Volume 13 Supplement 4
HRQoL improves in treatment-naïve HIV-1 subjects initiated on lopinavir/ritonavir (LPV/r) with raltegravir (RAL) or tenofovir/emtricitabine (TDF/FTC)
© Baran et al; licensee BioMed Central Ltd. 2010
Published: 8 November 2010
The clinical status of HIV-1 infected patients initiated on modern anti-retroviral (ARV) therapy is consistently improved as indicated by reduced viral load (VL) and increased CD4+ T-cell count, however, the reported impact on patients' health related quality of life (HRQoL) has been variable. An appropriate assessment of HRQoL response over time in ARV-naïve HIV-1 infected subjects initiated on LPV/r combined with RAL or TDF/FTC could reveal the impact of these therapies on functional status and wellbeing.
The PROGRESS study is an ongoing, randomized, open-label 96-week trial of LPV/r 400/100 mg BID combined with either RAL 400 mg BID (n=101) or TDF/FTC 300/200 mg QD (n=105) in ARV-naïve subjects. Subjects completed the MOS-HIV, a validated, disease-specific HRQoL instrument, at baseline and weeks 8, 24, and 48. The MOS-HIV comprises 35 items in eleven dimensions. Dimension specific scores and the two summary scores (Physical Component Summary [PCS], Mental Component Summary [MCS]) each range from 0 to 100 points, with higher scores indicating better function or well being. Changes in score from baseline were analyzed using ANCOVA with the following covariates: baseline score, treatment arm, gender, race/ethnicity, age, time since HIV-1 diagnosis, baseline CD4+ T-cell count, and plasma HIV-1 RNA level (VL).
Both LPV/r + RAL and LPV/r + TDF/FTC treatment arms achieved similar VL and CD4+ T-cell endpoints at 48 weeks; a similar proportion of subjects in each arm discontinued the study prematurely. For each assessment period, >79% of all subjects completed the MOS-HIV survey. There were no statistically significant differences between treatment arms in MOS-HIV scores on any dimension or summary score at any assessment period (p>0.100). When pooling data across all subjects, MCS improved significantly from baseline at week 8 (mean change: +2.3, p = 0.013), week 24 (+3.5, p<0.001), and week 48 (+2.2, p=0.041). PCS improved significantly from baseline only at week 24 (+1.8, p=0.033). The General Health Perceptions dimension, an overall evaluation of health, was significantly improved at week 8 (+5.4, p= 0.009), week 24 (+7.9, p<0.001), and week 48 (+6.0, p=0.019).
LPV/r in combination with either RAL or TDF/FTC improved HRQoL related to both mental and physical states as well as overall health in ARV naïve, HIV-1 infected subjects at weeks 8, 24, and 48. Additional HRQoL data through week 96 are being collected.
This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.