Activists Condemn Gilead for Exhorbitant Price of Their New Hepatitis C Drug

For Immediate Release December 9, 2013
Contact: Lynda Dee 410-332-1170 or lyndamdee@aol.com

Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™, and Urges Rapid and Wide Dissemination of Support Program Details for Uninsured and Underinsured People Living with Hepatitis C

The Fair Pricing Coalition (FPC) today condemned Gilead Sciences for the price set for its direct acting antiviral (DAA) Sovaldi™ (sofosbuvir), a once-daily, first- in-class nucleotide polymerase inhibitor approved by the U.S. Food and Drug Administration on December 6, 2013, for the treatment of chronic hepatitis C,including those co-infected with HIV. While FPC believes that all hepatitis C virus (HCV) drugs are priced too high, the coalition of HIV and viral hepatitis treatment activists is especially dismayed by the wholesale acquisition cost (WAC) of $84,000 for a 12-week course of Sovaldi™. For comparison purposes, the FPC notes the 12-week WAC for the recently approved NS3/4A protease inhibitor Olysio™ (simeprevir) is $66,360.

“Sovaldi™ is a very safe and highly effective drug that will significantly shorten HCV therapy and either reduce or eliminate the need for injected pegylated interferon,” explained FPC Co-Chair Lynda Dee. “However, this does not give Gilead unconscionable pricing carte blanche, particularly when considering that Sovaldi™ still needs to be combined with ribavirin for the treatment of HCV genotype 2 for 12 weeks or genotype 3 for 24 weeks.

Recent Studies Show Concerns With The Use of Tenofovir (Viread), Popular Drug in HIV Treatment

Tenofovir impairs enzyme that stops cells aging

This study let us know that NRTI drugs, already known for causing the damage to mitochondrial DNA that leads to peripheral neuropathy, fat loss and some other side-effects, also exert an effect on cellular DNA, and that in this case tenofovir may be the drug to keep an eye on.

Telomerase shortening is, by definition, a side-effect that won’t start causing symptoms for many years, and the study does provide a cautionary note in discussions about the possibility of very long-term side-effects associated with the use of tenofovir, both in HIV treatment and in pre-exposure prophylaxis.

More information here


************************************************************************************************************************************************

Changes in Fat Mitochondrial DNA and Function in Subjects Randomized to Abacavir+Lamivudine or Tenofovir DF+ Emtricitabine With Atazanavir-Ritonavir or Efavirenz: AIDS Clinical Trials Group Study A5224s, Substudy of A5202

"In conclusion, we have shown significant perturbation in mitochondrial indices after 96 weeks of nonthymidine NRTI containing regimens which were assigned randomly. In the TDF/FTC group, changes in oxidative phosphorylation complex I and complex IV activity levels consistently were inversely correlated with changes in several objective measures of body fat, including in both subcutaneous and visceral compartments"

  Patients with human immunodeficiency virus type 1 (HIV-1) infection receiving thymidine nucleoside reverse-transcriptase inhibitors (NRTIs) experience a high rate of metabolic abnormalities, including lipoatrophy. Depletion of adipose tissue mitochondrial DNA (mtDNA) and impairment of the oxidative phosphorylation system are associated with lipoatrophy induced by thymidine NRTI containing regimens. Mitochondrial oxidative phosphorylation enzymes nicotinamide adenine dinucleotide (reduced; NADH) dehydrogenase (complex I) and cytochrome c oxidase (complex IV) contain polypeptides of mtDNA-encoded subunits and so are affected by mtDNA depletion.
In the current era of nonthymidine NRTI containing regimens, lipoatrophy incidence has significantly decreased but has not been completely prevented . In addition, subjects who have established lipoatrophy while taking thymidine NRTI containing regimens experience only a slow and incomplete resolution of lipoatrophy after switching to nonthymidine NRTI based therapy , putting into question the mitochondrial toxicity.

More information here

************************************************************************************************************************************************

Fortunately, 10 year observational data on the use of TDF show encouraging results in stabilization of reduced creatinine clearance

Association Between Tenofovir Exposure and Reduced Kidney Function in a Cohort of HIV-Positive Patients: Results From 10 Years of Follow-up

 "In this cohort, TDF exposure was associated with reduced kidney function, but the loss in eGFR attributable to TDF is relatively mild in a long-term perspective.

There has been debate about the association between TDF exposure and renal dysfunction and about the clinical impact of the loss in eGFR due to TDF exposure. Our study shows that the association was not of a high magnitude and that the quantified loss in eGFR attributable to TDF is relatively modest after many years of exposure. Importantly, the loss attributable to TDF seems to occur during the first year of exposure and stabilizes after that. Although the loss is maintained, it does not seem to further deteriorate with additional years of exposure. The clinical impact of this association need to be analyzed, taking into account the efficacy of TDF, but it is highly plausible that TDF exposure, although associated with reduced kidney function, has no severe adverse effects over the long term for most HIV-positive patients.”

More information here

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]

---

Less 

Here is the petition: 

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

SIGN PETITION: Gilead Sciences: Please collaborate with Bristol Myers for the Cure for Hepatitis C NOW!

Gilead Sciences: Please collaborate with Bristol Myers for the Cure for Hepatitis C NOW!

The most effective new therapy ever discovered for the treatment of hepatitis C will never see the light of day unless we are able to convince big pharma giant Gilead Sciences to move forward at once with this development. This treatment combines Bristol-Myers Squibb drug daclatasvir and Gilead’s GS-7977 (now named sofosbuvir). Together these two drugs cured 100% of the most prevalent type of hepatitis C (genotype 1) 

http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now

Activists Caution HIV+ Patients and their Physicians About Monotherapy in Upcoming Access Program

FOR IMMEDIATE RELEASE: February 9, 2012

Contact: Nelson Vergel (NelsonVergel@yahoo.com)

Activists Caution HIV+ Patients and their Physicians About

Monotherapy in Upcoming Access Program

New York, February 9, 2012—AIDS activists and physician advocates welcome the news that ViiV Healthcare will be providing  expanded access of dolutegravir (DTG), a new investigational integrase inhibitor for HIV patients with few remaining HIV treatment options.  However, they warn patients and physicians to avoid functional monotherapy, or the introduction of dolutegravir as an "add-on" to a failing treatment regimen if the patient’s virus is resistant to all other currently available antiretroviral drugs (ARVs).  Functional monotherapy has been shown to permit rapid HIV resistance to new medications, which can result in more rapid disease progression, health deterioration, and death.

Currently, the U.S. Department of Health and Human Services (DHHS) adult HIV treatment guidelines recommend three ARVs be given in combination to suppress HIV.  But many patients have HIV that has mutated rendering their virus multi-drug resistant (MDR-HIV).  Those with MDR-HIV cannot construct a viable HIV suppressive regimen with current FDA-approved and commercially available ARVs.  "The DHHS guidelines specify that patients that have developed HIV drug resistance to all commercially available antiretrovirals require access to at least two new active drugs to maximize their chances for treatment response.  However, “another new drug to combine with dolutegravir will not be commercially available for at least two years, and some patients cannot wait that long,” said Nelson Vergel, an activist founder of SalvageTherapies.org.  "For them, access to another research drug in combination with DTG is the only hope for survival," added Vergel.

In studies to date, dolutegravir (DTG) appears to be the most potent integrase inhibitor soon to enter the ARV market.  Unlike Gilead's upcoming elvitegravir, DTG has been shown to be effective against HIV that has developed resistance to Merck's Isentress (raltegravir), the only FDA-approved integrase inhibitor currently on the market.

Fortunately, another new ARV that can help patients with MDR-HIV is in active development and clinical trials.  Ibalizumab, a monoclonal antibody from a small biotech firm, Taimed Biologics, may soon be available via patient participation in research studies.  While ibalizumab has yet to enter phase three studies, it can also be provided to patients at risk of death via a named (or single) patient access application permitted by the FDA via a physician’s direct request to Taimed.  However, it is for the company to approve such requests for compassionate access.

There are no documented estimates of how many people have MDR-HIV in the United States.  A report in the Journal of Clinical Infectious Diseases estimates that about 260,000 patients are being treated with HIV in the United States.  However, it is virtually impossible to know how many are now without sufficient treatment options since no registry for such patients exists.  But most experts agree that this population is probably small – possibly up to 10% of the total in treatment.

"With little immune function left and resistance to all approved HIV medications, I have tried desperately to get access to two new drugs to help save my life,” said Christopher Cacioppo, a patient with MDR-HIV in  San Diego who believes he is running out of time. “My doctor tells me that I have little choice but to wait for the dolutegravir expanded access program and some as yet unknown and unavailable second new drug."

A coalition of activists and physicians have been in discussions with Taimed and ViiV for nearly two years to obtain compassionate-use access to their new ARVs in combination for those with MDR-HIV in greatest need of new treatment options.  The AIDS Community Research Initiative of America (ACRIA), a New York City-based community research and education organization, and physicians in San Francisco have proposed solutions to overcome this “two-drug access barrier” in an effort to secure urgent access to patients across the country.

Physicians and providers with patients with MDR-HIV in need of two new ARVs are urged to complete this form.

###

Pharma Continues to Raise Cost of HIV Meds Despite the AIDS Drug Assistance Program Crisis

http://news.change.org/stories/pharma-continues-to-raise-cost-of-hiv-meds-despite-the-aids-drug-assistance-program-crisis

Greedy Gilead Sciences Raises Price Of Top Selling Products

What a nasty time to increase prices. The greedy bastards. They make more money than anyone on HIV. And they are still slow at providing access to the developing world for tenofovir so that people can switch from toxic Zerit and AZT. Shame on them.

http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201104041217dowjonesdjonline000185&title=gilead-sciences-raises-price-of-top-selling-products

Gilead Sciences Raises Price Of Top Selling Products

By Thomas Gryta, Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- Gilead Sciences Inc. (GILD), known for selling 
HIV drugs, increased the prices of several of its top selling products 
at the beginning of the month.

The Foster City, Calif., drug maker increased the price of its biggest 
seller, HIV treatment Atripla, by 5.1%, according to a spokeswoman 
Monday. Gilead also raised the price of HIV drugs Truvada and Emtriva 
by 7.9%, and lung disease treatment Letairis by 4.9%.

For the company's HIV products, a price freeze for AIDS Drug 
Assistance Programs remains in effect, she said.

Cowen & Co. analyst Phil Nadeau said the increases are "consistent in 
magnitude and timing with Gilead's historical patterns." He said the 
increases will impact about 60% to 70% of the U.S. market, which is 
about 60% of Gilead's global sales of HIV drugs.

Gilead reported 2010 total product sales of $7.39 billion with Atripla 
bringing in $1.9 billion in the U.S.

Truvada had U.S. sales of $1.3 billion last year, while Emtriva had 
just $16.7 million. Letairis had 2010 sales of $240.3 million.