Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: An analysis of combined data from two randomised open-label trials

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dc.contributor.authorHicks, Charles B.
dc.contributor.authorCahn, Pedro
dc.contributor.authorCooper, David A.
dc.contributor.authorWalmsley, Sharon L.
dc.contributor.authorKatlama, Christine
dc.contributor.authorClotet, Bonaventura
dc.contributor.authorLazzarin, Adriano
dc.contributor.authorJohnson, Mark A.
dc.contributor.authorNeubacher, Daniel
dc.contributor.authorMayers, David
dc.contributor.authorValdez, Hector
dc.contributor.authorRESIST investigator group
dc.date.accessioned2024-05-23T18:53:36Z
dc.date.available2024-05-23T18:53:36Z
dc.date.issued2006
dc.description.abstractBackground: Treatment options for HIV-1 infected individuals who have received extensive previous antiretroviral therapy are limited. We compared efficacy and safety of the novel non-peptidic protease inhibitor tipranavir co-administered with ritonavir plus an optimised background regimen with that of an investigator-selected ritonavir-boosted comparator protease inhibitor (CPI-ritonavir) in such patients. Methods: We did a combined analysis of 48-week data from two ongoing, randomised, open-label, multinational, phase III, RESIST studies. HIV-1-infected adults with 3 months or longer previous triple antiretroviral class experience, two or more previous protease inhibitor regimens, HIV-1 RNA 1000 copies per mL or greater, and genotypically demonstrated primary resistance to protease inhibitor, were eligible. Primary endpoints were proportion of treatment responders (with reduction in viral load of 1 log(10) copies per mL or greater below baseline without treatment change) at 48 weeks and time to treatment failure through 48 weeks (intention-to-treat analysis). The RESIST studies are registered with ClinicalTrials.gov, numbers NCT00054717 (RESIST-1) and NCT00144170 (RESIST-2). Findings: 3324 patients were screened; 746 received tipranavir-ritonavir and 737 CPI-ritonavir. 486 (65.1%) patients on tipranavir-ritonavir and 192 (26.1%) on CPI-ritonavir remained on assigned treatment until week 48. At week 48, more patients achieved and maintained treatment response in the tipranavir-ritonavir group than in the CPI-ritonavir group (251 [33.6%] vs 113 [15.3%]; p<0.0001). Median time to treatment failure was significantly longer in the tipranavir-ritonavir group than in the CPI-ritonavir group (113 days vs 0 days; p<0.0001). Gastrointestinal system disorders and raised transaminase, cholesterol, and triglycerides were more frequent in the tipranavir-ritonavir group than in the CPI-ritonavir group. Interpretation: Compared with CPI-ritonavir, tipranavir-ritonavir with an optimised background regimen provides better virological and immunological responses over 48 weeks in patients who have received extensive previous antiretroviral treatment.
dc.identifier.citationHicks, C. B., Cahn, P., Cooper, D. A., Walmsley, S. L., Katlama, C., Clotet, B., ... Valdez, H. (2006). Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: An analysis of combined data from two randomised open-label trials. The Lancet.
dc.identifier.otherDOI: 10.1016/S0140-6736(06)69154-X
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1139
dc.relation.ispartofseriesThe Lancet
dc.subjectDurable efficacy
dc.subjectTipranavir-ritonavir
dc.subjectAntiretroviral drugs
dc.subjectTreatment-experienced HIV-1-infected patients
dc.subject48 weeks
dc.subjectRandomized Evaluation of Strategic Intervention
dc.subjectMulti-drug resistant patients
dc.subjectRESIST studies
dc.subjectCombined data
dc.titleDurable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: An analysis of combined data from two randomised open-label trials

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