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  • Oral presentation
  • Open Access

The MONET trial: correlation between Hepatitis C coinfection and HIV RNA responses during darunavir/ritonavir monotherapy, for patients with HIV RNA <50 copies/mL at baseline

  • 1,
  • 1,
  • 2,
  • 2Email author,
  • 2 and
  • 3
Retrovirology20107 (Suppl 1) :O15

https://doi.org/10.1186/1742-4690-7-S1-O15

  • Published:

Keywords

  • Poor Adherence
  • Primary Efficacy
  • Efficacy Analysis
  • Primary Efficacy Analysis
  • MONET Trial

Background

Co-infection with Hepatitis C has been associated with higher rates of treatment failure in cohort studies.

Methods

256 patients with HIV RNA <50 on current HAART for over 24 weeks (NNRTI based (43%), or PI based (57%), switched to DRV/r 800/100 mg once daily, either as monotherapy (n = 127) or with 2NRTI (triple therapy arm, n = 129). This sub-analysis investigated the effect of Hepatitis C co-infection on HIV RNA levels during the trial.

Results

At baseline, more patients were HCV antibody positive by serology in the DRV/r arm (17%) than in the control arm (9%). In the primary efficacy analysis at Week 48, 86.2% of patients in the monotherapy arm and 87.8% in the triple therapy arm had HIV RNA <50 copies/mL. Only four of the confirmed elevations in HIV RNA were above 400 copies/mL (two in each arm). In multivariate analysis (Per Protocol), hepatitis C co-infection was a significant predictor of confirmed HIV RNA elevations (p < 0.01). For patients infected only with HIV (HCV antibody negative at baseline), the percent HIV RNA <50 was 88.1% in the monotherapy arm versus 87.3% in the triple therapy arm. For patients HCV antibody positive at baseline, the percent HIV RNA <50 was 61.9% for the monotherapy arm versus 58.3% for the triple therapy arm. Three patients had acute HCV infection during the trial (all in the DRV/r arm): all three had HIV RNA elevations at the time of acute HCV infection.

Discussion

In this study for patients with HIV RNA <50 copies/mL at screening, switching to DRV/r monotherapy showed non-inferior efficacy versus 2NRTI + DRV/r. Hepatitis C co-infection was more prevalent in the DRV/r monotherapy arm, and was a significant, independent predictor of transient, low-level HIV RNA viraemia. Hepatitis C co-infection might be a marker of poor adherence, or might be directly correlated with HIV RNA viraemia.

Authors’ Affiliations

(1)
Hospital la Paz, Madrid, Spain
(2)
Tibotec, Mechelen, Belgium
(3)
MONET Study Group, Belgium

Copyright

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