The 96 week treatment result of the new heavy weight hepatitis B drug TAF announced: still strong and safer

Source: Sina medicine 2017-04-21 April 20, Gilead announced the 96 week efficacy and safety results of two ongoing phase III studies of hepatitis B new drug vemlidy (TAF, tenofovir and Elaphe) 25mg at the 2017 international hepatology Conference (ilc2017) The two phase III studies included patients with immune activated hepatitis B and those with hepatitis B who switched from Viread (TDF 300mg) to TAF In addition, Gilead plans to publish some preclinical data of compounds in development based on the strategy of curing hepatitis B at ilc2017 conference Vemlidy was approved by the FDA on November 10 last year based on the 48 week results of study 108 and study 110 It is used to treat patients with chronic hepatitis B virus (HBV) infection accompanied by compensatory liver disease It is the only new hepatitis B drug approved in the world in the past 10 years and has attracted much attention Vemlidy was also approved in Europe on January 11 The results of the previous 48 weeks showed that TAF 25mg was not inferior to TDF 300mg in reducing HBV viral load, and it could significantly improve the laboratory parameters of bone and kidney compared with TDF, and the proportion of patients whose ALT level returned to normal was higher The 96 week results published at ilc2017 showed that TAF had no drug resistance and had less effect on renal function and bone mineral density parameters (ාps-042, 񖓿fri-153) while maintaining high virus inhibition rate In addition, 96 weeks after treatment with TAF, the patient still maintained virologic inhibition, serum ALT level returned to normal, renal function and bone mineral density parameters were improved after 24 weeks of treatment (ාps-041: "hepatitis B and D: emergent treatment options") The specific results are as follows: in study 108, 425 patients with HBeAg negative were randomly divided into TAF and TDF groups according to 2:1 At the 96th week of treatment, the virological response rates of TAF and TDF treatment groups were 90% (257 / 285) and 91% (127 / 140), respectively In study 110, 873 HBeAg positive patients were randomly divided into 2:1 groups and given vemlidy or Viread At the 96th week of treatment, the virological response rates of TAF and TDF treatment groups were 73% (423 / 581) and 75% (218 / 292), respectively After analyzing 541 patients who completed 96 week treatment in study 108 and study 110, we found that in 180 patients who switched from TDF to TAF, they were able to maintain virological inhibition at 96 week, and the ALT level returned to normal 24 week later.