- Poster presentation: Purpose of the study First-line HAART with tenofovir DF (TDF) and FTC in pivotal trials has been associated with high efficacy and good tolerability. However, real-life clinical practice often differs from clinical trials due to co-morbidities, co-infections, and less intensive clinical monitoring. To evaluate efficacy and safety of first-line HAART in a day-to-day setting, this Gilead-sponsored non-interventional cohort was established. Methods Between July 2005 and August 2006, 533 HIV-1 infected antiretroviral-naïve patients from 50 German centres enrolled in this non-interventional cohort. All patients were followed every 3 months for 3 years to monitor efficacy (viral load [VL], CD4), tolerability, renal safety, regimen changes and resistance profile. All patients received TDF+FTC as a single tablet (Truvada, TVD) in combination with either an NNRTI or PI/r as their first antiretroviral regimen. Summary of results As of June 2008, 2 years of therapy have been documented for 330/533 (62%) patients. At treatment initiation, 81% were male; median age was 39 years; clinical AIDS diagnosis was documented in 22%; 47% started therapy with CD4 <200 cells/mm3. TVD was combined with an NNRTI (43%) or a PI/r (57%). After 24 months, in an As-Treated (AT) analysis, 85% patients achieved a VL <50 copies/ml (VL <500 copies/ml: 97%), median CD4 count increased from 217 at baseline to 450 cells/mm3 (IQR: 325–608). Truvada showed a good safety profile; 76 adverse events (AEs) of any grade were reported in 66/533 patients (12%); six of these were judged serious. Fourteen (2.6%) patients discontinued TVD due to AEs. Renal abnormalities of any grade were reported in 10 patients (1.9%). Virological failure was documented in nine patients, of which eight were genotyped; M184V/I was detected in three, K65R in two patients. Conclusion During 2 years of follow-up, the overall safety of TVD was good; renal AEs of any grade were reported in 1.9% of patients. K65R was detected in two patients. First-line HAART with TVD plus an NNRTI or PI/r in clinical practice showed comparable efficacy to that observed in controlled clinical trials.
MetadatenAuthor: | Jan Van Lunzen, Gerd FätkenheuerORCiDGND, Thomas Lutz, Stefan Klauke, Stefan Mauß, Heribert Knechten, Patrick Braun, Lothar Gallo, Britta Ranneberg |
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URN: | urn:nbn:de:hebis:30-70644 |
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DOI: | https://doi.org/10.1186/1758-2652-11-S1-P12 |
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Parent Title (English): | Journal of the International AIDS Society |
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Publisher: | Springer |
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Place of publication: | Berlin ; Heidelberg |
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Document Type: | Article |
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Language: | English |
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Date of Publication (online): | 2009/09/20 |
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Date of first Publication: | 2008/11/10 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Contributing Corporation: | Ninth International Congress on Drug Therapy in HIV Infection Glasgow, UK. 9–13 November 2008 |
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Release Date: | 2009/09/20 |
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Volume: | 11(Suppl 1) |
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Issue: | P12 |
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Page Number: | 1 |
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First Page: | 1 |
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Last Page: | 1 |
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Note: | © 2008 van Lunzen et al; licensee BioMed Central Ltd. |
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Source: | Journal of the International AIDS Society 2008, 11(Suppl 1):P12 ; doi:10.1186/1758-2652-11-S1-P12 ; from Ninth International Congress on Drug Therapy in HIV Infection Glasgow, UK. 9–13 November 2008 |
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HeBIS-PPN: | 218723490 |
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Institutes: | Medizin / Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Licence (German): | Deutsches Urheberrecht |
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