Harvoni: Another Amazing Drug Aimed at Hepatitis C

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All Hail, Harvoni!

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They say that you can't put a price tag on your health.  At more than $1000 a pill, the new wonder-drug, Harvoni, probably proves this aphorism.

On October 10, 2014,the FDA approved the fast-tracked Harvoni, a new drug aimed at the insidious hepatitis C virus.  In 2014, Harvoni was the third drug approved by the FDA to treat hepatitis C and notable for its remarkable efficacy and once-a-day, oral administration.

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What Is Hepatitis C?

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Hepatitis C is an RNA virus that causes hepatitis or inflammation of the liver.  Currently, hepatitis C is the leading infectious cause of chronic liver disease in the United States and affects 3 percent of the world's population.  Hepatitis C is spread by blood or blood products, and before the advent of adequate screening for the virus, many people became infected after blood transfusions.  Currently, most people develop hepatitis C after sharing needles while using illicit drugs.

Hepatitis C is an insidious pathogen that rarely causes a clinically evident acute illness. Instead, many people are diagnosed after presenting with chronic disease--on average, 10 to 18 years after being infected with the virus.  Additionally, infection with the hepatitis C virus leads to chronic disease in more than 85 percent of those infected. 

Hepatitis C has a pronounced affinity for hepatocytes or liver cells. Furthermore, the virus mutates quickly and thus does a good job evading the body's immune system.  Long-term or chronic inflammation eventually leads to widespread necrosis or death of liver cells and cirrhosis.  Cirrhosis appears as scar tissue mixed with regenerative nodules that give the liver a classic "lumpy" appearance.  Eventually, hepatitis C leads to diminished liver function and liver failure.  Finally, chronic infection with the hepatitis C increases the risk of hepatocellular carcinoma or liver cancer.  Of note, alcohol, smoking, obesity and co-infection with other diseases like HIV (or even hepatitis B virus) make hepatitis C infection much worse.  

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Treatment Before the Advent of Drugs Like Harvoni

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This past year, the FDA has been on a tear and approved 3 different drugs for the treatment of hepatitis C: Harvoni and its chemical cousins Olysio (simeprevir) and Sovaldi.  Once upon a time, however, the only drug treatment targeted at the hepatitis C virus was pegylated interferon combined with Ribavirin.  This option, although effective, is less effective at eliciting a sustained virologic response ("cure") than Harvoni and its cousins.  Moreover, interferon and Ribavirin are harder to administer, take longer to administer and have more adverse effects than drugs like Harvoni.   

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So What Is Harvoni?

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Harvoni belongs to a class of drugs known as direct-acting antivirals. These drugs are more precise and effective at targeting viral replication than pegylated interferon and Ribavirin.  Of note, Harvoni has proven highly effective in people who are classically resistant to hepatitis C treatment.  Moreover, Harvoni is administered as a combination oral pill and is the first in its class to be administered without pegylated interferon and Ribavirin.  In clinical trials, more than 90 percent of participants,both with and without cirrhosis, who received Harvoni achieved sustained virologic response ("cure") after a mere 12 weeks of therapy.

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What Does Harvoni Mean to You?

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If you or someone you know has hepatitis C, Harvoni is a very promising treatment.  First, studies show that antiviral treatment aimed at eradicating the hepatitis C virus can improve liver histology and prevent further liver deterioration.  Second, Harvoni, which comes in a combination pill form, is more effective and easier to take than regimens centered on pegylated interferon and Ribavirin.  Third, Harvoni has proven highly effective in people who are classically resistant to hepatitis C treatment (patients with cirrhosis or genotype 1).

On a final note, drugs like Harvoni have received a lot of press for being really expensive.  A 12-week regimen can cost a whopping $94,500 or more than $1,000 a pill! (Or, depending on how you look at it, the price of a Mercedes-Benz S550.)  Moreover, many state Medicaid programs are having a hard time covering the cost of such treatment and require that patients meet a strict set of clinical criteria to receive prior authorization.

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On a Final Note ...

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Drugs like Harvoni have been getting a bum rap for being so expensive.  Sure they cost a lot of money but the public health and quality-of-life costs of the alternative--no effective treatment for those with chronic hepatitis C--far outweighs the nearly one-hundred-large cost of treatment.  The development of drugs like Harvoni is a real medical breakthrough (and I don't use this term lightly).  This drug promises to help people with the most intractable disease avoid a lifetime of chronicity, and, of course, the toll that such chronicity takes on family, friends and loved ones.

Selected Sources

Dienstag JL. Chapter 304. Acute Viral Hepatitis. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 18e. New York, NY: McGraw-Hill; 2012.  Accessed October 14, 2014.

Dienstag JL. Chapter 306. Chronic Hepatitis. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 18e. New York, NY: McGraw-Hill; 2012. Accessed October 14, 2014.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376449.htm.  Accessed 10/14/2014.

“Simeprevir for the treatment of hepatitis C virus infection” by Laure Izquierdo et al from Pharmacogenetics and and Personalized Medicine published August 14, 2014.  Accessed 10/14/2014

“Emerging Therapies for Hepatitis C” by Do Young Kim et al from Gut Liver published September 2014.  Accessed 10/14/2014.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4164256/

Ryan KJ, Ray C. Chapter 13. Hepatitis Viruses. In: Ryan KJ, Ray C. eds. Sherris Medical Microbiology, 5e. New York, NY: McGraw-Hill; 2010. Accessed October 14, 2014.

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