Friday, February 18, 2011

Hepatitis C News;TMC435 Trial For Naive And Relapsed Patients Has Started/Feb 2011

HUDDINGE, Sweden, February 18, 2011/PRNewswire-FirstCall/ --
Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, notes that its development partner, Tibotec Pharmaceuticals, announced today that the global phase 3 studies with TMC435 in treatment-naive patients and patients who have relapsed after prior SOC treatment have started.
Phase 3 Program in brief:
- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive
- TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive
- TMC435-C3007 or PROMISE includes approximately 375 who have
relapsed after prior interferon-based treatment
Medivir's CEO, Ron Long,
"This is a momentous and important step for both the project and for Medivir as a company. It is impressive to see Tibotec's diligence and enterprise in developing TMC435 in a time-effective and thorough fashion."
The phase 3 milestone of Euro 5 million flagged in February 2010 will now be recognized as income in the first quarter 2011.

Tibotec released today the following statement:
Cork, Ireland, February 17, 2011 - Tibotec Pharmaceuticals announced today that two global, registrational phase 3 trials are recruiting patients to examine TMC435, its investigational hepatitis C protease inhibitor, in treatment-naive adults with chronic genotype 1 hepatitis C virus (HCV). A third global phase 3 trial is being conducted in genotype 1 HCV patients who have experienced a viral relapse after prior interferon-based treatment.

Approximately 3.2 million people in the U.S. live with chronic hepatitis C disease and more than 170 million people have the disease globally.[i],[ii] The response-guided trials will compare the efficacy, safety and tolerability of TMC435 given as a single 150 mg oral tablet once daily for 12 weeks versus placebo; each patient also will be treated with a background regimen of peginterferon and ribavirin for 24 or 48 weeks.

"TMC435 is an important component of our growing HCV pipeline said Brian Woodfall M.D., Vice President of Global Clinical Development at Tibotec." "The initiation of the TMC435 phase 3 clinical trial program reinforces our commitment to develop innovative new treatment options that may decrease the duration of treatment for patients with chronic hepatitis C infection."
Three global studies

The first global, phase 3, double-blind, randomized study, known as TMC435-C208 or QUEST-1 (QD dosing of TMC435 of previoUsly untreated GEnotype 1 patienTs-1), will evaluate a single TMC435 once-daily oral tablet (150 mg) versus placebo in treatment-naive HCV patients. Both groups will also receive peginterferon alfa-2a (Pegasys(R)) and ribavirin (Copegus(R)) as part of their treatment.

The second global, phase 3, double-blind, randomized study, known as TMC435-C216 or QUEST-2 (QD dosing of TMC435 of previoUsly untreated GEnotype 1 patienTs-2), also will evaluate a single TMC435 once-daily oral tablet (150 mg) versus placebo in treatment-naive HCV patients. However, patients in this trial will either receive peginterferon alfa-2a (Pegasys(R)) and ribavirin (Copegus(R)) or peginterferon alfa-2b (PegIntron(R)) and ribavirin (Rebetol(R)) as part of their treatment.

A third global, phase 3, double-blind randomized study, known as TMC435-C3007 or PROMISE (PROtease inhibitor TMC435 In PatientS who have previously rElapsed on IFN/RBV), will evaluate a single TMC435 once-daily oral tablet (150 mg) verses placebo in HCV patients who experienced viral relapse after previous interferon-based therapy. Both groups will receive peginterferon alfa-2a (Pegasys(R)) and ribavirin (Copegus(R)). The complete treatment duration for all three trials will be 24 or 48 weeks, depending on patient response.
In parallel to these trials phase 3 studies for TMC435 have also recently been launched in Japan. ...
Centers and inclusion criteria's
The studies will be conducted at more than 160 sites in 24 countries, including the U.S. and countries throughout Europe, and together seek to enroll approximately 1,125 HCV genotype 1 infected patients who are treatment-naive or have experienced a relapse after previous interferon-based HCV therapy. To be eligible, patients must have chronic hepatitis C infection, and must have had a liver biopsy within three years of the screening visit. For those patients who have not had a liver biopsy in the three years prior to the study, one will be performed before the baseline visit. In addition, eligible patients need to have completed a recent ultrasound with no findings suspicious of hepatocellular carcinoma (HCC). Patients with signs of hepatic decompensation, liver disease of any non-HCV etiology, co-infection with hepatitis B or HIV-1 and 2 or a history of malignancy within 5 years of the screening visits are ineligible for the study.

Patients in QUEST-1 and QUEST-2 trials must not have received any prior treatment for hepatitis C, and patients in the PROMISE trial must have previously received at least 24 weeks of (peg)interferon-based therapy, along with documented negative HCV RNA at last on-treatment measurement, and have relapsed (detectable HCV RNA) within one year of last taking medication.

The primary endpoint of the studies is to assess whether TMC435 is superior to placebo in achieving sustained virologic reponse (SVR), defined as HCV RNA less then 25 IU/ml undetectable, 24 weeks after the planned end of treatment (SVR 24), with the final analysis being performed after the last patient reaches week 72 of the study. Secondary endpoints include superiority of TMC435 versus placebo at 12 weeks (SVR 12), after planned end of treatment and at week 72 of the study. Evaluations of viral breakthroughs, relapse rates in treatment groups, safety and tolerability also will be assessed.
About TMC435 in other clinical studies
TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Medivir and Tibotec Pharmaceuticals, to treat chronic hepatitis C virus infections.

In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011.
For additional information for these studies, please see
About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.

For additional information, please contact Medivir ( ) Rein Piir, CFO & VP Investor Relations Mobile: +46-708-537-292 M:Communications Europe: Mary-Jane Elliott/ Amber Bielecka /Nick Francis +44(0)20-7920-2330 USA: Roland Tomforde +1-212-897-5497
Source: Medivir

Bristol-Myers Squibb Foundation Awards Nearly $1 Million to Improve HBV and HCV Awareness, Prevention and Care in China and India

The Bristol-Myers Squibb Foundation has awarded four new grants to help improve awareness, prevention and care of hepatitis B (HBV) and hepatitis C (HCV) in China and India. The grants total nearly $1 million USD and bring the Foundation’s commitment to reducing hepatitis-related health disparities in Asia to $8 million USD over the past three years. The grant recipients were announced at the Asian Pacific Association for the Study of the Liver (APASL) 2011 Conference in Bangkok, Thailand, where leaders in the hepatology field gathered to promote scientific advancement and education in the Asia Pacific region. (1)
The mission of the Bristol-Myers Squibb Foundation is to help reduce health disparities in communities where the need is greatest. China and India together have an estimated 123 million people chronically infected with HBV and 59 million people chronically infected with HCV, accounting for almost 50 percent of all HBV and HCV infections worldwide. (2,3)
The Foundation’s work related to hepatitis in Asia falls under the Delivering Hope™: Awareness, Prevention and Care umbrella programme. To date, Delivering Hope has supported 32 programme grants across Asia, specifically 14 grants in mainland China, three in Taiwan, 12 in India and three in Japan. “Our four new grant recipients reflect the best use of resources to reduce hepatitis B- and C- related disparities in China and India. They mobilise, serve and strengthen their local communities’ health care armament in the fight against these diseases,” said John Damonti, president, Bristol-Myers Squibb Foundation.
“We look forward to improved hepatitis awareness, prevention and care in these countries’ communities, as well as to applying our key learnings from these programmes in other countries.”

In keeping with the Foundation’s commitment to sharing lessons learned, funding recipients will prepare a comprehensive final report at the completion of their projects. These reports will be shared with the HBV and HCV community to enhance the body of knowledge on hepatitis prevention, care, and support.

Chinese Grant Recipient Aims to Inform HCV Public Policy Approximately 40 million people are infected with HCV in China, leading the Chinese government to declare it an urgent public health issue. (4) HCV prevalence is estimated to continue to grow, and associated comorbidities such as liver disease, cirrhosis and cancer, are a growing health concern. (5)
The Chinese grant winner, the Wu Jieping Medical Foundation, will conduct an operational study of the socio-economic burden of HCV patients and their families in China. The study will aim to recommend policies that will improve prevention and access to care. The grant will also fund a comprehensive intervention programme for a cohort of HCV patients.
India Grants Provide Hepatitis Education, Vaccination for Multiple Audiences India is one the fastest growing economies, yet approximately 25-30 percent of the population lives below the poverty line. More than 30 million people in India are infected with HBV (6) and 19 million are infected with HCV. (7)

The Foundation has awarded three grants to India-based organizations. United Way Mumbai will conduct an extensive HBV and HCV awareness campaign targeted at college students and high-risk groups. The campaign will promote HBV vaccination, HBV and HCV diagnosis and early referral to care. The Hepatitis Foundation of Tripura in conjunction with the government of the state of Tripura will institute at-birth HBV vaccinations and train health care professionals and community groups on disease education for mothers and their families. The Health Oriented Programmes and Education (HOPE) Initiative is a public-private sector partnership that will provide HBV education for school children in Uttar Pradesh, in the hope of spreading the word among their families and local communities. The Uttar Pradesh State government has endorsed the programme and will be an active partner in developing it across India’s most populous state.
About Chronic Hepatitis B Chronic hepatitis B is a serious global health issue and is transmitted by person-to-person contact with infected blood or bodily fluids. Worldwide, more than 2 billion people have been in contact with the hepatitis B virus and approximately 350 million people are chronically infected, (8) resulting in about one million deaths annually from liver cancer, cirrhosis or liver failure. (9)

About Hepatitis C Hepatitis C is a virus that infects the liver and is transmitted through direct contact with blood. An estimated 170 million people worldwide are infected with hepatitis C. (10) One to five percent of people with chronic infection will develop liver cancer. Although there is no vaccine to prevent hepatitis C, it is a curable disease. (11)

About Bristol-Myers Squibb Foundation and Delivering Hope The Bristol-Myers Squibb Foundation is an independent charitable organisation whose mission is to reduce health disparities and improve health outcomes around the world for patients disproportionately affected by serious disease. The Foundation accomplishes this by strengthening community-based health care worker capacity, integrating medical care and community-based supportive services, and mobilising communities in the fight against disease.

Since 2002, the Foundation has supported efforts in Asia, initially focusing on preventing mother-to-child transmission of hepatitis B and promoting hepatitis B immunisation in China. In 2006, the Foundation expanded those efforts to provide broader support for hepatitis B and C awareness, prevention and education, including the adoption of hepatitis B and C interventions and education in public health programmes.

Today, the Foundation’s priority hepatitis B and C programmes encompass capacity building for health care professionals and lay health workers, disease education and awareness, and sharing of best practices in the prevention and management of hepatitis B and C to inform public health policy. Beyond hepatitis, the Foundation also focuses on HIV/AIDS in Africa through its SECURE THE FUTUREƒ programme; cancer in Central and Eastern Europe through its Bridging Cancer Care programme; and diabetes and mental-health in the United States through its Together On Diabetes and Mental Health and Well-Being programmes. For more information, view the Bristol-Myers Squibb Foundation’s Web site at:

From HIV and Hepatitis

Treatment of Recurrent Hepatitis C after Liver Transplantation
SUMMARY: Hepatitis C patients with advanced liver disease may benefit from interferon-based therapy before receiving a liver transplant, but side effects are common and response rates are low, according to a systematic research review described in the January 2011 issue of Alimentary Pharmacology and Therapeutics. Injected antibodies do not prevent the new liver from becoming infected, but pegyalted interferon plus ribavirin can cures recurring HCV about 30% of the time.

Tenofovir Remains Effective against Hepatitis B Virus after 5 Years in HIV/HBV Coinfected Patients
By Liz Highleyman
SUMMARY: Tenofovir (Viread, also in the Truvada and Atripla combination pills) continues to potently suppress both hepatitis B virus (HBV) and HIV in coinfected patients for at least 5 years, according to a study published in the December 2010 issue of Gastroenterology. The findings support current guidelines recommending that HIV/HBV coinfected people should receive an antiretroviral therapy (ART) regimen that includes drugs with dual action against both viruses.

Liver Transplants Not Available Equally Across the Nation
KANSAS CITY, MO. — Epidemics of hepatitis C, obesity and alcoholism are fueling the need for liver transplants, with over 16,000 Americans waiting for one. But the chances of actually getting a transplant are worse in some parts of the country than others.FOX 4 Medical Reporter Meryl Lin McKean is Working for You with the report.


First-line NNRTI and Protease Inhibitor Regimens Work Equally Well for Children with HIV
By Liz Highleyman
SUMMARY: Initial antiretroviral therapy (ART) regimens containing protease inhibitors and those with non-nucleoside reverse transcriptase inhibitors (NNRTIs) both produced good outcomes for children with HIV, according to research published in the February 1, 2011 advance online edition of Lancet Infectious Diseases. Viral load dropped by a similar amount, but children who started on NNRTIs and those who waited longer to switch were more likely to develop drug resistance.

Does Lack of Anti-HIV Antibodies in Blood Help Protect against Infection?
SUMMARY: People whose immune systems mount a weaker response to HIV may be resistant to infection, since the T-cells that proliferate in the blood when they encounter invaders provide ideal targets for the virus, suggests research published in the February 9, 2011, advance online edition of Immunity. Investigators found that monkeys who were immunized with a gp41 vaccine and developed mucosal anti-HIV antibodies were almost fully protected against vaginal infection, even though they did not have detectable circulating blood antibodies.

Evaluation Resumes for Gilead's Rilpivirine/Truvada Single-tablet
SUMMARY: Gilead Sciences announced this week that the company has re-filed a New Drug Application (NDA) for its single-tablet antiretroviral regimen containing the investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (TMC278) plus tenofovir/emtricitabine (the drugs in the Truvada pill). In July the U.S. Food and Drug Administration (FDA) declined to accept the NDA pending further information about manufacturing and testing, but has now determined that the approval process may move forward.

Thousands of HIV patients may have undiagnosed Hepatitis C
13,000 people who are living with HIV in the UK may also have Hepatitis C but not realise it, according to a new report published in the Journal of Viral Hepatitis.
Peter Lloyd
18 February 2011

13,000 people who are living with HIV in the UK may also have Hepatitis C but not realise it, according to a new report published in the Journal of Viral Hepatitis. The figure represents nearly 70 per cent of the total estimate of people with HIV and Hepatitis C in the UK. The report is based on a study by the UK Collaborative HIV Cohort, which indicates that gay men remain a high risk group, second only to injecting drug users, with 7 per cent of HIV-positive gay men known to have Hepatitis C. The study looked at 31,765 patients provided with care at ten specialist HIV clinics between 1996 and 2007. 36 per cent had never been tested for Hepatitis C, despite guidelines from BHIVA (British HIV Association) recommending screening for all HIV-positive patients. Much of the increase of Hepatitis C among HIV-positive gay men is now understood to be due to sexual transmission.

If left untreated, the virus can lead to an increased risk of cirrhosis, liver cancer and even premature death. Re-infection is also fairly common. A study in Germany found that 22 per cent of HIV-positive gay men who had the virus and cleared it, either spontaneously or after treatment, became re-infected within less than six years. In August 2010, GMFA launched an advertising campaign to make HIV-positive men aware of the health risks of Hepatitis C and HIV co-infection, how it is transmitted, and the benefits of early diagnosis and treatment for those with Hepatitis C. Matthew Hodson, Head of Programmes at GMFA, says: “It’s a major concern that HIV-positive men aren’t being screened regularly for Hepatitis C. The virus often shows no symptoms and most people who get infected will not be able to get rid of it without treatment. We urge men with HIV to ask about Hepatitis C at their clinics and ensure they get tested. By getting diagnosed early, you can start treatment and stand the best chance of overcoming the virus.”

Off The Cuff

Wrong patient got kidney at USC
USC University Hospital shut down its kidney transplant program last month after realizing the error.

The hospital said transplants may resume as early as Friday.
By Alan Zarembo and Lisa Girion, Los Angeles Times
February 18, 2011
USC University Hospital halted kidney transplants last month after a kidney was accidentally transplanted into the wrong patient, according to a spokesman for the program that coordinates organ transplants in Los Angeles.The patient who received the wrong kidney escaped harm, apparently because the kidney happened to be an acceptable match, said Bryan Stewart, spokesman for the program, OneLegacy, which was notified of the error by the hospital

Ira's precious gift
18 Feb, 2011 11:27 PM
THE day Ira Effrett was told she did not have long to live was the day she was given the most beautiful gift – a donor liver to allow her to keep on living.
Mrs Effrett, 60, attended a check-up at The Austin hospital in Melbourne in September when doctors told her she did not have long to live.
Hours later, a voice down the telephone line asked her to travel back to the hospital from her Wendouree home immediately.
A donor liver was waiting to replace her liver that was badly damaged by primary biliary cirrhosis, a disease in which bile ducts die. After a nine-hour operation, Mrs Effrett was on the road to recovery.

/New On The Blog


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