1. Главная
  2. Ресурсы
  3. Библиотечный поиск
Randomized clinicaltrial: efficacy andsafety of telbivudineand lamivudine intreatment‐naïvepatients withHBV‐relateddecompensatedcirrhosis Henry Lik‐Yuen ChanY. C. ChenEdward Gane2012 год

Randomized clinical trial: efficacy and safety of telbivudine and lamivudine in treatment‐naïve patients with HBV‐related decompensated cirrhosis
статья из журнала

Страница публикацииПубликация в OpenAlex
Аннотация: Summary. Patients with decompensated cirrhosis owing to chronic hepatitis B viral (HBV) infection have a high morbidity/mortality rate, and the treatment remains a challenge. We studied the safety and efficacy of telbivudine and lamivudine in such patients. This noninferiority, double‐blind trial randomized 232 treatment‐naive patients with decompensated HBV (1:1) in 80 academic hospitals to receive once‐daily telbivudine 600 mg or lamivudine 100 mg for 104 weeks. Primary composite endpoint was proportion of patients with HBV DNA <10 000 copies/mL, normal alanine aminotransferase (ALT) and Child‐Turcotte‐Pugh score improvement/stabilization at week 52. Response rates using a post hoc modified endpoint (HBV DNA <300 copies/mL [57 IU/mL] and ALT normalization) in intent‐to‐treat analysis (missing = failure) were 56.3% vs 38.0% after 76 weeks ( P = 0.018) and 45.6% vs 32.9% after 104 weeks ( P = 0.093) for telbivudine vs lamivudine. Telbivudine treatment was an independent predictive factor for HBV DNA <300 copies/mL and ALT normalization ( P = 0.037). Response rates with protocol‐defined composite endpoint in intent‐to‐treat analysis (M = F) were 56.2 vs 54.0% (noninferiority not achieved) and 39.1% vs 36.4% (noninferiority achieved) in telbivudine and lamivudine groups at 52 and 104 weeks. Telbivudine treatment was associated with a significant improvement in glomerular filtration rate compared to lamivudine treatment and was also associated with a trend for improvement in survival (87% vs 79%). No cases of lactic acidosis were reported. Telbivudine compared to lamivudine was associated with a higher rate of patients with both viral suppression and ALT normalization, a trend towards a higher rate of survival and significant improvement in glomerular filtration.
Год издания: 2012
Авторы: Henry Lik‐Yuen Chan, Y. C. Chen, Edward Gane, Shiv Kumar Sarin, Dong Jin Suh, Teerha Piratvisuth, B R Prabhakar, S. G. Hwang, G Choudhuri, Rifaat Safadi, Tawesak Tanwandee, Anuchit Chutaputti, Cihan Yurdaydın, W. Bao, C. Avila, Aldo Trylesinski
Издательство: Wiley
Источник: Journal of Viral Hepatitis
Ключевые слова: Hepatitis B Virus Studies, Hepatitis C virus research, Liver Disease Diagnosis and Treatment
Другие ссылки: Journal of Viral Hepatitis (HTML)
PubMed (HTML)