RESUMO
AIM: To evaluate the safety and efficacy of 1,200 mg/day of ribavirin for 6 months in the treatment of chronic hepatitis B. MATERIALS AND 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.
Assuntos
Antivirais/uso terapêutico , Hepatite B Crônica/tratamento farmacológico , Ribavirina/uso terapêutico , Alanina Transaminase/metabolismo , DNA Viral/análise , Método Duplo-Cego , Feminino , Antígenos E da Hepatite B/análise , Vírus da Hepatite B/genética , Humanos , MasculinoRESUMO
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 index 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 hemoglobin reduction, which was reversible once the treatment 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.
Assuntos
Antivirais/uso terapêutico , Hepatite B Crônica/tratamento farmacológico , Ribavirina/uso terapêutico , Administração Oral , Adolescente , Adulto , Alanina Transaminase/sangue , Aspartato Aminotransferases/sangue , Biópsia , DNA Viral/análise , Método Duplo-Cego , Feminino , Hepatite B/genética , Hepatite B/imunologia , Antígenos de Superfície da Hepatite B/análise , Antígenos E da Hepatite B/análise , Hepatite B Crônica/enzimologia , Hepatite B Crônica/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Reação em Cadeia da Polimerase , Estudos ProspectivosRESUMO
Four hundred and sixty one samples randomly selected among blood donors from three blood banks in Havana City were investigated for HCV antibodies. Samples repeatedly reactive to Organcon Tecknica immunoenzymatic assay were considered positives and were further confirmed by an Ortho test. An epidemiological survey was conducted among all donors included in the sample to assess infection risk factors. Seven subjects (1.5%) resulted repeatedly reactive to the test, slightly higher than in developed countries. Mean age in positive patients was seven years higher than in negative subjects (39 vs 31.5), but the Student's test did not show any significant difference. Seropositivity was higher in males (1.7 vs 0.9) and very similar as to the color of skin (1.9 mulattos, 1.5 whites and 1.0 blacks) but it was not statistically significant (p > 0.05). Among risk factors with higher odd ratios were to have more than five sexual partners in the last five years and having worked in a health care institution, but this was not statistically significant (p > 0.05). The probability of receiving one unit of HCV infected blood was of 1.5% and 45% when receiving 40 units. Given the importance of the virus, the need of establishing specific control measures in the shortest period of time for HCV detection in blood is under-lined.
Assuntos
Doadores de Sangue , Hepacivirus/imunologia , Anticorpos Anti-Hepatite/sangue , Hepatite C/imunologia , Adulto , Cuba/epidemiologia , Feminino , Hepatite C/epidemiologia , Humanos , MasculinoRESUMO
A study was conducted on 106 newborns, whose AgsHB positive mothers received active protection against hepatitis B (83 with the Cuban-produced Heberbiovac HB vaccine and 23 with the Engerix-B vaccine manufactured by S. Kline as control group, following the scheme 0, 1 and 2 months with the first dose administered in the first 12 hours after birth. Samples were taken to study virus B markers at birth (umbilical cord) after 30, 60, 90 and 180 days. Laboratory determinations were carried out by the ELISA technique with diagnostic kits from the firm Organon Tecknica. Ten or more IU/L of anti-HBs present in serum was considered as the lowest protective level. Children were classified according to the AgeHB present in mothers, AgsHB in the umbilical cord and the concentration of Ags HB in maternal serum. 100% of the children who received the control vaccine showed serological evidence of seroconversion to anti HBs with protective titres, and the values of the geometric mean of the titres of antibodies were statistically significant (p < 0.01) in all the extractions, favoring the Cuban vaccine. The efficacy of the two preparations used in this research work was 100%. This study makes it possible to report on a recombinant vaccine against hepatitis B (Heberbiovac HB) which represents the first vaccine of this type produced in Latin America, the efficacy of which was proved in the field trial.
Assuntos
Anticorpos Anti-Hepatite B/imunologia , Vacinas contra Hepatite B/uso terapêutico , Hepatite B/prevenção & controle , Método Duplo-Cego , Sangue Fetal/imunologia , Antígenos de Hepatite/sangue , Antígenos de Hepatite/imunologia , Hepatite B/imunologia , Anticorpos Anti-Hepatite B/sangue , Vacinas contra Hepatite B/imunologia , Humanos , Recém-NascidoRESUMO
This article describes the National AIDS Prevention and Control Program in Cuba and presents the results of serologic studies of HIV prevalence. As of 30 May 1988 2,224,748 individuals (approximately one-third of the Cuban population plus 32,750 foreigners) of sexually active age from high-risk and other population groups had been screened to detect HIV antibody. Among resident Cubans a total of 227 HIV infections were found, indicating a prevalence of 0.01 seropositives per 100 people tested. The seroprevalence of HIV among blood donors is on the order of one infection per 50,000 people, and appears to have declined since 1986. The seroprevalence of HIV among groups at risk is relatively low compared to that found among similar groups in other countries.