Published online Jun 26, 2021. doi: 10.12998/wjcc.v9.i18.4690
Peer-review started: December 17, 2020
First decision: January 7, 2021
Revised: January 24, 2021
Accepted: April 21, 2021
Article in press: April 21, 2021
Published online: June 26, 2021
Processing time: 176 Days and 4.3 Hours
Tenofovir disoproxil fumarate (TDF) is a prodrug of a nucleotide analogue. As an antiviral drug, TDF has been proposed in the first-line treatment of chronic hepatitis B (CHB). The National Medical Products Administration has approved two brand names of TDF, namely, Qingzhong, which was commercialized by Jiangsu Chia-tai Tianqing Pharmaceutical Co Ltd., and Viread, which was commercialized by GlaxoSmithKline.
The safety and efficacy of Viread have been confirmed in previous trials. However, the cost of long-term treatment with Viread is high. As a generic TDF drug, Qingzhong exhibited comparable efficacy and safety with Viread in the treatment of naive Chinese CHB patients during a 48-wk trial, thus providing a less expensive option for treating CHB. However, the long-run performance of Qingzhong in the treatment of CHB remains unevaluated.
To investigate the efficacy and safety of the two TDF agents in the treatment of Chinese CHB patients.
This is a 5-year-long, multicenter, double-blinded, double-dummy, randomized-controlled, non-inferiority phase III trial, in which 330 Chinese CHB patients were finally included. The decrease in plasma level of hepatitis B virus (HBV) DNA was continuously monitored. In addition, viral suppression, alanine aminotransferase (ALT) levels, hepatitis B e antigen (HBeAg) loss rates, and HBeAg seroconversion rates were also determined.
Among the 330 CHB patients involved in this trial, there were 232 HBeAg(+) CHB participants. For these participants, the decrease in mean HBV DNA level relative to the baseline value was comparable between Groups A and B at the 96th week. In addition, similar percentages of participants in the two groups exhibited undetectable levels of HBV DNA, HBeAg loss, and HBeAg seroconversion at the 96th week. Similar results were observed for the remaining 98 HBeAg(-) CHB participants: Similar degrees of reduction in mean HBV DNA level relative to the baseline and similar percentages of participants who had undetectable levels of HBV DNA were observed between the two groups at the 96th week. Finally, the two groups of participants [participants with both HBeAg(+) and HBeAg(-) CHB] presented with similar rates of ALT normalization and similar incidences of adverse events.
This 96-wk-long phase III trial demonstrated the effectiveness and safety of utilizing Qingzhong in the treatment of Chinese patients with HBeAg (+) and HBeAg (-) CHB—the TDF drug showed comparable efficacy and safety with Viread. Hence, with its lower cost, Qingzhong may become a better choice for Chinese CHB patients who need long-term treatment with TDF drugs in the future.
Since this study only elaborated the performance of Qingzhong during a 96-wk period, the longer-term safety and efficacy of the TDF drug remain unsure. Therefore, the longer-term performance of Qingzhong in the treatment of CHB patients warrants further attention.