Bruno Spire1, Lella Nait-Ighil2, Pascal Pugliese3, Isabelle Poizot-Martin4, Vincent Jullien5, Anne-Geneviève Marcelin6, Eric Billaud7. 1. a INSERM UMR912 Aix-Marseille University , Marseille , France. 2. b Medical Départment , MSD France , Paris , France. 3. c Department of Infectious Diseases , L'Archet Hospital , Nice , France. 4. d Immuno-Hematology Clinic , Ste Marguerite Hospital , Marseille , France. 5. e Clinic Pharmacology Department , Cochin Hospital , Paris , France. 6. f Department of Virology , Pitié-Salpétrière Hospital , Paris , France. 7. g Department of Infectious Diseases , Hotel Dieu Hospital , Nantes , France.
Abstract
BACKGROUND: Good efficacy and safety of raltegravir in person living with HIV was demonstrated in clinical trials over five years, but real-life data, particularly about quality of life (QoL), are lacking. QoL was evaluated over time in adult patients first treated or switched to regimens containing raltegravir in an observational cohort study. METHODS: Patient QoL was evaluated using the Fatigue Impact Scale (FIS) and the HIV Symptom Index (HSI). Data were collected at baseline and at 1, 3, 6, 12, 18, and 24 months. Baseline FIS and HSI subscores were compared with the scores at each visit using the paired Wilcoxon test. The impact of time, sociodemographic and medical variables upon patient-perceived fatigue and symptoms was also assessed using mixed multivariate models. RESULTS: From baseline, all FIS and HSI subscores improved significantly after one month of treatment. In addition, psychosocial FIS subscores and both the frequency of bothersome symptoms and HSI subscores improved significantly at each visit. Physical FIS subscores also improved significantly, except at month 18, whereas both cognitive and total FIS subscores improved only after 6 months and 24 months, respectively. In multivariate analysis, employment was independently associated over time with improved improvement in both FIS and HSI subscores. CONCLUSION: Patient QoL improved significantly over a 24-month period of treatment with a raltegravir-containing regimen. FIS and HSI are sensitive tools to measure the impact of new antiretroviral combinations on a patient's perception of QoL.
BACKGROUND: Good efficacy and safety of raltegravir in person living with HIV was demonstrated in clinical trials over five years, but real-life data, particularly about quality of life (QoL), are lacking. QoL was evaluated over time in adult patients first treated or switched to regimens containing raltegravir in an observational cohort study. METHODS:Patient QoL was evaluated using the Fatigue Impact Scale (FIS) and the HIV Symptom Index (HSI). Data were collected at baseline and at 1, 3, 6, 12, 18, and 24 months. Baseline FIS and HSI subscores were compared with the scores at each visit using the paired Wilcoxon test. The impact of time, sociodemographic and medical variables upon patient-perceived fatigue and symptoms was also assessed using mixed multivariate models. RESULTS: From baseline, all FIS and HSI subscores improved significantly after one month of treatment. In addition, psychosocial FIS subscores and both the frequency of bothersome symptoms and HSI subscores improved significantly at each visit. Physical FIS subscores also improved significantly, except at month 18, whereas both cognitive and total FIS subscores improved only after 6 months and 24 months, respectively. In multivariate analysis, employment was independently associated over time with improved improvement in both FIS and HSI subscores. CONCLUSION:Patient QoL improved significantly over a 24-month period of treatment with a raltegravir-containing regimen. FIS and HSI are sensitive tools to measure the impact of new antiretroviral combinations on a patient's perception of QoL.
Authors: Thiago S Torres; Linda J Harrison; Alberto M La Rosa; Sandra W Cardoso; Lu Zheng; McNeil Ngongondo; Fatma Some; Umesh G Lalloo; Thando Mwelase; Ann C Collier; Michael D Hughes Journal: AIDS Date: 2018-03-13 Impact factor: 4.177