Health-related quality of life in HIV patients switching to twice-daily indinavir/ritonavir regimen or continuing with three-times-daily indinavir-based therapy.

Author(s): Badia X, Podzamczer D, Moral I, Roset M, Arnaiz JA, Lonca M, Casiro A, Roson B, Gatell JM, BestQol Study Group

Affiliation(s): Department of Clinical Epidemiology and Public Health, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. xbadia@cochrane.es

Publication date & source: 2004-12, Antivir Ther., 9(6):979-85.

Publication type: Clinical Trial; Randomized Controlled Trial

OBJECTIVE: To evaluate health-related quality of life (HRQoL) changes in patients treated with indinavir three-times daily after switching to a twice-daily indinavir/ritonavir regimen or continuing with the same regimen. METHODS: Patients on HAART including indinavir three-times-daily with undetectable viral load were randomly assigned to continue with this therapy or to change to a twice-daily indinavir/ritonavir (800/100 mg) regimen. The Medical Outcomes Study HIV Health Survey (MOS-HIV) questionnaire was used as the HRQoL measure. RESULTS: A total of 118 patients participated in the study, of which 59 (50%) were randomly assigned to continue with the three-times-daily regimen. Patients had a mean age of 39 years and 80% of them were male. At baseline, subjects included in the three-times-daily group presented a significantly greater number of symptoms than subjects in the twice-daily group, but no statistically significant differences were observed in MOS-HIV scores between the groups. In the intention-to-treat (ITT) analysis, a reduction in HRQoL scores was observed in both groups, which was greater in the twice-daily group. In the per protocol analysis, reduction of HRQoL was minimal. CONCLUSIONS: A HRQoL deterioration, greater in the twice-daily group, was observed in this study in the ITT analysis, while HRQoL remained stable in both groups in patients who continued with and tolerated the allocated regimen.