Mark S. Lesney

An adenine mutation in the MUTYH base repair excision gene increased the risk of developing hepatocellular carcinoma (HCC) in patients with chronic hepatitis C virus (HCV). The mutation was discovered in an analysis of 19 tagging single-nucleotide polymorphism (SNP) variants examined for multiple base repair excision genes (MUTYH, OGG1, and MTH1), according to the results of a retrospective analysis of patient genotypes reported in Free Radical Biology and Medicine (2018;129:88-96).

©Gio_tto/Thinkstock.com

In addition, the researchers examined MUTYH-null mice to assess the involvement of oxidative stress and DNA repair enzymes in hepatocarcinogenesis.

One significant SNP was found and confirmed from 93 Japanese patients with chronic HCV (38 with HCC and 55 controls), according to Akira Sakurada, MD, of Sapporo (Japan) Medical University, and his colleagues.

Patients diagnosed as having chronic HCV between 2007 and 2015 were enrolled. All patients were 45 years of age or older with detectable anti-HCV antibodies and HCV-RNA, as well as histopathological evidence of chronic hepatitis on liver biopsy. An exploratory cohort of 40 patients was first used before the 93 patient confirmatory analysis.

Genomic DNA was extracted from peripheral mononuclear cells of all of the patients studied.

Dr. Sakurada and his colleagues found significant associations for the single intron SNP (rs3219487) in the MUTYH gene. Human MutY homolog (MUTYH) protein is responsible for recognition and removal of an inappropriately inserted adenine (A).

The risk of developing HCC in patients with A/A or G/A genotypes was higher than in those with the G/G genotype (odds ratio = 9.27, 95% confidence interval = 2.39-32.1, P = .0005). In addition, they found that MUTYH mRNA levels were significantly lower in G/A or A/A genotyped subjects as compared with the wild type (G/G) (P = .0157 and P = .0108, respectively).

In their mouse model, the investigators found that liver tumors developed in MUTYH-null mice. As a physiological confirmation of their results, the researchers investigated a MUTYH-null mouse model. They found that decreased MUTYH activity in the null mice resulted in the development of HCC in these animals after 12 months of a high iron diet, but no tumors were observed when a dietary antioxidant (N-Acetyl-L-cysteine) was also provided.

“HCC may develop even in patients with an SVR [sustained virologic response]. This may be a problem especially for the numerous elderly patients. Our study suggests that SNP genotyping may predict the risk of developing HCC in such patients. We propose that in the setting of appropriate screening intervals, stratification of patients for whom antioxidant treatment would be appropriate could be achieved in this manner,” the researchers concluded.

The study was supported by grants from the Japan Society for Scientific Research. The authors reported they had nothing to disclose.

[email protected]

SOURCE: Sakurada A et al. Free Radic Biol Med. 2018;129:88-96.

An adenine mutation in the MUTYH base repair excision gene increased the risk of developing hepatocellular carcinoma (HCC) in patients with chronic hepatitis C virus (HCV). The mutation was discovered in an analysis of 19 tagging single-nucleotide polymorphism (SNP) variants examined for multiple base repair excision genes (MUTYH, OGG1, and MTH1), according to the results of a retrospective analysis of patient genotypes reported in Free Radical Biology and Medicine (2018;129:88-96).

©Gio_tto/Thinkstock.com

In addition, the researchers examined MUTYH-null mice to assess the involvement of oxidative stress and DNA repair enzymes in hepatocarcinogenesis.

One significant SNP was found and confirmed from 93 Japanese patients with chronic HCV (38 with HCC and 55 controls), according to Akira Sakurada, MD, of Sapporo (Japan) Medical University, and his colleagues.

Patients diagnosed as having chronic HCV between 2007 and 2015 were enrolled. All patients were 45 years of age or older with detectable anti-HCV antibodies and HCV-RNA, as well as histopathological evidence of chronic hepatitis on liver biopsy. An exploratory cohort of 40 patients was first used before the 93 patient confirmatory analysis.

Genomic DNA was extracted from peripheral mononuclear cells of all of the patients studied.

Dr. Sakurada and his colleagues found significant associations for the single intron SNP (rs3219487) in the MUTYH gene. Human MutY homolog (MUTYH) protein is responsible for recognition and removal of an inappropriately inserted adenine (A).

The risk of developing HCC in patients with A/A or G/A genotypes was higher than in those with the G/G genotype (odds ratio = 9.27, 95% confidence interval = 2.39-32.1, P = .0005). In addition, they found that MUTYH mRNA levels were significantly lower in G/A or A/A genotyped subjects as compared with the wild type (G/G) (P = .0157 and P = .0108, respectively).

In their mouse model, the investigators found that liver tumors developed in MUTYH-null mice. As a physiological confirmation of their results, the researchers investigated a MUTYH-null mouse model. They found that decreased MUTYH activity in the null mice resulted in the development of HCC in these animals after 12 months of a high iron diet, but no tumors were observed when a dietary antioxidant (N-Acetyl-L-cysteine) was also provided.

“HCC may develop even in patients with an SVR [sustained virologic response]. This may be a problem especially for the numerous elderly patients. Our study suggests that SNP genotyping may predict the risk of developing HCC in such patients. We propose that in the setting of appropriate screening intervals, stratification of patients for whom antioxidant treatment would be appropriate could be achieved in this manner,” the researchers concluded.

The study was supported by grants from the Japan Society for Scientific Research. The authors reported they had nothing to disclose.

[email protected]

SOURCE: Sakurada A et al. Free Radic Biol Med. 2018;129:88-96.

An adenine mutation in the MUTYH base repair excision gene increased the risk of developing hepatocellular carcinoma (HCC) in patients with chronic hepatitis C virus (HCV). The mutation was discovered in an analysis of 19 tagging single-nucleotide polymorphism (SNP) variants examined for multiple base repair excision genes (MUTYH, OGG1, and MTH1), according to the results of a retrospective analysis of patient genotypes reported in Free Radical Biology and Medicine (2018;129:88-96).

©Gio_tto/Thinkstock.com

In addition, the researchers examined MUTYH-null mice to assess the involvement of oxidative stress and DNA repair enzymes in hepatocarcinogenesis.

One significant SNP was found and confirmed from 93 Japanese patients with chronic HCV (38 with HCC and 55 controls), according to Akira Sakurada, MD, of Sapporo (Japan) Medical University, and his colleagues.

Patients diagnosed as having chronic HCV between 2007 and 2015 were enrolled. All patients were 45 years of age or older with detectable anti-HCV antibodies and HCV-RNA, as well as histopathological evidence of chronic hepatitis on liver biopsy. An exploratory cohort of 40 patients was first used before the 93 patient confirmatory analysis.

Genomic DNA was extracted from peripheral mononuclear cells of all of the patients studied.

Dr. Sakurada and his colleagues found significant associations for the single intron SNP (rs3219487) in the MUTYH gene. Human MutY homolog (MUTYH) protein is responsible for recognition and removal of an inappropriately inserted adenine (A).

The risk of developing HCC in patients with A/A or G/A genotypes was higher than in those with the G/G genotype (odds ratio = 9.27, 95% confidence interval = 2.39-32.1, P = .0005). In addition, they found that MUTYH mRNA levels were significantly lower in G/A or A/A genotyped subjects as compared with the wild type (G/G) (P = .0157 and P = .0108, respectively).

In their mouse model, the investigators found that liver tumors developed in MUTYH-null mice. As a physiological confirmation of their results, the researchers investigated a MUTYH-null mouse model. They found that decreased MUTYH activity in the null mice resulted in the development of HCC in these animals after 12 months of a high iron diet, but no tumors were observed when a dietary antioxidant (N-Acetyl-L-cysteine) was also provided.

“HCC may develop even in patients with an SVR [sustained virologic response]. This may be a problem especially for the numerous elderly patients. Our study suggests that SNP genotyping may predict the risk of developing HCC in such patients. We propose that in the setting of appropriate screening intervals, stratification of patients for whom antioxidant treatment would be appropriate could be achieved in this manner,” the researchers concluded.

The study was supported by grants from the Japan Society for Scientific Research. The authors reported they had nothing to disclose.

[email protected]

SOURCE: Sakurada A et al. Free Radic Biol Med. 2018;129:88-96.

WASHINGTON – Among HIV-infected women, those aged 18-29 years had the highest rates of gonorrhea and chlamydia. These results suggest that screening for these sexually transmitted infections (STIs) should be based on age and risk in HIV-infected women, said Jodie Dionne-Odom, MD, of the University of Alabama at Birmingham.

Courtesy CDC

Annual screening for gonorrhea and chlamydia is recommended for all sexually active adults with HIV, but prevalence varies by gender, age, and risk behavior, Dr. Dionne-Odom said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Odom and her colleagues calculated annual testing and positivity rates during 2007-2016 for chlamydia and gonorrhea among women engaged in HIV care in eight U.S. cities as part of the Centers for AIDS Research (CFAR) Clinical Networks and Integrated Clinical Services (CNICS) longitudinal cohort.

They assessed demographic data based on the most recent year the patient was in care and used validated surveys (AUDIT-C and ASSIST) to assess risk behaviors in the past 3-6 months. They collected information from 5,084 women and 158,745 HIV primary care and women’s health visits.

The median patient age was 47 years; 62.1% of the patients were black; 70% had CD4 counts greater than 350; and 73.6% had HIV viral loads of less than 500 copies/mL. In terms of reported risk, 60.6% of the women were sexually active, (85.5% of whom reported monogamy); 13.1% had problem alcohol use, and 11.6% had active drug use.

Sampling for gonorrhea and chlamydia were mostly from urogenital sites (86.6%), 6.6% were extragenital, and 6.8% were “other.” Nearly all (98.5%) of 23,492 chlamydia tests and 95.7% of 23,324 gonorrhea tests used nucleic acid amplification, Dr. Dionne-Odom said.

During the most recent year in care, 42.7% of women were tested for gonorrhea and chlamydia, and 3.4% were positive, with the annual positivity rates over the study ranging from 1.5% to 3.2% for chlamydia and 0.9% to 1.5% for gonorrhea. However, Dr. Dionne-Odom and her colleagues found that the prevalence of STIs was inversely related to patient age, with gonorrhea and chlamydia positivity in 2016 being 16% for chlamydia and 3.9% for gonorrhea among women aged 18-24 years, compared with 1.1% and 0.7%, respectively, for women older than 50 years.

“As with national data on women, HIV-infected women aged 18-29 years had the highest rates of gonorrhea and chlamydia. Our results show that targeted screening for chlamydia and gonorrhea in women with HIV based on age and risk is warranted,” Dr. Dionne-Odom concluded.

Dr. Dionne-Odom reported that she had no relevant disclosures.

[email protected]

WASHINGTON – Among HIV-infected women, those aged 18-29 years had the highest rates of gonorrhea and chlamydia. These results suggest that screening for these sexually transmitted infections (STIs) should be based on age and risk in HIV-infected women, said Jodie Dionne-Odom, MD, of the University of Alabama at Birmingham.

Courtesy CDC

Annual screening for gonorrhea and chlamydia is recommended for all sexually active adults with HIV, but prevalence varies by gender, age, and risk behavior, Dr. Dionne-Odom said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Odom and her colleagues calculated annual testing and positivity rates during 2007-2016 for chlamydia and gonorrhea among women engaged in HIV care in eight U.S. cities as part of the Centers for AIDS Research (CFAR) Clinical Networks and Integrated Clinical Services (CNICS) longitudinal cohort.

They assessed demographic data based on the most recent year the patient was in care and used validated surveys (AUDIT-C and ASSIST) to assess risk behaviors in the past 3-6 months. They collected information from 5,084 women and 158,745 HIV primary care and women’s health visits.

The median patient age was 47 years; 62.1% of the patients were black; 70% had CD4 counts greater than 350; and 73.6% had HIV viral loads of less than 500 copies/mL. In terms of reported risk, 60.6% of the women were sexually active, (85.5% of whom reported monogamy); 13.1% had problem alcohol use, and 11.6% had active drug use.

Sampling for gonorrhea and chlamydia were mostly from urogenital sites (86.6%), 6.6% were extragenital, and 6.8% were “other.” Nearly all (98.5%) of 23,492 chlamydia tests and 95.7% of 23,324 gonorrhea tests used nucleic acid amplification, Dr. Dionne-Odom said.

During the most recent year in care, 42.7% of women were tested for gonorrhea and chlamydia, and 3.4% were positive, with the annual positivity rates over the study ranging from 1.5% to 3.2% for chlamydia and 0.9% to 1.5% for gonorrhea. However, Dr. Dionne-Odom and her colleagues found that the prevalence of STIs was inversely related to patient age, with gonorrhea and chlamydia positivity in 2016 being 16% for chlamydia and 3.9% for gonorrhea among women aged 18-24 years, compared with 1.1% and 0.7%, respectively, for women older than 50 years.

“As with national data on women, HIV-infected women aged 18-29 years had the highest rates of gonorrhea and chlamydia. Our results show that targeted screening for chlamydia and gonorrhea in women with HIV based on age and risk is warranted,” Dr. Dionne-Odom concluded.

Dr. Dionne-Odom reported that she had no relevant disclosures.

[email protected]

WASHINGTON – Among HIV-infected women, those aged 18-29 years had the highest rates of gonorrhea and chlamydia. These results suggest that screening for these sexually transmitted infections (STIs) should be based on age and risk in HIV-infected women, said Jodie Dionne-Odom, MD, of the University of Alabama at Birmingham.

Courtesy CDC

Annual screening for gonorrhea and chlamydia is recommended for all sexually active adults with HIV, but prevalence varies by gender, age, and risk behavior, Dr. Dionne-Odom said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Odom and her colleagues calculated annual testing and positivity rates during 2007-2016 for chlamydia and gonorrhea among women engaged in HIV care in eight U.S. cities as part of the Centers for AIDS Research (CFAR) Clinical Networks and Integrated Clinical Services (CNICS) longitudinal cohort.

They assessed demographic data based on the most recent year the patient was in care and used validated surveys (AUDIT-C and ASSIST) to assess risk behaviors in the past 3-6 months. They collected information from 5,084 women and 158,745 HIV primary care and women’s health visits.

The median patient age was 47 years; 62.1% of the patients were black; 70% had CD4 counts greater than 350; and 73.6% had HIV viral loads of less than 500 copies/mL. In terms of reported risk, 60.6% of the women were sexually active, (85.5% of whom reported monogamy); 13.1% had problem alcohol use, and 11.6% had active drug use.

Sampling for gonorrhea and chlamydia were mostly from urogenital sites (86.6%), 6.6% were extragenital, and 6.8% were “other.” Nearly all (98.5%) of 23,492 chlamydia tests and 95.7% of 23,324 gonorrhea tests used nucleic acid amplification, Dr. Dionne-Odom said.

During the most recent year in care, 42.7% of women were tested for gonorrhea and chlamydia, and 3.4% were positive, with the annual positivity rates over the study ranging from 1.5% to 3.2% for chlamydia and 0.9% to 1.5% for gonorrhea. However, Dr. Dionne-Odom and her colleagues found that the prevalence of STIs was inversely related to patient age, with gonorrhea and chlamydia positivity in 2016 being 16% for chlamydia and 3.9% for gonorrhea among women aged 18-24 years, compared with 1.1% and 0.7%, respectively, for women older than 50 years.

“As with national data on women, HIV-infected women aged 18-29 years had the highest rates of gonorrhea and chlamydia. Our results show that targeted screening for chlamydia and gonorrhea in women with HIV based on age and risk is warranted,” Dr. Dionne-Odom concluded.

Dr. Dionne-Odom reported that she had no relevant disclosures.

[email protected]

WASHINGTON – Respondents to the 2015 United States Transgender Survey (USTS) reported living with HIV at nearly five times the rate in the U.S. population. Reported HIV rates were even higher among transgender women, especially transgender women of color, according to Sandy James, JD, PhD, the lead author of the USTS and its former research director (2014-2017).

© 2018 National Center for Transgender Equality

In addition, the survey results detailed high rates of physical and mental health issues, difficulties accessing health care, and negative experiences when receiving medical care.

“There [had been] a dearth of data available about trans people,” said Dr. James, and hard data are required to make any meaningful changes to health care systems, but “now we have numbers.”

The nationwide USTS was the largest survey ever to document the experiences of transgender adults in the United States, comprising 27,715 respondents from all 50 states, the District of Columbia, American Samoa, Guam, Puerto Rico, and U.S. military bases overseas.

The USTS provided a comprehensive examination of a wide range of life outcomes, including those related to health, employment, income, and education. This survey of transgender adults (18 years of age and older) was anonymous, was available in both English and Spanish, and was conducted in the summer of 2015 by the National Center for Transgender Equality.

The document details the stresses and dangers that transgender people face in their daily lives, including attempted suicide rates higher than the norm (40% having attempted suicide in their lifetime, nearly nine times the 4.6% rate in the U.S. population). Nearly 1 in 10 respondents were physically attacked in the past year because of being transgender, and nearly half (47%) of respondents reported having been sexually assaulted during their lifetime.

Respondents reported living with HIV (1.4%) at nearly five times the rate in the U.S. population (0.3%), with HIV rates higher among transgender women (3.4%), especially transgender women of color. Nearly one in five black transgender women were living with HIV, and Native American Indian and Latina women also reported higher rates of infection: 4.6% and 4.4%, respectively.

A total of 25% of respondents experienced a problem in the past year with their insurance related to being transgender, such as being denied coverage for care related to gender transition or being denied coverage for routine care because they were transgender.

In terms of the health care environment, 33% of those who saw a health care provider in the past year reported having at least one negative experience related to being transgender, with higher rates for people of color and people with disabilities. This included being refused treatment, being verbally harassed or physically or sexually assaulted, or having to teach the provider about transgender people to get appropriate care, according to the survey.

In addition, 23% of respondents reported that they did not see a doctor when they needed to in the past year because of fear of being mistreated as a transgender person, and 33% did not see a doctor when needed because they could not afford care.

“I urge you to go and find the survey and look at all of the results, it is really important,” Dr. James stated. He stressed the fact that the breakout reports, including the report on black respondents, the Latino/a response report (in both English and Spanish), and the other minority and individual state reports, can all provide a more detailed view of what is going on in the transgender community than anything previously available.

Dr. James reported having no disclosures.
 

[email protected]

SOURCE: James S. Sexually Transmitted Diseases 2018. 45 [Supplement 2] Session 5D. S289.

WASHINGTON – Respondents to the 2015 United States Transgender Survey (USTS) reported living with HIV at nearly five times the rate in the U.S. population. Reported HIV rates were even higher among transgender women, especially transgender women of color, according to Sandy James, JD, PhD, the lead author of the USTS and its former research director (2014-2017).

© 2018 National Center for Transgender Equality

In addition, the survey results detailed high rates of physical and mental health issues, difficulties accessing health care, and negative experiences when receiving medical care.

“There [had been] a dearth of data available about trans people,” said Dr. James, and hard data are required to make any meaningful changes to health care systems, but “now we have numbers.”

The nationwide USTS was the largest survey ever to document the experiences of transgender adults in the United States, comprising 27,715 respondents from all 50 states, the District of Columbia, American Samoa, Guam, Puerto Rico, and U.S. military bases overseas.

The USTS provided a comprehensive examination of a wide range of life outcomes, including those related to health, employment, income, and education. This survey of transgender adults (18 years of age and older) was anonymous, was available in both English and Spanish, and was conducted in the summer of 2015 by the National Center for Transgender Equality.

The document details the stresses and dangers that transgender people face in their daily lives, including attempted suicide rates higher than the norm (40% having attempted suicide in their lifetime, nearly nine times the 4.6% rate in the U.S. population). Nearly 1 in 10 respondents were physically attacked in the past year because of being transgender, and nearly half (47%) of respondents reported having been sexually assaulted during their lifetime.

Respondents reported living with HIV (1.4%) at nearly five times the rate in the U.S. population (0.3%), with HIV rates higher among transgender women (3.4%), especially transgender women of color. Nearly one in five black transgender women were living with HIV, and Native American Indian and Latina women also reported higher rates of infection: 4.6% and 4.4%, respectively.

A total of 25% of respondents experienced a problem in the past year with their insurance related to being transgender, such as being denied coverage for care related to gender transition or being denied coverage for routine care because they were transgender.

In terms of the health care environment, 33% of those who saw a health care provider in the past year reported having at least one negative experience related to being transgender, with higher rates for people of color and people with disabilities. This included being refused treatment, being verbally harassed or physically or sexually assaulted, or having to teach the provider about transgender people to get appropriate care, according to the survey.

In addition, 23% of respondents reported that they did not see a doctor when they needed to in the past year because of fear of being mistreated as a transgender person, and 33% did not see a doctor when needed because they could not afford care.

“I urge you to go and find the survey and look at all of the results, it is really important,” Dr. James stated. He stressed the fact that the breakout reports, including the report on black respondents, the Latino/a response report (in both English and Spanish), and the other minority and individual state reports, can all provide a more detailed view of what is going on in the transgender community than anything previously available.

Dr. James reported having no disclosures.
 

[email protected]

SOURCE: James S. Sexually Transmitted Diseases 2018. 45 [Supplement 2] Session 5D. S289.

WASHINGTON – Respondents to the 2015 United States Transgender Survey (USTS) reported living with HIV at nearly five times the rate in the U.S. population. Reported HIV rates were even higher among transgender women, especially transgender women of color, according to Sandy James, JD, PhD, the lead author of the USTS and its former research director (2014-2017).

© 2018 National Center for Transgender Equality

In addition, the survey results detailed high rates of physical and mental health issues, difficulties accessing health care, and negative experiences when receiving medical care.

“There [had been] a dearth of data available about trans people,” said Dr. James, and hard data are required to make any meaningful changes to health care systems, but “now we have numbers.”

The nationwide USTS was the largest survey ever to document the experiences of transgender adults in the United States, comprising 27,715 respondents from all 50 states, the District of Columbia, American Samoa, Guam, Puerto Rico, and U.S. military bases overseas.

The USTS provided a comprehensive examination of a wide range of life outcomes, including those related to health, employment, income, and education. This survey of transgender adults (18 years of age and older) was anonymous, was available in both English and Spanish, and was conducted in the summer of 2015 by the National Center for Transgender Equality.

The document details the stresses and dangers that transgender people face in their daily lives, including attempted suicide rates higher than the norm (40% having attempted suicide in their lifetime, nearly nine times the 4.6% rate in the U.S. population). Nearly 1 in 10 respondents were physically attacked in the past year because of being transgender, and nearly half (47%) of respondents reported having been sexually assaulted during their lifetime.

Respondents reported living with HIV (1.4%) at nearly five times the rate in the U.S. population (0.3%), with HIV rates higher among transgender women (3.4%), especially transgender women of color. Nearly one in five black transgender women were living with HIV, and Native American Indian and Latina women also reported higher rates of infection: 4.6% and 4.4%, respectively.

A total of 25% of respondents experienced a problem in the past year with their insurance related to being transgender, such as being denied coverage for care related to gender transition or being denied coverage for routine care because they were transgender.

In terms of the health care environment, 33% of those who saw a health care provider in the past year reported having at least one negative experience related to being transgender, with higher rates for people of color and people with disabilities. This included being refused treatment, being verbally harassed or physically or sexually assaulted, or having to teach the provider about transgender people to get appropriate care, according to the survey.

In addition, 23% of respondents reported that they did not see a doctor when they needed to in the past year because of fear of being mistreated as a transgender person, and 33% did not see a doctor when needed because they could not afford care.

“I urge you to go and find the survey and look at all of the results, it is really important,” Dr. James stated. He stressed the fact that the breakout reports, including the report on black respondents, the Latino/a response report (in both English and Spanish), and the other minority and individual state reports, can all provide a more detailed view of what is going on in the transgender community than anything previously available.

Dr. James reported having no disclosures.
 

[email protected]

SOURCE: James S. Sexually Transmitted Diseases 2018. 45 [Supplement 2] Session 5D. S289.

The Centers for Medicare and Medicaid Services is test driving a new quality measurement model that pushes hospital readmissions measures out from 30 to 90 days.

DAJ/Thinkstock

Previous research has identified vascular surgery as having twice as high rates of 90-day readmissions, compared with 30-day readmissions (Am J Manag Care. 2014;20[9]:e432-e438), and this could prove problematic in light of the CMS pilot project currently underway, according to Donald E. Fry, MD, of MPA Healthcare Solutions, Chicago, and his colleagues.

They performed a study that found a high level of adverse outcomes for common vascular procedures and that there was a significant variability in risk-adjusted outcomes among best- and poorest-performing hospitals in all major vascular procedures, indicating that a large opportunity exists for improvement in results.

Medicare’s value-based care Readmissions Reduction Model developed financial penalties for hospitals that fail to achieve acceptable performance scores, and in doing so shifted some of the financial risks of care to the providers based on a 30-day readmission model. In contrast, the pilot Bundled Payments for Care Improvement (BPCI) Advanced Program, which the CMS plans to launch in October 2018, will follow a 90-day period of postoperative care as its duration of financial accountability.

“While BPCI Advanced, has, until now, focused upon orthopedics, cardiovascular procedures, and high-volume medical admissions areas, it is anticipated that vascular surgery will be included in the future,” according to the investigators. Therefore, the researchers performed an in-depth analysis to examine the 90-day outcomes of common vascular surgeries across hospitals as a prelude to the vascular surgery field having to potentially confront this new CMS model (Surgery 2018 Jun 22 doi: 10.1016/j.surg.2018.03.025).

Dr. Fry and his colleagues used the Medicare Limited Data Set for 2012-2014 to follow the outcomes of major vascular surgery beginning with the inpatient stay and on through 90 days of postoperative care. A pool of more than 500 aggregated and individual candidate risk factors, including age and sex, was used in model development, based upon data from 359 hospitals with 10,815 patients in the Medicare Limited Data Set.

The researchers examined the risk-adjusted outcomes of four major groupings of vascular surgery procedures: elective open aortic; open peripheral vascular procedures; endovascular aortic; and percutaneous angioplasty procedures.

They found that the total adverse-outcome rate (AO) was 27.8% for open aortic procedures, 31.5% for open peripheral vascular procedures, 19.6% for endovascular aortic procedures, and 36.4% for percutaneous angioplasty procedures. The difference in risk-adjusted adverse-outcome rates between the best- and the poorest- performing deciles was 32.2% for open aortic procedures, 29.5% for open peripheral vascular procedures, 21.5% for endovascular aortic procedures, and 37.1% for percutaneous angioplasty procedures.

The model determined significant risk factors (P less than .001) for inpatient death (including malnutrition, intestinal ischemia, supplemental oxygen, and age greater than or equal to 85 years); prolonged length of stay (including supplemental oxygen, peritoneal adhesions, and chronic lung obstructive disease); 90-day postdischarge death (including heart failure, chronic infection, psychosis, and primary head/neck cancer); and 90-day postdischarge readmission (malnutrition, chronic obstructive lung disease, upper aerodigestive tract cancer, and skin ulceration) for these procedures.

For all cases, the total 90-day postdischarge mortality rate exceeded the inpatient death rate, and readmissions were the major driver of the total AO. They found that 22% of all patients readmitted across the entire 90-day interval had not seen a physician for follow-up after discharge. [This] “begs the question of whether more frequent physician or physician-extender follow-up can reduce this AO,” according to Dr. Fry and his colleagues. “Importantly, first readmissions during days 31-90 following discharge were almost as common as those occurring during the initial 30 days. Over 20% of total readmissions were subsequently repeat events during the 90-day interval,” they added.

They also found that the variability in risk-adjusted outcomes among the best and poorest performing hospitals was over 20% in all of the major vascular procedures and indicates a large opportunity for improvement in results.

“Understanding variables associated with higher risk can be used as a decision support tool to identify which patients will need increased vigilance to avoid AOs. Identification of very high risk may become a consideration in the assessment of the appropriateness of the surgical intervention. If providers know their outcomes and those outcomes are benchmarked against the whole population of hospitals, then clinical performance can be improved by specific care redesign initiatives,” the researchers concluded.

Dr. Fry is executive vice president of MPA Healthcare Solutions, which funded the research.

[email protected]

SOURCE: Fry DE et al. Surgery 2018 Jun 22. doi: 10.1016/j.surg.2018.03.025.

The Centers for Medicare and Medicaid Services is test driving a new quality measurement model that pushes hospital readmissions measures out from 30 to 90 days.

DAJ/Thinkstock

Previous research has identified vascular surgery as having twice as high rates of 90-day readmissions, compared with 30-day readmissions (Am J Manag Care. 2014;20[9]:e432-e438), and this could prove problematic in light of the CMS pilot project currently underway, according to Donald E. Fry, MD, of MPA Healthcare Solutions, Chicago, and his colleagues.

They performed a study that found a high level of adverse outcomes for common vascular procedures and that there was a significant variability in risk-adjusted outcomes among best- and poorest-performing hospitals in all major vascular procedures, indicating that a large opportunity exists for improvement in results.

Medicare’s value-based care Readmissions Reduction Model developed financial penalties for hospitals that fail to achieve acceptable performance scores, and in doing so shifted some of the financial risks of care to the providers based on a 30-day readmission model. In contrast, the pilot Bundled Payments for Care Improvement (BPCI) Advanced Program, which the CMS plans to launch in October 2018, will follow a 90-day period of postoperative care as its duration of financial accountability.

“While BPCI Advanced, has, until now, focused upon orthopedics, cardiovascular procedures, and high-volume medical admissions areas, it is anticipated that vascular surgery will be included in the future,” according to the investigators. Therefore, the researchers performed an in-depth analysis to examine the 90-day outcomes of common vascular surgeries across hospitals as a prelude to the vascular surgery field having to potentially confront this new CMS model (Surgery 2018 Jun 22 doi: 10.1016/j.surg.2018.03.025).

Dr. Fry and his colleagues used the Medicare Limited Data Set for 2012-2014 to follow the outcomes of major vascular surgery beginning with the inpatient stay and on through 90 days of postoperative care. A pool of more than 500 aggregated and individual candidate risk factors, including age and sex, was used in model development, based upon data from 359 hospitals with 10,815 patients in the Medicare Limited Data Set.

The researchers examined the risk-adjusted outcomes of four major groupings of vascular surgery procedures: elective open aortic; open peripheral vascular procedures; endovascular aortic; and percutaneous angioplasty procedures.

They found that the total adverse-outcome rate (AO) was 27.8% for open aortic procedures, 31.5% for open peripheral vascular procedures, 19.6% for endovascular aortic procedures, and 36.4% for percutaneous angioplasty procedures. The difference in risk-adjusted adverse-outcome rates between the best- and the poorest- performing deciles was 32.2% for open aortic procedures, 29.5% for open peripheral vascular procedures, 21.5% for endovascular aortic procedures, and 37.1% for percutaneous angioplasty procedures.

The model determined significant risk factors (P less than .001) for inpatient death (including malnutrition, intestinal ischemia, supplemental oxygen, and age greater than or equal to 85 years); prolonged length of stay (including supplemental oxygen, peritoneal adhesions, and chronic lung obstructive disease); 90-day postdischarge death (including heart failure, chronic infection, psychosis, and primary head/neck cancer); and 90-day postdischarge readmission (malnutrition, chronic obstructive lung disease, upper aerodigestive tract cancer, and skin ulceration) for these procedures.

For all cases, the total 90-day postdischarge mortality rate exceeded the inpatient death rate, and readmissions were the major driver of the total AO. They found that 22% of all patients readmitted across the entire 90-day interval had not seen a physician for follow-up after discharge. [This] “begs the question of whether more frequent physician or physician-extender follow-up can reduce this AO,” according to Dr. Fry and his colleagues. “Importantly, first readmissions during days 31-90 following discharge were almost as common as those occurring during the initial 30 days. Over 20% of total readmissions were subsequently repeat events during the 90-day interval,” they added.

They also found that the variability in risk-adjusted outcomes among the best and poorest performing hospitals was over 20% in all of the major vascular procedures and indicates a large opportunity for improvement in results.

“Understanding variables associated with higher risk can be used as a decision support tool to identify which patients will need increased vigilance to avoid AOs. Identification of very high risk may become a consideration in the assessment of the appropriateness of the surgical intervention. If providers know their outcomes and those outcomes are benchmarked against the whole population of hospitals, then clinical performance can be improved by specific care redesign initiatives,” the researchers concluded.

Dr. Fry is executive vice president of MPA Healthcare Solutions, which funded the research.

[email protected]

SOURCE: Fry DE et al. Surgery 2018 Jun 22. doi: 10.1016/j.surg.2018.03.025.

The Centers for Medicare and Medicaid Services is test driving a new quality measurement model that pushes hospital readmissions measures out from 30 to 90 days.

DAJ/Thinkstock

Previous research has identified vascular surgery as having twice as high rates of 90-day readmissions, compared with 30-day readmissions (Am J Manag Care. 2014;20[9]:e432-e438), and this could prove problematic in light of the CMS pilot project currently underway, according to Donald E. Fry, MD, of MPA Healthcare Solutions, Chicago, and his colleagues.

They performed a study that found a high level of adverse outcomes for common vascular procedures and that there was a significant variability in risk-adjusted outcomes among best- and poorest-performing hospitals in all major vascular procedures, indicating that a large opportunity exists for improvement in results.

Medicare’s value-based care Readmissions Reduction Model developed financial penalties for hospitals that fail to achieve acceptable performance scores, and in doing so shifted some of the financial risks of care to the providers based on a 30-day readmission model. In contrast, the pilot Bundled Payments for Care Improvement (BPCI) Advanced Program, which the CMS plans to launch in October 2018, will follow a 90-day period of postoperative care as its duration of financial accountability.

“While BPCI Advanced, has, until now, focused upon orthopedics, cardiovascular procedures, and high-volume medical admissions areas, it is anticipated that vascular surgery will be included in the future,” according to the investigators. Therefore, the researchers performed an in-depth analysis to examine the 90-day outcomes of common vascular surgeries across hospitals as a prelude to the vascular surgery field having to potentially confront this new CMS model (Surgery 2018 Jun 22 doi: 10.1016/j.surg.2018.03.025).

Dr. Fry and his colleagues used the Medicare Limited Data Set for 2012-2014 to follow the outcomes of major vascular surgery beginning with the inpatient stay and on through 90 days of postoperative care. A pool of more than 500 aggregated and individual candidate risk factors, including age and sex, was used in model development, based upon data from 359 hospitals with 10,815 patients in the Medicare Limited Data Set.

The researchers examined the risk-adjusted outcomes of four major groupings of vascular surgery procedures: elective open aortic; open peripheral vascular procedures; endovascular aortic; and percutaneous angioplasty procedures.

They found that the total adverse-outcome rate (AO) was 27.8% for open aortic procedures, 31.5% for open peripheral vascular procedures, 19.6% for endovascular aortic procedures, and 36.4% for percutaneous angioplasty procedures. The difference in risk-adjusted adverse-outcome rates between the best- and the poorest- performing deciles was 32.2% for open aortic procedures, 29.5% for open peripheral vascular procedures, 21.5% for endovascular aortic procedures, and 37.1% for percutaneous angioplasty procedures.

The model determined significant risk factors (P less than .001) for inpatient death (including malnutrition, intestinal ischemia, supplemental oxygen, and age greater than or equal to 85 years); prolonged length of stay (including supplemental oxygen, peritoneal adhesions, and chronic lung obstructive disease); 90-day postdischarge death (including heart failure, chronic infection, psychosis, and primary head/neck cancer); and 90-day postdischarge readmission (malnutrition, chronic obstructive lung disease, upper aerodigestive tract cancer, and skin ulceration) for these procedures.

For all cases, the total 90-day postdischarge mortality rate exceeded the inpatient death rate, and readmissions were the major driver of the total AO. They found that 22% of all patients readmitted across the entire 90-day interval had not seen a physician for follow-up after discharge. [This] “begs the question of whether more frequent physician or physician-extender follow-up can reduce this AO,” according to Dr. Fry and his colleagues. “Importantly, first readmissions during days 31-90 following discharge were almost as common as those occurring during the initial 30 days. Over 20% of total readmissions were subsequently repeat events during the 90-day interval,” they added.

They also found that the variability in risk-adjusted outcomes among the best and poorest performing hospitals was over 20% in all of the major vascular procedures and indicates a large opportunity for improvement in results.

“Understanding variables associated with higher risk can be used as a decision support tool to identify which patients will need increased vigilance to avoid AOs. Identification of very high risk may become a consideration in the assessment of the appropriateness of the surgical intervention. If providers know their outcomes and those outcomes are benchmarked against the whole population of hospitals, then clinical performance can be improved by specific care redesign initiatives,” the researchers concluded.

Dr. Fry is executive vice president of MPA Healthcare Solutions, which funded the research.

[email protected]

SOURCE: Fry DE et al. Surgery 2018 Jun 22. doi: 10.1016/j.surg.2018.03.025.

Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.

©Thinkstock

They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.

Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.

A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.

The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.

However, predictors of CEs risk between vascular and general surgery were significantly different.

For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.

For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.

The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.

“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.

They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”

Dr. Acheampong and his colleagues reported having no disclosures.

[email protected]

SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.

Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.

©Thinkstock

They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.

Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.

A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.

The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.

However, predictors of CEs risk between vascular and general surgery were significantly different.

For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.

For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.

The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.

“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.

They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”

Dr. Acheampong and his colleagues reported having no disclosures.

[email protected]

SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.

Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.

©Thinkstock

They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.

Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.

A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.

The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.

However, predictors of CEs risk between vascular and general surgery were significantly different.

For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.

For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.

The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.

“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.

They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”

Dr. Acheampong and his colleagues reported having no disclosures.

[email protected]

SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.

Mortality within 90 days of infection was 45% among 51 patients diagnosed with antibiotic-resistant Candida auris infections in a multihospital outbreak in New York City from 2012 to 2017.

Transmission is ongoing in health care facilities, primarily among patients with extensive health care exposures, according to a report published in Emerging Infectious Diseases.

Shawn Lockhart/CDC

In the intensive case-patient analysis conducted by the New York State Health Department, 21 cases were from seven hospitals in Brooklyn, 16 were from three hospitals and one private medical office in Queens, 12 were from five hospitals and one long-term acute care hospital in Manhattan, and 1 was from a hospital in the Bronx. The remaining clinical case was identified in a western New York hospital in a patient who had recently been admitted to an involved Brooklyn hospital.

Among these patients, 31 (61%) had resided in long-term care facilities immediately before being admitted to the hospital in which their infection was diagnosed, and 19 of these 31 resided in skilled nursing facilities with ventilator beds; 1 (2%) resided in a long-term acute care hospital; 5 (10%) had been transferred from another hospital; and 4 (8%) had traveled internationally within 5 years before diagnosis, according to the investigators.

Isolates from 50 patients (98%) were resistant to fluconazole and 13 (25%) were resistant to fluconazole and amphotericin B. No initial isolates were resistant to echinocandins, although subsequent isolates obtained from 3 persons who had received an echinocandin acquired resistance to it, according to the researchers. Whole-genome sequencing performed at The Centers for Disease Control and Prevention indicated that 50 of 51 isolates belonged to a South Asia clade; the remaining isolate was the only one susceptible to fluconazole.

The work was supported by the CDC. No disclosures were reported.

[email protected]

SOURCE: Adams E et al. Emerg Infect Dis. 2018 Sep 12; 24(10); ID: 18-0649.

Mortality within 90 days of infection was 45% among 51 patients diagnosed with antibiotic-resistant Candida auris infections in a multihospital outbreak in New York City from 2012 to 2017.

Transmission is ongoing in health care facilities, primarily among patients with extensive health care exposures, according to a report published in Emerging Infectious Diseases.

Shawn Lockhart/CDC

In the intensive case-patient analysis conducted by the New York State Health Department, 21 cases were from seven hospitals in Brooklyn, 16 were from three hospitals and one private medical office in Queens, 12 were from five hospitals and one long-term acute care hospital in Manhattan, and 1 was from a hospital in the Bronx. The remaining clinical case was identified in a western New York hospital in a patient who had recently been admitted to an involved Brooklyn hospital.

Among these patients, 31 (61%) had resided in long-term care facilities immediately before being admitted to the hospital in which their infection was diagnosed, and 19 of these 31 resided in skilled nursing facilities with ventilator beds; 1 (2%) resided in a long-term acute care hospital; 5 (10%) had been transferred from another hospital; and 4 (8%) had traveled internationally within 5 years before diagnosis, according to the investigators.

Isolates from 50 patients (98%) were resistant to fluconazole and 13 (25%) were resistant to fluconazole and amphotericin B. No initial isolates were resistant to echinocandins, although subsequent isolates obtained from 3 persons who had received an echinocandin acquired resistance to it, according to the researchers. Whole-genome sequencing performed at The Centers for Disease Control and Prevention indicated that 50 of 51 isolates belonged to a South Asia clade; the remaining isolate was the only one susceptible to fluconazole.

The work was supported by the CDC. No disclosures were reported.

[email protected]

SOURCE: Adams E et al. Emerg Infect Dis. 2018 Sep 12; 24(10); ID: 18-0649.

Mortality within 90 days of infection was 45% among 51 patients diagnosed with antibiotic-resistant Candida auris infections in a multihospital outbreak in New York City from 2012 to 2017.

Transmission is ongoing in health care facilities, primarily among patients with extensive health care exposures, according to a report published in Emerging Infectious Diseases.

Shawn Lockhart/CDC

In the intensive case-patient analysis conducted by the New York State Health Department, 21 cases were from seven hospitals in Brooklyn, 16 were from three hospitals and one private medical office in Queens, 12 were from five hospitals and one long-term acute care hospital in Manhattan, and 1 was from a hospital in the Bronx. The remaining clinical case was identified in a western New York hospital in a patient who had recently been admitted to an involved Brooklyn hospital.

Among these patients, 31 (61%) had resided in long-term care facilities immediately before being admitted to the hospital in which their infection was diagnosed, and 19 of these 31 resided in skilled nursing facilities with ventilator beds; 1 (2%) resided in a long-term acute care hospital; 5 (10%) had been transferred from another hospital; and 4 (8%) had traveled internationally within 5 years before diagnosis, according to the investigators.

Isolates from 50 patients (98%) were resistant to fluconazole and 13 (25%) were resistant to fluconazole and amphotericin B. No initial isolates were resistant to echinocandins, although subsequent isolates obtained from 3 persons who had received an echinocandin acquired resistance to it, according to the researchers. Whole-genome sequencing performed at The Centers for Disease Control and Prevention indicated that 50 of 51 isolates belonged to a South Asia clade; the remaining isolate was the only one susceptible to fluconazole.

The work was supported by the CDC. No disclosures were reported.

[email protected]

SOURCE: Adams E et al. Emerg Infect Dis. 2018 Sep 12; 24(10); ID: 18-0649.

BOSTON – The use of an intravascular ultrasound (IVUS)–based scoring system could predict stent failure at 2 years in the treatment of May-Thurner syndrome, according to Steven D. Abramowitz, MD, of the MedStar Washington Hospital Center, Washington, and his colleagues.

Martin Allred/Nationwide Photographers

Dr. Abramowitz presented their research in the Vascular and Endovascular Society (VESS) sessions held at the Vascular Annual Meeting.

“IVUS has become an important adjuvant diagnostic tool in the treatment of deep venous disease, and as such may provide a useful assessment and predictive tool for treatment success in stenting of May-Thurner syndrome,” said Dr. Abramowitz.

In their study, 118 consecutive patients with May-Thurner syndrome underwent IVUS-guided stent placement from April 2009 through May 2015 at two collaborating institutions. Patients had a mean age of 46 years and included 86 (73%) women. At the time of treatment, 45, 30, 25, and 18 patients had Clinical Etiology Anatomy Pathophysiology disease 3, 4, 5, and 6, respectively.

Dr. Abramowitz described how he and his colleagues derived an IVUS-driven scoring system to assess the following categories of May-Thurner syndrome (nonocclusive or occlusive), disease chronicity (nonthrombotic, acute, or chronic), venous disease length (less than 180 mm or greater than 181 mm), venous inflow compliance (presence or absence of respiratory variation), iliocaval confluence disease involvement (present or absent), iliocaval con-fluence stenting obligation (stented or spared), and presence of perivenous collaterals before and after stenting (none or resolved).

Six of the categories were scored with 0 or 1 and one category was scored with 0, 1, or 2. Scores were tabulated for each patient at the time of initial intervention.

All 118 (100%) patients received anticoagulation and 78 (66%) were on an antiplatelet agent. Thirty-eight (32%) developed moderate in-stent stenosis, required thrombolysis, or underwent additional stenting procedures and were considered treatment failures during the observed period.

Eighty patients (68%) required no additional intervention and were considered treatment successes. The mean IVUS score for all patients was 5.22. The mean IVUS score in the treatment failure cohort was 5.64 compared with a score of 4.67 in the treatment success group, a significant difference. Patients with a score above 4 on this 7-point scale had an increased relative risk (1.6) of stent failure at 2 years.

“An IVUS-driven scoring system score of 4 or greater during initial intervention for May-Thurner syndrome predicts failure at 2 years. Additional treatment modalities should be considered at implantation to prevent failure,” said Dr. Abramowitz.

In an interview, Dr. Abramowitz added: “There is an emerging body of research regarding outcomes of deep venous intervention. However, we are still looking to generate clinically relevant data that will help guide interventionists to achieve durable technical success and long-term positive clinical outcomes for our patients.

“At this time, there is very little data to help correlate what physicians see on venography and IVUS during the treatment of May-Thurner Lesions. This data is hopefully the first step in allowing us to guide intra-operative decision making. IVUS is an excellent tool that has been proven by other studies to aid in the diagnosis and management of venous disease. With this data we also hope that it becomes a drive of patient management as well. Ideally, this data will transition into also guiding anticoagulation management, postoperative surveillance strategies and outcomes stratification for patients,” Dr. Abramowitz concluded.

[email protected]

BOSTON – The use of an intravascular ultrasound (IVUS)–based scoring system could predict stent failure at 2 years in the treatment of May-Thurner syndrome, according to Steven D. Abramowitz, MD, of the MedStar Washington Hospital Center, Washington, and his colleagues.

Martin Allred/Nationwide Photographers

Dr. Abramowitz presented their research in the Vascular and Endovascular Society (VESS) sessions held at the Vascular Annual Meeting.

“IVUS has become an important adjuvant diagnostic tool in the treatment of deep venous disease, and as such may provide a useful assessment and predictive tool for treatment success in stenting of May-Thurner syndrome,” said Dr. Abramowitz.

In their study, 118 consecutive patients with May-Thurner syndrome underwent IVUS-guided stent placement from April 2009 through May 2015 at two collaborating institutions. Patients had a mean age of 46 years and included 86 (73%) women. At the time of treatment, 45, 30, 25, and 18 patients had Clinical Etiology Anatomy Pathophysiology disease 3, 4, 5, and 6, respectively.

Dr. Abramowitz described how he and his colleagues derived an IVUS-driven scoring system to assess the following categories of May-Thurner syndrome (nonocclusive or occlusive), disease chronicity (nonthrombotic, acute, or chronic), venous disease length (less than 180 mm or greater than 181 mm), venous inflow compliance (presence or absence of respiratory variation), iliocaval confluence disease involvement (present or absent), iliocaval con-fluence stenting obligation (stented or spared), and presence of perivenous collaterals before and after stenting (none or resolved).

Six of the categories were scored with 0 or 1 and one category was scored with 0, 1, or 2. Scores were tabulated for each patient at the time of initial intervention.

All 118 (100%) patients received anticoagulation and 78 (66%) were on an antiplatelet agent. Thirty-eight (32%) developed moderate in-stent stenosis, required thrombolysis, or underwent additional stenting procedures and were considered treatment failures during the observed period.

Eighty patients (68%) required no additional intervention and were considered treatment successes. The mean IVUS score for all patients was 5.22. The mean IVUS score in the treatment failure cohort was 5.64 compared with a score of 4.67 in the treatment success group, a significant difference. Patients with a score above 4 on this 7-point scale had an increased relative risk (1.6) of stent failure at 2 years.

“An IVUS-driven scoring system score of 4 or greater during initial intervention for May-Thurner syndrome predicts failure at 2 years. Additional treatment modalities should be considered at implantation to prevent failure,” said Dr. Abramowitz.

In an interview, Dr. Abramowitz added: “There is an emerging body of research regarding outcomes of deep venous intervention. However, we are still looking to generate clinically relevant data that will help guide interventionists to achieve durable technical success and long-term positive clinical outcomes for our patients.

“At this time, there is very little data to help correlate what physicians see on venography and IVUS during the treatment of May-Thurner Lesions. This data is hopefully the first step in allowing us to guide intra-operative decision making. IVUS is an excellent tool that has been proven by other studies to aid in the diagnosis and management of venous disease. With this data we also hope that it becomes a drive of patient management as well. Ideally, this data will transition into also guiding anticoagulation management, postoperative surveillance strategies and outcomes stratification for patients,” Dr. Abramowitz concluded.

[email protected]

BOSTON – The use of an intravascular ultrasound (IVUS)–based scoring system could predict stent failure at 2 years in the treatment of May-Thurner syndrome, according to Steven D. Abramowitz, MD, of the MedStar Washington Hospital Center, Washington, and his colleagues.

Martin Allred/Nationwide Photographers

Dr. Abramowitz presented their research in the Vascular and Endovascular Society (VESS) sessions held at the Vascular Annual Meeting.

“IVUS has become an important adjuvant diagnostic tool in the treatment of deep venous disease, and as such may provide a useful assessment and predictive tool for treatment success in stenting of May-Thurner syndrome,” said Dr. Abramowitz.

In their study, 118 consecutive patients with May-Thurner syndrome underwent IVUS-guided stent placement from April 2009 through May 2015 at two collaborating institutions. Patients had a mean age of 46 years and included 86 (73%) women. At the time of treatment, 45, 30, 25, and 18 patients had Clinical Etiology Anatomy Pathophysiology disease 3, 4, 5, and 6, respectively.

Dr. Abramowitz described how he and his colleagues derived an IVUS-driven scoring system to assess the following categories of May-Thurner syndrome (nonocclusive or occlusive), disease chronicity (nonthrombotic, acute, or chronic), venous disease length (less than 180 mm or greater than 181 mm), venous inflow compliance (presence or absence of respiratory variation), iliocaval confluence disease involvement (present or absent), iliocaval con-fluence stenting obligation (stented or spared), and presence of perivenous collaterals before and after stenting (none or resolved).

Six of the categories were scored with 0 or 1 and one category was scored with 0, 1, or 2. Scores were tabulated for each patient at the time of initial intervention.

All 118 (100%) patients received anticoagulation and 78 (66%) were on an antiplatelet agent. Thirty-eight (32%) developed moderate in-stent stenosis, required thrombolysis, or underwent additional stenting procedures and were considered treatment failures during the observed period.

Eighty patients (68%) required no additional intervention and were considered treatment successes. The mean IVUS score for all patients was 5.22. The mean IVUS score in the treatment failure cohort was 5.64 compared with a score of 4.67 in the treatment success group, a significant difference. Patients with a score above 4 on this 7-point scale had an increased relative risk (1.6) of stent failure at 2 years.

“An IVUS-driven scoring system score of 4 or greater during initial intervention for May-Thurner syndrome predicts failure at 2 years. Additional treatment modalities should be considered at implantation to prevent failure,” said Dr. Abramowitz.

In an interview, Dr. Abramowitz added: “There is an emerging body of research regarding outcomes of deep venous intervention. However, we are still looking to generate clinically relevant data that will help guide interventionists to achieve durable technical success and long-term positive clinical outcomes for our patients.

“At this time, there is very little data to help correlate what physicians see on venography and IVUS during the treatment of May-Thurner Lesions. This data is hopefully the first step in allowing us to guide intra-operative decision making. IVUS is an excellent tool that has been proven by other studies to aid in the diagnosis and management of venous disease. With this data we also hope that it becomes a drive of patient management as well. Ideally, this data will transition into also guiding anticoagulation management, postoperative surveillance strategies and outcomes stratification for patients,” Dr. Abramowitz concluded.

[email protected]

A combination intervention that included standard of care antiretroviral therapy (ART), systems navigation, and psychosocial counseling showed success in HIV-infected people who inject drugs (PWID), according to the results of a randomized study in the Lancet.

andrewsafonov/Thinkstock

The intervention patients showed an increase in both the use of ART and medication-assisted treatment (MAT) for drug use. In addition, they showed a reduced mortality, compared with standard-of-care controls. The study was carried out in one community site in the Ukraine and two health center sites in Vietnam.

A unique aspect of the study was that each HIV-positive PWID recruited one or more HIV-negative injection partners who were followed throughout the study to determine any change in their HIV status, according to a report by William C. Miller, MD, PhD, of the Ohio State University, Columbus, and his colleagues.

The study included 502 eligible and enrolled HIV-positive PWID along with 806 eligible and enrolled injection partners. The subjects comprised 85% men, with 65% of the participants between the ages of 30-39 years at time of enrollment. Patients were randomized to the intervention group (25%) or the standard of care–only group (75%).

At 1 year, self-reported ART use was higher among the index participants in the intervention group than in the standard of care group (probability ratio,1.7; 95% confidence interval, 1.4-1.9) and viral suppression also was higher with the intervention group than with standard of care (PR 1.7; 95% CI, 1.3-2.2). In addition, MAT use was higher with the intervention than with standard of care (PR, 1.7; 95% CI, 1.3-2.2). Seven HIV infections occurred during the study, all in the injection partners of the standard of care group, with none in the intervention group partners, but the study was not powered to determine if this was a significant difference.

Mortality was lower in the intervention group than in the standard of care group with 5.6 deaths/100 person-years (95% CI, 2.6-10.6) in the intervention group vs. 12.1 deaths/100 person-years (95% CI, 9.1-15.6) in the standard of care group (hazard ratio, 0.47; 95% CI 0.22-0.90). Similarly, mortality also was lower among injection partners in the intervention group than in the standard of care group (0.46 deaths/100 person-years; 95% CI, 0.01-2.6 vs. 2.6 deaths/100 person-years; 95% CI, 1.5-4.1, respectively (HR, 0.17; 95% CI, 0.01-0.84).

“This vanguard study provides evidence that a flexible, scalable intervention increases ART and MAT use and reduced mortality among PWID,” according to the authors. “The intervention might have reduced HIV incidence, but incidence was low in both groups of uninfected partners. This low incidence presents a challenge for any similar future trial assessing transmission and precludes a future randomized controlled trial,” they concluded.

The study was funded by the National Institutes of Health and the authors reported no conflicts of interest within the scope of the study.

[email protected]

SOURCE: Miller WC et al. Lancet 2018;392:747-59.

A combination intervention that included standard of care antiretroviral therapy (ART), systems navigation, and psychosocial counseling showed success in HIV-infected people who inject drugs (PWID), according to the results of a randomized study in the Lancet.

andrewsafonov/Thinkstock

The intervention patients showed an increase in both the use of ART and medication-assisted treatment (MAT) for drug use. In addition, they showed a reduced mortality, compared with standard-of-care controls. The study was carried out in one community site in the Ukraine and two health center sites in Vietnam.

A unique aspect of the study was that each HIV-positive PWID recruited one or more HIV-negative injection partners who were followed throughout the study to determine any change in their HIV status, according to a report by William C. Miller, MD, PhD, of the Ohio State University, Columbus, and his colleagues.

The study included 502 eligible and enrolled HIV-positive PWID along with 806 eligible and enrolled injection partners. The subjects comprised 85% men, with 65% of the participants between the ages of 30-39 years at time of enrollment. Patients were randomized to the intervention group (25%) or the standard of care–only group (75%).

At 1 year, self-reported ART use was higher among the index participants in the intervention group than in the standard of care group (probability ratio,1.7; 95% confidence interval, 1.4-1.9) and viral suppression also was higher with the intervention group than with standard of care (PR 1.7; 95% CI, 1.3-2.2). In addition, MAT use was higher with the intervention than with standard of care (PR, 1.7; 95% CI, 1.3-2.2). Seven HIV infections occurred during the study, all in the injection partners of the standard of care group, with none in the intervention group partners, but the study was not powered to determine if this was a significant difference.

Mortality was lower in the intervention group than in the standard of care group with 5.6 deaths/100 person-years (95% CI, 2.6-10.6) in the intervention group vs. 12.1 deaths/100 person-years (95% CI, 9.1-15.6) in the standard of care group (hazard ratio, 0.47; 95% CI 0.22-0.90). Similarly, mortality also was lower among injection partners in the intervention group than in the standard of care group (0.46 deaths/100 person-years; 95% CI, 0.01-2.6 vs. 2.6 deaths/100 person-years; 95% CI, 1.5-4.1, respectively (HR, 0.17; 95% CI, 0.01-0.84).

“This vanguard study provides evidence that a flexible, scalable intervention increases ART and MAT use and reduced mortality among PWID,” according to the authors. “The intervention might have reduced HIV incidence, but incidence was low in both groups of uninfected partners. This low incidence presents a challenge for any similar future trial assessing transmission and precludes a future randomized controlled trial,” they concluded.

The study was funded by the National Institutes of Health and the authors reported no conflicts of interest within the scope of the study.

[email protected]

SOURCE: Miller WC et al. Lancet 2018;392:747-59.

A combination intervention that included standard of care antiretroviral therapy (ART), systems navigation, and psychosocial counseling showed success in HIV-infected people who inject drugs (PWID), according to the results of a randomized study in the Lancet.

andrewsafonov/Thinkstock

The intervention patients showed an increase in both the use of ART and medication-assisted treatment (MAT) for drug use. In addition, they showed a reduced mortality, compared with standard-of-care controls. The study was carried out in one community site in the Ukraine and two health center sites in Vietnam.

A unique aspect of the study was that each HIV-positive PWID recruited one or more HIV-negative injection partners who were followed throughout the study to determine any change in their HIV status, according to a report by William C. Miller, MD, PhD, of the Ohio State University, Columbus, and his colleagues.

The study included 502 eligible and enrolled HIV-positive PWID along with 806 eligible and enrolled injection partners. The subjects comprised 85% men, with 65% of the participants between the ages of 30-39 years at time of enrollment. Patients were randomized to the intervention group (25%) or the standard of care–only group (75%).

At 1 year, self-reported ART use was higher among the index participants in the intervention group than in the standard of care group (probability ratio,1.7; 95% confidence interval, 1.4-1.9) and viral suppression also was higher with the intervention group than with standard of care (PR 1.7; 95% CI, 1.3-2.2). In addition, MAT use was higher with the intervention than with standard of care (PR, 1.7; 95% CI, 1.3-2.2). Seven HIV infections occurred during the study, all in the injection partners of the standard of care group, with none in the intervention group partners, but the study was not powered to determine if this was a significant difference.

Mortality was lower in the intervention group than in the standard of care group with 5.6 deaths/100 person-years (95% CI, 2.6-10.6) in the intervention group vs. 12.1 deaths/100 person-years (95% CI, 9.1-15.6) in the standard of care group (hazard ratio, 0.47; 95% CI 0.22-0.90). Similarly, mortality also was lower among injection partners in the intervention group than in the standard of care group (0.46 deaths/100 person-years; 95% CI, 0.01-2.6 vs. 2.6 deaths/100 person-years; 95% CI, 1.5-4.1, respectively (HR, 0.17; 95% CI, 0.01-0.84).

“This vanguard study provides evidence that a flexible, scalable intervention increases ART and MAT use and reduced mortality among PWID,” according to the authors. “The intervention might have reduced HIV incidence, but incidence was low in both groups of uninfected partners. This low incidence presents a challenge for any similar future trial assessing transmission and precludes a future randomized controlled trial,” they concluded.

The study was funded by the National Institutes of Health and the authors reported no conflicts of interest within the scope of the study.

[email protected]

SOURCE: Miller WC et al. Lancet 2018;392:747-59.

WASHINGTON – Current guidelines recommend a minimum of annual screening for gonorrhea and chlamydia in all sexually active individuals with HIV infection. However, this goal, which is frequently not attained in HIV clinics, may be excessive in certain populations with HIV infection.

Courtesy CDC

In particular, women as well as men who have sex exclusively with women (MSW) may best be served by targeted, age-based screening rather than universal screening, according to a presentation by Susan A. Tuddenham, MD, an assistant professor of medicine at Johns Hopkins University, Baltimore.

“Detection and treatment of gonorrhea and chlamydia in HIV-positive patients in the United States is a priority both because of patient morbidity and because of the potential for these infections to enhance transmission of HIV,” said Dr. Tuddenham.

She and her colleagues assessed data from 16,864 gonorrhea and chlamydia tests of all adults in care at three HIV Research Network sites during 2011-2014. She presented the data at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

They assessed the number needed to screen (NNS) in order to identify a single infection across three risk populations of individuals with HIV infection: 1,123 women, 1,236 men who have sex only with women (MSW), and 3,501 men who have sex with men (MSM). NNS was defined as the number of persons tested divided by the number who tested positive and was calculated for the three risk groups for urogenital and extragenital (rectal and pharyngeal) sampling and by age.

Dr. Tuddenham and her colleagues found that NNS based on urogenital screening was similar in all three groups for those individuals aged younger than or equal to 25 years: 15 for women (95% confidence interval, 9-71); 21 for MSW (95% CI, 6-171); and 20 for MSM (95% CI, 12-36). However at ages greater than 25 years, the picture changed, with urogenital NNS increasing to 363 for women (95% CI, 167-1000); 160 for MSW (95% CI, 100-333). For MSM over the age of 25 years, however, the NNS only increased to 46 (95% CI, 38-56).

There were insufficient numbers of extragenital screenings of women and MSW for analysis. But for MSM, rectal NNS was 5 and 10 for those men aged 25 years and younger and those aged over age 25 years, respectively, and pharyngeal NNS was 8 and 20 for the two groups, respectively.

“Our results provide some support for age-based screening cutoffs for women and MSW, with universal screening appropriate for those less than or equal to 25 years of age, and targeted screening for those over 25,” said Dr. Tuddenham. She emphasized the importance of continued universal screening of MSM of all ages for gonorrhea/chlamydia, in particular using extragenital screening as well in order to capture those missed by urogenital screening alone.

Dr. Tuddenham reported that she had no disclosures.

[email protected]

WASHINGTON – Current guidelines recommend a minimum of annual screening for gonorrhea and chlamydia in all sexually active individuals with HIV infection. However, this goal, which is frequently not attained in HIV clinics, may be excessive in certain populations with HIV infection.

Courtesy CDC

In particular, women as well as men who have sex exclusively with women (MSW) may best be served by targeted, age-based screening rather than universal screening, according to a presentation by Susan A. Tuddenham, MD, an assistant professor of medicine at Johns Hopkins University, Baltimore.

“Detection and treatment of gonorrhea and chlamydia in HIV-positive patients in the United States is a priority both because of patient morbidity and because of the potential for these infections to enhance transmission of HIV,” said Dr. Tuddenham.

She and her colleagues assessed data from 16,864 gonorrhea and chlamydia tests of all adults in care at three HIV Research Network sites during 2011-2014. She presented the data at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

They assessed the number needed to screen (NNS) in order to identify a single infection across three risk populations of individuals with HIV infection: 1,123 women, 1,236 men who have sex only with women (MSW), and 3,501 men who have sex with men (MSM). NNS was defined as the number of persons tested divided by the number who tested positive and was calculated for the three risk groups for urogenital and extragenital (rectal and pharyngeal) sampling and by age.

Dr. Tuddenham and her colleagues found that NNS based on urogenital screening was similar in all three groups for those individuals aged younger than or equal to 25 years: 15 for women (95% confidence interval, 9-71); 21 for MSW (95% CI, 6-171); and 20 for MSM (95% CI, 12-36). However at ages greater than 25 years, the picture changed, with urogenital NNS increasing to 363 for women (95% CI, 167-1000); 160 for MSW (95% CI, 100-333). For MSM over the age of 25 years, however, the NNS only increased to 46 (95% CI, 38-56).

There were insufficient numbers of extragenital screenings of women and MSW for analysis. But for MSM, rectal NNS was 5 and 10 for those men aged 25 years and younger and those aged over age 25 years, respectively, and pharyngeal NNS was 8 and 20 for the two groups, respectively.

“Our results provide some support for age-based screening cutoffs for women and MSW, with universal screening appropriate for those less than or equal to 25 years of age, and targeted screening for those over 25,” said Dr. Tuddenham. She emphasized the importance of continued universal screening of MSM of all ages for gonorrhea/chlamydia, in particular using extragenital screening as well in order to capture those missed by urogenital screening alone.

Dr. Tuddenham reported that she had no disclosures.

[email protected]

WASHINGTON – Current guidelines recommend a minimum of annual screening for gonorrhea and chlamydia in all sexually active individuals with HIV infection. However, this goal, which is frequently not attained in HIV clinics, may be excessive in certain populations with HIV infection.

Courtesy CDC

In particular, women as well as men who have sex exclusively with women (MSW) may best be served by targeted, age-based screening rather than universal screening, according to a presentation by Susan A. Tuddenham, MD, an assistant professor of medicine at Johns Hopkins University, Baltimore.

“Detection and treatment of gonorrhea and chlamydia in HIV-positive patients in the United States is a priority both because of patient morbidity and because of the potential for these infections to enhance transmission of HIV,” said Dr. Tuddenham.

She and her colleagues assessed data from 16,864 gonorrhea and chlamydia tests of all adults in care at three HIV Research Network sites during 2011-2014. She presented the data at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

They assessed the number needed to screen (NNS) in order to identify a single infection across three risk populations of individuals with HIV infection: 1,123 women, 1,236 men who have sex only with women (MSW), and 3,501 men who have sex with men (MSM). NNS was defined as the number of persons tested divided by the number who tested positive and was calculated for the three risk groups for urogenital and extragenital (rectal and pharyngeal) sampling and by age.

Dr. Tuddenham and her colleagues found that NNS based on urogenital screening was similar in all three groups for those individuals aged younger than or equal to 25 years: 15 for women (95% confidence interval, 9-71); 21 for MSW (95% CI, 6-171); and 20 for MSM (95% CI, 12-36). However at ages greater than 25 years, the picture changed, with urogenital NNS increasing to 363 for women (95% CI, 167-1000); 160 for MSW (95% CI, 100-333). For MSM over the age of 25 years, however, the NNS only increased to 46 (95% CI, 38-56).

There were insufficient numbers of extragenital screenings of women and MSW for analysis. But for MSM, rectal NNS was 5 and 10 for those men aged 25 years and younger and those aged over age 25 years, respectively, and pharyngeal NNS was 8 and 20 for the two groups, respectively.

“Our results provide some support for age-based screening cutoffs for women and MSW, with universal screening appropriate for those less than or equal to 25 years of age, and targeted screening for those over 25,” said Dr. Tuddenham. She emphasized the importance of continued universal screening of MSM of all ages for gonorrhea/chlamydia, in particular using extragenital screening as well in order to capture those missed by urogenital screening alone.

Dr. Tuddenham reported that she had no disclosures.

[email protected]

Two once-daily oral HIV-1 medicines have been approved by the Food and Drug Administration, according to Merck: Delstrigo, a fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg), and Pifeltro (doravirine, 100 mg). Both drugs are indicated for treating HIV-1 infection in adult patients with no prior antiretroviral treatment.

Pifeltro is a nonnucleoside reverse transcriptase inhibitor to be used in combination with other antiretroviral medicines. Delstrigo contains a boxed warning regarding posttreatment acute exacerbation of hepatitis B infection.

Delstrigo and Pifeltro are not curative, according to the announcement by Merck, which manufactures both drugs.

The FDA approval of Delstrigo was based on findings from the DRIVE-AHEAD trial (NCT02403674), which randomized 728 participants with no history of antiretroviral treatment to receive once daily either Delstrigo or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV 600 mg/FTC 200 mg/TDF 300 mg). Delstrigo was associated with sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy when compared with EFV/FTC/TDF (84% vs. 81%, respectively), according to Merck.

Pifeltro was approved based on the results of the DRIVE-FORWARD trial (NCT02275780), which randomized 766 participants with no history of antiretroviral treatment to receive either Pifeltro once daily or darunavir 800 mg plus ritonavir 100 mg (DRV+r) once daily, each in combination with either emtricitabine (FTC)/TDF or abacavir (ABC)/lamivudine (3TC), as selected by the investigator. Pifeltro was associated with sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy when compared with DRV+r, each in combination with FTC/TDF or ABC/3TC (84% vs. 80%, respectively), according to the Merck announcement.

[email protected]

Two once-daily oral HIV-1 medicines have been approved by the Food and Drug Administration, according to Merck: Delstrigo, a fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg), and Pifeltro (doravirine, 100 mg). Both drugs are indicated for treating HIV-1 infection in adult patients with no prior antiretroviral treatment.

Pifeltro is a nonnucleoside reverse transcriptase inhibitor to be used in combination with other antiretroviral medicines. Delstrigo contains a boxed warning regarding posttreatment acute exacerbation of hepatitis B infection.

Delstrigo and Pifeltro are not curative, according to the announcement by Merck, which manufactures both drugs.

The FDA approval of Delstrigo was based on findings from the DRIVE-AHEAD trial (NCT02403674), which randomized 728 participants with no history of antiretroviral treatment to receive once daily either Delstrigo or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV 600 mg/FTC 200 mg/TDF 300 mg). Delstrigo was associated with sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy when compared with EFV/FTC/TDF (84% vs. 81%, respectively), according to Merck.

Pifeltro was approved based on the results of the DRIVE-FORWARD trial (NCT02275780), which randomized 766 participants with no history of antiretroviral treatment to receive either Pifeltro once daily or darunavir 800 mg plus ritonavir 100 mg (DRV+r) once daily, each in combination with either emtricitabine (FTC)/TDF or abacavir (ABC)/lamivudine (3TC), as selected by the investigator. Pifeltro was associated with sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy when compared with DRV+r, each in combination with FTC/TDF or ABC/3TC (84% vs. 80%, respectively), according to the Merck announcement.

[email protected]

Two once-daily oral HIV-1 medicines have been approved by the Food and Drug Administration, according to Merck: Delstrigo, a fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg), and Pifeltro (doravirine, 100 mg). Both drugs are indicated for treating HIV-1 infection in adult patients with no prior antiretroviral treatment.

Pifeltro is a nonnucleoside reverse transcriptase inhibitor to be used in combination with other antiretroviral medicines. Delstrigo contains a boxed warning regarding posttreatment acute exacerbation of hepatitis B infection.

Delstrigo and Pifeltro are not curative, according to the announcement by Merck, which manufactures both drugs.

The FDA approval of Delstrigo was based on findings from the DRIVE-AHEAD trial (NCT02403674), which randomized 728 participants with no history of antiretroviral treatment to receive once daily either Delstrigo or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV 600 mg/FTC 200 mg/TDF 300 mg). Delstrigo was associated with sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy when compared with EFV/FTC/TDF (84% vs. 81%, respectively), according to Merck.

Pifeltro was approved based on the results of the DRIVE-FORWARD trial (NCT02275780), which randomized 766 participants with no history of antiretroviral treatment to receive either Pifeltro once daily or darunavir 800 mg plus ritonavir 100 mg (DRV+r) once daily, each in combination with either emtricitabine (FTC)/TDF or abacavir (ABC)/lamivudine (3TC), as selected by the investigator. Pifeltro was associated with sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy when compared with DRV+r, each in combination with FTC/TDF or ABC/3TC (84% vs. 80%, respectively), according to the Merck announcement.

[email protected]