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WCTF.org Transplant NewsTransplant news, links, and other general medical news -- updated regularly.Saturday, April 26, 2008Ceremony honors organ donors in Chesapeake (WAVY 10)
Ceremony honors organ donors in Chesapeake (WAVY 10)
CHESAPEAKE, VA. (WAVY.com) -- Doctors, transplant recipients, friends and family honored the generosity of two hundred people who died last year - all were organ donors. Kidney transplant definition - Health and Medical Information Produced
Read doctor-produced health and medical information written for you to make informed decisions about your health concerns. [more]
Potential New Oral Treatment May Revolutionise Management of Deadly Hepatitis C Virus
Potential New Oral Treatment May Revolutionise Management of Deadly Hepatitis C Virus
WELWYN GARDEN CITY, England, April 27/PRNewswire/ -- - Phase II Study Demonstrates Impressive End-of Treatment Response - Roche's investigational treatment for hepatitis C, R1626, has shown an Results from the phase II study show that levels of the "These results demonstrate that R1626 holds significant Patients in this Phase IIa study will be followed for an Hepatitis C, one of the most common chronic blood-borne More About the Phase IIa Study and End-of-Treatment Results Presented at The Phase IIa study is a multicenter trial that enrolled 104 Patients were randomised into the following treatment groups: - Group A: R1626 1,500 mg twice a day plus peginterferon - Group B: R1626 3,000 mg twice a day plus peginterferon - Group C: R1626 1,500 mg twice a day plus peginterferon - Group D (standard of care group): peginterferon alfa-2a 180 Following the 4 weeks of treatment in this study, all patients The study found(1): - Data collected at 4 weeks showed that patients receiving the - At week 48, HCV was undetectable in 84% of patients receiving the Side Effect Profile: - A higher incidence of grade 4 neutropenia was reported in the R1626 - a High Barrier to the Development of Resistance In a separate oral presentation at EASL, it was reported that R1626 is not licensed for the treatment of hepatitis C About Roche in the UK Roche aims to improve people's health and quality of life with All trademarks used or mentioned in this release are protected References: (1). Nelson D, Pockros P, Godofsky E, et al. 84% end-of-treatment (2). Le Pogam S, Seshaadri A, Kang H, et al. Low level of resistance, low Source: Roche UK Contact: Olivia Garbutt, Roche, +44(0)1707-367842, Holly Brafman, Weber Shandwick, +44(0)207-067-0184
Europe-wide Organ Donor Card Aims to Slash Death Rates (Deutsche Welle)
Europe-wide Organ Donor Card Aims to Slash Death Rates (Deutsche Welle)
More than 3,500 EU citizens died last year because they did not get a donor organ in time. Now the EU is planning to introduce a pan-European donor card to address the problem. Three Studies Presented at 43rd EASL Strongly Indicate Better Efficacy for PEGASYS in Curing Hepatitis C
Three Studies Presented at 43rd EASL Strongly Indicate Better Efficacy for PEGASYS in Curing Hepatitis C
BASEL, Switzerland, April 26/PRNewswire/ -- - Roche Also Provides Comment on Results of "IDEAL" Trial Roche today announced that compelling new data from three studies Ascione, et al: A Prospective, Randomised, Investigator-Initiated Results of this independently-conducted study(1) were presented by The results showed that 68.7% of patients on Pegasys achieved a cure, T. Witthoeft, et al: Hepatitis C Treatment in Real-Life PRACTICE in Another study presented at EASL, called PRACTICE, analysed the response Craxi, et al: PROBE Compares the Pegylated Interferons PROBE, an observational study, was designed to prospectively evaluate the "We are pleased that three separate studies presented at EASL all Roche Comments on Schering-Plough "IDEAL" Study Roche reiterated its position on the Schering-Plough sponsored trial - different blinding for the Pegasys arm,
Despite these biases, it is interesting to note that significantly more About Hepatitis C Hepatitis C (HCV), the most common chronic blood-borne infection, is About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leading All trademarks used or mentioned in this release are protected by law. Film footage is available for broadcast journalists from The NewsMarket References 1.Ascione A, Tartaqlione MT, Lampasi F, et al. Peginterferon Alpha-2a 2.Witthoeft T, Hueppe D, John C, et al. Efficacy and safety of 3.Craxi A, Piccinino F, Alberti A, et al. Predictors of SVR in naïve HCV 4.McHutchinson J and Sulkowski M. Scientific Rationale and study design 5.Schering-Plough Reports Top-Line Results of the IDEAL Study.
Contact: Mike Nelson, Roche, +41(79)572-5165, Michelle Marchione, Axon Communications, +44 (0) 208 439 9449
Roche's Investigational Hepatitis C Polymerase Inhibitor, R1626, Demonstrated Significant End-of-Treatment Response in Phase IIa Study
Roche's Investigational Hepatitis C Polymerase Inhibitor, R1626, Demonstrated Significant End-of-Treatment Response in Phase IIa Study
- 84 percent of patients had undetectable levels of HCV at end of treatment - MILAN, Italy, April 26 /PRNewswire/ -- Roche's investigational therapy for chronic hepatitis C virus (HCV) infection, R1626, has shown a significant end-of-treatment response rate when given in combination with PEGASYS(R) (peginterferon alfa-2a) and COPEGUS(R) (ribavirin). R1626 also shows a high barrier to the development of resistance. After four weeks of treatment with this triple combination, followed by 44 weeks of PEGASYS and COPEGUS, levels of HCV were undetectable in 84 percent of patients infected with genotype 1 virus. This was higher than patients treated with PEGASYS and COPEGUS alone for the entire 48-week treatment period (65 percent). These new data were presented in a late-breaker oral session at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL), being held in Milan, Italy. R1626 was discovered and developed at Roche and belongs to a class of antivirals called polymerase inhibitors, which are being investigated with the current standard of care for hepatitis C combination therapy with pegylated interferon and ribavirin. "These results demonstrate that R1626 holds significant promise to potentially increase the number of hepatitis C patients who can be successfully treated," said Dr. David Nelson, Director of Hepatology and Liver Transplantation at the University of Florida, Gainesville, Florida. "Since most patients responded very early in treatment with R1626, we expect sustained virological response (SVR) rates that improve significantly on those achieved with the current standard of care. I look forward to SVR data from this Phase IIa study, and to results of the ongoing Phase IIb study." Patients in this Phase IIa study will be followed for an additional 24 weeks with no treatment to determine the SVR rate, which indicates successful treatment. More About the Phase IIa Study and End-of-Treatment Results The Phase IIa study is a multicenter trial that enrolled 104 patients with genotype 1 HCV, who had not previously received treatment. Its primary endpoint was to evaluate the four-week efficacy and safety of combining R1626 with PEGASYS alone or with PEGASYS plus COPEGUS, in comparison to a current HCV standard of care (SOC), pegylated interferon plus ribavirin. Patients were randomized into the following treatment groups: * Group A: R1626 1,500 mg twice a day plus PEGASYS 180 mcg weekly for
The study found: * Data collected at four weeks showed that patients receiving the triple
Rapid Development of R1626 - A Large Phase IIb Study is Now Fully Enrolled A large Phase IIb study with R1626 was initiated in November 2007 to define the optimal dose of R1626, in combination with PEGASYS and COPEGUS. This Phase IIb trial, called POLI 1, is now fully enrolled with approximately 500 patients, all with genotype 1 hepatitis C. About Hepatitis C Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of cirrhosis, liver cancer and the need for liver transplants. According to the Centers for Disease Control and Prevention (CDC), an estimated 4.1 million Americans (1.6 percent) have been infected with hepatitis C; 3.2 million are chronically infected. The number of new infections per year has declined from an average of 240,000 in the 1980s to about 26,000 in 2004. CDC estimates the number of hepatitis C-related deaths could increase to 38,000 annually by the year 2010, surpassing annual HIV/AIDS deaths. About PEGASYS PEGASYS, in combination with COPEGUS (ribavirin), are indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Efficacy has been demonstrated in patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that are clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy). In addition, PEGASYS in combination with COPEGUS is the first and only FDA-approved regimen for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV. PEGASYS is the only pegylated interferon indicated for the treatment of adult patients with chronic hepatitis B (HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation). PEGASYS is dosed at 180mcg as a subcutaneous injection taken once a week. COPEGUS is available as a 200mg tablet, and is administered orally two times a day as a split dose. Roche has backed PEGASYS with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy. IMPORTANT SAFETY INFORMATION PEGASYS, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A). Alpha interferons, including PEGASYS(R) (Peginterferon alfa-2a), may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information). Use with Ribavirin. Ribavirin, including COPEGUS(R), may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information). PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. PEGASYS is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal. PEGASYS and COPEGUS therapy is additionally contraindicated in patients with a hypersensitivity to COPEGUS or any of its components, in women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia). COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. If pregnancy should occur during treatment or during 6 months post-therapy, the patient must be advised of the significant teratogenic risk of COPEGUS therapy to the fetus. Healthcare providers and patients are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214. Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. During treatment, patients' clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score greater than or equal to 6) is observed. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and causal relationship between interferon alfa-based therapies and these events is difficult to establish. The most common adverse events reported for PEGASYS and COPEGUS combination therapy observed in clinical trials were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%). Serious adverse events in hepatitis C trials included neuropsychiatric disorders (homicidal ideation, suicidal ideation, suicide attempt, suicide, psychotic disorder and hallucinations), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, supraventricular arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, lupus, rheumatoid arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema). Adverse reactions reported during post-approval use of PEGASYS therapy, with and without ribavirin, include hearing impairment, hearing loss, serious skin reactions, including erythema multiforme major, and infections (bacterial, viral and fungal). About Roche Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2007 Roche was named Top Company of the Year by Med Ad News, one of the Top 20 Employers (Science) and ranked the No. 1 Company to Sell For (Selling Power). In previous years, Roche has been named as a Top Company for Older Workers (AARP) and one of the Best Companies to Work For in America (Fortune). For additional information about the U.S. pharmaceuticals business, visit our website http://www.rocheusa.com/. Product and treatment information for U.S. healthcare professionals is available at www.RocheExchange.com. All trademarks used or mentioned in this release are protected by law. Contacts: Mike Nelson Catherine Falcetti
CONTACT: Mike Nelson, Roche, BASEL, +41-79-572-5165, mobile, Web site: http://www.rocheusa.com/
Roche's R1626, First-in-Class Hepatitis C Polymerase Inhibitor, Demonstrates Impressive End-of-Treatment Response in Phase IIa Study
Roche's R1626, First-in-Class Hepatitis C Polymerase Inhibitor, Demonstrates Impressive End-of-Treatment Response in Phase IIa Study
BASEL, Switzerland, April 26/PRNewswire/ -- - R1626 Also Shows a High Barrier to the Development of Resistance Roche's investigational treatment for hepatitis C, R1626, has shown an After 4 weeks of treatment with this triple combination, followed by 44 Discovered and developed at Roche, R1626 is a potent polymerase inhibitor "These results demonstrate that R1626 holds significant promise to Patients in this Phase IIa study will be followed for an additional 24 Rapid development of R1626 - a Large Phase IIb Study is Now Fully A large Phase IIb study with R1626 was initiated in November 2007 to More About the Phase IIa Study and End-of-Treatment Results Presented at The Phase IIa study is a multicenter trial that enrolled 104 patients Patients were randomised into the following treatment groups: - Group A: R1626 1,500 mg twice a day plus Pegasys 180 mcg weekly for 4 - Group B: R1626 3,000 mg twice a day plus Pegasys 180 mcg weekly for 4 - Group C: R1626 1,500 mg twice a day plus Pegasys 180 mcg weekly plus - Group D (standard of care group): Pegasys 180 mcg weekly plus Copegus Following the 4 weeks of treatment in this study, all patients received The study found(1): - Data collected at 4 weeks showed that patients receiving the - At week 48, HCV was undetectable in 84% of patients receiving the - A higher incidence of grade 4 neutropaenia was reported in the R1626 - a High Barrier to the Development of Resistance In a separate oral presentation at EASL, it was reported that R1626 About Hepatitis C Hepatitis C, the most common chronic blood-borne infection, is About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leading All trademarks used or mentioned in this release are protected by law. References: (1). Nelson D, Pockros P, Godofsky E, et al. 84% end-of-treatment (2). Le Pogam S, Seshaadri A, Kang H, et al. Low level of resistance, low (3). World Health Organization. Initiative for Vaccine Research, Viral Source: Roche Contact: Mike Nelson, Roche, +41-79-572-5165, Michelle Marchione, Axon Communications, +44(0)208-439-9449
Two doctors under scanner for illegal kidney transplant (HT via Yahoo! India News)
Two doctors under scanner for illegal kidney transplant (HT via Yahoo! India News)
The crime branch is investigating two doctors from a reputable central Mumbai hospital for an illegal kidney transplant conducted nearly eight years ago. Also under the scanner are at least three members of the state government's authorisation committee for human organ transplantations for overlooking procedural discrepancies. Interim Results from Boceprevir Phase II Study in Genotype 1 Treatment-Naive Hepatitis C Patients Presented At EASL
Interim Results from Boceprevir Phase II Study in Genotype 1 Treatment-Naive Hepatitis C Patients Presented At EASL
MILAN, Italy, April 26 /PRNewswire/ -- Schering-Plough Corporation (NYSE:SGP) today reported that results from a planned interim analysis of an ongoing Phase II study of boceprevir, its investigational oral hepatitis C protease inhibitor, in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 were presented at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL). The ongoing study evaluates boceprevir in 28-week and 48-week treatment regimens. In a 28-week treatment regimen in which patients received 4 weeks of PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) prior to the addition of boceprevir (800 mg TID), the rate of sustained virological response at 12 weeks after the end of treatment (SVR 12) was 57 percent (ITT).(1-3) Importantly, this treatment regimen provided an indication of early predictability of response, with patients who had undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment achieving an SVR 12 rate of 86 percent. "These interim results are very encouraging, especially given the response seen with a shorter course of therapy in a difficult-to-treat patient population," said principal investigator Paul Kwo, M.D., associate professor of medicine and medical director, liver transplantation, Department of Medicine, Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, who presented the data. "Boceprevir has been well tolerated by patients in this study, including in the longer duration treatment arms, and we look forward to further results from this ongoing study." Overall, 77 percent of the 595 patients in the study were enrolled in the United States. African-Americans represent 16 percent of the patients enrolled and 7 percent of patients in the study are cirrhotic. In the ongoing study, known as HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir (800 mg TID) is being evaluated in three treatment regimens: 4 weeks of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) therapy followed by the addition of boceprevir to the combination for 24 or 44 weeks (totaling 28 or 48 weeks of treatment); boceprevir in combination with PEGINTRON and REBETOL at the doses described above for 28 or 48 weeks (triple combination); and boceprevir in combination with PEGINTRON and low-dose REBETOL (400-1000 mg daily) for 48 weeks, compared to a control of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) alone for 48 weeks (an approved treatment regimen). The primary endpoint of the study is sustained virologic response after 24 weeks of follow up. During a late-breaker oral presentation at EASL, Dr. Kwo presented interim results for the two 28-week boceprevir arms of the study. For patients receiving 4 weeks of PEGINTRON and REBETOL therapy prior to the addition of boceprevir, SVR 12 was 57 percent (59/103), compared to 55 percent (59/107) for patients in the boceprevir triple combination arm. For patients in these two boceprevir arms who had undetectable virus (HCV-RNA) after 4 weeks of boceprevir treatment (RVR), the SVR 12 rates were 86 percent (53/62) and 74 percent (31/42), respectively. SVR 12 rates are not yet available for patients in the 48-week boceprevir arms or the 48-week control arm, as treatment of these patients is ongoing. Safety data from the study showed that the most common adverse events reported in the boceprevir arms were fatigue, anemia, nausea and headache. No increase in skin adverse events (rash or pruritus) beyond what was seen in the PEGINTRON and REBETOL control arm was observed. Treatment discontinuations due to adverse events were between 11 and 15 percent for patients in the boceprevir arms, compared to 8 percent for the control arm. Early response rates at week 4 (RVR) and week 12 (EVR) of boceprevir treatment were increased for patients who received 4 weeks of PEGINTRON and REBETOL therapy prior to the administration of boceprevir (62 and 79 percent, respectively), compared to patients in the triple combination (38 and 69 percent) and control (8 and 34 percent) arms, respectively. In the 28-week boceprevir arms, these patients also had a reduction in viral breakthrough compared to patients in the triple combination arm (4 vs. 7 percent, respectively). "The results seen with this novel treatment paradigm will influence the design of our future clinical studies, as we plan to consider RVR at week 4 of boceprevir treatment as the criterion for determining which patients can receive a shorter course of boceprevir therapy and which patients should continue treatment for 48 weeks," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "Additionally, this strategy has the potential to reduce the likelihood of the development of resistance by identifying patients who are responders to interferon and ribavirin prior to their receiving a protease inhibitor." The rationale for this novel treatment regimen is based on the fact that both PEGINTRON and REBETOL reach steady-state concentrations by week 4, so patients have the protease inhibitor added at a time when the backbone drug levels have been optimized. In addition, the patient's immune system will have been activated and primed by PEGINTRON at the time that boceprevir is added to the regimen. This approach may minimize the period of time when there is a "functional monotherapy" with a direct antiviral, potentially reducing the likelihood for the development of resistance. The HCV SPRINT-1 study is currently ongoing at sites across the United States, Canada and Europe. Final results from the study are anticipated to be available in early 2009, and will be submitted for presentation at an appropriate medical meeting. About Hepatitis C Hepatitis C is a serious and potentially life-threatening disease. It is the most common blood-borne infection in America and Europe, and the most common form of liver disease, affecting nearly 5 million people in the United States, 5 million in Europe and some 200 million people worldwide. It is the leading cause of cirrhosis and liver cancer, and the number one reason for liver transplants in the United States and Europe. About PEGINTRON In the United States, PEGINTRON is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age. Important Safety Information Regarding U.S. Labeling for PEGINTRON and REBETOL Alpha interferons, including PEGINTRON and INTRON(R) A, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON and/or INTRON A therapy. Use with Ribavirin: Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen. Contraindications PEGINTRON is contraindicated in patients with hypersensitivity to PEGINTRON 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. INTRON A (Interferon alfa-2b, recombinant) for Injection is contraindicated in patients with hypersensitivity to INTRON A or any component of the product, autoimmune hepatitis, and decompensated liver disease. PEGINTRON or INTRON A in combination with REBETOL therapy is additionally contraindicated in patients with hypersensitivity to ribavirin or any other component of the product, women who are 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/min. Avoid 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. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients during therapy and 6 months post-treatment. Patients should use at least two effective forms of contraception and have monthly pregnancy tests during therapy and for 6 months after completion of therapy. 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 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214. Incidence of Adverse Events There are no new adverse events specific to PEGINTRON as compared to INTRON A; however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEGINTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEGINTRON. Psychiatric adverse events, which include insomnia, were common (57%) with PEGINTRON but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEGINTRON. The following serious or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots. In the PEGINTRON/REBETOL combination trial, the incidence of serious adverse events was 17% in the PEGINTRON/REBETOL groups compared to 14% in the INTRON A/ REBETOL group. The incidence of severe adverse events in the PEGINTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34% of those receiving INTRON A/REBETOL. In a study with weight-based ribavirin, there was a higher rate of anemia among patients in the weight-based dosing group (29%) compared to the flat-dosing group (19%). The majority of these cases were mild and responded to dose reductions. Serious adverse events were similar between the two groups (12%), and discontinuations for adverse events (15% in weight-based dosing and 14% in flat dosing) were also similar. Dose modifications due to adverse events occurred more frequently in the weight-based dosing group (29%) compared to the flat-dosing (23%) group. Additional Safety Information Relapse of drug addiction/overdose has occurred in patients on PEGINTRON therapy. Aggressive behavior sometimes directed towards others has occurred in patients with and without a previous psychiatric disorder during PEGINTRON and/or INTRON A treatment and follow-up. If patients develop psychiatric problems, including clinical depression, it is recommended that patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PEGINTRON and/or INTRON A be discontinued, and the patient be carefully followed with psychiatric intervention, as appropriate. Cases of encephalopathy have been observed in some patients, usually elderly, treated with higher doses of PEGINTRON and/or INTRON A. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha therapies, including PEGINTRON and INTRON A. Dental and periodontal disorders have been reported in patients receiving PEGINTRON or INTRON A in combination with REBETOL therapy. Please see important full U.S. prescribing information and the Medication Guide for PEGINTRON at www.schering-plough.com. About Schering-Plough Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com. SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's clinical development plans and the potential for boceprevir. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item 1A. "Risk Factors" in Schering-Plough's 2007 10-K/A. Endnotes: 1 SVR 12 is defined as undetectable HCV-RNA in plasma at 12 weeks after
CONTACT: Media, Robert J. Consalvo, +1-908-298-7409; or Investors, Alex Web site: http://www.schering-plough.com/ Company News On-Call: http://www.prnewswire.com/comp/777050.html NOTE TO EDITORS: Schering-Plough press releases are available on the company's Web site at http://www.schering-plough.com. Schering-Plough press releases are also available on PRNewswire's Web site at http://www.prnewswire.com/comp/777050.html ------- BARACLUDE(R) (Entecavir) Treatment Resulted In Greater Viral Load Suppression Compared to Adefovir at 96 Weeks In Antiviral-Naive Adult Chronic Hepatitis B E-Antigen Positive Patients
BARACLUDE(R) (Entecavir) Treatment Resulted In Greater Viral Load Suppression Compared to Adefovir at 96 Weeks In Antiviral-Naive Adult Chronic Hepatitis B E-Antigen Positive Patients
MILAN, Italy, April 26 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE:BMY) today announced new data from the E.A.R.L.Y. study (ETV-079), in which treatment of antiviral-naive adult chronic hepatitis B patients with BARACLUDE(R) (entecavir) resulted in greater long-term viral load reduction than adefovir at 96 weeks -- consistent with earlier 12-week results (primary endpoint). Suppression of viral load to undetectable levels is a measure of antiviral treatment response and is an important goal of chronic hepatitis B treatment. These data were presented today in Milan, Italy, at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL). The E.A.R.L.Y. study is an open-label, randomized, viral kinetics study of 69 antiviral-naive chronic hepatitis B e-antigen (HBeAg) positive patients, comparing the antiviral activity of BARACLUDE and adefovir. All patients in this study had a high viral load at study entry.(1) Of the 49 patients who remained in the study at 96 weeks, 79 percent (n=23/29) of BARACLUDE-treated patients and 50 percent (n=10/20) of adefovir-treated patients achieved undetectable viral load.(2) The mean reduction in viral load from baseline in patients treated with BARACLUDE was -7.82 log(10) copies/mL and was -5.96 log(10) copies/mL in patients treated with adefovir at week 96. "BARACLUDE maintains considerable antiviral efficacy through two years of treatment in this analysis," said Nancy Leung, M.D., of the Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China. "This is important information for health care providers to consider when evaluating initial treatment options to suppress viral load in antiviral-naive chronic hepatitis B patients." The safety profile was comparable between the treatment groups through 96 weeks. Three percent of patients receiving BARACLUDE(R) (entecavir) (n=1) and 12 percent of patients receiving adefovir (n=5) experienced a serious adverse event. No deaths were observed in either treatment group. The most common adverse events occurring in greater than 10 percent of patients in either treatment group were headache, nasopharyngitis, upper respiratory tract infection, influenza, pyrexia, urinary tract infection, cough, back pain, and diarrhea. Data Results By week 96, 22 of the 69 enrolled patients had discontinued the study. Of these, two patients receiving adefovir discontinued due to investigator-determined lack of treatment efficacy between the beginning of year two dosing and the 96-week analysis. The 96-week data reported below represent the results of the 49 patients who entered year two dosing (29 BARACLUDE-treated patients and 20 adefovir-treated patients), using the non-completer = failure (NC=F) method of analysis. Week 96 -- BARACLUDE-treated patients achieved a mean change in viral load of
-- BARACLUDE-treated patients achieved a mean change in viral load of
-- 83 percent of patients in the BARACLUDE arm (n=30) and 82 percent of
The primary endpoint for the study was mean reduction in HBV DNA levels at week 12. The secondary endpoints included the mean change in viral load from baseline through week 96, the proportion of patients in each treatment group who achieved ALT normalization, HBeAg loss and HBe seroconversion, and safety. Sixty-nine patients were randomized in the study and of these, 65 completed the first 12 weeks. Patients in this study received either 0.5 mg of BARACLUDE(R) (entecavir) once daily (n=33) or 10 mg of adefovir once daily (n=32) for a minimum of 52 weeks. Patients in the BARACLUDE treatment group had a mean baseline viral load of 10.26 log(10) copies/mL. Patients in the adefovir treatment group had a mean baseline viral load of 9.88 log(10) copies/mL. According to study protocol, patients who achieved a treatment response at 52 weeks discontinued treatment and entered a follow-up monitoring phase. Three BARACLUDE-treated patients and four adefovir-treated patients met this criterion and entered the follow-up monitoring phase lasting up to 48 weeks. Patients who did not achieve a treatment response at 52 weeks continued on study to 96 weeks. Treatment response in this study is defined as HBeAg seroconversion and viral load less than 10^4 copies/mL for 24 weeks, with undetectable viral load at the end of the 24-week period. Indication and Important Safety Information About BARACLUDE(R) (entecavir) 0.5 mg/1 mg Tablets BARACLUDE(R) (entecavir) is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults where the virus is multiplying and damaging the liver. BARACLUDE does not cure HBV or stop the spread of HBV to others. People should not take BARACLUDE if they are allergic to it or any of its ingredients. BARACLUDE has not been studied in children and is not recommended for anyone less than 16 years of age. People taking BARACLUDE(R) (entecavir) should tell their healthcare provider right away if they feel very weak or tired, have unusual muscle pain, have trouble breathing, have stomach pain with nausea and vomiting, feel cold -- especially in their arms and legs, feel dizzy or lightheaded, or have a fast or irregular heartbeat, as they may be signs of a serious condition called lactic acidosis (buildup of an acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. Some people who have taken medicines like BARACLUDE have developed serious liver problems called hepatotoxicity. This may occur with liver enlargement (hepatomegaly) and fat in the liver (steatosis). People should call their healthcare provider right away if they get any of the following signs of liver problems: yellowing (jaundice) of the skin or the white part of the eyes, darkening of the urine, lightening in the color of bowel movements (stools), not feeling like eating food for several days or longer, feeling sick to the stomach (nausea), or having lower stomach pain. Lactic acidosis and hepatotoxicity have happened in some people taking medicines like BARACLUDE. For people taking BARACLUDE who have or get HIV (the virus that can cause AIDS) and are not taking medicines for HIV at the same time, some HIV treatments that they may take in the future may be less likely to work. People are advised to get an HIV test before starting to take BARACLUDE and anytime that there is a chance they were exposed to HIV. BARACLUDE will not help HIV infection. In some people, hepatitis B symptoms may get worse or become very serious when they stop taking BARACLUDE. People should not stop BARACLUDE without talking to their healthcare provider. Healthcare providers will need to follow their patients and do blood tests to check the liver when BARACLUDE is stopped. People should tell their healthcare provider if they have or develop kidney problems because their healthcare provider may want to do tests to see if a lower dose is needed. Because BARACLUDE is removed from the body through the kidneys, a dose adjustment may be required. Healthcare providers may want to perform tests to determine whether a patient needs a lower dose or should take BARACLUDE less often than once a day. It is not known if BARACLUDE(R) (entecavir) is safe to use during pregnancy. It is not known if BARACLUDE helps to prevent a pregnant mother from passing HBV to her baby. A pregnant woman and her healthcare provider will need to decide if BARACLUDE is right for her. A woman should not breastfeed if she is taking BARACLUDE. People should discuss with their healthcare provider all prescription and non-prescription medicines, vitamins, herbal supplements, and other health preparations they are taking or plan to take. BARACLUDE may interact with medicines that leave the body through the kidneys. The safety and effectiveness of BARACLUDE in liver transplant recipients is unknown. The most common side effects of BARACLUDE in clinical studies were headache, tiredness, dizziness, and nausea. This list of side effects is not complete at this time because BARACLUDE is still under study. People should report any new or continuing symptom to their healthcare provider. BARACLUDE should be taken once daily on an empty stomach (at least two hours after a meal and two hours before the next meal). To learn more about BARACLUDE and for Full Prescribing Information, including boxed WARNINGS, please visit http://www.bms.com/. Bristol-Myers Squibb is a global biopharmaceutical and related health care products company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb at www.bms.com. BARACLUDE(R) (entecavir) is a trademark of Bristol-Myers Squibb Company. Full prescribing information for BARACLUDE, including boxed WARNINGS, is available at http://www.bms.com/. (1) Patients were required to have a screening viral load of greater than
CONTACT: Sonia Choi, Communications, +1-609-252-5132, Web site:
Ochsner Health System » Multi-Organ Transplant Institute
Since its inception in 1984, the Ochsner Multi-Organ Transplant Institute has performed more than 2,700 life-saving liver, kidney and pancreas, heart, and lung transplants making [continued]
Basic Science Discoveries Yield Progress in Hepatology (PR Newswire via Yahoo! Finance)
Basic Science Discoveries Yield Progress in Hepatology (PR Newswire via Yahoo! Finance)
At today's sessions of the 43rd Annual Meeting of the European Association for the Study of the Liver , experts reported advances in basic research that have important implications for the eventual treatment of people with chronic liver diseases. New Pegasys Data Show Hepatitis B Patients Achieve Highly Positive Treatment Response That Comes as Close to a Cure as Possible
New Pegasys Data Show Hepatitis B Patients Achieve Highly Positive Treatment Response That Comes as Close to a Cure as Possible
BASEL, Switzerland, April 26/PRNewswire/ -- - No Nucleoside/Nucleotide Analogue Treatments Have Shown Similar Results New data revealed today show that a significant number of patients with The clinical improvements associated with s antigen clearance include a These new data were presented at the European Association for the Study Remarkably, the number of patients achieving s-antigen clearance "These results with Pegasys in the treatment of HBV are unprecedented, More About the Study The data are from an international pivotal study of Pegasys which The results reported at EASL, at 4 years post-treatment, are collected Notes for Editors About Chronic Hepatitis B Chronic hepatitis B is a serious global healthcare problem that affects Pegasys in Hepatitis B Pegasys is the only pegylated interferon to be approved for the treatment About Roche Headquartered in Basel, Switzerland, Roche is one of the world's References: 1. Marcellin P, Piratvisuth T, Brunetto M, et al. Virological and 2. Fattovich G, Giustina G, Sanchez-Tapias J, et al. Delayed clearance of 3. Chen YC, Sheen IS, Chu CM, Liaw YF. Prognosis following spontaneous 4. Moucari R, Korevaar A, Asselah T, et al. High Rates of HBsAg 5. Wu TT, Hsu HC, Chen DS, et al. Clearance of hepatitis B surface 6. Liaw Y-F, Pao C-C, Chu C-M, et al. Changes of serum hepatitis B virus 7. Song BC, Suh DJ, Lee HC, et al. Hepatitis B e antigen seroconversion 8. Chien RN, Yeh CT, Tsai SL, et al. Determinants for sustained HBeAg 9. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al. Long-term therapy 10. Leung NW, Lai CL, Chang TT, et al. Extended lamivudine treatment in 11. Marcellin P, Chang TT, Lim SG, et al. Long-term efficacy and safety 12. Marcellin P, Lau GKK, Bonino F, et al. Peginterferon alfa-2a alone,
Contact: Mike Nelson, Roche, +41-(79)-572-5165; Michelle Marchione, Axon Communications, +44(0)208-439-9449
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