13th Annual Conference of the British HIV Association 29 March–1 April 2007, Brighton, UK

TREATMENT EXPERIENCE WITH DARUNAVIR/RITONAVIR (DRV/r) AND OPTIMIZED BACKGROUND REGIMEN (OBR) IN CLINICAL PRACTICE

HIV Med 2007; 8(Suppl. 1):12 (abstract no. P9)

Christopher Scott, Rachael Jones, Emma Low, Mark Bower, Brian Gazzard and Mark Nelson
Chelsea and Westminster Hospital, London, UK

BACKGROUND: DRV is a novel non-peptidic protease inhibitor (PI) with activity against HIV-1 protease inhibitor resistant virus when boosted with low dose ritonavir. We present week 24 responses in our patient cohort.

METHODS: Patients eligible for DRV expanded access program (EAP) were heavily pre-treated and PI experienced (71% exposed ≥3 PIs) patients received DRV/r 600/100 mg bd plus OBR. OBR consisted of reverse transcriptase inhibitors +/-PIs +/-enfuvirtide (ENF). CD4 count, viral load, total cholesterol, triglyceride and alanine aminotransferase (ALT) levels were measured at baseline and 24 weeks.

RESULTS: 14 patients enrolled into the EAP. 12 completed to week 24. Discontinuations: gastrointestinal side effects (1) and non-Hodgkin’s lymphoma (1). Median (range) baseline characteristics included CD4 251 cells/mm³ (27– 951), viral load 1242 copies/mL (<50–235,541), cholesterol 4.4 mmol/l (2.6– 9.2), triglycerides 2.5 mmol/l (0.7–7.7), ALT 27 U/l (12–128). Reasons for DRV utilization were virological failure on current regimen (10/14). Remainder switched at VL <50 (4/14). Reasons for switch at VL <50 were treatment rationalization (1/4), patient request (1/4) and toxicity on current regimen (2/4). Four patients used ENF together with DRV/r and OBR (3/4 were naïve to ENF). After 24 weeks’ therapy, 12/12 (100%) patients had viral load <50 copies/mL. Median CD4 cell count increase was 62 (P=0.328). After 24 weeks of therapy, no significant changes were seen in levels of total cholesterol (P=0.423), triglycerides (P=0.708) or ALT (P=0.108).

CONCLUSIONS: DRV is well tolerated and has shown impressive short term activity against protease resistant HIV. DRV in combination with OBR is a successful therapy.

2007-03-29
P9

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