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Drug reverses dabigatran’s effects in elderly/impaired
Credit: CDC
SAN FRANCISCO—An investigational, humanized antibody fragment known as idarucizumab can reverse the anticoagulation effects of dabigatran, new research suggests.
In a small study, idarucizumab led to sustained reversal of dabigatran’s effects in healthy subjects, elderly volunteers, and participants with mild to moderate renal impairment.
Furthermore, dabigatran anticoagulation could be re-established 24 hours after the subjects had received idarucizumab.
Joachim Stangier, PhD, of Boehringer Ingelheim Pharma GmbH & Co KG in Biberach, Germany, presented these results at the 2014 ASH Annual Meeting as abstract 344*. Boehringer Ingelheim is the company developing idarucizumab.
Dr Stangier said idarucizumab binds dabigatran with high affinity, off-target binding is not expected, and no procoagulant effects have been observed with the drug.
In a previous study of healthy volunteers, idarucizumab provided immediate, complete, and sustained reversal of dabigatran’s anticoagulant effect. The effect was sustained when idarucizumab was given at 2 g and 4 g doses.
For the current study, Dr Stangier and his colleagues wanted to evaluate whether and to what extent doses of up to 5 g of idarucizumab would reverse the anticoagulant effects of dabigatran in healthy subjects, elderly participants, and renally impaired volunteers. The team also wanted to determine the effects of dabigatran given after subjects had received idarucizumab.
The study included 46 male and female subjects who were 45 to 80 years of age. Healthy subjects received dabigatran etexilate at 220 mg twice daily, and subjects with mild to moderate renal impairment received 150 mg twice daily, both over 4 days.
Subjects then received idarucizumab at 1 g, 2.5 g, 5 g, or 5 g given as 2 x 2.5 g 1 hour apart. They received these doses as 5-minute intravenous infusions 2 hours after their last dose of dabigatran.
The researchers found that dabigatran-prolonged clotting times—thrombin time, diluted thrombin time, ecarin clotting time, and activated partial thromboplastin time—were reversed to baseline immediately after the end of idarucizumab infusion.
And the team observed sustained reversal of dabigatran’s anticoagulant effects in all subjects.
The researchers then readministered dabigatran to healthy subjects 24 hours after idarucizumab treatment and to subjects who received placebo instead of idarucizumab.
Dabigatran-mediated anticoagulation was similar in subjects who received idarucizumab and those who received placebo. And anticoagulation was restored to levels comparable to initial levels.
Dr Stangier said there were no clinically relevant adverse events (AEs) related to idarucizumab, and there were no relevant changes in any of the investigated safety parameters. There were no AEs indicative of immunogenic reactions.
AEs and local tolerability reactions were similar for placebo and idarucizumab. And there was no relationship between the frequency of AEs and drug dose, gender, or renal function.
The researchers did observe a dose-dependent, transient increase in urine protein and low-weight proteins, but values returned to the normal range within 4 hours to 24 hours.
Based on these results, Dr Stangier said idarucizumab fulfills the requirements for a fast-acting and specific antidote to dabigatran with a favorable safety profile. Additional clinical testing of the antidote is ongoing. 
*Information in the abstract differs from that presented.
Credit: CDC
SAN FRANCISCO—An investigational, humanized antibody fragment known as idarucizumab can reverse the anticoagulation effects of dabigatran, new research suggests.
In a small study, idarucizumab led to sustained reversal of dabigatran’s effects in healthy subjects, elderly volunteers, and participants with mild to moderate renal impairment.
Furthermore, dabigatran anticoagulation could be re-established 24 hours after the subjects had received idarucizumab.
Joachim Stangier, PhD, of Boehringer Ingelheim Pharma GmbH & Co KG in Biberach, Germany, presented these results at the 2014 ASH Annual Meeting as abstract 344*. Boehringer Ingelheim is the company developing idarucizumab.
Dr Stangier said idarucizumab binds dabigatran with high affinity, off-target binding is not expected, and no procoagulant effects have been observed with the drug.
In a previous study of healthy volunteers, idarucizumab provided immediate, complete, and sustained reversal of dabigatran’s anticoagulant effect. The effect was sustained when idarucizumab was given at 2 g and 4 g doses.
For the current study, Dr Stangier and his colleagues wanted to evaluate whether and to what extent doses of up to 5 g of idarucizumab would reverse the anticoagulant effects of dabigatran in healthy subjects, elderly participants, and renally impaired volunteers. The team also wanted to determine the effects of dabigatran given after subjects had received idarucizumab.
The study included 46 male and female subjects who were 45 to 80 years of age. Healthy subjects received dabigatran etexilate at 220 mg twice daily, and subjects with mild to moderate renal impairment received 150 mg twice daily, both over 4 days.
Subjects then received idarucizumab at 1 g, 2.5 g, 5 g, or 5 g given as 2 x 2.5 g 1 hour apart. They received these doses as 5-minute intravenous infusions 2 hours after their last dose of dabigatran.
The researchers found that dabigatran-prolonged clotting times—thrombin time, diluted thrombin time, ecarin clotting time, and activated partial thromboplastin time—were reversed to baseline immediately after the end of idarucizumab infusion.
And the team observed sustained reversal of dabigatran’s anticoagulant effects in all subjects.
The researchers then readministered dabigatran to healthy subjects 24 hours after idarucizumab treatment and to subjects who received placebo instead of idarucizumab.
Dabigatran-mediated anticoagulation was similar in subjects who received idarucizumab and those who received placebo. And anticoagulation was restored to levels comparable to initial levels.
Dr Stangier said there were no clinically relevant adverse events (AEs) related to idarucizumab, and there were no relevant changes in any of the investigated safety parameters. There were no AEs indicative of immunogenic reactions.
AEs and local tolerability reactions were similar for placebo and idarucizumab. And there was no relationship between the frequency of AEs and drug dose, gender, or renal function.
The researchers did observe a dose-dependent, transient increase in urine protein and low-weight proteins, but values returned to the normal range within 4 hours to 24 hours.
Based on these results, Dr Stangier said idarucizumab fulfills the requirements for a fast-acting and specific antidote to dabigatran with a favorable safety profile. Additional clinical testing of the antidote is ongoing.
*Information in the abstract differs from that presented.
Credit: CDC
SAN FRANCISCO—An investigational, humanized antibody fragment known as idarucizumab can reverse the anticoagulation effects of dabigatran, new research suggests.
In a small study, idarucizumab led to sustained reversal of dabigatran’s effects in healthy subjects, elderly volunteers, and participants with mild to moderate renal impairment.
Furthermore, dabigatran anticoagulation could be re-established 24 hours after the subjects had received idarucizumab.
Joachim Stangier, PhD, of Boehringer Ingelheim Pharma GmbH & Co KG in Biberach, Germany, presented these results at the 2014 ASH Annual Meeting as abstract 344*. Boehringer Ingelheim is the company developing idarucizumab.
Dr Stangier said idarucizumab binds dabigatran with high affinity, off-target binding is not expected, and no procoagulant effects have been observed with the drug.
In a previous study of healthy volunteers, idarucizumab provided immediate, complete, and sustained reversal of dabigatran’s anticoagulant effect. The effect was sustained when idarucizumab was given at 2 g and 4 g doses.
For the current study, Dr Stangier and his colleagues wanted to evaluate whether and to what extent doses of up to 5 g of idarucizumab would reverse the anticoagulant effects of dabigatran in healthy subjects, elderly participants, and renally impaired volunteers. The team also wanted to determine the effects of dabigatran given after subjects had received idarucizumab.
The study included 46 male and female subjects who were 45 to 80 years of age. Healthy subjects received dabigatran etexilate at 220 mg twice daily, and subjects with mild to moderate renal impairment received 150 mg twice daily, both over 4 days.
Subjects then received idarucizumab at 1 g, 2.5 g, 5 g, or 5 g given as 2 x 2.5 g 1 hour apart. They received these doses as 5-minute intravenous infusions 2 hours after their last dose of dabigatran.
The researchers found that dabigatran-prolonged clotting times—thrombin time, diluted thrombin time, ecarin clotting time, and activated partial thromboplastin time—were reversed to baseline immediately after the end of idarucizumab infusion.
And the team observed sustained reversal of dabigatran’s anticoagulant effects in all subjects.
The researchers then readministered dabigatran to healthy subjects 24 hours after idarucizumab treatment and to subjects who received placebo instead of idarucizumab.
Dabigatran-mediated anticoagulation was similar in subjects who received idarucizumab and those who received placebo. And anticoagulation was restored to levels comparable to initial levels.
Dr Stangier said there were no clinically relevant adverse events (AEs) related to idarucizumab, and there were no relevant changes in any of the investigated safety parameters. There were no AEs indicative of immunogenic reactions.
AEs and local tolerability reactions were similar for placebo and idarucizumab. And there was no relationship between the frequency of AEs and drug dose, gender, or renal function.
The researchers did observe a dose-dependent, transient increase in urine protein and low-weight proteins, but values returned to the normal range within 4 hours to 24 hours.
Based on these results, Dr Stangier said idarucizumab fulfills the requirements for a fast-acting and specific antidote to dabigatran with a favorable safety profile. Additional clinical testing of the antidote is ongoing.
*Information in the abstract differs from that presented.
Cord blood product gets orphan designation
Credit: NHS
The US Food and Drug Administration (FDA) has granted orphan designation to a cord blood product called NiCord for the treatment of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), Hodgkin lymphoma (HL), and myelodysplastic syndromes (MDS).
NiCord consists of cells from a single cord blood unit cultured in nicotinamide—a vitamin B derivative—and cytokines that are typically used for expansion—thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor.
The FDA’s orphan drug designation for NiCord coincides with the positive opinion of the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products regarding NiCord as a treatment for AML. Gamida Cell, the company developing NiCord, intends to file for orphan drug status with the EMA for other indications as well.
“Receipt of orphan drug status for NiCord in the US and Europe advances Gamida Cell’s commercialization plans a major step further, as both afford significant advantages,” said Yael Margolin, President and CEO of Gamida Cell.
Orphan drug designation provides various regulatory and economic benefits, including 7 years of market exclusivity upon product approval in the US and 10 years in the European Union.
Trials of NiCord
NiCord is currently being tested in a phase 1/2 study as an investigational therapeutic treatment for hematologic malignancies. In this study, NiCord is being used as the sole stem cell source.
In a previous study, presented at the 11th Annual International Cord Blood Symposium, researchers transplanted a NiCord unit and an unmanipulated cord blood unit in patients with ALL, AML, MDS, HL, or non-Hodgkin lymphoma.
A majority of patients in this small, phase 1/2 study achieved early platelet and neutrophil engraftment. And, in some patients, that engraftment persisted for 2 years.
Eight of the 11 patients enrolled achieved engraftment with the NiCord unit, and 2 engrafted with the unmanipulated cord blood unit. One patient had primary graft failure.
There were no adverse events attributable to the NiCord unit, but 4 patients developed grade 1-2 acute GVHD, and 1 patient developed limited chronic GVHD.
For more information on NiCord, visit the Gamida Cell website.
Credit: NHS
The US Food and Drug Administration (FDA) has granted orphan designation to a cord blood product called NiCord for the treatment of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), Hodgkin lymphoma (HL), and myelodysplastic syndromes (MDS).
NiCord consists of cells from a single cord blood unit cultured in nicotinamide—a vitamin B derivative—and cytokines that are typically used for expansion—thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor.
The FDA’s orphan drug designation for NiCord coincides with the positive opinion of the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products regarding NiCord as a treatment for AML. Gamida Cell, the company developing NiCord, intends to file for orphan drug status with the EMA for other indications as well.
“Receipt of orphan drug status for NiCord in the US and Europe advances Gamida Cell’s commercialization plans a major step further, as both afford significant advantages,” said Yael Margolin, President and CEO of Gamida Cell.
Orphan drug designation provides various regulatory and economic benefits, including 7 years of market exclusivity upon product approval in the US and 10 years in the European Union.
Trials of NiCord
NiCord is currently being tested in a phase 1/2 study as an investigational therapeutic treatment for hematologic malignancies. In this study, NiCord is being used as the sole stem cell source.
In a previous study, presented at the 11th Annual International Cord Blood Symposium, researchers transplanted a NiCord unit and an unmanipulated cord blood unit in patients with ALL, AML, MDS, HL, or non-Hodgkin lymphoma.
A majority of patients in this small, phase 1/2 study achieved early platelet and neutrophil engraftment. And, in some patients, that engraftment persisted for 2 years.
Eight of the 11 patients enrolled achieved engraftment with the NiCord unit, and 2 engrafted with the unmanipulated cord blood unit. One patient had primary graft failure.
There were no adverse events attributable to the NiCord unit, but 4 patients developed grade 1-2 acute GVHD, and 1 patient developed limited chronic GVHD.
For more information on NiCord, visit the Gamida Cell website.
Credit: NHS
The US Food and Drug Administration (FDA) has granted orphan designation to a cord blood product called NiCord for the treatment of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), Hodgkin lymphoma (HL), and myelodysplastic syndromes (MDS).
NiCord consists of cells from a single cord blood unit cultured in nicotinamide—a vitamin B derivative—and cytokines that are typically used for expansion—thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor.
The FDA’s orphan drug designation for NiCord coincides with the positive opinion of the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products regarding NiCord as a treatment for AML. Gamida Cell, the company developing NiCord, intends to file for orphan drug status with the EMA for other indications as well.
“Receipt of orphan drug status for NiCord in the US and Europe advances Gamida Cell’s commercialization plans a major step further, as both afford significant advantages,” said Yael Margolin, President and CEO of Gamida Cell.
Orphan drug designation provides various regulatory and economic benefits, including 7 years of market exclusivity upon product approval in the US and 10 years in the European Union.
Trials of NiCord
NiCord is currently being tested in a phase 1/2 study as an investigational therapeutic treatment for hematologic malignancies. In this study, NiCord is being used as the sole stem cell source.
In a previous study, presented at the 11th Annual International Cord Blood Symposium, researchers transplanted a NiCord unit and an unmanipulated cord blood unit in patients with ALL, AML, MDS, HL, or non-Hodgkin lymphoma.
A majority of patients in this small, phase 1/2 study achieved early platelet and neutrophil engraftment. And, in some patients, that engraftment persisted for 2 years.
Eight of the 11 patients enrolled achieved engraftment with the NiCord unit, and 2 engrafted with the unmanipulated cord blood unit. One patient had primary graft failure.
There were no adverse events attributable to the NiCord unit, but 4 patients developed grade 1-2 acute GVHD, and 1 patient developed limited chronic GVHD.
For more information on NiCord, visit the Gamida Cell website.
Targeting enzymes to treat leukemias
Credit: Volker Brinkmann
Enzymes linked to diabetes and obesity appear to play key roles in arthritis and leukemia, according to research published in Cell Metabolism.
Working with mice, researchers discovered that the same enzymes involved in turning carbohydrates into the building blocks of fats also influence the health of neutrophils.
“The link between these enzymes and neutrophils was a big surprise,” said study author Irfan J. Lodhi, PhD, of the Washington University School of Medicine in St. Louis.
“We had never thought about treating rheumatoid arthritis or leukemia by targeting enzymes that produce fatty acids, but this work supports that line of thinking.”
In the study, mice that couldn’t make enzymes needed to produce a certain type of fat abruptly lost weight and developed extremely low white blood cell counts, with very few neutrophils. Without this fat, called an ether lipid, neutrophils died.
That discovery could lead to the targeting of ether lipids as a way to reduce the number of neutrophils in inflammatory diseases and leukemias. The researchers believe limiting, rather than eliminating, ether lipids may be the best approach because neutrophils are important infection fighters.
“This may be a pathway to limit inflammation,” said study author Clay F. Semenkovich, MD, also of the Washington University School of Medicine.
“If we could reduce the activity of these enzymes without eliminating them entirely, it could lower the levels of ether lipids and potentially help patients with leukemia and inflammatory diseases such as arthritis.”
Dr Semenkovich said the enzymes specifically target neutrophils without affecting other immune cells, “so ether lipids appear to be a very precise target.”
The researchers also learned that inactivating the enzymes didn’t harm the precursors of neutrophils; only mature neutrophils were killed.
That could mean strategies to limit the production of ether lipids might lower neutrophil levels only temporarily so that when treatment stops, a patient’s neutrophil count would gradually rise, allowing the immune system to return to normal.
Credit: Volker Brinkmann
Enzymes linked to diabetes and obesity appear to play key roles in arthritis and leukemia, according to research published in Cell Metabolism.
Working with mice, researchers discovered that the same enzymes involved in turning carbohydrates into the building blocks of fats also influence the health of neutrophils.
“The link between these enzymes and neutrophils was a big surprise,” said study author Irfan J. Lodhi, PhD, of the Washington University School of Medicine in St. Louis.
“We had never thought about treating rheumatoid arthritis or leukemia by targeting enzymes that produce fatty acids, but this work supports that line of thinking.”
In the study, mice that couldn’t make enzymes needed to produce a certain type of fat abruptly lost weight and developed extremely low white blood cell counts, with very few neutrophils. Without this fat, called an ether lipid, neutrophils died.
That discovery could lead to the targeting of ether lipids as a way to reduce the number of neutrophils in inflammatory diseases and leukemias. The researchers believe limiting, rather than eliminating, ether lipids may be the best approach because neutrophils are important infection fighters.
“This may be a pathway to limit inflammation,” said study author Clay F. Semenkovich, MD, also of the Washington University School of Medicine.
“If we could reduce the activity of these enzymes without eliminating them entirely, it could lower the levels of ether lipids and potentially help patients with leukemia and inflammatory diseases such as arthritis.”
Dr Semenkovich said the enzymes specifically target neutrophils without affecting other immune cells, “so ether lipids appear to be a very precise target.”
The researchers also learned that inactivating the enzymes didn’t harm the precursors of neutrophils; only mature neutrophils were killed.
That could mean strategies to limit the production of ether lipids might lower neutrophil levels only temporarily so that when treatment stops, a patient’s neutrophil count would gradually rise, allowing the immune system to return to normal.
Credit: Volker Brinkmann
Enzymes linked to diabetes and obesity appear to play key roles in arthritis and leukemia, according to research published in Cell Metabolism.
Working with mice, researchers discovered that the same enzymes involved in turning carbohydrates into the building blocks of fats also influence the health of neutrophils.
“The link between these enzymes and neutrophils was a big surprise,” said study author Irfan J. Lodhi, PhD, of the Washington University School of Medicine in St. Louis.
“We had never thought about treating rheumatoid arthritis or leukemia by targeting enzymes that produce fatty acids, but this work supports that line of thinking.”
In the study, mice that couldn’t make enzymes needed to produce a certain type of fat abruptly lost weight and developed extremely low white blood cell counts, with very few neutrophils. Without this fat, called an ether lipid, neutrophils died.
That discovery could lead to the targeting of ether lipids as a way to reduce the number of neutrophils in inflammatory diseases and leukemias. The researchers believe limiting, rather than eliminating, ether lipids may be the best approach because neutrophils are important infection fighters.
“This may be a pathway to limit inflammation,” said study author Clay F. Semenkovich, MD, also of the Washington University School of Medicine.
“If we could reduce the activity of these enzymes without eliminating them entirely, it could lower the levels of ether lipids and potentially help patients with leukemia and inflammatory diseases such as arthritis.”
Dr Semenkovich said the enzymes specifically target neutrophils without affecting other immune cells, “so ether lipids appear to be a very precise target.”
The researchers also learned that inactivating the enzymes didn’t harm the precursors of neutrophils; only mature neutrophils were killed.
That could mean strategies to limit the production of ether lipids might lower neutrophil levels only temporarily so that when treatment stops, a patient’s neutrophil count would gradually rise, allowing the immune system to return to normal.
CAR T-cell therapy gets orphan designation for DLBCL
Credit: Charles Haymond
The European Commission has granted KTE-C19, a chimeric antigen receptor (CAR) T-cell therapy, orphan designation to treat patients with diffuse large B-cell lymphoma (DLBCL) in the European Union (EU).
To create KTE-C19, a patient’s T cells are genetically modified using a gammaretroviral vector to express a CAR designed to target CD19, a protein expressed on B cells.
The product received orphan designation to treat DLBCL in the US last March.
“We are pleased with the approval of orphan drug designation for KTE-C19 in the EU, another important milestone for Kite Pharma and for the progress of our lead program,” said Arie Belldegrun, MD, President and CEO of Kite Pharma, Inc., the company developing KTE-C19.
Orphan designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 persons in the EU, and where no satisfactory treatment is available.
In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase, and direct access to the centralized authorization procedure.
KTE-C19 in DLBCL
In a study published in the Journal of Clinical Oncology last year, researchers evaluated KTE-C19 in 15 patients with advanced B-cell malignancies.
The patients received a conditioning regimen of cyclophosphamide and fludarabine, followed 1 day later by a single infusion of KTE-C19. The researchers noted that the conditioning regimen is known to be active against B-cell malignancies and could have made a direct contribution to patient responses.
Of the 7 patients with chemotherapy-refractory DLBCL, 4 achieved a complete response to treatment, 2 achieved a partial response, and 1 had stable disease. Three of the complete responses were ongoing at the time of publication, with the duration ranging from 9 months to 22 months.
In the entire patient population, KTE-C19 elicited a number of adverse events, including fever, hypotension, delirium, and other neurologic toxicities. All but 2 patients experienced grade 3/4 adverse events.
Three patients developed unexpected neurologic abnormalities. One patient experienced aphasia and right-sided facial paresis. One patient developed aphasia, confusion, and severe, generalized myoclonus. And 1 patient had aphasia, confusion, hemifacial spasms, apraxia, and gait disturbances.
For more information on KTE-C19, visit Kite Pharma’s website.
Credit: Charles Haymond
The European Commission has granted KTE-C19, a chimeric antigen receptor (CAR) T-cell therapy, orphan designation to treat patients with diffuse large B-cell lymphoma (DLBCL) in the European Union (EU).
To create KTE-C19, a patient’s T cells are genetically modified using a gammaretroviral vector to express a CAR designed to target CD19, a protein expressed on B cells.
The product received orphan designation to treat DLBCL in the US last March.
“We are pleased with the approval of orphan drug designation for KTE-C19 in the EU, another important milestone for Kite Pharma and for the progress of our lead program,” said Arie Belldegrun, MD, President and CEO of Kite Pharma, Inc., the company developing KTE-C19.
Orphan designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 persons in the EU, and where no satisfactory treatment is available.
In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase, and direct access to the centralized authorization procedure.
KTE-C19 in DLBCL
In a study published in the Journal of Clinical Oncology last year, researchers evaluated KTE-C19 in 15 patients with advanced B-cell malignancies.
The patients received a conditioning regimen of cyclophosphamide and fludarabine, followed 1 day later by a single infusion of KTE-C19. The researchers noted that the conditioning regimen is known to be active against B-cell malignancies and could have made a direct contribution to patient responses.
Of the 7 patients with chemotherapy-refractory DLBCL, 4 achieved a complete response to treatment, 2 achieved a partial response, and 1 had stable disease. Three of the complete responses were ongoing at the time of publication, with the duration ranging from 9 months to 22 months.
In the entire patient population, KTE-C19 elicited a number of adverse events, including fever, hypotension, delirium, and other neurologic toxicities. All but 2 patients experienced grade 3/4 adverse events.
Three patients developed unexpected neurologic abnormalities. One patient experienced aphasia and right-sided facial paresis. One patient developed aphasia, confusion, and severe, generalized myoclonus. And 1 patient had aphasia, confusion, hemifacial spasms, apraxia, and gait disturbances.
For more information on KTE-C19, visit Kite Pharma’s website.
Credit: Charles Haymond
The European Commission has granted KTE-C19, a chimeric antigen receptor (CAR) T-cell therapy, orphan designation to treat patients with diffuse large B-cell lymphoma (DLBCL) in the European Union (EU).
To create KTE-C19, a patient’s T cells are genetically modified using a gammaretroviral vector to express a CAR designed to target CD19, a protein expressed on B cells.
The product received orphan designation to treat DLBCL in the US last March.
“We are pleased with the approval of orphan drug designation for KTE-C19 in the EU, another important milestone for Kite Pharma and for the progress of our lead program,” said Arie Belldegrun, MD, President and CEO of Kite Pharma, Inc., the company developing KTE-C19.
Orphan designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 persons in the EU, and where no satisfactory treatment is available.
In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase, and direct access to the centralized authorization procedure.
KTE-C19 in DLBCL
In a study published in the Journal of Clinical Oncology last year, researchers evaluated KTE-C19 in 15 patients with advanced B-cell malignancies.
The patients received a conditioning regimen of cyclophosphamide and fludarabine, followed 1 day later by a single infusion of KTE-C19. The researchers noted that the conditioning regimen is known to be active against B-cell malignancies and could have made a direct contribution to patient responses.
Of the 7 patients with chemotherapy-refractory DLBCL, 4 achieved a complete response to treatment, 2 achieved a partial response, and 1 had stable disease. Three of the complete responses were ongoing at the time of publication, with the duration ranging from 9 months to 22 months.
In the entire patient population, KTE-C19 elicited a number of adverse events, including fever, hypotension, delirium, and other neurologic toxicities. All but 2 patients experienced grade 3/4 adverse events.
Three patients developed unexpected neurologic abnormalities. One patient experienced aphasia and right-sided facial paresis. One patient developed aphasia, confusion, and severe, generalized myoclonus. And 1 patient had aphasia, confusion, hemifacial spasms, apraxia, and gait disturbances.
For more information on KTE-C19, visit Kite Pharma’s website.
Intermittent PPI = Continuous-Infusion PPI for High-Risk Bleeding Ulcers
Clinical question
Is intermittent proton pump inhibitor (PPI) therapy comparable with continuous-infusion PPI for the treatment of patients with high-risk bleeding ulcers who have undergone endoscopic therapy?
Bottom line
For patients with high-risk bleeding ulcers who have been treated endoscopically, treatment with intermittent proton pump inhibitor (PPI) therapy is as effective as continuous infusion of PPIs for the prevention of rebleeding. This systematic review, however, was not able to determine the most optimal intermittent PPI regimen for this purpose because the included studies included used various dosing schedules and administration routes. (LOE = 1a)
Reference
Study design: Meta-analysis (randomized controlled trials)
Funding source: Government
Allocation: Uncertain
Setting: Inpatient (ward only)
Synopsis
Current guidelines recommend that patients with bleeding ulcers and endoscopic evidence of active bleeding, nonbleeding visible vessels, and adherent clots should receive an intravenous bolus dose of PPI followed by a continuous PPI infusion for 72 hours to prevent rebleeding. In this study, investigators searched multiple databases including MEDLINE, EMBASE, and the Cochrane Register to find randomized clinical trials that evaluated this continuous PPI regimen versus the use of intermittent PPIs for the treatment of these high-risk bleeding ulcers. The intermittent PPI regimens differed in both dosage and administration, from pantoprazole 40 mg given orally every 12 hours to pantoprazole 80 mg given intravenously once, followed by 40 mg intravenously every 6 hours.
Two authors independently performed the search, selected studies for inclusion, extracted data, and assessed the risk of bias for included studies. Ten of the 13 selected studies reported on the primary outcome of recurrent bleeding within 7 days and found that intermittent PPI use was noninferior to continuous-infusion PPI therapy, with the noninferiority margin predefined as an absolute risk difference of 3%. Noninferiority criteria were also met for the secondary outcomes, including rebleeding at 3 days or 30 days, mortality, need for surgical intervention, need for transfusion, and hospital length of stay. No publication or reporting biases were detected.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question
Is intermittent proton pump inhibitor (PPI) therapy comparable with continuous-infusion PPI for the treatment of patients with high-risk bleeding ulcers who have undergone endoscopic therapy?
Bottom line
For patients with high-risk bleeding ulcers who have been treated endoscopically, treatment with intermittent proton pump inhibitor (PPI) therapy is as effective as continuous infusion of PPIs for the prevention of rebleeding. This systematic review, however, was not able to determine the most optimal intermittent PPI regimen for this purpose because the included studies included used various dosing schedules and administration routes. (LOE = 1a)
Reference
Study design: Meta-analysis (randomized controlled trials)
Funding source: Government
Allocation: Uncertain
Setting: Inpatient (ward only)
Synopsis
Current guidelines recommend that patients with bleeding ulcers and endoscopic evidence of active bleeding, nonbleeding visible vessels, and adherent clots should receive an intravenous bolus dose of PPI followed by a continuous PPI infusion for 72 hours to prevent rebleeding. In this study, investigators searched multiple databases including MEDLINE, EMBASE, and the Cochrane Register to find randomized clinical trials that evaluated this continuous PPI regimen versus the use of intermittent PPIs for the treatment of these high-risk bleeding ulcers. The intermittent PPI regimens differed in both dosage and administration, from pantoprazole 40 mg given orally every 12 hours to pantoprazole 80 mg given intravenously once, followed by 40 mg intravenously every 6 hours.
Two authors independently performed the search, selected studies for inclusion, extracted data, and assessed the risk of bias for included studies. Ten of the 13 selected studies reported on the primary outcome of recurrent bleeding within 7 days and found that intermittent PPI use was noninferior to continuous-infusion PPI therapy, with the noninferiority margin predefined as an absolute risk difference of 3%. Noninferiority criteria were also met for the secondary outcomes, including rebleeding at 3 days or 30 days, mortality, need for surgical intervention, need for transfusion, and hospital length of stay. No publication or reporting biases were detected.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question
Is intermittent proton pump inhibitor (PPI) therapy comparable with continuous-infusion PPI for the treatment of patients with high-risk bleeding ulcers who have undergone endoscopic therapy?
Bottom line
For patients with high-risk bleeding ulcers who have been treated endoscopically, treatment with intermittent proton pump inhibitor (PPI) therapy is as effective as continuous infusion of PPIs for the prevention of rebleeding. This systematic review, however, was not able to determine the most optimal intermittent PPI regimen for this purpose because the included studies included used various dosing schedules and administration routes. (LOE = 1a)
Reference
Study design: Meta-analysis (randomized controlled trials)
Funding source: Government
Allocation: Uncertain
Setting: Inpatient (ward only)
Synopsis
Current guidelines recommend that patients with bleeding ulcers and endoscopic evidence of active bleeding, nonbleeding visible vessels, and adherent clots should receive an intravenous bolus dose of PPI followed by a continuous PPI infusion for 72 hours to prevent rebleeding. In this study, investigators searched multiple databases including MEDLINE, EMBASE, and the Cochrane Register to find randomized clinical trials that evaluated this continuous PPI regimen versus the use of intermittent PPIs for the treatment of these high-risk bleeding ulcers. The intermittent PPI regimens differed in both dosage and administration, from pantoprazole 40 mg given orally every 12 hours to pantoprazole 80 mg given intravenously once, followed by 40 mg intravenously every 6 hours.
Two authors independently performed the search, selected studies for inclusion, extracted data, and assessed the risk of bias for included studies. Ten of the 13 selected studies reported on the primary outcome of recurrent bleeding within 7 days and found that intermittent PPI use was noninferior to continuous-infusion PPI therapy, with the noninferiority margin predefined as an absolute risk difference of 3%. Noninferiority criteria were also met for the secondary outcomes, including rebleeding at 3 days or 30 days, mortality, need for surgical intervention, need for transfusion, and hospital length of stay. No publication or reporting biases were detected.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
PEG Better and Faster than Lactulose for Initial Treatment of Hepatic Encephalopathy
Clinical question
Is polyethylene glycol 3350-electrolyte solution an effective treatment for hospitalized patients with acute hepatic encephalopathy?
Bottom line
Polyethylene glycol 3350-electrolyte solution (PEG) is a safe and effective therapy for the initial treatment of acute hepatic encephalopathy (HE) in hospitalized patients. As compared with lactulose alone, the use of PEG alone during the first 24 hours of presentation worked better at improving symptoms of HE. The benefit beyond this time is less clear as both groups in this study received lactulose after 24 hours. (LOE = 1b)
Reference
Study design
Randomized controlled trial (nonblinded)
Funding source
Government
Allocation
Concealed
Setting
Inpatient (ward only)
Synopsis
Lactulose has long been used as the standard therapy for the treatment of acute HE. This study evaluated the efficacy of PEG as compared with lactulose for the initial treatment of HE. Using concealed allocation, investigators randomized 50 adult patients with cirrhosis and evidence of acute HE to receive either PEG or lactulose.
Patients in the PEG group received 4 L of PEG orally or via nasogastric tube as a single dose over 4 hours. Patients in the lactulose group received 20 g to 30 g lactulose orally or via nasogastric tube for 3 or more doses over 24 hours, or a single dose of 200 g lactulose via rectal tube. Grade of HE was determined prior to treatment and again at 24 hours using the hepatic encephalopathy scoring algorithm (HESA).
After 24 hours, all patients received lactulose per the standard of care. Baseline characteristics of the 2 groups were similar, with an average age of 56 years and similar Model of End-stage Liver Disease (MELD) scores. Analysis was by intention to treat. Patients in both groups had a mean baseline HE grade of 2.3. For the primary outcome of improvement in HE grade by 1 or more at 24 hours, PEG was more effective than lactulose (91% vs 52% patients with improved scores, P < .01). Furthermore, the median time to HE resolution was shorter in the PEG group (1 day vs 2 days, P =.01) with a trend toward decreased hospital length of stay (4 days vs 8 days, P =.07). There were no adverse events that were definitively attributed to the study medications in either group.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question
Is polyethylene glycol 3350-electrolyte solution an effective treatment for hospitalized patients with acute hepatic encephalopathy?
Bottom line
Polyethylene glycol 3350-electrolyte solution (PEG) is a safe and effective therapy for the initial treatment of acute hepatic encephalopathy (HE) in hospitalized patients. As compared with lactulose alone, the use of PEG alone during the first 24 hours of presentation worked better at improving symptoms of HE. The benefit beyond this time is less clear as both groups in this study received lactulose after 24 hours. (LOE = 1b)
Reference
Study design
Randomized controlled trial (nonblinded)
Funding source
Government
Allocation
Concealed
Setting
Inpatient (ward only)
Synopsis
Lactulose has long been used as the standard therapy for the treatment of acute HE. This study evaluated the efficacy of PEG as compared with lactulose for the initial treatment of HE. Using concealed allocation, investigators randomized 50 adult patients with cirrhosis and evidence of acute HE to receive either PEG or lactulose.
Patients in the PEG group received 4 L of PEG orally or via nasogastric tube as a single dose over 4 hours. Patients in the lactulose group received 20 g to 30 g lactulose orally or via nasogastric tube for 3 or more doses over 24 hours, or a single dose of 200 g lactulose via rectal tube. Grade of HE was determined prior to treatment and again at 24 hours using the hepatic encephalopathy scoring algorithm (HESA).
After 24 hours, all patients received lactulose per the standard of care. Baseline characteristics of the 2 groups were similar, with an average age of 56 years and similar Model of End-stage Liver Disease (MELD) scores. Analysis was by intention to treat. Patients in both groups had a mean baseline HE grade of 2.3. For the primary outcome of improvement in HE grade by 1 or more at 24 hours, PEG was more effective than lactulose (91% vs 52% patients with improved scores, P < .01). Furthermore, the median time to HE resolution was shorter in the PEG group (1 day vs 2 days, P =.01) with a trend toward decreased hospital length of stay (4 days vs 8 days, P =.07). There were no adverse events that were definitively attributed to the study medications in either group.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
Clinical question
Is polyethylene glycol 3350-electrolyte solution an effective treatment for hospitalized patients with acute hepatic encephalopathy?
Bottom line
Polyethylene glycol 3350-electrolyte solution (PEG) is a safe and effective therapy for the initial treatment of acute hepatic encephalopathy (HE) in hospitalized patients. As compared with lactulose alone, the use of PEG alone during the first 24 hours of presentation worked better at improving symptoms of HE. The benefit beyond this time is less clear as both groups in this study received lactulose after 24 hours. (LOE = 1b)
Reference
Study design
Randomized controlled trial (nonblinded)
Funding source
Government
Allocation
Concealed
Setting
Inpatient (ward only)
Synopsis
Lactulose has long been used as the standard therapy for the treatment of acute HE. This study evaluated the efficacy of PEG as compared with lactulose for the initial treatment of HE. Using concealed allocation, investigators randomized 50 adult patients with cirrhosis and evidence of acute HE to receive either PEG or lactulose.
Patients in the PEG group received 4 L of PEG orally or via nasogastric tube as a single dose over 4 hours. Patients in the lactulose group received 20 g to 30 g lactulose orally or via nasogastric tube for 3 or more doses over 24 hours, or a single dose of 200 g lactulose via rectal tube. Grade of HE was determined prior to treatment and again at 24 hours using the hepatic encephalopathy scoring algorithm (HESA).
After 24 hours, all patients received lactulose per the standard of care. Baseline characteristics of the 2 groups were similar, with an average age of 56 years and similar Model of End-stage Liver Disease (MELD) scores. Analysis was by intention to treat. Patients in both groups had a mean baseline HE grade of 2.3. For the primary outcome of improvement in HE grade by 1 or more at 24 hours, PEG was more effective than lactulose (91% vs 52% patients with improved scores, P < .01). Furthermore, the median time to HE resolution was shorter in the PEG group (1 day vs 2 days, P =.01) with a trend toward decreased hospital length of stay (4 days vs 8 days, P =.07). There were no adverse events that were definitively attributed to the study medications in either group.
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.
LISTEN NOW: Hospitalist Chris Spoja discusses his decision to pursue a MMM degree
Listen to Chris Spoja, MD, a hospitalist with Sound Physicians, explain his decision to pursue a Master’s of Medical Management (MMM) degree.
Listen to Chris Spoja, MD, a hospitalist with Sound Physicians, explain his decision to pursue a Master’s of Medical Management (MMM) degree.
Listen to Chris Spoja, MD, a hospitalist with Sound Physicians, explain his decision to pursue a Master’s of Medical Management (MMM) degree.
Movers and Shakers in Hospital Medicine, January 2015
This month, The Hospitalist features new appointments, promotions, awards, and achievements of hospital medicine physicians and healthcare industry professionals.
Douglas Carlson, MD, FAAP, SFHM, has been appointed professor and chair of the department of pediatrics at Southern Illinois University in Springfield, Ill. Dr. Carlson is a pediatric hospitalist who served as director of the pediatric hospitalist medicine division at Washington University School of Medicine in St. Louis, Mo. Dr. Carlson currently serves as co-chair of the SHM Pediatric Committee, as well as Workforce Taskforce Leader for the Pediatric Hospital Medicine Leadership Committee and chair of the Pediatric Hospital Medicine National Conference Planning Committee.
Howard Epstein, MD, FHM, has been appointed executive vice president and chief medical officer at PreferredOne, a health services and insurance provider based in Golden Valley, Minn. Dr. Epstein comes to PreferredOne from the Institute for Clinical Systems Improvement (ICSI) in Bloomington, where he served as chief health systems officer. An SHM board member, Dr. Epstein previously helped found the hospital medicine and palliative care programs at Regions Hospital and HealthPartners Medical Group in St. Paul, Minn.
Les Hall, MD, has been appointed executive dean of the University of South Carolina School of Medicine, as well as CEO of Palmetto Health-USC Medical Group in Columbia, S.C. Prior to his role at the University of South Carolina, Dr. Hall served as associate dean for clinical affairs at the University of Missouri School of Medicine and chief medical officer of the University of Missouri Health System in Columbia, Mo. Dr. Hall is a practicing hospitalist and an active member of SHM, and he has continued to care for patients throughout his career as a healthcare leader.
• Liesbet Jansen, MD, was awarded the 2014 Dr. Alexander MacIntyre Award of Excellence by the Alliston (Ontario, Canada) and Area Physician Recruitment Committee for demonstrating excellence in medical practice and commitment to the local community. Dr. Jansen serves as a hospitalist and chief of family medicine at Stevenson Memorial Hospital in Alliston, Ontario, Canada.
Hans Jeppesen, MD, is the new chief of hospital medicine at North Shore Medical Center (NSMC) in Salem, Mass. In addition to overseeing the hospitalist team at NSMC, Dr. Jeppesen will also be responsible for caring for inpatients at NSMC Salem and Union (Lynn, Mass.) Hospitals. Before joining NSMC, Dr. Jeppesen served as chief of hospitalist services at Cambridge Health Alliance in Cambridge, Mass.
Todd Kislak is the new chief development officer for Hospitalists Now, Inc. (HNI), a national physician management company based in Austin, Texas. In his new role, Kislak is responsible for sales and business development as well as marketing for HNI. Kislak formerly served as vice president of marketing and development for IPC The Hospitalist Company, based in North Hollywood, Calif.
Kelly London, PA-C, has been awarded Non-Physician Hospitalist of the Year by the Maryland chapter of the Society of Hospital Medicine. London is the first nonphysician provider to receive the award, and was nominated along with other qualified nurse practitioners and physician assistants throughout Maryland. London serves on the hospitalist team at Anne Arundel Medical Center, managed by MDICS (Physicians Inpatient Care Specialists), in Annapolis, Md.
Jennifer Miraglia is the new executive director for the Chicago region of IPC The Hospitalist Company, a national hospital medicine management company based in North Hollywood, Calif. Before coming to IPC, Miraglia worked as regional vice president of operations for RehabCare, a division of Kindred Healthcare based in Louisville, Ky. IPC manages hospitalist services in over 400 hospitals across the United States.
Steven Pantilat, MD, MHM, FAAHPM, recently was awarded the Ritz E. Heerman Memorial Award by the California Hospital Association Board of Trustees for his work on improving the quality of palliative care services in California. Dr. Pantilat is the founding director of the University of California, San Francisco (UCSF) Palliative Care Program, and director of the UCSF Palliative Care Leadership Center. Dr. Pantilat is a past president of SHM and currently works as a professor of clinical medicine at UCSF.
Business Moves
• North Hollywood, Calif.-based IPC The Hospitalist Company has acquired the following practices: Hospital Practice Associates, Inc. (HPA), in Jacksonville, Fla.; John N. Campbell, MD, PC, in Grand Rapids, Mich.; Comprehensive Health Solutions, in Newtown Square, Penn.; Midland Hospitalists PLC in Midland, Mich.; and Clyo Internal Medicine in Dayton, Ohio. IPC is a national hospitalist management company serving over 400 hospitals and 1,200 post-acute care facilities across the country.
• The Greenville, S.C.-based Ob Hospitalist Group (OBHG) recently received the following honors: voted one of the Inc. 5,000 Fastest Growing Private Companies in America for the second year running for a growth rate of 239% since 2011; voted one of the Best Places to Work in South Carolina by the South Carolina Chamber of Commerce and SC Biz News, for the second consecutive year; listed on the Roaring Twenties List from SC Biz News as one of the 40 highest performing companies in South Carolina; and included on South Carolina’s 25 Fastest-Growing Companies list for the third year running. OBHG has been providing OB/GYN hospitalist services across the country since 2006.
• The OSF St. Elizabeth Medical Center in Ottawa, Ill., has just introduced a new hospitalist program at its 99-bed acute care hospital. Robert B. Maguire, MD, a veteran Ottawa doctor, has been chosen to lead the new hospitalist program as medical director. OSF St. Elizabeth will continue to recruit additional hospitalists to the new program with the help of 24ON Physicians/In Compass Health, Inc., a hospitalist staffing firm based in Alpharetta, Ga.
• Penn State Hershey Children’s Hospital is now providing pediatric care at Moses Taylor Hospital in Scranton, Penn. Moses Taylor Hospital is a 217-bed acute care facility operated by Commonwealth Health, the largest healthcare system in northern Pennsylvania, which consists of six hospitals and dozens of post-acute care practices and facilities.
• TeamHealth, a national physician management company based in Knoxville, Tenn., announced its acquisition of Premier Physician Services, Inc., based in Dayton, Ohio. Premier consists of eight hospitalist programs as well as 45 emergency medicine programs, 15 correctional care programs, and 15 occupational medicine programs, which TeamHealth will now oversee. TeamHealth provides physician management and healthcare staffing in 47 states.
This month, The Hospitalist features new appointments, promotions, awards, and achievements of hospital medicine physicians and healthcare industry professionals.
Douglas Carlson, MD, FAAP, SFHM, has been appointed professor and chair of the department of pediatrics at Southern Illinois University in Springfield, Ill. Dr. Carlson is a pediatric hospitalist who served as director of the pediatric hospitalist medicine division at Washington University School of Medicine in St. Louis, Mo. Dr. Carlson currently serves as co-chair of the SHM Pediatric Committee, as well as Workforce Taskforce Leader for the Pediatric Hospital Medicine Leadership Committee and chair of the Pediatric Hospital Medicine National Conference Planning Committee.
Howard Epstein, MD, FHM, has been appointed executive vice president and chief medical officer at PreferredOne, a health services and insurance provider based in Golden Valley, Minn. Dr. Epstein comes to PreferredOne from the Institute for Clinical Systems Improvement (ICSI) in Bloomington, where he served as chief health systems officer. An SHM board member, Dr. Epstein previously helped found the hospital medicine and palliative care programs at Regions Hospital and HealthPartners Medical Group in St. Paul, Minn.
Les Hall, MD, has been appointed executive dean of the University of South Carolina School of Medicine, as well as CEO of Palmetto Health-USC Medical Group in Columbia, S.C. Prior to his role at the University of South Carolina, Dr. Hall served as associate dean for clinical affairs at the University of Missouri School of Medicine and chief medical officer of the University of Missouri Health System in Columbia, Mo. Dr. Hall is a practicing hospitalist and an active member of SHM, and he has continued to care for patients throughout his career as a healthcare leader.
• Liesbet Jansen, MD, was awarded the 2014 Dr. Alexander MacIntyre Award of Excellence by the Alliston (Ontario, Canada) and Area Physician Recruitment Committee for demonstrating excellence in medical practice and commitment to the local community. Dr. Jansen serves as a hospitalist and chief of family medicine at Stevenson Memorial Hospital in Alliston, Ontario, Canada.
Hans Jeppesen, MD, is the new chief of hospital medicine at North Shore Medical Center (NSMC) in Salem, Mass. In addition to overseeing the hospitalist team at NSMC, Dr. Jeppesen will also be responsible for caring for inpatients at NSMC Salem and Union (Lynn, Mass.) Hospitals. Before joining NSMC, Dr. Jeppesen served as chief of hospitalist services at Cambridge Health Alliance in Cambridge, Mass.
Todd Kislak is the new chief development officer for Hospitalists Now, Inc. (HNI), a national physician management company based in Austin, Texas. In his new role, Kislak is responsible for sales and business development as well as marketing for HNI. Kislak formerly served as vice president of marketing and development for IPC The Hospitalist Company, based in North Hollywood, Calif.
Kelly London, PA-C, has been awarded Non-Physician Hospitalist of the Year by the Maryland chapter of the Society of Hospital Medicine. London is the first nonphysician provider to receive the award, and was nominated along with other qualified nurse practitioners and physician assistants throughout Maryland. London serves on the hospitalist team at Anne Arundel Medical Center, managed by MDICS (Physicians Inpatient Care Specialists), in Annapolis, Md.
Jennifer Miraglia is the new executive director for the Chicago region of IPC The Hospitalist Company, a national hospital medicine management company based in North Hollywood, Calif. Before coming to IPC, Miraglia worked as regional vice president of operations for RehabCare, a division of Kindred Healthcare based in Louisville, Ky. IPC manages hospitalist services in over 400 hospitals across the United States.
Steven Pantilat, MD, MHM, FAAHPM, recently was awarded the Ritz E. Heerman Memorial Award by the California Hospital Association Board of Trustees for his work on improving the quality of palliative care services in California. Dr. Pantilat is the founding director of the University of California, San Francisco (UCSF) Palliative Care Program, and director of the UCSF Palliative Care Leadership Center. Dr. Pantilat is a past president of SHM and currently works as a professor of clinical medicine at UCSF.
Business Moves
• North Hollywood, Calif.-based IPC The Hospitalist Company has acquired the following practices: Hospital Practice Associates, Inc. (HPA), in Jacksonville, Fla.; John N. Campbell, MD, PC, in Grand Rapids, Mich.; Comprehensive Health Solutions, in Newtown Square, Penn.; Midland Hospitalists PLC in Midland, Mich.; and Clyo Internal Medicine in Dayton, Ohio. IPC is a national hospitalist management company serving over 400 hospitals and 1,200 post-acute care facilities across the country.
• The Greenville, S.C.-based Ob Hospitalist Group (OBHG) recently received the following honors: voted one of the Inc. 5,000 Fastest Growing Private Companies in America for the second year running for a growth rate of 239% since 2011; voted one of the Best Places to Work in South Carolina by the South Carolina Chamber of Commerce and SC Biz News, for the second consecutive year; listed on the Roaring Twenties List from SC Biz News as one of the 40 highest performing companies in South Carolina; and included on South Carolina’s 25 Fastest-Growing Companies list for the third year running. OBHG has been providing OB/GYN hospitalist services across the country since 2006.
• The OSF St. Elizabeth Medical Center in Ottawa, Ill., has just introduced a new hospitalist program at its 99-bed acute care hospital. Robert B. Maguire, MD, a veteran Ottawa doctor, has been chosen to lead the new hospitalist program as medical director. OSF St. Elizabeth will continue to recruit additional hospitalists to the new program with the help of 24ON Physicians/In Compass Health, Inc., a hospitalist staffing firm based in Alpharetta, Ga.
• Penn State Hershey Children’s Hospital is now providing pediatric care at Moses Taylor Hospital in Scranton, Penn. Moses Taylor Hospital is a 217-bed acute care facility operated by Commonwealth Health, the largest healthcare system in northern Pennsylvania, which consists of six hospitals and dozens of post-acute care practices and facilities.
• TeamHealth, a national physician management company based in Knoxville, Tenn., announced its acquisition of Premier Physician Services, Inc., based in Dayton, Ohio. Premier consists of eight hospitalist programs as well as 45 emergency medicine programs, 15 correctional care programs, and 15 occupational medicine programs, which TeamHealth will now oversee. TeamHealth provides physician management and healthcare staffing in 47 states.
This month, The Hospitalist features new appointments, promotions, awards, and achievements of hospital medicine physicians and healthcare industry professionals.
Douglas Carlson, MD, FAAP, SFHM, has been appointed professor and chair of the department of pediatrics at Southern Illinois University in Springfield, Ill. Dr. Carlson is a pediatric hospitalist who served as director of the pediatric hospitalist medicine division at Washington University School of Medicine in St. Louis, Mo. Dr. Carlson currently serves as co-chair of the SHM Pediatric Committee, as well as Workforce Taskforce Leader for the Pediatric Hospital Medicine Leadership Committee and chair of the Pediatric Hospital Medicine National Conference Planning Committee.
Howard Epstein, MD, FHM, has been appointed executive vice president and chief medical officer at PreferredOne, a health services and insurance provider based in Golden Valley, Minn. Dr. Epstein comes to PreferredOne from the Institute for Clinical Systems Improvement (ICSI) in Bloomington, where he served as chief health systems officer. An SHM board member, Dr. Epstein previously helped found the hospital medicine and palliative care programs at Regions Hospital and HealthPartners Medical Group in St. Paul, Minn.
Les Hall, MD, has been appointed executive dean of the University of South Carolina School of Medicine, as well as CEO of Palmetto Health-USC Medical Group in Columbia, S.C. Prior to his role at the University of South Carolina, Dr. Hall served as associate dean for clinical affairs at the University of Missouri School of Medicine and chief medical officer of the University of Missouri Health System in Columbia, Mo. Dr. Hall is a practicing hospitalist and an active member of SHM, and he has continued to care for patients throughout his career as a healthcare leader.
• Liesbet Jansen, MD, was awarded the 2014 Dr. Alexander MacIntyre Award of Excellence by the Alliston (Ontario, Canada) and Area Physician Recruitment Committee for demonstrating excellence in medical practice and commitment to the local community. Dr. Jansen serves as a hospitalist and chief of family medicine at Stevenson Memorial Hospital in Alliston, Ontario, Canada.
Hans Jeppesen, MD, is the new chief of hospital medicine at North Shore Medical Center (NSMC) in Salem, Mass. In addition to overseeing the hospitalist team at NSMC, Dr. Jeppesen will also be responsible for caring for inpatients at NSMC Salem and Union (Lynn, Mass.) Hospitals. Before joining NSMC, Dr. Jeppesen served as chief of hospitalist services at Cambridge Health Alliance in Cambridge, Mass.
Todd Kislak is the new chief development officer for Hospitalists Now, Inc. (HNI), a national physician management company based in Austin, Texas. In his new role, Kislak is responsible for sales and business development as well as marketing for HNI. Kislak formerly served as vice president of marketing and development for IPC The Hospitalist Company, based in North Hollywood, Calif.
Kelly London, PA-C, has been awarded Non-Physician Hospitalist of the Year by the Maryland chapter of the Society of Hospital Medicine. London is the first nonphysician provider to receive the award, and was nominated along with other qualified nurse practitioners and physician assistants throughout Maryland. London serves on the hospitalist team at Anne Arundel Medical Center, managed by MDICS (Physicians Inpatient Care Specialists), in Annapolis, Md.
Jennifer Miraglia is the new executive director for the Chicago region of IPC The Hospitalist Company, a national hospital medicine management company based in North Hollywood, Calif. Before coming to IPC, Miraglia worked as regional vice president of operations for RehabCare, a division of Kindred Healthcare based in Louisville, Ky. IPC manages hospitalist services in over 400 hospitals across the United States.
Steven Pantilat, MD, MHM, FAAHPM, recently was awarded the Ritz E. Heerman Memorial Award by the California Hospital Association Board of Trustees for his work on improving the quality of palliative care services in California. Dr. Pantilat is the founding director of the University of California, San Francisco (UCSF) Palliative Care Program, and director of the UCSF Palliative Care Leadership Center. Dr. Pantilat is a past president of SHM and currently works as a professor of clinical medicine at UCSF.
Business Moves
• North Hollywood, Calif.-based IPC The Hospitalist Company has acquired the following practices: Hospital Practice Associates, Inc. (HPA), in Jacksonville, Fla.; John N. Campbell, MD, PC, in Grand Rapids, Mich.; Comprehensive Health Solutions, in Newtown Square, Penn.; Midland Hospitalists PLC in Midland, Mich.; and Clyo Internal Medicine in Dayton, Ohio. IPC is a national hospitalist management company serving over 400 hospitals and 1,200 post-acute care facilities across the country.
• The Greenville, S.C.-based Ob Hospitalist Group (OBHG) recently received the following honors: voted one of the Inc. 5,000 Fastest Growing Private Companies in America for the second year running for a growth rate of 239% since 2011; voted one of the Best Places to Work in South Carolina by the South Carolina Chamber of Commerce and SC Biz News, for the second consecutive year; listed on the Roaring Twenties List from SC Biz News as one of the 40 highest performing companies in South Carolina; and included on South Carolina’s 25 Fastest-Growing Companies list for the third year running. OBHG has been providing OB/GYN hospitalist services across the country since 2006.
• The OSF St. Elizabeth Medical Center in Ottawa, Ill., has just introduced a new hospitalist program at its 99-bed acute care hospital. Robert B. Maguire, MD, a veteran Ottawa doctor, has been chosen to lead the new hospitalist program as medical director. OSF St. Elizabeth will continue to recruit additional hospitalists to the new program with the help of 24ON Physicians/In Compass Health, Inc., a hospitalist staffing firm based in Alpharetta, Ga.
• Penn State Hershey Children’s Hospital is now providing pediatric care at Moses Taylor Hospital in Scranton, Penn. Moses Taylor Hospital is a 217-bed acute care facility operated by Commonwealth Health, the largest healthcare system in northern Pennsylvania, which consists of six hospitals and dozens of post-acute care practices and facilities.
• TeamHealth, a national physician management company based in Knoxville, Tenn., announced its acquisition of Premier Physician Services, Inc., based in Dayton, Ohio. Premier consists of eight hospitalist programs as well as 45 emergency medicine programs, 15 correctional care programs, and 15 occupational medicine programs, which TeamHealth will now oversee. TeamHealth provides physician management and healthcare staffing in 47 states.
New Job Isn’t Focus of Everyone Seeking Advanced Management Degrees
Many hospitalists might get an advanced degree in management because they covet a specific job, but that might not be the only reason.
Kevan Pickrel, MD, MHM, a regional chief medical officer for Sound Physicians in Southern California, says his decision to get a master’s in healthcare management from the University of Texas at Dallas came down to credibility.
“I got the additional degree for one reason: a seat at the table,” Dr. Pickrel says. “Physicians complain a lot about all the change and the autonomy they have lost but do little about it beyond grumbling at lunch. I believe in hospital medicine as a discipline and believe in the value of the specialty. I wanted to be sure my specialty had a voice, and the only way to set myself apart from ‘just another whining doc’ was to add the letters.”
Making it happen was not a simple task, he says.
“Finding the time wasn’t easy,” he says. “I burned vacation time and leaned on my colleagues a lot. There are any number of physician- or executive-targeted programs offered that make it possible. Possible, but not easy.”
Chris Spoja, DO, a Sound hospitalist in Idaho, says he’d like to prepare himself for a chief medical officer job. He is planning to get his Master of Medical Management (MMM) from the University of Southern California (USC) next year, after he participates in a local leadership program in Idaho, which will allow him to network with people in his area.
“I would like to position myself to at least have that option,” he says, noting that the USC program will allow him to do most of his coursework online, participating in group discussions over Skype or doing work on his own. But he’ll have to visit the campus in Los Angeles for three days once a month.
“It’s not a small commitment,” he says. “But it’s doable.” TH
Tom Collins is a freelance writer in South Florida.
Many hospitalists might get an advanced degree in management because they covet a specific job, but that might not be the only reason.
Kevan Pickrel, MD, MHM, a regional chief medical officer for Sound Physicians in Southern California, says his decision to get a master’s in healthcare management from the University of Texas at Dallas came down to credibility.
“I got the additional degree for one reason: a seat at the table,” Dr. Pickrel says. “Physicians complain a lot about all the change and the autonomy they have lost but do little about it beyond grumbling at lunch. I believe in hospital medicine as a discipline and believe in the value of the specialty. I wanted to be sure my specialty had a voice, and the only way to set myself apart from ‘just another whining doc’ was to add the letters.”
Making it happen was not a simple task, he says.
“Finding the time wasn’t easy,” he says. “I burned vacation time and leaned on my colleagues a lot. There are any number of physician- or executive-targeted programs offered that make it possible. Possible, but not easy.”
Chris Spoja, DO, a Sound hospitalist in Idaho, says he’d like to prepare himself for a chief medical officer job. He is planning to get his Master of Medical Management (MMM) from the University of Southern California (USC) next year, after he participates in a local leadership program in Idaho, which will allow him to network with people in his area.
“I would like to position myself to at least have that option,” he says, noting that the USC program will allow him to do most of his coursework online, participating in group discussions over Skype or doing work on his own. But he’ll have to visit the campus in Los Angeles for three days once a month.
“It’s not a small commitment,” he says. “But it’s doable.” TH
Tom Collins is a freelance writer in South Florida.
Many hospitalists might get an advanced degree in management because they covet a specific job, but that might not be the only reason.
Kevan Pickrel, MD, MHM, a regional chief medical officer for Sound Physicians in Southern California, says his decision to get a master’s in healthcare management from the University of Texas at Dallas came down to credibility.
“I got the additional degree for one reason: a seat at the table,” Dr. Pickrel says. “Physicians complain a lot about all the change and the autonomy they have lost but do little about it beyond grumbling at lunch. I believe in hospital medicine as a discipline and believe in the value of the specialty. I wanted to be sure my specialty had a voice, and the only way to set myself apart from ‘just another whining doc’ was to add the letters.”
Making it happen was not a simple task, he says.
“Finding the time wasn’t easy,” he says. “I burned vacation time and leaned on my colleagues a lot. There are any number of physician- or executive-targeted programs offered that make it possible. Possible, but not easy.”
Chris Spoja, DO, a Sound hospitalist in Idaho, says he’d like to prepare himself for a chief medical officer job. He is planning to get his Master of Medical Management (MMM) from the University of Southern California (USC) next year, after he participates in a local leadership program in Idaho, which will allow him to network with people in his area.
“I would like to position myself to at least have that option,” he says, noting that the USC program will allow him to do most of his coursework online, participating in group discussions over Skype or doing work on his own. But he’ll have to visit the campus in Los Angeles for three days once a month.
“It’s not a small commitment,” he says. “But it’s doable.” TH
Tom Collins is a freelance writer in South Florida.
Who Should Be Screened for HIV Infection?
Case
A 31-year-old male with a history of asthma is admitted with an asthma exacerbation. He has no regular outpatient provider. He denies tobacco use and reports that he is in a monogamous relationship with his girlfriend. On rounds, a medical student mentions that new HIV screening guidelines have been released recently and asks whether this patient should be screened for HIV.
Background
By the mid-2000s, approximately one to 1.2 million people in the United States were infected with HIV.1 Approximately one quarter of these patients are estimated to be unaware of their HIV status, and this subgroup is believed responsible for a disproportionately higher percentage of new HIV infections each year.1
While older HIV screening recommendations focused on screening patients who were deemed to be at high risk for HIV infection, there has been a paradigm change in recent years toward universal screening of all patients.2,3 The ultimate goal is for earlier identification of infected patients, which will, in turn, lead to earlier treatment and better prevention efforts.
Universal screening has been supported by a number of different professional societies and screening guidelines.4
2013 Guideline
In 2013, the United States Preventive Services Task Force (USPSTF) issued new recommendations regarding HIV screening. Although the previous USPSTF guidelines (released in 2005) recommended screening patients who were believed to be at increased risk for contracting HIV, the 2013 guidelines now recommend screening all patients aged 15 to 65.4
Screening patients outside of this age range is recommended if the patient is deemed to be at increased risk for contracting HIV.4 The USPSTF provides criteria for identifying patients who are at increased risk of contracting HIV. These include:
- Men who have sex with men;
- People having unprotected vaginal or anal intercourse;
- People using injection drugs;
- People exchanging sex for drugs or money; and
- People requesting testing for other sexually transmitted diseases (STDs).4
Patients are also considered to be high risk if their sexual partners are infected with HIV, are bisexual, or use injection drugs.4
The shift toward universal HIV screening has been a trend for many years, because risk-based targeting of HIV screening will miss a significant number of HIV infections.2 In fact, the 2013 recommendations bring the USPSTF guidelines into agreement with current CDC guidelines, which were released in 2006.2
The CDC, in its 2006 guidelines, recommended screening for all patients 13 to 64 years old unless HIV prevalence in the patient population has been found to be less than 0.1%, the minimum prevalence deemed necessary for HIV screening to be cost-effective.2 The CDC guidelines also recommend HIV screening for all patients starting treatment for tuberculosis, patients being screened for STDs, and patients visiting STD clinics regardless of chief complaint.2 They recommend that HIV screening be performed in an “opt-out” fashion, meaning that patients are informed that screening will be performed unless they decline.2 Furthermore, they recommend against the need for a separate written consent form for HIV screening, as well as the prior requirement that pre-screening counseling be performed, because these requirements were felt to create potential time constraint barriers that prevented providers from screening patients.2
The CDC and the USPSTF are less conclusive with regard to frequency of rescreening for HIV infection. Both recommend rescreening patients considered high risk for HIV infection, but the interval for rescreening has not been concretely defined.2,4 The guidelines urge providers to use clinical judgment in deciding when to rescreen for HIV infection.2 For example, one reason for rescreening cited by the CDC would be the initiation of a new sexual relationship.2
In the 2013 guidelines, the USPSTF also recommends screening all pregnant women, including those presenting in labor without a known HIV status.4 This stance is supported by the American College of Gynecologists and Obstetricians.3 In high-risk patients with a negative screening test early in pregnancy, consideration should be given to repeat testing in the third trimester.3 Routinely screening pregnant women for HIV and starting appropriate therapy in positive patients has lowered the incidence of perinatal HIV transmission dramatically.2
Rationale
There are several reasons behind the shift to universal HIV screening, regardless of risk. First, providers often do not accurately identify patients’ HIV risk, often because patients are not aware of their actual risk or are uncomfortable discussing their high-risk behaviors with healthcare providers.2 Using risk factors as a basis of screening will miss a significant number of HIV-positive patients.4
Additionally, screening all patients will result in the detection of HIV infection in a greater number of patients during the early asymptomatic phase, rather than when they later become symptomatic from HIV or AIDS.2,4 Recent data has led the International Antiviral Society—USA Panel to issue updated recommendations advising initiation of antiretroviral therapy at all CD4 levels.5 Studies and observational data suggest that this could result in reduced AIDS complications and death rates.4
Early detection of HIV infection also has the potential of reducing spread of the virus.2,4 It has been suggested that early initiation of antiretroviral therapy could reduce risk of transmission to noninfected partners by lowering viral load in the infected patient.2 Knowledge of HIV status has also been shown to reduce high-risk behaviors.4
Moreover, by facilitating earlier detection of HIV, universal screening will allow for earlier and better counseling for infected patients.4 This has the potential to further alter behaviors and possibly reduce transmission of HIV and/or other sexually transmitted diseases.4 Additionally, routine screening of pregnant women allows for better detection of HIV-infected mothers.3 With appropriate interventions during pregnancy, including antiretroviral therapy, rates of mother-to-child transmission have decreased significantly.4
On the other hand, potential harms from HIV screening were considered during the USPSTF analysis, including risk of false positive test results, as well as the side effects of antiretroviral medications.4 Although there are known short-term and long-term side effects of antiretroviral medications, some of these side effects can be avoided by changing drug regimens.4 For many other side effects, the benefits appeared to outweigh the risks of these medications.4
Studies have also shown some potential side effects in infants exposed to antiretroviral medications, but the overall evidence is not strong.4 In the end, thorough analysis performed by the USPSTF resulted in the opinion that the benefits of HIV screening far outweigh the associated risks.4
Challenges for Hospitalists
Several potential drawbacks to universal HIV screening are relatively unique to hospitalists and other providers of hospital-based care.6 First, hospitalists must be prepared to counsel patients regarding their test results, particularly if patients are hospitalized for another issue. Second, hospitalists must be able to communicate these test results to primary care providers in a timely fashion, a challenge that is not unique to HIV testing.
The biggest concern for hospitalists is what to do with HIV test results that are still pending at the time of hospital discharge. Hospitalists will likely face this issue more as increasing numbers of patients are screened in a growing number of medical settings, including the ED and inpatient admissions. Hospitalists who plan to screen inpatients for HIV testing must ensure that these issues have been worked out prior to screening.
Back to the Case
Looking back to the initial case discussion, based on the 2006 CDC and 2013 USPSTF guidelines, this patient should be offered HIV screening if he has not been tested previously. Although the patient states that he is in a monogamous relationship and does not report any high-risk behaviors, patients often do not recognize the true risk associated with their behaviors and fail to accurately report them.2 Additionally, patients often are embarrassed by high-risk behaviors and may not report them completely to providers.2
The patient has admitted that he does not seek medical care on a regular basis. This inpatient admission may be his only interaction with the medical field for some time, and thus his only opportunity to undergo screening. But, prior to screening the patient, the hospitalist must ensure that he or she will be able to counsel the patient regarding test results, will be able to communicate those results to the patient’s primary care physician, and will be able to handle pending results if the patient is discharged before the test results are returned.
Drs. Gwyn, Carbo and Li are hospitalists at Beth Israel Deaconess Medical Center in Boston.
References
- Branson B. Current HIV epidemiology and revised recommendations for HIV testing in health-care settings. J Med Virol. 2007;79 Suppl 1:S6-S10.
- Moyer VA; U.S. Preventive Services Task Force. Screening for HIV: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2013;159(1):51-60.
- Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55(RR-14):1-17.
- Clark J, Lampe MA, Jamieson DJ. Testing women for human immunodeficiency virus infection: who, when, and how? Clin Obstet Gynceol. 2008;51(3):507-517.
- Thompson MA, Aberg JA, Hoy JF, et al. Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International Antiviral Society–USA Panel. JAMA. 2012;308(4):387-402.
- Arbelaez C, Wright EA, Losina E, et al. Emergency provider attitudes and barriers to universal HIV testing in the emergency department. J Emerg Med. 2012;42(1):7-14.
Case
A 31-year-old male with a history of asthma is admitted with an asthma exacerbation. He has no regular outpatient provider. He denies tobacco use and reports that he is in a monogamous relationship with his girlfriend. On rounds, a medical student mentions that new HIV screening guidelines have been released recently and asks whether this patient should be screened for HIV.
Background
By the mid-2000s, approximately one to 1.2 million people in the United States were infected with HIV.1 Approximately one quarter of these patients are estimated to be unaware of their HIV status, and this subgroup is believed responsible for a disproportionately higher percentage of new HIV infections each year.1
While older HIV screening recommendations focused on screening patients who were deemed to be at high risk for HIV infection, there has been a paradigm change in recent years toward universal screening of all patients.2,3 The ultimate goal is for earlier identification of infected patients, which will, in turn, lead to earlier treatment and better prevention efforts.
Universal screening has been supported by a number of different professional societies and screening guidelines.4
2013 Guideline
In 2013, the United States Preventive Services Task Force (USPSTF) issued new recommendations regarding HIV screening. Although the previous USPSTF guidelines (released in 2005) recommended screening patients who were believed to be at increased risk for contracting HIV, the 2013 guidelines now recommend screening all patients aged 15 to 65.4
Screening patients outside of this age range is recommended if the patient is deemed to be at increased risk for contracting HIV.4 The USPSTF provides criteria for identifying patients who are at increased risk of contracting HIV. These include:
- Men who have sex with men;
- People having unprotected vaginal or anal intercourse;
- People using injection drugs;
- People exchanging sex for drugs or money; and
- People requesting testing for other sexually transmitted diseases (STDs).4
Patients are also considered to be high risk if their sexual partners are infected with HIV, are bisexual, or use injection drugs.4
The shift toward universal HIV screening has been a trend for many years, because risk-based targeting of HIV screening will miss a significant number of HIV infections.2 In fact, the 2013 recommendations bring the USPSTF guidelines into agreement with current CDC guidelines, which were released in 2006.2
The CDC, in its 2006 guidelines, recommended screening for all patients 13 to 64 years old unless HIV prevalence in the patient population has been found to be less than 0.1%, the minimum prevalence deemed necessary for HIV screening to be cost-effective.2 The CDC guidelines also recommend HIV screening for all patients starting treatment for tuberculosis, patients being screened for STDs, and patients visiting STD clinics regardless of chief complaint.2 They recommend that HIV screening be performed in an “opt-out” fashion, meaning that patients are informed that screening will be performed unless they decline.2 Furthermore, they recommend against the need for a separate written consent form for HIV screening, as well as the prior requirement that pre-screening counseling be performed, because these requirements were felt to create potential time constraint barriers that prevented providers from screening patients.2
The CDC and the USPSTF are less conclusive with regard to frequency of rescreening for HIV infection. Both recommend rescreening patients considered high risk for HIV infection, but the interval for rescreening has not been concretely defined.2,4 The guidelines urge providers to use clinical judgment in deciding when to rescreen for HIV infection.2 For example, one reason for rescreening cited by the CDC would be the initiation of a new sexual relationship.2
In the 2013 guidelines, the USPSTF also recommends screening all pregnant women, including those presenting in labor without a known HIV status.4 This stance is supported by the American College of Gynecologists and Obstetricians.3 In high-risk patients with a negative screening test early in pregnancy, consideration should be given to repeat testing in the third trimester.3 Routinely screening pregnant women for HIV and starting appropriate therapy in positive patients has lowered the incidence of perinatal HIV transmission dramatically.2
Rationale
There are several reasons behind the shift to universal HIV screening, regardless of risk. First, providers often do not accurately identify patients’ HIV risk, often because patients are not aware of their actual risk or are uncomfortable discussing their high-risk behaviors with healthcare providers.2 Using risk factors as a basis of screening will miss a significant number of HIV-positive patients.4
Additionally, screening all patients will result in the detection of HIV infection in a greater number of patients during the early asymptomatic phase, rather than when they later become symptomatic from HIV or AIDS.2,4 Recent data has led the International Antiviral Society—USA Panel to issue updated recommendations advising initiation of antiretroviral therapy at all CD4 levels.5 Studies and observational data suggest that this could result in reduced AIDS complications and death rates.4
Early detection of HIV infection also has the potential of reducing spread of the virus.2,4 It has been suggested that early initiation of antiretroviral therapy could reduce risk of transmission to noninfected partners by lowering viral load in the infected patient.2 Knowledge of HIV status has also been shown to reduce high-risk behaviors.4
Moreover, by facilitating earlier detection of HIV, universal screening will allow for earlier and better counseling for infected patients.4 This has the potential to further alter behaviors and possibly reduce transmission of HIV and/or other sexually transmitted diseases.4 Additionally, routine screening of pregnant women allows for better detection of HIV-infected mothers.3 With appropriate interventions during pregnancy, including antiretroviral therapy, rates of mother-to-child transmission have decreased significantly.4
On the other hand, potential harms from HIV screening were considered during the USPSTF analysis, including risk of false positive test results, as well as the side effects of antiretroviral medications.4 Although there are known short-term and long-term side effects of antiretroviral medications, some of these side effects can be avoided by changing drug regimens.4 For many other side effects, the benefits appeared to outweigh the risks of these medications.4
Studies have also shown some potential side effects in infants exposed to antiretroviral medications, but the overall evidence is not strong.4 In the end, thorough analysis performed by the USPSTF resulted in the opinion that the benefits of HIV screening far outweigh the associated risks.4
Challenges for Hospitalists
Several potential drawbacks to universal HIV screening are relatively unique to hospitalists and other providers of hospital-based care.6 First, hospitalists must be prepared to counsel patients regarding their test results, particularly if patients are hospitalized for another issue. Second, hospitalists must be able to communicate these test results to primary care providers in a timely fashion, a challenge that is not unique to HIV testing.
The biggest concern for hospitalists is what to do with HIV test results that are still pending at the time of hospital discharge. Hospitalists will likely face this issue more as increasing numbers of patients are screened in a growing number of medical settings, including the ED and inpatient admissions. Hospitalists who plan to screen inpatients for HIV testing must ensure that these issues have been worked out prior to screening.
Back to the Case
Looking back to the initial case discussion, based on the 2006 CDC and 2013 USPSTF guidelines, this patient should be offered HIV screening if he has not been tested previously. Although the patient states that he is in a monogamous relationship and does not report any high-risk behaviors, patients often do not recognize the true risk associated with their behaviors and fail to accurately report them.2 Additionally, patients often are embarrassed by high-risk behaviors and may not report them completely to providers.2
The patient has admitted that he does not seek medical care on a regular basis. This inpatient admission may be his only interaction with the medical field for some time, and thus his only opportunity to undergo screening. But, prior to screening the patient, the hospitalist must ensure that he or she will be able to counsel the patient regarding test results, will be able to communicate those results to the patient’s primary care physician, and will be able to handle pending results if the patient is discharged before the test results are returned.
Drs. Gwyn, Carbo and Li are hospitalists at Beth Israel Deaconess Medical Center in Boston.
References
- Branson B. Current HIV epidemiology and revised recommendations for HIV testing in health-care settings. J Med Virol. 2007;79 Suppl 1:S6-S10.
- Moyer VA; U.S. Preventive Services Task Force. Screening for HIV: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2013;159(1):51-60.
- Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55(RR-14):1-17.
- Clark J, Lampe MA, Jamieson DJ. Testing women for human immunodeficiency virus infection: who, when, and how? Clin Obstet Gynceol. 2008;51(3):507-517.
- Thompson MA, Aberg JA, Hoy JF, et al. Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International Antiviral Society–USA Panel. JAMA. 2012;308(4):387-402.
- Arbelaez C, Wright EA, Losina E, et al. Emergency provider attitudes and barriers to universal HIV testing in the emergency department. J Emerg Med. 2012;42(1):7-14.
Case
A 31-year-old male with a history of asthma is admitted with an asthma exacerbation. He has no regular outpatient provider. He denies tobacco use and reports that he is in a monogamous relationship with his girlfriend. On rounds, a medical student mentions that new HIV screening guidelines have been released recently and asks whether this patient should be screened for HIV.
Background
By the mid-2000s, approximately one to 1.2 million people in the United States were infected with HIV.1 Approximately one quarter of these patients are estimated to be unaware of their HIV status, and this subgroup is believed responsible for a disproportionately higher percentage of new HIV infections each year.1
While older HIV screening recommendations focused on screening patients who were deemed to be at high risk for HIV infection, there has been a paradigm change in recent years toward universal screening of all patients.2,3 The ultimate goal is for earlier identification of infected patients, which will, in turn, lead to earlier treatment and better prevention efforts.
Universal screening has been supported by a number of different professional societies and screening guidelines.4
2013 Guideline
In 2013, the United States Preventive Services Task Force (USPSTF) issued new recommendations regarding HIV screening. Although the previous USPSTF guidelines (released in 2005) recommended screening patients who were believed to be at increased risk for contracting HIV, the 2013 guidelines now recommend screening all patients aged 15 to 65.4
Screening patients outside of this age range is recommended if the patient is deemed to be at increased risk for contracting HIV.4 The USPSTF provides criteria for identifying patients who are at increased risk of contracting HIV. These include:
- Men who have sex with men;
- People having unprotected vaginal or anal intercourse;
- People using injection drugs;
- People exchanging sex for drugs or money; and
- People requesting testing for other sexually transmitted diseases (STDs).4
Patients are also considered to be high risk if their sexual partners are infected with HIV, are bisexual, or use injection drugs.4
The shift toward universal HIV screening has been a trend for many years, because risk-based targeting of HIV screening will miss a significant number of HIV infections.2 In fact, the 2013 recommendations bring the USPSTF guidelines into agreement with current CDC guidelines, which were released in 2006.2
The CDC, in its 2006 guidelines, recommended screening for all patients 13 to 64 years old unless HIV prevalence in the patient population has been found to be less than 0.1%, the minimum prevalence deemed necessary for HIV screening to be cost-effective.2 The CDC guidelines also recommend HIV screening for all patients starting treatment for tuberculosis, patients being screened for STDs, and patients visiting STD clinics regardless of chief complaint.2 They recommend that HIV screening be performed in an “opt-out” fashion, meaning that patients are informed that screening will be performed unless they decline.2 Furthermore, they recommend against the need for a separate written consent form for HIV screening, as well as the prior requirement that pre-screening counseling be performed, because these requirements were felt to create potential time constraint barriers that prevented providers from screening patients.2
The CDC and the USPSTF are less conclusive with regard to frequency of rescreening for HIV infection. Both recommend rescreening patients considered high risk for HIV infection, but the interval for rescreening has not been concretely defined.2,4 The guidelines urge providers to use clinical judgment in deciding when to rescreen for HIV infection.2 For example, one reason for rescreening cited by the CDC would be the initiation of a new sexual relationship.2
In the 2013 guidelines, the USPSTF also recommends screening all pregnant women, including those presenting in labor without a known HIV status.4 This stance is supported by the American College of Gynecologists and Obstetricians.3 In high-risk patients with a negative screening test early in pregnancy, consideration should be given to repeat testing in the third trimester.3 Routinely screening pregnant women for HIV and starting appropriate therapy in positive patients has lowered the incidence of perinatal HIV transmission dramatically.2
Rationale
There are several reasons behind the shift to universal HIV screening, regardless of risk. First, providers often do not accurately identify patients’ HIV risk, often because patients are not aware of their actual risk or are uncomfortable discussing their high-risk behaviors with healthcare providers.2 Using risk factors as a basis of screening will miss a significant number of HIV-positive patients.4
Additionally, screening all patients will result in the detection of HIV infection in a greater number of patients during the early asymptomatic phase, rather than when they later become symptomatic from HIV or AIDS.2,4 Recent data has led the International Antiviral Society—USA Panel to issue updated recommendations advising initiation of antiretroviral therapy at all CD4 levels.5 Studies and observational data suggest that this could result in reduced AIDS complications and death rates.4
Early detection of HIV infection also has the potential of reducing spread of the virus.2,4 It has been suggested that early initiation of antiretroviral therapy could reduce risk of transmission to noninfected partners by lowering viral load in the infected patient.2 Knowledge of HIV status has also been shown to reduce high-risk behaviors.4
Moreover, by facilitating earlier detection of HIV, universal screening will allow for earlier and better counseling for infected patients.4 This has the potential to further alter behaviors and possibly reduce transmission of HIV and/or other sexually transmitted diseases.4 Additionally, routine screening of pregnant women allows for better detection of HIV-infected mothers.3 With appropriate interventions during pregnancy, including antiretroviral therapy, rates of mother-to-child transmission have decreased significantly.4
On the other hand, potential harms from HIV screening were considered during the USPSTF analysis, including risk of false positive test results, as well as the side effects of antiretroviral medications.4 Although there are known short-term and long-term side effects of antiretroviral medications, some of these side effects can be avoided by changing drug regimens.4 For many other side effects, the benefits appeared to outweigh the risks of these medications.4
Studies have also shown some potential side effects in infants exposed to antiretroviral medications, but the overall evidence is not strong.4 In the end, thorough analysis performed by the USPSTF resulted in the opinion that the benefits of HIV screening far outweigh the associated risks.4
Challenges for Hospitalists
Several potential drawbacks to universal HIV screening are relatively unique to hospitalists and other providers of hospital-based care.6 First, hospitalists must be prepared to counsel patients regarding their test results, particularly if patients are hospitalized for another issue. Second, hospitalists must be able to communicate these test results to primary care providers in a timely fashion, a challenge that is not unique to HIV testing.
The biggest concern for hospitalists is what to do with HIV test results that are still pending at the time of hospital discharge. Hospitalists will likely face this issue more as increasing numbers of patients are screened in a growing number of medical settings, including the ED and inpatient admissions. Hospitalists who plan to screen inpatients for HIV testing must ensure that these issues have been worked out prior to screening.
Back to the Case
Looking back to the initial case discussion, based on the 2006 CDC and 2013 USPSTF guidelines, this patient should be offered HIV screening if he has not been tested previously. Although the patient states that he is in a monogamous relationship and does not report any high-risk behaviors, patients often do not recognize the true risk associated with their behaviors and fail to accurately report them.2 Additionally, patients often are embarrassed by high-risk behaviors and may not report them completely to providers.2
The patient has admitted that he does not seek medical care on a regular basis. This inpatient admission may be his only interaction with the medical field for some time, and thus his only opportunity to undergo screening. But, prior to screening the patient, the hospitalist must ensure that he or she will be able to counsel the patient regarding test results, will be able to communicate those results to the patient’s primary care physician, and will be able to handle pending results if the patient is discharged before the test results are returned.
Drs. Gwyn, Carbo and Li are hospitalists at Beth Israel Deaconess Medical Center in Boston.
References
- Branson B. Current HIV epidemiology and revised recommendations for HIV testing in health-care settings. J Med Virol. 2007;79 Suppl 1:S6-S10.
- Moyer VA; U.S. Preventive Services Task Force. Screening for HIV: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2013;159(1):51-60.
- Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55(RR-14):1-17.
- Clark J, Lampe MA, Jamieson DJ. Testing women for human immunodeficiency virus infection: who, when, and how? Clin Obstet Gynceol. 2008;51(3):507-517.
- Thompson MA, Aberg JA, Hoy JF, et al. Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International Antiviral Society–USA Panel. JAMA. 2012;308(4):387-402.
- Arbelaez C, Wright EA, Losina E, et al. Emergency provider attitudes and barriers to universal HIV testing in the emergency department. J Emerg Med. 2012;42(1):7-14.