This is an abridged version of my Hep Blog
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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