Sustained virological response rates and health-related quality of life after interferon and ribavirin therapy in patients with chronic hepatitis C virus infection and persistently normal alanine aminotransferase levels.
BACKGROUND
Few studies have evaluated interferon and ribavirin therapy in hepatitis C virus-infected patients with persistently normal alanine aminotransferase (ALT) levels.


OBJECTIVE
To determine the efficacy and safety of combination therapy in this population, and to evaluate the impact of treatment on health-related quality of life.


METHODS
Forty-six hepatitis C virus-infected patients with persistently normal ALT levels and 92 matched subjects with elevated ALT levels were treated with interferon-alpha2b plus ribavirin for up to 48 weeks. Health-related quality of life was measured prior to therapy and 24 weeks after completion of treatment using the Hepatitis Quality of Life Questionnaire.


RESULTS
Overall, 32.6% of patients with normal ALT levels and 28.3% of those with elevated ALT levels had undetectable hepatitis C virus RNA at 24 weeks after completion of treatment (P = 0.60). Three patients in the normal ALT group had mild transient ALT elevations during therapy. Compared with baseline, treatment was associated with significant improvements in nearly all domains of health-related quality of life in both groups of patients.


CONCLUSIONS
In hepatitis C virus-infected patients with persistently normal ALT levels, interferon-alpha and ribavirin therapy is efficacious, safe, and associated with significant improvements in health-related quality of life.
Department of Medicine and Division of Gastroenterology, VA New York Harbor Healthcare System and NYU School of Medicine, New York, NY 10010, USA. edmund.bini@med.va.gov
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Mehandru
D000410:Alanine Transaminase / Q000097:blood*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification; D006526:Hepatitis C / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin; D000410:Alanine Transaminase