In a press release by AbbVie, the company whose all-oral regimen for treating hepatitis C (HCV) is now in Phase III clinical study, the FDA has designated their interferon-free regimen ABT-450/r + ABT-267 + ABT-333 — with and without ribavirin — as a “Breakthrough Therapy” for genotype 1. The designation will help expedite the development of this regimen, which represents a significant improvement over current treatment for hepatitis C.
The designation resulted in part from the positive data released from the Phase IIb study of the regimen in 571 patients with genotype 1 who were given 12 weeks of treatment. Both people new to treatment and people whose earlier treatment had failed were enrolled in the study.
The early data showed high rates of undetectable hepatitis C (called SVR, or cure) at 12 and 24 weeks after stopping the regimens, regardless of sex, subtype, fibrosis stage, viral load or IL28B genotype. More than 90% of all study participants had an SVR12 and SVR24. Very few (4, or 1.6%) stopped the study because of side effects.
The substantial improvements in treatment are clear: very high SVR rates and a wide spectrum of SVR among people with various levels of liver health, viral levels and IL28B status. Additionally, the 12-week regimen greatly shortens the half- or full-year treatment of current regimens.
Further, eliminating pegylated interferon, an injected drug with severe side-effects associated with it, will open up new treatment options for many people. Similarly, eliminating ribavirin — a category X drug for pregnancy and fetal health — creates new opportunities for treating pregnant women or in couples planning to have a child.
For more detailed data from the Phase IIb study, read coverage from HIVandHepatitis.com.