title: Effect of gender and race on the week 48 findings in treatment-naïve, HIV-1-infected patients enrolled in the randomized, phase III trials ECHO and THRIVE.
abstract: OBJECTIVE
  A week 48 efficacy and safety analysis with respect to gender and race was conducted using pooled data from the phase III, double-blind, double-dummy efficacy comparison in treatment-naïve, HIV-infected subjects of TMC278 and efavirenz (ECHO) and TMC278 against HIV, in a once-daily regimen versus efavirenz (THRIVE) trials.
  
  
  METHODS
  Treatment-naïve, HIV-1-infected adults were randomized to receive rilpivirine (RPV; TMC278) 25 mg once a day (qd), or efavirenz (EFV) 600 mg qd, plus tenofovir/emtricitabine (ECHO) or tenofovir/emtricitabine, zidovudine/lamivudine or abacavir/lamivudine (THRIVE).
  
  
  RESULTS
  A total of 1368 participants (76% male and 61% White, of those with available race data) were randomized and treated. No gender-related differences in response rate (percentage of patients with HIV-1 viral load < 50 HIV-1 RNA copies/mL, using an intent-to-treat, time-to-loss-of-virological-response algorithm) were observed (RPV: men, 85%; women, 83%; EFV: men, 82%; women, 83%). Response rates were lower in Black compared with Asian and White participants (RPV: 75% vs. 95% and 85%, respectively; EFV: 74% vs. 93% and 83%, respectively); this finding was mostly a result of higher discontinuation and virological failure rates in Black patients. Safety findings were generally similar across race and gender subgroups. However, nausea occurred more commonly in women than in men in both treatment groups. In men, diarrhoea was more frequent in the EFV group, and abnormal dreams/nightmares were more frequent in men in both the EFV and RPV groups.
  
  
  CONCLUSIONS
  Overall response rates were high for both RPV and EFV. No gender differences were observed. However, response rates were lower among Black patients, regardless of treatment group. Gender appeared to influence the incidence of gastrointestinal adverse events and abnormal dreams/nightmares for both treatments.
authors.affiliation: UMDNJ-New Jersey Medical School, Newark, NJ 07103, USA.
authors.forename: S
authors.initials: S
authors.lastname: Hodder
authors.forename: K
authors.initials: K
authors.lastname: Arasteh
authors.forename: J
authors.initials: J
authors.lastname: De Wet
authors.forename: J
authors.initials: J
authors.lastname: Gathe
authors.forename: J
authors.initials: J
authors.lastname: Gold
authors.forename: P
authors.initials: P
authors.lastname: Kumar
authors.forename: L
authors.initials: L
authors.lastname: Mohapi
authors.forename: W
authors.initials: W
authors.lastname: Short
authors.forename: H
authors.initials: H
authors.lastname: Crauwels
authors.forename: S
authors.initials: S
authors.lastname: Vanveggel
authors.forename: K
authors.initials: K
authors.lastname: Boven
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000453:epidemiology* / Q000208:ethnology; D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000328:Adult; D001741:Black or African American / Q000706:statistics & numerical data; D000480:Alkynes; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D048588:Benzoxazines / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count; D003521:Cyclopropanes; D015224:Dideoxynucleosides / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D054303:HIV Reverse Transcriptase / Q000037:antagonists & inhibitors; D015497:HIV-1; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D009570:Nitriles / Q000008:administration & dosage*; D063065:Organophosphonates / Q000008:administration & dosage*; D011743:Pyrimidines / Q000008:administration & dosage*; D000068696:Rilpivirine; D012737:Sex Factors; D000068698:Tenofovir; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects*; D015215:Zidovudine / Q000008:administration & dosage*; D000099227:Abacavir
chemical_list: D000225:Adenine; D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D015224:Dideoxynucleosides; D004338:Drug Combinations; D054303:HIV Reverse Transcriptase; D019259:Lamivudine; D009570:Nitriles; D063065:Organophosphonates; D011743:Pyrimidines; D000068696:Rilpivirine; D000068698:Tenofovir; D015215:Zidovudine; C492871:abacavir, lamivudine drug combination; D000099227:Abacavir; C109078:lamivudine, zidovudine drug combination; C098320:efavirenz