Etravirine Effective At HIV Supression: Duet Trials 1 And 2

Treatment with TMC125 (etravirine) leads to better virological suppression than placebo
as part of antiretroviral therapy in patients with documented resistance to non-nucleoside
reverse transcriptase inhibitors (NNRTIs), conclude two randomised trials in this week's issue
of The Lancet.



TMC125 is a well tolerated new NNRTI with activity against both wild-type and NNRTI-
resistant HIV-1. It is hoped that TMC125 will be part of the next generation of antiretrovirals
with activity against resistant virus and a high genetic barrier to the development of
resistance, which will help address a major unmet clinical need.



The DUET-1 and DUET-2 randomised, phase III studies examine the efficacy, safety, and
tolerability of TMC125 compared with placebo in treatment-experienced patients with
NNRTI-resistant HIV-1 infection. After 24 weeks, a higher proportion of patients who
received TMC125 achieved a viral load of less than 50 copies per mL than did those in the
placebo group (56% vs 39% in DUET-1 and 62% vs 44% in DUET-2). Furthermore, the safety
and tolerability profile of TMC125 was generally comparable with placebo.



The authors of DUET-2, Adriano Lazzarin (San Raffaele University, Milan, Italy) and colleagues
point out that: "The magnitude of the results seen with TMC125??¦and the similarity of the
responses across both trials done in different countries, indicate the higher genetic barrier to
resistance of TMC125 compared with currently available NNRTIs and its activity against NNRTI
resistant virus are central to the ability of TMC125??¦to produce significantly better virological
responses than the placebo group in treatment experienced patients. The maintenance of
the response to 24 weeks without additionally clinically relevant tolerability concerns further
suggests that TMC125 is an encouraging new agent in this antiretroviral class."



In an accompanying Comment, Bernard Hirschel and Thomas Perneger (Geneva Hospital,
Geneva, Switzerland) argue that important questions have been left unanswered, including:
"Quality-of-life measurements, and detailed correlations between resistant genotype and
treatment success which may help gauge etravirine's prospects in individual patients."



thelancet

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