Comparison of the effectiveness between tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection after 96-week treatment regimen
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Reviewed & translated by Nhi Phuong Quynh Le, B.A.
Edited by Dat Tien Nguyen, B.A, ScM. |
Posted on August 28th, 2023
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Tenofovir alafenamide (TAF) was a new form of tenofovir which was developed to treat patients with chronic hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF). Studies have shown that TAF are delivered to hepatocytes more efficiently. However, the improvement of the renal and bone safety of TAF and TDF was unknown. Thus, a study was conducted to compare the efficacy and safety of tenofovir alafenamide (TAF) to tenofovir disoproxil fumarate (TDF) for the treatment of chronic hepatitis B infection.
The two phase III clinical double-blind, randomized trials included 1,298 patients who were at least 18 years of age with chronic HBV infection. The study participants in both trials were randomly assigned in a 2:1 ratio to receive a treatment regimen of 25 mg TAF orally once daily or 300 mg TDF orally once daily. One study group enrolled HBeAg-positive patients and the other group enrolled HBeAg-negative patients. After 96 weeks, the researchers concluded that the rates of viral suppression were similar in patients who were given tenofovir alafenamide and tenofovir disoproxil fumarate. This similarity was observed in both HBeAg-positive patients (73% vs. 75%), and HBeAg-negative patients (90% vs. 91%). Both TAF and TDF resulted in similar degree of clinical benefits, but those who were treated with TAF experienced less unwanted effect on their bone and kidney functions. Treatment with tenofovir disoproxil fumarate resulted in more reduction to hip and lumbar spinal bone mineral density as well as glomerular filtration rate.
The phase 2 clinical randomized, placebo-controlled trial was conducted in South Africa including 494 healthy pregnant women from 18 to 40 years of age. The study participants were randomly assigned to receive a single dose of 5 μg, 10 μg, or 20 μg per serotype of GBS6 with or without aluminum phosphate (AlPO4) or placebo. The researchers collected serum samples from the participants before and after maternal immunization; cord blood or infant serum samples were obtained at delivery in order to assess for anti-CPS IgG. The researchers concluded that anti-CPS IgG concentrations were associated with a reduced risk of disease among infants; IgG thresholds that were determined to be associated with 75 to 95% reductions in the risk of disease were 0.184 to 0.827 μg per milliliter. In terms of safety, the researchers found that the incidence of adverse events was similar across the trial groups for both mothers and infants; more local reactions were observed in the groups that received GBS6 containing aluminum phosphate. Among the infants, minor congenital anomalies (umbilical hernia and congenital dermal melanocytosis) were reported as the most common serious adverse events.
The two phase III clinical double-blind, randomized trials included 1,298 patients who were at least 18 years of age with chronic HBV infection. The study participants in both trials were randomly assigned in a 2:1 ratio to receive a treatment regimen of 25 mg TAF orally once daily or 300 mg TDF orally once daily. One study group enrolled HBeAg-positive patients and the other group enrolled HBeAg-negative patients. After 96 weeks, the researchers concluded that the rates of viral suppression were similar in patients who were given tenofovir alafenamide and tenofovir disoproxil fumarate. This similarity was observed in both HBeAg-positive patients (73% vs. 75%), and HBeAg-negative patients (90% vs. 91%). Both TAF and TDF resulted in similar degree of clinical benefits, but those who were treated with TAF experienced less unwanted effect on their bone and kidney functions. Treatment with tenofovir disoproxil fumarate resulted in more reduction to hip and lumbar spinal bone mineral density as well as glomerular filtration rate.
The phase 2 clinical randomized, placebo-controlled trial was conducted in South Africa including 494 healthy pregnant women from 18 to 40 years of age. The study participants were randomly assigned to receive a single dose of 5 μg, 10 μg, or 20 μg per serotype of GBS6 with or without aluminum phosphate (AlPO4) or placebo. The researchers collected serum samples from the participants before and after maternal immunization; cord blood or infant serum samples were obtained at delivery in order to assess for anti-CPS IgG. The researchers concluded that anti-CPS IgG concentrations were associated with a reduced risk of disease among infants; IgG thresholds that were determined to be associated with 75 to 95% reductions in the risk of disease were 0.184 to 0.827 μg per milliliter. In terms of safety, the researchers found that the incidence of adverse events was similar across the trial groups for both mothers and infants; more local reactions were observed in the groups that received GBS6 containing aluminum phosphate. Among the infants, minor congenital anomalies (umbilical hernia and congenital dermal melanocytosis) were reported as the most common serious adverse events.