12MS7358 BQ Vol 9:Layout 1 - Henry Schein

Volume 9/Fall 2012B BioTherapeutics

Q u a r t e r l yDiagnostic and Pharmaceutical News for You and Your Medical Practice

Diagnostics I Pharmaceuticals I DxRx Solutions I Continuing Education I News

12MS7358_BQ_Vol_9:Layout 1 10/19/12 11:47 AM

Denavir has a broad window of treatment. So when patients feel it, they can treat it.Unlike some cold sore medications,1,2,3 topical, steroid-free Denavir can be applied at the fi rst tingle or when lesions appear,1 giving patients fast relief*1 from discomfort, drying and cracking.4 Denavir is not systemically absorbed** and has no known drug interactions.1 Plus, eligible patients pay no more than $15 with a money-saving coupon (subject to eligibility restrictions and limitations).†

Visit Denavir.com or call 1-888-DENAVIR (1-888-336-2847). * Compared to placebo. **The systemic absorption of penciclovir following topical administration has not been evaluated in patients less than 18 years of age.1

New American Therapeutics, Inc. holds the exclusive right to market and distribute Denavir in the United States. Denavir® is a registered trademark of New American Therapeutics, Inc.

(penciclovir cream, 1%)natxcorp.com

Progress through practical innovation

4 Becker Farm Road, Roseland, NJ 07068 ©2012 New American Therapeutics, Inc. 1/2012 DEN-0075

Denavir® (penciclovir cream, 1%) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.

IMPORTANT SAFETY INFORMATIONDenavir should only be used on herpes labialis on the lips or face. Application to mucous membranes is not recommended. Denavir should not be used in patients with known hypersensitivity to the product or any of its ingredients.

There are no adequate and well-controlled Denavir studies in pregnant women; therefore, Denavir should be used during pregnancy only if clearly needed. There is no information on whether Denavir is excreted in human milk after topical administration; a decision whether to discontinue Denavir should take into account the importance of the drug to the mother. The effect of Denavir has not been established in immunocompromised patients. Denavir does not cure cold sores.

In clinical studies, the most common adverse reaction with Denavir was headache, which occurred in 5.3% of patients who received Denavir and 5.8% of patients who received placebo. Other adverse reactions with Denavir occurred in less than 2% of patients and included application site reaction, decreased sensitivity to touch/local anesthesia, taste perversion, and rash. Other reported adverse reactions have included swelling of the

mouth or throat, pain, alterations in sense of smell, abnormal touch sensation, itching, skin discoloration, and hives.

Denavir is available by prescription only. Please see the Full Prescribing Information on the back.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.† If a patient’s co-pay or pharmacy bill exceeds $15, they can present the certifi cate to the pharmacist for an instant rebate of up to a maximum of $45 for each Denavir prescription. If their total out of pocket pharmacy bill exceeds $60 for any single Denavir prescription, they will be responsible for the additional balance. Not valid with any other offer. Subject to eligibility restrictions and limitations. This offer is not valid for prescriptions reimbursed in whole or part by Medicaid, Medicare, or any other federal or state program (including any prescription drug programs). This offer is not valid in Massachusetts except for cash-paying patients, or where otherwise prohibited by law.

References1. Denavir (penciclovir cream 1%) Prescribing Information, Cranford, NJ, New American Therapeutics, Inc. December 2010. 2. Valtrex (valacyclovir hydrochloride) Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline. September 2008. 3. Famvir (famciclovir) Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation. December, 2009. 4. Boon R, Goodman JJ, Martinez J, et al. for the Penciclovir Cream Herpes Labialis Study Group. Penciclovir cream for the treatment of sunlight-induced herpes labialis: a randomized, double-blind, placebo-controlled trial. Clin Ther. 2000; 22:76-90.

DON’T LET A COLD SORERUIN THE FANTASY. Denavir® (penciclovir cream, 1%) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.

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A Henry Schein Publication


Prescribing InformationDESCRIPTION

Denavir contains penciclovir, an antiviral agent active against herpes viruses. Denavir is available for topical administration as a 1% white cream. Each gram of Denavir contains 10 mg of penciclovir and the following inactive ingredients: cetomacrogol 1000 BP, cetostearyl alcohol, mineral oil, propylene glycol, purified water and white petrolatum.Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl) butyl]guanine. Its molecular formula is C

10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure:

Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP= -1.62).CLINICAL PHARMACOLOGY

Microbiology

Mechanism of Antiviral Activity: The antiviral compound penciclovir has in vitro inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2). In cells infected with HSV-1 or HSV-2, viral thymidine kinase phosphorylates penciclovir to a monophosphate form which, in turn, is converted to penciclovir triphosphate by cellular kinases. In vitro studies demonstrate that penciclovir triphosphate inhibits HSV polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited.Antiviral Activity In Vitro and In Vivo: In cell culture studies, penciclovir has antiviral activity against HSV-1 and HSV-2. Sensitiv-ity test results, expressed as the concentration of the drug required to inhibit growth of the virus by 50% (IC

50) or 99% (IC99) in cell culture, vary depending upon a number of factors, including the assay protocols. See Table 1.

Table 1

Method of Assay Virus Type Cell Type IC50 IC99 (mcg/mL) (mcg/mL)

Plaque Reduction HSV-1 (c.i.) MRC-5 0.2-0.6 HSV-1 (c.i.) WISH 0.04-0.5 HSV-2 (c.i.) MRC-5 0.9-2.1 HSV-2 (c.i.) WISH 0.1-0.8Virus Yield Reduction HSV-1 (c.i.) MRC-5 0.4-0.5 HSV-2 (c.i.) MRC-5 0.6-0.7DNA Synthesis Inhibition HSV-1 (SC16) MRC-5 0.04 HSV-2 (MS) MRC-5 0.05

(c.i.) = clinical isolates. The latent state of any herpes virus is not known to respond to any antiviral therapy.

Drug Resistance: Penciclovir-resistant mutants of HSV can result from qualitative changes in viral thymidine kinase or DNA polymerase. The most commonly encountered acyclovir-resistant mutants that are deficient in viral thymidine kinase are also resistant to penciclovir.Pharmacokinetics

Measurable penciclovir concentrations were not detected in plasma or urine of healthy male volunteers (n=12) following single or repeat application of the 1% cream at a dose of 180 mg penciclovir daily (approximately 67 times the estimated usual clinical dose).Pediatric Patients: The systemic absorption of penciclovir following topical administration has not been evaluated in patients <18 years of age.CLINICAL TRIALS

Denavir was studied in two double-blind, placebo (vehicle)-controlled trials for the treatment of recurrent herpes labialis in which otherwise healthy adults were randomized to either Denavir or placebo. Therapy was to be initiated by the subjects within 1 hour of noticing signs or symptoms and continued for 4 days, with application of study medication every 2 hours while awake. In both studies, the mean duration of lesions was approximately one-half-day shorter in the subjects treated with Denavir (N=1,516) as compared to subjects treated with placebo (N=1,541) (approximately 4.5 days versus 5 days, respectively). The mean duration of lesion pain was also approximately one-half-day shorter in the Denavir group compared to the placebo group.INDICATIONS AND USAGE

Denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.CONTRAINDICATIONS

Denavir is contraindicated in patients with known hypersensitivity to the product or any of its components.PRECAUTIONS

General

Denavir should only be used on herpes labialis on the lips and face. Because no data are available, application to human mucous membranes is not recommended. Particular care should be taken to avoid application in or near the eyes since it may cause irritation. Lesions that do not improve or that worsen on therapy should be evaluated for secondary bacterial infection. The effect of Denavir has not been established in immunocompromised patients.Information for Patients

Denavir is a prescription topical cream for the treatment of cold sores (recurrent herpes labialis) that occur on the face and lips. It is not a cure for cold sores and not all patients respond to it. Do not use if you are allergic to Denavir (penciclovir) or any of the ingredients in Denavir cream. Before you use Denavir, tell your doctor if you are pregnant, planning to become pregnant, or are breast-feeding.Directions: Wash your hands. Your face should be clean and dry. Apply a layer of Denavir cream to cover only the cold sore area or the area of tingling (or other symptoms) before the cold sore appears. Rub in the cream until it disappears. Apply the cream every 2 hours during waking hours for 4 days. Even though Denavir works at the blister stage, treatment should be started at the earliest sign of a cold sore (i.e. tingling, redness, itching, or bump). Wash your hands with soap and water after using Denavir cream. Store Denavir cream at room temperature (59°- 86°F). Keep out of reach of children.Possible side effects: Denavir cream was well tolerated in clinical studies in patients with cold sores. The most frequently reported side effect was headache. Common skin-related side effects of Denavir cream are application site reactions, local anesthesia, taste perversion, and rash.Carcinogenesis, Mutagenesis, Impairment of Fertility

In clinical trials, systemic drug exposure following the topical administration of penciclovir cream was negligible, as the penciclovir content of all plasma and urine samples was below the limit of assay detection (0.1 mcg/mL and 10 mcg/mL,

respectively). However, for the purpose of inter-species dose comparisons presented in the following sections, an assumption of 100% absorption of penciclovir from the topically applied product has been used. Based on use of the maximal recommend-ed topical dose of penciclovir of 0.05 mg/kg/day and an assumption of 100% absorption, the maximum theoretical plasma AUC

0-24 hrs for penciclovir is approximately 0.129 mcg.hr/mL.Carcinogenesis: Two-year carcinogenicity studies were conducted with famciclovir (the oral prodrug of penciclovir) in rats and mice. An increase in the incidence of mammary adenocarcinoma (a common tumor in female rats of the strain used) was seen in female rats receiving 600 mg/kg/day (approximately 395x the maximum theoretical human exposure to penciclovir following application of the topical product, based on area under the plasma concentration curve comparisons [24 hr. AUC]). No increases in tumor incidence were seen among male rats treated at doses up to 240 mg/kg/day (approximately 190x the maximum theoretical human AUC for penciclovir), or in male and female mice at doses up to 600 mg/kg/day (approximately 100x the maximum theoretical human AUC for penciclovir).Mutagenesis: When tested in vitro, penciclovir did not cause an increase in gene mutation in the Ames assay using multiple strains of S. typhimurium or E. coli (at up to 20,000 mcg/plate), nor did it cause an increase in unscheduled DNA repair in mammalian HeLa S3 cells (at up to 5,000 mcg/mL). However, an increase in clastogenic responses was seen with penciclovir in the L5178Y mouse lymphoma cell assay (at doses 1000 mcg/mL) and, in human lymphocytes incubated in vitro at doses

250 mcg/mL. When tested in vivo, penciclovir caused an increase in micronuclei in mouse bone marrow following the intravenous administration of doses 500 mg/kg ( 810x the maximum human dose, based on body surface area conversion).Impairment of Fertility: Testicular toxicity was observed in multiple animal species (rats and dogs) following repeated intra-venous administration of penciclovir (160 mg/kg/day and 100 mg/kg/day, respectively, approximately 1155 and 3255x the maximum theoretical human AUC). Testicular changes seen in both species included atrophy of the seminiferous tubules and reductions in epididymal sperm counts and/or an increased incidence of sperm with abnormal morphology or reduced motility. Adverse testicular effects were related to an increasing dose or duration of exposure to penciclovir. No adverse testicular or reproductive effects (fertility and reproductive function) were observed in rats after 10 to 13 weeks dosing at 80 mg/kg/day, or testicular effects in dogs after 13 weeks dosing at 30 mg/kg/day (575 and 845x the maximum theoretical human AUC, respectively). Intravenously administered penciclovir had no effect on fertility or reproductive performance in female rats at doses of up to 80 mg/kg/day (260x the maximum human dose [BSA]).There was no evidence of any clinically significant effects on sperm count, motility or morphology in 2 placebo-controlled clinical trials of Famvir® (famciclovir [the oral prodrug of penciclovir], 250 mg b.i.d.; n=66) in immunocompetent men with recurrent genital herpes, when dosing and follow-up were maintained for 18 and 8 weeks, respectively (approximately 2 and 1 spermatogenic cycles in the human).Pregnancy

Teratogenic Effects-Pregnancy Category B. No adverse effects on the course and outcome of pregnancy or on fetal development were noted in rats and rabbits following the intravenous administration of penciclovir at doses of 80 and 60 mg/kg/day, respectively (estimated human equivalent doses of 13 and 18 mg/kg/day for the rat and rabbit, respectively, based on body surface area conversion; the body surface area doses being 260 and 355x the maximum recommended dose following topical application of the penciclovir cream). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, penciclovir should be used during pregnancy only if clearly needed.Nursing Mothers

There is no information on whether penciclovir is excreted in human milk after topical administration. However, following oral administration of famciclovir (the oral prodrug of penciclovir) to lactating rats, penciclovir was excreted in breast milk at concentrations higher than those seen in the plasma. Therefore, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother. There are no data on the safety of penciclovir in newborns.Pediatric Use

An open-label, uncontrolled trial with penciclovir cream 1% was conducted in 102 patients, ages 12-17 years, with recurrent herpes labialis. The frequency of adverse events was generally similar to the frequency previously reported for adult patients. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.Geriatric Use

In 74 patients 65 years of age, the adverse events profile was comparable to that observed in younger patients.ADVERSE REACTIONS

In two double-blind, placebo-controlled trials, 1516 patients were treated with Denavir (penciclovir cream) and 1541 with pla-cebo. The most frequently reported adverse event was headache, which occurred in 5.3% of the patients treated with Denavir and 5.8% of the placebo-treated patients. The rates of reported local adverse reactions are shown in Table 2 below. One or more local adverse reactions were reported by 2.7% of the patients treated with Denavir and 3.9% of placebo-treated patients.

Table 2–Local Adverse Reactions Reported in Phase III Trials

Penciclovir Placebo

n= 1516 n=1541

% %

Application site reaction 1.3 1.8Hypesthesia/Local anesthesia 0.9 1.4Taste perversion 0.2 0.3Pruritus 0.0 0.3Pain 0.0 0.1Rash (erythematous) 0.1 0.1Allergic reaction 0.0 0.1

Two studies, enrolling 108 healthy subjects, were conducted to evaluate the dermal tolerance of 5% penciclovir cream (a 5-fold higher concentration than the commercial formulation) compared to vehicle using repeated occluded patch testing methodology. The 5% penciclovir cream induced mild erythema in approximately one-half of the subjects exposed, an ir-ritancy profile similar to the vehicle control in terms of severity and proportion of subjects with a response. No evidence of sensitization was observed.Post-Marketing Experience

The following events have been identified from worldwide post-marketing use of Denavir in treatment of recurrent herpes labialis (cold sores) in adults. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Denavir cream.General: Headache, oral/pharyngeal edema, parosmia.Skin: Application site reactions, aggravated condition, decreased therapeutic response, erythematous rash, local edema, pain, paresthesia, pruritus, skin discoloration and urticaria.OVERDOSAGE

Since penciclovir is poorly absorbed following oral administration, adverse reactions related to penciclovir ingestion are un-likely. There is no information on overdose.DOSAGE AND ADMINISTRATION

Denavir should be applied every 2 hours during waking hours for a period of 4 days. Treatment should be started as early as possible (i.e., during the prodrome or when lesions appear).HOW SUPPLIED

Denavir is supplied in a 1.5 gram and 5 gram tube containing 10 mg of penciclovir per gram.1.5 gram NDC 50816-624-015 gram NDC 50816-624-05Store at controlled room temperature, 20°-25° C (68°-77°F) [see USP]QUESTIONS? call 1-866-736-8798.

262F400

December 2010

DEN-0042

Manufactured for New American Therapeutics, Inc.

Cranford, NJ 07016by Novartis Pharma GmbH, Wehr, Germany

©2010 New American Therapeutics, Inc. Printed in U.S.A.

3 B BioTherapeuticsQ u a r t e r l y



www.usa.siemens.com/diagnostics

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Ta b l e o f C o n t e n t s

The BioTherapeutics Quarterly Journal is published four times a year by Henry Schein, Inc. Henry Schein’s corporate headquarters arelocated at 135 Duryea Road, Melville, NY. For journal sales information or to report corrections, e-mail [email protected] or call Kim Crabtree at 276-688-2090. Note that although we attempt to ensure the currency of the information contained in this publication as of the publication date, new biotherapeutic developments occur continually and, therefore, may not be noted in this publication. Not responsible for typographical errors.

Volume 9/Fall 2012B BioTherapeutics

Q u a r t e r l y

7 Letter to Henry Schein’s Valued Customers

9 CDC Press Release:New Hepatitis C Testing Guidelines

10 How Do The CDC Hepatitis C Guidelines Affect Me?

11 CDC Fact Sheet:Hepatitis C Testing

15 MMWR: Prevention and Control of Influenza with Vaccines: Recommendations of the ACIP,2012–13 Influenza Season

22 The Facts About Diabetes:A Leading Cause of Death in the U.S.

24 Diabetes:Numbers at a Glance 2012

26 FDA Consumer Health Information:Medications Target Long-Term Weight Control

28 CDC Vital Signs: Asthma in the U.S.

32 New Drug Approvals

33 Facts About Generic Drugs


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For more information, please visit www.insuretest.com.Manufactured by Enterix Inc., Edison, NJ 08837 USA, a Quest Diagnostics Company. ENTBA9013 08/2012







A Letter to Henry Schein’s Valued Customers

OUR Mission

To provide health care professionals with a practical

and relevant source of information regarding

diagnostics, pharmaceuticals, and vaccines in a quick

and easy-to-read publication that provides educational

updates and insight to assist you in prevention,

diagnosis, and treatment of disease.

Throughout our 80-year history, Henry Schein has served as a resource to our physician customers. The BioTherapeutics Quarterly journal is provided to our customers free of charge each quarter to bring you the latest news and information regarding the prevention, diagnosis, and treatment of disease. This issue marks our second anniversary of the journal and we hope you are finding it to be a useful tool in your practice.

In this issue, you will find articles on Hepatitis C Testing, Influenza, Asthma, Diabetes, and Weight Loss Products.

On August 16th, the CDC released new guidelines for Hepatitis C testing advising that all Baby Boomers shouldbe tested once for the disease. This new recommendation may save more than 120,000 lives by identifying thedisease. Information regarding this new development is featured on pages 9–13.

The MMWR article, “Prevention and Control of Influenza with Vaccines” highlights relative information for the2012-13 influenza season including the vaccine strains, recommendations for vaccination, a second dose for somepediatric patients, the available vaccine products on the market, and egg allergy.

November is Diabetes Awareness Month! The article in this issue comes to us from the National DiabetesEducation Program and provides a snapshot of this disease which plagues over 25 million Americans.

More than one third of U.S. adults are obese. The FDA has recently approved two new weight management drugswhich will be available in the U.S. soon. The FDA Consumer Health Information published on pages 26 and 27provides insight on this topic.

Asthma in the U.S. is growing every year as outlined in the enclosed CDC Vital Signs report. One in twelve people now have asthma. See page 28 for the latest information on this disease.

In addition to the above mentioned articles, stay up to date on New Drug Approvals on page 32 and Facts about Generic Drugs featured on pages 33–35.

Sincerely,

Louis FerraroVice President Merchandising and Product ManagementHenry Schein Medical


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CDC Press Release: New Hepatitis CTesting Recommendations

For immediate release:

Thursday, August 16, 2012 – CDC Now Recommends All Baby Boomers Receive One-Time Hepatitis C Test New approach will help avert major increases in liver disease and deaths in the U.S.

All U.S. baby boomers should get a one-time test for the hepatitis C virus, according to final recommendations publishedtoday by the Centers for Disease Control and Prevention. One in 30 baby boomers – the generation born from 1945through 1965 – has been infected with hepatitis C, and most don’t know it. Hepatitis C causes serious liver diseases,including liver cancer (the fastest-rising cause of cancer-related deaths) and is the leading cause of liver transplants in the United States.

The final recommendations are published in today’s issue of CDC’s Morbidity and Mortality Weekly Report. Draftrecommendations were issued in May, followed by a public comment period.

“A one-time blood test for hepatitis C should be on every baby boomer’s medical checklist,” said CDC Director Thomas R. Frieden, M.D., M.P.H. “The new recommendations can protect the health of an entire generation of Americans and save thousands of lives.”

CDC’s previous recommendations called for testing only individuals with certain known risk factors for hepatitis Cinfection. Risk-based screening will continue to be important, but is not sufficient alone. More than 2 million U.S. babyboomers are infected with hepatitis C – accounting for more than 75 percent of all American adults living with the virus.Studies show that many baby boomers were infected with the virus decades ago, do not perceive themselves to be at risk,and have never been screened.

More than 15,000 Americans, most of them baby boomers, die each year from hepatitis C-related illness, such as cirrhosisand liver cancer, and deaths have been increasing steadily for over a decade and are projected to grow significantly incoming years.

CDC estimates one-time hepatitis C testing of baby boomers could identify more than 800,000 additional people withhepatitis C. And with newly available therapies that can cure up to 75 percent of infections, expanded testing – along withlinkage to appropriate care and treatment – would prevent the costly consequences of liver cancer and other chronic liverdiseases and save more than 120,000 lives.

Comments received from individuals and organizations during the public comment period (May 22-June 8, 2012)overwhelmingly supported CDC’s original proposal. As a result, the agency did not make substantive changes to the draft recommendations.

For additional information about hepatitis, visit www.cdc.gov/hepatitis. Source: http://www.cdc.gov/nchhstp/newsroom/2012/HCV-Testing-Recs-PressRelease.html


10

How Do The CDC Hepatitis CTesting Guidelines Affect Me?

B BioTherapeuticsQ u a r t e r l y



The CDC just released new guidelines on hepatitis C. How do these guidelines impactme? I thought I only had to consider testing for hepatitis C when people were at risk.

Christopher J. Murphy MD, HCV Clinical Director, Ellis Medicine Family Practice Residency, Schenectady, NY

There are approximately 4 million people in the United States infected with hepatitis C. HCV is the leading cause of livertransplants and liver cancer, and yet three out of 4 of infected people don’t know it. Past guidelines recommended testingfor people with known risk factors for the disease, but studies showed that most persons do not perceive themselves to beat risk and are not tested. And frankly, many busy primary care doctors don't always ask all the right questions about risk,and if they do, patients may not divulge their risk behaviors.

The new CDC guidelines augment risk-based testing and recommend that all Americans born between 1945 and 1965(“baby boomers”) get a one-time test for HCV. This population accounts for over 75% of American adults infected with hepatitis C.

The Chronic Liver Disease Foundation endorses this birth-cohort screening that could identify another 800,000 HCV-infected Americans. CLDF also discussed the benefits of rapid screening for the HCV antibody, allowing forimmediate discussion of results. This discussion is important on 2 fronts – after-care and discussion of test results isimportant as 20% of people with a positive antibody test are not actively infected, and HCV-infected patients should be linked to care. New treatments are available that offer high cure rates, up to 75%, with more promising treatments on the horizon.

OraQuick® HCV is the first FDA-approved, CLIA-waived rapid HCV test to detect HCV antibodies in fingerstick or venipuncture whole blood. The simple platform allows healthcare providers to deliver an accurate diagnosis in 20 minutes, with sensitivities and specificities at 98% and higher.

As an educator of family practice residents in a health center, we have incorporated rapid HCV testing and treatment byassigning each resident with at least one active hepatitis C patient during their residency. We began rapid testing in theFamily Health Center in February 2012, have identified HCV-infected individuals that we link to care. We are working toincrease rapid HCV testing so everyone is comfortable with both point-of-care testing and linkage to care. The benefits ofimplementing these new guidelines with the baby boomers in your practice will be earlier identification of infectedpatients that can be linked to appropriate, earlier treatment before the development of liver cancer and cirrhosis.




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New Drug Approvals




AUGUST

JULYJuly 16, 2012PREPOPIK (Citric Acid; MagnesiumOxide; Sodium Picosulfate)Manufacturer: Ferring Pharms AS

About this product:PREPOPIK is a combination of sodium picosulfate,a stimulant laxative, and magnesium oxide andanhydrous citric acid which form magnesium citrate,an osmotic laxative, indicated for cleansing of thecolon as a preparation for colonoscopy in adults.

July 23, 2012TUDORZA PRESSAIR™

(Aclidinium Bromide)Manufacturer: Forest Labs

About this drug:TUDORZA PRESSAIR is an anticholinergicindicated for the long-term maintenance treatmentof bronchospasm associated with chronicobstructive pulmonary disease (COPD), includingchronic bronchitis and emphysema.

August 3, 2012ZALTRAP® (Ziv-Aflibercept)Manufacturer: Sanofi Aventis

About this drug:ZALTRAP®, in combination with 5-fluorouracil,leucovorin, irinotecan-(FOLFIRI), is indicated forpatients with metastatic colorectal cancer(mCRC) that is resistant to or has progressedfollowing an oxaliplatin-containing regimen.

August 9, 2012MARQIBO® (Vincristine Sulfate)Manufacturer: Talon Therapeutics

About this drug:Marqibo is a vinca alkaloid indicated for the treatmentof adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease hasprogressed following two or more anti-leukemiatherapies. This indication is based on overallresponse rate. Clinical benefit such as improvementin overall survival has not been verified.





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