New AbbVie Hepatitis C Regimen Shows Strong Cure Rates

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Although arriving a little late to the party, AbbVie Inc. (North Chicago) is touting impressive cure rates for its new daily hep C combo as it looks to find a bigger wedge in a market dominated by Gilead Sciences Inc. (Foster City CA).

The study results, which were presented at the Liver Congress in Barcelona, Spain the previous weekend, show that its once-daily combo treatment of its experimental antivirals ABT-493 and ABT-530 saw cure rates of 97%-100% over either 8 or 12 weeks in Phase 2 testing.

The drug was effective across the 6 genotypes of the disease. In patients without cirrhosis who were not helped by an older regimen, 97% of those with genotype 1 and 98% of those with genotype 2 had no detectable hep C virus in their blood 12 weeks after completing 8 weeks of therapy.

Patients with the hard-to-treat genotype 3 and no cirrhosis receiving the combo treatment as a first-line therapy also saw an impressive 97% cure rate with eight weeks of therapy. Cure rates of 100% were achieved with 12 weeks of treatment in genotype 3 patients with cirrhosis, and in non-cirrhotic patients with genotypes 4, 5 and 6.

“The recent evolution in hepatitis C treatment has resulted in high cure rates for many patients with specific genotypes, but there remain distinct areas of unmet need,” said Paul Kwo, professor at the Indiana University School of Medicine, in a statement released by AbbVie.

AbbVie already has a combo treatment on the U.S. market in the form of its next-gen cocktail drug treatment Viekira Pak. The treatment is approved for genotype 1, the most common form of the liver-destroying disease in the U.S., and patients have to take four pills a day.

AbbVie will hope that its new offering, should it gain approval, will be more attractive in a once-daily form for all hep C patients. But AbbVie currently has only about 5% of the hep C market–with first-to-market rival Gilead owning about 90% on the back of stellar sales and high cure rates from its two blockbusters Sovaldi and Harvoni. Both can be taken as a once daily regimen (although Sovaldi may need to be taken with other medicines) and collectively both drugs treat all 6 genotypes.

These treatments have been on the market for several years and AbbVie is just trying to pull even let alone pass its rival. It will also have to contend with a new combo treatment from Merck & Co. (Kenilworth NJ), known as Zepatier, which was approved by the FDA for hep C genotypes 1 and 4 earlier this year.

Data released last week showed the drug bested Sovaldi in a Phase 3 head-to-head trial in certain patients with gen 1 or 4. AbbVie closed the week up 3% at $61.44.

Monday, April 25, 2016 / Vol. 24 / No. 16