ABSTRACT
@#Worldwide, an estimated two billion people have evidence of HBV infection, and approximately 240 million have CHB. In April 2017, EASL added a drug newly approved for treatment of CHB, tenofoviralafenamide (TAF) to their list of recommended first-line therapies. Treatment with these therapies can achieve sustained suppression of HBV DNA replication, decreases in inflammation, and histological activity that decrease the risk of cirrhosis and hepatocellular carcinoma in both cirrhotic and noncirrhotic patients and, ultimately, of CHB-associated mortality [1, 2]. However, recent advances in understanding the HBV life cycle have enabled multiple, novel therapeutic targets to be identified and new therapies of direct-acting antiviral (DAAs) and host-targeting agents (HTAs) are indevelopment.</br> In most clinical trials, TAF was non-inferior to TDF in achieving HBV DNA levels below 29 IU/ml.No amino-acid substitutions associated with viral breakthrough were detected by deep sequencing, and no resistance to TAF.With clear evidence from major studies showing that TAF is safe, tolerable, and non-inferior to TDF, its recommendation as a first-line therapy is appropriate.</br> Long-term safety is an important consideration in the therapeutic management of patients with CHB because treatment is often life-long.</br> The efficacy of TAF in patients with resistance mutations associated with older nucleos(t)ide analogues is unclear. Although no evidence of TAF or TDF resistance was detected in the phase III studies through 96 weeks of treatment, very small numbers of patients had baseline mutations indicating resistance to lamivudine, adefovir or entecavir and efficacy data specifically for this group is not available.
ABSTRACT
Introduction@#Worldwide, an estimated two billion people have evidence of HBV infection, and approximately 240 million have CHB. In this study, a representative group of Mongolian adults was tested for hepatitis B virus (HBV) in 2017. The prevalence estimates of HBV the general Mongolian adult population were found to be 11.1%, respectively.</br> In April 2017, EASL added a drug newly approved for treatment of CHB, tenofovir alafenamide (TAF) to their list of recommended first-line therapies. The requirement for long-term therapy in chronic HBV highlights the importance of these efficacy and safety trends, however their true clinical relevance is yet to be established and further studies with long-term follow up and real-world clinical data are needed.@*Goal@#Evaluate for result of tenofovir alafenamide in the treatment of chronic hepatitis B infection.@*Materials and Methods@#The clinical trials have evaluated TAF in HBeAg-positive and HBeAg-negative chronic HBV patients. The trials have similar designs and are randomized, double blind, non-inferiority studies. The primary efficacy endpoint was the proportion of patients with HBV DNA<29 IU/ml at week 24 and 48. Other prespecified efficacy endpoints were the proportion of patients with HBsAg seroncoversion to anti-HBs at week 24 and 48. Key secondary safety end- points at week 24 and 48 included the percentage change in T-score, and Z-score bone mineral density (BMD), percentage change in BMD and change from baseline serum creatinine.@*Results@#The primary efficacy endpoint, an HBV DNA level <29 IU/ml at week 24, was achieved by 120 (59.1%) of 203 patients receiving TAF, which was non-inferior to the 63 (55.2%) of 114 patients receiving TDF who had an HBV DNA<29 IU/ml. After 24 weeks of treatment, patients receiving TAF had significantly smaller reductions in bone mineral density (BMD) compared with patients receiving TDF.@*Conclusion@#The development of TAF, specifically designed to deliver potent antiviral activity but with an improved safety profile compared with TDF, is therefore timely.
ABSTRACT
Introduction@#Worldwide, an estimated two billion people have evidence of HBV infection, and approximately 240 million have CHB. In this study, a representative group of Mongolian adults was tested for hepatitis B virus (HBV) in 2017. The latest data shows that 11,1% of Mongolian adult population are infected with HBV.@*Goal@#Evaluate the efficacy and safety of tenofovir alafenamide treatment in patients with chronic hepatitis B.@*Materials and Methods@#The clinical trials have evaluated TAF in HBeAg-positive and HBeAg-negative chronic HBV patients. The trials have similar design and randomized, single blind, non-inferiority studies. The primary efficacy endpoint was the proportion of patients with HBV-DNA<29IU/ml at weeks 24 and 48. Other prespecified efficacy endpoints were the proportion of patients with HBsAg seroconversion to antiHBs at weeks 24 and 48. Study protocol approved at Ethical review Committee of “Ach” Medical University in January 2019 (#19/01/06).@*Results@#The primary efficacy endpoint, an HBV-DNA<29IU/ml at weeks 48 and was achieved by 251 (79.9%) of 314 patients receiving TAF, which was non-inferior to the 113(74.8%) of 151 patients receiving TDF who had an HBV-DNA<29IU/ml. After 48 weeks of treatment, patients receiving TAF hed significantly smaller reductions in bone mineral density(BMD) compared with patients receiving TDF. At weeks 48, median changes in eGFR were signifi-cantly smaller in the TAF recipients compared with the TDF recipients.@*Conclusion@#TAF treatment has the same efficacy as TDF treatment. However, TAF treatment demonstrates more safety profile compared with TDF treatment. Patients receiving TAF had a significantly smaller median decrease in eGFR, by Cockcroft-Gault equation, than patients receiving TDF.
ABSTRACT
IntroductionGenotype 1 infection has been historically difficult to treat, but multiple recent studies have showntreatment results greater than high in these genotype 1b patients using well-tolerated, all-oral regimensconsisting of new direct-acting antiviral agents.GoalPurpose of the study was to define the effects of ledipasvir/sofosbuvir treatment on patients with HCVgenotype 1b infection.Materials and MethodsIn this study we enrolled 2 treatment-naive and 66 treatment-experienced, totally 68 patients who tookledipasvir/sofosbuvir during the period from January 2016 to March 2016. We used randomly selectedand double-blinded method in our clinical research. The descriptive and non-parametrical statisticaltests were conducted using SPSS Statistics 20.0.ResultsThe SVR12 and SVR24 rates were greater than 95% and no differences were observed in treatmentnaiveversus treatment-experienced patients.ConclusionTheSVR12 rates were found in 98.6% while the SVR24 was in 97.1% of 68 patients. Only 2.9% of thetotal cases were appeared relapse of HCV infection. These findings indicated needs of further studieson long-term effects of ledipasvir/sofosbuvir.