November 2, 2013

11/01/13

Liver disease patients, advocates and government leaders in health joined together before the AASLD Liver Meeting for the 1st International Rally for Liver Disease Awareness, in Washington.

Dr. T. Jake Liang, chief of the Liver Disease Branch at the National Institutes of Health, discussed the important role physicians play in the education and screening of patients about liver disease. Dr. Melanie B. Thomas, clinical oncologist and founder of the CanLiv foundation, spoke about the importance of interdiscplinary care for patients with liver disease. During the rally, Dr. Howard Koh, assistant secretary for health at the U.S. Department of Health and Human Services, outlined 10 areas in which the government has stepped up efforts to support education, outreach, and research about liver disease.

Source

British Journal of Cancer , (31 October 2013) | doi:10.1038/bjc.2013.689

J Huang, M Magnusson, A Törner, W Ye and A-S Duberg

Abstract

Background:

A few studies indicated that hepatitis C and hepatitis B virus (HCV/HBV) might be associated with pancreatic cancer risk. The aim of this nationwide cohort study was to examine this possible association.

Methods:

Hepatitis C virus- and hepatitis B virus-infected individuals were identified from the national surveillance database from 1990 to 2006, and followed to the end of 2008. The pancreatic cancer risk in the study population was compared with the general population by calculation of Standardized Incidence Ratios (SIRs), and with a matched reference population using a Cox proportional hazards regression model to calculate hazard ratios (HRs).

Results:

In total 340 819 person-years in the HCV cohort and 102 295 in the HBV cohort were accumulated, with 34 and 5 pancreatic cancers identified, respectively. The SIRHCV was 2.1 (95% confidence interval, CI: 1.4, 2.9) and the SIRHBV was 1.4 (0.5, 3.3). In the Cox model analysis, the HR for HCV infection was 1.9 (95% CI: 1.3, 2.7), diminishing to 1.6 (1.04, 2.4) after adjustment for potential confounders.

Conclusion:

Our results indicated that HCV infection might be associated with an increased risk of pancreatic cancer but further studies are needed to verify such association. The results in the HBV cohort indicated an excess risk, however, without statistical significance due to lack of power.

Source

Bristol seeks Japan approval of all-oral hepatitis C treatment

Sat Nov 2, 2013 9:30am EDT

* 84.7 pct of difficult-to-treat patients cured in trial

* Japan has about 1.2 million patients with chronic hepatitis C

By Bill Berkrot

Nov 2 (Reuters) - Bristol-Myers Squibb Co has filed with Japanese health regulators seeking approval of its experimental all-oral combination of hepatitis C treatments, the U.S. drugmaker said on Saturday.

The submission with Japan's Pharmaceutical and Medical Devices Agency marks the first time that any drugmaker has filed for approval of a hepatitis C treatment regimen that does not include either of the standard older treatments - the injected, difficult-to-tolerate interferon, or ribavirin, a pill.

Gilead Sciences Inc, widely seen as the leader in a crowded race to develop highly effective, interferon-free treatments for the serious liver disease, has sought U.S. approval of its highly regarded anti-viral drug sofosbuvir in combination with ribavirin. A Food and Drug Administration advisory panel last week voted unanimously to recommend its approval.

The Bristol-Myers filing was based on data from a Phase III study of Japanese patients who either could not tolerate interferon, which causes miserable flu-like symptoms, or those who had previously failed to be helped by treatment with the older drugs - a particularly tough-to-treat patient population.

Patients in the trial were given a combination of daclatasvir, from a promising new class of drugs called NS5A inhibitors, and the protease inhibitor asunaprevir for 24 weeks. Those who had no detectable levels of the virus in their blood 24 weeks after completing the therapy were deemed to be cured, a measure known as SVR24, for sustained virologic response.

The overall cure rate in the 222-patient study was 84.7 percent, according to the data to be presented next week at the American Association for the Study of Liver Diseases (AASLD) meeting in Washington.

Of those who were either ineligible for or intolerant of treatment with interferon, the cure rate was 87.4 percent, while 80.5 percent of past nonresponders to the older drugs were deemed cured.

"The Phase III study results of daclatasvir plus asunaprevir are exciting to see, especially in this difficult-to-treat patient population," Kazuaki Chayama, the study's lead investigator from Hiroshima University, said in a statement.

Twenty-eight patients dropped out of the study - a 12.6 percent discontinuation rate - and about 6 percent, or 13 patients, reported serious side effects, primarily elevated liver enzymes, an indication of inflammation.

JAPAN FOCUS

Bristol-Myers has made Japan a particular focus of its all-oral efforts at tackling the hepatitis C virus, which if left untreated can cause cirrhosis, liver cancer or the need for a transplant.

About 1.2 million people in Japan suffer from hepatitis C. The patients tend to be older than those in other developed countries and about 70 percent have Genotype 1b, a form of the virus with very low response rates to the older treatments.

Several other companies are also developing all-oral hepatitis C treatments, including AbbVie Inc, Merck & Co and Johnson & Johnson, and expect to be able to shorten treatment duration to 12 weeks from the current 24- or 48-week regimens.

Bristol early next year plans to begin Phase III testing of an all-oral, three-drug combination that adds BMS791325 - a non-nucleoside polymerase inhibitor - to the two drugs tested in the Japanese study. The company envisions that its three-drug therapy will involve one combination pill taken twice a day for a 12-week course of treatment.

About 170 million people worldwide are infected with the hepatitis C virus. Some analysts believe the market for all-oral hepatitis C treatments could reach $20 billion as many more people get tested for the virus, given new testing recommendations, very high cure rates, shorter treatment durations and tolerable side effects seen with the newer drugs in clinical trials.

It is believed that tens of thousands of hepatitis C patients have delayed treatment while awaiting the new drugs expected to start reaching the market next year in order to avoid the unpleasant side effects of interferon. Physicians would also like to see regimens that do not require ribavirin, which can cause anemia, rash and other side effects.

Source

Also See: BMS Submits First All-Oral, Interferon-Free and Ribavirin-Free Treatment Regimen for Regulatory Review in Japan for Patients with Chronic Hepatitis C Infection

High cure rates seen with Merck oral hepatitis drugs -study

By Bill Berkrot

Sat Nov 2, 2013 1:30pm GMT

Nov 2 (Reuters) - A combination of two oral hepatitis C treatments developed by Merck & Co led to high cure rates in previously untreated patients, indicating the company is a contender in the race to find new treatments for the liver destroying virus.

The treatments tested with and without the older drug ribavirin led to cure rates of 96 percent to 100 percent, according to interim data from a small midstage clinical trial.

The results appear to confirm Merck will be competitive in the crowded race to develop interferon-free treatments for hepatitis C, assuming they are repeated in larger studies that include more difficult to treat patient populations, such as those not helped by prior therapy.

The 65-patient, 3-arm study tested MK-5172, a protease inhibitor, combined with MK-8742 from a highly promising new class of drugs called NS5A inhibitors for 12 weeks of treatment.

Based on data available at the time the interim results were released, 55 of 56 patients who completed the therapy were considered to be cured of the virus which is transmitted through infected blood from sources such as infected hypodermic needles or blood transfusions.

Patients who have no detectable levels of the virus in their blood 12 weeks after completing 12 weeks of treatment were deemed to be cured - a measure known as SVR 12, for sustained virologic response.

In the arm of the study that did not include the older oral medicine ribavirin, all 11 patients who completed therapy with MK-5172 and the higher 50 milligram dose of MK-8742 taken once a day achieved SVR 12.

All 12 patients who began that arm of the study had Genotype 1b of the liver disease, which is prevalent in Europe and Japan. It is considered somewhat easier to treat than Genotype 1a, the most common form of the virus seen in the United States, which may require a third drug in the regimen to achieve similarly high cure rates.

The other two arms - one testing 50 mg of MK-8742 and one using 20 mg - did include ribavirin given twice a day.

With the lower dose of the NS5A inhibitor, all 21 patients who completed therapy were deemed cured. In the group that received the higher dose in the three-drug combination, 23 of 24, or 96 percent, reached SVR 12. About three quarters of the patients in those arms were Genotype 1a.

Of the 65 patients in the study, only one had experienced a relapse of the virus, according to the data to be presented on Sunday at the American Association for the Study of Liver Diseases (AASLD) meeting in Washington.

"We are encouraged by these preliminary data for the combination of MK-5172 and MK-8742. It's a one-two punch with both arms equally strong," said Eliav Barr, head of infectious diseases for Merck.

SHORTER TREATMENT DURATION

Current standard treatment regimens for hepatitis C take 24 or 48 weeks and includes injected interferon, which causes miserable flu-like symptoms that lead many patients to avoid or discontinue treatment.

Several companies are developing new all-oral combinations that in clinical trials have cut treatment duration to 12 weeks for many patients while significantly increasing cure rates from about 75 percent with current drugs.

Ultimately, physicians would like to also see regimens that do not require ribavirin, which has its own side effect issues, including anemia and rash.

It is believed that tens of thousands of hepatitis C patients have delayed treatment while awaiting the new drugs expected to start reaching the market next year.

Gilead Sciences is widely seen as being in the lead with a safe and effective all-oral combination, with Bristol-Myers-Squibb and AbbVie close behind.

Gilead last week won an approval recommendation from a U.S. Food and Drug Administration advisory panel for its highly regarded sofosbuvir.

Some analysts believe the market for all-oral hepatitis C treatments could reach $20 billion as many more people get tested for the virus, given the very high cure rates, shorter treatment durations and tolerable side effects.

An estimated 170 million people worldwide are infected with hepatitis C, which if left untreated can lead to cirrhosis, need for a transplant or liver cancer.

The Merck drugs were well tolerated with no serious adverse side effects reported. The most common side effects were fatigue, headache and nausea.

Merck plans to expand the Phase II trial to about 400 additional patients, testing its drugs with and without ribavirin, and including those also infected with the HIV virus, those with cirrhosis and patients who have failed to be cured by prior treatments. It is also looking at a regimen of only 8 weeks in previously untreated patients that would include ribavirin.

Source

Also See: Merck Announces Presentation of Interim Data from Study of Investigational Combination of HCV Therapies MK-5172 and MK-8742 at the 2013 American Association for the Study of Liver Diseases (AASLD) Annual Meeting

PRESS RELEASE November 2, 2013, 9:06 a.m. ET

  • Conatus Pharmaceuticals Presents Data Demonstrating Emricasan's Safety Profile at the AASLD Liver Meeting(R)
  • Normal levels of apoptosis and caspase activity in healthy volunteers are not reduced by emricasan
  • Emricasan currently in Phase 2b study in acute-on-chronic liver failure and Phase 2 study in severe alcoholic hepatitis

SAN DIEGO, Nov. 2, 2013 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced that data from the Phase 1 clinical trial of emricasan, a first-in class, orally active caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death, are being presented at The Liver Meeting(R), the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) on November 4, 2013 in Washington, D.C. The Phase 1 clinical trial was conducted to understand the activity of emricasan on caspase activity in healthy subjects.

Emricasan is a potent inhibitor of pro-apoptotic and pro-inflammatory caspases, and in prior Phase 1 and Phase 2 clinical trials, has been shown to rapidly suppress apoptotic caspase activity as determined by a key biomarker of inflammation and cell death, caspase cleaved CK18 (cCK18), in hepatitis C virus (HCV) patients to within ranges typically reported for healthy volunteers. Caspase activity is known to be elevated in many liver diseases and is associated with disease severity and progression. In the Phase 1 clinical trial, physiologically normal levels of apoptosis and pro-apoptotic caspase activity in healthy volunteers remained unaffected following exposure to emricasan.

"This novel observation provides important new information regarding the effect of pan caspase inhibition in healthy volunteers and further insight regarding the overall safety profile of emricasan," said Alfred P. Spada, Ph.D., Senior Vice President, Research and Development and Chief Scientific Officer of Conatus. "We believe the results of this study demonstrate that emricasan does not interfere with the normal level of caspase-mediated apoptosis in humans, and taken together with our prior results in HCV patients, suggests that emricasan may be an effective therapeutic agent for the treatment of chronic and acute liver disease."

In the Phase 1 clinical trial, emricasan was administered to 15 healthy volunteers at a dose of either 25 mg single dose or 25 mg twice daily for 10 days as part of a 24 day drug-drug interaction study with cyclosporine. This dose was shown in prior clinical trials to provide near maximal reduction of elevated cCK18 and serum transaminases in HCV patients. In this trial, blood samples were taken on day 0 and on study days 1, 17- 20, 22 and 24-27. Serial blood samples were collected out to 12 hours post-dose on study days 1, 17 and 24. Both drug levels and cCK18 were measured at each time point. Emricasan had no effect on cCK18 levels in healthy volunteers at any time point in the trial. Drug exposure was consistent with previously reported blood levels.

Poster Presentation Details:

 
Date/Time: November 4, 2013, 8:00 a.m. -- 5:30 p.m. ET
Presentation Title: "Physiologically normal levels of apoptosis in healthy
volunteers are not
reduced by the pan caspase inhibitor, emricasan"
Location: Poster Hall - Poster #1532
Session Title: Hepatotoxicity: Apoptosis and Necrosis


About Emricasan Clinical Development



Conatus is developing its lead compound, emricasan, for the treatment of patients in orphan populations with chronic liver disease and acute exacerbations of chronic liver disease. To date, emricasan has been studied in over 500 subjects in ten clinical trials. In a randomized Phase 2b clinical trial, emricasan demonstrated a statistically significant, consistent, rapid and sustained reduction in elevated levels of two key biomarkers of inflammation and cell death that are implicated in the severity and progression of liver disease. Emricasan is currently in a Phase 2b clinical trial in patients with acute-on-chronic liver failure, as well as a Phase 2 clinical trial in severe alcoholic hepatitis.



About Conatus Pharmaceuticals Inc.



Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing emricasan as a first-in class, orally active caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death, or apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the progression of liver disease. For additional information, please visit www.conatuspharma.com.



Forward-Looking Statements



This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release, including statements regarding the overall safety profile of emricasan, emricasan's lack of interference with the normal level of caspase-mediated apoptosis in humans, emricasan's effectiveness as a therapeutic agent for the treatment of chronic and acute liver disease and emricasan's potential to interrupt the progression of liver disease, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including: potential adverse side effects or other safety risks associated with emricasan; results of future clinical trials of emricasan; the uncertainty of the FDA approval process and other regulatory requirements; and those described in Conatus' prior press releases and the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in Conatus' forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Conatus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.



Source

Presented: November 3, 2013; Walter E. Washington Convention Center, Washington, DC

WASHINGTON, Nov. 2, 2013 /PRNewswire/ -- Researchers at Northwestern University and Emory University propose a simple tool to identify patients who are at risk of engaging in "medication tradeoffs." The study authors address the problem of patients with financial hardship who make the regular choice of meeting basic needs such as buying food rather than paying for medications after receiving a liver transplant.

Researchers conducted detailed, in-person interviews with 105 patients at the two transplant centers who underwent liver transplantation in 2011 and 2012 with the goal of exploring relationships between medication tradeoffs, medication non-adherence, and clinical outcomes. They determined that 17 percent of patients made medication tradeoffs, 10 percent reported an inability to purchase a medication due to cost, and 9 percent made the choice between buying medicine and buying food. Overall, 23 percent reported being non-adherent with medications.

According to Marina Serper, MD, "Individuals frequently have to make choices based on their economic situation. It is not surprising that they may choose to spend money on things other than medications, although you would expect this to be less prevalent in the posttransplant setting."

Patients with lower income, limited literacy, a higher number of chronic illnesses, and those taking more medications were more likely to have medication tradeoffs. Patients with tradeoffs were more than twice as likely to report non-adherence. Patients with tradeoffs had more hospitalizations after transplant than those who did not. The investigators suggested that the use of a tool similar to that used during the interviews conducted for this study would identify patients with cost-related barriers to proper medication adherence.

Dr. Serper added, "We need to be mindful of the effect of out-of-pocket costs on adherence and health outcomes in transplantation. Transplant centers routinely perform detailed psychosocial assessments prior to listing a patient for transplant, however, since financial situations may change, we may need to check in with patients more frequently after transplant, and intervene if needed."

Abstract title:
Medication Tradeoffs, Non-Adherence, and Clinical Outcomes among Liver Transplant Recipients

AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, held in Washington, November 2-5, will bring together more than 9,000 researchers from 55 countries.

A pressroom will be available from November 1 at the annual meeting. For copies of abstracts and press releases, or to arrange researcher interviews, contact Gregory Bologna at 703-299-9766.

Press releases and all abstracts are available online at www.aasld.org.

Media Contact: Gregory Bologna
703-299-9766
gbologna@aasld.org
Press Room: November 1 – 5, 2013
Walter E. Washington Convention Center, Washington, DC
Telephone: 202-249-4092

Researcher: Marina Serper, MD
Email: marina-serper@fsm.northwestern.edu
Phone: 215-718-4741

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.XpressPress.com.

SOURCE The American Association for the Study of Liver Diseases (AASLD)

RELATED LINKS
http://www.aasld.org

Source

Assessing the Global and Regional Burden of Liver Disease

Presented November 3, 2013, Walter E. Washington Convention Center, Washington, DC

WASHINGTON, Nov. 2, 2013 /PRNewswire/ -- Researchers from Australia presented their research on the underlying causes of liver cancer and cirrhosis deaths at the Annual Meeting of the American Association for the Study of Liver Diseases, concluding that these two diseases result in 1.75 million deaths each year. Viral hepatitis caused two thirds of those deaths. "If you consider deaths from hepatitis B and C together, said Benjamin Cowie, MBBS, PhD, FRACP, "the Global Burden of Death Study (GBD) 2010 estimates around 1.3 million people lost their lives to these infections, which is comparable to the respective burdens of HIV/AIDS, tuberculosis, and malaria."

This is the first study to categorize deaths attributable to viral hepatitis, alcohol, and other causes of cirrhosis and liver cancer separately. "This allows examination of the specific mortality associated with each condition, which clearly has great importance when considering interventions to address the population impact of liver disease in particular countries or regions, as well as globally," said Dr. Cowie.

According to the study, chronic liver disease is a leading cause of human mortality. Hepatitis B and C are responsible for 71 percent of liver cancer deaths and 58 percent of cirrhosis deaths, whereas alcohol is responsible for 25 percent of all deaths caused by liver cancer and cirrhosis. The toll taken by hepatitis B and C differs by region with hepatitis C causing a greater number of deaths in the US and Western Europe, and hepatitis B causing more deaths in China and India.

In addition to recommending a greater priority to be given to viral hepatitis globally, the regional differences in the predominant cause of chronic liver disease -- hepatitis B, hepatitis C, and alcohol abuse -- prompted the study authors to recommend prevention responses to be specific to regional needs.

"I think that there is clear evidence that in many countries, and at the global level, political and public health responses to chronic liver disease have not been commensurate with the burden of disease. This is especially the case for chronic viral hepatitis, said Dr. Cowie. "In Australia, for example, liver cancer is now the fastest increasing cause of cancer death - predominantly driven by chronic viral hepatitis - and less than 5% of people living with chronic viral hepatitis are currently receiving treatment."

"The GBD 2010 data suggest that addressing the global burden of liver disease, particularly chronic viral hepatitis, would be a fundamental step towards addressing a major cause of preventable deaths worldwide, concludes Dr. Cowie.

The 2010 GBD is the most recent version of the study and was funded by the Bill and Melinda Gates Foundation and coordinated by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. The GBD is a comprehensive regional and global assessment of mortality and disability from major diseases, injuries, and risk factors. The study is a collaborative effort between hundreds of experts worldwide. The study was published and can be found on the IHME website at www.healthmetricsandevaluation.org/gbd.

Abstract title:
The global burden of liver disease attributable to hepatitis B, hepatitis C, and alcohol: increasing mortality, differing causes

AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, held in Washington, November 2-5, will bring together more than 9,000 researchers from 55 countries.

A pressroom will be available from November 1 at the annual meeting. For copies of abstracts and press releases, or to arrange researcher interviews, contact Gregory Bologna at 703-299-9766.

Press releases and all abstracts are available online at www.aasld.org.

Media Contact: Gregory Bologna
703/299-9766
gbologna@aasld.org
Press Room: November 1 – 5, 2013
Walter E. Washington Convention Center, Washington, DC
Telephone: (202) 249-4092

Researcher: Benjamin Cowie, MBBS, PhD, FRACP
Email: benjamin.cowie@mh.org.au
Phone: (415) 539-5275

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.XpressPress.com.

SOURCE American Association for the Study of Liver Diseases (AASLD)

RELATED LINKS
http://www.aasld.org

Source

Presented: November 3, 2013; Walter E. Washington Convention Center, Washington, DC

WASHINGTON, Nov. 2, 2013 /PRNewswire/ -- In 2012, the Centers for Disease Control and Prevention (CDC) recommended a one-time screening for all Americans born between 1945 and 1965. It is estimated that 1 in 30 baby boomers has been infected with hepatitis C virus (HCV) and most don't know it. HCV is a serious liver disease including liver cancer, which is the fastest-rising cause of cancer-related deaths and the leading cause of liver transplants in the US.

Researchers at the Department of Veterans Affairs (VA) studied the health records of 5,500,392 veterans. Of those, 64.2 percent of baby boomers and 54.7 percent overall -- or more than 2.9 million -- had at least one VA screening for HCV. Of those screened, 9.9 percent of the baby boomers had HCV infection, compared with 1.7 percent of those born before 1945 and 1.1 percent of those born after 1965.

After extrapolating the infection data to the veterans not yet screened, researchers concluded that up to 51,000 more veterans of the baby boomer generation could be identified with HCV. The VA has been a leader in adopting new care models such as telehealth and Specialty Care Access Network-Extension for Community Healthcare Outcomes (SCAN ECHO) in order to expand the VA capacity to take care of any additional veterans identified as having HCV infection through expanded screening. SCAN ECHO is a collaboration between Dr. Sanjeev Arora, the Director of Project ECHO at the University of New Mexico, and the VA. The SCAN ECHO project links VA primary care providers in local VA community outpatient clinics with specialist teams at VA academic medical centers to help manage patients who have conditions requiring complex care. The SCAN ECHO model enables primary care providers to share best practices and obtain case-based learning. Through SCAN ECHO, VA primary care clinicians gain new competencies to provide care that was not previously available in their communities.

They concluded that those born between 1945 and 1965 had the highest rate of infection, and the data support the CDC's recommendation to test all baby boomers one time for HCV. According to Lisa Backus, MD, PhD, "Our work should serve as a reminder to all baby boomers to get screened for HCV. Our work should also serve as an example to other healthcare organizations to prompt them to assess their own HCV screening rates and HCV prevalence rates and to make such rates public. Sharing this type of information would give public health officials better information about the prevalence of HCV in the US and would give the general public more information for making healthcare decisions."

In discussing her work at the VA, Dr. Backus says, "We are obviously interested in monitoring the HCV screening and HCV prevalence rates in future years. The VA is implementing several measures to improve HCV screening rates and it will be important to ensure that these measures work and that HCV screening rates increase. In addition, we are always interested in variation and we found variation in screening rates across the VA healthcare system in our analysis. Such variation in HCV screening rates among VA facilities provides an opportunity to study facilities with high screening rates to determine best practices and then apply those practices across the system."

Abstract title:
Hepatitis C Virus Screening and Prevalence among US Veterans in Department of Veterans Affairs Care in 2012

AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, held in Washington, November 2-5, will bring together more than 9,000 researchers from 55 countries.

A pressroom will be available from November 1 at the annual meeting. For copies of abstracts and press releases, or to arrange researcher interviews, contact Gregory Bologna at 703-299-9766.

Press releases and all abstracts are available online at www.aasld.org.

Media Contact: Gregory Bologna
703-299-9766
gbologna@aasld.org
Press Room: November 1 – 5, 2013
Walter E. Washington Convention Center, Washington, DC
Telephone: (202) 249-4092

Researcher: Lisa Backus, MD, PhD
Email: lisa.backus@va.gov

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.XpressPress.com.

SOURCE AASLD

RELATED LINKS
http://www.aasld.org

Sourcde

Published on Nov 2, 2013

WebsEdgeHealth

AASLD TV sat down to talk to J. Gregory Fitz, MD, AASLD President about The Liver Meeting 2013 and some of the "can't miss" events of this year's conference.

Source

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Stockholm, Sweden — Medivir AB (OMX: MVIR) announces that new data will be presented on the investigational protease inhibitor simeprevir (TMC435) in treatment-naïve genotype 1 chronic hepatitis C patients and in treatment-experienced patients with compensated liver disease. These data will be presented at the ongoing Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place during November 1 to 5 in Washington, D.C.

In the analyses of the QUEST-1 and QUEST-2 phase III studies in treatment-naïve patients and the phase III PROMISE study in prior relapse patients, efficacy of simeprevir was demonstrated in hepatitis C patients, including patients with the IL28B TT genotype and METAVIR scores of F4 (cirrhosis).

On October 24, the U.S. Antiviral Drugs Advisory Committee of the FDA voted unanimously (19-0) to recommend approval of the new drug application filed by Janssen Research & Development, LLC for simeprevir administered once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C virus (HCV) in adult patients with compensated liver disease.

The data to be presented at the 2013 AASLD Annual Meeting include:

Poster Presentations: HCV Therapeutics: New Agents, Poster Hall, November 3, 8:00 a.m. - 5:30 p.m. (EST):

Simeprevir (TMC435) with peg-interferon α-2a/ribavirin for treatment of chronic HCV
genotype 1 infection in patients who relapsed after previous interferon-based therapy:
Efficacy and safety in patient sub-populations in the PROMISE Phase III trial

  • Lead Author: Xavier Forns, Hospital Clinic, Barcelona, Spain

Adding simeprevir to peginterferon/ribavirin for HCV shortens time with patient-reported
symptoms and impairment in quality of life: Results from the simeprevir Phase III QUEST
1, QUEST 2, and PROMISE studies

  • Lead Author: Jane A. Scott, Janssen

Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1
infection in treatment-naïve patients: Efficacy in difficult-to-treat patient sub-populations
in the QUEST-1 and 2 Phase III trials

  • Lead Author: Ira M. Jacobson, Weill Cornell Medical College, New York, USA

Resistance analyses of HCV isolates from patients treated with simeprevir in Phase 2b/3
studies

  • Lead Author: Oliver Lenz, Janssen

The relative efficacy and safety of simeprevir-based triple therapy compared to boceprevir and telaprevir in treatment naïve patients chronically infected with genotype-1 hepatitis C virus: Bayesian network meta-analyses

  • Lead Author: George Wan, Janssen

More information about these presentations can be accessed in a press release issued by Janssen, http://www.janssenrnd.com

The Phase 2a COSMOS data will be presented during the late-breaking oral session on Monday, November 4, 2:45-4:30 p.m. (EST) in Hall E:
SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study.

  • Lead Author: Ira M. Jacobson, Weill Cornell Medical College, New York, USA

Full session details and data presentation listings for the 2013 AASLD Annual Meeting can be found at: http://www.aasld.org/livermeeting.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292.

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 3 p.m. CET on 2 November 2013.

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is the focus of a rapidly evolving treatment landscape. Approximately 150 million people are infected with hepatitis C worldwide – including approximately 3.2 million people in the United States – and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.

About Simeprevir
Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and its affiliated companies and Medivir AB for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the viral protease enzyme that enables the hepatitis C virus to replicate in host cells.

Janssen is responsible for the global clinical development of simeprevir and has acquired exclusive, worldwide marketing rights, except for the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these Nordic countries under the marketing authorization held by Janssen-Cilag International NV.

Simeprevir was approved on September 27, 2013 in Japan for the treatment of genotype 1 hepatitis C and a Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. Simeprevir is also being studied in several interferon-free regimens using selected combinations of direct-acting antiviral agents with different mechanisms of action.
To date, more than 3,700 patients have been treated with simeprevir in clinical trials.

In October, Janssen Pharmaceuticals, Inc. acquired the investigational compound GSK2336805, an NS5a replication complex inhibitor in phase II development for the treatment of chronic HCV, from an affiliate of GlaxoSmithKline plc. Since being acquired, the compound has been renamed JNJ-56914845. Janssen Pharmaceuticals plans to initiate phase II studies to evaluate the use of JNJ-56914845 in interferon-free combinations with simeprevir and TMC647055, Janssen’s non-nucleoside polymerase inhibitor, for the treatment of chronic HCV in adult patients with compensated liver disease.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir AB, please visit the Company’s website: www.medivir.com

Source

Published on Nov 2, 2013

WebsEdgeHealth

AASLD TV interviewed Donald Jensen, MD/AASLD Treasurer and Gary Davis, MD, FACP, AASLD Secretary about some of the exciting new developments surrounding the new treatments coming out for HCV.

Source

  • Pivotal Phase III STARTVerso™ data show efficacy of faldaprevir* in difficult-to-cure patient populations such as those with HIV co-infection and advanced liver disease
  • 84% of patients benefited from a shorter time on treatment and the majority went on to achieve viral cure, with no compromise on safety and tolerability (STARTVerso™1&2)1
  • Second-generation protease inhibitor faldaprevir* is being investigated in combinations both with and without interferon

November 02, 2013 09:00 AM Eastern Daylight Time 

INGELHEIM, Germany--(EON: Enhanced Online News)--For media outside of the U.S.A., UK and Canada only

“Faldaprevir* may offer a simple and convenient option for patients, due to once-daily dosing and no food restrictions. Faldaprevir* is the foundation of our HCV pipeline and we look forward to presenting pivotal Phase III HCVerso® data for the treatment of HCV as part of an interferon-free regimen in 2014.”

Boehringer Ingelheim today announced new data from its Phase III clinical trial programme, STARTVerso™, which evaluates faldaprevir* in combination with pegylated interferon and ribavirin (PegIFN/RBV). Patients with genotype-1 (GT-1) hepatitis C (HCV) who have not received previous treatment (treatment-naïve: STARTVerso™1&2),1 treatment-experienced patients (STARTVerso™3),2 and HIV co-infected patients (STARTVerso™4)3 participated in this study programme. The results from these and additional studies will be presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting®, taking place 1-5 November in Washington, D.C.

In STARTVerso™1&2, 84% of treatment-naïve patients receiving faldaprevir* were able to shorten the total time on treatment from 48 to 24 weeks; 83% of these patients achieved viral cure (SVR12).1 Overall, 73% and 72% of patients achieved SVR12 with faldaprevir* 120mg and 240mg regimens, respectively. Interim results from STARTVerso™4 showed that 74% of patients with HCV/HIV co-infection treated with faldaprevir* had undetectable HCV 4 weeks after the conclusion of treatment (SVR4), a response rate similar to that seen with HCV mono-infection.3 Additionally, treatment of difficult-to-cure patients who have relapsed on previous HCV treatment (STARTVerso™3) demonstrated viral cure rates of 70% with faldaprevir*.2 In the same study, patients who partially responded and those who showed no response to previous treatment achieved viral cure rates of up to 58% and 33%, respectively.3 For the full STARTVerso™ results, see notes to editors.

“These data are encouraging and reinforce the potential benefits of faldaprevir* as an effective treatment for genotype-1 infected HCV patients,” said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York. “The broad populations studied in STARTVerso™ and the fact that very few patients discontinued treatment due to adverse events provides physicians with confidence in faldaprevir* as an important potential addition to the available agents for the treatment of hepatitis C.”

More than 2,200 patients have been studied in the STARTVerso™ trial programme, including patients with difficult-to-cure types of HCV:

  • Over 300 patients in the programme have HCV/HIV co-infection;3 these patients have higher levels of HCV in their blood and can be more difficult to cure4
  • 677 patients were treatment-experienced, meaning they had attempted previous HCV treatment but did not achieve viral cure2
  • 40% of patients in STARTVerso™3 had advanced liver disease (≥F3 fibrosis)2
  • 59% of patients in STARTVerso™1&2 had a non-CC IL28B genotype;1 in previous studies, these patients were less likely to achieve viral cure5

“The STARTVerso™ trial results are particularly promising given the inclusion of a broad range of patients and the similar success rates seen in both HCV mono and HCV/HIV co-infected patients. These data will form the basis of regulatory submissions and we look forward to the outcome,” said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. “Faldaprevir* may offer a simple and convenient option for patients, due to once-daily dosing and no food restrictions. Faldaprevir* is the foundation of our HCV pipeline and we look forward to presenting pivotal Phase III HCVerso® data for the treatment of HCV as part of an interferon-free regimen in 2014.”

Faldaprevir* as part of this interferon-based regimen is likely to offer advantages over first generation protease inhibitors with fewer skin reactions, gastrointestinal events and no additional anaemia. In the STARTVerso™ clinical trial programme, adverse events (AEs) were generally mild and well manageable. Most common AEs included jaundice due to transient bilirubin elevation (unconjugated hyperbilirubinemia), nausea, fatigue, diarrhoea, headache, anaemia and rash. 95% of patients completed faldaprevir* treatment.1,2,3 For full STARTVerso™ results, see notes to editors.

ADDITIONAL BOEHRINGER INGELHEIM DATA AT THE MEETING

Faldaprevir* in further clinical settings

Further studies adding to the robust portfolio of evidence for faldaprevir* will be presented at the meeting. These include studies exploring drug-drug interactions in patients who are taking oral birth control pills and common medication to treat drug dependence and studies evaluating faldaprevir* in patients who have renal impairment.

Faldaprevir* as part of an interferon-free regimen

Additional news from Boehringer Ingelheim was released today featuring data from the collaborative trial with Presidio Pharmaceuticals. The ongoing Phase II trial investigating the regimen of faldaprevir*, deleobuvir* and PPI-668 (with and without ribavirin) in genotype-1a infected patients was accepted as late breaker and will be presented on Monday.

* Faldaprevir and deleobuvir are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.

^SVR12 = sustained viral response 12 weeks after treatment completion, also described as “viral cure”

# # #

NOTES TO EDITORS

Phase III STARTVerso™ results

STARTVerso™1&2
Treatment-naïve patients were randomised 1:2:2 to receive 48 weeks of PegIFN/RBV plus: placebo (Arm 1); faldaprevir* 120mg once-daily for 12 or 24 weeks (Arm 2); or faldaprevir* 240mg once-daily for 12 weeks (Arm 3). SVR12 rates were:1

  • Arm 1: 50% (131/264)
  • Arm 2: 73% (382/521)
  • Arm 3: 72% (378/524)

Patients in arms 2 and 3 stopped all treatment at week 24 if HCV RNA <25IU/mL was detected or undetected at week 4 and undetected at week 8 of treatment. Results were:1

  • Arm 2: 84% (436/521) of which 83% (362/436) achieved SVR12
  • Arm 3: 84% (441/524) of which 83% (368/441) achieved SVR12

In the study, the most common AEs were gastrointestinal events and anaemia, occurring in 11%/18% and 14%/13% of patients treated with 120mg/240mg faldaprevir* regimens respectively. Hyperbilirubinemia occurred in 12% and 46% of patients, respectively.1

STARTVerso™3
The trial included 3 cohorts of treatment-experienced patients who had: prior relapse (cohort 1), prior partial response (cohort 2) and prior null response (cohort 3).2

Cohort 1
Patients were randomised 1:2:2 to receive 48 weeks of PegIFN/RBV plus: placebo (placebo); faldaprevir* 240mg once-daily for 12 weeks (FDV12W); or faldaprevir* 240mg once-daily for 24 weeks (FDV24W). SVR12 rates were:2

  • Placebo: 14% (7/49)
  • FDV12W: 70% (69/99)
  • FDV24W: 70% (71/102)
  • 87% of patients stopped all treatment at week 24 of whom 75% achieved SVR12

Cohort 2
Patients were randomised 1:2:2 to receive 48 weeks of PegIFN/RBV plus: placebo (placebo); faldaprevir* 240mg once-daily for 12 weeks (FDV12W); or faldaprevir* 240mg once-daily for 24 weeks (FDV24W). SVR12 rates were:2

  • Placebo: 3% (1/29)
  • FDV12W: 58% (33/57)
  • FDV24W: 47% (26/55)

Cohort 3
Patients were randomised 1:1 to receive faldaprevir* 240mg once-daily for 12 weeks (FDV12W) or faldaprevir* 240mg once-daily for 24 weeks (FDV24W) with PegIFN/RBV for 48 weeks. SVR12 rates were:2

  • FDV12W: 33% (48/145)
  • FDV24W: 33% (46/141)

AEs of at least moderate intensity included gastrointestinal side effects, which occurred in 20% and 17% of patients in the 12- and 24-week faldaprevir* arms respectively. Also, anemia occurred in 10% of patients in both faldaprevir* arms.2

STARTVerso™4
The ongoing trial includes patients co-infected with HCV and HIV who are HCV treatment-naïve or have relapsed after previous HCV therapy. Patients received 48 weeks of PegIFN/RBV plus either: faldaprevir* 120mg once-daily for 24 weeks (Arm A); or faldaprevir* 240mg once-daily for 12 or 24 weeks (dependent on randomisation at week 12) (Arm B). SVR4 rates were:3

  • Arm A: 72% (89/123)
  • Arm B, faldaprevir* 12 weeks: 79% (66/84)
  • Arm B, faldaprevir* 24 weeks: 84% (72/86)
  • Arm B, total: 76% (140/185a)
  • Total: 74% (229/308)

aincludes additional patients from 240mg treatment group who discontinued prior to week 12

Patients in whom HCV RNA <25IU/mL was detected or undetected at week 4 and undetected at week 8, were randomised 1:1 to stop treatment at week 24 or continue PegIFN/RBV to 48 weeks. Results were:3

  • Arm A: 77% (95/123) of which 89% (85/95) achieved SVR4
  • Arm B, total: 81% (150/185) of which 87% (131/150) achieved SVR4
  • Total: 80% (245/308) of which 88% (216/245) achieved SVR4

The most common AEs in the study were nausea, fatigue and diarrhoea , occurring in 28% and 44%; 32% and 35%; and 25% and 28% with the 120mg and 240mg faldaprevir* regimens respectively.3

The Boehringer Ingelheim NewsHome: An innovative resource for journalists

The Boehringer Ingelheim hepatitis C www.newshome.com is the one-stop-shop for clear, concise and easy to understand information about hepatitis C for media.

For the full ‘Notes to Editors’ and ‘References’ please visit:

https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/02_novermber_2013_hepatitisc.html

Contacts

Boehringer Ingelheim
Corporate Communications
Media + PR
Reinhard Malin
Tel: +49 (6132) 77-90815
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com
More information
www.boehringer-ingelheim.com

Source

  • High rate of virologic response in Phase II hepatitis C trial of a 12 week all-oral combination of Boehringer Ingelheim’s faldaprevir* and deleobuvir* and Presidio’s PPI-668* with and without ribavirin1

  • All patients (17/17) who have completed treatment achieved undetectable levels of hepatitis C virus at the end of treatment1
  • 13 of these patients have reached their 4-week post-treatment follow-up and all have undetectable hepatitis C virus (SVR4)1

November 02, 2013 09:00 AM Eastern Daylight Time 

INGELHEIM, Germany--(EON: Enhanced Online News)--For media outside of the U.S.A., UK and Canada only

“The huge diversity between hepatitis C patients, due to differing personal factors and variations in the virus, highlight the importance of an individualised approach to treatment”

Interim data presented today show that all patients (13/13) who reached their 4-week post-treatment follow-up have undetectable levels of hepatitis C virus (SVR4) after completing a 12-week regimen of faldaprevir*, deleobuvir*, PPI-668* and ribavirin.1 These data from Boehringer Ingelheim’s ongoing Phase II collaborative trial with Presidio Pharmaceuticals will be presented on Monday during the ‘Late-Breaking Posters’ session at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place in Washington, D.C. Additional data from the trial show 100% of patients (12/12) treated with a ribavirin-free regimen had hepatitis C virus (HCV) levels below the lower level of quantification at 4 weeks.1 Safety and tolerability appears to be better in this ribavirin-free treatment arm compared to those with ribavirin.1

“These interim results add to the growing body of evidence for faldaprevir* as an effective treatment for a broad range of genotype-1 infected hepatitis C patients, including the more difficult-to-cure. The trial is still in the early stages but the initial results look promising,” said Professor Klaus Dugi, Senior Vice President of Medicine at Boehringer Ingelheim. “These data further demonstrate the future potential of faldaprevir* as the foundation of interferon-free treatment regimens. Our pivotal HCVerso® studies which investigate the interferon-free regimen of faldaprevir*, deleobuvir* and ribavirin are currently in Phase III development. We look forward to the final results from both trials in Q2 next year.”

The ongoing Phase II trial features the 12-week regimen both with and without ribavirin in 36 genotype-1a infected patients, one of the more difficult-to-cure types of hepatitis C virus. In addition, more than half the patients in the study (20/36) had pre-existing HCV mutations. This includes the Q80K variant which is common in genotype-1a infected patients2 and has been associated with reduced responses to some HCV protease inhibitors3. Notably, all 12 patients in the study with pre-existing Q80K mutations are responding well to treatment with the faldaprevir*-based interferon-free regimen.1

To date, all patients in the study have received at least 4 weeks of treatment and 97% (35/36) achieved HCV levels below the lower limit of quantification at week 4. One patient had an initial virologic response but then exhibited viral breakthrough and was discontinued after 5 weeks of treatment. Overall, adverse events in the study have been mild to moderate, with the incidence and severity of skin rashes and gastrointestinal side effects similar to those observed in previous trials studying faldaprevir* and deleobuvir*. For further results see notes to editors.

Overview of Boehringer Ingelheim’s HCV trial programme

Boehringer Ingelheim’s hepatitis C clinical trial programme includes a broad range of genotype-1 infected patients. The programme features three treatment regimens, with faldaprevir* as the foundation:

Study   Regimen     Population     Status

STARTVerso™

 

Faldaprevir* pegylated interferon,
ribavirin

   

GT-1 , TN, TE, HCV/HIV
co-infection, advanced
liver disease

   

Regulatory submissions
pending

For results see the STARTVerso press release here

 

HCVerso®

 

Faldaprevir*,
deleobuvir*,
ribavirin

   

GT-1b, TN, TE, advanced
liver disease

   

Phase III results
expected Q2 2014

Presidio collaboration  

Faldaprevir*,
deleobuvir*,
PPI-668* +/- ribavirin

    GT-1a, TN, non-cc IL28B    

Phase II final results
expected Q2 2014

An individualised approach to hepatitis C

The breadth of patients studied in Boehringer Ingelheim’s hepatitis C trial programme reflects a population that physicians see in the clinic, including those with difficult types of hepatitis C virus to cure.

“The huge diversity between hepatitis C patients, due to differing personal factors and variations in the virus, highlight the importance of an individualised approach to treatment,” said Graham Foster, Professor of Hepatology, Queen Mary’s, London. “The difference between HCV genotypes is substantial. For example, genotype-1a and 1b share only around 70% of the same genetic material which is more distant than the genetic similarity between humans and some other animals and patients have differing degrees of liver damage that may require changes to the therapeutic approach. Given the diversity of the disease and the virus it is likely that each patient will need to be assessed on an individual basis and the best treatment assigned accordingly.”

For more information on the importance of an individualised approach to hepatitis C, view the video here

*Faldaprevir, deleobuvir and PPI668 are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.

# # #

NOTES TO EDITORS

Phase IIa Presidio collaboration trial results

The trial includes 36 treatment-naïve patients with genotype-1a HCV treated for 12 weeks with an all-oral regimen, with 24 weeks of post-treatment follow-up. The primary endpoint is viral cure 12 weeks after treatment completion (SVR12). There are three cohorts in this study:1

  • Cohort 1: faldaprevir* 120 mg once-daily (QD), PPI-668 200mg QD and deleobuvir* 600mg twice-daily (BID) with ribavirin (n=12)
  • Cohort 2: faldaprevir* 120 mg QD, PPI-668 200mg QD and deleobuvir* 400mg BID with ribavirin (n=12)
  • Cohort 3: faldaprevir* 120mg QD, PPI-668 200mg QD and deleobuvir* 600 mg BID, without ribavirin (n=12)

Thirty-six patients in this study have reached week 4 of treatment, 17 patients have reached the end of treatment (12 weeks) and 13 patients have reached their 4 week post-treatment follow-up. Interim results show:1

  • 97% of patients (35/36) achieved HCV levels below the lower limit of quantification at week 4
  • 100% of patients (17/17) that completed the full course of treatment had undetectable hepatitis C virus at the conclusion of treatment
  • 100% of patients (13/13) that completed the full course of treatment achieved SVR4

To date there has been just one treatment failure due to viral breakthrough. One patient had an initial virologic response but then exhibited viral breakthrough and was discontinued after 5 weeks of treatment. Only one AE was rated as ‘severe’ and attributable to study drugs; one patient reported severe fatigue in week 11 and the event was resolved with no change in treatment.1

NewsHome

The Boehringer Ingelheim NewsHome: An innovative resource for journalists

The Boehringer Ingelheim hepatitis C www.newshome.com is the one-stop-shop for clear, concise and easy to understand information about hepatitis C for the media.

About STARTVerso™ and HCVerso®

For information on the interferon-free Phase III HCVerso® trials please refer to the Clinical Trials backgrounder, available on NewsHome.

For the full ‘Notes to Editors’ and ‘References’ please visit:

https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/02_novermber_2013_hepatitisc1.html

Contacts

Contact:
Boehringer Ingelheim
Corporate Communications
Media + PR
Reinhard Malin
Tel: +49 (6132) 77-90815
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com

Source

~ Studies Support Efficacy and Safety of an All-Oral Sofosbuvir-Based Regimen for the Prevention and Treatment of Recurrent HCV Infection Following Liver Transplants ~

WASHINGTON--(BUSINESS WIRE)--Nov. 2, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from two Phase 2 studies evaluating an all-oral treatment regimen of the investigational once-daily nucleotide analogue sofosbuvir plus ribavirin (RBV) for both the prevention and treatment of recurrent chronic hepatitis C virus (HCV) infection among patients who undergo liver transplantation. The findings will be presented this week at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2013) in Washington, D.C.

HCV infection is the most common cause of liver transplantation in the United States and Europe. Recurrence of HCV infection is universal among patients with active disease at the time of transplantation and up to 50 percent develop cirrhosis of the liver within five years. Suppression of HCV RNA prior to liver transplantation should reduce the risk of re-infection and its serious complications, but currently available treatment options are often ineffective and poorly tolerated. Similarly, in the post-transplant setting, treatment is generally poorly tolerated and complicated by strong drug interactions with immunosuppressive agents used to prevent the body’s rejection of the transplanted liver.

In a study conducted among pre-transplant HCV patients (Study 2025), up to 48 weeks of sofosbuvir/RBV therapy was administered. Among patients with undetectable HCV (<25 IU/mL) at the time of transplantation, 64 percent (n=25/39) achieved undetectable HCV RNA 12 weeks post-transplant (pTVR12). Patients who achieve pTVR12 are considered cured of HCV infection. In a second study conducted among post-transplant HCV patients (Study 0126), patients with established recurrent HCV infection following liver transplantation received 24 weeks of sofosbuvir/RBV therapy. Seventy-seven percent (n=27/35) of patients in this study have achieved a sustained virologic response four weeks post-treatment (SVR4).

“Recurrence of HCV following liver transplantation almost always occurs in clinical practice. These patients are at higher risk for disease progression, the development of cirrhosis, liver graft failure, re-transplantation and increased morbidity and mortality,” said Michael P. Curry, MD, Medical Director, Liver Transplantation at Beth Israel Deaconess Medical Center, Boston, and an investigator for the pre- and post-liver transplant trials. “In these studies, sofosbuvir clearly demonstrated the potential to improve patient outcomes by either preventing or effectively treating recurrent HCV infection following liver transplantation.”

Three percent and five percent of patients discontinued treatment due to adverse events in the pre- and post-transplant studies, respectively. No serious adverse events reported were associated with sofosbuvir. The most common adverse events observed were consistent with the safety profile of RBV, and included fatigue, anemia, headache and nausea in the pre-transplant study, and fatigue, headache, arthralgia (joint pain) and diarrhea in the post-transplant study.

About the Pre-Transplant Study

Study 2025 is an on-going open-label Phase 2 study evaluating the efficacy and safety of sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) for up to 48 weeks or until liver transplantation. Sixty-one patients with HCV infection (Child-Pugh class A or B cirrhosis) and liver cancer, who were either treatment-naïve or treatment-experienced were enrolled.

About the Post-Transplant Study

Study 0126 is an ongoing open-label Phase 2 study evaluating the efficacy and safety of 24 weeks of treatment with sofosbuvir 400 mg once-daily plus RBV (starting at 400 mg/day) among 40 treatment-naïve and treatment-experienced patients with recurrent HCV infection. Patients in the study had received a transplant a median of four years prior to the study, and 40 percent were cirrhotic.

There were no deaths, graft losses or episodes of organ rejection among post-liver transplantation patients in the study.

Additional information about these studies can be found at www.clinicaltrials.gov.

Sofosbuvir is an investigational product and its safety and efficacy have not been established.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable longer-term results from Studies 025 and 126 and other ongoing and subsequent clinical trials involving sofosbuvir, alone or in combination with other products, for the treatment of HCV. In addition, regulatory authorities will not approve sofosbuvir for HCV-related indications and any marketing approval may have substantial limitations on its use. As a result, sofosbuvir may never be successfully commercialized. Further, Gilead may make a strategic decision to discontinue development of sofosbuvir if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.

Patrick O’Brien, 650-522-1936 (Investors)

Cara Miller, 650-522-1616 (Media)

Source

Results from Phase 3 VALENCE Study Confirm Efficacy and Safety of All-Oral Sofosbuvir-Based Regimen in Hepatitis C Patients with Genotype 3 Infection --

WASHINGTON--(BUSINESS WIRE)--Nov. 2, 2013-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from two studies, the Phase 3 VALENCE study and the Phase 2 LONESTAR-2 study, evaluating the investigational once-daily nucleotide analogue sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection among patients infected with genotype 3 HCV. These data will be presented this week at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2013) taking place in Washington, D.C.

In the Phase 3 VALENCE study, 85 percent (n=212/250) of treatment-naïve or treatment-experienced patients with genotype 3 HCV who received a 24-week regimen of sofosbuvir plus ribavirin (RBV) achieved a sustained virologic response 12 weeks after treatment (SVR12). Patients who achieve SVR12 are considered cured of HCV infection.

“The VALENCE results demonstrate the high efficacy of a 24-week, sofosbuvir-based, interferon-free treatment regimen for genotype 3 HCV patients with and without liver cirrhosis,” said Stefan Zeuzem, MD, Professor of Medicine and Chief of the Department of Medicine, Goethe University Hospital, Frankfurt, Germany, and principal investigator for the VALENCE study. “Notably, the majority of these patients had failed prior therapy, and sofosbuvir was able to produce a sustained virologic response.”

Additionally, the Phase 2 LONESTAR-2 study evaluated 12 weeks of sofosbuvir, RBV and pegylated interferon (peg-IFN) among patients who had previously failed treatment with peg-IFN/RBV, approximately half of whom had cirrhosis. In this study, 83 percent (n=20/24) of genotype 3 patients achieved SVR12.

There were few discontinuations due to adverse events in VALENCE and LONESTAR-2. Sofosbuvir was well tolerated in VALENCE and adverse events in LONESTAR-2 were consistent with the safety profile of peg-IFN/RBV.

About VALENCE

VALENCE is an ongoing placebo-controlled Phase 3 study in which patients with genotype 2 and 3 HCV infection were originally randomized (4:1) to receive sofosbuvir 400 mg once-daily plus weight-based RBV twice-daily (1,000 or 1,200 mg/day) for 12 weeks (n=334) or placebo (n=85). The study was subsequently amended to extend the treatment duration for genotype 3 patients (n=250) to 24 weeks. Patients randomized to receive placebo were offered treatment in an alternative protocol. Fifty-eight percent of trial participants were treatment-experienced and 21 percent had cirrhosis.

Among genotype 2 HCV patients receiving a 12-week all-oral course of sofosbuvir plus RBV, 93 percent (n=68/73) achieved SVR12.

Two patients receiving sofosbuvir and one patient receiving placebo discontinued treatment due to adverse events. The most common adverse events occurring in ≥10 percent of patients receiving sofosbuvir were headache, fatigue, pruritus, asthenia and nausea.

About LONESTAR-2

LONESTAR-2 is an ongoing open-label Phase 2 study evaluating the efficacy and safety of a 12-week regimen of sofosbuvir 400 mg once-daily, weight-based RBV twice-daily (1,000 or 1,200 mg/day) and peg-IFN (180 μg/week) among 47 patients with genotype 2 or 3 HCV infection. All patients in the study had previously failed treatment with peg-IFN/RBV and 55 percent had cirrhosis.

Ninety-six percent (n=22/23) of genotype 2 HCV patients achieved SVR12 in the study.

Two patients receiving sofosbuvir discontinued treatment due to adverse events. The most common adverse events occurring in ≥15 percent of the patients were consistent with the safety profiles of peg-IFN and RBV and included flu-like symptoms, fatigue and anemia.

Further information about these studies can also be found at www.clinicaltrials.gov.

Sofosbuvir is an investigational product and its safety and efficacy have not been established.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including risks related to the possibility of unfavorable results from ongoing and subsequent clinical trials involving sofosbuvir, including in combination with other products, for the treatment of HCV, and the possibility that regulatory authorities may not approve sofosbuvir for HCV-related indications and any marketing approval may have substantial limitations on its use. As a result, sofosbuvir may never be successfully commercialized. In addition, Gilead may make a strategic decision to discontinue development of sofosbuvir if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)

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WASHINGTON--(BUSINESS WIRE)--Nov. 2, 2013-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from a Phase 3 study, PHOTON-1, evaluating the investigational once-daily nucleotide analogue sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection among patients co-infected with HIV. In the trial, 76 percent (n=87/114) of genotype 1 HCV treatment-naïve patients receiving 24 weeks of an all-oral, interferon-free regimen of sofosbuvir plus ribavirin (RBV) achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. These data will be presented this week during the 64th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2013) in Washington, D.C.

Up to one-third of people living with HIV in the United States are co-infected with HCV. Current HCV medicines are associated with suboptimal cure rates among co-infected patients and can cause significant interactions with HIV drugs.

“There is a clear need for HCV treatment regimens that are more effective and safer for patients who are co-infected with HIV,” said Douglas Dieterich, MD, Professor of Medicine in the Division of Liver Diseases and Director of Continuing Medical Education in the Department of Medicine at Mount Sinai School of Medicine. “In this study, sofosbuvir-based all-oral therapy achieved high SVR rates in a hard-to-treat patient population. This regimen may have the potential to help us overcome the clinical challenge of treating HCV/HIV co-infection.”

PHOTON-1 also assessed 12 weeks of sofosbuvir plus RBV among genotype 2 and 3 HCV treatment-naïve patients with HIV. Among genotype 2 patients receiving this regimen, 88 percent (n=23/26) achieved SVR12, while 67 percent (n=28/42) of genotype 3 patients achieved SVR12. All patients in PHOTON-1 who did not achieve SVR12 had viral relapse after cessation of therapy, with the exception of two participants who were non-adherent to study drugs.

Treatment discontinuations due to adverse events were reported in three percent of patients receiving 24 weeks of therapy and four percent of patients receiving 12 weeks of therapy. The most common side effects observed in the study were consistent with the safety profile of RBV and included fatigue, nausea, headache and insomnia.

About PHOTON-1

PHOTON-1 is an ongoing open-label Phase 3 study being conducted at sites in the United States and Puerto Rico to evaluate the efficacy and safety of 12 or 24 weeks of sofosbuvir 400 mg once-daily plus weight-based RBV (1,000 or 1,200 mg/day) among HCV treatment-naïve patients with genotype 1, 2 or 3 HCV infection who are also HIV-positive.

Ninety-five percent of PHOTON-1 patients were receiving antiretroviral therapy for their HIV infection. The HIV treatment regimens permitted in the study were based on the results of a separate Phase 2 drug-drug interaction study conducted by Gilead demonstrating that sofosbuvir did not significantly affect the pharmacokinetic parameters of drugs from various classes of antiretrovirals. The most common HIV treatment regimens taken by patients in PHOTON-1 were Gilead’s Truvada® (emtricitabine/tenofovir disoproxil fumarate) administered with efavirenz, atazanavir/ritonavir, darunavir/ritonavir or raltegravir.

Additional information about PHOTON-1 can be found at www.clinicaltrials.gov.

Sofosbuvir is an investigational product and its safety and efficacy have not been established.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable longer-term resulting from clinical trials evaluating sofosbuvir, including in combination with other products and among patients with HCV/HIV co-infection or HCV monoinfection. In addition, regulatory authorities may not approve sofosbuvir for HCV-related indications and any marketing approval may have substantial limitations on its use. As a result, sofosbuvir may never be successfully commercialized. Further, Gilead may make a strategic decision to discontinue development of sofosbuvir if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Truvada is available at www.gilead.com.

Truvada is a registered trademark of Gilead Sciences, Inc.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)

Source