Time to viral rebound and safety after antiretroviral treatment interruption in postpartum women compared with men

Catherine N. Le, Paula Britto, Sean S. Brummel, Risa M. Hoffman, Jonathan Z. Li, Patricia M. Flynn, Taha E. Taha, Anne Coletti, Mary Glenn Fowler, Ronald J. Bosch, Rajesh T. Gandhi, Karin L. Klingman, James A. McIntyre, Judith S. Currier

Research output: Contribution to journalArticlepeer-review

Abstract

Objective(s):The short-term safety of treatment interruptions, a necessary part of cure studies, is not well established, particularly in women. We explored viral rebound kinetics and safety in a group of postpartum women discontinuing ART and compared results to men in historical interruption trials.Design:Prospective evaluation of time to virologic rebound.Methods:One thousand and seventy-six asymptomatic, virally suppressed, postpartum women living with HIV enrolled in the PROMISE trial with baseline CD4+ cell counts at least 350 cells/μl underwent antiretroviral treatment (ART) discontinuation. Proportion with virologic suppression at weeks 4 and 12 were compared with participants in ACTG treatment interruption trials (91% male population).Results:In PROMISE, using interval censored methods, the estimated median time to HIV viral rebound was 2 weeks. An estimated 6% of women would remain virally suppressed at 30 weeks. Of those who had viral rebound by 30 weeks (N = 993), less than 4% experienced grade 3 or higher laboratory events, and 1% experienced WHO stage 2 or higher clinical events. Overall, less than 1% of participants progressed from WHO Stage 1 to Stage 2 or higher after discontinuation of ART, and 3.9% experienced a decline in CD4+ cell count to less than 350 cells/μl or local treatment guidelines. A significantly higher proportion of women in PROMISE (25.4%) were virologically suppressed (<400 copies/ml) at 12 weeks compared with ACTG NWCS 371 participants (6.4%).Conclusion:Temporary treatment interruptions in healthy, HIV-infected women with high CD4+ cell counts can be well tolerated. Potential sex differences need to be considered in cure studies examining time to virologic rebound.

Original languageEnglish (US)
Pages (from-to)2149-2156
Number of pages8
JournalAIDS
Volume33
Issue number14
DOIs
StatePublished - Nov 15 2019

Keywords

  • HIV-1
  • cure
  • postpartum period
  • reservoir
  • sex differences
  • viral latency
  • women

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

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