Summary

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• 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.