Short-term Efficacy And Safety Analysis Of Tenofovir Df Monotherapy In Patients With Na?ve Chronic HBV Infection

Objective:To analyze the short-term treatment efficacy and safety of tenofovir df monotherapy in the patients with na?ve chronic HBV infection,including asymptomatic carrier of HBV,HBeAg positive chronic hepatitis B,and HBeAg negative chronic hepatitis B,which would provide a reference for the clinical physician to select antiviral drugs.Methods:The clinical data of 213 patients with na?ve chronic HBV infection admitted to the First Affiliated Hospital of Guangxi Medical University were analyzed retrospectively.The patients treated by TDF were subsumed into the observation group,including 74 patients with CHB(54 cases of HBeAg positive CHB,20 cases of HBeAg negative CHB)and 17 patients with ASC(women in pregnancy).89 cases CHB patients treated by ETV(30 cases of HBeAg negative CHB,59 cases of HBeAg positive CHB)and 33 cases HBV infected women in pregnancy treated by LdT(CHB 16 cases,ASC 17 cases)were subsumed into the control group.The efficacy results were drowned by comparing the cumulative rate of two groups of HBV DNA undetected,HBeAg loss or serological conversion,HbsAg loss and ALT/AST recurrence.Then we compared the incidence of adverse events in each group during treatment to assess safety,including hypophosphatemia,hypocalcemia,renal dysfunction,et al.Statistical analysis is carried out by using SPSS23.0 statistical software.Result:The proportion of men and women in 213 cases of chronic HBV infection included 80 cases of male patients and 133 cases of female patients(79cases of women in pregnancy and 54 cases of non-gestational women).Efficacy Assessment:(1)HBV DNA:the mean reduction in serum hepatitis B virus(HBV)DNA levels from baseline to week 4 of HBeAg negative CHB patients treated by TDF was greater than that treated by ETV.The mean reduction in serum HBV levels was similar in tenofovir and entecavir group at other time point.There were no statistically significant differences in the cumulative rates of HBV DNA undetected at 4weeks,12 weeks,24 weeks,36weeks,48weeks(p>0.05).(2)HBeAg loss and serological conversion:when comparing the cumulative rates of HBeAg loss and serological conversion at various time points and in HBeAg positive CHB,there were no statistically significant differences between the two groups(p>0.05).(3)HBsAg loss:after antiviral therapy by TDF,2 patients with HBeAg positive chronic hepatitis B achieved HBsAg loss and HBsAb appear at 21.71 weeks and 43.57 weeks,but no case of HBsAg loss was found in ETV group.(4)ALT and AST recurrence:after treated by TDF,most HBeAg positive and HBeAg negative CHB patients can reach ALT and AST recurrence at 24-36 Weeks.There were no statistically significant differences in the cumulative recurrence rates of ALT and AST in the TDF group compared with the ETV group(p>0.05).(5)TDF antiviral therapy for pregnant women:after antiviral treatment 12 weeks by TDF(before delivery),the HBV DNA levels of 97.82%pregnant women were<10~5IU/ml.The extent of HBV DNA reduction at 12 weeks after TDF preventive antiviral therapy was lower than LdT,but the difference of that at week 4 was no statistical significance between the TDF group and LdT group.The differences in the cumulative rates of HBV DNA undetected at week 4 and week 12 were not statistically significant between the TDF group and LdT group whether preventive or therapeutic antiviral therapy(p>0.05).HBeAg loss and serological conversion:the cumulative rates of HBeAg loss and serological conversion at week 4 and week 12 were very low in the preventive and therapeutic antiviral therapy of TDF and LdT,which were not statistically significant(p>0.05).Security assessment:no adverse events such as renal dysfunction,hypophosphatemia,hypocalcemia,or plasma creatine kinase(CK)elevations were observed in the early stage of TDF,ETV,and LdT antiviral therapy.Conclusion:(1)The efficacy of TDF and ETV monotherapy the patients with na?ve HBeAg positive CHB and HBeAg negative CHB is comparable.Both drugs can quickly inhibit HBV and improve biochemical parameters.(2)After antiviral treatment of TDF,the rates of HBeAg loss and serological conversion were not high in the early time.(3)When TDF was used for the antiviral treatment of pregnant women who are infected by HBV,after 12 weeks of antiviral treatment and before delivery,respectively,most women in pregnancy reached HBV DNA<10~5IU/ml.It is likely to reduce the incidence of HBV mother-to-child transmission.(4)The short-term safety and tolerance of TDF antiviral therapy are well,which can provide a reference for the clinical selection of drug use.