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Alan Franciscus

Editor-in-Chief

HCV Advocate



Wednesday, March 11, 2015

Gilead Sciences (NASDAQ:GILD) and AbbVie (NYSE:ABBV) Trying to Make the Most from Market Share

Gilead Sciences (NASDAQ:GILD) share prices are dropping as a result of the FDA giving the approval to AbbVie (NYSE:ABBV) of its hepatitis C drug, Viekira Pak. Through drastic price cuts, Gilead Sciences (NASDAQ:GILD) is facing a tough time trying to become market leader. Both companies have confirmed that the price reductions are so that they can attract more customers yet investors may not consider this a positive sign.
After Gilead Sciences (NASDAQ: GILD) launched Sovaldi, its drug for oral hepatitis C, it revolutionized the treatment. Before this, patients of hepatitis C had to be treatment with cures that had significant side effects like ribavirin and peg interferon that lasted nearly 48 weeks and had only 50%-80% cure rates.
However, Sovaldi’s treatment doesn’t eliminate ribavirin from the core, but it does put aside peg interferon and gives cure rates of 90%. This is why doctors embraced the drug with open arms and turned it into the quickest drug to achieve such successful levels of treatment. It made nearly $10.3 billion sales in the previous year. However, Gilead Sciences (NASDAQ: GILD) strengthened its drug back in October, when it won the approval by the FDA for its drug Harvoni.

Dubai-New oral drug can cure hepatitis C

Dubai: In what is being hailed by health practitioners as one of the biggest discoveries in five decades in the field of medicine, an international pharmaceutical company has discovered a powerful antiviral drug to treat the deadly disease hepatitis C that will soon be available in the UAE.
Experts in the medical field reacted with excitement at this breakthrough development. “We are very excited and thrilled by this discovery which has far-reaching implications,” said a senior doctor from a leading hospital group in Dubai. ”The mechanism by which this oral drug eliminates the virus in the affected population could hold the key to similar anti-viral medication to eliminate many viral diseases such as other forms of hepatitis, Ebola and, one day, even HIV.”
Dr Chacko George, specialist in Internal Medicine at RAK Hospital, said: “In the case of hepatitis C, 20-30 per cent of the people recover and about the same percentage get chronic liver disease or become carriers and even suffer from cancer. If there is an antiviral drug that can eliminate the virus in about 97 per cent of the first-timers and 93 per cent of those treated earlier, then it is one of the greatest breakthroughs in the history of treatment of this disease. This would mean that with this treatment, the infected person will be able to maintain an infection-free state or have such weak copies of the virus which won’t be able to replicate. It would mean a tremendous advancement in the treatment of the disease. It is discoveries like these that keep our medical appetite for discoveries alive.”

Future Treatment May Be Best for Kids with Hepatitis C

The best time to treat children infected with the hepatitis C virus may be off in the future when newer, better drugs with fewer side effects are expected to be approved for pediatric populations, according to the authors of a recent article in Clinical Liver Disease.   

Hepatitis C is a bloodborne virus that over time if left unchecked can severely damage the liver. But for children who are chronically infected, progression to advanced liver disease during their childhood years is uncommon, says lead author Christine Lee, MD.  

A major milestone in the treatment of hepatitis C is the recent development of direct-acting antiviral (DAA) agents and combination drug regimens, Lee stated in the article. These developments are likely to similarly revolutionize treatment of the virus in children in the near future however clinical trials are still being conducted.


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Sydney-Benitec Biopharma Doses Fourth Patient In Hepatitis C Trial

Benitec Biopharma (ASX: BLT; OTCPK: BTEBY), a biopharmaceutical company focused on providing potentially curative therapies with its proprietary gene-silencing technology called ddRNAi or "expressed RNAi," today announced that the fourth patient in the company's Phase I/IIa dose escalation clinical trial of its lead program TT-034 for treating hepatitis C was dosed at the Duke Clinical Research Unit.  This is the second patient to be dosed in Cohort Two, with the third and final patient in Cohort Two well advanced in their preparation for dosing. 
As previously announced, the parallel dosing of these patients follows a positive recommendation from the DSMB's review of the safety data from the first patient in this cohort.
All three patients in Cohort Two receive a dose of 1.25 x 10^11 vg/kg of TT-034, a concentration that is a half-log higher than the dose administered in Cohort One.  This dose level is still below the concentration expected to inhibit hepatitis C viral replication and therefore data from Cohort Two are expected to serve primarily as a further safety assessment.

Finding strengths—and weaknesses—in hepatitis C's armor

Using a specially selected library of different hepatitis C viruses, a team of researchers led by Johns Hopkins scientists has identified tiny differences in the pathogens' outer shell proteins that underpin their resistance to antibodies. The findings, reported in the January 2015 issue of the Journal of Clinical Investigation, suggest a reason why some patients' immune systems can't fend off hepatitis C infections, and they reveal distinct challenges for those trying to craft a successful vaccine to prevent them. Due to concerns about the rising costs of newly available hepatitis C drugs, researchers are looking to a vaccine as a more viable and less costly option.

The systems of some people who become infected with the liver-ravaging  C virus launch a robust immune attack, producing  that attach to a broad array of the germs with different genetic makeups. About one-third of these individuals successfully clear the pathogen from their bodies. However, says Justin Bailey, M.D., Ph.D., assistant professor of medicine in the Division of Infectious Diseases in the Johns Hopkins University School of Medicine, no single antibody has been found that can neutralize all strains of hepatitis C virus.

To better understand how hepatitis C viruses avoid even the most , Bailey; Stuart C. Ray, M.D., professor of medicine in the Division of Infectious Diseases in the Johns Hopkins University School of Medicine; and colleagues tested the power of 18 antibodies known to broadly attack the virus against a library of 19 viral strains that make up about 94 percent of the genetic variability of hepatitis C viruses in the most common genetic group, called genotype 1.

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Tuesday, March 10, 2015

India: Natco to launch Hepatitis C drug in India soon

Natco Pharma plans to launch the generic version of Sovaldi, the blockbuster drug used to treat chronic Hepatitis C in India soon. Sovaldi is made by U.S. pharma major Gilead Sciences, and Natco recently entered into a non-exclusive licensing agreement with Gilead to make and sell generic versions of Sovaldi in 91 developing countries.

The company, on Monday, launched the generic version of Sovaldi in Nepal under the brand Hepcinat. The product is priced at Rs.19,900 (US $316.68) per bottle of 28 tablets in Nepal, and covers the treatment duration of three months for a patient.

“We will be launching the drug in the next few weeks in India, and are awaiting approval from the Drugs Controller General of India (DCGI),” M. Adinarayana, Vice-President, Legal & Corporate Affairs, Natco Pharma, told this correspondent.

Hepatitis C on the rise in the Northland; concerns focused on baby boomers and people younger than 30

Eight doesn’t seem like a lot, but eight cases of hepatitis C virus in Duluth caught the attention of state health officials.

“Duluth actually is an area we’ve been looking at for a little while,” said Kristin Sweet, hepatitis unit supervisor for the Minnesota Department of Health.

Nationwide, officials have noticed a rise in the potentially dangerous, chronic liver disease. The focus is on two groups: baby boomers, some of whom may have had the virus for years without knowing it; and people younger than 30, a group whose size seems to be increasing along with the recent increase in heroin use.

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