Browsing by Author "Makanani, Bonus"

Now showing 1 - 3 of 3
  • Thumbnail Image
    Item
    Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy
    (Journal of acquired immune deficiency syndromes, 2018) Makanani, Bonus; Balkus, Jennifer E.; Jiao, Yuqing; Noguchi, Lisa M.; Palanee-Phillips, Thesla; Mbilizi, Yamikani; Moodley, Jothi; Kintu, Kenneth; Reddy, Krishnaveni; Kabwigu, Samuel; Jeenariain, Nitesha; Harkoo, Ishana; Mgodi, Nyaradzo; Piper, Jeanna; Rees, Helen; Scheckter, Rachel; Beigi, Richard; Baeten, Jared M. ,
    Monthly use of the dapivirine vaginal ring has been shown to be safe and effective for HIV-1 prevention in nonpregnant reproductive-aged women. The impact of dapivirine on pregnancy outcomes and infant is not known. We compared pregnancy incidence and outcomes by study arm among HIV-1–uninfected women who became pregnant while participating in MTN-020/ASPIRE. ASPIRE was a randomized, double-blind, placebocontrolled phase III safety and effectiveness study of the dapivirinering for HIV-1 prevention. Sexually active women aged 18–45 years from Malawi, South Africa, Uganda, and Zimbabwe were enrolled. Urine pregnancy tests were performed monthly, and, if positive, study product was withheld during pregnancy and breastfeeding. Pregnancy-related outcomes included the following: pregnancy incidence, pregnancy outcomes (live birth, preterm birth, pregnancy loss, and congenital anomalies), and infant growth.
  • Thumbnail Image
    Item
    Pregnancy outcomes of women conceiving on antiretroviral therapy (ART) compared to those commenced on ART during pregnancy.
    (Clinical Infectious Diseases, 2021) Theron, Gerhard; Brummel, Sean; Fairlie, Lee; Pinilla, Mauricio; McCarthy, Katie; Owor, Maxensia; Chinula, Lameck; Makanani, Bonus; Violari, Avy; Moodley, Dhayendre; Chakhtoura, Nahida; Browning, Renee; Hoffman, Risa; Glenn Fowler, Mary
    Globally, the number of HIV-infected women of child-bearing age conceiving on ART is increasing. Evidence of ART safety at conception and during pregnancy and adverse pregnancy outcomes remains conflicting. The PROMISE 1077 breastfeeding (BF) and formula feeding (FF) international multisite trials provide an opportunity to examine the impact of ART at conception on pregnancy outcomes with subsequent pregnancies. Methods The PROMISE 1077BF/1077FF trials were designed to address key questions in the management of HIV-infected women who did not meet clinical guidelines for ART treatment during the time of the trials. After the period of risk of mother-to-child transmission was over, women were randomized to either continue or discontinue ART. We compared subsequent pregnancy outcomes of non-breastfeeding women randomized to continue ART following delivery, or breastfeeding women randomized to continue ART following breastfeeding cessation who conceived while on ART to women randomized to discontinue ART, who re-started ART after pregnancy was diagnosed. Results Pregnancy outcomes of 939 subsequent pregnancies of 826 mothers were recorded. The intention-to-treat analyses showed increased incidence of low birth weight (<2500gm) for women who conceived while on ART {relative risk 2.65 (95% CI 1.20, 5.81)}, and also a higher risk of spontaneous abortion, stillbirth, or neonatal death {hazard ratio 1.40 (0.99, 1.98)} compared to women who re-started ART after they were found to be pregnant during trial follow up. Downloaded from https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciaa805/5860458 by guest on 22 June 2020 Accepted Manuscript Conclusions We found an increased risk for adverse pregnancy outcomes in women conceiving on ART emphasising the need for improved obstetric and neonatal care for this group.
  • Thumbnail Image
    Item
    Prevention of HIV-1 transmission through breastfeeding: Efficacy and safety of maternal antiretroviral therapy versus infant nevirapine prophylaxis for duration of breastfeeding in HIV-1-infected women with high CD4 cell count (IMPAACT PROMISE): a randomized, open label, clinical trial
    (Journal of acquired immune deficiency syndromes, 2018) Flynn, Patricia M.; Taha, Taha E.; Cababasay, Mae; Glenn Fowler, Mary; Mofenson, Lynne M.; Owor, Maxensia; Fiscus, Susan; Stranix-Chibanda, Lynda; Coutsoudis, Anna; Gnanashanmugam, Devasena; Chakhtoura, Nahida; McCarthy, Katie; Mukuzunga, Cornelius; Makanani, Bonus; Moodley, Dhayendre; Nematadzira, Teacler; Kusakara, Bangini; Patil, Sandesh; Vhembo, Tichaona; Bobat, Raziya; Mmbaga, Blandina T.; Masenya, Maysseb; Nyati, Mandisa; Theron, Gerhard; Mulenga, Helen; Butler, Kevin; Shapiro, David E.
    No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of mother-to-child transmission throughout the breastfeeding period. Setting—Fourteen sites in sub-Saharan Africa and India. Methods—A randomized, open label strategy trial was conducted in HIV-1-infected women with CD4 counts ≥350 cells/mm3 (or ≥country-specific ART threshold if higher) and their breastfeeding HIV-1-uninfected newborns. Randomization at 6-14 days postpartum was to mART or infant nevirapine prophylaxis (iNVP) continued until 18 months post-delivery or breastfeeding cessation, infant HIV-1 infection, or toxicity, whichever occurred first. The primary efficacy outcome was confirmed infant HIV-1 infection. Efficacy analyses included all randomized mother-infant pairs except those with infant HIV-1 infection at entry. Results—Between June 2011-October 2014, 2431 mother-infant pairs were enrolled; 97% of women were WHO Clinical Stage I, median screening CD4 count 686 cells/mm3. Median infant gestational age/birthweight were 39 weeks/2.9 kilograms. Seven of 1219 (0.57%) and seven of 1211 (0.58%) analyzed infants in the mART and iNVP arms, respectively, were HIV-infected (hazard ratio [HR] 1.0, 96% repeated confidence interval 0.3-3.1); infant HIV-free survival was high (97.1%, mART and 97.7%, iNVP, at 24 months). There were no significant differences between arms in median time to breastfeeding cessation (16 months) or incidence of severe, life-threatening or fatal adverse events for mothers or infants (14 and 42 per 100 person-years, respectively). Conclusion—Both mART and iNVP prophylaxis strategies were safe and associated with very low breastfeeding HIV-1 transmission and high infant HIV-1-free survival at 24 months.