FDA rescinds breakthrough therapy designation for daclatasvir

The FDA has rescinded breakthrough therapy designation status from Bristol-Myers Squibb for daclatasvir for the treatment of hepatitis C virus infection, according to a statement from the manufacturer.

“The FDA has informed Bristol-Myers Squibb that, due to the evolving HCV treatment landscape, the agency intends to rescind the breakthrough therapy designation for certain genotype 1 hepatitis C regimens related to daclatasvir,” the statement from Bristol-Myers Squibb said. “This will not impact our current submission/resubmission timetable of the new drug application for daclatasvir in combination with other antiviral agents for the treatment of hepatitis C.”

Daclatasvir (Bristol-Myers Squibb) was granted breakthrough therapy designation in early 2014 as part of a dual investigational regimen with asunaprevir (Bristol-Myers Squibb) for chronic HCV. BMS withdrew its application for asunaprevir from the FDA in October 2014.  

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Pakistan: Waiting for hepatitis drug

AN estimated 10 million hepatitis C patients in the country may hear the good news soon. A life-saving drug to be administered orally to such patients is expected to be cleared for distribution next week, long after it got the approval of the Drug Regulatory Authority of Pakistan. The matter has been pending with the Federal Ministry of Health Services Regulations and Coordination for the last three months, which somehow could not take out the time to give a formal nod to the medicine called Sovaldi. Whereas doctors have prescribed the tablet to a few thousand suffering Pakistanis in anticipation of its availability on the local market, one distribution company has been selected for its supply. The company is going to buy it from the United States. It was initially in competition with many other aspiring distributors, but managed to convince DRAP that it had the right combination of price and quality.

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Shorter Hepatitis C Treatment Durations May Be a Reality

Boston—Can treatment of hepatitis C infection with new direct-acting antivirals (DAAs) be shortened to less than 12 weeks? Interim results from a recent trial suggest treatment durations of eight or even four weeks may be possible with the right combination of drugs.

Shortened regimens would help contain health care costs, with 12-week courses of new DAAs hovering close to $100,000. Prolonged treatment may also compromise patient adherence to therapy, experts said.

“Optimized regimens may allow an eight-week duration that may be broadly applicable across diverse patient groups,” said Eric Lawitz, MD, vice president of scientific and research development at The Texas Liver Institute, in San Antonio, who led the study. Dr. Lawitz, also clinical professor of medicine at the San Antonio University of Texas Health Science Center, said large randomized trials are needed before changes to clinical practice can be made.

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New drugs, price war provide hope for hepatitis C patients

Sallie Wickens’ life followed a death-defying narrative that traced the medical arc of hepatitis C:

A blood-transfusion infection after a car accident in 1959, when she was 5; a positive test for the virus when she was 30; 10 years of deteriorating health; a debilitating course of interferon drug treatments that didn’t work; a liver so damaged she needed a transplant.

And then, her doctor, hepatologist Laura Alba, walked into an exam room last month at St. Luke’s Hospital and gave Wickens, 60, a big smile.

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Pa. considering moving away from costly Hepatitis C treatment

(Harrisburg) -- Pennsylvania might move away from a stunningly expensive prescription drug treatment for Medicaid patients with Hepatitis C, but the Commonwealth won't save as much as other states.

Missouri is one of the first states to move away from Sovaldi, which costs $1,000 a pill.

Pennsylvania might do the same, but the state's Medicaid program is waiting on final offers from two competitors that provide other drugs recently approved by the FDA for Hepatitis C treatment.

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LePage wrongly blames ‘illegals’ for diseases in Maine

Blaming immigrants for local woes — they’re taking your jobs, they’re a drain on public assistance programs and making your taxes go up — has long been a staple of Republican campaigns. The new strategy is to blame illegal immigrants for disease outbreaks in America, when there is no evidence to support this.

In spontaneous remarks during his State of the State address last week, Gov. Paul LePage tied these immigrants to a costly uptick in hepatitis C, HIV and tuberculosis.

“But this is the problem with some of the illegals that are here today,” the governor said. “When a refugee comes here from a foreign country, they get a medical assessment and we know their health. But when they are here illegally, they don’t get medical assessments.

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Canada: Gastrointestinal Society Releases New Video about Hepatitis C

Canada NewsWire
VANCOUVER Feb. 10 2015

Baby boomers need to be tested

VANCOUVER Feb. 10 2015 /CNW/ - As many as 350000 Canadians could be suffering with hepatitis C many of whom are unaware that they are infected thus continuing to spread the virus. Although there is a vaccine to prevent the spread of the hepatitis A and hepatitis B viruses there is no vaccine for hepatitis C. The good news is that with new treatments hepatitis C is now a curable disease.

Many Canadians with hepatitis C do not have any symptoms but for those who do symptoms are generally nonspecific such as mild fatigue or discomfort in the abdomen. However delaying treatment can actually make things worse; the infected individual may feel mostly fine but the virus is causing inflammation which slowly wreaks havoc on the liver eventually leading to cirrhosis severe symptoms and even liver cancer.

"It's very important that individuals with risk factors get tested for the hepatitis C virus" says Dr. James Gray Chair of the Gastrointestinal Society and Canadian Society of Intestinal Research Medical Advisory Council and Gastrointestinal Society co-founder "ideally we can put an end to the spread of hepatitis C by diagnosing treating and curing those who have the disease."

The GI Society has just released a video about hepatitis C to spread awareness and educate Canadians on the risk factors for this disease. The fast-paced whiteboard-style animation also includes information on diagnosis testing treatment management symptoms and more so you can do your part to help stop the spread of this disease. Watch the video online in English at www.badgut.org and in French at www.mauxdeventre.org. Dr. Gray narrates this animation in English and Jean Bruyère narrates in French.

Gail Attara Chief Executive Officer and co-founder of the Gastrointestinal Society who produced the video said "We are grateful for the medical support of Dr. James R. Gray Gastroenterologist and Clinical Professor University of British Columbia and Dr. Ed Tam Hepatologist of the Liver and Intestinal Research (LAIR) Centre. We are also very appreciative of the generous educational grants provided to us by AbbVie Corporation and Janssen Inc. that allowed us to produce this independent video."

Visit www.badgut.org watch and share this video (http://ow.ly/ICVF4); it could help save someone's life.

About the Gastrointestinal Society (GI Society)As the Canadian leaders in providing trusted evidence-based information on all areas of the gastrointestinal tract the Gastrointestinal (GI) Society and the Canadian Society of Intestinal Research are committed to improving the lives of people with GI and liver conditions by supporting research advocating for appropriate patient access to health care and promoting gastrointestinal and liver health.

SOURCEGI Society
PR Newswire
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