RESUMO
OBJECTIVES: Clevudine has demonstrated antiviral potency in the treatment of naïve chronic hepatitis B patients in pivotal studies. The objectives of this study were to evaluate the safety and efficacy of a 1-year treatment with clevudine in chronic hepatitis B patients. METHODS: This is a post-marketing surveillance using case report forms which were submitted to the health authorities. RESULTS: Analysis of individual data showed that hepatitis B virus (HBV) DNA after a 1-year treatment was <141,500 copies/ml in 96% of hepatitis B e antigen (HBeAg)-positive and 100% of HBeAg-negative patients. The proportion of patients with HBV DNA <2,000 copies/ml after a 1-year treatment was 74%: 71% of HBeAg-positive and 93% of HBeAg-negative patients. Most of the patients with HBV DNA below the detection limit with each assay at week 24 showed sustained viral suppression up to week 48. The proportion of patients who showed normal alanine aminotransferase at week 48 was 86% in HBeAg-positive patients and 87% in HBeAg-negative patients. The rates of HBeAg-loss were 21%. Two patients showed viral breakthrough during treatment. CONCLUSION: Clevudine monotherapy demonstrates potent antiviral activity as well as biochemical and serological response with a 0.7% rate of viral breakthrough in naïve chronic hepatitis B patients.
Assuntos
Antivirais/uso terapêutico , Arabinofuranosiluracila/análogos & derivados , Hepatite B Crônica/tratamento farmacológico , Alanina Transaminase/sangue , Antivirais/efeitos adversos , Arabinofuranosiluracila/efeitos adversos , Arabinofuranosiluracila/uso terapêutico , Antígenos de Superfície da Hepatite B/sangue , Antígenos E da Hepatite B/sangue , Vírus da Hepatite B/isolamento & purificação , Humanos , Masculino , Plasma/virologia , Falha de Tratamento , Resultado do Tratamento , Carga ViralRESUMO
The intrauterine device (IUD) is a widely used contraceptive method. One of the most serious and rare complications of using an IUD is colon perforation. We report a case of colonoscopic removal of an IUD that had perforated into the rectosigmoid colon in a 42-year-old woman who presented with no symptoms. Colonoscopy showed that the IUD had penetrated into rectosigmoid colon wall and that an arm of the IUD was embedded in the colon wall. We were able to remove the IUD easily by using colonoscopy. The endoscopic approach may be considered the first choice therapy for selected patients.