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.
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.
a North Manchester General Hospital , Crumpsall , Manchester , UK.
Ed L
EL
Wilkins
b Gilead Sciences, Inc , Foster City , CA , USA.
Calvin J
CJ
Cohen
c Clinique Medicale L'Actuel , Montreal , QC , Canada.
Benoit
B
Trottier
d University Hospital Essen , Essen , Germany.
Stefan
S
Esser
e Albion Street Centre , Surry Hills , NSW , Australia.
Don E
DE
Smith
f Landeskrankenhaus Graz West , Graz , Austria.
Bernhard
B
Haas
g Central Texas Clinical Research , Austin , TX , USA.
Cynthia
C
Brinson
b Gilead Sciences, Inc , Foster City , CA , USA.
Will
W
Garner
b Gilead Sciences, Inc , Foster City , CA , USA.
Susan
S
Chuck
h Gilead Sciences Europe Ltd , Uxbridge , UK.
David
D
Thorpe
b Gilead Sciences, Inc , Foster City , CA , USA.
Shampa
S
De-Oertel
D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions; D000068257:Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination / Q000009:adverse effects / Q000627:therapeutic use*; D000068678:Emtricitabine, Rilpivirine, Tenofovir Drug Combination / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000523:psychology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D011788:Quality of Life; D012367:RNA, Viral / Q000097:blood; D057566:Self Report; D013607:Tablets; D016896:Treatment Outcome; D019562:Viral Load; D016903:Drug Monitoring
D019380:Anti-HIV Agents; D000068257:Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D000068678:Emtricitabine, Rilpivirine, Tenofovir Drug Combination; D012367:RNA, Viral; D013607:Tablets
Antiretroviral therapy; efavirenz; rilpivirine; single-tablet regimen; treatment-naive