Quality of life in asymptomatic- and symptomatic HIV infected patients in a trial of ritonavir/saquinavir therapy

Objective: To compare the impact on quality of life (QoL) of treatment with ritonavir (RTV)/saquinavir (SQV) versus Rn/SQV/stavudine (d4T) in asymptom atic [Centers for Disease Control (CDC) class A] and symptomatic HIV-infect ed patients (CDC B and C) who did or did not receive anti retroviral therap y (ARVT) before entry into the study. Design: A multicenter randomized clinical trial. Patients: Protease inhibitor- and d4T-naive patients were allocated to RTV/ SQV (n = 84) versus RTV/SQV/d4T (n = 83). Main outcome measure: Changes from baseline in QoL assessed by the Medical Outcomes Study Health Survey for HIV (MOS-HIV) and a symptom checklist admi nistered at baseline and after 12, 24, 36 and 48 weeks. Results: Changes in QoL were comparable in both treatments, although more n europathy was reported in the RTV/SQV/d4T group. QoL improved significantly in both groups regarding health distress, energy/fatigue, mental health, h ealth perceptions, physical function and overall QoL, despite an increase i n reported symptoms. More favourable changes in cognitive and social functi on were observed in symptomatic compared with asymptomatic patients, with s ymptomatic patients showing an improvement and asymptomatic patients showin g a decline in function after baseline. ARVT-naive patients showed more fav ourable changes in mental health, health distress and social function compa red with patients with previous ARVT. Conclusion: RTV/SQV and RTV/SQV/d4T were equally effective in improving the QoL of patients over 48 weeks, despite an increase in reported symptoms. S ymptomatic patients reported more QoL benefit than asymptomatic patients, a nd ARVT-naive patients benefitted more than those with previous ARVT. The i mpact on patients' QoL should be considered in the search for the optimal m anagement of HIV infection. (C) 2000 Lippincott Williams & Wilkins.