Long-term quality of life outcomes in three antiretroviral treatment strategies for HIV-1 infection

Objective: To compare changes in quality of life (QoL) over 96 weeks in pat ients enrolled in a triple-therapy protocol, a treatment-intensification pr otocol, or an induction-maintenance therapy protocol, and to compare QoL be tween patients who continued and discontinued their antiretroviral regimen. Patients: Naive patients enrolled in a triple-therapy protocol (zidovudine/ lamivudine or stavudine/didanosine or stavudine/lamivudine supplemented wit h protease inhibitor therapy of choice) (n = 35), a protocol of treatment i ntensification (ritonavir/saquinavir or ritonavir/saquinavir/stavudine) (n = 74) in which therapy was intensified with nucleoside analogue(s) in cases of insufficient viral suppression, and a protocol of induction (saquinavir /nelfinavir/lamivudine/stavudine) maintenance (saquinavir/nelfinavir or sta vudine/nelfinavir) therapy (n = 50). Main outcome measure: Changes from baseline in QoL assessed by the Medical Outcomes Study HIV Health Survey at weeks 0, 12, 24, 36, 48, 72 and 96. Results: Patients in the triple-therapy and treatment-intensification proto cols showed more favourable changes in physical function, social function, mental health, energy/fatigue, health distress and overall QoL compared to patients in the induction-maintenance protocol, with patients in the first two protocols showing improvements in QoL and those in the induction-mainte nance protocol showing declining or unchanged QoL. Patients who discontinue d study medication due to insufficient efficacy, toxicities or at their own request showed less favourable changes in QoL compared with patients who c ontinued their regimen. The highest proportion of discontinuations was with in the induction-maintenance protocol. Conclusion: Antiretroviral treatment strategies that are effective and tole rable have the potential to improve patients' QoL over 96 weeks. (C) 2001 L ippincott Williams & Wilkins.