Impact of switching virologically suppressed, HIV-1-infected patients from twice-daily fixed-dose zidovudine/lamivudine to once-daily fixed-dose tenofovir disoproxil fumarate/emtricitabine.
OBJECTIVE
Evaluate the impact of switching from twice-daily zidovudine/lamivudine (AZT/3TC) to once-daily tenofovir DF plus emtricitabine (TDF/FTC) with efavirenz (EFV).


METHODS
Prospective, multicenter, single-arm 24-week trial.


METHODS
Patients on EFV + AZT/3TC for > or =8 weeks with HIV-1 RNA <400 copies/mL were switched to EFV + TDF/FTC and assessed for safety/tolerability, virologic and immunologic responses, adherence, and quality of life at 4, 12, and 24 weeks.


RESULTS
Of 402 patients, 2% discontinued for an adverse event (AE) and 1 patient for virologic failure. At 24 weeks, 87% had HIV RNA <400 copies/mL, and 74% versus 71% at baseline had undetectable (HIV RNA <50 copies/mL) viral load (ITT; M=F). Treatment-emergent AEs were infrequent (< or = 5%) with gastrointestinal complaints being the most common. At 24 weeks compared to baseline, hemoglobin (Hb) increased by a median of 0.6 g/dL (p < .001), and a decrease in creatinine clearance of 7.6 mL/min (p < .001) was observed. Fasting lipids decreased slightly (p < .02) in a subset of patients studied (n = 160). A higher percentage of patients reported being "very satisfied" with treatment and the absence of regimen side effects at 24 weeks versus baseline (p < .001). At 24 weeks, 86% of patients took > or = 95% of doses versus 78% at baseline (p = .002).


CONCLUSIONS
Patients switched to EFV + TDF/FTC maintained virologic suppression and the regimen was well tolerated. Patients reported increased satisfaction with treatment and fewer were bothered by side effects.
DeJesus
Edwin
E
Orlando Immunology Center, Orlando, Florida 32803, USA. edelesus@oicorlando.com
Ruane
Peter
P
McDonald
Cheryl
C
Garcia
Fernando
F
Sharma
Shetal
S
Corales
Roberto
R
Ravishankar
Jayashree
J
Khanlou
Homayoun
H
Shamblaw
David
D
Ecker
Janet
J
Ebrahimi
Ramin
R
Flaherty
John
J
D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D000368:Aged; D044966:Anti-Retroviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003404:Creatinine / Q000378:metabolism; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000523:psychology / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects; D008055:Lipids / Q000097:blood; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D010349:Patient Compliance; D017060:Patient Satisfaction; D011788:Quality of Life; D012367:RNA, Viral / Q000097:blood; D000068698:Tenofovir; D016896:Treatment Outcome; D019562:Viral Load; D015215:Zidovudine / Q000008:administration & dosage* / Q000009:adverse effects
D044966:Anti-Retroviral Agents; D006454:Hemoglobins; D008055:Lipids; D063065:Organophosphonates; D012367:RNA, Viral; D003841:Deoxycytidine; D019259:Lamivudine; D015215:Zidovudine; D000068698:Tenofovir; D003404:Creatinine; D000068679:Emtricitabine; D000225:Adenine