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Note the link provided on this blogs sidebar; The International Liver Congress™ 2011 by EASL (46th annual meeting)
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WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada,announced today that several new data analyses from Phase III studies ofVICTRELIS™ (boceprevir), its investigational oral hepatitis Cprotease inhibitor, will be presented at The International Liver CongressTM/ 46th European Association for the Study ofthe Liver (EASL) annual meeting. The meeting will be held from March 30– April 3 in Berlin. In total, more than 20 abstracts highlighting Merckmedicines and investigational therapies for chronic hepatitis C virus(HCV) infection will be presented, including 3 oral presentations and 17posters for VICTRELIS.
“How should I dispose of the used syringes,needles, and vials?”
Presented for the first time will be final results from a Phase IIIstudy of VICTRELIS administered in combination with Pegasys®(peginterferon alfa-2a) and ribavirin in adult patients with chronic HCVgenotype 1 infection who were non-responders or relapsers to previouspegylated interferon and ribavirin therapy.
The EASL presentations will also include new analyses of the pivotalPhase III data for VICTRELIS administered in combination with PEGINTRON®(peginterferon alfa-2b) and ribavirin from the HCV SPRINT-2 and HCVRESPOND-2 studies:
Response-guided therapy with VICTRELIS in combination with currentstandard therapy among patients with chronic HCV genotype 1, includingspecial populations such as those with advanced fibrosis / cirrhosis;
Overall safety profile of VICTRELIS administered in combination withcurrent standard therapy for chronic HCV; and
Potential predictive factors for chronic HCV treatment success,including response following 4 weeks of lead-in therapy and IL28Bpolymorphism.
The abstracts were published today and can be accessed on the EASL website.
For program information, please visit
http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww2.kenes.com%2Fliver-congress%2FPages%2FHome.aspx&esheet=6637167&lan=en-US&anchor=http%3A%2F%2Fwww2.kenes.com%2Fliver-congress%2FPages%2FHome.aspx&index=1&md5=a1281d668a88399d06b3edb21e57c8ac.
VICTRELIS (Boceprevir) Oral Presentations
Parallel Session: HCV Therapy, Thursday, March 31, 17:00 – 19:00,Hall 1
Boceprevir in Addition to Standard of Care Enhanced SVR in Hepatitis CVirus (HCV) Genotype-1 with Advanced Fibrosis/Cirrhosis: SubgroupAnalysis of SPRINT-2 and RESPOND-2 Studies; S. Bruno et al. 17:15 –17:30 CET
Boceprevir Resistance-Associated Variants (RAVS) are Observed MoreFrequently in HCV (Gt1)-Infected Patients with Poor Response toPeginterferon Alfa-2b/Ribavirin; S. Zeuzem et al. 17:45 – 18:00 CET
IL28B Polymorphism Predicts Virologic Response in Patients withHepatitis C Genotype 1 Treated with Boceprevir (BOC) Combination Therapy. F. Poordad et al. 18:30 – 18:45 CET
VICTRELIS (Boceprevir) Key Poster Presentations
High Sustained Virologic Response (SVR) Among Genotype 1 PreviousNon-Responders and Relapsers to Peginterferon/Ribavirin When Re-TreatedWith Boceprevir Plus Peginterferon Alfa-2A/Ribavirin. S. Flamm et al.Late-Breaker Abstract 1366. Thursday, March 31.
Response-Guided Therapy with Boceprevir Plus PeginterferonAlfa-2b/Ribavirin Reduces Duration in Naive and PeginterferonAlfa-2b/Ribavirin Previous-Treatment-Failure Patients with HCV Genotype1. M.P. Manns et al. Abstract 448. Thursday, March 31.
Overall Safety Profile of Boceprevir Plus PeginterferonAlfa-2b/Ribavirin. M.P. Manns et al. Abstract 449. Thursday, March 31.
Four-Week Therapy with Peginterferon Alfa-2b/Ribavirin EffectivelyPredicts Sustained Virologic Response in Treatment-Naïve andPrevious-Treatment-Failure Patients with HCV-1 Treated with BoceprevirPlus Peginterferon Alfa-2b/Ribavirin. J.M. Viering et al. Abstract 481.Thursday, March 31.
Utility of Historical Data Compared to Lead-In Response in PredictingSustained Virologic Response in Non-Responders and Relapsers toPeginterferon/Ribavirin When Re-Treated With Boceprevir+PeginterferonAlfa-2b/Ribavirin (P/R). R. Esteban et al. Abstract 418. Thursday, March31.
About the HCV RESPOND-2 and HCV SPRINT-2 Studies
The HCV RESPOND-2 study in treatment-failure patients and the HCVSPRINT-2 study in previously untreated patients each evaluated twotreatment strategies with VICTRELIS administered in combination withPEGINTRON and ribavirin to assess the ability to improve sustainedvirologic response (SVR) 1 and potentially shorten overalltreatment duration compared to treatment with PEGINTRON and ribavirinalone:
Response-guided therapy, in which treatment-failure patients withundetectable virus at week 8 were able to stop all treatment at 36weeks, and in which previously untreated
patients with undetectable virus during weeks 8 through 24 were ableto stop all treatment at 28 weeks; and
48 weeks of treatment (4-week PEGINTRON and ribavirin lead-in followedby the addition of VICTRELIS for 44 weeks).
In both studies, all patients were treated with a 4-week lead-in ofPEGINTRON (1.5 mcg/kg/week) and an investigational dose of ribavirin(600-1,400 mg/day), followed by the addition of VICTRELIS (800 mg threetimes a day).
As previously reported, the U.S. Food and Drug Administration hasgranted priority review status to the New Drug Application (NDA) forVICTRELIS and the Marketing Authorization Application (MAA) forVICTRELIS has been accepted for accelerated assessment by the EuropeanMedicines Agency. Data in the NDA and MAA have been provided in supportof the proposed use of boceprevir for the treatment of chronic HCVgenotype 1 infection, in combination with peginterferon alpha andribavirin, in adult patients with compensated liver disease who arepreviously untreated or who have failed previous therapy.
Merck is committed to building on its strong legacy in the field ofviral hepatitis by continuing to discover, develop and deliver vaccinesand medicines to help prevent and treat viral hepatitis. In hepatitis C,company researchers developed the first approved therapy for chronic HCVin 1991 and the first combination therapy in 1998. 2011 marks the10-year anniversary of the introduction of PEGINTRON and ribavirin incombination therapy, a current standard therapy for chronic HCVworldwide. In addition to ongoing studies with VICTRELIS, extensiveresearch efforts are underway to develop additional innovative oraltherapies for viral hepatitis care.
About PEGINTRON
PEGINTRON is indicated for use in combination with ribavirin for thetreatment of chronic hepatitis C in patients 3 years of age and olderwith compensated liver disease.
The following points should be considered when initiating therapy withPEGINTRON in combination with ribavirin: (1) These indications are basedon achieving undetectable HCV-RNA after treatment for 24 or 48 weeks andmaintaining a Sustained Virologic Response (SVR) 24 weeks after the lastdose. (2) Patients with the following characteristics are less likely tobenefit from re-treatment after failing a course of therapy: previousnonresponse, previous pegylated interferon treatment, significantbridging fibrosis or cirrhosis, and genotype 1 infection. (3) No safetyand efficacy data are available for treatment of longer than one year.
PEGINTRON is also indicated for use alone for the treatment of chronichepatitis C in patients with compensated liver disease previouslyuntreated with interferon alpha and who are at least 18 years of age.
The following points should be considered when initiating therapy withPEGINTRON alone: Combination therapy with ribavirin is preferred overPEGINTRON monotherapy unless there are contraindications to, orsignificant intolerance of, ribavirin. Combination therapy providessubstantially better response rates than monotherapy.
Selected Safety Information on PEGINTRON
WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS
Alpha interferons, including PEGINTRON, may cause or aggravate fatalor life-threatening neuropsychiatric, autoimmune, ischemic, andinfectious disorders. Patients should be monitored closely withperiodic clinical and laboratory evaluations. Patients withpersistently severe or worsening signs or symptoms of these conditionsshould be withdrawn from therapy. In many, but not all cases, thesedisorders resolve after stopping PEGINTRON therapy.
Use with Ribavirin: Ribavirin maycause birth defects and death of the unborn child. Extreme caremust be taken to avoid pregnancy in female patients and in femalepartners of male patients. Ribavirin causes hemolytic anemia. Theanemia associated with ribavirin therapy may result in a worsening ofcardiac disease. Ribavirin is genotoxic and mutagenic and shouldbe considered a potential carcinogen.
Contraindications
PEGINTRON is contraindicated in patients with known hypersensitivityreactions such as urticaria, angioedema, bronchoconstriction,anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis tointerferon alpha or any other component of the product, autoimmunehepatitis, and hepatic decompensation (Child-Pugh score greater than 6[class B and C]) in cirrhotic CHC patients before or during treatment.PEGINTRON/ribavirin combination therapy is additionally contraindicatedin women who are pregnant or may become pregnant, men whose femalepartners are pregnant, patients with hemoglobinopathies (e.g.,thalassemia major, sickle-cell anemia), and patients with creatinineclearance less than 50 mL per min.
Pregnancy
Ribavirin therapy should not be started until a report of a negativepregnancy test has been obtained immediately prior to planned initiationof therapy. Patients should use at least two effective forms ofcontraception and have monthly pregnancy tests during therapy and forsix months after completion of therapy. If this drug is used duringpregnancy, or if a patient becomes pregnant, the patient should beapprised of the potential hazard to a fetus. A Ribavirin PregnancyRegistry has been established to monitor maternal-fetal outcomes ofpregnancies in female patients and female partners of male patientsexposed to ribavirin during treatment, and for six months followingcessation of treatment. Physicians and patients are encouraged to reportsuch cases by calling 1-800-593-2214.
Patients with the following conditions should be closely monitoredand may require dose reduction or discontinuation of therapy:
Hemolytic anemia with ribavirin
Neuropsychiatric events
History of significant or unstable cardiac disease
Hypothyroidism, hyperthyroidism, hyperglycemia, diabetes mellitus thatcannot be effectively treated by medication
New or worsening ophthalmologic disorders
Ischemic and hemorrhagic cerebrovascular events
Severe decreases in neutrophil or platelet counts
History of autoimmune disorders
Pancreatitis and ulcerative or hemorrhagic/ischemic colitis andpancreatitis
Pulmonary infiltrates or pulmonary function impairment
Child-Pugh score greater than 6 (Class B and C)
Increased creatinine levels in patients with renal insufficiency
Serious, acute hypersensitivity reactions and cutaneous eruptions
Dental/periodontal disorders reported with combination therapy
Hypertriglyceridemia may result in pancreatitis (e.g., triglyceridesgreater than 1000 mg/dL)
Weight loss and growth inhibition reported with combination therapy inpediatric patients.
Life-threatening or fatal neuropsychiatric events, including suicidaland homicidal ideation, depression, relapse of drug addiction/overdose,and aggressive behavior, sometimes directed towards others, haveoccurred in patients with and without a previous psychiatric disorderduring PEGINTRON treatment and follow-up.
Adverse Events
Serious adverse reactions have occurred in approximately 12 percent ofsubjects in clinical trials. The most common serious events occurring insubjects treated with PEGINTRON and ribavirin were depression andsuicidal ideation, each occurring at a frequency of less than 1 percent.The most common fatal events occurring in subjects treated withPEGINTRON and ribavirin were cardiac arrest, suicidal ideation, andsuicide attempt, all occurring in less than 1 percent of subjects.
The incidence of serious adverse reactions was comparable betweenPEGINTRON monotherapy (about 12 percent) and PEGINTRON/ribavirincombination therapy weight-based (12 percent) or flat-dose (17 percent).In many but not all cases, adverse reactions resolved after dosereduction or discontinuation of therapy. Some patients experiencedongoing or new serious adverse reactions during the 6-month follow-upperiod. In a study with PEGINTRON/ribavirin (weight-based) combinationtherapy in adult patients, anemia with weight-based dosing occurred atan increased rate (29 percent vs. 19 percent); however, the majority ofthese cases were mild and responded to dose reductions. The incidence ofserious adverse reactions reported for the weight-based ribavirin groupwas 12 percent. There were 31 deaths in clinical trials which occurredduring treatment or during follow-up. Of the deaths, 19 were patients oneither PEGINTRON or PEGINTRON/ribavirin combination therapy and threeoccurred during the follow-up period but had been on PEGINTRON/ribavirincombination therapy.
Additional serious adverse reactions seen in clinical trials at afrequency of equal to or less than 1 percent included psychosis,aggressive reaction, relapse of drug addiction/overdose; nerve palsy(facial, oculomotor); cardiomyopathy, angina, pericardial effusion,retinal ischemia, retinal artery or vein thrombosis, blindness,decreased visual acuity, optic neuritis, transient ischemic attack,supraventricular arrhythmias, loss of consciousness; neutropenia,infection (sepsis, pneumonia, abscess, cellulitis); emphysema,bronchiolitis obliterans, pleural effusion, gastroenteritis,pancreatitis, gout, hyperglycemia, hyperthyroidism and hypothyroidism,autoimmune thrombocytopenia with or without purpura, rheumatoidarthritis, interstitial nephritis, lupus-like syndrome, sarcoidosis,aggravated psoriasis, urticaria, injection site necrosis, vasculitis,and phototoxicity.
Greater than 96 percent of all subjects in clinical trials experiencedone or more adverse events. Most common adverse reactions (greater than40 percent) in adult patients receiving either PEGINTRON orPEGINTRON/ribavirin are injection site inflammation/reaction,fatigue/asthenia, headache, rigors, fevers, nausea, myalgia, andanxiety/emotional lability/irritability.
The adverse reaction profile was similar between weight-based andflat-dose PEGINTRON/ribavirin therapies. Weight-basedPEGINTRON/ribavirin dosing resulted in increased rates of anemia. Mostcommon adverse reactions with PEGINTRON/ribavirin (weight-based) therapywere psychiatric, which occurred among 68-69 percent of patients andincluded depression, irritability, and insomnia, each reported byapproximately 30-40 percent of subjects in all treatment groups.Suicidal behavior (ideation, attempts, and suicides) occurred in 2percent of all patients during treatment or during follow-up aftertreatment cessation. Other common reactions included injection sitereactions, fatigue/ asthenia, headache, rigors, fever, nausea, myalgia,anxiety/emotional lability/irritability. The severity of some of thesesystemic symptoms tends to decrease as treatment continues.
Subjects receiving PEGINTRON/ribavirin as re-treatment after failing aprevious interferon combination regimen reported adverse reactionssimilar to previous treatment-naïve patients receiving this regimen.
In general, the adverse reaction profile in the pediatric population wassimilar to that observed in adults. Most common adverse reactions(greater than 25 percent) in pediatric patients receivingPEGINTRON/ribavirin are pyrexia, headache, neutropenia, fatigue,anorexia, injection site erythema, abdominal pain, and vomiting.
Please see full prescribing information at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.spfiles.com%2Fpipeg-intron.pdf&esheet=6637167&lan=en-US&anchor=http%3A%2F%2Fwww.spfiles.com%2Fpipeg-intron.pdf
About Merck
Today's Merck is a global healthcare leader working to help the world bewell. Merck is known as MSD outside the United States and Canada.Through our prescription medicines, vaccines, biologic therapies, andconsumer care and animal health products, we work with customers andoperate in more than 140 countries to deliver innovative healthsolutions. We also demonstrate our commitment to increasing access tohealthcare through far-reaching policies, programs and partnerships. Formore information, visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.merck.com&esheet=6637167&lan=en-US&anchor=www.merck.com&index=3&md5=5acf4ca589b6b993a6a676466d17083f .
Forward-Looking Statement
This news release includes “forward-looking statements” within themeaning of the safe harbor provisions of the United States PrivateSecurities Litigation Reform Act of 1995. Such statements may include,but are not limited to, statements about the benefits of the mergerbetween Merck and Schering-Plough, including future financial andoperating results, the combined company’s plans, objectives,expectations and intentions and other statements that are not historicalfacts. Such statements are based upon the current beliefs andexpectations of Merck’s management and are subject to significant risksand uncertainties. Actual results may differ from those set forth in theforward-looking statements.
The following factors, among others, could cause actual results todiffer from those set forth in the forward-looking statements: thepossibility that the expected synergies from the merger of Merck andSchering-Plough will not be realized, or will not be realized within theexpected time period; the impact of pharmaceutical industry regulationand health care legislation; the risk that the businesses will not beintegrated successfully; disruption from the merger making it moredifficult to maintain business and operational relationships; Merck’sability to accurately predict future market conditions; dependence onthe effectiveness of Merck’s patents and other protections forinnovative products; the risk of new and changing regulation and healthpolicies in the U.S. and internationally and the exposure to litigationand/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-lookingstatement, whether as a result of new information, future events orotherwise. Additional factors that could cause results to differmaterially from those described in the forward-looking statements can befound in Merck’s 2010 Annual Report on Form 10-K and the company’s otherfilings with the Securities and Exchange Commission (SEC) available atthe SEC’s Internet site http://www.businesswire.com/news/home/20110307006284/en/Merck-Announces-Data-Analyses-VICTRELIS%E2%84%A2-Boceprevir-Presented
Please see attached Prescribing Information, Medication Guide, andInstructions for Use including Boxed Warning for PEGINTRON. ThePrescribing Information, Medication Guide, and Instructions for Use arealso available at http://www.spfiles.com/pipeg-intron.pdf,http://www.spfiles.com/mgpeg-intron.pdf and http://www.spfiles.com/ifupeg-intron.pdf .
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