Academic Journal
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
| العنوان: | 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 |
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| المؤلفون: | Hodder, S, Arasteh, K, De Wet, J, Gathe, J, Gold, J, Kumar, P, Mohapi, L, Short, W, Crauwels, H, Vanveggel, S, Boven, K |
| المصدر: | HIV Medicine ; volume 13, issue 7, page 406-415 ; ISSN 1464-2662 1468-1293 |
| بيانات النشر: | Wiley |
| سنة النشر: | 2012 |
| المجموعة: | Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: | 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 ; TMC 278) 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 A sian 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1111/j.1468-1293.2012.00991.x |
| الاتاحة: | http://dx.doi.org/10.1111/j.1468-1293.2012.00991.x https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fj.1468-1293.2012.00991.x https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1468-1293.2012.00991.x |
| Rights: | http://onlinelibrary.wiley.com/termsAndConditions#vor |
| رقم الانضمام: | edsbas.D3D13D12 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1111/j.1468-1293.2012.00991.x |
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