Two companies have an effective 100% cure for Hepatitis C without interferon or ribavirin. But this cure is literally being withheld from millions

Two companies have an effective 100% cure for Hepatitis C without interferon or ribavirin.  But this cure is literally being withheld from millions by pharmaceutical giant Gilead Sciences because they are more concerned about profits than human lives.

This cure is a combination Bristol-Myers Squibb's drug daclatasvir and Gilead Science's GS-7977 (sofosbuvir). When these two drugs were used together, 100 percent of Hepatitis C patients were cured.  These results are amazing for the approximately 170 million people in the world with Hepatitis C.  The problem is that Gilead Sciences is unwilling to work with Bristol-Myers. The cure exists while people continue to suffer and die.

 Dr. Douglas J. Manion, a senior vice president for Bristol-Myers, said his company was "keen" on working with Gilead but that "thus far, they have been unwilling to engage in that collaboration."

Quote from Dr. Paul Thuluvath - Wall Street Journal:

"We had never, ever imagined—even in our wildest dreams—we could treat" hepatitis C so quickly, effectively and without serious side effects, said Paul Thuluvath, a doctor at Mercy Medical Center in Baltimore who had six patients test the new treatment. "I think the pharmaceutical companies have a moral responsibility to work together and bring it to market instead of [following] their own vested interests." 

Quote from Dr. Scott Friedman – New York Times:

“The only appropriate motivation should be what is the best and fastest way to get cures, not what is best for the shareholders,” said Dr. Scott Friedman, chief of liver diseases at the Mount Sinai School of Medicine in New York, who was not involved in the trial.” 

Quote from EASL Secretary General Mark Thursz:

EASL Secretary General Mark Thursz wants to see the two companies work together.

"The combination of daclatasvir and GS-7977 has shown positive results at Phase II. EASL is disappointed that development of this combination has been halted as daclatasvir and GS-7977 promised to deliver a highly effective oral regimen that we hoped would be available to HCV patients soon," said Thursz.

Act NOW and sign the petition to insist Gilead Sciences work with Bristol-Myers on the Phase III drug trials necessary to get this cure to market.   
www.HepC-Cured.org

More than 240,000 people have died since these results were released this past April and there is still no collaboration. How many more must die before Gilead Sciences starts putting human lives before profits?

To:
Gilead Sciences
Gilead Sciences
Gilead Sciences
Bristol-Myers Squibb, Media
John C. Martin, Gilead Sciences, CEO 

Open Letter to Gilead Sciences, their Board of Directors and shareholders:

The recent data from the Boston AASLD meeting confirmed the amazing 100% cure rate with Gilead’s sofosbuvir and Bristol-Myers Squibb’s daclatasvir. Not only did this combination cure genotypes 1, 2 and 3, this cure was achieved without the toxic and debilitating side effects of ribavirin which is known to cause severe anemia and other life-threatening conditions. There are even some concerns that ribavirin may in fact be carcinogenic (see http://www.aafp.org/afp/2005/0815/p655.html) So millions of patients and their families were so very hopeful about the possibility of quick access to this safer and effective HCV drug combination without ribavirin.

But to our continued disbelief and monumental heartbreak, Gilead refuses to move forward in this collaboration with Bristol-Myers Squibb and the most significant discovery in the history of hepatitis C. The rationale for this appears to be nothing more than Gilead’s determination to corner the market with its own in-house NS5a inhibitor GS-5885, which is not effective in the three genotypes and most likely will require the addition of the dreadful ribavirin. Other companies, such as Abbott, are now seeking their own ribavirin-free cocktails and hopefully will prove successful… but it will take years. In the meantime, Gilead could be forging ahead with this combination of sofosbuvir and daclatasvir and bring it to market much sooner than any others in development and start recouping its $11 billion investment as well as saving millions of lives. This would be a win-win situation for everyone involved, i.e., Gilead Sciences, its shareholders, the people suffering and dying with this disease, as well as their families who love them just as much as you love your own families.

Although we may not have hundreds of thousands of signatures on our petition and we have not yet been able to capture the world’s attention about this urgent and dire situation, do not take that as any indication of our intent to quit in the pursuit of this cure. We have no other choice in this matter and we will continue on… day after day, week after week, month after month… until we no longer have any life left in our bodies, or until another company comes up with a cure as safe and effective as this is.

Sincerely,
[Your name]

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Here is the petition: 

-http://www.change.org/petitions/gilead-sciences-stop-withholding-this-cure-for-hepatitis-c

What am I going to do now, Nelson?

What am I going to do now, Nelson? Aug 6, 2010 Hi Nelson, I hope all is well. Last year you told me about the trial with ibalizumab at ACRIA and I received the meds for about 1 year. In the beginning of thet trial the virus became undectadable but then it started to go up again and they took me out of the study. I was in the trial for about 1 year. My doctor changed my regimen to recycle meds...I'm resistant to all of them. I am now on Aptivus, Viread, Norvir and Trizivir. Do you know of any other trials in NYC? Thanks for your help.
		Response from Mr. Vergel I am so sorry that your virus developed resistance to ibalizumab (Taimed's intravenous CD4 monoclonal antibody that may be given once every two weeks). I am working with ACRIA and two San Francisco doctors in setting up a small expanded access pilot to combine two investigational agents by early summer 2011, but we are still waiting for data. But it is not a done deal. However, one of the drugs may be ibalizumab. GSK-ViiV are testing a second generation integrase inhibitor (GSK572) in phase II now and we are really hoping it can help people with raltegravir resistance. Some preliminary data show that it may help those with certain integrase mutations. GSK is also testing two non nucleosides in early phase 2. So, it will take at least 8 months to know where we are going with these agents. AVEXA, an Australian company that has an interesting nucleoside, may be back in the picture after their board reconsidered not dropping their drug due to activist pressure. I am following that drug closely also. BMS seems to have an entry inhibitor but they are a company that does not like to share information with treatment activists, so it has been a challenge to get them to tell us anything. It is unfortunate that in 2010 we still have this lack of communication going (but they are rare among companies). Progenics also had a once a week subcutaneous entry inhibitor that looks very exciting. They are also a company that has refused to meet with treatment activists. They are small and may not understand the power that activists have in the present to help advocate for new drugs. Koronis (http://www.koronispharma.com/KP1461forHIV.html) also has an interesting nucleoside that works very differently than the ones we have right now, but they have not tested it in people like you with a failing regimen. Some of these companies may or may not agree to provide drug in a compassionate manner for one patient (but remember that you need at least two new active drugs to avoid functional monotherapy). But if your doctor wants to ask them, the FDA has set up a way to do so provided that the companies are willing to help. The FDA procedure is http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm163982.htm It is getting harder and harder for companies to justify spending money on new drugs that attack new targets since they perceive the treatment experienced market to be too small to justify the investment. And many doctors are telling them that people like you and me do not exist anymore. So, it is more important than ever not to fall asleep in treatment activism. I am focusing a lot of my energies in helping people like you who may fall through the cracks if we do not provide at least two drugs at the same time that your virus does not have resistance to. One more thing. This is anecdotal but I have seen people in salvage's viral load go down a lot with good daily prophylaxis for herpes (acyclovir, Valtrx, or Famvir) (http://www.aidsmap.com/page/1431675/) twice a day and also with the use of an antibiotic called minoxycline ( http://www.aidsmap.com/page/1438246/), plus their HIV drug regimen. Talk to your doctor about these if you are not taking them already. Keep in contact with me. I will keep everyone informed through this column as things progress. Hang in there and please keep in touch with me. Nelson