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

Durable virological and immunological treatment response as a result of treatment with nevirapine in combination with fixed-dose tenofovir plus emtricitabine: Interim analysis (24 months) of a non-interventional cohort study

Dauerhaftes virologisches und immunologisches Therapieansprechen als Ergebnis einer Behandlung mit Nevirapin und einer fixen Dosiskombination aus Tenofovir und Emtricitabin: Interimanalyse (24 Monate) einer nicht-interventionellen Beobachtungsstudie

Meeting Abstract

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  • S. Klauke - Infektio Research GmbH & Co KG, Infektiologikum, Frankfurt, Germany
  • V. Cairns - Consultant Statistician, Oxford, United Kingdom
  • J. Goldbach - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany

10. Kongress für Infektionskrankheiten und Tropenmedizin (KIT 2010). Köln, 23.-26.06.2010. Düsseldorf: German Medical Science GMS Publishing House; 2010. DocP120

doi: 10.3205/10kit175, urn:nbn:de:0183-10kit1752

Published: June 2, 2010

© 2010 Klauke et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Objectives: Nevirapine in combination with fixed dose tenofovir plus emtricitabine has been shown to be a highly active antiretroviral treatment regimen. The favourable long term tolerability, i.e. the metabolic profile, as well as the lack of CNS-effects of nevirapine may lead to the decision to start with a nevirapine containing regimen or to switch from an efavirenz- or PI-based HAART to a nevirapine-containing regimen.

Methods: Interim-analysis was performed after 2 years of a prospective 3-year observational cohort study in patients (pts) who were treatment-naive (group1), switched therapy (HIV-RNA <50 copies/ml) (group2) or were treated after virologic failure (HIV-RNA >50 copies/ml) (group3). Laboratory values were determined on routine basis.

Results: 306 pts (252 male, 54 female) were treated at 43 sites in Germany: 119, 107 and 80 pts in the 3 groups, respectively. Baseline median CD4-cell counts in the 3 groups were 228, 462, 297 cells/µL and baseline median viral load values were 51180, 39, 16633 copies/mL, respectively. Respective median values at 24 months were 518, 448, 485 cells/µL and <50, <50, <50 copies/mL. After 24 months, discontinuation rates due to nevirapine-related adverse events were 4.2%, 4.7% and 3.8% in the 3 groups, respectively. Median LDL-cholesterol levels among all pts at baseline and after 24 months were 112 mg/dL and 117 mg/dL, respectively. Median HDL-cholesterol increased from 42 to 48.5 mg/dL and triglycerides decreased from 146.5 to 126 mg/dL. Gamma-GT values increased slightly from median 31 U/L to median 73 U/L. Median ALT and AST values among all pts continued within normal ranges: from 27 to 37 U/L for ALT and from 27 to 30 U/L for AST.

Conclusion: Treatment with nevirapine in combination with fixed dose tenofovir plus emtricitabine results in a durable virological and immunological treatment response and may have a beneficial effect on lipids. The safety data did not reveal an unexpected rate of discontinuations due to adverse events.