U.S. Multicenter Pilot Study of Daily Consensus Interferon (CIFN) Plus Ribavirin for Difficult-to-Treat HCV Genotype 1 Patients

January 16, 2011

Dig Dis Sci. 2011 Jan 11. [Epub ahead of print]

U.S. Multicenter Pilot Study of Daily Consensus Interferon (CIFN) Plus Ribavirin

for " Difficult-to-Treat " HCV Genotype 1 Patients.

Ho SB, Aqel B, Dieperink E, Liu S, Tetrick L, Falck-Ytter Y, Decomarmond C,

CI, McKee DP, Boyd W, Kulig CC, Bini EJ, Pedrosa MC.

VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA,

92161, USA, samuel.ho2@....

Abstract

BACKGROUND: Patients with chronic hepatitis C genotype 1 (HCV-1) and

difficult-to-treat characteristics respond poorly to pegylated interferon alfa

and ribavirin (RBV), and could benefit from an interferon with increased

activity (consensus interferon or CIFN), favorable viral kinetics from daily

dosing, and a longer duration of therapy. The purpose of this pilot study was to

determine the efficacy and safety of daily CIFN + RBV for initial treatment of

patients with HCV-1 infection.

METHODS: Patients with difficult-to-treat characteristics (92% male, 33% African

American, 78% Veterans Affairs [VA]; 67% high viral load, 59% stage 3-4

fibrosis, and mean weight of 204 lbs) were enrolled at seven VA and two

community medical centers. They were randomized to daily CIFN (15 mcg/day SQ)

and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72

weeks (from time of viral response +48 weeks) (group B, n = 31).

RESULTS: Intention to treat analysis for treatment groups A and B demonstrated

33% (11/33) and 32% (10/31) sustained virologic response (SVR), respectively.

Only 2/31 patients in group B received more than 52 weeks of treatment. The

overall group demonstrated a 31% (20/64) rapid virologic response rate (RVR),

54% (34/64) end of treatment virologic response and a 33% (21/64) SVR. Patients

with RVR at 4 weeks, early virologic response from 8-12 weeks, and late

virologic response from 16-24 weeks demonstrated SVR of 75% (15/20), 31% (4/13),

and 22% (2/9), respectively. Overall early non-protocol discontinuation occurred

in 26/64 (40%) patients.

CONCLUSION: Daily CIFN and ribavirin for initial treatment of HCV-1 patients has

potential for achieving a relatively high RVR rate, but discontinuations are

frequent and successful use of this regimen is highly dependent on adequate

patient support to maintain adherence.

PMID: 21221804 [PubMed - as supplied by publisher]

January 16, 2011