Abstract
BackgroundProtease inhibitor based antiretroviral therapy (PI-ART) was introduced in 1996 and has greatly reduced the incidence of HIV-related morbidity and mortality in the industrialised world. PI-ART would thus be expected to have a positive effect on health-related quality of life (HRQL). On the other hand, HRQL might be negatively affected by strict adherence requirements as well as by short and long-term adverse effects. The aim of this study was to assess the influence of two years of first generation PI-ART on HRQL in patients with a relatively advanced state of HIV-infection. Furthermore, we wanted to investigate the relation between developments in HRQL and viral response, self-reported adherence and subjective experience of adverse effects in patients with PI-ART.MethodsHRQL was measured by the Swedish Health-Related Quality of Life Questionnaire (SWED-QUAL). Sixty-three items from the SWED-QUAL forms two single-item and 11 multi-item dimension scales. For this study, two summary SWED-QUAL scores (physical HRQL composite score and emotional HRQL composite score) were created through a data reduction procedure. At the 2-year follow-up measurement (see below), items were added to measure adherence and subjective experience of adverse effects. Demographic and medical data were obtained from specific items in the questionnaires and from the medical files. Seventy-two patients who were among the first to receive PI-ART (indinavir or ritonavir based) responded to the questionnaire before the start of PI-ART. Of these, 54 responded to the same instrument after two years of treatment (13 had died, four had changed clinic and one did not receive the questionnaire).ResultsThe main findings were that the emotional HRQL deteriorated during two years of PI-ART, while the physical HRQL remained stable. Multiple linear regression analyses showed that experience of adverse effects contributed most to the deterioration of emotional HRQL.ConclusionIn this sample of patients with relatively advanced state of HIV-infection, our data suggested that a negative development of physical HRQL had been interrupted by the treatment and that the emotional dimension of HRQL deteriorated during two years after start of PI-ART. Subjective experience of adverse effects made a major contribution to the decrease in emotional HRQL. The results underline the importance of including HRQL measures in the evaluation of new life prolonging therapies.
Highlights
Protease inhibitor based antiretroviral therapy (PI-ART) was introduced in 1996 and has greatly reduced the incidence of HIV-related morbidity and mortality in the industrialised world
We found stable scores in the emotional domain of health-related quality of life (HRQL) in a previous pre protease inhibitor (PI)-ART era study, where patients with no or only single drug antiretroviral therapy were followed for two years
When we further investigated the relation between the change in HRQL and the variables viral response, adherence, subjective experience of adverse effects and baseline CD4 value, our study showed that it was the subjective experience of adverse effects that contributed most to the deterioration in the emotional HRQL
Summary
Protease inhibitor based antiretroviral therapy (PI-ART) was introduced in 1996 and has greatly reduced the incidence of HIV-related morbidity and mortality in the industrialised world. Protease inhibitor based antiretroviral therapy (PI-ART), defined as the combination of at least two nucleoside analogues with at least one protease inhibitor (PI) [1], was introduced in 1996 and has greatly reduced the incidence of HIV-related morbidity and mortality in the industrialised world [2,3]. HRQL has been shown to be related to the CD4 value, viral load and symptoms, so that patients with a more advanced state of HIV infection reported poorer HRQL [9,10,11,12,13,14,15]. Burgoyne et al [18,19] followed HRQL in 41 patients with different treatment status over a period of four years and found no overall change of HRQL and that HRQL was less sensitive to CD4 changes than to symptom changes as well as that change in HRQL was somewhat related to change in social support
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