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Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study
OBJECTIVE: To assess efficacy, adherence and tolerability of once daily antiretroviral therapy containing tenofovir disoproxil fumarate (DF) 300 mg in HIV-1-infected former injecting drug users receiving opiate treatment (IVDU). METHODS: European, 48-week, open-label, single-arm, multicenter study....
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3400973/ https://www.ncbi.nlm.nih.gov/pubmed/22024421 http://dx.doi.org/10.1186/2047-783X-16-10-427 |
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author | Esser, S Haberl, A Mulcahy, F Gölz, J Lazzarin, A Teofilo, E Vera, J Körber, A Staszewski, S |
author_facet | Esser, S Haberl, A Mulcahy, F Gölz, J Lazzarin, A Teofilo, E Vera, J Körber, A Staszewski, S |
author_sort | Esser, S |
collection | PubMed |
description | OBJECTIVE: To assess efficacy, adherence and tolerability of once daily antiretroviral therapy containing tenofovir disoproxil fumarate (DF) 300 mg in HIV-1-infected former injecting drug users receiving opiate treatment (IVDU). METHODS: European, 48-week, open-label, single-arm, multicenter study. Patients were either antiretroviral therapy-naïve, restarting therapy after treatment discontinuation without prior virological failure or switching from existing stable treatment. RESULTS: Sixty-seven patients were enrolled in the study and 41 patients completed treatment. In the primary analysis (intent-to-treat missing = failure) at week 48, 34% of patients (23/67; 95% CI: 23%-47%) had plasma HIV-1 RNA < 50 copies/mL. Using an intent-totreat missing = excluded approach, the week 48 proportion of patients with plasma HIV-1 RNA < 50 copies/mL increased to 56% (23/41; 95% CI: 40%-72%). Mean (standard deviation) increase from baseline in CD4+ cell count at week 48 was 176 (242) cells/mm(3). Although self-reported adherence appeared high, there were high levels of missing data and adherence results should be treated with caution. No new safety issues were identified. CONCLUSIONS: Levels of missing data were high in this difficult-to-treat population, but potent antiretroviral suppression was achieved in a substantial proportion of HIV-infected IVDU-patients. |
format | Online Article Text |
id | pubmed-3400973 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-34009732012-07-21 Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study Esser, S Haberl, A Mulcahy, F Gölz, J Lazzarin, A Teofilo, E Vera, J Körber, A Staszewski, S Eur J Med Res Research OBJECTIVE: To assess efficacy, adherence and tolerability of once daily antiretroviral therapy containing tenofovir disoproxil fumarate (DF) 300 mg in HIV-1-infected former injecting drug users receiving opiate treatment (IVDU). METHODS: European, 48-week, open-label, single-arm, multicenter study. Patients were either antiretroviral therapy-naïve, restarting therapy after treatment discontinuation without prior virological failure or switching from existing stable treatment. RESULTS: Sixty-seven patients were enrolled in the study and 41 patients completed treatment. In the primary analysis (intent-to-treat missing = failure) at week 48, 34% of patients (23/67; 95% CI: 23%-47%) had plasma HIV-1 RNA < 50 copies/mL. Using an intent-totreat missing = excluded approach, the week 48 proportion of patients with plasma HIV-1 RNA < 50 copies/mL increased to 56% (23/41; 95% CI: 40%-72%). Mean (standard deviation) increase from baseline in CD4+ cell count at week 48 was 176 (242) cells/mm(3). Although self-reported adherence appeared high, there were high levels of missing data and adherence results should be treated with caution. No new safety issues were identified. CONCLUSIONS: Levels of missing data were high in this difficult-to-treat population, but potent antiretroviral suppression was achieved in a substantial proportion of HIV-infected IVDU-patients. BioMed Central 2011-10-10 /pmc/articles/PMC3400973/ /pubmed/22024421 http://dx.doi.org/10.1186/2047-783X-16-10-427 Text en Copyright ©2011 I. Holzapfel Publishers |
spellingShingle | Research Esser, S Haberl, A Mulcahy, F Gölz, J Lazzarin, A Teofilo, E Vera, J Körber, A Staszewski, S Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study |
title | Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study |
title_full | Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study |
title_fullStr | Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study |
title_full_unstemmed | Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study |
title_short | Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study |
title_sort | efficacy, adherence and tolerability of once daily tenofovir df-containing antiretroviral therapy in former injecting drug users with hiv-1 receiving opiate treatment: results of a 48-week open-label study |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3400973/ https://www.ncbi.nlm.nih.gov/pubmed/22024421 http://dx.doi.org/10.1186/2047-783X-16-10-427 |
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