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Health-Related Quality of Life After 1 Year of Highly Active Antiretroviral Therapy
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We investigated the impact of the first year of highly active antiretroviral therapy (HAART) on health-related quality of life (HRQL).
..... Our results show the relation between treatment efficacy (expressed by several markers such as undetectable HIV-RNA at M12) and a normal HRQL at M12. When evaluating the normal HRQL at M12 as an outcome, undetectable
HIV-RNA at M12 was the most important predictor of efficacy, confirming results obtained in a previous study.. Our study provides additional evidence that normal HRQL is positively associated with adherence behavior..
...This study was conducted among patients who began a regimen containing a PI, and most maintained a PI-based regimen during follow-up. We cannot exclude the possibility that a regimen without PIs would provide different results, because the reduced toxicity of these alternative easier-to-take combinations may affect HAART-related perceived toxicity differently and may influence the results for all dimensions...
Medical data for patients in the French APROCO cohort were collected at enrollment (M0) and month 12 (M12). A self-administered questionnaire gathered information about HRQL (Medical Outcome Study 36-Item Short Form Health Survey) and toxicity-related symptoms. Using the twenty-fifth percentile of HRQL scales in the French population as a threshold, patients with normal values in at least three mental and three physical scales were considered to have a "normal HRQL."
Of the 1053 patients followed through M12, HRQL data at M0 and M12 were available for 654. Among the 233 patients with a normal baseline HRQL, 63 (27.0%) experienced a deterioration of HRQL at M12. Among the 421 patients with a low baseline HRQL, 121 achieved a normal HRQL at M12. Logistic regression showed that factors independently associated with a normal HRQL at M12 were normal baseline HRQL, baseline CD4 count <500 cells/mm3, time since HIV diagnosis <8 years, undetectable HIV-RNA at M12, and lower number of self-reported symptoms at M12... on average, a year of HAART leads to a significant improvement in most dimensions of HRQL... Our results also indicate that patients who do not have a normal HRQL at M12 are more likely to have experienced nonadherence episodes throughout the whole
follow-up period... Our results confirm previous clinical trial reports that HAART initiation is accompanied by a general improvement of
HRQL among treated HIV-infected patients. Previous observational studies in these populations have already pointed out that despite this global improvement, a patient's experience may modify the impact on some specific
dimensions of HRQL.. Patients who began HAART with less severe immune depression were less likely to have a normal quality of life after 1
year of treatment.. In our study, patients' subjective self-reports of symptoms were clearly associated with a poor HRQL at M12... Medically reported HAART-related adverse events were no longer associated with HRQL at M12 in the final model, mainly because self-perceived adverse effects are more likely to summarize a negative experience with treatment.
Our results, as previously reported by others, suggest that conventional clinical assessment of toxicity may be insufficient to capture the entire spectrum of symptoms that is part of patients' experience with their disease and
treatment. Moreover, these findings also indicate that the self-report of symptoms by patients on HAART, whether related to drug toxicity or not, is a good marker of posttreatment HRQL.
The continuation of a PI in the first year of HAART does not play a major role in determining a normal HRQL after 1 year of HAART, except for two dimensions (physical and social functioning). The switch to a non-PI-containing regimen was associated with an improvement of most HRQL scores, however, although such improvement was not sufficient to attain HRQL values comparable to those observed for patients remaining on a PI. It is possible that regimens without PIs, implying a reduced pill burden and easier schedule of administration, may have induced an increase in HRQL, as shown in a previous study.
Patients who reported no episodes of nonadherence at the M4 or M12 visit were more likely to have a normal HRQL. Only 29.1% of patients could be classified as adherent throughout the entire follow-up period.
An assessment of HRQL should be integrated to efficacy outcomes to evaluate and compare long-term strategies properly and to optimize the durability of response to antiretroviral therapy.
The French health care system guarantees all HIV-infected patients free-of-charge access to care The APROCO cohort contains a higher proportion of underprivileged populations than in most clinical trials or other longitudinal studies carried out in countries where free access to care is denied. Our results indicate that a careful investigation of perceived adverse effects experienced by patients, especially for the less immunodepressed patients, should become an integral part of clinical monitoring. Because poor HRQL is associated with nonadherence, this monitoring may be important to guarantee the long-term effectiveness of antiretroviral regimens.
In cancer research and clinical care, where some treatment strategies may simultaneously improve survival and be detrimental to the patient's HRQL, HRQL assessment has become routine to evaluate the benefits of medical innovation. The consideration of HRQL associated with various outcomes among HIV-positive patients must be taken into account to evaluate and compare long-term strategies to ensure maximum effectiveness and durability of response to antiretroviral therapy.
*Patrizia Carrieri; *Bruno Spire; *Segolene Duran; Christine Katlama; Dominique Peyramond; ¤Cecile Fran¨ois; ||Genevieve Chene; Jean-Marie Lang; *Jean-Paul Moatti; #Catherine Leport; APROCO Study Group
*INSERM U379/ ORS, Marseille; Pitie Salpetriere Hospital, Paris; Croix-Rousse Hospital, Lyon; Hotel-Dieu, Nantes; ||INSERM U330, Bordeaux; CISIH, Strasbourg; and #Faculte X Bichat, Paris, France
This study was supported by the Agence Nationale de Recherches sur le Sida (ANRS, Action Coordonnee no. 7), Association des Professeurs de Pathologie Infectieuse et Tropicale (APPIT), and associated pharmaceutic companies (Abbott, Boehringer-Ingelheim, Roche, Bristol-Myers Squibb
Pharma, Merck Dohm Chibret, and GlaxoSmithKline).
RESULTS
Of the 1053 patients who were enrolled in the APROCO cohort between May 1997 and June 1999 and had a follow-up visit 1 year after HAART initiation (M12), a total of 654 (62.1%) individuals had complete data concerning biomedical, social, and behavioral information as well as a quality of life assessment at both M0 and M12 and were thus eligible for the present analysis.
When we compared these 654 respondents with the 399 patients who were excluded from analyses, we found no significant difference in age, gender, or clinical stage at baseline. Significant differences were observed for the
baseline CD4 cell counts and plasma HIV-RNA levels and for antiretroviral naivete at enrollment, however. The respondent group also included a significantly higher proportion of patients infected through homosexual contacts. A significant difference was found in the proportion of patients with undetectable plasma HIV-RNA at M12 (65.9% for respondents vs. 53.9% for nonrespondents). Of the 399 excluded patients, 356 had completed the baseline self-administered questionnaire containing the MOS SF-36 scales. Comparison of these scales at enrollment showed that the 654 respondents had significantly higher values on these scales than the 356 excluded patients.
Of the 654 patients eligible for this analysis, 38.8% had a high school certificate. At enrollment, the median (interquartile range [IQR]) number of months since HIV diagnosis was 51 (IQR: 9-101) and 27.2% of patients knew they were HIV-positive for at least 8 years. Among the 654 patients, 29.8% had fewer than 200 CD4 cells/mm3, whereas 17.7% had more than 500 CD4 cells/mm3.
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