The Hep C Race Is Heating Up: AbbVie Vs. Gilead

Feb. 10, 2014 7:47 AM ETAbbVie Inc. (ABBV), GILD24 Comments
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Peter Geschek

In January, AbbVie (NYSE:ABBV) released positive results from the remaining Phase 3 studies of its all-oral hepatitis C regimen and said it will start submitting applications to the FDA early in the second quarter. Assuming a favorable response, AbbVie could start marketing the drugs in late 2014.

Meanwhile, Gilead (NASDAQ:GILD) is planning to submit in the first quarter an FDA application for a fixed-dose combination of the recently approved Sovaldi with the NS5A inhibitor ledipasvir.

Both companies have a breakthrough designation from the FDA.

Both the AbbVie and Gilead hepatitis C regimens appear effective, with cure rates in the high 90 percent range for both new-to-treatment and previously treated patients. AbbVie's combinations seem especially effective for the seriously ill segment of the patients.

The Gilead regimen consists of a single pill taken once daily plus ribavirin, if needed, which adds an additional pill taken twice daily.

AbbVie's regimen requires two pills to be taken in the morning, plus another pill at night. Again, if ribavirin is necessary, it's additional. AbbVie said it is working on a coformulation, to consolidate the pills in the future.


AbbVie calls its multinational HCV program the largest all-oral interferon-free clinical program in Genotype 1 patients conducted to date.

Genotype 1 is the most prevalent genotype in the developed world, and is roughly evenly distributed between Genotype 1a and 1b. AbbVie's Phase 3 program enrolled 2,300 patients at clinical sites in 25 countries.

The goal was to maximize SVR (sustained virologic response) rates across various patient types, from patients who are new-to-treatment to the most difficult ones to treat, such as nonresponders to interferon-based therapy and patients with advanced liver fibrosis or cirrhosis.

Late last year AbbVie released results from the Sapphire trials, which showed that the therapy plus ribavirin, in both new and previously treated patients, produced

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