Hepatitis C, Death, and Advance Directives | Lucinda Porter, RN

Hepatitis C, Death, and Advance Directives | Lucinda Porter, RN

Daclatasvir Marketing Authorization Application for Treatment of Chronic Hepatitis C Validated for Accelerated Regulatory Review by the Euro

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• PRESS RELEASE
• January 8, 2014, 7:05 a.m. ET

Daclatasvir Marketing Authorization Application for Treatment of Chronic Hepatitis C Validated for Accelerated Regulatory Review by the European Medicines Agency

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   --stol-Myers squibb application supports use of daclatasvir in 
      combination with other agents for treating HCV patients with genotypes 1, 
      2, 3 and 4 
 
   -- Submission includes EU's first all-oral and ribavirin-free 
      investigational regimen - for use in treatment naïve genotype 1, 2, 
      3 patients and protease inhibitor treatment failures 
 
   -- Company is prepared to work with authorities across Europe to help ensure 
      daclatasvir is reimbursed for HCV patients with high unmet needs, if 
      daclatasvir is approved 
PRINCETON, N.J.--(BUSINESS WIRE)--January 08, 2014-- 

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Medicines Agency (EMA) has validated the company's marketing authorization application (MAA) for the use of daclatasvir (DCV), an investigational NS5A complex inhibitor, for the treatment of adults with chronic hepatitis C (HCV) with compensated liver disease, including genotypes 1, 2, 3, and 4. The application seeks the approval of daclatasvir for use in combination with other agents, including sofosbuvir, for the treatment of chronic hepatitis C. The MAA validation marks the start of an accelerated regulatory review process for DCV, which has the potential, when used in combination with other agents, to address a high unmet need in the European Union (EU), where an estimated 9 million people are living with hepatitis C.

"Our extensive clinical trial program has demonstrated that daclatasvir has potential use as a foundational agent for multiple HCV treatment regimens," said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. "If daclatasvir is approved, we would focus on helping to ensure its availability to patients with limited treatment options and would work with EU health authorities to ensure access is achieved as quickly as possible."

In the European Union, the burden of liver disease and other morbidities from HCV infection is significant, with large numbers of patients in urgent need of new treatment options. Because of the progressive nature of HCV, decades may pass before patients become symptomatic. Many of these aging patients develop liver disease, making them more difficult to treat with the current standard of care of interferon plus ribavirin with or without a protease inhibitor. Viral hepatitis has also been cited as a cause for the increase in the incidence of HCC (hepatocellular carcinoma) in Europe.

The EMA submission is supported by data from multiple studies of daclatasvir with other HCV therapies. To date, DCV has been studied in more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care. In addition to demonstrating pan-genotypic potency in vitro, DCV has shown a low drug-drug interaction profile, supporting its potential use in multiple treatment regimens and in people with co-morbidities. No clinically relevant safety signals have been observed thus far in DCV clinical trials, and DCV has been generally well-tolerated in all investigational regimens and patient types.

The EU submission follows the recent Bristol-Myers Squibb regulatory filing in Japan seeking approval of a DCV-based regimen for the treatment of patients infected with HCV genotype 1b.

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. An estimated 170 million people worldwide are infected with hepatitis C. Up to 90 percent of those infected with hepatitis C will not clear the virus and will become chronically infected. According to the World Health Organization, 20 percent of people with chronic hepatitis C will develop cirrhosis and, of those, up to 25 percent may progress to liver cancer.

About Bristol-Myers Squibb's HCV Portfolio

Bristol-Myers Squibb's research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir, an investigational NS5A replication complex inhibitor that has been extensively studied as a foundational agent for multiple direct-acting antiviral (DAA) based combination therapies.

DCV is currently being studied in the ongoing Phase III UNITY Program, where it is being investigated as part of an all-oral 3DAA regimen with other Bristol-Myers Squibb investigational agents. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. Additional Phase III clinical trials are planned to start in early 2014.

Other compounds in the pipeline include:

   -- Asunaprevir (ASV) is an investigational NS3 protease inhibitor for 
      hepatitis C which has been studied as a component of DCV-based treatment 
      regimens 
 
   -- BMS-791325 is a non-nucleoside inhibitor of the NS5B polymerase, 
      currently in Phase III development for hepatitis C as a component of 
      DCV-based treatment regimens 
 
   -- PegInterferon-Lambda is an investigational type III interferon that has 
      the potential to offer an alternative to alfa-interferon in patients for 
      whom an interferon-based regimen is required or preferred 

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that DCV will receive regulatory approval or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2012, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

 
    CONTACT: Bristol-Myers Squibb Company 

Media:

Carrie Fernandez

Office: 609-252-4831

Cell: 215-859-2605

carrie.fernandez@bms.com

or

Jeff Smith

Office: +33(0)1 58 83 83 21

Cell: +33(0) 6 03 99 40 18

JR.Smith@bms.com

or

Investors:

Ranya Dajani, 609-252-5330

ranya.dajani@bms.com

or

Ryan Asay, 609-252-5020

ryan.asay@bms.com

 
    SOURCE: Bristol-Myers Squibb Company 
Copyright Business Wire 2014 
 

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Gilead’s Sovaldi Awarded Breakthrough Designation

KATEY TROUTMAN | MORE ARTICLES

JANUARY 05, 2014

A number of drugs currently in development were approved for a “breakthrough therapy” designation from the Food and Drug Administration this past year, with Gilead Sciences’ (NASDAQ:GILD) Sovaldi, amedicine used to treat hepatitis C, leading the group, reports Bloomberg.

2013 saw 27 new drug approvals for the breakthrough therapy designation. The program, which is new as of 2012, is intended to cut down on the red tape associated with bringing drugs to the market. In the program’s inaugural year, the FDA cleared 39 drugs for the designation.

According to the FDA, a breakthrough therapy is one that treats “a serious or life-threatening disease or condition” alone or in combination with other drugs, and which evidence suggests “may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.”

Gilead’s pill, developed for the treatment of hepatitis C, is designed to cut the treatment time of its patients by half. Other companies that were also given the sought-after breakthrough therapy designation include Imbruvica, a drug developed as part of a partnership between Johnson & Johnson (NYSE:JNJ) andPharmacyclics Inc. (NASDAQ:PCYC), and Gazyva, a drug developed to treat chronic lymphocytic leukemia by Roche Holding AG.

Analyst Michael Yee, who spoke to Bloomberg, has a positive view of the new designation, saying that it “makes Wall Street generally feel good, that the FDA pendulum is swinging more in terms of accommodation,” and that though the program is aimed at getting drugs to market more quickly, it ”doesn’t mean that FDA has lowered the hurdle. The FDA is being more collaborative, more accommodating, rather than being an antagonist.”

Sovaldi was the biggest drug to be approved for the breakthrough therapy designation in 2013, and it is expected to bring in more than $2.5 billion in revenue this year for Gilead, according to Bloomberg.

2013 was a big year for hepatitis C therapies: Gilead and three other companies — Johnson & Johnson, AbbVie Inc., and Bristol-Myers Squibb Co. — are all developing drugs for the market that eliminate the need for interferon injections, the current standard treatment for hepatitis disease.

 More from Wall St. Cheat Sheet:

Drug approved by FDA for treatment of Hepatitis C

 

Pathology Department at RMC develops research project to test efficacy of Sofosbuvir in South Asian races

 

 

Muhammad QasimTuesday, January 07, 2014
From Print Edition

 

Rawalpindi

Head of Pathology Department at Rawalpindi Medical College and Allied Hospitals has developed a research project to test efficacy of a new drug ‘Sofosbuvir’ approved by FDA of the USA for treatment of Hepatitis C in the South Asian races especially patients who have not responded to previous treatment with ‘combination therapy’ (Interferon plus Ribavirin).

Talking to ‘The News’ on Monday, the HoD Professor Dr. Abbas Hayat said that he decided to develop the research project in view of the huge price tag on this drug, high claims by the manufacturers and the rather disappointing results of equally acclaimed drugs in the past.

Hepatitis C is a viral infection of the liver, which spreads through contact with infected blood and blood products. It becomes chronic (persists for longer than six months) in approximately 85 per cent of the individuals infected. Chronic infection with Hepatitis C, if untreated or unresponsive to treatment, can eventually lead to cirrhosis of liver, liver failure and liver cancer. Infected individuals also face a much reduced quality of life, often understated in medical textbooks as ‘flu-like symptoms’, said Dr. Hayat.

He added that for the last two decades chronic Hepatitis C has been treated with interferon therapy, initially as a monotherapy and later in combination with Ribavirin (combination therapy). “Interferon (Lilly Research Labs), featured on the Newsweek cover as an anti-cancer drug in the early 1980s, and was marketed at an exorbitant price but proved to be of limited value,” said Dr. Hayat.

He added it was then rebranded as a miracle treatment for Hepatitis C with Ribavirin. Cochrane Institute which is a trusted non profit organisation shows very insignificant difference in mortality and morbidity in patients treated and those not treated with the combination therapy (Interferon plus Ribavirin) in a meta-analysis. However, this was long after the pharmaceutical pocketed huge revenues. Similar disappointing results were seen for Prozac and Zoloft in the treatment of depression, alleged Professor Hayat.

He explained that Sofosbuvir, a ‘direct acting anti viral’ (DAA), is an inhibitor of the NS5B RNA-dependent RNA polymerase, which is essential for the replication of the RNA virus that causes chronic Hepatitis C. The drug was approved by the FDA on December 16, 2013 by 15 votes to none for the treatment of chronic Hepatitis C caused by genotypes 1,2,3, and 4 of the virus and is likely to be marketed at $1000 a pill, with the total cost of a 12-week course adding up to a whopping $84,000, he said.

He added that among the best known examples of drugs that have been responsible for revealing genetic variation in response are isoniazid, succinylcholine, primaquine, coumarin anticoagulants, certain anaesthetic agents, the thiopurines, and debrisoquine. European people possessed a superior anti-hypertensive response to the Beta blockers, which was one of the anti-hypertension drugs, when compared with their African counterparts, he explained.

Besides response to the anti-hypertensive drugs, different races had different risks of warfarin therapy. “Clinical trials suggested that when the INR, which was the blood clotting indicator, was low, Asians had a better protection from the blood clot obstruction in their blood when compared with their white counterparts and needed lower doses of Warfarin to achieve the desired results as compared to white population. It is therefore imperative that the drug is subjected to a local trial before we start prescribing it to patients.”

He said he decided to develop a research project to test its efficacy in the South Asian races including population in Pakistan following an approach that in testing many of these drugs, genetic differences among various races and ethnicities are not taken into account and it is only much later, after poor patients have spent their life’s savings on treatment, that it is realized that the drug is not quite as effective in our population as advertised,” said Head of Pathology Department at RMC and Allied Hospitals.

Professor Hayat claimed that Medecins Sans Frontieres (MSF) has announced its support for the ‘patent opposition’ just filed at India’s Patent Office by the Initiative for Medicines, Access & Knowledge (I-MAK), which aims to prevent US pharmaceutical company Gilead (Pharmasset) from gaining a patent in India on sofosbuvir. “If the plaintiffs win this case, it will allow Indian companies to produce the drug locally which would reduce its cost substantially. This is now a major battleground for MSF’s Access Campaign,” he said.

He informed ‘The News’ that the patent battle achieved a major victory in India in 2007 when Glaxo was refused a patent for Combivir, a fixed-dose combination of two AIDS drugs (zidovudine/lamivudine, or AZT/3TC) which allowed Indian companies to market affordable generic versions of this drug, revolutionizing the treatment of AIDS worldwide.

In April last year, India’s Supreme Court issued a major judgment against Swiss pharmaceutical company Novartis AG, denying a request to issue a patent for its cancer drug, Glivec, said Professor Hayat.

He added that we should follow the example of our neighbours and reform patent laws allowing local manufacturers to market affordable generic versions of life-saving drugs after testing them on the local population for efficacy, dosage and side effects.

New Hep C drug approved in Canada Provinces still have to choose whether to cover $1,000-a-pill treatment

New Hep C drug approved in Canada

Provinces still have to choose whether to cover $1,000-a-pill treatment

Reported by Bryn Levy

First Posted: Jan 6, 2014 11:12am: 

Saskatchewan could be getting a new weapon in the fight against Hepatitis C.

Sovaldi, a drug manufactured by American company Gilead, was approved for sale in Canada back in December 2013.

The new medicine replaces a previous one used as part of a cocktail of drugs used to cure the condition, which progresses slowly, but eventually leads to scarring of the liver, cancer and death.

Gilead, the company that makes the drug,  claims it's better at dealing with genotypes of the disease where current medications don't have as high a success rate. It also requires a shorter course of treatment.

With 15 years experience treating bloodborne illnesses in addicts in the Prince Albert area, Dr. Leo Lanois said Sovaldi still isn't so different that it would eliminate the need for other drugs to be used in combination with it. Some of those carry the nastiest side effects of the process.

"[Hepatitis C treatments] all have the great flaw that they all require pegylated interferon, which is very hard for many people to take," he said.

The pegylated interferon is a drug that boosts a patients' immune response.  It can't be used by people who have immune conditions like psoriasis, or rheumatoid arthritis.

"If you've got rheumatoid arthritis (pegylated interferon) would cripple you," said Lanois.

Lanois said the immune booster also causes a flu-like syndrome and can trigger depression.  That's a serious problem due to the prevalence of Hep C among the province's intravenous drug users.

"HIV and Hep C are linked in this province to intravenous drug use and we have, unfortunately, a very high prevalence of intravenous drug users," he said.

The drug also comes with a stiff price tag.  A course of treatment runs over $80,000 (US) for patients in the U.S.

Kevin Wilson, executive director of the extended benefits branch of Saskatchewan Health's drug plan said there will still be some time before the pills are potentially covered in the province.

He explained that while the drug is approved for sale, there's still an assessment process for the provinces.

"There's a national agency, the Common Drug Review, that reviews new products on behalf of publicly funded drug plans," he said.  Wilson said that if Sovaldi is found to be a worthwhile treatment compared to current drugs, Saskatchewan would pool its rescources with other provinces to get the best price possible.

Lanois said restrictions are also a problem. While other provinces have changed their protocols as HIV treatment has progressed, Saskatchewan still won't cover current Hep C medications for people also infected with HIV. Lanois said that a large portion of the people that need treatment for Hep C are also infected with HIV.

"Hopefully the government will change its mind pretty soon and start funding it, but you know... every time you start funding a drug that costs $20,000 a month, that money's not there to treat other things."

Overall, Lanois said that while it's always a good thing when new treatments are made available, he doesn't think Sovaldi is anywhere close to the finish line

"This is just a very small step. I'm not really overly excited about this. I think it's nice to have.," said Lanois, adding that he hoped Hep C treatment would follow the trajectory of medications for HIV, which was quite expensive and carried a lot of complications at first, but has steadily gotten better.

"We're hoping tha tin a few years there will be drugs that will be much easier to take," he said. 

blevy@rawlco.com

Follow on Twitter: @BrynLevy

New FDA-Approved Treatments May Make Lives Easier for Hepatitis C Patients

Tuesday, January 07, 2014

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New FDA-Approved Treatments May Make Lives Easier for Hepatitis C Patients

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TWC News: New FDA-Approved Treatments May Make Lives Easier for Hepatitis C Patients
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More than 3 million Americans and counting are infected with Hepatitis C, and while there is a cure, until now, available treatments were grueling and only 70 percent effective. However, new drug options may now make patients' lives easier. NY1's Erin Billups filed the following report.

Hepatitis C patients are excited about recently FDA-approved treatment options now available that promise to be gentler and more effective.

"We want to get it as soon as possible," says Russell Myers, a client with Harlem United and a peer mentor. "I want to live, just like everybody else."

Russell Myers contracted HIV and Hepatitis C in the '70s through drug use. He's now clean and serves as a peer mentor and patient in Harlem United's co-infection program, which holds weekly support meetings.

Myers failed to finish the grueling Hep-C treatment in the early '90s, but made it through the nearly year-long process last year, only to find out that he wasn't cured.

"It was a low blow," he says. "I've seen a lot of people die from cirrhosis of the liver and not getting treatment."

There's a 30 to 40 percent non-responsive rate for those that undergo the old treatment, a cocktail of up to 14 pills a day and interferon shots once a week. It's accompanied by debilitating flu-like side effects.

Late last year, the FDA approved two new treatments, the most groundbreaking of which is sofosbuvir-branded Sovaldi™ from Gilead Sciences, which can be used with or without an interferon shot.

"With the new medication, it is possible to treat as short as 12 weeks," says Dr. Vera Antonios, an infectious diseases physician with Harlem United. "You're going to have better response rate, which is the most important thing."

For those co-infected with HIV, they're looking at 24 weeks of treatment.

The outlook is even better for Hep-C drugs still in trial phase.

The new treatment options come as health professionals prepare for what's expected to be a significant increase in Hepatitis C diagnoses and deaths among baby boomers.

The CDC believes that with more screening, another 800,000 baby boomers will discover they have Hep-C.

These landmark advances in treatment, though, offer a silver lining.

"It’ll be just more of a motivating element for them to really take charge and take care of themselves," says Brooke Wyatt, coordinator of the Hepatitis C co-infection program with Harlem United.

The new treatments are extremely expensive, but Gilead Sciences has promised to help those who can't afford it.

Coffee, chocolate linked to improved liver health in HIV/HCV patients

Healio › Infectious Disease › Hepatitis C Resource Center › Coffee, chocolate linked to improved liver health in HIV/HCV patients

Coffee, chocolate linked to improved liver health in HIV/HCV patients

Carrieri MP. J Hepatol. 2014;60:46-53.

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• December 26, 2013

Patients coinfected with HIV and hepatitis C may experience a reduction in abnormal liver enzymes and an overall improvement in liver function with increased consumption of coffee and chocolate, a study determined.

“Our results provide the first evidence that daily chocolate intake and, more generally, polyphenol rich food intake, may contribute to decreased AST [aspartate aminotransferase] and ALT [alanine aminotransferase] levels and potentially improve liver function in HIV-HCV coinfected patients,” the researchers wrote. “They also suggest that polyphenols contained in coffee, but also in cocoa, can be involved in the causal process, which leads to reduced inflammation.”

The study examined longitudinal data including self-administered questionnaires and medical data from 990 patients included in a cohort study on HIV-HCV coinfected patients at 17 clinics in France. The researchers analyzed the association between consumption of at least 3 cups of coffee daily and abnormal AST and ALT values defined as 2.5 times above the upper normal limit. They also assessed the association between daily chocolate consumption and abnormal AST and ALT values.

Using multivariate analysis with adjusted odds ratio estimates based on logistic regression analyses, the researchers found patients reporting elevated coffee consumption were less likely to present with abnormal ALT (adjusted OR=0.65; 95% CI, 0.43-0.97) or abnormal AST (aOR=0.63; 95% CI, 0.4-0.99). Patients reporting daily chocolate intake also were less likely to present with abnormal ALT (aOR=0.57; 95% CI, 0.33-0.98), but the reduced likelihood of presenting with abnormal levels of AST did not rise to statistical significance.

Patients who reported elevated coffee consumption and daily chocolate consumption, however, demonstrated reduced incidence of elevated AST (aOR=0.54; 95% CI, 0.36-0.82) and ALT (aOR=0.57; 95% CI, 0.4-0.82).

The researchers called for further studies to better determine the role of consumption and whether supplementation might have an impact on liver disease and injury.

Disclosure: The researchers report no relevant financial disclosures.