Volume 13 Supplement 4
Week 48 efficacy of 900/100 mg daily of darunavir/ritonavir in treatment-experienced HIV-1 patients with virological success: DARDAR study
© Schneider et al; licensee BioMed Central Ltd. 2010
Published: 8 November 2010
Simplification of antitretroviral treatment (ARV) is particularly important. If darunavir/ritonavir (DRV/r) can be used at a 800/100mg once a day (q.d.) on patients with a wild-type virus, it is recommended at a 600/100mg twice a day (b.i.d.) on pre-treated patients. POWER study suggests the similarity of efficiency of the 800/100 mg q.d. and 600/100mg b.i.d. in patients with a minimal number of DRV resistance mutations.
Evaluate the capacity of DRV/r(900/100mg) q.d. to maintain viral load(VL) indetectability at W24, after switch from DRV/r 600/100mg bid, in virologically supressed pre-treated HIV-1 patients.
This observational study included 45 patients if they had a VL<50copies/ml and a steady treatment associating DRV/r 600/100 mg b.i.d. with INTI and/or INNTI. A genotypic test was perform on the plasmatic HIV-1 RNA, on the last detectable VL (>50cp/ml) before starting DRV, and in case of virological failure. The follow up is done at D0, W4/W12/W24/W36 and W48 including VL measure, CD4 cells count, residual plasmatic concentrations of darunavir and ritonavir. Virological failure was defined as two consecutives VL >50cp/ml at a minimal 15 days interval. The primary endpoint was the proportion of patients with a VL <50cp/ml at W24.
Between 02/2008 and 02/2009, 45 patients were included with an anterior ARV treatment of 13[1,20] years, with exposure to 3 ARV classes among 34( 75%) patients and a previous failure ≥ 2 PI for 20(44%) patients. CD4 cell count was 478/mm3 [317-560]; nadir CD4: 93/mm3 [39-165].They were treated by DRV/r b.i.d. since 10[3;44] months. DRV/r was associated with: 2 INTI (76%), 3 INTI (8%), 2 INTI/1INNTI( 5%). 93% plasmatic RNA genotypic tests were amplified. Five patients had ≥ 3 DRV impacting resistance mutations, six patients 2 mutations, and nine patients 1 mutation. The proportion of patients with VL<50cp/mL[IC95] at W24 was 93%[81-98] and 91%[78-97] at W48, in ITT and PP analysis.
Three virological failures were observed at W12 and one at W48. For 1 patient, 2 primary PI mutations (I50V and L33F) were observed.
This study suggests that DRV/r can be used once a day even for patients with a previous IP failure. This approach is particularly important for the once daily use of combination INTI. It also enables a reduction of the ritonavir dose.
This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.