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Week 96 analysis of rilpivirine or efavirenz in HIV ‐1‐infected patients with baseline viral load ≤ 100 000 copies/m L in the pooled ECHO and THRIVE phase 3, randomized, double‐blind trials
Author(s) -
Molina JM,
Clumeck N,
Orkin C,
Rimsky LT,
Vanveggel S,
Stevens M
Publication year - 2014
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/hiv.12071
Subject(s) - rilpivirine , efavirenz , medicine , reverse transcriptase inhibitor , regimen , viral load , tolerability , confidence interval , virology , human immunodeficiency virus (hiv) , gastroenterology , adverse effect , antiretroviral therapy
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/m L 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/m L , 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 ( VF res ) (8% for rilpivirine vs. 6% for efavirenz; P = 0.46) were similar in the two groups. Among patients with VF res , a comparable proportion in each group developed nonnucleoside reverse transcriptase inhibitor ( NNRTI ) resistance‐associated mutations ( RAMs ). Among those with VF res , more patients in the rilpivirine group than in the efavirenz group developed N [t] RTI RAMs , mostly M 184 I / V . The mean (95% CI ) CD 4 cell count increased from baseline to week 96 by 224 (208–240) cells/μ L in the rilpivirine group and by 206 (188–225) cells/μ L 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/m L over 96 weeks. Frequencies of VF res and emergent NNRTI RAMs in each group were similar. More patients with VF res in the rilpivirine group than in the efavirenz group developed N [t] RTI RAMs (mostly M 184 I / V ). Rilpivirine had a more favourable safety/tolerability profile than efavirenz.