Postpartum Viral Load Rebound in HIV-1–Infected Women Treated with Highly Active Antiretroviral Therapy: AIDS Clinical Trials Group Protocol A5150

Section of Infectious Diseases, Rush University Medical Center, Chicago, IL, USA.
HIV Clinical Trials (Impact Factor: 2.63). 01/2011; 12(1):9-23. DOI: 10.1310/hct1201-9
Source: PubMed


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.
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.
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.
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.

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Available from: Susan E Cohn, Mar 14, 2014
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    • "PrEP effectiveness is highly dependent on adherence,7,8,21–23 and PrEP efficacy trials offer an early opportunity to identify populations for whom medication adherence may be challenging. Women who desire children might adhere to prevention strategies to protect a potential child from acquiring HIV-14,24–26 or, alternatively, may not adhere out of fear of side effects, including effects on the fetus. Understanding PrEP adherence in the context of conception is important given the potential of periconception PrEP as an HIV-1 risk-reduction strategy.10–12,27 "
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    ABSTRACT: Introduction: Pre-exposure prophylaxis (PrEP) may be an important safer conception strategy for HIV-1–uninfected women with HIV-1–infected partners. Understanding medication adherence in this population may inform whether PrEP is a feasible safer conception strategy. Methods: We evaluated predictors of pregnancy and adherence to study medication among HIV-1–uninfected women enrolled in a randomized placebo-controlled trial of PrEP among African HIV-1–serodiscordant couples. Participants were counseled on HIV-1 risk reduction, contraception, and adherence and tested for pregnancy at monthly study visits. Pill counts of dispensed drug were performed and, at a subset of visits, plasma was collected to measure active drug concentration. Results: Among 1785 women, pregnancy incidence was 10.2 per 100 person-years. Younger age, not using contraception, having an additional sexual partner, and reporting unprotected sex were associated with increased likelihood of pregnancy. Monthly clinic pill counts estimated that women experiencing pregnancy took 97% of prescribed doses overall, with at least 80% pill adherence for 98% of study months, and no difference in adherence in the periconception period compared with previous periods (P = 0.98). Tenofovir was detected in plasma at 71% of visits where pregnancy was discovered. By multiple measures, adherence was similar for women experiencing and not experiencing pregnancy (P ≥ 0.1). Conclusions: In this clinical trial of PrEP, pregnancy incidence was 10% per year despite excellent access to effective contraception. Women experiencing pregnancy had high medication adherence, suggesting that PrEP may be an acceptable and feasible safer conception strategy for HIV-1–uninfected women with HIV-1–serodiscordant partners.
    JAIDS Journal of Acquired Immune Deficiency Syndromes 09/2014; 67(1):91-97. DOI:10.1097/QAI.0000000000000246 · 4.56 Impact Factor
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    • "Our work shows similar incidence rates by age category: Myer et al. reported a rate of 11.5 (95% CL 9.4, 14.0) per 100 person-years among women under age 25 and on antiretroviral therapy; we reported a rate of 10.4 (8.2, 13.3) per 100 person-years. The relatively high rates of pregnancy seen here, taken in context with recent results suggesting that pregnancy during HAART is associated with increased rates of virologic failure [11, 19], point to the need to better integrate reproductive healthcare services with provision of antiretroviral therapy. "
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    ABSTRACT: Little is known about rates of incident pregnancy among HIV-positive women initiating highly active antiretroviral therapy (HAART). We conducted a retrospective clinical cohort study among therapy-naïve women ages 18-45 initiating HAART between 1 April 2004 and 30 September 2009 at an adult HAART clinic in Johannesburg, South Africa. We used Poisson regression to characterize rates and rate ratios of pregnancy. We evaluated 5,996 women who experienced 727 pregnancies during 14,095 person-years at risk. The overall rate of pregnancy was 5.2 per 100 person-years (95% confidence limits [CL] 4.8, 5.5). By six years, cumulative incidence of first pregnancy was 22.9% (95% CL 20.6%, 25.4%); among women ages 18-25 at HAART initiation, cumulative incidence was 52.2% (95% CL 35.0%, 71.8%). The strongest predictor of incidence of pregnancy was age, with women 18-25 having 13.2 times the rate of pregnancy of women ages 40-45 in adjusted analysis. CD4 counts below 100 and worse adherence to HAART were associated with lower rates of incident pregnancy. Women experience high rates of incident pregnancy after HAART initiation. Understanding which women are most likely to experience pregnancy will help planning and future efforts to understand the implications of pregnancy for response to HAART.
    Infectious Diseases in Obstetrics and Gynecology 06/2012; 2012:917059. DOI:10.1155/2012/917059
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    ABSTRACT: Although women of reproductive age are the largest group of HIV-infected individuals in sub-Saharan Africa, little is known about the impact of pregnancy on response to highly active antiretroviral therapy (HAART) in that setting. We examined the effect of incident pregnancy after HAART initiation on virologic response to HAART. We evaluated a prospective clinical cohort of adult women who initiated HAART in Johannesburg, South Africa between 1 April 2004 and 30 September 2009, and followed up until an event, death, transfer, drop-out, or administrative end of follow-up on 31 March 2010. Women over age 45 and women who were pregnant at HAART initiation were excluded from the study; final sample size for analysis was 5,494 women. Main exposure was incident pregnancy, experienced by 541 women; main outcome was virologic failure, defined as a failure to suppress virus to ≤ 400 copies/ml by six months or virologic rebound >400 copies/ml thereafter. We calculated adjusted hazard ratios using marginal structural Cox proportional hazards models and weighted lifetable analysis to calculate adjusted five-year risk differences. The weighted hazard ratio for the effect of pregnancy on time to virologic failure was 1.34 (95% confidence limit [CL] 1.02, 1.78). Sensitivity analyses generally confirmed these main results. Incident pregnancy after HAART initiation was associated with modest increases in both relative and absolute risks of virologic failure, although uncontrolled confounding cannot be ruled out. Nonetheless, these results reinforce that family planning is an essential part of care for HIV-positive women in sub-Saharan Africa. More work is needed to confirm these findings and to explore specific etiologic pathways by which such effects may operate.
    PLoS ONE 08/2011; 6(8):e22778. DOI:10.1371/journal.pone.0022778 · 3.23 Impact Factor
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