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Prolonged (6 months) treatment of chronic hepatitis B virus infection with recombinant leukocyte A interferon
V Carreño1, J C Porres, I Mora
1Department of Gastroenterology, Fundación Jiménez Díaz, Universidad Autónoma, Madrid, Spain.
Insights
Recombinant interferon (rIFN)-alpha-2A therapy demonstrated antiviral effects in chronic active hepatitis B (CAH) patients. Long-term treatment led to sustained viral marker negativity and improved liver health with good tolerability.
Area of Science:
- Hepatology
- Virology
- Immunology
Background:
- Chronic active hepatitis B (CAH) is a persistent viral infection impacting liver health.
- Hepatitis B virus (HBV) replication markers like HBeAg, HBV-DNAp, and HBV-DNA indicate disease activity.
- Effective antiviral therapies are crucial for managing CAH and preventing liver damage.
Purpose of the Study:
- To evaluate the efficacy and safety of recombinant interferon (rIFN)-alpha-2A in treating patients with CAH.
- To assess the impact of different rIFN-alpha-2A dosages on viral markers and liver function.
- To determine the long-term outcomes of rIFN-alpha-2A therapy in CAH patients.
Main Methods:
- Twelve patients with CAH positive for HBsAg, HBeAg, HBV-DNAp, and HBV-DNA were enrolled.
- Patients received either 20 or 10 million IU/m2 of rIFN-alpha-2A intramuscularly, twice weekly for 6 months.
- Outcomes were monitored through viral markers, liver function tests, and histological assessments over a 24-month follow-up period.
Main Results:
- Within 3 months, 83% of patients showed negative HBV-DNAp.
- After 15 months, 38% of patients (responders) had negative HBV-DNAp, HBV-DNA, and HBeAg.
- Responders exhibited significant reductions in HBsAg concentration, GPT levels, and Knodell's histological index.
- Lower rIFN-alpha-2A doses showed a higher response rate (5/6) compared to higher doses (2/6).
- No unacceptable toxicity was observed, and all patients completed treatment.
Conclusions:
- Long-term rIFN-alpha-2A therapy exerts a significant antiviral effect in CAH patients.
- The treatment is well-tolerated and leads to sustained suppression of HBV replication.
- rIFN-alpha-2A therapy can improve liver function and histology in responders.
- Dosage may influence treatment response, with lower doses potentially being more effective.
Abstract:
Twelve hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B virus DNA polymerase (HBV-DNAp) and hepatitis B virus DNA (HBV-DNA) positive patients with chronic active hepatitis (CAH) were treated with doses of either 20 X 10(6) IU/m2 or 10 X 10(6) IU/m2 body surface of recombinant interferon (rIFN)-alpha-2A, I.M., twice a week, during a period of 6 months. No appreciable differences with respect to clinical history, liver function tests and markers of HBV replication between the two groups were apparent at the time of entry into the trial. At the third month of treatment HBV-DNAp became negative in 10 out of 12 patients (83%). After a 15-month follow-up, HBV-DNAp, HBV-DNA and HBeAg were negative in 7 out of 12 patients (38%) (responders). Furthermore, at 24 months, 2 non-responder patients became HBV-DNA and HBV-DNAp negative and one responder lost serum HBsAg. In addition, HBsAg concentration, GPT level and histological Knodell's index decreased significantly in the responder patients, while no changes were observed in non-responders. Five out of six patients who received a low rIFN dose responded to the treatment, and only 2 out of 6 with a higher dose. No unacceptable toxicity was noted in any of the 12 patients. All of them completed the course of treatment. The results suggest that long-term rIFN-alpha-2A therapy has an antiviral effect in CAH due to HBV infection and is well tolerated.