January 24, 2012

Entry point for hepatitis C infection identified

Public release date: 24-Jan-2012

Contact: Jeanne Galatzer-Levy
jgala@uic.edu
312-996-1583
University of Illinois at Chicago

A molecule embedded in the membrane of human liver cells that aids in cholesterol absorption also allows the entry of hepatitis C virus, the first step in hepatitis C infection, according to research at the University of Illinois at Chicago College of Medicine.

The cholesterol receptor offers a promising new target for anti-viral therapy, for which an approved drug may already exist, say the researchers, whose findings were reported online in advance of publication in Nature Medicine.

An estimated 4.1 million Americans are infected with hepatitis C virus, or HCV, which attacks the liver and leads to inflammation, according to the National Institutes of Health. Most people have no symptoms initially and may not know they have the infection until liver damage shows up decades later during routine medical tests.

Previous studies showed that cholesterol was somehow involved in HCV infection. The UIC researchers suspected that a receptor called NPC1L1, known to help maintain cholesterol balance might also be transporting the virus into the cell.

The receptor is common in the gut of many species -- but is found on liver cells only in humans and chimpanzees, says Susan Uprichard, assistant professor in medicine and microbiology and immunology and principal investigator in the study. These primates, she said, are the only animals that can be infected by HCV.

Uprichard and her coworkers showed that knocking down or blocking access to the NPC1L1 receptor prevented the virus from entering and infecting cells.

Bruno Sainz, Jr., UIC postdoctoral research associate in medicine and first author of the paper, said because the receptor is involved in cholesterol metabolism it was already well-studied. A drug that "specifically and uniquely targets NPC1L1" already exists and is approved for use to lower cholesterol levels, he said.

The FDA-approved drug ezetimibe (sold under the trade-name Zetia) is readily available and perfectly targeted to the receptor, Sainz said, so the researchers had an ideal method for testing NPC1L1's involvement in HCV infection.

They used the drug to block the receptor before, during and after inoculation with the virus, in cell culture and in a small-animal model, to evaluate the receptor's role in infection and the drug's potential as an anti-hepatitis agent.

The researchers showed that ezetimibe inhibited HCV infection in cell culture and in mice transplanted with human liver cells. And, unlike any currently available drugs, ezetimibe was able to inhibit infection by all six types of HCV.

The study, Uprichard said, opens up a number of possibilities for therapeutics.

Hepatitis C is the leading cause for liver transplantation in the U.S., but infected patients have problems after transplant because the virus attacks the new liver, Uprichard said.

While current drugs are highly toxic and often cannot be tolerated by transplant patients taking immunosuppressant drugs, ezetimibe is quite safe and has been used long-term without harm by people to control their cholesterol, Uprichard said. Because it prevents entry of the virus into cells, ezetimibe may help protect the new liver from infection.

For patients with chronic hepatitis C, ezetimibe may be able to be used in combination with current drugs.

"We forsee future HCV therapy as a drug-cocktail approach, like that used against AIDS," Uprichard said. "Based on cell culture and mouse model data, we expect ezetimibe, an entry inhibitor, may have tremendous synergy with current anti-HCV drugs resulting in an improvement in the effectiveness of treatment."

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The study was supported by NIH Public Health Service grants, the American Cancer Society Research Scholar grant, the UIC Center for Clinical and Translational Science NIH grant, the UIC Council to Support Gastrointestinal and Liver Disease, and a grant from the Ministry of Health, Labor and Welfare of Japan.

Naina Barretto, Danyelle Martin, Snawar Hussain, Katherine Marsh and Xuemei Yu, of UIC; Nobuhiko Hiraga, Michio Imamura and Kazuaki Chayama, of Hiroshima University in Japan; and Waddah Alrefai of UIC and the Jesse Brown VA Medical Center in Chicago also contributed to the study.

[Editor's Note: Images available at newsphoto.lib.uic.edu/v/uprichard/]

For more information about the University of Illinois Medical Center, visit www.uillinoismedcenter.org

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Hope for Hepatitis C

Hope-for-Hepatitis-C

Posted by John Staples • January 18th, 2012

Imagine, for a moment, that you recently received a brand new Time-O-Matic Time Machine as a gift. How far back would you have to set the dial to see that meaningful progress has been made in the treatment of hepatitis C?

First, let’s say you set the dial to January 2011 and –- Puff-kachunk! — you’re there. Standard treatment for chronic hepatitis C genotype 1 infection consisted of 48 weeks of pegylated interferon-alpha and ribavirin, an approach more likely to produce adverse effects than clearance of the virus.

Your next trip (Zing-kersplat!) takes you to May 2011. The oral serine protease inhibitors boceprevir and telaprevir have just become available for treatment of chronic HCV genotype 1 infection. When added to pegylated interferon and ribavirin, these direct-acting antivirals dramatically improve the rate of sustained virologic response (SVR). But many patients still do not respond to treatment, and medication intolerance remains an issue. You step into your Time-O-Matic and return to January 2012 feeling somewhat discouraged.

Fortunately, this week’s NEJM might raise your spirits. In it, Dr. Anna S. Lok (University of Michigan, Ann Arbor, MI) and colleagues report on an open-label, phase 2a study that used a combination of two direct-acting antivirals to treat chronic HCV genotype 1 infection. Twenty-one ‘null responders’ (patients who failed to achieve ≥2log10 decline in HCV RNA after ≥12 weeks of peginterferon and ribavirin) were randomized to 24 weeks of treatment in one of two treatment arms:

• Group A received BMS-790052 (an oral, first-in-class, NS5A replication complex inhibitor) and BMS-650032 (an oral NS3 protease inhibitor);
• Group B received BMS-790052 and BMS-650032 plus peginterferon alfa-2a and ribavirin.

Four of eleven (36%) patients in Group A and ten of ten (100%) of patients in Group B achieved an undetectable HCV RNA twelve weeks after completion of study treatment (SVR12, the primary end point). There were no deaths, serious adverse events, or discontinuations. The most common mild-to-moderate adverse effects were diarrhea, fatigue, headache, and nausea.

These results are exciting. The high rate of SVR12 achieved in Group B suggests that more effective treatment regimens may soon be available for null responders. But for editorialist Dr Raymond T. Chung (Massachusetts General Hospital, Boston, MA), it’s the Group A proof-of-concept results that really put HCV therapy “on the threshold of a treatment revolution.” The 36% of Group A patients achieving SVR12 demonstrate that combination direct-acting antivirals with non-overlapping resistance profiles can achieve HCV clearance without the use of interferon. If interferon and its adverse effects can be avoided, there is hope that treatment might be offered and accepted by a much greater number of patients.

“Current HCV treatment regimens are far from perfect,“ says primary care physician and NEJM deputy editor Dr. Mary Beth Hamel, “so it’s satisfying to see encouraging results from this kind of early-phase trial. It will be exciting to see what the future brings.”

Curious? Go ahead. Step into the Time-O-Matic and set the dial to see how far HCV therapy has progressed by January 2017. The rest of us, however, will just have to wait.

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Fort Lauderdale, FL, January 24, 2012 --(PR.com)-- A new national helpline, 877-HELP-4-HEP, run by and for people affected by hepatitis C will formally launch February 1, 2012. This new consumer resource is the result of a year-long collaboration among five national nonprofits with a combined 90 years’ experience in phone-based peer counseling.

Being diagnosed with hepatitis C creates many emotional and social challenges. It is especially complicated by the lack of comprehensive medical, mental health, and community support services. People with hepatitis C report spending countless hours trying to find a reliable support and information. Resources are few and often transient based on available funding.

Judi, one of the 877-HELP-4-HEP counselors states, “People with hepatitis C just can’t seem to get the help they need. Sometimes, I’m the fourth or fifth person they have spoken to. As a peer counselor, I can share common experiences and talk about different coping strategies and resources. When I was diagnosed I had many of the concerns and questions that they are having and since then have spoken to people with similar experiences. I can really set their minds at ease with answers to their questions that contribute to a sense of well-being and hope.”

Unique to 877-HELP-4-HEP (877-435-7443) are specially trained peer counselors using a structured approach to help callers navigate through screening, diagnosis, medical evaluation, and treatment. Follow-up contact by the counselors keep callers engaged at each step of their journey and help them make and follow through with their hepatitis C related decisions.

Additional HELP-4-HEP assets include an up-to-date national database of 25,000 referral resources and a secure shared caller database for counseling continuity. Andi Thomas, the helpline’s managing partner, stated, “What sets us apart is our standardized health messaging and the follow-up call feature. HELP-4-HEP is designed to maintain contact with callers to improve health outcomes as well as document and measure the impact of our services.”

HELP-4-HEP is administered by The Support Partnership whose mission is to improve the well-being of people affected by viral hepatitis through collaborations that increase service quality, access, and impact. Founding partners are HealthPro (formerly Hep-C ALERT), FL; Hepatitis C Association, NJ; Hepatitis Education Project, WA; Hep C Connection, CO; and Project Inform, CA.
877-HELP-4-HEP (877-435-7443) operates Monday through Friday 9:00am to 7pm EST. To learn more, visit www.help4hep.org or email info@help4hep.org.
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Contact Information

The Support Partnership
Andi Thomas
954-692-0450
Contact
www.help4hep.org
Denny Simon
908-812-2488

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Germany’s IQWiG sees added benefits for Incivo (Telaprevir)

Article | 24 January 2012

In an early benefit assessment pursuant to Germany’s Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG), has examined whether Incivo (telaprevir) offers an added benefit compared with the present standard therapy.

According to the findings of the assessment, telaprevir offers advantages in various groups of patients with chronic hepatitis C infection of genotype 1. The available studies provide proof, indications or "hints” of an added benefit. However, not only the probability but also the extent of added benefit varies, said the IQWiG.

The European Commission has approved Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Incivo, a direct acting antiviral (DAA) protease inhibitor, for the treatment of genotype-1 chronic hepatitis C virus (HCV), in combination with peginterferon alfa and ribavirin, in adults (The Pharma Letter September 21, 2011). The drug was developed in collaboration with the USA’s Vertex and Japan’s Mitsubishi Tanabe and is approved and marketed under the trade name Incivek in the USA and Canada (TPLs May 24 and August 23).

In accordance with the approval status, different patient groups are treated for different periods, which was allowed for in the assessment. The dual combination of peginterferon alfa and ribavirin is the present standard therapy, and this was compared with the triple combination of these two standard drugs and telaprevir.

Studies largely only provide data on morbidity and adverse effects

Overall three relevant studies were identified. The outcomes considered were "mortality,” "secondary complications of treatment (morbidity)” measured in the studies by means of the surrogate outcome "SVR,” as well as "health-related quality of life” and "adverse effects.”

The quality-of-life results for treatment-naive (ie, previously untreated) patients without cirrhosis were not statistically significant. No evaluable data on this outcome were available for other patient groups. Due to the too short study duration, the event rates for mortality were too low in all patient groups to be able to draw robust conclusions.

Extent of added benefit cannot be classified on the basis of the surrogate outcome for morbidity

The extent of added benefit cannot be classified on the basis of the surrogate outcome "SVR,” the agency noted. This parameter is not a patient-relevant outcome in itself and there are no studies in which SVR is validated as a surrogate outcome in accordance with the usual criteria employed by IQWiG. Nevertheless, the Institute accepts SVR in the context of this assessment as a surrogate for the reduced incidence of liver cancer. This is because it is currently accepted that patients with no detectable hepatitis C virus in the blood are at lower risk of liver cancer. However, it is not known how many cases of liver cancer can in fact be prevented by telaprevir and it is therefore unclear whether the added benefit can be classified as "minor” "considerable” or "major.” According to the corresponding legal ordinance, the added benefit is thus "unquantifiable.”.Under consideration of the beneficial and harmful effects of telaprevir, overall IQWiG reaches different conclusions for different patient groups.

Advantages for treatment-naive patients without cirrhosis who have a high viral load

Different results for morbidity were shown for treatment-naive patients without cirrhosis, depending on the viral load in the blood at the start of treatment. Proof of an added benefit of telaprevir was only determined for patients with a high viral load. However, the extent of the added benefit is unquantifiable as it refers to the surrogate outcome "SVR.”

For treatment-naive patients without cirrhosis, the data also provide proof and an indication of greater harm due to the adverse effects anaemia and rash, respectively, the extent being classified as "considerable” in the former and "minor” in the latter case. In the consideration of the beneficial and harmful effects of telaprevir, this did not lead to a restriction in the overall conclusion for patients with a high viral load, as these side effects were nearly exclusively classified as "not serious,” said the IQWiG.

In contrast, for treatment-naive patients without cirrhosis who have a low viral load at baseline, the data provide an indication of lesser benefit of telaprevir versus the comparator therapy. This is due to the fact that an added benefit regarding SVR is not proven, so that only the harmful effects are taken into account. An added benefit of telaprevir is not proven for treatment-naive patients with cirrhosis, as the manufacturer dossier did not contain any evaluable data.

Indication of an advantage also in patients with unsuccessful pre-treatment

Depending on the cirrhosis status, different results were shown for patients in whom treatment had so far been unsuccessful (non-responders). Regarding morbidity, the data provide an indication of an added benefit of telaprevir in patients without cirrhosis. The data only provide a "hint” of an added benefit in non-responders with cirrhosis. In this context, "indication” and "hint” refer to the surrogate outcome "SVR.” Therefore the extent of added benefit is unquantifiable. As in the case of treatment-naive patients without cirrhosis, indications of greater harm due to the side effects "anaemia” and "rash” did not lead to a restriction in the overall conclusion.

No additional benefit for relapsed patients

In patients without cirrhosis who relapsed after standard therapy, the treatment regimen deviated from the approval status. Consequently, the added benefit cannot be assessed on the basis of the available data so that an added benefit is not proven, noted the IQWiG.

In patients with cirrhosis who relapsed, the data provide an indication of an added benefit regarding SVR. However, at the same time they also provide an indication of greater harm (extent: considerable) regarding serious adverse events. Under consideration of the beneficial and harmful effects of telaprevir, the IQWiG concluded that overall an added benefit is not proven for this patient group.

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PR-Logo-Businesswire

PRESS RELEASE

Jan. 24, 2012, 7:00 a.m. EST

JERUSALEM, Jan 24, 2012 (BUSINESS WIRE) – BioLineRx (tase:BLRX), a biopharmaceutical development company, announced today it has signed a worldwide, exclusive license agreement with Genoscience, a French company focused on viral disease therapeutics, to develop and commercialize BL-8020, an orally available treatment for Hepatitis C.

BL-8020 has been developed for anti-viral therapy by Professor Philippe Halfon, Co-Founder and President of Genoscience. Prof. Halfon is a founder of several biotechnology companies and is world renowned for his work on HIV (AIDS virus), HPV (human papilloma virus causing cervical cancer) and Hepatitis.

BL-8020 acts via a unique mechanism of action, by inhibiting Hepatitis C virus (HCV)-induced autophagy, which differs from the mechanism of currently used anti-HCV agents. BL-8020's safety and efficacy were demonstrated in pre-clinical studies. These studies have shown that BL-8020, when combined with other anti-Hepatitis C virus (HCV) agents, has a synergistic effect. BL-8020's synergistic effect on other therapies is likely to increase their potency and reduce the numerous adverse effects often associated with these drugs, by enabling utilization of lower dosages. In addition BL-8020 may reduce therapy duration, which is currently up to 48 weeks. The use of two drugs acting by different mechanisms is also likely to be beneficial for patients who have developed resistance to current treatments and is an effective strategy used against other viruses such as HIV.

Dr. Kinneret Savitsky, CEO of BioLineRx, said, "We are excited about entering the field of Hepatitis C therapeutics, which is a very important field in the pharmaceutical market today. The current global Hepatitis market is estimated at approximately $6.5 billion and is growing steadily. Current therapies are characterized by numerous severe side effects, long treatment duration and development of resistance. In these respects, BL-8020 has a demonstrated safety and efficacy profile, may shorten therapy duration and may combat resistance by acting as an add-on platform which can potentially be combined with other oral Hepatitis C therapies to increase their efficacy."

"We were impressed by the drug development expertise of the BioLineRx team and are very pleased to collaborate with them for the further development of our product for the treatment of Hepatitis C," said Prof. Philippe Halfon, Co-Founder and President of Genoscience. "There is clearly a huge unmet medical need in finding a safe and effective treatment for the disease, and based on pre-clinical results, its unique mechanism of action and synergistic effect, we believe that our product, especially when combined with other available Hepatitis C drugs, has the potential to bring remedy to millions worldwide."

About Hepatitis C

Hepatitis C infection is a blood borne infection of the liver caused by the Hepatitis C virus (HCV) which becomes chronic in about 85% of cases. According to the World Health Organization (WHO), more than 170 million people worldwide are chronically infected with HCV. In addition, HCV infection is the leading cause of liver transplantation and is a risk factor for liver cancer. The global Hepatitis market was estimated at $6.5 billion in 2010 and is forecasted to grow to $11.5 billion in 2016.

About BioLineRx

BioLineRx Ltd. is a publicly-traded biopharmaceutical development company. It is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx's current portfolio consists of five clinical stage candidates: BL-1020 for schizophrenia has commenced a Phase II/III study; BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction, is currently undergoing a pivotal CE-Mark registration trial and has been out-licensed to Ikaria Inc. for a total deal value of $282.5 million, in addition to sales royalties; BL-5010 for non-surgical removal of skin lesions has completed a Phase I/II study; BL-1021 for neuropathic pain is in Phase I development and BL-7040 for treating Inflammatory Bowel Disease (IBD) has completed Phase I. In addition, BioLineRx has 12 products in various pre-clinical development stages for a variety of indications, including central nervous system diseases, oncology, infectious diseases, cardiovascular and autoimmune diseases.

BioLineRx's business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government's Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization. For more information on BioLineRx, please visit www.biolinerx.com .

The estimates and judgments with respect to BL-8020 included in this release are considered forward-looking statements, which involve certain risks and uncertainties, and are based on information available to the Company at the time of this release. Such estimates may not be realized or may be only partially realized, due to the significant uncertainty characterizing research and development activities in general, particularly those of drug development, including changes in regulation or uncertainty relating to the application of regulation, unexpected delays in obtaining regulatory approval, unexpected delays in patient recruitment for clinical trials, unexpected delays in other clinical trial preparatory activities, inefficiencies, inability to manufacture, toxicity, a high level of risk/reward in comparison. Any forward-looking statements represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

SOURCE: BioLineRx Ltd.

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Rapid HIV Test Results Better With Blood

By Michael Smith, North American Correspondent, MedPage Today
Published: January 23, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

A rapid HIV test gives slightly less exact results when used with oral samples compared with blood samples, researchers reported.

In pooled results from a systematic review and meta-analysis, the sensitivity of the Oraquick rapid test was 98.03% when oral samples were used, compared with 99.68% using blood, according to Nitika Pant Pai, MD, of McGill University Health Centre in Montreal, and colleagues.

On the other hand, the specificity of the test was similar regardless of the type of samples at 99.74% for oral samples and 99.91% for blood, Pant Pai and colleagues reported online in The Lancet Infectious Diseases.

The Oraquick test, originally approved as a point-of-care HIV test for use with blood, received approval from the FDA in 2004 for use with oral mucosal transudate, the researchers noted. The test has become especially popular in developing countries.

Given the increased emphasis on HIV testing, data on the performance of the Oraquick test using the different sampling approaches will be important to help clinicians and patients interpret results, they argued.

Pant Pai and colleagues analyzed data from 45 studies, including 24 that could be used to understand the comparative accuracy of the test using oral or blood samples, and 21 that could be used to analyze positive predictive values. Because they depend on prevalence, positive and negative predictive values can only be derived from cross-sectional or other population-based studies.

Seven of the 24 accuracy studies contained head-to-head comparisons, while six only gave results for oral samples and 11 only looked at whole blood samples.

Pooling the analyses showed that the sensitivity of the test was about 2% lower when oral samples were used, but specificity was about the same, the researchers reported. In other words, using oral samples was likely to yield more false-positive results.

The researchers calculated positive predictive values using the 21 studies that permitted the analysis. They found that the test's value was similar regardless of sample type in high-prevalence regions, but differed if prevalence was low.

In high-prevalence groups, defined as more than 1% of the population infected with HIV, the positive predictive value of the test was 98.5% using blood samples and 98.65% using oral samples.

But in low-prevalence populations, the value for blood samples was 97.65% compared with 88.55% for oral samples.

Put another way, if the prevalence is low, a positive result using oral samples is less likely to be correct than if blood were used.

The researchers cautioned that although the test's sensitivity seems to be lower with oral versus blood specimens, the estimates "were at the extreme upper end of the range and there is a great deal of overlap" in confidence intervals.

It's possible that the "clinical significance of this difference might also be overshadowed by intrinsic variability in host status and time of testing relative to exposure," they added.

Much of the data comes from high-income settings and the rest from well controlled studies in developing settings, they noted, so the results may not reflect routine testing services in poorer areas.

Finally, the results only apply to the Oraquick test, they wrote.

The Oraquick test is attractive because it is convenient and non-invasive, commented Chi Chiu Leung, MBBS, of the Hong Kong Department of Health, and Shui Shan Lee, MD, of the Chinese University of Hong Kong.

Those characteristics might help increase the rate of HIV testing, they argued in an accompanying comment article, but they appear to come "at the cost of a substantial false-positive rate."

That false-positive rate has to be taken into consideration by clinicians as the rapid test becomes more widely used, they concluded, especially in areas where the prevalence of HIV is low.

Confirmatory testing will remain important, given that the diagnosis of HIV has such profound implications, they wrote.

The study was supported by the Canadian Institutes for Health Research. The authors said they had no conflicts of interest.

The comment authors said they had no conflicts of interest.

Primary source: The Lancet Infectious Diseases
Source reference:

Pant Pai N, et al "Head-to-head comparison of accuracy of a rapid point-of-care HIV test with oral versus whole-blood specimens: a systematic review and meta-analysis" Lancet Infect Dis 2012.

Additional source: The Lancet Infectious Diseases
Source reference:

Leung C, Lee S "Rapid HIV tests: from meta-analysis to field application" Lancet Infect Dis 2012.

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Teens Lacking in Protection Against Hepatitis A

30789_1

By Todd Neale, Senior Staff Writer, MedPage Today
Published: January 23, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Most adolescents have not been vaccinated against hepatitis A virus, leaving them vulnerable to serious disease as they move into adulthood, a cross-sectional study showed.
In 2009, only 42% of U.S. teens ages 13 to 17 had received at least one dose of the vaccine and only 29.5% had received two doses, according to Christina Dorell, MD, MPH, of the CDC's National Center for Immunization and Respiratory Diseases in Atlanta, and colleagues.
Rates were highest in states that had been covered by recommendations for routine hepatitis A vaccination the longest, the researchers reported in the February issue of Pediatrics.

Finally, in 2006, ACIP recommended routine vaccination for all U.S. children starting at age 1, bringing the remaining 33 states and the District of Columbia into the fold.

Gradual implementation of the recommendations has been associated with a dramatic drop in rates of hepatitis A infection in the U.S. The virus likely will persist, however, because of introductions through contaminated food, international travel, and international adoption, placing unvaccinated individuals at risk.

To assess vaccine coverage in U.S. adolescents, Dorell and colleagues turned to the 2009 National Immunization Survey-Teen, which collected information through landline telephone surveys of parents and guardians and mailed surveys of vaccination providers.

Most of the 20,066 teens, ages 13 to 17, included in the current analysis had not received any doses of vaccine by 2009.

One-dose coverage was 74.3% among the states covered by a routine vaccination recommendation since 1999; 54% among those covered by a recommendation for consideration of the vaccine since 1999; and 27.8% for the remaining states not covered by a recommendation until 2006.

The most consistent predictor of having been vaccinated was receipt of a recommendation from a healthcare professional. That was associated with a 30% to 160% relative increase and 21% to 34% absolute increase in coverage rates among the three groups of states.

"Recommendations from healthcare providers increase parental acceptance of vaccination, and parents change their minds about delaying and refusing vaccines because of information or assurances from healthcare providers," according to Dorrell and colleagues.

Only one-quarter of the teens in the study received such a recommendation, however.

"Provider concerns about vaccine reimbursement and insurance coverage and some physicians' perception that hepatitis A is not a significant health problem have been identified as barriers to recommending [the vaccine]," the authors wrote.

"As a result, it may be useful to continue educating vaccination providers about the severity of hepatitis A infection among adolescents and adults and the safety and high efficacy of [the vaccine], which can be given to anyone needing or wishing protection."

Aside from provider input, other factors that were tied to vaccination rates were presence of a state requirement, racial and ethnic background, type of living area (urban, suburban, or rural), household income, and geographic region.

The researchers acknowledged some limitations of the study, including the possibility that it may not be representative of households without landline telephones. Also, they relied on parental report to determine whether a healthcare provider gave a recommendation about the vaccine. There was the possibility of nonresponse bias and the potential for incomplete information from the provider regarding vaccination.

The authors reported that they had no conflicts of interest.

Primary source: Pediatrics
Source reference:
Dorell C, et al "Hepatitis A vaccination coverage among adolescents in the United States" Pediatrics 2012; 129: 213-221.

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