Thiago S Torres1,2, Linda J Harrison1, Alberto M La Rosa3, Sandra W Cardoso2, Lu Zheng1, McNeil Ngongondo1,4, Fatma Some5, Umesh G Lalloo6, Thando Mwelase7, Ann C Collier8, Michael D Hughes1. 1. Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA. 2. LAPCLIN-AIDS, Instituto Nacional de Infectologia Evandro Chagas (INI), Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil. 3. Asociación Civil Impacta Salud y Educación, Lima, Peru. 4. UNC Project, Lilongwe, Malawi. 5. AMPATH at Moi University Teaching Hospital, Eldoret, Kenya. 6. Durban Adult HIV CRS, Durban. 7. Wits Health Consortium Department of Medicine, University of Witwatersrand, Johannesburg, South Africa. 8. Department of Medicine, University of Washington, Seattle, Washington, USA.
Abstract
OBJECTIVE: We evaluated improvement of quality of life (QoL) after 1 year of second-line antiretroviral therapy (ART) use in resource-limited settings (RLS) among adult men and women, comparing two randomized treatment arms. DESIGN: The AIDS Clinical Trial Group A5273 was a randomized clinical trial of second-line ART comparing lopinavir/ritonavir (LPV/r) + raltegravir with LPV/r + nucleos(t)ide reverse transcriptase inhibitors (NRTIs) in participants failing a non-NRTI-containing regimen at 15 sites in nine RLS. Participants completed the AIDS Clinical Trial Group short-form-21 which has eight QoL domains with a standard score ranging from 0 (worst) to 100 (best). METHODS: Differences in QoL by randomized arm, as well as by demographic and clinical variables, were evaluated by regression models for baseline and week 48 QoL scores fitted using the generalized estimating equations method. RESULTS: A total of 512 individuals (49% men, median age 39 years) were included. A total of 512 and 492 participants had QoL assessments at baseline and week 48, respectively. QoL improved significantly from baseline to week 48 (P < 0.001 for all domains). There was no significant difference between treatment arms for any domain. Individuals with higher viral load and lower CD4 cell count at baseline had lower mean QoL at baseline but larger improvements such that mean QoL was similar at week 48. CONCLUSION: Improvements in QoL were similar after starting second-line ART of LPV/r combined with either raltegravir or NRTIs in RLS. QoL scores at baseline were lower among participants with worse disease status prior to starting second-line, but after 1 year similar QoL scores were achieved.
RCT Entities:
OBJECTIVE: We evaluated improvement of quality of life (QoL) after 1 year of second-line antiretroviral therapy (ART) use in resource-limited settings (RLS) among adult men and women, comparing two randomized treatment arms. DESIGN: The AIDS Clinical Trial Group A5273 was a randomized clinical trial of second-line ART comparing lopinavir/ritonavir (LPV/r) + raltegravir with LPV/r + nucleos(t)ide reverse transcriptase inhibitors (NRTIs) in participants failing a non-NRTI-containing regimen at 15 sites in nine RLS. Participants completed the AIDS Clinical Trial Group short-form-21 which has eight QoL domains with a standard score ranging from 0 (worst) to 100 (best). METHODS: Differences in QoL by randomized arm, as well as by demographic and clinical variables, were evaluated by regression models for baseline and week 48 QoL scores fitted using the generalized estimating equations method. RESULTS: A total of 512 individuals (49% men, median age 39 years) were included. A total of 512 and 492 participants had QoL assessments at baseline and week 48, respectively. QoL improved significantly from baseline to week 48 (P < 0.001 for all domains). There was no significant difference between treatment arms for any domain. Individuals with higher viral load and lower CD4 cell count at baseline had lower mean QoL at baseline but larger improvements such that mean QoL was similar at week 48. CONCLUSION: Improvements in QoL were similar after starting second-line ART of LPV/r combined with either raltegravir or NRTIs in RLS. QoL scores at baseline were lower among participants with worse disease status prior to starting second-line, but after 1 year similar QoL scores were achieved.
Authors: E G Bing; R D Hays; L P Jacobson; B Chen; S J Gange; N E Kass; J S Chmiel; S L Zucconi Journal: Qual Life Res Date: 2000-02 Impact factor: 4.147
Authors: Camelia Protopopescu; Fabienne Marcellin; Bruno Spire; Marie Préau; Renaud Verdon; Dominique Peyramond; François Raffi; Geneviève Chêne; Catherine Leport; Maria-Patrizia Carrieri Journal: Qual Life Res Date: 2007-02-01 Impact factor: 4.147
Authors: M A Boyd; N Kumarasamy; C L Moore; C Nwizu; M H Losso; L Mohapi; A Martin; S Kerr; A H Sohn; H Teppler; O Van de Steen; J-M Molina; S Emery; D A Cooper Journal: Lancet Date: 2013-06-15 Impact factor: 79.321
Authors: Thiago S Torres; Linda J Harrison; Alberto M La Rosa; Lu Zheng; Sandra W Cardoso; Godwin Ulaya; Nazim Akoojee; Dileep Kadam; Ann C Collier; Michael D Hughes Journal: AIDS Care Date: 2021-01-23