September 1, 2010

The Lancet Oncology, Volume 11, Issue 9, Pages 827 - 834, September 2010
doi:10.1016/S1470-2045(10)70167-4 Cite or Link Using DOI
Published Online: 04 August 2010

Original Text

Eric A Engels MD a, Eo Rin Cho PhD b, Prof Sun Ha Jee PhD c

Summary

Background

Hepatitis B virus (HBV) infection is common throughout Asia and Africa. Whether chronic HBV infection increases risk of non-Hodgkin lymphoma (NHL) is unclear. We aimed to assess the association between chronic HBV infection and subsequent development of NHL in a South Korean cohort.

Methods

The Korean Cancer Prevention Study is a cohort study of South Korean workers and their dependants enrolled during 1992—95. From this cohort, we excluded individuals who died before Jan 1, 1993, who had cancer at or before the initial visit, who had missing information about weight, height, alanine aminotransferase or aspartate aminotransferase concentrations, or alcohol use, or who had evidence of HIV or HCV infection. Of 1 284 586 eligible participants, 603 585 had baseline data for serum hepatitis B surface antigen (HBsAg) status and were included in our study. We regarded HBsAg positivity at baseline as evidence of chronic HBV infection. Participants were followed up from baseline until Dec 31, 2006. We used national databases of inpatient and outpatient diagnoses and mortality records to ascertain occurrence of haematological malignancies. We assessed incidence of NHL overall and of NHL subtypes, malignant immunoproliferation, Hodgkin's lymphoma, multiple myeloma, and various leukaemias. We used Cox regression to evaluate associations with HBsAg status, adjusting for sex, age, and enrolment year.

Findings

53 045 (9%) of 603 585 participants tested positive for HBsAg at baseline. Subsequently, 133 HBsAg-positive and 905 HBsAg-negative individuals developed NHL. HBsAg-positive participants had an increased risk of NHL overall compared with those who were HBsAg-negative (incidence 19·4 vs 12·3 per 100 000 person-years; hazard ratio [HR] 1·74, 95% CI 1·45—2·09, adjusted for sex, age at baseline, and enrolment year). Among NHL subtypes, HBsAg positivity was associated with increased risk of diffuse large B-cell lymphoma (n=325, incidence 6·86 vs 3·79 per 100 000 person-years; adjusted HR 2·01, 1·48—2·75) and other or unknown subtypes (n=591, incidence 10·5 vs 7·07 per 100 000 person-years; adjusted HR 1·65, 1·29—2·11), compared with HBsAg negativity. Increased risk was also recorded for malignant immunoproliferation (n=14, incidence 0·44 vs 0·15 per 100 000 person-years; adjusted HR 3·79, 1·05—13·7). Risk of these malignancies was consistently raised in HBsAg-positive participants throughout 14 years of follow-up. HBsAg positivity was not associated with follicular or T-cell NHL, Hodgkin's lymphoma, multiple myeloma, or various leukaemias.

Interpretation

During extended follow-up, HBsAg-positive individuals had an increased risk of NHL, suggesting that chronic HBV infection promotes lymphomagenesis.

Funding

Korean Seoul City Research and the National Research and Development Program for Cancer Control, Ministry for Health, Welfare and Family Affairs, Republic of Korea; US National Cancer Institute.
 
a Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD, USA
b Institute of Human Genomic Study, College of Medicine, Korea University, Seoul, South Korea
c Department of Epidemiology, Institute for Health Promotion, Graduate School of Public Health, Seoul, South Korea

Correspondence to: Prof Sun Ha Jee, Department of Epidemiology and Health Promotion, Graduate School of Public Health, Yonsei University, Seoul, South Korea
 
Source
—Liz Highleyman
HCV Advocate

The hepatitis C virus (HCV) is relatively hardy compared with some other viruses, which has implications for transmission and prevention. HCV may survive outside the body for days in dried blood on surfaces, or for months in a liquid medium under favorable conditions. Paradoxically, however, HCV has proven difficult to maintain in laboratory cell cultures, which has hampered research on potential treatments.

Survival in the Lab

Due to the difficulty of maintaining viable HCV in the laboratory, researchers have relied on “replicon” models of a specific strain of HCV (JFH-1 genotype 2a) in a liver cancer cell line. But this year researchers from Massachusetts Institute of Technology and Rockefeller University finally found a way to sustain viral replication in healthy liver cells for up to three weeks.

As described in the February 16, 2010 Proceedings of the National Academy of Sciences, Sangeeta Bhatia and colleagues developed a way to maintain healthy hepatocytes, or liver cells, for four to six weeks by precisely arranging them on a specially patterned plate and mixing them with fibroblast cells that support their growth. The liver cells could then be infected with HCV for two to three weeks, giving time to study response to candidate drugs. The HCV strain used for this research came from a Japanese patient with fulminant hepatitis; the researchers hope to modify their system to maintain a genotype 1 HCV strain, the most common type in the U.S. and the hardest to treat.

Survival on Surfaces

According to the U.S. Centers for Disease Control and Prevention (CDC), HCV can survive on environmental surfaces at room temperature for at least 16 hours but no longer than four days. The more fragile HIV virus, in contrast, only lives on surfaces for a few hours, while influenza viruses may survive for several hours up to about a day.

The CDC estimate is based on a study by Kris Krawczynski and colleagues, presented at the 2003 American Society for the Study of Liver Diseases (AASLD) meeting and published in the May 2007 issue of Infection Control and Hospital Epidemiology. The researchers examined the stability of genotype 1a HCV in dried blood plasma from an infected chimpanzee.

Plasma samples were dried in test tubes overnight (for about 16 hours) then either rehydrated immediately using sterile water and stored at -70ºC (about -160ºF, the temperature of biomedical research freezers), or put in a controlled environment chamber with 42% humidity at 25ºC (77ºF, room temperature) for four or seven days before rehydration. The rehydrated virus was then injected into a different chimp to see whether it remained infectious.

HCV RNA (genetic material) was detectable in plasma dried overnight and stored for seven days, though viral load decreased by 1 log, or ten-fold, compared with the original plasma sample. The test chimpanzee injected with virus dried overnight developed detectable HCV RNA and elevated alanine aminotransferase (ALT), became HCV antibody positive, and had detectable HCV antigen in liver cells. Injection of rehydrated virus stored for four or seven days, however, did not lead to infection. The researchers therefore concluded that HCV could remain infectious on surfaces outside the body somewhere between 16 hours and four days.

Viability outside the body, however, can vary widely depending on conditions. Viruses survive longer on hard surfaces such as stainless steel and less time on soft surfaces like fabric. HCV can live longer at cooler temperatures and prefers humidity to dry conditions.

Survival in Liquid

HCV survives longer in liquids than it does when dried on surfaces. In one recent study, described in the June 15, 2010 Journal of Infectious Diseases, Sandra Ciesek from Hannover Medical School in Germany and colleagues looked at the environmental stability and infectivity of HCV grown in a laboratory cell culture, as well as its susceptibility to chemical disinfectants. The researchers measured changes in viral load and introduced recovered HCV RNA into cultured Huh7.5 liver cancer cells to test for infectiousness.

In a liquid environment, HCV was detectable for up to five months at lower temperatures. However, the researchers noted that the risk of HCV infection may not accurately be reflected by measuring HCV RNA levels, because viral infectivity and viral load were not directly correlated. Further, they found that various alcohols and commercially available antiseptics reduced HCV to undetectable levels, though diluting hand disinfectants reduced their virucidal activity.

In another study published in the February 2010 Virology Journal, Hongshuo Song from Peking University and colleges found that JFH-1 cell culture-derived HCV could survive in liquid culture medium for two days at 37ºC (98ºF, body temperature) and 16 days at 25ºC, but was relatively stable at 4ºC (about 40º, average refrigerator temperature) without major loss of infectivity for at least six weeks.

This cell culture-derived HCV was vulnerable to heat; infectious virus could be inactivated in four minutes at 65ºC (about 150ºF) or eight minutes at 60ºC (140ºF), but this took 40 minutes at 56ºC (about 130ºF). Ultraviolet light efficiently inactivated HCV within two minutes. Exposures to formaldehyde and various detergents destroyed infectious HCV effectively in both culture medium and human serum.

HCV’s ability to live for a prolonged period in liquid blood underlies its transmission via nasal drug use (HCV RNA was detected on 5% of straws from hepatitis C patients who “snorted air”—simulating drug use—in one recent study), tattooing, sharing personal care equipment such as razors, childbirth, certain sexual activities, and re-use of medical equipment in healthcare settings.

Epidemiologic studies show that hepatitis C prevalence is higher among people who have undergone various medical procedures including kidney dialysis, indicating that HCV can spread from one patient to another via contaminated equipment if proper infection control practices are not followed. In 2008, for example, several patients at a Las Vegas endoscopy clinic contracted hepatitis C when clinicians gave multiple people injections from the same vials of anesthesia medication.

Survival in Syringes

HCV survival in blood in syringes is a key concern, given that sharing needles for drug injection is the most common route of hepatitis C transmission. In a presentation at the 17th Conference on Retroviruses and Opportunistic Infections in February, Elijah Paintsil from Yale University School of Medicine reported findings from a laboratory study looking at how long HCV can live in syringes.

The researchers first filled syringes with HCV-infected blood and depressed the plunger, simulating what happens when a user “boots,” or draws blood up into a syringe to mix with drugs and then reinjects it. Either immediately or after storing for up to two months at various temperatures, the team flushed out the syringes and attempted to grow recovered virus in genotype 2 HCV in cell cultures. They analyzed both low-volume (2 microliter) insulin syringes with permanently attached needles and high-volume (32 microliter) tuberculin syringes with detachable needles.

In the low-volume syringes, the likelihood of finding infectious HCV declined rapidly, with no viable virus recovered after one day of storage at 37ºC or three days at 22ºC (72ºF). At 4ºC, viable virus could be detected in two-thirds of syringes after one day of storage, about 25% after three days, and about 5% after seven days.

But in high-volume syringes, infectious HCV could still be recovered from nearly all syringes stored at 4ºC for seven days, from about half of those stored for 35 days, and from about 10% even after 63 days. At higher temperatures of 22ºC or 37ºC, viable HCV could still be recovered from a small percentage of syringes after two months.

The longer survival of HCV in syringes helps explain why HCV transmission occurs ten times more often than HIV transmission from accidental needle sticks, and why harm reduction measures such as needle exchange have reduced HIV incidence more than new HCV incidence.

At an accompanying press conference Paintsil said that while it might be advisable for needle exchange programs to offer smaller insulin syringes, some individuals (for example, transgender people who inject hormones) want larger syringes, and the most important thing is to provide enough so that people never have to share.

Understanding how long HCV can survive outside the body can inform practices to reduce the risk of viral transmission. According to Krawczynski and colleagues, “The potential for HCV to survive in the environment re-emphasizes the importance of cleaning and disinfection procedures, safe therapeutic injection practices, and harm reduction counseling and services for injection drug users.”

Source
Gastroenterology. 2010 Sep;139(3):965-974. Epub 2010 Jun 2.

Dahari H, Feinstone SM, Major ME.

Department of Medicine, University of Illinois at Chicago, Chicago, Illinois.

Abstract

BACKGROUND & AIMS: Studies in patients and chimpanzees that spontaneously cleared hepatitis C virus (HCV) infections demonstrated that natural immunity to the virus is induced during primary infections and that this immunity can be cross protective. These discoveries led to optimism about prophylactic HCV vaccines, and several studies were performed in chimpanzees, although most included fewer than 6 animals. To draw meaningful conclusions about the efficacy of HCV vaccines in chimpanzees, we performed statistical analyses of data from previously published studies from different groups.

METHODS: We performed a meta-analysis that compared parameters among naïve (n = 63), vaccinated (n = 53), and rechallenged (n = 36) animals, including peak RNA titer postchallenge, time points of peak RNA titer, duration of viremia, and proportion of persistent infections.

RESULTS: Each vaccination study induced immune responses that were effective in rapidly controlling HCV replication. Levels of induced T-cell responses did not indicate vaccine success. There was no reduction in the rate of HCV persistence in vaccinated animals, compared with naïve animals, when nonstructural proteins were included in the vaccine. Vaccines that contained only structural proteins had clearance rates that were significantly higher than vaccines that contained nonstructural components (P = .015).

CONCLUSIONS: The inclusion of nonstructural proteins in HCV vaccines might be detrimental to protective immune responses, and/or structural proteins might activate T-cell responses that mediate viral clearance.

PMID: 20621699 [PubMed - as supplied by publisher]

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ABC News segment on hepatitis C ... Silent Killer: Hepatitis C

Hepatitis C care quality condemned by MPs

1 September, 2010

Wide variations in hepatitis C treatment are contributing to a 60% rise in the number of people dying from liver disease over the past decade, MPs have warned.

Although hepatitis C’s exact contribution to rising mortality is difficult to calculate, the report from the All-Party Parliamentary Hepatology Group said it was certainly “underestimated” because so few people are diagnosed andcondemned the wide variation in the quality of patient services in NHS hospitals.

Liver disease is the fifth biggest killer after heart disease, cancer, stroke and lung disorders, and the number of deaths is rising by about 8% per year. It killed more than 10,000 people in the UK in 2008. Common causes include alcoholism, but hepatitis C is a growing contributory factor, according to MPs.

Many of the 250,000 to 466,000 people living with hepatitis C in the UK currently have no idea they have the disease because it can remain symptomless for many years. Around 13,000 people are newly infected every year but only about a third receive treatment which has been shown to cure half of cases, said the report. Success rates with treatment varies widely between hospitals, from just 10% of patients treated to 100%.

Furthermore, the UK’s use of hepatitis C drugs is the second lowest out of 14 comparable countries.

The report, In The Dark, pointed to a “worrying shortage of basic monitoring in hepatitis C services, such as numbers of patients referred, numbers offered treatment, numbers initiating treatment and treatment results”.

This has a negative impact on local and national planning of services while some hospitals refuse to treat drug-users, contrary to national guidance.

The number of people living with cirrhosis of the liver caused by hepatitis C is expected to rise by more than a third to 10,960 by 2015.

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Inhibitex Successfully Completes Phase 1a Trial of INX-189

Sept. 1, 2010, 7:00 a.m. EDT

Proof-of-Concept Trial in Patients with Chronic Hepatitis C Planned for Q4 2010

ATLANTA, Sep 01, 2010 (BUSINESS WIRE) -- Inhibitex, Inc. /quotes/comstock/15*!inhx/quotes/nls/inhx (INHX 1.59, +0.17, +11.97%) , announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial are as follows:

-- INX-189 was generally well tolerated at all dose levels;

-- No drug-related serious adverse events;

-- No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache and nasal congestion;

-- No grade II or higher laboratory abnormality adverse events or clinically significant changes in ECGs; and

-- Pharmacokinetic data supports INX-189's potential for once daily (QD) dosing.

"We are encouraged with the initial safety and pharmacokinetic profile of INX-189 in this first-in-man trial," stated Dr. Joseph Patti, Senior Vice President and Chief Scientific Officer of Inhibitex, Inc. "Based upon the pharmacokinetics observed in this study, we continue to believe that INX-189 has the potential to demonstrate antiviral activity with a low once-daily dose, and we look forward to assessing its ability to reduce HCV RNA viral loads in patients with chronic hepatitis C in a Phase 1b multiple ascending dose trial we plan to start in the fourth quarter."

About Inhibitex

Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company's pipeline includes FV-100, which is in Phase II clinical development for the treatment of shingles, and INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections. The Company also has additional HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM(R) protein platform to Pfizer for the development of staphylococcal vaccines. For additional information about the Company, please visit http://www.inhibitex.com/.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this press release, including statements regarding the Company's plans to present detailed results from the Phase 1a trial during a future medical meeting and its intention to initiate a Phase 1b multiple ascending dose trial in the fourth quarter of 2010 are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk of: either the Company, the FDA, a data and safety monitoring board, or an investigational review board delaying, suspending or terminating the clinical development of INX-189 for a lack of safety or antiviral activity, manufacturing-related issues, questions or issues regarding the design of the planned Phase 1b clinical study of INX-189, or any other reasons; the Company obtaining, maintaining and protecting the intellectual property incorporated into and supporting the commercial viability of INX-189; and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission, or SEC, on March 26, 2010, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, as filed with the SEC on August 12, 2010. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.

There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.

Inhibitex(R) and MSCRAMM(R) are registered trademarks of Inhibitex, Inc.

SOURCE: Inhibitex, Inc.

Inhibitex, Inc.
Russell H. Plumb
Chief Executive Officer
678-746-1136
rplumb@inhibitex.com

or

Lee M. Stern, CFA
The Trout Group
646-378-2922
lstern@troutgroup.com

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US-made Unitract™ 1mL syringes also approved in Australia and Europe

Unitract™ 1mL syringes attain five-year shelf life expiration date

LEWISBERRY, Pa., Sept. 1 /PRNewswire-FirstCall/ -- Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS, ASX: UNS), today announced that its Unitract™ Tuberculin (TB) Syringe has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA).

The Unitract™ TB syringe is a variant of the Unitract™ 1mL Insulin Syringe for which Unilife secured FDA clearance earlier this year. Unlike insulin syringes which are primarily used by people with diabetes, TB syringes are used for the administration of a range of therapeutic drugs and vaccines within acute-care hospitals and other healthcare facilities.

The Unitract™ range of 1mL syringes is the world's first and only known syringe that allows operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place. The products are well positioned to help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse. Primary target markets of the products include healthcare facilities, pharmaceutical companies and patients who self-administer prescription medication. Production of the Unitract™ 1mL syringe is occurring at Unilife's FDA-registered manufacturing facility in Lewisberry, Pennsylvania.

Mr. Alan Shortall, Chief Executive Officer of Unilife, stated, "U.S. FDA 510k market clearance for our Unitract™ TB syringe marks an important step in our company's efforts to bring a complete line of safety syringes to market, as it is our second product to receive this clearance. With TB syringes most commonly used within acute-care hospitals and other healthcare facilities, FDA clearance of our Unitract™ TB syringe significantly broadens our capacity to market our unique products across the U.S. and other key international markets."

Unilife has also recently secured its EC certification to apply the CE Mark to its Unitract™ 1mL syringes manufactured at its Lewisberry facility, allowing the sale and distribution of these products within the European Union and Australia.

The Company also expects to complete studies required to attain a five-year shelf life expiration date for its full range of Unitract™ 1mL syringes in September. The inclusion of a five-year expiry date on medical device packaging is considered to be the gold-standard within the industry, and should help to finalize discussions with a number of interested U.S. healthcare distributors in the near future.

About Unilife Corporation

Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.

This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our registration statement on Form 10 and those described from time to time in our periodic reports which we file with the Securities and Exchange Commission.

General: UNIS-G

Investor Contacts (US):
Todd Fromer / Garth Russell,
KCSA Strategic Communications
Phone + 1 212-682-6300

Stuart Fine
Carpe DM Inc
Phone + 1 908 469 1788

Investor Contacts (Australia)
Jeff Carter
Unilife Corporation
Phone + 61 2 8346 6500

SOURCE Unilife Corporation

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http://www.unilife.com/

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Psychiatr Serv 61:885-891, September 2010
doi: 10.1176/appi.ps.61.9.885
© 2010 American Psychiatric Association

Stanley D. Rosenberg, Ph.D., Richard W. Goldberg, Ph.D., Lisa B. Dixon, M.D., M.P.H., George L. Wolford, Ph.D., Eric P. Slade, Ph.D., Seth Himelhoch, M.D., M.P.H., Gerard Gallucci, M.D., Wendy Potts, M.S., Stephanie Tapscott, M.S. and Christopher J. Welsh, M.D.

Dr. Rosenberg is affiliated with the Departments of Psychiatry and of Community and Family Medicine, Dartmouth Medical School, 1 Medical Center Dr., Lebanon, NH 03756 (e-mail: stanley.rosenberg@dartmouth.edu). Dr. Goldberg, Dr. Dixon, Dr. Slade, Dr. Himelhoch, Ms. Potts, Ms. Tapscott, and Dr. Welsh are with the Department of Psychiatry, University of Maryland University College, Baltimore. Dr. Wolford is with the Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire. Dr. Gallucci is with the Department of Psychiatry, Johns Hopkins University, Baltimore.

OBJECTIVES: People with co-occurring severe mental illness and a substance use disorder are at markedly elevated risk of infection from HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV), but they generally do not receive basic recommended screening or preventive and treatment services. Barriers to services include lack of programs offered by mental health providers and client refusal of available services. Clients from racial-ethnic minority groups are even less likely to accept recommended services. The intervention tested was designed to facilitate integrated infectious disease programming in mental health settings and to increase acceptance of such services among clients. METHODS: A randomized controlled trial (N=236) compared enhanced treatment as usual (control) with a brief intervention to deliver best-practice services for blood-borne diseases in an urban sample of clients with co-occurring disorders who were largely from racial-ethnic minority groups. The "STIRR" intervention included Screening for HIV and HCV risk factors, Testing for HIV and hepatitis, Immunization against hepatitis A and B, Risk reduction counseling, and medical treatment Referral and support at the site of mental health care. RESULTS: Clients randomly assigned to the STIRR intervention had high levels (over 80%) of participation and acceptance of core services. They were more likely to be tested for HBV and HCV, to be immunized against hepatitis A virus and HBV, and to increase their knowledge about hepatitis and reduce their substance abuse. However, they showed no reduction in risk behavior, were no more likely to be referred to care, and showed no increase in HIV knowledge. Intervention costs were $541 per client (including $234 for blood tests). CONCLUSIONS: STIRR appears to be efficacious in providing a basic, best-practice package of interventions for clients with co-occurring disorders.

Related Article:

September 2010: This Month's Highlights
Psychiatr Serv 2010 61: 860. [Full Text] [PDF]
 
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DES PLAINES, Ill., Sept. 1 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) announced today it has received approval from the U.S. Food and Drug Administration (FDA) to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus (HBV) in a patient's blood. It is the first and only approved test capable of automating HBV viral load testing from sample extraction to final results.

The Abbott RealTime HBV assay, based on real-time PCR (polymerase chain reaction) technology, is now available for laboratories that use the Abbott m2000 automated instrument system for molecular diagnostic testing. The test offers sensitive measurement (quantitation) of HBV in human plasma or serum from individuals chronically infected with HBV.

The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. Assay results must be interpreted within the context of all relevant clinical and lab findings. Use of the assay to determine the clinical stage of HBV infection has not been established. Clinical performance characteristics have been established for individuals treated with adefovir dipivoxil. The assay is not intended as a screening test for HBV or as a diagnostic test for confirming the presence of HBV infection.

"The Abbott RealTime HBV assay, which is the first and only automated HBV viral load test approved by the FDA, is an important tool for helping physicians make and adjust treatment decisions for newly diagnosed patients and those taking anti-viral medications," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "The test will also help improve laboratory productivity by automating the most labor intensive steps of HBV testing."

Abbott's molecular HBV assay detects and measures all known HBV genotypes (A-H) by targeting an essential, highly conserved segment of the HBV genome. The capability for detecting HBV genotypes is important for both monitoring the disease and guiding treatment decisions. For example, genotype C is prevalent in Asia and is associated with more severe liver disease and development of hepatocellular carcinoma. In contrast, genotype B (also prevalent in Asia) has a better prognosis, is rarely associated with progression to liver cancer, and patients seem to respond better to certain antiviral therapies. Immigration and international travel have increased the incidence of HBV strains predominantly found outside the United States.

In addition, the Abbott RealTime HBV assay offers a broad dynamic range, capable of quantitating both very low levels of the virus (10 IU/mL) and very high levels of the virus (1 billion IU/mL) in a patient's blood. This broad dynamic range is an important factor in helping physicians accurately assess a patient's response to therapy.

The Abbott RealTime HBV assay, initially introduced in Europe and other markets in 2007, was developed for use on the Abbott m2000 system, an automated instrument for DNA and RNA testing. The m2000 is designed to efficiently detect viruses and bacteria in patient samples in less than six hours. The Abbott m2000 instrument is available in most major markets throughout the world. Outside the United States, an extensive menu for infectious disease testing is available that includes HIV-1 viral load, HBV viral load, chlamydia, chlamydia/gonorrhea (CT/NG) combination, hepatitis C (HCV) viral load, HCV genotyping, cytomegalovirus (CMV), Epstein Barr virus (EBV) and human papillomavirus (HPV). In December 2009, Abbott Molecular introduced the first oncology assay on its m2000 system outside the United States — the Abbott RealTime mS9 Colorectal Cancer — that detects the methylated form of Septin 9, a gene linked to colorectal cancer, in blood specimens. In the United States, the following tests are currently available on the m2000 platform: RealTime HIV-1, CT/NG, and now HBV.

About Hepatitis B

According to the World Health Organization, hepatitis B is a serious global public health problem, but preventable with safe and effective vaccines that have been available since 1982. Of the two billion people who have been infected with the hepatitis B virus, more than 350 million have chronic (lifelong) infections. These chronically infected persons are at high risk of death from cirrhosis of the liver and liver cancer, diseases that kill about one million people each year. Although the vaccine will not cure chronic hepatitis, it is 95 percent effective in preventing chronic infections from developing.

The prevalence of HBV infection and the method of transmission vary greatly around the world. In countries with a high prevalence of chronic HBV infection, the most common route of infection is from mother to child at birth or from child to child during early childhood. In areas of low prevalence, the infection is usually acquired during adulthood through intravenous drug use or high-risk sexual activity.

About Abbott Molecular

Abbott Molecular, abbottmolecular.com, is an emerging leader in molecular diagnostics - the analysis of DNA, RNA, and proteins at the molecular level. Some of Abbott Molecular's tests are designed to detect subtle but key changes in human genes and chromosomes. The results of these tests may aid in the earlier detection or diagnosis of disease, may influence the selection of appropriate therapies, or may improve monitoring of disease recurrence.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/.

SOURCE Abbott

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http://www.abbott.com/

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