3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

TIPRANAVIR/RITONAVIR (TPV/R) DEMONSTRATES SUPERIOR IMMUNOLOGIC RESPONSE TO COMPARATOR PROTEASE INHIBITORS (CPIS) IN A PI-EXPERIENCED POPULATION WITH ADVANCED DISEASE

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WePe16.7B07

Grinsztejn B.¹, Hicks C.², Cahn P.³, Villacian J.⁴, McCallister S.^4
1Fiocruz, Rio de Janeiro, Brazil, ²Duke University Medical Center, Durham, United States of America, ³Foundacion Huesped, Buenos Aires, United States of America, ⁴Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, United States of America

INTRODUCTION: Even modest improvements the immunologic status of patients with CD4+ <200 cells/mm³ have shown a significant impact on clinical outcomes, reducing the incidence of AIDS-defining events, and death. The phase 3, prospective, multicenter, randomized, open-label RESIST studies allowed for investigation of the immunologic response to TPV in PI-experienced patients with advanced disease.

METHODS: Patients with >3-class antiretroviral experience including >2 PI-based regimens; >1 primary PI mutation and <2 mutations at amino acids 33, 82, 84, 90; and viral load >1000 copies/mL and any CD4+ count were eligible. Before randomization, an optimized CPI/r-based regimen was selected; the selected PI could be new or continued from the current regimen.

RESULTS: 1483 patients with a median baseline viral load of 4.8 log₁₀ copies/mL, and median CD4+ cell count of 162 cells/mm³ were treated. Preselected CPIs were lopinavir (LPV; 50%), amprenavir (APV; 26%), saquinavir (SQV; 20%), or indinavir (IDV;4%). Median CD4+ change was +34 cells/mm³ with TPV/r and +4 cells/mm³ with CPI/r (P<0.0001). When stratified by preselected CPI, increases in CD4+ were significantly greater with TPV/r than with LPV/r (+31 cells/mm³ vs +6 cells/mm³; P<0.0012), SQV/r (+36 cells/mm³ vs +11 cells/mm³; P<0.005), and APV/r (+30 cells/mm³ vs +0 cells/mm³; P<0.0001). A subgroup of patients (n=265) with very advanced disease (median baseline CD4+ cell count 72 cells/mm³ in the TPV/r arm, and 77 cells/mm³ in the CPI/r arm) included T20 in their background regimen. These patients experienced a change in CD4+ cell count of +55 cells/mm³ (P<0.0001) with TPV, +6 cells/mm³ with CPI (P = 0.3765). TPV also had a superior response to CPI in patients without T20 (+27 cells/mm³ vs +3 cells/mm³).

CONCLUSIONS: TPV provides a significantly greater CD4+ response than CPI in PI-experienced patients. In patients with very advanced disease, combination of TPV with T20 provides a robust immunological response.

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Clinical | WePe16.7B07 | C Hicks
Immune Reconstitution

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