Efficacy, Safety and Pharmacokinetics of Once-Daily Saquinavir Soft-Gelatin Capsule-Ritonavir in Antiretroviral-Naive, HIV-Infected PatientsReport as inadecuate




Efficacy, Safety and Pharmacokinetics of Once-Daily Saquinavir Soft-Gelatin Capsule-Ritonavir in Antiretroviral-Naive, HIV-Infected Patients - Download this document for free, or read online. Document in PDF available to download.

Journal of the International AIDS Society

, 8:36

First Online: 10 May 2006

Abstract

ContextOnce-daily HIV treatment regimens are being used in clinical practice with the objective of improving patient acceptance and adherence.

ObjectiveTo evaluate the efficacy and safety of saquinavir-soft-gelatin capsule SGC-ritonavir combination 1600 mg-100 mg vs efavirenz 600 mg both once daily and combined with 2 nucleoside analogs twice daily.

SettingTwenty-six centers in the United States, Canada, and Puerto Rico.

PatientsA total of 171 antiretroviral naive HIV-infected individuals were enrolled in a 48-week, phase 3, open-label, randomized study.

Main Outcome MeasureProportion of patients with HIV-RNA levels < 50 copies-mL. The pharmacokinetic profile of saquinavir-SGC was analyzed in a subset of randomly selected patients.

ResultsIn the primary intent-to-treat population at week 48, 51% 38-75 and 71% 55-77 of patients in the saquinavir-SGC-ritonavir and efavirenz groups, respectively, achieved HIV-RNA suppression < 50 copies-mL P =.5392, 95% 1-sided confidence interval CI = -33.5%. In the on-treatment OT population, 73% 38-52 and 93% 54-58 of patients in the saquinavir-SGC-ritonavir and efavirenz groups, respectively, had effective viral suppression < 50 copies-mL P =.5015, 95% 1-sided CI = -33.4%. Mean CD4+ cell counts increased by 239 and 204 cells-microliters mcL, in the saquinavir-SGC-ritonavir and efavirenz groups, respectively, in the OT analysis P =.058. Both regimens were reasonably well tolerated, although more gastrointestinal adverse events were reported with saquinavir-SGC-ritonavir. Pharmacokinetic profiles in 6 patients showed an observed median Cmin at 24 hours of 429 ng-mL range, 68-1750 ng-mL.

ConclusionOnce-daily efavirenz was statistically superior to once-daily saquinavir-SGC-ritonavir. Gastrointestinal adverse effects were commonly associated with treatment failure in the saquinavir-SGC-ritonavir arm of the study.

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Author: Montaner SG Julio - Malte Schutz - Robert Schwartz - Dushyantha T Jayaweera - Alfred F Burnside - Sharon Walmsley - Micha

Source: https://link.springer.com/







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