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A multicentre randomized clinical trial of recombinant alpha-2a interferon therapy in patients with chronic hepatitis
M Rumi1, R Romeo, F De Filippi
1Istituto di Medicina Interna, Università di Milano, Italy.
Insights
Recombinant alpha-2a interferon treatment hastened hepatitis B virus DNA clearance in chronic hepatitis B patients. However, it did not significantly impact hepatitis B e antigen loss or seroconversion rates.
Area of Science:
- Hepatology
- Virology
- Immunology
Background:
- Chronic hepatitis B is a significant global health concern.
- Hepatitis B e antigen (HBeAg) and hepatitis B virus DNA (HBV-DNA) are key markers of viral activity.
- Effective antiviral therapies are crucial for managing chronic hepatitis B.
Purpose of the Study:
- To evaluate the efficacy of recombinant alpha-2a interferon in treating chronic hepatitis B.
- To assess the impact of interferon treatment on HBeAg and HBV-DNA clearance.
- To determine the effect on liver enzyme levels and liver damage.
Main Methods:
- A randomized controlled trial involving 56 previously untreated patients.
- Patients received either recombinant alpha-2a interferon (3MU IM thrice weekly for 6 months) or no treatment.
- HBeAg, HBV-DNA levels, ALT, and liver biopsy data were monitored.
Main Results:
- HBV-DNA clearance was significantly hastened in the treated group at 6 months (39% vs. 16%, p < 0.05).
- HBeAg loss and anti-HBe seroconversion rates were similar between treated and untreated groups at all time points.
- Normal aminotransferase levels were achieved in comparable proportions of both groups by the end of follow-up.
Conclusions:
- Six-month low-dose recombinant alpha-2a interferon treatment accelerates HBV-DNA clearance in chronic hepatitis B.
- The treatment did not significantly improve HBeAg clearance or seroconversion rates.
- Further research may explore optimal interferon dosing or combination therapies.
Abstract:
Fifty six previously untreated patients who had been positive for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) for more than 1 year with detectable serum levels of hepatitis B virus DNA (HBV-DNA) and a liver biopsy performed in the 6 months before enrollment, were randomized to receive recombinant alpha-2a interferon at doses of 3MU intramuscolarly thrice weekly for 6 months or no treatment. Treated and untreated patients had similar clinical characteristics in terms of ALT elevation, HBV-DNA levels, and degree of liver damage. Twenty one had chronic persistent or lobular hepatitis; 28 had chronic active hepatitis and 7 had cirrhosis. The percentages of patients who lost HBeAg at month 6, 12 and 18 were 22%, 32% and 38% in the treated group, and 16%, 20% and 37% in the controls (differences = ns). At the same time intervals, HBV-DNA detected by dot spot hybridization, cleared off in 39%, 39% and 41% of treated patients as compared to 16%, 36% and 37% of controls (difference = p < 0.05 for HBV-DNA clearance at month 6). At the end of follow-up, 12 treated patients (41%, including 8 antiHBe seroconverters) and 10 untreated controls (42%, including 6 anti-HBe seroconverters) had normal aminotransferase levels. Conclusions show that in patients with chronic hepatitis B, clearance of HBV-DNA but not of HBeAg was hastened by a 6-month treatment with low doses of recombinant alpha-2a interferon.