The therapeutic alliance (interchangeably, the therapeutic relationship) is a subjective measure of the relationship between a clinician and a patient. It is an indicator of clinical trustworthiness: what a patient is referring to when she (he) expresses trust in her provider. The therapeutic alliance also is known as the working alliance, the therapeutic bond, and the helping alliance,¹ and it is an important factor in patient satisfaction ratings—the gauging parameter through which clinicians and institutions measure the quality of care they provide.²

A therapeutic alliance is essential to the delivery of psychiatric care. Itself, it can be a healing factor³ and has been linked to patients’ adherence to treatment and continuation of care.⁴ For example, psychiatric patients who perceive the therapeutic alliance more positively have:

• a better long-term health outcome after discharge
• a significantly better psychological quality of life⁵
• a better follow-up record of outpatient care after inpatient discharge^4,6
• better adherence to prescribed treatment⁷
• a reduced likelihood of relapse and readmission.⁶

Patient satisfaction is an indirect measure of the therapeutic alliance; many variables of the therapeutic relationship can affect that satisfaction. In this article, we call those variables patient factors and delivery factors; our aim, using the example of 2 hypothetical cases, is to highlight their importance in patients’ perception of the therapeutic alliance they have with providers.

CASE Paranoid delusions lead to termination of care
Mr. D, age 21, unmarried, unemployed, and with no medical or psychiatric history, is transferred from the medical floor to the inpatient psychiatric unit after coming to the hospital’s emergency room (ER) with a report of chest pain. Workup on the medical floor was negative for a serious cardiac event.

On questioning, Mr. D tells the team that his chest pain is caused by National Security Agency (NSA) satellites “locking” onto his heart and causing veins in his heart to “pop.”

Mr. D agrees to be transferred to the psychiatric unit. Once there, however, he refuses to take the psychotropic medications that have been prescribed or to comply with the balance of the treatment protocol. He is adamant about the influence of NSA satellites, and requests daily imaging to locate evidence of the path of the satellite tracking device that he claims is inside his body.

The treatment team repeatedly refuses to comply with Mr. D’s demand for imaging. He becomes angry and says that he does not think he is getting proper care because the nature of his problem is medical, not psychiatric.

Mr. D repeatedly asserts that he will not take any of the psychotropic medications that have been prescribed for him and will not attend follow-up appointments with the psychiatry team because he does not need treatment. He accuses the treatment team of conspiring with the NSA and causing his chest pain.

Mr. D asks to be discharged.

Patient factors: Unmodifiable and static
As Mr. D’s case exemplifies, patient factors are a set of elements, intrinsic to a given patient, that affect that patient’s perceptions independent of the quality of the care delivered. Included among patient factors are personal sociodemographic and psychopathological characteristics. These patient factors influence the therapeutic relationship in many ways.

Sociodemographics. It has been reported that patients of minority heritage and those who are male, young, and unmarried tend to be less satisfied with medical treatment in general and with psychiatric inpatient treatment in particular.^8,9 Females and older patients, on the other hand, are more likely to be satisfied with the perceived delivery of care and the therapeutic alliance.^8-10

Psychopathology affects patients’ perception of the delivery of care and the therapeutic alliance. Patients who are highly distressed psychologically and those who suffer chronic psychiatric illness, for example, tend to perceive themselves as having benefitted less from treatment than healthier counterparts.^9,11 Such patients also tend to see their therapeutic outcome in a much less favorable light.^11,12 Patients with borderline personality disorder and antisocial personality disorder^12-14 and those hospitalized involuntarily⁸ tend to (1) be less satisfied with their therapeutic outcome and (2) see the therapeutic alliance less favorably compared with those who do not have these psychopathologies.

CASE Denied a blanket, she feels like a 'burden'
Ms. X, age 34, married and a homemaker, has a history of bipolar I disorder. She brings herself to the ER complaining of depression and suicidal ideation.

After Ms. X is seen by the psychiatry consult service in the ER, she reports that she feels frustrated and angry and thinks that the hospital’s physicians do not really want to help her. She states that she felt that the ER staff “dismissed” her, in part because she spent 4 hours in the ER waiting room before she was given a bed.

Ms. X says that, once she was placed in a room, she felt that the nursing staff and medical assistants ignored her because they did not give her the extra blanket she requested. She said she was cold as a result, while she waited to see the psychiatrist and the ER physician.

Ms. X states that she came to the ER seeking help because she felt depressed and thought that no one cared about her. Coming to the hospital made her feel worse, after all, she said, because there she has been treated like she is a burden, much like she is treated at home.

Delivery factors: Amenable to change
These mutable elements of the therapeutic alliance are dependent on the quality of the care, as they were in Ms. X’s case; they can be changed. Included among delivery factors is the quality of the relationship between provider and patient—that is, how the psychiatrist and the nursing staff relate to the patient.

Perceptions are key. Delivery factors rank as one of the most important elements that influence the patient’s perception of the therapeutic alliance.^15,16 Given the objectives of psychiatric treatment—to relieve psychiatric symptoms, improve patient functioning, and alleviate psychological distress—it is no wonder that delivery factors play an important role in the perception of the therapeutic alliance: The quality of the provider−patient relationship is the axis around which treatment takes place. This relationship constantly ranks high on surveys of what is important to patients¹⁵—especially in an inpatient psychiatric setting.

Attitudes are modifiable. From the treating psychiatrist to nursing and ancillary staffs, all team members need to express attitudes and behaviors that reflect positively on the patient.¹⁷ Behaviors such as involving the patient fully in therapeutic decision-making; exuding an attitude of caring, equanimity, empathy, sincerity, and respect; and listening to the patient’s concerns can go a long way to improving the therapeutic relationship. Displaying such attitudes and behaviors also help improve the larger vision of psychiatric intervention: to bring about positive therapeutic changes.

Summing up
Ratings of the therapeutic alliance are the currency of patient satisfaction. The value of this therapeutic currency is affected by delivery factors, which are adjustable, and patient factors, which are not. Taken together, however, both types of factors are the foundation of patient satisfaction and the therapeutic alliance.

The therapeutic alliance (interchangeably, the therapeutic relationship) is a subjective measure of the relationship between a clinician and a patient. It is an indicator of clinical trustworthiness: what a patient is referring to when she (he) expresses trust in her provider. The therapeutic alliance also is known as the working alliance, the therapeutic bond, and the helping alliance,¹ and it is an important factor in patient satisfaction ratings—the gauging parameter through which clinicians and institutions measure the quality of care they provide.²

A therapeutic alliance is essential to the delivery of psychiatric care. Itself, it can be a healing factor³ and has been linked to patients’ adherence to treatment and continuation of care.⁴ For example, psychiatric patients who perceive the therapeutic alliance more positively have:

• a better long-term health outcome after discharge
• a significantly better psychological quality of life⁵
• a better follow-up record of outpatient care after inpatient discharge^4,6
• better adherence to prescribed treatment⁷
• a reduced likelihood of relapse and readmission.⁶

Patient satisfaction is an indirect measure of the therapeutic alliance; many variables of the therapeutic relationship can affect that satisfaction. In this article, we call those variables patient factors and delivery factors; our aim, using the example of 2 hypothetical cases, is to highlight their importance in patients’ perception of the therapeutic alliance they have with providers.

CASE Paranoid delusions lead to termination of care
Mr. D, age 21, unmarried, unemployed, and with no medical or psychiatric history, is transferred from the medical floor to the inpatient psychiatric unit after coming to the hospital’s emergency room (ER) with a report of chest pain. Workup on the medical floor was negative for a serious cardiac event.

On questioning, Mr. D tells the team that his chest pain is caused by National Security Agency (NSA) satellites “locking” onto his heart and causing veins in his heart to “pop.”

Mr. D agrees to be transferred to the psychiatric unit. Once there, however, he refuses to take the psychotropic medications that have been prescribed or to comply with the balance of the treatment protocol. He is adamant about the influence of NSA satellites, and requests daily imaging to locate evidence of the path of the satellite tracking device that he claims is inside his body.

The treatment team repeatedly refuses to comply with Mr. D’s demand for imaging. He becomes angry and says that he does not think he is getting proper care because the nature of his problem is medical, not psychiatric.

Mr. D repeatedly asserts that he will not take any of the psychotropic medications that have been prescribed for him and will not attend follow-up appointments with the psychiatry team because he does not need treatment. He accuses the treatment team of conspiring with the NSA and causing his chest pain.

Mr. D asks to be discharged.

Patient factors: Unmodifiable and static
As Mr. D’s case exemplifies, patient factors are a set of elements, intrinsic to a given patient, that affect that patient’s perceptions independent of the quality of the care delivered. Included among patient factors are personal sociodemographic and psychopathological characteristics. These patient factors influence the therapeutic relationship in many ways.

Sociodemographics. It has been reported that patients of minority heritage and those who are male, young, and unmarried tend to be less satisfied with medical treatment in general and with psychiatric inpatient treatment in particular.^8,9 Females and older patients, on the other hand, are more likely to be satisfied with the perceived delivery of care and the therapeutic alliance.^8-10

Psychopathology affects patients’ perception of the delivery of care and the therapeutic alliance. Patients who are highly distressed psychologically and those who suffer chronic psychiatric illness, for example, tend to perceive themselves as having benefitted less from treatment than healthier counterparts.^9,11 Such patients also tend to see their therapeutic outcome in a much less favorable light.^11,12 Patients with borderline personality disorder and antisocial personality disorder^12-14 and those hospitalized involuntarily⁸ tend to (1) be less satisfied with their therapeutic outcome and (2) see the therapeutic alliance less favorably compared with those who do not have these psychopathologies.

CASE Denied a blanket, she feels like a 'burden'
Ms. X, age 34, married and a homemaker, has a history of bipolar I disorder. She brings herself to the ER complaining of depression and suicidal ideation.

After Ms. X is seen by the psychiatry consult service in the ER, she reports that she feels frustrated and angry and thinks that the hospital’s physicians do not really want to help her. She states that she felt that the ER staff “dismissed” her, in part because she spent 4 hours in the ER waiting room before she was given a bed.

Ms. X says that, once she was placed in a room, she felt that the nursing staff and medical assistants ignored her because they did not give her the extra blanket she requested. She said she was cold as a result, while she waited to see the psychiatrist and the ER physician.

Ms. X states that she came to the ER seeking help because she felt depressed and thought that no one cared about her. Coming to the hospital made her feel worse, after all, she said, because there she has been treated like she is a burden, much like she is treated at home.

Delivery factors: Amenable to change
These mutable elements of the therapeutic alliance are dependent on the quality of the care, as they were in Ms. X’s case; they can be changed. Included among delivery factors is the quality of the relationship between provider and patient—that is, how the psychiatrist and the nursing staff relate to the patient.

Perceptions are key. Delivery factors rank as one of the most important elements that influence the patient’s perception of the therapeutic alliance.^15,16 Given the objectives of psychiatric treatment—to relieve psychiatric symptoms, improve patient functioning, and alleviate psychological distress—it is no wonder that delivery factors play an important role in the perception of the therapeutic alliance: The quality of the provider−patient relationship is the axis around which treatment takes place. This relationship constantly ranks high on surveys of what is important to patients¹⁵—especially in an inpatient psychiatric setting.

Attitudes are modifiable. From the treating psychiatrist to nursing and ancillary staffs, all team members need to express attitudes and behaviors that reflect positively on the patient.¹⁷ Behaviors such as involving the patient fully in therapeutic decision-making; exuding an attitude of caring, equanimity, empathy, sincerity, and respect; and listening to the patient’s concerns can go a long way to improving the therapeutic relationship. Displaying such attitudes and behaviors also help improve the larger vision of psychiatric intervention: to bring about positive therapeutic changes.

Summing up
Ratings of the therapeutic alliance are the currency of patient satisfaction. The value of this therapeutic currency is affected by delivery factors, which are adjustable, and patient factors, which are not. Taken together, however, both types of factors are the foundation of patient satisfaction and the therapeutic alliance.

The therapeutic alliance (interchangeably, the therapeutic relationship) is a subjective measure of the relationship between a clinician and a patient. It is an indicator of clinical trustworthiness: what a patient is referring to when she (he) expresses trust in her provider. The therapeutic alliance also is known as the working alliance, the therapeutic bond, and the helping alliance,¹ and it is an important factor in patient satisfaction ratings—the gauging parameter through which clinicians and institutions measure the quality of care they provide.²

A therapeutic alliance is essential to the delivery of psychiatric care. Itself, it can be a healing factor³ and has been linked to patients’ adherence to treatment and continuation of care.⁴ For example, psychiatric patients who perceive the therapeutic alliance more positively have:

• a better long-term health outcome after discharge
• a significantly better psychological quality of life⁵
• a better follow-up record of outpatient care after inpatient discharge^4,6
• better adherence to prescribed treatment⁷
• a reduced likelihood of relapse and readmission.⁶

Patient satisfaction is an indirect measure of the therapeutic alliance; many variables of the therapeutic relationship can affect that satisfaction. In this article, we call those variables patient factors and delivery factors; our aim, using the example of 2 hypothetical cases, is to highlight their importance in patients’ perception of the therapeutic alliance they have with providers.

CASE Paranoid delusions lead to termination of care
Mr. D, age 21, unmarried, unemployed, and with no medical or psychiatric history, is transferred from the medical floor to the inpatient psychiatric unit after coming to the hospital’s emergency room (ER) with a report of chest pain. Workup on the medical floor was negative for a serious cardiac event.

On questioning, Mr. D tells the team that his chest pain is caused by National Security Agency (NSA) satellites “locking” onto his heart and causing veins in his heart to “pop.”

Mr. D agrees to be transferred to the psychiatric unit. Once there, however, he refuses to take the psychotropic medications that have been prescribed or to comply with the balance of the treatment protocol. He is adamant about the influence of NSA satellites, and requests daily imaging to locate evidence of the path of the satellite tracking device that he claims is inside his body.

The treatment team repeatedly refuses to comply with Mr. D’s demand for imaging. He becomes angry and says that he does not think he is getting proper care because the nature of his problem is medical, not psychiatric.

Mr. D repeatedly asserts that he will not take any of the psychotropic medications that have been prescribed for him and will not attend follow-up appointments with the psychiatry team because he does not need treatment. He accuses the treatment team of conspiring with the NSA and causing his chest pain.

Mr. D asks to be discharged.

Patient factors: Unmodifiable and static
As Mr. D’s case exemplifies, patient factors are a set of elements, intrinsic to a given patient, that affect that patient’s perceptions independent of the quality of the care delivered. Included among patient factors are personal sociodemographic and psychopathological characteristics. These patient factors influence the therapeutic relationship in many ways.

Sociodemographics. It has been reported that patients of minority heritage and those who are male, young, and unmarried tend to be less satisfied with medical treatment in general and with psychiatric inpatient treatment in particular.^8,9 Females and older patients, on the other hand, are more likely to be satisfied with the perceived delivery of care and the therapeutic alliance.^8-10

Psychopathology affects patients’ perception of the delivery of care and the therapeutic alliance. Patients who are highly distressed psychologically and those who suffer chronic psychiatric illness, for example, tend to perceive themselves as having benefitted less from treatment than healthier counterparts.^9,11 Such patients also tend to see their therapeutic outcome in a much less favorable light.^11,12 Patients with borderline personality disorder and antisocial personality disorder^12-14 and those hospitalized involuntarily⁸ tend to (1) be less satisfied with their therapeutic outcome and (2) see the therapeutic alliance less favorably compared with those who do not have these psychopathologies.

CASE Denied a blanket, she feels like a 'burden'
Ms. X, age 34, married and a homemaker, has a history of bipolar I disorder. She brings herself to the ER complaining of depression and suicidal ideation.

After Ms. X is seen by the psychiatry consult service in the ER, she reports that she feels frustrated and angry and thinks that the hospital’s physicians do not really want to help her. She states that she felt that the ER staff “dismissed” her, in part because she spent 4 hours in the ER waiting room before she was given a bed.

Ms. X says that, once she was placed in a room, she felt that the nursing staff and medical assistants ignored her because they did not give her the extra blanket she requested. She said she was cold as a result, while she waited to see the psychiatrist and the ER physician.

Ms. X states that she came to the ER seeking help because she felt depressed and thought that no one cared about her. Coming to the hospital made her feel worse, after all, she said, because there she has been treated like she is a burden, much like she is treated at home.

Delivery factors: Amenable to change
These mutable elements of the therapeutic alliance are dependent on the quality of the care, as they were in Ms. X’s case; they can be changed. Included among delivery factors is the quality of the relationship between provider and patient—that is, how the psychiatrist and the nursing staff relate to the patient.

Perceptions are key. Delivery factors rank as one of the most important elements that influence the patient’s perception of the therapeutic alliance.^15,16 Given the objectives of psychiatric treatment—to relieve psychiatric symptoms, improve patient functioning, and alleviate psychological distress—it is no wonder that delivery factors play an important role in the perception of the therapeutic alliance: The quality of the provider−patient relationship is the axis around which treatment takes place. This relationship constantly ranks high on surveys of what is important to patients¹⁵—especially in an inpatient psychiatric setting.

Attitudes are modifiable. From the treating psychiatrist to nursing and ancillary staffs, all team members need to express attitudes and behaviors that reflect positively on the patient.¹⁷ Behaviors such as involving the patient fully in therapeutic decision-making; exuding an attitude of caring, equanimity, empathy, sincerity, and respect; and listening to the patient’s concerns can go a long way to improving the therapeutic relationship. Displaying such attitudes and behaviors also help improve the larger vision of psychiatric intervention: to bring about positive therapeutic changes.

Summing up
Ratings of the therapeutic alliance are the currency of patient satisfaction. The value of this therapeutic currency is affected by delivery factors, which are adjustable, and patient factors, which are not. Taken together, however, both types of factors are the foundation of patient satisfaction and the therapeutic alliance.

WASHINGTON – What has the increased access to contraception over the last 50 years meant for American women?

We asked Ob.Gyn. News editorial advisory board member Dr. Eve Espey, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, along with three experts in family planning, to explore how expanded contraception options have affected public health, what barriers still remain, and what new products are in the pipeline.

Perhaps the biggest impact for women has been the ability to participate in the workforce, and that includes women entering medical school.

“Over the last 50 years, we’ve seen a big increase in the number of women who are professionals, who are physicians,” Dr. Espey said during the roundtable. “And during that same period of time, we’ve seen the growth of more focus on family planning.”

“I think that really would not be possible without the ability to control our fertility,” said Dr. Sarah W. Prager, associate professor of obstetrics and gynecology and director of the Ryan Family Planning Program at the University of Washington, Seattle.

And the widespread availability of contraception has translated into a decrease in maternal mortality as a result of fewer unintended pregnancies. “The implications for public health – for women and children in this country – is huge,” Dr. Prager said.

LARCs

One of the big shifts in contraceptive trends has been the slow but increasing uptake of long-acting reversible contraceptives (LARCs), such as IUDs and implants. After a drop-off in the 1970s following safety problems with the Dalkon Shield, there has been a resurgence in interest.

In the last decade, the rate of LARC use has grown from about 2% to 10%, corresponding to a slight drop in rates of unintended pregnancy, said Dr. Nikki B. Zite, professor and residency program director in the department of obstetrics and gynecology at the University of Tennessee, Knoxville.

The Contraceptive CHOICE Project, which enrolled more than 9,000 women who were provided with the no-cost reversible contraceptive method of their choice, found that about three-quarters of the women chose an IUD or an implant, which was associated with significant reductions in unintended and teen pregnancies.

“What we saw was that when we removed barriers to contraception in general, that uptake of IUDs and implants really went up,” said Dr. Tessa Madden, director of the division of family planning and associate professor in the department of obstetrics and gynecology at Washington University, St. Louis.

There is no “best” contraceptive method, Dr. Madden said. “Contraception really needs to be tailored to the individual woman [ensuring] that her values and preferences about contraception are taken into consideration during counseling, to help her choose the method that’s going to be the best fit for her.”

Resources

There are resources available to aid in tailoring contraception methods to the needs of patients.

U.S. Medical Eligibility Criteria for Contraceptive Use, guidance that is available through the Centers for Disease Control and Prevention, allows physicians to tailor the method to a patient’s comorbid medical conditions, Dr. Zite said. Physicians can search by contraceptive method or patient characteristic to determine the risk for a given patient, rated on a scale of 1-4 (where 1 or 2 means generally safe, 3 means that the risks may outweigh the benefits, and 4 means that the risks clearly outweigh the benefits).

“It’s a really easy starting-off point to use with patients and physicians when trying to decide what contraceptive method is safe for their patient,” Dr. Zite said.

Common medical comorbidities, including obesity, diabetes, thyroid disease, and hypertension, are all addressed in the medical eligibility criteria.

Another resource is the U.S. Selected Practice Recommendations for Contraceptive Use, which can help in deciding when it is appropriate to start a contraceptive method, what exams and tests are needed before initiation, what follow-up is needed, and how to handle problems such as missed pills or potential side effects.

Barriers

Over the years, many of the barriers to contraceptive access have been reduced. Some forms of emergency contraception are now available over the counter to women of all ages; more states are considering laws allowing women to access up to a year’s supply of hormonal contraceptives at one time; and a few states have passed laws allowing pharmacists to prescribe hormonal birth control directly. In addition, the Affordable Care Act’s mandate for insurers to cover approved methods of contraception without cost sharing has eliminated some cost barriers.

But other systems barriers still remain, such as making women return for multiple visits for the insertion of an IUD or implant, or limiting LARC use only to women who have already had a child. “There’s not a reason to avoid use of IUDs in women that have not had babies but there are still providers out there who will not insert an IUD, so we need to still do a better job to increase access even more,” Dr. Zite said.

Future trends

What new contraceptive options are in the pipeline? Dr. Prager predicted more development in the area of longer-acting injectables and implants, potentially even biodegradable implants. Also likely is the development of nonsurgical sterilization methods for women that eliminate some of the risk and cost barriers. And male contraceptive methods are in the works, both hormonal and nonhormonal, Dr. Prager said.

There’s an increasing interested in nonhormonal longer-acting methods, beyond just the copper IUD, Dr. Madden said, and there are new products on the horizon in that area. Researchers are exploring new methods to protect against HIV and other sexually transmitted infections, while offering contraception, Dr. Zite said.

Dr. Espey reported having no relevant financial disclosures. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Zite is an unpaid trainer for Nexplanon and serves on an international IUD advisory board for Bayer. Dr. Madden serves on a scientific advisory board for Bayer and on a data safety monitoring board for phase IV safety studies of Bayer contraceptive products.

Throughout 2016, Ob.Gyn. News is celebrating its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of infertility treatment, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

[email protected]

On Twitter @maryellenny

WASHINGTON – What has the increased access to contraception over the last 50 years meant for American women?

We asked Ob.Gyn. News editorial advisory board member Dr. Eve Espey, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, along with three experts in family planning, to explore how expanded contraception options have affected public health, what barriers still remain, and what new products are in the pipeline.

Perhaps the biggest impact for women has been the ability to participate in the workforce, and that includes women entering medical school.

“Over the last 50 years, we’ve seen a big increase in the number of women who are professionals, who are physicians,” Dr. Espey said during the roundtable. “And during that same period of time, we’ve seen the growth of more focus on family planning.”

“I think that really would not be possible without the ability to control our fertility,” said Dr. Sarah W. Prager, associate professor of obstetrics and gynecology and director of the Ryan Family Planning Program at the University of Washington, Seattle.

And the widespread availability of contraception has translated into a decrease in maternal mortality as a result of fewer unintended pregnancies. “The implications for public health – for women and children in this country – is huge,” Dr. Prager said.

LARCs

One of the big shifts in contraceptive trends has been the slow but increasing uptake of long-acting reversible contraceptives (LARCs), such as IUDs and implants. After a drop-off in the 1970s following safety problems with the Dalkon Shield, there has been a resurgence in interest.

In the last decade, the rate of LARC use has grown from about 2% to 10%, corresponding to a slight drop in rates of unintended pregnancy, said Dr. Nikki B. Zite, professor and residency program director in the department of obstetrics and gynecology at the University of Tennessee, Knoxville.

The Contraceptive CHOICE Project, which enrolled more than 9,000 women who were provided with the no-cost reversible contraceptive method of their choice, found that about three-quarters of the women chose an IUD or an implant, which was associated with significant reductions in unintended and teen pregnancies.

“What we saw was that when we removed barriers to contraception in general, that uptake of IUDs and implants really went up,” said Dr. Tessa Madden, director of the division of family planning and associate professor in the department of obstetrics and gynecology at Washington University, St. Louis.

There is no “best” contraceptive method, Dr. Madden said. “Contraception really needs to be tailored to the individual woman [ensuring] that her values and preferences about contraception are taken into consideration during counseling, to help her choose the method that’s going to be the best fit for her.”

Resources

There are resources available to aid in tailoring contraception methods to the needs of patients.

U.S. Medical Eligibility Criteria for Contraceptive Use, guidance that is available through the Centers for Disease Control and Prevention, allows physicians to tailor the method to a patient’s comorbid medical conditions, Dr. Zite said. Physicians can search by contraceptive method or patient characteristic to determine the risk for a given patient, rated on a scale of 1-4 (where 1 or 2 means generally safe, 3 means that the risks may outweigh the benefits, and 4 means that the risks clearly outweigh the benefits).

“It’s a really easy starting-off point to use with patients and physicians when trying to decide what contraceptive method is safe for their patient,” Dr. Zite said.

Common medical comorbidities, including obesity, diabetes, thyroid disease, and hypertension, are all addressed in the medical eligibility criteria.

Another resource is the U.S. Selected Practice Recommendations for Contraceptive Use, which can help in deciding when it is appropriate to start a contraceptive method, what exams and tests are needed before initiation, what follow-up is needed, and how to handle problems such as missed pills or potential side effects.

Barriers

Over the years, many of the barriers to contraceptive access have been reduced. Some forms of emergency contraception are now available over the counter to women of all ages; more states are considering laws allowing women to access up to a year’s supply of hormonal contraceptives at one time; and a few states have passed laws allowing pharmacists to prescribe hormonal birth control directly. In addition, the Affordable Care Act’s mandate for insurers to cover approved methods of contraception without cost sharing has eliminated some cost barriers.

But other systems barriers still remain, such as making women return for multiple visits for the insertion of an IUD or implant, or limiting LARC use only to women who have already had a child. “There’s not a reason to avoid use of IUDs in women that have not had babies but there are still providers out there who will not insert an IUD, so we need to still do a better job to increase access even more,” Dr. Zite said.

Future trends

What new contraceptive options are in the pipeline? Dr. Prager predicted more development in the area of longer-acting injectables and implants, potentially even biodegradable implants. Also likely is the development of nonsurgical sterilization methods for women that eliminate some of the risk and cost barriers. And male contraceptive methods are in the works, both hormonal and nonhormonal, Dr. Prager said.

There’s an increasing interested in nonhormonal longer-acting methods, beyond just the copper IUD, Dr. Madden said, and there are new products on the horizon in that area. Researchers are exploring new methods to protect against HIV and other sexually transmitted infections, while offering contraception, Dr. Zite said.

Dr. Espey reported having no relevant financial disclosures. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Zite is an unpaid trainer for Nexplanon and serves on an international IUD advisory board for Bayer. Dr. Madden serves on a scientific advisory board for Bayer and on a data safety monitoring board for phase IV safety studies of Bayer contraceptive products.

Throughout 2016, Ob.Gyn. News is celebrating its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of infertility treatment, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

[email protected]

On Twitter @maryellenny

WASHINGTON – What has the increased access to contraception over the last 50 years meant for American women?

We asked Ob.Gyn. News editorial advisory board member Dr. Eve Espey, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, along with three experts in family planning, to explore how expanded contraception options have affected public health, what barriers still remain, and what new products are in the pipeline.

Perhaps the biggest impact for women has been the ability to participate in the workforce, and that includes women entering medical school.

“Over the last 50 years, we’ve seen a big increase in the number of women who are professionals, who are physicians,” Dr. Espey said during the roundtable. “And during that same period of time, we’ve seen the growth of more focus on family planning.”

“I think that really would not be possible without the ability to control our fertility,” said Dr. Sarah W. Prager, associate professor of obstetrics and gynecology and director of the Ryan Family Planning Program at the University of Washington, Seattle.

And the widespread availability of contraception has translated into a decrease in maternal mortality as a result of fewer unintended pregnancies. “The implications for public health – for women and children in this country – is huge,” Dr. Prager said.

LARCs

One of the big shifts in contraceptive trends has been the slow but increasing uptake of long-acting reversible contraceptives (LARCs), such as IUDs and implants. After a drop-off in the 1970s following safety problems with the Dalkon Shield, there has been a resurgence in interest.

In the last decade, the rate of LARC use has grown from about 2% to 10%, corresponding to a slight drop in rates of unintended pregnancy, said Dr. Nikki B. Zite, professor and residency program director in the department of obstetrics and gynecology at the University of Tennessee, Knoxville.

The Contraceptive CHOICE Project, which enrolled more than 9,000 women who were provided with the no-cost reversible contraceptive method of their choice, found that about three-quarters of the women chose an IUD or an implant, which was associated with significant reductions in unintended and teen pregnancies.

“What we saw was that when we removed barriers to contraception in general, that uptake of IUDs and implants really went up,” said Dr. Tessa Madden, director of the division of family planning and associate professor in the department of obstetrics and gynecology at Washington University, St. Louis.

There is no “best” contraceptive method, Dr. Madden said. “Contraception really needs to be tailored to the individual woman [ensuring] that her values and preferences about contraception are taken into consideration during counseling, to help her choose the method that’s going to be the best fit for her.”

Resources

There are resources available to aid in tailoring contraception methods to the needs of patients.

U.S. Medical Eligibility Criteria for Contraceptive Use, guidance that is available through the Centers for Disease Control and Prevention, allows physicians to tailor the method to a patient’s comorbid medical conditions, Dr. Zite said. Physicians can search by contraceptive method or patient characteristic to determine the risk for a given patient, rated on a scale of 1-4 (where 1 or 2 means generally safe, 3 means that the risks may outweigh the benefits, and 4 means that the risks clearly outweigh the benefits).

“It’s a really easy starting-off point to use with patients and physicians when trying to decide what contraceptive method is safe for their patient,” Dr. Zite said.

Common medical comorbidities, including obesity, diabetes, thyroid disease, and hypertension, are all addressed in the medical eligibility criteria.

Another resource is the U.S. Selected Practice Recommendations for Contraceptive Use, which can help in deciding when it is appropriate to start a contraceptive method, what exams and tests are needed before initiation, what follow-up is needed, and how to handle problems such as missed pills or potential side effects.

Barriers

Over the years, many of the barriers to contraceptive access have been reduced. Some forms of emergency contraception are now available over the counter to women of all ages; more states are considering laws allowing women to access up to a year’s supply of hormonal contraceptives at one time; and a few states have passed laws allowing pharmacists to prescribe hormonal birth control directly. In addition, the Affordable Care Act’s mandate for insurers to cover approved methods of contraception without cost sharing has eliminated some cost barriers.

But other systems barriers still remain, such as making women return for multiple visits for the insertion of an IUD or implant, or limiting LARC use only to women who have already had a child. “There’s not a reason to avoid use of IUDs in women that have not had babies but there are still providers out there who will not insert an IUD, so we need to still do a better job to increase access even more,” Dr. Zite said.

Future trends

What new contraceptive options are in the pipeline? Dr. Prager predicted more development in the area of longer-acting injectables and implants, potentially even biodegradable implants. Also likely is the development of nonsurgical sterilization methods for women that eliminate some of the risk and cost barriers. And male contraceptive methods are in the works, both hormonal and nonhormonal, Dr. Prager said.

There’s an increasing interested in nonhormonal longer-acting methods, beyond just the copper IUD, Dr. Madden said, and there are new products on the horizon in that area. Researchers are exploring new methods to protect against HIV and other sexually transmitted infections, while offering contraception, Dr. Zite said.

Dr. Espey reported having no relevant financial disclosures. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Zite is an unpaid trainer for Nexplanon and serves on an international IUD advisory board for Bayer. Dr. Madden serves on a scientific advisory board for Bayer and on a data safety monitoring board for phase IV safety studies of Bayer contraceptive products.

Throughout 2016, Ob.Gyn. News is celebrating its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of infertility treatment, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.

[email protected]

On Twitter @maryellenny

NEWPORT BEACH, CALIF. – If you inject fillers, Manhattan plastic surgeon Lawrence Bass, MD, recommends that you keep hyaluronidase handy.

It’s the go-to for intravascular injections and helpful for nodules and granulomas, the main filler worries, but some offices don’t stock it. “Complications are rare, but they can be devastating. You have to be prepared.”

Massage, aspiration, transdermal nitroglycerin, and other options might help when, for example, a patient’s lip turns purple after a nasolabial fold injection, but “really, it’s all about hyaluronidase,” whether the filler is hyaluronic acid or not. The enzyme digests hyaluronic acid – both the injected kind and what patients have naturally – and loosens and disperses other fillers.

A patient who says that the injection hurt more than usual is an indication that the vessel may have been injected, Dr. Bass said. In such cases, “you have to deal with it immediately,” and repeat dosing if skin color doesn’t improve within an hour, he noted. “If you manage patients correctly, you can usually settle it with little or no deformity.”

There are two hyaluronidase options in the United States: Vitrase, an ovine formulation, and Hylenex, a recombinant human formulation. It probably doesn’t matter which one is used, he said. Soft tissue vascular compromise generally requires 200 units, and retinal artery occlusion, 500 units or more. Restylane is the easiest filler to digest because it’s the least cross-linked; Juvederm is more difficult; and Belotero is the most difficult, Dr. Bass noted.

Nodules and granulomas from filler injections have a slower onset than vascular compromise. Infected nodules can appear months after injection, and granulomas – red or purplish hypersensitivity reactions with indistinct borders, often with all injection sites involved at once – can appear years afterwards, set off by the flu or some other inflammatory trigger, according to Miles Graivier, MD, a plastic surgeon in Roswell, Ga., who shared the podium with Dr. Bass at the meeting.

Dr. Graivier described his approach to granulomas as “very aggressive.” Patients with granulomas receive oral steroids plus intralesional triamcinolone/fluorouracil/lidocaine injections every 2 weeks or more frequently. Hyaluronidase is used to disperse the filler. Resistant patients also get oral allopurinol. Laser liquefaction can help with both granulomas and infected nodules, he added.

Retinal artery occlusion is probably the most feared filler complication. It’s most likely with glabellar or periorbital injections but possible with any facial injection. “It’s a real horror show when it happens. The bottom line is you must restore circulation within 60-90 minutes” with retrobulbar hyaluronidase injections “or patients will lose vision permanently,” Dr. Bass said. People might not feel comfortable with retrobulbar injections, “but when the alternative is blindness, maybe you want to give them a try,” he added.

A 25 gauge, 1.5 inch needle is introduced to the lateral limbus at the orbital rim. “You pass the needle along the orbital floor to the equator of the globe,” – about 13-14 mm – “angle it up to enter the muscular conus, and inject 500 units or more.” Injecting at the orbital floor is less risky, but probably less effective, he said.

Hard nodules, meanwhile, present early after injection and are usually a result of too much filler or poor technique, Dr. Graivier said. For hard nodules, “hyaluronidase is the number one treatment,” although cracking, massage, and saline injection might help.

Infected nodules look like abscesses, but usually grow nothing on culture. Hyaluronidase is also first line for infected nodules, along with drainage and broad spectrum oral antibiotics for at least 6 weeks, and, if they don’t work, intravenous antibiotics, he added.

Dr. Bass is an investigator and speaker for Cynosure; an investigator for Endo Pharmaceuticals and Neothetics, and an advisor to Merz. Dr. Graivier is an advisor for Merz, and an investigator for Merz, Galderma, Evolus, Ideal Implants, Exilis, and Cynosure. The Graivier Center for Plastic Surgery is a training center for Cynosure.

The Summit in Aesthetic Medicine is held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

[email protected]

NEWPORT BEACH, CALIF. – If you inject fillers, Manhattan plastic surgeon Lawrence Bass, MD, recommends that you keep hyaluronidase handy.

It’s the go-to for intravascular injections and helpful for nodules and granulomas, the main filler worries, but some offices don’t stock it. “Complications are rare, but they can be devastating. You have to be prepared.”

Massage, aspiration, transdermal nitroglycerin, and other options might help when, for example, a patient’s lip turns purple after a nasolabial fold injection, but “really, it’s all about hyaluronidase,” whether the filler is hyaluronic acid or not. The enzyme digests hyaluronic acid – both the injected kind and what patients have naturally – and loosens and disperses other fillers.

A patient who says that the injection hurt more than usual is an indication that the vessel may have been injected, Dr. Bass said. In such cases, “you have to deal with it immediately,” and repeat dosing if skin color doesn’t improve within an hour, he noted. “If you manage patients correctly, you can usually settle it with little or no deformity.”

There are two hyaluronidase options in the United States: Vitrase, an ovine formulation, and Hylenex, a recombinant human formulation. It probably doesn’t matter which one is used, he said. Soft tissue vascular compromise generally requires 200 units, and retinal artery occlusion, 500 units or more. Restylane is the easiest filler to digest because it’s the least cross-linked; Juvederm is more difficult; and Belotero is the most difficult, Dr. Bass noted.

Nodules and granulomas from filler injections have a slower onset than vascular compromise. Infected nodules can appear months after injection, and granulomas – red or purplish hypersensitivity reactions with indistinct borders, often with all injection sites involved at once – can appear years afterwards, set off by the flu or some other inflammatory trigger, according to Miles Graivier, MD, a plastic surgeon in Roswell, Ga., who shared the podium with Dr. Bass at the meeting.

Dr. Graivier described his approach to granulomas as “very aggressive.” Patients with granulomas receive oral steroids plus intralesional triamcinolone/fluorouracil/lidocaine injections every 2 weeks or more frequently. Hyaluronidase is used to disperse the filler. Resistant patients also get oral allopurinol. Laser liquefaction can help with both granulomas and infected nodules, he added.

Retinal artery occlusion is probably the most feared filler complication. It’s most likely with glabellar or periorbital injections but possible with any facial injection. “It’s a real horror show when it happens. The bottom line is you must restore circulation within 60-90 minutes” with retrobulbar hyaluronidase injections “or patients will lose vision permanently,” Dr. Bass said. People might not feel comfortable with retrobulbar injections, “but when the alternative is blindness, maybe you want to give them a try,” he added.

A 25 gauge, 1.5 inch needle is introduced to the lateral limbus at the orbital rim. “You pass the needle along the orbital floor to the equator of the globe,” – about 13-14 mm – “angle it up to enter the muscular conus, and inject 500 units or more.” Injecting at the orbital floor is less risky, but probably less effective, he said.

Hard nodules, meanwhile, present early after injection and are usually a result of too much filler or poor technique, Dr. Graivier said. For hard nodules, “hyaluronidase is the number one treatment,” although cracking, massage, and saline injection might help.

Infected nodules look like abscesses, but usually grow nothing on culture. Hyaluronidase is also first line for infected nodules, along with drainage and broad spectrum oral antibiotics for at least 6 weeks, and, if they don’t work, intravenous antibiotics, he added.

Dr. Bass is an investigator and speaker for Cynosure; an investigator for Endo Pharmaceuticals and Neothetics, and an advisor to Merz. Dr. Graivier is an advisor for Merz, and an investigator for Merz, Galderma, Evolus, Ideal Implants, Exilis, and Cynosure. The Graivier Center for Plastic Surgery is a training center for Cynosure.

The Summit in Aesthetic Medicine is held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

[email protected]

NEWPORT BEACH, CALIF. – If you inject fillers, Manhattan plastic surgeon Lawrence Bass, MD, recommends that you keep hyaluronidase handy.

It’s the go-to for intravascular injections and helpful for nodules and granulomas, the main filler worries, but some offices don’t stock it. “Complications are rare, but they can be devastating. You have to be prepared.”

Massage, aspiration, transdermal nitroglycerin, and other options might help when, for example, a patient’s lip turns purple after a nasolabial fold injection, but “really, it’s all about hyaluronidase,” whether the filler is hyaluronic acid or not. The enzyme digests hyaluronic acid – both the injected kind and what patients have naturally – and loosens and disperses other fillers.

A patient who says that the injection hurt more than usual is an indication that the vessel may have been injected, Dr. Bass said. In such cases, “you have to deal with it immediately,” and repeat dosing if skin color doesn’t improve within an hour, he noted. “If you manage patients correctly, you can usually settle it with little or no deformity.”

There are two hyaluronidase options in the United States: Vitrase, an ovine formulation, and Hylenex, a recombinant human formulation. It probably doesn’t matter which one is used, he said. Soft tissue vascular compromise generally requires 200 units, and retinal artery occlusion, 500 units or more. Restylane is the easiest filler to digest because it’s the least cross-linked; Juvederm is more difficult; and Belotero is the most difficult, Dr. Bass noted.

Nodules and granulomas from filler injections have a slower onset than vascular compromise. Infected nodules can appear months after injection, and granulomas – red or purplish hypersensitivity reactions with indistinct borders, often with all injection sites involved at once – can appear years afterwards, set off by the flu or some other inflammatory trigger, according to Miles Graivier, MD, a plastic surgeon in Roswell, Ga., who shared the podium with Dr. Bass at the meeting.

Dr. Graivier described his approach to granulomas as “very aggressive.” Patients with granulomas receive oral steroids plus intralesional triamcinolone/fluorouracil/lidocaine injections every 2 weeks or more frequently. Hyaluronidase is used to disperse the filler. Resistant patients also get oral allopurinol. Laser liquefaction can help with both granulomas and infected nodules, he added.

Retinal artery occlusion is probably the most feared filler complication. It’s most likely with glabellar or periorbital injections but possible with any facial injection. “It’s a real horror show when it happens. The bottom line is you must restore circulation within 60-90 minutes” with retrobulbar hyaluronidase injections “or patients will lose vision permanently,” Dr. Bass said. People might not feel comfortable with retrobulbar injections, “but when the alternative is blindness, maybe you want to give them a try,” he added.

A 25 gauge, 1.5 inch needle is introduced to the lateral limbus at the orbital rim. “You pass the needle along the orbital floor to the equator of the globe,” – about 13-14 mm – “angle it up to enter the muscular conus, and inject 500 units or more.” Injecting at the orbital floor is less risky, but probably less effective, he said.

Hard nodules, meanwhile, present early after injection and are usually a result of too much filler or poor technique, Dr. Graivier said. For hard nodules, “hyaluronidase is the number one treatment,” although cracking, massage, and saline injection might help.

Infected nodules look like abscesses, but usually grow nothing on culture. Hyaluronidase is also first line for infected nodules, along with drainage and broad spectrum oral antibiotics for at least 6 weeks, and, if they don’t work, intravenous antibiotics, he added.

Dr. Bass is an investigator and speaker for Cynosure; an investigator for Endo Pharmaceuticals and Neothetics, and an advisor to Merz. Dr. Graivier is an advisor for Merz, and an investigator for Merz, Galderma, Evolus, Ideal Implants, Exilis, and Cynosure. The Graivier Center for Plastic Surgery is a training center for Cynosure.

The Summit in Aesthetic Medicine is held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

[email protected]

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Identification of a case of acute hepatitis C virus (HCV) infection in a frequent blood donor without other risk factors should be considered a sentinel event and should prompt public health investigation, according to research published in Morbidity and Mortality Weekly Report, because this could indicate a possible health care–associated infection.

©vchal/Thinkstock

Negative media reports about the safety of the hepatitis B vaccine in China harmed perception of the vaccine’s safety among patients, according to a recent study. Although the reports were erroneous, the failure of public health departments to communicate effectively contributed to a rise in the number of parents refusing to vaccinate their children.

An experimental, highly specific and sensitive HCV core antigen enzyme immunoassay (HCV-Ags EIA) was found to have the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL. Investigators found that the HCV-Ags EIA reliably differentiated viremic HCV infection from resolved HCV infection, thus accomplishing screening and diagnosis of viremic HCV infection in one step.

Loss of confidence in the hepatitis B vaccine following disproved allegations that the vaccine caused multiple sclerosis persists in France, according to research published in Human Vaccines & Immunotherapeutics.

The approval of the direct-acting antiviral agents (DAAs) grazoprevir and elbasvir with an indication for all levels of kidney function and dialysis has altered the landscape for the treatment of hepatitis C virus in patients with chronic kidney disease, according to a review in Clinical Liver Disease. The authors say this is because other DAAs are either not approved for use in patients with advanced chronic kidney disease or no safety data are available for the dialysis population.

A study in the Journal of Viral Hepatitis found that insulin resistance was associated with an increased risk for loss of vaccine-acquired anti-HBs (hepatitis B surface antigen) in a large sample of a nondiabetic, general population, indicating a possible role of insulin resistance in vaccine-induced immunity.

Grazoprevir, a second-generation HCV NS3/4A protease inhibitor, combined with ribavirin was associated with a rapid and sustained suppression of HCV RNA in a randomized study. The authors said the results support further evaluation of grazoprevir-based treatment regimens.

HIV–HCV coinfected patients treated with a fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) showed significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation, according to a study in the Journal of Viral Hepatitis.

A Swedish study found that diabetes mellitus and cirrhosis are strong risk factors for hepatocellular carcinoma development after sustained virologic response (SVR) following treatment for chronic HCV has been achieved. However, the risk to develop hepatocellular carcinoma diminished significantly 2 years after SVR.

Chinese investigators said serum levels of platelet-derived growth factor (PDGF) decreased remarkably through fibrosis progression and could be used as a noninvasive biomarker for the assessment of fibrosis stage in patients with chronic hepatitis B virus (HBV).

A genome-wide association study of liver fibrosis progression in patients coinfected with HCV and HIV identified a new locus associated with fibrosis severity on chromosome 3p25. The authors said the results may help define new targets for drug development or new prognostic tests.

The RNA helicase DDX5 and E3 ligase Mex3b are important cellular targets for the design of novel, epigenetic therapies to combat HBV infection and poor-prognosis HBV-associated liver cancer, according to a study in Hepatology.

A Japanese study found that daclatasvir (DCV) and asunaprevir (ASV) dual therapy in hemodialysis patients infected with HCV is effective and safe with similar results, compared with patients with normal renal function.

A study evaluating the antiviral effect of ribavirin priming, and its influence on sustained virologic response after combination treatment, found that the lowest response pattern in HCV-infected patients was observed in prior nonresponder patients to pegylated interferon-alfa plus ribavirin combination therapy. The authors said this suggests that not only the individual interferon, but also the ribavirin sensitivity contributes significantly to the nonresponsive state.

A veterinary study provided evidence that hepatitis E virus is able to damage the blood-brain barrier and replicate in the brain and spinal cord.

An all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV genotype 4 subtypes in both treatment-naive and -experienced patients, including those with compensated cirrhosis, according to results of a recent study.

AGA Resource
Through the Hepatitis C Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for your patients.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Identification of a case of acute hepatitis C virus (HCV) infection in a frequent blood donor without other risk factors should be considered a sentinel event and should prompt public health investigation, according to research published in Morbidity and Mortality Weekly Report, because this could indicate a possible health care–associated infection.

©vchal/Thinkstock

Negative media reports about the safety of the hepatitis B vaccine in China harmed perception of the vaccine’s safety among patients, according to a recent study. Although the reports were erroneous, the failure of public health departments to communicate effectively contributed to a rise in the number of parents refusing to vaccinate their children.

An experimental, highly specific and sensitive HCV core antigen enzyme immunoassay (HCV-Ags EIA) was found to have the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL. Investigators found that the HCV-Ags EIA reliably differentiated viremic HCV infection from resolved HCV infection, thus accomplishing screening and diagnosis of viremic HCV infection in one step.

Loss of confidence in the hepatitis B vaccine following disproved allegations that the vaccine caused multiple sclerosis persists in France, according to research published in Human Vaccines & Immunotherapeutics.

The approval of the direct-acting antiviral agents (DAAs) grazoprevir and elbasvir with an indication for all levels of kidney function and dialysis has altered the landscape for the treatment of hepatitis C virus in patients with chronic kidney disease, according to a review in Clinical Liver Disease. The authors say this is because other DAAs are either not approved for use in patients with advanced chronic kidney disease or no safety data are available for the dialysis population.

A study in the Journal of Viral Hepatitis found that insulin resistance was associated with an increased risk for loss of vaccine-acquired anti-HBs (hepatitis B surface antigen) in a large sample of a nondiabetic, general population, indicating a possible role of insulin resistance in vaccine-induced immunity.

Grazoprevir, a second-generation HCV NS3/4A protease inhibitor, combined with ribavirin was associated with a rapid and sustained suppression of HCV RNA in a randomized study. The authors said the results support further evaluation of grazoprevir-based treatment regimens.

HIV–HCV coinfected patients treated with a fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) showed significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation, according to a study in the Journal of Viral Hepatitis.

A Swedish study found that diabetes mellitus and cirrhosis are strong risk factors for hepatocellular carcinoma development after sustained virologic response (SVR) following treatment for chronic HCV has been achieved. However, the risk to develop hepatocellular carcinoma diminished significantly 2 years after SVR.

Chinese investigators said serum levels of platelet-derived growth factor (PDGF) decreased remarkably through fibrosis progression and could be used as a noninvasive biomarker for the assessment of fibrosis stage in patients with chronic hepatitis B virus (HBV).

A genome-wide association study of liver fibrosis progression in patients coinfected with HCV and HIV identified a new locus associated with fibrosis severity on chromosome 3p25. The authors said the results may help define new targets for drug development or new prognostic tests.

The RNA helicase DDX5 and E3 ligase Mex3b are important cellular targets for the design of novel, epigenetic therapies to combat HBV infection and poor-prognosis HBV-associated liver cancer, according to a study in Hepatology.

A Japanese study found that daclatasvir (DCV) and asunaprevir (ASV) dual therapy in hemodialysis patients infected with HCV is effective and safe with similar results, compared with patients with normal renal function.

A study evaluating the antiviral effect of ribavirin priming, and its influence on sustained virologic response after combination treatment, found that the lowest response pattern in HCV-infected patients was observed in prior nonresponder patients to pegylated interferon-alfa plus ribavirin combination therapy. The authors said this suggests that not only the individual interferon, but also the ribavirin sensitivity contributes significantly to the nonresponsive state.

A veterinary study provided evidence that hepatitis E virus is able to damage the blood-brain barrier and replicate in the brain and spinal cord.

An all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV genotype 4 subtypes in both treatment-naive and -experienced patients, including those with compensated cirrhosis, according to results of a recent study.

AGA Resource
Through the Hepatitis C Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for your patients.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Identification of a case of acute hepatitis C virus (HCV) infection in a frequent blood donor without other risk factors should be considered a sentinel event and should prompt public health investigation, according to research published in Morbidity and Mortality Weekly Report, because this could indicate a possible health care–associated infection.

©vchal/Thinkstock

Negative media reports about the safety of the hepatitis B vaccine in China harmed perception of the vaccine’s safety among patients, according to a recent study. Although the reports were erroneous, the failure of public health departments to communicate effectively contributed to a rise in the number of parents refusing to vaccinate their children.

An experimental, highly specific and sensitive HCV core antigen enzyme immunoassay (HCV-Ags EIA) was found to have the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL. Investigators found that the HCV-Ags EIA reliably differentiated viremic HCV infection from resolved HCV infection, thus accomplishing screening and diagnosis of viremic HCV infection in one step.

Loss of confidence in the hepatitis B vaccine following disproved allegations that the vaccine caused multiple sclerosis persists in France, according to research published in Human Vaccines & Immunotherapeutics.

The approval of the direct-acting antiviral agents (DAAs) grazoprevir and elbasvir with an indication for all levels of kidney function and dialysis has altered the landscape for the treatment of hepatitis C virus in patients with chronic kidney disease, according to a review in Clinical Liver Disease. The authors say this is because other DAAs are either not approved for use in patients with advanced chronic kidney disease or no safety data are available for the dialysis population.

A study in the Journal of Viral Hepatitis found that insulin resistance was associated with an increased risk for loss of vaccine-acquired anti-HBs (hepatitis B surface antigen) in a large sample of a nondiabetic, general population, indicating a possible role of insulin resistance in vaccine-induced immunity.

Grazoprevir, a second-generation HCV NS3/4A protease inhibitor, combined with ribavirin was associated with a rapid and sustained suppression of HCV RNA in a randomized study. The authors said the results support further evaluation of grazoprevir-based treatment regimens.

HIV–HCV coinfected patients treated with a fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) showed significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation, according to a study in the Journal of Viral Hepatitis.

A Swedish study found that diabetes mellitus and cirrhosis are strong risk factors for hepatocellular carcinoma development after sustained virologic response (SVR) following treatment for chronic HCV has been achieved. However, the risk to develop hepatocellular carcinoma diminished significantly 2 years after SVR.

Chinese investigators said serum levels of platelet-derived growth factor (PDGF) decreased remarkably through fibrosis progression and could be used as a noninvasive biomarker for the assessment of fibrosis stage in patients with chronic hepatitis B virus (HBV).

A genome-wide association study of liver fibrosis progression in patients coinfected with HCV and HIV identified a new locus associated with fibrosis severity on chromosome 3p25. The authors said the results may help define new targets for drug development or new prognostic tests.

The RNA helicase DDX5 and E3 ligase Mex3b are important cellular targets for the design of novel, epigenetic therapies to combat HBV infection and poor-prognosis HBV-associated liver cancer, according to a study in Hepatology.

A Japanese study found that daclatasvir (DCV) and asunaprevir (ASV) dual therapy in hemodialysis patients infected with HCV is effective and safe with similar results, compared with patients with normal renal function.

A study evaluating the antiviral effect of ribavirin priming, and its influence on sustained virologic response after combination treatment, found that the lowest response pattern in HCV-infected patients was observed in prior nonresponder patients to pegylated interferon-alfa plus ribavirin combination therapy. The authors said this suggests that not only the individual interferon, but also the ribavirin sensitivity contributes significantly to the nonresponsive state.

A veterinary study provided evidence that hepatitis E virus is able to damage the blood-brain barrier and replicate in the brain and spinal cord.

An all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV genotype 4 subtypes in both treatment-naive and -experienced patients, including those with compensated cirrhosis, according to results of a recent study.

AGA Resource
Through the Hepatitis C Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for your patients.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Identification of a case of acute hepatitis C virus (HCV) infection in a frequent blood donor without other risk factors should be considered a sentinel event and should prompt public health investigation, according to research published in Morbidity and Mortality Weekly Report, because this could indicate a possible health care–associated infection.

©vchal/Thinkstock

Negative media reports about the safety of the hepatitis B vaccine in China harmed perception of the vaccine’s safety among patients, according to a recent study. Although the reports were erroneous, the failure of public health departments to communicate effectively contributed to a rise in the number of parents refusing to vaccinate their children.

An experimental, highly specific and sensitive HCV core antigen enzyme immunoassay (HCV-Ags EIA) was found to have the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL. Investigators found that the HCV-Ags EIA reliably differentiated viremic HCV infection from resolved HCV infection, thus accomplishing screening and diagnosis of viremic HCV infection in one step.

Loss of confidence in the hepatitis B vaccine following disproved allegations that the vaccine caused multiple sclerosis persists in France, according to research published in Human Vaccines & Immunotherapeutics.

The approval of the direct-acting antiviral agents (DAAs) grazoprevir and elbasvir with an indication for all levels of kidney function and dialysis has altered the landscape for the treatment of hepatitis C virus in patients with chronic kidney disease, according to a review in Clinical Liver Disease. The authors say this is because other DAAs are either not approved for use in patients with advanced chronic kidney disease or no safety data are available for the dialysis population.

A study in the Journal of Viral Hepatitis found that insulin resistance was associated with an increased risk for loss of vaccine-acquired anti-HBs (hepatitis B surface antigen) in a large sample of a nondiabetic, general population, indicating a possible role of insulin resistance in vaccine-induced immunity.

Grazoprevir, a second-generation HCV NS3/4A protease inhibitor, combined with ribavirin was associated with a rapid and sustained suppression of HCV RNA in a randomized study. The authors said the results support further evaluation of grazoprevir-based treatment regimens.

HIV–HCV coinfected patients treated with a fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) showed significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation, according to a study in the Journal of Viral Hepatitis.

A Swedish study found that diabetes mellitus and cirrhosis are strong risk factors for hepatocellular carcinoma development after sustained virologic response (SVR) following treatment for chronic HCV has been achieved. However, the risk to develop hepatocellular carcinoma diminished significantly 2 years after SVR.

Chinese investigators said serum levels of platelet-derived growth factor (PDGF) decreased remarkably through fibrosis progression and could be used as a noninvasive biomarker for the assessment of fibrosis stage in patients with chronic hepatitis B virus (HBV).

A genome-wide association study of liver fibrosis progression in patients coinfected with HCV and HIV identified a new locus associated with fibrosis severity on chromosome 3p25. The authors said the results may help define new targets for drug development or new prognostic tests.

The RNA helicase DDX5 and E3 ligase Mex3b are important cellular targets for the design of novel, epigenetic therapies to combat HBV infection and poor-prognosis HBV-associated liver cancer, according to a study in Hepatology.

A Japanese study found that daclatasvir (DCV) and asunaprevir (ASV) dual therapy in hemodialysis patients infected with HCV is effective and safe with similar results, compared with patients with normal renal function.

A study evaluating the antiviral effect of ribavirin priming, and its influence on sustained virologic response after combination treatment, found that the lowest response pattern in HCV-infected patients was observed in prior nonresponder patients to pegylated interferon-alfa plus ribavirin combination therapy. The authors said this suggests that not only the individual interferon, but also the ribavirin sensitivity contributes significantly to the nonresponsive state.

A veterinary study provided evidence that hepatitis E virus is able to damage the blood-brain barrier and replicate in the brain and spinal cord.

An all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV genotype 4 subtypes in both treatment-naive and -experienced patients, including those with compensated cirrhosis, according to results of a recent study.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Identification of a case of acute hepatitis C virus (HCV) infection in a frequent blood donor without other risk factors should be considered a sentinel event and should prompt public health investigation, according to research published in Morbidity and Mortality Weekly Report, because this could indicate a possible health care–associated infection.

©vchal/Thinkstock

Negative media reports about the safety of the hepatitis B vaccine in China harmed perception of the vaccine’s safety among patients, according to a recent study. Although the reports were erroneous, the failure of public health departments to communicate effectively contributed to a rise in the number of parents refusing to vaccinate their children.

An experimental, highly specific and sensitive HCV core antigen enzyme immunoassay (HCV-Ags EIA) was found to have the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL. Investigators found that the HCV-Ags EIA reliably differentiated viremic HCV infection from resolved HCV infection, thus accomplishing screening and diagnosis of viremic HCV infection in one step.

Loss of confidence in the hepatitis B vaccine following disproved allegations that the vaccine caused multiple sclerosis persists in France, according to research published in Human Vaccines & Immunotherapeutics.

The approval of the direct-acting antiviral agents (DAAs) grazoprevir and elbasvir with an indication for all levels of kidney function and dialysis has altered the landscape for the treatment of hepatitis C virus in patients with chronic kidney disease, according to a review in Clinical Liver Disease. The authors say this is because other DAAs are either not approved for use in patients with advanced chronic kidney disease or no safety data are available for the dialysis population.

A study in the Journal of Viral Hepatitis found that insulin resistance was associated with an increased risk for loss of vaccine-acquired anti-HBs (hepatitis B surface antigen) in a large sample of a nondiabetic, general population, indicating a possible role of insulin resistance in vaccine-induced immunity.

Grazoprevir, a second-generation HCV NS3/4A protease inhibitor, combined with ribavirin was associated with a rapid and sustained suppression of HCV RNA in a randomized study. The authors said the results support further evaluation of grazoprevir-based treatment regimens.

HIV–HCV coinfected patients treated with a fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) showed significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation, according to a study in the Journal of Viral Hepatitis.

A Swedish study found that diabetes mellitus and cirrhosis are strong risk factors for hepatocellular carcinoma development after sustained virologic response (SVR) following treatment for chronic HCV has been achieved. However, the risk to develop hepatocellular carcinoma diminished significantly 2 years after SVR.

Chinese investigators said serum levels of platelet-derived growth factor (PDGF) decreased remarkably through fibrosis progression and could be used as a noninvasive biomarker for the assessment of fibrosis stage in patients with chronic hepatitis B virus (HBV).

A genome-wide association study of liver fibrosis progression in patients coinfected with HCV and HIV identified a new locus associated with fibrosis severity on chromosome 3p25. The authors said the results may help define new targets for drug development or new prognostic tests.

The RNA helicase DDX5 and E3 ligase Mex3b are important cellular targets for the design of novel, epigenetic therapies to combat HBV infection and poor-prognosis HBV-associated liver cancer, according to a study in Hepatology.

A Japanese study found that daclatasvir (DCV) and asunaprevir (ASV) dual therapy in hemodialysis patients infected with HCV is effective and safe with similar results, compared with patients with normal renal function.

A study evaluating the antiviral effect of ribavirin priming, and its influence on sustained virologic response after combination treatment, found that the lowest response pattern in HCV-infected patients was observed in prior nonresponder patients to pegylated interferon-alfa plus ribavirin combination therapy. The authors said this suggests that not only the individual interferon, but also the ribavirin sensitivity contributes significantly to the nonresponsive state.

A veterinary study provided evidence that hepatitis E virus is able to damage the blood-brain barrier and replicate in the brain and spinal cord.

An all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV genotype 4 subtypes in both treatment-naive and -experienced patients, including those with compensated cirrhosis, according to results of a recent study.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

Identification of a case of acute hepatitis C virus (HCV) infection in a frequent blood donor without other risk factors should be considered a sentinel event and should prompt public health investigation, according to research published in Morbidity and Mortality Weekly Report, because this could indicate a possible health care–associated infection.

©vchal/Thinkstock

Negative media reports about the safety of the hepatitis B vaccine in China harmed perception of the vaccine’s safety among patients, according to a recent study. Although the reports were erroneous, the failure of public health departments to communicate effectively contributed to a rise in the number of parents refusing to vaccinate their children.

An experimental, highly specific and sensitive HCV core antigen enzyme immunoassay (HCV-Ags EIA) was found to have the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL. Investigators found that the HCV-Ags EIA reliably differentiated viremic HCV infection from resolved HCV infection, thus accomplishing screening and diagnosis of viremic HCV infection in one step.

Loss of confidence in the hepatitis B vaccine following disproved allegations that the vaccine caused multiple sclerosis persists in France, according to research published in Human Vaccines & Immunotherapeutics.

The approval of the direct-acting antiviral agents (DAAs) grazoprevir and elbasvir with an indication for all levels of kidney function and dialysis has altered the landscape for the treatment of hepatitis C virus in patients with chronic kidney disease, according to a review in Clinical Liver Disease. The authors say this is because other DAAs are either not approved for use in patients with advanced chronic kidney disease or no safety data are available for the dialysis population.

A study in the Journal of Viral Hepatitis found that insulin resistance was associated with an increased risk for loss of vaccine-acquired anti-HBs (hepatitis B surface antigen) in a large sample of a nondiabetic, general population, indicating a possible role of insulin resistance in vaccine-induced immunity.

Grazoprevir, a second-generation HCV NS3/4A protease inhibitor, combined with ribavirin was associated with a rapid and sustained suppression of HCV RNA in a randomized study. The authors said the results support further evaluation of grazoprevir-based treatment regimens.

HIV–HCV coinfected patients treated with a fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) showed significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation, according to a study in the Journal of Viral Hepatitis.

A Swedish study found that diabetes mellitus and cirrhosis are strong risk factors for hepatocellular carcinoma development after sustained virologic response (SVR) following treatment for chronic HCV has been achieved. However, the risk to develop hepatocellular carcinoma diminished significantly 2 years after SVR.

Chinese investigators said serum levels of platelet-derived growth factor (PDGF) decreased remarkably through fibrosis progression and could be used as a noninvasive biomarker for the assessment of fibrosis stage in patients with chronic hepatitis B virus (HBV).

A genome-wide association study of liver fibrosis progression in patients coinfected with HCV and HIV identified a new locus associated with fibrosis severity on chromosome 3p25. The authors said the results may help define new targets for drug development or new prognostic tests.

The RNA helicase DDX5 and E3 ligase Mex3b are important cellular targets for the design of novel, epigenetic therapies to combat HBV infection and poor-prognosis HBV-associated liver cancer, according to a study in Hepatology.

A Japanese study found that daclatasvir (DCV) and asunaprevir (ASV) dual therapy in hemodialysis patients infected with HCV is effective and safe with similar results, compared with patients with normal renal function.

A study evaluating the antiviral effect of ribavirin priming, and its influence on sustained virologic response after combination treatment, found that the lowest response pattern in HCV-infected patients was observed in prior nonresponder patients to pegylated interferon-alfa plus ribavirin combination therapy. The authors said this suggests that not only the individual interferon, but also the ribavirin sensitivity contributes significantly to the nonresponsive state.

A veterinary study provided evidence that hepatitis E virus is able to damage the blood-brain barrier and replicate in the brain and spinal cord.

An all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV genotype 4 subtypes in both treatment-naive and -experienced patients, including those with compensated cirrhosis, according to results of a recent study.

[email protected]

On Twitter @richpizzi

The RADEO toolkit also provides strategies for facilitating policy formation, evaluating current processes, tracking progress against implementation goals, and identifying best practices. Although the RADEO toolkit is designed for the inpatient setting, it also discusses care transitions for patients on opioid therapy to the outpatient setting.

Download the toolkit today at www.hospitalmedicine.org/RADEO. Check out all available quality improvement and patient safety toolkits at www.hospitalmedicine.org/qi.

The RADEO toolkit also provides strategies for facilitating policy formation, evaluating current processes, tracking progress against implementation goals, and identifying best practices. Although the RADEO toolkit is designed for the inpatient setting, it also discusses care transitions for patients on opioid therapy to the outpatient setting.

Download the toolkit today at www.hospitalmedicine.org/RADEO. Check out all available quality improvement and patient safety toolkits at www.hospitalmedicine.org/qi.

The RADEO toolkit also provides strategies for facilitating policy formation, evaluating current processes, tracking progress against implementation goals, and identifying best practices. Although the RADEO toolkit is designed for the inpatient setting, it also discusses care transitions for patients on opioid therapy to the outpatient setting.

Download the toolkit today at www.hospitalmedicine.org/RADEO. Check out all available quality improvement and patient safety toolkits at www.hospitalmedicine.org/qi.

The Commission on Care has issued its final report, which called for the expansion of community care for all veterans through the creation of integrated community-based health care networks similar to TRICARE, expansion of eligibility for veterans, and the creation of a facility and capital asset realignment process based on the DoD Base Realignment and Closure Commission among its 18 recommendations.

Mandated by the Veterans Access, Choice and Accountability Act in the wake of the wait time, the 15-member Commission on Care was charged with providing recommendations for reforming veterans’ health care to President Obama. The commission’s recommendations carry considerable weight. The Choice Act mandated that the VA and other federal agencies “implement each recommendation that the President considers feasible, advisable, and able to implement without further legislation.”

The commission’s first recommendation was to scrap the Choice Program and establish the VHA Care System, a system of “integrated veteran-centric, community-based delivery networks that will optimize the balance of access, quality, and cost-effectiveness.” Local VHA leadership would develop the VHA Care System  and base it on “local needs and veterans’ preferences.” The VHA would be mandated to furnish credentials to community providers, with the highest priority access given to service-connected veterans. The time and distance criteria used by the Choice Program would be eliminated, and veterans would be able to choose any primary care provider from within the system.

The Commission offered 4 possible models for implementing the VHA Care System. In the recommended option (an integrated network of VHA, DoD, other federally funded providers, and community providers, which requires a referral to access specialty care), the commission predicts as many as 60% of veterans would shift to community care for primary care needs, though far fewer would seek referrals in the community. The commission also predicted about a 15% increase in enrollment and an additional $5 billion in cost by FY 2019.

Another recommendation called for a “robust strategy for meeting and managing VHA’s facility and capital-asset needs.” According to the commission, the VA must reevaluate the future of individual facilities “in light of a transformative new delivery model.” A new commission, based on the military closure commissions, would help determine which facilities would remain open and which would close. “If VA could sell, repurpose, or otherwise divest itself of unused or underutilized buildings in a timely, cost-effective manner, it would free funds for the purposes for which they are appropriated,” the commission argued.

The commission also focused on personnel issues in a number of its recommendations, calling for the transformation of VHA culture and staff engagement, performance metrics for all employees, a new personnel system, and increased cultural and military competency, “to embrace diversity, promote cultural sensitivity, and improve veteran health outcomes.”

All but 2 commissioners signed the report. The commission charged that “many profound deficiencies in VHA operations require urgent reform, and that America’s veterans deserve a better organized, high-performing health care system.” While the changes may seem sweeping to many, the 2 dissenting commissioners urged even more significant changes. In a dissent letter acquired by the Washington Free Beacon, these commissioners argue that “the disappointing reality is that the commission’s final report is deeply compromised, disjointed, and incomplete. The report repeatedly invokes the need for a ‘bold transformation’ at the VHA. Yet, with a few exceptions, there is a decided lack of boldness in the Commission’s recommendations.”

Reaction has been slow as officials at the White House, VA, and veterans group digest the 308-page report. Some groups, however, already are raising concerns. The American Legion issued a statement: “Increased privatization of veteran health care services is not in the best interest of veterans or the American taxpayer. While we are still reviewing the complete report, we note that the commission had a very limited interaction with veterans who actually use VA health care, and even less time spent in VA facilities.”

The President also issued a brief noncommittal statement. “The commission's report includes a number of specific proposals that I look forward to reviewing closely over the coming weeks. We will continue to work with veterans, Congress, and our partners in the veteran advocacy community to further our ongoing transformation of the veterans’ health care system. Our veterans deserve nothing less for their sacrifices and their service.”

The VA offered a brief reaction to the report, finding commonalities in its current reform efforts. “While we will examine the report closely over the coming weeks and respond in a more detailed fashion, I am pleased to see that many of their recommendations are in line with our MyVA efforts to transform the VA into a veteran-centric organization,” Secretary of Veterans Affairs Robert A. McDonald said in the statement. “There are some things that can be done right now to help us continue our progress. Congress must act on our proposals to consolidate our Community Care programs, modernize and reform the claims appeals process, and pass the bi-partisan Veterans First Act.”

[Click through to the 18 recommendations offered by the commission.]

The full set of recommendations covers a broad range of issue for the VA:

Recommendation #1: Across the United States, with local input and knowledge, VHA should establish high-performing, integrated community health care networks, to be known as the VHA Care System, from which veterans will access high-quality health care services.

Recommendation #2: Enhance clinical operations through more effective use of providers and other health professionals, and improved data collection and management.

Recommendation #3: Develop a process for appealing clinical decisions that provides veterans protections at least comparable to those afforded patients under other federally supported programs.

Recommendation #4: Adopt a continuous improvement methodology to support VHA transformation, and consolidate best practices and continuous improvement efforts under the Veterans Engineering Resource Center.

Recommendation #5: Eliminate health care disparities among veterans treated in the VHA Care System by committing adequate personnel and monetary resources to address the causes of the problem and ensuring the VHA Health Equity Action Plan is fully implemented.

Recommendation #6: Develop and implement a robust strategy for meeting and managing VHA’s facility and capital-asset needs.

Recommendation #7: Modernize VA’s IT systems and infrastructure to improve veterans’ health and well-being and provide the foundation needed to transform VHA’s clinical and business processes. 

Recommendation #8: Transform the management of the supply chain in VHA.

Recommendation #9: Establish a board of directors to provide overall VHA Care System governance, set long-term strategy, and direct and oversee the transformation process.

Recommendation #10: Require leaders at all levels of the organization to champion a focused, clear, benchmarked strategy to transform VHA culture and sustain staff engagement.

Recommendation #11: Rebuild a system for leadership succession based on a benchmarked health care competency model that is consistently applied to recruitment, development, and advancement within the leadership pipeline.

Recommendation #12: Transform organizational structures and management processes to ensure adherence to national VHA standards, while also promoting decision making at the lowest level of the organization, eliminating waste and redundancy, promoting innovation, and fostering the spread of best practices.

Recommendation #13: Streamline and focus organizational performance measurement in VHA using core metrics that are identical to those used in the private sector, and establish a personnel performance management system for health care leaders in VHA that is distinct from performance measurement, is based on the leadership competency model, assesses leadership ability, and measures the achievement of important organizational strategies.

Recommendation #14: Foster cultural and military competence among all VHA Care System leadership, providers, and staff to embrace diversity, promote cultural sensitivity, and improve veteran health outcomes.

Recommendation #15: Create a simple-to-administer alternative personnel system, in law and regulation, which governs all VHA employees, applies best practices from the private sector to human capital management, and supports pay and benefits that are competitive with the private sector.

Recommendation #16: Require top executives to lead the transformation of HR, commit funds, and assign expert resources to achieve an effective human capital management system.

Recommendation #17: Provide a streamlined path to eligibility for health care for those with an other-than-honorable discharge who have substantial honorable service. 

Recommendation #18: Establish an expert body to develop recommendations for VA care eligibility and benefit design.   

The Commission on Care has issued its final report, which called for the expansion of community care for all veterans through the creation of integrated community-based health care networks similar to TRICARE, expansion of eligibility for veterans, and the creation of a facility and capital asset realignment process based on the DoD Base Realignment and Closure Commission among its 18 recommendations.

Mandated by the Veterans Access, Choice and Accountability Act in the wake of the wait time, the 15-member Commission on Care was charged with providing recommendations for reforming veterans’ health care to President Obama. The commission’s recommendations carry considerable weight. The Choice Act mandated that the VA and other federal agencies “implement each recommendation that the President considers feasible, advisable, and able to implement without further legislation.”

The commission’s first recommendation was to scrap the Choice Program and establish the VHA Care System, a system of “integrated veteran-centric, community-based delivery networks that will optimize the balance of access, quality, and cost-effectiveness.” Local VHA leadership would develop the VHA Care System  and base it on “local needs and veterans’ preferences.” The VHA would be mandated to furnish credentials to community providers, with the highest priority access given to service-connected veterans. The time and distance criteria used by the Choice Program would be eliminated, and veterans would be able to choose any primary care provider from within the system.

The Commission offered 4 possible models for implementing the VHA Care System. In the recommended option (an integrated network of VHA, DoD, other federally funded providers, and community providers, which requires a referral to access specialty care), the commission predicts as many as 60% of veterans would shift to community care for primary care needs, though far fewer would seek referrals in the community. The commission also predicted about a 15% increase in enrollment and an additional $5 billion in cost by FY 2019.

Another recommendation called for a “robust strategy for meeting and managing VHA’s facility and capital-asset needs.” According to the commission, the VA must reevaluate the future of individual facilities “in light of a transformative new delivery model.” A new commission, based on the military closure commissions, would help determine which facilities would remain open and which would close. “If VA could sell, repurpose, or otherwise divest itself of unused or underutilized buildings in a timely, cost-effective manner, it would free funds for the purposes for which they are appropriated,” the commission argued.

The commission also focused on personnel issues in a number of its recommendations, calling for the transformation of VHA culture and staff engagement, performance metrics for all employees, a new personnel system, and increased cultural and military competency, “to embrace diversity, promote cultural sensitivity, and improve veteran health outcomes.”

All but 2 commissioners signed the report. The commission charged that “many profound deficiencies in VHA operations require urgent reform, and that America’s veterans deserve a better organized, high-performing health care system.” While the changes may seem sweeping to many, the 2 dissenting commissioners urged even more significant changes. In a dissent letter acquired by the Washington Free Beacon, these commissioners argue that “the disappointing reality is that the commission’s final report is deeply compromised, disjointed, and incomplete. The report repeatedly invokes the need for a ‘bold transformation’ at the VHA. Yet, with a few exceptions, there is a decided lack of boldness in the Commission’s recommendations.”

Reaction has been slow as officials at the White House, VA, and veterans group digest the 308-page report. Some groups, however, already are raising concerns. The American Legion issued a statement: “Increased privatization of veteran health care services is not in the best interest of veterans or the American taxpayer. While we are still reviewing the complete report, we note that the commission had a very limited interaction with veterans who actually use VA health care, and even less time spent in VA facilities.”

The President also issued a brief noncommittal statement. “The commission's report includes a number of specific proposals that I look forward to reviewing closely over the coming weeks. We will continue to work with veterans, Congress, and our partners in the veteran advocacy community to further our ongoing transformation of the veterans’ health care system. Our veterans deserve nothing less for their sacrifices and their service.”

The VA offered a brief reaction to the report, finding commonalities in its current reform efforts. “While we will examine the report closely over the coming weeks and respond in a more detailed fashion, I am pleased to see that many of their recommendations are in line with our MyVA efforts to transform the VA into a veteran-centric organization,” Secretary of Veterans Affairs Robert A. McDonald said in the statement. “There are some things that can be done right now to help us continue our progress. Congress must act on our proposals to consolidate our Community Care programs, modernize and reform the claims appeals process, and pass the bi-partisan Veterans First Act.”

[Click through to the 18 recommendations offered by the commission.]

The full set of recommendations covers a broad range of issue for the VA:

Recommendation #1: Across the United States, with local input and knowledge, VHA should establish high-performing, integrated community health care networks, to be known as the VHA Care System, from which veterans will access high-quality health care services.

Recommendation #2: Enhance clinical operations through more effective use of providers and other health professionals, and improved data collection and management.

Recommendation #3: Develop a process for appealing clinical decisions that provides veterans protections at least comparable to those afforded patients under other federally supported programs.

Recommendation #4: Adopt a continuous improvement methodology to support VHA transformation, and consolidate best practices and continuous improvement efforts under the Veterans Engineering Resource Center.

Recommendation #5: Eliminate health care disparities among veterans treated in the VHA Care System by committing adequate personnel and monetary resources to address the causes of the problem and ensuring the VHA Health Equity Action Plan is fully implemented.

Recommendation #6: Develop and implement a robust strategy for meeting and managing VHA’s facility and capital-asset needs.

Recommendation #7: Modernize VA’s IT systems and infrastructure to improve veterans’ health and well-being and provide the foundation needed to transform VHA’s clinical and business processes. 

Recommendation #8: Transform the management of the supply chain in VHA.

Recommendation #9: Establish a board of directors to provide overall VHA Care System governance, set long-term strategy, and direct and oversee the transformation process.

Recommendation #10: Require leaders at all levels of the organization to champion a focused, clear, benchmarked strategy to transform VHA culture and sustain staff engagement.

Recommendation #11: Rebuild a system for leadership succession based on a benchmarked health care competency model that is consistently applied to recruitment, development, and advancement within the leadership pipeline.

Recommendation #12: Transform organizational structures and management processes to ensure adherence to national VHA standards, while also promoting decision making at the lowest level of the organization, eliminating waste and redundancy, promoting innovation, and fostering the spread of best practices.

Recommendation #13: Streamline and focus organizational performance measurement in VHA using core metrics that are identical to those used in the private sector, and establish a personnel performance management system for health care leaders in VHA that is distinct from performance measurement, is based on the leadership competency model, assesses leadership ability, and measures the achievement of important organizational strategies.

Recommendation #14: Foster cultural and military competence among all VHA Care System leadership, providers, and staff to embrace diversity, promote cultural sensitivity, and improve veteran health outcomes.

Recommendation #15: Create a simple-to-administer alternative personnel system, in law and regulation, which governs all VHA employees, applies best practices from the private sector to human capital management, and supports pay and benefits that are competitive with the private sector.

Recommendation #16: Require top executives to lead the transformation of HR, commit funds, and assign expert resources to achieve an effective human capital management system.

Recommendation #17: Provide a streamlined path to eligibility for health care for those with an other-than-honorable discharge who have substantial honorable service. 

Recommendation #18: Establish an expert body to develop recommendations for VA care eligibility and benefit design.   

The Commission on Care has issued its final report, which called for the expansion of community care for all veterans through the creation of integrated community-based health care networks similar to TRICARE, expansion of eligibility for veterans, and the creation of a facility and capital asset realignment process based on the DoD Base Realignment and Closure Commission among its 18 recommendations.

Mandated by the Veterans Access, Choice and Accountability Act in the wake of the wait time, the 15-member Commission on Care was charged with providing recommendations for reforming veterans’ health care to President Obama. The commission’s recommendations carry considerable weight. The Choice Act mandated that the VA and other federal agencies “implement each recommendation that the President considers feasible, advisable, and able to implement without further legislation.”

The commission’s first recommendation was to scrap the Choice Program and establish the VHA Care System, a system of “integrated veteran-centric, community-based delivery networks that will optimize the balance of access, quality, and cost-effectiveness.” Local VHA leadership would develop the VHA Care System  and base it on “local needs and veterans’ preferences.” The VHA would be mandated to furnish credentials to community providers, with the highest priority access given to service-connected veterans. The time and distance criteria used by the Choice Program would be eliminated, and veterans would be able to choose any primary care provider from within the system.

The Commission offered 4 possible models for implementing the VHA Care System. In the recommended option (an integrated network of VHA, DoD, other federally funded providers, and community providers, which requires a referral to access specialty care), the commission predicts as many as 60% of veterans would shift to community care for primary care needs, though far fewer would seek referrals in the community. The commission also predicted about a 15% increase in enrollment and an additional $5 billion in cost by FY 2019.

Another recommendation called for a “robust strategy for meeting and managing VHA’s facility and capital-asset needs.” According to the commission, the VA must reevaluate the future of individual facilities “in light of a transformative new delivery model.” A new commission, based on the military closure commissions, would help determine which facilities would remain open and which would close. “If VA could sell, repurpose, or otherwise divest itself of unused or underutilized buildings in a timely, cost-effective manner, it would free funds for the purposes for which they are appropriated,” the commission argued.

The commission also focused on personnel issues in a number of its recommendations, calling for the transformation of VHA culture and staff engagement, performance metrics for all employees, a new personnel system, and increased cultural and military competency, “to embrace diversity, promote cultural sensitivity, and improve veteran health outcomes.”

All but 2 commissioners signed the report. The commission charged that “many profound deficiencies in VHA operations require urgent reform, and that America’s veterans deserve a better organized, high-performing health care system.” While the changes may seem sweeping to many, the 2 dissenting commissioners urged even more significant changes. In a dissent letter acquired by the Washington Free Beacon, these commissioners argue that “the disappointing reality is that the commission’s final report is deeply compromised, disjointed, and incomplete. The report repeatedly invokes the need for a ‘bold transformation’ at the VHA. Yet, with a few exceptions, there is a decided lack of boldness in the Commission’s recommendations.”

Reaction has been slow as officials at the White House, VA, and veterans group digest the 308-page report. Some groups, however, already are raising concerns. The American Legion issued a statement: “Increased privatization of veteran health care services is not in the best interest of veterans or the American taxpayer. While we are still reviewing the complete report, we note that the commission had a very limited interaction with veterans who actually use VA health care, and even less time spent in VA facilities.”

The President also issued a brief noncommittal statement. “The commission's report includes a number of specific proposals that I look forward to reviewing closely over the coming weeks. We will continue to work with veterans, Congress, and our partners in the veteran advocacy community to further our ongoing transformation of the veterans’ health care system. Our veterans deserve nothing less for their sacrifices and their service.”

The VA offered a brief reaction to the report, finding commonalities in its current reform efforts. “While we will examine the report closely over the coming weeks and respond in a more detailed fashion, I am pleased to see that many of their recommendations are in line with our MyVA efforts to transform the VA into a veteran-centric organization,” Secretary of Veterans Affairs Robert A. McDonald said in the statement. “There are some things that can be done right now to help us continue our progress. Congress must act on our proposals to consolidate our Community Care programs, modernize and reform the claims appeals process, and pass the bi-partisan Veterans First Act.”

[Click through to the 18 recommendations offered by the commission.]

The full set of recommendations covers a broad range of issue for the VA:

Recommendation #1: Across the United States, with local input and knowledge, VHA should establish high-performing, integrated community health care networks, to be known as the VHA Care System, from which veterans will access high-quality health care services.

Recommendation #2: Enhance clinical operations through more effective use of providers and other health professionals, and improved data collection and management.

Recommendation #3: Develop a process for appealing clinical decisions that provides veterans protections at least comparable to those afforded patients under other federally supported programs.

Recommendation #4: Adopt a continuous improvement methodology to support VHA transformation, and consolidate best practices and continuous improvement efforts under the Veterans Engineering Resource Center.

Recommendation #5: Eliminate health care disparities among veterans treated in the VHA Care System by committing adequate personnel and monetary resources to address the causes of the problem and ensuring the VHA Health Equity Action Plan is fully implemented.

Recommendation #6: Develop and implement a robust strategy for meeting and managing VHA’s facility and capital-asset needs.

Recommendation #7: Modernize VA’s IT systems and infrastructure to improve veterans’ health and well-being and provide the foundation needed to transform VHA’s clinical and business processes. 

Recommendation #8: Transform the management of the supply chain in VHA.

Recommendation #9: Establish a board of directors to provide overall VHA Care System governance, set long-term strategy, and direct and oversee the transformation process.

Recommendation #10: Require leaders at all levels of the organization to champion a focused, clear, benchmarked strategy to transform VHA culture and sustain staff engagement.

Recommendation #11: Rebuild a system for leadership succession based on a benchmarked health care competency model that is consistently applied to recruitment, development, and advancement within the leadership pipeline.

Recommendation #12: Transform organizational structures and management processes to ensure adherence to national VHA standards, while also promoting decision making at the lowest level of the organization, eliminating waste and redundancy, promoting innovation, and fostering the spread of best practices.

Recommendation #13: Streamline and focus organizational performance measurement in VHA using core metrics that are identical to those used in the private sector, and establish a personnel performance management system for health care leaders in VHA that is distinct from performance measurement, is based on the leadership competency model, assesses leadership ability, and measures the achievement of important organizational strategies.

Recommendation #14: Foster cultural and military competence among all VHA Care System leadership, providers, and staff to embrace diversity, promote cultural sensitivity, and improve veteran health outcomes.

Recommendation #15: Create a simple-to-administer alternative personnel system, in law and regulation, which governs all VHA employees, applies best practices from the private sector to human capital management, and supports pay and benefits that are competitive with the private sector.

Recommendation #16: Require top executives to lead the transformation of HR, commit funds, and assign expert resources to achieve an effective human capital management system.

Recommendation #17: Provide a streamlined path to eligibility for health care for those with an other-than-honorable discharge who have substantial honorable service. 

Recommendation #18: Establish an expert body to develop recommendations for VA care eligibility and benefit design.   

Imatinib tablet

Long-term results from the DASISION trial suggest that dasatinib and imatinib produce similar outcomes in patients with newly diagnosed chronic phase chronic myeloid leukemia (CP-CML).

Although patients who received dasatinib experienced faster and deeper molecular responses than patients who received imatinib, the overall survival and progression-free survival rates were similar between the treatment arms.

Overall, adverse events (AEs) were similar between the arms as well.

Researchers said these results suggest that dasatinib should continue to be considered an option for patients with newly diagnosed CP-CML.

The team reported the results of this study in the Journal of Clinical Oncology. The research was sponsored by Bristol-Myers Squibb.

The trial enrolled 519 patients with newly diagnosed CP-CML. They were randomized to receive dasatinib at 100 mg once daily (n=259) or imatinib at 400 mg once daily (n=260). Baseline characteristics were well-balanced between the arms.

At 5 years of follow-up, 61% of patients in the dasatinib arm and 63% of patients in the imatinib arm remained on treatment.

Response and survival

The cumulative 5-year rate of major molecular response was 76% in the dasatinib arm and 64% in the imatinib arm (P=0.0022). The rates of MR^4.5 were 42% and 33%, respectively (P=0.0251).

The estimated 5-year overall survival was 91% in the dasatinib arm and 90% in the imatinib arm (hazard ratio=1.01; 95% CI, 0.58 to 1.73).

The estimated 5-year progression-free survival was 85% and 86%, respectively (hazard ratio=1.06; 95% CI, 0.68 to 1.66).

Safety

In both treatment arms, most AEs were grade 1 or 2. Grade 3/4 AEs occurred in 15% of patients in the dasatinib arm and 11% of patients in the imatinib arm.

Rates of grade 3/4 hematologic AEs tended to be higher in the dasatinib arm than the imatinib arm.

But the rates of most drug-related, nonhematologic AEs were lower in the dasatinib arm than the imatinib arm or were comparable between the arms.

The exception was drug-related pleural effusion, which was more common with dasatinib (28%) than with imatinib (0.8%).

Drug-related AEs were largely manageable, although they led to treatment discontinuation in 16% of dasatinib-treated patients and 7% of imatinib-treated patients.

By 5 years, 26 patients (10%) in each treatment arm had died. Nine patients in the dasatinib arm died of disease progression, as did 17 patients in the imatinib arm.

Imatinib tablet

Long-term results from the DASISION trial suggest that dasatinib and imatinib produce similar outcomes in patients with newly diagnosed chronic phase chronic myeloid leukemia (CP-CML).

Although patients who received dasatinib experienced faster and deeper molecular responses than patients who received imatinib, the overall survival and progression-free survival rates were similar between the treatment arms.

Overall, adverse events (AEs) were similar between the arms as well.

Researchers said these results suggest that dasatinib should continue to be considered an option for patients with newly diagnosed CP-CML.

The team reported the results of this study in the Journal of Clinical Oncology. The research was sponsored by Bristol-Myers Squibb.

The trial enrolled 519 patients with newly diagnosed CP-CML. They were randomized to receive dasatinib at 100 mg once daily (n=259) or imatinib at 400 mg once daily (n=260). Baseline characteristics were well-balanced between the arms.

At 5 years of follow-up, 61% of patients in the dasatinib arm and 63% of patients in the imatinib arm remained on treatment.

Response and survival

The cumulative 5-year rate of major molecular response was 76% in the dasatinib arm and 64% in the imatinib arm (P=0.0022). The rates of MR^4.5 were 42% and 33%, respectively (P=0.0251).

The estimated 5-year overall survival was 91% in the dasatinib arm and 90% in the imatinib arm (hazard ratio=1.01; 95% CI, 0.58 to 1.73).

The estimated 5-year progression-free survival was 85% and 86%, respectively (hazard ratio=1.06; 95% CI, 0.68 to 1.66).

Safety

In both treatment arms, most AEs were grade 1 or 2. Grade 3/4 AEs occurred in 15% of patients in the dasatinib arm and 11% of patients in the imatinib arm.

Rates of grade 3/4 hematologic AEs tended to be higher in the dasatinib arm than the imatinib arm.

But the rates of most drug-related, nonhematologic AEs were lower in the dasatinib arm than the imatinib arm or were comparable between the arms.

The exception was drug-related pleural effusion, which was more common with dasatinib (28%) than with imatinib (0.8%).

Drug-related AEs were largely manageable, although they led to treatment discontinuation in 16% of dasatinib-treated patients and 7% of imatinib-treated patients.

By 5 years, 26 patients (10%) in each treatment arm had died. Nine patients in the dasatinib arm died of disease progression, as did 17 patients in the imatinib arm.

Imatinib tablet

Long-term results from the DASISION trial suggest that dasatinib and imatinib produce similar outcomes in patients with newly diagnosed chronic phase chronic myeloid leukemia (CP-CML).

Although patients who received dasatinib experienced faster and deeper molecular responses than patients who received imatinib, the overall survival and progression-free survival rates were similar between the treatment arms.

Overall, adverse events (AEs) were similar between the arms as well.

Researchers said these results suggest that dasatinib should continue to be considered an option for patients with newly diagnosed CP-CML.

The team reported the results of this study in the Journal of Clinical Oncology. The research was sponsored by Bristol-Myers Squibb.

The trial enrolled 519 patients with newly diagnosed CP-CML. They were randomized to receive dasatinib at 100 mg once daily (n=259) or imatinib at 400 mg once daily (n=260). Baseline characteristics were well-balanced between the arms.

At 5 years of follow-up, 61% of patients in the dasatinib arm and 63% of patients in the imatinib arm remained on treatment.

Response and survival

The cumulative 5-year rate of major molecular response was 76% in the dasatinib arm and 64% in the imatinib arm (P=0.0022). The rates of MR^4.5 were 42% and 33%, respectively (P=0.0251).

The estimated 5-year overall survival was 91% in the dasatinib arm and 90% in the imatinib arm (hazard ratio=1.01; 95% CI, 0.58 to 1.73).

The estimated 5-year progression-free survival was 85% and 86%, respectively (hazard ratio=1.06; 95% CI, 0.68 to 1.66).

Safety

In both treatment arms, most AEs were grade 1 or 2. Grade 3/4 AEs occurred in 15% of patients in the dasatinib arm and 11% of patients in the imatinib arm.

Rates of grade 3/4 hematologic AEs tended to be higher in the dasatinib arm than the imatinib arm.

But the rates of most drug-related, nonhematologic AEs were lower in the dasatinib arm than the imatinib arm or were comparable between the arms.

The exception was drug-related pleural effusion, which was more common with dasatinib (28%) than with imatinib (0.8%).

Drug-related AEs were largely manageable, although they led to treatment discontinuation in 16% of dasatinib-treated patients and 7% of imatinib-treated patients.

By 5 years, 26 patients (10%) in each treatment arm had died. Nine patients in the dasatinib arm died of disease progression, as did 17 patients in the imatinib arm.

Carfilzomib (Kyprolis)

Photo from Amgen

The European Commission (EC) has expanded the approved use of the proteasome inhibitor carfilzomib (Kyprolis).

The drug is now approved for use in combination with dexamethasone to treat adults with multiple myeloma (MM) who have received at least 1 prior therapy.

Carfilzomib was previously approved by the EC for use in combination with lenalidomide and dexamethasone to treat adult MM patients who have received at least 1 prior therapy.

The EC approved the extended indication for carfilzomib based on data from the phase 3 ENDEAVOR trial.

The trial included 929 MM patients whose disease had relapsed after 1 to 3 prior therapeutic regimens.

The patients received either carfilzomib plus dexamethasone (n=464) or bortezomib plus dexamethasone (n=465) until disease progression.

The primary endpoint was progression-free survival. The median progression-free survival was 18.7 months in the carfilzomib arm and 9.4 months in the bortezomib arm. The hazard ratio was 0.53 (P<0.0001).

Overall survival data were not yet mature at last follow-up.

Treatment discontinuation due to adverse events and on-study deaths were comparable between the 2 treatment arms.

However, a number of known adverse events were reported at a higher rate in the carfilzomib arm than the bortezomib arm, including dyspnea (28% vs 13%), hypertension (25% vs 3%), pyrexia (27% vs 14%), cough (25% vs 15%), cardiac failure (8% vs 3%), and acute renal failure (8% vs 5%).

Carfilzomib is marketed as Kyprolis by Onyx Pharmaceuticals, Inc., a subsidiary of Amgen that holds development and commercialization rights to the drug globally, with the exception of Japan.

Carfilzomib (Kyprolis)

Photo from Amgen

The European Commission (EC) has expanded the approved use of the proteasome inhibitor carfilzomib (Kyprolis).

The drug is now approved for use in combination with dexamethasone to treat adults with multiple myeloma (MM) who have received at least 1 prior therapy.

Carfilzomib was previously approved by the EC for use in combination with lenalidomide and dexamethasone to treat adult MM patients who have received at least 1 prior therapy.

The EC approved the extended indication for carfilzomib based on data from the phase 3 ENDEAVOR trial.

The trial included 929 MM patients whose disease had relapsed after 1 to 3 prior therapeutic regimens.

The patients received either carfilzomib plus dexamethasone (n=464) or bortezomib plus dexamethasone (n=465) until disease progression.

The primary endpoint was progression-free survival. The median progression-free survival was 18.7 months in the carfilzomib arm and 9.4 months in the bortezomib arm. The hazard ratio was 0.53 (P<0.0001).

Overall survival data were not yet mature at last follow-up.

Treatment discontinuation due to adverse events and on-study deaths were comparable between the 2 treatment arms.

However, a number of known adverse events were reported at a higher rate in the carfilzomib arm than the bortezomib arm, including dyspnea (28% vs 13%), hypertension (25% vs 3%), pyrexia (27% vs 14%), cough (25% vs 15%), cardiac failure (8% vs 3%), and acute renal failure (8% vs 5%).

Carfilzomib is marketed as Kyprolis by Onyx Pharmaceuticals, Inc., a subsidiary of Amgen that holds development and commercialization rights to the drug globally, with the exception of Japan.

Carfilzomib (Kyprolis)

Photo from Amgen

The European Commission (EC) has expanded the approved use of the proteasome inhibitor carfilzomib (Kyprolis).

The drug is now approved for use in combination with dexamethasone to treat adults with multiple myeloma (MM) who have received at least 1 prior therapy.

Carfilzomib was previously approved by the EC for use in combination with lenalidomide and dexamethasone to treat adult MM patients who have received at least 1 prior therapy.

The EC approved the extended indication for carfilzomib based on data from the phase 3 ENDEAVOR trial.

The trial included 929 MM patients whose disease had relapsed after 1 to 3 prior therapeutic regimens.

The patients received either carfilzomib plus dexamethasone (n=464) or bortezomib plus dexamethasone (n=465) until disease progression.

The primary endpoint was progression-free survival. The median progression-free survival was 18.7 months in the carfilzomib arm and 9.4 months in the bortezomib arm. The hazard ratio was 0.53 (P<0.0001).

Overall survival data were not yet mature at last follow-up.

Treatment discontinuation due to adverse events and on-study deaths were comparable between the 2 treatment arms.

However, a number of known adverse events were reported at a higher rate in the carfilzomib arm than the bortezomib arm, including dyspnea (28% vs 13%), hypertension (25% vs 3%), pyrexia (27% vs 14%), cough (25% vs 15%), cardiac failure (8% vs 3%), and acute renal failure (8% vs 5%).

Carfilzomib is marketed as Kyprolis by Onyx Pharmaceuticals, Inc., a subsidiary of Amgen that holds development and commercialization rights to the drug globally, with the exception of Japan.