Long-term titrated recombinant interferon-alpha 2a in chronic hepatitis C: a randomized controlled trial

Area of Science:

• Hepatology
• Virology
• Immunology

Background:

• Chronic hepatitis C (HCV) remains a significant global health concern.
• Effective and well-tolerated treatments are crucial for managing HCV infection.
• Interferon-alpha 2a (IFN-alpha 2a) has been explored for its antiviral properties.

Purpose of the Study:

• To evaluate the efficacy and tolerability of a 12-month titrated dose regimen of recombinant interferon-alpha 2a (IFN-alpha 2a) in patients with chronic hepatitis C.
• To assess long-term outcomes, including viral clearance and liver inflammation, after treatment cessation.

Main Methods:

• A randomized controlled trial involving 67 patients with chronic hepatitis C.
• Patients were assigned to either titrated IFN-alpha 2a treatment (n=35) or no therapy (controls, n=32).
• Treatment involved a starting dose of 6 MU IFN-alpha 2a, adjusted based on alanine aminotransferase (ALT) response, over 12 months.

Main Results:

• At treatment end, 49% of treated patients achieved normal ALT levels and undetectable hepatitis C virus (HCV) RNA by PCR, compared to 0% in controls (P < 0.001).
• Sustained remission (normal ALT and undetectable HCV RNA) was observed in 23% of treated patients at 12 months post-treatment, versus 4% in controls (P = 0.031).
• Liver biopsies showed reduced hepatic inflammation in 80% of treated patients versus 29% of controls (P < 0.001).

Conclusions:

• A 12-month titrated dose of recombinant IFN-alpha 2a is well-tolerated and effective in achieving long-term HCV RNA clearance and normal ALT levels in a significant proportion of patients.
• Absence of cirrhosis before treatment was the sole predictor of sustained response.
• The treatment demonstrated a positive impact on liver inflammation, suggesting potential long-term benefits beyond viral eradication.