Abstract
Background/Aim: We aimed to demonstrate the efficacy and safety of tenofovir disoproxilorotate (TDO) compared with that of tenofovir disoproxil fumarate (TDF) in patients with chronic hepatitis B. Methods: This multicenter, open-label, prospective clinical trial (KCT0004185) was conducted to evaluate the efficacy and safety of TDO on switching from TDF for 24 weeks in virologically suppressed chronic hepatitis B patients. The primary efficacy endpoint was the maintenance of virologic response. Safety was assessed by evaluating major adverse events, changes in renal function, and occurrence of hepatocellular carcinoma (HCC). Results: TDO treatment was not inferior in terms of virological response when compared with that on TDF treatment, with a noninferiority margin of −10% (risk difference, −3.17%; 95% confidence interval, −7.5–1.15%). The biological response of TDO was also comparable to that of TDF, with no significant difference in the proportion of patients with normalized alanine transaminase levels. After 24 weeks of treatment, hepatitis B core-related antigen (HBcrAg) significantly decreased to a mean titer of 3.91 log U/mL from 4.15 log U/mL at baseline (p = 0.01). There were no cases of grade 3 or higher adverse events and HCC. The mean estimated glomerular filtration rate increased from 91.09 mL/min to 93.34 mL/min (p = 0.056), and the mean serum level of phosphorus increased from 3.33 mg/dL to 3.44 mg/dL (p = 0.045), suggesting improvement in renal function with TDO treatment. Conclusion: In patients with chronic hepatitis B, the efficacy of TDO was noninferior to that of TDF, with a significant decrease in the HBcrAg titer and improved renal function.
Highlights
Chronic hepatitis B is a major global health concern
A total of 67 patients with chronic hepatitis B were screened from September 2019 to
hepatitis B e antigen (HBeAg) was positive in 27% (17 of 63) of the study population, and the mean serum hepatitis B core-related antigen (HBcrAg) titer was measured as 4.25 log U/mL
Summary
Chronic hepatitis B is a major global health concern. In 2017, the World HealthOrganization estimated that 257 million people have suffered from the infection, resulting in approximately 887,000 deaths, mostly from cirrhosis and hepatocellular carcinoma [1].Antiviral treatment with nucleos(t)ide analogs (NA) can delay liver disease progression and decrease liver-related complications [2–4]. Chronic hepatitis B is a major global health concern. Organization estimated that 257 million people have suffered from the infection, resulting in approximately 887,000 deaths, mostly from cirrhosis and hepatocellular carcinoma [1]. Antiviral treatment with nucleos(t)ide analogs (NA) can delay liver disease progression and decrease liver-related complications [2–4]. The functional cure for chronic hepatitis B, defined by the loss of hepatitis B surface antigen (HBsAg), with NA treatment is uncommon [5], and hepatitis B viral reactivation occurs frequently when NA treatment is discontinued [6]. A long-term antiviral treatment is required for most patients with chronic hepatitis B. Long-term NA treatment is expensive and can result in drug resistance and adverse events
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