Drug updated on 4/17/2024
| Dosage Form | Tablet (oral; 25 mg) |
| Drug Class | HBV nucleoside analog reverse transcriptase inhibitors |
| 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.
Summary
- Tenofovir alafenamide (Vemlidy) is 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. It has demonstrated good viral suppression with no significant safety concerns, particularly in children and adolescents aged 0-19 years living with HIV over a period of 24-48 weeks.
- Four systematic reviews/meta-analyses studies were reviewed to gather insights on the effectiveness and safety of Vemlidy compared to other antiviral treatments such as Tenofovir Disoproxil Fumarate (TDF) and Entecavir (ETV).
- In comparison studies, Vemlidy showed similar virological response rates to those seen with TDF, suggesting comparable effectiveness. The therapeutic effect was superior when combining TDF and ETV than using only one drug.
- Despite having the highest density of adverse events per patient treated among nucleos(t)ide analogues according to one study, it's important to note that this could be due to the relatively smaller number of patients involved in these studies. Treatment involving both Vemlidy or TDF is considered safe overall given their low incidence rate for adverse events.
- For HBeAg-positive as well as HBeAg-negative populations, both Vemlidy along with its counterpart TDF have been shown to be the most effective agents for suppressing virologic activity; however, Vemlidy stood out specifically across various outcomes including normalization of alanine aminotransferase, HBeAg loss, and seroconversion.
- Based on current clinical guidelines favoring these treatments for managing chronic HBV infection, Vemlidy offers comparable efficacy to TDF and superior outcomes in some aspects compared to Entecavir (ETV), despite being relatively new. This positions Vemlidy as an appealing treatment option within the nucleos(t)ide analogue class for chronic hepatitis B.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Vemlidy (tenofovir alafenamide) Prescibing Information. | 2022 | Gilead Sciences, Inc. Foster City, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Effectiveness and safety of tenofovir alafenamide in children and adolescents living with HIV: a systematic review. | 2023 | Journal of the International AIDS Society |
| 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 |
| Antiviral treatment for treatment-naïve chronic hepatitis B: systematic review and network meta-analysis of randomized controlled trials. | 2019 | Systematic Reviews |