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Hepatitis C Treatment Crosses a New Threshold

Hepatitis C Treatment Crosses a Threshold

Hepatitis C Treatment Crosses a Threshold

The much-anticipated approval of the first all-oral hepatitis C treatment occurred this past Friday. The Food and Drug Administration (FDA) approved Gilead Sciences’ Sovaldi (sofosbuvir). Treatment for genotypes 2 and 3 uses Sovaldi plus ribavirin, making it the first interferon-free treatment. As expected, Sovaldi will be used with peginterferon and ribavirin for patients with genotypes 1 and 4.

The FDA and Gilead threw in a few surprises. The FDA sanctioned a broader application of sofosbuvir, opening the door for all-oral hepatitis C treatment for patients with hepatocellular carcinoma (liver cancer) who are waiting for a liver transplant. The big surprise is that Sovaldi can be used with ribavirin for genotype 1 patients who cannot use interferon.

Other special populations for whom Sovaldi may be used:

  • Patients with cirrhosis
  • HCV/HIV-1 co-infected patients
  • Patients with renal impairment
  • Older adults (I am reluctant to accept that age 65 and over is labeled geriatric; I am feeling very young now that I am hep C-free.)

Gilead’s surprise is the price tag. The wholesale acquisition cost of twelve weeks of Sovaldi is $84,000 or $1000 a pill. This does not include the cost of peginterferon, ribavirin, labs, medical costs, and drugs for side effects. Since genotype 3 patients will need 24 weeks of treatment, the cost would be $168,000. A 48-week treatment for hepatocellular carcinoma patients awaiting transplant would be nearly a half million. I understand that research is costly, but this is ridiculous. I don’t care who is paying for it—insurance, Medicare, or Warren Buffet—this is shameful.

However, the price does not change the amazing fact that Sovaldi ushers in a new era of easier hepatitis C treatment. Although the FDA approval does not completely eliminate the need for peginterferon, it begins to. Most experts believe that peginterferon will vanish from general use within a year.

Here is a brief summary of Sovaldi. I’ve provided the Sovaldi Prescribing Information for those who want to read more.

Sovaldi in combination with peginterferon and ribavirin for adults with genotype 1 or 4

Pros

  • Short 12-week treatment duration, with limited exposure to peginterferon and ribavirin, which translates into an easier to tolerate side effect profile
  • High cure rate at around 90% overall
    • Genotype 1 89%; genotype 4 96%
    • Cirrhosis 80%
    • Hardest to treat (genotype 1, cirrhosis, IL28B non-C/C, high viral load) 71%
  • Once daily pill
  • Highest rate of response in Blacks 87% vs. Non-blacks at 91%
  • Low drug-resistance profile
  • Fewer known drug interactions than other direct-acting antivirals (Incivek, Victrelis, and Olysio)

 Cons

  • Peginterferon and ribavirin side effects
  • Cost
    • Treatment not approved for genotypes 5 or 6 yet

 Sovaldi with ribavirin for the treatment of adults with genotypes 2 or 3

Pros

  • No peginterferon
  • Short 12-week treatment duration for genotype 2, with limited exposure to ribavirin/24 weeks of treatment for genotype 3 patients
  • High cure rate at around 93-95% overall for genotype 2
    • Cirrhosis 60-94%
    • Hardest to treat (genotype 1, cirrhosis, IL28B non-C/C, high viral load) 71%
  • Improved cure rate at around 84% overall for genotype 3
    • Cirrhosis 60-92%
    • Hardest to treat (genotype 1, cirrhosis, IL28B non-C/C, high viral load) 71%
  • Easier to tolerate side effect profile
  • Once daily pill
  • Highest rate of response in Blacks 87% vs. Non-blacks at 91%
  • Low drug-resistance profile
  • Fewer known drug interactions than other direct-acting antivirals (Incivek, Victrelis, and Olysio)

 Cons

  • Ribavirin side effects
  • Costs

Now let’s see how the insurance companies handle Sovaldi. I predict they will pay for it, since it is cheaper than the medical costs related to the potential complications of hepatitis C. I am particularly interested in hearing from readers whose medical providers prescribe Sovaldi. Please let me know if your insurance covered it.

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