The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

For Immediate Release

October 10, 2014

Release

The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.

“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”

Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.

Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.

Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.

In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.

The most common side effects reported in clinical trial participants were fatigue and headache.

Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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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.

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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Less 

Here is the petition: 

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

HCV Treatment Pipeline Update

Great summary of the research/development pipeline for new Hep C drugs.  It does not include side effects, however.

http://www.pipelinereport.org/toc/HCV/dec-treatment-pipeline-update

New HIV, Hepatitis C and TB Medications in the Research Pipeline' Report from TAG and I'Base

I highly recommend this excellent pipeline report for an update of what drugs are in the development pipeline for HIV, Hepatitis C and TBÑ

2012 Pipeline Report

Ten News Items That Have Made Me Happy During the Past Month

These past several weeks have been great on many fronts. While taking a shower this morning, I counted a few of the great pieces of news that have come our way amidst all the negative news that the media dwells on to increase ratings. 

http://www.thebody.com/content/67329/ten-news-items-that-have-made-me-happy-during-the.html

Things You May Not Have Known About Hepatitis C

Merck’s Cavalier Attitude Towards the Welfare of HIV/HCV Coinfected Patients

What You Don’t Know, You Can Sell

tagline Spring 2012<http://www.treatmentactiongroup.org/tagline/2012/spring/tagline/2012/spring>



by Tracy Swan

In places where access to antiretroviral therapy is widespread, people
living with HIV are now dying from a common and curable coinfection:
hepatitis C virus (HCV). HIV increases the risk for, and accelerates the
rate of, liver disease from hepatitis C. Pegylated interferon and
ribavirin, medications used to treat HCV, are less effective in people with
HIV than in their HCV-monoinfected counterparts.

In 2011, the first hepatitis C protease inhibitors, Merck’s boceprevir and
Vertex’s telaprevir, were approved based on trials in people with hepatitis
C monoinfection. Both drugs are being studied in coinfected people, thanks
to pressure from the international HIV/HCV community and encouragement from
regulatory agencies.

Despite outrage from activists, Merck refused to study drug-drug
interactions (DDIs) between boceprevir (Victrelis), their HCV protease
inhibitor, and drugs commonly used to treat HIV, putting coinfected study
volunteers at risk for drug-drug interactions in their own clinical trial.

Drug-drug interactions can have serious consequences for HIV/HCV-coinfected
people, who risk forfeiting current and future treatment options for HIV
and possibly HCV as well. DDIs can lower drug concentrations to an
ineffective level, leading to drug resistance, or increase drug
concentrations, worsening side effects and leading to treatment
discontinuation; they can even be life-threatening, as was the case with
ribavirin and didanosine (DDI; Videx).

The boceprevir coinfection study opened in mid-2009, before Merck had
performed drug-drug interaction studies with HIV protease inhibitors in
healthy volunteers, a common step in drug development. Nonetheless,
coinfected study volunteers were allowed to use them; in fact, by default,
HIV protease inhibitors— or Merck’s own integrase inhibitor, raltegravir
(Isentress)—were the only HIV treatment options for study volunteers, since
non-nucleoside reverse transcriptase inhibitors were not allowed. Activists
kept asking Merck to perform DDIs throughout boceprevir’s development, but
Merck’s attitude remained cavalier; they did not launch key drug-drug
interaction studies until two years later, months after boceprevir was
approved.

The results of DDI studies with three ritonavir-boosted HIV protease
inhibitors, atazanavir/r (Reyataz), darunavir/r (Prezista), and lopinavir/r
(Kaletra) in healthy volunteers (rather than the actual trial participants
who were using boceprevir with HIV protease drugs for almost a year) were
presented in March at the 19th Conference on Retroviruses and Opportunistic
Infections (CROI) in Seattle. The news was not good. Combining boceprevir
with these HIV protease inhibitors lowered concentrations of each HIV
protease inhibitor, at both the highest and lowest (peak and trough) levels.

Boceprevir lowered the peak concentration of atazanavir/r by 25 percent,
and the trough by 49 percent; darunavir/r peak decreased by 36 percent and
trough by 59 percent; for lopinavir/r, coadministration with boceprevir
dropped the peak concentration by 30 percent and trough by 43 percent. In
turn, boceprevir levels dropped by 45 percent when coadministered with
lopinavir/r and by 32 percent when administered with daruanvir/r; only
atazanavir/r had no effect on the concentration of boceprevir.

Failure to characterize these drug-drug interactions put study
participants—and coinfected patients— at an unacceptable level of risk,
although clinical implications—or real-life impact on HIV and hepatitis C
treatment outcomes—of these drug interactions are not clear. Nonetheless,
the U.S. Food and Drug Administration warned that “drug interactions
between the hepatitis C virus (HCV) protease inhibitor Victrelis
(boceprevir) and certain ritonavir-boosted human immunodeficiency virus
(HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can
potentially reduce the effectiveness of these medicines when they are used
together.”

Regulators from the European Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP) went a step further, recommending
that “doctors treating patients co-infected with hepatitis C and HIV should
be aware of the findings of the drug interaction study. They should not
co-administer Victrelis with ritonavir-boosted darunavir or lopinavir in
HIV and hepatitis C co-infected patients. Co-administration of Victrelis
with ritonavir-boosted atazanavir may be considered on a case-by-case basis
if deemed necessary in patients with suppressed HIV viral loads and with an
HIV strain without any suspected resistance to the HIV regimen. Increased
clinical and laboratory monitoring is warranted.”

Vertex’s rival protease inhibitor, telaprevir (Incivek) has outsold
boceprevir: in the fourth quarter of 2011, telaprevir trounced boceprevir
$456.8 million to $87 million. The opportunity to capture the coinfection
market share may have motivated Merck’s decision to delay drug-drug
interaction studies. HCV is more likely to be diagnosed and treated in
HIV-positive people than people with HCV alone, for several reasons. HIV
treatment guidelines recommend HCV testing for all HIV-positive people; the
infrastructure to deliver treatment is already in place; and hepatitis C is
known to be more aggressive in people with HIV, so physicians and patients
are more game to try for a cure.

After Vertex reported drug interactions between telaprevir and ritonavir
boosted HIV protease inhibitors, boceprevir became a more attractive option
for co-infected people. Merck’s vice president of clinical research, Robin
Issacs, alluded to off-label use in the company’s February 8 press release.
“Though VICTRELIS is not indicated for the treatment of chronic HCV in
those who are also infected with HIV, we recognize that some physicians
have prescribed or may be considering prescribing VICTRELIS for patients
taking ritonavir-boosted HIV protease inhibitors. We felt it was important
to share these data as part of our commitment to patient safety and
transparency.”

*Where was Merck’s commitment to safety during boceprevir’s development? We
can only hope that no patients have been harmed.*

The boceprevir experience underscores the importance of timely DDI studies.
There are other medications used by people with hepatitis C—whether or not
they are coinfected with HIV—that warrant study, such as methadone,
buprenorphine, and commonly prescribed psychiatric medications. Merck
representatives have stated that the company will be more proactive with
their promising second-generation hepatitis C protease inhibitor, MK-5172.

Activists have released a
statement<http://www.treatmentactiongroup.org/hcv/2012/hepatitis-c-drug-development-and-drug-drug-interaction-studies>
calling
on regulatory agencies and pharmaceutical companies to study DDIs between
experimental HCV drugs that are broken down by the body in a similar way
with hormonal contraceptives, methadone, buprenorphine, lipid lowering
agents, immunosuppressive drugs, herbal remedies, and commonly prescribed
psychiatric medications in addition to HIV medications. •