British Columbia expands HCV coverage to include Victrelis...

Article posted on 3/26/12 via Vancouver 24 hours. Looks like Victrelis is now available in British Columbia via PharmaCare for patients with genotype 1 infection. 

B.C. expands coverage for hep C

By ERICA BULMAN, 24 HOURS

PharmaCare coverage for eligible patients with chronic hepatitis C (genotype 1) is being expanded to include the drug boceprevir, approved by Health Canada in July 2011.

New hep C patients who haven’t been treated, those who have relapsed after treatment or responded only partially to another treatment, will be eligible.

Boceprevir is taken in combination with two other drugs — peginterferon and ribavirin — over 24 to 44 weeks.

“The rapid approval of boceprevir is a major step forward towards the potential future elimination of hepatitis C infections in British Columbians,” said Dr. Mel Krajdenof the BC Centre for Disease Control. “Viral cure is known to reduce mortality, improve quality of life and prevent progression of liver disease.”

Without PharmaCare or private drug plan coverage, boceprevir would cost patients about $1,050 per week, the province estimated.

In clinical trials, patients who’d never received treatment and took the boceprevir combination had a 25% higher cure rate over those who didn’t.

In patients unsuccessful in other therapies, the boceprevir cure rate was 38% higher than those who received peginterferon and ribavirin alone.

There are about 64,000 British Columbians currently diagnosed with hep C, 25% of whom have cleared their infection without treatment, according to the province.

Untreated the disease can result in liver failure and death.

More difficult-to-treat patients relapse in Gilead GS-7977 hepatitis C trial...

Posted on 3/6/12 on Reuters.com: Two more G1 null responder patients relapsed on 12 weeks of Gilead nuc GS-7977 + PEG and RBV. Investors are spooked, but really shouldn't be.  GS-7977 + PEG & RBV is a powerful drug combo, but given the head-spinning replicative capacity of this virus and it's lack of a proof-reading mechanism, 12 weeks is probably not long enough to quash the virus in a null responder patient and will probably require more than just one DAA targeting more than just one cycle of the virus's replicative process. The most intriguing part of this is the speculation of just what the 'Rescue Protocol' involves in terms of added drugs to GS-7977 and duration of therapy.

More patients relapse in Gilead hepatitis C trial

Tue Mar 6, 2012 5:17pm EST

(Reuters) - Two more patients in a 10-patient segment of a mid-stage trial testing Gilead Sciences Inc's experimental hepatitis C drug GS-7977 had the virus return within four weeks of treatment, researchers said on Tuesday.

The company, which recently paid nearly $11 billion to acquire the drug and its developer, Pharmasset, said last month that six out of 10 patients with a prior "null response" to standard hepatitis C therapy saw the virus return within four weeks of treatment with a combination of GS-7977 and the antiviral drug ribavirin.

The latest results from the mid-stage trial bring to eight the number of patients who have relapsed.
One patient has not reached the four-week point and the other showed a response to the drug, Dr. Edward Gane from New Zealand's Auckland City Hospital and the study's lead investigator said here at the Conference on Retroviruses and Opportunistic Infections.

The trial segment he updated involved patients infected with genotype 1 hepatitis C -- the most common, but also the most difficult to treat, subset of the disease.

"The majority of null responders have relapsed post treatment," Dr. Gane said, adding that such patients will likely need either a longer duration of therapy or combination treatment with other direct-acting antiviral agents.

He said the relapsed patients will be offered a "rescue protocol" in the form of another trial of GS-7977 in combination with a different experimental drug.

Shares of Gilead have dropped 18 percent since the company's announcement of the trial results, which suggested that an all-oral treatment for hepatitis C may be further away than many had hoped.

Dr. Gane said ongoing pivotal-stage trials of GS-7977 "should establish that interferon-free treatment is not a dream. It's a reality that should be here within the next five years."

Current hepatitis C drug regimens require injections of interferon, which causes severe flu-like symptoms and cannot be tolerated by some patients.

GS-7977 is designed to block an enzyme essential to the replication of the hepatitis C virus. It is one of a new class of treatments designed to be given without injections of interferon, which helps boost the body's immune system but can also cause debilitating flu-like side effects.

Gilead has said it expects to announce at the end of this month results from a mid-stage trial of GS-7977 in previously untreated hepatitis C patients.

Hepatitis C is a liver-destroying disease that affects some 170 million people worldwide. Untreated, it can lead to cirrhosis, liver cancer and the need for a liver transplant.

In 2015, Gilead's GS-7977 Plus Ribavirin Will Earn Decision Resources' Proprietary Clinical Gold Standard Status for the Treatment of Non-Responder Patients with Hepatitis C Virus...

Press release posted 2/28/12 on Marketwatch.com. Although their output is always of exceptional high-quality, Decision Resources' ability to pick a 'whip-your-head-right-around, spill-your-coffee-and-read-at-all-costs' attention-grabbing headline in hopes that you'll buy their product, is unprecedented in the market analysis marketplace. That's the type of unexpurgated crassness we'd like to see more of.  You have to love them. Apparently, the oracles at DR have already decided that they will award GS-7977 plus RBV the "Decision Resources' Proprietary Clinical Gold Standard" for treatment of non-responders in 2015. That's some unshakable confidence, let's hope they're right because no one is going to let them forget this press release. Despite the puffery, some interesting analysis is to be gleaned from this press release. They've obviously been doing some serious homework. DR expects that "the overall HCV drug market will experience significant growth, expanding from almost $1.7 billion in 2010 to $14.4 billion in 2015 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Thereafter, the market will decrease to $11.2 billion in 2020, owing to a decline in the size of the treatment-eligible population due to declining prevalence and effective new regimens." Compelling reason enough on why the HCV drug development marketplace is red hot at the moment.  


In 2015, Gilead's GS-7977 Plus Ribavirin Will Earn Decision Resources' Proprietary Clinical Gold Standard Status for the Treatment of Non-Responder Patients with Hepatitis C Virus

* GS-7977 Plus Ribavirin Will Displace the Current Proprietary Clinical Gold Standard, Telaprevir in Combination with Peg-IFNa/Ribavirin, According to Findings from Decision Resources


BURLINGTON, Mass., Feb 28, 2012 (BUSINESS WIRE) -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, based on clinical data and the opinions of interviewed thought leaders, telaprevir (Vertex's Incivek, Johnson & Johnson's Incivo) in combination with peg-IFNa (Roche's Pegasys or Merck's Victrelis) and ribavirin (Roche's Copegus; Merck's Rebetol; generics) has earned Decision Resources' proprietary clinical gold standard status for the treatment of non-responder patients with hepatitis C virus (HCV). Owing to its competitive advantages in safety and tolerability as well as delivery, the interferon-free combination of Gilead's GS-7977 (formerly PSI-7977) plus ribavirin will displace telaprevir plus peg-IFNa/ribavirin and earn proprietary clinical gold standard status for HCV non-responders in 2015, following its launch for the indication in 2014 in the United States.

Decision Resources' analysis of the hepatitis C virus drug market also finds that surveyed U.S. gastroenterologists and managed care organization (MCO) pharmacy directors agree that the percentage of genotype-1 null responders achieving sustained virologic response is one of the attributes that most influences their decisions regarding prescribing and formulary status determinations, respectively, in HCV non-responders.

"Clinical data and the opinions of interviewed thought leaders indicate that several emerging regimens utilizing novel, HCV-specific direct-acting antivirals have advantages over sales-leading telaprevir plus peg-IFNa/ribavirin on this attribute," said Decision Resources Analyst Seamus Levine-Wilkinson, Ph.D.

According to insights from surveyed U.S. gastroenterologists and MCO pharmacy directors, the absence of interferon-free treatment options for HCV is one of the greatest unmet needs in HCV. Clinical data and the opinions of interviewed thought leaders indicate that GS-7977 has demonstrated the potential to significantly fulfill this unmet need.

The findings also reveal that surveyed U.S. gastroenterologists indicate that they would prescribe the quadruple regimen of Bristol-Myers Squibb's NS5A inhibitor daclatasvir (BMS-790052) plus Bristol-Myers Squibb's protease inhibitor asunaprevir (BMS-650032) plus peg-IFNa/ribavirin to 41 percent of their HCV non-responder patients. Decision Resources' forecast for this quadruple regimen is more conservative due to anticipated reimbursement restrictions, positioning in later lines of therapy, competition from IFN-free regimens and competition asunaprevir will face from other protease inhibitors.

The launch of novel HCV-specific agents will increase the size of the drug-treated population mainly as a result of re-treatment of prior non-responders as well as increased referral and drug treatment rates. The overall HCV drug market will experience significant growth, expanding from almost $1.7 billion in 2010 to $14.4 billion in 2015 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Thereafter, the market will decrease to $11.2 billion in 2020, owing to a decline in the size of the treatment-eligible population due to declining prevalence and effective new regimens.

Decision Resources' Robust Market Forecast and Opportunities Analysis

Decision Resources provides a comprehensive view of what is happening in a specific drug market now and in the decade ahead. The research includes analysis of the unmet need and near-term drug development opportunities that exist within a drug market powered by primary research from physicians and payers. The robust market forecast and opportunities analysis is comprised of the Pharmacor 2012 advisory service and the DecisionBase 2012 report series.

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SOURCE: Decision Resources

     
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