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Title: Combined Regimen of Darunavir and Ritonavir Produces Significant Virologic Response in ARV-Experienced Patients: Presented at HIV-DART

"Combined Regimen of Darunavir and Ritonavir Produces Significant Virologic Response in ARV-Experienced Patients: Presented at HIV-DART"

By Marjan Hezareh, PhD CANCUN, MEXICO -- December 14, 2006 -- Clinically meaningful changes in viral loads and CD4 cell counts after treatment with a combined regimen of darunavir (TMC114) and low-dose ritonavir 600/100 mg twice daily was observed after 24 weeks in an interim analysis of results from antiretroviral-experienced patients. At HIV DART 2006, the Frontiers in Drug Development for Antiretroviral Therapies meeting, Joseph Gathe Jr., MD, president, Therapeutic Concepts, Houston, Texas, presented interim data from one of the centers participating in the multicenter, international US Expanded Access Program (EAP). Darunavir is a protease inhibitor (PI) currently approved in the US, Canada, Russia, and Argentina, for use with low-dose ritonavir at a recommended dose of 600/100 mg twice daily for the treatment of HIV infection in antiretroviral-experienced patients. The primary objective of the EAP is to provide access to darunavir for antiretroviral-experienced patients with limited treatment options. The secondary objective was to evaluate and gather additional safety data on the combination regimen. The study enrolled HIV-positive patients with prior experience with 3 classes of antiretroviral including 2 PIs. Patients coinfected with hepatitis B and/or hepatitis C were also eligible. Restriction on CD4 count to 200 cells/mm[³ or less was lifted in January 2006.

Eligible patients received darunavir and ritonavir 600/100 mg twice daily plus an optimized background regimen without PI combinations except for atazanavir and indinavir.

Dr. Gathe Jr. presented analysis of data from 38 and 23 patients who had completed 12 and 24 weeks of treatment, respectively. At baseline, patients had a mean age of 48 years, 92% of patients were male, 61% Caucasian, and 5% had HCV co-infection. Mean viral load was 126,775 copies/mL and median CD4 count was 144 cells/mm³.

At weeks 12 and 24, 54% and 50% of patients achieved a viral load below 50 copies/mL, respectively. At week 24, mean viral load reduction was -2.17 log10 copies/mL and mean CD4 count increase was 109 cells/mm³. The CD4 data at baseline was available for 22 out of 38 patients who had completed 24 weeks of treatment. Among these patients, 10 had a CD4 count < 50 cells/mm³ but 80% displayed a CD4 count > 100 cells/mm³ by week 24.

Overall, 9 adverse events were considered to be possibly related to darunavir by week 24 (2 mild rashes, 1 mild nausea, 2 Grade 2 increased ALT, 1 Grade 2 hypercholesterolemia, 1 Grade 2 increased in creatinine, and 1 Grade 2 increased in total bilirubin). No serious adverse events related to darunavir were reported.

[Presentation title: Single-Center Experience of Duranavir (DRV) in 38 HIV-Infected Adults Enrolled in US Expanded Access Program. Abstract 65]

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