ArQule Announces Top-Line Results of Phase 3 Clinical Study of Tivantinib in Hepatocellular Carcinoma in Japan

ArQule Announces Top-Line Results of Phase 3 Clinical Study of Tivantinib in Hepatocellular Carcinoma in Japan

BURLINGTON, Mass.--(BUSINESS WIRE)--
March 27, 2017
ArQule, Inc. (ARQL) today reported that its partner, Kyowa Hakko Kirin, announced top-line results of the JET-HCC Phase 3 trial of tivantinib in Japan, and that the trial did not meet its primary endpoint of progression free survival (PFS).

JET-HCC is a randomized, double-blind placebo-controlled study that enrolled approximately 190 Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma (HCC) with a history of prior sorafenib therapy, to evaluate the efficacy and safety of tivantinib.

The primary endpoint of the trial is PFS, and the top-line results did not show a significant difference in PFS between the tivantinib group and the placebo group. There were no new safety issues observed in the trial.

The details of the study results will be presented in an upcoming scientific forum.

“I would like to thank our partner, Kyowa Hakko Kirin, and all the participants in their study,” said Paolo Pucci, Chief Executive Officer of ArQule. “The results are disappointing as there is a need for a second-line HCC therapy in Japan.”

http://finance.yahoo.com/news/arqule-announces-top-line-results-110000642.html

Hepatitis C - Medicare Part D: High costs put some drugs out of reach

Medicare Part D: High costs put some drugs out of reach
March 27, 2017 12:45 PM
By Katie Wedell / Dayton Daily News

DAYTON, Ohio — High-priced prescription drugs are driving up the cost of Medicare Part D catastrophic coverage, which is bad news for both patients and taxpayers, according to a new report from the Department of Health and Human Services Office of Inspector General.

Patients on specialty drugs for cancer, hepatitis C, multiple sclerosis and other diseases are seeing higher out-of-pocket costs because of inflated list prices that accelerate their move into a coverage gap known as the “doughnut hole,” the report says.

The government’s spending is only going to grow, as 3 out of 4 hepatitis C patients are baby boomers who are aging into eligibility for Medicare Part D.

Drugs like Harvoni are extremely effective, he said, but are beyond reach for many of those afflicted with hepatitis C....
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MSF joins Europe-wide action challenging patent on key hepatitis C drug

MSF joins Europe-wide action challenging patent on key hepatitis C drug

Patent opposition aims to increase affordable access to hepatitis C drug sofosbuvir for millions

27 March 2017

Rome/Geneva, – Médecins Sans Frontières (MSF) has today filed a patent challenge on the hepatitis C drug sofosbuvir with the European Patient Office (EPO) in an effort to increase access to affordable hepatitis C treatment.

MSF has joined Médecins du Monde (MdM) and other civil society organisations from 17 countries in simultaneously filing patent challenges on the pharmaceutical corporation Gilead’s monopoly on sofosbuvir, in a bid to remove the barriers that prevent millions of people receiving treatment.

“With an estimated 80 million people worldwide living with hepatitis C, treatment should be available to everyone who needs it, no matter where they live – including in Europe,” said Dr Isaac Chikwanha, hepatitis C medical advisor for MSF’s Access Campaign.

“The price of sofosbuvir is keeping treatment out of reach for millions of people who need it, and treatment is being rationed or is just unavailable across the globe, including in many of the countries where MSF works, such as Russia, and many other middle-income countries including Thailand and Brazil. A drug that cures doesn’t do any good if the people who need it can’t afford it.”

Sofosbuvir forms the backbone of most hepatitis C combination treatments for people, one of a range of oral ‘direct-acting antivirals’ to come to market within the last four years that has caused cure rates to skyrocket.

In Europe, Gilead charges as much as US$59,000 per 12-week sofosbuvir treatment (€55,000) – in the United States, Gilead initially set the price at $84,000, or a staggering $1,000 per pill. Meanwhile, studies have shown that it costs less than $1 per pill to produce the drug.

“Gilead’s patent monopolies on sofosbuvir are blocking access to affordable hepatitis C treatment, including generic versions, in many countries including those in Europe,” said Aliénor Devalière, EU policy advisor for MSF’s Access Campaign. “The patents on some of these drugs can – and should – be challenged; the science behind sofosbuvir isn’t new.”

"People all over the world, and in the projects where MSF works, need affordable access to life-saving medicines."

Access to affordable medicines has become a global challenge. Countries where Gilead retains monopoly control over sofosbuvir cannot import or produce generic versions; for many people living in some middle-income countries, Gilead’s restrictive voluntary licensing agreements still keep sofosbuvir out of reach for people and their governments.

Patent challenges – or patent oppositions – can remove or shorten the length of a patent and enable the robust generic competition needed to dramatically reduce prices.  Key patents on sofosbuvir have already been revoked in China and Ukraine, and decisions are pending in other countries, including Argentina, India, Brazil, Russia and Thailand.

“Successful patent oppositions have created access to life-saving drugs for millions of people in the past, and are now being employed as a legal measure to improve access to hepatitis C treatment,” said Yuanquiong Hu, legal advisor for MSF’s Access Campaign.

“MSF has filed or supported patent challenges in many countries. People all over the world, and in the projects where MSF works, need affordable access to life-saving medicines.”

If the patent challenge is successful, it could accelerate the availability of affordable generic versions of sofosbuvir in Europe. It would also encourage all countries to take measures to open up access to affordable generic versions of sofosbuvir by either negotiating better deals with Gilead right now, and/or taking actions including issuing compulsory licences to import or manufacture more affordable generics.

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Note: Copies of these patent oppositions will be available on the Patent Oppositions Database (an online resource for groups and individuals wanting to challenge patents on medicines): https://www.patentoppositions.org/en/drugs/sofosbuvir

http://www.msf.org/en/article/msf-joins-europe-wide-action-challenging-patent-key-hepatitis-c-drug

State Health Registry issues ‘Cancer in Iowa: 2017’ report, highlights increase in liver cancer cases

Increase In Liver Cancer Cases

An excerpt from the report released by the Iowa State Health Registry is provided below, full press release available here

The report, based on data from the Iowa Cancer Registry and the Iowa Department of Public Health, is available online in the “Publications” section on the registry’s website or by calling the registry at 319-335-8609. The report includes county-by-county statistics, summaries of new research projects, and a special section focused on liver cancer.

Liver cancer is the 13th leading cause of cancer deaths in Iowa. However, unlike most other common cancers, both new cases of and deaths from liver cancer are on the rise in Iowa and throughout the U.S.

The rate of new liver cancer cases in Iowa has roughly tripled over the past 35 years, from two cases per 100,000 people in 1975 to 1979 to six cases per 100,000 in 2010 to 2014.

Michael Voigt, clinical professor of internal medicine and a specialist in gastroenterology and hepatology at University of Iowa Hospitals and Clinics, says that chronic infections of hepatitis B or hepatitis C are the major risk factors for liver cancer, and these infections are correlated with the increase in the number of cases.

“Liver cancer is predominantly due to hepatitis B or hepatitis C infection, and chronic viral hepatitis ultimately causes more deaths than breast cancer, heart failure, or prostate cancer,” Voigt says. “Deaths from hepatitis C are at an all-time high, and the number of cases in people under 30 years of age is increasing dramatically in Iowa.”

However, Voigt notes that because there is a vaccination for hepatitis B and effective treatment of both hepatitis B and C, liver cancer is highly preventable. “The Centers for Disease Control and Prevention (CDC) recommends that everyone born between 1945 and 1965 be tested for hepatitis C,” he says. “It is a silent killer, and the majority of people with hepatitis C are unaware of it.”

Though most cases of liver cancer prove to be fatal, national data show that in recent years deaths have been increasing slower than new cases. Iowa data shows a similar trend but has lower rates overall, possibly due to earlier detection and improvements in treatment of chronic hepatitis.

George Weiner, director of Holden Comprehensive Cancer Center at the University of Iowa, says that researchers consider the disease from all angles in order to reduce the number of cancer deaths.

“Cancer prevention, early detection, and therapy are all important as we seek to reduce the burden of cancer, including liver cancer,” Weiner says. “We are continuing to make progress through research in all of these areas.”

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The 2017 Hepatitis C Community Summit – a key step on the road to elimination

The 2017 Hepatitis C Community Summit – a key step on the road to elimination

In the lead-up to the annual International Liver Congress (ILC) in Amsterdam, Eberhard Schatz of the Correlation Network writes about the Hepatitis C Community Summit that will be held in Amsterdam on the 18-19^th of April to focus on community related initiatives and their key role in the hepatitis C elimination movement. Read more about the Summit and register here.

Eberhard Schatz

23 Mar 2017

Next month, April, brings the annual meeting of the European Association for the Study of the Liver (EASL), the International Liver Congress (ILC) 2017 in Amsterdam. The ILC serves as one of the most important international meetings on liver research in the calendar year. This year, also in Amsterdam just prior to the opening day of the ILC, the Correlation Network Hepatitis C Initiative has organized the two-day Hepatitis C Community Summit on the 18^th and 19^th of April.

It is now critically important to reach out to risk groups, such as networks of people who inject drugs, to involve and inform them about treatment options, to provide barrier-free access, and to meet people where they are.

To face the challenges ahead and to effectively provide access to all patients in need, we think the medical world, hepatologists, and consequently the International Liver Congress, must take into account crucial aspects of public health and community involvement to reach global hepatitis elimination goals.

Due to the fact that treatment with new direct-acting antivirals is quick and effective, it is now critically important to reach out to risk groups, such as networks of people who inject drugs, to involve and inform them about treatment options, to provide barrier-free access, and to meet people where they are: in community centres, harm reduction and low-threshold service settings, opioid substitution treatment centres, etc.

The Hepatitis C Community Summit fills a gap in the world of hepatitis C virus (HCV) research, bringing together diverse partners from Europe to provide a platform for community inclusion with all those involved in HCV treatment, most notably civil society. The Summit will bring attention to bear on hepatitis C from the perspectives of medical experts and researchers, as well as patients and representatives of harm reduction and community services in order.

The Summit aims to provide an overview on existing (community related) initiatives, to address challenges and barriers ahead, and provide a platform for exchange across professional borders.

The Summit aims to provide an overview on existing (community related) initiatives, to address challenges and barriers ahead, and provide a platform for exchange across professional borders. In this regard, we are very happy that EASL, WHO, and other important stakeholders and speakers will be contributing to the event.

In addition to attending community members, patient representatives, service providers in community and harm reduction settings, researchers, and several policy makers, we invite ILC participants to join the two-day programme. There will be a welcome, keynote, short plenary speeches from the full spectrum of knowledge in the hepatitis field, and roundtable discussions on the first day as well as two plenary sessions, parallel workshop-style sessions, and a final reception during the second day.

The Summit will be concluded with the launch of a ‘Community Declaration’, a consensus statement highlighting the importance of community involvement in the process of eliminating HCV. This declaration will initially be endorsed by the Hepatitis C Community Summit organizing partners:

• AFEW International,
• Correlation Network,
• European AIDS Treatment Group (EATG),
• European African Treatment Advocates Network (EATAN),
• European Network of People Who Use Drugs (EuroNPUD),
• and International Doctors for Healthier Drug Policies (IDHDP).

We look forward to seeing you in Amsterdam!

Source - http://blogs.biomedcentral.com/on-health/2017/03/23/the-2017-hepatitis-c-community-summit-a-key-step-on-the-road-to-elimination/

HIV and Hepatitis C are No Longer the Most Serious Infectious Threats to People Who Inject Drugs

Paul E. Sax, MD
Contributing Editor
NEJM Journal Watch
Infectious Diseases

HIV and ID Observations
An ongoing dialogue on HIV/AIDS, infectious diseases,
all matters medical, and some not so medical.

In Case You Missed It

HIV and Hepatitis C are No Longer the Most Serious Infectious Threats to People Who Inject Drugs

I had dinner with my daughter Mimi the other evening, and was ruminating about how things have changed since I started work as an Infectious Diseases doctor around 25 years ago.

Here’s an excerpt of our chat:

Me:  There are way more cases of endocarditis in young people than there used to be, a complication of injecting drugs. People in their 20s and 30s with life-threatening infections, getting admitted to the hospital, needing antibiotics for weeks, sometimes surgery … it’s awful. [I didn’t mean for this to sound like a cautionary speech to my 21-year-old daughter, but reading it now — guilty as charged.]
Mimi:  Endocarditis?
Me:  Infection of the heart valves. It’s an incredibly serious problem, much more difficult to treat than HIV and HCV. Even with our best antibiotics, some people need major heart surgery — their lives are never the same. And sometimes the infection spreads through the blood to the lungs, spine, brain… Some even die!

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Treat All - Are we nearing the end in the fight against hepatitis C?

Journal: Expert Review of Gastroenterology & Hepatology

Are we nearing the end in the fight against hepatitis C?
Joel V. Chua & Shyam Kottilil
Received 09 Jan 2017, Accepted 17 Mar 2017
Accepted author version posted online: 24 Mar 2017

http://dx.doi.org/10.1080/17474124.2017.1309287

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With a robust choice of DAA regimens available, even patients that were in the past considered hard to treat such cirrhotic patients, or those previously excluded from treatment due to chronic kidney disease, now have therapeutic options.  For example, elbasvir-grazoprevir is preferred to be used in HCV-infected patients with chronic kidney disease; while decompensated HCV cirrhotic patient are able to be treated with sofosbuvir-ledipasvir-ribavirin, or sofosbuvirvelpatasvir-ribavirin, or sofosbuvir-daclatasvir-ribavirin regimens.  In addition, highly effective and safe pangenotypic DAA regimens such as the once daily fixed dose combination sofosbuvirvelpatasvir, as well as daclatasvir plus sofosbuvir, increases the breath of those that can be treated and cured.  These advancement in drug therapy against HCV, coupled with increasing availability of generic DAAs [6] outside of the U.S. will increase access to these highly efficacious cure drugs worldwide.

Though having safe and highly effective drug regimens that can “virtually” cure all HCV infected individuals is an integral part of any hepatitis C eradication strategy, it still is just one component to achieving disease elimination..
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Gilead hepatitis C drug patent faces European challenge

Gilead hepatitis C drug patent faces European challenge
International groups representing doctors and patients have launched a fresh challenge to the patent on Gilead Sciences' hepatitis C drug sofosbuvir at the European Patent Office in order to increase access to the treatment.

MSF and MdM, who have been joined by 28 groups from across Europe, said key patents on sofosbuvir had already been revoked in China and Ukraine, and decisions were pending in other countries, including Argentina, India, Brazil, Russia and Thailand.

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