4th International AIDS Society Conference on HIV Pathogenesis and Treatment


Sydney, Australia - July 22 - 25, 2007

TIPRANAVIR/RITONAVIR (500/200 MG BID) DEMONSTRATED POTENT AND DURABLE VIROLOGIC RESPONSES AND A FAVOURABLE SAFETY PROFILE IN HIV-1 POSITIVE WOMEN PARTICIPATING IN RESIST

IAS Conf HIV Pathog Treat 2007 Jul 22-25;4th: Abstract No. MOPDB04

Walmsley S.1, Squires K.2, Kraft M.3, Scherer J.3, Weiss L.4, Easterbrook P.5, Orani A.6
1University of Toronto, Medicine, Toronto, Canada, 2Jefferson Medical College, Medicine, Philadelphia, United States, 3Boehringer Ingelheim, Ingelheim, Germany, 4Hopital Europeen Georges Pompidou, Service d'Immunologie clinique, Paris, France, 5Kings College Hospital, London, United Kingdom, 6Clinica di Malattie Infettive, Lecco, Italy

OBJECTIVES: To evaluate efficacy and safety of tipranavir/r (TPV/r) in treatment experienced women.

METHODS: Sub-analysis of Week 48 efficacy and safety RESIST data. PK samples were obtained 10-14 hours post-dosing.

RESULTS: 12.6% of RESIST participants were women: 117 TPV/r; 86 CPI/r. Men and women had similar baseline characteristics. At Week 48, 22.1% (139/629) men and 25.6% (30/117) women randomized to TPV/r had VLs <50 copies/mL (ITT NCF). After adjusting for PI stratum, enfuvirtide use, and background RTI sensitivity, mean VL change at last observation to Week 48 from baseline was -1.30 (95% C.I. -1.49, -1.10) log10 copies/mL for men and -1.46 (95% C.I. -1.74 to –1.18) log10 copies/mL in women taking TPV/r (p=0.1890). A Logistic regression analysis gave Odds Ratio of 1.15 (95% CI 0.71-1.84; p=0.5728) for TPV/r virological responses (Week 48 VL <50 copies/mL) in women vs. men. The adjusted mean CD4 change from baseline at Week 48 was: men: +52.4 (36.8, 67.9); women: +84.2 (61.5, 106.9) (p=0.0017). Although women had higher steady-state plasma TPV trough concentrations than men (adjusted means: 45.3 µM vs. 38.75 µM), the overall safety profile of TPV/r was similar in both sexes. Overall AEs per patient exposure year (PEY) were slightly higher in TPV/r-treated women (556.3) than men (459.9) but rates of AEs leading to discontinuation were similar (women: 10.6; men: 10.3). Severe (women: 24.2; men: 29.6) or serious (women: 19.9; men: 22.9) AE rates were slightly higher for men. Rates of bleeding, fat redistribution, hepatitis, hyperglycemia, hyperlipidemia, IHD, pancreatitis, QT prolongation, systemic/severe infections, renal failure, skin rash indicated no significant gender differences.

CONCLUSIONS: Over 48 weeks, no gender-related differences in efficacy and safety were seen in RESIST patients taking TRV/r, despite women having higher steady-state plasma TPV trough concentrations. Women experienced greater immunologic reconstitution than men.

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2007-07-22
MOPDB04
Pathogenesis and Treatment in Women

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