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- Title
Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies.
- Authors
Lambert-Niclot, Sidonie; Grude, Maxime; Meynard, Jean-Luc; Marcelin, Anne-Geneviève; Valantin, Marc-Antoine; Flandre, Philippe; Izopet, Jacques; Moinot, Laetitia; Bouteloup, Vincent; Calvez, Vincent
- Abstract
Background Using 3 randomized Protease inhibitor (PI) monotherapy studies: Kalesolo, Dream and Monoi, we performed a pooled-analysis. Our objective was to determine in PI monotherapy and standard tritherapy: 1) distribution of ultrasensitive viral load (USVL) at week 96 (W96); 2) factors associated with virological failure (VF) at W96 and 3) factors associated with USVL<1 copy at W96. Methods VF was defined as 2 consecutive measurements of Human Immunodeficiency Virus Type 1 RNA viral load>50 copies/mL and analysed in Intention-To-Treat. A logistic model was used to investigate which variables were predictive of a VF and Fisher test to investigate differences in USVL at W96. Results Among 609 patients, 73% were male with median age of 44.4 years (IQR 39.8-52.1), baseline CD4/CD8 ratio was 0.8 (IQR 0.6-1.10), baseline CD4 was 564.5/mm3 (IQR 422-707) and 59% presented a baseline USVL<1 copy/mL. At W96, the proportion of USVL<1 copy/mL was significantly different between PI monotherapy and standard tritherapy in pooled-analysis (65% versus 74%; p=0.04). Overall, baseline USVL<1copy/mL, tritherapy and to be a female were associated with USVL<1 copy/mL at W96 (p<0.0001, p=0.049 and p=0.006). In PI monotherapy receiving DRV/r was associated with USVL<1 copy/mL at W96 (p=0.003). Factors associated to virological succes at W96 were higher baseline CD4 (p=0.034) and baseline USVL<1 copy/mL (p=0.0005). Conclusion Pooled-analysis of 3 PI monotherapy trials showed better efficacy of tritherapy in terms of USVL at W96. Furthermore regarding USVL at W96, to receive LPV/r seems to be more deleterious than DRV/r. Baseline USVL impacts VF at W96 more specifically in tritherapy arm. Clinical Trials Registration NCT00421551, NCT00946595, and NCT00140751.
- Subjects
DIAGNOSIS of HIV infections; THERAPEUTIC use of protease inhibitors; BIOMARKERS; FISHER exact test; HIV infections; STATISTICS; T cells; DATA analysis; VIRAL load; TREATMENT effectiveness; CD4 lymphocyte count
- Publication
Clinical Infectious Diseases, 2018, Vol 67, Issue 12, p1883
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/ciy382