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Randomized Controlled Trial
. 2017 Jun 1;75 Suppl 2(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

Mina Hosseinipour  1 , Julie A E Nelson, Clement Trapence, Sarah E Rutstein, Florence Kasende, Virginia Kayoyo, Blessings Kaunda-Khangamwa, Kara Compliment, Christopher Stanley, Fabian Cataldo, Monique van Lettow, Nora E Rosenberg, Hannock Tweya, Salem Gugsa, Veena Sampathkumar, Erik Schouten, Michael Eliya, Frank Chimbwandira, Levison Chiwaula, Atupele Kapito-Tembo, Sam Phiri; PURE Malawi Consortium
Affiliations
Randomized Controlled Trial

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

Mina Hosseinipour et al. J Acquir Immune Defic Syndr. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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+.

Trial registration: ClinicalTrials.gov NCT02005835.

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Conflict of interest statement

Conflict of Interest: The authors declare no conflict of interest

Figures

Figure 1
Figure 1
Flow Algorithm highlighting participant and sample flow to evaluate HIV drug resistance.
Figure 2
Figure 2
HIV drug resistance prevention outcomes at 6 months according to study arm. HIV viral suppression (Resistance prevention) was higher in Arm 2 and Arm 3.
See this image and copyright information in PMC

References

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