Week 96 analysis of rilpivirine or efavirenz in HIV-1-infected patients with baseline viral load ≤ 100 000 copies/mL in the pooled ECHO and THRIVE phase 3, randomized, double-blind trials.

Abstract

OBJECTIVES:

These 96-week, ECHO/THRIVE pooled analyses evaluated data for antiretroviral treatment-naïve, HIV-1-infected adults with viral load (VL) ≤ 100 000 HIV-1 RNA copies/mL receiving rilpivirine or efavirenz.

METHODS:

ECHO and THRIVE were phase 3, randomized, double-blind trials. Patients received rilpivirine 25 mg once daily (qd) or efavirenz 600 mg qd, with a fixed (ECHO) or investigator-chosen (THRIVE) nucleoside/tide reverse transcriptase inhibitor (N[t]RTI) background regimen. Response rate (the percentage of patients with VL < 50 copies/mL, using an intent-to-treat-population, time-to-loss-of-virological-response algorithm), virological failure (VF), resistance development, safety and tolerability were evaluated.

RESULTS:

Baseline characteristics were comparable between the rilpivirine (n = 368) and efavirenz (n = 329) groups. At week 96, response rates [84% for rilpivirine vs. 80% for efavirenz; difference 4.0%; 95% confidence interval (CI) -1.7% to 9.7%] and incidences of VF for the resistance analysis (VFres) (8% for rilpivirine vs. 6% for efavirenz; P = 0.46) were similar in the two groups. Among patients with VFres , a comparable proportion in each group developed nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutations (RAMs). Among those with VFres , more patients in the rilpivirine group than in the efavirenz group developed N[t]RTI RAMs, mostly M184I/V. The mean (95% CI) CD4 cell count increased from baseline to week 96 by 224 (208-240) cells/μL in the rilpivirine group and by 206 (188-225) cells/μL in the efavirenz group. Treatment-related grade 2-4 overall adverse events, any rash and dizziness were less frequent for rilpivirine than for efavirenz (P < 0.0001).

CONCLUSIONS:

Rilpivirine demonstrated antiviral efficacy similar to that of efavirenz in antiretroviral treatment-naïve adults with baseline VL ≤ 100 000 copies/mL over 96 weeks. Frequencies of VFres and emergent NNRTI RAMs in each group were similar. More patients with VFres in the rilpivirine group than in the efavirenz group developed N[t]RTI RAMs (mostly M184I/V). Rilpivirine had a more favourable safety/tolerability profile than efavirenz.

• Authors: J-M Molina, N Clumeck, C Orkin, L T Rimsky, S Vanveggel, M Stevens, ECHO and THRIVE Study Groups
• Journal: HIV medicine (HIV Med) Vol. 15 Issue 1 Pg. 57-62 (Jan 2014) ISSN: 1468-1293 [Electronic] England
• PMID: 23980523 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2013 British HIV Association.

Chemical References

• Alkynes
• Benzoxazines
• Cyclopropanes
• Nitriles
• Pyrimidines
• Reverse Transcriptase Inhibitors
• Rilpivirine
• efavirenz

Topics

• Adult
• Alkynes
• Benzoxazines (therapeutic use)
• Cyclopropanes
• Double-Blind Method
• Drug Resistance, Viral
• Female
• HIV Infections (drug therapy, virology)
• HIV-1 (drug effects, isolation & purification)
• Humans
• Male
• Nitriles (therapeutic use)
• Pyrimidines (therapeutic use)
• Reverse Transcriptase Inhibitors (therapeutic use)
• Rilpivirine
• Viral Load (drug effects)