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	<title>Symptom Advice .com &#187; viral replication</title>
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		<title>BARACLUDE&#174; (entecavir) Approved by European Commission for Treatment of Chronic Hepatitis B in Adult Patients with Evidence of Decompensated Live</title>
		<link>http://symptomadvice.com/baraclude-entecavir-approved-by-european-commission-for-treatment-of-chronic-hepatitis-b-in-adult-patients-with-evidence-of-decompensated-live/</link>
		<comments>http://symptomadvice.com/baraclude-entecavir-approved-by-european-commission-for-treatment-of-chronic-hepatitis-b-in-adult-patients-with-evidence-of-decompensated-live/#comments</comments>
		<pubDate>Tue, 22 Mar 2011 02:00:31 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[liver symptoms]]></category>
		<category><![CDATA[food and drug administration]]></category>
		<category><![CDATA[hepatitis b]]></category>
		<category><![CDATA[liver inflammation]]></category>
		<category><![CDATA[viral replication]]></category>

		<guid isPermaLink="false">http://symptomadvice.com/baraclude-entecavir-approved-by-european-commission-for-treatment-of-chronic-hepatitis-b-in-adult-patients-with-evidence-of-decompensated-live/</guid>
		<description><![CDATA[Bristol-Myers Squibb (NYSE:BMY) announced today that BARACLUDE&#174; (entecavir) &#104;&#097;&#115; &#098;&#101;&#101;&#110; approved &#098;&#121; the European Commission on February 28th 2011 &#116;&#111; treat chronic hepatitis B (CHB) &#105;&#110; adult patients &#119;&#105;&#116;&#104; evidence of decompensated liver disease. Paris (PRWEB) March 7, 2011 Bristol-Myers Squibb (NYSE:BMY) announced today that BARACLUDE&#174; (entecavir) &#104;&#097;&#115; &#098;&#101;&#101;&#110; approved &#098;&#121; the European Commission on [...]]]></description>
			<content:encoded><![CDATA[<p></p><p><img src="http://symptomadvice.com/wp-content/uploads/2011/03/1300759232-49.jpg" style="clear:both;clear:both;margin:0 15px 15px 0;width:500px" />
<p>Bristol-Myers Squibb (NYSE:BMY) announced today that BARACLUDE&#174; (entecavir) &#104;&#097;&#115; &#098;&#101;&#101;&#110; approved &#098;&#121; the European Commission on February 28th 2011 &#116;&#111; treat chronic hepatitis B (CHB) &#105;&#110; adult patients &#119;&#105;&#116;&#104; evidence of decompensated liver disease. </p>
<p>Paris (PRWEB) March 7, 2011 </p>
<p> Bristol-Myers Squibb (NYSE:BMY) announced today that BARACLUDE&#174; (entecavir) &#104;&#097;&#115; &#098;&#101;&#101;&#110; approved &#098;&#121; the European Commission on February 28th 2011 &#116;&#111; treat chronic hepatitis B (CHB) &#105;&#110; adult patients &#119;&#105;&#116;&#104; evidence of decompensated liver disease. </p>
<p>BARACLUDE&#174; &#119;&#097;&#115; &#097;&#108;&#114;&#101;&#097;&#100;&#121; approved &#105;&#110; Europe &#105;&#110; June 2006 &#102;&#111;&#114; &#117;&#115;&#101; &#105;&#110; adult patients &#119;&#105;&#116;&#104; CHB &#119;&#105;&#116;&#104; compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.</p>
<p>This approval grants BARACLUDE&#174; marketing authorisation &#105;&#110; the 27 countries of the European Union. &#105;&#110; the U.S., the Food and Drug Administration (FDA) approved the decompensated indication &#102;&#111;&#114; BARACLUDE&#174; &#105;&#110; October 2010.</p>
<p>Decompensated liver disease &#105;&#115; characterised &#098;&#121; failure of the liver &#116;&#111; maintain adequate function, &#117;&#115;&#117;&#097;&#108;&#108;&#121; due &#116;&#111; severe scarring, leading &#116;&#111; fibrosis and/or cirrhosis caused &#098;&#121; chronic liver inflammation.&#185; &#105;&#116; represents the &#101;&#110;&#100; stage of hepatitis. Natural history data demonstrate that &#117;&#112; &#116;&#111; 40% of patients &#119;&#105;&#116;&#104; CHB develop cirrhosis &#111;&#118;&#101;&#114; &#116;&#104;&#101;&#105;&#114; lifetimes, at &#097; reported rate of 2-6% &#112;&#101;&#114; year. Among CHB patients &#119;&#105;&#116;&#104; cirrhosis, 3-5% &#112;&#101;&#114; year progress &#116;&#111; decompensated cirrhosis and 2-5% develop hepatocellular carcinoma (HCC).&#178;,&#179; Currently, the median survival rate &#105;&#110; decompensated patients &#105;&#115; two &#116;&#111; &#116;&#104;&#114;&#101;&#101; years, &#119;&#105;&#116;&#104; only 28% of patients surviving &#102;&#111;&#114; more than five years.&#185;,&#8308;</p>
<p>Once liver disease progresses &#116;&#111; the decompenstated stage, &#097; liver transplant &#105;&#115; often &#110;&#101;&#099;&#101;&#115;&#115;&#097;&#114;&#121;.</p>
<p>&#8220;The approval of this additional indication &#105;&#115; an important milestone &#102;&#111;&#114; CHB patients living &#119;&#105;&#116;&#104; decompensated liver disease, &#097; difficult &#116;&#111; treat population whose mortality rates &#097;&#114;&#101; high,&#8221; said Professor Jorg Petersen. &#8220;The data used &#116;&#111; support this indication shows that BARACLUDE&#174; &#105;&#115; efficacious &#105;&#110; treating decompensated patients.&#8221;</p>
<p>This approval &#105;&#115; based on &#097; randomised, open-label, multi-centre study (ETV-048) that compared the efficacy &amp; safety of BARACLUDE&#174; (1.0 mg &#111;&#110;&#099;&#101; daily) &#119;&#105;&#116;&#104; adefovir (10.0 mg &#111;&#110;&#099;&#101; daily) administered &#105;&#110; patients &#119;&#105;&#116;&#104; HBeAg positive or negative CHB &#119;&#104;&#111; had evidence of liver decompensation.</p>
<p>Data demonstrated that BARACLUDE&#174; showed greater viral suppression compared &#116;&#111; adefovir at 24 and 48 weeks following treatment initiation. At 48 weeks, 57% (57/100) of patients treated &#119;&#105;&#116;&#104; BARACLUDE&#174; achieved an undetectable viral load (d300 copies/ml) compared &#116;&#111; 20% (18/91) of patients on adefovir.</p>
<p>ETV-048 Study ResultsThe 048 study evaluated 191 patients &#119;&#104;&#111; &#119;&#101;&#114;&#101; &#101;&#105;&#116;&#104;&#101;&#114; HBeAG-positive or HBeAG-negative. Patients &#119;&#101;&#114;&#101; &#101;&#105;&#116;&#104;&#101;&#114; treatment-na&#239;ve or had &#098;&#101;&#101;&#110; previously treated excluding pre-treatment &#119;&#105;&#116;&#104; BARACLUDE&#174;, adefovir or tenofovir.</p>
<p>Patients &#119;&#101;&#114;&#101; randomised &#116;&#111; receive BARACLUDE&#174; (1.0 mg &#111;&#110;&#099;&#101; daily) or adefovir (10.0 mg &#111;&#110;&#099;&#101; daily) and &#119;&#101;&#114;&#101; analysed &#116;&#104;&#114;&#111;&#117;&#103;&#104; 48 weeks.</p>
<p>Baseline demographics &#119;&#101;&#114;&#101; similar &#102;&#111;&#114; &#098;&#111;&#116;&#104; groups. Importantly, at baseline, patients had &#097; mean CPT (child-pugh score) of 8.81 &#105;&#110; the BARACLUDE&#174; arm and 8.35 &#105;&#110; the adefovir arm, and the mean MELD (Model &#102;&#111;&#114; &#101;&#110;&#100; stage Liver Disease) score &#119;&#097;&#115; 17.1 and 15.3, respectively. &#098;&#111;&#116;&#104; of &#116;&#104;&#101;&#115;&#101; parameters measure the severity of hepatic decompensation.</p>
<p>The mean age of the study population &#119;&#097;&#115; 52 years and the majority of the subjects &#119;&#101;&#114;&#101; male (74%) and &#101;&#105;&#116;&#104;&#101;&#114; Asian (54%) or Caucasian (33%).&#8309;</p>
<p>In the primary efficacy endpoint of mean change from baseline &#105;&#110; serum HBV DNA at Week 24, BARACLUDE&#174; &#119;&#097;&#115; superior &#116;&#111; adefovir (-4.48 &#118;&#101;&#114;&#115;&#117;&#115; -3.40; p &lt; 0.0001).</p>
<p>Secondary efficacy endpoints included mean change from baseline &#105;&#110; serum HBV DNA at Week 48 (-4.66 &#105;&#110; the BARACLUDE&#174; arm and -3.90 &#105;&#110; the adefovir arm). &#105;&#110; addition &#097; greater proportion of patients on BARACLUDE&#174; achieved an undetectable viral load compared &#116;&#111; patients on adefovir at 48 weeks: 57% (57/100) &#118;&#101;&#114;&#115;&#117;&#115; 20% (18/91), respectively. Also patients on the BARACLUDE&#174; arm decreased &#116;&#104;&#101;&#105;&#114; MELD score from baseline &#098;&#121; -2.6% &#118;&#101;&#114;&#115;&#117;&#115; -1.7% &#105;&#110; the adefovir arm at Week 48, &#101;&#118;&#101;&#110; &#116;&#104;&#111;&#117;&#103;&#104; baseline MELD score had &#098;&#101;&#101;&#110; higher &#119;&#105;&#116;&#104; 17.1 &#102;&#111;&#114; BARACLUDE&#174; than 15.3 &#102;&#111;&#114; adefovir. Further the normalization of ALT (Alanine Aminotransferase enzyme) &#119;&#097;&#115; achieved &#116;&#111; &#097; higher proportion &#105;&#110; the BARACLUDE&#174;-treated patients (d1 x Upper Limit of Normal) at Week 48 [63% (49/78)] compared &#119;&#105;&#116;&#104; adefovir-treated patients [46% (33/71)].</p>
<p>The time &#116;&#111; onset of HCC or death &#119;&#097;&#115; comparable &#105;&#110; the two treatment groups; on-study cumulative death rates &#119;&#101;&#114;&#101; 23% (23/102) and 33% (29/89) &#102;&#111;&#114; patients treated &#119;&#105;&#116;&#104; BARACLUDE&#174; and adefovir, respectively; and on-study cumulative rates of HCC &#119;&#101;&#114;&#101; 12% (12/102) and 20% (18/89) &#102;&#111;&#114; BARACLUDE&#174; and adefovir, respectively.</p>
<p>BARACLUDE&#174; &#119;&#097;&#115; generally well tolerated and safety results &#119;&#101;&#114;&#101; comparable between the treatment groups and consistent &#119;&#105;&#116;&#104; &#116;&#104;&#111;&#115;&#101; previously reported &#102;&#111;&#114; &#097; population &#119;&#105;&#116;&#104; decompensated liver disease. Serious adverse events occurred &#105;&#110; 69% of the BARACLUDE&#174; patients and 66% of the adefovirpatientsand discontinuations due &#116;&#111; adverse events occurred &#105;&#110; 7% of the Baraclude patients and 6 % of the adefovir patients.&#8309;
<p> Important Information About BARACLUDE&#174;
<p> Discovered at Bristol-Myers Squibb, BARACLUDE&#174; &#105;&#115; &#105;&#110;&#100;&#105;&#099;&#097;&#116;&#101;&#100; &#102;&#111;&#114; the treatment of chronic hepatitis B virus (HBV) infection &#105;&#110; adults &#119;&#105;&#116;&#104;:
<ul>
<li> Compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. </li>
<li> Decompensated liver disease. </li>
</ul>
<p> &#097; higher rate of serious hepatic adverse events (regardless of causality) &#104;&#097;&#115; &#098;&#101;&#101;&#110; observed &#105;&#110; patients &#119;&#105;&#116;&#104; decompensated liver disease, &#105;&#110; &#112;&#097;&#114;&#116;&#105;&#099;&#117;&#108;&#097;&#114; &#105;&#110; &#116;&#104;&#111;&#115;&#101; &#119;&#105;&#116;&#104; Child-Turcotte-Pugh (CTP) class C disease, compared &#119;&#105;&#116;&#104; rates &#105;&#110; patients &#119;&#105;&#116;&#104; compensated liver function. &#105;&#110; addition, patients &#119;&#105;&#116;&#104; decompensated liver disease &#109;&#097;&#121; be at higher risk &#102;&#111;&#114; lactic acidosis and specific renal adverse events &#115;&#117;&#099;&#104; &#097;&#115; hepatorenal syndrome. Clinical and laboratory parameters should be closely monitored &#105;&#110; this patient population.
<p> *For &#102;&#117;&#108;&#108; prescribing information &#102;&#111;&#114; BARACLUDE&#174;, &#112;&#108;&#101;&#097;&#115;&#101; consult the Summary of Product Characteristics.
<p> About Chronic Hepatitis B (CHB)Chronic hepatitis B &#105;&#115; &#097; serious global health issue. Worldwide, more than 2 billion people &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; &#105;&#110; contact &#119;&#105;&#116;&#104; the hepatitis B virus and approximately 350 million people &#097;&#114;&#101; chronically infected.&#8310;
<p> About Decompensated Liver DiseaseDecompensated liver disease &#105;&#115; characterised &#098;&#121; failure of the liver &#116;&#111; maintain adequate function, often due &#116;&#111; severe scarring leading &#116;&#111; fibrosis and/or cirrhosis caused &#098;&#121; chronic liver inflammation.&#185; Symptoms of liver decompensation can include but &#097;&#114;&#101; not limited &#116;&#111;: jaundice (yellowing of the skin or eyes), ascites (swollen abdomen from abnormal accumulation of fluid), oesophageal varices (distorted blood vessels that &#109;&#097;&#121; &#099;&#097;&#117;&#115;&#101; potentially fatal bleeding), and hepatic encephalopathy (neuropsychiatric abnormality resulting &#105;&#110; personality changes, intellectual impairment and reduced levels of consciousness).&#185;
<p> About Bristol-Myers SquibbBristol-Myers Squibb &#105;&#115; &#097; global biopharmaceutical company committed &#116;&#111; discovering, developing and delivering innovative medicines that &#104;&#101;&#108;&#112; patients prevail &#111;&#118;&#101;&#114; serious diseases.
<p> BARACLUDE&#174; (entecavir) &#105;&#115; &#097; registered trademark of Bristol-Myers Squibb Company.
<p> Contact:Media: Annie Simond, office: +33 1 58 83 65 66, annie(dot)simond(at)bms(dot)com
<p> References&#185; D&#8217;Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival &#105;&#110; cirrhosis: &#097; systematic review of 118 studies. J. Hepatol. 2006; 44: 217&#8211;31. &#178; Chu C-M and Liaw Y-F. Hepatitis B virus-related cirrhosis: Natural history and treatment. Seminars &#105;&#110; Liver Disease 2006;26(2):142-152.&#179; Fattovich G, Stroffolini T, Zagni I, Donato F. Hepatocellular carcinoma &#105;&#110; cirrhosis: Incidence and risk factors. Gastroenterology 2004;127(5 Suppl 1):S35-S50.&#8308; Fattovich G, Pantalena M, Zagni I &#101;&#116; al. Effect of hepatitis B and C virus infections on the natural history of compensated cirrhosis: &#097; cohort study of 297 patients. &#097;&#109;. J. Gastroenterol. 2002; 97: 2886&#8211;95.&#8309; Y. Liaw, &#101;&#116; al. Efficacy and Safety of Entecavir &#118;&#101;&#114;&#115;&#117;&#115; Adefovir &#105;&#110; Chronic Hepatitis B Patients &#119;&#105;&#116;&#104; Evidence of Hepatic Decompensation. Abstract and Poster 442. AASLD 2009.&#8310; World Helath Organization Web site. Fact sheet N&#8226; 204. &#119;&#104;&#111;.int/mediacentre/factsheets/fs204/en/. Accessed 3 December 2010.
<p> ###
<p> Annie SimondBristol-Myers Squibb+33 1 58 83 65 66Email Information </p></p>
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		</item>
		<item>
		<title>CORRECT: PRESS RELEASE: Positive Phase 2 Interim -2-</title>
		<link>http://symptomadvice.com/correct-press-release-positive-phase-2-interim-2/</link>
		<comments>http://symptomadvice.com/correct-press-release-positive-phase-2-interim-2/#comments</comments>
		<pubDate>Sun, 20 Mar 2011 18:00:26 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[liver symptoms]]></category>
		<category><![CDATA[ritonavir]]></category>
		<category><![CDATA[viral replication]]></category>

		<guid isPermaLink="false">http://symptomadvice.com/correct-press-release-positive-phase-2-interim-2/</guid>
		<description><![CDATA[Results from multiple Phase 1 studies evaluating &#116;&#104;&#101; interaction between telaprevir &#097;&#110;&#100; ritonavir-boosted protease inhibitors, NNRTIs &#097;&#110;&#100; NRTIs (Abstract #119) &#8212; Telaprevir slightly increased &#116;&#104;&#101; exposure &#116;&#111; ritonavir-boosted atazanavir. Ritonavir-boosted atazanavir slightly reduced &#116;&#104;&#101; exposure &#116;&#111; telaprevir. This interaction was &#110;&#111;&#116; considered &#116;&#111; be clinically significant. &#097; HIV regimen that includes ritonavir-boosted atazanavir is being [...]]]></description>
			<content:encoded><![CDATA[<p></p><p><img src="http://symptomadvice.com/wp-content/uploads/2011/03/1300644026-36.jpg" style="clear:both;clear:both;margin:0 15px 15px 0;width:500px" />
<p> Results from multiple Phase 1 studies evaluating &#116;&#104;&#101; interaction between telaprevir &#097;&#110;&#100; ritonavir-boosted protease inhibitors, NNRTIs &#097;&#110;&#100; NRTIs (Abstract #119)</p>
<p> &#8212; Telaprevir slightly increased &#116;&#104;&#101; exposure &#116;&#111; ritonavir-boosted</p>
<p> atazanavir. Ritonavir-boosted atazanavir slightly reduced &#116;&#104;&#101; exposure</p>
<p> &#116;&#111; telaprevir. This interaction was &#110;&#111;&#116; considered &#116;&#111; be clinically</p>
<p> significant. &#097; HIV regimen that includes ritonavir-boosted atazanavir is</p>
<p> being evaluated in &#097;&#110; ongoing Phase 2 study &#111;&#102; telaprevir-based therapy</p>
<p> in people infected with &#098;&#111;&#116;&#104; hepatitis C &#097;&#110;&#100; HIV.</p>
<p> &#8212; &#097;&#110; interaction between efavirenz &#097;&#110;&#100; telaprevir (750 mg, every eight</p>
<p> hours) was observed, but &#097; higher dose &#111;&#102; telaprevir (1,125 mg, every</p>
<p> eight hours) &#099;&#111;&#117;&#108;&#100; largely offset &#116;&#104;&#101; interaction. This higher dose of</p>
<p> telaprevir is being evaluated &#097;&#115; &#112;&#097;&#114;&#116; &#111;&#102; &#097;&#110; ongoing Phase 2 study in</p>
<p> people co-infected with hepatitis C &#097;&#110;&#100; HIV who &#097;&#114;&#101; also receiving</p>
<p> efavirenz &#097;&#115; &#112;&#097;&#114;&#116; &#111;&#102; &#116;&#104;&#101;&#105;&#114; HIV treatment.</p>
<p> &#8212; Significant interactions were observed between telaprevir and</p>
<p> boosted-lopinavir, darunavir &#097;&#110;&#100; fosamprenavir, &#115;&#117;&#099;&#104; that</p>
<p> telaprevir-based combination therapy is &#110;&#111;&#116; &#099;&#117;&#114;&#114;&#101;&#110;&#116;&#108;&#121; being evaluated</p>
<p> &#102;&#111;&#114; people &#116;&#097;&#107;&#105;&#110;&#103; these HIV medicines.</p>
<p> Telaprevir is &#097;&#110; investigational, oral inhibitor that acts &#100;&#105;&#114;&#101;&#099;&#116;&#108;&#121; &#111;&#110; &#116;&#104;&#101; HCV protease, &#097;&#110; enzyme essential &#102;&#111;&#114; viral replication. &#116;&#111; date, &#109;&#111;&#114;&#101; than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 &#097;&#110;&#100; Phase 3 studies.</p>
<p> Vertex is developing telaprevir in collaboration with Tibotec BVBA &#097;&#110;&#100; Mitsubishi Tanabe Pharma. Vertex has rights &#116;&#111; commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights &#116;&#111; commercialize telaprevir in Europe, South America, Australia, &#116;&#104;&#101; Middle East &#097;&#110;&#100; &#099;&#101;&#114;&#116;&#097;&#105;&#110; other countries. Mitsubishi Tanabe Pharma has rights &#116;&#111; commercialize telaprevir in Japan &#097;&#110;&#100; &#099;&#101;&#114;&#116;&#097;&#105;&#110; Far East countries.</p>
<p> Telaprevir has &#098;&#101;&#101;&#110; granted priority review &#098;&#121; &#116;&#104;&#101; U.S. Food &#097;&#110;&#100; Drug Administration (FDA) &#097;&#110;&#100; &#098;&#121; Health Canada &#097;&#110;&#100; accelerated assessment &#098;&#121; &#116;&#104;&#101; European Medicines Agency &#102;&#111;&#114; &#116;&#104;&#101; treatment &#111;&#102; people chronically infected with genotype 1 hepatitis C virus (HCV). &#116;&#104;&#101; applications include data from three registrational studies, ADVANCE, ILLUMINATE &#097;&#110;&#100; REALIZE, &#119;&#104;&#105;&#099;&#104; evaluated telaprevir in people with hepatitis C who were &#110;&#101;&#119; &#116;&#111; treatment &#097;&#115; well &#097;&#115; &#116;&#104;&#111;&#115;&#101; who &#100;&#105;&#100; &#110;&#111;&#116; achieve &#097; viral cure &#097;&#102;&#116;&#101;&#114; treatment with &#099;&#117;&#114;&#114;&#101;&#110;&#116;&#108;&#121; &#097;&#118;&#097;&#105;&#108;&#097;&#098;&#108;&#101; medicines. &#102;&#111;&#114; complete information &#111;&#110; &#116;&#104;&#101; clinical trials &#111;&#114; &#097; fact sheet &#111;&#110; &#116;&#104;&#101; trial designs visit: vrtx.com/press.cfm.</p>
<p> About Hepatitis C &#097;&#110;&#100; HIV Co-Infection</p>
<p> &#116;&#104;&#101;&#114;&#101; &#097;&#114;&#101; 1 million people living with HIV in &#116;&#104;&#101; United States.(2) It&#8217;s estimated that &#117;&#112; &#116;&#111; 30 percent &#111;&#102; people living with HIV/AIDS &#097;&#114;&#101; also infected with hepatitis C.(3) &#116;&#104;&#101;&#114;&#101; have &#098;&#101;&#101;&#110; dramatic improvements in &#116;&#104;&#101; treatment &#111;&#102; HIV &#097;&#110;&#100; &#116;&#104;&#101; prognosis &#102;&#111;&#114; people living with HIV. However, liver disease progresses &#109;&#111;&#114;&#101; rapidly in people co-infected with hepatitis C &#097;&#110;&#100; HIV, with &#097;&#110; increased rate &#111;&#102; progression &#116;&#111; cirrhosis, decompensated liver disease, hepatocellular carcinoma &#097;&#110;&#100; death.(3,4,5)</p>
<p> Hepatitis C is &#097; &#115;&#101;&#114;&#105;&#111;&#117;&#115; liver disease caused &#098;&#121; &#116;&#104;&#101; hepatitis C virus, &#119;&#104;&#105;&#099;&#104; is spread through direct contact with &#116;&#104;&#101; blood &#111;&#102; infected people &#097;&#110;&#100; ultimately affects &#116;&#104;&#101; liver.(6) Chronic hepatitis C can lead &#116;&#111; &#115;&#101;&#114;&#105;&#111;&#117;&#115; &#097;&#110;&#100; life-threatening liver problems, including liver damage, cirrhosis, liver failure &#111;&#114; liver cancer.(6) &#116;&#104;&#111;&#117;&#103;&#104; &#109;&#097;&#110;&#121; people with hepatitis C may &#110;&#111;&#116; experience symptoms, others may have symptoms &#115;&#117;&#099;&#104; &#097;&#115; fatigue, fever, jaundice &#097;&#110;&#100; abdominal pain.(6) Approximately 60 percent &#111;&#102; genotype 1 hepatitis C patients who undergo treatment with &#097;&#110; initial 48-week regimen with pegylated-interferon &#097;&#110;&#100; ribavirin, &#116;&#104;&#101; &#099;&#117;&#114;&#114;&#101;&#110;&#116;&#108;&#121; approved medicines, do &#110;&#111;&#116; achieve SVR,(7,8,9) &#111;&#114; viral cure.(10) &#105;&#102; treatment is &#110;&#111;&#116; successful &#097;&#110;&#100; &#097; person &#100;&#111;&#101;&#115; &#110;&#111;&#116; achieve &#097; viral cure, they remain &#097;&#116; &#097;&#110; increased risk &#102;&#111;&#114; progressive liver disease.(11,12,13,14,15)</p>
<p> &#109;&#111;&#114;&#101; than 170 million people worldwide &#097;&#114;&#101; chronically infected with hepatitis C. In &#116;&#104;&#101; United States, &#110;&#101;&#097;&#114;&#108;&#121; 4 million people have chronic hepatitis C &#097;&#110;&#100; 75 percent &#111;&#102; them &#097;&#114;&#101; unaware &#111;&#102; &#116;&#104;&#101;&#105;&#114; infection.(16) &#116;&#104;&#101; majority &#111;&#102; people with hepatitis C in &#116;&#104;&#101; United States were born between 1946 &#097;&#110;&#100; 1964, accounting &#102;&#111;&#114; &#116;&#119;&#111; &#111;&#102; every three people with chronic hepatitis C.(15) Hepatitis C is &#116;&#104;&#101; leading cause &#111;&#102; liver transplantations in &#116;&#104;&#101; United States &#097;&#110;&#100; is reported &#116;&#111; contribute &#116;&#111; 4,600 &#116;&#111; 12,000 deaths annually.(12) &#098;&#121; 2029, total annual medical costs in &#116;&#104;&#101; United States &#102;&#111;&#114; people with hepatitis C &#097;&#114;&#101; expected &#116;&#111; &#109;&#111;&#114;&#101; than double, from $30 billion in 2009 &#116;&#111; approximately $85 billion.(15)</p>
<p> PEGASYS(R) &#097;&#110;&#100; COPEGUS(R) &#097;&#114;&#101; registered trademarks &#111;&#102; Hoffman-LA Roche.</p>
<p> Reyataz(R) is &#097; registered trademark &#111;&#102; Bristol-Myers Squibb.</p>
<p> Atripla(R) is &#097; registered trademark &#111;&#102; Bristol-Myers Squibb &#097;&#110;&#100; Gilead Sciences, LLC.</p>
<p> Special Note &#114;&#101;&#103;&#097;&#114;&#100;&#105;&#110;&#103; Forward-looking Statements</p>
<p> This press release &#099;&#111;&#110;&#116;&#097;&#105;&#110;&#115; forward-looking statements &#097;&#115; defined in &#116;&#104;&#101; Private Securities Litigation Reform Act &#111;&#102; 1995, including statements &#114;&#101;&#103;&#097;&#114;&#100;&#105;&#110;&#103; (i) &#116;&#104;&#101; interim results being encouraging &#098;&#101;&#099;&#097;&#117;&#115;&#101; they showed &#097; high proportion &#111;&#102; people in &#116;&#104;&#101; study had &#097; rapid response &#116;&#111; telaprevir; (ii) Vertex&#8217;s plan &#116;&#111; &#117;&#115;&#101; &#119;&#104;&#097;&#116; &#105;&#116; is learning from &#116;&#104;&#101; study &#116;&#111; inform &#097; Phase 3 co-infection study &#111;&#102; telaprevir planned &#102;&#111;&#114; &#116;&#104;&#101; end &#111;&#102; 2011; (iii) expectations that final SVR results from &#116;&#104;&#101; study &#119;&#105;&#108;&#108; be &#097;&#118;&#097;&#105;&#108;&#097;&#098;&#108;&#101; in 2012 &#097;&#110;&#100; (iv) &#116;&#104;&#101; possibility that &#097; higher dose &#111;&#102; telaprevir &#099;&#111;&#117;&#108;&#100; largely offset &#116;&#104;&#101; interaction observed between efavirenz &#097;&#110;&#100; telaprevir. While Vertex believes &#116;&#104;&#101; forward-looking statements contained in this press release &#097;&#114;&#101; accurate, &#116;&#104;&#101;&#114;&#101; &#097;&#114;&#101; &#097; number &#111;&#102; factors that &#099;&#111;&#117;&#108;&#100; cause actual events &#111;&#114; results &#116;&#111; differ materially from &#116;&#104;&#111;&#115;&#101; indicated &#098;&#121; &#115;&#117;&#099;&#104; forward-looking statements. &#116;&#104;&#111;&#115;&#101; risks &#097;&#110;&#100; uncertainties include, &#097;&#109;&#111;&#110;&#103; other &#116;&#104;&#105;&#110;&#103;&#115;, &#116;&#104;&#101; risks that efforts &#116;&#111; develop telaprevir &#097;&#115; &#097; treatment &#102;&#111;&#114; patients co-infected with genotype 1 HCV &#097;&#110;&#100; HIV may &#110;&#111;&#116; proceed due &#116;&#111; technical, scientific, commercial, financial &#111;&#114; other reasons; that final outcomes, including SVR rates, from this clinical trial &#097;&#110;&#100; any future clinical trials &#111;&#102; telaprevir in patients with HCV-HIV co-infection may &#110;&#111;&#116; be favorable; that RVR &#097;&#110;&#100; cEVR may &#110;&#111;&#116; be predictive &#111;&#102; SVR in patients with HCV-HIV co-infection &#097;&#110;&#100; &#116;&#104;&#101; other risks listed under Risk Factors in Vertex&#8217;s annual report &#097;&#110;&#100; quarterly reports filed with &#116;&#104;&#101; Securities &#097;&#110;&#100; Exchange Commission &#097;&#110;&#100; &#097;&#118;&#097;&#105;&#108;&#097;&#098;&#108;&#101; through Vertex&#8217;s website &#097;&#116; vrtx.com. Vertex disclaims any obligation &#116;&#111; update &#116;&#104;&#101; information contained in this press release &#097;&#115; &#110;&#101;&#119; information &#098;&#101;&#099;&#111;&#109;&#101;&#115; &#097;&#118;&#097;&#105;&#108;&#097;&#098;&#108;&#101;.</p>
<p> Vertex &#099;&#114;&#101;&#097;&#116;&#101;&#115; &#110;&#101;&#119; possibilities in medicine. Our team aims &#116;&#111; discover, develop &#097;&#110;&#100; commercialize innovative therapies so people with &#115;&#101;&#114;&#105;&#111;&#117;&#115; diseases can lead better lives.</p>
<p> Vertex scientists &#097;&#110;&#100; our collaborators &#097;&#114;&#101; working &#111;&#110; &#110;&#101;&#119; medicines &#116;&#111; cure &#111;&#114; significantly advance &#116;&#104;&#101; treatment &#111;&#102; hepatitis C, cystic fibrosis, epilepsy &#097;&#110;&#100; other life-threatening diseases.</p>
<p> Founded &#109;&#111;&#114;&#101; than 20 years &#097;&#103;&#111; in Cambridge, MA, &#119;&#101; now have ongoing worldwide research programs &#097;&#110;&#100; sites in &#116;&#104;&#101; U.S., U.K. &#097;&#110;&#100; Canada.</p>
<p> &#102;&#111;&#114; &#109;&#111;&#114;&#101; information &#097;&#110;&#100; &#116;&#111; view Vertex&#8217;s press releases, &#112;&#108;&#101;&#097;&#115;&#101; visit vrtx.com.</p>
<p> References: (1) 2010 Guidelines &#102;&#111;&#114; Antiretroviral Treatment &#111;&#102; HIV From &#116;&#104;&#101; International AIDS Society-USA Panel JAMA. 2010;304(17):1897. (2) Centers &#102;&#111;&#114; Disease Control &#097;&#110;&#100; Prevention. HIV/AIDS &#097;&#110;&#100; Viral Hepatitis. &#097;&#118;&#097;&#105;&#108;&#097;&#098;&#108;&#101; &#097;&#116; cdc.gov/hepatitis/Populations/hiv.htm. Accessed February 17, 2011. (3) Health Resources &#097;&#110;&#100; Services Administration. Care &#097;&#110;&#100; Treatment &#102;&#111;&#114; Hepatitis C &#097;&#110;&#100; HIV Co-infection. &#097;&#118;&#097;&#105;&#108;&#097;&#098;&#108;&#101; &#097;&#116; hab.hrsa.gov/tools/coinfection/coinfectionsub.html &#097;&#110;&#100; hab.hrsa.gov/tools/coinfection/index.html Accessed February 28, 2011. (4) Benhamou Y, Bochet M, Di Martino V, Charlotte F, Azria F, Coutellier &#097;, &#101;&#116; al. Liver fibrosis progression in human immunodeficiency virus &#097;&#110;&#100; hepatitis C virus coinfected patients. Hepatology 1999;30(4):1054-58. (5) Martin-Carbonero L, Benhamou Y, Puoti M, Berenguer J, Mallolas J, Quereda C, &#101;&#116; al. Incidence &#097;&#110;&#100; predictors &#111;&#102; severe liver fibrosis in human immunodeficiency virus-infected patients with chronic hepatitis C: &#097; European collaborative study. CID 2004;38:128-33. (6) Martinez-Sierra C, Arizcorreta &#097;, Diaz F, Roldan R, Martin-Herrera M, Perez- Guzman E, &#101;&#116; al. Progression &#111;&#102; chronic hepatitis C &#116;&#111; liver fibrosis &#097;&#110;&#100; cirrhosis in patients coinfected with hepatitis C virus &#097;&#110;&#100; human immunodeficiency virus. CID 2003;36:491-8. (7) Centers &#102;&#111;&#114; Disease Control &#097;&#110;&#100; Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. &#097;&#118;&#097;&#105;&#108;&#097;&#098;&#108;&#101; &#097;&#116;: cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed May 25, 2010. (8) Manns MP, McHutchison JG, Gordon SC, &#101;&#116; al. Peginterferon alfa-2b &#112;&#108;&#117;&#115; ribavirin compared with interferon alfa-2b &#112;&#108;&#117;&#115; ribavirin &#102;&#111;&#114; initial treatment &#111;&#102; chronic hepatitis C: &#097; randomised trial. Lancet. 2001;358:958-965. (9) Fried MW, Shiffman ML, Reddy KR, &#101;&#116; al. Peginterferon alfa-2a &#112;&#108;&#117;&#115; ribavirin &#102;&#111;&#114; chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982. (10) McHutchison JG, Lawitz EJ, Shiffman ML, &#101;&#116; al; IDEAL Study Team. Peginterferon alfa-2b &#111;&#114; alfa-2a with ribavirin &#102;&#111;&#114; treatment &#111;&#102; hepatitis C infection. N Engl J Med. 2009;361:580-593. (11) Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management &#097;&#110;&#100; treatment &#111;&#102; hepatitis C; &#097;&#110; update. Hepatology. 2009;49 (4):1-40. (12) Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome &#111;&#102; sustained virological responders &#097;&#110;&#100; non-responders in &#116;&#104;&#101; Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology.</p>
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		<title>=&gt; BARACLUDE(R) (entecavir) Approved by the European Commission for the Treatment of Chronic Hepatitis B in Adult Patients With Evidence of Decompensated Liver Disease &lt;=</title>
		<link>http://symptomadvice.com/baracluder-entecavir-approved-by-the-european-commission-for-the-treatment-of-chronic-hepatitis-b-in-adult-patients-with-evidence-of-decompensated-liver-disease/</link>
		<comments>http://symptomadvice.com/baracluder-entecavir-approved-by-the-european-commission-for-the-treatment-of-chronic-hepatitis-b-in-adult-patients-with-evidence-of-decompensated-liver-disease/#comments</comments>
		<pubDate>Fri, 04 Mar 2011 08:51:15 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[fibrosis symptoms]]></category>
		<category><![CDATA[adult patients]]></category>
		<category><![CDATA[chronic hepatitis]]></category>
		<category><![CDATA[decompensated cirrhosis]]></category>
		<category><![CDATA[entecavir]]></category>
		<category><![CDATA[liver inflammation]]></category>
		<category><![CDATA[viral replication]]></category>

		<guid isPermaLink="false">http://symptomadvice.com/baracluder-entecavir-approved-by-the-european-commission-for-the-treatment-of-chronic-hepatitis-b-in-adult-patients-with-evidence-of-decompensated-liver-disease/</guid>
		<description><![CDATA[Paris (ots/PRNewswire) &#8211; Bristol-Myers Squibb announced today that BARACLUDE(R) (entecavir) has been approved &#098;&#121; the European Commission &#111;&#110; February 28th 2011 to treat chronic hepatitis B (CHB) in adult patients with evidence &#111;&#102; decompensated liver disease. BARACLUDE(r) was already approved in Europe in June 2006 &#102;&#111;&#114; &#117;&#115;&#101; in adult patients with CHB with compensated liver [...]]]></description>
			<content:encoded><![CDATA[<p></p><p><img src="http://symptomadvice.com/wp-content/uploads/2011/03/1299228676-93.jpg" style="clear:both;clear:both;margin:0 15px 15px 0" />Paris (ots/PRNewswire) &#8211; Bristol-Myers Squibb announced today that BARACLUDE(R) (entecavir) has been approved &#098;&#121; the European Commission &#111;&#110; February 28th 2011 to treat chronic hepatitis B (CHB) in adult patients with evidence &#111;&#102; decompensated liver disease. BARACLUDE(r) was already approved in Europe in June 2006 &#102;&#111;&#114; &#117;&#115;&#101; in adult patients with CHB with compensated liver disease and evidence &#111;&#102; active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence &#111;&#102; active inflammation and/or fibrosis. &#116;&#104;&#105;&#115; approval grants BARACLUDE(r) marketing authorisation in the 27 countries &#111;&#102; the European Union. In the U.S., the Food and Drug Administration (FDA) approved the decompensated indication &#102;&#111;&#114; BARACLUDE(r) in October 2010. Decompensated liver disease &#105;&#115; characterised &#098;&#121; failure &#111;&#102; the liver to maintain adequate function, &#117;&#115;&#117;&#097;&#108;&#108;&#121; due to severe scarring, leading to fibrosis and/or cirrhosis caused &#098;&#121; chronic liver inflammation.[1] It represents the &#101;&#110;&#100; stage &#111;&#102; hepatitis. Natural history data demonstrate that &#117;&#112; to 40% &#111;&#102; patients with CHB develop cirrhosis &#111;&#118;&#101;&#114; their lifetimes, at &#097; reported rate &#111;&#102; 2-6% per year.[1] &#097;&#109;&#111;&#110;&#103; CHB patients with cirrhosis, 3-5% per year progress to decompensated cirrhosis and 2-5% develop hepatocellular carcinoma (HCC).[2,3] Currently, the median survival rate in decompensated patients &#105;&#115; two to three years, with &#111;&#110;&#108;&#121; 28% &#111;&#102; patients surviving &#102;&#111;&#114; more &#116;&#104;&#097;&#110; five years.[1,4] &#111;&#110;&#099;&#101; liver disease progresses to the decompenstated stage, &#097; liver transplant &#105;&#115; often &#110;&#101;&#099;&#101;&#115;&#115;&#097;&#114;&#121;. &#8220;The approval &#111;&#102; &#116;&#104;&#105;&#115; additional indication &#105;&#115; &#097;&#110; important milestone &#102;&#111;&#114; CHB patients living with decompensated liver disease, &#097; difficult to treat population &#119;&#104;&#111;&#115;&#101; mortality rates are high,&#8221; said Professor Jorg Petersen. &#8220;The data used to support &#116;&#104;&#105;&#115; indication shows that BARACLUDE(r) &#105;&#115; efficacious in treating decompensated patients.&#8221; &#116;&#104;&#105;&#115; approval &#105;&#115; based &#111;&#110; &#097; randomised, open-label, multi-centre study (ETV-048) that compared the efficacy&amp;safety &#111;&#102; BARACLUDE(r) (1.0 mg &#111;&#110;&#099;&#101; daily) with adefovir (10.0 mg &#111;&#110;&#099;&#101; daily) administered in patients with HBeAg positive or negative CHB &#119;&#104;&#111; had evidence &#111;&#102; liver decompensation. Data demonstrated that BARACLUDE(r) showed greater viral suppression compared to adefovir at 24 and 48 weeks following treatment initiation. At 48 weeks, 57% (57/100) &#111;&#102; patients treated with BARACLUDE(r) achieved &#097;&#110; undetectable viral load (less &#116;&#104;&#097;&#110; or equal to 300 copies/ml) compared to 20% (18/91) &#111;&#102; patients &#111;&#110; adefovir. ETV-048 Study Results The 048 study evaluated 191 patients &#119;&#104;&#111; &#119;&#101;&#114;&#101; &#101;&#105;&#116;&#104;&#101;&#114; HBeAG-positive or HBeAG-negative. Patients &#119;&#101;&#114;&#101; &#101;&#105;&#116;&#104;&#101;&#114; treatment-naive or had been previously treated excluding pre-treatment with BARACLUDE(r), adefovir or tenofovir. Patients &#119;&#101;&#114;&#101; randomised to receive BARACLUDE(r) (1.0 mg &#111;&#110;&#099;&#101; daily) or adefovir (10.0 mg &#111;&#110;&#099;&#101; daily) and &#119;&#101;&#114;&#101; analysed through 48 weeks. Baseline demographics &#119;&#101;&#114;&#101; similar &#102;&#111;&#114; both groups. Importantly, at baseline, patients had &#097; mean CPT (child-pugh score) &#111;&#102; 8.81 in the BARACLUDE(r) arm and 8.35 in the adefovir arm, and the mean MELD (Model &#102;&#111;&#114; &#101;&#110;&#100; stage Liver Disease) score was 17.1 and 15.3, respectively. Both &#111;&#102; these parameters measure the severity &#111;&#102; hepatic decompensation. The mean age &#111;&#102; the study population was 52 years and the majority &#111;&#102; the subjects &#119;&#101;&#114;&#101; male (74%) and &#101;&#105;&#116;&#104;&#101;&#114; Asian (54%) or Caucasian (33%).[5] In the primary efficacy endpoint &#111;&#102; mean change from baseline in serum HBV DNA at Week 24, BARACLUDE(r) was superior to adefovir (-4.48 versus -3.40; p &lt; 0.0001). Secondary efficacy endpoints included mean change from baseline in serum HBV DNA at Week 48 (-4.66 in the BARACLUDE(r) arm and -3.90 in the adefovir arm). In addition &#097; greater proportion &#111;&#102; patients &#111;&#110; BARACLUDE(r) achieved &#097;&#110; undetectable viral load compared to patients &#111;&#110; adefovir at 48 weeks: 57% (57/100) versus 20% (18/91), respectively. Also patients &#111;&#110; the BARACLUDE(r) arm decreased their MELD score from baseline &#098;&#121; -2.6% versus -1.7% in the adefovir arm at Week 48, even &#116;&#104;&#111;&#117;&#103;&#104; baseline MELD score had been higher with 17.1 &#102;&#111;&#114; BARACLUDE(r) &#116;&#104;&#097;&#110; 15.3 &#102;&#111;&#114; adefovir. Further the normalization &#111;&#102; ALT (Alanine Aminotransferase enzyme) was achieved to &#097; higher proportion in the BARACLUDE(r)-treated patients (less &#116;&#104;&#097;&#110; or equal to 1 x Upper Limit &#111;&#102; Normal) at Week 48 [63% (49/78)] compared with adefovir-treated patients [46% (33/71)]. The time to onset &#111;&#102; HCC or death was comparable in the two treatment groups; on-study cumulative death rates &#119;&#101;&#114;&#101; 23% (23/102) and 33% (29/89) &#102;&#111;&#114; patients treated with BARACLUDE(r) and adefovir, respectively; and on-study cumulative rates &#111;&#102; HCC &#119;&#101;&#114;&#101; 12% (12/102) and 20% (18/89) &#102;&#111;&#114; BARACLUDE(r) and adefovir, respectively. BARACLUDE(r) was generally well tolerated and safety results &#119;&#101;&#114;&#101; comparable &#098;&#101;&#116;&#119;&#101;&#101;&#110; the treatment groups and consistent with &#116;&#104;&#111;&#115;&#101; previously reported &#102;&#111;&#114; &#097; population with decompensated liver disease. Serious adverse events occurred in 69% &#111;&#102; the BARACLUDE(r) patients and 66% &#111;&#102; the adefovirpatientsand discontinuations due to adverse events occurred in 7% &#111;&#102; the Baraclude patients and 6 % &#111;&#102; the adefovir patients.[5] Important Information &#097;&#098;&#111;&#117;&#116; BARACLUDE(r) Discovered at Bristol-Myers Squibb, BARACLUDE(r) &#105;&#115; &#105;&#110;&#100;&#105;&#099;&#097;&#116;&#101;&#100; &#102;&#111;&#114; the treatment &#111;&#102; chronic hepatitis B virus (HBV) infection in adults with: &#8211; Compensated liver disease and evidence &#111;&#102; active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence &#111;&#102; active inflammation and/or fibrosis. &#8211; Decompensated liver disease. &#097; higher rate &#111;&#102; serious hepatic adverse events (regardless &#111;&#102; causality) has been observed in patients with decompensated liver disease, in &#112;&#097;&#114;&#116;&#105;&#099;&#117;&#108;&#097;&#114; in &#116;&#104;&#111;&#115;&#101; with Child-Turcotte-Pugh (CTP) class C disease, compared with rates in patients with compensated liver function. In addition, patients with decompensated liver disease may &#098;&#101; at higher risk &#102;&#111;&#114; lactic acidosis and specific renal adverse events such as hepatorenal syndrome. Clinical and laboratory parameters &#115;&#104;&#111;&#117;&#108;&#100; &#098;&#101; closely monitored in &#116;&#104;&#105;&#115; patient population. * &#102;&#111;&#114; &#102;&#117;&#108;&#108; prescribing information &#102;&#111;&#114; BARACLUDE(r), please consult the Summary &#111;&#102; Product Characteristics. &#097;&#098;&#111;&#117;&#116; Chronic Hepatitis B (CHB) Chronic hepatitis B &#105;&#115; &#097; serious global health issue. Worldwide, more &#116;&#104;&#097;&#110; 2 billion people &#104;&#097;&#118;&#101; been in contact with the hepatitis B virus and approximately 350 million people are chronically infected.[6] &#097;&#098;&#111;&#117;&#116; Decompensated Liver Disease Decompensated liver disease &#105;&#115; characterised &#098;&#121; failure &#111;&#102; the liver to maintain adequate function, often due to severe scarring leading to fibrosis and/or cirrhosis caused &#098;&#121; chronic liver inflammation.[1] Symptoms &#111;&#102; liver decompensation can include &#098;&#117;&#116; are not limited to: jaundice (yellowing &#111;&#102; the skin or eyes), ascites (swollen abdomen from abnormal accumulation &#111;&#102; fluid), oesophageal varices (distorted blood vessels that may &#099;&#097;&#117;&#115;&#101; potentially fatal bleeding), and hepatic encephalopathy ( neuropsychiatric abnormality resulting in personality changes, intellectual impairment and reduced levels &#111;&#102; consciousness).[1] &#097;&#098;&#111;&#117;&#116; Bristol-Myers Squibb Bristol-Myers Squibb &#105;&#115; &#097; global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that &#104;&#101;&#108;&#112; patients prevail &#111;&#118;&#101;&#114; serious diseases. BARACLUDE(R) (entecavir) &#105;&#115; &#097; registered trademark &#111;&#102; Bristol-Myers Squibb Company. References 1. D&#039;Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators &#111;&#102; survival in cirrhosis: &#097; systematic review &#111;&#102; 118 studies. J. Hepatol. 2006; 44: 217-31. 2. Chu C-M and Liaw Y-F. Hepatitis B virus-related cirrhosis: Natural history and treatment. Seminars in Liver Disease 2006;26(2):142-152. 3. Fattovich G, Stroffolini T, Zagni I, Donato F. Hepatocellular carcinoma in cirrhosis: Incidence and risk factors. Gastroenterology 2004;127(5 Suppl 1):S35-S50. 4. Fattovich G, Pantalena M, Zagni I &#101;&#116; al. Effect &#111;&#102; hepatitis B and C virus infections &#111;&#110; the natural history &#111;&#102; compensated cirrhosis: &#097; cohort study &#111;&#102; 297 patients. Am. J. Gastroenterol. 2002; 97: 2886-95. 5. Y. Liaw, &#101;&#116; al. Efficacy and Safety &#111;&#102; Entecavir versus Adefovir in Chronic Hepatitis B Patients with Evidence &#111;&#102; Hepatic Decompensation. Abstract and Poster 442. AASLD 2009. 6. World Helath Organization Web site. Fact sheet N- 204. &#119;&#104;&#111;.int/mediacentre/factsheets/fs204/en/. Accessed 3 December 2010.ots Originaltext: Bristol-Myers Squibb GmbH&amp;Co.KG aA Im Internet recherchierbar: presseportal.deContact: Contact: Media: Annie Simond, office: +33-1-58-83-65-66,&copy;&nbsp;2011&nbsp;news aktuell</p>
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