Effectiveness of interferon alpha-2b and ribavirin combination therapy in the treatment of naive chronic hepatitis C patients in clinical practice.
OBJECTIVE
Studies in many diseases have shown that efficacy in clinical trials often does not translate into effectiveness in clinical practice. The aims of this study were to determine the rate of sustained virological response (SVR) and the factors associated with SVR in therapy naive chronic hepatitis C patients treated with interferon alpha-2b and ribavirin combination therapy at a university outpatient clinic.


METHODS
The medical records of 153 consecutive chronic hepatitis C patients treated between June 1998 and May 2001 were reviewed.


RESULTS
The mean subject age was 44 years, 64% were men, 85% were white, 56% had HCV genotype 1, and 21% had cirrhosis on biopsy. The overall SVR rate was 42% (29% in genotype 1/4; 65% in genotype 2/3). Side effects resulted in interferon or ribavirin dose reductions in 22% of patients and premature termination of treatment in 10%. The SVR rate was significantly higher in the 102 patients who received >80% of the recommended dose and duration of therapy compared with the 51 patients who did not (53% vs. 20%, P = 0.00008). HCV genotype, subject race, and adherence were independently associated with SVR (P < 0.01). Although the incidence of side effects and medication adherence was similar in blacks and whites, adherent blacks had a significantly lower SVR rate (14% vs. 58%, P < 0.01).


CONCLUSIONS
Despite the inclusion of a broader spectrum of patients and less frequent monitoring, combination antiviral therapy in our treatment-naive chronic hepatitis C patients was of similar efficacy to that reported in large multicenter trials. In addition, our data show that medication adherence is an important predictor of SVR in an academic clinical practice.
Shehab
Thomas M
TM
Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor, USA.
Fontana
Robert J
RJ
Oberhelman
Kelly
K
Marrero
Jorge A
JA
Su
Grace L
GL
Lok
Anna S F
AS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin