Combination thymosin-alpha 1 and interferon-alpha 2b in the treatment of anti-HBe-positive chronic hepatitis B in Turkey.
OBJECTIVE
The most prevalent type of chronic hepatitis B in Turkey is anti-HBe-positive. No consistently effective therapy is yet available for the treatment of these patients. The aim of this study was to assess the efficacy and safety of interferon-alpha and thymosin-alpha 1 combination in the treatment of naive anti-HBe-positive and HBV DNA-positive chronic hepatitis B patients.


METHODS
Twenty-one patients were enrolled in the study. All patients had documented anti-HBe-positive, HBV DNA-positive chronic active hepatitis B without evidence of cirrhosis. Patients received a 26-week combination course of 1.6 mg thymosin-alpha 1 subcutaneously twice a week and 10 MIU interferon-alpha subcutaneously three times a week, followed by interferon-alpha monotherapy at the same dose for another 26 weeks. After treatment patients were observed for a further 26 weeks. Endpoints were a normalization of alanine aminotransferase and negativity of HBV DNA at weeks 52 and 78, as well as an improvement in liver histology at week 78.


RESULTS
Eighteen (87.7%) of the 21 patients responded by losing serum HBV DNA and normalizing alanine aminotransferase values at the end of the 52-week treatment period. Sixteen (76.2%) of these patients became sustained responders, with normal alanine aminotransferase and negative HBV DNA at the end of 78 weeks. Two patients were non-responders, two relapsed and one had a breakthrough during therapy. Significant improvements in the Knodell histological activity index were observed in the responders. No adverse events other than those seen previously with interferon monotherapy were reported.


CONCLUSIONS
Combination interferon-alpha 2b and thymosin-alpha 1 treatment may provide a safe and effective therapeutic approach for the difficult-to-treat anti-HBe-positive chronic hepatitis B patients. Further controlled studies are needed to assess the full role of this treatment strategy.
Saruc
Murat
M
Department of Gastroenterology, Celal Bayar University, School of Medicine, Manisa, Turkey. muratsaruc@turk.net
Yuceyar
Hakan
H
Kucukmetin
Nurten
N
Demir
Mehmet Akif
MA
Kandiloglu
Ali Riza
AR
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D000077596:Thymalfasin; D013947:Thymosin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome; D014421:Turkey
D000276:Adjuvants, Immunologic; D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D013947:Thymosin; D000077596:Thymalfasin