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J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S149-S155. doi: 10.1097/QAI.0000000000001368.

Viral Suppression and HIV Drug Resistance at 6 Months Among Women in Malawi's Option B+ Program: Results From the PURE Malawi Study.

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*University of North Carolina Project, Lilongwe, Malawi; †Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC; ‡Department of Microbiology, University of North Carolina School of Medicine, Chapel Hill, NC; §Lighthouse Trust, Lilongwe, Malawi; ‖Dignitas International, Zomba, Malawi; ¶Malaria Alert Centre, College of Medicine, University of Malawi, Blantyre, Malawi; #Lineberger Cancer Center, University of North Carolina School of Medicine, Chapel Hill, NC; **Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; ††The International Union Against Tuberculosis and Lung Disease, Paris, France; ‡‡Mothers2Mothers, Lilongwe, Malawi; §§Management Sciences for Health, Lilongwe, Malawi; ‖‖Department of HIV and AIDS, Ministry of Health, Lilongwe, Malawi; ¶¶Department of Economics, Chancellor College, University of Malawi, Zomba, Malawi; and ##Department of Public Health, School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.



In 2011, Malawi launched Option B+, a program of universal antiretroviral therapy (ART) treatment for pregnant and lactating women to optimize maternal health and prevent pediatric HIV infection. For optimal outcomes, women need to achieve HIVRNA suppression. We report 6-month HIVRNA suppression and HIV drug resistance in the PURE study.


PURE study was a cluster-randomized controlled trial evaluating 3 strategies for promoting uptake and retention; arm 1: Standard of Care, arm 2: Facility Peer Support, and arm 3: Community Peer support. Pregnant and breastfeeding mothers were enrolled and followed according to Malawi ART guidelines. Dried blood spots for HIVRNA testing were collected at 6 months. Samples with ART failure (HIVRNA ≥1000 copies/ml) had resistance testing. We calculated odds ratios for ART failure using generalized estimating equations with a logit link and binomial distribution.


We enrolled 1269 women across 21 sites in Southern and Central Malawi. Most enrolled while pregnant (86%) and were WHO stage 1 (95%). At 6 months, 950/1269 (75%) were retained; 833/950 (88%) had HIVRNA testing conducted, and 699/833 (84%) were suppressed. Among those with HIVRNA ≥1000 copies/ml with successful amplification (N = 55, 41% of all viral loads > 1000 copies/ml), confirmed HIV resistance was found in 35% (19/55), primarily to the nonnucleoside reverse transcriptase inhibitor class of drugs. ART failure was associated with treatment default but not study arm, age, WHO stage, or breastfeeding status.


Virologic suppression at 6 months was <90% target, but the observed confirmed resistance rates suggest that adherence support should be the primary approach for early failure in option B+.


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