TY - JOUR
T1 - U.S. multicenter pilot study of daily consensus interferon (CIFN) plus ribavirin for "difficult-to-treat" HCV genotype 1 patients
AU - Ho, Samuel B.
AU - Aqel, Bashar
AU - Dieperink, Eric
AU - Liu, Shanglei
AU - Tetrick, Lori
AU - Falck-Ytter, Yngve
AU - Decomarmond, Charles
AU - Smith, Coleman I.
AU - McKee, Daniel P.
AU - Boyd, William
AU - Kulig, Clark C.
AU - Bini, Edmund J.
AU - Pedrosa, Marcos C.
N1 - Funding Information:
Declaration of funding interests This study was funded by Three Rivers Pharmaceuticals and Valeant Pharmaceuticals International and supported by the Veterans Affairs Research Service.
Funding Information:
has served as a speaker for Three Rivers Pharmaceuticals, and has received research funding from Three Rivers Pharmaceuticals, Valeant Pharmaceuticals International, and Human Genome Systems. Bashar Aqel,Eric Dieperink,Shanglei Liu and Lori Tetrick have no disclosures. Yngve Falck-Ytter: Research support and speaker’s honorarium from Roche Pharmaceuticals. Coleman Smith: Research support and speaker’s honorarium from Bristol-Myers Squibb, Novartis Pharmaceuticals, Schering-Plough Corporation, Gilead, and Roche Pharmaceuticals. Edmund J. Bini: Research support and speaker’s from Bristol-Myers Squibb, Pharmasset, Schering-Plough Corporation, Gilead, Roche Pharmaceuticals, Valeant, Vertex. Marcos C. Pedrosa: Research support and speaker’s honorarium from Schering-Plough Corporation.
PY - 2011/3
Y1 - 2011/3
N2 - 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.
AB - 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.
KW - Consensus interferon
KW - Hepatitis C
KW - Ribavirin
KW - Veterans Affairs
UR - http://www.scopus.com/inward/record.url?scp=79952451796&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79952451796&partnerID=8YFLogxK
U2 - 10.1007/s10620-010-1504-y
DO - 10.1007/s10620-010-1504-y
M3 - Article
C2 - 21221804
AN - SCOPUS:79952451796
SN - 0163-2116
VL - 56
SP - 880
EP - 888
JO - Digestive diseases and sciences
JF - Digestive diseases and sciences
IS - 3
ER -