Public release date: 22-Sep-2010
Contact: Dawn Peters
healthnews@wiley.com
781-388-8408
Wiley-Blackwell
Hyponatremia may lead to neurological complications
A new study published in the October issue of the journal Hepatology found that patients with severe portal-hypertensive bleeding who are treated with terlipressin may experience an acute reduction of sodium in their blood. This reduction in serum sodium, known as hyponatremia, can cause adverse reactions such as neurological complications, and is rapidly reversible upon terlipressin withdrawal. Researchers suggest that serum sodium should be closely monitored in these patients and caution that use of solutions with high sodium content to treat this condition may cause a too rapid recovery of sodium leading to adverse events.
Cirrhosis and portal vein thrombosis are two of the primary causes of severe portal hypertension—an increase in blood pressure of the (portal) vein between digestive organs and the liver. This increase in pressure contributes to the development of varices, or large veins, that can weaken over time and lead to gastrointestinal bleeding. Terlipressin is commonly used to treat acute variceal bleeding, however its effect on serum sodium is largely unknown and the focus of the current retrospective study, led by Pere Ginès, MD, from the Hospital Clínic in Barcelona, Spain.
The study included 58 consecutive patients treated with terlipressin for gastrointestinal bleeding due to portal-hypertension. Median age of participants was 54 years, with 77% of the cohort being male and 22% female. Initially patients were treated with somatostatin, but switched to terlipressin due to uncontrolled bleeding or rebleeding in 57% and 43% of cases, respectively.
Researchers noted a significant reduction in serum sodium concentration during terlipressin treatment (from 134.9 at baseline to 130.5 mEq/L at day 5 of treatment). A reduction of sodium in the blood was found in 67% of patients with 31% having a moderate decrease (5-10 mEq/L) and 36% experiencing a marked decrease in serum sodium (greater than 10mEq/L). Only 19 patients were determined to have no change in serum sodium levels.
Further results indicate that patients with a low model for end-stage liver disease (MELD) score and normal or near-normal baseline serum sodium had the highest risk of hyponatremia. "The reduction in serum sodium concentration, common in terlipressin therapy, develops rapidly after onset of treatment, said Dr. Ginès. "In some patients hyponatremia can be severe, leading to neurological complications which usually resolve upon withdrawl from treatment."
The research team found that 3 of the 21 patients who had a marked reduction in serum sodium developed neurological manifestations. Two of the patients with neurological complications improved after withdrawal of therapy and administration of hypertonic saline. One patient who developed a progressive impairment in neurological status leading to coma, did not improve after terlipressin withdrawal and treatment with hypertonic saline, and later died due to multiorgan failure.
"In patients with high risk of reduction in serum sodium levels (low MELD scores and normal or near-normal baseline serum sodium concentration), serum sodium concentration should be monitored closely during treatment and terlipressin stopped if hyponatremia develops. Hypotonic fluids should probably be avoided to prevent a further reduction in serum sodium concentration," concluded Dr. Ginès. "Physicians should be aware of our findings in order to prevent the possible neurological complications related to acute hyponatremia or rapid recovery of serum sodium levels."
###
Article: "Hyponatremia in Patients Treated with Terlipressin for Severe Gastrointestinal Bleeding due to Portal Hypertension." Elsa Solà, Sabela Lens, Mónica Guevara, Marta Martín-Llahí, Claudia Fagundes, Gustavo Pereira, Marco Pavesi, Javier Fernández, Juan González-Abraldes, Angels Escorsell, Antoni Mas, Jaume Bosch, Vicente Arroyo, and Pere Ginès. Hepatology; Published Online: August 5, 2010 (DOI: 10.1002/hep.23893); Print Issue Date: October 2010. http://onlinelibrary.wiley.com/doi/10.1002/hep.23893/abstract
These studies are published in Hepatology. Media wishing to receive a PDF of the articles may contact healthnews@wiley.com.
Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3350
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Source
October 2, 2010
Merck Announces Pivotal Phase III Data for Boceprevir will be Presented at the American Association for the Study of Liver Diseases 2010 Annual Meeting
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Oct 1, 2010 - Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting. In total, more than 20 oral and poster presentations of clinical studies highlighting Merck medicines and investigational therapies for chronic hepatitis C virus (HCV) infection will be presented.
Boceprevir, in combination with PEGINTRON® (peginterferon alfa-2b) and REBETOL® (ribavirin, USP) (Peg/riba), is being studied for the treatment of patients with HCV genotype 1 infection who were previously treated (treatment-failure; HCV RESPOND-2) and in patients who are new to treatment (treatment-naïve; HCV SPRINT-2).
As previously reported, Merck plans to submit a New Drug Application (NDA) for boceprevir to the U.S. Food and Drug Administration (FDA) on a rolling basis, and expects to complete regulatory submissions in the U.S. and E.U. in 2010.
The AASLD presentations of the boceprevir Phase III data will include sustained virologic response (SVR)1 rates by patient sub-groups, including treatment-naïve patients (African-American/Black and non-African-American/Black), patients who experienced prior relapse, prior non-responders, and patients with a poor response to interferon, defined as having achieved less than a 1 log decrease in viral load (HCV-RNA) after a 4-week Peg/riba lead-in period.
The HCV RESPOND-2 and HCV SPRINT-2 studies each evaluated two treatment strategies with boceprevir to assess the ability to improve SVR and potentially shorten overall treatment duration compared to Peg/riba alone:
• Response-guided therapy, in which treatment-failure patients with undetectable virus at week 8 were able to stop all treatment at 36 weeks, and in which treatment-naïve patients with undetectable virus during weeks 8 through 24 were able to stop all treatment at 28 weeks; and
• 48 weeks of treatment (4-week Peg/riba lead-in followed by the addition of boceprevir for 44 weeks).
In both studies, all patients were treated with a 4-week lead-in of PEGINTRON (1.5 mcg/kg/week) and an investigational dose of REBETOL (600-1,400 mg/day), followed by the addition of boceprevir (800 mg three times a day).
The abstracts were published today and can be accessed on the AASLD website. For program information, please visit http://www.aasld.org/.
Boceprevir Oral Presentations
HCV SPRINT-2 Final Results (Late-Breaking Oral Session)
Boceprevir (BOC) Combined with Peginterferon alfa-2b/Ribavirin (P/R) for Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype (G) 1: SPRINT-2 Final Results; F. Poordad et al. Abstract LB-4. Monday, Nov. 1, 5:30 – 5:45 PM, Location: Hynes Auditorium
HCV RESPOND-2 Final Results (Viral Hepatitis Plenary Session)
HCV RESPOND-2 Final Results: High Sustained Virologic Response Among Genotype 1 Previous Non-Responders and Relapsers to Peginterferon/Ribavirin when Re-Treated with Boceprevir Plus PEGINTRON (Peginterferon alfa-2b)/Ribavirin; B. R. Bacon et al. Abstract 216. Tuesday, Nov. 2, 9:15 – 9:30 AM, Location: Hynes Auditorium
Boceprevir Poster Presentations
HCV SPRINT-2 (Late-Breaking Poster Session)
Response-Guided Therapy (RGT) with Boceprevir (BOC) + Peginterferon alfa-2b/Ribavirin (P/R) for Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype (G) 1 Was Similar to a 48-Wk Fixed-Duration Regimen with BOC + P/R in SPRINT-2; J. Bronowicki et al. Abstract LB-15. Monday, Nov. 1, 8:00 AM – 5:00 PM, Location: Hynes Exhibit Hall C
HCV SPRINT-1 Phase II Data
Hemoglobin Decline During Lead-In Phase as an Early Predictor of Anemia After the Addition of Boceprevir: A Retrospective Analysis of HCV SPRINT-1; F. Poordad et al. Abstract 933. Sunday, Oct. 31, 8:00 AM – 5:30 PM, Location: Hynes Exhibit Hall C
Frequencies of Resistance-Associated Amino Acid Variants Following Combination Treatment with Boceprevir Plus PEGINTRON (PegInterferon Alfa-2b)/Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 1 (G1); J. M. Vierling et al. Abstract 801. Sunday, Oct. 31, 8:00 AM – 5:30 PM, Location: Hynes Exhibit Hall C
Other Key Merck Data
High Correlation Between Week 4 and Week 12 as the Definition for Null Response to Peginterferon alfa (PEG) plus Ribavirin (R) Therapy: Results from the IDEAL Trial; F. Poordad et al. Abstract 797. Sunday, Oct. 31, 8:00 AM – 5:30 PM, Location: Hynes Exhibit Hall C
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. Extensive research efforts are underway to develop differentiated oral therapies that bring innovation to viral hepatitis care.
About PEGINTRON
PEGINTRON is indicated for use in combination with REBETOL (ribavirin) for the treatment of chronic hepatitis C in patients three years of age and older with compensated liver disease.
The following points should be considered when initiating therapy with PEGINTRON in combination with REBETOL: (1) These indications are based on achieving undetectable
HCV-RNA after treatment for 24 or 48 weeks and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose. (2) Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection. (3) No safety and efficacy data are available for treatment of longer than one year.
PEGINTRON is also indicated for use alone for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with interferon alpha and who are at least 18 years of age.
The following points should be considered when initiating therapy with PEGINTRON alone: Combination therapy with REBETOL is preferred over PEGINTRON monotherapy unless there are contraindications to, or significant intolerance of, REBETOL. Combination therapy provides substantially better response rates than monotherapy.
Contraindications
PEGINTRON is contraindicated in patients with known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis to interferon alpha or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment. PEGINTRON/REBETOL combination therapy is additionally contraindicated in women who are pregnant or may become pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL per min.
Pregnancy
REBETOL therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Patients should use at least two effective forms of contraception and have monthly pregnancy tests during therapy and for six months after completion of therapy. If this drug is used during pregnancy, or if a patient becomes pregnant, the patient should be apprised of the potential hazard to a fetus. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for six months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Patients with the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy:
• Hemolytic anemia with ribavirin
• Neuropsychiatric events
• History of significant or unstable cardiac disease
• Hypothyroidism, hyperthyroidism, hyperglycemia, diabetes mellitus that cannot be effectively treated by medication
• New or worsening ophthalmologic disorders
• Ischemic and hemorrhagic cerebrovascular events
• Severe decreases in neutrophil or platelet counts
• History of autoimmune disorders
• Pancreatitis and ulcerative or hemorrhagic/ischemic colitis and pancreatitis
• Pulmonary infiltrates or pulmonary function impairment
• Child-Pugh score greater than 6 (Class B and C)
• Increased creatinine levels in patients with renal insufficiency
• Serious, acute hypersensitivity reactions and cutaneous eruptions
• Dental/periodontal disorders reported with combination therapy
• Hypertriglyceridemia may result in pancreatitis (e.g., triglycerides greater than 1000 mg/dL)
• Weight loss and growth inhibition reported with combination therapy in pediatric patients.
Life-threatening or fatal neuropsychiatric events, including suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior, sometimes directed towards others, have occurred in patients with and without a previous psychiatric disorder during PEGINTRON treatment and follow-up.
Adverse events
Serious adverse reactions have occurred in approximately 12 percent of subjects in clinical trials. The most common serious events occurring in subjects treated with PEGINTRON and REBETOL were depression and suicidal ideation, each occurring at a frequency of less than 1 percent. The most common fatal events occurring in subjects treated with PEGINTRON and REBETOL were cardiac arrest, suicidal ideation, and suicide attempt, all occurring in less than 1 percent of subjects.
The incidence of serious adverse reactions was comparable between PEGINTRON monotherapy (about 12 percent) and PEGINTRON/REBETOL combination therapy weight-based (12 percent) or flat-dose (17 percent). In many but not all cases, adverse reactions resolved after dose reduction or discontinuation of therapy. Some patients experienced ongoing or new serious adverse reactions during the 6-month follow-up period. In a study with PEGINTRON/REBETOL (weight-based) combination therapy in adult patients, anemia with weight-based dosing occurred at an increased rate (29 percent vs. 19 percent); however, the majority of these cases were mild and responded to dose reductions. The incidence of serious adverse reactions reported for the weight-based REBETOL group was 12 percent. There were 31 deaths in clinical trials which occurred during treatment or during follow-up. Of the deaths, 19 were patients on either PEGINTRON or PEGINTRON/REBETOL combination therapy and three occurred during the follow-up period but had been on PEGINTRON/REBETOL combination therapy.
Additional serious adverse reactions seen in clinical trials at a frequency of equal to or less than 1 percent included psychosis, aggressive reaction, relapse of drug addiction/overdose; nerve palsy (facial, oculomotor); cardiomyopathy, angina, pericardial effusion, retinal ischemia, retinal artery or vein thrombosis, blindness, decreased visual acuity, optic neuritis, transient ischemic attack, supraventricular arrhythmias, loss of consciousness; neutropenia, infection (sepsis, pneumonia, abscess, cellulitis); emphysema, bronchiolitis obliterans, pleural effusion, gastroenteritis, pancreatitis, gout, hyperglycemia, hyperthyroidism and hypothyroidism, autoimmune thrombocytopenia with or without purpura, rheumatoid arthritis, interstitial nephritis, lupus-like syndrome, sarcoidosis, aggravated psoriasis, urticaria, injection site necrosis, vasculitis, and phototoxicity.
Greater than 96 percent of all subjects in clinical trials experienced one or more adverse events. Most common adverse reactions (greater than 40 percent) in adult patients receiving either PEGINTRON or PEGINTRON/REBETOL are injection site inflammation/reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia, and anxiety/emotional lability/irritability.
The adverse reaction profile was similar between weight-based and flat-dose PEGINTRON/REBETOL therapies. Weight-based PEGINTRON/REBETOL dosing resulted in increased rates of anemia. Most common adverse reactions with PEGINTRON/REBETOL (weight-based) therapy were psychiatric, which occurred among 68-69 percent of patients and included depression, irritability, and insomnia, each reported by approximately 30-40 percent of subjects in all treatment groups. Suicidal behavior (ideation, attempts, and suicides) occurred in 2 percent of all patients during treatment or during follow-up after treatment cessation. Other common reactions included injection site reactions, fatigue/ asthenia, headache, rigors, fever, nausea, myalgia, anxiety/emotional lability/irritability. The severity of some of these systemic symptoms tends to decrease as treatment continues.
Subjects receiving PEGINTRON/REBETOL as re-treatment after failing a previous interferon combination regimen reported adverse reactions similar to previous treatment-naïve patients receiving this regimen.
In general, the adverse reaction profile in the pediatric population was similar to that observed in adults. Most common adverse reactions (greater than 25 percent) in pediatric patients receiving PEGINTRON/REBETOL are pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, abdominal pain, and vomiting.
Please see full prescribing information at http://www.spfiles.com/pipeg-intron.pdf.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit http://www.merck.com/.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2009 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (http://www.sec.gov/).
Please see attached Prescribing Information and Medication Guide including Boxed Warning for PEGINTRON and REBETOL. The full Prescribing Information and Medication Guide is also available at http://www.spfiles.com/pipeg-intron.pdf .
PEGINTRON® and REBETOL® are registered trademarks of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA
Source
Boceprevir, in combination with PEGINTRON® (peginterferon alfa-2b) and REBETOL® (ribavirin, USP) (Peg/riba), is being studied for the treatment of patients with HCV genotype 1 infection who were previously treated (treatment-failure; HCV RESPOND-2) and in patients who are new to treatment (treatment-naïve; HCV SPRINT-2).
As previously reported, Merck plans to submit a New Drug Application (NDA) for boceprevir to the U.S. Food and Drug Administration (FDA) on a rolling basis, and expects to complete regulatory submissions in the U.S. and E.U. in 2010.
The AASLD presentations of the boceprevir Phase III data will include sustained virologic response (SVR)1 rates by patient sub-groups, including treatment-naïve patients (African-American/Black and non-African-American/Black), patients who experienced prior relapse, prior non-responders, and patients with a poor response to interferon, defined as having achieved less than a 1 log decrease in viral load (HCV-RNA) after a 4-week Peg/riba lead-in period.
The HCV RESPOND-2 and HCV SPRINT-2 studies each evaluated two treatment strategies with boceprevir to assess the ability to improve SVR and potentially shorten overall treatment duration compared to Peg/riba alone:
• Response-guided therapy, in which treatment-failure patients with undetectable virus at week 8 were able to stop all treatment at 36 weeks, and in which treatment-naïve patients with undetectable virus during weeks 8 through 24 were able to stop all treatment at 28 weeks; and
• 48 weeks of treatment (4-week Peg/riba lead-in followed by the addition of boceprevir for 44 weeks).
In both studies, all patients were treated with a 4-week lead-in of PEGINTRON (1.5 mcg/kg/week) and an investigational dose of REBETOL (600-1,400 mg/day), followed by the addition of boceprevir (800 mg three times a day).
The abstracts were published today and can be accessed on the AASLD website. For program information, please visit http://www.aasld.org/.
Boceprevir Oral Presentations
HCV SPRINT-2 Final Results (Late-Breaking Oral Session)
Boceprevir (BOC) Combined with Peginterferon alfa-2b/Ribavirin (P/R) for Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype (G) 1: SPRINT-2 Final Results; F. Poordad et al. Abstract LB-4. Monday, Nov. 1, 5:30 – 5:45 PM, Location: Hynes Auditorium
HCV RESPOND-2 Final Results (Viral Hepatitis Plenary Session)
HCV RESPOND-2 Final Results: High Sustained Virologic Response Among Genotype 1 Previous Non-Responders and Relapsers to Peginterferon/Ribavirin when Re-Treated with Boceprevir Plus PEGINTRON (Peginterferon alfa-2b)/Ribavirin; B. R. Bacon et al. Abstract 216. Tuesday, Nov. 2, 9:15 – 9:30 AM, Location: Hynes Auditorium
Boceprevir Poster Presentations
HCV SPRINT-2 (Late-Breaking Poster Session)
Response-Guided Therapy (RGT) with Boceprevir (BOC) + Peginterferon alfa-2b/Ribavirin (P/R) for Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype (G) 1 Was Similar to a 48-Wk Fixed-Duration Regimen with BOC + P/R in SPRINT-2; J. Bronowicki et al. Abstract LB-15. Monday, Nov. 1, 8:00 AM – 5:00 PM, Location: Hynes Exhibit Hall C
HCV SPRINT-1 Phase II Data
Hemoglobin Decline During Lead-In Phase as an Early Predictor of Anemia After the Addition of Boceprevir: A Retrospective Analysis of HCV SPRINT-1; F. Poordad et al. Abstract 933. Sunday, Oct. 31, 8:00 AM – 5:30 PM, Location: Hynes Exhibit Hall C
Frequencies of Resistance-Associated Amino Acid Variants Following Combination Treatment with Boceprevir Plus PEGINTRON (PegInterferon Alfa-2b)/Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 1 (G1); J. M. Vierling et al. Abstract 801. Sunday, Oct. 31, 8:00 AM – 5:30 PM, Location: Hynes Exhibit Hall C
Other Key Merck Data
High Correlation Between Week 4 and Week 12 as the Definition for Null Response to Peginterferon alfa (PEG) plus Ribavirin (R) Therapy: Results from the IDEAL Trial; F. Poordad et al. Abstract 797. Sunday, Oct. 31, 8:00 AM – 5:30 PM, Location: Hynes Exhibit Hall C
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. Extensive research efforts are underway to develop differentiated oral therapies that bring innovation to viral hepatitis care.
About PEGINTRON
PEGINTRON is indicated for use in combination with REBETOL (ribavirin) for the treatment of chronic hepatitis C in patients three years of age and older with compensated liver disease.
The following points should be considered when initiating therapy with PEGINTRON in combination with REBETOL: (1) These indications are based on achieving undetectable
HCV-RNA after treatment for 24 or 48 weeks and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose. (2) Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection. (3) No safety and efficacy data are available for treatment of longer than one year.
PEGINTRON is also indicated for use alone for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with interferon alpha and who are at least 18 years of age.
The following points should be considered when initiating therapy with PEGINTRON alone: Combination therapy with REBETOL is preferred over PEGINTRON monotherapy unless there are contraindications to, or significant intolerance of, REBETOL. Combination therapy provides substantially better response rates than monotherapy.
Contraindications
PEGINTRON is contraindicated in patients with known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis to interferon alpha or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment. PEGINTRON/REBETOL combination therapy is additionally contraindicated in women who are pregnant or may become pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL per min.
Pregnancy
REBETOL therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Patients should use at least two effective forms of contraception and have monthly pregnancy tests during therapy and for six months after completion of therapy. If this drug is used during pregnancy, or if a patient becomes pregnant, the patient should be apprised of the potential hazard to a fetus. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for six months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Patients with the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy:
• Hemolytic anemia with ribavirin
• Neuropsychiatric events
• History of significant or unstable cardiac disease
• Hypothyroidism, hyperthyroidism, hyperglycemia, diabetes mellitus that cannot be effectively treated by medication
• New or worsening ophthalmologic disorders
• Ischemic and hemorrhagic cerebrovascular events
• Severe decreases in neutrophil or platelet counts
• History of autoimmune disorders
• Pancreatitis and ulcerative or hemorrhagic/ischemic colitis and pancreatitis
• Pulmonary infiltrates or pulmonary function impairment
• Child-Pugh score greater than 6 (Class B and C)
• Increased creatinine levels in patients with renal insufficiency
• Serious, acute hypersensitivity reactions and cutaneous eruptions
• Dental/periodontal disorders reported with combination therapy
• Hypertriglyceridemia may result in pancreatitis (e.g., triglycerides greater than 1000 mg/dL)
• Weight loss and growth inhibition reported with combination therapy in pediatric patients.
Life-threatening or fatal neuropsychiatric events, including suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior, sometimes directed towards others, have occurred in patients with and without a previous psychiatric disorder during PEGINTRON treatment and follow-up.
Adverse events
Serious adverse reactions have occurred in approximately 12 percent of subjects in clinical trials. The most common serious events occurring in subjects treated with PEGINTRON and REBETOL were depression and suicidal ideation, each occurring at a frequency of less than 1 percent. The most common fatal events occurring in subjects treated with PEGINTRON and REBETOL were cardiac arrest, suicidal ideation, and suicide attempt, all occurring in less than 1 percent of subjects.
The incidence of serious adverse reactions was comparable between PEGINTRON monotherapy (about 12 percent) and PEGINTRON/REBETOL combination therapy weight-based (12 percent) or flat-dose (17 percent). In many but not all cases, adverse reactions resolved after dose reduction or discontinuation of therapy. Some patients experienced ongoing or new serious adverse reactions during the 6-month follow-up period. In a study with PEGINTRON/REBETOL (weight-based) combination therapy in adult patients, anemia with weight-based dosing occurred at an increased rate (29 percent vs. 19 percent); however, the majority of these cases were mild and responded to dose reductions. The incidence of serious adverse reactions reported for the weight-based REBETOL group was 12 percent. There were 31 deaths in clinical trials which occurred during treatment or during follow-up. Of the deaths, 19 were patients on either PEGINTRON or PEGINTRON/REBETOL combination therapy and three occurred during the follow-up period but had been on PEGINTRON/REBETOL combination therapy.
Additional serious adverse reactions seen in clinical trials at a frequency of equal to or less than 1 percent included psychosis, aggressive reaction, relapse of drug addiction/overdose; nerve palsy (facial, oculomotor); cardiomyopathy, angina, pericardial effusion, retinal ischemia, retinal artery or vein thrombosis, blindness, decreased visual acuity, optic neuritis, transient ischemic attack, supraventricular arrhythmias, loss of consciousness; neutropenia, infection (sepsis, pneumonia, abscess, cellulitis); emphysema, bronchiolitis obliterans, pleural effusion, gastroenteritis, pancreatitis, gout, hyperglycemia, hyperthyroidism and hypothyroidism, autoimmune thrombocytopenia with or without purpura, rheumatoid arthritis, interstitial nephritis, lupus-like syndrome, sarcoidosis, aggravated psoriasis, urticaria, injection site necrosis, vasculitis, and phototoxicity.
Greater than 96 percent of all subjects in clinical trials experienced one or more adverse events. Most common adverse reactions (greater than 40 percent) in adult patients receiving either PEGINTRON or PEGINTRON/REBETOL are injection site inflammation/reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia, and anxiety/emotional lability/irritability.
The adverse reaction profile was similar between weight-based and flat-dose PEGINTRON/REBETOL therapies. Weight-based PEGINTRON/REBETOL dosing resulted in increased rates of anemia. Most common adverse reactions with PEGINTRON/REBETOL (weight-based) therapy were psychiatric, which occurred among 68-69 percent of patients and included depression, irritability, and insomnia, each reported by approximately 30-40 percent of subjects in all treatment groups. Suicidal behavior (ideation, attempts, and suicides) occurred in 2 percent of all patients during treatment or during follow-up after treatment cessation. Other common reactions included injection site reactions, fatigue/ asthenia, headache, rigors, fever, nausea, myalgia, anxiety/emotional lability/irritability. The severity of some of these systemic symptoms tends to decrease as treatment continues.
Subjects receiving PEGINTRON/REBETOL as re-treatment after failing a previous interferon combination regimen reported adverse reactions similar to previous treatment-naïve patients receiving this regimen.
In general, the adverse reaction profile in the pediatric population was similar to that observed in adults. Most common adverse reactions (greater than 25 percent) in pediatric patients receiving PEGINTRON/REBETOL are pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, abdominal pain, and vomiting.
Please see full prescribing information at http://www.spfiles.com/pipeg-intron.pdf.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit http://www.merck.com/.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2009 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (http://www.sec.gov/).
Please see attached Prescribing Information and Medication Guide including Boxed Warning for PEGINTRON and REBETOL. The full Prescribing Information and Medication Guide is also available at http://www.spfiles.com/pipeg-intron.pdf .
PEGINTRON® and REBETOL® are registered trademarks of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA
Source
October 1, 2010
Vancouver Hepatitis C Treatment Program for Injection Drug Users Proves Popular and Successful
SUMMARY: An ongoing initiative to offer interferon-based therapy for chronic hepatitis C virus (HCV) infection to injection drug users has demonstrated promising outcomes, according to a study presented at the recent 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2010) in Boston. Retention in the program has been good despite some patients continuing active drug use, and about half of those who underwent treatment have achieved sustained virological response (SVR).
By Liz Highleyman
Some healthcare providers have traditionally been reluctant to offer chronic hepatitis C treatment to current or former injection drug users due to concerns about poor adherence and toxicities. Studies have shown, however, that such patients can do well on treatment, and current practice guidelines state that drug users should be considered on an individual basis and not routinely excluded from therapy.
B. Conway from the University of British Columbia and colleagues performed an evaluation of a program providing hepatitis C treatment to injection drug users in Vancouver's Downtown East Side neighborhood.
Starting in March 2005, participants were recruited at the Pender Community Health Centre and evaluated for possible treatment for HCV infection. Diagnostic testing was offered for HCV and HIV, and patients who were deemed eligible for hepatitis C therapy were offered the opportunity to be included in the program.
Participants attended weekly clinic visits. All treated patients received once-weekly pegylated interferon as directly observed therapy plus daily self-administered ribavirin. Participants also received extensive medical, addiction, and counseling support and a standardized proactive approach to management of treatment-related side effects.
Results
- At the time the study abstract was submitted, 370 potential participants had been screened and 165 courses of treatment were administered.
- Most participants (84%) were men, the mean age was 49 years, 52% had hard-to-treat HCV genotype 1, and 10% were coinfected with HIV.
- 53% reported injection drug use within the previous 30 days.
- Willingness to undergo hepatitis C treatment was positively associated with male sex (adjusted odds ratio [aOR] 3.73) and current enrollment in an opiate substitution pharmacotherapy program (aOR 1.63).
- Combined drug use was associated with less willingness to start therapy (aOR 0.36).
- Among treated participants with an appropriate duration of follow-up, the SVR rate 24 weeks after finishing treatment was 54%:
--HCV genotype 2: 75%;
--HCV genotype 3: 63%.
- Type of pegylated interferon (Pegasys or PegIntron) and HIV coinfection status were not associated with virological treatment failure.
Investigator affiliations: Univ. of British Columbia, Vancouver, Canada; Vancouver Coastal Health, Vancouver, Canada.
9/28/10
Reference
B Conway, L Gallagher, E Knight, and others. Treatment of HCV Infection in Injection Drug Users (IDUs): An Update on a Multidisciplinary Program in Vancouver. 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2010). Boston, September 12-15, 2010. Abstract V-1790.
Source
Three-quarters of People with Hepatitis C in the U.S. Have Hard-to-treat Genotype 1
SUMMARY: Nearly 75% of people with chronic hepatitis C virus (HCV) infection in 3 U.S. states have HCV genotype 1, the hardest type to treat, according to public health surveillance data presented at the recent 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2010) in Boston. Among African-Americans -- a group known to respond poorly to interferon-based therapy -- more than 90% had genotype 1.
By Liz Highleyman
Hepatitis C virus genotype is a key factor in predicting how well interferon-based therapy will work. Patients with HCV genotype 1 are treated with pegylated interferon plus ribavirin for a standard duration of 48 weeks, with a sustained virological response (SVR) rate just under 50%, while those with genotypes 2 or 3 are typically treated for 24 weeks and have an SVR rate of 70%-80%. Genotypes 4 (which is also considered hard to treat), 5, and 6 are seldom seen in the U.S.
Monina Klevens from the Centers for Disease Control and Prevention (CDC) and colleagues collected data on hepatitis C cases reported during 2009 to health departments in Connecticut, Minnesota, 34 counties in New York State, and New York City, as part of an enhanced population-based surveillance project.
Results
--20.2% were from elsewhere in New York State;
--15.5% were from Minnesota;
--2.1% were from Connecticut.
--HCV genotype 2: 11.9% (range 10.2%-16.6%);
--HCV genotype 3: 11.6% (range 8.0%-18.5%);
--HCV genotypes 4, 5, or 6: 3.3%.
--Hispanics/Latinos: 78.7%;
--Whites (non-Hispanic): 68.1%.
Investigator affiliations: Centers for Disease Control and Prevention, Atlanta, GA; Colorado Dept. of Public Health, CO; Connecticut Dept. of Public Health, CT; Minnesota Dept. of Health, MN; New York State Dept. of Health, NY; New York City Dept. of Health and Mental Hygiene, New York, NY.
10/1/10
Reference
M Klevens, R Jiles, D Daniels, and others. Distribution of Reported Hepatitis C Genotypes in Sites Conducting Enhanced Hepatitis Surveillance, 2009. 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2010). Boston, September 12-15, 2010. Abstract V-1789.
Source
By Liz Highleyman
Hepatitis C virus genotype is a key factor in predicting how well interferon-based therapy will work. Patients with HCV genotype 1 are treated with pegylated interferon plus ribavirin for a standard duration of 48 weeks, with a sustained virological response (SVR) rate just under 50%, while those with genotypes 2 or 3 are typically treated for 24 weeks and have an SVR rate of 70%-80%. Genotypes 4 (which is also considered hard to treat), 5, and 6 are seldom seen in the U.S.
Monina Klevens from the Centers for Disease Control and Prevention (CDC) and colleagues collected data on hepatitis C cases reported during 2009 to health departments in Connecticut, Minnesota, 34 counties in New York State, and New York City, as part of an enhanced population-based surveillance project.
Results
- A total of 16,620 confirmed cases of HCV infection were reported by the participating sites.
- 3081 of these individuals (18.5%) had an available HCV genotype test result
--20.2% were from elsewhere in New York State;
--15.5% were from Minnesota;
--2.1% were from Connecticut.
- Overall, the genotype distribution in these cases was as follows:
--HCV genotype 2: 11.9% (range 10.2%-16.6%);
--HCV genotype 3: 11.6% (range 8.0%-18.5%);
--HCV genotypes 4, 5, or 6: 3.3%.
- Younger adults (age 18-39 years) were more likely to have HCV genotype 3 than people age 40-59 years or those age 60 and older (16.6%, 11.9%, and 5.5%, respectively).
- Genotype 1 frequency varied across racial/ethnic groups:
--Hispanics/Latinos: 78.7%;
--Whites (non-Hispanic): 68.1%.
- Most people with HCV genotypes 1, 2, and 3 were born in the U.S. (87.4%, 81.2%, and 70.8%, respectively)
- In contrast, most people (71.4%) with genotype 4 and all those with genotype 6 were foreign-born.
Investigator affiliations: Centers for Disease Control and Prevention, Atlanta, GA; Colorado Dept. of Public Health, CO; Connecticut Dept. of Public Health, CT; Minnesota Dept. of Health, MN; New York State Dept. of Health, NY; New York City Dept. of Health and Mental Hygiene, New York, NY.
10/1/10
Reference
M Klevens, R Jiles, D Daniels, and others. Distribution of Reported Hepatitis C Genotypes in Sites Conducting Enhanced Hepatitis Surveillance, 2009. 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2010). Boston, September 12-15, 2010. Abstract V-1789.
Source
September 2010 Briefing - HIV & AIDS
Friday, October 01, 2010
Here are what the editors at HealthDay consider to be the most important developments in HIV & AIDS for September 2010. This roundup includes the latest research news from journal articles, as well as the FDA approvals and regulatory changes that are the most likely to affect clinical practice.
FDA: Certain Lots of Epogen and Procrit Recalled
MONDAY, Sept. 27 (HealthDay News) -- The U.S. Food and Drug Administration and Amgen have notified health care professionals that certain lots of epoetin alfa (Epogen and Procrit) are being recalled, as product vials may contain extremely thin glass flakes (lamellae) that could result in serious adverse events.
More Information
HIV Prevalence 19% Among Men Who Have Sex With Men
FRIDAY, Sept. 24 (HealthDay News) -- The prevalence of HIV among men who have sex with men (MSM) remains high in the United States, and 44 percent of infected MSM do not know they are infected, according to research published in the Sept. 24 issue of the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.
Full Text
Gel Not Shown to Reduce HIV-1 Incidence in Women
MONDAY, Sept. 20 (HealthDay News) -- PRO2000 microbicide gel is not efficacious against vaginal HIV-1 transmission, according to research published online Sept. 20 in The Lancet.
Abstract
Full Text (subscription or payment may be required)
Comment (subscription or payment may be required)
Sacrifice Makes Industry Gifts Seem More Acceptable
TUESDAY, Sept. 14 (HealthDay News) -- Residents who are reminded of the sacrifices they made to attain their medical education tend to rate the acceptability of industry-sponsored gifts higher than those who are not reminded, according to research published in the Sept. 15 issue of the Journal of the American Medical Association.
Abstract
Full Text (subscription or payment may be required)
Re-Consent Important Before Secondary Use of Genetic Data
MONDAY, Sept. 13 (HealthDay News) -- Most research participants want to be asked for secondary consent -- referred to as re-consent -- before their existing personal genetic data are added to the federal database of Genotypes and Phenotypes (dbGaP), according to research published in the September issue of the Journal of Empirical Research on Human Research Ethics.
Full Text
High HIV Rate for Men Having Sex With Men in France
FRIDAY, Sept. 10 (HealthDay News) -- Although overall HIV incidence rates in France declined between 2003 and 2008, the rate was drastically higher among men who have sex with men (MSM) than among other groups, according to research published online Sept. 9 in The Lancet Infectious Diseases.
Abstract
Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)
Annual Medical Liability Costs Surpass $50 Billion
THURSDAY, Sept. 9 (HealthDay News) -- The annual costs of the medical liability system in the United States total more than $50 billion, which accounts for a relatively small but non-trivial portion of total health care spending, according to an article in the September issue of Health Affairs.
Abstract
Full Text (subscription or payment may be required)
Nevirapine Reuse in Children With HIV May Be Safe
WEDNESDAY, Sept. 8 (HealthDay News) -- After achieving viral suppression with protease inhibitor-based therapy, most children infected with HIV at birth despite being given nevirapine may safely be switched back to nevirapine-based therapy without fear of drug resistance, according to a study published in the Sept. 8 issue of the Journal of the American Medical Association.
Abstract
Full Text (subscription or payment may be required)
Urban Clinic Increases HIV Testing Uptake in Adolescents
TUESDAY, Sept. 7 (HealthDay News) -- After the publication of national recommendations for routine HIV testing and the implementation of rapid testing, the rate of HIV testing among adolescents at an urban adolescent primary care clinic substantially increased, according to research published in the September issue of the Archives of Pediatrics & Adolescent Medicine.
Abstract
Full Text (subscription or payment may be required)
Source
Here are what the editors at HealthDay consider to be the most important developments in HIV & AIDS for September 2010. This roundup includes the latest research news from journal articles, as well as the FDA approvals and regulatory changes that are the most likely to affect clinical practice.
FDA: Certain Lots of Epogen and Procrit Recalled
MONDAY, Sept. 27 (HealthDay News) -- The U.S. Food and Drug Administration and Amgen have notified health care professionals that certain lots of epoetin alfa (Epogen and Procrit) are being recalled, as product vials may contain extremely thin glass flakes (lamellae) that could result in serious adverse events.
More Information
HIV Prevalence 19% Among Men Who Have Sex With Men
FRIDAY, Sept. 24 (HealthDay News) -- The prevalence of HIV among men who have sex with men (MSM) remains high in the United States, and 44 percent of infected MSM do not know they are infected, according to research published in the Sept. 24 issue of the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.
Full Text
Gel Not Shown to Reduce HIV-1 Incidence in Women
MONDAY, Sept. 20 (HealthDay News) -- PRO2000 microbicide gel is not efficacious against vaginal HIV-1 transmission, according to research published online Sept. 20 in The Lancet.
Abstract
Full Text (subscription or payment may be required)
Comment (subscription or payment may be required)
Sacrifice Makes Industry Gifts Seem More Acceptable
TUESDAY, Sept. 14 (HealthDay News) -- Residents who are reminded of the sacrifices they made to attain their medical education tend to rate the acceptability of industry-sponsored gifts higher than those who are not reminded, according to research published in the Sept. 15 issue of the Journal of the American Medical Association.
Abstract
Full Text (subscription or payment may be required)
Re-Consent Important Before Secondary Use of Genetic Data
MONDAY, Sept. 13 (HealthDay News) -- Most research participants want to be asked for secondary consent -- referred to as re-consent -- before their existing personal genetic data are added to the federal database of Genotypes and Phenotypes (dbGaP), according to research published in the September issue of the Journal of Empirical Research on Human Research Ethics.
Full Text
High HIV Rate for Men Having Sex With Men in France
FRIDAY, Sept. 10 (HealthDay News) -- Although overall HIV incidence rates in France declined between 2003 and 2008, the rate was drastically higher among men who have sex with men (MSM) than among other groups, according to research published online Sept. 9 in The Lancet Infectious Diseases.
Abstract
Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)
Annual Medical Liability Costs Surpass $50 Billion
THURSDAY, Sept. 9 (HealthDay News) -- The annual costs of the medical liability system in the United States total more than $50 billion, which accounts for a relatively small but non-trivial portion of total health care spending, according to an article in the September issue of Health Affairs.
Abstract
Full Text (subscription or payment may be required)
Nevirapine Reuse in Children With HIV May Be Safe
WEDNESDAY, Sept. 8 (HealthDay News) -- After achieving viral suppression with protease inhibitor-based therapy, most children infected with HIV at birth despite being given nevirapine may safely be switched back to nevirapine-based therapy without fear of drug resistance, according to a study published in the Sept. 8 issue of the Journal of the American Medical Association.
Abstract
Full Text (subscription or payment may be required)
Urban Clinic Increases HIV Testing Uptake in Adolescents
TUESDAY, Sept. 7 (HealthDay News) -- After the publication of national recommendations for routine HIV testing and the implementation of rapid testing, the rate of HIV testing among adolescents at an urban adolescent primary care clinic substantially increased, according to research published in the September issue of the Archives of Pediatrics & Adolescent Medicine.
Abstract
Full Text (subscription or payment may be required)
Source
Breaking News – Governor Vetoes Hepatitis Bills
Posted on October 1, 2010
From our friends at Cal Hep:
Late in the evening on September 30th, two hours before deadline to sign or veto bills, Governor Schwarzenegger vetoed two bills that would have reduced the number of new HIV, hepatitis B and hepatitis C cases. Having worked to develop, draft and support these bills, the staff and member organizations of the California Hepatitis Alliance (calHEP) are extremely disappointed by this news. The Governor’s Office chose to ignore the recommendations of numerous medical and scientific bodies, including the Institute of Medicine of the National Academies of Medicine and Science, and his own administration’s Department of Public Health to make syringes more widely available through pharmacies and needle exchanges in order to reduce the number of viral hepatitis infections among injection drug users.
Governor Schwarzenegger did sign a bill to sustain the status quo: cities and counties may authorize pharmacists to furnish 10 or fewer syringes to an adult, and cities and counties may authorize syringe exchange services. Currently almost half of Californians live in jurisdictions where there is no safe legal access to sterile syringes without a prescription, and where law enforcement may arrest a person for attempting to comply with the U.S. Public Health service recommendation to injection drug users that they use a new sterile syringe for each injection. Contact CalHEP for information on how to support your local efforts to improve syringe access.
VETOED: SB 1029 by State Senator Leland Yee would have allowed pharmacists and physicians to furnish 30 or fewer syringes without prescription and would have allowed adults to possess up to 30 for personal use.
VETOED: AB 1858 would have allowed California Department of Public Health to authorized syringe exchange services in locations where the conditions exist for the rapid spread of viral hepatitis, HIV and other deadly or disabling diseases spread by the sharing of syringes.
Both bills were supported by California Medical Association, California Nurses Association, Health Officers Association of California, as well as numerous health and patient advocacy groups. We are grateful to the work of Drug Policy Alliance and San Francisco AIDS Foundation in providing support for the lobbying effort throughout the year. We are especially grateful to Senator Leland Yee (D-San Francisco) and Assemblymember Bob Blumenfield (D-Van Nuys) and their offices for leading these life saving efforts.We encourage you to contact the lawmakers to thank them for their commitment to improving California’s health.
CalHEP will continue to fight for evidence-based policies and programs to reduce the burden of the hepatitis B and C epidemics in California. We thank those of you who contacted your legislators and the Governor to encourage support for these bills.
Source
From our friends at Cal Hep:
Late in the evening on September 30th, two hours before deadline to sign or veto bills, Governor Schwarzenegger vetoed two bills that would have reduced the number of new HIV, hepatitis B and hepatitis C cases. Having worked to develop, draft and support these bills, the staff and member organizations of the California Hepatitis Alliance (calHEP) are extremely disappointed by this news. The Governor’s Office chose to ignore the recommendations of numerous medical and scientific bodies, including the Institute of Medicine of the National Academies of Medicine and Science, and his own administration’s Department of Public Health to make syringes more widely available through pharmacies and needle exchanges in order to reduce the number of viral hepatitis infections among injection drug users.
Governor Schwarzenegger did sign a bill to sustain the status quo: cities and counties may authorize pharmacists to furnish 10 or fewer syringes to an adult, and cities and counties may authorize syringe exchange services. Currently almost half of Californians live in jurisdictions where there is no safe legal access to sterile syringes without a prescription, and where law enforcement may arrest a person for attempting to comply with the U.S. Public Health service recommendation to injection drug users that they use a new sterile syringe for each injection. Contact CalHEP for information on how to support your local efforts to improve syringe access.
VETOED: SB 1029 by State Senator Leland Yee would have allowed pharmacists and physicians to furnish 30 or fewer syringes without prescription and would have allowed adults to possess up to 30 for personal use.
VETOED: AB 1858 would have allowed California Department of Public Health to authorized syringe exchange services in locations where the conditions exist for the rapid spread of viral hepatitis, HIV and other deadly or disabling diseases spread by the sharing of syringes.
Both bills were supported by California Medical Association, California Nurses Association, Health Officers Association of California, as well as numerous health and patient advocacy groups. We are grateful to the work of Drug Policy Alliance and San Francisco AIDS Foundation in providing support for the lobbying effort throughout the year. We are especially grateful to Senator Leland Yee (D-San Francisco) and Assemblymember Bob Blumenfield (D-Van Nuys) and their offices for leading these life saving efforts.We encourage you to contact the lawmakers to thank them for their commitment to improving California’s health.
CalHEP will continue to fight for evidence-based policies and programs to reduce the burden of the hepatitis B and C epidemics in California. We thank those of you who contacted your legislators and the Governor to encourage support for these bills.
Source
Advanced HIV test may benefit high-risk groups
Updated: 2010-09-30 08:14:17 CST
In areas of the country that struggle with higher than average HIV rates, more early-stage testing may be needed to help newly infected individuals start therapy at the point when the virus is most treatable.
A new report from the Centers for Disease Control and Prevention states that this may be one of the most cost effective ways for reducing HIV rates in areas that have the largest problems.
Pooled nucleic acid amplification HIV testing - which tests for genetic material from the virus, rather than antibodies produced by the body to fight it - typically detects infections earlier than traditional testing methods. However, the report states that the procedure may only be cost-effective to implement in areas hit the hardest by the epidemic.
Clinics that treat high-risk populations reported that administering the test was more cost-effective than dealing of the consequences of allowing infections to progress to later stages.
While the screening strategy may not be feasible to implement at all HIV testing locations, researchers said that it may significantly improve the quality of life of individuals in areas where the disease is more common.
Source
In areas of the country that struggle with higher than average HIV rates, more early-stage testing may be needed to help newly infected individuals start therapy at the point when the virus is most treatable.
A new report from the Centers for Disease Control and Prevention states that this may be one of the most cost effective ways for reducing HIV rates in areas that have the largest problems.
Pooled nucleic acid amplification HIV testing - which tests for genetic material from the virus, rather than antibodies produced by the body to fight it - typically detects infections earlier than traditional testing methods. However, the report states that the procedure may only be cost-effective to implement in areas hit the hardest by the epidemic.
Clinics that treat high-risk populations reported that administering the test was more cost-effective than dealing of the consequences of allowing infections to progress to later stages.
While the screening strategy may not be feasible to implement at all HIV testing locations, researchers said that it may significantly improve the quality of life of individuals in areas where the disease is more common.
Source
Achillion begins anti-hepatitis drug trials
New Haven drug developer Achillion Pharmaceuticals Inc. says it has begun two human clinical trials in the U.S. and Europe to determine the dosing effectiveness of a prototype treatment against the hepatitis C virus.
Some 120 patients with chronic hepatitis C participating in the two double-blind trials -- one to run 28 days, the other 12 weeks -- will be randomly dosed with small-molecule ACH-1625 drug or with a placebo.
The trial will determine the dosing at which ACH-1625 blocks a particular enzyme the hepatitis C virus needs to replicate, Achillion officials say.
Results of the 28-day trial will be disclosed in the first quarter of 2011; the 12-week study findings will come near the end of next year.
"This Phase II clinical trial will allow us to establish the most appropriate once-daily dose to use in longer-term trials, and will augment our existing safety database for ACH-1625 in humans," said Elizabeth A. Olek, Achillion's chief medical officer. "The results will also provide important combination data for use of ACH-1625 with standard of care.''
Achillion officials are eager to prove their treatment, with a more convenient dosing, is a safer and more tolerable viral suppressant over a longer period.
Source
Also See: Achillion Announces Dosing of First Patient in Phase II Trial of ACH-1625 for the Treatment of Hepatitis C
Some 120 patients with chronic hepatitis C participating in the two double-blind trials -- one to run 28 days, the other 12 weeks -- will be randomly dosed with small-molecule ACH-1625 drug or with a placebo.
The trial will determine the dosing at which ACH-1625 blocks a particular enzyme the hepatitis C virus needs to replicate, Achillion officials say.
Results of the 28-day trial will be disclosed in the first quarter of 2011; the 12-week study findings will come near the end of next year.
"This Phase II clinical trial will allow us to establish the most appropriate once-daily dose to use in longer-term trials, and will augment our existing safety database for ACH-1625 in humans," said Elizabeth A. Olek, Achillion's chief medical officer. "The results will also provide important combination data for use of ACH-1625 with standard of care.''
Achillion officials are eager to prove their treatment, with a more convenient dosing, is a safer and more tolerable viral suppressant over a longer period.
Source
Also See: Achillion Announces Dosing of First Patient in Phase II Trial of ACH-1625 for the Treatment of Hepatitis C
New Data on Multiple Bristol-Myers Squibb Compounds to be Presented at AASLD 2010
PRINCETON, N.J., Oct 01, 2010 (BUSINESS WIRE) -- New data on multiple Bristol-Myers Squibb Company /quotes/comstock/13*!bmy/quotes/nls/bmy (BMY 27.28, +0.03, +0.10%) compounds will be presented at the 61st annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston from October 29 to November 2.
Data will be presented on BARACLUDE(R) (entecavir) in patients with chronic hepatitis B, and on compounds in clinical development for the treatment of hepatitis C, using multiple scientific approaches to target the hepatitis C virus (HCV). Key hepatitis C presentations include data on novel combinations of investigational agents, including BMS-790052, a NS5A inhibitor, and BMS-650032, an NS3 inhibitor. Additionally, 12-week Phase 2a data on PEG-Interferon lambda, a novel type 3 interferon with enhanced specificity for hepatocyte binding, will be presented.
The Company will also present outcomes research data in both hepatitis C and hepatocellular carcinoma.
"Bristol-Myers Squibb is focused on developing innovative medicines to treat liver disease," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. "Building on our established expertise in viral hepatitis and oncology, the data at this year's Liver Meeting demonstrates the breadth and strength of our hepatitis C portfolio. We are pursuing multiple targets with the potential to be used in combination regimens to advance the treatment of this serious disease."
BARACLUDE, BMS-790052, and BMS-650032 were discovered by Bristol-Myers Squibb Research and Development. PEG-Interferon lambda was discovered by ZymoGenetics, Inc. Bristol-Myers Squibb and ZymoGenetics announced a global collaboration for PEG-Interferon lambda and its related development program in 2009. In September 2010, Bristol-Myers Squibb announced its intent to acquire ZymoGenetics.
The Bristol-Myers Squibb data presentations at AASLD are as follows:
Hepatitis B
October 30 2:00 - 7:30 p.m. Efficacy and Safety of Entecavir in Nucleos(t)ide Naive Asians with HBeAg Positive and Negative Chronic Hepatitis B: Results from Studies ETV-022/027 (Abstract #485)
R. Gish
California Pacific Medical Center
San Francisco,California
October 30 2:00 - 7:30 p.m. Long-term Entecavir Treatment for up to 5 Years in Asians with HBeAg- Positive Nucleos(t)ide Naive Chronic Hepatitis B: Results from ETV-022 and -901 (Abstract #478)
C. Pan
Mount Sinai School of Medicine
New York, New York
Hepatitis C
October 31, 8:00 - 5:30 p.m. Pegylated Interferon Lambda (PEG-IFN-) Phase 2 Dose-Ranging, Active-Controlled Study in Combination with Ribavirin (RBV) for Treatment-Naive HCV Patients (Genotypes 1, 2, 3 or 4): Safety Viral Response, and Impact of IL-28B Host Genotype through Week 12 (Abstract #821)
A.J. Muir
Duke University School of Medicine
Durham, North Carolina
October 31, 8:00 - 5:30 p.m. Co-administration of BMS-790052 and BMS-650032 Does Not Result in a Clinically Meaningful Pharmacokinetic Interaction in Healthy Subjects (Abstract #827)
M. Bifano
Bristol-Myers Squibb
October 31, 8:00 - 5:30 p.m. Pharmacokinetics of PEG-Interferon Lambda (PEG-IFN-) Following Fixed Dosing in Treatment-Naive Hepatitis C Subjects (Single Dose Interim Data from a Dose-Ranging Phase 2a Study) (Abstract #830)
K.A. Byrnes-Blake
ZymoGenetics
October 31, 8:00 - 5:30 p.m. The Effect of Treatment Group, HCV Genotype, and IL-28B Genotype on Early HCV Viral Kinetics in a Phase 2a Study of PEG-Interferon Lambda (PEG-IFN-) in Hepatitis C Patients (Abstract #831)
J.A. Freeman
ZymoGenetics
November 1, 8:00 a.m. - 5:30 p.m. Combination therapy with BMS-790052 and BMS-650032 alone or with pegIFN/RBV results in undetectable HCV RNA through 12 weeks of therapy in HCV genotype 1 null responders (Abstract # LB-8)
A. S. Lok
University of Michigan
Ann Arbor, Michigan
November 2, 7:00 a.m. - 12:00 p.m. Genotypic and Phenotypic Analysis of HCV NS5A Inhibitor Resistance Variants: Correlations Between In Vitro and In Vivo Observations (Abstract #1853)
M. Gao
Bristol-Myers Squibb
November 2, 7:00 a.m. - 12:00 p.m. In Vitro Activity of the Combination of Pegylated Interferon-Lambda with Direct-Acting Antivirals in the HCV Replicon Model (Abstract #1854)
F. McPhee
Bristol-Myers Squibb
November 2, 7:00 a.m. - 12:00 p.m. BMS-824393 is a Potent Hepatitis C Virus NS5A Inhibitor with Substantial Antiviral Activity When Given as Monotherapy in Subjects with Chronic Genotype 1 HCV Infection (Abstract #1858)
R. Nettles
Bristol-Myers Squibb
November 2, 7:00 a.m. - 12:00 p.m. BMS-790052, a First-in-Class Potent Hepatitis C Virus NS5A Inhibitor, Demonstrates Multiple-Dose Proof-of-Concept in Subjects with Chronic Genotype 1 HCV Infection (Abstract #1881)
R. Nettles
Bristol-Myers Squibb
November 2, 7:00 a.m. - 12:00 p.m. Chronic Hepatitis C Infections and the Risk of Depression and Other Adverse Events (Abstract #1895)
J. McCombs
University of Southern California
Los Angeles, California
November 2, 7:00 a.m. - 12:00 p.m. The impact of hepatitis C on health-related quality of life, work productivity, and healthcare utilization (Abstract #1942)
M. daCosta DiBonaventura
Kantar Health
New York, New York
Hepatocellular Carcinoma
November 2, 7:00 a.m. - 12:00 p.m. Treatment of Hepatocellular Carcinoma (HCC) in Two Major Care Centers in the United States (US) (Abstract #1846)
Tertiary M. Schwartz
Mt. Sinai
New York, New York
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.comor follow us on Twitter at http://twitter.com/bmsnews .
Full prescribing information for BARACLUDE is available at http://www.bms.com/.
Forward-Looking Statements
This press release contains "forward-looking statements" relating to the acquisition of ZymoGenetics by Bristol-Myers Squibb. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the acquisition will be completed, or if it is completed, that it will close within the anticipated time period. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2009, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "future"; "anticipate"; "potential"; "believe"; or similar statements are forward-looking statements. Risks and uncertainties include uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of the ZymoGenetics shareholders will tender their shares in the offer; the risk that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of disruption from the transaction making it more difficult to maintain relationships with employees, licensees, other business partners or governmental entities; as well as risks detailed from time to time in ZymoGenetics' public disclosure filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2009, subsequent quarterly filings on Form 10-Q and the Solicitation/Recommendation Statement filed in connection with the tender offer. The information contained in this release is as of September 28, 2010.
This press release is neither an offer to purchase nor a solicitation of an offer to sell shares of ZymoGenetics. Bristol-Myers Squibb Company and Zeus Acquisition Corporation have filed a tender offer statement with the SEC, and have mailed an offer to purchase, forms of letter or transmittal and related documents to ZymoGenetics shareholders. ZymoGenetics has filed with the SEC, and has mailed to ZymoGenetics shareholders a solicitation/recommendation statement on Schedule 14D-9. These documents contain important information about the tender offer and stockholders of ZymoGenetics are urged to read them carefully when they become available.
These documents will be available at no charge at the SEC's website at http://www.sec.gov/. The tender offer statement and the related materials may be obtained for free by directing a request by mail to Georgeson Inc., 199 Water Street, 26th Floor, New York, New York 10038 or by calling toll-free (800) 491-3096. In addition, a copy of the offer to purchase, letter or transmittal and certain other related tender offer documents (once they become available) may also be obtained free of charge from Bristol-Myers Squibb by directing a request to: Public Affairs, Telephone No.: (609) 252-6579; E-Mail: jennifer.mauer@bms.com.
SOURCE: Bristol-Myers Squibb Company
Bristol-Myers Squibb Company
Media:
Cristi Barnett, 609-252-6028
cristi.barnett@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com
Source
Data will be presented on BARACLUDE(R) (entecavir) in patients with chronic hepatitis B, and on compounds in clinical development for the treatment of hepatitis C, using multiple scientific approaches to target the hepatitis C virus (HCV). Key hepatitis C presentations include data on novel combinations of investigational agents, including BMS-790052, a NS5A inhibitor, and BMS-650032, an NS3 inhibitor. Additionally, 12-week Phase 2a data on PEG-Interferon lambda, a novel type 3 interferon with enhanced specificity for hepatocyte binding, will be presented.
The Company will also present outcomes research data in both hepatitis C and hepatocellular carcinoma.
"Bristol-Myers Squibb is focused on developing innovative medicines to treat liver disease," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. "Building on our established expertise in viral hepatitis and oncology, the data at this year's Liver Meeting demonstrates the breadth and strength of our hepatitis C portfolio. We are pursuing multiple targets with the potential to be used in combination regimens to advance the treatment of this serious disease."
BARACLUDE, BMS-790052, and BMS-650032 were discovered by Bristol-Myers Squibb Research and Development. PEG-Interferon lambda was discovered by ZymoGenetics, Inc. Bristol-Myers Squibb and ZymoGenetics announced a global collaboration for PEG-Interferon lambda and its related development program in 2009. In September 2010, Bristol-Myers Squibb announced its intent to acquire ZymoGenetics.
The Bristol-Myers Squibb data presentations at AASLD are as follows:
Hepatitis B
October 30 2:00 - 7:30 p.m. Efficacy and Safety of Entecavir in Nucleos(t)ide Naive Asians with HBeAg Positive and Negative Chronic Hepatitis B: Results from Studies ETV-022/027 (Abstract #485)
R. Gish
California Pacific Medical Center
San Francisco,California
October 30 2:00 - 7:30 p.m. Long-term Entecavir Treatment for up to 5 Years in Asians with HBeAg- Positive Nucleos(t)ide Naive Chronic Hepatitis B: Results from ETV-022 and -901 (Abstract #478)
C. Pan
Mount Sinai School of Medicine
New York, New York
Hepatitis C
October 31, 8:00 - 5:30 p.m. Pegylated Interferon Lambda (PEG-IFN-) Phase 2 Dose-Ranging, Active-Controlled Study in Combination with Ribavirin (RBV) for Treatment-Naive HCV Patients (Genotypes 1, 2, 3 or 4): Safety Viral Response, and Impact of IL-28B Host Genotype through Week 12 (Abstract #821)
A.J. Muir
Duke University School of Medicine
Durham, North Carolina
October 31, 8:00 - 5:30 p.m. Co-administration of BMS-790052 and BMS-650032 Does Not Result in a Clinically Meaningful Pharmacokinetic Interaction in Healthy Subjects (Abstract #827)
M. Bifano
Bristol-Myers Squibb
October 31, 8:00 - 5:30 p.m. Pharmacokinetics of PEG-Interferon Lambda (PEG-IFN-) Following Fixed Dosing in Treatment-Naive Hepatitis C Subjects (Single Dose Interim Data from a Dose-Ranging Phase 2a Study) (Abstract #830)
K.A. Byrnes-Blake
ZymoGenetics
October 31, 8:00 - 5:30 p.m. The Effect of Treatment Group, HCV Genotype, and IL-28B Genotype on Early HCV Viral Kinetics in a Phase 2a Study of PEG-Interferon Lambda (PEG-IFN-) in Hepatitis C Patients (Abstract #831)
J.A. Freeman
ZymoGenetics
November 1, 8:00 a.m. - 5:30 p.m. Combination therapy with BMS-790052 and BMS-650032 alone or with pegIFN/RBV results in undetectable HCV RNA through 12 weeks of therapy in HCV genotype 1 null responders (Abstract # LB-8)
A. S. Lok
University of Michigan
Ann Arbor, Michigan
November 2, 7:00 a.m. - 12:00 p.m. Genotypic and Phenotypic Analysis of HCV NS5A Inhibitor Resistance Variants: Correlations Between In Vitro and In Vivo Observations (Abstract #1853)
M. Gao
Bristol-Myers Squibb
November 2, 7:00 a.m. - 12:00 p.m. In Vitro Activity of the Combination of Pegylated Interferon-Lambda with Direct-Acting Antivirals in the HCV Replicon Model (Abstract #1854)
F. McPhee
Bristol-Myers Squibb
November 2, 7:00 a.m. - 12:00 p.m. BMS-824393 is a Potent Hepatitis C Virus NS5A Inhibitor with Substantial Antiviral Activity When Given as Monotherapy in Subjects with Chronic Genotype 1 HCV Infection (Abstract #1858)
R. Nettles
Bristol-Myers Squibb
November 2, 7:00 a.m. - 12:00 p.m. BMS-790052, a First-in-Class Potent Hepatitis C Virus NS5A Inhibitor, Demonstrates Multiple-Dose Proof-of-Concept in Subjects with Chronic Genotype 1 HCV Infection (Abstract #1881)
R. Nettles
Bristol-Myers Squibb
November 2, 7:00 a.m. - 12:00 p.m. Chronic Hepatitis C Infections and the Risk of Depression and Other Adverse Events (Abstract #1895)
J. McCombs
University of Southern California
Los Angeles, California
November 2, 7:00 a.m. - 12:00 p.m. The impact of hepatitis C on health-related quality of life, work productivity, and healthcare utilization (Abstract #1942)
M. daCosta DiBonaventura
Kantar Health
New York, New York
Hepatocellular Carcinoma
November 2, 7:00 a.m. - 12:00 p.m. Treatment of Hepatocellular Carcinoma (HCC) in Two Major Care Centers in the United States (US) (Abstract #1846)
Tertiary M. Schwartz
Mt. Sinai
New York, New York
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.comor follow us on Twitter at http://twitter.com/bmsnews .
Full prescribing information for BARACLUDE is available at http://www.bms.com/.
Forward-Looking Statements
This press release contains "forward-looking statements" relating to the acquisition of ZymoGenetics by Bristol-Myers Squibb. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the acquisition will be completed, or if it is completed, that it will close within the anticipated time period. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2009, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "future"; "anticipate"; "potential"; "believe"; or similar statements are forward-looking statements. Risks and uncertainties include uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of the ZymoGenetics shareholders will tender their shares in the offer; the risk that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of disruption from the transaction making it more difficult to maintain relationships with employees, licensees, other business partners or governmental entities; as well as risks detailed from time to time in ZymoGenetics' public disclosure filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2009, subsequent quarterly filings on Form 10-Q and the Solicitation/Recommendation Statement filed in connection with the tender offer. The information contained in this release is as of September 28, 2010.
This press release is neither an offer to purchase nor a solicitation of an offer to sell shares of ZymoGenetics. Bristol-Myers Squibb Company and Zeus Acquisition Corporation have filed a tender offer statement with the SEC, and have mailed an offer to purchase, forms of letter or transmittal and related documents to ZymoGenetics shareholders. ZymoGenetics has filed with the SEC, and has mailed to ZymoGenetics shareholders a solicitation/recommendation statement on Schedule 14D-9. These documents contain important information about the tender offer and stockholders of ZymoGenetics are urged to read them carefully when they become available.
These documents will be available at no charge at the SEC's website at http://www.sec.gov/. The tender offer statement and the related materials may be obtained for free by directing a request by mail to Georgeson Inc., 199 Water Street, 26th Floor, New York, New York 10038 or by calling toll-free (800) 491-3096. In addition, a copy of the offer to purchase, letter or transmittal and certain other related tender offer documents (once they become available) may also be obtained free of charge from Bristol-Myers Squibb by directing a request to: Public Affairs, Telephone No.: (609) 252-6579; E-Mail: jennifer.mauer@bms.com.
SOURCE: Bristol-Myers Squibb Company
Bristol-Myers Squibb Company
Media:
Cristi Barnett, 609-252-6028
cristi.barnett@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com
Source
Vertex Edges Merck In First Round of Hepatitis C Fight
Oct. 1 2010 - 3:13 pm
By ROBERT LANGRETH
New details of studies of rival hepatitis C drugs from Merck and Vertex Pharmaceuticals were released today in advance of a crucial upcoming meeting of liver specialists at the end of the month in Boston. The drugs, so-called hepatitis C protease inhibitors, represent the first class of agents that directly target the hepatitis C virus. Both have substantially boosted the cure rate in big trials, raising excitement among hepatitis c specialists.
While the drugs haven’t been compared directly, it appears that Vertex’s telaprevir drug is is a nudge better. Unless differences in tolerability and side effects emerge, if both drugs are approved, doctors may look at the data and go with the Vertex drug first because its cure rates appear to be a few percentage points higher.
Here’s what Howard Liang of Leerink Swann wrote in a note today:
“Apples-to-apples” comparison of boceprevir vs. telaprevir in treatment-experienced patients is possible for the first time and appears to favor telaprevir. In prior relapsers, SVR was 69%-75% for boceprevir vs. 83-88% for telaprevir. In what we would call partial responders MRK has a different definition, SVR was 40-52% for boceprevir vs. 54-59% for telaprevir. Cross-trial comparisons are always difficult but we believe the totality and consistency of both treatment-experienced and treatment-naïve data give an impression that telaprevir may be more potent.
If there are significant side effects to the Vertex compound that haven’t emerged yet, it could totally negate Vertex’s apparent advantage. But if Vertex’s drug is perceived by doctors as slightly more effective, who does Merck sell its drug to?
Merck R&D head Peter Kim may have some answers to this question. He is going to the liver meeting where he will face lots of questions from Wall Street types about where Merck’s drug will fit in. He needs to rebut the doubts about his company’s drug.
Source
By ROBERT LANGRETH
New details of studies of rival hepatitis C drugs from Merck and Vertex Pharmaceuticals were released today in advance of a crucial upcoming meeting of liver specialists at the end of the month in Boston. The drugs, so-called hepatitis C protease inhibitors, represent the first class of agents that directly target the hepatitis C virus. Both have substantially boosted the cure rate in big trials, raising excitement among hepatitis c specialists.
While the drugs haven’t been compared directly, it appears that Vertex’s telaprevir drug is is a nudge better. Unless differences in tolerability and side effects emerge, if both drugs are approved, doctors may look at the data and go with the Vertex drug first because its cure rates appear to be a few percentage points higher.
Here’s what Howard Liang of Leerink Swann wrote in a note today:
“Apples-to-apples” comparison of boceprevir vs. telaprevir in treatment-experienced patients is possible for the first time and appears to favor telaprevir. In prior relapsers, SVR was 69%-75% for boceprevir vs. 83-88% for telaprevir. In what we would call partial responders MRK has a different definition, SVR was 40-52% for boceprevir vs. 54-59% for telaprevir. Cross-trial comparisons are always difficult but we believe the totality and consistency of both treatment-experienced and treatment-naïve data give an impression that telaprevir may be more potent.
If there are significant side effects to the Vertex compound that haven’t emerged yet, it could totally negate Vertex’s apparent advantage. But if Vertex’s drug is perceived by doctors as slightly more effective, who does Merck sell its drug to?
Merck R&D head Peter Kim may have some answers to this question. He is going to the liver meeting where he will face lots of questions from Wall Street types about where Merck’s drug will fit in. He needs to rebut the doubts about his company’s drug.
Source
GlobeImmune Announces Late-Breaker Oral Presentation of GI-5005 Prior Non-Responder Data at AASLD 2010 Meeting
Oct 01, 2010 09:05 ET
Immunology Data Also to Be Presented in Poster Session
LOUISVILLE, CO--(Marketwire - October 1, 2010) - GlobeImmune Inc. today announced that an abstract related to GI-5005, its Phase 2 investigational hepatitis C virus (HCV) product candidate, has been accepted for a late breaking oral presentation at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place October 29 through November 2, 2010, in Boston.
At the AASLD annual meeting, GlobeImmune will present end-of-study data, including sustained virologic response (SVR) rate from prior non-responders, from a Phase 2 clinical study investigating the safety and efficacy of GI-5005. The study compared GI-5005 plus peg-interferon (peg-IFN) and ribavirin, the current standard of care (SOC), versus SOC alone in patients with chronic type 1 hepatitis C infection. Prior non-responders were defined as those patients who did not achieve viral negativity by PCR after a minimum of 12 weeks of SOC. Patients that had achieved viral negativity by PCR during prior SOC but had relapsed during or after completion of SOC therapy were excluded from the study.
The abstract, titled "GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin Improves Sustained Virologic Response Versus PEG-INF/Ribavirin in Prior Non-Responders With Genotype 1 Chronic HCV Infection," is published online at the AASLD Web site.
Dr. Paul J. Pockros of Scripps Clinic is the lead author of the abstract that will be presented as part of a late breaker oral session beginning at 6 p.m. EDT on Monday, November 1, 2010 in the Hynes Auditorium. The presentation will include complete response and sustained virologic response rates for patients who received the GI-5005 plus SOC as well as SOC patients in the control arm of the study.
Additionally, Dr. John M. Vierling of Baylor College of Medicine will present a poster titled "GI-5005 Therapeutic Vaccine Improves Deficit in Cellular Immunity in IL28B Genotype T/T, Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 When Added to Standard of Care PEG-IFN-Alfa-2A/Ribavirin," on Tuesday, November 2, 2010 in the Hynes Exhibit Hall C.
GI-5005 is a therapeutic vaccine candidate that the company believes generates HCV specific T-cell responses and improves virologic responses in patients with chronic hepatitis C infection.
About GlobeImmune
GlobeImmune Inc. is a private company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate cancer cells and/or virally-infected cells. The Company's lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV). GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company's lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein. GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. In May 2009, the Company announced a global partnership with Celgene focused on the discovery, development and commercialization of multiple product candidates for the treatment of cancer.
For additional information, please visit the company's Web site at http://www.globeimmune.com/.
This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.
Source
Immunology Data Also to Be Presented in Poster Session
LOUISVILLE, CO--(Marketwire - October 1, 2010) - GlobeImmune Inc. today announced that an abstract related to GI-5005, its Phase 2 investigational hepatitis C virus (HCV) product candidate, has been accepted for a late breaking oral presentation at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place October 29 through November 2, 2010, in Boston.
At the AASLD annual meeting, GlobeImmune will present end-of-study data, including sustained virologic response (SVR) rate from prior non-responders, from a Phase 2 clinical study investigating the safety and efficacy of GI-5005. The study compared GI-5005 plus peg-interferon (peg-IFN) and ribavirin, the current standard of care (SOC), versus SOC alone in patients with chronic type 1 hepatitis C infection. Prior non-responders were defined as those patients who did not achieve viral negativity by PCR after a minimum of 12 weeks of SOC. Patients that had achieved viral negativity by PCR during prior SOC but had relapsed during or after completion of SOC therapy were excluded from the study.
The abstract, titled "GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin Improves Sustained Virologic Response Versus PEG-INF/Ribavirin in Prior Non-Responders With Genotype 1 Chronic HCV Infection," is published online at the AASLD Web site.
Dr. Paul J. Pockros of Scripps Clinic is the lead author of the abstract that will be presented as part of a late breaker oral session beginning at 6 p.m. EDT on Monday, November 1, 2010 in the Hynes Auditorium. The presentation will include complete response and sustained virologic response rates for patients who received the GI-5005 plus SOC as well as SOC patients in the control arm of the study.
Additionally, Dr. John M. Vierling of Baylor College of Medicine will present a poster titled "GI-5005 Therapeutic Vaccine Improves Deficit in Cellular Immunity in IL28B Genotype T/T, Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 When Added to Standard of Care PEG-IFN-Alfa-2A/Ribavirin," on Tuesday, November 2, 2010 in the Hynes Exhibit Hall C.
GI-5005 is a therapeutic vaccine candidate that the company believes generates HCV specific T-cell responses and improves virologic responses in patients with chronic hepatitis C infection.
About GlobeImmune
GlobeImmune Inc. is a private company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. Tarmogens generate activated killer T cells that are designed to locate and eliminate cancer cells and/or virally-infected cells. The Company's lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection (HCV). GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The Company's lead oncology program, GI-4000, targets cancers caused by mutated versions of the Ras oncoprotein. GI-4000 is being investigated in clinical trials for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer. In May 2009, the Company announced a global partnership with Celgene focused on the discovery, development and commercialization of multiple product candidates for the treatment of cancer.
For additional information, please visit the company's Web site at http://www.globeimmune.com/.
This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and the results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.
Source
Idenix Announces Data Presentations at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
CAMBRIDGE, Mass., Oct. 1 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that three abstracts have been accepted for presentation at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD, October 29-November 2, 2010 in Boston, Massachusetts). The abstracts being presented are on three of the company's hepatitis C clinical programs: IDX184, IDX320 and IDX375. Full abstracts can now be viewed at the AASLD website at http://www.aasld.org/.
The accepted abstracts are as follows:
• Lalezari, et al, "A Phase IIa Study of IDX184 in Combination with Pegylated Interferon (PegIFN) and Ribavirin (RBV) in Treatment-Naïve HCV Genotype 1-Infected Subjects" will be featured as an oral presentation on Sunday, October 31st at 3:45 p.m.
• Reesink, et al, "Antiviral Activity, Safety and Pharmacokinetics of IDX320, a Novel Macrocyclic HCV Protease Inhibitor, in a 3-Day Proof-of-Concept Study in Patients with Chronic Hepatitis C" will be presented in a late-breaking poster session on Monday, November 1st between 8:00 a.m. – 5:30 p.m.
• Bruijne, et al, "Phase I Study in Healthy Volunteers and Patients with IDX375, a Novel Non-Nucleoside HCV Polymerase Inhibitor" will be presented in a poster session on Tuesday, November 2nd between 7:00 a.m. – 12:00 p.m.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of infections caused by hepatitis C virus. For further information about Idenix, please refer to http://www.idenix.com/.
Forward-looking Statements
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "will," "expects," "goal," "estimates," "projects," "would," "could," "targets," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the company's clinical development programs or commercialization activities in hepatitis C, or any potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of our drug candidates, the likelihood and success of any future clinical trials involving our drug candidates or successful development of novel combinations of direct-acting antivirals for the treatment of hepatitis C. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays, including the current clinical hold on IDX184 and IDX320; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on its collaborations with Novartis Pharma AG and GlaxoSmithKline; changes in the company's business plan or objectives; the ability of the company to attract and retain qualified personnel; competition in general; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in each of the company's annual report on Form 10-K for the year ended December 31, 2009 and quarterly report on form 10-Q for the quarter ended June 30, 2010, as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the company files with the SEC.
All forward-looking statements reflect the company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the company's estimates change.
Idenix Pharmaceuticals Contact:
Jonae Barnes (617) 224-4485 (investors)
Kelly Barry (617) 995-9033 (media)
SOURCE Idenix Pharmaceuticals, Inc.
RELATED LINKS
http://www.idenix.com/
Source
The accepted abstracts are as follows:
• Lalezari, et al, "A Phase IIa Study of IDX184 in Combination with Pegylated Interferon (PegIFN) and Ribavirin (RBV) in Treatment-Naïve HCV Genotype 1-Infected Subjects" will be featured as an oral presentation on Sunday, October 31st at 3:45 p.m.
• Reesink, et al, "Antiviral Activity, Safety and Pharmacokinetics of IDX320, a Novel Macrocyclic HCV Protease Inhibitor, in a 3-Day Proof-of-Concept Study in Patients with Chronic Hepatitis C" will be presented in a late-breaking poster session on Monday, November 1st between 8:00 a.m. – 5:30 p.m.
• Bruijne, et al, "Phase I Study in Healthy Volunteers and Patients with IDX375, a Novel Non-Nucleoside HCV Polymerase Inhibitor" will be presented in a poster session on Tuesday, November 2nd between 7:00 a.m. – 12:00 p.m.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of infections caused by hepatitis C virus. For further information about Idenix, please refer to http://www.idenix.com/.
Forward-looking Statements
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "will," "expects," "goal," "estimates," "projects," "would," "could," "targets," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the company's clinical development programs or commercialization activities in hepatitis C, or any potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of our drug candidates, the likelihood and success of any future clinical trials involving our drug candidates or successful development of novel combinations of direct-acting antivirals for the treatment of hepatitis C. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays, including the current clinical hold on IDX184 and IDX320; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on its collaborations with Novartis Pharma AG and GlaxoSmithKline; changes in the company's business plan or objectives; the ability of the company to attract and retain qualified personnel; competition in general; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in each of the company's annual report on Form 10-K for the year ended December 31, 2009 and quarterly report on form 10-Q for the quarter ended June 30, 2010, as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the company files with the SEC.
All forward-looking statements reflect the company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the company's estimates change.
Idenix Pharmaceuticals Contact:
Jonae Barnes (617) 224-4485 (investors)
Kelly Barry (617) 995-9033 (media)
SOURCE Idenix Pharmaceuticals, Inc.
RELATED LINKS
http://www.idenix.com/
Source
Idera Pharmaceuticals Announces IMO-2125 Presentation at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
CAMBRIDGE, Mass., Oct 01, 2010 (BUSINESS WIRE) -- Idera Pharmaceuticals, Inc. /quotes/comstock/15*!idra/quotes/nls/idra (IDRA 3.25, -0.04, -1.22%) today announced that data related to IMO-2125, its novel immune modulator for the treatment of chronic hepatitis C virus (HCV) infection, will be presented at the 61st Annual Meeting of the American Association of the Study of Liver Diseases in Boston, Massachusetts October 29 -- November 2, 2010. The full abstract can now be accessed through the AASLD website, http://www.aasld.org/.
"IMO-2125, a TLR9 Agonist, Induces Immune Responses which Correlate with Reductions in Viral Load in Null Responder HCV Patients", M. Rodriguez-Torres, et al., will be presented in a session entitled HCV Therapy: From Discovery to Clinical Development on Sunday, October 31, 2010 at 3:30 p.m. ET.
About IMO-2125
IMO-2125, a Toll-like Receptor (TLR) 9 agonist, is a novel immune modulator being developed as a potential component of treatment for chronic hepatitis C virus (HCV) infection. IMO-2125 is designed to stimulate an immune response in HCV patients, causing the body to generate natural interferons and other cytokines to suppress the virus. IMO-2125 is currently in a Phase 1 clinical trial in null-responder patients, defined as those who did not achieve a 2 log10 reduction with prior standard of care treatment, as monotherapy for 4 weeks. IMO-2125 is also being evaluated in a Phase 1 clinical trial in treatment-naive patients in combination with ribavirin for 4 weeks.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals develops drug candidates to treat infectious diseases, autoimmune and inflammatory diseases, cancer, and respiratory diseases, and for use as vaccine adjuvants. Our proprietary drug candidates are designed to modulate specific Toll-like Receptors, which are a family of immune system receptors that direct immune system responses. Our pioneering DNA and RNA chemistry expertise enables us to create drug candidates for internal development and generates opportunities for multiple collaborative alliances. For more information, visit http://www.iderapharma.com/.
Idera Forward Looking Statements
This press release contains forward-looking statements concerning Idera Pharmaceuticals, Inc. that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated by such forward-looking statements, including whether results obtained in preclinical studies and early clinical trials will be indicative of results obtained in future clinical trials; whether products based on Idera's technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; whether the Company's collaborations with Merck KGaA and an affiliate of Merck & Co., Inc. will be successful; whether the patents and patent applications owned or licensed by the Company will protect the Company's technology and prevent others from infringing it; whether Idera's cash resources will be sufficient to fund the Company's operations; and such other important factors as are set forth under the caption "Risk Factors" in Idera's Quarterly Report on Form 10-Q for the three months ended June 30, 2010, which important factors are incorporated herein by reference. Idera disclaims any intention or obligation to update any forward-looking statements.
SOURCE: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc.
Teri Dahlman, 617-679-5519
tdahlman@iderapharma.com
or
MacDougall Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com
Source
"IMO-2125, a TLR9 Agonist, Induces Immune Responses which Correlate with Reductions in Viral Load in Null Responder HCV Patients", M. Rodriguez-Torres, et al., will be presented in a session entitled HCV Therapy: From Discovery to Clinical Development on Sunday, October 31, 2010 at 3:30 p.m. ET.
About IMO-2125
IMO-2125, a Toll-like Receptor (TLR) 9 agonist, is a novel immune modulator being developed as a potential component of treatment for chronic hepatitis C virus (HCV) infection. IMO-2125 is designed to stimulate an immune response in HCV patients, causing the body to generate natural interferons and other cytokines to suppress the virus. IMO-2125 is currently in a Phase 1 clinical trial in null-responder patients, defined as those who did not achieve a 2 log10 reduction with prior standard of care treatment, as monotherapy for 4 weeks. IMO-2125 is also being evaluated in a Phase 1 clinical trial in treatment-naive patients in combination with ribavirin for 4 weeks.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals develops drug candidates to treat infectious diseases, autoimmune and inflammatory diseases, cancer, and respiratory diseases, and for use as vaccine adjuvants. Our proprietary drug candidates are designed to modulate specific Toll-like Receptors, which are a family of immune system receptors that direct immune system responses. Our pioneering DNA and RNA chemistry expertise enables us to create drug candidates for internal development and generates opportunities for multiple collaborative alliances. For more information, visit http://www.iderapharma.com/.
Idera Forward Looking Statements
This press release contains forward-looking statements concerning Idera Pharmaceuticals, Inc. that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated by such forward-looking statements, including whether results obtained in preclinical studies and early clinical trials will be indicative of results obtained in future clinical trials; whether products based on Idera's technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; whether the Company's collaborations with Merck KGaA and an affiliate of Merck & Co., Inc. will be successful; whether the patents and patent applications owned or licensed by the Company will protect the Company's technology and prevent others from infringing it; whether Idera's cash resources will be sufficient to fund the Company's operations; and such other important factors as are set forth under the caption "Risk Factors" in Idera's Quarterly Report on Form 10-Q for the three months ended June 30, 2010, which important factors are incorporated herein by reference. Idera disclaims any intention or obligation to update any forward-looking statements.
SOURCE: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc.
Teri Dahlman, 617-679-5519
tdahlman@iderapharma.com
or
MacDougall Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com
Source
Medivir Announces Publication Of Five TMC435 Abstracts For Presentation At The 61st AASLD Meeting
~ Including a Late-breaking Oral Presentation of 24-Week interim data of the TMC435 phase 2b PILLAR study ~
STOCKHOLM, Oct 01, 2010 (BUSINESS WIRE) -- Regulatory News:Medivir AB (omx:MVIR), a research-based speciality pharmaceutical company focused on infectious diseases, today announces that five abstracts related to its hepatitis C drug in development, TMC435, have been accepted for presentation at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place from 29 October -- 2 November 2010 in Boston, USA. The abstracts have been published today and can be accessed on the AASLD website http://www.aasld.org/ (http://www.aasld.org/). In accordance with the AASLD embargo policy, information about the studies and the accepted titles only are provided below. TMC435, a hepatitis C protease inhibitor, is being jointly developed by Medivir and Tibotec Pharmaceuticals.
At the meeting, in a late-breaking oral presentation, the results from a pre-planned Week 24 interim analysis of the ongoing Phase 2b PILLAR study of TMC435 will be presented. In this study, patients were dosed once-daily with TMC435 in combination with peg interferon a-2a (PegIFN) and ribavirin (RBV) in treatment naive patients infected with HCV genotype 1 (G1). 24-Week interim analysis data will be reported including rapid virologic response (RVR), complete early viral response (cEVR), sustained viral response rates after four weeks (SVR4), and twelve weeks (SVR12) respectively. Secondary endpoints, including the assessment of antiviral activity, viral breakthrough, safety and tolerability, and response rates in IL-28B genotypes, will also be presented.
Additionally, there will be four poster presentations shown at the meeting. Two poster presentations will describe the antiviral activity, safety, tolerability, and pharmacokinetics from a phase 2a open-label, proof-of-concept study of TMC435 in patients infected with HCV genotype 2 to 6.
The other two poster presentations will describe the virologic analysis of G1 infected patients following treatment with once-daily TMC435 in the phase 2a (OPERA-1) study and in vitro studies investigating the mechanism of interaction between TMC435 and hepatic transporters.
Accepted titles for Abstracts to be presented at the 2010 AASLD meeting are as follows:
Late Breaker Oral Presentation for presentation at Monday 1 Nov. 17:45 (EST):
LB-5. "Efficacy and safety of TMC435 in combination with peginterferon a-2a and ribavirin in treatment-naive genotype-1 HCV patients: 24-week interim results from the PILLAR study."
Poster Presentations:
278. "In vitro studies investigating the mechanism of interaction between TMC435 and hepatic transporters." To be presented: Saturday 30 Oct, 14:00 (EST).
812. "Virologic analysis of genotype-1-infected patients treated with once-daily TMC435 during the Optimal Protease inhibitor Enhancement of Response to Therapy (OPERA)-1 study." To be presented: Sunday 31 Oct, 08:00 (EST).
895. "A Phase 2a, open-label study to assess the antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2--6." To be presented: Sunday 31 Oct, 08:00 (EST).
1873. "Pharmacokinetic-pharmacodynamic analyses of TMC435 in patients infected with Hepatitis C Virus (HCV) genotypes 2 to 6." To be presented: Tuesday 2 Nov, 07:00 (EST).
About Medivir
Medivir is a research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product Xerese(TM)/Xerclear(TM). Medivir's key pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.
Xerese(TM)/Xerclear(TM) is an innovative treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GSK to be sold OTC in Europe and Russia and with Meda in North America. Medivir has retained the Rx rights for Xerclear(TM) in Sweden and Finland.
For more information about Medivir, please visit the Company's website: http://www.medivir.se/ (http://www.medivir.se/)
About TMC435 clinical trial programs
TMC435 is a once daily protease inhibitor jointly developed by Medivir and Tibotec Pharmaceuticals to treat hepatitis C virus infections. TMC435 is currently being studied in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. TMC435 is planned to enter phase 3 studies early 2011.
PILLAR Study (TMC435-C205)
TMC435-C205 is an ongoing randomized double-blind global phase 2b study in 386 genotype-1 treatment-naive patients. It evaluates once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.
ASPIRE Study (TMC435-C206)
TMC435-C206 is an ongoing randomized double-blind global phase 2b study in 463 genotype-1 treatment-experienced patients. It evaluates once daily treatment of TMC435 in with different doses of given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.
TMC435-C215
TMC435-C215 is an ongoing Japanese phase 2b study in 92 genotype-1 treatment-naive patients. It evaluates once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A. Opera-2 (TMC435-C202) TMC435-C202 is a completed phase 2a study in treatment-naive genotype 2 to 6 HCV patients. It is a once daily treatment of TMC435 during seven days, at 200 mg. Subsequently, patients could continue with SoC treatment consisting of pegylated interferon and ribavirin upon agreement with the study doctor.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
This information was brought to you by Cision http://www.cisionwire.com/
SOURCE: Medivir
http://www.medivir.se/
Rein Piir
CFO & VP Investor Relations
Office: +46 8 546 831 23
Mobile: +46 708 537 292
or
M:Communications
Europe:
Mary-Jane Elliott/Emma Thompson
+44(0)20 7920 2330
or
M:Communications
USA: Jason Marshall
+1 212 897 5497
Medivir@mcomgroup.com (Medivir@mcomgroup.com)
Source
Comparative efficacy and overall safety of different doses of consensus interferon for treatment of chronic HCV infection: a systematic review and meta-analysis
European Journal of Clinical Pharmacology
DOI: 10.1007/s00228-010-0881-7
Seyed-Moayed Alavian, Bita Behnava and Seyed Vahid Tabatabaei
Abstract
Background
About one-half of patients with hepatitis C genotype 1 and one-third with genotype 2/3 have treatment failure with peginterferon alpha and ribavirin. Consensus interferon (CIFN) is an option for retreatment of these patients.
Objective
To summarize comparative safety and efficacy of different regimens of CIFN for the treatment of patients with chronic hepatitis C infection.
Data source
Medline, Scopus, ISI, and Cochran Central Register of Clinical Trials were used.
Study eligibility criteria
Randomized clinical trials (RCTs) were eligible for inclusion in the study.
Participants
HIV and HBV seronegative patients with positive HCV-RNA during the 6 months before the start of the study were eligible for inclusion.
Interventions
Different regimens of CIFN were studied.
Study appraisal and synthesis methods
Studies were appraised based on methods of random sequence generation, allocation concealment, and blinding. The random effects model of DerSimonian and Laird was employed to run the meta-analysis. The end-point was sustained virological response (SVR).
Results
Data of 10 RCTs including 1,600 subjects were extracted. High daily induction dose regimen of CIFN did not yield a higher rate of SVR than low daily induction dose treatment regimen, RR = 0.83 (95% CI 0.58–1.17). A dose of 9 μg thrice weekly (tiw) was associated with a significantly higher rate of SVR compared with 3 μg [RR = 3.14 (95% CI 1.68–5.58)]‹. Withdrawal rate was similar [RR = 1.28 (95% CI 0.65–2.50)] but dose modification was higher in 9 μg [RR = 3.22 (95% CI 1.08–9.60)]. A dose of 18/15 μg tiw was not more effective than 9 μg over a similar treatment duration [RR = 1.02 (95% CI 0. 87–1.19)].
Limitations
Limitations include inadequate reporting of methodological information and side effects, lack of publication bias assessment due to the small number of studies in each analysis.
Conclusions
High dose daily induction therapy with CIFN is not superior to low dose therapy in terms of SVR. It seems that 9 μg tiw is the optimal treatment dose of CIFN for treatment of HCV infection. Optimal duration and safety profile of CIFN therapy have yet been elucidated.
Keywords Consensus interferon - Induction therapy - High dose - Low dose - Meta-analysis - Systematic review
Source
DOI: 10.1007/s00228-010-0881-7
Seyed-Moayed Alavian, Bita Behnava and Seyed Vahid Tabatabaei
Abstract
Background
About one-half of patients with hepatitis C genotype 1 and one-third with genotype 2/3 have treatment failure with peginterferon alpha and ribavirin. Consensus interferon (CIFN) is an option for retreatment of these patients.
Objective
To summarize comparative safety and efficacy of different regimens of CIFN for the treatment of patients with chronic hepatitis C infection.
Data source
Medline, Scopus, ISI, and Cochran Central Register of Clinical Trials were used.
Study eligibility criteria
Randomized clinical trials (RCTs) were eligible for inclusion in the study.
Participants
HIV and HBV seronegative patients with positive HCV-RNA during the 6 months before the start of the study were eligible for inclusion.
Interventions
Different regimens of CIFN were studied.
Study appraisal and synthesis methods
Studies were appraised based on methods of random sequence generation, allocation concealment, and blinding. The random effects model of DerSimonian and Laird was employed to run the meta-analysis. The end-point was sustained virological response (SVR).
Results
Data of 10 RCTs including 1,600 subjects were extracted. High daily induction dose regimen of CIFN did not yield a higher rate of SVR than low daily induction dose treatment regimen, RR = 0.83 (95% CI 0.58–1.17). A dose of 9 μg thrice weekly (tiw) was associated with a significantly higher rate of SVR compared with 3 μg [RR = 3.14 (95% CI 1.68–5.58)]‹. Withdrawal rate was similar [RR = 1.28 (95% CI 0.65–2.50)] but dose modification was higher in 9 μg [RR = 3.22 (95% CI 1.08–9.60)]. A dose of 18/15 μg tiw was not more effective than 9 μg over a similar treatment duration [RR = 1.02 (95% CI 0. 87–1.19)].
Limitations
Limitations include inadequate reporting of methodological information and side effects, lack of publication bias assessment due to the small number of studies in each analysis.
Conclusions
High dose daily induction therapy with CIFN is not superior to low dose therapy in terms of SVR. It seems that 9 μg tiw is the optimal treatment dose of CIFN for treatment of HCV infection. Optimal duration and safety profile of CIFN therapy have yet been elucidated.
Keywords Consensus interferon - Induction therapy - High dose - Low dose - Meta-analysis - Systematic review
Source
Millions of Americans Are Living with Hidden Epidemics of Hepatitis B and C, Top Experts Warn
WASHINGTON, Sept. 27 /PRNewswire-USNewswire/ -- The American Association for the Study of Liver Diseases (AASLD) and the Trust for America's Health (TFAH) issued a new report today calling for action to be taken to transform how the country deals with viral hepatitis – to help identify millions of Americans who know they are living with chronic forms of hepatitis B and C and to assure access to treatment for all who need it, to prevent even more Americans from becoming infected.
(Logo: http://www.newscom.com/cgi-bin/prnh/20100204/TFAHLOGO)
(Logo: http://photos.prnewswire.com/prnh/20100204/TFAHLOGO)
"This report is a critical next step that builds on a recent groundbreaking Institute of Medicine report on viral hepatitis and translates it into a series of action items which will be critically important to control the silent epidemic of viral hepatitis in the U.S.," said Arun J Sanyal MD, President of AASLD.
The report, HBV & HCV: America's Hidden Epidemics, examines how new measures included in the Patient Protection and Affordable Care Act (ACA) combined with new scientific advancements could be used to spare millions of Americans from developing cirrhosis, liver cancer, or other life threatening complications as they age – which could also lead to billions of dollars in health care savings.
"HBV and HCV are ticking time bombs. If we don't act now to diagnose the millions of Baby Boomers and others, we'll be too late to spare them from developing serious liver diseases. We'll all end up paying the price, since Medicare and Medicaid will end up picking up the tab for much of the care," said Jeff Levi, Ph.D., Executive Director of TFAH. "Health reform and new science give us a once-in-a-generation opportunity to rethink how we deal with these silent killers."
Some key findings in the report include that:
• An estimated 65 to 75 percent of the five million Americans currently infected with the hepatitis B virus (HBV) or hepatitis C virus (HCV) do not even know they have the virus;
• The Institute of Medicine (IOM) estimates that 150,000 Americans could die from liver cancer or end-stage liver disease associated with hepatitis B virus (HBV) or hepatitis C virus (HCV) in the next decade;
• The death rate from HCV is expected to triple in the next 10 to 20 years;
• An independent analysis found total medical costs for HCV patients could more than double over the next 20 years – from $30 to $80 billion per year;
• Liver cancer treatment can be more than $62,000 for the first year cost and the first-year cost of a liver transplant can be more than $267,000;
• Two-thirds of HCV cases are Baby Boomers – and if they are left untreated, it could lead to a major increase in upcoming Medicare spending;
• One in 10 Asian and Pacific Islander Americans are estimated to have a chronic HBV infection;
• An estimated 540,000 to 858,000 African Americans are estimated to have a chronic HCV infection;
• Approximately 800 to 1,000 infants in the United States are infected with HBV at birth each year; and
• At least 100,000 patients have been notified about potential exposure to HBV, HCV, and/or HIV while receiving health care since 1998.
Some highlight recommendations from AASLD and TFAH in the report include:
• HBV and HCV screening and HBV vaccination should be the standard of care in the reformed health system. All Americans should be screened for HBV and HCV and all Americans should be vaccinated for HBV;
• All pregnant women should be screened for HBV and appropriate health measures should be taken to prevent perinatal transmission from infected mothers to their newborns. All newborns should receive their initial (birthdose) of hepatitis vaccine within twelve hours of birth;
• Every person diagnosed with HBV or HCV should have access to and receive a minimum standardized level of care and receive support services;
• Strong public education campaigns and improved surveillance must be put in place to help prevent new infections;
• Policies must be established to ensure that health care associated hepatitis infections are treated as a "never event;" and
• The investment in hepatitis-related biomedical and behavior must be significantly increased – and should be more proportionate to the public health threat associated with hepatitis.
The full report is available on AASLD's website http://www.aasld.org/ and TFAH's website http://www.healthyamericans.org/.
The American Association for the Study of Liver Diseases (AASLD) is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease and whose vision is to prevent and cure liver disease through its mission to advance the science and practice of Hepatology, Liver Transplantation and Hepatobiliary Surgery, thereby promoting liver health and optimal care of patients with liver and biliary tract diseases. http://www.aasld.org/
Trust for America's Health is a non-profit, non-partisan organization dedicated to saving lives by protecting the health of every community and working to make disease prevention a national priority. www.healthyamericans.org
SOURCE Trust for America's Health
RELATED LINKS
http://www.healthyamericans.org/
http://www.aasld.org/
Source
(Logo: http://www.newscom.com/cgi-bin/prnh/20100204/TFAHLOGO)
(Logo: http://photos.prnewswire.com/prnh/20100204/TFAHLOGO)
"This report is a critical next step that builds on a recent groundbreaking Institute of Medicine report on viral hepatitis and translates it into a series of action items which will be critically important to control the silent epidemic of viral hepatitis in the U.S.," said Arun J Sanyal MD, President of AASLD.
The report, HBV & HCV: America's Hidden Epidemics, examines how new measures included in the Patient Protection and Affordable Care Act (ACA) combined with new scientific advancements could be used to spare millions of Americans from developing cirrhosis, liver cancer, or other life threatening complications as they age – which could also lead to billions of dollars in health care savings.
"HBV and HCV are ticking time bombs. If we don't act now to diagnose the millions of Baby Boomers and others, we'll be too late to spare them from developing serious liver diseases. We'll all end up paying the price, since Medicare and Medicaid will end up picking up the tab for much of the care," said Jeff Levi, Ph.D., Executive Director of TFAH. "Health reform and new science give us a once-in-a-generation opportunity to rethink how we deal with these silent killers."
Some key findings in the report include that:
• An estimated 65 to 75 percent of the five million Americans currently infected with the hepatitis B virus (HBV) or hepatitis C virus (HCV) do not even know they have the virus;
• The Institute of Medicine (IOM) estimates that 150,000 Americans could die from liver cancer or end-stage liver disease associated with hepatitis B virus (HBV) or hepatitis C virus (HCV) in the next decade;
• The death rate from HCV is expected to triple in the next 10 to 20 years;
• An independent analysis found total medical costs for HCV patients could more than double over the next 20 years – from $30 to $80 billion per year;
• Liver cancer treatment can be more than $62,000 for the first year cost and the first-year cost of a liver transplant can be more than $267,000;
• Two-thirds of HCV cases are Baby Boomers – and if they are left untreated, it could lead to a major increase in upcoming Medicare spending;
• One in 10 Asian and Pacific Islander Americans are estimated to have a chronic HBV infection;
• An estimated 540,000 to 858,000 African Americans are estimated to have a chronic HCV infection;
• Approximately 800 to 1,000 infants in the United States are infected with HBV at birth each year; and
• At least 100,000 patients have been notified about potential exposure to HBV, HCV, and/or HIV while receiving health care since 1998.
Some highlight recommendations from AASLD and TFAH in the report include:
• HBV and HCV screening and HBV vaccination should be the standard of care in the reformed health system. All Americans should be screened for HBV and HCV and all Americans should be vaccinated for HBV;
• All pregnant women should be screened for HBV and appropriate health measures should be taken to prevent perinatal transmission from infected mothers to their newborns. All newborns should receive their initial (birthdose) of hepatitis vaccine within twelve hours of birth;
• Every person diagnosed with HBV or HCV should have access to and receive a minimum standardized level of care and receive support services;
• Strong public education campaigns and improved surveillance must be put in place to help prevent new infections;
• Policies must be established to ensure that health care associated hepatitis infections are treated as a "never event;" and
• The investment in hepatitis-related biomedical and behavior must be significantly increased – and should be more proportionate to the public health threat associated with hepatitis.
The full report is available on AASLD's website http://www.aasld.org/ and TFAH's website http://www.healthyamericans.org/.
The American Association for the Study of Liver Diseases (AASLD) is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease and whose vision is to prevent and cure liver disease through its mission to advance the science and practice of Hepatology, Liver Transplantation and Hepatobiliary Surgery, thereby promoting liver health and optimal care of patients with liver and biliary tract diseases. http://www.aasld.org/
Trust for America's Health is a non-profit, non-partisan organization dedicated to saving lives by protecting the health of every community and working to make disease prevention a national priority. www.healthyamericans.org
SOURCE Trust for America's Health
RELATED LINKS
http://www.healthyamericans.org/
http://www.aasld.org/
Source
Long-term interferon therapy after radiofrequency ablation is effective in treating patients with HCV-associated hepatocellular carcinoma
Hepatology International
DOI: 10.1007/s12072-010-9214-2
Soji Shimomura, Naoto Ikeda, Masaki Saito, Akio Ishii, Tomoyuki Takashima, Yoshiyuki Sakai, Shohei Yoshikawa, Nobuhiro Aizawa, Hironori Tanaka and Yoshinori Iwata, et al.
Abstract
Purpose
This study investigates the usefulness of long-term interferon (IFN) therapy following radiofrequency ablation (RFA) for HCV-associated hepatocellular carcinoma (HCC).
Methods
This is a retrospective observational study. Patients underwent pegylated IFN-α/ribavirin combination therapy for 48 weeks and then were maintained on IFN-α administration on average for 68 weeks (mean total duration 116 weeks). Patients who underwent IFN monotherapy were maintained on IFN administration on average for 78 weeks.
Results
There were biases in the background factors between the IFN and non-IFN groups. Therefore, a covariate adjustment was performed using the propensity score. An analysis of 20-matched patients from each group showed the 5-year cumulative survival rate was higher in the IFN group than in the non-IFN group (100 and 76%, respectively), and the 3-year cumulative recurrence rate was significantly lower in the IFN group than in the non-IFN group (38.0 and 64.2%, respectively). In 14 patients (i.e., IFN responders), the serum alanine aminotransferase (ALT) level remained normalized at 30 IU/mL or lower, regardless of disappearance of serum HCV RNA. In these patients, the cumulative recurrence rate was low, the hazard ratio was 0.158 (95% confidence interval = 0.045–0.561, P = 0.004), and the serum albumin level was retained.
Conclusion
These results show the importance of maintaining the liver function and suggest that long-term IFN administration after RFA inhibits recurrence and contributes to an improved outcome in patients (in particular, IFN responders) who initially develop HCC.
Keywords Hepatitis C virus - Interferon - Hepatocellular carcinoma - Prevention - Radiofrequency ablation
S. Shimomura and N. Ikeda equally contributed to this study.
Source
DOI: 10.1007/s12072-010-9214-2
Soji Shimomura, Naoto Ikeda, Masaki Saito, Akio Ishii, Tomoyuki Takashima, Yoshiyuki Sakai, Shohei Yoshikawa, Nobuhiro Aizawa, Hironori Tanaka and Yoshinori Iwata, et al.
Abstract
Purpose
This study investigates the usefulness of long-term interferon (IFN) therapy following radiofrequency ablation (RFA) for HCV-associated hepatocellular carcinoma (HCC).
Methods
This is a retrospective observational study. Patients underwent pegylated IFN-α/ribavirin combination therapy for 48 weeks and then were maintained on IFN-α administration on average for 68 weeks (mean total duration 116 weeks). Patients who underwent IFN monotherapy were maintained on IFN administration on average for 78 weeks.
Results
There were biases in the background factors between the IFN and non-IFN groups. Therefore, a covariate adjustment was performed using the propensity score. An analysis of 20-matched patients from each group showed the 5-year cumulative survival rate was higher in the IFN group than in the non-IFN group (100 and 76%, respectively), and the 3-year cumulative recurrence rate was significantly lower in the IFN group than in the non-IFN group (38.0 and 64.2%, respectively). In 14 patients (i.e., IFN responders), the serum alanine aminotransferase (ALT) level remained normalized at 30 IU/mL or lower, regardless of disappearance of serum HCV RNA. In these patients, the cumulative recurrence rate was low, the hazard ratio was 0.158 (95% confidence interval = 0.045–0.561, P = 0.004), and the serum albumin level was retained.
Conclusion
These results show the importance of maintaining the liver function and suggest that long-term IFN administration after RFA inhibits recurrence and contributes to an improved outcome in patients (in particular, IFN responders) who initially develop HCC.
Keywords Hepatitis C virus - Interferon - Hepatocellular carcinoma - Prevention - Radiofrequency ablation
S. Shimomura and N. Ikeda equally contributed to this study.
Source
Hepatitis C Virus Seromarkers and Subsequent Risk of Hepatocellular Carcinoma: Long-Term Predictors From a Community-Based Cohort Study
Journal of Clinical Oncology
Published online before print September 20, 2010,
doi: 10.1200/JCO.2010.29.1500
JCO.2010.29.1500
©American Society of Clinical Oncology
Mei-Hsuan Lee, Hwai-I Yang, Sheng-Nan Lu, Chin-Lan Jen, Shiou-Hwei Yeh, Chun-Jen Liu, Pei-Jer Chen, San-Lin You, Li-Yu Wang, Wei J. Chen and Chien-Jen Chen
+ Author Affiliations
Corresponding author: Chien-Jen Chen, ScD, Genomics Research Center, Academia Sinica, 128 Academia Rd, Section 2, Nankang, Taipei, 115, Taiwan; e-mail: cjchen@ntu.edu.tw.
Abstract
Purpose Hepatitis C virus (HCV) contributes to one third of hepatocellular carcinoma cases worldwide. Long-term predictors for HCV-related hepatocellular carcinoma are essential for early intervention. Serum HCV RNA and ALT levels and HCV genotype were assessed for their predictability of hepatocellular carcinoma risk.
Methods A prospective cohort of 925 participants positive for antibodies against HCV and age 30 to 65 years was recruited and followed from 1991 to 2006. Serum HCV RNA and ALT levels and HCV genotypes at enrollment and during follow-up were examined. Newly developed hepatocellular carcinoma was identified by health examination and computerized linkage with national cancer registration and death certification profiles. Multivariate adjusted hazard ratios with 95% CIs were estimated using Cox regression models.
Results Fifty-five participants newly developed hepatocellular carcinoma during 8,476 person-years of follow-up, giving an incidence rate of 648.9 per 100,000 person-years. The cumulative hepatocellular carcinoma risk increased from 1.1% for HCV RNA seronegative status to 6.4% for low HCV RNA levels and to 14.7% for high HCV RNA levels (P < .001). The cumulative risk also increased with elevated serum ALT levels from 1.7% for persistently ≤ 15 U/L to 4.2% for ever more than 15 U/L but never more than 45 U/L and to 13.8% for ALT ever ≥ 45 U/L (P < .001). Having HCV genotype 1 was associated with a higher cumulative hepatocellular carcinoma risk (12.6%) than not having HCV genotype 1 (4.5%; P < .001).
Conclusion Elevated serum levels of HCV RNA and ALT and HCV genotype 1 infection are independent risk predictors of hepatocellular carcinoma. These findings have strong implications for the management of chronic HCV.
Received March 5, 2010.
Accepted July 6, 2010.
Source
Published online before print September 20, 2010,
doi: 10.1200/JCO.2010.29.1500
JCO.2010.29.1500
©American Society of Clinical Oncology
Mei-Hsuan Lee, Hwai-I Yang, Sheng-Nan Lu, Chin-Lan Jen, Shiou-Hwei Yeh, Chun-Jen Liu, Pei-Jer Chen, San-Lin You, Li-Yu Wang, Wei J. Chen and Chien-Jen Chen
+ Author Affiliations
Corresponding author: Chien-Jen Chen, ScD, Genomics Research Center, Academia Sinica, 128 Academia Rd, Section 2, Nankang, Taipei, 115, Taiwan; e-mail: cjchen@ntu.edu.tw.
Abstract
Purpose Hepatitis C virus (HCV) contributes to one third of hepatocellular carcinoma cases worldwide. Long-term predictors for HCV-related hepatocellular carcinoma are essential for early intervention. Serum HCV RNA and ALT levels and HCV genotype were assessed for their predictability of hepatocellular carcinoma risk.
Methods A prospective cohort of 925 participants positive for antibodies against HCV and age 30 to 65 years was recruited and followed from 1991 to 2006. Serum HCV RNA and ALT levels and HCV genotypes at enrollment and during follow-up were examined. Newly developed hepatocellular carcinoma was identified by health examination and computerized linkage with national cancer registration and death certification profiles. Multivariate adjusted hazard ratios with 95% CIs were estimated using Cox regression models.
Results Fifty-five participants newly developed hepatocellular carcinoma during 8,476 person-years of follow-up, giving an incidence rate of 648.9 per 100,000 person-years. The cumulative hepatocellular carcinoma risk increased from 1.1% for HCV RNA seronegative status to 6.4% for low HCV RNA levels and to 14.7% for high HCV RNA levels (P < .001). The cumulative risk also increased with elevated serum ALT levels from 1.7% for persistently ≤ 15 U/L to 4.2% for ever more than 15 U/L but never more than 45 U/L and to 13.8% for ALT ever ≥ 45 U/L (P < .001). Having HCV genotype 1 was associated with a higher cumulative hepatocellular carcinoma risk (12.6%) than not having HCV genotype 1 (4.5%; P < .001).
Conclusion Elevated serum levels of HCV RNA and ALT and HCV genotype 1 infection are independent risk predictors of hepatocellular carcinoma. These findings have strong implications for the management of chronic HCV.
Received March 5, 2010.
Accepted July 6, 2010.
Source
Prevalence of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis among a Largely Middle-Aged Population Utilizing Ultrasound and Liver Biopsy: A Prospective Study
Gastroenterology. 2010 Sep 18. [Epub ahead of print]
Williams CD, Stengel J, Asike MI, Torres DM, Shaw J, Contreras M, Landt CL, Harrison SA.
Gastroenterology and Hepatology Service, Department of Medicine; Brooke Army Medical Center.
Abstract
INTRODUCTION: The prevalence of nonalcoholic fatty liver disease (NAFLD) has not been well established. The purpose of this study was to prospectively define the prevalence of both NAFLD and nonalcoholic steatohepatitis (NASH).
METHODS: Outpatients 18 to 70 years old were recruited from Brooke Army Medical Center. All patients completed a baseline questionnaire and ultrasound. If fatty liver was identified, then laboratory data and a liver biopsy (LB) were obtained.
RESULTS: 400 patients were enrolled. 328 patients completed the questionnaire and ultrasound. Mean age (range 28-70) was 54.6 years (7.35); 62.5% Caucasian, 22% Hispanic, and 11.3% African American; 50.9% female; mean body mass index (BMI) was 29.8 kg/m(2) (5.64); diabetes and hypertension prevalence were 16.5% and 49.7% respectively. The prevalence of NAFLD was 46%. NASH was confirmed in 40 patients (12.2% of total cohort, 29.9% of ultrasound positive patients). Hispanics had the highest prevalence of NAFLD (58.3%), then Caucasians (44.4%) and African-Americans (35.1%). NAFLD patients were more likely to be male (58.9%), older (p=0.004), hypertensive (p<0.00005), and diabetic (p<0.00005). They had a higher BMI (p<0.0005), ate fast food more often (p=0.049) and exercised less (p=0.02), than their non-NAFLD counterparts. Hispanics had a higher prevalence of NASH compared with Caucasians (19.4% vs 9.8%, p=0.03). ALT, AST, BMI, insulin, QUICKI, and CK 18 correlated with NASH. Among the 54 diabetic patients, NAFLD was found in 74% and NASH in 22.2%.
CONCLUSION: The prevalence of NAFLD and NASH are higher than previously estimated. Hispanics and diabetic patients are at greatest risk for both NAFLD and NASH.
PMID: 20858492 [PubMed - as supplied by publisher]
Source
Williams CD, Stengel J, Asike MI, Torres DM, Shaw J, Contreras M, Landt CL, Harrison SA.
Gastroenterology and Hepatology Service, Department of Medicine; Brooke Army Medical Center.
Abstract
INTRODUCTION: The prevalence of nonalcoholic fatty liver disease (NAFLD) has not been well established. The purpose of this study was to prospectively define the prevalence of both NAFLD and nonalcoholic steatohepatitis (NASH).
METHODS: Outpatients 18 to 70 years old were recruited from Brooke Army Medical Center. All patients completed a baseline questionnaire and ultrasound. If fatty liver was identified, then laboratory data and a liver biopsy (LB) were obtained.
RESULTS: 400 patients were enrolled. 328 patients completed the questionnaire and ultrasound. Mean age (range 28-70) was 54.6 years (7.35); 62.5% Caucasian, 22% Hispanic, and 11.3% African American; 50.9% female; mean body mass index (BMI) was 29.8 kg/m(2) (5.64); diabetes and hypertension prevalence were 16.5% and 49.7% respectively. The prevalence of NAFLD was 46%. NASH was confirmed in 40 patients (12.2% of total cohort, 29.9% of ultrasound positive patients). Hispanics had the highest prevalence of NAFLD (58.3%), then Caucasians (44.4%) and African-Americans (35.1%). NAFLD patients were more likely to be male (58.9%), older (p=0.004), hypertensive (p<0.00005), and diabetic (p<0.00005). They had a higher BMI (p<0.0005), ate fast food more often (p=0.049) and exercised less (p=0.02), than their non-NAFLD counterparts. Hispanics had a higher prevalence of NASH compared with Caucasians (19.4% vs 9.8%, p=0.03). ALT, AST, BMI, insulin, QUICKI, and CK 18 correlated with NASH. Among the 54 diabetic patients, NAFLD was found in 74% and NASH in 22.2%.
CONCLUSION: The prevalence of NAFLD and NASH are higher than previously estimated. Hispanics and diabetic patients are at greatest risk for both NAFLD and NASH.
PMID: 20858492 [PubMed - as supplied by publisher]
Source
Hepatitis D virus: an update
Liver International
Early View (Articles online in advance of print)
Stéphanie Pascarella 1, Francesco Negro 2,3
Article first published online: 28 SEP 2010
DOI: 10.1111/j.1478-3231.2010.02320.x
© 2010 John Wiley & Sons A/S
1 Department of Pathology and Immunology, University of Geneva, Geneva, Switzerland
2 Division of Clinical Pathology, University Hospital, Geneva, Switzerland
3 Division of Gastroenterology and Hepatology, University Hospital, Geneva, Switzerland
*Correspondence: Correspondence Prof Francesco Negro, Divisions of Clinical Pathology and of Gastroenterology and Hepatology, University Hospital, 4 rue Gabrielle-Perret-Gentil, 1211 Geneva 14, Switzerland Tel: +41 22 3795 800 Fax: +41 22 3729 366 e-mail: francesco.negro@hcuge.ch
Keywords:
cirrhosis;delta hepatitis;fulminant hepatitis;hepatitis D virus
Abstract
Hepatitis D virus (HDV) infection involves a distinct subgroup of individuals simultaneously infected with the hepatitis B virus (HBV) and characterized by an often severe chronic liver disease. HDV is a defective RNA agent needing the presence of HBV for its life cycle. HDV is present worldwide, but the distribution pattern is not uniform. Different strains are classified into eight genotypes represented in specific regions and associated with peculiar disease outcome. Two major specific patterns of infection can occur, i.e. co-infection with HDV and HBV or HDV superinfection of a chronic HBV carrier. Co-infection often leads to eradication of both agents, whereas superinfection mostly evolves to HDV chronicity. HDV-associated chronic liver disease (chronic hepatitis D) is characterized by necro-inflammation and relentless deposition of fibrosis, which may, over decades, result in the development of cirrhosis. HDV has a single-stranded, circular RNA genome. The virion is composed of an envelope, provided by the helper HBV and surrounding the RNA genome and the HDV antigen (HDAg). Replication occurs in the hepatocyte nucleus using cellular polymerases and via a rolling circle process, during which the RNA genome is copied into a full-length, complementary RNA. HDV infection can be diagnosed by the presence of antibodies directed against HDAg (anti-HD) and HDV RNA in serum. Treatment involves the administration of pegylated interferon-α and is effective in only about 20% of patients. Liver transplantation is indicated in case of liver failure.
Source
Early View (Articles online in advance of print)
Stéphanie Pascarella 1, Francesco Negro 2,3
Article first published online: 28 SEP 2010
DOI: 10.1111/j.1478-3231.2010.02320.x
© 2010 John Wiley & Sons A/S
1 Department of Pathology and Immunology, University of Geneva, Geneva, Switzerland
2 Division of Clinical Pathology, University Hospital, Geneva, Switzerland
3 Division of Gastroenterology and Hepatology, University Hospital, Geneva, Switzerland
*Correspondence: Correspondence Prof Francesco Negro, Divisions of Clinical Pathology and of Gastroenterology and Hepatology, University Hospital, 4 rue Gabrielle-Perret-Gentil, 1211 Geneva 14, Switzerland Tel: +41 22 3795 800 Fax: +41 22 3729 366 e-mail: francesco.negro@hcuge.ch
Keywords:
cirrhosis;delta hepatitis;fulminant hepatitis;hepatitis D virus
Abstract
Hepatitis D virus (HDV) infection involves a distinct subgroup of individuals simultaneously infected with the hepatitis B virus (HBV) and characterized by an often severe chronic liver disease. HDV is a defective RNA agent needing the presence of HBV for its life cycle. HDV is present worldwide, but the distribution pattern is not uniform. Different strains are classified into eight genotypes represented in specific regions and associated with peculiar disease outcome. Two major specific patterns of infection can occur, i.e. co-infection with HDV and HBV or HDV superinfection of a chronic HBV carrier. Co-infection often leads to eradication of both agents, whereas superinfection mostly evolves to HDV chronicity. HDV-associated chronic liver disease (chronic hepatitis D) is characterized by necro-inflammation and relentless deposition of fibrosis, which may, over decades, result in the development of cirrhosis. HDV has a single-stranded, circular RNA genome. The virion is composed of an envelope, provided by the helper HBV and surrounding the RNA genome and the HDV antigen (HDAg). Replication occurs in the hepatocyte nucleus using cellular polymerases and via a rolling circle process, during which the RNA genome is copied into a full-length, complementary RNA. HDV infection can be diagnosed by the presence of antibodies directed against HDAg (anti-HD) and HDV RNA in serum. Treatment involves the administration of pegylated interferon-α and is effective in only about 20% of patients. Liver transplantation is indicated in case of liver failure.
Source
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