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FDA Approves Technivie for Chronic Hepatitis Genotype 4

The Food and Drug Administration (FDA) has approved AbbVie’s Technivie when used in combination with antiviral Ribavirin for treatment of patients with the chronic hepatitis C Genotype 4 who do not have scarring and cirrhosis. Genotype 4 is one of the rarer genotypes.

Technivie is the first treatment which demonstrates success in Genotype 4 infections without requiring the use of interferon.

In a recent clinical trial with 135 participants, the treatment showed 100% sustained virologic response (SVR) 12 weeks post treatment. Without the combination of Ribavirin, 91% received SVR.

The most common side effects reported were fatigue, weakness, nausea, insomnia, pruritus (itching) and other skin reactions.

Approximately 1% of the clinical trial participants experienced elevations of liver enzymes greater than five times the upper limit of the normal liver enzyme level. This occurred more frequently in females taking contraceptives with ethinyl estradiol.1,2,3

For information on the approval of Technivie, visit the announcements from AbbVie and the FDA.