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

cyclophilin inhibitors have immunospuppressive activity. So far, one candidate, DEBIO-025, is
in clinical trials for HCV.
DEBIO-025 is active against hepatitis C and HIV. Safety, pharmacokinetics, and activity of
1,200 mg/day of DEBIO-25 were assessed in a 15-day study of people with HIV, and HIV/
HCV coinfection. HCV RNA decreased by at least 2 log in all but one of 19 participants;
those with genotype 3 and 4 had larger drops (-4.2±1.1 and -3.4±1.9, respectively) than
people with HCV genotype 1 (-3.0±0.9).
Adverse events included abnormally elevated bilirubin (reported in ten participants, four of
whom discontinued treatment), and lowered platelet count; all abnormalities resolved upon
discontinuation of treatment (Flisiak 2006). An ongoing, five-arm phase II study is assessing
safety, pharmacokinetics, and activity of lower doses (400–800 mg/day) of Debio 25 plus
standard of care in people with HCV genotype 1 who did not respond to pegylated interferon
and ribavirin. Results are expected in mid-to-late 2010.
Nitazoxanide: the Upstart
Avid followers of HCV-specific antiviral agents were surprised by results from a phase II study
of nitazoxanide (Alinia ® ), which was FDA-approved in 2002, to treat diarrhea from two
intestinal parasites (Cryptosporidium parvum and Giardia lambia).
Nitazoxanide (oral)
Product Manufacturer Status
Nitazoxanide Romark Phase II
In part of the sponsor’s aptly titled STEALTH-C (Studies to Evaluate Alinia for Treatment of
Hepatitis C) program, nitazoxanide was evaluated in a study of 96 treatment-naïve and
24 treatment-experienced people with hepatitis C genotype 4 (see Table 6. STEALTH-C:
HCV Genotype 4 Study Design and Interim Results, page 26). An ongoing trial in the US,
STEALTH-2, is evaluating a 4-week nitazoxanide lead-in, followed by 48 weeks of pegyated
interferon, ribavirin and nitazoxanide versus placebo and standard of care, in 60 treatmentexperienced
people with HCV genotype 1.
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