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.
This study was conducted to identify the perception regarding palliative care among Korean doctors and referral barriers toward palliative care for terminal cancer patients. Methods: Between May and June 2010, 477 specialists mainly caring cancer patients using a web-based, self-administered questionnaire. Results: A total of 128 doctors (26.8%) responded. All respondents (100%) deemed palliative care a necessary service for terminal cancer patients. More than 80% of the respondents agreed to each of the following statements: all cancer centers should provide palliative care service (80.5%); all terminal cancer patients should receive concurrent palliative care along with anti-cancer therapies (89.1%) and caring for terminal cancer patients requires interdisciplinary approach (96.9). While more than 58% of the respondents were satisfied with their performance of physical and psychological symptoms management and emotional support provided by patient's family members, 64% of the responded answered that their general management of the end-of-life care was less than satisfactory. Doctors without prior experience in referring their patients to palliative care specialists accounted for 26.6% of the respondents. The most common barrier to hospice referral, cited by 47.7% of the respondents, was "refusal of patient or family member", followed by "lack of available palliative care resources" (46.1%). Conclusion: Although most doctors do recognize the importance of palliative care for advanced cancer patients, comprehensive and sufficient palliative medicine, including interdisciplinary cooperation and end-of-life care, has not been put into practice. Thus, more active palliative consultation or referral is needed for effective care of terminal cancer patients.
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