Tenofovir alafenamide

(Vemlidy®)

Tenofovir alafenamide

Drug updated on 5/17/2024

Dosage FormTablet (oral; 25 mg)
Drug ClassHBV 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.

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Summary
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  • 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 shown a good viral suppression rate in pediatric populations, specifically infants, children, and adolescents living with HIV over a period of 24-48 weeks.
  • Four studies were analyzed to gather information about Vemlidy's efficacy and safety profile.
  • In comparison to tenofovir disoproxil fumarate (TDF) and entecavir (ETV), it was found that while TAF shows no significant difference in virological response compared to TDF, combination therapies such as TDF+ETV might be more effective under certain circumstances.
  • The safety profile analysis revealed that among various nucleos(t)ide analogues used for treating chronic hepatitis B, Vemlidy had the highest density of adverse events per treated patient. This raises concerns about its perceived improved safety profile over other drugs like TDF, especially regarding renal and bone health.
  • For adult populations who have not previously undergone therapy for CHB, both tenofovir alafenamide along with tenofovir disoproxil fumarate are considered the most effective agents for virologic suppression across HBeAg-positive and negative groups; however, within HBeAg-positive patients specifically, Vemlidy showed superior results including achieving normal alanine aminotransferase levels and seroconversion.
  • While considering the use of Vemlidy or any other drug from the same class, factors like disease state, comorbidities, and existing treatment history should be taken into account. Also, the preference between Vemlidy and TDF may vary based on subgroup considerations such as age and HBeAg status.