Browsing by Author "Saidi, Friday"

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial
    (Journal of acquired immune deficiency syndromes, 2019) Sebikari, Dorothy; Farhad, Mona; Fenton, Terry; Owor, Maxensia; Stringer, Jeffrey S. A.; Qin, Min; Chakhtoura, Nahida; Chi, Benjamin H.; Saidi, Friday; Nevrekar, Neetal; Violari, Avy; Chipato, Tsungai; McIntyre, James A.; Moodley, Dhayendre; Taha, Taha E.; Theron, Gerhard; Glenn Fowler, Mary
    In the multi-country PROMISE 1077BF trial, the risk of low birth weight (LBW; <2500g) and preterm delivery (PTD; <37 weeks) was higher among women initiating a protease inhibitor (PI)-based antiretroviral treatment (ART) regimen than in those receiving ZDV alone. Among those assigned to a PI regimen, tenofovir/emtricitibine was associated with the more severe outcomes of very LBW (VLBW; <1500g) and very PTD (VPTD; <34 weeks) compared to zidovudine/lamivudine. Methods: We used multivariate logistic regression to further explore treatment findings, taking into account demographic baseline clinical and post-entry obstetrical factors. We evaluated individual adverse outcomes and composites that included stillbirth and early loss/spontaneous abortion. Results: Among 3333 women delivering at least one live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least one prior PTD. Seventeen percent of newborns were LBW, 1% were VLBW, 17% had PTD, and 3% VPTD. Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone. Other risk factors remaining significant in at least one of the multivariate models included: country, gestational age at entry, maternal age, maternal BMI, prior PTD, history of alcohol use, baseline HIV viral titer, multiple gestation and several obstetric risk factors. Conclusion: ART effects on adverse pregnancy outcomes reported in the randomized PROMISE trial remained strongly significant even after controlling for demographic, baseline clinical and obstetrical risk factors, which were also associated with these outcomes.
  • Thumbnail Image
    Item
    Tenofovir concentrations in hair strongly predict virologic suppression in breastfeeding women
    (AIDS (London, England), 2019) Murnane, Pamela M.; Bacchetti, Peter; Currier, Judith S.; Brummel, Sean; Okochi, Hideaki; Phung, Nhi; Louie, Alexander; Kuncze, Karen; Hoffman, Risa M.; Nematadzira, Teacler; Soko, Dean K.; Owor, Maxensia; Saidi, Friday; Flynn, Patricia M.; Glenn Fowler, Mary; Gandhi, Monica
    Antiretroviral treatment (ART) adherence is often suboptimal in the perinatal period. We measured hair tenofovir (TFV) concentrations as a metric of adherence in postpartum women to understand patterns and predictors of adherence throughout this critical period. Additionally, we examined the association between hair TFV concentrations and virologic outcomes. Methods: Between 12/2012–09/2016, hair samples were collected longitudinally from delivery through breastfeeding from women on ART in the PROMISE study (NCT01061151) in sub-Saharan Africa. Hair TFV levels were measured using validated methods. Using generalized estimating equations, we estimated the association between hair TFV levels and virologic suppression (<400 copies/mL) over time and assessed predictors of hair TFV levels. Results: Hair TFV levels were measured at 370 visits in 71 women from delivery through a median of 14 months (IQR 12–15) of breastfeeding. Levels ranged from below detection (0.002) to 1.067 nanograms/milligram (geometric mean: 0.047). After ≥90 days on ART, 69 women had at least one viral load measured (median 5 measures, range 1–9); 18 (26%) experienced viremia at least once. Each doubling of TFV level more than doubled odds of concurrent virologic suppression (OR 2.35, 95%CI: 1.44–3.84, p=0.0006) and was associated with 1.43 times the odds of future suppression (95%CI: 0.75–2.73, p=0.28). Relative to the first 3 months after delivery, hair levels were highest in months 6–12 (1.42 fold higher, 95%CI: 1.09–1.85, p=0.01). Conclusion: Hair TFV levels strongly predicted concurrent virologic suppression among breastfeeding women. Objective adherence metrics can supplement virologic monitoring to optimize treatment outcomes in this important transition period.