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Efficacy and safety of TDF/FTC-containing first-line HAART in clinical practice – 2-year data from the German Outpatient Cohort

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Journal of the International AIDS Society200811 (Suppl 1) :P12

  • Published:


  • Tenofovir
  • Virological Failure
  • Pivotal Trial
  • Good Safety Profile
  • Renal Abnormality

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.


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.


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.

Authors’ Affiliations

Universitätsklinikum Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie, Hamburg, Germany
Med. Einrichtungen der Universität Köln, Klinik I für Innere Medizin, Köln, Germany
Infektiologikum Frankfurt, Praxis Friedensstraße, Frankfurt, Germany
Infektiologikum Frankfurt, Praxis Stresemannallee, Frankfurt, Germany
Center for HIV and Hepatogastroenterology, Düsseldorf, Germany
Praxiszentrum Blondelstrasse, Aachen, Germany
Gilead Sciences, Martinsried, Germany


© van Lunzen et al; licensee BioMed Central Ltd. 2008

This article is published under license to BioMed Central Ltd.