Rosetta Genomics Granted U.S. Patent Allowance for the Use of microRNAs to Treat Liver Cancer

Expands the Company's Patent Portfolio in Oncology Therapeutics

PRINCETON, NJ and REHOVOT, ISRAEL -- (Marketwired) -- 11/07/13 -- Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces receipt of a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) related to U.S. Patent Application No. 13/481,105 titled "Targeting microRNAs for the Treatment of Liver Cancer."

This allowance is for a therapeutic patent that protects a method for treating hepatocellular carcinoma (HCC), or liver cancer, and covers the administration of a compound comprising a modified oligonucleotide that is an anti-miR-222. In addition, various modifications of the nucleotide are claimed. There is an additional claim which refers to the reduction of the levels of serum alpha-fetoprotein or serum des-gamma-carboxyprothrombin in the subject to be treated.

"HCC is the fifth most common cancer in the world and the third leading cause of cancer deaths. Because standard chemotherapy usually has no beneficial outcome on HCC patients, there is significant need for new therapeutic modalities and novel therapeutic targets in order to develop more effective treatments for HCC," said E. Robert Wassman, M.D., Chief Medical Officer of Rosetta Genomics. "Since microRNAs are master regulators of gene expression, their de-regulation can trigger changes that lead to the disease phenotype, and the modulation of their activity can be a key to the development of novel therapies."

"We continue to fortify and protect our global leadership position in microRNA technology with the addition of this valuable patent allowance," commented Kenneth A. Berlin, President and CEO of Rosetta Genomics. "Our solid patent position in microRNAs provides us with the opportunity to license, partner or otherwise derive value from this powerful technology for use in a variety of diagnostic and targeted therapeutics in oncology where there continues to be a large, unmet medical need."

Rosetta Genomics maintains an active intellectual property strategy to protect its leadership position in microRNA technology. Rosetta's portfolio includes 33 issued patents, including 30 in the U.S. In addition, Rosetta has 43 patent applications pending, of which 23 are in the U.S. These applications protect the specific microRNAs used in the Company's products and cover composition of matter, diagnostic applications, therapeutic applications and discovery process applications for microRNAs in humans.

About Liver Cancer
According to the National Cancer Institute, primary liver and bile duct cancers are the fifth most common cause of cancer death in men and the ninth most common cause of cancer death in women. Over the past two decades, the incidence rates for these cancers have increased in people of all races and in both genders; mortality rates have increased in all groups except Asians/Pacific Islanders. Men are more than twice as likely as women to develop and die from liver and bile duct cancers, and African Americans and Hispanics are almost twice as likely to develop these cancers as whites. Although Hispanics and Asians/Pacific Islanders have lower incidence rates of most types of cancer than whites, they have much higher rates of liver cancer.

Liver cancer is closely associated with hepatitis virus infections. Almost all cases of liver cancer in the United States occur in people who first had cirrhosis, usually resulting from hepatitis B or C infection or from heavy alcohol use. Ingestion of foods contaminated with aflatoxin and obesity may also increase liver cancer risk. Vaccinating for hepatitis B provides long-term protection from hepatitis B infection and has been shown to lower the risk of liver cancer in children, although it is not yet known whether it lowers the risk in adults. There is no standard or routine screening test for liver cancer. Standard treatments for liver cancer include surgery, radiation therapy, chemotherapy, percutaneous ethanol injection and targeted therapy.

About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based diagnostic testing services offered by Rosetta Genomics. The Rosetta Cancer Origin Test™ can accurately identify the primary tumor type in primary and metastatic cancer including cancer of unknown or uncertain primary (CUP). Rosetta Mesothelioma Test™ diagnoses mesothelioma, a cancer connected to asbestos exposure. The Rosetta Lung Cancer Test™ accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma. Rosetta's assays are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the Rosetta Cancer Origin Test™, 60,000 from the Rosetta Mesothelioma Test™, 65,000 from the Rosetta Kidney Cancer Test™ and 226,000 patients from the Rosetta Lung Cancer Test™. The Company's assays are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. For more information, please visit www.rosettagenomics.com. Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.

About Rosetta Genomics
Rosetta develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000, Rosetta's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. Rosetta's cancer testing services are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. Frost & Sullivan recognized Rosetta Genomics with the 2012 North American Next Generation Diagnostics Entrepreneurial Company of the Year Award.

Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, Rosetta's Cancer of Origin Test™, Rosetta's development or commercialization of molecular diagnostics, the market acceptance of Rosetta's cancer testing services, particularly the Rosetta Cancer Origin Test™, Rosetta's development of personalized medicine products and services, Rosetta licensing, partnering or otherwise deriving value from microRNA technology for use in a variety of diagnostic and targeted therapeutics and Rosetta developing therapeutic products., constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those risks more fully discussed in the "Risk Factors" section of Rosetta's Annual Report on Form 20-F for the year ended December 31, 2012 as filed with the SEC. In addition, any forward-looking statements represent Rosetta's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.

Company Contact:
Rosetta Genomics
Ken Berlin
President & CEO
(609) 419-9000, ext. 1326
investors@rosettagenomics.com
Investor Contacts:
LHA
Anne Marie Fields
(212) 838-3777
afields@lhai.com
or
Bruce Voss
(310) 691-7100
bvoss@lhai.com

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Inhibition of ASBT Improves Liver Function in an Animal Model of Cholestatic Liver Disease

Data Presented Today at Annual Meeting of the American Association for the Study of Liver Diseases in Washington DC Provides Additional Preclinical Validation for LUM001 Currently Being Evaluated in Phase II Studies in Multiple Cholestatic Liver Disease Populations

SAN DIEGO, Nov. 5, 2013 /PRNewswire/ -- Lumena Pharmaceuticals, a company developing oral therapeutics for cholestatic liver diseases, today announced that inhibition of the apical sodium-dependent bile acid transporter (ASBT) improves liver function in animal models of cholestasis. The data will be presented at 11:15 a.m. EST today in an oral presentation titled "SC-435, an Oral Inhibitor of ASBT, Improves Liver Function in a Rat Partial Bile Duct Ligation Model of Cholestasis," at the 64^thAnnual Meeting of the American Association for the Study of Liver Diseases in Washington DC.

The study showed that inhibiting ASBT with SC-435, a close analog of LUM001, the company's lead drug candidate for the treatment of cholestatic liver disease, significantly improved markers of liver function in rats that had undergone partial bile duct ligation (pBDL) surgery to induce a state of cholestasis. Rats subjected to pBDL showed an impaired liver function as demonstrated by an increase in biomarkers of liver function, including serum liver alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin and ɤ-glutamyl transferase (GGT) over baseline at three days post-surgery. Rats that received SC-435 showed an increase in excretion of bile acids in the feces, a reduction of serum bile acids and improvements in biomarker profiles of liver function at seven days post pBDL. The benefits of treatment with SC-435 were maintained at 14 days post pBDL, and histology studies showed that livers from rats treated with the ASBT inhibitor had less cell death and inflammatory cell infiltration. Taken together, the results show that inhibiting ASBT reduces circulating bile acid levels and improves liver function in animal models, suggesting that ASBT inhibition may be an attractive approach to treating cholestatic liver disease.

"This study provides additional preclinical proof of concept for Lumena's approach to the treatment of cholestatic liver diseases currently being evaluated in multiple Phase II clinical studies," said Bradley T. Keller, Ph.D., vice president, research at Lumena Pharmaceuticals, who presented the data. "Inhibiting bile acid recirculation to the liver pharmacologically has the potential to improve liver function and dramatically impact patient health in a population in dire need of non-invasive treatment options."

Cholestatic liver diseases are characterized by elevated bile acids, progressive liver damage and severe itching, which is generally the most debilitating symptom afflicting adults and children with these diseases. Treatment with anti-pruritics typically provides only modest relief. Procedures that remove bile from the circulation can lower serum bile acids, reducing itch and improving liver function in some patients, but tend to be invasive in nature. ASBT recycles intestinal bile acids back into the circulation and blocking it with a once-daily oral presentation, such as LUM001, reduces serum bile acids and may offer a novel therapeutic approach for alleviating the severe itching and progressive liver damage associated with many cholestatic liver diseases.

LUM001 has been studied in 12 clinical trials in more than 1,400 subjects. In previous trials, LUM001 was shown to be generally well tolerated, the most common side effect, gastrointestinal disturbance, was usually mild and transient in nature. Clinical studies have demonstrated that LUM001 can reduce serum bile acid levels. Reductions in bile acids may be effective in alleviating symptoms and improving liver function in many patients with cholestatic liver disease. Lumena is currently evaluating LUM001 in Phase II studies in children with Alagille syndrome and adults with primary biliary cirrhosis. The company plans to initiate additional Phase II studies in patients with progressive familial intrahepatic cholestasis and primary sclerosing cholangitis in late 2013.

About Lumena Pharmaceuticals
Lumena Pharmaceuticals is a San Diego-based company developing oral therapeutics for patients with rare and debilitating liver diseases. Lumena's lead candidate, LUM001, has been studied in more than 1,400 patients in 12 different clinical studies and is being evaluated in Phase II studies in patients with Alagille syndrome and primary biliary cirrhosis. The company is privately held and has raised $23 million in Series A financing from Pappas Ventures, RiverVest Venture Partners and Alta Partners.

SOURCE Lumena Pharmaceuticals

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Our hidden epidemic: hepatitis in Australia

By Serkan Ozturk on November 10, 2013

Nearly half of the estimated 207,000 people living with chronic hepatitis B in Australia continue to remain undiagnosed while 15 percent of people living with chronic hepatitis C in Australia have not yet been diagnosed, according to official figures released this week.

The statistics were revealed in the Kirby Institute’s Annual Surveillance Report 2013 released at the Australasian HIV&AIDS Conference in Darwin this week.

The report found that almost 400 deaths in 2012 were related to hepatitis B-related liver disease despite the rate of diagnosis of newly acquired hepatitis B infection declining among those aged 30 years or older as well as reducing substantially among people aged 15 -29 since 2003. In 2012, NSW had the highest number of diagnoses of hepatitis B infection, with 34.7 percent of the national total.

Hepatitis NSW CEO, Stuart Loveday, said if not diagnosed and managed properly, hepatitis B infection can lead to cirrhosis, liver cancer or liver failure.

“Deaths from primary liver cancer are climbing faster than any other cause of cancer death in Australia and untreated chronic hepatitis B is a major contributor,” Loveday said.

“An estimated 383 deaths in 2012 were attributable to hepatitis B-related liver disease.

“It is important to remember that many people with hepatitis B don’t experience any symptoms at all so getting tested is critical.”

Professor of Gastroenterology and Hepatology at Australian National University, Narci Teoh, said treatments currently available for hepatitis B were highly effective, well tolerated and very simple to administer.

“We can tailor and individualise those treatments to people,” Professor Teoh said.

“It is critical for people with hepatitis B to be informed and start a conversation with their doctor in order to understand what this virus does and how to look after themselves and their liver.”

Loveday said vaccination was the simplest way to prevent contracting hepatitis B.

“While most children born in Australia have been vaccinated, if you think you might be at risk of contracting hepatitis B, consult your doctor about getting vaccinated,” he said.

The Annual Surveillance Report also found that an estimated 310,000 people living in Australia in 2012 had been exposed to hepatitis C with it thought 173,500 had chronic hepatitis C infection and early liver disease, 51,500 had chronic hepatitis C infection and moderate liver disease and 6,500 were living with hepatitis C related cirrhosis.

The other 80,000 people believed to have to have been exposed have cleared their infection.

The Kirby Institute estimates that almost 80 percent of all infections for hepatitis C occur among people who inject drugs, with only one percent of those people currently receiving treatment. Unlike other types of hepatitis, there is currently no vaccine to prevent hepatitis C and medication is the only way to manage the disease.

In February, the previous Labor federal government announced it will provide more than $220 million over five years to subsidise hepatitis C medications boceprevir (Victrelis) and telaprevir (Incivo) through the Pharmaceutical Benefits Scheme (PBS). It is believed that 10-15 percent of all people living with HIV in Australia may also have hepatitis C and that co-infection remains a serious issue.

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CV work-up key before NASH liver transplant

YOUR DOSE OF MEDICINE By Charles C. Chante, MD (The Philippine Star) | Updated November 10, 2013 - 12:00am

Nonalcoholic steatohepatitis patients may need a more thorough cardiovascular work-up before liver transplantation, according to a study presented at the meeting.

Standard pretransplant cardiac screening results were similar for 115 nonalcoholic steatohepatitis (NASH) and 127 alcohol-induced cirrhosis patients. Most patients had received transthoracic echocardiograms, and many had had other tests, including dobutamine stress echocardiograms, cardiac catheterizations, and ECGs.

The Revised Cardiac Risk index, a common heart screen for noncardiac surgeries that focuses mostly on ischemia, predicted cardiac events in 6.6% of both groups.

The rate of cardiac events was higher in the NASH group; 26% had significant cardiac events within a year of surgery, two-thirds  of those within a month. Cardiac arrests and arrhythmias — some fatal — were the most common events in the NASH group. Meanwhile, about 8% of the alcoholic-cirrhosis patients had cardiac events during their first postop year.

The inaccuracy of the screening of NASH patients illustrates the need for better methods of identifying cardiac risks prior to liver transplants, investigator in gastroenterology and hepatology at Nothwestern University, Chicago said.

“Current algorithms are designed to predict MI and plaque rupture. We tend to overutilize dobutamine stress echoes and other noninvasive stress tests to look for ischemic heart disease.”

In addition to atherosclerosis, NASH patients may have low systemic resistance, chronotropic incompetence, and other problems that a too-narrow focus on ischemia might miss. The cardiac arrests and arrhythmia noted in the study may not have been “related to plaque rupture. We really need to better risk-stratify these patients,” he said, hoping to develop a liver-transplant specific cardiac risk index.

Tricuspid regurgitation might have predictive value, as well as pulmonary hypertension and prolonged Qc interval, although the latter two did not differ significantly between the two groups before transplant.

Indeed, there were just two statistical differences; left ventricular hypertrophy was slightly more common in alcoholic cirrhosis patients (20% vs. 15%), and that group was more likely than the NASH group to have clean coronary arteries on left heart catheterization (20% vs. 14%).

The mean age in the NASH group was 58 years, and 45% of NASH patients were women. The mean age in the alcoholic-cirrhosis group was 53 years, and 18% of patients were women. Mean MELD (Model for End-Stage Liver Disease) scores were about 25 for both groups.

NASH patients were more likely to be obese, dyslipidemic, and hypertensive. But even after controlling for those factors, as well as for smoking and prior history of coronary artery disease, NASH patients were still more likely to have an adverse cardiovascular event within a year of transplant.

Most patients in both groups were alive at 1 year, but only 4% were alive in the NASH group at 10 years, compared with 18% in the alcoholic-cirrhosis group.

Before surgery, about 50% of NASH patients were on a beta-blocker, and 10% on a statin, although more than half had statin indications.

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AASLD interview – AbbVie taking a broad approach in hepatitis C

Source:  EP Vantage
Company:  AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Johnson & Johnson, Merck & Co
Tags:  Analysis, Free Content, Company Strategy, Phase III, Filing & Registration, Systemic Anti-Infectives, Gastro-Intestinal, Interview
Date: November 04, 2013\

While rivals Gilead Sciences and  Johnson & Johnson have submitted their hepatitis C regimens to the FDA in somewhat piecemeal fashion,  AbbVie says it will be taking a broad approach when it brings its three-drug combination to the US regulator.

AbbVie’s view is that submitting data from six clinical trials will give physicians the greatest flexibility in choosing the appropriate treatment regimen for patients depending on disease progression or whether they have relapsed after previous treatments. “We have put together a package of studies which we think will provide a clear picture of the potential of these agents in specific patient populations, so that physicians will be able to choose exactly what to use for each individual patient,” says Barry Bernstein, the Illinois group’s vice-president of infectious disease development.

Decision time

Gilead’s sofosbuvir and J&J’s simprevir, now known as  Sovriad, are due FDA decisions in weeks and could possibly be used in combination before the year is out, so AbbVie knows time is of the essence. The first couple of its phase III trials will probably read out before the end of 2013 – which one will be first is not exactly clear, as it will depend on the final patient visit. The first to begin enrolling was the Sapphire I trial, in 600 hep C genotype 1 patients who have never sought treatment before.

But Mr Bernstein, speaking to EP Vantage on the sidelines of the AASLD meeting in Washington, DC, says he is not especially worried about how much of a head-start the other two agents get. “What’s paramount to clinicians and patients is, ‘What is my chance of being cured?” That’s far more important than when a regimen is approved, whether it’s a month later or a month earlier.”

He cites the example of AbbVie’s rheumatoid arthritis drug Humira, an anti-tumour necrosis factor-alpha (TNF) antibody that now is the world’s biggest selling drug. “Humira was the third TNF to come to the market and today it’s the market leader. I think that reflects that drug and its characteristics. Yes, we want to get these medicines to patients as quickly as we possibly can. We think the regimens will perform very well in phase III and will provide a real meaningful transformation.”

In addition, the AbbVie combination has the potential to be the first combination that has no mention of interferon on its label –  sofosbuvir will probably be able to be used without interferon in some settings, but not all, should it be approved on schedule by December 6.

Eliminating interferon and its flu-like side effects will be a huge step forward in persuading patients to seek treatment, which is one of the reasons why new agents like Incivek and  Victrelis, which must be used with interferon, have not achieved the success that was once predicted for them (All change in hep C as expectations shift dramatically to sofosbuvir, October 28, 2013).

Balancing act

One criticism of AbbVie’s combination – ritonavir-boosted ABT-450 coformulated with  ABT-267, with a third agent, ABT-333 – is its relative complexity and pill burden. The regimen requires patients to take two of the two-agent pills twice a day, while one  ABT-333 pill is taken twice a day.

In spite of its complexity, Mr Bernstein believes the blend of the NS3/4A  protease inhibitor ABT-450, NS5A inhibitor  ABT-267 and non-nucleoside  NS5B inhibitor  ABT-333 will be the best way for patients and physicians to maximise their chance of a sustained viral response (SVR), which amounts to a cure.

“It’s critical that the regimen not compromise SVR rates. If three [drugs] are necessary to maintain very high SVR rates, to maximise what you can achieve, that’s what we should do for patients,” he says.

Tested as a two-drug combination, ABT-450 and  ABT-267 perform very well – phase II data presented yesterday at AASLD showed it could achieve SVR 12 weeks following the end of the treatment regimen in 95% of patients who had never sought treatment, and 90% in patients who had failed to respond to interferon-based treatments.

But Mr Bernstein strikes a cautionary note. “I think there’s a big difference between a 90% and a 95% rate or a 98% rate. When you hear about the number of patients who succeed it doesn’t sound like much, but when you talk about the number of patients who fail, it’s twice as many failures.

“That’s something we simply feel very strongly about. In all of our discussions with clinicians and patients the paramount concern is to maximise their chance of a cure. This is a disease which can have horrible morbidity and mortality, and patients want their best chance of clearing it.”

Trial Name	Setting	Trial ID
Sapphire I	Genotype 1, never treated before	NCT01716585
Sapphire II	Genotype 1, treatment-experienced	NCT01715415
Pearl II	Genotype 1b, treatment experienced, with or without ribavirin	NCT01674725
Pearl III	Genotype 1b, never treated before, with or without ribavirin	NCT01767116
Pearl IV	Genotype 1a, never treated before, with or without ribavirin	NCT01833533
Turquoise II	Genotype 1 with compensated cirrhosis	NCT01704755

To contact the writer of this story email Jonathan Gardner in Washington at jonathang@epvantage.com or follow  @JonEPVantage on Twitter

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AASLD – Sofosbuvir-simeprevir pairing scores big

Source : EP Vantage
Company:  Johnson & Johnson, Bristol-Myers Squibb, Gilead Sciences, Medivir
Tags:  Comment, Free Content, Company Strategy, USA, Trial Results, Phase II, Phase III, Filing & Registration, Systemic Anti-Infectives, Gastro-Intestinal
Date: November 05, 2013

If there had been any question over whether the two hepatitis C projects nearing US launch would be used together on approval, today there should be no doubt. The combination of Gilead Sciences’ sofosbuvir with  Johnson & Johnson’s simeprevir achieved a greater than 90% viral suppression rate in patients who have previously failed to clear their disease on an interferon-based therapy.

The fact that the regimen did so without an assist from ribavirin is even better news, since eliminating its risk of anaemia is recognised as big an improvement as removing the flu-like symptoms associated with interferon. Given that the data presented at AASLD are phase II, and the FDA will almost surely not sanction the combination yet, it is probable that physicians will want to reserve the new treatment for advanced patients with few options.

Without explicitly endorsing off-label use of the two agents together, Ira Jacobson, a Cornell University medical professor who presented the Cosmos trial data at AASLD, said, “It has occurred to many clinicians that approval of these two agents will represent the first time that physicians and patients will have access to agents in these two classes together.

“All of us want to help our patient to the maximum extent possible, so it’s not difficult to imagine extrapolating from these data and considering the application of this regimen even in the absence of additional data to patients in particular need.”

Beat and raise?

With a 90% viral suppression rate four weeks after the end of treatment, expectations were already sky high. The big question was whether the cure rate would hold or even improve, and whether the  ribavirin is necessary to achieve these rates.

The sofosbuvir-simeprevir combination did not disappoint. The first cohort to complete the 12 weeks of follow-up after the end of treatment consisted of genotype 1 patients who had not responded to prior interferon with little to no fibrosis. The non-ribavirin arms both achieved sustained viral response (SVR) of 93%, regardless of whether patients underwent 12 or 24 weeks of treatment. With 24 weeks of treatment, the arm with ribavirin had an SVR rate of 79%, and in the 12-week arm the SVR was 96%.

“There is no incremental benefit going to 24 weeks,” Fred Poordad, a San Antonio University of Texas medical professor, said of the Cosmos data in a review of ongoing phase II trials. “I wonder if ribavirin would add an incremental benefit.”

Dr Jacobson also presented interim results on patients with advanced fibrosis or cirrhosis that were no less encouraging. Four weeks after the end of a 12-week treatment regimen patients taking the new antivirals together were hitting 100% viral suppression, and 96% if  ribavirin was added to the mix. 100% of patients who had never received an interferon-based treatment had viral suppression, with the only relapse in that liver-disease cohort having been a single patient taking  ribavirin.

How important is ribavirin to hep C treatment? It certainly made interferon better, but the side effects, particularly anaemia, required careful management and caused occasional discontinuations, said Gregory Fitz, internal medicine department chair at the University of Texas Southwestern and AASLD’s president.

“If these other agents can avoid that toxicity I think having regimens that are both interferon and ribavirin-free is a step forward,” Dr Fitz said.

Sofosbuvir and  simeprevir, now called Sovriad after approval in Japan, have both received unanimous support from FDA advisory committees.  Sovriad is due a US decision by November 28 and  sofosbuvir by December 6,

After the data release yesterday afternoon, shares in J&J’s partner Medivir, which licensed out the protease inhibitor in 2004, were up 6% to SEK84 today.

Chatter

With the growing chatter about the sofosbuvir-simeprevir combination, some other very positive developments in hepatitis C were lost in the noise, but were no less significant. Bristol-Myers Squibb reported positive phase II data from its combination of  daclatasvir, asunaprevir and  BMS-791325, with 12-week SVR above 90% in genotype 1 – the only weakness being response in cirrhotics in one of two dosing groups.

Gilead reported data on the use of  sofosbuvir and  ribavirin in pre and post-liver-transplant genotype 1 patients, a population in particular need of treatment options; this showed that a 12-week regimen before transplant achieved a post-transplant viral suppression rate of 64%. A 24-week course to treat infection relapse following liver transplant achieved viral suppression in 77% of patients four weeks after the end of treatment.

And in genotype 2 and 3 patients, sofosbuvir with an interferon and  ribavirin backbone achieved a 96% viral suppression rate in genotype 2 and 83% in genotype 3.

Two years ago, Incivek and  Victrelis marked a step forward, improving cure rates and reducing the time some patients needed to take interferon and  ribavirin. It now looks as though physicians within a month might be able to start recommending a regimen free of both of these mainstay treatments, and many appear ready to do so in patients who are running short of options.

To contact the writer of this story email Jonathan Gardner in Washington at jonathang@epvantage.com or follow  @JonEPVantage  on Twitter

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