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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.
HIV Med 2012; 13(7):406-15HM

Abstract

OBJECTIVES

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+Show Affiliations

UMDNJ-New Jersey Medical School, Newark, NJ 07103, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22416849

Citation

Hodder, S, et al. "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." HIV Medicine, vol. 13, no. 7, 2012, pp. 406-15.
Hodder S, Arasteh K, De Wet J, et al. 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. HIV Med. 2012;13(7):406-15.
Hodder, S., Arasteh, K., De Wet, J., Gathe, J., Gold, J., Kumar, P., ... Boven, K. (2012). 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. HIV Medicine, 13(7), pp. 406-15. doi:10.1111/j.1468-1293.2012.00991.x.
Hodder S, et al. 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. HIV Med. 2012;13(7):406-15. PubMed PMID: 22416849.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Hodder,S, AU - Arasteh,K, AU - De Wet,J, AU - Gathe,J, AU - Gold,J, AU - Kumar,P, AU - Mohapi,L, AU - Short,W, AU - Crauwels,H, AU - Vanveggel,S, AU - Boven,K, Y1 - 2012/03/14/ PY - 2011/12/20/accepted PY - 2012/3/16/entrez PY - 2012/3/16/pubmed PY - 2012/9/29/medline SP - 406 EP - 15 JF - HIV medicine JO - HIV Med. VL - 13 IS - 7 N2 - OBJECTIVES: 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. SN - 1468-1293 UR - https://www.unboundmedicine.com/medline/citation/22416849/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 L2 - https://doi.org/10.1111/j.1468-1293.2012.00991.x DB - PRIME DP - Unbound Medicine ER -