November 30, 2010

The World's Illuminated in Red for World AIDS Day

By Shyla Batliwalla
Tuesday, November 30, 2010 6:05 PM ET

Eighty monuments around the world will turn red in support of the (RED) campaign's 2015 goal to have zero children born infected with HIV.

There are currently over 33 million people worldwide living with AIDS. In 2009, nearly half a million babies were born HIV positive; 90 percent of those babies were in Africa. While these statistics might seem grim, there is hope. With proper treatment, spreading HIV to an unborn baby is 99 percent preventable.

Wednesday, Nov. 1 is World AIDS Day. Governments around the world are gearing up to show their support and commitment to ending the AIDS pandemic. In honor of the ongoing fight, over one dozen countries will light up 80 of the most famous landmarks on the planet to promote awareness.

This global movement is sponsored by (RED), an organization that brings together key international corporations to raise funds for HIV/AIDS prevention programs in Africa. Brands like Nike, Starbucks, Gap, American Express and Armani create and sell products exclusively for the (RED) campaign. Fifty percent of the proceeds generated from sales are donated directly to (RED).

Since its inception in 2006, (RED) has generated over $150 million towards the fight against AIDS. The World AIDS day campaign underlines their achievable goal to end mother-to-child transmission of HIV by 2015. When this goal is realized, the first AIDS free generation in 30 years will be created.

As evening sets in Sydney, Australia, the iconic Opera House will be illuminated in red with U2's Bono kicking off the campaign. Time zone by time zone, similarly significant attractions will turn red for just one night. From Table Mountain in South Africa and the London Eye in London to the Empire State Building in New York and LAX in LA, on Wednesday the world will see red as a symbol of hope that an end to the fight against AIDS is near.

(RED) CEO Susan Ellis said, "This is a time of great hope and promise in the battle against AIDS, because we are on the verge of ensuring that virtually no child will come into the world carrying the burden of HIV. Our World AIDS Day awareness campaign, 'The AIDS Free Generation is Due in 2015' is a reminder to everyone that we must work together to overcome the financial challenges at this critical juncture and to keep the world focused on this issue and this achievable goal."

Show your solidarity on Global AIDS day by using Twitter, Facebook, FourSquare and MeetUp to send images and words of support. (RED) will be collecting the data on a map to show how the world is united in the fight against AIDS. With enough support, (RED)'s goal to have zero children born with HIV in 2015 will become a reality.


Study finds anti-microbials a common cause of drug-induced liver injury and failure

Public release date: 30-Nov-2010

Contact: Dawn Peters

Disproportionate number of women and minorities affected

New research shows that anti-microbial medications are a common cause of drug-induced liver injury (DILI) leading to acute liver failure (ALF), with women and minorities disproportionately affected. While ALF evolves slowly, once it does occur a spontaneous recovery is unlikely; however liver transplantation offers an excellent survival rate. Full findings of this ten-year prospective study are published in the December issue of Hepatology, a journal of the American Association for the Study of Liver Diseases.

Patients with liver failure resulting from DILI may experience deep jaundice, fluid retention, advanced coagulopathy and coma. More than 1100 drugs, herbal remedies, natural products, vitamins, minerals, dietary supplements, and recreational and illicit compounds are known to cause liver injury, which reportedly affect 1 in 100,000 to 1 in 10,000 patients. Prior research shows DILI is a frequent cause of hepatitis, and accounts for 5%-10% of hospitalizations for jaundice and 12% of all cases of ALF (excluding acetaminophen).

In the current study, researchers investigated liver injury and failure caused by drugs other than acetaminophen. Detailed case reports were collected from 1,198 subjects with ALF enrolled at 23 sites participating in the National Institutes of Health-funded Acute Liver Failure Study Group, led by Principal Investigator, William M. Lee, M.D., from the University of Texas Southwestern Medical Center in Dallas, TX. Researchers identified 133 patients with DILI with 71% of those cases in women.

"Our findings confirm prior medical evidence that found a high female predominance in DILI ALF, suggesting that women may be more susceptible to liver injury or use more prescription drugs than men," said Dr. Adrian Reuben, Professor of Medicine at the Medical University of South Carolina and lead study author.

Furthermore, the research team documented a disproportionately high number of minorities with DILI ALF, including African-American (16%), Hispanic (15%) and other minority groups (12%). "We observed inexplicably high numbers of minority patients with DILI ALF. This racial disparity is atypical for acetaminophen-induced ALF in the U.S. and further studies should explore this discrepancy," commented Dr. Reuben.

Researchers identified 61 different agents that, alone or in combination, could cause liver injury and failure in the study population. Anti-microbial agents were found to be the most common cause of DILI ALF cases and included anti-tuberculosis drugs (25), sulphur-containing drugs (12), nitrofurantoin (12), other antibiotics (7), antifungal agents (6), and anti-retroviral drugs (4). Patients who develop ALF after taking these drugs typically do not experience a spontaneous recovery—the transplant-free survival rate in this study was 27%.

There were 56 eligible subjects who underwent liver transplantation of whom all but four survived, giving an overall survival for the entire cohort 66.2%. The authors highlight that the 23.3% of transplantation waitlist deaths attest to the urgent need for donor organs in this setting. "Liver transplantation offers excellent survival for ALF patients, however further investigation should include more detail on drug use duration, and the impact of alcohol use and diabetes, to provide additional understanding of idiosyncratic drug-induced liver injury and failure," Dr. Reuben concluded.


Article: "Drug-Induced Acute Liver Failure: Results of a United States Multicenter, Prospective Study." Adrian Reuben, David G. Koch, William M. Lee and the Acute Liver Failure Study Group. Hepatology; Published Online: October 14, 2010 (DOI: 10.1002/hep.23937); Print Issue Date: December 2010.

This study is published in Hepatology. Media wishing to receive a PDF of this article may contact

About the Journal

Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit

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Mymetics HIV Vaccine Shows Strong Preliminary Phase I Data


Nov. 30, 2010, 8:10 a.m. EST

HIV-1 Vaccine Designed to Block Early Transmission and Infection Events, Preventing Virus From Settling and Spreading Within the Body; In Phase I Trial, Vaccine Generated Both Serum Antibodies and Mucosal Antibodies in the Genital and Intestinal Tracts

EPALINGES, SWITZERLAND, Nov 30, 2010 (MARKETWIRE via COMTEX) -- Mymetics Corporation /quotes/comstock/11k!mymx (MYMX 0.13, +0.01, +8.33%) , a pioneer in the development of vaccines preventing mucosal transmission of human infectious diseases, announced today strong preliminary results of a Phase I trial on its promising HIV vaccine, MYMV101. Unlike most current vaccines, seeking to eliminate pathogens once they have already entered the bloodstream, Mymetics' vaccines are designed to block early transmission and infection events, preventing virus from settling and spreading within the body. This represents a highly promising but, until now, poorly investigated approach to preventing HIV infection.

The Phase I trial was conducted on 24 healthy women. The vaccine was well tolerated and immunogenic in both low and high dose vaccinated groups. The majority of volunteers developed not only serum antibodies but also mucosal antibodies in the genital and intestinal tracts.

"These new results represent a major achievement for Mymetics," commented Sylvain Fleury, CSO of Mymetics. "Very few HIV vaccine candidates developed over the last 25 years could elicit both blood and mucosal antibodies as a front-line defense mechanism against the entry of HIV-1 across mucosal tissues."

Jacques-Francois Martin, CEO of Mymetics, added, "Our vaccine represents a first line of defense before the virus can settle in the tissue and spread within the body. These preliminary Phase I results in HIV-1/AIDS represent an important validation of our pioneering work and approach. They also confirm a previous preclinical study where the vaccine provided unprecedented 100% protection in primates."

The Phase I trial, started in December 2009, is a placebo-controlled, double-blind, single-site study, conducted by Prof. G. Leroux-Roels at the Center for Vaccinology (CEVAC) at the University of Ghent (Belgium), under the supervision of Kinesis-Pharma, a CRO under contract with Mymetics. During the vaccination, women received high or low dose vaccinations. The first two injections were performed intra-muscularly and the last two via intra-nasal spray. The final clinical report is expected in January 2011, which will then also include the analysis of the neutralizing characteristics of the antibodies.

HIV-1, the virus that causes AIDS, is primarily transmitted through sexual contact, exposing the mucosal tissues of the genital organs as the first entry door for the virus before it reaches the blood. HIV-1 infected about 2.7 million new people in 2008, while an estimated 2 million people died of AIDS in the same year. HIV-1-related illness remains one of the leading causes of death globally and is projected to remain a significant cause of premature mortality in the coming decades.

Mymetics' vaccine strategy The vast majority of pathogens enter their target hosts through mucosal surfaces such as the respiratory, genito-urinary or gastrointestinal tracts. Once they have reached the blood, pathogens can migrate to various organs where they replicate. Most current vaccines seek to eliminate pathogens once they have already entered the bloodstream, by which time control of the pathogen can be significantly more challenging (e.g. HIV-1). Classical vaccines work by inducing mostly blood antibodies (mainly IgG) and are poor at triggering the antibodies that predominate in all mucosal tissues (mainly IgA).

Mymetics has created a vaccine against HIV-1, using its virosome technology and judicious antigen design. The vaccine primarily induces mucosal antibodies, preventing HIV-1 attachment to epithelial cells and providing an efficient first line of defense on mucosal surface such as the genital tract. The vaccine also induces blood antibodies, which will ideally function as a complementary second line of defense. By minimizing homology between the vaccine and native human proteins, Mymetics further aims to avoid auto-immune complications resulting from cross-reactivity.

About CEVAC The Center for Vaccinology (CEVAC) is an academic research unit affiliated with Ghent University and located in the Ghent University Hospital (Ghent, Belgium), and that provides a wide array of services to the biotech industry and vaccine manufacturers. CEVAC conducts Phase I, II and III clinical vaccine trials according to ICH-GCP standards and offers a panel of laboratory services in the field of immunology and vaccinology, such as serological tests, cytokine measurements, B and T lymphocyte detection and function assays. More information can be retrieved at

About Kinesis Kinesis Pharma B.V. (founded 1997) is an independent, privately owned drug development consultancy and contract research organization. Kinesis operates internationally with headquarters in Breda (The Netherlands) and a regional office in Singapore. The organization leverages the expertise and experience of its highly-skilled, multi-disciplinary workforce to accelerate drug development. Kinesis Pharma facilitates fast and high quality development and registration of medicinal products with consultancy services in Chemistry, Manufacturing and Control- (CMC), non-clinical- and clinical development and regulatory support. Kinesis operates in close collaboration with pharmaceutical, nutraceutical and biotech companies and has successfully managed the development and registration of pharmaceutical and biotechnology-derived products in different therapeutic areas, including infectious diseases.

About Mymetics Mymetics Corporation is a Swiss-based biotechnology company registered in the US /quotes/comstock/11k!mymx (MYMX 0.13, +0.01, +8.33%) developing next-generation preventative vaccines for infectious diseases. Mymetics' core technology and expertise are centered on the use of virosomes, lipid-based carriers containing functional fusion viral proteins, in combination with rationally designed antigens. The company's vaccines are designed to induce protection against early transmission and infection, focusing on the mucosal immune response as a first-line defense, which for some pathogens may be essential for the development of an effective vaccine. Mymetics is led by an experienced, international management team and is supported by a strong Scientific Advisory Board composed of renowned experts. The company has established contacts with world leaders in vaccine development.

Mymetics currently has 5 vaccines in its pipeline: HIV-1/AIDS, Influenza, Respiratory Syncytial Virus, Malaria and Herpes Simplex Virus. The company's HIV vaccine is entering a new proof-of-concept preclinical trial following unprecedented results in a first study, and is completing a Phase I clinical trial in human volunteers. A Phase 1b clinical trial for its Malaria vaccine on children in Tanzania has been completed, while RSV and HSV vaccine candidates are in the preclinical phase. The Influenza vaccine has been out-licensed to Solvay Pharmaceuticals (now Abbott). For further information, please visit

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The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements, which are identified by the words "believe," "expect," "anticipate," "intend," "plan" and similar expressions. The statements contained herein which are not based on historical facts are forward-looking statements that involve known and unknown risks and uncertainties that could significantly affect our actual results, performance or achievements in the future and, accordingly, such actual results, performance or achievements may materially differ from those expressed or implied in any forward-looking statements made by or on our behalf. These risks and uncertainties include, but are not limited to, risks associated with our ability to successfully develop and protect our intellectual property, our ability to raise additional capital to fund future operations and compliance with applicable laws and changes in such laws and the administration of such laws. See Mymetics' most recent Form 10-K for a discussion of such risks, uncertainties and other factors. Readers are cautioned not to place undue reliance on these forward- looking statements which speak only as of the date the statements were made.Contact:

Ronald Kempers
Mymetics Corporation
Tel: +41 21 653 4535

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Linnden Communications
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On Eve of World AIDS Day, UNICEF Report Says Virtual Elimination of Pediatric HIV/AIDS Appears Within Reach

WASHINGTON, Nov. 30, 2010 /PRNewswire-USNewswire/ -- As the world prepares to commemorate World AIDS Day on December 1, UNICEF released their report, "Unite for Children, Unite Against AIDS," declaring that the achievable goal of eliminating HIV infections in children is the new global measure of success in the fight against pediatric AIDS.

Children and AIDS: Fifth Stocktaking Report, 2010 offers key insights into the changing landscape of HIV/AIDS prevention, care, and treatment for children, and documents that those on the frontlines of the epidemic have turned a significant corner in scaling-up prevention of mother-to-child transmission (PMTCT) of HIV services worldwide.

"The momentum of the global health community behind the elimination of pediatric HIV and AIDS should be applauded," said Charles Lyons, President and CEO of the Elizabeth Glaser Pediatric AIDS Foundation. "We must build on our success, scale-up what we know works, and encourage new innovations to overcome even the greatest of obstacles."

The UNICEF report highlighted that while overall progress is real and should be recognized, many challenges remain. Although a majority of HIV-positive pregnant women in low- and middle-income countries are receiving antiretroviral (ARV) drugs to prevent transmission of the virus to their infants, the report suggests that all pregnant women living with HIV must have access to the more complex drug regimens called for under the new World Health Organization (WHO) guidelines for PMTCT. Implementing and sustaining these benefits worldwide will require full integration of PMTCT services within national maternal and child health programs.

The report also cites significant gains in PMTCT coverage, but also notes that only one-third of infants born to HIV-positive mothers receive ARVs to prevent transmission, increasing only slightly from 2008. Significant improvements are needed for mothers and mother-baby pairs to ensure that services continue during breastfeeding, all babies are tested early for HIV, and every HIV-infected infant get onto therapy as soon as possible.

Pioneering solutions must also be employed to better engage communities and create demand for these services and ensure that women and babies remain in care. While the goal is to have every woman deliver in a health facility, obstacles such as severe weather or lengthy travel distances often result in women delivering their babies at home. As a way to overcome some of these issues, the Elizabeth Glaser Pediatric AIDS Foundation joined with UNICEF last month to launch the Mother Baby Pack (MBP). Created to tackle logistical challenges in delivering critical medicines to pregnant mothers and their newborn babies, the MBP is given to mothers during their first prenatal visit, and contains the antiretroviral drugs (ARVs) and prophylactic antibiotics needed to prevent HIV transmission from mother to baby.

"There are still more than 1,000 babies newly infected with HIV every day. Virtually every one of those infections is preventable," said Lyons. "Reaching mothers and babies around the world with the services they need to prevent the spread of HIV is not only the right thing to do, it will also help us realize a generation born free of HIV."

About the Foundation:

The Foundation is a global leader in the fight against pediatric HIV and AIDS, and has reached nearly 10 million women with services to prevent transmission of HIV to their babies. It works at 5,000 sites in 17 countries to implement prevention, care, and treatment services; to further advance innovative research; and to execute strategic and targeted global advocacy activities in order to bring dramatic change to the lives of millions of women, children, and families worldwide.

SOURCE Elizabeth Glaser Pediatric AIDS Foundation



Walgreens and Greater Than AIDS Mark World AIDS Day with Commitment to Outreach, Education and Accessibility


Nov. 30, 2010, 11:00 a.m. EST

More than 800 Walgreens pharmacists specially trained to help patients living with HIV/AIDS

DEERFIELD, Ill., Nov 30, 2010 (BUSINESS WIRE) -- Walgreens (NYSE, NASDAQ: WAG) is marking World AIDS Day with an increased commitment to HIV/AIDS outreach, education and accessibility by partnering with Greater Than AIDS, a national movement that brings together the public and private sectors in response to the HIV/AIDS crisis in the United States.

On Dec. 1, World AIDS Day, Walgreens will kick off its collaboration with Greater Than AIDS by streaming HIV messaging on the Walgreens digital board that rises 341 feet above midtown Manhattan in New York's Times Square. In addition, more than 200 Walgreens drugstores in heavily-affected communities across America are debuting new signage and informational materials that carry a Greater Than AIDS message. All materials encourage customers to learn more about HIV and ways they can be Greater than AIDS by going to In June 2011, Walgreens will team up with Greater Than AIDS to support "HIV Take Action" Month with special promotions, and participating Walgreens pharmacies will offer in-store services -- including HIV testing. And throughout the year, Walgreens digital billboards in Times Square and Las Vegas will post photos submitted by every day Americans that celebrate personal "deciding moments" in response to HIV/AIDS.

"Pharmacists are some of the most trusted health care professionals in the nation," said Walgreens president of pharmacy services Kermit Crawford. "It's our job to not only provide information about medication options but to also listen to patient needs. Our pharmacy staff will help play a large role in our effort with Greater Than AIDS to promote HIV/AIDS awareness and prevention, especially among African Americans and other disproportionately affected groups."

"What is particularly powerful about the partnership between Greater Than AIDS and Walgreens is that it brings HIV information to people where they live, along with other health issues," said Drew Altman, Ph.D., president and CEO of the Kaiser Family Foundation, which provides direction to Greater Than AIDS.. "Walgreens is setting a powerful example of corporate leadership by putting its brand and vast retail footprint behind an issue of such public health importance."

More than 800 Walgreens pharmacists at retail and medical facility locations across the country and call centers are specially trained to help patients living with HIV/AIDS. Over the next year, Walgreens plans to add another 150 locations that offer special HIV/AIDS services. Online, patients can find more HIV/AIDS information regarding treatment, medications and support services at

Last May, Walgreens joined the Global Business Coalition (GBC) on HIV/AIDS, Tuberculosis and Malaria, bringing its experience as a trusted pharmacy, health and wellness provider to the leading business movement on global health. GBC brings together businesses across various sectors to help fight global epidemics. As a resource for those impacted by HIV/AIDS, Walgreens is actively driving awareness around medication adherence, sensitivity and support through local outreach from its network of more than 7,600 community pharmacies and partnerships with local organizations across the country.

About Walgreens

Walgreens ( is the nation's largest drugstore chain with fiscal 2010 sales of $67 billion. The company operates 7,608 drugstores in all 50 states, the District of Columbia and Puerto Rico. Each day, Walgreens provides nearly 6 million customers the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice in communities across America. Walgreens scope of pharmacy services includes retail, specialty, infusion, medical facility and mail service, along with pharmacy benefit solutions and respiratory services. These services improve health outcomes and lower costs for payers including employers, managed care organizations, health systems, pharmacy benefit managers and the public sector. Walgreens Take Care Health Systems subsidiary is the largest and most comprehensive manager of worksite health centers and in-store convenient care clinics, with more than 700 locations throughout the country.

About Greater Than AIDS

Greater Than AIDS ( is an unprecedented collaboration among a broad coalition of public and private sector partners united in response to the HIV/AIDS crisis in the United States, in particular among Black Americans and other disproportionately affected groups. Through a national media campaign and targeted community outreach, Greater Than AIDS aims to increase knowledge and understanding about HIV/AIDS and confront the stigma surrounding the disease.

SOURCE: Walgreens

Vivika Vergara, (847) 914-2923


Pharmasset Initiates Dosing in a Combination Study of PSI-7977 and PSI-938 for Chronic Hepatitis C

- Phase 1 combination study of a pyrimidine (PSI-7977) and purine (PSI-938) nucleotide analog in patients with chronic hepatitis C

- Interim data expected in first quarter of 2011

PRINCETON, N.J., Nov. 30, 2010 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that dosing has begun in Part 2 of a Phase 1 study. This is the first clinical study combining a purine (PSI-938) and a pyrimidine (PSI-7977) nucleotide analog for HCV, and is designed to evaluate once daily doses of PSI-7977 and PSI-938 in patients with HCV who have not been treated previously.

"We are excited to be initiating this combination study with two proprietary nucleotide analogs for HCV," stated Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "Based on our in vitro data, we believe the combination of two nucleotide analogs could provide potent antiviral activity across multiple HCV genotypes and could also have a higher barrier to resistance compared to other DAA combinations. We believe nucleotide analogs have a number of key attributes that may make them ideal partners for other DAA combinations, in addition to a 'nuc-nuc' combination."

About the Phase 1 Trial

In Part 1 of the Phase 1 multiple ascending dose study of PSI-938, suppression of HCV RNA below the limit of detection (LOD, <15 IU/mL) was observed in over half of the patients who received PSI-938 at daily doses of 200 mg or 300 mg for seven days. Part 2 of the study is designed to evaluate the combination of PSI-938 and PSI-7977. The primary objective is to assess the safety, tolerability and pharmacokinetics of PSI-938 administered alone for 14 days, and in combination with PSI-7977 for 7 to 14 days. The secondary objective is to evaluate viral kinetics of HCV RNA during monotherapy and combination nucleotide dosing. Approximately forty patients are expected to be enrolled into four cohorts as follows:

• PSI-938 QD administered as monotherapy for 14 days, followed by;

• PSI-938 QD for 7 days followed by PSI-938 plus PSI-7977 QD for 7 days and

• PSI-7977 QD for 7 days followed by PSI-938 plus PSI-7977 QD for 7 days, followed by;

• PSI-938 plus PSI-7977 QD for 14 days

We expect to report preliminary results from Part 2 of this Phase 1 study during the first quarter of calendar year 2011. We also expect to initiate a Phase 2 study of PSI-938 in combination with PSI-7977 during mid-2011. This Phase 2 study proposes to explore durations of PSI-938 and PSI-7977 in interferon-free combinations with an SVR endpoint.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have four clinical-stage product candidates. RG7128, a cytosine nucleoside analog for chronic HCV infection, is in two Phase 2b clinical studies in combination with Pegasys(R) plus Copegus(R) and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys(R) and Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage HCV candidates include PSI-7977, an unpartnered uracil nucleotide analog that has recently initiated dosing in a Phase 2b study in patients with HCV genotypes 1, 2, or 3, and PSI-938, an unpartnered guanosine nucleotide analog which recently completed a 7-day monotherapy study. We also have in our pipeline an additional purine nucleotide analog, PSI-661, in advanced preclinical development.

Pegasys(R) and Copegus(R) are registered trademarks of Roche.

Richard E. T. Smith, Ph.D.
VP, Investor Relations and Corporate Communications
Office +1 (609) 613-4181

Forward-Looking Statements

Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.

SOURCE Pharmasset, Inc.



Research Shows Small Percentage Of Healthcare Professionals Still Reusing Syringes, Performing Injections In Ways That Put Patients At Risk

Article Date: 30 Nov 2010 - 2:00 PST

Although the majority of U.S. healthcare professionals are following recommended safe injection practices, some are putting patients at risk through the reuse of syringes and single-dose vials, according to a peer-reviewed study authored by the Premier healthcare alliance in December's American Journal of Infection Control.

Increasing reports of outbreaks of hepatitis B and C viruses and bacterial infections - more than 50 outbreaks nationwide - have resulted in infections in hundreds of patients and more than 100,000 have potentially been exposed. The majority of these outbreaks resulted from unsafe injection practices and lapses in basic infection control and aseptic technique.

Premier surveyed 5,500 U.S. healthcare professionals to gain a fuller understanding of current injection practice patterns and to guide outreach, education and prevention efforts. Results showed that:

-- Six percent, or 318, "sometimes or always" use single-dose/single-use vials on more than one patient;

-- Nearly 1 percent, or 45, "sometimes or always" reuse a syringe, only changing the needle for use on a second patient; and

-- Fifteen percent, or 797, reported reuse of a syringe to enter a multi-dose vial.

- Of this group, 6.5 percent, or 51, reported saving vials for use on another patient, representing approximately 1 percent of all respondents.

- Half of the 51 reported working in hospital settings, and the other half reported working in non-hospital settings such as ambulatory surgical centers and physician offices.

Dr. Joseph Perz of the Centers for Disease Control and Prevention (CDC) said, "The survey revealed that a dangerous minority of providers engage in unsafe practices such as syringe reuse. This is not acceptable. Safe practice is not optional; it's a basic expectation anywhere injections are delivered."

CDC guidelines recommend that single-dose vials should not be used for multiple patients. The guidelines also recommend syringes and needles should be used only once, not reused for another patient or to access a medication or solution that might be used for a subsequent patient.

For example, when a syringe is reused to draw up additional medication for a single patient, the medication vial becomes contaminated. Any subsequent use of either the syringe or the vial on another patient places that second patient at risk of infection.

Premier's study confirms that confusion regarding labeling of medication vials, lack of awareness and education about safe practices, and mistaken beliefs about the risks associated with syringe reuse all contribute to the problem

"Reducing risk to patients from unsafe injection practices will require surveillance, oversight, enforcement, and provider and patient education," said Gina Pugliese RN, MS, vice president of the Premier Safety Institute® and co-author of the study. "Most important will be the safety culture of the organization to empower patients to speak up and healthcare professionals to take responsibility for preventing colleagues from engaging in unsafe practices."
Premier also recommends reducing risks through partnerships among professional, governmental and non-governmental organizations with a focus on the redesign of devices, products and processes.
Evelyn McKnight was one of 99 patients who became infected with the hepatitis C virus at an oncology clinic in Fremont, Neb.

"I was infected during chemotherapy for breast cancer due to healthcare professionals not following safe injection practices," said McKnight, president and co-founder of the Hepatitis Outbreaks National Organization for Reform (HONOReform), a national advocacy organization dedicated to safe medical injections for patients. "This survey sheds light on the extent of unsafe practices and the need for a collaborative effort to solve this problem."

HONOReform and Premier are members of the Safe Injection Practices Coalition (SIPC), a collaborative partnership of healthcare-related organizations that promote safe injection practices in all U.S. healthcare settings. SIPC developed the One & Only Campaign, a public health education and awareness program aimed at educating healthcare providers and patients about safe injection practices. A free educational video for healthcare providers, developed by SIPC, is also available from Premier.

Organizations which shared this survey with their members: American Academy of Anesthesiologist Assistants; Accreditation Association for Ambulatory Health Care; American Association of Critical-Care Nurses; American Society of Health-System Pharmacists; Association for Professionals in Infection Control and Epidemiology; Infusion Nurses Society; Pittsburgh Regional Health Initiative; Society for Healthcare Epidemiology of America; Society of Gastroenterology Nurses and Associates; and Innovatix.

Source: Premier healthcare alliance


Caleco Pharma Corp. Files Amendment To EU Patent Office Application


Nov. 30, 2010, 9:04 a.m. EST

Amendments Strengthens Proposed Claims Relating to Compounds Exhibiting Anti-Viral Activity

LONG VALLEY, NEW JERSEY, Nov 30, 2010 (MARKETWIRE via COMTEX) -- Caleco Pharma Corp. ("Caleco") /quotes/comstock/11k!caeh (CAEH 0.06, -0.02, -20.00%) (frankfurt:T3R)(wkn:A0N9Y0) (, a diversified healthcare company with biopharmaceutical and consumer health product development programs that develop products derived from natural sources such as plant extracts, today reports that it has amended its intellectual property (IP) filing with the European Patent Office in The Hague to further secure and strengthen Caleco's anti-viral pipeline.

In response to the EU Patent Office's Examination Report, Caleco reports that the company's European Patent Application number 08725530.3 is amended with regard to compositions comprising derivatives and derivative combinations of Lamiridosin and Iridoid for treatment of Hepatitis C. The molecular specifications required in these amendments resulted in the exclusion of certain derivative claims. However, these claims will not be abandoned, but instead, these claims will be pursued through one or more divisional applications.

John Boschert, Caleco's CEO, said, "By amending our filing we are seeking to solidify our intellectual property position in the billion dollar Hepatitis C and anti-viral marketplace. We plan to continue to pursue a broader pipeline of semi-synthetic derivatives that will be prepared for further testing in 2011. The Hepatitis C patient population remains greatly underserved by existing treatment options and we are eager to move these compounds into the next stage of development."

About Caleco Pharma Corp.

Caleco is focused on the ongoing research and development of its pipeline of over-the-counter and prescription medications including its proprietary antiviral and "Liver Health" OTC formulations. In addition Caleco is developing Dermatological Products based on the active ingredients found in its proprietary formulation. Caleco's intellectual property covering the Liver Health formulations and derivatives consists of patent applications in the United States, Europe and Canada and four European Drug Master File applications.

Caleco's shares are traded in the United States on the OTC Bulletin Board /quotes/comstock/11k!caeh (CAEH 0.06, -0.02, -20.00%) and in Germany on the Frankfurt Stock Exchange (frankfurt:T3R)(wkn:A0N9Y0).

This press release may contain, in addition to historic information, forward-looking statements. These statements may involve known and unknown risks and uncertainties and other factors that may cause the actual results to be materially different from the results implied herein. In particular, there are no assurances that: (i) the United States Patents and Trademarks Office and the European Union Patent office will grant Caleco a patent in connection with its current patent applications; (ii) Caleco will be able to manufacture and produce its products or that its products will be effective; (iii) Caleco Pharma Europe will be able to successfully distribute Lamiridosin in Europe; (iv) Caleco will be able to carry out any pre-clinical or clinical trials of its products; (v) Caleco will be able to obtain additional financing in order to meet the costs of the clinical studies of the "Liver Health" formulation; and (vi) Caleco will be able to control the costs of the clinical studies of the "Liver Health" formulation. Readers are cautioned not to place undue reliance on the forward-looking statements made in this press release.


BlueWater Advisory Group - Investor Relations
Bryan Crane
Managing Director


Scoring system is 93 percent accurate for diagnosing Wilson's disease in pediatric patients

Public release date: 30-Nov-2010

Contact: Dawn Peters

Penicillamine challenge ineffective for detecting the disease in asymptomatic children

An Italian research team confirmed that the scoring system for Wilson's disease (WD) provides good diagnostic accuracy with 93% positive and 92% negative predictive values, respectively in children with mild liver disease. In asymptomatic children, a urinary copper excretion above 40 μg/24 hours was suggestive of WD, however the penicillamine challenge test (PCT) did not provide an accurate diagnosis in this patient subset. Results of the study appear in the December issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

WD is a rare genetic disorder where excessive amounts of copper accumulate in the liver, kidneys, brain, and eyes (cornea). Patients may experience a brown ring (Kayser-Fleischer ring) around the cornea of the eye, various liver diseases, slurred speech, and tremors, with symptoms appearing between the ages of 5 to 35. According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) approximately one in 40,000 individuals develop WD, which affects men and women equally.

A prompt diagnosis of WD is vital to avoid rapid progression of liver and neurological damage. "Unfortunately, diagnosis of WD is a challenging task, especially in childhood, because conventional criteria established for adults are not always appropriate for children," explained Raffaele Iorio, M.D., of the University Federico II in Italy and lead author of the study.

In order to evaluate the current standard diagnostic criteria and WD scoring system, the research team collected data on 40 children with WD and 58 children with liver disease other than WD, ranging in age from 1 to 21 years of age. Both groups were symptom-free with the predominant sign of liver disease being elevated aminotransferases (higher levels of enzymes from liver cells that when released into the blood, signify liver disease). Molecular analysis and liver copper content test were also performed to confirm the WD diagnosis.
Results showed the optimal urinary copper diagnostic was 40μg/24h which had a sensitivity of 79% and specificity of 88%. Researchers found no significant difference in urinary copper after PCT in either WD patients or control subjects. "The data found by Iorio et al. demonstrates that the current AASLD guideline approach to the diagnosis of WD—obtaining a slit lamp exam, a serum ceruloplasmin and a 24-hour urine copper followed by a liver biopsy in some patients—is useful even in young, clinically asymptomatic children," confirmed Dr. Michael Schilsky, Associate Professor of Medicine and Surgery at Yale University Medical Center, in his and Dr. Rosencrantz's editorial also publishing this month in Hepatology.

Dr. Iorio concluded, "Establishing a WD diagnosis in children with mild liver disease is often problematic. Our study determined that genetic diagnosis is critical and the WD scoring system is a reliable method of analysis for these pediatric patients."


Article: "Re-Evaluation of the Diagnostic Criteria for Wilson Disease in Children with Mild Liver Disease." Emanuele Nicastro, Giusy Ranucci, Pietro Vajro, Angela Vegnente, Raffaele Iorio. Hepatology; Published Online: October 21, 2010 (DOI: 10.1002/hep.23910); Print Issue Date: December 2010.

Editorial: "Mining for a Diagnosis of Wilson Disease in Children: Genetics, Score and Ore." Richard A. Rosencrantz and Michael L. Schilsky. Hepatology; Published Online: November 23, 2010 (DOI: 10.1002/hep.24054); Print Issue Date: December 2010.

These studies are published in Hepatology. Media wishing to receive a PDF of the articles may contact

About the Journal

Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit

About Wiley-Blackwell

Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit or our new online platform, Wiley Online Library (, one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.


November 29, 2010

The Faces of Hepatitis C

The Faces of Hepatitis C

You are a doctor or a nurse--You are a fifth grade grade teacher

Your skin is white or brown or black--you are Mecxican or Asian,
Caucasian,or African American

You are very old, have grandchildren,near the end of your golden

You are middle-aged--children grown and gone-ready to "enjoy"
your life --

You are a young mother with a small child-a young father trying to
provide for his family--

You are a teenager--waiting for proms,boy or girlfriends, your first
kiss dreaming of college and a car of your own--

You are a newborn lying in your mother's arms

YOU are the Faces of Hepatitis C

I may not recognize you as you pass me on the street or in the store
where I shop or the church where I worship, but you are there

The Faces of Hepatitis C

My heart cries out for you,for what fate has given you--it was not
your fault--it was just meant to be

My heart swells with pride for you--your courage,your faith--you
have been asked to keep going when others would have given

You wait anxiously for another loving person to give you the
"The Gift of Life"

The gift of their own liver at the end of THEIR life.
I am filled with love for each of you--my brother--my sister
and those I have met and those I will never know--

You see--I am one of those faces

The faces of Hepatitis

Given by God...written by Selles Dole

Selles lost her battle with HCV November 29, 2008

May You Always Sleep In The Arms Of Angels

FDA Approves Merit Medical's HiQuality Clinical Trial Protocol for the Treatment of Primary Liver Cancer

Nov 29, 2010 (GlobeNewswire via COMTEX) --

First large-scale multi-site U.S. study comparing doxorubicin-eluting QuadraSphere(TM) Microspheres to conventional chemoembolization

Interventional radiologists from U.S., Europe, South America participating in liver cancer study

SOUTH JORDAN, Utah, Nov. 29, 2010 (GLOBE NEWSWIRE) -- The Food and Drug Administration (FDA) has approved Merit Medical Systems, Inc.'s /quotes/comstock/15*!mmsi/quotes/nls/mmsi (MMSI 14.89, -0.06, -0.40%) phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere(TM) Microspheres (hqTACE) for delivery of doxorubicin. The clinical trial will involve U.S. and international interventional radiologists who treat patients with localized, unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer. The FDA action will result in the first phase 3 study in the U.S. comparing drug-eluting microspheres to conventional chemoembolization (cTACE) in the treatment of hepatocellular carcinoma. Currently in the U.S. there is no FDA-approved embolic for the treatment of liver cancer.

QuadraSphere is indicated for embolization of hypervascular tumors and peripheral arteriovenous malformations. The identical product marketed in Europe as HepaSphere Microspheres(TM) has been CE-marked in the European Union since 2007 for embolization of HCC and hepatic metastases, with or without delivery of doxorubicin.

"I am extremely pleased with the efforts of our BioSphere Regulatory and Medical Affairs Department headed by Dr. Melodie R. Domurad, PhD," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "We are very excited about the initiation of this important study."

Merit Medical is a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy. It has recently added the BioSphere microsphere products to its line of tumor treatment options.

The phase 3 study is a prospective, randomized, blinded and controlled investigation of HepaSphere/QuadraSphere Microspheres for delivery of doxorubicin for the treatment of hepatocellular cancer. Known as the HiQuality Study (HepaSphere/QuadraSphere in Liver Cancer Treatment), the primary endpoint of the clinical trial is survival. Secondary endpoints include tumor response by mRECIST criteria, safety, resource utilization such as length of hospitalization, and adverse events. The study will enroll 500 patients and be conducted in approximately 20 clinical sites in the U.S., Europe, and South America.

Dr. Riccardo Lencioni, who developed the guidelines for image acquisition and interpretation for the trial stated, "This study meets the highest standards for clinical research in hepatocellular carcinoma, as recommended in Design and Endpoints of Clinical Trials in Hepatocellular Carcinoma, guidelines for clinical research in HCC by an expert panel convened by the American Association for the Study of Liver Disease, and published in the Journal of the National Cancer Institute. The design of the investigation is rigorous, and has been extensively reviewed by the FDA."

Dr. Lencioni, M.D., Associate Professor of Radiology at the University of Pisa in Italy and Director of the Division of Diagnostic Imaging and Intervention at the Department of Hepatology and Liver Transplantation at the Pisa University Hospital, will be overseeing the central imaging review and evaluation of tumor response. Professor Lencioni is Chairman of the Membership Committee and a member of the Executive Committee of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) and Chairman of the Programme Committee of the European Conference on Interventional Oncology (ECIO). He is also a member of the Steering Committee of the World Conference on Interventional Oncology (WCIO). Professor Lencioni has been one of the founders of the International Liver Cancer Association (ILCA), and is a member of the Governing Board. Professor Lencioni has received more than 40 international awards; authored 134 articles or editorials; and is the editor of seven books. Professor Lencioni has served on the editorial board of Cardiovascular and Interventional Radiology, Investigative Radiology, European Radiology, Journal of Hepatology, Journal of Interventional Oncology, and La Radiologia Medica.

Michael Soulen, M.D. from the University of Pennsylvania Medical Center and Professor of Radiology specializing in Interventional Radiology, will direct the study as principal investigator. Active in the Society of Interventional Radiology (SIR), Dr. Soulen has served on the Executive Council, chaired the 1999 Annual Scientific Meeting, and acted as Director of Research Education for the SIR Foundation. He also serves on committees of the Radiological Society of North America (RSNA) and the American College of Radiology (ACR). Dr. Soulen chairs the steering committee of the World Conference of Interventional Oncology (WCIO). He is also an editorial board member and/or reviewer for numerous publications, including the Journal of Vascular and Interventional Radiology. He has published nearly100 peer-reviewed articles and more than 50 editorials, chapters and invited manuscripts.

About Liver Cancer

Liver cancer is the third leading cause of cancer deaths worldwide. The sharp rise in hepatitis C infections, alcohol consumption and obesity are reported as key contributing factors to the increase in liver cirrhosis and liver cancer. Liver transplantation or tumor resection is considered potentially a curative treatment; however, only about 25 percent of liver cancers are diagnosed when they can be treated surgically.

Surgical removal is not possible for more than two-thirds of primary liver cancer patients and 90 percent of patients with secondary liver cancer. According to the U.S. National Cancer Institute (NCI), no standard treatment currently exists for liver cancer when tumors cannot be surgically removed and liver transplantation is not a viable option. However, both the NCI and the Society of Interventional Radiologists (SIR) report that transarterial chemoembolization (TACE) has shown promising results.

hqTACE - Merit Advances Chemoembolization

Drug-eluting embolization treats hepatocellular carcinoma through the dual action of delivering chemotherapy into the tumors while also cutting off the blood supply that supports them. QuadraSphere adds two benefits to embolization therapy. First, by ionically binding the doxorubicin throughout the microspheres and eluting it into the cancer in a sustained manner, more drug can be delivered into the tumor, with less escaping into peripheral circulation. Complementary to the targeted delivery, QuadraSphere Microspheres have a unique formulation that makes them highly compressible and conformable, so they mold to the vessel lumen, creating both excellent contact with the vessel walls for delivery of chemotherapy and very efficient occlusion of the vessels feeding the tumor. Initial clinical results have demonstrated improved safety and reduced adverse events compared to treatment by conventional chemoembolization.

About Conventional Transarterial Chemoembolization (cTACE)

Conventional transarterial chemoembolization (cTACE) is a two-stage process involving the injection of chemotherapeutic drugs, typically emulsified with iodized oil, directly into the blood vessels that feed a tumor. The drug is followed by the delivery of an embolic agent used as a plug to block the tumor's blood supply and temporarily retain the cytotoxic drugs in place. However, the occlusion is limited in area and some of the chemotherapy still escapes into circulation, which leads to adverse effects.

About Merit

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 130 individuals. Merit employs approximately 2,170 people worldwide with facilities in Salt Lake City and South Jordan, Utah; Angleton, Texas; Richmond, Virginia; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Copenhagen, Denmark; and Rockland, Massachusetts.

The Merit Medical Systems, Inc. logo is available at

Statements contained in this release which are not purely historical are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit's Annual Report on Form 10-K for the year ended December 31, 2009. Such risks and uncertainties include risks relating to Merit's recent acquisition of BioSphere (including, without limitation, the risk that the operations of the two companies will not be integrated successfully; and the risk that Merit may be unable to successfully develop, commercialize and market new products and technology which Merit acquired through the acquisition); uncertainties associated with potential healthcare policy changes which may have a material adverse effect on Merit; possible infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; downturn of the national economy and the corresponding effect on Merit's revenues, collections and supplier relations; potential termination of supplier relationships, or failure of suppliers to perform; product recalls and product liability claims; delays in obtaining regulatory approvals, or the failure to maintain such approvals; Merit's inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through recent, proposed or future acquisitions, including without limitation the Endotek acquisition; concentration of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's products obsolete; market acceptance of new products; introduction of products in a timely fashion; price and product competition; availability of labor and materials; cost increases; fluctuations in and obsolescence of inventory; volatility of the market price of Merit's common stock; foreign currency fluctuations; changes in key personnel; work stoppage or transportation risks; modification or limitation of governmental or private insurance reimbursement policies; changes in health care markets related to health care reform initiatives; impact of force majeure events on Merit's business, including severe weather conditions; failure to comply with applicable environmental laws; and other factors referred to in Merit's Annual Report on Form 10-K for the year ended December 31, 2009 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.

This news release was distributed by GlobeNewswire,

SOURCE: Merit Medical Systems, Inc.

CONTACT: Merit Medical Systems, Inc.
Anne-Marie Wright, Vice President, Corporate Communications
(801) 208-4167
Fax: (801) 253-1688


Study Highlights Liver Health Risk in UK

Large numbers of people are putting liver health at risk as they shun visits to GP on alcohol related matters' says new study but new test can help. The LiverCheck test developed by YorkTest can be used at home and is an easy way to understand the health of your liver.

LEEDS, England, Nov. 25, 2010 /PRNewswire/ -- Growing groups of the so-called "worried well" are putting their lives at risk by shunning visits to their GP over alcoholic health related matters, according to new evidence.

The study, which appears in Hepatology, based its findings on 1039 UK subjects (561 female/478 male) who took a LiverCheck home liver function test and showed that 73% would not consider going to their GP concerning their liver health, revealing the extent to which people are putting themselves at risk from liver disease.

Luckily LiverCheck, the UK's only home-to-lab blood testing kit, is able to help. The test, which is available from YorkTest Laboratories, can test for levels of the two enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), which if found in high levels in the blood stream have been shown to increase higher risk of mortality.

Rajiv Jalan, Professor of Hepatology at University College London and co-author of the article says:

"This data confirms the medical importance of ALT and AST as a marker for premature mortality as a consequence of liver disease. Due to the nature of the illness, the symptoms only appear when irreversible damage has been done so a screening procedure to detect the early signs of liver damage is essential. A GP is always your first port of call but for some a self test does have a vital role to play in saving lives."

Further findings from the study also paint a worrying picture of the UK's current drinking habits with 44% admitting they drink alcohol on a daily basis. 26% also admitted they regularly consumed more than twice the government guidelines on safe drinking and with Christmas and New Year fast approaching it is thought that this figure could double.

It is hoped with the easy to use LiverCheck that people are able to understand their liver health helping to address a potentially life threatening problem which previously had been unavailable to thousands of people adversely affected by alcohol consumption.

The LiverCheck Liver Function Test is currently available from YorkTest for 99 pounds. YorkTest are based in York, West Yorkshire and specialise in home laboratory tests including food intolerance testing, allergy testing, homocysteine tests, and more. For more information visit

Dr. Gillian Hart
0800 074 6185



Therapeutic Acetaminophen Not Linked to Liver Injury in Children

Laurie Barclay, MD

November 29, 2010 — Hepatoxicity after therapeutic dosing of acetaminophen in children is rarely reported in defined-population studies, according to the results of a systematic review reported online November 22 in Pediatrics.

"Use of the drug has recently come under increased scrutiny by the Food and Drug Administration because of the increased recognition of the contribution of acetaminophen to acute liver injury globally," Dr. Laura James, section chief of clinical pharmacology and toxicology at Arkansas Children's Hospital and professor of pediatrics at University of Arkansas for Medical Sciences, told Medscape Medical News when asked for independent comment. "While most experts view acetaminophen to be safe when used as directed, there have been rare reports of toxicity occurring with recommended dosing of the drug. Individual susceptibilities in drug response and toxicity may occur with the use of any drug, including acetaminophen."

Eric J. Lavonas, MD, from Rocky Mountain Poison and Drug Center at Denver Health in Colorado, and colleagues systematically reviewed the medical literature to assess the rate at which liver injury has been reported for children prescribed therapeutic doses of acetaminophen, defined as up to 75 mg/kg per day orally or intravenously or up to 100 mg/kg per day rectally.

Studies in which acetaminophen was given to a defined pediatric population for at least 24 hours were identified from a search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials. Trained reviewers also searched these sources for all case reports of liver injury after therapeutic acetaminophen dosing and extracted data from each report. Major and minor hepatic adverse events (AEs) were defined prospectively, and the Naranjo algorithm allowed evaluation of causality.

Among 62 identified studies enrolling a total of 32,414 children, there were no reports (0%; 95% confidence interval [CI], 0.000 - 0.009) of a child showing signs or symptoms of liver disease, having received an antidote or liver transplantation, or having died. A total of 10 children were reported to have major or minor hepatic AEs (0.031%; 95% CI, 0.015 - 0.057), and the highest transaminase value reported was 600 IU/L, with Naranjo scores (2 - 3) suggesting "possible" causation. However, none of the children had other evidence of liver dysfunction.

Among 22 identified case reports, there were 9 cases in which the Naranjo score suggested "probable" causation. The investigators concluded that hepatoxicity after therapeutic dosing of acetaminophen in children is rarely reported in defined-population studies. Although case reports suggest that this phenomenon may occur, few reports contain sufficient data to support a probable causal relationship.

"The limitations of the report are that the study reviewed previously published studies that were not expressly designed to systematically collect laboratory measurements that would detect liver injury," Dr. James said. "The clinical signs and symptoms of liver injury can be subtle until significant liver injury is present. Acetaminophen is a drug with a narrow safety index and thus careful dosing of the drug is a necessity for safe use."

Other limitations noted by the study authors include imperfect indexing strategies of medical databases, publication bias, possible errors introduced by manual search, possible failure to detect liver inflammation in some children, lack of routine blood testing on children without signs or symptoms of liver injury in most studies, and possible differences in clinical trial participants from the general population of children who take acetaminophen. A major limitation that the reviewers pointed out is that incomplete safety reporting is common in published clinical trials.

The reviewers also warn that their findings should not be used to estimate the proportion of children taking acetaminophen who experience elevations in asymptomatic transaminase levels, because if routine screening had been performed in all studies, it would likely have revealed additional cases of hepatic enzyme elevation. They also note that threshold criteria used to define severe liver injury are arbitrary. Because few children in these studies received exactly 75 mg/kg per day of acetaminophen, and many did not receive the drug for longer than 3 to 5 days, this study has limited power to detect infrequent hepatic AEs associated with longer therapy and/or maximal therapeutic dosing.

"Pediatricians should continue to educate families and patients about the safe use of acetaminophen, including informing families about the widespread use of acetaminophen in many over-the-counter products and prescription pain medications," Dr. James concluded. "Ongoing studies will help determine the factors that may contribute to individual susceptibilities to acetaminophen-induced liver injury."

This review was internally funded. The Rocky Mountain Poison and Drug Center, Denver Health receives research funding from McNeil Consumer Healthcare, but the development and analysis of the database described in the review article was not supported by McNeil Consumer Healthcare. The study authors have disclosed no relevant financial relationships. Dr. James is the recipient of 2 National Institutes of Health grants for the study of acetaminophen toxicity. She also has a patent pending for the measurement of acetaminophen protein adducts in human blood samples.

Pediatrics. Published online November 22, 2010. Abstract


Immunitor Awarded the Key U.S. Patent Related to Oral Vaccine Technology Platform


Nov. 29, 2010, 7:38 a.m. EST

VANCOUVER, British Columbia, Nov 29, 2010 (GlobeNewswire via COMTEX) -- Immune Network Ltd. /quotes/comstock/11i!immff (IMMFF 0.03, +0.02, +194.12%) , advises that its potential acquisition, Immunitor USA Inc., has been issued a key patent by the U.S. Patent and Trademark Office (USPTO).

The patent (US 7,838,006 "Viral vaccine composition, process and methods of use") contains claims covering the composition of matter for Immunitor's lead product, V5. The patent also covers the process of making and use of the matter for treating and preventing the broad range of infectious diseases. Immunitor was previously awarded a U.S. patent covering another lead compound specifically designed for treatment of AIDS (US 7,384,637).

According to Vichai Jirathitikal, the principal inventor on these two patents, "The USPTO has validated the novelty and utility of Immunitor's technology and its use in the treatment and prophylaxis of a range of most diverse diseases and conditions." The co-inventor, Aldar Bourinbaiar, Immunitor's CEO, added: "With the issuance of these two patents, our lead programs are further protected, significantly enhancing their commercial value."

Over the course of the company's development, Immunitor has achieved a broad and deep intellectual-property position in the orally delivered immunotherapeutics area. The company's patent portfolio now includes more than eight pending patents (including two international), with at least two dozen scientific publications in the peer-reviewed medical literature describing various aspects of the technology in infectious and autoimmune diseases, cancer, and metabolic diseases such as atherosclerosis and obesity. The combined annual market for these and related indications is close to $100 billion.

Immunitor is the industry leader in tableted oral vaccines and immunotherapies. During the past three years Immunitor completed two phase II clinical trials using V5 for treatment of chronic hepatitis B and hepatitis C. This year Immunitor seized upon an unexpected clinical outcome, which revealed the intriguing potential of V5 in curing tuberculosis in almost 95% of patients within one month. The results of the first trial in patients with tuberculosis who were co-infected with hepatitis C virus and HIV were published in October issue of Journal of Vaccines and Vaccination ( Patient enrollment for two additional phase 2b placebo-controlled trials involving 120 patients with difficult-to-treat forms of tuberculosis has been just completed in Ukraine and results are anticipated in early 2011.

To date, all clinical trials of V5 have provided strong evidence of an excellent safety profile and provided insights into the unparalleled efficacy that will guide Immunitor in the design of follow-on hepatitis and tuberculosis studies, which are now being arranged in South Africa, Pakistan, India and China.

Immune Network is continuing its work toward meeting the pre-conditions for completion of a merger or similar transaction with Immunitor. Several aspects of the updated corporation and its anticipated transactions will be announced early in December 2010.

A temporary website for Immune Network is at The Immune Network Ltd. logo is available at  .

Safe Harbor Statement

The information in this release, other than historical information, may be considered forward-looking statements within the provisions of the Private Securities Litigation Reform Act of 1995. Projection and other forward-looking statements and management expectations regarding future events and/or financial performance of the Company -- although given in good faith -- are inherently uncertain and actual events and/or results may differ materially.

This news release was distributed by GlobeNewswire,

SOURCE: Immune Network Ltd

CONTACT: Immune Network Ltd


The Lesser-Known Complications of HIV/AIDS

Erin N. Marcus, MD
Posted: November 29, 2010 07:51 AM

At the age of 56, Jules Levin felt pretty invincible, despite being HIV positive. He went to the gym regularly and controlled his disease well by taking his antiretroviral medicines every day.

Then he slipped one day while on vacation and broke his wrist. He underwent an operation to insert pins in his bones and needed to wear a cast for a month, keep his arm elevated, and then do physical therapy for two months to get to the point where he could lift a five pound weight. "It was one of the most difficult things I've ever been through in my life," he said. "I ran, biked, lifted weights and now all of a sudden I couldn't turn the page of a newspaper. It just really got to me."

After a few simple tests, the reason for Levin's fracture became clear: His bones were weak from osteoporosis, a disease that's most commonly seen in older women, but that's also associated with HIV.

"The giddiness of the age of HAART is over," said Levin, referring to highly active antiretroviral therapy, the life-saving drug regimen prescribed to people with HIV. "We should have an aging clinic in every hospital that's serving HIV patients."

Osteoporosis is one of many conditions associated with old age that is now being seen with increasing frequency in people with HIV. Research suggests that long-term exposure to the virus, and to the inflammation it triggers, make people vulnerable to premature aging and to a host of conditions seen with aging, heart and kidney disease, dementia, and osteoporosis.

Additionally, the overall population of people with HIV is getting older, thanks to improved medical therapy. At present, 1 in 4 people with HIV is age 50 or older. The U.S. Senate Special Committee on Aging has predicted that half of all adults with HIV will be older than 50 by the year 2015. Over the past few years, the National Institute of Health has increased its funding for research on HIV and aging, and the White House hosted a conference on October 27 on HIV and aging.

"The evidence is pretty clear," said Levin, who directs The National AIDS Treatment Advocacy Project (NATAP), a New York-based HIV education and advocacy group. "We're going to see early frailty, early senescence and people are going to start dying at earlier ages."

Compared to other conditions associated with HIV and aging, osteoporosis is relatively straightforward to forestall and treat. To maintain bone strength, it's important for all people with HIV to make sure they are consuming an adequate amount of calcium and Vitamin D. A recent article in the journal Clinical Infectious Diseases recommends 1,000 to 1,500 mg of calcium and 800 to 1,000 IUs of Vitamin D daily, as well as at least 30 minutes of weight-bearing exercise, such as jogging or walking, at least three days a week. Calcium is plentiful in dairy products and sardines, and is available in supplements such as calcium carbonate and calcium citrate. The National Institutes of Health has an online information sheet listing ways to get calcium. It's also important to avoid smoking and heavy alcohol use, since these can cause osteoporosis.

HIV is thought to be associated with osteoporosis for a variety of reasons. The infection, itself, causes inflammation, which in turn impacts the cells that maintain bones. Many conditions common in people with HIV, such as Vitamin D deficiency, being underweight and low testosterone, are associated with osteoporosis. Antiretroviral therapy and other medications frequently prescribed to people with HIV, such as Prednisone, also cause bone loss.

Even though many antiretrovirals can cause bone loss, osteoporosis is not a reason to stop taking them. "Antiretroviral therapy is life-saving, and we know that stopping antiretroviral therapy is not a good strategy for preventing complications," said Dr. Todd Brown, an endocrinology specialist at Johns Hopkins University who co-wrote the article in Clinical Infectious Diseases.

Brown and his coauthors recommend that all HIV-positive men older than age 50 and women who are past menopause undergo testing for osteoporosis, since it's a condition that usually doesn't cause symptoms until the person breaks a bone. His own research has found that osteoporosis is "alarmingly" prevalent among African Americans in inner city Baltimore. "Because of the perception that osteoporosis is a white disease, people of color get short shrift for screening," he said. "This concept that African Americans are protected shouldn't be a reason to neglect them."

Once someone is diagnosed with osteoporosis, it's important to take action to prevent falling, such as removing clutter and slippery rugs from the floor. Physical therapy can help improve strength and balance, which also reduce the risk of a fall. The person also should get his or her vision checked and review his or her medication list with a doctor to try to minimize any drug side effects or interactions that might cause drowsiness or unsteadiness.

A class of medicines called bisphosphonates can improve bone strength, but do have some rare risks. "While they do decrease the risk of fracture, they're not totally benign drugs," Brown said. "On the flip side, you shouldn't not use them in the patient who is at high risk of a fracture."

Levin urges all people with HIV to be assertive about discussing osteoporosis and other age-related conditions with their doctor. "My guess is that 90 percent of patients know nothing about any of this and a lot of clinicians and case managers don't know about it either," he said. "Every patient should ask their clinician, 'are you aware, are you monitoring me for heart disease, diabetes, bone disease, cognitive impairment, kidney disease?' This is an important issue for everybody."

A similar version of this article originally appeared on the website of New America Media.


November 28, 2010

First-ever covalent irreversible inhibition of a protease central to hepatitis C infection

Public release date: 28-Nov-2010
Contact: Kathryn Morris
Yates Public Relations

Publication in Nature Chemical Biology demonstrates that irreversible covalent inhibition can increase selectivity, potency and duration of action, broadens applications for targeted covalent drugs to the protease gene family

WALTHAM, MA – November 28, 2010 – Avila Therapeutics™, Inc., a biotechnology company developing novel targeted covalent drugs, has published research in Nature Chemical Biology demonstrating the first-ever selective irreversible inhibition of a viral protease using a targeted covalent drug. In the paper titled "Selective Irreversible Inhibition of a Protease by Targeting a Non-Catalytic Cysteine", Avila used its proprietary Avilomics™ platform to design covalent irreversible protease inhibitors that are highly selective, potent and with superior duration of action as compared to conventional protease inhibitors.

Importantly, the published research demonstrates that covalent drugs can be designed and targeted to irreversibly and covalently bond to molecular domains specific to proteases. This is the first report of the irreversible covalent approach being successfully extended to proteases, a very broad class of proteins that includes many important potential drug targets.

"This research elevates covalent drug design to a fundamentally new level," said Simon Campbell, PhD, CBE, FMedSci, FRS, a renowned scientist and former Senior Vice President for Worldwide Drug Discovery and Medicinal R&D Europe of Pfizer. "By creating extremely selective protease inhibitors with their platform, Avila is showing the remarkable therapeutic potential of irreversible covalent drugs to address a broad spectrum of drug targets."

"This publication showcases the creation of a whole new class of small molecule drugs," said Juswinder Singh, PhD, Chief Scientific Officer of Avila and a co-author of the paper. "This approach can make a difference to patients living with HCV infection, and we expect to make an impact in other important areas such as cancer and inflammatory disease."

In order to maximize selectivity and minimize off-target effects, the irreversible covalent inhibitors of HCV protease were designed to covalently target a unique structure in the HCV protease not found in human proteases. Key findings include:

• A representative irreversible covalent inhibitor designed, by Avila, was shown to inhibit the HCV protease (also known as "NS3") in cells at a concentration of 6 nM .

• Specific covalent bond formation between the drug and target protease was demonstrated through use of mass spectrometry and also x-ray crystallography.

• Very high selectivity of the Avila compounds was demonstrated by showing no notable inhibition of a panel of human proteases in biochemical assays with additional specificity demonstrated in cellular assays; this was contrasted experimentally with Telaprevir, an HCV protease inhibitor in late-stage clinical testing which demonstrated off-target biochemical activity against several human targets.

Avila has subsequently optimized additional drug candidates, yielding current development candidates, AVL-181 and AVL-192, which have excellent pharmacokinetics and bind potently to wild- type HCV protease as well as multiple genotypes and mutant forms of HCV protease.


About Avila Therapeutics™, Inc.

Avila focuses on design and development of targeted covalent drugs to achieve best-in class outcomes that cannot be achieved through traditional chemistries. This approach is called "protein silencing". The company's product pipeline has been built using its proprietary Avilomics™ platform and is currently focused on viral infection, cancer and autoimmune disease. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners. For additional information, please visit


AASLD: Library of Slides and Posters

Coverage of the
61st Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD 2010)
October 29 - November 2, 2010, Boston, MA

Library of Slides and Posters

Efficacy and Safety of TMC435 in Combination With Peginterferon a-2a and Ribavirin in Treatment-naïve Genotype-1 HCV Patients: 24-Week Interim Results from the PILLAR Study
M Fried and others. AASLD 2010.

In vitro studies investigating the mechanism of interaction between TMC435 and hepatic transporters
M Huisman and others. AASLD 2010.

Virologic analysis of genotype-1-infected patients treated with once-daily TMC435 during the Optimal Protease inhibitor Enhancement of Response to TherApy (OPERA)-1 study
O Lenz and others. AASLD 2010.

A Phase IIa, open-label study to assess the antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2–6
C Moreno and others. AASLD 2010.

Pharmacokinetic-pharmacodynamic analyses of TMC435 in patients infected with hepatitis C virus genotypes 2–6
V Sekar and others. AASLD 2010.

4-Week Virologic Response and Safety of ABT-450 Given with Low-dose Ritonavir (ABT-450/r) First As 3-Day Monotherapy Then in Combination with Pegylated Interferon Alpha-2a and Ribavirin (SOC) in Genotype 1 (GT1) HCV-infected Treatment-naïve Subjects
E Lawitz and others. AASLD 2010.

Initial Antiviral Activity of the HCV NS3 Protease Inhibitor ABT-450 When Given with Low-dose Ritonavir as 3-Day Monotherapy: Preliminary Results of Study M11-602 in Genotype 1 (GT1) HCV-infected Treatment-naïve Subjects
E Lawitz and others. AASLD 2010.

HCV RESPOND-2 Final Results High Sustained Virologic Response Among Genotype 1 Previous Non-Responders and Relapsers to Peginterferon/Ribavirin when Re- Treated with Boceprevir Plus PEGINTRON (Peginterferon alfa-2b)/Ribavirin
B Bacon and others. AASLD 2010.

Boceprevir Combined with Peginterferon alfa-2b/Ribavirin for Treatment-Naïve Patients with HCV Genotype 1
F Poordad and others. AASLD 2010.

Frequencies of Resistance-Associated Amino Acid Variants Following Combination Treatment with Boceprevir Plus PEGINTRON (PegInterferon Alfa-2b)/Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 1 (G1)
J Vierling and others. AASLD 2010.

Hemoglobin Decline During Lead-in Phase as an Early Predictor of Anemia After the Addition of Boceprevir: A Retrospective Analysis of HCV SPRINT-1
F Poordad and others. AASLD 2010.

Response-Guided Therapy with Boceprevir + Peginterferon alfa-2b/Ribavirin for Treatment-Naïve Patients with Hepatitis C Virus Genotype 1 Was Similar to a 48-Wk Fixed-Duration Regimen with Boceprevir + Peginterferon alfa-2b/Ribavirin in SPRINT-2
J Bronowicki and others. AASLD 2010.

Strong antiviral activity and safety of IFN-sparing treatment with the protease inhibitor BI 201335, the HCV polymerase inhibitor BI 207127, and ribavirin, in patients with chronic hepatitis C: the SOUND-C1 trial
S Zeuzem and others. AASLD 2010.

Virological response and safety of 4 weeks’ treatment with the protease inhibitor BI 201335 combined with 48 weeks of peginterferon alfa 2a and ribavirin for treatment of HCV GT-1 patients who failed peginterferon/ribavirin
T Berg and others. AASLD 2010.

Genotypic and phenotypic analysis of the NS5B polymerase region from viral isolates of HCV chronically infected patients treated with BI 207127 for 5 days’ monotherapy
L Lagace, and others. AASLD 2010.

BMS-790052, a First-in-Class Potent Hepatitis C Virus NS5A Inhibitor, Demonstrates Multiple-Dose Proof-of-Concept in Subjects With Chronic GT1 HCV Infection
R Nettles and others. AASLD 2010.

Coadministration of BMS-790052 and BMS-650032 Does Not Result in a Clinically Meaningful Pharmacokinetic Interaction in Healthy Subjects
M Bifano and others. AASLD 2010.

Pipeline Asset Update for BMS-790052 (NS5A inhibitor) and BMS-650032 (NS3 inhibitor)
Btistol-Myers Squibb Company. AASLD 2010.

Combination Therapy With BMS-790052 and BMS-650032 Alone or With Pegylated Interferon and Ribavirin (pegIFN/RBV) Results in Undetectable HCV RNA Through 12 Weeks of Therapy in HCV Genotype 1 Null Responders
A Lok and others. AASLD 2010.

BMS-824393 Is a Potent Hepatitis C Virus NS5A Inhibitor With Substantial Antiviral Activity When Given as Monotherapy in Subjects With Chronic G1 HCV Infection
R Nettles and others. AASLD 2010.

Safety and Antiviral Activity of MK-5172, a Novel HCV NS3/4a Protease Inhibitor with Potent Activity Against Known Resistance Mutants, in Genotype 1 and 3 HCV-Infected Patients
A Petry and others. AASLD 2010.

Safety, Tolerability, and Pharmacokinetics after Single and Multiple Doses of MK-5172, a Novel HCV NS3/4a Protease Inhibitor with Potent Activity Against Known Resistance Mutants, in Healthy Subjects
A Petry and others. AASLD 2010.

High Correlation Between Week 4 and Week 12 as the Definition for Null Response to Peginterferon alfa (PEG) Plus Ribavirin (R) Therapy: Results From the IDEAL Trial
F Poordad and others. AASLD 2010.

Impact of PegIntron (PEG) Maintenance Therapy (MT) on Fibrosis Biomarkers (FibroTest [FT]/FibroSURE) in Prior Nonresponders With METAVIR Fibrosis Scores (MFS) of F2/F3: Final Results From the EPIC3 Program
T Poynard and others. AASLD 2010.

The Effect of Treatment Group, HCV Genotype, and IL28B Genotype on Early HCV Viral Kinetics in a Phase 2a Study of PEG-Interferon Lambda (pegIFNë) in Hepatitis C Patients
J Freeman and others. AASLD 2010.

Pegylated Interferon Lambda (pegIFNë) Phase 2 Dose-Ranging, Active-Controlled Study in Combination With Ribavirin (RBV) for Treatment-Naive HCV Patients (Genotypes 1, 2, 3, or 4): Safety, Viral Response, and Impact of IL28B Host Genotype Through Week 12
A Muir and others. AASLD 2010.

Pharmacokinetics of PEG-Interferon Lambda (pegIFNë) Following Fixed Dosing in Treatment-Naive Hepatitis C Subjects (Single-Dose Interim Data From a Dose-Ranging Phase 2a Study)
K Byrnes-Blake and others. AASLD 2010.

Sustained Viral Response (SVR) Rates in Genotype 1 Treatment-naïve Patients with Chronic Hepatitis C (CHC) Infection Treated with Vaniprevir (MK-7009), a NS3/4a Protease Inhibitor, in Combination with Pegylated Interferon Alfa-2a and Ribavirin for 28 Days
M Manns and others. AASLD 2010.

Genotypic and Phenotypic Analysis of HCV NS5A Inhibitor Resistance Variants: Correlations Between In Vitro and In Vivo Observations
M Gao and others. AASLD 2010.

Impaired Fasting Glucose Is Associated With Lower Rates of Sustained Virologic Response (SVR) in Patients With Genotype 1 Chronic Hepatitis C (CHC): Retrospective Analysis of the IDEAL Study
M Sulkowski and others. AASLD 2010.

Analysis of Site Performance in Academic and Community-Based Centers in the IDEAL Study
J Jou and others. AASLD 2010.

Baseline, Donor, and On-treatment Predictors of Sustained Virologic Response in Patients Treated for Recurrent Hepatitis C Following Orthotopic Liver Transplant: Subanalysis of the PROTECT Study
F Gordon and others. AASLD 2010.

Chronic Hepatitis C (HCV) Infections and the Risk of Depression and Other Adverse Events
J McCombs and others. AASLD 2010.

Sensitive Detection of Y448H NS5B Mutant Viruses in Patients Infected with Genotype 1a and 1b HCV
A Bae and others. AASLD 2010.

Safety, Pharmacokinetics, and Antiviral Activity of Single Oral Doses of the HCV NS3 Protease Inhibitor GS-9256
R Goldwater and others. AASLD 2010.

Enhanced in Vitro Antiviral Activity and Suppression of Resistance by Combining GS-9256, A Novel Protease Inhibitor, With GS-9190, a Non-Nucleoside NS5B Inhibitor
H Mo and others. AASLD 2010.

Antiviral Response and Resistance Analysis of Treatment-Naïve HCV Infected Subjects Receiving Single and Multiple Doses of GS-9190
J Harris and others. AASLD 2010.

Nonclinical Profi le and Phase I Results in Healthy Volunteers of the Novel and Potent HCV NS5A Inhibitor GS-5885
J Link and others. AASLD 2010.

Characterization of HCV Resistance from Single and Multiple Dose Clinical Trials of GS-9256, a Novel NS3 Protease Inhibitor
K Wong and others. AASLD 2010.

Three-Day, Dose-Ranging Study Of The HCV NS3 Protease Inhibitor GS-9451
E Lawitz and others. AASLD 2010.

Dual, Triple, and Quadruple Combination Treatment with a Protease Inhibitor (GS-9256) and a Polymerase Inhibitor (GS-9190) alone and in Combination with Ribavirin(RBV) or PegIFN/RBV for up to 28 days in Treatment Naïve, Genotype 1 HCV Subjects
S Zeuzem and others. AASLD 2010.