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Alan Franciscus
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HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated October 13, 2014

Monday, November 24, 2014

Hepatitis C Breakthrough

The Centers for Disease Control (CDC) estimates that more than 3 million Americans have hepatitis C and many don’t know they have it. Hepatitis C can remain hidden for decades before signs such as immune dysfunction, jaundice and fatigue develop. If left untreated, it can cause cirrhosis, or scarring of the liver, and eventually liver failure

Baby boomers have been designated as especially at risk. The CDC has called for all people born between 1945 and 1965 to be tested for the hepatitis C virus.

Finally, there are drugs to eradicate the hepatitis C virus that do not require use of the dreaded drugs we have used for many years – namely Interferon and/or Ribavirin.

Read more...

Harvoni Takes the Sting Out of Hepatitis C Treatment

For the first time, hepatitis C can be cured without interferon and ribavirin, which can cause fatigue and depression.

Finally, there’s a medication to cure hepatitis C that doesn’t require use of the dreaded drugs interferon or ribavirin.

The U.S. Food and Drug Administration earlier this month approved Harvoni, a once-daily tablet manufactured by Gilead Sciences. Harvoni is a combination medication that includes sofosbuvir (Sovaldi), another Gilead breakthrough treatment approved late last year, and ledipasvir, which is also made by Gilead.

The new medication costs $95,000 for a 12-week course of treatment. On the surface it appears even more expensive than Sovaldi, which costs $84,000 for a 12-week supply. Both medications have been proven to cure hepatitis C in a majority of people with genotype 1 hepatitis C within that time frame.

Read more...


Sunday, November 23, 2014

Spain: Hepatitis C ‘superdrug’ available on national health system

THE long-awaited new Hepatitis C drug will be available on Spain’s national health system shortly, but only for certain patients.

According to Dr María Londoño from the Hospital Clínic in Barcelona, a member of the Spanish Agency for Medication and Healthcare Products, the drug Sovaldi will be administered to sufferers awaiting a liver transplant or who have undergone one, those with liver cirrhosis, or who have found more traditional treatment to have been ineffective.

Those with minor fibrosis – which accounts for the majority of Hepatitis C sufferers – will not be given the new drug.

Read more...

Saturday, November 22, 2014

Pakistan: The disease that kills

Hepatitis C has become an epidemic in Pakistan and there is no end in sight since the governments neither have the will nor the wherewithal to control this disease

The press is full of discussions about Ebola, dengue fever, polio and whatever other disease catches the fancy of our media and our ‘ruling class’ at any given time. I do not for a moment wish to denigrate the efforts to control any disease especially the ones I mention above. But there are other health problems that do not get adequate coverage. And no, I am not referring to a simple matter like waterborne diseases that could be controlled if clean water became available for people to drink.

Let me mention a particular condition that afflicts close to 12 million Pakistanis, more than 20000 new patients acquire this disease every year; a number greater than in any other country in the world, and more than 400 Pakistanis die from this disease every day. And in the Punjab alone there are more than six million people infected with the viruses causing this disease. What disease is this? Well dear readers if you have not figured it out yet, it is what we call Hepatitis C. (Statistics from Jang-Mera Shahr Lahore, October 28, 2014).

Statistics presented in a conference on Hep C held under the aegis of the Punjab Department of Health and as reported in the news item mentioned above suggest that the world over, on the average, one person receives one or two injections every year. However, in Pakistan, the average is between 13 and 14 injections every year and 70 percent of these injections are given using unsterilized needles or syringes.

Read more....

Friday, November 21, 2014

Ireland: Early access no cure-all for HepC

Dara Gantly on the pressure to provide full access to powerful new treatments.

It is not often we hear the word ‘cure’ mentioned in the development of a new class of drug, but the direct-acting antiviral (DAAs) agents for people with the hepatitis C virus (HCV) have that exact potential. Indeed, this revolution in treatment could mean the ‘eradication’ for the condition. The only barrier to achieving this will be the ability to access and afford these new therapies. The ‘US$1,000 pill’ tagline has, as you might expect, caused quite a stir among healthcare funders and media alike, with some experts describing the costs of the drugs “as breathtaking as their effectiveness”.

From the standard treatment for chronic HCV genotype 1 with ribavirin, pegylated interferon and a protease inhibitor — which could involve 18 tablets a day, last a year, have a limited response rate and cause severe side-effects — patients with HCV are now being presented with three months or less of oral medications that are offering a 90 to 95 per cent ‘cure’ rate, with experts talking about the eradication of hepatitis C over the next decade.

Read more... 

At The Crossroads: How Will Medicare Grapple With Hep C?

My recent story about the high cost of new hepatitis C treatments focused on the difficulty of deciding who gets these new drugs now and who has to wait. That's because, while new drugs like Sovaldi and Harvoni (both made by Gilead) promise to cure a lot of people, they're so expensive we simply couldn't afford to treat everyone who's infected right now. I looked at how Rhode Island's Medicaid agency is grappling with this question, by restricting treatment to patients with the most advanced liver disease, and placing some other requirements on patients, such as being drug free for at least six months prior to being approved for treatment.

All the experts I've been speaking with for this series tell me that Medicaid covers a disproportionate number of people infected with hepatitis C; it's a disease, in many ways, of the disenfranchised. But it's also been called the disease of a generation, baby boomers - people born between 1945 and 1965 (and if that's you, get tested!). They'll soon age into Medicare.

Read more...

CHMP Grants Positive Opinions of AbbVie's VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) for the Treatment of Chronic Hepatitis C in Europe

- Major regulatory milestone achieved toward approval in the European Union
- Final decision from the European Commission expected in the first quarter of 2015

NORTH CHICAGO, Ill., Nov. 21, 2014 /PRNewswire/ -- The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted positive opinions for AbbVie's (NYSE: ABBV) investigational, all-oral, interferon-free treatment of VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) with or without ribavirin (RBV) for patients with genotype 1 (GT1) and genotype 4 (GT4) chronic hepatitis C virus (HCV) infection. The European Commission will review the opinions and make a final decision sometime in the first quarter of 2015.

"The CHMP positive opinions mark an important milestone in our HCV development program and recognize the potential our treatment brings to people in Europe living with this chronic condition," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Our treatment has been developed with the goal of achieving high cure rates in a broad range of genotype 1 patients with low rates of discontinuation and relapse."

The marketing authorization applications (MAAs) were submitted to the EMA on May 6, 2014 under an accelerated assessment, designated to new medicines of major public health interest. Review of the MAAs is being conducted under the centralized licensing procedure, which if approved will result in marketing authorizations valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

Robust Clinical Program Supported Positive OpinionsThe CHMP opinions are supported by a robust clinical development program consisting of six pivotal Phase 3 studies (SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II)1,2,3,4,5 including more than 2,300 GT1 patients in over 25 countries. In addition, the positive opinions were supported by a Phase 2 study, PEARL-I, in GT4 patients without cirrhosis6, as well as preliminary data from the TURQUOISE-I study in GT1 HCV and HIV-1 co-infected patients7 and from the CORAL-I study in liver transplant recipients with recurrent GT1 HCV infection who were new to treatment after transplantation.8

Approximately nine million people in Europe are infected with HCV, which over time may lead to cirrhosis and liver failure in about 10-20 percent of people with chronic HCV.9,10 Genotype 1 is the most common type of HCV genotype9, accounting for 60 percent of cases worldwide.10 In Europe, the most prevalent genotype is 1b (47 percent).11  Genotype 4, most common in the Middle East, sub-Saharan Africa and Egypt, is becoming increasingly prevalent in several European countries including Italy, France, Greece and Spain.12 

The U.S. Food and Drug Administration (FDA) granted priority review for AbbVie's treatment for patients with GT1 chronic HCV infection on June 13, 2014. AbbVie's treatment was also granted Breakthrough Therapy designation by the FDA, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint compared to available therapy.

About AbbVie's Investigational Chronic HCV TreatmentVIEKIRAX™ + EXVIERA™ is being investigated for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX consists of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily, and EXVIERA consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily, with or without ribavirin, dosed twice daily.

AbbVie's chronic HCV treatment combines three direct-acting antivirals, each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process.
For genotype 4 chronic HCV patients, AbbVie's treatment consists of the fixed-dose combination of paritaprevir/ritonavir (150mg/100mg) with ombitasvir (25mg) only, dosed once daily with ribavirin, dosed twice daily.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

Additional information about AbbVie's HCV development program can be found on www.clinicaltrials.gov.


SOURCE AbbVie