gms | German Medical Science

10. Kongress für Infektionskrankheiten und Tropenmedizin (KIT 2010)

Deutsche Gesellschaft für Infektiologie,
Deutsche AIDS-Gesellschaft,
Deutsche Gesellschaft für Tropenmedizin und Internationale Gesundheit,
Paul-Ehrlich-Gesellschaft für Chemotherapie

23.06. - 26.06.2010, Köln

Results from the German etravirine early access programme

Ergebnisse aus dem Etravirin "Early Access Programme" in Deutschland

Meeting Abstract

  • A. Stoehr - ifi – Institut für Interdisziplinäre Medizin, Hamburg, Germany
  • H.-J. Stellbrink - ICH (Infektionsmedizinisches Centrum Hamburg), Hamburg, Germany
  • S. Marks - Janssen-Cilag B.V., Tilburg, Netherlands
  • H. Vanaken - Tibotec BVBA, Mechelen, Belgium
  • C. Vogt - Tibotec – Division of Janssen-Cilag GmbH, Neuss, Germany
  • A. Hill - Tibotec BVBA, Mechelen, Belgium; University of Liverpool, United Kingdom
  • TMC125-C214 Study Group

10. Kongress für Infektionskrankheiten und Tropenmedizin (KIT 2010). Köln, 23.-26.06.2010. Düsseldorf: German Medical Science GMS Publishing House; 2010. DocP116

DOI: 10.3205/10kit171, URN: urn:nbn:de:0183-10kit1710

Published: June 2, 2010

© 2010 Stoehr et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

Background: The next generation NNRTI etravirine (ETR, TMC125) has shown strong and durable efficacy in the DUET trials (combined with darunavir/ritonavir, NRTIs and optional enfuvirtide).

Methods: The TMC125-C214 trial (etravirine early access programme) included patients with triple class experience (NRTI, PI, NNRTI) and who were unable to use currently approved NNRTIs owing to either intolerance or drug resistance. Patients received etravirine 200mg BID with optimised background antiretrovirals chosen by the investigators. The subset of patients starting etravirine in Germany was analysed.

Results: Of the 225 patients included, 13% were female, 92% were Caucasian, with a mean age of 48 years. The baseline mean CD4 count was 266 cells/µL (range 2–1,078), with baseline mean HIV RNA 3.7 log10 copies/mL (range 1.1–6.5). 184/225 (82%) patients received NRTIs with etravirine, of whom 177 used 3TC or FTC, 132 used TDF and 54 used abacavir. Other antiretrovirals used included darunavir (76%), raltegravir (23%), enfuvirtide (21%) and maraviroc (8%). The percentage of patients with HIV RNA below 50 (or 400) copies/mL was 40% (71%) at Week 4, 60% (86%) at Week 12 and 67% (83%) at Week 24 (observed data analysis). CD4 counts rose by a mean 67 cells/µL at Week 12 and 81 cells/µL at Week 24. There were 57 serious adverse events reported, 1 of which (gastrointestinal haemorrhage) was judged to be possibly related to etravirine by the investigators. 2 patients died during the trial (1 bronchial carcinoma, 1 hyponatremia); non of these death was considered to be treatment related.

Conclusions: The use of etravirine with other new antiretrovirals in the German early access programme led to high rates of HIV RNA suppression, similar to the DUET trials, in this treatment experienced cohort.