Patient-reported outcomes in the single-tablet regimen (STaR) trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate in antiretroviral treatment-naive adults infected with HIV-1 through 48 weeks of treatment

Bibliographic Data

ID19443374
AuthorsEd L Wilkins (North Manchester General Hospital, corresponding author), Calvin J Cohen, Calvin Cohen (Gilead Sciences (United States)), Benoit Trottier (0000-0002-9285-848X), Stefan Eßer (0000-0002-3625-9650, Essen University Hospital), Don Smith (0000-0002-1308-4595, Albion Centre), Don E Smith, Bernhard Haas (Landeskrankenhaus Feldkirch), Cynthia Brinson, Will Garner (0000-0003-0738-8696, Gilead Sciences (United States)), Susan Chuck, Susan K Chuck (Gilead Sciences (United States)), David Thorpe (0000-0002-3649-1724, Gilead Sciences (United Kingdom)), Shampa De-Oertel (Gilead Sciences (United States))
Year2016
Volume28
Issue3
Pages401-408
Publication date2016-03-03
Open AccessNo
TypeARTICLE
VenueAIDS Care (JOURNAL)
Journal identifiersISSN: 0954-0121 • E-ISSN: 1360-0451
PublisherInforma UK Limited (PUBLISHER • GB)
DOI10.1080/09540121.2015.1096890
PMID26489045
OpenAlexW2191099001
LanguageEN
Citations received2
References cited40

This 96-week, randomized, open-label study was designed to assess the efficacy and safety of two single-tablet regimens in treatment naïve HIV-1-infected adults: rilpivirine (RPV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) and efavirenz (EFV) + FTC/TDF. Assessments included patient-reported Medication Adherence Self-Report Inventory, SF-12v2 Quality of Life assessment, HIV Treatment Satisfaction Questionnaire, and HIV Symptom Index Questionnaire through Week 48. Additional evaluations included study drug discontinuations due to treatment-emergent adverse events (TEAEs). A total of 786 participants (n=394 RPV/FTC/TDF, n=392 EFV/FTC/TDF) were included. Fewer RPV/FTC/TDF-treated than EFV/FTC/TDF-treated participants discontinued study drug due to TEAEs (2.5% vs. 8.7%), with 41% (14/34) TEAE-related discontinuations in the EFV/FTC/TDF group occurring within the first four weeks of treatment. Treatment adherence and satisfaction remained high through Week 48 and quality of life improved from baseline in both groups. There were no significant between-group differences in virologic success (HIV-1 RNA <50 copies/mL) regardless of adherence (<95% or ≥95%). Significant between-group differences favouring RPV/FTC/TDF were observed for the HIV SIQ symptoms of difficulty falling or staying asleep (p = .022) and diarrhea or loose bowel movements (p = .002). In conclusion, 48-week treatment with RPV/FTC/TDF or EFV/FTC/TDF was associated with high adherence, high treatment satisfaction, and improved quality of life. TEAE-related discontinuations and patient-reported symptoms indicate that RPV/FTC/TDF may be somewhat better tolerated than EFV/FTC/TDF

Adverse effect · Antiretroviral therapy · Efavirenz · Emtricitabine · Regimen · Rilpivirine · Viral load · HIV Research and Treatment · HIV/AIDS drug development and treatment · HIV/AIDS Research and Interventions · Medicine · Internal Medicine · Virology

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