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Clin Infect Dis. 2018 Nov 28;67(12):1883-1889. doi: 10.1093/cid/ciy382.

Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies.

Author information

1
Sorbonne Université, Paris, France.
2
INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP), Paris, France.
3
AP-HP, Laboratoire de Virologie, Hôpital Saint-Antoine, Paris, France.
4
Département de Maladies Infectieuses, Hôpital Saint-Antoine, Paris, France.
5
AP-HP, Laboratoire de Virologie, Hôpital Pitié Salpêtrière, Paris, France.
6
Département de Maladies Infectieuses, Hôpital Pitié Salpêtrière, Paris.
7
INSERM, U1043, Toulouse, France.
8
Université Toulouse III Paul-Sabatier, Toulouse, France.
9
CHU de Toulouse, Laboratoire de Virologie, Toulouse, France.
10
Inserm, Bordeaux Population Health Research Center, Université Bordeaux, ISPED, Bordeaux, France.
11
CHU de Bordeaux, Pole de Sante Publique, Bordeaux, France.

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.

PMID:
29767684
DOI:
10.1093/cid/ciy382
[Indexed for MEDLINE]
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