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O213. Low-level viraemia during treatment with darunavir/r monotherapy versus DRV/r + 2NRTIs in the MONET trial

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Journal of the International AIDS Society201013 (Suppl 4) :O19

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  • Lower Detection
  • Lower Detection Limit
  • Patient Visit
  • Virological Failure
  • Baseline Visit


Patients with HIV RNA suppression below 50 copies/mL may still have HIV RNA detectable by more sensitive PCR assay techniques.


In the MONET trial, 256 patients with HIV RNA <50 copies/mL on current HAART, and no history of virological failure, switched to DRV/r 800/100 mg once daily, either as monotherapy (n=127) or with 2NRTI (n=129). HIV RNA was evaluated by the Roche Amplicor Ultrasensitive assay (lower detection limit=50 copies/mL), for all patient visits to Week 96. With this assay, "Optical Density=background" was used to assess whether HIV RNA was detectable or undetectable below 50 copies/mL.


Patients were 81% male, 91% Caucasian, and had median baseline CD4 count of 575 cells/uL. At the baseline visit, the percentage of patients with HIV RNA undetectable below 50 copies/mL (OD=background) was 80% in the DRV/r mono arm and 79% in the DRV/r + 2NRTI arm. The percentage with HIV RNA at different levels at the Week 96 visit is shown in Table 1 (observed data analysis)

Table 1


DRV/r mono (n=105)

DRV/r + 2NRTIs (n=114

HIV RNA <50, OD = background



HIV RNA <50, detectable



HIV RNA 50-400 copies/mL



HIV RNA <400 copies/mL



Including all samples from patient visits from Week 4 to Week 96, HIV RNA was above 50 copies/mL in 69/1009 samples in the DRV/r monotherapy arm (50-400: 84%, 400-1000: 12%, >1000: 4%) and 47/1051 samples in the DRV/r + 2NRTI arm (50-400: 83%, 400-1000: 8.5%, >1000: 8.5%).


In this study for patients with HIV RNA <50 copies/mL at baseline, switching to DRV/r monotherapy showed similar levels of HIV RNA suppression to DRV/r + 2NRTIs, using more sensitive PCR assay techniques.

Authors’ Affiliations

CHU Saint-Pierre / Maladies Infectieuses, Brussels, Belgium
Hospital la Paz, Madrid, Spain
Hospital for Infectious Diseases, Warsaw, Poland
Med. Einrichtungen der Universität Köln, Klinik I für Innere Medizin, Köln, Germany
Pharmacology Research Laboratories, Liverpool University, Liverpool, UK
Janssen-Cilag, Tilburg, Netherlands
Janssen-Cilag, Neuss, Germany


© Clumeck et al; licensee BioMed Central Ltd. 2010

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 (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.