Postpartum viral load rebound in HIV-1-infected women treated with highly active antiretroviral therapy: AIDS Clinical Trials Group Protocol A5150.

TitlePostpartum viral load rebound in HIV-1-infected women treated with highly active antiretroviral therapy: AIDS Clinical Trials Group Protocol A5150.
Publication TypeJournal Article
Year of Publication2011
AuthorsSha BE, Tierney C, Cohn SE, Sun X, Coombs RW, Frenkel LM, Kalams SA, Aweeka FT, Bastow B, Bardeguez A, Kmack A, Stek A
Corporate AuthorsAids Clinical Trials Group ACTG A5150 Team
JournalHIV Clin Trials
Volume12
Issue1
Pagination9-23
Date Published2011 Jan-Feb
ISSN1528-4336
KeywordsAdult, Antiretroviral Therapy, Highly Active, Female, HIV Infections, HIV-1, Humans, Infant, Newborn, Logistic Models, Patient Compliance, Postpartum Period, Pregnancy, Pregnancy Complications, Infectious, Prospective Studies, RNA, Viral, Viral Load
Abstract

BACKGROUND: Pregnancy may lead to increases in HIV-1 RNA levels postpartum. The AIDS Clinical Trials Group (ACTG) A5150 study was designed to characterize the incidence of viral load rebound during the immediate 24 weeks postpartum and explore factors associated with viral load rebound.

METHODS: We enrolled pregnant women in the United States who were ≥13 years of age, between 22 to 30 weeks gestation, and who planned to be on stable highly active antiretroviral therapy (HAART) for ≥8 weeks predelivery and to continue this therapy after delivery for the duration of the study. Choice of antiretrovirals (ARVs) was determined by the primary HIV provider. Viral load rebound was defined as an increase of ≥0.7 log10 (5-fold) from the average of the weeks 34 and 36 gestation viral loads to week 24 postpartum or an absolute increase to ≯500 copies/mL for those with viral load <50 copies/mL.

RESULTS: Eighty-four women enrolled for postpartum follow-up. Sixty-three had follow-up and viral load obtained through week 24 postpartum. Overall, 18/63 (28.6%; 95% confidence interval [CI], 17.9-41.4) met criteria for viral load rebound. Nineteen of the 63 women made changes or discontinued their ARV regimen prior to week 24 postpartum. For those who remained on stable ARVs, rebound occurred in 8/44 (18.2%; 95% CI, 8.2-32.7) compared with 10/19 (52.6%; 95% CI, 28.9-75.5) who did not remain on a stable ARV regimen.

CONCLUSIONS: In the early postpartum period, HIV-1-infected women commonly have increases in viral load. Unplanned changes in ARV regimens and discontinuations of treatment are frequent.

DOI10.1310/hct1201-9
Alternate JournalHIV Clin Trials
PubMed ID21388937
PubMed Central IDPMC3227722
Grant ListAI38855 / AI / NIAID NIH HHS / United States
AI38858 / AI / NIAID NIH HHS / United States
AI68634 / AI / NIAID NIH HHS / United States
AI68636 / AI / NIAID NIH HHS / United States
HHSN267200800001C / HD / NICHD NIH HHS / United States
N01 HD033162 / HD / NICHD NIH HHS / United States
N01 HD033345 / HD / NICHD NIH HHS / United States
P30 AI027763 / AI / NIAID NIH HHS / United States
U01 AI027550-17 / AI / NIAID NIH HHS / United States
U01 AI034853 / AI / NIAID NIH HHS / United States
U01 AI034853-12 / AI / NIAID NIH HHS / United States
U01 AI038855 / AI / NIAID NIH HHS / United States
U01 AI038855-09 / AI / NIAID NIH HHS / United States
U01 AI038858 / AI / NIAID NIH HHS / United States
U01 AI038858-09 / AI / NIAID NIH HHS / United States
U01 AI046376 / AI / NIAID NIH HHS / United States
U01 AI046376-05 / AI / NIAID NIH HHS / United States
U01 AI068634 / AI / NIAID NIH HHS / United States
U01 AI068634-01 / AI / NIAID NIH HHS / United States
U01 AI068636-05 / AI / NIAID NIH HHS / United States
U01 AI069418 / AI / NIAID NIH HHS / United States
U01 AI069418-01 / AI / NIAID NIH HHS / United States
U01 AI069424 / AI / NIAID NIH HHS / United States
U01 AI069424-03 / AI / NIAID NIH HHS / United States
U01 AI069434 / AI / NIAID NIH HHS / United States
U01 AI069434-01 / AI / NIAID NIH HHS / United States
U01 AI069439 / AI / NIAID NIH HHS / United States
U01 AI069439-01 / AI / NIAID NIH HHS / United States
U01 AI069452 / AI / NIAID NIH HHS / United States
U01 AI069452-06 / AI / NIAID NIH HHS / United States
U01 AI069470 / AI / NIAID NIH HHS / United States
U01 AI069470-06 / AI / NIAID NIH HHS / United States
U01 AI069471 / AI / NIAID NIH HHS / United States
U01 AI069471-06 / AI / NIAID NIH HHS / United States
U01 AI069484 / AI / NIAID NIH HHS / United States
U01 AI069484-02 / AI / NIAID NIH HHS / United States
U01 AI069494 / AI / NIAID NIH HHS / United States
U01 AI069494-01 / AI / NIAID NIH HHS / United States
U01 AI069495 / AI / NIAID NIH HHS / United States
U01 AI069495-06 / AI / NIAID NIH HHS / United States
U01 AI069502 / AI / NIAID NIH HHS / United States
U01 AI069502-06 / AI / NIAID NIH HHS / United States
U01 AI069532 / AI / NIAID NIH HHS / United States
U01 AI069532-01 / AI / NIAID NIH HHS / United States
UL1 RR024156 / RR / NCRR NIH HHS / United States
UL1 RR024156-03 / RR / NCRR NIH HHS / United States