Data are limited on the safety and effectiveness of oral antivirals other than lamivudine and adefovir dipivoxil for treatment of chronic hepatitis B (CHB) in patients with decompensated liver disease. This Phase 2, double-blind study randomized 112 patients with CHB and decompensated liver disease to receive either tenofovir disoproxil fumarate (TDF; n = 45), emtricitabine (FTC)/TDF (fixed-dose combination; n = 45), or entecavir (ETV; n = 22). The primary endpoint was safety; more specifically, tolerability failure (adverse events resulting in permanent treatment discontinuation) and confirmed serum creatinine increase ≥0.5 mg/dL from baseline or confirmed serum phosphorus <2 mg/dL. Patients with insufficient viral suppression (e.g., confirmed HBV DNA ≥400 copies/mL at week 8 or 24) could begin open-label FTC/TDF but were considered failures in this interim week 48 analysis for efficacy endpoints. Tolerability failure was infrequent across arms: 6.7% TDF, 4.4% FTC/TDF, and 9.1% ETV (
P
= 0.622) as were confirmed renal parameters meeting threshold 8.9%, 6.7%, and 4.5% (
P
= 1.000), respectively. Six patients died (none considered related to study drug) and six received liver transplants (none had HBV recurrence). The adverse event and laboratory profiles were consistent with advanced liver disease and complications, with no unexpected safety signals. At week 48, HBV DNA was <400 copies/mL (69 IU/mL) in 70.5% (TDF), 87.8% (FTC/TDF), and 72.7% (ETV) of patients. Proportions with normal alanine aminotransferase were: 57% (TDF), 76% (FTC/TDF), and 55% (ETV). Hepatitis B e antigen (HBeAg) loss/seroconversion occurred in 21%/21% (TDF), 27%/13% (FTC/TDF), and 0%/0% (ETV). Child-Turcotte-Pugh and Modification for End-stage Liver Disease scores improved in all groups.
Conclusion:
All treatments were well tolerated in patients with decompensated liver disease due to CHB with improvement in virologic, biochemical, and clinical parameters. (Hepatology 2011.)
The goal of oral antiviral treatment for chronic hepatitis B (CHB) is to achieve and maintain undetectable HBV DNA levels. Treatment options with enhanced potency, and low risk of resistance development for patients infected with lamivudine resistant (LAM-R) HBV are required. Tenofovir disoproxil fumarate (TDF) monotherapy was effective and well tolerated without TDF resistance development in CHB patients with LAM-R, for up to 240weeks. Clinical trial number: NCT00737568.
The ability of iron oxide-coated sand (IOCS) to adsorb strontium from synthetic wastes simulating the tank wastes at the Hanford Nuclear Reservation was examined in this study. These wastes have high pH and high ionic strength, containing up to 5.5 M Na+, 3.7 M NO3-, and 1.2 M OH-. The use of IOCS in such applications may be advantageous because it is inexpensive, is nontoxic, and can be prepared from readily available materials. IOCS can selectively remove strontium from solutions, even when they contain overwhelmingly higher concentrations of potentially competing cations such as Ca2+, Al3+, and Cr3+. Sr-EDTA chelates do not adsorb to IOCS. However, the interference caused by EDTA can be substantially overcome by the addition of excess Ca to the solution since Ca displaces Sr from EDTA. The adsorbed Sr can be released, and the IOCS can be regenerated by exposure to dilute acid (pH approximately 3) for short periods. The physical and adsorptive properties of the IOCS remain essentially unaltered over at least several dozens of regeneration cycles, corresponding to treatment of at least 20000 bed volumes of influent. The only byproduct of the regeneration process is a small volume of residual waste containing essentially only strontium and dilute acid.
Background. Our study examined hepatitis B virus (HBV) awareness and knowledge in Asian communities in British Columbia (BC). Methods. A statistical random sample representation of Chinese, Korean, Filipino, South Asian, and Southeast Asian populations in Greater Vancouver was surveyed by telephone. Multiple logistic regression analysis was performed to identify predictors of HBV knowledge. Results. General awareness of HBV was reported in 78.8% (798/1013). HBV awareness was the highest in Chinese (89%) and Filipino (88%) populations and the lowest in the South Asian (56%) population. “Reasonable” knowledge of HBV was elicited in 76.8% (778/1013). Higher HBV knowledge was associated with younger age (p = 0.014), higher education (p < 0.0001), Chinese ethnicity (p < 0.0001), and use of media (p = 0.01) and Internet (p = 0.024) for health information. Compared to the Chinese (OR = 1.0) population, “reasonable” knowledge of HBV was lower in Korean (OR = 0.3, 95% CI: 0.1–0.5), Filipino (OR = 0.3, 95% CI: 0.2–0.6), South Asian (OR = 0.3, 95% CI: 0.2–0.4), and Southeast Asian (OR = 0.3, 95% CI: 0.1–0.6) populations. 54.8% (555/1013) felt that HBV education was inadequate and 80.1% (811/1013) preferred HBV education in their native languages. Conclusion. Compared to the Chinese population, other Asian communities in BC have lower HBV awareness and knowledge. Public education should target older and less educated and Korean, Filipino, South Asian, and Southeast Asian populations in their native languages via media and Internet.
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