A simplified combination antiretroviral therapy regimen enhances adherence, treatment satisfaction and quality of life: results of a randomized clinical trial.
OBJECTIVE
The aim of the study was to investigate the effect of a simplified regimen, in terms of reducing pill burden, dietary requirements and possible adverse effects, on patients' adherence, treatment satisfaction and quality of life (QoL).


METHODS
Antiretroviral-naïve patients who achieved a viral load < 50 HIV-1 RNA copies/ml after induction therapy with twice-daily (bid) lopinavir/ritonavir (LPV/r) and fixed-dose zidovudine (ZDV)/lamivudine (3TC) (CBV) were randomly assigned to continue CBV/LPV/r or switch to fixed-dose ZDV/3TC/abacavir (TZV). Patients completed standardized questionnaires on adherence, treatment satisfaction and QoL at randomization (between weeks 12 and 24) and at weeks 48, 72 and 96.


RESULTS
Patients on CBV/LPV/r were more likely to have skipped medicines in the last week (P = 0.035) and during the preceding weekend (P = 0.027) than patients on TZV. Patients on CBV/LPV/r were significantly less satisfied with the convenience of their treatment (P = 0.004) and tended to be less satisfied with the side effects of their treatment (P = 0.091) and continuation of their present treatment (P = 0.056) than patients on TZV. Patients on CBV/LPV/r reported significantly lower levels of role functioning (P = 0.013) than patients on TZV.


CONCLUSIONS
In this randomized controlled trial, simplification of therapy to fixed-dose TZV among patients with suppressed HIV RNA was perceived to be more convenient, and resulted in improved adherence and better role functioning, than continuing treatment with CBV/LPV/r.
Department of Internal and Infectious Diseases, Rijnstate Hospital, Arnhem, the Netherlands.
N
N
Langebeek
H G
HG
Sprenger
E H
EH
Gisolf
P
P
Reiss
M A G
MA
Sprangers
Jc
J
Legrand
C
C
Richter
P T
PT
Nieuwkerk
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D001530:Belgium; D015224:Dideoxynucleosides / Q000627:therapeutic use; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use; D061466:Lopinavir / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D016017:Odds Ratio; D017060:Patient Satisfaction; D011788:Quality of Life; D019438:Ritonavir / Q000627:therapeutic use; D015215:Zidovudine / Q000627:therapeutic use; D016903:Drug Monitoring; D000099227:Abacavir
D015224:Dideoxynucleosides; D019259:Lamivudine; D061466:Lopinavir; D019438:Ritonavir; D015215:Zidovudine; D000099227:Abacavir
adherence; antiretroviral therapy; compliance; quality of life; randomized controlled trial; simplified regimen; treatment satisfaction