Monthly Archives: February 2011

Scripps Pioneers Individualized Medicine by Offering Genetic Testing to Hepatitis C Patients

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Individualized Therapies Now Available for Drug Treatment of Hepatitis C

SAN DIEGO, Feb. 25, 2011 (GLOBE NEWSWIRE) — Scripps Health is one of the first health systems in the United States to offer genetic testing as part of its care for hepatitis C patients planning to undergo drug treatment.

The tests offer hope to the more than 4 million patients diagnosed annually in the U.S. with hepatitis C and could spare them from taking interferon, which is commonly prescribed. Interferon causes flu-like symptoms as a side effect and costs more than $50,000 annually. Instead, the genetic test determines whether patients have a common gene variant that predicts a favorable cure rate if they are treated with the drug combination therapy of pegylated interferon and ribavirin.

A manuscript describing this approach to treatment, authored by Paul J. Pockros, MD, clinical director of research at the Scripps Translational Science Institute, head of the Division of Gastroenterology and Hepatology and director of the Liver Disease Center at Scripps Clinic, will be published in the journal Drugs in March.

“This is a huge step forward in the movement toward individualized medicine,” said Dr. Pockros, “As a physician, knowing what drug therapies will have benefit and which ones won’t based on a patient’s IL28B  genotype is significant because we are able to be more targeted in our approach to treatment.”
This is the first of numerous genetic tests that will accurately give doctors vastly improved data, leading to better prescription of drug treatments. Later this year, a second test will be available that will accurately predict anemia in hepatitis C patients taking the pegylated interferon and ribavirin drug combination. Anemia is one of the most common side effects of the regimen. This will allow doctors to modify the therapy before starting the regimen to prevent patients from developing this problematic side effect.

Genetic testing for hepatitis C patients carries significant implications for patient care, as there are more than 4 million infected people in the United States, most of them undiagnosed and untreated.
Scripps Clinic now routinely orders IL28B genotyping on all patients with Hepatitis C who are potential candidates for anti-viral therapy. If the patients have a favorable IL28B genotype and advanced fibrosis on liver biopsy, doctors can initiate therapy with the current standard of care.  If patients have a less favorable genotype or they have mild fibrosis, doctors can recommend waiting for FDA approval of direct acting antiviral drugs to improve their chances of response.

Currently, LabCorps Diagnostics is performing the IL28B testing for Scripps patients, a procedure covered by most insurance plans. The results are transmitted to the treating physician in about one week and the treatment choice is tailored based on the patient’s likelihood to have a favorable response.

The hepatitis C genetic testing is the latest example of Scripps’ leadership in individualized medicine. Scripps doctors were the first to use genetic testing for cardiovascular patients planning to undergo elective stent procedures to determine if they have one or more of the common gene variants linked to an inability to metabolize the anti-clotting drug Plavix (clopidrogel).  Plavix is the second-most commonly prescribed drug in the United States and is given to most patients after they receive coronary stents.

ABOUT SCRIPPS HEALTH
Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Healthis a $2.3 billion nonprofit community health system based in San Diego, Calif. Scripps treats a half-million patients annually through the dedication of 2,500 affiliated physicians and 13,000 employees among its five acute-care hospital campuses, home health care services, and an ambulatory care network of physician offices and 22 outpatient centers and clinics. Scripps has been recognized by Thomson Reuters as one of the Top 10 health systems in the nation for quality care. Scripps is also at the forefront of clinical research, genomic medicine, wireless health and graduate medical education. With three highly respected graduate medical education programs, Scripps is a longstanding member of the Association of American Medical Colleges. More information can be found at www.scripps.org.

This information was brought to you by Cision http://www.cisionwire.com

CONTACT:  Johnny Hagerman
          858-361-8962
          hagerman.johnny@scrippshealth.org
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Prevalence of Acute Hepatitis B Higher Among Adults with Diabetes

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The incidence of acute hepatitis B is significantly higher among adults with diabetes than those without diabetes, and is increased, specifically, among people aged 23 to 59 years, according to new data presented today at the Advisory Committee on Immunization Practices meeting.

People aged 60 years and older with diabetes also had a higher incidence of acute hepatitis B when compared with adults without diabetes, but this was not statistically significant, according to Meredith Reilly, MPH, from the division of viral hepatitis at the CDC.

Read More……..

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SVR Signals Good Prognosis in Decompensated Cirrhosis Due to HCV

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By: MARY ANN MOON, Internal Medicine News Digital Network

A sustained virologic response to antiviral therapy signals a favorable prognosis in patients with decompensated cirrhosis due to chronic hepatitis C, reported Dr. Angelo Iacobellis and his colleagues in the March issue of Clinical Gastroenterology and Hepatology. 
Mean survival was 20 months longer in patients who achieved a sustained virologic response (SVR) with antiviral therapy than in patients who did not achieve SVR (73 vs. 53 months; P = .004). Thus, antiviral therapy “might represent a life-sparing intervention” for patients who have progressed to the stage of liver decompensation and who aren’t eligible for liver transplant, said Dr. Iacobellis and his associates at Casa Sollievo della Sofferenza in San Giovanni Rotondo, Italy. 
Read more……………..
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Lack of Health Insurance Limits Hepatitis C Patients’ Access to Latest Antiviral Therapy

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High Costs, Insurance Status, and Eligibility Issues Restrict Treatment Options

New research has determined that patients in the U.S. with hepatitis C virus (HCV) are twice as likely to not have health insurance coverage compared with those without the disease. In fact researchers found only a third of HCV infected Americans have access to antiviral therapy; the remaining are either uninsured or not candidates for therapy due to treatment contraindications. Details of this study are published in the March issue of Hepatology, a peer-reviewed journal of the American Association for the Study of Liver Diseases (AASLD). 

HCV is the most common cause of chronic liver disease, hepatocellular (liver) cancer, and liver transplantation in the U.S., with up to 85% of HCV-positive individuals (3.5 million) developing chronic HCV infection. Symptoms of chronic HCV are non-specific which can inhibit diagnosis and as many as 75% of patients are unaware of their HCV infection (Hagan et al., 2006). Furthermore, the Centers for Disease Control and Prevention (CDC) estimates that HCV causes 12,000 deaths in the U.S. each year. 

“Successful treatment with antiviral therapy improves health-related quality of life in patients with HCV and could potentially reduce morbidity and mortality in patients,” said Zobair Younossi, MD, MPH, from the Center of Liver Diseases at Inova Fairfax Hospital in Virginia and lead author of the study. “A significant number of HCV patients, however, may not even have access to antiviral therapy due to lack of adequate health insurance coverage.” It is estimated to cost up to $48,000 per year for monitoring and treatment of HCV. 

For the current study, researchers analyzed health insurance status and treatment candidacy of HCV-positive individuals using 2005-2008 data collected from the National Health and Nutritional Examination Survey (NHANES). This information was collected via household interviews, physical examinations and extensive laboratory sample data from subjects who were 18 years of age or older and living in the U.S. 

Analysis showed that 1.16% of study subjects were infected with HCV. Among those with HCV only 61% were insured compared to 81% of HCV-negative individuals. HCV infection was an independent predictor of being uninsured even after adjusting for demographic disparity in the HCV-positive group. Approximately 67% of HCV-positive patients were eligible for treatment, however only 54% of those treatment candidates had insurance coverage. 

Some individuals with HCV may not be eligible for antiviral therapy due to contraindications to treatment. Previous studies have found that only half of HCV patients exhibit a positive response to peginterferon/ribavirin treatment. “The side effect profile of the current antiviral therapy requires careful selection of treatment candidates with a number of chronic conditions,” said Dr. Younossi. The authors noted that patients with comorbidities such as active cardiac disease, severe depression, or renal failure are typically ineligible for antiviral therapy due to severe adverse events that may occur with treatment. 

Research showed that only 36% of HCV-positive patients who were eligible for antiviral therapy had health insurance. “Access to care for HCV patients is critical. Our results have important implications for HCV-infected patients and should be considered as new health care reform legislation takes effect,” Dr. Younossi concluded. 

Article: “Insurance Status and Treatment Candidacy of Hepatitis C Patients: Analysis of Population-based Data from the United States.” Maria Stepanova, Fasiha Kanwal, Hashem B. El-Serag, Zobair M. Younossi. Hepatology; Published Online: February 11, 2011 (DOI: 10.1002/hep.24131); Print Issue Date: March 2011. http://onlinelibrary.wiley.com/doi/10.1002/hep.24131/abstract. 

Source: Wiley-Blackwell

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New Vaccine Technology Protects Mice from Hepatitis C Virus

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The new vaccine technology was developed by Peter J. Holst, a former PhD student now a postdoc with the Experimental Virology group, which also includes Professor Allan Randrup Thomsen and Associate Professor Jan Pravsgaard Christensen.

The technology works by stimulating and accelerating the immune system, and showing the body’s defence mechanisms of the parts of the virus that are more conserved and do not mutate as fast and as often, such as the molecules on the surface of the HCV.

Read the complete story here:

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Medivir Announces Positive Phase 2b 48-week (SVR24) Interim Results of TMC435 in Treatment-Naive Patients Chronically Infected With Genotype-1 Hepatitis C Virus

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HUDDINGE, Sweden, February 22, 2011 /PRNewswire-FirstCall/ — Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces today further positive results from the phase 2b PILLAR (C205) study of TMC435 in treatment-naive patients with hepatitis C virus (HCV) genotype-1.

– TMC435 was safe and well tolerated with no clinically relevant differences in adverse events between treatment groups and standard of care (SoC).
– In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 24
– Potent and consistent antiviral efficacy was demonstrated with SVR24 rates of up to 84%

“We are very pleased by both the efficacy and safety shown by TMC435 in this 48-Week interim analysis. With the additional features of once daily dosing, TMC435 also has a more convenient and competitive dosing regimen” stated Bertil Samuelsson, CSO of Medivir. “The recently published start of three global phase 3 clinical trials is an important milestone in the continued development of TMC435. We are now looking forward to the 48-week interim data from the phase 2b trial C206 (ASPIRE) in treatment-experienced patients during Q2 2011.”

The 48-week interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naive patients showed further consistent high antiviral activity, and the good safety and tolerability previously demonstrated was confirmed. The 24-week (EOT) interim results were presented at the AASLD conference in Boston, MA, in November 2010.

Study design
In the PILLAR study, 75mg or 150mg TMC435 was given for either 12 or 24 weeks in combination with 24 weeks of ribavirin and pegIFNalpha-2A, the current standard of care (SoC). Patients in the TMC435 arms stopped all treatment at week 24 if certain predefined response-guided criteria were met. In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 24. Patients who did not meet the above response-guided criteria continued with SoC until week 48 as did the placebo group.

Evaluation criteria
A protocol-defined interim analysis was performed when all patients completed their Week 48 visit or discontinued treatment earlier. Final SVR4 and SVR24 data were available for 98% (303/309; n/N) and 93% (288/309; n/N) of TMC435 treated patients, respectively. SVR24 is determined 24 weeks after the planned end of treatment (EoT) and was therefore not yet available for the patients in the placebo group and for some of those in the TMC435 group who received 48 weeks of treatment. SVR4, which is determined 4 weeks after the planned EoT, was available for 77% (59/77; n/M) of the patients in the placebo group.

Results – Efficacy
Potent and sustained antiviral efficacy was demonstrated in the SVR4 and SVR24 rates with no major differences between TMC435 doses or length of triple therapy. At week 4 after cessation of treatment 87.2%, 86.5%, 84.9% and 88.5% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels. At week 24 after cessation of treatment 83.6%, 76.1%, 83.1% and 84.4% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels, i.e. SVR24. At week 4 after cessation of treatment 71.2% in the placebo SoC group had achieved undetectable HCV RNA levels.

The results are derived from an intent-to-treat (ITT) analysis of the patient population who took at least one dose of the study medication and who reached the criteria for stopping all treatment at 24 weeks (83%).

 Click here for tables

Results – Safety and Tolerability
TMC435 was generally safe and well tolerated and overall incidence of adverse events (AEs) was similar across treatment groups. AEs leading to discontinuation of TMC435 or placebo treatment were reported in 7.8% of the placebo subjects and in 7.1% of the TMC435 treated subjects. In the safety analyses, special attention was given to the following AEs of interest: hepatobiliary AEs, pruritus, rash, anemia, and cardiac events. For each category of AEs of interest; the incidence was similar between TMC435 and placebo.

In laboratory parameters, there were no clinically relevant differences between any TMC435 groups and placebo except for mild on treatment reversible bilirubin elevations (total, direct and indirect) in the 150 mg TMC435 arm, which were normalized after TMC435 dosing was completed. There were no meaningful differences between treatment groups for any of the other laboratory parameters. Significant and rapid decreases in transaminases (ALT and AST) were observed in all TMC435 treatment groups.

Conference Call For Analysts and Investors:
There will be a conference call today, February 22 2011, for investors and sell-side analysts at 09:00 (EDT) / 14:00 (GMT) / 15:00 (CET) with the management team of Medivir to discuss this announcement. To dial-in to the conference call please use the following numbers:

Participant Telephone Numbers:
+1-718-354-1385 USA
+46(0)8-5352-6408 Sweden
+44(0)20-7806-1951 UK
Confirmation Code: 6641746

Alternatively, please contact Lindsey Neville at M:Communications on Tel: +44(0)207-920-2333, Email: Neville@mcomgroup.com.

Notes to Editors

About TMC435 in other clinical studies

TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Medivir and Tibotec Pharmaceuticals, to treat chronic hepatitis C virus infections.
The clinical phase 3 program started recently including

– TMC435-C208 or QUEST-1 includes approximately 375
treatment-naive patients
– TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive
patients
– TMC435-C3007 or PROMISE includes approximately 375 who have
relapsed after prior interferon-based treatment

In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011.

A phase 3 program for TMC435 has also recently been launched in Japan.

For additional information for these studies, please see http://www.clinicaltrials.gov

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OraSure Technologies Receives FDA Approval for Its OraQuick(R) HCV Rapid Test Using Fingerstick Whole Blood

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BETHLEHEM, Pa., Feb 22, 2011 (GlobeNewswire via COMTEX) — OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its OraQuick(R) HCV Rapid Antibody Test has now been approved by the U.S. Food and Drug Administration (“FDA”) for use in detecting HCV antibodies with a fingerstick whole blood sample. The fingerstick whole blood claim is the second application to be approved by the FDA for the OraQuick(R) HCV test. The product received an initial approval for use in persons at risk for HCV infection with venous whole blood specimens in June 2010.

The OraQuick(R) HCV Rapid Antibody Test is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus that is approved by the FDA. The test, which utilizes the OraQuick(R) technology platform, provides results in 20 minutes.

“Receiving FDA approval to test individuals at risk using a fingerstick whole blood sample significantly expands the flexibility and versatility of our OraQuick(R) Rapid HCV Antibody Test,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “By eliminating the need for a blood draw, healthcare providers will be able to identify more individuals infected with hepatitis C and get them into care.”

There are an estimated 4.1 million Americans, or 1.6 percent of the U.S. population, that are or have been infected with HCV. New infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.

The Company previously received approval to affix the CE mark to its OraQuick HCV test in December 2009 for use with oral fluid, fingerstick whole blood, venous whole blood, serum and plasma. The CE Mark was required in order to sell the product in the European Union.

As previously announced, OraSure has entered into agreements with Merck & Co. (NYSE:MRK), through its predecessor Schering Plough Corp., to collaborate on the development and promotion of the OraQuick HCV test. Under these agreements, Merck will provide detailing and other promotional support for the test in the physicians’ office markets in the United States and internationally.

About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities.

OraSure Technologies is the leading supplier of oral-fluid testing solutions for drugs of abuse and for the detection of antibodies to HIV.

For more information on the Company, please go to www.orasure.com

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Deaths from Acute Hepatitis B Virus Infection Associated with Assisted Blood Glucose Monitoring in an Assisted-Living Facility

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Morbidity and Mortality Weekly Report (MMWR)
February 18, 2011 / 60(06);182

Sharing of blood glucose monitoring equipment in assisted-living facilities has resulted in at least 16 outbreaks of hepatitis B virus (HBV) infection in the United States since 2004 (1,2). On October 12, 2010, the North Carolina Division of Public Health (NCDPH) and the Wayne County Health Department were notified by a local hospital of four residents of a single assisted-living facility with suspected acute HBV infection. NCDPH requested HBV testing of all persons who had resided in the facility during January 1–October 13, 2010, and defined an outbreak-associated case as either 1) positive hepatitis B surface antigen and core immunoglobulin M (IgM) results or 2) clinical evidence of acute hepatitis (jaundice or serum aminotransferase levels twice the upper limit of normal) with onset ≥6 weeks after admission to the facility. Records were reviewed for potential health-care–associated exposures and HBV-related risk factors. Infection control practices were assessed through observations and interviews with facility staff.

The investigation identified unsafe practices, including sharing of reusable fingerstick lancing devices approved for single patient use only and shared use of blood glucose meters without cleaning and disinfection between patients. Of 87 persons who had resided in the facility during the study period, 47 were excluded from analysis because of HBV immunity (20 persons), chronic infection (one person), or unknown HBV status (26 persons). Of the remaining 40, eight met the case definition. Of these, all were hospitalized, and six died from hepatitis complications. All eight were among the 15 residents whom facility staff had assisted with blood glucose monitoring; none of 25 residents who had not been assisted with blood glucose monitoring were infected.

Despite long-standing and recently expanded infection control recommendations (2,3), HBV transmission continues to occur through sharing of fingerstick lancing devices and other blood glucose monitoring equipment. These practices put residents at risk for severe illness and death. In accordance with NCDPH recommendations, the facility now uses individually assigned blood glucose meters and single-use, autodisabling fingerstick lancing devices. The facility also offered HBV vaccine to all susceptible residents. NCDPH and the state licensing agency issued a notification to all health-care providers and licensed health-care facilities statewide warning of the potential for HBV transmission through unsafe diabetes-care practices. This outbreak underscores the need for increased efforts to promote compliance with infection-control guidelines in assisted-living facilities.

Reported by
Z Moore, MD, J-M Maillard, MD, M Davies, MD, North Carolina Dept of Health and Human Svcs; N Dailey, MD, EIS Officer, CDC.

References

  1. CDC. Transmission of hepatitis B virus among persons undergoing blood glucose monitoring in long-term–care facilities—Mississippi, North Carolina, and Los Angeles County, California, 2003–2004. MMWR 2005;54;220–3.
  2. CDC. Infection prevention during blood glucose monitoring and insulin administration. Atlanta, GA: US Department of Health and Human Services, CDC; 2010; Available at http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html. Accessed February 10, 2011.
  3. Food and Drug Administration. Use of fingerstick devices on more than one person poses risk for transmitting bloodborne pathogens: initial communication: update 11/29/2010. Washington, DC: US Department of Health and Human Services, FDA; 2010; Available at http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm224025.htmExternal Web Site Icon. Accessed February 10, 2011.
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