Hepatitis C: New Treatments in the Pipeline - CD8 T cells - The Body

• Civacir
An ongoing, phase II study is evaluating safety, pharmacokinetics, and efficacy of Civacir
(hepatitis C immune globulin) in preventing or lessening the severity of recurrent HCV, in
30 liver transplant recipients. Results are expected in mid-2010.
Novel Interferon Formulations
Companies have been working on ways to optimize interferon, since it will remain the
backbone of HCV treatment for some years. These new formulations of interferon are longlasting;
they may be more effective, and perhaps less toxic than pegylated interferon.
Novel Interferon Formulations (Subcutaneous Injection or Mini-Pump Device)
Product Manufacturer Status
Albuferon Human Genome Sciences/Novartis Phase III
Locteron Biolex Therapeutics/OctoPlus N .V . Phase IIa
Omega Interferon Intarcia Phase II
Peg-Interferon Lambda Zymogenetics Phase I
• Albuferon
Albuferon is a formulation of interferon alfa-2b that has been fused to human albumin, to
confer long-term exposure from a single infusion. Currently, albuferon is given every two
weeks (versus once weekly administration of pegylated interferon, and daily injections of
consensus interferon).
Phase II studies have compared different doses and schedules in both treatment-naïve and
treatment-experienced people (see Table 7. Albuferon vs. Standard of Care in Treatment-
Naïve People with HCV Genotype 1; and Table 8. Albuferon in Non-Responders to Pegylated
Interferon Plus Ribavirin, below).
A pair of phase III studies, ACHIEVE 1 (treatment-naïve patients with HCV genotype 1, and
ACHIEVE 2/3 (treatment-naïve patients with HCV genotype 2 or 3) are currently underway.
However, the1,200 µg dose has been reduced to 900 µg, due to the greater incidence of serious
pulmonary adverse events in the 1,200 µg arm. Efficacy of the 900 µg dose is expected to be
equivalent to standard of care, based on data from the treatment-naïve phase II study.
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