Comparable HIV suppression by pegylated-IFN-α2a or pegylated-IFN-α2b during a 4-week analytical treatment interruption

Abstract

We report on the post-hoc analysis of three clinical studies (NCT01935089, NCT00594880 and NCT00051818) with chronically HIV-infected, immune-reconstituted individuals with similar entry criteria, and demographics interrupting antiretroviral therapy (ART) without or with 5 weeks of weekly pegylated (Peg)-IFN-α2b or Peg-IFN-α2a immunotherapy added onto ART. Results show similar rates of viral suppression between both immunotherapies when continued during a 4-week ART interruption, despite Peg-IFN-α2a maintaining significantly higher trough blood levels.

Conflict of interest statement

Conflicts of Interest

The authors declare that they do not have a commercial or other association that might pose a conflict of interest.

Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

Figures

Fig. 1.. Effect of Peg-IFN-α2b and Peg-IFN-α2a on HIV-1 RNA and plasma IFN-α levels.

(a) Time points from clinical trials NCT00594880, NCT01935089 and NCT00051818 used in the current retrospective analysis; (b) Frequency of individuals based on HIV RNA copies/ml after a 4-week analytical treatment interruption (ATI) in participants of the NCT00051818, NCT00594880, and NCT01935089 clinical trials; (c) Plasma levels of IFN-α during 5 weeks of in vivo treatment with Peg-IFN-α2a+ART or Peg-IFN-α2b+ART for participants of the NCT00594880, and NCT01935089 clinical trials. In panel (a) treatment is represented by blue boxes [antiretroviral therapy (ART)], green boxes [combined administration of ART and pegylated interferon alfa-2a (Peg-IFN-α2a) or Peg-IFN-α2b], orange boxes (ATI, Peg-IFN-α2a or Peg-IFN-α2b monotherapy) or pink boxes (ATI, no IFN-α immunotherapy); Blue arrows indicate time points used for data and cryopreserved plasma sample analysis that are shown in panels (b) and (c). In panel (b) blue and orange boxes illustrate frequency of individuals with HIV RNA ≥50 copies/ml and <50 copies/ml respectively after a 4-week ATI. In panel (c) available data for study participants are shown at baseline (Baseline: ART) and after 5 weeks of combined administration of ART and Peg-IFN-α2a or Peg-IFN-α2b together with the median and interquartile range, and significant P values. Statistics were performed with JMP Pro11 (SAS Institute, Cary, NC). In panel (b) Chi-Square tests were used to test the whether there was a difference in the frequency of participants with plasma HIV-1 RNA <50 copies/ml at the end of a 4-week ATI among the NCT01935089 (Peg-IFN-α2b as immunotherapy), the NCT00594880 (Peg-IFN-α2a as immunotherapy), and the NCT00051818 (ATI without immunotherapy) clinical trials. In panel (c) differences between baseline and 5 weeks of combined administration of ART and Peg-IFN-α2a or Peg-IFN-α2b were tested, using Wilcoxon Signed-Rank or paired t-tests depending on data distribution.