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Harvoni: A Page in Hepatitis C Treatment’s History Books

This is an abridged version of my Hep Blog

Harvoni makes hepatitis C history

Harvoni makes hepatitis C history

This is an historic day. The FDA approved Harvoni, a drug for chronic hepatitis C virus (HCV) infection with high cure rates and mild side effects. Understandably, patients are anxious to get started on treatment. However, there are things you need to know about Harvoni before you can start.

Gilead Sciences’ Harvoni is one pill containing two drugs. Both are direct-acting antivirals (DAAs) which means they directly interfere with hepatitis C virus replication. One drug, sofosbuvir (brand name Sovaldi), has been on the market since late 2013. It is a polymerase inhibitor. The second drug is ledipasvir, an NS5A inhibitor.

Here is a brief summary of Harvoni, along with prescribing information for those who want to read more.

  • Harvoni is approved for treatment of genotype 1 HCV infection in adults.
  • Harvoni’s cure rates range from 94 to 99%.
  • It is a single pill taken daily, with or without food.
  • Patients who have never been treated for HCV, whether they have cirrhosis or not, take Harvoni for 12 weeks.
  • Treatment-naïve patients without cirrhosis whose pre-treatment viral load (HCV RNA) is less than 6 million IU/mL may be considered for 8 weeks of treatment.  This is about 40% of eligible patients.
  • Patients without cirrhosis who have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin, take Harvoni for 12 weeks.
  • Patients with cirrhosis who have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin, take Harvoni for 24 weeks.
  • Do not take Harvoni with drugs/herbs that are P-gp inducers (e.g., rifampin, St. John’s wort). Other drugs that may interact with Harvoni include antacids and other acid-reducing drugs, digoxin, anti-seizure medications, simeprevir (Olysio), rosuvastatin,  HIV and TB drugs.
  • The most side effects were fatigue and headache, followed by nausea, diarrhea, and insomnia.
  • The cost of twelve weeks of Harvoni is $94,000, or $1125 a pill.

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  • Mikila November 28, 2014, 4:44 PM

    Hello Lucinda and I hope you had a wonderful Thanksgiving. I’ve taken Harvoni since October 21,2014. Through the grace of GOD, I have reached undetectable status with normal Liver Function Tests. I will continue on with treatment until March 2015. I’m just curious though, have you heard of anyone relapsing with Harvoni after treatment stops? I so happy to hear you are Hep C free and I too am upset about the cost. I work in the Pharmaceutical Industry as a Chemist and I understand the R & D cost but it crazy to turn people down for Treatment. Lord what is America coming down too. I will Pray everyone gets the drug. I TOO AM NOW PISSED OFF.

  • Kay April 7, 2015, 9:56 AM

    I am almost one month into Harvoni treatment with no side affects to speak of. Actually, I am feeling better as I go along. I am very thankful for the opportunity to rid my body of this disease. My hopes are very high for a cure within 12 weeks!

  • susan ridge May 4, 2016, 1:33 AM

    I am on day 26 of Harvoni, and my symptoms seem to be to the extreme. Insomnia, on & off anxiety, arm and shoulder pain, numbness in arms and hand, upper back into shoulder aches, brain feels “foggy” at times. Perhaps this is from almost zero sleep for weeks now. I am awaiting my first blood tests results so far after going into treatment. I am hoping the side effects will subside as I continue on. I would love to hear if anyone else has the same discomforts as I do. It’s scary but I am grateful I was able to recieve treatment as I have heard it is not covered for all. It should be.

    • Lucinda Porter May 4, 2016, 12:54 PM

      Lack of sleep explains all of this – I suggest you talk to your doc about getting help for sleep. I also suggest joining the Hep Forum http://forums.hepmag.com/ Hope you get some sleep soon!