Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 25 mg) |
| Drug Class | HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI) |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 12 years of age and older with compensated liver disease.
Latest News
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Mother-to-child transmission (MTCT) Reduction in Highly Viremic Mothers: Tenofovir disoproxil fumarate (TDF) significantly reduced the MTCT rate in infants aged 6-12 months (relative risk (RR): 0.10, 95% conficen interval (CI): 0.07-0.16). Both TDF and tenofovir alafenamide (TAF) showed similar effectiveness in reducing MTCT, with TDF slightly higher in probability ranking (0.77 vs. 0.72).
- Virological Response in chronic hepatitis B (CHB) Patients: TDF demonstrated a superior virological response in CHB patients compared to entecavir (ETV) at multiple time points: 12 weeks (odds ratio (OR)=1.12, 95% CI: 0.89-1.41), 24 weeks (OR=1.33, 95% CI: 1.11-1.61), 48 weeks (OR=1.62, 95% CI: 1.16-2.25), 72 weeks (OR=1.43, 95% CI: 0.78-2.62), and 96 weeks (OR=1.56, 95% CI: 0.87-2.81). No significant difference was observed between TAF and TDF post-48 weeks.
- No safety concerns were reported in highly viremic mothers and their infants across TDF, TAF, and control regimens.
- In HIV-HBV co-infected pregnant women, significant concerns were reported regarding serious adverse events in infants (RR 1.76, 95% CI 1.27-2.43) and mothers (RR 0.90, 95% CI 0.62-1.32), although the certainty of the evidence was very low.
- In highly viremic mothers, both TDF and TAF were effective in reducing MTCT without safety concerns; in HIV-HBV co-infected pregnant women, evidence was inconclusive with reported serious adverse events in infants and mothers but insufficient data for firm conclusions; in CHB patients, TAF was associated with worsening lipid profiles, especially in those with diabetes and hypertension, and showed a higher density of adverse events per treated patient compared to other nucleoside analogues (NAs), while TDF-treated patients had a superior virological response compared to ETV-treated patients with no significant difference between TAF and TDF responses.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Vemlidy (tenofovir alafenamide) Prescribing Information. | 2024 | Gilead Sciences, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Preventing Vertical Transmission in Chronic Hepatitis B Mothers: A Systematic Review and Meta-Analysis | 2024 | Clinical Infectious Diseases : an Official Publication of the Infectious Diseases |
| Antivirals for prevention of hepatitis B virus mother-to-child transmission in human immunodeficiency virus positive pregnant women co-infected with hepatitis B virus | 2023 | The Cochrane Database of Systematic Reviews |
| Risk of dyslipidemia in chronic hepatitis B patients taking tenofovir alafenamide: a systematic review and meta-analysis | 2023 | Hepatology International |
| Tenofovir Alafenamide Fumarate, Tenofovir Disoproxil Fumarate and Entecavir: Which is the Most Effective Drug for Chronic Hepatitis B? A Systematic Review and Meta-analysis | 2021 | Journal of Clinical and Translational Hepatology |
| Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review | 2020 | Journal of Gastroenterology |