Alliance Health Networks’ Hepatitis Connect Partners with One80Center to Raise Awareness About Hepatitis C Treatment and Testing

Members at Beverly Hills Rehab Center with HCV Can Now Benefit from Quality Resources and Front-Line Treatment Information on the Hepatitis-Focused Social Network

Salt Lake City and Los Angeles (PRWEB) October 16, 2012

Alliance Health Networks, the leading social networking company serving consumers and the healthcare industry, today announced it has partnered with One80Center. The partnership encourages clients at the Beverly Hills rehab and wellness center with the Hepatitis C virus (HCV) to join the Hepatitis Connect social network and help raise awareness about the need for Hepatitis C testing and treatment.

People with HCV at One80Center, a drug and alcohol rehabilitation center specializing in unparalleled addiction treatment in a private setting, will greatly benefit from joining http://www.hepatitisconnect.com - a unique online resource that provides the latest treatment updates product reviews and relevant news articles. Hepatitis Connect is part of Alliance Health’s growing portfolio of more than 50 health condition-specific social networks currently serving more than 1.5 million registered users. Membership in HepatitisConnect.com is free and anonymous.

“By working in connection with quality institutions like One80Center, Hepatitis Connect hopes to raise awareness about the need for Hepatitis C testing and treatment,” said John Lavitt, Hepatitis Connect site administrator and patient advocate. “With incredibly effective new treatments available, there is no point for this silent plague to continue. At Hepatitis Connect, our ultimate goal is to help save lives.”

The Center for Disease Control and Prevention estimates that more than two million people in the United States are unaware they are infected with Hepatitis C. The CDC recently issued a recommendation that anyone born between 1945 and 1965 - every baby boomer in the United States - be tested. People in drug & alcohol recovery often test positive.

“Our focus when a client enters treatment is to help them develop the tools that will lead to sustainable recovery,” said Alex Shohet, co-founder of One80Center and a former board member of the American Liver Foundation. “Before the Internet, I went through Hepatitis C treatment myself and wish I had access to a supportive community like Hepatitis Connect. To recommend such a resource helps us further empower our members infected with HCV to develop the skills necessary to live a healthy, happy and productive life.”

“These referral partnerships add tremendous value to our social networks,” said Dan Hickey, senior vice president of products at Alliance Health Networks. “We intend to pursue similar opportunities with other providers serving people for whom peer support often proves enormously beneficial.”

About Alliance Health Networks

Alliance Health Networks is building a free and independent social engagement platform that gives people the power to navigate their personal health journey. The company owns and operates more than 50 social networks and 20 mobile versions serving over 1.5 million registered members. Alliance Health leverages social networks to help consumers more actively manage their care through personal connections, powerful tools, and deeper insights. For more information, visit: http://www.alliancehealthnetworks.com.

Media Contacts:

Alliance Health Networks Public Relations
Jeff DuBois
801-461-9789
jeff(at)methodcommunications(dot)com

John Lavitt
Patient Advocate & Site Administrator
Hepatitis Connect
310-962-7376
jmlavitt(at)alliancehealth(dot)com

Source

Cognitive training helps adults with HIV, UAB study finds

Tuesday, October 16, 2012 

By Jennifer Lollar

As more effective antiretroviral therapy has evolved over the past 30 years, HIV/AIDS has shifted from an acute to a chronic condition. But as patients live longer, research indicates that they are experiencing cognitive impairments at a higher rate than people without the disease.

A new study by researchers at the University of Alabama at Birmingham, published online Oct. 15, 2012 in the Journal of the Association of Nurses in AIDS Care, shows that cognitive training exercises can help — improving mental processing speed and the ability to complete daily tasks in middle-age and older adults with HIV.

“Today, more than 25 percent of people living with HIV in the United States are older than 50,” says the study’s lead author, David Vance, Ph.D., associate professor in the UAB School of Nursing, associate director of the UAB Center for Nursing Research and scientist in the UAB Edward R. Roybal Center for Research on Applied Gerontology. “Thirty to 60 percent of adults living with HIV experience cognitive problems at some point in the illness, a condition known as ‘HIV-associated neurocognitive disorders.’ It’s imperative for people with HIV and their treatment teams be proactive in addressing cognitive problems as they emerge, because without treatment these issues — which mimic premature aging — can lead to difficulties in working and living independently.”

In a pilot study conducted at UAB, 46 middle-age and older adults with HIV were randomly assigned to 10 hours of computerized speed-of-processing training or to no cognitive training. “Speed of processing” refers to how quickly a person can automatically perform simple tasks — such as assimilating information, comprehending relationships and developing reasonable conclusions — that require attention and focused concentration without really having to think them through.

Speed-of-processing training is essentially exercising the brain. In the UAB study, it involved subjects using a computer program to perform challenging activities designed to preserve, enhance or develop cognitive abilities. Researchers measured the cognitive function of each group before and after the study. The study utilized computerized brain-speed training from Posit Science for the experimental group. The UAB faculty on this study have no financial ties to Posit Science.

Speed-of-processing training has been studied extensively in older adults, Vance says. “These studies have shown that even as people age, computer-based cognitive training improves speed of processing, sustained visual attention, and complex reaction time. The goal was to see if the same held true for people with HIV-based cognitive issues.”

That turned out to be the case, Vance says. “The group that did the computer-based training showed significant improvements in visual processing speed and attention — an important measure of brain function — as well as in timed instrumental activities of daily living, which measure how quickly a person can do everyday activities, versus the group that did not use the computer-based training,” he explains.

In an exit survey, participants who did the computer-based training also indicated that they felt the training had improved their functioning moderately or better in mental abilities, memory, speed of processing and attention.

“This study shows people with HIV have non-pharmacologic options to consider that can improve cognitive functioning in areas that directly affect quality of life,” Vance says. “Based on this research, my team would suggest cognitive exercises to people with HIV who have noticed issues and who want to improve their brain health.”

Vance adds that even though this was a small study group, the findings are encouraging and that further studies about this type of intervention should include a larger sample of patients and compare different types of cognitive training exercises.

Neil Giuliano, CEO of San Francisco AIDS Foundation, noted that this may open new possibilities for taking on the cognitive issues that are a key component of addressing HIV and aging.

“By 2015, most Americans with HIV will be over 50,” Giuliano said. “This is an important pilot study, and one that merits further research to better understand the role addressing cognitive function can play in achieving better long term outcomes for older adults with HIV.”

Source

Percutaneous RFA for HCC leads to frequent recurrences, high survival rates

Kim YS. J Hepatol. 2012;doi:10.1016/j.jhep.2012.09.020.

October 12, 2012

Patients with hepatocellular carcinomas treated with percutaneous radiofrequency ablation experienced frequent tumor recurrences but had high 10-year survival rates in a recent study.

Researchers evaluated data from 1,305 patients who underwent percutaneous radiofrequency ablation (RFA) for 1,502 hepatocellular carcinomas between April 1999 and April 2011, with a median follow-up of 33.4 months.

RFA was successful within one session in 94.8% of cases and complete ablation occurred in 1,482 tumors during initial treatments, indicating an effectiveness rate of 98.7%. The tumor progression rate was 9.7% at 1 year, 27% at 5 years and 36.9% at 10 years. Risk for tumor progression was associated with larger tumor size (B=0.584, P=.001) via multivariate analysis.

Among 1,283 participants who survived longer than 30 days after complete treatment, recurrence occurred in 795 cases, with one to 17 incidents per patient. Intrahepatic distant recurrence occurred in 54.8% of patients during follow-up, with a cumulative rate of 24.4% at 1 year, 73.1% at 5 years and 88.5% at 10 years and a 59.7% survival rate (mean recurrence-free survival time=43.6 months). Extrahepatic recurrence occurred in 12.6% of patients, with a cumulative rate of 2.7% at 1 year, 19.1% at 5 years and 38.2% at 10 years and a survival rate of 32.3% (mean recurrence-free survival time=113.3 months).

There were 407 deaths; causes included HCC progression (333 patients), hepatic failure or complications related to cirrhosis (39 patients) or other systemic or organ complications (35 patients). Mean overall survival time was 82.9 months after RFA, with cumulative survival rates of 95.5% at 1 year, 59.7% at 5 years and 32.3% at 10 years. Investigators observed associations between poor survival and Child-Turcotte-Pugh class B (B=–1.054, P<.001), advanced age (B=0.043, P=.01), extrahepatic recurrence (B=0.971, P=.007) and not having received antiviral therapy during follow-up (B=–0.699, P=.034).

“Ten-year survival outcomes after percutaneous radiofrequency ablation as a first-line therapeutic option of hepatocellular carcinoma are excellent and comparable to those of surgery, even though tumor recurrences are relatively frequent,” the researchers concluded. “Aggressive antiviral therapy after radiofrequency ablation appears to prolong survival of the patients if the underlying liver disease is related to hepatitis viral infection.”

Source

Advanced probe reliably measured LSM in nonobese NAFLD patients

Wong VWS. Am J Gastroenterol. 2012;doi:10.1038/ajg.2012.331.

October 16, 2012

A new, larger transient elastography probe measured liver stiffness effectively in patients with nonalcoholic fatty liver disease, but its accuracy and reliability were reduced among obese patients in a recent study.

Researchers used M and new XL probes to perform liver stiffness measurement (LSM) on 193 patients with nonalcoholic fatty liver disease (NAFLD) in France and Hong Kong. The XL probe is larger, uses a lower ultrasound frequency than the M probe and is intended to improve measurement success among obese patients. Biopsy was performed within 24 hours after LSM, and liver histology served as reference standard to determine LSM accuracy.

Overall accuracy was similar between probes, and measurements correlated well (r2=0.9025, P<.001), but the XL probe often indicated lower LSM measurements (80% of patients). AUROC analysis produced the following values according to fibrosis staging:

• F2 or higher: 0.83 for M probe; 0.80 for XL
• F3 or higher: 0.87 for M; 0.85 for XL
• F4: 0.89 for M; 0.91 for XL

Investigators established an ideal cutoff of 7.2 kPa for F3 disease or higher, with a sensitivity and specificity of 78%, a PPV of 60% and NPV of 89%.

The XL probe obtained 10 valid acquisitions (95% of cases compared with 81%, P<.001)and a success rate greater than 60% (90% of cases compared with 74%, P<.001)more frequently than the M probe. Failure occurred in 10% of patients with the M probe vs. 2% with the XL (P=.002).

Success rate differences were more pronounced among obese patients, with 10 valid acquisitions obtained in 93% of patients compared with 60% using the M probe (P<.001).

Discordance of two or more stages between histology and XL probe results occurred in 9% of patients. Investigators observed an independent association between discordance and a BMI greater than 35 kg/m2 (aOR=9.09; 95% CI, 1.10-75.43).

“XL probe achieved successful and reliable LSM in the majority of NAFLD patients … but obesity is associated with less accurate and reliable measurements,” the researchers wrote. “With high negative predictive value, the technique can be used to exclude advanced fibrosis and cirrhosis reliably in routine clinical practice.”

Disclosure: See the study for a full list of relevant disclosures.

Source

Bristol-Myers Squibb to Present New Data Demonstrating Company’s Continuing Commitment to Research and Development in Liver Disease at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting

• Late breaker oral presentation will feature first report of SVR₄ results from an interferon- and ribavirin-free, 12-week, triple DAA, investigational regimen of daclatasvir, asunaprevir and BMS-791325 in hepatitis C (HCV)
• Oral presentations on HCV investigational compounds daclatasvir, asunaprevir and peginterferon lambda-1a (Lambda) demonstrate diversity of portfolio
• Late breaker poster presentations will report Phase II data on Lambda in the treatment of HCV and chronic hepatitis B

Tuesday, October 16, 2012 11:28 am EDT

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 27 abstracts on the Company’s research in liver disease have been accepted for presentation at The Liver Meeting^® 2012, the 63^rd annual meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, November 9 – 13.

Bristol-Myers Squibb is studying a portfolio of compounds with the potential to address unmet medical needs for patients with liver disease, including the investigational compounds daclatasvir, asunaprevir, Lambda and BMS-791325 being studied in hepatitis C (HCV), Lambda being studied in hepatitis B (HBV), and BARACLUDE^®(entecavir). BARACLUDE is currently indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in aminotransferases (ALT or AST), or histologically active disease.

Key presentations include:

• A late breaker oral presentation of SVR₄ results with an interferon- and ribavirin (RBV)-free, 12-week regimen of daclatasvir, asunaprevir and BMS-791325 in a Phase II study of treatment-naïve patients with chronic HCV genotypes 1, 2 or 3
• An oral presentation of SVR₁₂ results with a regimen of daclatasvir and asunaprevir, with or without alfa interferon (alfa)/RBV, in a Phase II study of chronic HCV genotype 1 null responders
• A late breaker oral presentation on the first report of SVR₄ results from 12-week treatment arms of a Phase II study of daclatasvir and GS-7977, with or without RBV, in treatment-naïve patients with chronic HCV genotype 1, 2 or 3
• A late breaker poster presentation on SVR₁₂ results from the D-LITE Phase II study of Lambda in combination with RBV and either daclatasvir or asunaprevir in patients with chronic HCV genotype 1
• A late breaker poster presentation on Lambda versus alfa in a Phase II study of patients with chronic hepatitis B

“Bristol-Myers Squibb has a long-term commitment to viral hepatitis and has been at the forefront of the evolving science in both hepatitis B and C, where there remains considerable unmet medical need,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “In hepatitis C, we believe improving treatment outcomes requires a personalized approach to meet the needs of the diverse patient population. The data we are presenting at AASLD help expand our understanding of the potential efficacy and safety profiles of our investigational hepatitis C compounds and support our ongoing Phase III development programs.”

The Company will also show three presentations of outcomes research/real-world data that add to the understanding of the prevalence of and current treatment patterns in HBV, HCV and hepatocellular carcinoma (HCC).

The complete list of Bristol-Myers Squibb data presentations is below. Abstracts can be accessed on the AASLD website at http://aasld2012.abstractcentral.com/.

 

Title		Date/Time
Chronic Hepatitis B: BARACLUDE (entecavir) Clinical Data
Entecavir + Adefovir Versus Lamivudine + Adefovir Or Entecavir Alone In Lamivudine-Resistant Chronic Hepatitis B: 96-Week Data From The DEFINE Study		November 10, 2:00 – 7:30 p.m.
Antiviral Efficacy of Entecavir in Black/African American and Hispanic patients with Chronic Hepatitis B who are nucleos(t)ide-naïve		November 10, 2:00 – 7:30 p.m.
Randomized, observational study of long-term entecavir treatment versus other standard of care nucleos(t)ide analog therapy in nucleos(t)ide-naïve patients with chronic hepatitis B from a ‘real-world’ clinical practice setting in China		November 10, 2:00 – 7:30 p.m.
Disease and Treatment Perceptions Among Asian Americans Diagnosed with Chronic Hepatitis B Infection		November 10, 2:00 – 7:30 p.m.
Hepatitis C: Direct-Acting Antiviral Data
Sustained Virologic Response in Chronic HCV Genotype (GT) 1-Infected Null Responders With Combination of Daclatasvir (DCV; NS5A Inhibitor) and Asunaprevir (ASV; NS3 Inhibitor) With or Without Peginterferon Alfa- 2a/Ribavirin (PEG/RBV)		November 11, 4:45 – 5:00 p.m.
First Ever Successful Use of Daclatasvir and GS-7977, an Interferon-Free Oral Regimen, in a Liver Transplant Recipient with Severe Recurrent Hepatitis C		November 10, 2:00 – 7:30 p.m.
Comparison of Pre-Existing and Emerging Resistance-Associated Variants in US, EU and Japanese HCV Genotype 1b Prior Interferon Alfa (IFN-α) Non Responders and IFN-α Ineligible Patients Treated with Daclatasvir and Asunaprevir		November 11, 8:00 a.m. – 5:30 p.m.
Characterization of HCV NS5A Resistance Variants in Naive Patients Infected with Genotypes 2 and 3 Receiving Short-Term Treatment of Daclatasvir in Combination with Pegylated Interferon-Alfa and Ribavirin		November 11, 8:00 a.m. – 5:30 p.m.
Characterization of HCV Genotype 1 NS5A Resistance Variants From the Phase 2b COMMAND-1 Study: Daclatasvir Plus Peginterferon-alfa /ribavirin in Treatment-naive Patients		November 11, 8:00 a.m. – 5:30 p.m.
Twelve- or 16-Week Treatment With Daclatasvir Combined With Peginterferon Alfa and Ribavirin for Hepatitis C Virus Genotype 2 or 3 Infection: Command GT2/3 Study		November 11, 8:00 a.m. – 5:30 p.m.
Daclatasvir, an NS5A Replication Complex Inhibitor, Combined With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive HCV-Genotype 1 or 4 Subjects: Phase 2b COMMAND-1 SVR12 Results		November 11, 8:00 a.m. – 5:30 p.m.
High Rate of Sustained Virologic Response with the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B inhibitor), With or Without Ribavirin, in Treatment-Naïve Patients Chronically Infected With HCV Genotype 1, 2, or 3		November 12, 3:15 – 3:30 p.m.
An Interferon-free, Ribavirin-free 12-Week Regimen of Daclatasvir (DCV), Asunaprevir (ASV), and BMS-791325 Yielded SVR4 of 94% in Treatment- Naïve Patients with Genotype (GT) 1 Chronic Hepatitis C Virus (HCV) Infection		November 12, 3:30 – 3:45 p.m.
Asunaprevir in Japanese Subjects in Phase 2: Exposure-Safety Versus US/EU-Based Subjects and Preliminary Assessment of Correlation with Single Nucleotide Polymorphisms (SNPs) in Liver Uptake Transporters		November 13, 8:00 a.m. – Noon
Effect of Hepatic Impairment on the Pharmacokinetics of Asunaprevir (BMS-650032, ASV)		November 13, 8:00 a.m. – Noon
Hepatitis C and B: PEG-Interferon Lambda Data
Peginterferon Lambda-1a (Lambda) is less likely to induce clinically significant neuropsychiatric symptoms during the treatment of chronic hepatitis C virus (HCV) infection, compared to Peginterferon alfa-2a (Alfa)		November 11, 8:00 a.m. – 5:30 p.m.
Peginterferon Lambda-1a (Lambda) is Associated With Less Autoimmune Thyroid Disease and Serious Autoimmune Disease Than Peginterferon Alfa- 2a (Alfa) When Used in Combination With Ribavirin (RBV) for the Treatment of Chronic Hepatitis C Virus Infection		November 11, 8:00 a.m. – 5:30 p.m.
Peginterferon Lambda, a New Potential Therapeutic Option for the Treatment of Chronic Hepatitis B: A Phase 2B Comparison with Peginterferon Alfa in Patients with HBeAg-Positive Disease		November 12, 8:00 a.m. – 5:30 p.m.
Sustained Virologic Response (SVR12) in HCV Genotype 1 Patients Receiving Peginterferon Lambda in Combination With Ribavirin and Either Daclatasvir or Asunaprevir: Interim Results From the D-LITE Study		November 12, 8:00 a.m. – 5:30 p.m.
Peginterferon Lambda–1a (Lambda) Compared to Peginterferon Alfa–2a (Alfa) in Treatment–Naïve Patients With HCV Genotypes (GT) 1 or 4: SVR24 Results From EMERGE Phase 2b		November 13, 8:45 – 9:00 a.m.
First Report of Peginterferon Lambda/Ribavirin in Combination With Either Daclatasvir or Asunaprevir in HCV Genotype 1 Japanese Subjects: Early Sustained Virologic Response (SVR4) Results From the D-LITE Japanese Sub-Study		November 13, Noon – 12:15 p.m.
Baseline CXCR3 Ligand Levels are Associated With Early Virologic Response to Treatment With Peginterferon Lambda-1a in Chronic Hepatitis C Patients in a Phase 2b Study		November 13, 8:00 a.m. – Noon
Pegylated Interferons Lambda-1a and Alfa-2a Display Different Gene Induction and Cytokine Release Profiles in Both Human Hepatocytes and Peripheral Blood Mononuclear Cells		November 13, 8:00 a.m. – Noon
Hepatitis C: Outcomes Research / Real-World Data
Genome-Wide Association Study to Identify Potential Single Nucleotide Polymorphisms Associated with Hepatocellular Carcinoma among Chronic Hepatitis C Patients		November 11, 8:00 a.m. – 5:30 p.m.
Reasons for Treatment (Tx) Discontinuation Among Hepatitis C (HCV) Patients Treated in Clinical Practice		November 13, 8:00 a.m.- Noon
Hepatocellular Carcinoma: Brivanib Data
Brivanib (BRI) versus Sorafenib (SOR) as First-line Therapy in Patients with Unresectable, Advanced Hepatocellular Carcinoma (HCC): Results from the Phase 3 BRISK-FL Study		November 12, 4:15 – 4:30 p.m.
Hepatocellular Carcinoma: Outcomes Research
Observations of Hepatocellular Carcinoma (HCC) Management Patterns from the Global HCC BRIDGE Study: Global Comparison of Outcomes by Locoregional Therapy		November 13, 8:00 a.m. – Noon

INDICATION and IMPORTANT SAFETY INFORMATION about BARACLUDE (entecavir) Tablets:

INDICATION

BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The following points should be considered when initiating BARACLUDE (entecavir):

• This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease.
• Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease.
• Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY

• Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
• Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE (entecavir) is used to treat chronic HBV infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART).
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, alone or in combination with antiretrovirals.

Warnings and Precautions

• Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.
• Lactic acidosis with BARACLUDE (entecavir) use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. BARACLUDE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Adverse Reactions

• In clinical trials in patients with compensated liver disease, the most common (≥3%) adverse reactions of any severity with at least a possible relation to study drug for BARACLUDE-treated subjects were headache, fatigue, dizziness, and nausea. In these trials, the most common adverse reactions of moderate to severe intensity (grades 2-4) were diarrhea, dyspepsia, nausea, vomiting, fatigue, headache, dizziness, somnolence, and insomnia.
• In the decompensated liver disease trial, the most common adverse reactions of any severity among patients treated with BARACLUDE, regardless of causality, included: peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%). In this trial, 18% (18/102) of BARACLUDE (entecavir) patients and 20% (18/89) of adefovir patients died during the first 48 weeks of therapy. The majority of those deaths were due to liver related causes.

Drug Interactions

BARACLUDE is primarily eliminated by the kidneys, therefore coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Patients should be monitored closely when receiving BARACLUDE with other renally-eliminated drugs.

Pregnancy and Nursing Mothers

• There are no adequate and well-controlled studies of BARACLUDE in pregnant women. BARACLUDE should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits.
• There are no studies on the effect of BARACLUDE (entecavir) on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
• It is not known whether BARACLUDE is excreted into human milk; however, many drugs are excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants from BARACLUDE, risks and benefits should be considered when deciding whether to discontinue breast-feeding or discontinue BARACLUDE in nursing women.

Pediatric Use

• Safety and effectiveness of BARACLUDE in pediatric patients below the age of 16 years have not been established.

Renal Impairment

• Dosage adjustment of BARACLUDE is recommended for patients with a creatinine clearance <50 mL/min, including those on hemodialysis or continuous ambulatory peritoneal dialysis.
• The safety and efficacy of BARACLUDE in liver transplant recipients are unknown. Renal function must be carefully monitored both before and during treatment with BARACLUDE in a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus.

Dosage and Administration

BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).

The recommended dose of BARACLUDE:

• in nucleoside-naïve adults and adolescents (16+ yrs) with compensated liver disease is 0.5 mg once daily
• in adults and adolescents (16+ yrs) with compensated liver disease, and refractory to lamivudine or with known lamivudine or telbivudine resistance mutations (rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L) is 1 mg once daily
• in adults with decompensated liver disease is 1 mg once daily

The optimal duration of treatment with BARACLUDE (entecavir) for patients with chronic HBV infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

Additional Information

BARACLUDE is not a cure for HBV. Patients should be advised that treatment with BARACLUDE has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.

Please see accompanying Full Prescribing Information, including Boxed WARNINGS, or click here.

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.com or follow us on Twitter at http://twitter.com/bmsnews.

BARACLUDE^® (entecavir) is a registered trademark of Bristol-Myers Squibb.

Contact:

Bristol-Myers Squibb
Media:
Cristi Barnett, 609-252-6028
cristi.barnett@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com

Source

Twice-daily INCIVO® (Telaprevir), in Combination With Peginterferon Alfa and Ribavirin, is Effective in Treating People Living With Genotype-1 Chronic Hepatitis C Virus

By Janssen Pharmaceutical

BEERSE, Belgium, October 16, 2012 -- /PRNewswire/ --

NOT INTENDED FOR US JOURNALISTS

- OPTIMIZE study results to be presented in late-breaking poster presentation at the American Association for the Study of Liver Diseases (AASLD) 2012 show non-inferior sustained virological response (SVR12) rates in previously untreated genotype-1 patients receiving an INCIVO® (telaprevir) based regimen twice-daily versus every eight hours -

Janssen Research & Development Infectious Diseases - Diagnostics BVBA (Janssen) will present results from the OPTIMIZE Phase 3 trial for INCIVO® (telaprevir), during a late-breaking poster presentation at the 63rd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston (http://www.aasld.org/lm2012). The study, which was completed in September, investigates the efficacy and safety of the twice-daily dosing (BID) of telaprevir versus dosing every eight hours (q8h) in people chronically infected with genotype-1 hepatitis C virus (HCV) who had not been previously treated.^[1]

"This is the first Phase 3 study to evaluate twice daily dosing of the new class of protease inhibitors for the treatment of hepatitis C, so this will be significant news for patients and clinicians," said Maria Buti, Lead Study Investigator and Professor of Medicine at Hospital General Universitari VAll d'Hebron, Barcelona. "Telaprevir has already halved the treatment duration for the majority of people with hepatitis C whilst significantly improving cure rates, compared to previous standard of care, peginterferon alfa and ribavirin (PR). These data offers hope for yet further improvements to treatment regimens, with no compromise on cure rates."

The results demonstrated that BID dosing of telaprevir 1,125mg in combination with peginterferon alfa and ribavirin (PR), achieved similar cure rates, also known as sustained virological response (SVR12) to q8h dosing of telaprevir 750mg (74.3% versus 72.8%), thereby meeting its primary objective of non-inferiority versus q8h dosing.^[1] The safety and tolerability of telaprevir was comparable across dosing arms and consistent with previous studies. The most common adverse events experienced were fatigue, pruritus, anemia, nausea and rash.^[1]

OPTIMIZE was a randomized, open-label, multicenter Phase 3 study in patients with genotype-1 chronic HCV infection who had not been previously treated. During the study, 744 patients were randomized to either BID dosing of telaprevir 1,125mg or q8h dosing of telaprevir 750mg (current INCIVO® label), in combination with PR. At 12 weeks, telaprevir treatment ended and patients continued on PR alone for up to week 24 or week 48 depending on their viral response at week 4. Patients were followed up for a further 12 weeks to monitor cure rates (SVR12).^[1]

Additional telaprevir data to be presented at AASLD will include:

- Efficacy and safety of telaprevir in patients co-infected with HCV and HIV^[2]

- Interim analysis results from the telaprevir Global Early Access Programme highlighting the efficacy and safety of treatment amongst genotype-1 HCV patients with severe fibrosis or compensated cirrhosis^[3]

- Factors predictive of anemia development in treatment-experienced patients receiving telaprevir plus PR in the REALIZE trial^[4]

- Rate of disappearance of telaprevir resistant variants using clonal and population sequence data from Phase 3 studies^[5]

- Evaluation of liver and plasma HCV RNA kinetics and telaprevir levels in genotype-1 HCV patients treated with telaprevir (TVR) using serial fine needle aspirates (FNA)^[6]

- Deep sequencing of the HCV NS3/4A region confirms low prevalence of telaprevir-resistant variants both at baseline and end of study^[7]

About INCIVO®

INCIVO® (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic HCV in adult patients with compensated liver disease (including cirrhosis) who are treatment naïve, and who have previously been treated with interferon alfa (pegylated or non pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.^[8] INCIVO is a small molecule, selective inhibitor of the HCV serine protease, and a member of the new class of medicine for the treatment of genotype-1 chronic HCV, direct acting antivirals (DAAs). Unlike previous treatments, DAAs act directly on viral enzymes and prevent the virus from replicating. INCIVO was approved by the European Commission on 19 September 2011.

Telaprevir was developed by Janssen Research & Development Infectious Diseases - Diagnostics BVBA, one of the Janssen Pharmaceutical Companies, in collaboration with Vertex Pharmaceuticals Incorporated (Vertex) and Mitsubishi Tanabe Pharma Corporation (Mitsubishi Tanabe Pharma). Janssen has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Vertex has rights to commercialize telaprevir in North America where it is being marketed under the brand name INCIVEK^[TM]. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries where it is being marketed as TELAVIC®.

Important Safety Information

Please see full Summary of Product Characteristics or visit http://www.emea.europa.eu for more details.

The overall safety profile of telaprevir is based on the Phase 2/3 clinical development programme containing 2,641 patients who received a telaprevir based regimen. In clinical trials, the incidence of adverse events of at least moderate intensity was higher in the telaprevir group than in the placebo group (both groups receiving peginterferon alfa and ribavirin). The most frequently reported adverse reactions (incidence ≥ 5.0%) of at least grade 2 in severity were anemia, rash, pruritus, nausea, and diarrhoea during the telaprevir treatment phase, and the most frequently reported adverse reactions (incidence ≥ 1.0%)of at least Grade 3 were anemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea.^[8]

Rash events were reported in 55% of patients with a telaprevir based regimen compared to 33% of patients treated with peginterferon alfa and ribavirin only and more than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir combination treatment in 4.8% of patients. Rash led to discontinuation of telaprevir alone in 5.8% of patientsand 2.6% of patients discontinued telaprevir combination treatment for rash events compared to none of those receiving peginterferon alfa and ribavirin.^[8]

Hemoglobin values of < 10 g/dl were observed in 34% of patients who received telaprevir combination treatment and in 14% of patients who received peginterferon alfa and ribavirin. In placebo-controlled Phase 2 and 3 trials, 1.9% of patients discontinued telaprevir alone due to anemia, and 0.9% of patients discontinued INCIVO combination treatment due to anemia compared to 0.5% receiving peginterferon alfa and ribavirin.^[8]

About HCV

HCV is a blood-borne infectious disease that affects the liver.^[9],[10] With an estimated 130-210 million people infected worldwide,^[11]and three to four million people newly infected each year, HCV puts a significant burden on patients and society.^[12] Estimations indicate that HCV caused more than 86,000 deaths and 1.2 million disability-adjusted life-years (DALYs) in the WHO European region in 2002 (latest available data).^[13] Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases.^[14] About one-quarter of the liver transplants performed in 25 European countries in 2004 were attributable to HCV (latest available data).^[13] The previously accepted standard treatment for HCV was peginterferon alfa combined with ribavirin,^[14] however this only cleared the virus for 40-50 percent of genotype-1 chronic HCV patients.^[15],[16]

About Janssen

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development Infectious Diseases - Diagnostics BVBA is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

1. Buti M, Agarwal K, Horsmans Y, et al. OPTIMIZE Trial: Non-inferiority of twice-daily telaprevir versus administration of every 8 hours in treatment-naïve, genotype 1 HCV infected patients. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

2. Sulkowski MS, Sherman KE, Soriano V , et al. Telaprevir in Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Co-infected Patients: SVR24 Final Study Results. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

3. Colombo M et al. Treatment of Hepatitis C Genotype 1 Patients with Severe Fibrosis or Compensated Cirrhosis: The International Telaprevir Early Access Program. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

4. Zeuzem S, DeMasi R, Baldini A, et al. Factors predictive of anemia development in treatment-experienced patients receiving telaprevir (T;TVR) plus peginterferon/ribavirin (PR) in the REALIZE trial. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

5. Sullivan J, De Meyer S, Haseltine E, et al. Rate of disappearance of telaprevir resistant variants using clonal and population sequence data from Phase 3 studies. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

6. Talal A, Dimova R, Zhang E, et al. Evaluation of Liver And Plasma HCV RNA Kinetics And Telaprevir Levels In Genotype 1 HCV Patients Treated With Telaprevir (TVR) Using Serial Fine Needle Aspirates (FNA). 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

7. Dierynck I, De Meyer S, Thys K, et al. Deep Sequencing of the HCV NS3/4A Region Confirms Low Prevalence of Telaprevir-resistant Variants Both at Baseline and End of Study. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

8. Incivo® Summary of Product Characteristics, updated 2011

9. Simin, M et al. Cochrane systematic review: pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C. Alimentary Pharmacology & Therapeutics. 2007; 25(10):1153-62.

10. Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009 Dec 17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission

11. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. Journal of Hepatology. 2011; 55: 245-264.

12. WHO. State of the art of vaccine research and development. Viral Cancers. Available from http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf).

13. Mühlberger, N et al. HCV-related burden of disease in Europe: a systematic assessment of incidence, prevalence, morbidity, and mortality. BMC Public Health. 2009; 9(34):1-14.

14. Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Review of Vaccines 2008;7(7): 915-923.

15. McHutchison, J et al. Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection. N Engl J Med. 2009; 361:580-93.

16. The Hepatitis C Trust. Treatments: Potential New Drugs. [cited 2010 Feb 20] Available from: http://www.hepctrust.org.uk/treatment/potential-new-drugs/Drugs+that+target+the+virus.

SOURCE Janssen Pharmaceutical

Source

Biotron Limited to report new clinical data from BIT225 Hepatitis C Phase 2a trial in a late-breaking presentation at the AASLD 2012 annual conference

- 100% of HCV trial patients receiving 400mg of BIT225 daily for 1 month, had undetectable virus at the 48 week time point

Sydney, NSW, Australia, October 16, 2012 - Biotron Limited ('Biotron'), a clinical-stage drug development company focused on development of new generation antiviral drugs, today announced that the Company will report new clinical data from its Phase 2a trial of BIT225
in patients infected with Hepatitis C virus (HCV). The data will be detailed in a late-breaking
presentation at the American Association for the Study of Liver Diseases (AASLD) 2012
annual conference in Boston, USA.

Previously released data from the 28 day Phase 2a trial of BIT225 demonstrated that BIT225
significantly increased the response to the current approved anti-HCV treatment, with improved outcomes for those patients infected with HCV. At the three-month time point 87% of patients who received BIT225 in addition to standard of care (SOC), interferon alfa-2b plus ribavirin (IFN/RBV), were clear of virus, compared to 63% of those receiving IFN/RBV alone.

The abstract titled “High sustained viral response with a HCV p7 inhibitor, BIT225: Antiviral
activity and tolerability of BIT225 plus pegylated interferon alfa 2b and weight-based ribavirin for 28 days in HCV treatment-naïve patients" will be presented in a late-breaking presentation on November 12 at The Liver Meeting® 2012, the 63rd annual meeting of the AASLD, which will take place from November 9-13 in Boston, Massachusetts.

Key new data that will be presented include results from the week 48 follow-up of trial participants. These latest results demonstrate that 100% of patients who received 400mg dose of BIT225 in addition to IFN/RBV maintained a sustained virological response (SVR), with virus levels below the limit of detection. Patients who received 200mg of BIT225 in addition to IFN/RBV had 87.5% SVR, while patients who only received treatment with IFN/RBV had 75% SVR.

The 48-week data extends the previous three-month data, and demonstrates that BIT225
appeared to continue to provide additional benefit to patients after the conclusion of dosing.
Biotron’s BIT225 targets the HCV viral protein p7, which has crucial roles in virus replication and reproduction. It is a new target, and BIT225 is a first-in-class direct acting antiviral for the treatment of HCV.

As well as being synergistic with current approved SOC HCV treatments, preclinical studies
have demonstrated that BIT225 also works well in vitro with some polymerase inhibitors, another new drug class in clinical development.

BIT225 is also in development for treatment of HIV, with a Phase 1b/2a trial currently in progress. BIT225 offers a unique opportunity for potential use in the HIV/HCV co-infected
population. A trial in this patient population is anticipated to commence before the end of
2012.

Source

BiolineRX reports successful hepatitis C preclinical trial

The company will launch a human Phase I/II clinical trial in Europe to test the drug's safety and efficacy during the first quarter of 2013.

16 October 12 13:51, Globes' correspondent

BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX) today announced success in a preclinical trial of it oral treatment for hepatitis C, BL-8020, and that it will launch a human Phase I/II clinical trial in Europe to test the drug's safety and efficacy during the first quarter of 2013

BL-8020 has a unique mechanism of action for treating hepatitis C, compared with other current treatments, which suggests that it is effective across different strains and can be combined with other therapeutics as part of an interferon-free regimen. BL-8020 inhibits hepatitis-induced autophagy (a mechanism by which cells degrade damaged or unnecessary cellular components, including invading viruses) in the host cells, thereby reducing the ability of the hepatitis virus to replicate.

BiolineRX has an exclusive worldwide license for BL-8020 from France Genoscience SA.

BiolineRX CEO Dr. Kinneret Savitsky said, "The unique characteristics of BL-8020 make it attractive as an adjunct therapy to other oral cocktail therapies, therefore not directly competing in the crowded hepatitis market of currently approved therapies or those under development."

BiolineRX's share price rose 10.5% on the TASE today, following the announcement to NIS 1.28, after closing at $3.05 on Nasdaq yesterday, giving a market cap of $54 million.

Published by Globes [online], Israel business news - www.globes-online.com - on October 16, 2012

Source

Simeprevir (TMC435) Data In Hepatitis C To Be Presented At The Annual Meeting of the American Association for the Study of Liver Diseases

BOSTON, Oct. 16, 2012 /PRNewswire/ -- Janssen Research & Development Ireland (Janssen) will present new data on simeprevir (TMC435), an investigational protease inhibitor, in hepatitis C (HCV) patients at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which takes place November 9 to 13 in Boston.

"We are pleased that these data have been selected for presentation at the AASLD annual meeting," said Wim Parys , Head of Infectious Diseases, Janssen. "The data represent an important step forward in Janssen's efforts to understand the potential utility of simeprevir in a number of different treatment combinations and hepatitis C patient populations."

Simeprevir is being studied in Phase III trials as a once-daily oral treatment in combination with pegylated interferon (IFN) and ribavirin (RBV) for genotype 1 HCV patients. It is also being studied in separate Phase II studies with other direct-acting antiviral (DAA) agents as part of IFN-free regimens, with and without RBV.

The data to be presented at the 2012 annual meeting of the AASLD include:

Oral Presentation: Parallel Session 12, HCV New Agents: Hard to Treat Patients, Hynes Ballroom B & C, November 11, 4:45 - 6:15 p.m. (ET)

• Efficacy and tolerability of TMC435 150 mg once daily with peginterferon alfa-2a and ribavirin for treatment of HCV genotype 1 infection in patients with Metavir score F3 and F4 (PILLAR and ASPIRE trials)
  • Lead Author: Fred Poordad, M.D., Alamo Medical Research Center, San Antonio, TX
• No clinically significant interaction between the investigational HCV protease inhibitor TMC435 and the immunosuppressives cyclosporine and tacrolimus
  • Lead Author: Sivi Ouwerkerk-Mahadevan , M.D., Janssen Research & Development

Poster Presentations: Clinical HCV 1, Poster Hall, November 11, 8:00 a.m. - 5:30 p.m. (ET)

• Safety and tolerability of TMC435 in combination with peginterferon alfa-2a and ribavirin for treatment of HCV genotype 1 infection in treatment-naive and -experienced patients (Phase IIb PILLAR and ASPIRE trials)
  • Lead Author: Michael W. Fried , M.D., University of North Carolina at Chapel Hill, Chapel Hill, NC
• No pharmacokinetic interaction between the investigational HCV protease inhibitor TMC435 and an oral contraceptive containing ethinylestradiol and norethindrone
  • Lead Author: Sivi Ouwerkerk-Mahadevan , M.D., Janssen Research & Development

About Simeprevir
Simeprevir (TMC435) is an NS3/4A protease inhibitor jointly developed by Janssen and Medivir AB to treat chronic hepatitis C (HCV). Simeprevir is being studied in combination with pegylated interferon (IFN) and ribavirin (RBV), and in combination with direct-acting antiviral (DAA) agents in all oral IFN- free regimens, with and without RBV.

Global Phase III studies of simeprevir include QUEST-1 and QUEST-2 in treatment-naive patients, PROMISE in patients who have relapsed after prior IFN-based treatment and ATTAIN in treatment-experienced patients. In parallel to these trials, Phase III studies for simeprevir are ongoing in both treatment-naive and treatment-experienced HIV-HCV co-infected patients, HCV genotype 4 infected patients and in Japanese HCV genotype 1 patients.

Simeprevir is also being studied in Phase II IFN-free trials with or without RBV in combination with:

• Janssen's TMC647055 and ritonavir in treatment-naive, relapser or null responder HCV genotype 1 patients;
• Gilead Sciences, Inc.'s sofosbuvir (GS-7977) in null responder HCV genotype 1 patients; and
• Bristol- Myers Squibb 's daclatasvir in treatment-naive or previous null responder HCV genotype 1 patients.

For additional information about simeprevir, please visit www.clinicaltrials.gov.

About Hepatitis C
Hepatitis C (HCV), a blood-borne infectious disease of the liver and a leading cause of chronic liver disease and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 170 to 210 million people are infected with HCV worldwide, with three to four million people newly infected each year.

About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; significant adverse litigation or government action; impact of business combinations; financial distress and bankruptcies experienced by significant customers and suppliers; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and sovereign risk; disruptions due to natural disasters; manufacturing difficulties or delays; and product efficacy or safety concerns resulting in product recalls or regulatory action. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

SOURCE Janssen Research & Development Ireland (Janssen)

PR Newswire (http://s.tt/1qb0J)

Source

A Hep C Hip Check

By Brian Orelli, The Motley Fool

Posted 6:53PM 10/15/12

Posted under: Investing

On its cakewalk to hepatitis C supremacy, Gilead Sciences (NAS: GILD) just got a hip check from Abbott Labs (NYS: ABT) .

Nearly all of the hepatitis C patients taking a combination of three Abbott drugs -- ABT-450, ABT-267, and ABT-333 -- and a generic called ribavirin were free of virus 12 weeks after finishing the drug regimen, which itself lasted 12 weeks. Just one of the 77 patients who have gotten that far in the trial had a relapse. There were also two patients with missing data, so those patients could bring down the 99% cure rate a little.

What's truly amazing is that 93% of patients who failed to respond to previous treatments were free of virus 12 weeks after treatment ended. That number might come down a little when we get data for longer sustained virological response, but it still towers over the current treatments. Vertex Pharmaceuticals' (NAS: VRTX) Incivek cured 32 % of null responders. Patients who had a partial response to previous treatment, which tend to have better response the next time, achieved only a 52 % cure rate for Merck's (NYS: MRK) Victrelis.

Abbott's four-drug regimen isn't exactly simple, especially compared with Gilead's combination of GS-7977 and GS-5885. Gilead might also include ribavirin in the combination, but three drugs are still less than four.

Abbott might be able to combine the drugs to reduce the number of pills taken, but under the current treatment regimen, there won't be a single pill because two of the drugs are taken once daily while another has to be taken twice daily.

Pill burden is a big issue for HIV patients and has helped Gilead make a lot of money with its combination pills, but I'm not sure it'll be as big of an issue for hepatitis C patients. HIV patients have to take the drugs for the rest of their lives; hepatitis C drugs will be taken for only a few months.

This is only phase 2 data; we need to wait for the phase 3 data to declare a winner. I think doctors will prescribe the drug with the best efficacy assuming it has a tolerable safety profile. If the two drug combinations are fairly equal on both those fronts, then the one with the best convenience will certainly win.

Of course, cure rates can't get higher than 100%, so safety and convenience will become an increasingly important aspect of hepatitis C drug characteristics. Investors in hepatitis C drugmakers, such as Achillion Pharmaceuticals (NAS: ACHN) and Idenix Pharmaceuticals (NAS: IDIX) , with drugs further back in the clinic had better take notice if they don't want to get stomped on.

Source

Related Article: Abbott's Investigational Interferon-Free Hepatitis C Treatment Regimen Achieved SVR12 (Observed Data) Rates in 99 Percent of Treatment-Naïve and 93 Percent in Prior Null Responders for Genotype 1 Patients in Phase 2b Study

DOH survey shows public has liver disease misconceptions

Updated Sunday, October 14, 2012 0:03 am TWN, The China Post

By Wen Shin Kuo--A survey conducted by the Department of Health (DOH, 衛生署) from July 20 to 27 of 3,668 participants aged from 25 to 64 showed worrying results, with the majority of participants having misconceptions on liver-related diseases such as Hepatitis B and C.

In a multiple-choice question on what were the main causes of liver diseases, the most popular answer was “staying up late” (93.3 percent), with “alcohol consumption” (91.9 percent), “Hepatitis B” (81.3 percent), “working overtime” (70 percent), “liver-related diseases” (69.8 percent), “overdosing on medication” (65.4 percent), “Hepatitis C” (64.3 percent), “family history” (64.1 percent) and so on as the more popular answers.

Of the 3,668 participants, 16.4 percent answered that they have Hepatitis B, and only 0.9 percent said they have Hepatitis C. Almost 80 percent of the participants were liver-disease free.

When those with Hepatitis B were asked if they had consulted a doctor after learning that they had the disease, 29.9 percent replied that they did not think it necessary to consult a doctor. When further questioned as to why they did not deem it necessary to seek medical help, 73.8 percent of that group replied that they did not develop any symptoms, and therefore did not seek medical help. Other answers were that they “did not know where to seek help” (20 percent), “did not think they needed to seek medical help” (16.9 percent), “had no time” (13.1 percent) and finally “forgot” (2.3 percent).

According to the Bureau of Health Promotion (健康局), Hepatitis B and C make up 80 percent of the main causes of liver cancer. Every year there are 13,175 deaths due to chronic liver diseases, liver sclerosis and liver cancer, according to the DOH. The DOH is urging the public to raise its awareness of preventative measures against contracting Hepatitis B and C in order to prevent further risks of liver diseases. The DOH encourages the public to seek medical help if they test positive for Hepatitis B and C. If the disease is closely monitored, liver disease treatment and liver cancer prevention can be better addressed.

Source

U.S. Food and Drug Administration Approves Labeling Update for BARACLUDE(R) (entecavir) (0.5 mg/1 mg Tablets) to Include Data on African Americans and Liver Transplant Recipients with Chronic Hepatitis B in Adult Patients

Studies provide data on BARACLUDE in special populations

PRESS RELEASE

Oct. 15, 2012, 3:47 p.m. EDT

PRINCETON, N.J., Oct 15, 2012 (BUSINESS WIRE) -- Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the labeling for BARACLUDE(R) (entecavir) to include data on African Americans and liver transplant recipients with chronic hepatitis B infection. BARACLUDE, a nucleoside analogue discovered at Bristol-Myers Squibb, was first approved by the U.S. Food and Drug Administration in March 2005 for use in adult chronic hepatitis B patients with compensated liver disease. BARACLUDE is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. The following points should be considered when initiating BARACLUDE: This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naive and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease; virologic, biochemical, serologic, and safety data are available from a controlled study in adult patients with chronic HBV infection and decompensated liver disease; virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy. The current labeling update was accepted based on one study in African-American patients and one study in post-liver transplant recipients, each investigating BARACLUDE in these populations.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted. Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE (entecavir) is used to treat chronic HBV infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, alone or in combination with antiretrovirals. Please see the Important Safety Information section of this press release for additional risk information, including Boxed WARNINGS.

BARACLUDE in Racial/Ethnic Groups (Study ETV-085 Results)

There are no significant racial differences in entecavir pharmacokinetics. The safety and efficacy of BARACLUDE 0.5 mg once daily were assessed in a single-arm, open-label trial in hepatitis B e antigen (HBeAg) positive or negative, nucleoside-naive, African American (n=40) and Hispanic (n=6) patients with chronic HBV infection.In this trial, 76% of patients were male, the mean age was 42 years, 57% were HBeAg-positive. The mean baseline HBV DNA was 7.0 log10 IU/mL, and the mean baseline ALT was 162 U/L.At 48 weeks of treatment, 32 of 46 (70%) patients had HBV DNA <50 IU/mL (approximately 300 copies/mL), 31 of 46 (67%) patients had aminotransferase (ALT) normalization (less-than or equal to 1 times ULN), and 12 of 26 (46%) HBeAg-positive patients had HBe seroconversion. Safety data were similar to those observed in the larger, controlled BARACLUDE clinical trials. Due to low enrollment, safety and efficacy were not established in Hispanic patients.

BARACLUDE in Liver Transplant Recipients (Study ETV-109 Results)

The safety and efficacy of BARACLUDE were assessed in a single-arm, open-label trial in 65 patients who received a liver transplant for complications from chronic HBV infection. Eligible patients who had HBV DNA less than 172 IU/mL (approximately 1000 copies per mL) at the time of transplant were treated with BARACLUDE 1 mg once daily in addition to post-transplantation management consistent with the standard practice at a site, including hepatitis B immune globulin. The trial population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of patients had HBeAg-negative disease at the time of transplant.

Four of the 65 patients received 4 weeks or less of BARACLUDE (entecavir) (2 deaths, 1 retransplantation, and 1 protocol violation) and were not considered evaluable. Of the 61 patients who received more than 4 weeks of BARACLUDE, 60 received hepatitis B immune globulin post-transplant. Fifty-three patients (82% of all 65 patients treated) completed the trial and had HBV DNA measurements at or after 72 weeks treatment post transplant. All 53 patients had HBV DNA <50 IU/mL (approximately 300 copies/mL). Eight evaluable patients did not have HBV DNA data available at 72 weeks, including 3 patients who died prior to study completion. No patients had HBV DNA values greater-than or equal to 50 IU/mL while receiving BARACLUDE (plus hepatitis B immune globulin). All 61 evaluable patients lost HBsAg post-transplant; 2 of these subjects experienced recurrence of measurable HBsAg without recurrence of HBV viremia. This trial was not designed to determine whether addition of BARACLUDE to hepatitis B immune globulin decreased proportion of patients with measurable HBV DNA post-transplant compared to hepatitis B immune globulin alone. If BARACLUDE treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function must be carefully monitored both before and during treatment with BARACLUDE.

Chronic hepatitis B infection remains an area of concern among African Americans. In the United States, approximately 1.4 to 2.0 million individuals are chronically infected with chronic hepatitis B.

Patients with chronic hepatitis B and end-stage liver disease may undergo a liver transplantation as a treatment option. However, recurrence of a disease that caused the need for a liver transplant, such as chronic hepatitis B, can damage the new liver.

"Treating patients with chronic hepatitis B who have undergone a liver transplant can be complicated," said Dr. Michael Charlton, MBBS, FACP, Hepatology Director and Liver Transplant Director, Mayo Clinic. "These data included in the BARACLUDE label will help healthcare providers prescribe treatment among chronic hepatitis B patients, including liver transplant recipients."

INDICATION and IMPORTANT SAFETY INFORMATION about BARACLUDE (entecavir):

INDICATION

BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The following points should be considered when initiating BARACLUDE:

-- This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naive and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease.

-- Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease.

-- Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY

-- Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

-- Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE (entecavir) is used to treat chronic HBV infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART).

-- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, alone or in combination with antiretrovirals.

Warnings and Precautions

-- Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.

-- Lactic acidosis with BARACLUDE use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. BARACLUDE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Adverse Reactions

-- In clinical trials in patients with compensated liver disease, the most common (greater-than or equal to 3%) adverse reactions of any severity with at least a possible relation to study drug for BARACLUDE-treated subjects were headache, fatigue, dizziness, and nausea. In these trials, the most common adverse reactions of moderate to severe intensity (grades 2-4) were diarrhea, dyspepsia, nausea, vomiting, fatigue, headache, dizziness, somnolence, and insomnia.

-- In the decompensated liver disease trial, the most common adverse reactions of any severity among patients treated with BARACLUDE (entecavir), regardless of causality, included: peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%). In this trial, 18% (18/102) of BARACLUDE patients and 20% (18/89) of adefovir patients died during the first 48 weeks of therapy. The majority of those deaths were due to liver related causes.

Drug Interactions

BARACLUDE is primarily eliminated by the kidneys, therefore coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Patients should be monitored closely when receiving BARACLUDE with other renally-eliminated drugs.

Pregnancy and Nursing Mothers

-- There are no adequate and well-controlled studies of BARACLUDE in pregnant women. BARACLUDE should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits.

-- There are no studies on the effect of BARACLUDE on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.

-- It is not known whether BARACLUDE is excreted into human milk; however, many drugs are excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants from BARACLUDE, risks and benefits should be considered when deciding whether to discontinue breast-feeding or discontinue BARACLUDE in nursing women.

Pediatric Use

-- Safety and effectiveness of BARACLUDE in pediatric patients below the age of 16 years have not been established.

Renal Impairment

-- Dosage adjustment of BARACLUDE (entecavir) is recommended for patients with a creatinine clearance <50 mL/min, including those on hemodialysis or continuous ambulatory peritoneal dialysis.

Liver Transplant Recipients

-- Renal function must be carefully monitored both before and during treatment with BARACLUDE in a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus.

Dosage and Administration

BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).

The recommended dose of BARACLUDE:

-- in nucleoside-naive adults and adolescents (16+ yrs) with compensated liver disease is 0.5 mg once daily

-- in adults and adolescents (16+ yrs) with compensated liver disease, and refractory to lamivudine or with known lamivudine or telbivudine resistance mutations (rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L) is 1 mg once daily

-- in adults with decompensated liver disease is 1 mg once daily

The optimal duration of treatment with BARACLUDE for patients with chronic HBV infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

Additional Information

BARACLUDE (entecavir) is not a cure for HBV. Patients should be advised that treatment with BARACLUDE has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.

Please see accompanying Full Prescribing Information, including Boxed WARNINGS, or visit www.BARACLUDE.com or click here.

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.com or follow us on Twitter at http://twitter.com/bmsnews .

SOURCE: Bristol-Myers Squibb Company

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