[Role of ribavirin in the treatment of chronic hepatitis B].
OBJECTIVE
To evaluate the safety and efficacy of 1,200 mg/day of ribavirin for 6 months in the treatment of chronic hepatitis B.


METHODS
An open study was carried out with 25 patients with chronic hepatitis B who had previously received placebo (first phase) as part of a randomized, double blind study and who remained HBeAg and HBV DNA positive. In the second phase they received oral ribavirin (1,200 mg/day) for 24 weeks and the results of the first phase were compared with those of the second. All the patients had a recent histological diagnosis and were anti-HCV and anti-HIV negative. In both phases clinical and laboratory evaluations were carried out at weeks, 0, 4, 8, 12, 16, 24, 32, 40 and 48 which included blood tests, liver function tests and serological markers of HBV, and HBV DNA when HBeAg became negative. Liver biopsy was performed at the beginning of the first phase, 6 months later and at the end of the second phase.


RESULTS
Mean values of alanine aminotransferase (ALT) showed a clear downward trend and were reduced by 50% at the end of the study while during the first phase these values were similar to basal values (range 32.3-45.5 IU). In the second phase, seroconversion of HBeAg was 56.0% (p = 0.00001) and HBV DNA was negative in 36%. The number of patients who showed improvement in Knodell's index was 86.7% in the second phase vs. 13.3% in the first phase (p = 0.00001). The drug was well tolerated and the only significant adverse reactions were a reduction in hemoglobin levels greater than 10% of the basal value in 84% of the patients, gastric acidity in 40% and fatigue in 32%.


CONCLUSIONS
Ribavirin therapy at a dose of 1,200 mg/day for 24 weeks was well tolerated and efficacious in returning serum ALT levels to normal, in the seroconversion of HBeAg and negativization of HBV DNA as well as in reducing liver necrosis and inflammation. This study confirms that ribavirin may be considered a therapeutic option in the treatment of chronic hepatitis B.
Galban García
E
E
Instituto de Gastroenterología de Cuba, La Habana, Cuba.
Vega Sánchez
H
H
Gra Oramas
B
B
Rodríguez Pérez
A
A
Doval Hernández
M A
MA
Haedo Castro
D
D
Rolo
F
F
Lorenzo Morejón
I
I
Ramos Sánchez
V
V
D000410:Alanine Transaminase / Q000378:metabolism; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000032:analysis; D004311:Double-Blind Method; D005260:Female; D006513:Hepatitis B e Antigens / Q000032:analysis; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D012254:Ribavirin / Q000627:therapeutic use*
D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D012254:Ribavirin; D000410:Alanine Transaminase
Papel de la ribavirina en el tratamiento de la hepatitis crónica B.