- Poster presentation
- Open Access
Virological response with fully active etravirine (ETR; TMC125) after 48 weeks of treatment: pooled results from the DUET-1 and DUET-2 trials
© Clumeck et al; licensee BioMed Central Ltd. 2008
- Published: 10 November 2008
- Viral Load
- Fold Change
- Active Agent
- Virological Response
The NNRTI etravirine (ETR; TMC125) has demonstrated durable antiviral activity and favourable tolerability in treatment-experienced patients in the Phase III DUET trials. We report week 48 virological response in the subgroup of patients who were fully sensitive to ETR, analysed according to enfuvirtide (ENF) use and number of active background agents.
HIV-1-infected, treatment-experienced patients with documented NNRTI-resistance, ≥3 primary PI mutations and viral load (VL) >5000 copies/mL were randomised 1:1 to receive ETR 200 mg BID or placebo following a meal plus a background regimen (BR) of darunavir/ritonavir, NRTI(s) and optional ENF. The current analysis included all patients who were fully sensitive to ETR. Phenotypic Sensitivity Score (PSS; Antivirogram®) was used to determine the number of active background agents; ETR was considered active if the fold change in EC50 (FC) was ≤3; darunavir if FC ≤10; NRTIs if FC was < cut-off defined on Antivirogram® and ENF if used de novo. The pooled analysis was pre-specified.
In patients with virus fully sensitive to ETR, the virological response was higher in the ETR + BR group than in the placebo + BR group, irrespective of ENF use or number of active background agents. These results complement current guidelines, which recommend a minimum of two active agents in any treatment regimen.
This article is published under license to BioMed Central Ltd.