Margaret Dudley, a 61-year old resident of San Antonio, Texas, mother of three and grandmother of six, was diagnosed with the Hepatitis C virus (HCV) in September, 2011. A cosmetic tattoo delivered the life-threatening virus.

Margaret immediately began researching everything she could about the disease, and most important, seeking a cure. She learned there was a groundbreaking cure. In April 2012, Bristol-Myers Squibb (BMS) announced it achieved a 100 percent cure rate for HCV. In phase two trials, Bristol-Myers Squibb, using its drug daclatasvir in combination with sofosbuvir from Gilead Sciences, achieved a major milestone: 100 percent cure rate for HCV type 1, with similar results with the same drugs for HCV type 2 and HCV type 3. The two companies each own a drug that in combination has cured hepatitis patients in 12 weeks. The all-oral combination is a huge advance, due not only to the remarkable results, but because they had mild side effects (mild to moderate fatigue, headache, nausea) that were well-tolerated, unlike the traditional two-drug chemo-style treatment, interferon and ribavirin, both of which have severe and debilitating side effects and only cure about 40 percent of the time.  Read more »

Reported by Jules Levin | AASLD | Nov 9-13 2012 Boston

High Rate of Sustained Virologic Response With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B Inhibitor), With or Without Ribavirin, in Treatment-Naive Patients Chronically Infected With HCV GT 1, 2, or 3

Recent data from the Boston AASLD meeting confirm the spectacular Phase II combination results of Gilead’s sofosbuvir administered with BMS’ daclatasvir. (See results). These are truly amazing SVR rates which are much better than the current standard of care and without the use of the dreaded combination of interferon and ribavirin. Thousands of patients were so very hopeful about the possibility of quick access to this much more safe and effective, easily administered HCV drug combination.

How can Gilead Sciences in good conscience abandon a proven drug combination that has 100% cure rate in some patient populations with minimal side effects?  This combination has also shown to be safe in people with cirrhosis and a very real candidate for use in the liver transplant population. What is Gilead doing about providing early access to these very sick people who may actually die before Gilead completes the drug studies necessary for an all-Gilead combination regimen?

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AASLD 2012: Dual Regimen Cures Most Patients

Published on Thursday, 15 November 2012 00:00 | Written by Liz Highleyman

A 12-week once-daily regimen of 2 direct-acting hepatitis C drugs — sofosbuvir (formerly GS-7977) and daclatasvir (formerly BMS-790052) — produced sustained virological response rates for treatment-naive patients in the 90% to 100% range, and appeared effective regardless of HCV subtype, IL28B pattern, or use of ribavirin, according to a late-breaker presentation at the American Association for the Study of Liver Diseases Liver Meeting (AASLD 2012) this week in Boston. The developers are not planning further studies of this combination, however, leaving its fate uncertain.

Last year’s approval of the first direct-acting hepatitis C drugs ushered in a new era of treatment, but many patients and providers are holding out for all-oral therapy without pegylated interferon and its difficult side effects — and if possible without ribavirin, which causes anemia.

It has become difficult to keep track of the numerous investigational anti-HCV drugs in the pipeline and the many different combination regimens at various stages of the development process.

But one combination that stands out on the basis of early studies is Gilead Sciences’ once-daily nucleotide analog polymerase inhibitor sofosbuvir plus Bristol-Myers Squibb’s HCV NS5A replication complex inhibitor daclatasvir.

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Promising HCV Combo May Not See Light of Day

By Michael Smith, North American Correspondent, MedPage Today
Published: November 14, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

BOSTON – In a trial described by one expert as a “home run,” a combination of two investigational oral hepatitis C (HCV) medications delivered highly promising results.

But despite the excellent results, it’s unlikely the combination of daclatasvir and sofosbuvir will go forward – the drugs are owned by different pharmaceutical companies.

Interim results showed that the combination, with or without the standard HCV drug ribavirin, led to cure rates approaching 100%, according to Mark Sulkowski, MD, of Johns Hopkins University.

The combination appeared to yield similar results regardless of viral genotype or the presence of ribavirin, Sulkowski told a late-breaker session at the annual meeting here of the American Association for the Study of Liver Diseases.

“That’s a home run,” commented hepatologist Paul Pockros, MD, of Scripps Clinic in La Jolla, Calif., who was not involved in the study.

“The issue is they’re not likely to go forward,” he told MedPage Today.

Daclatasvir, an NS5A replication complex inhibitor, is owned by Bristol-Myers Squibb, while sofosbuvir, a nucleotide analog NS5B polymerase inhibitor, is being developed by Gilead Sciences.

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Hepatitis C Drug Derailed by Deal


Earlier this year, researchers reported impressive results for a treatment that offered a potential cure for intractable cases of hepatitis C. But now, millions of patients waiting for such a breakthrough may never get it.

The story of how the promising therapy got stalled despite positive research illustrates a little-acknowledged truism in the pharmaceutical industry: Sometimes drugs die not because they don’t work or are unsafe, but because they don’t make business sense.

The hepatitis C treatment paired a pill from Bristol-Myers Squibb Co. with another from a biotech called Pharmasset under an agreement struck last year. After the successful early research, Bristol was “very keen” to quickly move into final testing, according to Douglas Manion, a Bristol drug-development official. But by that time, things had changed: Pharmasset had been bought by Bristol’s rival Gilead Sciences Inc. And Gilead “declined to collaborate,” said Dr. Manion.

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Gilead – Hepatitis C – New drug combination cures 98 – 100%

WASHINGTON (AP) — Shares of drugmaker Gilead Sciences Inc. hit an all-time high in trading Tuesday after the company released overwhelmingly positive results for an experimental hepatitis C drug that analysts say could be a best-in-class medication.

Over the weekend Gilead presented results from its combination of sofosbuvir and daclatasvir that cured between 98 and 100 percent of patients within 12 weeks.

About 3.2 million people in the United States have hepatitis C, a blood-borne disease linked to 12,000 U.S. deaths a year. The traditional two-drug treatment for the virus cures only about 40 percent of people and causes side effects like nausea, fatigue and vomiting.

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A Success Story – Hepatitis C Cure

I am feeling incredibly grateful and the two others that I know of on exactly the same trial also made SVR4. It turns out we’re on the world’s most successful trial for Genotype 1’s. All of the genotype 1’s on the GS-7977 + Daclatasvir protocol made it to SVR4. Four weeks post treatment and they are still listed as virus undetectable. This looks like this really is the Interferon and Ribavirin free cure. What great good fortune we had to have done it!
I’ve basically felt well since I stopped the treatment almost six weeks ago now. I have a bit of tiredness and sluggishness sometimes, nothing major.”

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By Angela Covo | | 

Hepatitis-C (HCV) is a virus that attacks the liver – it can be deadly and its effects (fatigue, nausea, weight loss, body aches) can be disabling. The disease can also behave like a silent killer, destroying a person’s liver over years without any symptoms. The Centers for Disease Control (CDC) recently issued a warning and recommends that everyone between the ages of 45 and 65 be tested — potentially millions more could have the virus and not even know it. This story is about a cure for the disease — a cure patients can’t get access to.

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Gilead preps late-stage sprint on blockbuster hep C studies

July 30, 2012 | By 

It looks as if Gilead can’t be shamed into a late-stage hepatitis C collaboration with Bristol-Myers Squibb after all.

Despite taking heat for its refusal to commit to BMS ($BMY), Gilead ($GILD) has now mapped out a plan to get its own in-house combo into a late-stage study later this year. And it believes it has the goods to jump ahead, nailing down the pivotal data needed for a 2014 regulatory filing after a high-speed, forced march into the clinic.

A few weeks ago BMS CEO Lamberto Andreotti blasted Gilead for refusing to push ahead on a Phase III study combining Gilead’s GS-7977–purchased for a princely sum when the company bought out Pharmasset for $11 billion–with BMS’s daclatasvir after the oral treatment offered stellar results in a mid-stage study. Daclatasvir is an NS5a inhibitor and the combo produced high cure rates at 12 weeks for the genotype 2/3 as well as genotype 1 hep C groups. Not surprisingly, BMS–which acquired the nuc INX-189 in the $2.5 billion Inhibitex buyout– wanted to jump into a late-stage study with a combo that promised to swiftly move ahead as a new market leader. And experts in the field were left chomping at the bit.

Read more: Gilead preps late-stage sprint on blockbuster hep C studies – FierceBiotech

Sufferers pin hopes on faster and safer drugs | By Theresa Clift |

Margaret Dudley, 61, begins her morning like many others — with a cup of coffee and a scan of Internet news sites. Unlike most, though, she’s looking for a headline she believes could save her life. Then she spends her day trying to make it happen, pushing research firms to speed their work on promising drugs.

It has been her routine since September, when she was shocked to receive a diagnosis of chronic hepatitis C, or HCV.

She might find the news she’s looking for sooner than she expects. Half a dozen companies are doing trials for drugs that could work faster and without the side effects of current treatment.

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