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NEW YORK — Kadmon Pharmaceuticals earlier this month announced that it has launched a new 600 mg/day dose pack of Ribasphere RibaPak (ribavirin, USP), Kadmon's proprietary ribavirin regimen available in a daily, two-pill compliance package for enhanced therapy adherence.
The new dose pack is designed to provide added dosing control to improve the management of hemolytic anemia in certain patients prescribed the triple therapy of a protease inhibitor, pegylated alpha interferon and ribavirin for the treatment of chronic hepatitis C virus infection.
"Anemia, particularly severe anemia, is an important concern with hepatitis C treatments, one which may be effectively controlled through ribavirin dose reduction," stated John Ryan, EVP and chief medical officer of Kadmon. "Anemia can also affect treatment adherence and a patient's ability to complete therapy. The new 600 mg/day Ribasphere RibaPak dose pack ensures that physicians can seamlessly reduce ribavirin dose without compromising the adherence advantages of RibaPak."
Pooled data from studies of the protease inhibitors Victrelis (boceprevir) and Incivek (telaprevir), approved in 2011 for the treatment of genotype 1 chronic hepatitis C virus, showed that anemia was a frequently observed adverse event in both treatment-naive and treatment-experienced patients, in some cases exhibiting a doubling of incidence over control (peginterferon/ribavirin). In clinical studies, anemia has been managed with ribavirin dose reduction and/or with off-label use of erythropoietin.
With the new 600 mg/day dose pack, Ribasphere RibaPak now is available in four dosing options: 600 mg/day, 800 mg/day, 1,000 mg/day and 1,200 mg/day. Ribasphere RibaPak offers a unique packaging and dosage form designed to simplify treatment, reducing ribavirin pill burden by up to 66% over a 48-week course of treatment, and to make it easier for the patient to keep track of his or her treatment.
Adherence to therapy is an important component in the successful treatment of hepatitis C. The risk of noncompliance includes treatment failure or relapse and, because of the direct antiviral mechanism of protease inhibitors, missed doses of a protease inhibitor could lead to viral resistance.