408. Safety and Efficacy Outcomes by N(t)RTI Background Regimen over 96 Weeks in Treatment-Nave HIV-1-infected Patients Treated with Rilpivirine or Efavirenz in the Phase III ECHO and THRIVE Trials
Session: Poster Abstract Session: HIV - Antiretroviral Therapy
Friday, October 21, 2011
Room: Poster Hall B1

Background:

ECHO and THRIVE were two Phase III, randomized, double-blind, double-dummy trials comparing the efficacy, safety and tolerability of rilpivirine (RPV; TMC278) 25mg qd vs efavirenz (EFV) 600mg qd, both plus background N(t)RTIs, in treatment-nave HIV-1-infected adults. An analysis of pooled 96-week safety and efficacy data by N(t)RTI regimen is presented.

Methods:

Patients were randomized 1:1 to receive RPV or EFV plus TDF/FTC (ECHO) or TDF/FTC, AZT/3TC or ABC/3TC (THRIVE).

Results:

1368 patients were randomized and treated. At Week 96, a similar percentage of RPV vs EFV patients achieved viral load <50 copies/mL (ITT-TLOVR), regardless of N(t)RTI backbone: Overall: 78% vs 78%; TDF/FTC: 77% vs 77%; AZT/3TC: 81% vs 77%; ABC/3TC: 77% vs 85% of patients, respectively. Safety data by N(t)RTI background regimen are presented [Table].

Minimal changes from baseline in serum creatinine, with no impact on glomerular filtration rate, were seen with RPV across all N(t)RTI subgroups; smallest changes were seen with AZT/3TC.

Conclusion:

Over 96 weeks, RPV 25mg qd had similar response rates to EFV 600mg qd for each of the N(t)RTI regimens. RPV was associated with a numerically lower rate of grade 24 treatment-related AEs, AEs leading to discontinuation, treatment-related neurologic AEs (mainly driven by dizziness), psychiatric and rash-related AEs and grade 34 lipid-related laboratory abnormalities than EFV for the TDF/FTC and ATZ/3TC subgroups. The sample size of the ABC/3TC group is small and results should be interpreted with caution. This subgroup had the highest incidence of grade 34 liver and lipid-related laboratory abnormalities when used with EFV, and treatment-related psychiatric AEs with both EFV and RPV.


Subject Category: H. HIV/AIDS and other retroviruses

Mark Bloch, MBBS, MMed, Holdsworth House Medical Practice, Sydney, NSW, Australia, Lawrence R Crane, MD, FACP, FIDSA, Wayne State University, Detroit, MI, Jacques Reynes, MD, PhD, Montpellier University Hospital , Montpellier, France, Bart Rijnders, MD, PhD, Erasmus University Medical Center, Rotterdam, Netherlands, William Towner, MD, Kaiser Permanente, Los Angeles, CA, Katarina Westling, MD, PhD, Department of Medicine, Division of Infectious Diseases, Karolinska University Hospital/Huddinge, Karolinska Institutet, Stockholm, Sweden, Simon Vanveggel, MSc, Tibotec BVBA, Beerse, Belgium and Katia Boven, MD, Tibotec Inc., Titusville, NJ

Disclosures:

M. Bloch, Janssen: Investigator, Conference Travel Support and Research grant
Gilead: Grant Investigator and Investigator, Research grant

L. R. Crane, Janssen/Tibotec: Research Contractor, Reimbursement for the enrollment of patients into clinical trials

J. Reynes, Janssen/Tibotec: Board Member and Investigator, Consulting fee and Research support

B. Rijnders, Janssen/Tibotec: Investigator, Received 20,000 euros for inclusion of patients in a clinical trial

W. Towner, Pfizer: Grant Investigator and Investigator, Research grant and Research support
Gilead: Investigator, Research support
Tibotec: Investigator, Research support
Merck: Grant Investigator and Investigator, Research grant and Research support

K. Westling, Janssen-Cilag: Investigator and Scientific Advisor, Consulting fee and Research grant
Bristol-Myers Squibb: Scientific Advisor, Consulting fee
Abbott: Scientific Advisor, Consulting fee
Gilead: Speaker's Bureau, Speaker honorarium

S. Vanveggel, Janssen/Tibotec: Employee, Salary

K. Boven, Tibotec: Employee, Salary

Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.