|Title||Rilpivirine versus efavirenz in HIV-1-infected subjects receiving emtricitabine/tenofovir DF: pooled 96-week data from ECHO and THRIVE Studies.|
|Publication Type||Journal Article|
|Year of Publication||2013|
|Authors||Nelson MR, Elion RA, Cohen CJ, Mills A, Hodder SL, Segal-Maurer S, Bloch M, Garner W, Guyer B, Williams S, Chuck S, Vanveggel S, Deckx H, Stevens M|
|Journal||HIV Clin Trials|
|Date Published||2013 May-Jun|
|Keywords||Adenine, Adolescent, Adult, Aged, Anti-HIV Agents, Benzoxazines, Deoxycytidine, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Emtricitabine, Female, HIV Infections, HIV Reverse Transcriptase, HIV-1, Humans, Male, Middle Aged, Nitriles, Organophosphonates, Pyrimidines, Reverse Transcriptase Inhibitors, Rilpivirine, Tenofovir, Young Adult|
OBJECTIVES: Week 96 efficacy and safety of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (RPV) was compared to efavirenz (EFV) in subset of 1,096 subjects who received emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in pooled data from 2 phase 3 studies.
METHODS: ECHO and THRIVE are double-blind, double-dummy, randomized, active-controlled, non-inferiority phase 3 studies of RPV versus EFV plus 2 NRTIs in antiretroviral-naïve adult subjects. The primary and secondary endpoints were the proportion of subjects with HIV-1 RNA <50 copies/ mL using an intent-to-treat, time to loss of virologic response (ITT-TLOVR) analysis at weeks 48 and 96, respectively. Safety, tolerability, immunologic response, adherence level, and other measures were also evaluated.
RESULTS: At week 48, noninferior efficacy of RPV+FTC/TDF over EFV+FTC/TDF was established, and at week 96 RPV+FTC/TDF remained noninferior (77% overall response rate in both groups). Through week 96, rates of virologic failure were higher in the RPV+FTC/ TDF group, with low and similar rates of virologic failure and resistance mutations occurring during the second year of follow-up. Treatment with RPV+FTC/TDF was associated with a lower rate of discontinuation due to adverse events and grade 2-4 adverse events including dizziness, abnormal dreams/nightmares, rash, and lipid abnormalities.
CONCLUSIONS: The pooled ECHO and THRIVE studies demonstrated noninferiority of RPV+FTC/TDF in achieving virologic response with safety and tolerability advantages over EFV+FTC/TDF through 96 weeks. Higher rates of virologic failure in the RPV+FTC/TDF group were balanced with higher rates of discontinuations due to adverse events in the EFV+FTC/TDF group.
|Alternate Journal||HIV Clin Trials|