Switching to gonadotropins increased the odds of live births for women with normogonadotropic anovulation with little success for continuing with clomifene citrate, based on data from 666 women.

Women who have not become pregnant after six cycles of clomifene are often defined as having failed the treatment, but the effectiveness of continuing clomifene citrate or switching to gonadotropins had not been addressed in randomized trials, wrote Nienke S. Weiss, MD, of VU University Medical Center, Amsterdam, and her colleagues.

In a study published online in the Lancet, the researchers randomized 166 women to gonadotropins and intrauterine insemination, 165 to gonadotropins and intercourse, 163 to clomifene citrate and intrauterine insemination, and 172 to clomifene citrate and intercourse. The study population included women aged 18 years and older who had not become pregnant after six cycles of clomifene citrate. The clomifene citrate was given as oral doses of 50-150 mg daily, and gonadotropin was given subcutaneously at a starting dose of 50 IU or 75 IU daily.

Overall, live births were significantly more likely for women given gonadotropins, compared with those given clomifene citrate (52% of 327 women vs. 41% of 334 women, respectively; P = .0124). Rates of multiple pregnancies were similar and relatively low among the treatment groups.

Intrauterine insemination had no significant impact on live birth rates, compared with intercourse (49% vs. 43%, respectively; P = .1152).

A total of three adverse events were reported including one stillbirth and one case of congenital abnormality in the clomifene group and one delivery at 20 weeks’ gestational age caused by cervical insufficiency in the gonadotropin group. More miscarriages were reported in the gonadotropin group than in the clomifene group, but the study was not powered to address this difference, which should be addressed in future studies, the researchers said.

The findings were limited by each center’s use of its own ovulation induction protocols, the researchers noted. “Our results can be used by couples treated with first-line ovulatory drugs who weigh the pros and cons of switching to gonadotropins and addition of intrauterine insemination,” they said.

The study was supported by the Netherlands Organization for Health Research and Development.

[email protected]

SOURCE: Weiss N et al. Lancet. 2017 Dec 19. doi: 10.1016/S0140-6736(17)33308-1.

Switching to gonadotropins increased the odds of live births for women with normogonadotropic anovulation with little success for continuing with clomifene citrate, based on data from 666 women.

Women who have not become pregnant after six cycles of clomifene are often defined as having failed the treatment, but the effectiveness of continuing clomifene citrate or switching to gonadotropins had not been addressed in randomized trials, wrote Nienke S. Weiss, MD, of VU University Medical Center, Amsterdam, and her colleagues.

In a study published online in the Lancet, the researchers randomized 166 women to gonadotropins and intrauterine insemination, 165 to gonadotropins and intercourse, 163 to clomifene citrate and intrauterine insemination, and 172 to clomifene citrate and intercourse. The study population included women aged 18 years and older who had not become pregnant after six cycles of clomifene citrate. The clomifene citrate was given as oral doses of 50-150 mg daily, and gonadotropin was given subcutaneously at a starting dose of 50 IU or 75 IU daily.

Overall, live births were significantly more likely for women given gonadotropins, compared with those given clomifene citrate (52% of 327 women vs. 41% of 334 women, respectively; P = .0124). Rates of multiple pregnancies were similar and relatively low among the treatment groups.

Intrauterine insemination had no significant impact on live birth rates, compared with intercourse (49% vs. 43%, respectively; P = .1152).

A total of three adverse events were reported including one stillbirth and one case of congenital abnormality in the clomifene group and one delivery at 20 weeks’ gestational age caused by cervical insufficiency in the gonadotropin group. More miscarriages were reported in the gonadotropin group than in the clomifene group, but the study was not powered to address this difference, which should be addressed in future studies, the researchers said.

The findings were limited by each center’s use of its own ovulation induction protocols, the researchers noted. “Our results can be used by couples treated with first-line ovulatory drugs who weigh the pros and cons of switching to gonadotropins and addition of intrauterine insemination,” they said.

The study was supported by the Netherlands Organization for Health Research and Development.

[email protected]

SOURCE: Weiss N et al. Lancet. 2017 Dec 19. doi: 10.1016/S0140-6736(17)33308-1.

Switching to gonadotropins increased the odds of live births for women with normogonadotropic anovulation with little success for continuing with clomifene citrate, based on data from 666 women.

Women who have not become pregnant after six cycles of clomifene are often defined as having failed the treatment, but the effectiveness of continuing clomifene citrate or switching to gonadotropins had not been addressed in randomized trials, wrote Nienke S. Weiss, MD, of VU University Medical Center, Amsterdam, and her colleagues.

In a study published online in the Lancet, the researchers randomized 166 women to gonadotropins and intrauterine insemination, 165 to gonadotropins and intercourse, 163 to clomifene citrate and intrauterine insemination, and 172 to clomifene citrate and intercourse. The study population included women aged 18 years and older who had not become pregnant after six cycles of clomifene citrate. The clomifene citrate was given as oral doses of 50-150 mg daily, and gonadotropin was given subcutaneously at a starting dose of 50 IU or 75 IU daily.

Overall, live births were significantly more likely for women given gonadotropins, compared with those given clomifene citrate (52% of 327 women vs. 41% of 334 women, respectively; P = .0124). Rates of multiple pregnancies were similar and relatively low among the treatment groups.

Intrauterine insemination had no significant impact on live birth rates, compared with intercourse (49% vs. 43%, respectively; P = .1152).

A total of three adverse events were reported including one stillbirth and one case of congenital abnormality in the clomifene group and one delivery at 20 weeks’ gestational age caused by cervical insufficiency in the gonadotropin group. More miscarriages were reported in the gonadotropin group than in the clomifene group, but the study was not powered to address this difference, which should be addressed in future studies, the researchers said.

The findings were limited by each center’s use of its own ovulation induction protocols, the researchers noted. “Our results can be used by couples treated with first-line ovulatory drugs who weigh the pros and cons of switching to gonadotropins and addition of intrauterine insemination,” they said.

The study was supported by the Netherlands Organization for Health Research and Development.

[email protected]

SOURCE: Weiss N et al. Lancet. 2017 Dec 19. doi: 10.1016/S0140-6736(17)33308-1.

The Children’s Health Insurance Plan remains without funding as a temporary government funding bill that included a 6-year extension of the popular bipartisan program failed to garner enough support in the Senate.

On Jan. 19, senators voted 50-49 in favor of a procedural motion to end debate and formally consider the temporary funding bill, short of the 60 votes needed to clear that hurdle.

screen capture/OPM Alert aap

The continuing resolution also featured a few other health care provisions, including delays to the medical device tax and the so-called Cadillac tax on high-valued health insurance plans offered by employers.

In comments made on the Senate floor prior to the vote, Finance Committee Chairman Orrin Hatch (R-Utah) called out Democrats for failing to pass the bill.

“There’s really nothing wrong with the substance of the bill, Mr. President, or at least very few of our Democratic colleagues are complaining about what’s actually in the bill” he said. “Instead, they’re complaining about what’s not in it.”

Democrats made their stand on the absence of language on Deferred Action for Childhood Arrivals (DACA), which addresses the immigration status of young people – often called Dreamers – who were brought to this country illegally as children.

Democrats also complained that funding for community health centers was not included.

Sen. Hatch, one of the original authors of the CHIP authorizing legislation, continued to argue for the program and the overall funding bill.

“This new bill before us would reauthorize CHIP for 6 six years,” he noted. “A 6-year extension would be the longest in the history of the program. In all other respects, the bill is identical to the one the Finance Committee reported [in September] with broad bipartisan support,” although no further action was taken on it after receiving near unanimous support in committee.

Finance Committee Ranking Member Ron Wyden (D-Ore.) took exception to the characterization that Democrats were not in support of the CHIP provision.

“The Chairman and I did negotiate a CHIP extension back in September, and the Senate Finance did report it out in a near unanimous, bipartisan basis,” he said. “CHIP could have passed the Congress within days, but the House Republicans had other ideas.”

Sen. Wyden noted that CHIP reauthorization was attached to other legislative actions in the House that all failed to garner enough support instead of being sent through as a stand-alone bill that likely would have received large bipartisan support.

And even though the extension would be for 6 years, Sen. Wyden also questioned why it wasn’t receiving permanent authorization.

“Congress learned that making CHIP permanent actually saves taxpayer dollars,” he said. “It’s a better deal than a 6-year extension, less of an expense for the taxpayer. True fiscal conservatives ought to be tripping over themselves to pass a permanent bill without preconditions. But at every turn in the CHIP debate, Republican leaders have found a new hostage.”

Sen. McConnell said following the failed voted that the Senate would resume activities beginning at noon on Jan. 20 – with votes expected – in hopes of finding a solution.

[email protected]

The Children’s Health Insurance Plan remains without funding as a temporary government funding bill that included a 6-year extension of the popular bipartisan program failed to garner enough support in the Senate.

On Jan. 19, senators voted 50-49 in favor of a procedural motion to end debate and formally consider the temporary funding bill, short of the 60 votes needed to clear that hurdle.

screen capture/OPM Alert aap

The continuing resolution also featured a few other health care provisions, including delays to the medical device tax and the so-called Cadillac tax on high-valued health insurance plans offered by employers.

In comments made on the Senate floor prior to the vote, Finance Committee Chairman Orrin Hatch (R-Utah) called out Democrats for failing to pass the bill.

“There’s really nothing wrong with the substance of the bill, Mr. President, or at least very few of our Democratic colleagues are complaining about what’s actually in the bill” he said. “Instead, they’re complaining about what’s not in it.”

Democrats made their stand on the absence of language on Deferred Action for Childhood Arrivals (DACA), which addresses the immigration status of young people – often called Dreamers – who were brought to this country illegally as children.

Democrats also complained that funding for community health centers was not included.

Sen. Hatch, one of the original authors of the CHIP authorizing legislation, continued to argue for the program and the overall funding bill.

“This new bill before us would reauthorize CHIP for 6 six years,” he noted. “A 6-year extension would be the longest in the history of the program. In all other respects, the bill is identical to the one the Finance Committee reported [in September] with broad bipartisan support,” although no further action was taken on it after receiving near unanimous support in committee.

Finance Committee Ranking Member Ron Wyden (D-Ore.) took exception to the characterization that Democrats were not in support of the CHIP provision.

“The Chairman and I did negotiate a CHIP extension back in September, and the Senate Finance did report it out in a near unanimous, bipartisan basis,” he said. “CHIP could have passed the Congress within days, but the House Republicans had other ideas.”

Sen. Wyden noted that CHIP reauthorization was attached to other legislative actions in the House that all failed to garner enough support instead of being sent through as a stand-alone bill that likely would have received large bipartisan support.

And even though the extension would be for 6 years, Sen. Wyden also questioned why it wasn’t receiving permanent authorization.

“Congress learned that making CHIP permanent actually saves taxpayer dollars,” he said. “It’s a better deal than a 6-year extension, less of an expense for the taxpayer. True fiscal conservatives ought to be tripping over themselves to pass a permanent bill without preconditions. But at every turn in the CHIP debate, Republican leaders have found a new hostage.”

Sen. McConnell said following the failed voted that the Senate would resume activities beginning at noon on Jan. 20 – with votes expected – in hopes of finding a solution.

[email protected]

The Children’s Health Insurance Plan remains without funding as a temporary government funding bill that included a 6-year extension of the popular bipartisan program failed to garner enough support in the Senate.

On Jan. 19, senators voted 50-49 in favor of a procedural motion to end debate and formally consider the temporary funding bill, short of the 60 votes needed to clear that hurdle.

screen capture/OPM Alert aap

The continuing resolution also featured a few other health care provisions, including delays to the medical device tax and the so-called Cadillac tax on high-valued health insurance plans offered by employers.

In comments made on the Senate floor prior to the vote, Finance Committee Chairman Orrin Hatch (R-Utah) called out Democrats for failing to pass the bill.

“There’s really nothing wrong with the substance of the bill, Mr. President, or at least very few of our Democratic colleagues are complaining about what’s actually in the bill” he said. “Instead, they’re complaining about what’s not in it.”

Democrats made their stand on the absence of language on Deferred Action for Childhood Arrivals (DACA), which addresses the immigration status of young people – often called Dreamers – who were brought to this country illegally as children.

Democrats also complained that funding for community health centers was not included.

Sen. Hatch, one of the original authors of the CHIP authorizing legislation, continued to argue for the program and the overall funding bill.

“This new bill before us would reauthorize CHIP for 6 six years,” he noted. “A 6-year extension would be the longest in the history of the program. In all other respects, the bill is identical to the one the Finance Committee reported [in September] with broad bipartisan support,” although no further action was taken on it after receiving near unanimous support in committee.

Finance Committee Ranking Member Ron Wyden (D-Ore.) took exception to the characterization that Democrats were not in support of the CHIP provision.

“The Chairman and I did negotiate a CHIP extension back in September, and the Senate Finance did report it out in a near unanimous, bipartisan basis,” he said. “CHIP could have passed the Congress within days, but the House Republicans had other ideas.”

Sen. Wyden noted that CHIP reauthorization was attached to other legislative actions in the House that all failed to garner enough support instead of being sent through as a stand-alone bill that likely would have received large bipartisan support.

And even though the extension would be for 6 years, Sen. Wyden also questioned why it wasn’t receiving permanent authorization.

“Congress learned that making CHIP permanent actually saves taxpayer dollars,” he said. “It’s a better deal than a 6-year extension, less of an expense for the taxpayer. True fiscal conservatives ought to be tripping over themselves to pass a permanent bill without preconditions. But at every turn in the CHIP debate, Republican leaders have found a new hostage.”

Sen. McConnell said following the failed voted that the Senate would resume activities beginning at noon on Jan. 20 – with votes expected – in hopes of finding a solution.

[email protected]

MONTREAL – Does rurality matter in cancer treatment? According to lessons from a Scottish study, the answer may be yes, but in unexpected ways.

Patients who lived further away from a cancer treatment center were more likely to be treated within the 62 days postreferral window that the Scottish government has set as a target. Compared with those living within 15 minutes of a cancer center, the adjusted odds ratio for patients living at least an hour away to receive timely treatment was 1.42 (95% confidence interval, 1.25-1.61). For those living on remote islands, the aOR was 1.32 (95% CI, 1.09-1.59).

Kari Oakes/Frontline Medical News

[email protected]

SOURCE: Murchie P. NAPCRG 2017 Abstract CR15.

MONTREAL – Does rurality matter in cancer treatment? According to lessons from a Scottish study, the answer may be yes, but in unexpected ways.

Patients who lived further away from a cancer treatment center were more likely to be treated within the 62 days postreferral window that the Scottish government has set as a target. Compared with those living within 15 minutes of a cancer center, the adjusted odds ratio for patients living at least an hour away to receive timely treatment was 1.42 (95% confidence interval, 1.25-1.61). For those living on remote islands, the aOR was 1.32 (95% CI, 1.09-1.59).

Kari Oakes/Frontline Medical News

[email protected]

SOURCE: Murchie P. NAPCRG 2017 Abstract CR15.

MONTREAL – Does rurality matter in cancer treatment? According to lessons from a Scottish study, the answer may be yes, but in unexpected ways.

Patients who lived further away from a cancer treatment center were more likely to be treated within the 62 days postreferral window that the Scottish government has set as a target. Compared with those living within 15 minutes of a cancer center, the adjusted odds ratio for patients living at least an hour away to receive timely treatment was 1.42 (95% confidence interval, 1.25-1.61). For those living on remote islands, the aOR was 1.32 (95% CI, 1.09-1.59).

Kari Oakes/Frontline Medical News

[email protected]

SOURCE: Murchie P. NAPCRG 2017 Abstract CR15.

Photo by Petr Kratochvil

Results of a pilot study suggest that systematic bright light exposure can improve sleep in fatigued cancer survivors.

Subjects who were exposed to bright light every morning for 4 weeks had a significantly greater improvement in sleep efficiency than those who were exposed to dim light over the same period.

In fact, subjects in the bright light group were able to achieve clinically normal levels of sleep efficiency, and subjects in the dim light group were not.

Sleep efficiency is the percentage of time in bed that subjects spent sleeping.

Lisa M. Wu, PhD, of Northwestern University in Chicago, Illinois, and her colleagues reported these results in the Journal of Clinical Sleep Medicine.

The team noted that cancer patients report sleep disturbances at a significantly higher rate than the general population. Between 23% and 44% of cancer patients experience insomnia symptoms even years after treatment.

With this in mind, the researchers studied 44 individuals who had completed cancer treatment and met criteria for clinically significant fatigue at screening.

The subjects had an average age of 53.6, and 75% percent were female. Roughly 55% (n=24) had been diagnosed with a hematologic malignancy.

The subjects were randomized to a bright white light intervention or a dim red light intervention. Subjects in both treatment arms were provided with a light box and instructed to use it every morning for 30 minutes for 4 weeks. Sleep was evaluated using wrist actigraphy and the Pittsburgh Sleep Quality Index.

At baseline, 52.6% of subjects in the dim light group and 60% in the bright light group exceeded the clinical cutoff for poor sleep efficiency (≤ 85%). The mean sleep efficiency was 81.8% and 82.8%, respectively.

During the study period, sleep efficiency improved significantly more among subjects exposed to the bright light than those exposed to the dim light (P=0.003).

The mean sleep efficiency was in the clinically normal range for subjects in the bright light group at the end of the intervention (86.06%) and 3 weeks after (85.77%).

However, the cutoff for poor sleep efficiency was not reached in the dim light group, either at the end of the intervention (mean=79.35%) or 3 weeks after (mean=80.88%).

Total sleep time tended to increase over the study period for subjects in the bright light group, but there was no significant difference in total sleep time between the bright light and dim light groups.

Likewise, there was no significant between-group difference in waking after sleep onset, although this outcome tended to decrease over the study period for subjects in the bright light group.

“Systematic light exposure using bright white light is a low-cost and easily disseminated intervention that offers a feasible and potentially effective alternative to improve sleep in cancer survivors,” Dr Wu said.

However, she and her colleagues noted that larger-scale studies are needed.

Photo by Petr Kratochvil

Results of a pilot study suggest that systematic bright light exposure can improve sleep in fatigued cancer survivors.

Subjects who were exposed to bright light every morning for 4 weeks had a significantly greater improvement in sleep efficiency than those who were exposed to dim light over the same period.

In fact, subjects in the bright light group were able to achieve clinically normal levels of sleep efficiency, and subjects in the dim light group were not.

Sleep efficiency is the percentage of time in bed that subjects spent sleeping.

Lisa M. Wu, PhD, of Northwestern University in Chicago, Illinois, and her colleagues reported these results in the Journal of Clinical Sleep Medicine.

The team noted that cancer patients report sleep disturbances at a significantly higher rate than the general population. Between 23% and 44% of cancer patients experience insomnia symptoms even years after treatment.

With this in mind, the researchers studied 44 individuals who had completed cancer treatment and met criteria for clinically significant fatigue at screening.

The subjects had an average age of 53.6, and 75% percent were female. Roughly 55% (n=24) had been diagnosed with a hematologic malignancy.

The subjects were randomized to a bright white light intervention or a dim red light intervention. Subjects in both treatment arms were provided with a light box and instructed to use it every morning for 30 minutes for 4 weeks. Sleep was evaluated using wrist actigraphy and the Pittsburgh Sleep Quality Index.

At baseline, 52.6% of subjects in the dim light group and 60% in the bright light group exceeded the clinical cutoff for poor sleep efficiency (≤ 85%). The mean sleep efficiency was 81.8% and 82.8%, respectively.

During the study period, sleep efficiency improved significantly more among subjects exposed to the bright light than those exposed to the dim light (P=0.003).

The mean sleep efficiency was in the clinically normal range for subjects in the bright light group at the end of the intervention (86.06%) and 3 weeks after (85.77%).

However, the cutoff for poor sleep efficiency was not reached in the dim light group, either at the end of the intervention (mean=79.35%) or 3 weeks after (mean=80.88%).

Total sleep time tended to increase over the study period for subjects in the bright light group, but there was no significant difference in total sleep time between the bright light and dim light groups.

Likewise, there was no significant between-group difference in waking after sleep onset, although this outcome tended to decrease over the study period for subjects in the bright light group.

“Systematic light exposure using bright white light is a low-cost and easily disseminated intervention that offers a feasible and potentially effective alternative to improve sleep in cancer survivors,” Dr Wu said.

However, she and her colleagues noted that larger-scale studies are needed.

Photo by Petr Kratochvil

Results of a pilot study suggest that systematic bright light exposure can improve sleep in fatigued cancer survivors.

Subjects who were exposed to bright light every morning for 4 weeks had a significantly greater improvement in sleep efficiency than those who were exposed to dim light over the same period.

In fact, subjects in the bright light group were able to achieve clinically normal levels of sleep efficiency, and subjects in the dim light group were not.

Sleep efficiency is the percentage of time in bed that subjects spent sleeping.

Lisa M. Wu, PhD, of Northwestern University in Chicago, Illinois, and her colleagues reported these results in the Journal of Clinical Sleep Medicine.

The team noted that cancer patients report sleep disturbances at a significantly higher rate than the general population. Between 23% and 44% of cancer patients experience insomnia symptoms even years after treatment.

With this in mind, the researchers studied 44 individuals who had completed cancer treatment and met criteria for clinically significant fatigue at screening.

The subjects had an average age of 53.6, and 75% percent were female. Roughly 55% (n=24) had been diagnosed with a hematologic malignancy.

The subjects were randomized to a bright white light intervention or a dim red light intervention. Subjects in both treatment arms were provided with a light box and instructed to use it every morning for 30 minutes for 4 weeks. Sleep was evaluated using wrist actigraphy and the Pittsburgh Sleep Quality Index.

At baseline, 52.6% of subjects in the dim light group and 60% in the bright light group exceeded the clinical cutoff for poor sleep efficiency (≤ 85%). The mean sleep efficiency was 81.8% and 82.8%, respectively.

During the study period, sleep efficiency improved significantly more among subjects exposed to the bright light than those exposed to the dim light (P=0.003).

The mean sleep efficiency was in the clinically normal range for subjects in the bright light group at the end of the intervention (86.06%) and 3 weeks after (85.77%).

However, the cutoff for poor sleep efficiency was not reached in the dim light group, either at the end of the intervention (mean=79.35%) or 3 weeks after (mean=80.88%).

Total sleep time tended to increase over the study period for subjects in the bright light group, but there was no significant difference in total sleep time between the bright light and dim light groups.

Likewise, there was no significant between-group difference in waking after sleep onset, although this outcome tended to decrease over the study period for subjects in the bright light group.

“Systematic light exposure using bright white light is a low-cost and easily disseminated intervention that offers a feasible and potentially effective alternative to improve sleep in cancer survivors,” Dr Wu said.

However, she and her colleagues noted that larger-scale studies are needed.

More women received recommended mammograms after cost sharing for the service was eliminated under the Affordable Care Act, a study shows.

In health plans that eliminated cost sharing, such as copays, deductibles, or other out-of-pocket costs, the rate of biennial screening mammography increased from 60% in the 2-year period before the cost-sharing elimination to 65% in the 2-year period following the new regulation, according to an analysis in the New England Journal of Medicine.

John Foxx/Thinkstock

The findings extend that of past studies that show older women who need mammograms are sensitive to out-of-pocket costs and the presence of supplemental coverage, the authors conclude. If the cost-sharing provisions of the ACA are rescinded, the results also “raise concern that fewer older women will receive recommended breast-cancer screening.”

However, the authors also note that since mammogram rates in the health plans that eliminated cost sharing remained below those in plans with full coverage and less than three-quarters of women in control plans received biennial breast cancer screenings, that “the removal of out-of-pocket payments alone may not raise screening rates to desired levels.”

[email protected]

SOURCE: Trivedi A et al. N Engl J Med. 2018 Jan 18;378:262-9.
 

More women received recommended mammograms after cost sharing for the service was eliminated under the Affordable Care Act, a study shows.

In health plans that eliminated cost sharing, such as copays, deductibles, or other out-of-pocket costs, the rate of biennial screening mammography increased from 60% in the 2-year period before the cost-sharing elimination to 65% in the 2-year period following the new regulation, according to an analysis in the New England Journal of Medicine.

John Foxx/Thinkstock

The findings extend that of past studies that show older women who need mammograms are sensitive to out-of-pocket costs and the presence of supplemental coverage, the authors conclude. If the cost-sharing provisions of the ACA are rescinded, the results also “raise concern that fewer older women will receive recommended breast-cancer screening.”

However, the authors also note that since mammogram rates in the health plans that eliminated cost sharing remained below those in plans with full coverage and less than three-quarters of women in control plans received biennial breast cancer screenings, that “the removal of out-of-pocket payments alone may not raise screening rates to desired levels.”

[email protected]

SOURCE: Trivedi A et al. N Engl J Med. 2018 Jan 18;378:262-9.
 

More women received recommended mammograms after cost sharing for the service was eliminated under the Affordable Care Act, a study shows.

In health plans that eliminated cost sharing, such as copays, deductibles, or other out-of-pocket costs, the rate of biennial screening mammography increased from 60% in the 2-year period before the cost-sharing elimination to 65% in the 2-year period following the new regulation, according to an analysis in the New England Journal of Medicine.

John Foxx/Thinkstock

The findings extend that of past studies that show older women who need mammograms are sensitive to out-of-pocket costs and the presence of supplemental coverage, the authors conclude. If the cost-sharing provisions of the ACA are rescinded, the results also “raise concern that fewer older women will receive recommended breast-cancer screening.”

However, the authors also note that since mammogram rates in the health plans that eliminated cost sharing remained below those in plans with full coverage and less than three-quarters of women in control plans received biennial breast cancer screenings, that “the removal of out-of-pocket payments alone may not raise screening rates to desired levels.”

[email protected]

SOURCE: Trivedi A et al. N Engl J Med. 2018 Jan 18;378:262-9.
 

Children and adolescents with drug-resistant epilepsy who undergo surgery appear to have significantly higher rates of seizure freedom and better quality of life and behavior scores at 12 months than those who receive medical therapy alone, according to a study published in the October 26, 2017, issue of the New England Journal of Medicine. Serious anticipated adverse events may occur after surgery, however.

“The improvements that were observed in other cognitive, behavioral, and quality of life scores in the surgery group may have been due to a reduction in the frequency of seizures; conversely, the deterioration in these measures in the medical-therapy group may be attributed to a continuation of seizures,” said Rekha Dwivedi, PhD, a postdoctoral fellow at the All India Institute of Medical Sciences in New Delhi, and colleagues.

Comparing Methods Intended to Improve Outcomes

Children and adolescents with drug-resistant epilepsy have an increased risk of poor long-term intellectual and psychosocial outcomes, along with a poor health-related quality of life. Neurosurgical treatment may improve seizures in children and adolescents with drug-resistant epilepsy, but evidence of benefit from randomized trials in this age group is limited.

A meta-analysis of uncontrolled studies comparing seizure outcomes of surgeries in children indicated that 74% of patients with brain lesions and 45% without lesions had become seizure-free at one year of follow-up. In a retrospective analysis involving 142 children and adolescents with drug-resistant epilepsy who had undergone surgery, 79.3% of patients were free from disabling seizures after a mean follow-up of approximately four years.

To investigate the effects of surgery further, Dr. Dwivedi and colleagues performed a single-center trial. They sought to compare epilepsy surgery with continued medical therapy alone in patients on a waiting list for surgery.

Researchers randomized 116 patients age 18 or younger with drug-resistant epilepsy to brain surgery appropriate to the underlying cause of epilepsy, along with appropriate medical therapy, or to medical therapy alone. Patients for whom there was no consensus regarding the location of an epileptic focus, patients who had any other systemic illness, and patients with a history of status epilepticus were excluded.

Participants assigned to the surgery group underwent the procedure within a month after randomization. Those assigned to the medical-therapy group remained on a waiting list. Surgery for these patients was scheduled for one year or longer after randomization. The primary outcome was seizure freedom at 12 months. Secondary outcomes included the Hague Seizure Severity scale score, the Binet–Kamat intelligence quotient or the social quotient on the Vineland Social Maturity Scale, the T score on the Child Behavior Checklist, and the Pediatric Quality of Life Inventory score.

Most of the Surgery Group Became Seizure-Free at 12 Months

Median age was 9 in the surgery group and 10 in the medical-therapy group. In all, 14 patients had temporal lobe resections, 12 patients had resection of a lesion in a lobe other than the temporal lobe, 15 patients had hemispherotomy, 10 patients had a corpus callosotomy, and six patients had a disconnection or resection of hypothalamic hamartoma.

At 12 months, 44 of 57 patients (77%) in the surgery group became seizure-free, compared with four of 59 patients (7%) in the medical-therapy group. Furthermore, 21 patients (37%) in the surgery group were completely seizure-free during the entire 12-month period.

All patients who had undergone temporal lobectomy or hypothalamic hamartoma surgeries were seizure-free at the last follow-up. Of the patients who had undergone extratemporal resection or hemispherotomy, 11 of 12 patients (92%) and 13 of 15 (87%), had complete freedom from seizures, respectively.

Two of 15 patients (13%) in the medical-therapy group who were on the waiting list for a temporal lobectomy were seizure-free at 12 months, along with one of 19 patients (5%) who were on a waiting list for extratemporal resection and one of 16 patients (6%) who were waiting for a corpus callostomy. Patients with a planned hemispherotomy or intervention for hypothalamic hamartoma were not seizure-free at 12 months.

In addition, between-group differences in the change from baseline to 12 months significantly favored surgery with respect to the Hague Seizure Severity scale score, the Child Behavior Checklist, the Pediatric Quality of Life Inventory, and the Vineland Social Maturity Scale, but not the Binet–Kamat intelligence quotient, said the researchers.

Adverse Events and Study Limitations

Serious adverse events occurred in 19 patients (33%) in the surgery group and no patients in the medical-therapy group. Monoparesis occurred in two patients who had undergone temporal lobectomy or resection of parietal focal cortical dysplasia. Hemiparesis occurred in 15 patients who had undergone hemispherotomy. Finally, generalized hypotonia and language deficits occurred in one patient who had undergone frontal lobectomy.

Ten patients in the medical-therapy group had physical injuries associated with seizures (eg, cuts, burns, and fractures). One patient had an adverse event associated with an antiepileptic drug, and autistic features developed in another patient. No deaths occurred in either group.

One study limitation was that patients included in this trial underwent many types of epilepsy surgeries to treat various underlying pathologic causes of seizures. Another limitation was that there was an overrepresentation of hypothalamic hamartomas, compared with some other series, said the researchers.

—Erica Tricarico

Suggested Reading

Dwivedi R, Ramanujam B, Chandra PS, et al. Surgery for drug-resistant epilepsy in children. N Engl J Med. 2017;377(17):1639-1647.

Children and adolescents with drug-resistant epilepsy who undergo surgery appear to have significantly higher rates of seizure freedom and better quality of life and behavior scores at 12 months than those who receive medical therapy alone, according to a study published in the October 26, 2017, issue of the New England Journal of Medicine. Serious anticipated adverse events may occur after surgery, however.

“The improvements that were observed in other cognitive, behavioral, and quality of life scores in the surgery group may have been due to a reduction in the frequency of seizures; conversely, the deterioration in these measures in the medical-therapy group may be attributed to a continuation of seizures,” said Rekha Dwivedi, PhD, a postdoctoral fellow at the All India Institute of Medical Sciences in New Delhi, and colleagues.

Comparing Methods Intended to Improve Outcomes

Children and adolescents with drug-resistant epilepsy have an increased risk of poor long-term intellectual and psychosocial outcomes, along with a poor health-related quality of life. Neurosurgical treatment may improve seizures in children and adolescents with drug-resistant epilepsy, but evidence of benefit from randomized trials in this age group is limited.

A meta-analysis of uncontrolled studies comparing seizure outcomes of surgeries in children indicated that 74% of patients with brain lesions and 45% without lesions had become seizure-free at one year of follow-up. In a retrospective analysis involving 142 children and adolescents with drug-resistant epilepsy who had undergone surgery, 79.3% of patients were free from disabling seizures after a mean follow-up of approximately four years.

To investigate the effects of surgery further, Dr. Dwivedi and colleagues performed a single-center trial. They sought to compare epilepsy surgery with continued medical therapy alone in patients on a waiting list for surgery.

Researchers randomized 116 patients age 18 or younger with drug-resistant epilepsy to brain surgery appropriate to the underlying cause of epilepsy, along with appropriate medical therapy, or to medical therapy alone. Patients for whom there was no consensus regarding the location of an epileptic focus, patients who had any other systemic illness, and patients with a history of status epilepticus were excluded.

Participants assigned to the surgery group underwent the procedure within a month after randomization. Those assigned to the medical-therapy group remained on a waiting list. Surgery for these patients was scheduled for one year or longer after randomization. The primary outcome was seizure freedom at 12 months. Secondary outcomes included the Hague Seizure Severity scale score, the Binet–Kamat intelligence quotient or the social quotient on the Vineland Social Maturity Scale, the T score on the Child Behavior Checklist, and the Pediatric Quality of Life Inventory score.

Most of the Surgery Group Became Seizure-Free at 12 Months

Median age was 9 in the surgery group and 10 in the medical-therapy group. In all, 14 patients had temporal lobe resections, 12 patients had resection of a lesion in a lobe other than the temporal lobe, 15 patients had hemispherotomy, 10 patients had a corpus callosotomy, and six patients had a disconnection or resection of hypothalamic hamartoma.

At 12 months, 44 of 57 patients (77%) in the surgery group became seizure-free, compared with four of 59 patients (7%) in the medical-therapy group. Furthermore, 21 patients (37%) in the surgery group were completely seizure-free during the entire 12-month period.

All patients who had undergone temporal lobectomy or hypothalamic hamartoma surgeries were seizure-free at the last follow-up. Of the patients who had undergone extratemporal resection or hemispherotomy, 11 of 12 patients (92%) and 13 of 15 (87%), had complete freedom from seizures, respectively.

Two of 15 patients (13%) in the medical-therapy group who were on the waiting list for a temporal lobectomy were seizure-free at 12 months, along with one of 19 patients (5%) who were on a waiting list for extratemporal resection and one of 16 patients (6%) who were waiting for a corpus callostomy. Patients with a planned hemispherotomy or intervention for hypothalamic hamartoma were not seizure-free at 12 months.

In addition, between-group differences in the change from baseline to 12 months significantly favored surgery with respect to the Hague Seizure Severity scale score, the Child Behavior Checklist, the Pediatric Quality of Life Inventory, and the Vineland Social Maturity Scale, but not the Binet–Kamat intelligence quotient, said the researchers.

Adverse Events and Study Limitations

Serious adverse events occurred in 19 patients (33%) in the surgery group and no patients in the medical-therapy group. Monoparesis occurred in two patients who had undergone temporal lobectomy or resection of parietal focal cortical dysplasia. Hemiparesis occurred in 15 patients who had undergone hemispherotomy. Finally, generalized hypotonia and language deficits occurred in one patient who had undergone frontal lobectomy.

Ten patients in the medical-therapy group had physical injuries associated with seizures (eg, cuts, burns, and fractures). One patient had an adverse event associated with an antiepileptic drug, and autistic features developed in another patient. No deaths occurred in either group.

One study limitation was that patients included in this trial underwent many types of epilepsy surgeries to treat various underlying pathologic causes of seizures. Another limitation was that there was an overrepresentation of hypothalamic hamartomas, compared with some other series, said the researchers.

—Erica Tricarico

Suggested Reading

Dwivedi R, Ramanujam B, Chandra PS, et al. Surgery for drug-resistant epilepsy in children. N Engl J Med. 2017;377(17):1639-1647.

Children and adolescents with drug-resistant epilepsy who undergo surgery appear to have significantly higher rates of seizure freedom and better quality of life and behavior scores at 12 months than those who receive medical therapy alone, according to a study published in the October 26, 2017, issue of the New England Journal of Medicine. Serious anticipated adverse events may occur after surgery, however.

“The improvements that were observed in other cognitive, behavioral, and quality of life scores in the surgery group may have been due to a reduction in the frequency of seizures; conversely, the deterioration in these measures in the medical-therapy group may be attributed to a continuation of seizures,” said Rekha Dwivedi, PhD, a postdoctoral fellow at the All India Institute of Medical Sciences in New Delhi, and colleagues.

Comparing Methods Intended to Improve Outcomes

Children and adolescents with drug-resistant epilepsy have an increased risk of poor long-term intellectual and psychosocial outcomes, along with a poor health-related quality of life. Neurosurgical treatment may improve seizures in children and adolescents with drug-resistant epilepsy, but evidence of benefit from randomized trials in this age group is limited.

A meta-analysis of uncontrolled studies comparing seizure outcomes of surgeries in children indicated that 74% of patients with brain lesions and 45% without lesions had become seizure-free at one year of follow-up. In a retrospective analysis involving 142 children and adolescents with drug-resistant epilepsy who had undergone surgery, 79.3% of patients were free from disabling seizures after a mean follow-up of approximately four years.

To investigate the effects of surgery further, Dr. Dwivedi and colleagues performed a single-center trial. They sought to compare epilepsy surgery with continued medical therapy alone in patients on a waiting list for surgery.

Researchers randomized 116 patients age 18 or younger with drug-resistant epilepsy to brain surgery appropriate to the underlying cause of epilepsy, along with appropriate medical therapy, or to medical therapy alone. Patients for whom there was no consensus regarding the location of an epileptic focus, patients who had any other systemic illness, and patients with a history of status epilepticus were excluded.

Participants assigned to the surgery group underwent the procedure within a month after randomization. Those assigned to the medical-therapy group remained on a waiting list. Surgery for these patients was scheduled for one year or longer after randomization. The primary outcome was seizure freedom at 12 months. Secondary outcomes included the Hague Seizure Severity scale score, the Binet–Kamat intelligence quotient or the social quotient on the Vineland Social Maturity Scale, the T score on the Child Behavior Checklist, and the Pediatric Quality of Life Inventory score.

Most of the Surgery Group Became Seizure-Free at 12 Months

Median age was 9 in the surgery group and 10 in the medical-therapy group. In all, 14 patients had temporal lobe resections, 12 patients had resection of a lesion in a lobe other than the temporal lobe, 15 patients had hemispherotomy, 10 patients had a corpus callosotomy, and six patients had a disconnection or resection of hypothalamic hamartoma.

At 12 months, 44 of 57 patients (77%) in the surgery group became seizure-free, compared with four of 59 patients (7%) in the medical-therapy group. Furthermore, 21 patients (37%) in the surgery group were completely seizure-free during the entire 12-month period.

All patients who had undergone temporal lobectomy or hypothalamic hamartoma surgeries were seizure-free at the last follow-up. Of the patients who had undergone extratemporal resection or hemispherotomy, 11 of 12 patients (92%) and 13 of 15 (87%), had complete freedom from seizures, respectively.

Two of 15 patients (13%) in the medical-therapy group who were on the waiting list for a temporal lobectomy were seizure-free at 12 months, along with one of 19 patients (5%) who were on a waiting list for extratemporal resection and one of 16 patients (6%) who were waiting for a corpus callostomy. Patients with a planned hemispherotomy or intervention for hypothalamic hamartoma were not seizure-free at 12 months.

In addition, between-group differences in the change from baseline to 12 months significantly favored surgery with respect to the Hague Seizure Severity scale score, the Child Behavior Checklist, the Pediatric Quality of Life Inventory, and the Vineland Social Maturity Scale, but not the Binet–Kamat intelligence quotient, said the researchers.

Adverse Events and Study Limitations

Serious adverse events occurred in 19 patients (33%) in the surgery group and no patients in the medical-therapy group. Monoparesis occurred in two patients who had undergone temporal lobectomy or resection of parietal focal cortical dysplasia. Hemiparesis occurred in 15 patients who had undergone hemispherotomy. Finally, generalized hypotonia and language deficits occurred in one patient who had undergone frontal lobectomy.

Ten patients in the medical-therapy group had physical injuries associated with seizures (eg, cuts, burns, and fractures). One patient had an adverse event associated with an antiepileptic drug, and autistic features developed in another patient. No deaths occurred in either group.

One study limitation was that patients included in this trial underwent many types of epilepsy surgeries to treat various underlying pathologic causes of seizures. Another limitation was that there was an overrepresentation of hypothalamic hamartomas, compared with some other series, said the researchers.

—Erica Tricarico

Suggested Reading

Dwivedi R, Ramanujam B, Chandra PS, et al. Surgery for drug-resistant epilepsy in children. N Engl J Med. 2017;377(17):1639-1647.

By one measure at least – the proportion of outpatient visits for influenza-like illness (ILI) – this flu season is now the worst in almost a decade, according to data from the Centers for Disease Control and Prevention.

For the week ending Jan. 13, visits for ILI rose to 6.3% of outpatient visits nationwide – the highest figure reported since the 2009-2010 season, which hit an early peak of 7.7% in October of 2009. The slight pause that occurred in the first week of January as the rate only rose from 5.7% to 5.8% now looks more like the earlier trend from December, when the level of outpatient visits more than doubled over a 3-week period, data from the CDC FluView website show.

“The geographic spread of influenza in Puerto Rico and 49 states was reported as widespread” for the week ending Jan. 13, and 24 states had the highest level of ILI activity on the CDC’s 1-10 scale, the CDC influenza division reported Jan 19.

There were 10 flu-related pediatric deaths reported during the week, with two occurring in the week ending Jan. 13. A total of 30 deaths in children have been associated with influenza so far for the 2017-2018 season, the CDC said.

[email protected]

By one measure at least – the proportion of outpatient visits for influenza-like illness (ILI) – this flu season is now the worst in almost a decade, according to data from the Centers for Disease Control and Prevention.

For the week ending Jan. 13, visits for ILI rose to 6.3% of outpatient visits nationwide – the highest figure reported since the 2009-2010 season, which hit an early peak of 7.7% in October of 2009. The slight pause that occurred in the first week of January as the rate only rose from 5.7% to 5.8% now looks more like the earlier trend from December, when the level of outpatient visits more than doubled over a 3-week period, data from the CDC FluView website show.

“The geographic spread of influenza in Puerto Rico and 49 states was reported as widespread” for the week ending Jan. 13, and 24 states had the highest level of ILI activity on the CDC’s 1-10 scale, the CDC influenza division reported Jan 19.

There were 10 flu-related pediatric deaths reported during the week, with two occurring in the week ending Jan. 13. A total of 30 deaths in children have been associated with influenza so far for the 2017-2018 season, the CDC said.

[email protected]

By one measure at least – the proportion of outpatient visits for influenza-like illness (ILI) – this flu season is now the worst in almost a decade, according to data from the Centers for Disease Control and Prevention.

For the week ending Jan. 13, visits for ILI rose to 6.3% of outpatient visits nationwide – the highest figure reported since the 2009-2010 season, which hit an early peak of 7.7% in October of 2009. The slight pause that occurred in the first week of January as the rate only rose from 5.7% to 5.8% now looks more like the earlier trend from December, when the level of outpatient visits more than doubled over a 3-week period, data from the CDC FluView website show.

“The geographic spread of influenza in Puerto Rico and 49 states was reported as widespread” for the week ending Jan. 13, and 24 states had the highest level of ILI activity on the CDC’s 1-10 scale, the CDC influenza division reported Jan 19.

There were 10 flu-related pediatric deaths reported during the week, with two occurring in the week ending Jan. 13. A total of 30 deaths in children have been associated with influenza so far for the 2017-2018 season, the CDC said.

[email protected]

Imagine a single blood test that would cost less than $500 and could screen for at least eight cancer types.

It’s early days for the technology, called CancerSEEK, but the test had a sensitivity of 69%-98%, depending on the cancer type, and a specificity of 99% in a cohort of 1,005 patients with stage I-III cancers and 850 healthy controls, wrote Joshua D. Cohen of the Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins University, Baltimore, and his colleagues. The report was published in Science.

SilverV/Thinkstock

CancerSEEK tests for mutations in 2,001 genomic positions and eight proteins. The researchers examined a 61-amplicon panel with each amplicon analyzing an average of 33 base pairs within a gene. They theorized the test could detect between 41% and 95% of the cancers in the Catalog of Somatic Mutations in Cancer dataset. They next used multiplex-PCR techniques to minimize errors associated with large sequencing and identified protein biomarkers for early stage cancers that may not release detectable ctDNA.

The researchers used the technology to examine blood samples from 1,005 patients with stage I (20%), stage II (49%), or stage III (31%) cancers of the ovary, liver, stomach, pancreas, esophagus, colorectum, lung, or breast prior to undergoing neoadjuvant chemotherapy. Participants had a median age of 64 years (range of 22-93 years). The healthy controls did not have a history of cancer, chronic kidney disease, autoimmune disease, or high-grade dysplasia.

SOURCE: Cohen JD et al., Science 2018 Jan 18. doi: 10.1126/science.aar3247.

Imagine a single blood test that would cost less than $500 and could screen for at least eight cancer types.

It’s early days for the technology, called CancerSEEK, but the test had a sensitivity of 69%-98%, depending on the cancer type, and a specificity of 99% in a cohort of 1,005 patients with stage I-III cancers and 850 healthy controls, wrote Joshua D. Cohen of the Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins University, Baltimore, and his colleagues. The report was published in Science.

SilverV/Thinkstock

CancerSEEK tests for mutations in 2,001 genomic positions and eight proteins. The researchers examined a 61-amplicon panel with each amplicon analyzing an average of 33 base pairs within a gene. They theorized the test could detect between 41% and 95% of the cancers in the Catalog of Somatic Mutations in Cancer dataset. They next used multiplex-PCR techniques to minimize errors associated with large sequencing and identified protein biomarkers for early stage cancers that may not release detectable ctDNA.

The researchers used the technology to examine blood samples from 1,005 patients with stage I (20%), stage II (49%), or stage III (31%) cancers of the ovary, liver, stomach, pancreas, esophagus, colorectum, lung, or breast prior to undergoing neoadjuvant chemotherapy. Participants had a median age of 64 years (range of 22-93 years). The healthy controls did not have a history of cancer, chronic kidney disease, autoimmune disease, or high-grade dysplasia.

SOURCE: Cohen JD et al., Science 2018 Jan 18. doi: 10.1126/science.aar3247.

Imagine a single blood test that would cost less than $500 and could screen for at least eight cancer types.

It’s early days for the technology, called CancerSEEK, but the test had a sensitivity of 69%-98%, depending on the cancer type, and a specificity of 99% in a cohort of 1,005 patients with stage I-III cancers and 850 healthy controls, wrote Joshua D. Cohen of the Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins University, Baltimore, and his colleagues. The report was published in Science.

SilverV/Thinkstock

CancerSEEK tests for mutations in 2,001 genomic positions and eight proteins. The researchers examined a 61-amplicon panel with each amplicon analyzing an average of 33 base pairs within a gene. They theorized the test could detect between 41% and 95% of the cancers in the Catalog of Somatic Mutations in Cancer dataset. They next used multiplex-PCR techniques to minimize errors associated with large sequencing and identified protein biomarkers for early stage cancers that may not release detectable ctDNA.

The researchers used the technology to examine blood samples from 1,005 patients with stage I (20%), stage II (49%), or stage III (31%) cancers of the ovary, liver, stomach, pancreas, esophagus, colorectum, lung, or breast prior to undergoing neoadjuvant chemotherapy. Participants had a median age of 64 years (range of 22-93 years). The healthy controls did not have a history of cancer, chronic kidney disease, autoimmune disease, or high-grade dysplasia.

SOURCE: Cohen JD et al., Science 2018 Jan 18. doi: 10.1126/science.aar3247.

The Trump administration has announced a new division within the U.S. Health & Human Services Department that aims to protect health care providers who have religious or moral objections to performing medical services, such as abortion.

In a Jan. 18 announcement, HHS Office for Civil Rights Director Roger Severino said the new Conscience and Religious Freedom Division will focus on outreach, policy making, and vigorously enforcing existing federal laws that protect conscience and religious freedom rights. The new branch will enable health providers to file conscience and religious freedom complaints, which will then be investigated by the division.

“The fact that individual health care providers are going to have a place to go if they feel they have valid complaint is really momentous,” Dr. Raviele said in an interview. “It’s respecting the rights of all of us and not just some special interest groups ... I also think [the new division] will make states [and] hospital systems less likely to try to infringe on people’s conscientious rights.”

The HIV Medicine Association called the formation of the new HHS division appalling, and said the office appears to protect health care providers who discriminate against vulnerable patients, such as women, LGBTQ patients, and minorities.

“The new division, designed to ‘protect’ health care providers who discriminate in the care and services they provide, defies the fundamental medical ethic to first do no harm,” HIV Medicine Association Chair Melanie Thompson, MD, said in a statement. “Using federal dollars to shield providers who choose to discriminate rather than protect vulnerable patients and provide services to improve their health is counter to the mission of HHS, wasteful of scarce federal funds, and will result in delayed or lack of care for vulnerable individuals, threatening their health and lives.”

The HHS Conscience and Religious Freedom Division is necessary to address the “sustained attack on conscience rights,” said Jane Orient, MD, executive director for the conservative Association of American Physicians and Surgeons.

“Many powerful and influential forces are attempting to impose their views on Americans, predominantly on Christians, forcing them to perform acts they believe to be immoral, [or risk] losing their job, their business, their livelihood, or even their life savings,” Dr. Orient said in an interview. “...We hope that the OCR will help to return our nation to its foundational principles of freedom and respect for people of conscience.”

[email protected]

The Trump administration has announced a new division within the U.S. Health & Human Services Department that aims to protect health care providers who have religious or moral objections to performing medical services, such as abortion.

In a Jan. 18 announcement, HHS Office for Civil Rights Director Roger Severino said the new Conscience and Religious Freedom Division will focus on outreach, policy making, and vigorously enforcing existing federal laws that protect conscience and religious freedom rights. The new branch will enable health providers to file conscience and religious freedom complaints, which will then be investigated by the division.

“The fact that individual health care providers are going to have a place to go if they feel they have valid complaint is really momentous,” Dr. Raviele said in an interview. “It’s respecting the rights of all of us and not just some special interest groups ... I also think [the new division] will make states [and] hospital systems less likely to try to infringe on people’s conscientious rights.”

The HIV Medicine Association called the formation of the new HHS division appalling, and said the office appears to protect health care providers who discriminate against vulnerable patients, such as women, LGBTQ patients, and minorities.

“The new division, designed to ‘protect’ health care providers who discriminate in the care and services they provide, defies the fundamental medical ethic to first do no harm,” HIV Medicine Association Chair Melanie Thompson, MD, said in a statement. “Using federal dollars to shield providers who choose to discriminate rather than protect vulnerable patients and provide services to improve their health is counter to the mission of HHS, wasteful of scarce federal funds, and will result in delayed or lack of care for vulnerable individuals, threatening their health and lives.”

The HHS Conscience and Religious Freedom Division is necessary to address the “sustained attack on conscience rights,” said Jane Orient, MD, executive director for the conservative Association of American Physicians and Surgeons.

“Many powerful and influential forces are attempting to impose their views on Americans, predominantly on Christians, forcing them to perform acts they believe to be immoral, [or risk] losing their job, their business, their livelihood, or even their life savings,” Dr. Orient said in an interview. “...We hope that the OCR will help to return our nation to its foundational principles of freedom and respect for people of conscience.”

[email protected]

The Trump administration has announced a new division within the U.S. Health & Human Services Department that aims to protect health care providers who have religious or moral objections to performing medical services, such as abortion.

In a Jan. 18 announcement, HHS Office for Civil Rights Director Roger Severino said the new Conscience and Religious Freedom Division will focus on outreach, policy making, and vigorously enforcing existing federal laws that protect conscience and religious freedom rights. The new branch will enable health providers to file conscience and religious freedom complaints, which will then be investigated by the division.

“The fact that individual health care providers are going to have a place to go if they feel they have valid complaint is really momentous,” Dr. Raviele said in an interview. “It’s respecting the rights of all of us and not just some special interest groups ... I also think [the new division] will make states [and] hospital systems less likely to try to infringe on people’s conscientious rights.”

The HIV Medicine Association called the formation of the new HHS division appalling, and said the office appears to protect health care providers who discriminate against vulnerable patients, such as women, LGBTQ patients, and minorities.

“The new division, designed to ‘protect’ health care providers who discriminate in the care and services they provide, defies the fundamental medical ethic to first do no harm,” HIV Medicine Association Chair Melanie Thompson, MD, said in a statement. “Using federal dollars to shield providers who choose to discriminate rather than protect vulnerable patients and provide services to improve their health is counter to the mission of HHS, wasteful of scarce federal funds, and will result in delayed or lack of care for vulnerable individuals, threatening their health and lives.”

The HHS Conscience and Religious Freedom Division is necessary to address the “sustained attack on conscience rights,” said Jane Orient, MD, executive director for the conservative Association of American Physicians and Surgeons.

“Many powerful and influential forces are attempting to impose their views on Americans, predominantly on Christians, forcing them to perform acts they believe to be immoral, [or risk] losing their job, their business, their livelihood, or even their life savings,” Dr. Orient said in an interview. “...We hope that the OCR will help to return our nation to its foundational principles of freedom and respect for people of conscience.”

[email protected]

Phase 3 clinical results show an oral, two-drug antiretroviral therapy (ART) of dolutegravir and rilpivirine to be an effective and safe alternative to a triple-drug current antiretroviral regimen (CAR) for maintaining virologic suppression of HIV-1 in adults.

Josep M Llibre, MD, from the department of infectious diseases at the Pujol University Hospital Germans Trias in Barcelona and his colleagues conducted a phase 3, randomized, parallel-group (SWORD-1 and SWORD-2), multicenter, noninferiority investigation. The pooled, open-label study reported on a total of 1,028 individuals, median age 43 years, who met a base criteria of stable viral suppression (viral load fewer than 50 copies/mL) by a first or second CAR regimen consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third drug (nonnucleoside reverse transcriptase inhibitors, integrase strand transfer inhibitors, or a protease inhibitor) for a minimum of 6 months at time of screening. The overall population was 80% white, with women making up 22% of the pooled populations. Random assignment with stratification according to class, age, and planned substudy participation resulted in 512 participants continuing their CAR regimen and an intention-to-treat population of 516 participants switching to the oral, once-daily, two-drug dolutegravir/rilpivirine regimen (dolutegravir 50 mg plus rilpivirine 25 mg).

Analysis of pooled SWORD1 and SWORD2 trials at the primary 48-week endpoint showed 95% of the participants for both the intent-to-treat, two-drug dolutegravir/rilpivirine therapy and the population maintaining their standard triple-drug CAR therapy continued to have successful viral suppression as evidenced by viral loads of fewer than 50 copies/mL. This result together with an adjusted treatment difference of –2.2% (95% confidence interval, –3.0 to 2.5) supports a noninferiority with a predefined margin of –8% of the dolutegravir/rilpivirine therapy to CAR for viral suppression as reported in the Lancet.

Reports of at least one adverse event by week 48 were slightly higher for the dolutegravir/rilpivirine therapy group (77%) when compared with those in the CAR group (71%). The most commonly experienced adverse effects were nasopharyngitis (10% each for dolutegravir/rilpivirine and CAR) and headache (8% for dolutegravir/rilpivirine vs. 5% for CAR). However, adverse effects were associated with higher withdrawals from the dolutegravir/rilpivirine therapy group, compared with the CAR group (3% vs. less than 1%, respectively) by the primary 48-week endpoint.

“Once-daily oral dolutegravir/rilpivirine therapy would be the first oral two-drug regimen that provides patients with an alternative to guideline-preferred triple-drug regimens, avoids major NRTI [nucleoside reverse transcriptase inhibitor] toxicities, has limited potential for drug-drug interactions, and does not increase lipid concentrations or inflammatory biomarkers,” according to Dr. Llibre and his colleagues.

The authors disclosed associations with financial and regulatory sponsor ViiV Healthcare and partner participation by Janssen Pharmaceutica NV in the development of the dolutegravir/rilpivirine two-drug regimen.

[email protected]

Source: Llibre JM et al. Lancet. 2018 Jan 10. doi: 10.1016/S0140-6736(17)33095-7.

Phase 3 clinical results show an oral, two-drug antiretroviral therapy (ART) of dolutegravir and rilpivirine to be an effective and safe alternative to a triple-drug current antiretroviral regimen (CAR) for maintaining virologic suppression of HIV-1 in adults.

Josep M Llibre, MD, from the department of infectious diseases at the Pujol University Hospital Germans Trias in Barcelona and his colleagues conducted a phase 3, randomized, parallel-group (SWORD-1 and SWORD-2), multicenter, noninferiority investigation. The pooled, open-label study reported on a total of 1,028 individuals, median age 43 years, who met a base criteria of stable viral suppression (viral load fewer than 50 copies/mL) by a first or second CAR regimen consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third drug (nonnucleoside reverse transcriptase inhibitors, integrase strand transfer inhibitors, or a protease inhibitor) for a minimum of 6 months at time of screening. The overall population was 80% white, with women making up 22% of the pooled populations. Random assignment with stratification according to class, age, and planned substudy participation resulted in 512 participants continuing their CAR regimen and an intention-to-treat population of 516 participants switching to the oral, once-daily, two-drug dolutegravir/rilpivirine regimen (dolutegravir 50 mg plus rilpivirine 25 mg).

Analysis of pooled SWORD1 and SWORD2 trials at the primary 48-week endpoint showed 95% of the participants for both the intent-to-treat, two-drug dolutegravir/rilpivirine therapy and the population maintaining their standard triple-drug CAR therapy continued to have successful viral suppression as evidenced by viral loads of fewer than 50 copies/mL. This result together with an adjusted treatment difference of –2.2% (95% confidence interval, –3.0 to 2.5) supports a noninferiority with a predefined margin of –8% of the dolutegravir/rilpivirine therapy to CAR for viral suppression as reported in the Lancet.

Reports of at least one adverse event by week 48 were slightly higher for the dolutegravir/rilpivirine therapy group (77%) when compared with those in the CAR group (71%). The most commonly experienced adverse effects were nasopharyngitis (10% each for dolutegravir/rilpivirine and CAR) and headache (8% for dolutegravir/rilpivirine vs. 5% for CAR). However, adverse effects were associated with higher withdrawals from the dolutegravir/rilpivirine therapy group, compared with the CAR group (3% vs. less than 1%, respectively) by the primary 48-week endpoint.

“Once-daily oral dolutegravir/rilpivirine therapy would be the first oral two-drug regimen that provides patients with an alternative to guideline-preferred triple-drug regimens, avoids major NRTI [nucleoside reverse transcriptase inhibitor] toxicities, has limited potential for drug-drug interactions, and does not increase lipid concentrations or inflammatory biomarkers,” according to Dr. Llibre and his colleagues.

The authors disclosed associations with financial and regulatory sponsor ViiV Healthcare and partner participation by Janssen Pharmaceutica NV in the development of the dolutegravir/rilpivirine two-drug regimen.

[email protected]

Source: Llibre JM et al. Lancet. 2018 Jan 10. doi: 10.1016/S0140-6736(17)33095-7.

Phase 3 clinical results show an oral, two-drug antiretroviral therapy (ART) of dolutegravir and rilpivirine to be an effective and safe alternative to a triple-drug current antiretroviral regimen (CAR) for maintaining virologic suppression of HIV-1 in adults.

Josep M Llibre, MD, from the department of infectious diseases at the Pujol University Hospital Germans Trias in Barcelona and his colleagues conducted a phase 3, randomized, parallel-group (SWORD-1 and SWORD-2), multicenter, noninferiority investigation. The pooled, open-label study reported on a total of 1,028 individuals, median age 43 years, who met a base criteria of stable viral suppression (viral load fewer than 50 copies/mL) by a first or second CAR regimen consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third drug (nonnucleoside reverse transcriptase inhibitors, integrase strand transfer inhibitors, or a protease inhibitor) for a minimum of 6 months at time of screening. The overall population was 80% white, with women making up 22% of the pooled populations. Random assignment with stratification according to class, age, and planned substudy participation resulted in 512 participants continuing their CAR regimen and an intention-to-treat population of 516 participants switching to the oral, once-daily, two-drug dolutegravir/rilpivirine regimen (dolutegravir 50 mg plus rilpivirine 25 mg).

Analysis of pooled SWORD1 and SWORD2 trials at the primary 48-week endpoint showed 95% of the participants for both the intent-to-treat, two-drug dolutegravir/rilpivirine therapy and the population maintaining their standard triple-drug CAR therapy continued to have successful viral suppression as evidenced by viral loads of fewer than 50 copies/mL. This result together with an adjusted treatment difference of –2.2% (95% confidence interval, –3.0 to 2.5) supports a noninferiority with a predefined margin of –8% of the dolutegravir/rilpivirine therapy to CAR for viral suppression as reported in the Lancet.

Reports of at least one adverse event by week 48 were slightly higher for the dolutegravir/rilpivirine therapy group (77%) when compared with those in the CAR group (71%). The most commonly experienced adverse effects were nasopharyngitis (10% each for dolutegravir/rilpivirine and CAR) and headache (8% for dolutegravir/rilpivirine vs. 5% for CAR). However, adverse effects were associated with higher withdrawals from the dolutegravir/rilpivirine therapy group, compared with the CAR group (3% vs. less than 1%, respectively) by the primary 48-week endpoint.

“Once-daily oral dolutegravir/rilpivirine therapy would be the first oral two-drug regimen that provides patients with an alternative to guideline-preferred triple-drug regimens, avoids major NRTI [nucleoside reverse transcriptase inhibitor] toxicities, has limited potential for drug-drug interactions, and does not increase lipid concentrations or inflammatory biomarkers,” according to Dr. Llibre and his colleagues.

The authors disclosed associations with financial and regulatory sponsor ViiV Healthcare and partner participation by Janssen Pharmaceutica NV in the development of the dolutegravir/rilpivirine two-drug regimen.

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Source: Llibre JM et al. Lancet. 2018 Jan 10. doi: 10.1016/S0140-6736(17)33095-7.