J Gastroenterol 2000; 35:347–352 Efficacy of ribavirin in patients with chronic hepatitis B Enrique Galban-García, Hector Vega-Sanchez, Bienvenido Gra-Oramas, Jorge L. Jorge-Riaño, Miguel Soneiras-Perez, Dora Haedo-Castro, Felipe Rolo-Gómez, Irma Lorenzo-Morejon, and Vitalia Ramos-Sanchez Instituto Nacional de Gastroenterologia MINSAP, La Habana, Cuba Introduction Chronic infection caused by hepatitis B virus (HBV) is associated with progressive liver failure, hepatic cir- rhosis, and primary hepatocellular carcinoma; all these problems represent some of the most important causes of death in some parts of the world. Although there are highly effective vaccines to prevent this infection, more than 300 million persons all over the world are already chronically infected; they would not receive any benefit. 1 Therefore, an effective treatment for chronic hep- atitis B is extremely important for the world medical community. To date, alpha-interferon has been the only available alternative for the treatment of chronic hepatitis B that is internationally approved. It is also known that it is effective in about 33%–40% of patients when it is used in adequate doses and under appropriate conditions; results are mainly measured in terms of aminotrans- ferase normalization and inhibition of viral replication (hepatitis B envelope antigen [HBeAg] seroconversion and/or polymerase HBV-DNA negativization). 2–7 Unfortunately, these effects are sometimes transitory and those patients suffering relapses do not always respond again to a second treatment. On the other hand, a significant number of patients receiving interferon present with adverse reactions at therapeutic doses, and they are forced to stop the treatment; therefore, it is important to be able to use alternative drugs. Some nucleoside analogues are being studied as possible therapeutic agents against chronic hepatitis B; among these agents are ribavirin and lamivudine (3TC). 9 Ribavirin (1-beta-D-ribofuranosyl-1,2,4-triazole-3- carboxamide), is a guanosine analogue with a broad antiviral spectrum. It inhibits mRNA guanylation and DNA and RNA polymerase; in this way it blocks viral Editorial on page 404 Abstract: This study aimed to evaluate the efficacy and safety of a 6-month course of ribavirin (Rb) (1200 mg/ day) in the treatment of chronic hepatitis B (CHB). Sixty patients with CHB were randomly assigned in a double-blind placebo (Pl) controlled study; 30 patients received oral Rb (1200 mg/day) and 30 received Pl for 24 weeks. Patients were hepatitis B surface antigen (HBsAg); hepatitis B envelope antigen (HBeAg); and hepatitis B virus (HBV)-DNA-positive, with alanine aminotransferase (ALT) levels 1.5 times higher than normal values. Clinical evaluations and laboratory tests were carried out at regular intervals; tests included total blood cell count, liver function tests, and HBV serum markers. Baseline and control liver biopsies were carried out. HBeAg seroconversion occurred in 50.0% of the patients in the Rb group (vs 6.6% in the Pl group; P = 0.00019); HBV DNA negativization occurred in 33.3% in the Rb group (vs 6.6% in the Pl group; P = 0.009); and improvement in the necroinflammatory in- dex occurred in 53.3% in the Rb group (vs 23.3% in the Pl group; P = 0.02). The drug was well tolerated; the most important side effect in the Rb group was hemo- globin reduction, which was reversible once the treat- ment was stopped. Ribavirin was an effective treatment, demonstrated by decreased ALT levels, alleviation of histological damage, seroconversion of HBeAg, and HBV-DNA negativization; Rb may be an alternative agent in the treatment of CHB, without significant side effects. Key words: ribavirin, hepatitis B, hepatitis B surface antigen Received: June 1, 1999 / Accepted: October 22, 1999 Reprint requests to: E. Galban-García, Calle 25 #503 Entre Hel, Vedado, La Habana, Cuba