Emtricitabine is more effective than stavudine for combination therapy in people with HIV

Abstract

QuestionIs emtricitabine as effective and safe as stavudine when taken with didanosine and efavirenz by people with HIV-1?Study designRandomised double-blind controlled trial.Main resultsEmtricitabine significantly increased the probability of a persistent virological response when compared with stavudine (interim analysis, median follow-up of 42 weeks: percentage of participants with <50 copies/ml: 85% for emtricitabine v 76% for stavudine, p=0.005. End-point analysis, median follow-up 60 weeks: 76% for emtricitabine v 54% for stavudine, p=0.001). At 42 weeks, people taking emtricitabine had significantly increased mean CD4 cell counts compared with stavudine (increase from baseline: 156 cells/μl for emtricitabine v 119 cells/μl for stavudine; p=0.01), although there were no significant difference between groups at 48 weeks (p=0.15). The probability of virological failure was significantly less in the emtricitabine group (4% for emtricitabine v 12% for stavudine; p=0.001). Adverse events leading to stopping treatment were lower with emtricitabine compared with stavudine (7% v 15%; p=0.005).Authors’ conclusionsEmtricitabine is a more effective virological agent, has a longer lasting response, and is better tolerated than stavudine when taken as a first-line treatment with didanosine and efavirenz by people with HIV-1. At the time of study, the emtricitabine/didanosine/efavirenz regimen was the only once daily highly active antiretroviral therapy available.