404. Week 96 Safety and Efficacy by Gender and Race Subgroups in Treatment-Na´ve HIV-1-Infected Patients 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 which showed non-inferior efficacy of rilpivirine (RPV; TMC278) 25mg qd vs efavirenz (EFV) 600mg qd in treatment-na´ve, HIV-1-infected adults over 96 weeks. Analyses of pooled 96-week safety and efficacy data by gender and race subgroups are presented.

Methods:

1368 patients were randomized 1:1 to receive RPV or EFV plus TDF/FTC (ECHO) or plus TDF/FTC, AZT/3TC or ABC/3TC (THRIVE). Pooled 96 week safety and efficacy were analyzed by gender and race (Caucasian, Black/African American [AA], Asian, other/not allowed to ask [n=40], missing [n=2]) subgroups.

 

Results:

Week 96 efficacy and safety outcomes are shown by gender and race subgroups [Table].

Conclusion:

Over 96 weeks, response rates were similar for RPV and EFV by gender and race subgroup. Lower responses to both NNRTIs were seen in Black/AA patients compared to Asian and Caucasian patients, regardless of treatment group. The safety advantages of RPV over EFV were similar across gender and race subgroups. Safety findings were generally similar across gender and race subgroups, with the exception of a higher incidence of nausea with female vs male patients. There was also more dizziness in Asians vs in other races, and more abnormal dreams/nightmares in male and Caucasian patients compared with in other subgroups.

 


Subject Category: H. HIV/AIDS and other retroviruses

Claudia Martorell, MD, MPH, FACP, The Research Institute, Springfield, MA, Cynthia Mayer, DO, FACOI, St. Joseph's Comprehensive Research Institute, Tampa, FL, Rebeca Northland, MD, University of Chile School of Medicine, Santiago, Chile, Esteban Ribera, MD, Hospital Vall D'Hebrˇn, Barcelona, Spain, Armin Rieger, MD, Medical University of Vienna, Vienna, Austria, Sharon Walmsley, MD, FRCP, University Health Network, Toronto, ON, Canada, Simon Vanveggel, MSc, Tibotec BVBA, Beerse, Belgium and Katia Boven, MD, Tibotec Inc., Titusville, NJ

Disclosures:

C. Martorell, Tibotec: Investigator and Speaker's Bureau, Research support and Speaker honorarium
VIIV: Investigator and Speaker's Bureau, Research support and Speaker honorarium
Gilead: Investigator and Speaker's Bureau, Research support and Speaker honorarium

C. Mayer, Gilead: Speaker's Bureau, Speaker honorarium
Bristol Myers Squibb: Speaker's Bureau, Speaker honorarium
Abbott: Speaker's Bureau, Speaker honorarium
ViiV: Speaker's Bureau, Speaker honorarium

R. Northland, None

E. Ribera, Bristol-Myers Squibb: Board Member, Consultant and Speaker's Bureau, Grant recipient
Gilead: Board Member, Consultant and Speaker's Bureau, Grant recipient
GlaxoSmithKline: Board Member, Consultant and Speaker's Bureau, Grant recipient
Janssen-Cilag: Board Member, Consultant and Speaker's Bureau, Grant recipient
Merck Sharp & Dohme: Board Member, Consultant and Speaker's Bureau, Grant recipient
Abbott: Consultant and Speaker's Bureau, Grant recipient
Boehringer & Ingelheim: Consultant and Speaker's Bureau, Grant recipient
Pfizer: Consultant and Speaker's Bureau, Grant recipient
Roche: Consultant and Speaker's Bureau, Grant recipient
Schering-Plough: Consultant and Speaker's Bureau, Grant recipient
ViiV: Consultant and Speaker's Bureau, Grant recipient

A. Rieger, Tibotec/Janssen Cilag: Consultant and Investigator, Consulting fee

S. Walmsley, Tibotec: Grant Investigator, Investigator and Scientific Advisor, Consulting fee and Research support
ViiV: Grant Investigator, Investigator, Other, Scientific Advisor and Speaker's Bureau, Consulting fee, Educational grant, Research support and Travel Costs
Abbott: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
Merck: Grant Investigator, Investigator, Other, Scientific Advisor and Speaker's Bureau, Educational grant, Research support, Speaker honorarium and Travel Costs
Gilead: Grant Investigator, Investigator and Speaker's Bureau, Research support and Speaker honorarium
Bristol Myers Squibb: Other, Educational grant and Travel Costs

S. Vanveggel, Tibotec - Johnson & Johnson: 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.