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48 week changes in Quality of Life and adherence in the MONET trial: darunavir/ritonavir with and without nucleoside analogues for patients with HIV RNA <50 at screening
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Reported by Jules Levin
11th Workshop on Adverse Drug Reactions and Co-morbidities in HIV, Philadelphia, USA, October 2009
C Stephan, JW Goethe University, Frankfurt, Germany, J Arribas, Hospital la Paz, Madrid, Spain, Andrew Hill, Pharmacology Research Laboratories, University of Liverpool, UK, A Carosi, Instituto di Malattie Infettive e Tropicale, Brescia, Italy, Anne Anceau, Janssen-Cilag, Issy-les-Moulineaux, France, Christiane Moecklinghoff, Janssen-Cilag EMEA, Neuss, Germany
AUTHOR CONCLUSIONS
In this study for patients with HIV RNA <50 copies/mL at screening, switching to DRV/r monotherapy showed maintained quality of life, compared with the triple therapy arm (DRV/r + 2 NRTI).
Patient-reported adherence levels were high throughout the MONET trial, and did not correlate with HIV RNA levels <50 copies/mL at Week 48.
These results need to be confirmed and validated in other studies. It is not clear why there was a significant benefit in emotional well-being in the DRV/r monotherapy arm.
INTRODUCTION
In the MONET trial, 256 patients with HIV RNA <50 copies/mL on current HAART for over 24 weeks switched to darunavir/ritonavir (DRV/r) 800/100 mg once daily, either as monotherapy or with two nucleoside analogues.
After 48 weeks of treatment, the percentage of patients with HIV RNA suppression below 50 copies/mL in the monotherapy arm was 86.2%, versus 87.8% in the triple therapy arm, showing non-inferior efficacy (Arribas 2009).
The "Functional Assessment of HIV Infection" (FAHI) Quality of Life questionnaire (Cella 1996) was used to measure the patients' experience of darunavir/ritonavir with our without nucleoside analogues. The "Medication Adherence Self-Report Inventory" (MASRI) questionnaire was used to measure patient adherence to randomised treatment.
METHODS
In the MONET trial, 256 patients with HIV RNA <50 on current HAART for over 24 weeks (NNRTI based (43%), or PI based (57%)), switched to DRV/r 800/100 mg once daily, either as monotherapy (n=127) or with 2 NRTI (n=129). Patients were assessed for Quality of Life using the FAHI questionnaire and for adherence using the MASRI questionnaire, at baseline, and at study visits to Week 48 (Week 24 and 48 only for FAHI).
The FAHI questionnaire includes five domains: physical, emotional, functional, social and cognitive. Each domain included several questions. For each question, patients gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much).
The mean FAHI scores were compared between treatment arms at each timepoint using t-tests. The total score was also compared between the treatment arms, and the percentage of patients with at least a 10% improvement from baseline. The data were analysed using Last Observation Carried Forwards for patients with data at Week 24 but not at Week 48. The results were similar when analysed using only observed data at Week 48 (data not shown).
The percentage of trial medication taken at each visit was calculated from the MASRI questionnaire results.
In the MASRI analysis, sub-optimal adherence was defined as at least one study visit with reported adherence less than 95%. Optimal adherence was reported adherence of at least 95% at all study visits.
81% of patients were male and 91% Caucasian, with a median age 43 years, and baseline CD4 count of 575 cells/uL. Baseline characteristics are shown in Table 1.
FAHI results
Mean changes in quality of life parameters to Week 48, as measured by the FAHI questionnaire, are shown in Table 2a and 2b. There was no statistically significant difference between the treatment arms for changes in quality of life domains to Week 48, except for Emotional Well-being, which showed a significantly greater rise in the DRV/r monotherapy arm.
Patients in the DRV/r monotherapy arm were significantly more likely to show a clinically meaningful improvement (10% rise from baseline) in the total FAHI score (p=0.019), but this difference was seen only in the observed data analysis, not the LOCF analysis (p>0.05).
MASRI results
By the MASRI questionnaire, mean adherence levels were over 95% at all visits in both groups (Table 4).
At the Week 48 visit, 20/120 patients in the DRV/r monotherapy arm and 19/128 patients in the triple therapy arm had HIV RNA levels above 50 copies/mL. Table 4 shows the correlation between HIV RNA levels at Week 48 for patients who had always had >95% adherence, versus patients who had at least one visit with <95% adherence.
In both treatment arms, adherence levels under 95% did not correlate with HIV RNA >50 copies/mL at Week 48 -however most HIV RNA elevations were transient.
REFERENCES
Arribas J et al. The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/mL. AIDS 2009, in press.
Cella, D et al (1996). Development and validation of the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument. Quality of Life Research 1996, 5, 450-463.
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