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Abstract
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
Walmsley S.1, Squires K.2, Kraft M.3, Scherer J.3, Weiss L.4, Easterbrook P.5, Orani A.6
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.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
MOPDB04
Suggested Citation
"WalmsleyS., et al.
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.
Poster discussion:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
MOPDB04"
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