis.

Investigators analyzed data on 245 posttransplant patients with hepatitis C (HCV) collected from 38 academic medical centers and 15 community medical centers in North America and Europe participating in the prospective, longitudinal, observational HCV-Target study. Of the 227 patients who started treatment, 69% completed treatment, 3% discontinued treatment prematurely, and 28% are undergoing treatment.

Dr. Robert Brown

Among the 68 patients with HCV genotype 1 and a known virologic outcome who were treated with sofosbuvir and simeprevir with or without ribavirin, 61 (90%) achieved a sustained virologic response for 4 weeks (SVR4).

Response rates in that group varied, however, depending on whether patients had cirrhosis (SVR4 in 32 of 37, 86%) or no cirrhosis (SVR4 in 29 of 31, 94%). Results also varied in that group by genotype, with SVR4 in 30 of 36 patients with genotype 1a infection (83%) and SVR4 in 18 of 19 patients with genotype 1b (95%), Dr. Robert S. Brown Jr. and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

“This is the regimen that probably holds the highest interest,” Dr. Brown said, because most of the patients in the study were genotype 1, and most genotype 1 patients received sofosbuvir and simeprevir with or without ribavirin.

A total of 10 of 12 patients with HCV genotype 1 infection who were treated with sofosbuvir plus pegylated interferon and ribavirin achieved SVR4 (83%).

A total of 9 of 10 patients with HCV genotype 2 infection who had complete data and who received sofosbuvir plus ribavirin achieved SVR4 (90%), reported Dr. Brown, the Frank Cardile Professor of Medicine and Pediatrics (in Surgery) at Columbia University, New York, and director of the Center for Liver Disease and Transplantation at New York-Presbyterian Hospital/Columbia University Medical Center.

Three of five patients with genotype 3 infection and complete data who received sofosbuvir plus ribavirin achieved SVR4 (60%), and one patient with genotype 3 achieved SVR4 after treatment with sofosbuvir, pegylated interferon, and ribavirin.

Adverse events were reported by 82% of patients, with rates ranging from 77% to 92% in different treatment groups. “The majority of these were mild and manageable,” Dr. Brown noted. The overall rate of serious adverse events was 8%, ranging from 0% to 21% in different treatment groups, though some of those cases were unlikely to be related to treatment, he added.

In general, interferon-free regimens had low rates of serious adverse events, Dr. Brown said. No patients developed acute liver graft rejection.

“Hepatitis C following liver transplant does remain a problem in 2014, because reinfection is universal and therapeutic options, at least to date, have been limited,” he said. The study’s real-world data supplement encouraging results from small, controlled trials of newer anti-HCV agents in posttransplant patients.

Most of the patients in the study were treated for recurrent HCV “well after” transplantation, Dr. Brown said. “The optimal treatment regimen and the duration of therapy still remain to be determined.”

Treatment regimens in the HCV-Target study are selected by physicians according to the local standard of care.

The study was too small to do a multivariate analysis of predictive factors for SVR4, Dr. Brown commented.

The HCV-Target study was funded by AbbVie, Bristol Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Kadmon, Janssen, Merck, and Vertex. Dr. Brown reported financial associations with AbbVie, Genentech, Gilead, Janssen, Merck, Salix, Vertex, and Vital Therapies.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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BOSTON – Treating recurrent hepatitis C infection after liver transplantation using sofosbuvir-containing regimens produced a sustained virologic response 4 weeks later in 60%-90% of 237 patients, depending on genotype and the presence of cirrhosis.

Investigators analyzed data on 245 posttransplant patients with hepatitis C (HCV) collected from 38 academic medical centers and 15 community medical centers in North America and Europe participating in the prospective, longitudinal, observational HCV-Target study. Of the 227 patients who started treatment, 69% completed treatment, 3% discontinued treatment prematurely, and 28% are undergoing treatment.

Dr. Robert Brown

Among the 68 patients with HCV genotype 1 and a known virologic outcome who were treated with sofosbuvir and simeprevir with or without ribavirin, 61 (90%) achieved a sustained virologic response for 4 weeks (SVR4).

Response rates in that group varied, however, depending on whether patients had cirrhosis (SVR4 in 32 of 37, 86%) or no cirrhosis (SVR4 in 29 of 31, 94%). Results also varied in that group by genotype, with SVR4 in 30 of 36 patients with genotype 1a infection (83%) and SVR4 in 18 of 19 patients with genotype 1b (95%), Dr. Robert S. Brown Jr. and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

“This is the regimen that probably holds the highest interest,” Dr. Brown said, because most of the patients in the study were genotype 1, and most genotype 1 patients received sofosbuvir and simeprevir with or without ribavirin.

A total of 10 of 12 patients with HCV genotype 1 infection who were treated with sofosbuvir plus pegylated interferon and ribavirin achieved SVR4 (83%).

A total of 9 of 10 patients with HCV genotype 2 infection who had complete data and who received sofosbuvir plus ribavirin achieved SVR4 (90%), reported Dr. Brown, the Frank Cardile Professor of Medicine and Pediatrics (in Surgery) at Columbia University, New York, and director of the Center for Liver Disease and Transplantation at New York-Presbyterian Hospital/Columbia University Medical Center.

Three of five patients with genotype 3 infection and complete data who received sofosbuvir plus ribavirin achieved SVR4 (60%), and one patient with genotype 3 achieved SVR4 after treatment with sofosbuvir, pegylated interferon, and ribavirin.

Adverse events were reported by 82% of patients, with rates ranging from 77% to 92% in different treatment groups. “The majority of these were mild and manageable,” Dr. Brown noted. The overall rate of serious adverse events was 8%, ranging from 0% to 21% in different treatment groups, though some of those cases were unlikely to be related to treatment, he added.

In general, interferon-free regimens had low rates of serious adverse events, Dr. Brown said. No patients developed acute liver graft rejection.

“Hepatitis C following liver transplant does remain a problem in 2014, because reinfection is universal and therapeutic options, at least to date, have been limited,” he said. The study’s real-world data supplement encouraging results from small, controlled trials of newer anti-HCV agents in posttransplant patients.

Most of the patients in the study were treated for recurrent HCV “well after” transplantation, Dr. Brown said. “The optimal treatment regimen and the duration of therapy still remain to be determined.”

Treatment regimens in the HCV-Target study are selected by physicians according to the local standard of care.

The study was too small to do a multivariate analysis of predictive factors for SVR4, Dr. Brown commented.

The HCV-Target study was funded by AbbVie, Bristol Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Kadmon, Janssen, Merck, and Vertex. Dr. Brown reported financial associations with AbbVie, Genentech, Gilead, Janssen, Merck, Salix, Vertex, and Vital Therapies.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

BOSTON – Treating recurrent hepatitis C infection after liver transplantation using sofosbuvir-containing regimens produced a sustained virologic response 4 weeks later in 60%-90% of 237 patients, depending on genotype and the presence of cirrhosis.

Investigators analyzed data on 245 posttransplant patients with hepatitis C (HCV) collected from 38 academic medical centers and 15 community medical centers in North America and Europe participating in the prospective, longitudinal, observational HCV-Target study. Of the 227 patients who started treatment, 69% completed treatment, 3% discontinued treatment prematurely, and 28% are undergoing treatment.

Dr. Robert Brown

Among the 68 patients with HCV genotype 1 and a known virologic outcome who were treated with sofosbuvir and simeprevir with or without ribavirin, 61 (90%) achieved a sustained virologic response for 4 weeks (SVR4).

Response rates in that group varied, however, depending on whether patients had cirrhosis (SVR4 in 32 of 37, 86%) or no cirrhosis (SVR4 in 29 of 31, 94%). Results also varied in that group by genotype, with SVR4 in 30 of 36 patients with genotype 1a infection (83%) and SVR4 in 18 of 19 patients with genotype 1b (95%), Dr. Robert S. Brown Jr. and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

“This is the regimen that probably holds the highest interest,” Dr. Brown said, because most of the patients in the study were genotype 1, and most genotype 1 patients received sofosbuvir and simeprevir with or without ribavirin.

A total of 10 of 12 patients with HCV genotype 1 infection who were treated with sofosbuvir plus pegylated interferon and ribavirin achieved SVR4 (83%).

A total of 9 of 10 patients with HCV genotype 2 infection who had complete data and who received sofosbuvir plus ribavirin achieved SVR4 (90%), reported Dr. Brown, the Frank Cardile Professor of Medicine and Pediatrics (in Surgery) at Columbia University, New York, and director of the Center for Liver Disease and Transplantation at New York-Presbyterian Hospital/Columbia University Medical Center.

Three of five patients with genotype 3 infection and complete data who received sofosbuvir plus ribavirin achieved SVR4 (60%), and one patient with genotype 3 achieved SVR4 after treatment with sofosbuvir, pegylated interferon, and ribavirin.

Adverse events were reported by 82% of patients, with rates ranging from 77% to 92% in different treatment groups. “The majority of these were mild and manageable,” Dr. Brown noted. The overall rate of serious adverse events was 8%, ranging from 0% to 21% in different treatment groups, though some of those cases were unlikely to be related to treatment, he added.

In general, interferon-free regimens had low rates of serious adverse events, Dr. Brown said. No patients developed acute liver graft rejection.

“Hepatitis C following liver transplant does remain a problem in 2014, because reinfection is universal and therapeutic options, at least to date, have been limited,” he said. The study’s real-world data supplement encouraging results from small, controlled trials of newer anti-HCV agents in posttransplant patients.

Most of the patients in the study were treated for recurrent HCV “well after” transplantation, Dr. Brown said. “The optimal treatment regimen and the duration of therapy still remain to be determined.”

Treatment regimens in the HCV-Target study are selected by physicians according to the local standard of care.

The study was too small to do a multivariate analysis of predictive factors for SVR4, Dr. Brown commented.

The HCV-Target study was funded by AbbVie, Bristol Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Kadmon, Janssen, Merck, and Vertex. Dr. Brown reported financial associations with AbbVie, Genentech, Gilead, Janssen, Merck, Salix, Vertex, and Vital Therapies.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Key clinical point: Direct-acting antivirals can help most patients with recurrent HCV after liver transplantation.

Major finding: A sustained virologic response after 4 weeks was seen in 60%-90% of patients, depending on genotype and cirrhosis.

Data source: An analysis of a multicenter database on 227 patients treated with sofosbuvir-containing regimens since December 2013 for recurrent HCV after liver transplantation.

Disclosures: The study was funded by AbbVie, Bristol Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Kadmon, Janssen, Merck, and Vertex. Dr. Brown reported financial associations with AbbVie, Genentech, Gilead, Janssen, Merck, Salix, Vertex, and Vital Therapies.

HCV Regimen Worked After Sofosbuvir Combos Failed

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BOSTON – All but 1 of 51 patients who failed sofosbuvir-containing treatment regimens for hepatitis C achieved a sustained virologic response for 12 weeks after retreatment with ledipasvir and sofosbuvir plus ribavirin.

The study was supposed to include only patients with genotype 1 hepatitis C virus (HCV), but the one patient who failed retreatment turned out to have genotype 3a and had been enrolled in error, Dr. David L. Wyles said at the annual meeting of the American Association for the Study of Liver Diseases.

Among the 50 patients with genotype 1, retreatment achieved a sustained virologic response for 12 weeks (SVR12) in 100%, reported Dr. Wyles of the University of California, San Diego, and his associates.

The patients had failed to achieve SVR12 after prior treatment in clinical trials using sofosbuvir plus pegylated interferon and ribavirin (25 patients), sofosbuvir with or without ribavirin (21 patients), or sofosbuvir and placebo (5 patients).

The cohort had a mean age of 54 years, 31 patients were male (61%), 8 were African American (16%), and the mean body mass index was 30 kg/m2. Fifteen patients had cirrhosis (29%).

Genetic resistance analyses conducted before retreatment showed that no patients had the sofosbuvir-associated variant S282T, but two patients had the NS5B treatment-emergent variant L159F, and each of them achieved SVR12 after retreatment.

Adverse events were reported by 41 patients (80%) and serious adverse events by 2 patients (4%), including bipolar disorder, chest pain, anemia, and cholecystitis. The most common adverse events included fatigue in 13 patients (25%), headache in 11 (22%), diarrhea in 7 (14%), rash in 6 (12%), and insomnia or nausea in 5 patients each (10% each). Most adverse events were mild or moderate in severity.

Gilead funded the study. Dr. Wyles is a consultant for Gilead, AbbVie, and Bristol-Myers Squibb.

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BOSTON – All but 1 of 51 patients who failed sofosbuvir-containing treatment regimens for hepatitis C achieved a sustained virologic response for 12 weeks after retreatment with ledipasvir and sofosbuvir plus ribavirin.

The study was supposed to include only patients with genotype 1 hepatitis C virus (HCV), but the one patient who failed retreatment turned out to have genotype 3a and had been enrolled in error, Dr. David L. Wyles said at the annual meeting of the American Association for the Study of Liver Diseases.

Among the 50 patients with genotype 1, retreatment achieved a sustained virologic response for 12 weeks (SVR12) in 100%, reported Dr. Wyles of the University of California, San Diego, and his associates.

The patients had failed to achieve SVR12 after prior treatment in clinical trials using sofosbuvir plus pegylated interferon and ribavirin (25 patients), sofosbuvir with or without ribavirin (21 patients), or sofosbuvir and placebo (5 patients).

The cohort had a mean age of 54 years, 31 patients were male (61%), 8 were African American (16%), and the mean body mass index was 30 kg/m2. Fifteen patients had cirrhosis (29%).

Genetic resistance analyses conducted before retreatment showed that no patients had the sofosbuvir-associated variant S282T, but two patients had the NS5B treatment-emergent variant L159F, and each of them achieved SVR12 after retreatment.

Adverse events were reported by 41 patients (80%) and serious adverse events by 2 patients (4%), including bipolar disorder, chest pain, anemia, and cholecystitis. The most common adverse events included fatigue in 13 patients (25%), headache in 11 (22%), diarrhea in 7 (14%), rash in 6 (12%), and insomnia or nausea in 5 patients each (10% each). Most adverse events were mild or moderate in severity.

Gilead funded the study. Dr. Wyles is a consultant for Gilead, AbbVie, and Bristol-Myers Squibb.

BOSTON – All but 1 of 51 patients who failed sofosbuvir-containing treatment regimens for hepatitis C achieved a sustained virologic response for 12 weeks after retreatment with ledipasvir and sofosbuvir plus ribavirin.

The study was supposed to include only patients with genotype 1 hepatitis C virus (HCV), but the one patient who failed retreatment turned out to have genotype 3a and had been enrolled in error, Dr. David L. Wyles said at the annual meeting of the American Association for the Study of Liver Diseases.

Among the 50 patients with genotype 1, retreatment achieved a sustained virologic response for 12 weeks (SVR12) in 100%, reported Dr. Wyles of the University of California, San Diego, and his associates.

The patients had failed to achieve SVR12 after prior treatment in clinical trials using sofosbuvir plus pegylated interferon and ribavirin (25 patients), sofosbuvir with or without ribavirin (21 patients), or sofosbuvir and placebo (5 patients).

The cohort had a mean age of 54 years, 31 patients were male (61%), 8 were African American (16%), and the mean body mass index was 30 kg/m2. Fifteen patients had cirrhosis (29%).

Genetic resistance analyses conducted before retreatment showed that no patients had the sofosbuvir-associated variant S282T, but two patients had the NS5B treatment-emergent variant L159F, and each of them achieved SVR12 after retreatment.

Adverse events were reported by 41 patients (80%) and serious adverse events by 2 patients (4%), including bipolar disorder, chest pain, anemia, and cholecystitis. The most common adverse events included fatigue in 13 patients (25%), headache in 11 (22%), diarrhea in 7 (14%), rash in 6 (12%), and insomnia or nausea in 5 patients each (10% each). Most adverse events were mild or moderate in severity.

Gilead funded the study. Dr. Wyles is a consultant for Gilead, AbbVie, and Bristol-Myers Squibb.

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BOSTON – All but 1 of 51 patients who failed sofosbuvir-containing treatment regimens for hepatitis C achieved a sustained virologic response for 12 weeks after retreatment with ledipasvir and sofosbuvir plus ribavirin.

The study was supposed to include only patients with genotype 1 hepatitis C virus (HCV), but the one patient who failed retreatment turned out to have genotype 3a and had been enrolled in error, Dr. David L. Wyles said at the annual meeting of the American Association for the Study of Liver Diseases.

Among the 50 patients with genotype 1, retreatment achieved a sustained virologic response for 12 weeks (SVR12) in 100%, reported Dr. Wyles of the University of California, San Diego, and his associates.

Sherry Boschert/ Frontline Medical News
Dr. David L. Wyles

The patients had failed to achieve SVR12 after prior treatment in clinical trials using sofosbuvir plus pegylated interferon and ribavirin (25 patients), sofosbuvir with or without ribavirin (21 patients), or sofosbuvir and placebo (5 patients).

The cohort had a mean age of 54 years, 31 patients were male (61%), 8 were African American (16%), and the mean body mass index was 30 kg/m2. Fifteen patients had cirrhosis (29%).

Genetic resistance analyses conducted before retreatment showed that no patients had the sofosbuvir-associated variant S282T, but two patients had the NS5B treatment-emergent variant L159F, and each of them achieved SVR12 after retreatment.

Adverse events were reported by 41 patients (80%) and serious adverse events by 2 patients (4%), including bipolar disorder, chest pain, anemia, and cholecystitis. The most common adverse events included fatigue in 13 patients (25%), headache in 11 (22%), diarrhea in 7 (14%), rash in 6 (12%), and insomnia or nausea in 5 patients each (10% each). Most adverse events were mild or moderate in severity.

Gilead funded the study. Dr. Wyles is a consultant for Gilead, AbbVie, and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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BOSTON – All but 1 of 51 patients who failed sofosbuvir-containing treatment regimens for hepatitis C achieved a sustained virologic response for 12 weeks after retreatment with ledipasvir and sofosbuvir plus ribavirin.

The study was supposed to include only patients with genotype 1 hepatitis C virus (HCV), but the one patient who failed retreatment turned out to have genotype 3a and had been enrolled in error, Dr. David L. Wyles said at the annual meeting of the American Association for the Study of Liver Diseases.

Among the 50 patients with genotype 1, retreatment achieved a sustained virologic response for 12 weeks (SVR12) in 100%, reported Dr. Wyles of the University of California, San Diego, and his associates.

Sherry Boschert/ Frontline Medical News
Dr. David L. Wyles

The patients had failed to achieve SVR12 after prior treatment in clinical trials using sofosbuvir plus pegylated interferon and ribavirin (25 patients), sofosbuvir with or without ribavirin (21 patients), or sofosbuvir and placebo (5 patients).

The cohort had a mean age of 54 years, 31 patients were male (61%), 8 were African American (16%), and the mean body mass index was 30 kg/m2. Fifteen patients had cirrhosis (29%).

Genetic resistance analyses conducted before retreatment showed that no patients had the sofosbuvir-associated variant S282T, but two patients had the NS5B treatment-emergent variant L159F, and each of them achieved SVR12 after retreatment.

Adverse events were reported by 41 patients (80%) and serious adverse events by 2 patients (4%), including bipolar disorder, chest pain, anemia, and cholecystitis. The most common adverse events included fatigue in 13 patients (25%), headache in 11 (22%), diarrhea in 7 (14%), rash in 6 (12%), and insomnia or nausea in 5 patients each (10% each). Most adverse events were mild or moderate in severity.

Gilead funded the study. Dr. Wyles is a consultant for Gilead, AbbVie, and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

BOSTON – All but 1 of 51 patients who failed sofosbuvir-containing treatment regimens for hepatitis C achieved a sustained virologic response for 12 weeks after retreatment with ledipasvir and sofosbuvir plus ribavirin.

The study was supposed to include only patients with genotype 1 hepatitis C virus (HCV), but the one patient who failed retreatment turned out to have genotype 3a and had been enrolled in error, Dr. David L. Wyles said at the annual meeting of the American Association for the Study of Liver Diseases.

Among the 50 patients with genotype 1, retreatment achieved a sustained virologic response for 12 weeks (SVR12) in 100%, reported Dr. Wyles of the University of California, San Diego, and his associates.

Sherry Boschert/ Frontline Medical News
Dr. David L. Wyles

The patients had failed to achieve SVR12 after prior treatment in clinical trials using sofosbuvir plus pegylated interferon and ribavirin (25 patients), sofosbuvir with or without ribavirin (21 patients), or sofosbuvir and placebo (5 patients).

The cohort had a mean age of 54 years, 31 patients were male (61%), 8 were African American (16%), and the mean body mass index was 30 kg/m2. Fifteen patients had cirrhosis (29%).

Genetic resistance analyses conducted before retreatment showed that no patients had the sofosbuvir-associated variant S282T, but two patients had the NS5B treatment-emergent variant L159F, and each of them achieved SVR12 after retreatment.

Adverse events were reported by 41 patients (80%) and serious adverse events by 2 patients (4%), including bipolar disorder, chest pain, anemia, and cholecystitis. The most common adverse events included fatigue in 13 patients (25%), headache in 11 (22%), diarrhea in 7 (14%), rash in 6 (12%), and insomnia or nausea in 5 patients each (10% each). Most adverse events were mild or moderate in severity.

Gilead funded the study. Dr. Wyles is a consultant for Gilead, AbbVie, and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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Inside the Article

Vitals

Key clinical point: Retreatment with ledipasvir and sofosbuvir achieved a sustained virologic response for 12 weeks after therapy in patients with hepatitis C who failed other sofosbuvir regimens.

Major finding: All 50 patients with genotype 1 HCV achieved SVR12, and 1 patient with genotype 3a did not.

Data source: Analysis of data on patients who failed prior treatment with sofosbuvir plus pegylated interferon and ribavirin, sofosbuvir with or without ribavirin, or sofosbuvir and placebo in clinical trials.

Disclosures: Gilead funded the study. Dr. Wyles is a consultant for Gilead, AbbVie, and Bristol-Myers Squibb.

Best HCV value? Screen all baby boomers, treat all infections

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Best HCV value? Screen all baby boomers, treat all infections

BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

BOSTON – Screening all adults born between 1945 and 1965 for hepatitis C and then treating all infected patients with oral drug regimens is the most cost effective strategy for society, because better outcomes more than offset the higher costs of wider screening and newer drugs, Dr. Zobair Younossi said.

A computer simulation analysis that compared four strategies for screening and treatment (plus the option of no screening or treatment) found that birth cohort screening and treatment of all hepatitis C virus–positive patients would save more than 4 million life-years at an incremental cost of $36,585 per quality-adjusted life-year (QALY), he reported at the annual meeting of the American Association for the Study of Liver Diseases.

That strategy produced an incremental cost-effectiveness ratio well below the widely accepted threshold of $50,000 per QALY used to define cost effectiveness in health care, said Dr. Younossi, professor of medicine at Virginia Commonwealth University’s Inova Campus and chair of Liver Disease Services for Inova, Falls Church, Va.

Dr. Zobair Younossi

In first-generation treatment with direct-acting antivirals – namely, triple therapy with protease inhibitors – the mean cost to achieve a sustained virologic response was $172,889, he said, “and we did not get a lot of pushback from the payers at that point.”

Risk-based screening for HCV has been recommended, and the Centers for Disease Control and Prevention recently recommended birth cohort screening of people born between 1945 and 1965, the so-called baby boomers, Dr. Younossi said.

Still, studies suggest that less than 10% of patients with chronic HCV have been treated successfully, because of the failure of risk-based screening to identify all infected patients and the low efficacy and high rate of side effects from regimens based on interferon and ribavirin, he said.

Higher costs, lower risks

Dr. Younossi’s study used computer simulations to analyze the economic impact of various screening strategies followed by treatment with oral anti-HCV regimens.

The four strategies involved either risk-based screening or birth cohort screening, followed by treatment that either gave all HCV-infected patients oral regimens or that based treatment on staging, giving oral medications only to patients with significant fibrosis. The investigators also considered a fifth strategy: no screening and no treatment.

Birth cohort screening would lead to 1,162,323 patients being diagnosed with previously unknown chronic HCV, they estimated.

To estimate treatment costs, the investigators began with risk-based screening probabilities from a previous study: They assumed that 98% of patients would be medically eligible for treatment and have no contraindications to all-oral treatment regimens, and 98% of those treated would achieve a sustained virologic response for 12 weeks (SVR12), based on results of published trials.

The cost of oral direct-acting antiviral therapy was based on the cost of sofosbuvir – around $1,000 per day for 12 weeks, Dr. Younossi said. Costs for testing, staging, monitoring, and other data were taken from previous treatment models. The investigators calculated QALY from patients’ health utility reports in clinical trials.

Costs averaged approximately $88,000 per patient with birth cohort screening and treating all positive patients, $72,000 per patient with birth cohort screening and treatment based on staging, $60,000-$61,000 per patient for the risk-based screening strategies, and $53,000 per patient with no screening and no treatment.

The probabilities of cirrhosis, hepatocellular carcinoma, or liver transplant were much lower with either birth cohort screening strategy, however, compared with the risk-based strategies or no screening. The probability of cirrhosis was approximately 1% with birth cohort screening and treating all positive patients, 7% with birth cohort screening and treatment based on staging, 55%-60% with the risk-based strategies, and 67% with no screening.

The risk of hepatocellular carcinoma was 4% with birth cohort screening and treating all positive patients, 5% with birth cohort screening and treatment based on staging, 15% with either risk-based screening strategy, and 20% with no screening. The risk of liver transplant was 0.6% with either birth cohort screening strategy, 3% with either risk-based screening strategy, and nearly 4% with no screening.

A total of 4% of patients would be expected to die of liver-related causes after birth cohort screening and treating all positive patients, compared with 7% liver-related mortality after birth cohort screening and staging-based treatment, 25% liver-related mortality in either of the risk-based screening groups, and 34% liver-related mortality with no screening.

HCV costlier than other conditions?

When considering governmental health policy and budgetary issues, Dr. Younossi explained, the cost of curing HCV is not very different from lifetime treatment costs for type 2 diabetes, rheumatoid arthritis, or breast cancer with metastases – and it’s significantly lower than lifetime treatment costs for HIV or relapsing-remitting multiple sclerosis.

 

 

As advocates for patients, physicians need to lobby officials so that “as they are dividing the pie, hepatology and HCV are represented,” he said. “These regimens are cost effective.”

The study was an underestimation of savings from birth cohort screening and treating all HCV positives, Dr. Younossi noted, because it did not incorporate an estimated $3 billion per year in savings from work productivity in the United States by curing HCV.

A physician in the audience countered Dr. Younossi’s call for more enlightened health policy supporting funding for HCV treatment, noting that drug companies also need to be pressured to lower the price of the newer drugs.

“The biggest bridge we have to cross is the cost of the drugs,” he said. “This is like denying somebody treatment for tuberculosis by making the cost of the drug too high.”

“I agree,” Dr. Younossi said. “We have to focus on our colleagues in the industry. But we also have to focus on our colleagues in Congress and the policymakers to make sure that, even if we get help from the industry side, we also get help from the policymakers to provide us” with the funding for access to HCV screening and treatment.

Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead and Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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AT THE LIVER MEETING 2014

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Inside the Article

Vitals

Key clinical point: Screening adults born in 1945-1965 and treating all who have HCV with oral anti-HCV regimens is most cost effective.

Major finding: The strategy’s incremental cost of $36,585 is below the $50,000 per QALY threshold for cost effectiveness.

Data source: A computer simulation analysis that compared four strategies for screening and treatment, with treatment costs based on an estimated $1,000/day for sofosbuvir.

Disclosures: Dr. Younossi reported having no financial disclosures. One of his coinvestigators reported financial associations with Gilead, which markets sofosbuvir, and Bristol-Myers Squibb.