Emtricitabine, rilpivirine, and tenofovir alafenamide

(Odefsey®)

Emtricitabine, rilpivirine, and tenofovir alafenamide

Latest News

loading GIF

Drug updated on 5/17/2024

Dosage FormTablet (oral; emtricitabine/ rilpivirine/tenofovir alafenamide; 200 mg/25 mg/ 25 mg)
Drug ClassHIV nucleoside analog reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated as a complete regimen for the treatment of HIV-1 infection in patients weighing at least 35kg as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY.

Summary
This AI-generated content is provided without warranty and may be inaccurate or outdated; it should be used only as a research starting point, with no liability accepted for reliance on it. Learn more.

  • Emtricitabine, rilpivirine, and tenofovir alafenamide (Odefsey) is indicated as a complete regimen for the treatment of HIV-1 infection in patients weighing at least 35kg. It can be used as initial therapy for those with no antiretroviral treatment history and an HIV-1 RNA level less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically suppressed.
  • The information was derived from one study which was a Randomized Controlled Trial that compared Odefsey's efficacy, safety, and tolerability directly against regimens consisting of rilpivirine, emtricitabine, and tenofovir disoproxil fumarate (RPV/FTC/TDF) or efavirenz, emtricitabine, and tenofovir disoproxil fumarate (EFV/FTC/TDF).
  • Clinical efficacy showed that switching to Odefsey from either RPV/FTC/TDF or EFV/FTC/TDF resulted in noninferior outcomes over a duration of 96 weeks. Specifically, maintaining viral suppression rates were comparable between groups switched to Odefsey versus those continuing on their previous regimens.
  • In terms of safety profile, improvements were observed among participants who switched to Odefsey regarding bone mineral density and renal tubular markers, suggesting it may pose less risk towards bone health and kidney function compared to other drugs like RPV/FTC/TDF and EFV/FTC/TDF.
  • There were no cases reported about resistance emerging during the course of treatment amongst patients who had been shifted onto an Odefsey regimen, while there were instances noted within both the RPV/FTC/TAF group along with individuals continuing on EFV/FTC/TDF, indicating potential benefits in terms of resistance profile when switching to Odefsey.
  • The study did not provide specific subgroup analyses based on population characteristics such as age, sex, race, or presence of comorbid conditions. However, the results might be generally applicable to adult patients meeting the criteria of virological suppression and previous stable antiretroviral regimen without a history of treatment failure.