Viral clearance in HCV viraemic patients with normal alanine aminotransferase after combination therapy: a controlled, open-labelled study.
BACKGROUND
In patients with chronic hepatitis C virus infection and persistently normal alanine aminotransferase levels, liver fibrosis has been reported in 0-22% of cases and advanced liver disease in 5-10% of cases.


OBJECTIVE
To determine whether patients with persistently normal alanine aminotransferase levels clear infection after anti-viral therapy at equal or different rates from infected patients with raised alanine aminotransferase levels.


METHODS
Thirty-five hepatitis C virus RNA-positive patients with fibrosis at liver histology (Group 1) were matched for genotype, sex, age and histology with patients with raised alanine aminotransferase levels (Group 2). Both groups were treated with 3 MU interferon-alpha2b plus ribavirin (1000-1200 mg) for 12 months.


RESULTS
End-of-therapy response was achieved in 71.4%[95% confidence interval (CI), 56.4-86.3] of patients in Group 1 and in 52.3% (95% CI, 42.8-61.9) of those in Group 2 (P = 0.04). At week 72, 22 patients (62.8%; 95% CI, 46.8-78.1) in Group 1 and 50 patients (47.5%; 95% CI, 38.0-57.1) in Group 2 showed a sustained virological response (P = 0.11). Non-1 genotype was the only independent predictor of sustained response (P = 0.002), with an odds ratio of 3.45 (95% CI, 1.58-7.50). At month 3 of therapy, the positive predictive values for non-response were 100% and 96% in Groups 1 and 2, respectively.


CONCLUSIONS
Interferon and ribavirin induce comparable sustained virological response in patients with persistently normal or raised alanine aminotransferase levels. Stage 1 fibrosis, rather than alanine aminotransferase levels, may be the criterion on which to decide whether or not to treat patients with persistently normal alanine aminotransferase levels.
Division of Gastroenterology, 'Casa Sollievo della Sofferenza' Hospital, IRCCS, S. Giovanni Rotondo, Italy. a.mangia@tin.it
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Mangia
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Spinzi
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Vuturo
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Pazienza
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Iacobellis
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Piattelli
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Giacobbe
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Leandro
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Piermanni
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Minoli
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Montalto
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Andriulli
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000378:metabolism*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000201:enzymology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D004338:Drug Combinations; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin; D000410:Alanine Transaminase