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Self-reported antiretroviral adherence: association with maternal viral load suppression in HIV-1-infected postpartum women in Promoting Maternal and Infant Survival Everywhere (PROMISE): randomized, open label trial in sub-Saharan Africa and India

Title
Self-reported antiretroviral adherence: association with maternal viral load suppression in HIV-1-infected postpartum women in Promoting Maternal and Infant Survival Everywhere (PROMISE): randomized, open label trial in sub-Saharan Africa and India
Presenter
Neetal Nevrekar
Authors
N. Nevrekar * (1), K. Butler (2), D.E Shapiro (2), P. Atuhaire (3), T.E Taha (4), B. Makanani (5), L. Chinula (6), M. Owor (3), D. Moodley (7), T. Chipato (8), P.M Flynn (9), J. Currier (10), M.G. Fowler (11), A. Gupta (12), N. Suryavanshi (1)
Institutions
(1) Byramjee Jeejeebhoy Government Medical College - Johns Hopkins University Clinical Research Site, Pune, India, (2) Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, United States, (3) Makerere University - John Hopkins University Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Uganda, (4) Johns Hopkins University, Bloomberg School of Public Health, Baltimore, United States, (5) Blantyre CRS, Blantyre, Malawi, (6) University of Malawi, Department of Obstetrics and Gynecology, Lilongwe, Malawi, (7) Nelson R. Mandela School of Medicine, Durban, South Africa, (8) University of Zimbabwe, Department of Obstetrics and Gynecology, Harare, Zimbabwe, (9) St. Jude Children's Research Hospital, Department of Infectious Diseases, Memphis, United States, (10) UCLA Center for Clinical AIDS Research and Education, Los Angeles, United States, (11) Johns Hopkins University, Departments of Pathology and Epidemiology, Baltimore, United States, (12) School of Medicine, Johns Hopkins University, Baltimore, United States

BACKGROUND: Optimal adherence to antiretroviral therapy (ART) is crucial to promote maternal-infant health. We assessed self-reported adherence to maternal ART (mART) and infant nevirapine (iNVP) and the association of mART adherence with viral load suppression in postpartum women in PROMISE.
METHODS: The PROMISE trial enrolled 2431 postpartum, breastfeeding mother-infant pairs between 2011- 2014 in sub-Saharan Africa and India. Randomization was to mART plus 6 weeks iNVP versus iNVP only prophylaxis until breastfeeding cessation or 18 months postpartum, whichever occurred first. Self-reported adherence, measured through 18 months postpartum across all study visits as dichotomous and continuous measures was assessed in a secondary analysis. Among women in the mART arm, longitudinal time-to-event analyses with the adherence measures as predictors for time to first occurrence of maternal viral load (MVL) '¥400 copies/ml and '¥1000 copies/ml were performed.
RESULTS: There were 1220 women in the mART arm with twice daily protease-inhibitor (LPV/r/TDF/FTC) as the preferred regimen and 1211 in the iNVP arm. Baseline median CD4 was 686 (IQR 553-869) and median MVL was 322 copies/mL (IQR 40-1422). Self-reported adherence was lower in the mART arm compared to the iNVP arm (no missed doses within 4 weeks of all study visits: 65.8% vs 83.3%; within 2 weeks: 70.9% vs 85.2%; P<0.0001 comparing mART versus iNVP for both time periods). The self-reported adherence to iNVP at week 6 was high in both arms: 97% in mART arm; 95% in iNVP arm. In time-to-event analyses, the continuous measurement of self-reported maternal adherence to mART was associated with time to first MVL '¥400 copies/ml (P<0.0001). Missing 1 full day of doses over the past 3 days prior to a study visit was associated with a 58% higher risk of having a MVL '¥400 copies/ml (Hazard ratio (HR): 1.58; 95% CI: 1.33, 1.87) and 66% risk of MVL '¥1000 copies/ml (HR: 1.66; 95% CI: 1.37, 1.99).
CONCLUSIONS: Our data from the PROMISE trial found that postpartum women were more adherent to providing their infants nevirapine than taking ART for themselves. The self-reported missed mART doses reliably predicted high MVL. Strategies to optimize postpartum maternal ART adherence are urgently needed.