Objective:To evaluate the short-term antiviral efficacy and safety profile of tenofovir amibufenamide (TMF) in patients with hepatitis B cirrhosis.Methods:The biochemical indexes, renal function, and complication status in patients with hepatitis B cirrhosis who were treated with tenofovir amibufenamide (TMF) in Beijing You'an Hospital Affiliated to Capital Medical University from March 2022 to June 2024 were retrospectively analyzed.Results:A total of 98 cases with hepatitis B cirrhosis were included. Among them, 62 and 36 cases with hepatitis B cirrhosis had previously undergone partial resection for hepatocellular carcinoma. 66.7% (62/93) of the treated patients were HBV DNA negative before treatment. The longest follow-up time for medication was 24 months, with an average follow-up of (14.1±4.7) months. There were no statistically significant differences in aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin (TBil) levels at 18 months of treatment compared with those before treatment ( P>0.05). The ALT return to normal rate was 91.3%. The HBV DNA negativity rate was 90.6% and 93.5% at 18 and 12 months of follow-up, respectively. There were no significant changes in the estimated glomerular filtration rate (eGFR) and low-density lipoprotein cholesterol (LDL-C) compared with those before treatment ( P>0.05). 36 cases were still HBV DNA positive (including 31 treated and 5 never treated) before treatment. A total of 29 cases were followed up for 12 months, and 24 cases (82.8%) had HBV DNA negative conversion. Conclusion:TMF antiviral therapies have an HBV DNA negative rate of over 80% at 12 months and can improve the liver function in patients with hepatitis B cirrhosis. However, there were no significant changes in renal function and blood lipids before and after treatment.

Objective:To evaluate the short-term antiviral efficacy and safety profile of tenofovir amibufenamide (TMF) in patients with hepatitis B cirrhosis.Methods:The biochemical indexes, renal function, and complication status in patients with hepatitis B cirrhosis who were treated with tenofovir amibufenamide (TMF) in Beijing You'an Hospital Affiliated to Capital Medical University from March 2022 to June 2024 were retrospectively analyzed.Results:A total of 98 cases with hepatitis B cirrhosis were included. Among them, 62 and 36 cases with hepatitis B cirrhosis had previously undergone partial resection for hepatocellular carcinoma. 66.7% (62/93) of the treated patients were HBV DNA negative before treatment. The longest follow-up time for medication was 24 months, with an average follow-up of (14.1±4.7) months. There were no statistically significant differences in aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin (TBil) levels at 18 months of treatment compared with those before treatment ( P>0.05). The ALT return to normal rate was 91.3%. The HBV DNA negativity rate was 90.6% and 93.5% at 18 and 12 months of follow-up, respectively. There were no significant changes in the estimated glomerular filtration rate (eGFR) and low-density lipoprotein cholesterol (LDL-C) compared with those before treatment ( P>0.05). 36 cases were still HBV DNA positive (including 31 treated and 5 never treated) before treatment. A total of 29 cases were followed up for 12 months, and 24 cases (82.8%) had HBV DNA negative conversion. Conclusion:TMF antiviral therapies have an HBV DNA negative rate of over 80% at 12 months and can improve the liver function in patients with hepatitis B cirrhosis. However, there were no significant changes in renal function and blood lipids before and after treatment.

At present, 3 drugs specially for coronavirus disease 2019 have conditional marketing authorization (CMA) in China, including molnupiravir, nirmatrelvir/ritonavir, and azvudine. The data of clinical efficacy and safety of these drugs are relatively insufficient. Molnupiravir is not the main inhibitor or inducer of drug metabolizing enzyme or transporter and is less likely to have drug interactions, which may be more beneficial to patients with chronic diseases needing long-term drug treatments. Ritonavir in Paxlovid is a strong inhibitor to the key drug metabolism enzyme---CYP3A4, and may interact with a variety of drugs such as drugs for arrhythmia, diabetes, nervous system diseases, etc., resulting in increased drug safety risks in the treatment of underlying diseases. The reproductive and genetic toxicity recorded in the drug label of azvudine is worrying. Joint efforts of our government, hospital managers, clinicians and pharmacists are necessary to achieve the safety management of the 3 drugs, including improving the relevant CMA management regulations, strengthening the efficacy and safety monitoring of these drugs, conducting real world clinical research, and monitoring the variation and drug resistance of the virus.

At present, 3 drugs specially for coronavirus disease 2019 have conditional marketing authorization (CMA) in China, including molnupiravir, nirmatrelvir/ritonavir, and azvudine. The data of clinical efficacy and safety of these drugs are relatively insufficient. Molnupiravir is not the main inhibitor or inducer of drug metabolizing enzyme or transporter and is less likely to have drug interactions, which may be more beneficial to patients with chronic diseases needing long-term drug treatments. Ritonavir in Paxlovid is a strong inhibitor to the key drug metabolism enzyme---CYP3A4, and may interact with a variety of drugs such as drugs for arrhythmia, diabetes, nervous system diseases, etc., resulting in increased drug safety risks in the treatment of underlying diseases. The reproductive and genetic toxicity recorded in the drug label of azvudine is worrying. Joint efforts of our government, hospital managers, clinicians and pharmacists are necessary to achieve the safety management of the 3 drugs, including improving the relevant CMA management regulations, strengthening the efficacy and safety monitoring of these drugs, conducting real world clinical research, and monitoring the variation and drug resistance of the virus.

Objective To evaluate the effects of nucleos (t)ide analogues initial treatment on virology and complications in hepatitis B virus (HBV) related decompensated liver cirrhosis.Methods From May 2012 to October 2013,a total of 209 patients with HBV related decompensated liver cirrhosis of 18 hospitals in China were enrolled.According to antiviral medicine taken by them,they were divided into entecavir (ETV) group (n =161),lamivudine (LAM) monotherapy or combined with adefovir (ADV)group (n=48,LAM 22 cases,LAM+ADV 26 cases).During the 12-month follow up period,ChildPugh scores,the level of HBV DNA and complications of liver cirrhosis were documented every three months,the safety evaluation was also carried out.The t-test or chi-square test was performed for statistical analysis.Results In ETV group,before treatment and 12 months after treatment,Child-Pugh scores were 7.91±2.05 and 5.75±1.72,respectively,and the latter was lower than the former (t=10.130,P＜0.01); in LAM alone or combined with ADV group,Child-Pugh scores were 8.08±2.23 and 5.85±1.44,respectively,and the latter was lower than the former (t=5.480,P＜0.01).However there was no significant difference in Child-Pugh scores between the two groups in different time points (both P＞0.05).The undetectable rates of HBV DNA gradually increased along with the treatment period.After 12 months treatment,the undetectable rate of HBV DNA of ETV group was 91.0％ (61/67),and that of LAM alone or combined with ADV group was 87.5％ (35/40),there was no significant difference between the two groups (P＞0.05).Before treatment and 12 months after treatment,the incidences of ascites were 59.4％ (82/138) and 15.0％ (12/80) in ETV group,the latter was lower than the former (x2 =40.740,P＜0.01) ; the incidences of ascites in LAM alone or combined with ADV group were 62.2％ (28/45) and 8.1％ (3/37),and the latter was lower than the former (x2=25.290,P＜ 0.01).After 12 months treatment,the rates of esophageal varices disappearance of ETV group and LAM alone or combined with ADV group were 26.6％ (33/124) and 25.0％ (7/28),accordingly the rates of gastric varices disappearance were 2.5％ (1/40) and 1/19,and the difference was not statistically significant between the two groups (both P＞0.05).There was no significant difference in serum urea nitrogen,serum creatinine and estimated glomerular filtration rates between the two groups before treatment and at different time points after treatment (all P＞0.05).Conclusion The efficacy and safety of ETV and LAM alone or combined with ADV are similar in patients with HBV related decompensated liver cirrhosis,however,the long-term efficacy should be identified by further clinical observation.