Efficacy And Safety Of Tenofovir Disoproxil Fumarate For Chronic Hepatitis B

Background：There are about400million people infected by hepatitis B virus（HBV).Chronic infection can lead to chronic hepatitis B(CHB), cirrhosis, andhepatocellular carcinoma. Higher levels of HBV DNA are associated with anincreased risk for hepatic disease and the liver relatedcomplications.Nowadays,lamivudine(LAM), adefovir dipivoxil(ADV),telbivudine(LdT), entecavir (ETV)are widly used for chronic HBV infection.Sequential therapies with multiple nucleoside analogues (NAs) can promoteselection for multidrug-resistant strains of HBV and inadequate viral response.As a result, increased numbers of CHB patients with NAs treatment failures arebecoming a global problem. Owing to its potent antiviral activity and lowresistance,TDF was approved by FDA for the treatment of CHB in2008. ButTDF has just been approved of CHB for clinical applications in China,so it isless for efficacy studies on TDF for the application of the crowd.While Chinaas a big country of hepatitis B, it is important to explicate the drug for patientsof the efficacy and safety.Objective：To evaluate the efficacy and safety of tenofovir disoproxil fumarate forchronic hepatitis B in China.Methods：Retrospectinely analyze50paitents with CHB who had completed a48-week therapy of TDF the First Bethune Hospitao of Ji Lin University fromMay in2012to March in2015.Record the clinical and laboratory indicators ofall the patients.Evaluate HBV DNA level rate of undetectable HBV DNA, attreatment weeks0(baseline)，4，12，24，36and48. Evaluate the serum alanineaminotransferase(ALT)normalization rate， hepatitis B e antigen(HBeAg) serological clear and conversion rate, hepatitis B surface antigen (HBsAg)serological clear and conversion rate，and adverse events rate when thetreatment completed. By statistical analysis to estimate the efficacy and safetyof TDF for various kinds of CHB in China.Results：1. With the treatment of TDF，HBV DNA levels declined persistently,themost robust decline in HBV DNA levels was observed at baseline to weeks of12.HBV DNA levels of the patients declined with the treatment of TDF，HBVDNA levels of baseline and weeks of12,24,36,48were6.30（5.29，7.72）log10IU/mL,2.84（2.03，3.57）log10IU/mL,1.86（1.70，2.88）log10IU/mL,1.70（1.70，2.02）log10IU/mL,1.70（1.70，1.70）log10IU/mL respectly,except forweeks of36and48,the difference were statistically significant（P<0.001）2. HBV DNA levels of na ve patients was higher than experiencedpatients,hepatitis B e antigen (HBeAg)–positive patients was higher thanHBeAg-negative patients（P<0.05）,there was no difference of HBV DNAlevels between the two groups after48and36weeks of treatment（P>0.05）.There was no significantly difference of HBV DNAlevels betweenpatients with drug-resistance mutations and without drug-resistance mutations,adefovir dipivoxil tablets-associated mutations and other drugs-associatedmutations at baseline and12,24,36,48weeks of treatment（P>0.05）.3. there was no significantly difference of HBV DNA levels betweenpatients with baseline high virus level and non-high virus level after weeks of24treatment（P>0.05）.4. after12weeks of treatment, HBV DNA in17cases （89.5%）of na vepatients and23cases（74.2%）of experienced patients became undetectable,there was no significantly difference（P>0.05）. HBV DNA in15cases （75%） of patients with drug-resistance mutations and8cases（72.7%）of patients withdrug-resistance mutations became undetectable, there was no significantlydifference（P>0.05）. HBV DNA in4cases （80%）of patients with adefovirdipivoxil tablets-associated mutations and12case（s80%）of patients with otherdrugs-associated mutations became undetectable, there was no significantlydifference（P>0.05）. HBV DNA in13cases （92.9%）of HBeAg-positivepatients and31cases （86.1%） of HBeAg-negative patients becameundetectable, there was no significantly differenc（P>0.05）.5. At week48，the rates of viral breakthrough，HBsAg serological clearand conversion，HBeAg serological clear and conversion,ALT normalizationwere0%，0%,16.7%，11.1%，100%respectively．Conclusion：For the treatment of CHB，TDF can suppress HBV DNA replication veryquickly and efficiently.For CHB patients,TDF can achieve a high rate of ALTnormalization,some degree HBeAg serological clear and conversion rate, a lowrate of adverse events.So TDF is an efficacious and safe therapeutic option forthe treatment of Chinese patients with CHB.