February 18, 2012

Hard-to-Treat Group Trips Up HCV Drug

By Michael Smith, North American Correspondent, MedPage Today

Published: February 17, 2012

A promising hepatitis C medication has run into a roadblock in a small group of hard-to-treat patients, according to the drug's maker.

The drug, dubbed GS-7977, was being used with a standard drug, ribavirin, but without the other standby, pegylated interferon, to treat 10 patients with genotype one virus, according to Gilead Sciences.

But after a good early response in eight patients, six of them relapsed within a month of finishing the 12-week therapy. The remaining two have not relapsed but have just finished treatment, the company said.

In a conference call, company officials said the results were unexpected but will not derail the drug, which has been shown to be safe and effective in some groups of hepatitis C patients.

The patients who relapsed were so-called "null responders" who had previously been treated with the standard ribavirin and interferon, but who had not cleared the virus.

They are a "challenging patient population to cure," said Norbert Bischofberger, PhD, Gilead's chief scientific officer.

The drug is also being tested, using the same approach, in patients who have not previously been treated and in patients with genotypes two and three of the virus, who are easier to treat.

Preliminary data in the genotype two and three patients, presented last year, showed that 10 of 10 had been cured. Data on the treatment-naive patients is to be presented next month.

The finding in the null responders has "answered an important question," according to Gilead CEO John Milligan, PhD, and hints that in some patient groups more than one direct-acting agent may be needed for a cure.

Bischofberger told those on the conference call that it's also possible, in his opinion, that the 12-week duration of treatment was simply not long enough to knock the virus down.

The direct-acting agents, which target elements of the virus itself, are a new departure in hepatitis C therapy, which for years has relied on boosting the immune system overall using ribavirin and interferon.

GS-7977 is a nucleotide analog polymerase inhibitor; other drugs, both approved and under development, attack the viral protease enzyme or other targets.

But the advent of the direct-acting agents has sparked a push to stop using interferon, which is difficult for many patients to tolerate, and some studies have suggested that a combination of the new agents would work well without the older drug.

In this case, exactly why such a high percentage of the patients relapsed remains unclear, Milligan said, reminding those on the call that the data are "preliminary results" in only eight patients.

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Also See: Gilead Announces Data For Genotype 1 Null Responder Hepatitis C Patients Enrolled In ELECTRON Study

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PRESS RELEASE

Feb. 18, 2012, 9:00 a.m. EST

PRINCETON, N.J., Feb 18, 2012 (BUSINESS WIRE) -- The Bristol-Myers Squibb Foundation has awarded three new grants to improve prevention, diagnosis and care of hepatitis B (HBV) and hepatitis C (HCV) in China and India as part of its Delivering Hope(TM): Awareness, Prevention and Care umbrella program which is committed to reducing hepatitis-related health disparities in Asia. 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.

The grant recipients, which range in scope from national and regional government health, charitable non-profit and advocacy organizations, were announced at the Asian Pacific Association for the Study of the Liver (APASL) 2012 Conference in Taipei, Taiwan, where leaders in the hepatology field gathered to promote scientific advancement and education in the Asia Pacific region. Organizations and projects receiving support include:

-- The Chinese Foundation for Hepatitis Prevention and Control (CFHPC), working in partnership with the Chinese Center for Disease Control and Prevention and Shanxi Center for Disease Control, will enhance HCV prevention, diagnosis, support and care through training of physicians and health providers at various levels, as well as patient and community outreach in the Shanxi Province.

-- The Shanghai Charity Foundation (China) will create a first of its kind program targeting high risk groups with disease management initiatives for HCV and HBV in Shanghai. This will include vaccinations, screenings and behavior change programs to strengthen prevention efforts.

-- The Liver Foundation, West Bengal (India) will establish and maintain an advocacy platform focused on empowerment of hepatitis patients, ensuring knowledge and awareness of their disease, rights and privileges, as well as access to care.

"The benefit of these organizations and programs lies in their ability to empower people in local communities with knowledge about prevention, diagnosis and care of hepatitis C and hepatitis B," said John Damonti, president, Bristol-Myers Squibb Foundation. "Through Delivering Hope, The Bristol-Myers Squibb Foundation continues to harness expertise and resources in community-based programs, and leverage those best practices to help others."

The mission of the Bristol-Myers Squibb Foundation is to help reduce health disparities in communities where the need is greatest. Marking a decade of support, Delivering Hope has invested and initiated 38 program grants across Asia totaling more than $9.7 million USD, specifically 16 grants in mainland China, three in Taiwan, 15 in India and four in Japan. In keeping with the Foundation's commitment to sharing lessons learned, funding recipients participated in a two-day conference to discuss tracking and reporting outcomes, impact and best practices. These reports will be shared with the HBV and HCV community to enhance the body of knowledge on hepatitis prevention, care and support.

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, resulting in about one million deaths annually from liver cancer, cirrhosis or liver failure.

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. 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.

About Bristol-Myers Squibb Foundation and Delivering Hope

The Bristol-Myers Squibb Foundation is an independent charitable organization 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 mobilizing communities in the fight against disease.

The Foundation has supported efforts in Asia since 2002, initially focusing on preventing mother-to-child transmission of hepatitis B and promoting hepatitis B immunization 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 programs.

Today, the Foundation's priority hepatitis B and C programs 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 FUTURE(R) program; cancer in Central and Eastern Europe through its Bridging Cancer Care(TM) program; and diabetes and mental-health in the United States through its Together On Diabetes(R) and Mental Health and Well-Being in the U.S. programs. For more information, view the Bristol-Myers Squibb Foundation's Web site at: http://www.bms.com/foundation/pages/home.aspx .

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com , or follow us on Twitter at http://twitter.com/bmsnews .

SOURCE: Bristol-Myers Squibb

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