Compare the Efficacy of Tenofovir Disoproxil Fumarate Monotherapy versus the Entecavir plus Adefovir Disoproxil Combination in Managing Hepatitis B
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on March 12th, 2025
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Nucleotide analogue antivirals represent the most effective and convenient way to manage chronic hepatitis B infection on an outpatient basis. However, because the treatment often needs to be continued long term, the development of antiviral resistance is a concern. In cases of adefovir disoproxil resistance, a study was conducted to evaluate whether adding entecavir to the current regimen or switching to a tenofovir disoproxil fumarate monotherapy regimen would be more effective for managing chronic hepatitis B.
The study took place in Huangzhou, China and involved 100 participants diagnosed with hepatitis B infection who had a baseline HBV DNA level of approximately 8.1 log IU/mL. Genotypic analysis of the virus was conducted to confirm the presence of adefovir resistance mutation. The patients were randomly assigned to receive one of two daily treatments: 300 mg of tenofovir disoproxil fumarate, or a combination of 0.5 mg entecavir and 10 mg adefovir disoproxil. All three antiviral agents are nucleotide analogues that inhibit viral replication by binding to and blocking the reverse transcriptase enzyme that hepatitis B virus uses to synthesize its DNA, which would otherwise integrate into the host genome to establish chronic infection. Both tenofovir and adefovir mimic the structure of the adenosine nucleotide, while entecavir mimics guanosine.
After 96 weeks of treatment, the researchers observed substantial reductions in HBV DNA levels for both the tenofovir disoproxil fumarate monotherapy group and the adefovir disoproxil plus entecavir combination group, without a significant difference in efficacy between the two regimens. Biochemical analyses revealed that patients treated with adefovir and entecavir had notably lower phosphate levels in their blood, a known complication of prolonged adefovir use. Although this study provides valuable long-term comparative insights, it has notable limitations, including an imbalanced gender ratio in the cohort and a lack of detailed reporting on adverse events.
The study took place in Huangzhou, China and involved 100 participants diagnosed with hepatitis B infection who had a baseline HBV DNA level of approximately 8.1 log IU/mL. Genotypic analysis of the virus was conducted to confirm the presence of adefovir resistance mutation. The patients were randomly assigned to receive one of two daily treatments: 300 mg of tenofovir disoproxil fumarate, or a combination of 0.5 mg entecavir and 10 mg adefovir disoproxil. All three antiviral agents are nucleotide analogues that inhibit viral replication by binding to and blocking the reverse transcriptase enzyme that hepatitis B virus uses to synthesize its DNA, which would otherwise integrate into the host genome to establish chronic infection. Both tenofovir and adefovir mimic the structure of the adenosine nucleotide, while entecavir mimics guanosine.
After 96 weeks of treatment, the researchers observed substantial reductions in HBV DNA levels for both the tenofovir disoproxil fumarate monotherapy group and the adefovir disoproxil plus entecavir combination group, without a significant difference in efficacy between the two regimens. Biochemical analyses revealed that patients treated with adefovir and entecavir had notably lower phosphate levels in their blood, a known complication of prolonged adefovir use. Although this study provides valuable long-term comparative insights, it has notable limitations, including an imbalanced gender ratio in the cohort and a lack of detailed reporting on adverse events.