Handmade oil painting reproduction of Reading the News, one of the most famous James Tissot paintings.
Patient Preferences and Assessment of Likely Adherence to Hepatitis C Virus Treatment
Brett Hauber; A. F. Mohamed; C. Beam; J. Medjedovic; J. Mauskopf
Authors and Disclosures
Posted: 09/19/2011; J Viral Hepat. 2011;18(9):619-627. © 2011 Blackwell Publishing
Discussion Only
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The results of this study indicate that sustained viral response was the most important attribute of a drug treatment to patients. However, the results of the choice-format conjoint survey also indicate that patients were willing to accept decreases in the probability of achieving sustained viral response to reduce side effects of treatment. Alopecia was the least important of the side effects included in this analysis, while depression and days with flu-like symptoms were relatively more important to patients. The extent to which treatment interferes with work was also an important consideration for patients. In addition, both patient characteristics (prior treatment experience) and treatment attributes (the number of days with flu-like symptoms) affected patients' ratings of likely adherence.
Using adaptive conjoint analysis, Fraenkel et al. [30] also found that treatment benefit (measured as virus eradication in 45% of patients with no cirrhosis after 10 or more years) was the most important HCV treatment attribute among treatment-naïve patients, whereas fatigue, depression and flu-like illness had similar but smaller influences on subjects' preferences. However, patients with moderate or severe fibrosis placed a greater importance on treatment benefit and less on treatment-related side effects than patients with mild or no fibrosis. Significant differences between our study and Fraenkel et al. [30] are that we included different treatment attributes and both treatment-naïve and treatment-experienced patients.
There have been several nonconjoint studies published on HCV patients' preferences.[31–34] Two studies looked at patients' role in decision-making regarding initiating treatment.[31,32] Fraenkel[31] concluded that physicians need to determine patients' levels of uncertainty in decision-making, whereas Tinè[32] reported that chronic HCV patients defer to their physicians in initiating treatment. Schackman et al. [33] found that treatment-naïve patients were more concerned about side effects than physicians and nurses using standard gamble. Witkos et al. [34] examined claims data of Canadian HCV patients and concluded that disease severity, age, HIV status and province of residence increased the likelihood of receiving treatment.
One of the strength of this study is in the use of a choice-format conjoint survey that reflects the attributes of current drug treatments for chronic HCV infection based on published literature and eight face-to-face subject pretest interviews. The results from well-designed choice-format conjoint analyses in health economics have been shown to provide useful information about the relative importance of different treatment attributes to patients and physicians.[24,35,36] Another strength of the study is the use of an innovative method to estimate the likely impact of different medication attributes on adherence. This method provides quantitative estimates that can be used to predict adherence to new medications that have different attributes from current medications.[37,38] Although the impact of patient characteristics and treatment attributes on patients' adherence ratings was estimated in our study using hypothetical scenarios, the results of this study are consistent with previously published results that indicate that nonadherence is owing to treatment-related adverse events for 75% of patients with poor adherence.[6] Because our estimation method gave results that were consistent with observed determinants of adherence to treatment for chronic HCV infection, these estimates could be used in economic models of the cost-effectiveness of a new treatment regimen compared to current treatments. Adherence could be included in these models in an attempt to convert the efficacy results seen in clinical trials to effectiveness in 'real-world' practice.
While choice-format conjoint analysis methods are widely used in health economics to elicit preferences for treatment features and outcomes, they have limitations. One inherent limitation is that subjects evaluate hypothetical treatments. These constructed choice questions are intended to simulate possible clinical decisions but do not have the same clinical, financial and emotional consequences of actual decisions. Thus, differences can arise between stated and actual choices. We have attempted to minimize such potential differences by offering alternatives that mimic real-world trade-offs as closely as possible. In addition, some health professionals are skeptical that people have sufficient understanding of treatment information to competently evaluate treatment alternatives. Diagnosis among subjects in this study was self-reported and not confirmed by physician consultation or chart review. However, we believe the likelihood is small that people without HCV would be likely to complete a study such as this because the study is cognitively challenging and requires an investment in time in exchange for little personal gain. Finally, we recruited subjects through an Internet-based chronic illness panel which means that the sample used in this study is not necessarily representative of the people with HCV in the United States.
Because the treatment alternatives that patients considered and the patients' adherence ratings are based on hypothetical treatment scenarios, the adherence results presented in this study should not be construed as an absolute prediction of the rate of nonadherence to treatment. First, there likely is some underlying rate of nonadherence that is not explained by patient characteristics (prior treatment experience) or treatment attributes (days of flu-like symptoms). Therefore, our estimate of predicted adherence to treatment based on these adherence ratings must, at a minimum, be interpreted as the relative effect of known patient or treatment characteristics on adherence. In addition, a previous study found that self-reported adherence was greater than measured adherence in this patient population indicating that patients underestimated their own rate of nonadherence or were unwilling to acknowledge the level of their nonadherence.[5] If this is the case, the adherence estimates from this study may represent a lower bound on the impact of the number of days of flu-like symptoms on nonadherence. In summary, the results of our analyses have shown that, although efficacy is clearly the most important treatment attribute, other attributes related to treatment side effects are also important and may reduce adherence to current treatments. Because adherence to therapy, especially in those with genotype 1 HCV infections, has been shown to be important for achieving a sustained viral response, new treatment regimens that reduce side effects relative to current treatments might result in higher adherence rates and better clinical effectiveness.
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Inhibitex Commences Dosing of Phase 2 Clinical Trial of INX-189 in HCV Infected Genotype 2/3 Patients
Phase 1b Extension Trial in HCV-Infected Genotype 1 Patients to Evaluate Higher Doses of INX-189 Also Initiated
September 19, 2011 07:27 AM Eastern Daylight Time
ATLANTA--(EON: Enhanced Online News)--Inhibitex, Inc. (Nasdaq: INHX), announced today that it has recently commenced dosing in a 90-patient randomized, placebo controlled, treatment guided, Phase 2 clinical trial to evaluate the safety, tolerability and antiviral activity of INX-189 in combination with pegylated interferon and ribavirin in chronic HCV-infected genotype 2 and 3 treatment naïve patients. The trial is designed to evaluate three once-daily doses of INX-189 (25 mg, 50 mg and 100 mg) administered in combination with pegylated interferon and ribavirin for 12 weeks, and also includes a control arm in which patients will receive placebo and standard of care treatment (a combination of pegylated interferon and ribavirin for 24 weeks). Each INX-189 combination treatment cohort in the trial will include 25 patients, and the control arm will include 15 patients.
Patients in the INX-189 containing treatment arms that achieve an extended rapid viral response, or eRVR, defined as having HCV RNA below the level of detection after 28 days and 12 weeks of dosing, will stop all therapy after 12 weeks. Those patients who do not achieve an eRVR will continue receiving pegylated interferon and ribavirin for 12 additional weeks.
The Company also announced the initiation of an additional clinical trial of INX-189 designed to evaluate higher doses of INX-189 administered as monotherapy or in combination with ribavirin for seven days. The first cohort in this expanded Phase 1b trial will receive 200 mg INX-189 once daily as monotherapy. Other planned cohorts include 100 mg INX-189 twice daily as monotherapy, 100 mg INX-189 once daily in combination with ribavirin, and possibly higher monotherapy doses of INX-189. Each treatment cohort in the trial will include 10 patients, eight of which will receive INX-189 and two of which will receive placebo.
About HCV and INX-189
Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV). It is estimated that over 4 million Americans and 170 million individuals worldwide are infected with HCV, the majority of which represent chronic infections that can cause liver disease, cirrhosis and cancer, and is the leading cause of liver transplants in the United States.
Inhibitex is developing a series of proprietary nucleotide inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. INX-189 is a protide of a 2’-C-methyl guanosine analogue. The Company believes that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily, low dose oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV.
About Inhibitex
Inhibitex, Inc. is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company’s clinical-stage pipeline currently includes two Phase 2 development programs; INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections and FV-100, a nucleoside analogue in development for the treatment of shingles-associated pain. The Company also has other HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM® protein platform to Pfizer for the development of a staphylococcal vaccine, which is currently being evaluated in a Phase 1/2 clinical trial. For additional information about the Company, please visit http://www.inhibitex.com/ .
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this press release, including statements regarding the number of patients the Company expects to enroll in the ongoing Phase 2 trial and the planned cohorts, and possibly including higher monotherapy doses of INX-189, in the ongoing supplementary Phase 1b trial, and the Company’s belief that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily, low dose oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV, are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk of the Company, the FDA, a data safety monitoring board, an institutional review board (IRB), delaying, limiting, suspending or terminating the clinical development of INX-189 at any time for a lack of safety, tolerability, biologic activity or efficacy, commercial viability, regulatory issues, or any other reason and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2010 and its Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2011. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.
Inhibitex® and MSCRAMM® are registered trademarks of Inhibitex, Inc.
Contacts
Inhibitex
Russell H. Plumb, 678-746-1136
Chief Executive Officer
rplumb@inhibitex.com
or
The Trout Group
Lee M. Stern, 646-378-2922
CFA
lstern@troutgroup.com
Inhibitex Commences Dosing of Phase 2 Clinical Trial of INX-189 in HCV Infected Genotype 2/3 Patients
Phase 1b Extension Trial in HCV-Infected Genotype 1 Patients to Evaluate Higher Doses of INX-189 Also Initiated
September 19, 2011 07:27 AM Eastern Daylight Time
ATLANTA--(EON: Enhanced Online News)--Inhibitex, Inc. (Nasdaq: INHX), announced today that it has recently commenced dosing in a 90-patient randomized, placebo controlled, treatment guided, Phase 2 clinical trial to evaluate the safety, tolerability and antiviral activity of INX-189 in combination with pegylated interferon and ribavirin in chronic HCV-infected genotype 2 and 3 treatment naïve patients. The trial is designed to evaluate three once-daily doses of INX-189 (25 mg, 50 mg and 100 mg) administered in combination with pegylated interferon and ribavirin for 12 weeks, and also includes a control arm in which patients will receive placebo and standard of care treatment (a combination of pegylated interferon and ribavirin for 24 weeks). Each INX-189 combination treatment cohort in the trial will include 25 patients, and the control arm will include 15 patients.
Patients in the INX-189 containing treatment arms that achieve an extended rapid viral response, or eRVR, defined as having HCV RNA below the level of detection after 28 days and 12 weeks of dosing, will stop all therapy after 12 weeks. Those patients who do not achieve an eRVR will continue receiving pegylated interferon and ribavirin for 12 additional weeks.
The Company also announced the initiation of an additional clinical trial of INX-189 designed to evaluate higher doses of INX-189 administered as monotherapy or in combination with ribavirin for seven days. The first cohort in this expanded Phase 1b trial will receive 200 mg INX-189 once daily as monotherapy. Other planned cohorts include 100 mg INX-189 twice daily as monotherapy, 100 mg INX-189 once daily in combination with ribavirin, and possibly higher monotherapy doses of INX-189. Each treatment cohort in the trial will include 10 patients, eight of which will receive INX-189 and two of which will receive placebo.
About HCV and INX-189
Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV). It is estimated that over 4 million Americans and 170 million individuals worldwide are infected with HCV, the majority of which represent chronic infections that can cause liver disease, cirrhosis and cancer, and is the leading cause of liver transplants in the United States.
Inhibitex is developing a series of proprietary nucleotide inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. INX-189 is a protide of a 2’-C-methyl guanosine analogue. The Company believes that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily, low dose oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV.
About Inhibitex
Inhibitex, Inc. is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company’s clinical-stage pipeline currently includes two Phase 2 development programs; INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections and FV-100, a nucleoside analogue in development for the treatment of shingles-associated pain. The Company also has other HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM® protein platform to Pfizer for the development of a staphylococcal vaccine, which is currently being evaluated in a Phase 1/2 clinical trial. For additional information about the Company, please visit http://www.inhibitex.com/ .
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this press release, including statements regarding the number of patients the Company expects to enroll in the ongoing Phase 2 trial and the planned cohorts, and possibly including higher monotherapy doses of INX-189, in the ongoing supplementary Phase 1b trial, and the Company’s belief that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily, low dose oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV, are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk of the Company, the FDA, a data safety monitoring board, an institutional review board (IRB), delaying, limiting, suspending or terminating the clinical development of INX-189 at any time for a lack of safety, tolerability, biologic activity or efficacy, commercial viability, regulatory issues, or any other reason and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2010 and its Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2011. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.
Inhibitex® and MSCRAMM® are registered trademarks of Inhibitex, Inc.
Contacts
Inhibitex
Russell H. Plumb, 678-746-1136
Chief Executive Officer
rplumb@inhibitex.com
or
The Trout Group
Lee M. Stern, 646-378-2922
CFA
lstern@troutgroup.com
(Ivanhoe Newswire)--- According to the CDC, Hepatitis C is the most common chronic blood borne infection in the United States affecting more than 3.2 million people. But, a new drug has been found to significantly increase the cure rates for those infected.
Hepatitis C virus (HCV) is a disease that can cause severe liver damage, joint pain and even damage to the nervous system and brain. HCV genotype 1 is the most common form of the virus and also the most difficult to treat. In a recent study researchers discovered adding a new drug, telaprevir, to the current combination of treatment has been effective in improving cure rates to almost 80%.
The new study involved a group of 540 patients in which some were treated for a total of 24 weeks with a combination of the drugs pegylated interferon, ribavirin and telaprevir for 12 weeks and pegylated interferon and ribavirin only, for an additional 12 weeks. Other patients in the study were treated for a total of 48 weeks with the 3-drug combination.
Researchers found that many of the patients were able to stop treatment after 24 weeks and had undetectable levels of HCV.
“Vertex conducted a study to determine the optimal duration of treatment in this group who had excellent early response. If viral levels were undetectable from weeks four to 12 with the 3-drug combination, patients were randomized to receive pegylated interferon and ribavirin for an additional 12 weeks (total duration 24 weeks) or for an additional 36 weeks (total duration 48 weeks). This study convincingly showed that there was no advantage in this group with the longer duration. Current guideline is to stop all treatment in this group at 24 weeks,” Dr. Paul Thuluvath told Ivanhoe. Medical Director of the Institute for Digestive Health & Liver Disease at Mercy Medical Center in Baltimore, Maryland, who has been involved in the research regarding the new class of drugs used to treat HCV.
These new findings have made researchers hopeful that the duration of treatment for Hepatitis C can be shortened even further for patients suffering from this disease.
“Future developments in this field will include oral medications without interferon injections and probably even shortened durations of treatment. The progress in HCV treatment has been remarkable in the past five years and we expect continued progress in the management of the ‘silent epidemic’ of HCV that causes considerable morbidity and mortality from liver failure and liver cancer,” Dr. Thuluvath told Ivanhoe.
SOURCE: The New England Journal of Medicine, September 15, 2011. And Centers for Disease Control (www. cdc.gov )
In Case You Missed It
In Case You Missed It
Merck aims at hepatitis, c. difficile drugs
By Ransdell Pierson
By Ransdell Pierson
NEW YORK | Wed Sep 14, 2011
NEW YORK (Reuters) - The head of infectious diseases at Merck & Co said the company's future all-oral treatments for hepatitis C and its experimental drug for infections with clostridium difficile bacteria could transform treatment and reap big sales.
Merck and biotechnology company Vertex Pharmaceuticals Inc earlier this year introduced rival new oral treatments for hepatitis C that work by blocking the protein protease. But they both must be taken with an injectable interferon that prolongs treatment and causes flu-like side effects.
Roger Pomerantz, who was named head of Merck's infectious disease segment last year, estimated the highly effective new hepatitis C drugs target only about 10 million to 15 million people in developed countries and some emerging markets.
By contrast, he said a newer all-oral treatment regimen that eliminates interferon could target as many as 180 million patients globally, including those in remote and rural regions of Africa and South America.
"We're at just the tip of the iceberg" with current treatments, he said in an interview on Wednesday. "The big change will be when we can provide a simple, compact all-oral regimen."
"Hepatitis C is arguably the largest market opportunity in infectious diseases in my lifetime because of the sheer numbers and the fact that we can cure it," said Pomerantz, who headed Johnson & Johnson's infectious disease division before being hired away by Merck.
Pomerantz said the company also has high hopes for a new way of fighting clostridium difficile (c. difficile), bacteria which are spread in hospitals and are most dangerous for the elderly and others with weakened immune systems.
The sometimes-deadly infections occur in patients who have been treated with broad-spectrum antibiotics that kill off "friendly" bacteria in the gut, allowing clostridium difficile to take root and prosper there. They cause colitis, including attacks of diarrhea and fever that can recur and are not well-controlled by current treatments.
"Over the past five years there has been a new hyper-virulent strain that is more deadly than the usual c. difficile, so we have a perfect storm" situation, Pomerantz said.
Merck's treatment reduced the rate of recurring attacks by more than 70 percent in mid-stage trials, Pomerantz said.
The company hopes to launch the new drug in 2013 or 2014, Pomerantz said. It is a combination of two monoclonal antibodies that block toxins produced by c. difficile.
(Reporting by Ransdell Pierson, editing by Bernard Orr and Matthew Lewis)
See Full Text
Despite the fact that hepatitis C virus (HCV) persists chronically in about 80 percent of those infected, some liver cells remain free of the virus even after many years. Now Sung Key Jang of Pohang University of Science and Technology, South Korea, et al. explain that paradox. During chronic HCV infection, a cellular protein, HMGB1, helps restrain viral reproduction. That prevents HCV from sweeping the liver, and results in a lower blood burden of virus than in the case of hepatitis B. This first description of HMGB1-related responses triggered by HCV infection is published in the September 2011 issue of the Journal of Virology.
The researchers show further that HCV-infected cells secrete HMGB1 proteins into the extracellular milieu. There, these proteins trigger a receptor on the cytoplasmic membrane, called TLR4, causing both an interferon response, which fights the virus, and an inflammatory response.
Two different responses coming from the same receptor at the same time is a common phenomenon. But that can make designing drugs all the more complicated. Boosting the interferon response could vanquish the virus, but the inflammatory response would be harmful. However, Jang says that it might be possible to get the one response without the other. If HMGB1 in the TLR4 receptor is like a hand that fits nicely in a glove, thus triggering both responses, perhaps a drug could be fashioned which could fit a piece of the receptor, like two fingers in a glove, thus triggering only the interferon response. This is an unpublished hypothesis, says Jang, but one that his group is working on.
In the paper, the researchers note that HMGB1 is a "danger" signal. The Danger model of immunology, derived by Polly Matzinger of the National Institute of Allergy and Infectious Disease, NIH, posits that immune responses are initiated by signals from damaged cells. Rather than distinguishing between "self" and "nonself," as per conventional wisdom, the Danger model suggests that when cells are stressed, injured, or killed (by external forces rather than through so-called programmed cell death), they give off alarm signals that activate the immune system to clear the damaging agents.
About 18 million people worldwide are infected with HCV. That virus causes inflammation (hepatitis), massive death of liver cells (cirrhosis), and hepatocellular carcinoma. Liver cancer, primarily hepatocellular carcinoma, which is also caused by heptatitis B virus, is the third leading cause of cancer deaths worldwide, and the ninth leading cause of cancer deaths in the United States, according to Morbidity and Mortality Weekly Report.
(J. Ha Jung, J. Hoon Park, M. Hyeok Jee, S. Ju Keum, M.-S. Cho, S. Kew Yoon, and S. Key Jang, 2011. Hepatitis C virus infection is blocked by HMGB1 released from virus-infected cells. J. Virol. 85:9359-9368.)
Provided by American Society for Microbiology
AUTHORS: Carrie McAdam-Marx, Lisa J. McGarry, Christopher A. Hane, Joseph Biskupiak, Baris Deniz, Diana I. Brixner
PDF READ THE FULL ARTICLE
SUMMARY: BACKGROUND:
Approximately 3.2-3.9 million U.S. residents are infected with the hepatitis C virus (HCV). Total annual costs (direct and indirect) in the United States for HCV were estimated to be $5.46 billion in 1997, and direct medical costs have been predicted to increase to $10.7 billion for the 10-year period from 2010 through 2019, due in part to the increasing number of HCV patients developing advanced liver disease (AdvLD).
OBJECTIVE: To quantify in a sample of commercially insured enrollees (a) total per patient per year (PPPY) all-cause costs to the payer, overall and by the stage of liver disease, for patients diagnosed with HCV; and (b) incremental all-cause costs for patients diagnosed with HCV relative to a matched non-HCV cohort.
METHODS: This retrospective, matched cohort study included patients aged at least 18 years and with at least 6 months of continuous enrollment in a large managed care organization (MCO) claims database from July 1, 2001, through March 31, 2010. Patients with a diagnosis of HCV (ICD-9-CM codes 070.54, 070.70) were identified and stratified into those with and without AdvLD, defined as decompensated cirrhosis (ICD-9-CM codes 070.44, 070.71, 348.3x, 456.0, 456.1, 456.2x, 572.2, 572.3, 572.4, 782.4, 789.59); hepatocellular carcinoma (HCC, ICD-9-CM code 155); or liver transplant (ICD-9-CM codes V42.7, 50.5 or CPT codes 47135, 47136). For patients without AdvLD, the index date was the first HCV diagnosis date observed at least 6 months after the first enrollment date, and at least 6 months of continuous enrollment after the index date were required.
HCV patients without AdvLD were stratified into those with and without compensated cirrhosis (ICD-9-CM codes 571.2, 571.5, 571.6).
For patients with AdvLD, the index date was the date of the first AdvLD diagnosis observed at least 6 months after the first enrollment date, and at least 1 day of enrollment after the index date was required. Cases were matched in an approximate 1:10 ratio to comparison patients without an HCV diagnosis or AdvLD diagnosis who met all other inclusion criteria based on gender, age, hospital referral region state, pre-index health care costs, alcoholism, human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), and a modified Charlson Comorbidity Index.
For the HCV and comparison patient cohorts, PPPY all-cause costs to the payer were calculated as total allowed charges summed across all patients divided by total patient-days of follow-up for the cohort, multiplied by 365, inflation-normalized to 2009 dollars. Because the calculation of PPPY cost generated a single value for each cohort, bootstrapping was used to generate descriptive statistics. Incremental PPPY costs for HCV patients relative to non-HCV patients were calculated as between-group differences in PPPY costs. T-tests for independent samples were used to compare costs between case and comparison cohorts.
RESULTS: A total of 34,597 patients diagnosed with HCV, 78.0% with HCV without AdvLD, 4.4% with compensated cirrhosis, 12.3% with decompensated cirrhosis, 2.8% with HCC, and 2.6% with liver transplant, were matched to 330,435 comparison patients.
Mean (SD) age of all HCV cases was 49.9 (8.5) years; 61.7% were male. Incremental mean (SD) PPPY costs in 2009 dollars for all HCV patients relative to comparison patients were $ 9,681 ($176) PPPY. Incremental PPPY costs were $5,870 ($157) and $5,330 ($491) for HCV patients without liver disease and with compensated cirrhosis, respectively. Incremental PPPY costs for patients with AdvLD were $27,845 ($ 965) for decompensated cirrhosis, $43,671 ($2,588) for HCC, and $ 93,609 ($4,482) for transplant. Incremental prescription drug costs, including the cost of antiviral drugs, were $2,739 ($37) for HCV patients overall, $2,659 ($41) for HCV without liver involvement, and $3,102 ($157) for HCV with compensated cirrhosis. These between-group differ- ences were statistically significant at P < 0.001.
CONCLUSIONS: Based on a retrospective analysis of data from a large, MCO claims database, patients diagnosed with HCV had annual all-cause medical costs that were almost twice as high as those of enrollees without a diagnosis of HCV. Health care costs increased dramatically with AdvLD. Data from this study may help MCOs project future HCV costs and facilitate planning for HCV patient management efforts.
A new study has found that HIV-infected men who have unprotected sex with other men (MSM) are at increased risk for contacting hepatitis C virus (HCV) through sex.
HCV transmission primarily occurs through exposure to blood, and persons who inject drugs at greatest risk.
HCV transmission primarily occurs through exposure to blood, and persons who inject drugs at greatest risk.
But when Mount Sinai researchers observed a large increase in the number of new cases of HCV transmission among HIV-infected men who did not inject drugs, they took a closer look to examine the role of sexual transmission among these men.
The researchers identified 74 HIV-infected men between October 2005 and December 2010 who had documented new HCV infection and yet reported no other risk factor for HCV infection, including injection drug use.
And they found that the men who had recently contracted HCV were 23 times more likely to have had unprotected anal sex with men.
In addition, HCV genetic analysis suggested that HCV was transmitted within social networks of these men, consistent with the presence of a city-wide epidemic.
"While hepatitis C is rarely transmitted among stable heterosexual couples, this is clearly not the case among HIV-infected MSM in New York City," said Dr. Daniel Fierer, Assistant Professor of Medicine and Infectious Diseases at Mount Sinai School of Medicine.
"MSM, and to some extent their health care providers are generally not aware that having unprotected receptive sex can result in HCV infection.
"The good news is that the cure rate for new HCV infections is very high with early treatment, but without regular testing of the men at risk, these largely asymptomatic infections may be missed and this opportunity lost," he added.
The results of the study are published in the latest edition of the CDC's Morbidity and Mortality Weekly Report.
Stem Cells
South Korea Sets Sights on Becoming Stem Cell Powerhouse
South Korea's president vowed on Monday a series of regulatory reforms to help regain its place as a stem cell research powerhouse, trying to reclaim momentum five years after a cloning scandal.
President Lee Myung-bak said that by breathing new life into the industry, it could become "core new growth engine" for Asia's fourth biggest economy along the same lines as its lucrative IT sector.
"Just a decade ago, Korea took the lead in stem cell research in the world along with the United States," Lee said in a bi-weekly radio address.
"Unfortunately, there was a disappointing incident, which caused inevitable damage to the entire stem-cell research community in Korea," Lee said, referring to the scandal involving the pre-eminent scientist, Hwang Woo-suk.
South Korea had once been considered a global leader in human embryonic stem cell research until review boards said in 2005 that the team led by Hwang had manipulated key data in its studies on cloning stem cells, sparking a fraud case that shook the global scientific community.
As a result of the scandal, South Korea all but put stem cell research into the deep freeze.
Lee said the lapse had allowed other countries such as the United States, Japan, Britain and China to get the jump on South Korea, depriving the country of valuable revenue.
"While we were faltering in our quest for stem cell research, other nations streamlined their regulations and aggressively expanded their investments in research," he said.
"CORE GROWTH ENGINE"
Lee said the government would invest nearly 100 billion won ($90 million) in stem cell research next year and that it would reform related regulations to make clinical and licensing procedures easier.
He said the reforms would help the Korea Food and Drug Administration (KFDA) and other agencies "to ensure that they proactively adapt to the changes in the international environment".
"The government has decided to foster the stem cell industry as a core new growth engine following the footsteps of the IT industry," he said.
Stem cells are the body's master cells and the source of all cells and tissues. Because of their ability to generate different types of cells and multiply and self-renew, scientists hope to harness them to treat a variety of diseases and disorders, including cancer and diabetes, and injuries.
Stem cell research is "very rewarding and significant in that it can give hope to those who suffer from rare and intractable diseases," Lee said.
"In addition, from a business perspective, it can be said to be a high-value-added industry.
"This field is new and offers infinite room for advancement, and how well we manage at this initial stage will make an enormous difference down the road. The country should now set its eyes on emerging as a stem cell powerhouse."
The government will create a national stem cell bank for use to produce, preserve and supply stem cells to various researchers in the country on a stable basis, Lee added.
In July, the KFDA approved stem cell medication in the form of a treatment for heart attack victims for the world's first clinical use.
That Hearticellgram-AMI treatment, developed by FCB-Pharmicell, signaled the country's first salvo to put research in the field back on the frontline.
Healthy You
Stem Cells
South Korea Sets Sights on Becoming Stem Cell Powerhouse
South Korea's president vowed on Monday a series of regulatory reforms to help regain its place as a stem cell research powerhouse, trying to reclaim momentum five years after a cloning scandal.
President Lee Myung-bak said that by breathing new life into the industry, it could become "core new growth engine" for Asia's fourth biggest economy along the same lines as its lucrative IT sector.
"Just a decade ago, Korea took the lead in stem cell research in the world along with the United States," Lee said in a bi-weekly radio address.
"Unfortunately, there was a disappointing incident, which caused inevitable damage to the entire stem-cell research community in Korea," Lee said, referring to the scandal involving the pre-eminent scientist, Hwang Woo-suk.
South Korea had once been considered a global leader in human embryonic stem cell research until review boards said in 2005 that the team led by Hwang had manipulated key data in its studies on cloning stem cells, sparking a fraud case that shook the global scientific community.
As a result of the scandal, South Korea all but put stem cell research into the deep freeze.
Lee said the lapse had allowed other countries such as the United States, Japan, Britain and China to get the jump on South Korea, depriving the country of valuable revenue.
"While we were faltering in our quest for stem cell research, other nations streamlined their regulations and aggressively expanded their investments in research," he said.
"CORE GROWTH ENGINE"
Lee said the government would invest nearly 100 billion won ($90 million) in stem cell research next year and that it would reform related regulations to make clinical and licensing procedures easier.
He said the reforms would help the Korea Food and Drug Administration (KFDA) and other agencies "to ensure that they proactively adapt to the changes in the international environment".
"The government has decided to foster the stem cell industry as a core new growth engine following the footsteps of the IT industry," he said.
Stem cells are the body's master cells and the source of all cells and tissues. Because of their ability to generate different types of cells and multiply and self-renew, scientists hope to harness them to treat a variety of diseases and disorders, including cancer and diabetes, and injuries.
Stem cell research is "very rewarding and significant in that it can give hope to those who suffer from rare and intractable diseases," Lee said.
"In addition, from a business perspective, it can be said to be a high-value-added industry.
"This field is new and offers infinite room for advancement, and how well we manage at this initial stage will make an enormous difference down the road. The country should now set its eyes on emerging as a stem cell powerhouse."
The government will create a national stem cell bank for use to produce, preserve and supply stem cells to various researchers in the country on a stable basis, Lee added.
In July, the KFDA approved stem cell medication in the form of a treatment for heart attack victims for the world's first clinical use.
That Hearticellgram-AMI treatment, developed by FCB-Pharmicell, signaled the country's first salvo to put research in the field back on the frontline.
Healthy You
The study showed that blueberries may have the potential to reduce a variety of risk factors for metabolic syndrome and cardiovascular disease. Phytochemicals - a type of naturally-occurring antioxidants - are thought to be responsible for the health benefits of blueberries as reported by diabeticlive.com .
Tampa, FL (PRWEB) September 19, 2011
Blueberry Consumption Associated with Reduced Risk of Metabolic Syndrome: Fruits have long been recommended as part of a healthy diet, along with vegetables. Aside from providing a healthy, natural boost of energy that is free of the processing and refining that strips nutrition from many of our foods, they contain a variety of compounds and nutrients that afford long-term health benefits. Researchers at the University of Michigan Cardiovascular Center recently conducted a study on blueberries to determine their effect on illnesses such as cardiovascular disease and metabolic syndrome as reported by diabeticlive.com.
The research team at the Cardiovascular Center used rats with a strong predisposition to obesity and diabetes for the study. The rats were divided into two groups; one group was fed a high-fat diet along with blueberry powder, while the other group was fed a low-fat diet with blueberry powder. A control group was fed no blueberries.
The study showed that blueberries may have the potential to reduce a variety of risk factors for metabolic syndrome and cardiovascular disease. Phytochemicals - a type of naturally-occurring antioxidants - are thought to be responsible for the health benefits of blueberries.
The researchers used freeze-dried blueberries crushed into powder since the rats would not likely have eaten full blueberries. The powder was then mixed in with the rats' other food; the blueberry mixture accounted for 2% of the rats' total diet.
The reduction in risk of metabolic syndrome is an important implication for diabetes. Metabolic syndrome is a series of health problems that, when occurring together, increase risk of cardiovascular disease and diabetes. Among the risk factors for metabolic syndrome are raised triglycerides, increased waist circumference (obesity), reduced HDL cholesterol, and increased blood pressure. The blueberry supplements given to the rats in the study appeared to reduce the risk of metabolic syndrome.
The rats had less abdominal fat, lower cholesterol levels, improved insulin sensitivity and fasting glucose, and lower triglyceride levels. They also showed reduced liver size; an enlarged liver is associated with obesity and insulin resistance.
E. Mitchell Seymour, M.S., was the lead researcher on the study. Seymour offered insight as to the mechanism powering the health benefits of the blueberries: "We found by looking at fat muscle tissue, that blueberry intake affected genes related to fat-burning and storage. Looking at muscle tissue, we saw altered genes related to glucose uptake."
According to Steven Bolling, M.D., head of the Cardioprotection Laboratory and heart surgeon at the University of Michigan, "The benefits of eating fruits and vegetables has been well-researched, but our findings in regard to blueberries shows the naturally occurring chemicals they contain, such as anthocyanins, show promise in mitigating these health conditions."
A Bout of Exercise May be the Cure
Article is published in the American Journal of Physiology—
Regulatory, Integrative, and Comparative Physiology
Bethesda, Md. (Sept. 16, 2011)—Researchers have long known that regular exercise increases the number of organelles called mitochondria in muscle cells. Since mitochondria are responsible for generating energy, this numerical boost is thought to underlie many of the positive physical effects of exercise, such as increased strength or endurance. Exercise also has a number of positive mental effects, such as relieving depression and improving memory. However, the mechanism behind these mental effects has been unclear. In a new study in mice, researchers at the University of South Carolina have discovered that regular exercise also increases mitochondrial numbers in brain cells, a potential cause for exercise’s beneficial mental effects.
Their article is entitled "Exercise Training Increases Mitochondrial Biogenesis in the Brain." It appears in the Articles in PresS section of the American Journal of Physiology – Regulatory, Integrative, and Comparative Physiology, published by the American Physiological Society.
Methodology
The researchers assigned mice to either an exercise group, which ran on an inclined treadmill six days a week for an hour, or to a sedentary group, which was exposed to the same sounds and handling as the exercise group but remained in their cages during the exercise period. After eight weeks, researchers examined brain and muscle tissue from some of the mice in each group to test for signs of increases in mitochondria. Additionally, some of the mice from each group performed a "run to fatigue" test to assess their endurance after the eight-week period.
Results
Confirming previous studies, the results showed that mice in the exercise group had increased mitochondria in their muscle tissue compared to mice in the sedentary group. However, the researchers also found that the exercising mice also showed several positive markers of mitochondria increase in the brain, including a rise in the expression of genes for proxisome proliferator-activated receptor-g coactivator 1-alpha, silent information regulator T1, and citrate synthase, all regulators for mitochondrial biogenesis; and mitochondrial DNA. These results correlate well with the animals’ increased fitness. Overall, mice in the exercise group increased their run to fatigue times from about 74 minutes to about 126 minutes. No change was seen for the sedentary mice.
Importance of the Findings
These findings suggest that exercise training increases the number of mitochondria in the brain much like it increases mitochondria in muscles. The study authors note that this increase in brain mitochondria may play a role in boosting exercise endurance by making the brain more resistant to fatigue, which can affect physical performance. They also suggest that this boost in brain mitochondria could have clinical implications for mental disorders, making exercise a potential treatment for psychiatric disorders, genetic disorders, and neurodegenerative diseases.
"These findings could lead to the enhancement of athletic performance through reduced mental and physical fatigue, as well as to the expanded use of exercise as a therapeutic option to attenuate the negative effects of aging, and the treatment and/or prevention of neurological diseases," the authors say.
Study Team
The study was conducted by Jennifer L. Steiner, E. Angela Murphy, Jamie L. McClellan, Martin D. Carmichael, and J. Mark Davis, all of the University of South Carolina.
Investigators tout trial successes for hep C, influenza drugs at ICAAC
While Sangamo was making waves with its news on Carl June's latest gene therapy study, two other developers were reporting successes with their experimental treatments at ICAAC.
Bristol-Myers Squibb ($BMS) reported that its experimental hepatitis C treatment--MS-790052--effectively cured 83% of patients after 24 weeks of therapy. BMS's Douglas Manion, vice president of development and virology, told Bloomberg that "the new standard of care should be 60% to 80% cure rates."
That program is now headed into late stage studies. Leerink Swann has estimated peak sales at $125 million. BMS has four programs ongoing for hepatitis C, a hot field that has attracted considerable attention with the marketing success of Vertex's Incivek......
Pharmaceutical
Investigators tout trial successes for hep C, influenza drugs at ICAAC
While Sangamo was making waves with its news on Carl June's latest gene therapy study, two other developers were reporting successes with their experimental treatments at ICAAC.
Bristol-Myers Squibb ($BMS) reported that its experimental hepatitis C treatment--MS-790052--effectively cured 83% of patients after 24 weeks of therapy. BMS's Douglas Manion, vice president of development and virology, told Bloomberg that "the new standard of care should be 60% to 80% cure rates."
That program is now headed into late stage studies. Leerink Swann has estimated peak sales at $125 million. BMS has four programs ongoing for hepatitis C, a hot field that has attracted considerable attention with the marketing success of Vertex's Incivek......
Pharmaceutical
Summer is ending and that means we can look forward to the flu season. But reaching for the Tylenol is no longer a sure thing, since the venerable pain reliever remains largely out of stock. This is due, of course, to ongoing manufacturing difficulties that Johnson & Johnson has had for nearly two years thanks to bottles that smelled musty, contained too much active ingredients or metallic specks, among other things............
Lynne Taylor
The over-prescribing of medicines in Europe is becoming "chronic," especially among elderly patients, a leading health policy expert has claimed.
The over-prescribing of medicines in Europe is becoming "chronic," especially among elderly patients, a leading health policy expert has claimed.
A study by Salzburg Medical University has found that prescriptions issued to patients with an average age of 82 were unnecessary in 36% of cases, while for 30% the drugs they were being given were inappropriate, according to Guenther Leiner, president of leading health policy conference the European Health Forum Gastein (EHFG)........
FYI
The FDA called the report "irresponsible and misleading" and another TV doc, ABC's Richard Besser, MD, accused Oz of fear-mongering
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