Self-reported symptoms after starting HAART help predict adherence

By Brian Boyle, MD for HIV&

Problems with adherence to antiretrovirals are a significant reason for the failure of highly active antiretroviral therapy (HAART), especially in antiretroviral naïve patents. Antiretroviral side effects and intolerance are obstacles to achieving adequate adherence to assure sustained virologic and immunologic success with HAART.

In a study published in HIV Clinical Trials, researchers in France evaluated the relationship between antiretroviral side effects and adherence in 336 patients. Through a standardized questionnaire administered after their first and fourth months of therapy, patients were asked to list which, if any, of 13 side effects they had had during the prior four weeks and to state the severity of that side effect. To assess adherence, patients filled out a detailed table of the pills they had taken during the four days immediately preceding the visit, and were asked in a general question if they had “totally” or “partially” taken their medications or had “interrupted their treatment” during the four days preceding the visit.

The investigators found that the most commonly reported side effects in patients started on protease inhibitor-based HAART were fatigue and diarrhoea and that fatigue was the symptom most often reported by patients to be “quite a bit” or ” a lot” distressing. They found that side effects were higher in patients started on a HAART regimen that included ritonavir and in previously antiretroviral-naïve patients.

The self-reports of adherence indicated the difficulty patients have with protease inhibitor-based HAART adherence, regardless of side effects. They showed that only 66% of the patients were adherent at both the first and fourth month visits after starting HAART, and that approximately 10% were nonadherent at both visits. As would be expected, the decrease in viral load was significantly lower in nonadherent patients, and at the end of the fourth month of therapy, 81% of adherent patients versus 69.6% of nonadherent patients had a viral load less than 500 copies/mL.

Using a multivariate analysis, factors found to be associated with nonadherence in this study included younger age, unstable housing, prior antiretroviral experience, lack of social supports, higher levels of alcohol consumption, and a higher number of side effects reported after the first month of HAART. While the number of self-reported side effects after the first month of HAART was significantly different between the adherent and nonadherent patients (p=.01), the number of HAART side effects was relatively high in both adherent and nonadherent patients and there was significant overlap, with the adherent patients having a median of 4 symptoms (range 2 to 6), while the nonadherent patients had a median of 5 symptoms (range 3 to 7). According to the authors, these findings “strongly suggest that patients’ self-report of symptoms soon after HAART initiation, whether or not these symptoms are related to drug toxicity, is a good marker of the patients’ difficulties in managing the daily life course of their treatment.”

The authors conclude based upon these data that “in the era of HAART, patients’ perception of symptoms during the first four months of therapy is a critical determinant of adherence” and that “management of symptoms should be an important component of interventions to promote adherence.”


S Duran and others. Self-Reported Symptoms After Initiation of a Protease Inhibitor in HIV-Infected Patients and Their Impact on Adherence to HAART. HIV Clinical Trials. 2001; 2:38-45.


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