title: Rilpivirine versus efavirenz with emtricitabine/tenofovir disoproxil fumarate in treatment-naïve HIV-1-infected patients with HIV-1 RNA ≤100,000 copies/mL: week 96 pooled ECHO/THRIVE subanalysis.
abstract: The once daily, single-tablet regimen (STR) combining rilpivirine (RPV), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) provides a simplified treatment option for antiretroviral therapy (ART)-naïve patients with baseline HIV-1 RNA (BLVL) of ≤100,000 copies/mL. The aim of this analysis is to compare long-term efficacy, safety, and tolerability of RPV+FTC/TDF vs. efavirenz (EFV)+FTC/TDF as individual components in subjects with BLVL ≤100,000 copies/mL. Week 96 efficacy and safety data from subjects with BLVL ≤100,000 copies/mL, who received daily RPV 25 mg or EFV 600 mg with FTC/TDF in the phase 3, randomized, double-blind, double-dummy, active-controlled, registrational trials ECHO and THRIVE, were analyzed. Virologic response was evaluated by intent-to-treat, time to loss of virological response (ITT-TLOVR), and Snapshot algorithms. Through Week 96, RPV+FTC/TDF demonstrated non-inferior efficacy to EFV+FTC/TDF (84% vs. 81%, respectively; ITT-TLOVR) in 543 subjects with BLVL ≤100,000 copies/mL, and overall rates of virologic failure (VF) were 5.9% vs. 2.4%, respectively. Resistance development was lower in Year 2 than Year 1. Subjects in both arms with suboptimal adherence (≤95%) had lower virologic responses (63% vs. 62%, respectively). Treatment with RPV+FTC/TDF was associated with significantly fewer treatment-related adverse events (AEs), grade 2-4 AEs, neurological and psychiatric AEs (including dizziness and abnormal dreams/nightmares), and rash. Additionally, grade 2-4 treatment-emergent laboratory abnormalities and grade 1-3 lipid abnormalities were significantly less common with RPV+FTC/TDF than EFV+FTC/TDF. RPV+FTC/TDF demonstrated non-inferior efficacy to EFV+FTC/TDF in ART-naïve subjects with BLVL ≤100,000 copies/mL and was associated with a higher rate of VF but a more favorable safety and tolerability profile through Week 96.
authors.affiliation: 1 Hanover Medical School , Hanover, Germany .
authors.forename: Georg
authors.initials: G
authors.lastname: Behrens
authors.forename: Bart
authors.initials: B
authors.lastname: Rijnders
authors.forename: Mark
authors.initials: M
authors.lastname: Nelson
authors.forename: Chloe
authors.initials: C
authors.lastname: Orkin
authors.forename: Calvin
authors.initials: C
authors.lastname: Cohen
authors.forename: Anthony
authors.initials: A
authors.lastname: Mills
authors.forename: Richard A
authors.initials: RA
authors.lastname: Elion
authors.forename: Simon
authors.initials: S
authors.lastname: Vanveggel
authors.forename: Marita
authors.initials: M
authors.lastname: Stevens
authors.forename: Laurence
authors.initials: L
authors.lastname: Rimsky
authors.forename: David
authors.initials: D
authors.lastname: Thorpe
authors.forename: Matthew
authors.initials: M
authors.lastname: Bosse
authors.forename: Kirsten
authors.initials: K
authors.lastname: White
authors.forename: Lijie
authors.initials: L
authors.lastname: Zhong
authors.forename: Jennifer
authors.initials: J
authors.lastname: DeMorin
authors.forename: Susan K
authors.initials: SK
authors.lastname: Chuck
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D048588:Benzoxazines / Q000008:administration & dosage / Q000627:therapeutic use*; D003521:Cyclopropanes; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000235:genetics / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage / Q000627:therapeutic use*; D063065:Organophosphonates / Q000008:administration & dosage / Q000627:therapeutic use*; D011743:Pyrimidines / Q000008:administration & dosage / Q000627:therapeutic use*; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D000068696:Rilpivirine; D000068698:Tenofovir; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects; D055815:Young Adult
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D000998:Antiviral Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D009570:Nitriles; D063065:Organophosphonates; D011743:Pyrimidines; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D003841:Deoxycytidine; D000068698:Tenofovir; D000068696:Rilpivirine; D000068679:Emtricitabine; D000225:Adenine; C098320:efavirenz