Forty-eight weeks treatment with clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection: a double-blind randomized study

Background/Aims

Clevudine is a pyrimidine analogue with potent activity against hepatitis B virus (HBV) replication in vitro. In a previous pivotal phase III clinical study, 24 weeks treatment with clevudine 30 mg has been shown to profoundly suppress HBV replication and normalize serum alanine aminotransferase level.

Methods

In this study, we compare the efficacy and safety of clevudine (30 mg daily) versus lamivudine (100 mg daily) for 48 weeks in treatment-naive chronic hepatitis B e antigen (HBeAg) positive patients.

Results

Ninety-two chronic HBeAg positive patients were randomized to receive clevudine 30 mg daily or lamivudine 100 mg daily in a 1:1 ratio. The clevudine group demonstrated greater viral suppression at week 48 when compared with the lamivudine group (median reduction: 4.27 vs. 3.17 log₁₀ copies/ml at week 48, p<0.0001). At week 48, serum HBV DNA level was below 300 copies/mL in 73% and 40% in the clevudine and lamivudine groups, respectively (p=0.001). HBeAg seroconversion occurred in 18% of patients in the clevudine group versus 12% in the lamivudine group at week 48. Lamivudine-resistant mutations were detected in 11 (24%) patients in the lamivudine group, who showed viral rebound during lamivudine therapy but no resistance was found in the clevudine group during 48-week treatment period.

Conclusions

A 48-week dosing with clevudine 30 mg daily was superior to lamivudine 100 mg daily in suppressing HBV replication, with no emergence of viral breakthrough in patients with HBeAg positive chronic hepatits B.     

Suppression of mouse skin tumor promotion and induction of apoptosis in HL-60 cells by Alpinia oxyphylla Miquel (Zingiberaceae)

There have been considerable efforts to search for naturally occurring substances for the intervention of carcinogenesis. Many components from dietary or medicinal plants have been identified that possess substantial chemopreventive properties. An example is curcumin (Curcuma longa Linn., Zingiberaceae), which has been shown to inhibit tumor promotion in experimental carcinogenesis. Alpinia oxyphylla Miquel, another plant of the ginger family used in oriental herbal medicine, contains diarylheptanoids whose structures are analogous to that of curcumin. In the present study, we have tested A.oxyphylla for its ability to suppress tumor promotion. Thus, topical application of the methanolic extract of dried fruits of A.oxyphylla significantly ameliorated 12-O-tetradecanoylphorbol-13-acetate (TPA)-induced skin tumor promotion as well as ear edema in female ICR mice. In another study, treatment of HL-60 cells with the methanolic extract of A.oxyphylla significantly reduced the viability of the cells and also inhibited DNA synthesis. Microscopic examination of the treated cells showed characteristic morphology of apoptosis. Furthermore, cells treated with the extract of A.oxyphylla exhibited internucleosomal DNA fragmentation in time- and concentration-dependent manners. TPA- stimulated generation of superoxide anion in differentiated HL-60 cells was also blunted by A.oxyphylla. Taken together, these findings suggest that A.oxyphylla possesses potential chemopreventive and antitumorigenic activities.      

Intentional paediatric poisoning presentations to emergency departments during the COVID-19 pandemic

Objective

To characterise paediatric poisoning presentations to EDs and determine if the advent of the COVID-19 pandemic was associated with increased intentional paediatric poisoning presentations.

Methods

We performed a retrospective analysis of paediatric poisoning presentations to three EDs (two regional and one metropolitan). Simple and multiple logistic regression analysis were performed to determine the association between COVID-19 and intentional poisoning events. In addition, we calculated the frequency with which patients reported various psychosocial risk factors as being an implicating factor in engaging in an intentional poisoning event.

Results

A total of 860 poisoning events met inclusion criteria during the study period (January 2018–October 2021), with 501 being intentional, and 359 unintentional. There was an increased proportion of intentional poisoning presentations during the COVID-19 pandemic (261 intentional and 218 unintentional in the pre-COVID-19 period vs 241 intentional and 140 unintentional during the COVID-19 period). In addition, we found a statistically significant association between intentional poisoning presentations and an initial COVID-19 lockdown (adjusted odds ratio 26.32, P < 0.05). ‘The COVID-19 lockdown’ or ‘COVID-19’ was reported to be implicating factor for psychological stress in patients who presented with intentional poisonings during the COVID-19 pandemic.

Conclusions

Intentional paediatric poisoning presentations increased during the COVID-19 pandemic in our study population. These results may support an emerging body of evidence that the psychological strain of COVID-19 disproportionately impacts adolescent females.