Harvoni: New Once-Daily Combination for Hepatitis C

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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The FDA recently approved Harvoni (ledipasvir/sofosbuvir), a new combination oral medication for the treatment of hepatitis C that stops the replication of the virus.

What is Harvoni?
Harvoni 90 mg/400 mg tablets are a once-daily treatment that can be used without injectable pegylated interferon alpha (Pegintron, Pegasys) or oral ribavirin (Copegus, Ribasphere, Rebetol).

Why is Harvoni different from other hepatitis C treatments?
Harvoni is unique because it is the first combination pill approved to treat chronic hepatitis C genotype 1 infection and it DOES NOT require combination treatment with pegylated interferon or ribavirin—medications that use to be first line therapy, but have serious side effects.

The pegylated interferon alpha injectable often contributes to patients not finishing their course of hepatitis C therapy, mainly due to the unfavorable side effects. Discontinuation of peginterferon alpha is primarily due to adverse reactions like flu-like symptoms and psychiatric or stomach problems.

Who is Harvoni for?

As mentioned above, Harvoni is approved for the treatment of hepatitis C genotype 1 patients. Genotype is the genetic makeup of a person or virus, and each genotype has unique characteristics. The differences are important when it comes to treating the hepatitis C virus.

In the past, patients with genotype 2 and 3 had a better response and shorter treatment duration with mainstay treatments like interferon and ribavirin than those with genotype 1. However, genotype 1 is more common, affecting around 75% of Americans infected with hepatitis C. Genotypes 2 and 3 account for 20 – 25% of those infected, while genotypes 4, 5, and 6 account for a much smaller number, even outside the US.

Harvoni, with its combination of ledipasvir and sofosbuvir, has a very good response rate in comparison to older treatment options, and a shorter treatment duration, which is great news for genotype 1 patients.

What about cost?

Here’s the bad news. The wholesale price for a 12-week course of treatment with Harvoni is estimated to be $94,500. Many patients may only need an 8-week course, but the cost will still be very high. The recommended length of treatment with Harvoni will depend on prior treatment history, cirrhosis status, and baseline viral load, but it can be given in courses of 8 weeks, 12 weeks, or 24 weeks.

Are there other new hepatitis C treatments available?

There are two other recently approved hepatitis C medications that are also changing treatment of the virus: Sovaldi and Olysio.

Sovaldi (sofosbuvir) 400 mg tablets are a once-daily treatment that can also be used without the injectable pegylated interferon. The active ingredient in Sovaldi, sofosbuvir, is also one of the active ingredients in Harvoni.

Olysio (simeprevir) 150 mg capsules are another once-daily treatment, but the official FDA recommendation is still that Olysio be used in combination with pegylated interferon and ribavirin.

Like Harvoni, both Sovaldi and Olysio are also very expensive—the wholesale price for one month of Sovaldi is $28,000, and the wholesale price for 12-week course of Olysio is $66,360, according to the manufacturers.

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