Skip to content

Advertisement

  • Oral presentation
  • Open Access

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

  • 1,
  • 2,
  • 3,
  • 4,
  • 5,
  • 6 and
  • 7
Journal of the International AIDS Society201013 (Suppl 4) :O19

https://doi.org/10.1186/1758-2652-13-S4-O19

  • Published:

Keywords

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

Background

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

Methods

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.

Results

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

HIV RNA

DRV/r mono (n=105)

DRV/r + 2NRTIs (n=114

HIV RNA <50, OD = background

79.0%

80.7%

HIV RNA <50, detectable

17.1%

14.9%

HIV RNA 50-400 copies/mL

2.9%

3.5%

HIV RNA <400 copies/mL

1.0%

0.9%

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%).

Conclusions

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

(1)
CHU Saint-Pierre / Maladies Infectieuses, Brussels, Belgium
(2)
Hospital la Paz, Madrid, Spain
(3)
Hospital for Infectious Diseases, Warsaw, Poland
(4)
Med. Einrichtungen der Universität Köln, Klinik I für Innere Medizin, Köln, Germany
(5)
Pharmacology Research Laboratories, Liverpool University, Liverpool, UK
(6)
Janssen-Cilag, Tilburg, Netherlands
(7)
Janssen-Cilag, Neuss, Germany

Copyright

Advertisement