Endometrial cancer survival lowest in Non-Hispanic black women

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Endometrial cancer survival lowest in Non-Hispanic black women

For aggressive endometrial cancer subtypes, Non-Hispanic black women had mortality rates more than 1.5-fold higher than those of non-Hispanic white women diagnosed with the same subtype of endometrial cancer and at the same stage of disease, according to a study published in Cancer Epidemiology, Biomarkers & Prevention.

Dr. Michele Cote

Using cancer incidence and mortality data from the Surveillance, Epidemiology, End Results (SEER) database, Dr. Michele Cote of Wayne State University, Detroit, and her colleagues examined patient records from 120,513 endometrial cancer cases diagnosed from 2000 to 2011 in the United States. Compared with non-Hispanic white women, non-Hispanic black women had poorer survival at every stage of diagnosis regardless of endometrial cancer subtype, while 5-year survival rates were similar or higher among Asian and Hispanic women compared with non-Hispanic white women (Cancer Epidemiol Biomarkers Prev. 2015;Aug 19. doi: 10.1158/1055-9965.EPI-15-0316).

However, endometrial cancer incidence rates increased among all racial and ethnic groups over the 12-year study period, with rates increasing as much as 2.5 percent per year among non-Hispanic black women and Asian women.

“Prior studies have suggested that disparities in outcomes from endometrial cancer might be explained by differences in tumor subtype or stage at diagnosis, but our data suggest that disparities persist even when these factors are controlled for,” Dr. Cote said in a statement.

Click here for the full article.

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For aggressive endometrial cancer subtypes, Non-Hispanic black women had mortality rates more than 1.5-fold higher than those of non-Hispanic white women diagnosed with the same subtype of endometrial cancer and at the same stage of disease, according to a study published in Cancer Epidemiology, Biomarkers & Prevention.

Dr. Michele Cote

Using cancer incidence and mortality data from the Surveillance, Epidemiology, End Results (SEER) database, Dr. Michele Cote of Wayne State University, Detroit, and her colleagues examined patient records from 120,513 endometrial cancer cases diagnosed from 2000 to 2011 in the United States. Compared with non-Hispanic white women, non-Hispanic black women had poorer survival at every stage of diagnosis regardless of endometrial cancer subtype, while 5-year survival rates were similar or higher among Asian and Hispanic women compared with non-Hispanic white women (Cancer Epidemiol Biomarkers Prev. 2015;Aug 19. doi: 10.1158/1055-9965.EPI-15-0316).

However, endometrial cancer incidence rates increased among all racial and ethnic groups over the 12-year study period, with rates increasing as much as 2.5 percent per year among non-Hispanic black women and Asian women.

“Prior studies have suggested that disparities in outcomes from endometrial cancer might be explained by differences in tumor subtype or stage at diagnosis, but our data suggest that disparities persist even when these factors are controlled for,” Dr. Cote said in a statement.

Click here for the full article.

[email protected]

For aggressive endometrial cancer subtypes, Non-Hispanic black women had mortality rates more than 1.5-fold higher than those of non-Hispanic white women diagnosed with the same subtype of endometrial cancer and at the same stage of disease, according to a study published in Cancer Epidemiology, Biomarkers & Prevention.

Dr. Michele Cote

Using cancer incidence and mortality data from the Surveillance, Epidemiology, End Results (SEER) database, Dr. Michele Cote of Wayne State University, Detroit, and her colleagues examined patient records from 120,513 endometrial cancer cases diagnosed from 2000 to 2011 in the United States. Compared with non-Hispanic white women, non-Hispanic black women had poorer survival at every stage of diagnosis regardless of endometrial cancer subtype, while 5-year survival rates were similar or higher among Asian and Hispanic women compared with non-Hispanic white women (Cancer Epidemiol Biomarkers Prev. 2015;Aug 19. doi: 10.1158/1055-9965.EPI-15-0316).

However, endometrial cancer incidence rates increased among all racial and ethnic groups over the 12-year study period, with rates increasing as much as 2.5 percent per year among non-Hispanic black women and Asian women.

“Prior studies have suggested that disparities in outcomes from endometrial cancer might be explained by differences in tumor subtype or stage at diagnosis, but our data suggest that disparities persist even when these factors are controlled for,” Dr. Cote said in a statement.

Click here for the full article.

[email protected]

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Online resource launched to prevent inpatient hospital falls

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Online resource launched to prevent inpatient hospital falls

An online resource guide offers 21 targeted solutions for reducing the rate of falls in hospitals and urgent care settings, The Joint Commission Center for Transforming Healthcare announced in a statement.

Using the fall prevention methodology of the Targeted Solutions Tool, developed in collaboration with seven hospitals and five health care organizations, a typical 200-bed hospital could potentially reduce the number of patients injured from a fall from 117 to 45, avoiding approximately $1 million in costs annually, the agency claims.

Some of the recommendations for reducing in-hospital falls include:

• Creating awareness among staff.

• Using a validated fall risk assessment tool.

• Engaging patients and their families in the fall safety program.

• Hourly rounding with scheduled restroom use for patients.

• Engaging all hospital staff and patients to ensure no patient walks without assistance.

“Hundreds of thousands of patients fall in hospitals every year and many of these falls result in moderate to severe injuries that can prolong hospital stays and require the patient to undergo additional treatment,” Dr. Erin DuPree, vice president and chief medical officer of the Joint Commission Center for Transforming Healthcare, said in a statement.

The Joint Commission Center for Transforming Healthcare was created in 2008 as a nonprofit affiliate of The Joint Commission.

Check out the online resource here.

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An online resource guide offers 21 targeted solutions for reducing the rate of falls in hospitals and urgent care settings, The Joint Commission Center for Transforming Healthcare announced in a statement.

Using the fall prevention methodology of the Targeted Solutions Tool, developed in collaboration with seven hospitals and five health care organizations, a typical 200-bed hospital could potentially reduce the number of patients injured from a fall from 117 to 45, avoiding approximately $1 million in costs annually, the agency claims.

Some of the recommendations for reducing in-hospital falls include:

• Creating awareness among staff.

• Using a validated fall risk assessment tool.

• Engaging patients and their families in the fall safety program.

• Hourly rounding with scheduled restroom use for patients.

• Engaging all hospital staff and patients to ensure no patient walks without assistance.

“Hundreds of thousands of patients fall in hospitals every year and many of these falls result in moderate to severe injuries that can prolong hospital stays and require the patient to undergo additional treatment,” Dr. Erin DuPree, vice president and chief medical officer of the Joint Commission Center for Transforming Healthcare, said in a statement.

The Joint Commission Center for Transforming Healthcare was created in 2008 as a nonprofit affiliate of The Joint Commission.

Check out the online resource here.

[email protected]

An online resource guide offers 21 targeted solutions for reducing the rate of falls in hospitals and urgent care settings, The Joint Commission Center for Transforming Healthcare announced in a statement.

Using the fall prevention methodology of the Targeted Solutions Tool, developed in collaboration with seven hospitals and five health care organizations, a typical 200-bed hospital could potentially reduce the number of patients injured from a fall from 117 to 45, avoiding approximately $1 million in costs annually, the agency claims.

Some of the recommendations for reducing in-hospital falls include:

• Creating awareness among staff.

• Using a validated fall risk assessment tool.

• Engaging patients and their families in the fall safety program.

• Hourly rounding with scheduled restroom use for patients.

• Engaging all hospital staff and patients to ensure no patient walks without assistance.

“Hundreds of thousands of patients fall in hospitals every year and many of these falls result in moderate to severe injuries that can prolong hospital stays and require the patient to undergo additional treatment,” Dr. Erin DuPree, vice president and chief medical officer of the Joint Commission Center for Transforming Healthcare, said in a statement.

The Joint Commission Center for Transforming Healthcare was created in 2008 as a nonprofit affiliate of The Joint Commission.

Check out the online resource here.

[email protected]

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Blacks more than twice as likely as whites to experience sudden cardiac arrest

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Blacks more than twice as likely as whites to experience sudden cardiac arrest

In a population-based study, black Americans experienced sudden cardiac arrest (SCA) roughly 6 years younger than white Americans, at age 61 vs. age 67.2, although outcomes were not significantly different.

Kyndaron Reinier, Ph.D., of the Cedars-Sinai Medical Center in Los Angeles, and her associates examined patient data from 2,144 sudden cardiac death patients (including 126 blacks and 1,262 whites) in the Portland, Ore., metropolitan area from 2002 to 2012.

SCA occurrence was more than doubled in black men and women (175 and 90/100,000, respectively), compared with white men and women (84 and 40/100,000), after adjustment for age.

Although both blacks and whites with SCA were equally likely to have a clinically recognized history of coronary artery disease, blacks with SCA had higher rates of prearrest clinical risk factors for coronary disease, including diabetes (52% vs. 33%), high blood pressure (77% vs. 65%), and chronic kidney failure (34% vs. 19%), than did whites. All differences were statistically significant.

“While our results for SCA burden are consistent with the published literature, the findings related to age, comorbidities, and noncoronary cardiac risk factors are new and likely warrant urgent attention. SCA occurs at a significantly younger age in blacks, with a higher prevalence of clinical risk factors beyond previously documented coronary disease,” the authors wrote.

Read the full article here: Circulation 2015 (doi: 10.1161/CIRCULATIONAHA.115.015673)

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In a population-based study, black Americans experienced sudden cardiac arrest (SCA) roughly 6 years younger than white Americans, at age 61 vs. age 67.2, although outcomes were not significantly different.

Kyndaron Reinier, Ph.D., of the Cedars-Sinai Medical Center in Los Angeles, and her associates examined patient data from 2,144 sudden cardiac death patients (including 126 blacks and 1,262 whites) in the Portland, Ore., metropolitan area from 2002 to 2012.

SCA occurrence was more than doubled in black men and women (175 and 90/100,000, respectively), compared with white men and women (84 and 40/100,000), after adjustment for age.

Although both blacks and whites with SCA were equally likely to have a clinically recognized history of coronary artery disease, blacks with SCA had higher rates of prearrest clinical risk factors for coronary disease, including diabetes (52% vs. 33%), high blood pressure (77% vs. 65%), and chronic kidney failure (34% vs. 19%), than did whites. All differences were statistically significant.

“While our results for SCA burden are consistent with the published literature, the findings related to age, comorbidities, and noncoronary cardiac risk factors are new and likely warrant urgent attention. SCA occurs at a significantly younger age in blacks, with a higher prevalence of clinical risk factors beyond previously documented coronary disease,” the authors wrote.

Read the full article here: Circulation 2015 (doi: 10.1161/CIRCULATIONAHA.115.015673)

In a population-based study, black Americans experienced sudden cardiac arrest (SCA) roughly 6 years younger than white Americans, at age 61 vs. age 67.2, although outcomes were not significantly different.

Kyndaron Reinier, Ph.D., of the Cedars-Sinai Medical Center in Los Angeles, and her associates examined patient data from 2,144 sudden cardiac death patients (including 126 blacks and 1,262 whites) in the Portland, Ore., metropolitan area from 2002 to 2012.

SCA occurrence was more than doubled in black men and women (175 and 90/100,000, respectively), compared with white men and women (84 and 40/100,000), after adjustment for age.

Although both blacks and whites with SCA were equally likely to have a clinically recognized history of coronary artery disease, blacks with SCA had higher rates of prearrest clinical risk factors for coronary disease, including diabetes (52% vs. 33%), high blood pressure (77% vs. 65%), and chronic kidney failure (34% vs. 19%), than did whites. All differences were statistically significant.

“While our results for SCA burden are consistent with the published literature, the findings related to age, comorbidities, and noncoronary cardiac risk factors are new and likely warrant urgent attention. SCA occurs at a significantly younger age in blacks, with a higher prevalence of clinical risk factors beyond previously documented coronary disease,” the authors wrote.

Read the full article here: Circulation 2015 (doi: 10.1161/CIRCULATIONAHA.115.015673)

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NICE releases guidelines on medicine optimization

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NICE releases guidelines on medicine optimization

Effective systems and processes are a key part of minimizing the risk of preventable medicine-related problems and ensuring best possible outcomes for care, according to newly released clinical guidelines from the Medicines Prescribing Centre of the U.K.-based National Institute for Health and Care Excellence (NICE).

The guidelines, developed by a multidisciplinary Guideline Development Group (GDG) of NICE staff, health professionals, and lay members, were designed to ensure that National Health Service patients get the best possible outcomes from their medicines.

“Relevant information about medicines should be shared with patients, and their family members or carers, where appropriate, and between health and social care practitioners when a person moves from one care setting to another, to support high-quality care,” wrote the authors of the guidelines, led by Dr. Weeliat Chong, chair of the GDG.

The report identified four key recommendations as priorities for implementation:

• Consider using multiple methods (such as health record review, patient surveys and direct observation of medicines administration) to identify medicine-related patient safety incidents

• Organizations should ensure that medicines reconciliation (i.e., making sure medicines prescribed on admission correspond to those that the patient was taking before admission) is carried out by a trained and competent health professional with effective communication skills, technical knowledge of processes for managing medicines, and therapeutic knowledge of medicines use.

• Health and social care practitioners should share relevant information about the [patients] and their medicines via medicines-related communication systems when a person transfers from one care setting to another.

• Consider sending the patient’s medicines discharge information to [his or her] nominated community pharmacy, when possible and in agreement with the patient.

Click here for the full report.

[email protected]

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Effective systems and processes are a key part of minimizing the risk of preventable medicine-related problems and ensuring best possible outcomes for care, according to newly released clinical guidelines from the Medicines Prescribing Centre of the U.K.-based National Institute for Health and Care Excellence (NICE).

The guidelines, developed by a multidisciplinary Guideline Development Group (GDG) of NICE staff, health professionals, and lay members, were designed to ensure that National Health Service patients get the best possible outcomes from their medicines.

“Relevant information about medicines should be shared with patients, and their family members or carers, where appropriate, and between health and social care practitioners when a person moves from one care setting to another, to support high-quality care,” wrote the authors of the guidelines, led by Dr. Weeliat Chong, chair of the GDG.

The report identified four key recommendations as priorities for implementation:

• Consider using multiple methods (such as health record review, patient surveys and direct observation of medicines administration) to identify medicine-related patient safety incidents

• Organizations should ensure that medicines reconciliation (i.e., making sure medicines prescribed on admission correspond to those that the patient was taking before admission) is carried out by a trained and competent health professional with effective communication skills, technical knowledge of processes for managing medicines, and therapeutic knowledge of medicines use.

• Health and social care practitioners should share relevant information about the [patients] and their medicines via medicines-related communication systems when a person transfers from one care setting to another.

• Consider sending the patient’s medicines discharge information to [his or her] nominated community pharmacy, when possible and in agreement with the patient.

Click here for the full report.

[email protected]

Effective systems and processes are a key part of minimizing the risk of preventable medicine-related problems and ensuring best possible outcomes for care, according to newly released clinical guidelines from the Medicines Prescribing Centre of the U.K.-based National Institute for Health and Care Excellence (NICE).

The guidelines, developed by a multidisciplinary Guideline Development Group (GDG) of NICE staff, health professionals, and lay members, were designed to ensure that National Health Service patients get the best possible outcomes from their medicines.

“Relevant information about medicines should be shared with patients, and their family members or carers, where appropriate, and between health and social care practitioners when a person moves from one care setting to another, to support high-quality care,” wrote the authors of the guidelines, led by Dr. Weeliat Chong, chair of the GDG.

The report identified four key recommendations as priorities for implementation:

• Consider using multiple methods (such as health record review, patient surveys and direct observation of medicines administration) to identify medicine-related patient safety incidents

• Organizations should ensure that medicines reconciliation (i.e., making sure medicines prescribed on admission correspond to those that the patient was taking before admission) is carried out by a trained and competent health professional with effective communication skills, technical knowledge of processes for managing medicines, and therapeutic knowledge of medicines use.

• Health and social care practitioners should share relevant information about the [patients] and their medicines via medicines-related communication systems when a person transfers from one care setting to another.

• Consider sending the patient’s medicines discharge information to [his or her] nominated community pharmacy, when possible and in agreement with the patient.

Click here for the full report.

[email protected]

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NICE recommends rivaroxaban for acute coronary syndrome

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NICE recommends rivaroxaban for acute coronary syndrome

Rivaroxaban has been recommended by the U.K. National Institute for Health and Care Excellence (NICE) as a treatment option for prevention of blood clots in adults who have had acute coronary syndrome with elevated cardiac biomarkers, the agency announced in a statement.

NICE officials recommended rivaroxaban (Xarelto), in combination with aspirin plus clopidogrel or aspirin alone, as an option for preventing atherothrombotic events in patients who have had a heart attack. Assessment of clinical-effectiveness evidence was based on data from an international, multicenter, randomized controlled trial. An independent appraisal committee considered clinical and cost-effectiveness evidence before making the recommendation.

Rivaroxaban, manufactured by Bayer and marketed by Janssen Pharmaceuticals, is an orally active direct factor Xa inhibitor.

Clinicians should regularly reassess the benefits and risks of continuing treatment with rivaroxaban, the agency recommended, and a decision on continuation of treatment should be made no later than 12 months after starting treatment.

Read the full guideline statement here.

[email protected]

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Rivaroxaban has been recommended by the U.K. National Institute for Health and Care Excellence (NICE) as a treatment option for prevention of blood clots in adults who have had acute coronary syndrome with elevated cardiac biomarkers, the agency announced in a statement.

NICE officials recommended rivaroxaban (Xarelto), in combination with aspirin plus clopidogrel or aspirin alone, as an option for preventing atherothrombotic events in patients who have had a heart attack. Assessment of clinical-effectiveness evidence was based on data from an international, multicenter, randomized controlled trial. An independent appraisal committee considered clinical and cost-effectiveness evidence before making the recommendation.

Rivaroxaban, manufactured by Bayer and marketed by Janssen Pharmaceuticals, is an orally active direct factor Xa inhibitor.

Clinicians should regularly reassess the benefits and risks of continuing treatment with rivaroxaban, the agency recommended, and a decision on continuation of treatment should be made no later than 12 months after starting treatment.

Read the full guideline statement here.

[email protected]

Rivaroxaban has been recommended by the U.K. National Institute for Health and Care Excellence (NICE) as a treatment option for prevention of blood clots in adults who have had acute coronary syndrome with elevated cardiac biomarkers, the agency announced in a statement.

NICE officials recommended rivaroxaban (Xarelto), in combination with aspirin plus clopidogrel or aspirin alone, as an option for preventing atherothrombotic events in patients who have had a heart attack. Assessment of clinical-effectiveness evidence was based on data from an international, multicenter, randomized controlled trial. An independent appraisal committee considered clinical and cost-effectiveness evidence before making the recommendation.

Rivaroxaban, manufactured by Bayer and marketed by Janssen Pharmaceuticals, is an orally active direct factor Xa inhibitor.

Clinicians should regularly reassess the benefits and risks of continuing treatment with rivaroxaban, the agency recommended, and a decision on continuation of treatment should be made no later than 12 months after starting treatment.

Read the full guideline statement here.

[email protected]

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Elderly LARC patients had similar nCRT outcomes to younger patients

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Elderly LARC patients had similar nCRT outcomes to younger patients

Clinical outcomes of elderly patients treated with neoadjuvant chemoradiation (nCRT) for locally advanced rectal cancer (LARC) were similar enough to outcomes of younger patients that doctors may want to reconsider using age alone for determining eligibility for nCRT and surgery, investigators reported online in the Annals of Oncology.

Dr. D. M. Jiang of the University of Ottawa (Ont.) and associates collected data from 1,172 patients with LARC who received nCRT and curative intent surgery, 25% (n = 295) of whom were 70 years old or older, from five major Canadian cancer centers between 2005 and 2012. When compared with younger patients, elderly patients were less likely to receive adjuvant chemotherapy (ACT) (60% vs. 79%; P less than .0001), oxaliplatin-based ACT (12% vs. 31%; P less than .0001), less likely to complete nCT (76% vs. 86%; P less than .001), and more likely to be anemic at initiation of nCRT (42% vs. 30%; P = .0004).

The investigators found that increasing age was not predictive of disease-free survival (hazard ratio, 1.00; 95% confidence interval, 0.99-1.02; P = .49) or cancer-specific survival (HR, 1.002; 95% CI, 0.98-1.02; P = .88) among LARC patients; however, advanced age correlated with an inferior overall survival (HR, 1.02; 95% CI, 1.00-1.03; P = .04).

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Clinical outcomes of elderly patients treated with neoadjuvant chemoradiation (nCRT) for locally advanced rectal cancer (LARC) were similar enough to outcomes of younger patients that doctors may want to reconsider using age alone for determining eligibility for nCRT and surgery, investigators reported online in the Annals of Oncology.

Dr. D. M. Jiang of the University of Ottawa (Ont.) and associates collected data from 1,172 patients with LARC who received nCRT and curative intent surgery, 25% (n = 295) of whom were 70 years old or older, from five major Canadian cancer centers between 2005 and 2012. When compared with younger patients, elderly patients were less likely to receive adjuvant chemotherapy (ACT) (60% vs. 79%; P less than .0001), oxaliplatin-based ACT (12% vs. 31%; P less than .0001), less likely to complete nCT (76% vs. 86%; P less than .001), and more likely to be anemic at initiation of nCRT (42% vs. 30%; P = .0004).

The investigators found that increasing age was not predictive of disease-free survival (hazard ratio, 1.00; 95% confidence interval, 0.99-1.02; P = .49) or cancer-specific survival (HR, 1.002; 95% CI, 0.98-1.02; P = .88) among LARC patients; however, advanced age correlated with an inferior overall survival (HR, 1.02; 95% CI, 1.00-1.03; P = .04).

Read the full article here.

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Clinical outcomes of elderly patients treated with neoadjuvant chemoradiation (nCRT) for locally advanced rectal cancer (LARC) were similar enough to outcomes of younger patients that doctors may want to reconsider using age alone for determining eligibility for nCRT and surgery, investigators reported online in the Annals of Oncology.

Dr. D. M. Jiang of the University of Ottawa (Ont.) and associates collected data from 1,172 patients with LARC who received nCRT and curative intent surgery, 25% (n = 295) of whom were 70 years old or older, from five major Canadian cancer centers between 2005 and 2012. When compared with younger patients, elderly patients were less likely to receive adjuvant chemotherapy (ACT) (60% vs. 79%; P less than .0001), oxaliplatin-based ACT (12% vs. 31%; P less than .0001), less likely to complete nCT (76% vs. 86%; P less than .001), and more likely to be anemic at initiation of nCRT (42% vs. 30%; P = .0004).

The investigators found that increasing age was not predictive of disease-free survival (hazard ratio, 1.00; 95% confidence interval, 0.99-1.02; P = .49) or cancer-specific survival (HR, 1.002; 95% CI, 0.98-1.02; P = .88) among LARC patients; however, advanced age correlated with an inferior overall survival (HR, 1.02; 95% CI, 1.00-1.03; P = .04).

Read the full article here.

[email protected]

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Disability with chronic widespread pain linked to alcohol consumption

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Disability with chronic widespread pain linked to alcohol consumption

People who report having chronic widespread pain are less likely to report their symptoms as disabling if they also report regularly consuming alcohol, suggesting an undiscovered link between alcohol use and pain severity, according to research published in Arthritis Care & Research.

In a population-based study in the United Kingdom, Dr. Gary J. Macfarlane and his coinvestigators examined self-reported data from 13,574 participants (mean age 55 years, 57% female), of whom 16.5% (n = 2,239) had chronic widespread pain (CWP). Potential confounding factors for which information was available included age, gender, cigarette smoking status, employment status, weight, height, and level of deprivation, noted Dr. Macfarlane of the University of Aberdeen (Scotland).

©Kirby Hamilton/iStockphoto.com

The prevalence of CWP Disability index scores for the proportion of persons who never drank alcohol regularly (at least once per week for 1 month or longer) and who had disabling pain was 47.2%, and the percentage decreased to 18.6% as alcohol consumption increased to 21-35 drinks per week, a difference that remained statistically significant even after adjusting for potential confounders (adjusted odds ratio, 0.33; 95% confidence interval, 0.19-0.58). However, the 51.1% rate of disabling pain in people with very high alcohol consumption (greater than 35 alcoholic drinks per week) was similar to those who did not consume any alcohol (adjusted OR, 0.78; 95% CI, 0.37-1.68). The investigators also found a similar relationship between reported CWP and level of alcohol consumption such that individuals who drank 21-35 drinks per week were 24% less likely to report having CWP (adjusted OR, 0.76; 95% CI, 0.61-0.94).

The authors noted that very few studies have explored the link between reporting chronic pain and alcohol consumption, but cautioned that more studies will be needed to further explore the connection.

“The available evidence, from two studies, does not allow us to conclude that the association is causal: It should not be interpreted that alcohol has a therapeutic benefit,” they wrote.

Read the full article here: Arthritis Care & Research. 2015. doi: 10.1002/acr.22604.

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People who report having chronic widespread pain are less likely to report their symptoms as disabling if they also report regularly consuming alcohol, suggesting an undiscovered link between alcohol use and pain severity, according to research published in Arthritis Care & Research.

In a population-based study in the United Kingdom, Dr. Gary J. Macfarlane and his coinvestigators examined self-reported data from 13,574 participants (mean age 55 years, 57% female), of whom 16.5% (n = 2,239) had chronic widespread pain (CWP). Potential confounding factors for which information was available included age, gender, cigarette smoking status, employment status, weight, height, and level of deprivation, noted Dr. Macfarlane of the University of Aberdeen (Scotland).

©Kirby Hamilton/iStockphoto.com

The prevalence of CWP Disability index scores for the proportion of persons who never drank alcohol regularly (at least once per week for 1 month or longer) and who had disabling pain was 47.2%, and the percentage decreased to 18.6% as alcohol consumption increased to 21-35 drinks per week, a difference that remained statistically significant even after adjusting for potential confounders (adjusted odds ratio, 0.33; 95% confidence interval, 0.19-0.58). However, the 51.1% rate of disabling pain in people with very high alcohol consumption (greater than 35 alcoholic drinks per week) was similar to those who did not consume any alcohol (adjusted OR, 0.78; 95% CI, 0.37-1.68). The investigators also found a similar relationship between reported CWP and level of alcohol consumption such that individuals who drank 21-35 drinks per week were 24% less likely to report having CWP (adjusted OR, 0.76; 95% CI, 0.61-0.94).

The authors noted that very few studies have explored the link between reporting chronic pain and alcohol consumption, but cautioned that more studies will be needed to further explore the connection.

“The available evidence, from two studies, does not allow us to conclude that the association is causal: It should not be interpreted that alcohol has a therapeutic benefit,” they wrote.

Read the full article here: Arthritis Care & Research. 2015. doi: 10.1002/acr.22604.

[email protected]

People who report having chronic widespread pain are less likely to report their symptoms as disabling if they also report regularly consuming alcohol, suggesting an undiscovered link between alcohol use and pain severity, according to research published in Arthritis Care & Research.

In a population-based study in the United Kingdom, Dr. Gary J. Macfarlane and his coinvestigators examined self-reported data from 13,574 participants (mean age 55 years, 57% female), of whom 16.5% (n = 2,239) had chronic widespread pain (CWP). Potential confounding factors for which information was available included age, gender, cigarette smoking status, employment status, weight, height, and level of deprivation, noted Dr. Macfarlane of the University of Aberdeen (Scotland).

©Kirby Hamilton/iStockphoto.com

The prevalence of CWP Disability index scores for the proportion of persons who never drank alcohol regularly (at least once per week for 1 month or longer) and who had disabling pain was 47.2%, and the percentage decreased to 18.6% as alcohol consumption increased to 21-35 drinks per week, a difference that remained statistically significant even after adjusting for potential confounders (adjusted odds ratio, 0.33; 95% confidence interval, 0.19-0.58). However, the 51.1% rate of disabling pain in people with very high alcohol consumption (greater than 35 alcoholic drinks per week) was similar to those who did not consume any alcohol (adjusted OR, 0.78; 95% CI, 0.37-1.68). The investigators also found a similar relationship between reported CWP and level of alcohol consumption such that individuals who drank 21-35 drinks per week were 24% less likely to report having CWP (adjusted OR, 0.76; 95% CI, 0.61-0.94).

The authors noted that very few studies have explored the link between reporting chronic pain and alcohol consumption, but cautioned that more studies will be needed to further explore the connection.

“The available evidence, from two studies, does not allow us to conclude that the association is causal: It should not be interpreted that alcohol has a therapeutic benefit,” they wrote.

Read the full article here: Arthritis Care & Research. 2015. doi: 10.1002/acr.22604.

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Bipolar disorder diagnoses higher than referrals

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Fewer patients were referred to psychiatrists for suspected bipolar disorder than the number of patients diagnosed with the illness, Canadian researchers reported in the Journal of Affective Disorders.

Dr. Andrée Daigneault and her colleagues found that, over a 10-year period, the number of patients referred for suspicion of bipolar disorder (n = 583) was lower than the number of bipolar disorder diagnoses (n = 640).

To conduct the study, the investigators looked at records from Hôpital du Sacré-Coeur de Montréal’s Module Evaluation/Liaison (MEL) division. The hospital’s psychiatrists examined 18,111 patients from 1998 to 2010 and carried out 10,492 (58%) assessments, reported Dr. Daigneault of the hospital and the Douglas Mental Health University Institute, Montreal, and her associates.

Of all patients assessed by the MEL, 583 patients were referred for a suspicion of bipolar disorder, while 640 patients received the diagnosis from a MEL psychiatrist (40.3% type I, 40.5% type II). The proportion of patients referred to the MEL for suspicion of bipolar disorder remained stable over the 10 years of the study and held between 2.2% and 4.6% annually. Both bipolar I and II disorders were more commonly diagnosed in secondary care than in primary, the authors noted. They also found no increase in the proportion of bipolar disorder referrals over the 10 years of the study.

“If the psychiatric and medical communities seem to become increasing familiar with [bipolar disorder], our study fails to demonstrate that [bipolar disorder] is overly suspected or identified in primary care,” the authors wrote. They said their data suggest that general practitioners “have not been influenced by the popularity of [bipolar disorder], as could have been suggested if rates of [bipolar] suspicions increased over time or surpassed that of [bipolar] diagnoses.”

Read the full article here: (J. Affect. Disord. 2015;174:225-32 [doi:10.1016/j.jad.2014.10.057]).

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Fewer patients were referred to psychiatrists for suspected bipolar disorder than the number of patients diagnosed with the illness, Canadian researchers reported in the Journal of Affective Disorders.

Dr. Andrée Daigneault and her colleagues found that, over a 10-year period, the number of patients referred for suspicion of bipolar disorder (n = 583) was lower than the number of bipolar disorder diagnoses (n = 640).

To conduct the study, the investigators looked at records from Hôpital du Sacré-Coeur de Montréal’s Module Evaluation/Liaison (MEL) division. The hospital’s psychiatrists examined 18,111 patients from 1998 to 2010 and carried out 10,492 (58%) assessments, reported Dr. Daigneault of the hospital and the Douglas Mental Health University Institute, Montreal, and her associates.

Of all patients assessed by the MEL, 583 patients were referred for a suspicion of bipolar disorder, while 640 patients received the diagnosis from a MEL psychiatrist (40.3% type I, 40.5% type II). The proportion of patients referred to the MEL for suspicion of bipolar disorder remained stable over the 10 years of the study and held between 2.2% and 4.6% annually. Both bipolar I and II disorders were more commonly diagnosed in secondary care than in primary, the authors noted. They also found no increase in the proportion of bipolar disorder referrals over the 10 years of the study.

“If the psychiatric and medical communities seem to become increasing familiar with [bipolar disorder], our study fails to demonstrate that [bipolar disorder] is overly suspected or identified in primary care,” the authors wrote. They said their data suggest that general practitioners “have not been influenced by the popularity of [bipolar disorder], as could have been suggested if rates of [bipolar] suspicions increased over time or surpassed that of [bipolar] diagnoses.”

Read the full article here: (J. Affect. Disord. 2015;174:225-32 [doi:10.1016/j.jad.2014.10.057]).

[email protected]

Fewer patients were referred to psychiatrists for suspected bipolar disorder than the number of patients diagnosed with the illness, Canadian researchers reported in the Journal of Affective Disorders.

Dr. Andrée Daigneault and her colleagues found that, over a 10-year period, the number of patients referred for suspicion of bipolar disorder (n = 583) was lower than the number of bipolar disorder diagnoses (n = 640).

To conduct the study, the investigators looked at records from Hôpital du Sacré-Coeur de Montréal’s Module Evaluation/Liaison (MEL) division. The hospital’s psychiatrists examined 18,111 patients from 1998 to 2010 and carried out 10,492 (58%) assessments, reported Dr. Daigneault of the hospital and the Douglas Mental Health University Institute, Montreal, and her associates.

Of all patients assessed by the MEL, 583 patients were referred for a suspicion of bipolar disorder, while 640 patients received the diagnosis from a MEL psychiatrist (40.3% type I, 40.5% type II). The proportion of patients referred to the MEL for suspicion of bipolar disorder remained stable over the 10 years of the study and held between 2.2% and 4.6% annually. Both bipolar I and II disorders were more commonly diagnosed in secondary care than in primary, the authors noted. They also found no increase in the proportion of bipolar disorder referrals over the 10 years of the study.

“If the psychiatric and medical communities seem to become increasing familiar with [bipolar disorder], our study fails to demonstrate that [bipolar disorder] is overly suspected or identified in primary care,” the authors wrote. They said their data suggest that general practitioners “have not been influenced by the popularity of [bipolar disorder], as could have been suggested if rates of [bipolar] suspicions increased over time or surpassed that of [bipolar] diagnoses.”

Read the full article here: (J. Affect. Disord. 2015;174:225-32 [doi:10.1016/j.jad.2014.10.057]).

[email protected]

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FDA approves Daklinza for HCV genotype 3 infections

New HCV drug approvals are not dramatic improvements
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FDA approves Daklinza for HCV genotype 3 infections

The U.S. Food and Drug Administration has approved Daklinza (daclatasvir), a hepatitis C virus (HCV) drug that, when used in combination with sofosbuvir, does not require coadministration of interferon or ribavirin for the treatment of HCV genotype 3 infections, the agency announced in a statement on July 24, 2015.

In a clinical trial, 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks, and were monitored for 24 weeks post treatment; 98% of the treatment-naive participants with no cirrhosis of the liver (and 58% of the treatment-naive participants with cirrhosis) achieved a sustained virologic response. Among the participants who were treatment experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved sustained virologic response.

“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

The most common side effects of Daklinza with sofosbuvir were fatigue and headache.

According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which approximately 10 percent are genotype 3.

Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, N.J.

Read the full FDA statement at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm.

AGA Resource
Through the AGA Roadmap to the Future of Practice, AGA offers a Hepatitis C Clinical Service line to support high-quality patient care, which is available at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c.

References

Body

The recent FDA approval of Daklinza and Technivie for hepatitis C offer some additional weapons in the treatment of hepatitis C; however, their approval does not dramatically alter the treatment landscape at this point. Technivie is FDA approved for genotype 4, a small fraction of patients with hepatitis C, and does not offer much improvement over off-label use of Harvoni or Viekira Pak for genotype 4 patients. Daklinza is FDA approved in combination with sofosbuvir for 12 weeks for treatment-naive patients with genotype 3 and should also be considered for off-label use for genotype 2 patients.  

While SVRs for noncirrhotic treatment-naive genotype 3 patients are high, achieving high SVRs in patients with cirrhosis requires treatment extension to 24 weeks to achieve an SVR around 90% at a cost of nearly $300,000. While this is an improvement on sofosbuvir plus ribavirin for treatment-experienced patients with cirrhosis, it nevertheless is an extremely expensive option that will likely be met with resistance from payers. It will also likely be displaced as a treatment option for genotype 2 and 3 patients when Gilead's pan-genotypic NS5A inhibitor (GS-5816) makes it to market as anticipated within the next year.

Dr. Sean Koppe is director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. He has no conflicts of interest.

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Body

The recent FDA approval of Daklinza and Technivie for hepatitis C offer some additional weapons in the treatment of hepatitis C; however, their approval does not dramatically alter the treatment landscape at this point. Technivie is FDA approved for genotype 4, a small fraction of patients with hepatitis C, and does not offer much improvement over off-label use of Harvoni or Viekira Pak for genotype 4 patients. Daklinza is FDA approved in combination with sofosbuvir for 12 weeks for treatment-naive patients with genotype 3 and should also be considered for off-label use for genotype 2 patients.  

While SVRs for noncirrhotic treatment-naive genotype 3 patients are high, achieving high SVRs in patients with cirrhosis requires treatment extension to 24 weeks to achieve an SVR around 90% at a cost of nearly $300,000. While this is an improvement on sofosbuvir plus ribavirin for treatment-experienced patients with cirrhosis, it nevertheless is an extremely expensive option that will likely be met with resistance from payers. It will also likely be displaced as a treatment option for genotype 2 and 3 patients when Gilead's pan-genotypic NS5A inhibitor (GS-5816) makes it to market as anticipated within the next year.

Dr. Sean Koppe is director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. He has no conflicts of interest.

Body

The recent FDA approval of Daklinza and Technivie for hepatitis C offer some additional weapons in the treatment of hepatitis C; however, their approval does not dramatically alter the treatment landscape at this point. Technivie is FDA approved for genotype 4, a small fraction of patients with hepatitis C, and does not offer much improvement over off-label use of Harvoni or Viekira Pak for genotype 4 patients. Daklinza is FDA approved in combination with sofosbuvir for 12 weeks for treatment-naive patients with genotype 3 and should also be considered for off-label use for genotype 2 patients.  

While SVRs for noncirrhotic treatment-naive genotype 3 patients are high, achieving high SVRs in patients with cirrhosis requires treatment extension to 24 weeks to achieve an SVR around 90% at a cost of nearly $300,000. While this is an improvement on sofosbuvir plus ribavirin for treatment-experienced patients with cirrhosis, it nevertheless is an extremely expensive option that will likely be met with resistance from payers. It will also likely be displaced as a treatment option for genotype 2 and 3 patients when Gilead's pan-genotypic NS5A inhibitor (GS-5816) makes it to market as anticipated within the next year.

Dr. Sean Koppe is director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. He has no conflicts of interest.

Title
New HCV drug approvals are not dramatic improvements
New HCV drug approvals are not dramatic improvements

The U.S. Food and Drug Administration has approved Daklinza (daclatasvir), a hepatitis C virus (HCV) drug that, when used in combination with sofosbuvir, does not require coadministration of interferon or ribavirin for the treatment of HCV genotype 3 infections, the agency announced in a statement on July 24, 2015.

In a clinical trial, 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks, and were monitored for 24 weeks post treatment; 98% of the treatment-naive participants with no cirrhosis of the liver (and 58% of the treatment-naive participants with cirrhosis) achieved a sustained virologic response. Among the participants who were treatment experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved sustained virologic response.

“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

The most common side effects of Daklinza with sofosbuvir were fatigue and headache.

According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which approximately 10 percent are genotype 3.

Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, N.J.

Read the full FDA statement at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm.

AGA Resource
Through the AGA Roadmap to the Future of Practice, AGA offers a Hepatitis C Clinical Service line to support high-quality patient care, which is available at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c.

The U.S. Food and Drug Administration has approved Daklinza (daclatasvir), a hepatitis C virus (HCV) drug that, when used in combination with sofosbuvir, does not require coadministration of interferon or ribavirin for the treatment of HCV genotype 3 infections, the agency announced in a statement on July 24, 2015.

In a clinical trial, 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks, and were monitored for 24 weeks post treatment; 98% of the treatment-naive participants with no cirrhosis of the liver (and 58% of the treatment-naive participants with cirrhosis) achieved a sustained virologic response. Among the participants who were treatment experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved sustained virologic response.

“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

The most common side effects of Daklinza with sofosbuvir were fatigue and headache.

According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which approximately 10 percent are genotype 3.

Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, N.J.

Read the full FDA statement at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm.

AGA Resource
Through the AGA Roadmap to the Future of Practice, AGA offers a Hepatitis C Clinical Service line to support high-quality patient care, which is available at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c.

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FDA approves Daklinza for HCV genotype 3 infections

New HCV drug approvals are not dramatic improvements
Article Type
Changed
Fri, 01/18/2019 - 15:04
Display Headline
FDA approves Daklinza for HCV genotype 3 infections

The U.S. Food and Drug Administration has approved Daklinza (daclatasvir), a hepatitis C virus (HCV) drug that, when used in combination with sofosbuvir, does not require coadministration of interferon or ribavirin for the treatment of HCV genotype 3 infections, the agency announced in a statement on July 24, 2015.

In a clinical trial, 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks, and were monitored for 24 weeks post treatment; 98% of the treatment-naive participants with no cirrhosis of the liver (and 58% of the treatment-naive participants with cirrhosis) achieved a sustained virologic response. Among the participants who were treatment experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved sustained virologic response.

“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

The most common side effects of Daklinza with sofosbuvir were fatigue and headache.

According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which approximately 10 percent are genotype 3.

Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, N.J.

Read the full FDA statement at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm.

References

Body

The recent FDA approval of Daklinza and Technivie for hepatitis C offer some additional weapons in the treatment of hepatitis C; however, their approval does not dramatically alter the treatment landscape at this point. Technivie is FDA approved for genotype 4, a small fraction of patients with hepatitis C, and does not offer much improvement over off-label use of Harvoni or Viekira Pak for genotype 4 patients. Daklinza is FDA approved in combination with sofosbuvir for 12 weeks for treatment-naive patients with genotype 3 and should also be considered for off-label use for genotype 2 patients.  

While SVRs for noncirrhotic treatment-naive genotype 3 patients are high, achieving high SVRs in patients with cirrhosis requires treatment extension to 24 weeks to achieve an SVR around 90% at a cost of nearly $300,000. While this is an improvement on sofosbuvir plus ribavirin for treatment-experienced patients with cirrhosis, it nevertheless is an extremely expensive option that will likely be met with resistance from payers. It will also likely be displaced as a treatment option for genotype 2 and 3 patients when Gilead's pan-genotypic NS5A inhibitor (GS-5816) makes it to market as anticipated within the next year.

Dr. Sean Koppe is director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. He has no conflicts of interest.

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Body

The recent FDA approval of Daklinza and Technivie for hepatitis C offer some additional weapons in the treatment of hepatitis C; however, their approval does not dramatically alter the treatment landscape at this point. Technivie is FDA approved for genotype 4, a small fraction of patients with hepatitis C, and does not offer much improvement over off-label use of Harvoni or Viekira Pak for genotype 4 patients. Daklinza is FDA approved in combination with sofosbuvir for 12 weeks for treatment-naive patients with genotype 3 and should also be considered for off-label use for genotype 2 patients.  

While SVRs for noncirrhotic treatment-naive genotype 3 patients are high, achieving high SVRs in patients with cirrhosis requires treatment extension to 24 weeks to achieve an SVR around 90% at a cost of nearly $300,000. While this is an improvement on sofosbuvir plus ribavirin for treatment-experienced patients with cirrhosis, it nevertheless is an extremely expensive option that will likely be met with resistance from payers. It will also likely be displaced as a treatment option for genotype 2 and 3 patients when Gilead's pan-genotypic NS5A inhibitor (GS-5816) makes it to market as anticipated within the next year.

Dr. Sean Koppe is director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. He has no conflicts of interest.

Body

The recent FDA approval of Daklinza and Technivie for hepatitis C offer some additional weapons in the treatment of hepatitis C; however, their approval does not dramatically alter the treatment landscape at this point. Technivie is FDA approved for genotype 4, a small fraction of patients with hepatitis C, and does not offer much improvement over off-label use of Harvoni or Viekira Pak for genotype 4 patients. Daklinza is FDA approved in combination with sofosbuvir for 12 weeks for treatment-naive patients with genotype 3 and should also be considered for off-label use for genotype 2 patients.  

While SVRs for noncirrhotic treatment-naive genotype 3 patients are high, achieving high SVRs in patients with cirrhosis requires treatment extension to 24 weeks to achieve an SVR around 90% at a cost of nearly $300,000. While this is an improvement on sofosbuvir plus ribavirin for treatment-experienced patients with cirrhosis, it nevertheless is an extremely expensive option that will likely be met with resistance from payers. It will also likely be displaced as a treatment option for genotype 2 and 3 patients when Gilead's pan-genotypic NS5A inhibitor (GS-5816) makes it to market as anticipated within the next year.

Dr. Sean Koppe is director of hepatology at the University of Illinois Hospital & Health Sciences System, Chicago. He has no conflicts of interest.

Title
New HCV drug approvals are not dramatic improvements
New HCV drug approvals are not dramatic improvements

The U.S. Food and Drug Administration has approved Daklinza (daclatasvir), a hepatitis C virus (HCV) drug that, when used in combination with sofosbuvir, does not require coadministration of interferon or ribavirin for the treatment of HCV genotype 3 infections, the agency announced in a statement on July 24, 2015.

In a clinical trial, 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks, and were monitored for 24 weeks post treatment; 98% of the treatment-naive participants with no cirrhosis of the liver (and 58% of the treatment-naive participants with cirrhosis) achieved a sustained virologic response. Among the participants who were treatment experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved sustained virologic response.

“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

The most common side effects of Daklinza with sofosbuvir were fatigue and headache.

According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which approximately 10 percent are genotype 3.

Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, N.J.

Read the full FDA statement at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm.

The U.S. Food and Drug Administration has approved Daklinza (daclatasvir), a hepatitis C virus (HCV) drug that, when used in combination with sofosbuvir, does not require coadministration of interferon or ribavirin for the treatment of HCV genotype 3 infections, the agency announced in a statement on July 24, 2015.

In a clinical trial, 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks, and were monitored for 24 weeks post treatment; 98% of the treatment-naive participants with no cirrhosis of the liver (and 58% of the treatment-naive participants with cirrhosis) achieved a sustained virologic response. Among the participants who were treatment experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved sustained virologic response.

“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

The most common side effects of Daklinza with sofosbuvir were fatigue and headache.

According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which approximately 10 percent are genotype 3.

Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, N.J.

Read the full FDA statement at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm.

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