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Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial
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Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial
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Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial
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Journal Article
Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial
2016
Overview
Background
In the ANRS EASIER trial where treatment-experienced patients switched from enfuvirtide (ENF) to raltegravir (RAL), a high incidence of transaminase elevation was reported in the RAL arm.
Methods
We compared the incidence of emergent liver enzyme elevations (LEE) of grade 2 or more among patients randomized to the maintenance ENF arm or the switch RAL arm up to W24. We also assessed the overall incidence of LEE over the 48-week duration of the trial and baseline risk factors for grade 2 or more alanine aminotransferase (ALT) elevation using univariate and multivariate analyses.
Results
During the first 24 weeks, 6/84 (7.1 %) and 2/85 patients (2.4 %) presented with ALT elevation of grade 2 or more in the RAL and ENF arms, respectively (p = 0.21). Grade 2 or more γGT and ALP elevations were seen in 18 and 11 % (p = 0.35), and 5 and 1 % (p = 0.14) of patients in the RAL and ENF arms, respectively. The 48-week incidence of grade 2 or more LEE was 11.6 per 100-pts-years for ALT, 24.5 per 100-pts-years for γ-GT and 4.5 per 100-pts-years for ALP, respectively. In the multivariate analysis, tipranavir/ritonavir use (OR 3.66; 95 % CI [1.20–11.1], p = 0.022) and elevated ALT at baseline (OR 10.3; 95 % CI [2.67–39.6], p < 10
−3
) were significantly associated with a grade 2 or more ALT elevation during follow-up.
Conclusion
The incidence of LEE was relatively high in these highly treatment-experienced patients switching to a RAL-based regimen. Both tipranavir/ritonavir use and high baseline ALT levels were associated with an increased risk of ALT.
Trial registration:
ClinicalTrials.gov identifier: NCT00454337
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V
Subject
/ Alanine Transaminase - blood
/ Chemical and Drug Induced Liver Injury - epidemiology
/ Chemical and Drug Induced Liver Injury - etiology
/ Complications and side effects
/ Drug Substitution - adverse effects
/ Enzymes
/ Female
/ HIV
/ HIV Envelope Protein gp41 - adverse effects
/ HIV Envelope Protein gp41 - therapeutic use
/ HIV Fusion Inhibitors - adverse effects
/ HIV Fusion Inhibitors - therapeutic use
/ HIV Infections - drug therapy
/ HIV Integrase Inhibitors - adverse effects
/ HIV Integrase Inhibitors - therapeutic use
/ Human immunodeficiency virus
/ Humans
/ Liver
/ Male
/ Medicine
/ Peptide Fragments - adverse effects
/ Peptide Fragments - therapeutic use
/ Raltegravir Potassium - adverse effects
/ Raltegravir Potassium - therapeutic use
/ Virology
