Antiviral Activity and Safety of Lb80380 in Hepatitis B E Antigen–Positive Chronic Hepatitis B Patients With Lamivudine-Resistant Disease
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| Název: | Antiviral Activity and Safety of Lb80380 in Hepatitis B E Antigen–Positive Chronic Hepatitis B Patients With Lamivudine-Resistant Disease |
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| Autoři: | Yoon, SK, Yuen, MF, Han, KH, Um, SH, Kim, HR, Kim, J, Kim, CR, Lai, CL |
| Zdroj: | Hepatology. 51:767-776 |
| Informace o vydavateli: | Ovid Technologies (Wolters Kluwer Health), 2010. |
| Rok vydání: | 2010 |
| Témata: | Adult, Male, 0301 basic medicine, Hepatitis B virus, Guanine, Drug Resistance, Organophosphonates, Hepatitis B, Chronic - Blood - Drug Therapy - Immunology, Dna, Viral - Blood, Hepatitis B E Antigens - Blood, Lamivudine - Therapeutic Use, Young Adult, 03 medical and health sciences, Hepatitis B, Chronic, Drug Resistance, Viral, Humans, Chronic - Blood - Drug Therapy - Immunology, Viral, Hepatitis B e Antigens, Guanine - Adverse Effects - Analogs & Derivatives - Therapeutic Use, 0303 health sciences, Dna, Middle Aged, Hepatitis B, Hepatitis B Virus - Genetics, Reverse Transcriptase Inhibitors - Therapeutic Use, 3. Good health, Phosphonic Acids - Adverse Effects - Therapeutic Use, Lamivudine, DNA, Viral, Reverse Transcriptase Inhibitors, Female, Viral - Blood |
| Popis: | We aimed to determine the antiviral activity and safety of a new nucleotide analogue, LB80380, in chronic hepatitis B (CHB) patients with lamivudine-resistant virus. Sixty-five patients with lamivudine-resistant virus were randomized to receive five ascending daily doses (30, 60, 90, 150, 240 mg) of LB80380. LB80380 was given together with lamivudine for the first 4 weeks, followed by 8 weeks of LB80380 monotherapy. This was then followed by 24 weeks of adefovir. Hepatitis B virus (HBV) DNA levels, serology, liver biochemistry, and safety were monitored. The extent of the HBV DNA reduction at week 12 was dose-dependent. The mean reduction from baseline was 2.81, 3.21, 3.92, 4.16, and 4.00 log10 copies/mL for the five ascending dose groups. The dose-proportionate effect was statistically significant ( P < 0.001) with a decrease of HBV DNA levels by an average of 1.54 log10 copies/mL for every 1-unit increase in log10 dose of LB80380. In 93.4% of patients, HBV DNA decreased by >2 log10 copies/mL, and 11.5% of patients had undetectable HBV DNA levels ( Conclusion: LB80380 at doses of up to 240 mg is safe, well tolerated, and effective at reducing viral load in CHB patients with lamivudine-resistant virus for a period of 12 weeks. (Hepatology 2010.) |
| Druh dokumentu: | Article |
| Jazyk: | English |
| ISSN: | 0270-9139 |
| DOI: | 10.1002/hep.23462 |
| Přístupová URL adresa: | https://pubmed.ncbi.nlm.nih.gov/20091678 https://mdanderson.elsevierpure.com/en/publications/antiviral-activity-and-safety-of-lb80380-in-hepatitis-b-e-antigen https://core.ac.uk/display/37984585 https://pubmed.ncbi.nlm.nih.gov/20091678/ https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.23462 https://www.cabdirect.org/abstracts/20103110929.html https://www.cabdirect.org/cabdirect/abstract/20103110929 http://hdl.handle.net/10722/163301 |
| Rights: | Wiley TDM |
| Přístupové číslo: | edsair.doi.dedup.....817b88ca4075efd3696a5513f0c40089 |
| Databáze: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstrakt: | We aimed to determine the antiviral activity and safety of a new nucleotide analogue, LB80380, in chronic hepatitis B (CHB) patients with lamivudine-resistant virus. Sixty-five patients with lamivudine-resistant virus were randomized to receive five ascending daily doses (30, 60, 90, 150, 240 mg) of LB80380. LB80380 was given together with lamivudine for the first 4 weeks, followed by 8 weeks of LB80380 monotherapy. This was then followed by 24 weeks of adefovir. Hepatitis B virus (HBV) DNA levels, serology, liver biochemistry, and safety were monitored. The extent of the HBV DNA reduction at week 12 was dose-dependent. The mean reduction from baseline was 2.81, 3.21, 3.92, 4.16, and 4.00 log10 copies/mL for the five ascending dose groups. The dose-proportionate effect was statistically significant ( P < 0.001) with a decrease of HBV DNA levels by an average of 1.54 log10 copies/mL for every 1-unit increase in log10 dose of LB80380. In 93.4% of patients, HBV DNA decreased by >2 log10 copies/mL, and 11.5% of patients had undetectable HBV DNA levels ( Conclusion: LB80380 at doses of up to 240 mg is safe, well tolerated, and effective at reducing viral load in CHB patients with lamivudine-resistant virus for a period of 12 weeks. (Hepatology 2010.) |
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| ISSN: | 02709139 |
| DOI: | 10.1002/hep.23462 |