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Pilot study of combination therapy with ribavirin and interferon alfa for the retreatment of chronic hepatitis B e antibody–positive patients
Author(s) -
Cotonat Teresa,
Quiroga Juan Antonio,
LópezAlcorocho Juan Manuel,
Clouet Rosa,
Pardo Margarita,
Manzarbeitia Félix,
Carreño Vicente
Publication year - 2000
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.510310234
Subject(s) - medicine , ribavirin , gastroenterology , hbsag , alpha interferon , discontinuation , alanine transaminase , interferon alfa , interferon , combination therapy , viral load , antibody , viremia , hepatitis b virus , immunology , hepatitis c virus , virus
Abstract Twenty‐four patients with chronic hepatitis B virus (HBV), antibody to hepatitis B e antigen (anti‐HBe), HBV DNA positivity, and alanine transaminase (ALT) elevation who failed previous interferon alfa (IFN‐α) therapy were included in a pilot study of combination therapy with ribavirin and IFN‐α. The patients received daily oral ribavirin (1,000‐1,200 mg according to body weight) plus 5 million units (MU) IFN‐α2b three times a week for 12 months and were followed‐up for 12 months. The median viremia level decreased significantly at the end of treatment (1.2 × 10 3 copies/mL) and follow‐up (4.0 × 10 2 copies/mL) compared with the baseline (3.0 × 10 6 copies/mL; P < .05). After 12 months, 8 of 24 (33%) patients had cleared HBV DNA and 12 (50%) had normal ALT levels. At the end of the study virological and biochemical response was 50% and 21%, respectively. Thus, virological and biochemical response sustained in 5 of 24 (21%) patients retreated with ribavirin and IFN‐α; none of them lost hepatitis B surface antigen (HBsAg). Liver histology improved in 2 of 4 sustained responders but in none of the 12 nonresponders with paired biopsies ( P = .05). The response was independent of dose and duration of previous treatment, viral load, or the distribution of HBV precore wild‐type/mutant variants. However, sustained responders had significantly higher necroinflammation ( P = .036) and fibrosis ( P = .007) scores. IFN‐α–related side effects were mild and reversible on discontinuation. In 4 (17%) patients who suffered nausea and diarrhea the ribavirin dosage was reduced by 50% after 1 month of therapy and finally discontinued in all of them. No patient had liver disease decompensation. In summary, combination therapy with ribavirin and IFN‐α may be efficacious to treat viremic anti‐HBe–positive patients with chronic hepatitis B who have failed previous IFN therapy.