HIV disease progression among women following seroconversion during a tenofovirbased HIV prevention trial
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Date
2017
Journal Title
Journal ISSN
Volume Title
Publisher
PLoS ONE
Abstract
Little is known regarding HIV disease outcomes among individuals who become infected
with HIV while receiving antiretroviral medications for prevention. We compared HIV disease
parameters among women who seroconverted while receiving tenofovir-containing
oral or vaginal pre-exposure prophylaxis (PrEP) to placebo.
Methods
Participants with HIV seroconversion in a randomized placebo-controlled trial of oral tenofovir,
oral tenofovir/emtricitabine, and vaginal tenofovir gel (MTN-003) were followed in a longitudinal
cohort study (MTN-015). The effect of oral and vaginal tenofovir-containing PrEP on
HIV disease progression was compared to placebo using linear mixed effects and Cox proportional
hazard models, as appropriate. Additional analyses were performed to compare
the outcomes among participants with detectable tenofovir or emtricitabine in plasma at the
first quarterly visit in MTN-003.
Results
A total of 224 participants were included in the analysis; 93% from South Africa and 94%
clade C virus. No differences in HIV RNA at steady state or the trajectory over 12 months
were observed for each active arm compared to placebo; tenofovir gel recipients had higher CD4+ T cell counts (722 vs 596 cells/mm3; p = 0.02) at 90 days after estimated HIV seroconversion
and higher average rates of change over 12 months compared to placebo (-181 vs
-92 cells/mm3 per year; p = 0.08). With a median follow-up of 31 months, no significant differences
were observed for time to CD4+ T cell count 350 cells/mm3, or the composite
endpoint of CD4+ T cells 350 cells/mm3, initiation of antiretroviral therapy or death for each
active arm compared to placebo. Additionally, there were no significant differences in the
HIV RNA or CD4+ T cell counts at baseline, the change to month 12, or any disease progression
outcomes among participants with oral drug detected and no oral drug detected
compared to placebo.
Conclusions
No clinically significant differences in HIV seroconversion outcomes were observed among
women randomized to tenofovir-containing oral or vaginal PrEP regimens, however low
overall adherence limits the generalizability of these findings.
Description
Keywords
HIV disease, Women, Seroconversion, Tenofovirbased
Citation
Riddler SA, Husnik M, Ramjee G, Premrajh A, Tutshana BO, Pather A, et al. (2017) HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS ONE 12(6): e0178594. https://doi.org/10.1371/journal.pone.0178594