8th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV San Francisco, California - September 24 - 26, 2006

BODY MASS CHANGE AND ANTHROPOMETRIC-RELATED ADVERSE EVENTS AT WEEK 24 IN TREATMENT-EXPERIENCED HIV-INFECTED PATIENTS RECEIVING TMC114/R OR CONTROL PIS IN POWER 1, 2 AND 3

Antiviral Therapy 2006; 11:L21 (abstract no. 30)

A Roberts¹, J Hoy², G Beatty³, T Vangeneugden⁴ and E Lefebvre^5
1George Washington University Medical Center, Washington, DC, USA; ²The Alfred Hospital, Melbourne, Australia; ³University of California San Francisco, San Francisco, CA, USA; ⁴Tibotec BVBA, Mechelen, Belgium; ⁵Tibotec Inc., Yardley, PA, USA

BACKGROUND: 24-week data from the randomized, controlled POWER 1 and 2 trials (TMC114-C213 and C202) and the POWER 3 analysis of two non-randomized, open-label trials (TMC114-C215 and C208) were pooled to examine the incidence of adverse events (AEs) related to anthropometric measurements in treatment-experienced HIV patients receiving the protease inhibitor (PI) TMC114 (darunavir) with low-dose ritonavir (TMC114/r) at the recommended 600/100mg bid dose.

METHODS: PI-, NRTI- and NNRTI-experienced patients, with plasma HIV-1 RNA >1,000 copies/ml and ≥1 primary mutation, initiated treatment with TMC114/r 600/100mg bid in POWER 1, 2 and 3 (n=458), or investigator-selected control PIs in POWER 1 and 2 (n=124). Patients also received an optimized background regimen (≥2 NRTIs ± enfuvirtide). Patients’ weight and height were measured and body mass index (BMI) calculated. Waist and hip circumferences were also recorded. Clinically relevant anthropometric-related changes observed between screening and Week 24 were reported as AEs. Patients in POWER 2 completed ACTG body image questionnaires at Day 1 and Week 24.

RESULTS: The previous mean duration of PI use for TMC114/r patients in POWER 1 and 2, and POWER 3, was 64.5 and 68.9 months, respectively; this was 65.1 months for the control group. At Week 24, changes in mean body weight from baseline in TMC114/r and control patients were +2 kg and -0.2 kg, respectively. No clinically relevant changes from baseline in BMI and waist or hip circumference occurred during TMC114/r treatment. AEs related to anthropometric measurements reported in TMC114/r and control patients, respectively, were lipoatrophy (2% versus 2%), weight loss (1% versus 5%) and fat redistribution (1% versus 0%). All other anthropometric-related AEs were reported in <1% of patients, with the majority occurring as isolated events. There were no relevant differences between TMC114/r and control groups across the answering scale of the POWER 2 body image questionnaire.

CONCLUSIONS: No clinically relevant changes from baseline in BMI or waist and hip circumferences were observed in treatment-experienced patients receiving TMC114/r 600/100 mg bid. The incidence of AEs related to fat redistribution was low. Analysis of patients over a long-term follow up period of 96 weeks is ongoing.

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2006-09-24
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