April 17, 2013

Published in Journal Watch Gastroenterology April 12, 2013

In phase II trials, a 12-week regimen resulted in high virologic response 24 weeks after treatment, no sofosbuvir-specific adverse effects, and no virologic breakthrough.

Sofosbuvir is a nucleotide analogue that inhibits NS5B-directed hepatitis C virus (HCV) RNA replication. In vitro studies suggest that sofosbuvir has anti-viral activity against all HCV genotypes and a high barrier to resistance. The current industry-funded, phase II companion studies evaluated the efficacy of sofosbuvir in combination with peginterferon and ribavirin in HCV-infected patients without cirrhosis.

Lawitz and colleagues randomized 122 treatment-naive patients with HCV genotype 1 in a 2:2:1 allocation to receive sofosbuvir (200 mg or 400 mg) or placebo daily in combination with peginterferon (180 µg weekly) plus ribavirin (1000–1200 mg daily) for 12 weeks. Patients with HCV genotypes 2 or 3 received open-label sofosbuvir plus peginterferon and ribavirin for 12 weeks. Some patients received an additional 12 to 36 weeks of peginterferon/ribavirin depending on viral response. In the randomized cohort, sustained virologic response (SVR) rates at 12 weeks post-treatment were 90%, 91%, and 58% in the 200 mg, 400 mg, and placebo groups, respectively. Although SVR rates were similar between the sofosbuvir groups, 3 patients in the 200-mg group had viral relapse versus none in the 400-mg group. Among the cohort with genotypes 2 and 3, the SVR rate was 92%. The most common adverse effects were peginterferon- and ribavirin-related.

Kowdley and colleagues randomized 316 treatment-naive patients with HCV genotypes 1, 4, or 6 in a 1:2:3 allocation to receive sofosbuvir (400 mg) daily in combination with peginterferon (180 µg weekly) and ribavirin (1000–1200 mg daily) for 12 weeks, the same drug regimen for 24 weeks, or the 12-week regimen followed by either sofosbuvir monotherapy or sofosbuvir plus ribavirin for another 12 weeks. SVR rates were 89%, 89%, and 87% at 24 weeks post-treatment for the 3 groups, respectively. SVR rates were 82% for 11 patients with genotype 4 and 100% for 5 patients with genotype 6. Baseline viral load and IL28B genotype did not affect SVR rates. As with the companion study, most adverse effects were associated with peginterferon and ribavirin and not with sofosbuvir. No evidence of HCV resistance was noted in either study.

Comment: Key observations from these trial findings include: (1) the average sustained virologic response rate was 90% for a 12-week sofosbuvir regimen in all HCV genotypes; (2) 12 weeks of therapy seems to be as effective as 24 weeks; (3) sofosbuvir should be administered at a dose of 400 mg daily; (4) sofosbuvir is well tolerated and adds no new adverse effects to the regimen; (5) resistance development does not seem to be a concern; and (6) traditional predictors of response, such as IL28B genotype and baseline viral load, do not seem to affect response rates. The ongoing phase III studies will hopefully verify the safety and efficacy of the sofosbuvir regimen. Future studies should evaluate its efficacy in patients who are treatment-experienced or have cirrhosis.

Atif Zaman, MD, MPH

Published in Journal Watch Gastroenterology April 12, 2013

Citation(s):

Lawitz E et al. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic treatment-naïve patients with genotypes 1, 2, and 3 hepatitis C infection: A randomised, double-blind, phase 2 trial. Lancet Infect Dis 2013 Mar 15; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S1473-3099(13)70033-1)

    Kowdley KV et al. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): An open-label, randomised, multicentre phase 2 trial. Lancet 2013 Mar 15; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(13)60247-0)

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    Journal Watch Blogs

    Paul E. Sax, MD is the Editor-in-Chief, Journal Watch HIV/AIDS Clinical Care, Clinical Director of the Division of Infectious Diseases at Brigham and Women's Hospital, and Professor of Medicine at Harvard Medical School.

    Paul Sax • April 10th, 2013

    Two weeks, two companies, two press releases, two future HCV drugs that begin with “S”:

    1. March 28, 2013: Janssen Research & Development announced that it has submitted a New Drug Application to the FDA seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic HCV in adult patients.
    2. April 8, 2013: Gilead Sciences announced that it has submitted a New Drug Application to the FDA for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic HCV infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with ribavirin and pegylated interferon for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

    For several years now, all clinicians who see patients with hepatitis C have been promising them better treatments “soon”, with admittedly little precision about exactly what this “soon” actually means.

    But with these filings, we have a pretty good idea. It will be less than a year — maybe much less. Why is that?

    • The FDA has roughly 10 months to review these applications. (The exact timing is somewhere on the FDA web site, see if you can find it.)
    • These two drugs have looked pretty great in clinical studies to date.
    • The bar to leap over to be substantially better than current standard -of-care treatment for HCV isn’t exactly high — a fact that could get at least one drug, if not both, priority review and even more rapid approval.
    • One of my patients has joked that I’ve been saying “in a few years” for availability of better HCV treatment options for at least “a few years” now — so my time is up.

    Of course, stuff could happen that holds up the approvals. A toxicity could arise that hasn’t been reported previously, or a tricky drug-drug interaction could crop up. Or the sun could explode.

    But if these things don’t happen, then for patients with HCV genotypes 2 and 3, a non-interferon option looks like it’s right around the corner — sofosbuvir and ribavirin. For those with genotypes 1 and 4, a shortened, more effective, and all-round improved interferon-based regimen will arrive at the same time — pegylated interferon/ribavirin plus either simeprevir or sofosbuvir.

    And even better, how about an off-label combination of these two new drugs as in this clinical study – in which case the interferon can be dropped entirely, right?

    Let the choir sing out when that happens, and enjoy a hearty celebratory brunch at the famous Cambridge deli pictured above in honor of the new regimen.

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    PR-Logo-Newswire

    PRESS RELEASE

    April 17, 2013, 8:00 a.m. EDT

    Abstract Accepted for Presentation at the International Liver Congress 2013 --

    NORCROSS, Ga., April 17, 2013 /PRNewswire via COMTEX/ -- Galectin Therapeutics /quotes/zigman/9334018/quotes/nls/galt GALT +9.80% , the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that its abstract was accepted by the European Association for the Study of the Liver for presentation on April 27, 2013 at the International Liver Congress to be held in Amsterdam, The Netherlands. The abstract, "Regression of fibrosis and reversal of cirrhosis in thioacetamide-induced liver fibrosis following treatment with galectin inhibitors" provides evidence in a pre-clinical model that Galectin's drugs are able to reverse established fibrosis and cirrhosis.

    "Data continues to accumulate showing the effectiveness of our galectin inhibitor drugs in pre-clinical models," said Dr. Peter G. Traber, President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics. "Research will be presented on how both GR-MD-02 and GM-CT-01 are effective in reversing fibrosis and cirrhosis in established disease. The findings add confidence for the possibility of this mechanism extending to human disease. Following the presentation, additional information will be announced and the data will be posted on the Galectin website."

    About Galectin TherapeuticsGalectin Therapeutics /quotes/zigman/9334018/quotes/nls/galt GALT +9.80% is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.

    Forward Looking StatementsThis press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others: incurrence of operating losses since our inception, uncertainty as to adequate financing of our operations, extensive and costly regulatory oversight that could restrict or prevent product commercialization, inability to achieve commercial product acceptance, inability to protect our intellectual property, dependence on strategic partnerships, product competition, and others stated in risk factors contained in our SEC filings. We cannot assure that we have identified all risks or that others may emerge which we do not anticipate. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.

    SOURCE Galectin Therapeutics Inc.

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    PR-Logo-Businesswire

    PRESS RELEASE

    April 17, 2013, 7:30 a.m. EDT

    SEATTLE, Apr 17, 2013 (BUSINESS WIRE) -- NanoString(R) Technologies, Inc., a privately held provider of life science tools for translational research and molecular diagnostic products, today announced that it has secured an option to an exclusive worldwide license for a 186-gene signature that could be used to determine the prognosis of patients diagnosed with the most common type of liver cancer, hepatocellular carcinoma (HCC), or with hepatitis C-related early-stage cirrhosis. HCC is the third leading cause of cancer mortality worldwide and Hepatitis C cirrhosis-related HCC is the most rapidly increasing cause of cancer related death in the United States.

    NanoString secured the option to an exclusive worldwide license from The Broad Institute, a leading non-profit research institute of genomic medicine in Cambridge, Massachusetts, acting on behalf of the inventors' institutions. The HCC gene signature was invented by Todd Golub, MD, Chief Scientific Officer of the Broad Institute and a group of researchers from the Dana-Farber Cancer Institute, the Icahn Sinai School of Medicine at Mount Sinai, Massachusetts General Hospital, Massachusetts Institute of Technology, The Hospital Clinic of Barcelona, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Institucio Catalana de Recarca i Estudis Avancats (ICREA), and Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd).

    During the period in which the option can be exercised, NanoString plans to assess the feasibility of developing an in vitro diagnostic assay based on the HCC gene signature for use on the nCounter(R) Analysis System.

    A paper in the New England Journal of Medicine in 2008 by Hoshida, et al, described the HCC gene signature in connection with a method for conducting gene expression analysis on RNA extracted from liver tissue adjacent to HCC tumors. Using this method, the authors discovered a 186-gene signature that identifies those HCC patients who have a poor prognosis because of a high rate of recurrence after primary treatment. This gene signature was highly correlated with survival in a training set of 82 Japanese patients and was validated in an independent set of 225 patients from the United States and Europe. A paper recently published online in Gastroenterology by Hoshida et al, demonstrated that this same 186-gene signature also identifies those patients with hepatitis C-related early-stage cirrhosis who have a poor prognosis because of their high rate of developing HCC.

    Josep M. Llovet, MD, Professor of Medicine and Director of the HCC Program, Liver Diseases, Mount Sinai, Professor ICREA at IDIBAPS-Hospital Clinic, and a co-inventor of the HCC gene signature, commented: "By identifying those HCC patients who are at the greatest risk of recurrence, doctors may choose to monitor these patients more regularly or to enter them into clinical trials in the adjuvant setting to reduce the risk of HCC recurrence. The signature also identifies patients with hepatitis C-related early-stage cirrhosis at high risk of developing HCC who are good candidates for entry into surveillance programs or clinical trials of new agents in the chemo-preventive setting."

    Yujin Hoshida, M.D., Ph.D., who led the discovery of the signature while a postdoctoral fellow in Todd Golub's laboratory at the Broad Institute and is on the faculty at Mount Sinai, commented: "This platform could provide the multiplexed gene expression capabilities needed for clinical diagnostic use of this HCC gene signature, especially given the potential for a large scale global surveillance testing opportunity. We are excited to take this next step in translating the liver cancer gene signature we have applied in research into a clinical diagnostic available to patients worldwide."

    "NanoString is dedicated to helping patients and physicians by providing information that can inform major clinical decisions to improve patient care," said Brad Gray, President and CEO of NanoString. "On the heels of launching our Prosigna breast cancer assay in the European Union and Israel, we are excited at the prospect of once again partnering with a customer of our Life Sciences business to translate their discovery into a diagnostic product."

    About Hepatocellular Carcinoma

    Hepatocellular carcinoma (HCC), the most common form of liver cancer, is an increasingly prevalent clinical problem and is the third most common cause of cancer-related death globally. The incidence rates of HCC in the United States have historically been lower than in many countries. However, in recent decades, HCC age-adjusted incidence rates have doubled and primary liver cancer mortality rates have increased faster than mortality rates for any other leading cause of cancer. HCC develops from advanced fibrosis of the liver, or cirrhosis, which is estimated to affect one to two percent of the world's population. The prognosis for patients with advanced HCC is poor, with a reported five-year survival rate of approximately 10 percent due to the high rate of recurrence after initial treatment of the primary tumor. Like many cancers, patient outcomes are better when the disease is detected and treated at an early stage.

    About NanoString Technologies, Inc.

    NanoString Technologies is a privately held provider of life science tools for translational research and molecular diagnostic products. The company's nCounter(R) Analysis System, which has been employed in basic and translational research since it was first introduced in 2008 and cited in more than 200 peer-reviewed publications, has also now been applied to diagnostic use. The system offers a cost-effective way to easily profile the expression of hundreds of genes, miRNAs, or copy number variations, simultaneously with high sensitivity and precision. The company's technology enables a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The nCounter-based Prosigna(TM) Breast Cancer Prognostic Gene Signature Assay is the first in vitro diagnostic kit to be marketed through the company's recently formed diagnostics business.

    The nCounter Analysis System is currently available for "Research Use Only" in North America. For more information, please visit www.nanostring.com.

    The NanoString Technologies logo, NanoString, NanoString Technologies and nCounter are registered trademarks, and Prosigna is a trademark, of NanoString Technologies, Inc.

    As co-inventors of the HCC gene signature, Drs. Llovet and Hoshida would be entitled to a portion of future royalty payments from NanoString.

    http://cts.businesswire.com/ct/CT?id=bwnews&sty=20130417005422r1&sid=cmtx4&distro=nx 

    SOURCE: NanoString Technologies, Inc.

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    Patients to benefit from potential for improved efficacy in less commonly used types of ARV therapies and one-pill-daily combination drugs

    LONDON, April 17,2013 /PRNewswire/ -- The anticipated launch of drugs currently in the pipeline, together with the introduction of oral combination pills, are set to have a profound impact on the European HIV drugs market.

    New analysis from Frost & Sullivan (http://www.lifesciences.frost.com), Analysis of theEuropean HIV Drugs Market, finds that the market earned $5.58 billion in 2012 and estimates this to reach $9.24 billion in 2019. The research covers the most actively used antiretroviral (ARV) therapies: nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitor (PI), non-nucleoside reverse transcriptase inhibitor (NNRTI), integrase inhibitors, and other therapeutics (ARV compounds like CCR5 receptor antagonists, fusion inhibitors, maturation inhibitors, attachment inhibitors and PK boosters).

    "In addition to popularly existing therapies like NRTI, NNRTI, PI and integrase inhibitors, new drug candidates over the last decade have spurred the HIV drugs market," notes Frost & Sullivan Healthcare Research Analyst Deepika Pramod Chopda. "The development of new candidates, derived from the less commonly used types of ARV therapies like PK boosters, maturation inhibitors, and attachment inhibitors, is driving the overall market."

    With technically advanced features like easy consumption and higher adherence to combination therapy, these candidates assist highly active antiretroviral therapies (HAART), which are a combination of three or four types of ARV therapies. Their value-added features and improved efficacy are expected to boost the prospects of less common drug types.

    The introduction of one-pill-daily combination drugs will also be a key factor in market development. A reduction in the number of drugs that need to be consumed directly reduces patient expenditure levels. Other advantages include convenience and ease of consumption.

    This trend is poised to have a steady impact on the growth of the HIV drugs market. It is also likely to shift the focus from syringes, as a source of drug administration, to directly consumable pills.

    A major restraint to market expansion remains poor compliance rates due to the absence of established treatment procedures. This can be offset by improving access to disease awareness campaigns, treatment guidelines, counselling sessions and targeted diagnostics from health governing bodies.

    "Awareness building efforts related to HIV prevention among high-risk groups is increasing," concludes Chopda. "Better understanding about the need to practice safe-sex, use sterilised needles and conduct blood transfusion in a sterile environment, are also helping market prospects."

    If you are interested in more information on this research, please send an email to Anna Zanchi, Corporate Communications, at anna.zanchi@frost.com

    Analysis of the European HIV Drugs Market is part of the Life Sciences Growth Partnership Service programme. Frost & Sullivan's related research services include: European HIV Diagnostics Market and U.S HIV/AIDS Therapies Market. All research included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.

    About Frost & Sullivan

    Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best-practice models to drive the generation, evaluation, and implementation of powerful growth strategies.Frost & Sullivanleverages 50 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 40 offices on six continents. To join our Growth Partnership, please visithttp://www.frost.com

    Contact
    Anna Zanchi
    Corporate Communications – Europe
    P: +39.02.4851 6133
    E: anna.zanchi@frost.com
    http://www.frost.com

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    RNA-Based Drug Offers New Hope To Hepatitis C Patients

    image3A1

    RNA molecule folded back upon itself [Source: Wikipedia]

    Written By: Peter Murray
    Posted: 04/17/13 8:35 AM

    About 170 million people in the world suffer from chronic hepatitis C, a viral infection that often leads to cirrhosis or cancer of the liver. Right now, modern medicine can cure about 50 to 80 percent of hepatitis C cases, but often the treatments have side effects that are themselves very harmful. A new drug may present a way for patients to rid their bodies of infection without subjecting to the same harsh side effects.

    Developed by Santaris Pharma A/S headquartered in Denmark, miravirsen is part of a class of drugs known as RNA interference (RNAi) drugs. RNAi works differently than traditional antivirals that target and disable proteins or other parts of the virus. RNAi drugs are not toxic chemicals but small pieces of the single-stranded RNA molecules that binds other RNA molecules. And rather than disrupting the function of the virus, miravirsin works by binding an RNA molecule in the host cell nucleus that hepatitis C needs to replicate. Without replicating and spreading through the body, the viral infection will be short-lived. This kind of “mopping” up of host cell resources that the virus needs have led some to dub miravirsen the “sponge drug.”

    In this phase 2 trial, the goal was to see how much miravirsin was needed to temporarily halt the hepatitis C virus. Three different doses and a placebo were given weekly among 36 patients with chronic hepatitis C over a month. The effects were dose dependent, with viral levels in five out of nine patients receiving the highest dose rendered undetectable. According to Harry Janssen, the study’s lead author, the results are comparable to current hepatitis C treatments. Four of these five patients, however, showed a rebound in their viral levels when the study was concluded 18 weeks later, indicating that a treatment with lasting effects will likely need to be longer than five weeks.

    The current study, published in the April 4 issue of The New England Journal of Medicine, was meant to determine an effective dose for miravirsin, as well as evaluate its safety. A much larger study will be needed to determine its overall effectiveness. And while longterm side effects still remain a possibility, the observed short-term side effects were minimal, consisting only of a rash and pain at the site of injection.

    image1A1

    Miravirsin binds to a molecule in host cells called miR-122 that the hepatitis C virus needs to replicate. [Source: Santaris Pharma A/S]

    For one group in the United States, hepatitis C is a big problem. About 2 million baby boomers – those born between 1945 and 1965 – have hepatitis C. They make up about 27 percent of the US population, yet account for three-quarters of all hepatitis C cases in the US. It’s thought that the majority of baby boomers contracted infections during the 70s and 80s, when the spread of hepatitis was at its peak. The disproportionate number of cases for the group prompted the Center for Disease Control to issue a recommendation last August that baby boomers be tested regularly for hepatitis C.

    There are five types of hepatitis, A thru E. Types B and C are of special concern as they have led to chronic diseases for hundreds of millions around the world and combined are the most common cause of liver cirrhosis and cancer. For about 75 to 85 percent of people who contract hepatitis C, the infection becomes a chronic disease.

    Since its discovery in 1998, scientists have been trying to use RNAi to halt the ability of viruses to hijack host cell machinery in order to replicate. But for all the hope it had inspired, the path from idea to actual treatment turned out to be much more difficult to traverse than companies had hoped it would be. In 2006 pharmaceutical giant Merck bought Sirna Therapeutics, the San Francisco-based pioneer in making RNAi-based drugs. In 2010 Roche ended its $500 million program to develop RNAi-based drugs. Months before, Novartis opted to not spend the $100 million needed to continue a partnership with the Cambridge, Massachusetts-based RNAi leader, Alnylam. It seemed that, while making the RNA molecules is easy enough, delivering the notoriously fragile molecules to their target cells has proven harder than expected.

    But things may be turning around for the as yet unproven technology. Earlier this year the first RNAi-based treatment received FDA approval. Kynamro will be used to treat people with homozygous familial hypercholesterolemia, a rare condition that causes high cholesterol due to the body’s inability to remove low density lipoproteins (“bad” cholesterol, although see here) from blood. The RNAi’s in Kynamro work by limiting the body’s ability to produce lipid particles that a processed to become LDLs. In a clinical trial the treatment decreased levels of LDL by 25 percent.

    The most common way to treat hepatitis C is with antivirals combined with interferon, a protein that boosts the body’s immune system and slows virus replication, and ribavirin, an antiviral that helps slow the spread of the virus in the body. A major drawback from the current treatment are its side effects that include flu-like symptoms, fatigue, depression, anxiety, diarrhea and nausea. If its phase 3 trial looks anything like its phase 2, miravirsen could be the next RNA-based therapy to get FDA approval and not only help rid patients of infection, but spare them severe side effects at the same time.

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    HBV/HCV coinfection linked to younger age, HIV, male sex

    Tyson GL. Hepatology. 2013;doi:10.1002/hep.26400.

    April 17, 2013

    Exposure to HBV among patients with HCV is common, although coinfection is relatively rare and associated with male sex, younger age and HIV positivity, according to recent results.

    Researchers collected data on patients in the National Veterans Affairs HCV Clinical Case Registry who were tested for HCV between 1997 and 2005. The cohort included 168,239 people exposed to HCV and tested for HBV.

    Patients with records indicating two positive HCV tests, or one test and an ICD-9 code for HCV were considered exposed; those with positivity for HCV RNA or a genotype were classified as infected. Patients with positive test results for hepatitis B surface antigen (HBsAg), HBV DNA, hepatitis B e antigen (HBeAg) or hepatitis B core or Be antibodies were considered exposed. Those with a positive HBsAg, HBV DNA or HBeAg test within 1 year of HCV diagnosis were considered coinfected.

    HBV exposure occurred in 34.7% of the cohort. HCV infection was observed in 102,971 patients, 1.4% of whom were HBV coinfected.

    Factors independently associated with HBV/HCV coinfection included patients aged 50 years or younger (OR=0.77; 95% CI, 0.69-0.86 for patients aged 51 to 64 years and OR=0.5; 95% CI, 0.36-0.69 for 65 years and older), male sex (OR=1.76; 95% CI, 1.17-2.64), HIV positivity (OR=2.03; 95% CI, 1.72-2.38), cocaine and other drug use (OR=1.23; 95% CI, 1.09-1.40 for cocaine), having undergone blood transfusion (OR=1.63; 95% CI, 1.28-2.08) and having sicklemia, hemophilia or thalassemia (OR=1.95; 95% CI, 1.04-3.68). Investigators said Hispanics were at reduced risk for coinfection (OR=0.68; 95% CI, 0.51-0.92 vs. Caucasians).

    “This is the largest study in the US to examine the prevalence and predictors of HBV coinfection in a cohort of patients with HCV,” the researchers wrote. “Based on these findings, all patients with HCV exposure should be tested for HBV. Additionally, this study identified risk factors more frequent in patients with HBV coinfection than HCV mono-infection. These predictors of HBV coinfection can be used to target screening and prevention programs to those individuals who may be at greatest risk for coinfection.”

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