Long-cycle Structured Treatment Interruption Does Not Improve Health-related Quality of Life or Symptom Distress when Compared to Continuous HAART

Although HAART delays disease progression and improves clinical outcomes, it does not eradicate HIV infection. HIV patients manage their chronic HIV illness by taking HAART for many years or for the rest of their lives. Patients on HAART must maintain almost perfect adherence to their prescribed medications to experience clinical efficacy and to improve their health-related quality of life (HRQL).

Achieving near perfect adherence to HAART is an arduous task. The complexity of many regimens and the numerous side effects related to HAART fuel non-adherence. Not surprisingly, surmounting these difficulties and challenges sometimes produces feelings of resentment of the need for therapy.

Structured intermittent therapy (SIT) is a treatment interruption approach that involves pre-specified cycles on and off HAART to provide less total time receiving therapy. SIT may promote adherence to HAART for some individuals by reducing the associated toxicities and cost of the regimen while preserving clinical efficacy and future therapeutic options. Results of some studies suggest SIT may offer alternatives to continuous HAART, but there are concerns regarding the use of serial cycles of SIT due to the potential for the development of drug-resistant virus during re-initiation of therapy.

Fewer studies have examined symptom distress in patients with HIV infection who have received HAART.

In the current study, researchers aimed to evaluate the effects of repeated, long-cycle structured intermittent versus continuous HAART on health-related quality of life (HRQL) and symptom distress in patients with chronic HIV infection and HIV viral RNA <50 copies/ml.

This was a prospective survey of 46 adult patients enrolled in a randomized clinical trial evaluating intermittent versus continuous HAART on immunological and virologic parameters. Twenty-three patients randomized to structured intermittent therapy received serial cycles of 4 weeks on/8 weeks off HAART.

HRQL was measured by the physical and mental health summary scores of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Symptom distress was measured by the Symptom Distress Scale. Patients completed initial questionnaires prior to randomization and at weeks 4, 12, and 40 of the trial via a touch screen computer in an outpatient clinic.

Results

Baseline demographic and clinical characteristics were equivalent in both treatment groups.

Although the mental health summary score declined significantly over time for the structured intermittent group, linear mixed modeling ANOVA indicated no significant difference across time for MOS-HIV summary and Symptom Distress Scale scores between the two treatment arms.

The authors conclude, “In this small sample, repeated long-cycle structured intermittent therapy may not provide HRQL or symptom distress advantage compared to continuous HAART in patients with chronic HIV infection over 10 months of treatment. Further research in a heterogenous chronic HIV population and longer follow-up period is warranted.”

Discussion

As stated in the their conclusion, the results of this small pilot study suggest that repeated long-cycle SIT may not improve HRQL or reduce symptom distress in patients with chronic HIV infection when compared to continuous HAART over a 10-month-period.

The researchers were surprised to find that in the patients who received SIT in this study, “mental health decreased significantly from baseline after completing the first cycle of off/on HAART and did not improve upon completion of two more intermittent cycles and fourth off HAART period. Rather, patients reported significantly poorer mental health after three cycles of SIT and their fourth period off HAART when compared to baseline and first off HAART period.”

The researchers found that this trend towards poorer mental health was reflected in decreases in mean MHS scores of approximately 3 and 4 points. The magnitude of these changes did not reach clinical importance, but the authors note, “It is noteworthy that poorer mental health was evidenced despite no significant changes in physical health or symptom distress over time. Thus, perhaps this finding requires further evaluation in larger studies.”

In contrast to the patients in the STI group, mental health remained relatively unchanged over a 10-month-period in the patients who received continuous HAART. “This stability in mental health was accompanied by no significant changes in physical health or symptom distress over time,” according to the authors.

HIV and Hepatitis.com Articles on Treatment Interuptions

03/31/06

Reference
AE Powers, E April, SF Marden, and others. Effect of long-cycle structured intermittent versus continuous HAART on quality of life in patients with chronic HIV infection. AIDS 20(6): 837-845, April 4, 2006.