This FDA Approval Is Exciting News for Hepatitis-C Patients

People with hepatitis-C and those who carry the virus without even realizing it -- you have a reason to celebrate this weekend.

Hepatitis-C is a contagious virus that attacks the liver and can be found in acute or chronic forms. In nearly all instances, acute cases of hepatitis-C lead to a chronic form of the condition, which can cause cirrhosis of the liver and possibly even liver cancer. According to the Centers for Disease Control and Prevention, nearly 3.2 million people in the U.S. (about 1% of the population) are estimated to have a chronic version of the hepatitis-C virus, which is known as one of the silent killers because many of its symptoms go undetected. To put things mildly, it's a serious disease currently commanding a lot of attention from researchers.

That attention manifested itself into the approval by the Food and Drug Administration of Abbott Laboratories' (NYSE: ABT  ) first-ever hepatitis-C genotyping test on Thursday. Known as the Realtime HCV Genotype II, this fully automated test is capable of examining patients' blood to determine which specific genotype of the HCV virus is present out of the 11 known subtypes. Since different medications work better on certain genotypes, Abbott's Realtime HCV Genotype II test is going to revolutionize the speed of, and personalization, of hepatitis-C care.

Abbott's perfect timing
This approval from Abbott also comes on the heels of some fantastic new opportunities with regard to how hepatitis-C patients are treated.

One of today's FDA-approved treatments is Vertex Pharmaceuticals' (NASDAQ: VRTX  ) Incivek, which is an oral medication administered with ribavirin and a type of interferon called peginterferon alfa. While relatively effective, interferon can cause lingering flu-like symptoms in patients for up to 48 weeks, which can make the side-effects of the medication as unpleasant as the chronic HCV disease is itself. However, new drugs are currently in the works which could change all that.

Gilead Sciences (NASDAQ: GILD  ) and AbbVie (NYSE: ABBV  ) have the two most-advanced all oral hepatitis-C medications, which could revolutionize patient care.

I've been stating for months that Gilead's sofosbuvir has blockbuster potential written all over it. In its four late-stage clinical trials, sofosbuvir performed considerably better than the placebo in every instance. Delivering an impressive sustained viral response (SVR) of 90% in genotype 1 patients, the drug, when combined with a ribavirin, was also very effective at knocking out detectable levels of the virus in genotype 2 and 3 patients after a 12-week treatment course. Currently under review by the FDA, sofosbuvir may find dual success as a stand-alone compound and as a combination therapy.

AbbVie's hepatitis-C drug combination could be as equally exciting, with the combo producing a 97% SVR in mid-stage trials, and with it receiving the relatively new breakthrough therapy designation from the FDA in May. If AbbVie's success continues over to phase 3 trials, then, with the breakthrough therapy designation already attached, it should sail right through to an expected approval.

However, not all drugmakers have been so lucky. Bristol-Myers Squibb (NYSE: BMY  ) , for example, shelled out $2.5 billion to purchase Inhibitex early last year, only to have its lead hepatitis-C candidate, later renamed BMS-986094, cause the death of a patient in trials and get completely scrapped, resulting in a $1.8 billion writedown.

This is a reason to celebrate
Overall, though, those with hepatitis-C and those who carry the highly mutable virus and who aren't aware of it could be on the precipice of a big shift in the quality and type of care they receive. With Abbott's test now approved, we have the personalization required to treat hepatitis-C patients; it should be only a matter of months before we have two potential blockbusters from Gilead and AbbVie dueling it out to improve patient quality of life.

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Editor's note: A previous version of this article incorrectly stated that Incivek is administered through an IV and did not state that ribavirin is also part of the treatment. The Fool regrets the error.


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  • Report this Comment On June 22, 2013, at 3:56 PM, clloyd53 wrote:

    This blood test comes three weeks after I had a liver biopsy. That cost Medicare thousands. And myself a $700 copay. Since boomers are the largest population with Hepatitis C. And they are entering retirement age. With other impairments that could make Interferon treatment deadly. I can guarantee you. The first manufacturer that comes out with this new class of drugs. Will be smiling all the way to the bank.

  • Report this Comment On June 22, 2013, at 7:10 PM, John23139 wrote:

    Geno type is determined by a blood test. No new technology there.

    The liver biopsy is a sample of the liver tissue used to determine the "stage" of damage done to the liver at the time of the biopsy.

    Both geno and stage are needed prior to being considered for participation in any trial as per FDA and standard medical practices.

    There would never be a biopsy performed before blood testing results were in indicating futher investigation is needed. Tip of the Hat to the Trial groups and Gilead, these folks are Great spirits doing Great things............

    JR Richmond, Virginia

  • Report this Comment On August 27, 2013, at 11:38 PM, rooniesmom wrote:

    I had a test in 2005 using a HCV RNA genotype, LIPA. The lab that did it was Quest Diagnosis in VA. They were one of the few labs in this country that could even do the confirmatory testing for HCV. (I was also the Director of a transplant organization and had to deal with them on a regular basis since 1992. They were great!!!)

    The only difference is my test took took 3 days for results. (It was draw 0n Dec 27 and they had the results on the Dec 30 A couple of days with this kind of test is not significant.) I did 2 courses of 2 different treatments, in 2000 and 2010

    I had to wait more three days to get the drugs involved.

    This is a case of one pharmaceutical company doing some fancy footwork to corner the market on an FDA loophole.

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