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HCV coinfections can be safely treated in patients with HIV
BOSTON – Patients with HIV and hepatitis C coinfection had high levels of sustained viral response with regimens combining select antiretroviral agents with telaprevir, pegylated interferon, and ribavirin, said investigators at the annual meeting of the American Association for the Study of Liver Diseases.
The key to avoiding adverse drug interactions between telaprevir (Incivek) and highly active antiretroviral therapy (HAART) regimens is careful selection of HIV therapy, said Dr. Mark Sulkowski, medical director of the viral hepatitis center at Johns Hopkins University in Baltimore.
Dr. Sulkowski and his colleagues showed in a randomized phase III study that a combination of specific antiretroviral agents with telaprevir and pegylated interferon alfa-2a (PEG-IFN) and ribavirin (RBV) was associated with a 74% SVR24 rate, compared with HAART and PEG-IFN only.
"Overall, 74% of patients treated with telaprevir in combination with peg-interferon and ribavirin achieved SVR [sustained virological response], compared to 45% of those treated with placebo. Drug interactions with telaprevir and selected antiretroviral therapies, specifically atazanavir/ritonavir and efavirenz, were not clinically meaningful," Dr. Sulkowski said.
A separate study by European investigators showed that the likelihood that patients with HIV/HCV coinfection will clear HCV from serum may depend on the presence of ribavirin in a regimen, and on HCV genotype.
"Ribavirin is important in the management of acute hepatitis C in HIV-positive patients. Almost all patients with genotype 2 and 3 infections were able to clear virus with combination therapy [PEG-IFN and RBV]," said lead investigator Dr. Christoph Boesecke of the University of Bonn, Germany.
Safety Concerns
Some infectious disease specialists have expressed concern that the addition of a direct-acting antiviral agent in combination with PEG-IFN/RBV could compromise the efficacy and/or safety of a HAART regimen.
To test the HAART/direct-acting antiviral agent combination, Dr. Sulkowski and his colleagues enrolled patients with HIV/HCV coinfection in a two-part study. In part A, patients were assigned on a 1:1 ratio to receive either telaprevir or placebo, each with PEG-IFN/RBV.
In part B, patients on a HAART regimen (either a combination of efavirenz, tenofovir, and emtricitabine or ritonavir-boosted atazanavir, tenofovir, and emtricitabine or lamivudine) were assigned on a 2:1 basis to receive telaprevir or placebo plus PEG-IFN/RBV. All patients were treated for 48 weeks, with an additional 24 weeks of follow-up.
HCV RNA levels on study were measured at various time points, and the investigators looked for drug interactions, adverse events, viral breakthrough, and other clinical measures.
At 24 weeks post treatment, the HCV sustained virologic response rate (SVR24) among patients treated with telaprevir and PEG-IFN/RBV but not an antiretroviral therapy was 71%, compared with 33% among those treated with placebo and PEG-IFN/RBV.
Among patients on the HAART regimen containing efavirenz plus telaprevir and PEG-IFN/RBV, 69% had an SVR24, compared with 38% of those who received the same HAART regimen without telaprevir. Among those on the atazanavir-containing regimen, 73% had an SVR24, compared with 50% of controls who received only PEG-IFN/RBV plus HAART.
The serum concentrations of both atazanavir and efavirenz were similar whether the patients had received telaprevir or not, and there were no cases of HIV viral breakthrough, although CD4 cell counts decreased among patients taking PEG-IFN/RBV and either telaprevir or placebo. Nonetheless, investigators did not see HIV-related adverse events, Dr. Sulkowski said.
Patients on efavirenz did require a telaprevir dose increase, but the required increase was adequate for maintaining exposure to the direct-acting antiviral agent, he added.
Genotype Matters
Dr. Boesecke and his colleagues in the European AIDS Treatment Network looked at the effect of HCV genotype and ribavirin on SVR rates in the treatment of coinfected patients. They reported on 303 HIV-infected men from the Austria, France, Germany, and the United Kingdom who had been diagnosed with acute HCV infections. Of this group, 273 were treated with PEG-IFN/RBV, and 30 were treated with PEG-IFN alone. In all, 88% of the patients who received ribavirin had weight-based doses (1,000 mg for those 75 kg and under, and 1,200 mg for those over 75 kg).
A majority of the patients (69%) were infected with genotype 1; 4% had genotype 2; 11% had genotype 3; and 16% had genotype 4 infections. About one-third of patients had 24 weeks of therapy, and the remaining third had 48 weeks. Median time from HCV diagnosis to the start of treatment was about 10 weeks.
Among all patients, 52% of those received PEG-IFN alone, and 52% of those who also received ribavirin had a rapid virologic response (RVR), defined as HCV RNA negative at 4 weeks. Respective SVR24 rates were 66.7% and 69.6%.
When the investigators broke it out by genotype, however, they found that while the addition of ribavirin did not significantly change either RVR or SVR24 rates among patients with genotype 1 or 3 infections, 60% of patients with genotype 2 or 3 infections on PEG-IFN monotherapy had a 60% SVR24,, whereas those on PEG-IFN/RBV had a 94% SVR24. indicating a significant benefit to adding RBV (P = .016). The RVR rates were not significantly different in these patients, however.
There were no significant differences in either the total number or severity of adverse events among the various genotypes. In 10% of all cases a ribavirin dose reduction was required, and interferon dose reductions were required in 6% of cases.
Toxicities required stopping HCV therapy in 17 patients (6%).
"We saw high sustained virologic response rates if you treat hepatitis C early on, when it’s still acute, compared to when the disease is left to a chronic course in HIV patients," said Dr. Boesecke
Dr. Sulkowski’s study was supported by Vertex Pharmaceuticals. He is a consultant to the company and has received grant and research support from it. Dr. Boesecke’s study was supported by the European AIDS Treatment Network. He reported no conflict of interest.
BOSTON – Patients with HIV and hepatitis C coinfection had high levels of sustained viral response with regimens combining select antiretroviral agents with telaprevir, pegylated interferon, and ribavirin, said investigators at the annual meeting of the American Association for the Study of Liver Diseases.
The key to avoiding adverse drug interactions between telaprevir (Incivek) and highly active antiretroviral therapy (HAART) regimens is careful selection of HIV therapy, said Dr. Mark Sulkowski, medical director of the viral hepatitis center at Johns Hopkins University in Baltimore.
Dr. Sulkowski and his colleagues showed in a randomized phase III study that a combination of specific antiretroviral agents with telaprevir and pegylated interferon alfa-2a (PEG-IFN) and ribavirin (RBV) was associated with a 74% SVR24 rate, compared with HAART and PEG-IFN only.
"Overall, 74% of patients treated with telaprevir in combination with peg-interferon and ribavirin achieved SVR [sustained virological response], compared to 45% of those treated with placebo. Drug interactions with telaprevir and selected antiretroviral therapies, specifically atazanavir/ritonavir and efavirenz, were not clinically meaningful," Dr. Sulkowski said.
A separate study by European investigators showed that the likelihood that patients with HIV/HCV coinfection will clear HCV from serum may depend on the presence of ribavirin in a regimen, and on HCV genotype.
"Ribavirin is important in the management of acute hepatitis C in HIV-positive patients. Almost all patients with genotype 2 and 3 infections were able to clear virus with combination therapy [PEG-IFN and RBV]," said lead investigator Dr. Christoph Boesecke of the University of Bonn, Germany.
Safety Concerns
Some infectious disease specialists have expressed concern that the addition of a direct-acting antiviral agent in combination with PEG-IFN/RBV could compromise the efficacy and/or safety of a HAART regimen.
To test the HAART/direct-acting antiviral agent combination, Dr. Sulkowski and his colleagues enrolled patients with HIV/HCV coinfection in a two-part study. In part A, patients were assigned on a 1:1 ratio to receive either telaprevir or placebo, each with PEG-IFN/RBV.
In part B, patients on a HAART regimen (either a combination of efavirenz, tenofovir, and emtricitabine or ritonavir-boosted atazanavir, tenofovir, and emtricitabine or lamivudine) were assigned on a 2:1 basis to receive telaprevir or placebo plus PEG-IFN/RBV. All patients were treated for 48 weeks, with an additional 24 weeks of follow-up.
HCV RNA levels on study were measured at various time points, and the investigators looked for drug interactions, adverse events, viral breakthrough, and other clinical measures.
At 24 weeks post treatment, the HCV sustained virologic response rate (SVR24) among patients treated with telaprevir and PEG-IFN/RBV but not an antiretroviral therapy was 71%, compared with 33% among those treated with placebo and PEG-IFN/RBV.
Among patients on the HAART regimen containing efavirenz plus telaprevir and PEG-IFN/RBV, 69% had an SVR24, compared with 38% of those who received the same HAART regimen without telaprevir. Among those on the atazanavir-containing regimen, 73% had an SVR24, compared with 50% of controls who received only PEG-IFN/RBV plus HAART.
The serum concentrations of both atazanavir and efavirenz were similar whether the patients had received telaprevir or not, and there were no cases of HIV viral breakthrough, although CD4 cell counts decreased among patients taking PEG-IFN/RBV and either telaprevir or placebo. Nonetheless, investigators did not see HIV-related adverse events, Dr. Sulkowski said.
Patients on efavirenz did require a telaprevir dose increase, but the required increase was adequate for maintaining exposure to the direct-acting antiviral agent, he added.
Genotype Matters
Dr. Boesecke and his colleagues in the European AIDS Treatment Network looked at the effect of HCV genotype and ribavirin on SVR rates in the treatment of coinfected patients. They reported on 303 HIV-infected men from the Austria, France, Germany, and the United Kingdom who had been diagnosed with acute HCV infections. Of this group, 273 were treated with PEG-IFN/RBV, and 30 were treated with PEG-IFN alone. In all, 88% of the patients who received ribavirin had weight-based doses (1,000 mg for those 75 kg and under, and 1,200 mg for those over 75 kg).
A majority of the patients (69%) were infected with genotype 1; 4% had genotype 2; 11% had genotype 3; and 16% had genotype 4 infections. About one-third of patients had 24 weeks of therapy, and the remaining third had 48 weeks. Median time from HCV diagnosis to the start of treatment was about 10 weeks.
Among all patients, 52% of those received PEG-IFN alone, and 52% of those who also received ribavirin had a rapid virologic response (RVR), defined as HCV RNA negative at 4 weeks. Respective SVR24 rates were 66.7% and 69.6%.
When the investigators broke it out by genotype, however, they found that while the addition of ribavirin did not significantly change either RVR or SVR24 rates among patients with genotype 1 or 3 infections, 60% of patients with genotype 2 or 3 infections on PEG-IFN monotherapy had a 60% SVR24,, whereas those on PEG-IFN/RBV had a 94% SVR24. indicating a significant benefit to adding RBV (P = .016). The RVR rates were not significantly different in these patients, however.
There were no significant differences in either the total number or severity of adverse events among the various genotypes. In 10% of all cases a ribavirin dose reduction was required, and interferon dose reductions were required in 6% of cases.
Toxicities required stopping HCV therapy in 17 patients (6%).
"We saw high sustained virologic response rates if you treat hepatitis C early on, when it’s still acute, compared to when the disease is left to a chronic course in HIV patients," said Dr. Boesecke
Dr. Sulkowski’s study was supported by Vertex Pharmaceuticals. He is a consultant to the company and has received grant and research support from it. Dr. Boesecke’s study was supported by the European AIDS Treatment Network. He reported no conflict of interest.
BOSTON – Patients with HIV and hepatitis C coinfection had high levels of sustained viral response with regimens combining select antiretroviral agents with telaprevir, pegylated interferon, and ribavirin, said investigators at the annual meeting of the American Association for the Study of Liver Diseases.
The key to avoiding adverse drug interactions between telaprevir (Incivek) and highly active antiretroviral therapy (HAART) regimens is careful selection of HIV therapy, said Dr. Mark Sulkowski, medical director of the viral hepatitis center at Johns Hopkins University in Baltimore.
Dr. Sulkowski and his colleagues showed in a randomized phase III study that a combination of specific antiretroviral agents with telaprevir and pegylated interferon alfa-2a (PEG-IFN) and ribavirin (RBV) was associated with a 74% SVR24 rate, compared with HAART and PEG-IFN only.
"Overall, 74% of patients treated with telaprevir in combination with peg-interferon and ribavirin achieved SVR [sustained virological response], compared to 45% of those treated with placebo. Drug interactions with telaprevir and selected antiretroviral therapies, specifically atazanavir/ritonavir and efavirenz, were not clinically meaningful," Dr. Sulkowski said.
A separate study by European investigators showed that the likelihood that patients with HIV/HCV coinfection will clear HCV from serum may depend on the presence of ribavirin in a regimen, and on HCV genotype.
"Ribavirin is important in the management of acute hepatitis C in HIV-positive patients. Almost all patients with genotype 2 and 3 infections were able to clear virus with combination therapy [PEG-IFN and RBV]," said lead investigator Dr. Christoph Boesecke of the University of Bonn, Germany.
Safety Concerns
Some infectious disease specialists have expressed concern that the addition of a direct-acting antiviral agent in combination with PEG-IFN/RBV could compromise the efficacy and/or safety of a HAART regimen.
To test the HAART/direct-acting antiviral agent combination, Dr. Sulkowski and his colleagues enrolled patients with HIV/HCV coinfection in a two-part study. In part A, patients were assigned on a 1:1 ratio to receive either telaprevir or placebo, each with PEG-IFN/RBV.
In part B, patients on a HAART regimen (either a combination of efavirenz, tenofovir, and emtricitabine or ritonavir-boosted atazanavir, tenofovir, and emtricitabine or lamivudine) were assigned on a 2:1 basis to receive telaprevir or placebo plus PEG-IFN/RBV. All patients were treated for 48 weeks, with an additional 24 weeks of follow-up.
HCV RNA levels on study were measured at various time points, and the investigators looked for drug interactions, adverse events, viral breakthrough, and other clinical measures.
At 24 weeks post treatment, the HCV sustained virologic response rate (SVR24) among patients treated with telaprevir and PEG-IFN/RBV but not an antiretroviral therapy was 71%, compared with 33% among those treated with placebo and PEG-IFN/RBV.
Among patients on the HAART regimen containing efavirenz plus telaprevir and PEG-IFN/RBV, 69% had an SVR24, compared with 38% of those who received the same HAART regimen without telaprevir. Among those on the atazanavir-containing regimen, 73% had an SVR24, compared with 50% of controls who received only PEG-IFN/RBV plus HAART.
The serum concentrations of both atazanavir and efavirenz were similar whether the patients had received telaprevir or not, and there were no cases of HIV viral breakthrough, although CD4 cell counts decreased among patients taking PEG-IFN/RBV and either telaprevir or placebo. Nonetheless, investigators did not see HIV-related adverse events, Dr. Sulkowski said.
Patients on efavirenz did require a telaprevir dose increase, but the required increase was adequate for maintaining exposure to the direct-acting antiviral agent, he added.
Genotype Matters
Dr. Boesecke and his colleagues in the European AIDS Treatment Network looked at the effect of HCV genotype and ribavirin on SVR rates in the treatment of coinfected patients. They reported on 303 HIV-infected men from the Austria, France, Germany, and the United Kingdom who had been diagnosed with acute HCV infections. Of this group, 273 were treated with PEG-IFN/RBV, and 30 were treated with PEG-IFN alone. In all, 88% of the patients who received ribavirin had weight-based doses (1,000 mg for those 75 kg and under, and 1,200 mg for those over 75 kg).
A majority of the patients (69%) were infected with genotype 1; 4% had genotype 2; 11% had genotype 3; and 16% had genotype 4 infections. About one-third of patients had 24 weeks of therapy, and the remaining third had 48 weeks. Median time from HCV diagnosis to the start of treatment was about 10 weeks.
Among all patients, 52% of those received PEG-IFN alone, and 52% of those who also received ribavirin had a rapid virologic response (RVR), defined as HCV RNA negative at 4 weeks. Respective SVR24 rates were 66.7% and 69.6%.
When the investigators broke it out by genotype, however, they found that while the addition of ribavirin did not significantly change either RVR or SVR24 rates among patients with genotype 1 or 3 infections, 60% of patients with genotype 2 or 3 infections on PEG-IFN monotherapy had a 60% SVR24,, whereas those on PEG-IFN/RBV had a 94% SVR24. indicating a significant benefit to adding RBV (P = .016). The RVR rates were not significantly different in these patients, however.
There were no significant differences in either the total number or severity of adverse events among the various genotypes. In 10% of all cases a ribavirin dose reduction was required, and interferon dose reductions were required in 6% of cases.
Toxicities required stopping HCV therapy in 17 patients (6%).
"We saw high sustained virologic response rates if you treat hepatitis C early on, when it’s still acute, compared to when the disease is left to a chronic course in HIV patients," said Dr. Boesecke
Dr. Sulkowski’s study was supported by Vertex Pharmaceuticals. He is a consultant to the company and has received grant and research support from it. Dr. Boesecke’s study was supported by the European AIDS Treatment Network. He reported no conflict of interest.
AT THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES
Major Finding: Among patients with HIV and hepatitis C coinfection, 74% of those treated with telaprevir in combination with pegylated interferon and ribavirin achieved a sustained virologic response, compared with 45% of those treated with placebo and peg-interferon.
Data Source: Randomized placebo-controlled trial and prospective cohort study
Disclosures: Dr. Sulkowski’s study was supported by Vertex Pharmaceuticals. He is a consultant to the company and has received grant and research support from it. Dr. Boesecke’s study was supported by the European AIDS Treatment Network. He reported no conflict of interest.
Triple therapy has poor safety in cirrhotic hepatitis C
BOSTON – In patients with chronic hepatitis C virus infections and compensated cirrhosis, a combination of a direct-acting antiviral agent, pegylated interferon, and ribavirin produced high on-treatment virologic response rates, but at the cost of significantly increased toxicities in an interim analysis of a French multicenter trial looking at the safety of the regimen.
Although the efficacy of direct-acting antiviral regimens involving the protease inhibitors telaprevir (Incivek) and boceprevir (Victrelis) combined with pegylated interferon alfa-2a or -2b in combination with ribavirin (PEG-IFN/RBV) in cirrhotic nonresponders to prior therapy was good , their safety was "poor," according to Dr. Christophe Hézode of the Hôpital Henri Mondor in Créteil, France.
Virologic response at 16 weeks in a per-protocol analysis was associated with a virologic response rate of 92% with telaprevir and 77% with boceprevir.
However, there were increased rates of serious adverse events and more difficult-to-manage anemia than in phase III trials for telaprevir and boceprevir, which included only a few patients with cirrhosis, Dr. Hézode said at the annual meeting of the American Association for the Study of Liver Diseases.
In treatment-experienced cirrhotic patients with platelet counts of 100,000/mm3 or serum albumin levels below 35 g/L, clinicians should weigh the risks and benefits of such regimens, with patients treated on a case-by-case basis because of the high risk for severe complications, Dr. Hézode said.
"However, cirrhotic experienced patients without predictors of severe complications clearly should be treated, but cautiously and carefully monitored," he added.
Dr. Hézode and his coinvestigators in the French Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (telaprevir or boceprevir), Pegylated Interferon, and Ribavirin (CUPIC) trial studied two cohorts of patients with chronic hepatitis C virus (HCV) infections, and compensated cirrhosis (Child Pugh class A) who had either relapsed or had only a partial response to prior therapy, with partial response defined as at least a 2 log10 decline inV RNA but failure to clear virus by week 24.
He presented data on 497 patients who had completed 16 weeks of therapy on one of two regimens. In one cohort, 292 patients received 12 weeks of telaprevir 750 mg every 8 hours, and PEG-IFN alfa-2a (Pegasys) 180 mcg/wk with ribavirin 1,000-1,200 mg/day, followed by PEG-IFN/RBV through 48 weeks. In the second cohort, patients received a 4-week initiation phase with PEG-IFN alfa-2b (PegIntron) and ribavirin, followed by 44 weeks of boceprevir 800 mg every 8 hours, PEG-IFN 1.5 mcg/kg per wk, and ribavirin 800-1,400 mg/day.
At week 16, 45% of patients on telaprevir had had at least one serious adverse event, with 14.7% terminating therapy because of a serious side effect. In all, nearly one-fourth (22.6%) discontinued therapy, and there were five deaths: from septicemia, septic shock, pneumopathy, endocarditis, and bleeding esophageal varices. Other complications in this group included grade 3 or 4 infections in 6.5%, grade 3 or 4 hepatic decompensation in 2%, grade 3/4 asthenia in 5.5%, and renal failure in 1.7%.
Hematologic adverse events included anemia of grade 2 or greater in 30.4%, erythropoietin use in 53.8%, blood transfusion in 16.1%, and ribavirin dose reduction in 13%. In addition, 2.7% of patients had grade 3 or 4 neutropenia, and 1.7% had grade 3 or 4 thrombocytopenia.
In the boceprevir group, 32.7% had at least one serious adverse event, 26.3% discontinued prematurely, and 7.3% discontinued because of serious events. The cause of one death was described as pneumopathy. Grade 3/4 adverse events involved infections in 2.4%, hepatic decompensation in 2.9%, and asthenia in 5.8%. There were no cases of renal failure in this group.
Hematologic events in patients on boceprevir included grade 2 or greater anemia in 27.8%, erythropoietin use in 46.3%, blood transfusion in 6.3%, and ribavirin dose reduction in 10.7%.
Grade 3/4 neutropenia was seen in 4.4%, and grade 3/4 thrombocytopenia in 5.4%. Two patients (1%) in this cohort received thrombopoietin.
In a multivariate analysis, significant baseline predictors of severe complications (death, severe infection, and hepatic decompensation) included platelet counts of 100,000/mm3 or lower (odds ratio, 3.11; P = .0098) and a serum albumin level below 35 g/L (OR, 6.33; P less than .0001).
Baseline predictors for severe anemia (hemoglobin less than 8 g/dL) or blood transfusion included female gender (OR, 2.19; P = .023), no lead-in phase (OR, 2.25; P = .018), age 65 years or older (OR, 3.04; P = .0014), and hemoglobin 12 g/dL or lower for women and 13 g/dL or lower for men (OR, 5.30; P less than .0001),
The study was sponsored by ANRS, the French National Agency for Research in AIDS and Viral Hepatitis, with support from INSERM, the French National Institute for Health and Medical Research. Dr. Hézode said that he has no financial conflicts of interest, but disclosed serving as a speaker and adviser for Abbott, BMS, Gilead, Janssen, Merck, and Roche.
BOSTON – In patients with chronic hepatitis C virus infections and compensated cirrhosis, a combination of a direct-acting antiviral agent, pegylated interferon, and ribavirin produced high on-treatment virologic response rates, but at the cost of significantly increased toxicities in an interim analysis of a French multicenter trial looking at the safety of the regimen.
Although the efficacy of direct-acting antiviral regimens involving the protease inhibitors telaprevir (Incivek) and boceprevir (Victrelis) combined with pegylated interferon alfa-2a or -2b in combination with ribavirin (PEG-IFN/RBV) in cirrhotic nonresponders to prior therapy was good , their safety was "poor," according to Dr. Christophe Hézode of the Hôpital Henri Mondor in Créteil, France.
Virologic response at 16 weeks in a per-protocol analysis was associated with a virologic response rate of 92% with telaprevir and 77% with boceprevir.
However, there were increased rates of serious adverse events and more difficult-to-manage anemia than in phase III trials for telaprevir and boceprevir, which included only a few patients with cirrhosis, Dr. Hézode said at the annual meeting of the American Association for the Study of Liver Diseases.
In treatment-experienced cirrhotic patients with platelet counts of 100,000/mm3 or serum albumin levels below 35 g/L, clinicians should weigh the risks and benefits of such regimens, with patients treated on a case-by-case basis because of the high risk for severe complications, Dr. Hézode said.
"However, cirrhotic experienced patients without predictors of severe complications clearly should be treated, but cautiously and carefully monitored," he added.
Dr. Hézode and his coinvestigators in the French Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (telaprevir or boceprevir), Pegylated Interferon, and Ribavirin (CUPIC) trial studied two cohorts of patients with chronic hepatitis C virus (HCV) infections, and compensated cirrhosis (Child Pugh class A) who had either relapsed or had only a partial response to prior therapy, with partial response defined as at least a 2 log10 decline inV RNA but failure to clear virus by week 24.
He presented data on 497 patients who had completed 16 weeks of therapy on one of two regimens. In one cohort, 292 patients received 12 weeks of telaprevir 750 mg every 8 hours, and PEG-IFN alfa-2a (Pegasys) 180 mcg/wk with ribavirin 1,000-1,200 mg/day, followed by PEG-IFN/RBV through 48 weeks. In the second cohort, patients received a 4-week initiation phase with PEG-IFN alfa-2b (PegIntron) and ribavirin, followed by 44 weeks of boceprevir 800 mg every 8 hours, PEG-IFN 1.5 mcg/kg per wk, and ribavirin 800-1,400 mg/day.
At week 16, 45% of patients on telaprevir had had at least one serious adverse event, with 14.7% terminating therapy because of a serious side effect. In all, nearly one-fourth (22.6%) discontinued therapy, and there were five deaths: from septicemia, septic shock, pneumopathy, endocarditis, and bleeding esophageal varices. Other complications in this group included grade 3 or 4 infections in 6.5%, grade 3 or 4 hepatic decompensation in 2%, grade 3/4 asthenia in 5.5%, and renal failure in 1.7%.
Hematologic adverse events included anemia of grade 2 or greater in 30.4%, erythropoietin use in 53.8%, blood transfusion in 16.1%, and ribavirin dose reduction in 13%. In addition, 2.7% of patients had grade 3 or 4 neutropenia, and 1.7% had grade 3 or 4 thrombocytopenia.
In the boceprevir group, 32.7% had at least one serious adverse event, 26.3% discontinued prematurely, and 7.3% discontinued because of serious events. The cause of one death was described as pneumopathy. Grade 3/4 adverse events involved infections in 2.4%, hepatic decompensation in 2.9%, and asthenia in 5.8%. There were no cases of renal failure in this group.
Hematologic events in patients on boceprevir included grade 2 or greater anemia in 27.8%, erythropoietin use in 46.3%, blood transfusion in 6.3%, and ribavirin dose reduction in 10.7%.
Grade 3/4 neutropenia was seen in 4.4%, and grade 3/4 thrombocytopenia in 5.4%. Two patients (1%) in this cohort received thrombopoietin.
In a multivariate analysis, significant baseline predictors of severe complications (death, severe infection, and hepatic decompensation) included platelet counts of 100,000/mm3 or lower (odds ratio, 3.11; P = .0098) and a serum albumin level below 35 g/L (OR, 6.33; P less than .0001).
Baseline predictors for severe anemia (hemoglobin less than 8 g/dL) or blood transfusion included female gender (OR, 2.19; P = .023), no lead-in phase (OR, 2.25; P = .018), age 65 years or older (OR, 3.04; P = .0014), and hemoglobin 12 g/dL or lower for women and 13 g/dL or lower for men (OR, 5.30; P less than .0001),
The study was sponsored by ANRS, the French National Agency for Research in AIDS and Viral Hepatitis, with support from INSERM, the French National Institute for Health and Medical Research. Dr. Hézode said that he has no financial conflicts of interest, but disclosed serving as a speaker and adviser for Abbott, BMS, Gilead, Janssen, Merck, and Roche.
BOSTON – In patients with chronic hepatitis C virus infections and compensated cirrhosis, a combination of a direct-acting antiviral agent, pegylated interferon, and ribavirin produced high on-treatment virologic response rates, but at the cost of significantly increased toxicities in an interim analysis of a French multicenter trial looking at the safety of the regimen.
Although the efficacy of direct-acting antiviral regimens involving the protease inhibitors telaprevir (Incivek) and boceprevir (Victrelis) combined with pegylated interferon alfa-2a or -2b in combination with ribavirin (PEG-IFN/RBV) in cirrhotic nonresponders to prior therapy was good , their safety was "poor," according to Dr. Christophe Hézode of the Hôpital Henri Mondor in Créteil, France.
Virologic response at 16 weeks in a per-protocol analysis was associated with a virologic response rate of 92% with telaprevir and 77% with boceprevir.
However, there were increased rates of serious adverse events and more difficult-to-manage anemia than in phase III trials for telaprevir and boceprevir, which included only a few patients with cirrhosis, Dr. Hézode said at the annual meeting of the American Association for the Study of Liver Diseases.
In treatment-experienced cirrhotic patients with platelet counts of 100,000/mm3 or serum albumin levels below 35 g/L, clinicians should weigh the risks and benefits of such regimens, with patients treated on a case-by-case basis because of the high risk for severe complications, Dr. Hézode said.
"However, cirrhotic experienced patients without predictors of severe complications clearly should be treated, but cautiously and carefully monitored," he added.
Dr. Hézode and his coinvestigators in the French Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (telaprevir or boceprevir), Pegylated Interferon, and Ribavirin (CUPIC) trial studied two cohorts of patients with chronic hepatitis C virus (HCV) infections, and compensated cirrhosis (Child Pugh class A) who had either relapsed or had only a partial response to prior therapy, with partial response defined as at least a 2 log10 decline inV RNA but failure to clear virus by week 24.
He presented data on 497 patients who had completed 16 weeks of therapy on one of two regimens. In one cohort, 292 patients received 12 weeks of telaprevir 750 mg every 8 hours, and PEG-IFN alfa-2a (Pegasys) 180 mcg/wk with ribavirin 1,000-1,200 mg/day, followed by PEG-IFN/RBV through 48 weeks. In the second cohort, patients received a 4-week initiation phase with PEG-IFN alfa-2b (PegIntron) and ribavirin, followed by 44 weeks of boceprevir 800 mg every 8 hours, PEG-IFN 1.5 mcg/kg per wk, and ribavirin 800-1,400 mg/day.
At week 16, 45% of patients on telaprevir had had at least one serious adverse event, with 14.7% terminating therapy because of a serious side effect. In all, nearly one-fourth (22.6%) discontinued therapy, and there were five deaths: from septicemia, septic shock, pneumopathy, endocarditis, and bleeding esophageal varices. Other complications in this group included grade 3 or 4 infections in 6.5%, grade 3 or 4 hepatic decompensation in 2%, grade 3/4 asthenia in 5.5%, and renal failure in 1.7%.
Hematologic adverse events included anemia of grade 2 or greater in 30.4%, erythropoietin use in 53.8%, blood transfusion in 16.1%, and ribavirin dose reduction in 13%. In addition, 2.7% of patients had grade 3 or 4 neutropenia, and 1.7% had grade 3 or 4 thrombocytopenia.
In the boceprevir group, 32.7% had at least one serious adverse event, 26.3% discontinued prematurely, and 7.3% discontinued because of serious events. The cause of one death was described as pneumopathy. Grade 3/4 adverse events involved infections in 2.4%, hepatic decompensation in 2.9%, and asthenia in 5.8%. There were no cases of renal failure in this group.
Hematologic events in patients on boceprevir included grade 2 or greater anemia in 27.8%, erythropoietin use in 46.3%, blood transfusion in 6.3%, and ribavirin dose reduction in 10.7%.
Grade 3/4 neutropenia was seen in 4.4%, and grade 3/4 thrombocytopenia in 5.4%. Two patients (1%) in this cohort received thrombopoietin.
In a multivariate analysis, significant baseline predictors of severe complications (death, severe infection, and hepatic decompensation) included platelet counts of 100,000/mm3 or lower (odds ratio, 3.11; P = .0098) and a serum albumin level below 35 g/L (OR, 6.33; P less than .0001).
Baseline predictors for severe anemia (hemoglobin less than 8 g/dL) or blood transfusion included female gender (OR, 2.19; P = .023), no lead-in phase (OR, 2.25; P = .018), age 65 years or older (OR, 3.04; P = .0014), and hemoglobin 12 g/dL or lower for women and 13 g/dL or lower for men (OR, 5.30; P less than .0001),
The study was sponsored by ANRS, the French National Agency for Research in AIDS and Viral Hepatitis, with support from INSERM, the French National Institute for Health and Medical Research. Dr. Hézode said that he has no financial conflicts of interest, but disclosed serving as a speaker and adviser for Abbott, BMS, Gilead, Janssen, Merck, and Roche.
AT THE ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES
Major Finding: At 16 weeks of therapy, 45% of treatment-experienced cirrhotic patients on a combination of telaprevir, pegylated interferon, and ribavirin experienced a serious adverse event, as did 32.7% of patients treated with boceprevir, interferon, and ribavirin.
Data Source: Data are from an ongoing multicenter, prospective cohort study.
Disclosures: The study was sponsored by ANRS, the French National Agency for Research in AIDS and Viral Hepatitis, with support from INSERM, the French National Institute for Health and Medical Research. Dr. Hézode said that he has no financial conflicts of interest, but disclosed serving as a speaker and adviser for Abbott, BMS, Gilead, Janssen, Merck, and Roche.
SurgiSIS myringoplasty shortens operative time
WASHINGTON – SurgiSIS, a material derived from porcine small intestinal mucosa, can be safely and effectively used for myringoplasty in children, based on data from a prospective, blinded study of 404 patients.
Patients’ tissue is not always available for tympanic membrane repair, and harvesting the graft may increase intraoperative time, said Dr. Riccardo D’Eredita of Vincenza (Italy) Civil Hospital. SurgiSIS (SIS) "promotes early vessel growth, provides scaffolding for remodeling tissues, and is inexpensive and ready to use." He presented the findings at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery Foundation.
The material has been used widely in children, and data from previous studies show that SurgiSIS is gradually replaced by host cells, said Dr. D’Eredita. After 30 days, host cells invade SurgiSIS. After 1 year, SurgiSIS is no longer evident, and has been replaced by the patients’ collagen.
In this study, 404 children underwent tympanic membrane repair in 432 ears; 217 were randomized to myringoplasty with SurgiSIS and 215 were randomized to repair using the patients’ own temporalis fascia.
Overall, the group without SurgiSIS had a 97% rate of stable closures and the group with SurgiSIS had a 95% rate. Surgical time was approximately 15 minutes less for SurgiSIS-treated patients, Dr. D’Eredita said.
The researchers assessed the healing of the tympanic membranes over a 10-year period and found comparable reduction of inflammation in the two groups. There were no adverse reactions in the SIS group.
Dr. D’Eredita had no financial conflicts to disclose.
WASHINGTON – SurgiSIS, a material derived from porcine small intestinal mucosa, can be safely and effectively used for myringoplasty in children, based on data from a prospective, blinded study of 404 patients.
Patients’ tissue is not always available for tympanic membrane repair, and harvesting the graft may increase intraoperative time, said Dr. Riccardo D’Eredita of Vincenza (Italy) Civil Hospital. SurgiSIS (SIS) "promotes early vessel growth, provides scaffolding for remodeling tissues, and is inexpensive and ready to use." He presented the findings at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery Foundation.
The material has been used widely in children, and data from previous studies show that SurgiSIS is gradually replaced by host cells, said Dr. D’Eredita. After 30 days, host cells invade SurgiSIS. After 1 year, SurgiSIS is no longer evident, and has been replaced by the patients’ collagen.
In this study, 404 children underwent tympanic membrane repair in 432 ears; 217 were randomized to myringoplasty with SurgiSIS and 215 were randomized to repair using the patients’ own temporalis fascia.
Overall, the group without SurgiSIS had a 97% rate of stable closures and the group with SurgiSIS had a 95% rate. Surgical time was approximately 15 minutes less for SurgiSIS-treated patients, Dr. D’Eredita said.
The researchers assessed the healing of the tympanic membranes over a 10-year period and found comparable reduction of inflammation in the two groups. There were no adverse reactions in the SIS group.
Dr. D’Eredita had no financial conflicts to disclose.
WASHINGTON – SurgiSIS, a material derived from porcine small intestinal mucosa, can be safely and effectively used for myringoplasty in children, based on data from a prospective, blinded study of 404 patients.
Patients’ tissue is not always available for tympanic membrane repair, and harvesting the graft may increase intraoperative time, said Dr. Riccardo D’Eredita of Vincenza (Italy) Civil Hospital. SurgiSIS (SIS) "promotes early vessel growth, provides scaffolding for remodeling tissues, and is inexpensive and ready to use." He presented the findings at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery Foundation.
The material has been used widely in children, and data from previous studies show that SurgiSIS is gradually replaced by host cells, said Dr. D’Eredita. After 30 days, host cells invade SurgiSIS. After 1 year, SurgiSIS is no longer evident, and has been replaced by the patients’ collagen.
In this study, 404 children underwent tympanic membrane repair in 432 ears; 217 were randomized to myringoplasty with SurgiSIS and 215 were randomized to repair using the patients’ own temporalis fascia.
Overall, the group without SurgiSIS had a 97% rate of stable closures and the group with SurgiSIS had a 95% rate. Surgical time was approximately 15 minutes less for SurgiSIS-treated patients, Dr. D’Eredita said.
The researchers assessed the healing of the tympanic membranes over a 10-year period and found comparable reduction of inflammation in the two groups. There were no adverse reactions in the SIS group.
Dr. D’Eredita had no financial conflicts to disclose.
AT THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF OTOLARYNGOLOGY - HEAD AND NECK SURGERY FOUNDATION
Major Finding: The number of stable surgical closures was similar in children who had tympanic membrane repair with porcine small intestinal mucosa (212) compared with use of their own tissue (204).
Data Source: The data comprise 432 ears in 404 children.
Disclosures: Dr. D’Eredita had no financial conflicts to disclose.
Facial Nerve Dysfunction Seen in 25% of Pediatric Parotidectomy Patients
WASHINGTON – Facial nerve dysfunction affected 23% of 43 children who had parotidectomies in a single-center study presented at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery Foundation.
The findings suggest that facial nerve dysfunction after parotidectomy is common enough in children to merit preoperative counseling, said Dr. James A. Owusu of the University of Minnesota, Minneapolis.
Facial nerve dysfunction rates reported in the literature range from 9% to 60% in adults after parotidectomy, but the condition has not been well studied in children.
Dr. Owusu and his colleagues reviewed the charts of 43 patients younger than age 18 years who underwent parotidectomies at a single tertiary care center between 1999 and 2011. Patients who only had parotid biopsies and those without follow-up data were excluded from the study. The average age of the patients was 4 years, and 58% were girls.
Postoperatively, 33 children (77%) had normal nerve function and 10 (23%) had abnormal nerve function. One patient experienced immediate facial nerve paralysis and nine experienced immediate facial nerve paresis. The marginal mandibular branch was affected in seven patients, the frontal branch in one patient, the buccal branch in one, and both marginal mandibular and frontal branches in one.
The most common diagnosis that led to a parotidectomy was atypical mycobacterium infection (37%), followed by branchial cleft abnormality (19%) and lymphangioma (16%). Nearly all (41) of the children underwent superficial parotidectomy; 2 underwent total parotidectomy.
"Age, gender, and pathologic diagnosis were not predictive of postoperative nerve dysfunction," Dr. Owusu said.
In patients with paresis, full nerve recovery occurred within 1 month for 2 patients, within 2 months for 1 patient, within 6 months for 3 patients, and within 10 months for 2 patients. Final nerve status was not available for 1 patient.
The study was limited by its small size and focus on a single center, Dr. Owusu said.
Dr. Owusu had no financial conflicts to disclose.
WASHINGTON – Facial nerve dysfunction affected 23% of 43 children who had parotidectomies in a single-center study presented at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery Foundation.
The findings suggest that facial nerve dysfunction after parotidectomy is common enough in children to merit preoperative counseling, said Dr. James A. Owusu of the University of Minnesota, Minneapolis.
Facial nerve dysfunction rates reported in the literature range from 9% to 60% in adults after parotidectomy, but the condition has not been well studied in children.
Dr. Owusu and his colleagues reviewed the charts of 43 patients younger than age 18 years who underwent parotidectomies at a single tertiary care center between 1999 and 2011. Patients who only had parotid biopsies and those without follow-up data were excluded from the study. The average age of the patients was 4 years, and 58% were girls.
Postoperatively, 33 children (77%) had normal nerve function and 10 (23%) had abnormal nerve function. One patient experienced immediate facial nerve paralysis and nine experienced immediate facial nerve paresis. The marginal mandibular branch was affected in seven patients, the frontal branch in one patient, the buccal branch in one, and both marginal mandibular and frontal branches in one.
The most common diagnosis that led to a parotidectomy was atypical mycobacterium infection (37%), followed by branchial cleft abnormality (19%) and lymphangioma (16%). Nearly all (41) of the children underwent superficial parotidectomy; 2 underwent total parotidectomy.
"Age, gender, and pathologic diagnosis were not predictive of postoperative nerve dysfunction," Dr. Owusu said.
In patients with paresis, full nerve recovery occurred within 1 month for 2 patients, within 2 months for 1 patient, within 6 months for 3 patients, and within 10 months for 2 patients. Final nerve status was not available for 1 patient.
The study was limited by its small size and focus on a single center, Dr. Owusu said.
Dr. Owusu had no financial conflicts to disclose.
WASHINGTON – Facial nerve dysfunction affected 23% of 43 children who had parotidectomies in a single-center study presented at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery Foundation.
The findings suggest that facial nerve dysfunction after parotidectomy is common enough in children to merit preoperative counseling, said Dr. James A. Owusu of the University of Minnesota, Minneapolis.
Facial nerve dysfunction rates reported in the literature range from 9% to 60% in adults after parotidectomy, but the condition has not been well studied in children.
Dr. Owusu and his colleagues reviewed the charts of 43 patients younger than age 18 years who underwent parotidectomies at a single tertiary care center between 1999 and 2011. Patients who only had parotid biopsies and those without follow-up data were excluded from the study. The average age of the patients was 4 years, and 58% were girls.
Postoperatively, 33 children (77%) had normal nerve function and 10 (23%) had abnormal nerve function. One patient experienced immediate facial nerve paralysis and nine experienced immediate facial nerve paresis. The marginal mandibular branch was affected in seven patients, the frontal branch in one patient, the buccal branch in one, and both marginal mandibular and frontal branches in one.
The most common diagnosis that led to a parotidectomy was atypical mycobacterium infection (37%), followed by branchial cleft abnormality (19%) and lymphangioma (16%). Nearly all (41) of the children underwent superficial parotidectomy; 2 underwent total parotidectomy.
"Age, gender, and pathologic diagnosis were not predictive of postoperative nerve dysfunction," Dr. Owusu said.
In patients with paresis, full nerve recovery occurred within 1 month for 2 patients, within 2 months for 1 patient, within 6 months for 3 patients, and within 10 months for 2 patients. Final nerve status was not available for 1 patient.
The study was limited by its small size and focus on a single center, Dr. Owusu said.
Dr. Owusu had no financial conflicts to disclose.
AT THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF OTOLARYNGOLOGY - HEAD AND NECK SURGERY FOUNDATION
Major Finding: After parotidectomies, 23% of children experienced facial nerve dysfunction, but most were fully recovered within 6 months.
Data Source: Investigators reviewed the charts of 43 children who underwent parotidectomies at a single center between 1999 and 2011.
Disclosures: Dr. Owusu had no financial conflicts to disclose.
PET/CT Pinpoints Physiological Evidence of Chemo Brain
CHICAGO – PET/CT scans routinely used in the care of oncology patients may prove useful in pinpointing physiological changes associated with chemo brain.
An analysis of 18F-fluorodeoxyglucose (18F-FDG) PET/CT images taken before and after chemotherapy in breast cancer patients revealed significant declines in glucose metabolism in two key regions of the brain. The affected areas were the superior medial frontal gyrus and temporal operculum, which are responsible for mental agility, problem solving, daily decision making, sequencing, and long-term memory, Dr. Rachel Lagos reported at the annual meeting of the Radiological Society of North America.
Interestingly, no changes in metabolism were observed in 61 other regions of the brain studied.
"If we can come up with an answer to explain why that is, or to reverse this, then we can solve the problem," Dr. Lagos said in an interview. "The good news is that we already know what these two areas do, so we know at a social level what to prepare women and their families for. We can give them some tools for coping, rather than just a pat on the hand."
Although many cancer patients complain of a mental fog or loss of coping skills, some clinicians remain skeptical without definitive scientific evidence. Previous studies have used magnetic resonance imaging, but this modality only allows clinicians to see anatomic details such as small losses in brain volume. With PET/CT, one can see the effects of chemotherapy on brain function over time, explained Dr. Lagos, a diagnostic radiology resident at West Virginia University in Morgantown.
The retrospective analysis involved PET/CT scans taken at the time of initial cancer staging and 12 months after chemotherapy from 116 women with advanced breast cancer, all of whom also received tamoxifen (Nolvadex, Soltamox). The investigators compared the scans to identify areas of reduced 18F-FDG uptake, representing lower glucose metabolism, and then plotted the changes as Z-score values. One patient with brain metastases was excluded from the analysis.
Statistically significant declines in glucose metabolism were observed post chemotherapy in the superior medial frontal gyrus as a whole (P = .025), when it was evaluated from left to right (P = .023), and in the temporal operculum (P = .036), Dr. Lagos said.
The investigators did not calculate an average value for the change in Z scores, but the decline in values ranged from 2.5 to 8.0 points, she said.
In 21 patients, the affected regions of the brain regained their metabolism, which corresponds to anecdotal information from patients that chemo brain lifts about 1-2 years after treatment.
"With the small data I’ve been able to accumulate so far, it’s hopeful that this kind of brain phenomenon is temporary," Dr. Lagos said.
The next step is to prospectively assess brain function starting at the time of cancer diagnosis and continuing throughout long-term follow-up, which potentially could lead to improved treatments or prevention, she said. In the meantime, the results provide physiologic evidence for chemo brain, and may prompt peers and counselors to use simple interventions such as creating lists for patients of their daily activities or meal plans to compensate for the mental fog.
Dr. Patrick J. Peller, a radiologist with the Mayo Clinic in Rochester, Minn., who hosted the poster session, said the study provides an understanding of the substrate for the often frustrating symptoms that patients experience, and could facilitate interventions to prevent chemo brain.
"Once you have a way to measure something, it sometimes drives your ability to treat it," he said in an interview. "We don’t have that treatment right now, just like we don’t have treatment for Alzheimer’s disease, but my sense is that it’s possible that our treatment for Alzheimer’s might work in some of these patients because it helps in compensation and not actually changing the underlying disease.
"If it improves the patient’s memory function, it might work in this situation, and you might be able to measure if it’s working with this technique."
Dr. Lagos and Dr. Peller reported no relevant financial disclosures.
CHICAGO – PET/CT scans routinely used in the care of oncology patients may prove useful in pinpointing physiological changes associated with chemo brain.
An analysis of 18F-fluorodeoxyglucose (18F-FDG) PET/CT images taken before and after chemotherapy in breast cancer patients revealed significant declines in glucose metabolism in two key regions of the brain. The affected areas were the superior medial frontal gyrus and temporal operculum, which are responsible for mental agility, problem solving, daily decision making, sequencing, and long-term memory, Dr. Rachel Lagos reported at the annual meeting of the Radiological Society of North America.
Interestingly, no changes in metabolism were observed in 61 other regions of the brain studied.
"If we can come up with an answer to explain why that is, or to reverse this, then we can solve the problem," Dr. Lagos said in an interview. "The good news is that we already know what these two areas do, so we know at a social level what to prepare women and their families for. We can give them some tools for coping, rather than just a pat on the hand."
Although many cancer patients complain of a mental fog or loss of coping skills, some clinicians remain skeptical without definitive scientific evidence. Previous studies have used magnetic resonance imaging, but this modality only allows clinicians to see anatomic details such as small losses in brain volume. With PET/CT, one can see the effects of chemotherapy on brain function over time, explained Dr. Lagos, a diagnostic radiology resident at West Virginia University in Morgantown.
The retrospective analysis involved PET/CT scans taken at the time of initial cancer staging and 12 months after chemotherapy from 116 women with advanced breast cancer, all of whom also received tamoxifen (Nolvadex, Soltamox). The investigators compared the scans to identify areas of reduced 18F-FDG uptake, representing lower glucose metabolism, and then plotted the changes as Z-score values. One patient with brain metastases was excluded from the analysis.
Statistically significant declines in glucose metabolism were observed post chemotherapy in the superior medial frontal gyrus as a whole (P = .025), when it was evaluated from left to right (P = .023), and in the temporal operculum (P = .036), Dr. Lagos said.
The investigators did not calculate an average value for the change in Z scores, but the decline in values ranged from 2.5 to 8.0 points, she said.
In 21 patients, the affected regions of the brain regained their metabolism, which corresponds to anecdotal information from patients that chemo brain lifts about 1-2 years after treatment.
"With the small data I’ve been able to accumulate so far, it’s hopeful that this kind of brain phenomenon is temporary," Dr. Lagos said.
The next step is to prospectively assess brain function starting at the time of cancer diagnosis and continuing throughout long-term follow-up, which potentially could lead to improved treatments or prevention, she said. In the meantime, the results provide physiologic evidence for chemo brain, and may prompt peers and counselors to use simple interventions such as creating lists for patients of their daily activities or meal plans to compensate for the mental fog.
Dr. Patrick J. Peller, a radiologist with the Mayo Clinic in Rochester, Minn., who hosted the poster session, said the study provides an understanding of the substrate for the often frustrating symptoms that patients experience, and could facilitate interventions to prevent chemo brain.
"Once you have a way to measure something, it sometimes drives your ability to treat it," he said in an interview. "We don’t have that treatment right now, just like we don’t have treatment for Alzheimer’s disease, but my sense is that it’s possible that our treatment for Alzheimer’s might work in some of these patients because it helps in compensation and not actually changing the underlying disease.
"If it improves the patient’s memory function, it might work in this situation, and you might be able to measure if it’s working with this technique."
Dr. Lagos and Dr. Peller reported no relevant financial disclosures.
CHICAGO – PET/CT scans routinely used in the care of oncology patients may prove useful in pinpointing physiological changes associated with chemo brain.
An analysis of 18F-fluorodeoxyglucose (18F-FDG) PET/CT images taken before and after chemotherapy in breast cancer patients revealed significant declines in glucose metabolism in two key regions of the brain. The affected areas were the superior medial frontal gyrus and temporal operculum, which are responsible for mental agility, problem solving, daily decision making, sequencing, and long-term memory, Dr. Rachel Lagos reported at the annual meeting of the Radiological Society of North America.
Interestingly, no changes in metabolism were observed in 61 other regions of the brain studied.
"If we can come up with an answer to explain why that is, or to reverse this, then we can solve the problem," Dr. Lagos said in an interview. "The good news is that we already know what these two areas do, so we know at a social level what to prepare women and their families for. We can give them some tools for coping, rather than just a pat on the hand."
Although many cancer patients complain of a mental fog or loss of coping skills, some clinicians remain skeptical without definitive scientific evidence. Previous studies have used magnetic resonance imaging, but this modality only allows clinicians to see anatomic details such as small losses in brain volume. With PET/CT, one can see the effects of chemotherapy on brain function over time, explained Dr. Lagos, a diagnostic radiology resident at West Virginia University in Morgantown.
The retrospective analysis involved PET/CT scans taken at the time of initial cancer staging and 12 months after chemotherapy from 116 women with advanced breast cancer, all of whom also received tamoxifen (Nolvadex, Soltamox). The investigators compared the scans to identify areas of reduced 18F-FDG uptake, representing lower glucose metabolism, and then plotted the changes as Z-score values. One patient with brain metastases was excluded from the analysis.
Statistically significant declines in glucose metabolism were observed post chemotherapy in the superior medial frontal gyrus as a whole (P = .025), when it was evaluated from left to right (P = .023), and in the temporal operculum (P = .036), Dr. Lagos said.
The investigators did not calculate an average value for the change in Z scores, but the decline in values ranged from 2.5 to 8.0 points, she said.
In 21 patients, the affected regions of the brain regained their metabolism, which corresponds to anecdotal information from patients that chemo brain lifts about 1-2 years after treatment.
"With the small data I’ve been able to accumulate so far, it’s hopeful that this kind of brain phenomenon is temporary," Dr. Lagos said.
The next step is to prospectively assess brain function starting at the time of cancer diagnosis and continuing throughout long-term follow-up, which potentially could lead to improved treatments or prevention, she said. In the meantime, the results provide physiologic evidence for chemo brain, and may prompt peers and counselors to use simple interventions such as creating lists for patients of their daily activities or meal plans to compensate for the mental fog.
Dr. Patrick J. Peller, a radiologist with the Mayo Clinic in Rochester, Minn., who hosted the poster session, said the study provides an understanding of the substrate for the often frustrating symptoms that patients experience, and could facilitate interventions to prevent chemo brain.
"Once you have a way to measure something, it sometimes drives your ability to treat it," he said in an interview. "We don’t have that treatment right now, just like we don’t have treatment for Alzheimer’s disease, but my sense is that it’s possible that our treatment for Alzheimer’s might work in some of these patients because it helps in compensation and not actually changing the underlying disease.
"If it improves the patient’s memory function, it might work in this situation, and you might be able to measure if it’s working with this technique."
Dr. Lagos and Dr. Peller reported no relevant financial disclosures.
AT THE ANNUAL MEETING OF THE RADIOLOGICAL SOCIETY OF NORTH AMERICA
Major Finding: Statistically significant declines in glucose metabolism were observed post chemotherapy in the superior medial frontal gyrus as a whole (P = .025), when it was evaluated from left to right (P = .023), and in the temporal operculum (P = .036).
Data Source: This was a retrospective analysis of PET/CT scans from 115 patients with advanced breast cancer.
Disclosures: Dr. Lagos and Dr. Peller reported no relevant financial disclosures.
Changes Warrant Residency Reforms
Surgical residency programs have not kept up with radical changes in the practice of surgery over the past two decades, but innovations ranging from curriculum reform to increasing the length of residency could help to improve the overall performance of recent surgical residency graduates, according to an analysis in Annals of Surgery.
"The changes that have occurred have been disruptive to residency training, and to date there has been minimal compensation for these," Dr. Frank Lewis and Dr. Mary Klingensmith wrote. "Evidence is now emerging of significant issues in the overall performance of recent graduates from at least three sources – the evaluation of external agents who incorporate these graduates into their practice or group, the opinions of the residents themselves, and the performance of graduates on the oral examination of the American Board of Surgery during the last 8 years" (Ann. Surg. 2012;256:553-59).
The changes include not only the 80-hour workweek for surgical residents, but also clinical areas, according to Dr. Lewis, executive director of the American Board of Surgery, and Dr. Klingensmith, residency program director at Washington University in St. Louis.
The effect of the 80-hour workweek has been a reduction by 6 months to a year of in-hospital experience during 5 years of residency. Most of that reduced time corresponds to night and weekend experience, when residents would be more likely to see urgent and emergent conditions, and to have a greater degree of independent functioning, autonomy, and indirect supervision, they said.
The most significant clinical change has been the development of laparoscopic surgery for intra-abdominal surgical management, which is replacing open surgery and the abdominal incision. Because surgeons in academic settings have been slower to adopt laparoscopy, resident training in the use of this technology has proceeded slowly, they explained.
"While the Residency Review Committee (RRC) for Surgery has been steadily increasing the requirements for surgical resident training, it is still the rule that the most complex laparoscopic surgery is reserved for fellows in postresidency fellowships and not for residents during surgical training, although there is no reason this should be the case," they noted.
In addition, operations performed by general surgeons, and the way in which they are done, have changed significantly in the past 20 years, according to the analysis. For example, the advent of better medical management for benign peptic ulcer disease – along with flexible endoscopy and endoscopic retrograde cholangiopancreatography – means that fewer surgical interventions for peptic ulcer complications and biliary tree stone disease are necessary.
Furthermore, technological innovations have allowed vascular surgeons, rather than general surgeons, to perform most abdominal vascular surgery. Finally, the two surgeons reported, abdominal trauma injuries – which require surgical intervention in 80%-90% of cases – have declined dramatically since 1992.
These types of changes "will undoubtedly continue, and the directions in which surgery will evolve in the future are not predictable," Dr. Lewis and Dr. Klingensmith wrote.
They laid out seven potential ways in which surgical residency programs can address the changes:
• There should be a continuous process to define and continually update the surgical residency curriculum, which needs to keep pace with the fast-changing surgical practice landscape, and to "prune" information related to diseases that no longer are seen frequently in practice.
"The starting point for making changes in residency is to recognize that much of what is being taught is obsolete, and addresses diseases that are no longer a significant problem, or those for which surgical treatment is rarely needed," they said.
• Residency programs should improve the efficacy of resident learning by reducing clerical functions for residents, using physician extenders where appropriate, and utilizing mobile computing technology to deliver "a more defined and comprehensive curriculum to residents at an individual level."
• Educators could make better use of simulators in certain areas, such as laparoscopic surgery and endoscopic surgery.
• There should be an earlier specialty focus in residency training for those surgical residents who already know which specialty they would like to pursue.
• Surgical residency should include expanded laparoscopic surgery training.
• Residency programs could increase in length to make up for the time lost to the 80-hour workweek rule. Four-fifths of surgical residents already elect to take a postresidency fellowship in a specialty or subspecialty area, so "any discussion of extending residency only applies to the 20% of residents who currently complete only general surgical residency and do not seek subspecialty training," they said. "Extending residency by 1 year to obtain more extensive training in general surgery per se would not seem to be an insurmountable issue if the benefits clearly warranted it."
• Surgical training should expand to include additional skills, such as the use of ultrasound for better diagnosis of conditions in breast, endocrine, vascular, and trauma diseases and the use of interventional catheter techniques for the diagnosis or treatment of a variety of conditions.
It’s not possible to reverse the changes that have occurred over the past 2 decades, and in fact the workweek could see further shortening, as has happened in Europe, the investigators noted. "The most effective way in which to address the changes is therefore to look at the things which can be changed in resident training, the many areas in which improvements in resident teaching are possible, and the areas in which residents’ capabilities could be productively expanded."
The investigators did not report any conflicts of interest.
Surgical residency programs have not kept up with radical changes in the practice of surgery over the past two decades, but innovations ranging from curriculum reform to increasing the length of residency could help to improve the overall performance of recent surgical residency graduates, according to an analysis in Annals of Surgery.
"The changes that have occurred have been disruptive to residency training, and to date there has been minimal compensation for these," Dr. Frank Lewis and Dr. Mary Klingensmith wrote. "Evidence is now emerging of significant issues in the overall performance of recent graduates from at least three sources – the evaluation of external agents who incorporate these graduates into their practice or group, the opinions of the residents themselves, and the performance of graduates on the oral examination of the American Board of Surgery during the last 8 years" (Ann. Surg. 2012;256:553-59).
The changes include not only the 80-hour workweek for surgical residents, but also clinical areas, according to Dr. Lewis, executive director of the American Board of Surgery, and Dr. Klingensmith, residency program director at Washington University in St. Louis.
The effect of the 80-hour workweek has been a reduction by 6 months to a year of in-hospital experience during 5 years of residency. Most of that reduced time corresponds to night and weekend experience, when residents would be more likely to see urgent and emergent conditions, and to have a greater degree of independent functioning, autonomy, and indirect supervision, they said.
The most significant clinical change has been the development of laparoscopic surgery for intra-abdominal surgical management, which is replacing open surgery and the abdominal incision. Because surgeons in academic settings have been slower to adopt laparoscopy, resident training in the use of this technology has proceeded slowly, they explained.
"While the Residency Review Committee (RRC) for Surgery has been steadily increasing the requirements for surgical resident training, it is still the rule that the most complex laparoscopic surgery is reserved for fellows in postresidency fellowships and not for residents during surgical training, although there is no reason this should be the case," they noted.
In addition, operations performed by general surgeons, and the way in which they are done, have changed significantly in the past 20 years, according to the analysis. For example, the advent of better medical management for benign peptic ulcer disease – along with flexible endoscopy and endoscopic retrograde cholangiopancreatography – means that fewer surgical interventions for peptic ulcer complications and biliary tree stone disease are necessary.
Furthermore, technological innovations have allowed vascular surgeons, rather than general surgeons, to perform most abdominal vascular surgery. Finally, the two surgeons reported, abdominal trauma injuries – which require surgical intervention in 80%-90% of cases – have declined dramatically since 1992.
These types of changes "will undoubtedly continue, and the directions in which surgery will evolve in the future are not predictable," Dr. Lewis and Dr. Klingensmith wrote.
They laid out seven potential ways in which surgical residency programs can address the changes:
• There should be a continuous process to define and continually update the surgical residency curriculum, which needs to keep pace with the fast-changing surgical practice landscape, and to "prune" information related to diseases that no longer are seen frequently in practice.
"The starting point for making changes in residency is to recognize that much of what is being taught is obsolete, and addresses diseases that are no longer a significant problem, or those for which surgical treatment is rarely needed," they said.
• Residency programs should improve the efficacy of resident learning by reducing clerical functions for residents, using physician extenders where appropriate, and utilizing mobile computing technology to deliver "a more defined and comprehensive curriculum to residents at an individual level."
• Educators could make better use of simulators in certain areas, such as laparoscopic surgery and endoscopic surgery.
• There should be an earlier specialty focus in residency training for those surgical residents who already know which specialty they would like to pursue.
• Surgical residency should include expanded laparoscopic surgery training.
• Residency programs could increase in length to make up for the time lost to the 80-hour workweek rule. Four-fifths of surgical residents already elect to take a postresidency fellowship in a specialty or subspecialty area, so "any discussion of extending residency only applies to the 20% of residents who currently complete only general surgical residency and do not seek subspecialty training," they said. "Extending residency by 1 year to obtain more extensive training in general surgery per se would not seem to be an insurmountable issue if the benefits clearly warranted it."
• Surgical training should expand to include additional skills, such as the use of ultrasound for better diagnosis of conditions in breast, endocrine, vascular, and trauma diseases and the use of interventional catheter techniques for the diagnosis or treatment of a variety of conditions.
It’s not possible to reverse the changes that have occurred over the past 2 decades, and in fact the workweek could see further shortening, as has happened in Europe, the investigators noted. "The most effective way in which to address the changes is therefore to look at the things which can be changed in resident training, the many areas in which improvements in resident teaching are possible, and the areas in which residents’ capabilities could be productively expanded."
The investigators did not report any conflicts of interest.
Surgical residency programs have not kept up with radical changes in the practice of surgery over the past two decades, but innovations ranging from curriculum reform to increasing the length of residency could help to improve the overall performance of recent surgical residency graduates, according to an analysis in Annals of Surgery.
"The changes that have occurred have been disruptive to residency training, and to date there has been minimal compensation for these," Dr. Frank Lewis and Dr. Mary Klingensmith wrote. "Evidence is now emerging of significant issues in the overall performance of recent graduates from at least three sources – the evaluation of external agents who incorporate these graduates into their practice or group, the opinions of the residents themselves, and the performance of graduates on the oral examination of the American Board of Surgery during the last 8 years" (Ann. Surg. 2012;256:553-59).
The changes include not only the 80-hour workweek for surgical residents, but also clinical areas, according to Dr. Lewis, executive director of the American Board of Surgery, and Dr. Klingensmith, residency program director at Washington University in St. Louis.
The effect of the 80-hour workweek has been a reduction by 6 months to a year of in-hospital experience during 5 years of residency. Most of that reduced time corresponds to night and weekend experience, when residents would be more likely to see urgent and emergent conditions, and to have a greater degree of independent functioning, autonomy, and indirect supervision, they said.
The most significant clinical change has been the development of laparoscopic surgery for intra-abdominal surgical management, which is replacing open surgery and the abdominal incision. Because surgeons in academic settings have been slower to adopt laparoscopy, resident training in the use of this technology has proceeded slowly, they explained.
"While the Residency Review Committee (RRC) for Surgery has been steadily increasing the requirements for surgical resident training, it is still the rule that the most complex laparoscopic surgery is reserved for fellows in postresidency fellowships and not for residents during surgical training, although there is no reason this should be the case," they noted.
In addition, operations performed by general surgeons, and the way in which they are done, have changed significantly in the past 20 years, according to the analysis. For example, the advent of better medical management for benign peptic ulcer disease – along with flexible endoscopy and endoscopic retrograde cholangiopancreatography – means that fewer surgical interventions for peptic ulcer complications and biliary tree stone disease are necessary.
Furthermore, technological innovations have allowed vascular surgeons, rather than general surgeons, to perform most abdominal vascular surgery. Finally, the two surgeons reported, abdominal trauma injuries – which require surgical intervention in 80%-90% of cases – have declined dramatically since 1992.
These types of changes "will undoubtedly continue, and the directions in which surgery will evolve in the future are not predictable," Dr. Lewis and Dr. Klingensmith wrote.
They laid out seven potential ways in which surgical residency programs can address the changes:
• There should be a continuous process to define and continually update the surgical residency curriculum, which needs to keep pace with the fast-changing surgical practice landscape, and to "prune" information related to diseases that no longer are seen frequently in practice.
"The starting point for making changes in residency is to recognize that much of what is being taught is obsolete, and addresses diseases that are no longer a significant problem, or those for which surgical treatment is rarely needed," they said.
• Residency programs should improve the efficacy of resident learning by reducing clerical functions for residents, using physician extenders where appropriate, and utilizing mobile computing technology to deliver "a more defined and comprehensive curriculum to residents at an individual level."
• Educators could make better use of simulators in certain areas, such as laparoscopic surgery and endoscopic surgery.
• There should be an earlier specialty focus in residency training for those surgical residents who already know which specialty they would like to pursue.
• Surgical residency should include expanded laparoscopic surgery training.
• Residency programs could increase in length to make up for the time lost to the 80-hour workweek rule. Four-fifths of surgical residents already elect to take a postresidency fellowship in a specialty or subspecialty area, so "any discussion of extending residency only applies to the 20% of residents who currently complete only general surgical residency and do not seek subspecialty training," they said. "Extending residency by 1 year to obtain more extensive training in general surgery per se would not seem to be an insurmountable issue if the benefits clearly warranted it."
• Surgical training should expand to include additional skills, such as the use of ultrasound for better diagnosis of conditions in breast, endocrine, vascular, and trauma diseases and the use of interventional catheter techniques for the diagnosis or treatment of a variety of conditions.
It’s not possible to reverse the changes that have occurred over the past 2 decades, and in fact the workweek could see further shortening, as has happened in Europe, the investigators noted. "The most effective way in which to address the changes is therefore to look at the things which can be changed in resident training, the many areas in which improvements in resident teaching are possible, and the areas in which residents’ capabilities could be productively expanded."
The investigators did not report any conflicts of interest.
EXPERT ANALYSIS FROM ANNALS OF SURGERY
Hospitalist Approach Good Model for Managing Patients
Applying the HM model to specialties that can dedicate themselves to managing inpatients could improve care efficiency, says the coauthor of a new report from the American Hospital Association's (AHA) Physician Leadership Forum.
The 20-page report, "Creating the Hospital of the Future: The Implications for Hospital-Focused Physician Practice [PDF]," codified a daylong summit of hospitalist leaders and hospital administrators following the annual Health Forum/AHA Leadership Summit last July in San Francisco. SHM helped organize the meeting, which focused on the growing role and importance of "hyphenated hospitalists."
"With the hospitalist movement, it's critical that there is coordination between the inpatient and the outpatient world … but also inpatient-wise, there should be some coordination of services between the various specialties that are dedicated to the hospital," says John Combes, MD, AHA senior vice president. "We have an opportunity here, as more and more subspecialties develop hospital-based and hospital-focused practices, to construct it right."
Dr. Combes says the model is not applicable to all specialties, but early adoption by fields including OBGYN, orthopedics, neurology, and surgery is a good sign. Hospitalist could look at forming large, multispecialty groups to bring all hospital-focused programs under one proverbial roof. "So there's not only coordination at the hospital level, but also at the group level," he adds.
The continued growth of specialty hospitalists might hinge on whether research shows that the approach improves patient outcomes.
"The jury is out on that right now," Dr. Combes says. "As hospitalists get better at defining what their role is within the inpatient setting—particularly around care coordination, care improvement, efficiency, reduction of unnecessary procedures and testing—we'll be able to document more value."
Visit our website for more information about hospital-based medical practices.
Applying the HM model to specialties that can dedicate themselves to managing inpatients could improve care efficiency, says the coauthor of a new report from the American Hospital Association's (AHA) Physician Leadership Forum.
The 20-page report, "Creating the Hospital of the Future: The Implications for Hospital-Focused Physician Practice [PDF]," codified a daylong summit of hospitalist leaders and hospital administrators following the annual Health Forum/AHA Leadership Summit last July in San Francisco. SHM helped organize the meeting, which focused on the growing role and importance of "hyphenated hospitalists."
"With the hospitalist movement, it's critical that there is coordination between the inpatient and the outpatient world … but also inpatient-wise, there should be some coordination of services between the various specialties that are dedicated to the hospital," says John Combes, MD, AHA senior vice president. "We have an opportunity here, as more and more subspecialties develop hospital-based and hospital-focused practices, to construct it right."
Dr. Combes says the model is not applicable to all specialties, but early adoption by fields including OBGYN, orthopedics, neurology, and surgery is a good sign. Hospitalist could look at forming large, multispecialty groups to bring all hospital-focused programs under one proverbial roof. "So there's not only coordination at the hospital level, but also at the group level," he adds.
The continued growth of specialty hospitalists might hinge on whether research shows that the approach improves patient outcomes.
"The jury is out on that right now," Dr. Combes says. "As hospitalists get better at defining what their role is within the inpatient setting—particularly around care coordination, care improvement, efficiency, reduction of unnecessary procedures and testing—we'll be able to document more value."
Visit our website for more information about hospital-based medical practices.
Applying the HM model to specialties that can dedicate themselves to managing inpatients could improve care efficiency, says the coauthor of a new report from the American Hospital Association's (AHA) Physician Leadership Forum.
The 20-page report, "Creating the Hospital of the Future: The Implications for Hospital-Focused Physician Practice [PDF]," codified a daylong summit of hospitalist leaders and hospital administrators following the annual Health Forum/AHA Leadership Summit last July in San Francisco. SHM helped organize the meeting, which focused on the growing role and importance of "hyphenated hospitalists."
"With the hospitalist movement, it's critical that there is coordination between the inpatient and the outpatient world … but also inpatient-wise, there should be some coordination of services between the various specialties that are dedicated to the hospital," says John Combes, MD, AHA senior vice president. "We have an opportunity here, as more and more subspecialties develop hospital-based and hospital-focused practices, to construct it right."
Dr. Combes says the model is not applicable to all specialties, but early adoption by fields including OBGYN, orthopedics, neurology, and surgery is a good sign. Hospitalist could look at forming large, multispecialty groups to bring all hospital-focused programs under one proverbial roof. "So there's not only coordination at the hospital level, but also at the group level," he adds.
The continued growth of specialty hospitalists might hinge on whether research shows that the approach improves patient outcomes.
"The jury is out on that right now," Dr. Combes says. "As hospitalists get better at defining what their role is within the inpatient setting—particularly around care coordination, care improvement, efficiency, reduction of unnecessary procedures and testing—we'll be able to document more value."
Visit our website for more information about hospital-based medical practices.
Hospital Food Not Immune to Toxigenic Bacteria
A recent study showed 28% of patient meals sampled from a university hospital in Houston were found to be contaminated with toxigenic Clostridium difficile bacterium, and researchers think undercooked food is to blame.
"The temperatures at which hospital foods are cooked may be too low to kill the bug," according to Hoonmo Koo, MD, assistant professor of medicine and an infectious-disease specialist at Baylor College of Medicine in Houston and lead author of the study, "Contamination of Hospital Food with Clostridium Difficile." The study results were presented at the annual meeting of the Infectious Diseases Society of America in October.
Sampled food included chicken, beef, seafood, and fruits and vegetables, but the highest instance of contamination occurred in 60% of dessert items, which were kept at an average of 62 degrees, the report noted.
Jonathan Pell, MD, assistant professor of hospital medicine at the University of Colorado School of Medicine in Denver, says food contaminated with C. diff might not be unique to the hospital setting.
"As far as we know, food at Arby's has the same concentration of toxigenic C. diff," Dr. Pell said in an email to The Hospitalist. He notes the strain of bacteria found in food is typically different from that found in affected humans, a fact outlined in a report by the Centers for Disease Control and Prevention (CDC). The report states that toxinotype V strains of C. diff—those often found in food animals—are "currently an uncommon cause of human illness, which may occur more frequently among persons without traditional risk factors associated with [C. diff-associated disease], such as recent exposure to a healthcare setting."
Despite the need for further research, hospitalists and health professionals are encouraged to continue practicing thorough hand-washing hygiene in the hospital setting to prevent the spread of bacteria.
Visit our website for more information about C. diff infection prevention.
A recent study showed 28% of patient meals sampled from a university hospital in Houston were found to be contaminated with toxigenic Clostridium difficile bacterium, and researchers think undercooked food is to blame.
"The temperatures at which hospital foods are cooked may be too low to kill the bug," according to Hoonmo Koo, MD, assistant professor of medicine and an infectious-disease specialist at Baylor College of Medicine in Houston and lead author of the study, "Contamination of Hospital Food with Clostridium Difficile." The study results were presented at the annual meeting of the Infectious Diseases Society of America in October.
Sampled food included chicken, beef, seafood, and fruits and vegetables, but the highest instance of contamination occurred in 60% of dessert items, which were kept at an average of 62 degrees, the report noted.
Jonathan Pell, MD, assistant professor of hospital medicine at the University of Colorado School of Medicine in Denver, says food contaminated with C. diff might not be unique to the hospital setting.
"As far as we know, food at Arby's has the same concentration of toxigenic C. diff," Dr. Pell said in an email to The Hospitalist. He notes the strain of bacteria found in food is typically different from that found in affected humans, a fact outlined in a report by the Centers for Disease Control and Prevention (CDC). The report states that toxinotype V strains of C. diff—those often found in food animals—are "currently an uncommon cause of human illness, which may occur more frequently among persons without traditional risk factors associated with [C. diff-associated disease], such as recent exposure to a healthcare setting."
Despite the need for further research, hospitalists and health professionals are encouraged to continue practicing thorough hand-washing hygiene in the hospital setting to prevent the spread of bacteria.
Visit our website for more information about C. diff infection prevention.
A recent study showed 28% of patient meals sampled from a university hospital in Houston were found to be contaminated with toxigenic Clostridium difficile bacterium, and researchers think undercooked food is to blame.
"The temperatures at which hospital foods are cooked may be too low to kill the bug," according to Hoonmo Koo, MD, assistant professor of medicine and an infectious-disease specialist at Baylor College of Medicine in Houston and lead author of the study, "Contamination of Hospital Food with Clostridium Difficile." The study results were presented at the annual meeting of the Infectious Diseases Society of America in October.
Sampled food included chicken, beef, seafood, and fruits and vegetables, but the highest instance of contamination occurred in 60% of dessert items, which were kept at an average of 62 degrees, the report noted.
Jonathan Pell, MD, assistant professor of hospital medicine at the University of Colorado School of Medicine in Denver, says food contaminated with C. diff might not be unique to the hospital setting.
"As far as we know, food at Arby's has the same concentration of toxigenic C. diff," Dr. Pell said in an email to The Hospitalist. He notes the strain of bacteria found in food is typically different from that found in affected humans, a fact outlined in a report by the Centers for Disease Control and Prevention (CDC). The report states that toxinotype V strains of C. diff—those often found in food animals—are "currently an uncommon cause of human illness, which may occur more frequently among persons without traditional risk factors associated with [C. diff-associated disease], such as recent exposure to a healthcare setting."
Despite the need for further research, hospitalists and health professionals are encouraged to continue practicing thorough hand-washing hygiene in the hospital setting to prevent the spread of bacteria.
Visit our website for more information about C. diff infection prevention.
What's in Your Toolbox?
When I was a resident, an attending physician in my geriatrics rotation always ended rounds with the question: "What did you put in your toolbox today?"
One of my favorite parts of my job is resident education. For a few months out of the year, I have an internal medicine resident shadow me. This provides me with an opportunity to teach, and perhaps inspire some of them to go into rheumatology, as my mentors in medical school inspired me.
But it is challenging to be responsible for someone’s learning. When I was in medical school I always appreciated the professors whose lectures catered to the levels of our medical knowledge – not talking above or below us. Now that I find myself in a similar position I am quite self-conscious of this. My goal is to teach residents information that will be most helpful for them in their general practice without wasting their time.
Since the bulk of internal medicine residency is focused on inpatient care, and since rheumatology is mostly an outpatient field, there is a fairly large gap between what residents know now and what they will have to know in a few short years. I have a short list of things that I think every internal medicine resident should learn.
– A good clinical eye has to be cultivated. The art of the physical exam is one of the few things that cannot be learned from books. I can think of a few eponymous physical exam findings and maneuvers specific to rheumatology – oh, to make Heberden and Bouchard, Gottron, Yergason, Finklestein, Patrick, and Schober proud – that can help any primary care physician make an accurate diagnosis. The neurological exam is also of some import in our field and so, thanks to Tinel, Phalen, Jendrassik, and Lasegue, I have a few tricks up my sleeve.
– The needle is our friend. Joint aspiration and injection are valuable tools in the primary care physician’s toolbox. A lot of patients present with knee osteoarthritis and it is an easy way to relieve pain, especially when there are comorbidities that preclude the use of NSAIDs. Also useful for when there is a question of septic arthritis on the wards and they can’t wait for the busy rheumatologist to get to the hospital after a long day at clinic, and the orthopedic resident is not cooperating.
– Back pain is ubiquitous. It is, in fact, one of most common reasons for an outpatient sick visit. But there are many different varieties of low back pain, and again, the arts of taking a good history and performing a good physical exam are relevant. I stress to the medical residents that imaging is not always necessary, HLA B27 testing is superfluous, and physical therapy is underutilized but extremely important.
– Know gout well. Much has been made of how poorly gout is managed in the primary care setting (though the numbers do seem to be improving). I still occasionally see patients who stop and start their urate-lowering drugs whenever they are in a flare – precisely not what they should be doing. If there is a relationship between the metabolic syndrome and gout, then shouldn’t primary care providers be just as familiar with the management of gout as they are with the management of hypertension, hyperlipidemia, and diabetes?
– Not all that glitters is gold. One of the more valuable lessons I hope residents leave with after a month with me is that an elevated ESR does not always mean PMR, and an elevated RF does not always mean rheumatoid arthritis. The differentials for these entities are slightly broader and need to be thoroughly investigated. Since primary care providers often order these tests I think they should also be able to interpret it.
Dr. Chan practices rheumatology in Pawtucket, R.I. E-mail her [email protected].
When I was a resident, an attending physician in my geriatrics rotation always ended rounds with the question: "What did you put in your toolbox today?"
One of my favorite parts of my job is resident education. For a few months out of the year, I have an internal medicine resident shadow me. This provides me with an opportunity to teach, and perhaps inspire some of them to go into rheumatology, as my mentors in medical school inspired me.
But it is challenging to be responsible for someone’s learning. When I was in medical school I always appreciated the professors whose lectures catered to the levels of our medical knowledge – not talking above or below us. Now that I find myself in a similar position I am quite self-conscious of this. My goal is to teach residents information that will be most helpful for them in their general practice without wasting their time.
Since the bulk of internal medicine residency is focused on inpatient care, and since rheumatology is mostly an outpatient field, there is a fairly large gap between what residents know now and what they will have to know in a few short years. I have a short list of things that I think every internal medicine resident should learn.
– A good clinical eye has to be cultivated. The art of the physical exam is one of the few things that cannot be learned from books. I can think of a few eponymous physical exam findings and maneuvers specific to rheumatology – oh, to make Heberden and Bouchard, Gottron, Yergason, Finklestein, Patrick, and Schober proud – that can help any primary care physician make an accurate diagnosis. The neurological exam is also of some import in our field and so, thanks to Tinel, Phalen, Jendrassik, and Lasegue, I have a few tricks up my sleeve.
– The needle is our friend. Joint aspiration and injection are valuable tools in the primary care physician’s toolbox. A lot of patients present with knee osteoarthritis and it is an easy way to relieve pain, especially when there are comorbidities that preclude the use of NSAIDs. Also useful for when there is a question of septic arthritis on the wards and they can’t wait for the busy rheumatologist to get to the hospital after a long day at clinic, and the orthopedic resident is not cooperating.
– Back pain is ubiquitous. It is, in fact, one of most common reasons for an outpatient sick visit. But there are many different varieties of low back pain, and again, the arts of taking a good history and performing a good physical exam are relevant. I stress to the medical residents that imaging is not always necessary, HLA B27 testing is superfluous, and physical therapy is underutilized but extremely important.
– Know gout well. Much has been made of how poorly gout is managed in the primary care setting (though the numbers do seem to be improving). I still occasionally see patients who stop and start their urate-lowering drugs whenever they are in a flare – precisely not what they should be doing. If there is a relationship between the metabolic syndrome and gout, then shouldn’t primary care providers be just as familiar with the management of gout as they are with the management of hypertension, hyperlipidemia, and diabetes?
– Not all that glitters is gold. One of the more valuable lessons I hope residents leave with after a month with me is that an elevated ESR does not always mean PMR, and an elevated RF does not always mean rheumatoid arthritis. The differentials for these entities are slightly broader and need to be thoroughly investigated. Since primary care providers often order these tests I think they should also be able to interpret it.
Dr. Chan practices rheumatology in Pawtucket, R.I. E-mail her [email protected].
When I was a resident, an attending physician in my geriatrics rotation always ended rounds with the question: "What did you put in your toolbox today?"
One of my favorite parts of my job is resident education. For a few months out of the year, I have an internal medicine resident shadow me. This provides me with an opportunity to teach, and perhaps inspire some of them to go into rheumatology, as my mentors in medical school inspired me.
But it is challenging to be responsible for someone’s learning. When I was in medical school I always appreciated the professors whose lectures catered to the levels of our medical knowledge – not talking above or below us. Now that I find myself in a similar position I am quite self-conscious of this. My goal is to teach residents information that will be most helpful for them in their general practice without wasting their time.
Since the bulk of internal medicine residency is focused on inpatient care, and since rheumatology is mostly an outpatient field, there is a fairly large gap between what residents know now and what they will have to know in a few short years. I have a short list of things that I think every internal medicine resident should learn.
– A good clinical eye has to be cultivated. The art of the physical exam is one of the few things that cannot be learned from books. I can think of a few eponymous physical exam findings and maneuvers specific to rheumatology – oh, to make Heberden and Bouchard, Gottron, Yergason, Finklestein, Patrick, and Schober proud – that can help any primary care physician make an accurate diagnosis. The neurological exam is also of some import in our field and so, thanks to Tinel, Phalen, Jendrassik, and Lasegue, I have a few tricks up my sleeve.
– The needle is our friend. Joint aspiration and injection are valuable tools in the primary care physician’s toolbox. A lot of patients present with knee osteoarthritis and it is an easy way to relieve pain, especially when there are comorbidities that preclude the use of NSAIDs. Also useful for when there is a question of septic arthritis on the wards and they can’t wait for the busy rheumatologist to get to the hospital after a long day at clinic, and the orthopedic resident is not cooperating.
– Back pain is ubiquitous. It is, in fact, one of most common reasons for an outpatient sick visit. But there are many different varieties of low back pain, and again, the arts of taking a good history and performing a good physical exam are relevant. I stress to the medical residents that imaging is not always necessary, HLA B27 testing is superfluous, and physical therapy is underutilized but extremely important.
– Know gout well. Much has been made of how poorly gout is managed in the primary care setting (though the numbers do seem to be improving). I still occasionally see patients who stop and start their urate-lowering drugs whenever they are in a flare – precisely not what they should be doing. If there is a relationship between the metabolic syndrome and gout, then shouldn’t primary care providers be just as familiar with the management of gout as they are with the management of hypertension, hyperlipidemia, and diabetes?
– Not all that glitters is gold. One of the more valuable lessons I hope residents leave with after a month with me is that an elevated ESR does not always mean PMR, and an elevated RF does not always mean rheumatoid arthritis. The differentials for these entities are slightly broader and need to be thoroughly investigated. Since primary care providers often order these tests I think they should also be able to interpret it.
Dr. Chan practices rheumatology in Pawtucket, R.I. E-mail her [email protected].
ONLINE EXCLUSIVE: Flexibility, Compensation Attract Hospitalists to Locum Tenens
Competition is cutthroat in the world of locum tenens physicians. As agencies fight to hire hospitalists and other subspecialists they can assign to positions across the nation, those temporary staffers become a commodity in and of themselves.
Dr. Mohammed is one of those hard assets.
Dr. Mohammed’s reason for transitioning to full-time locum work is simple: flexibility.
“With locums, you have a variety of choices,” he says. “When you’re going into your first permanent job interview, you’re just desperate. You don’t know how the system functions. ... If I would have known about the locum opportunity before I started doing the permanent job, then I would have taken the locums right away.”
Dr. Mohammed, whose ultimate goal is to work for a government facility in South Florida, says he is excited about the opportunities locums work offers. He can move around the country with little difficulty and gain exposure in urban settings, rural hospitals, and everything in between.
And, of course, there is the money. Locum physicians can gross 30% to 40% more per year for the same number of shifts as a typical FTE hospitalist.
“Definitely income─there’s no question,” Dr. Mohammed adds. “When you’re coming out of residency, you don’t have very good income. Some of us that have school debt, family responsibilities—you just want to take care of the financial part.”
Richard Quinn is a freelance writer in New Jersey.
Competition is cutthroat in the world of locum tenens physicians. As agencies fight to hire hospitalists and other subspecialists they can assign to positions across the nation, those temporary staffers become a commodity in and of themselves.
Dr. Mohammed is one of those hard assets.
Dr. Mohammed’s reason for transitioning to full-time locum work is simple: flexibility.
“With locums, you have a variety of choices,” he says. “When you’re going into your first permanent job interview, you’re just desperate. You don’t know how the system functions. ... If I would have known about the locum opportunity before I started doing the permanent job, then I would have taken the locums right away.”
Dr. Mohammed, whose ultimate goal is to work for a government facility in South Florida, says he is excited about the opportunities locums work offers. He can move around the country with little difficulty and gain exposure in urban settings, rural hospitals, and everything in between.
And, of course, there is the money. Locum physicians can gross 30% to 40% more per year for the same number of shifts as a typical FTE hospitalist.
“Definitely income─there’s no question,” Dr. Mohammed adds. “When you’re coming out of residency, you don’t have very good income. Some of us that have school debt, family responsibilities—you just want to take care of the financial part.”
Richard Quinn is a freelance writer in New Jersey.
Competition is cutthroat in the world of locum tenens physicians. As agencies fight to hire hospitalists and other subspecialists they can assign to positions across the nation, those temporary staffers become a commodity in and of themselves.
Dr. Mohammed is one of those hard assets.
Dr. Mohammed’s reason for transitioning to full-time locum work is simple: flexibility.
“With locums, you have a variety of choices,” he says. “When you’re going into your first permanent job interview, you’re just desperate. You don’t know how the system functions. ... If I would have known about the locum opportunity before I started doing the permanent job, then I would have taken the locums right away.”
Dr. Mohammed, whose ultimate goal is to work for a government facility in South Florida, says he is excited about the opportunities locums work offers. He can move around the country with little difficulty and gain exposure in urban settings, rural hospitals, and everything in between.
And, of course, there is the money. Locum physicians can gross 30% to 40% more per year for the same number of shifts as a typical FTE hospitalist.
“Definitely income─there’s no question,” Dr. Mohammed adds. “When you’re coming out of residency, you don’t have very good income. Some of us that have school debt, family responsibilities—you just want to take care of the financial part.”
Richard Quinn is a freelance writer in New Jersey.




