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.
Prospective evaluation of time to virologic rebound.
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).
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%).
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.
aUniversity of California Los Angeles, Los Angeles, California
bHarvard T.H. Chan School of Public Health
cBrigham and Women's Hospital, Boston, Massachusetts
dSt. Jude Children's Research Hospital, Memphis, Tennessee
eJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
fFHI 360, Durham, North Carolina
gJohns Hopkins U. School of Medicine, Baltimore, Maryland
hMassachusetts General Hospital and Ragon Institute, Harvard Medical School, Boston, Massachusetts
iDAIDS, NIAID, Bethesda, Maryland, USA
jAnova Health Institute, Johannesburg
kSchool of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.
Correspondence to Catherine N. Le, MD, University of California Los Angeles, 8635 W Third Street, Suite 465W, Los Angeles, CA 90048, USA. E-mail: firstname.lastname@example.org
Received 24 April, 2019
Revised 24 June, 2019
Accepted 27 June, 2019
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