Detectable Viral Load in Late Pregnancy among Women in the Rwanda Option B+ PMTCT Program: Enrollment Results from the Kabeho Study.

Michelle M Gill,Gilles F Ndayisaba,Heather J Hoffman,Placidie Mugwaneza,Dieudonne Ndatimana,Heather J Hoffman,Emily A Bobrow,Laura Guay,Cyprien Baribwira,Anita Asiimwe,Laura Guay,Laura Guay,Jason Blackard

doi:10.1371/journal.pone.0168671

Abstract

There are limited viral load (VL) data available from programs implementing “Option B+,” lifelong antiretroviral treatment (ART) to all HIV-positive pregnant and postpartum women, in resource-limited settings. Extent of viral suppression from a prevention of mother-to-child transmission of HIV program in Rwanda was assessed among women enrolled in the Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV (Kabeho) Study. ARV drug resistance testing was conducted on women with VL>2000 copies/ml. In April 2013-January 2014, 608 pregnant or early postpartum HIV-positive women were enrolled in 14 facilities. Factors associated with detectable enrollment VL (>20 copies/ml) were examined using generalized estimating equations. The most common antiretroviral regimen (56.7%, 344/607) was tenofovir/lamivudine/efavirenz. Median ART duration was 13.5 months (IQR 3.0–48.8); 76.1% of women were on ART at first antenatal visit. Half of women (315/603) had undetectable RNA-PCR VL and 84.6% (510) had <1,000 copies/ml. Detectable VL increased among those on ART > 36 months compared to those on ART 4–36 months (72/191, 37.7% versus 56/187, 29.9%), though the difference was not significant. The odds of having detectable enrollment VL decreased significantly as duration on ART at enrollment increased (AOR = 0.99, 95% CI: 0.9857, 0.9998, p = 0.043). There was a higher likelihood of detectable VL for women with lower gravidity (AOR = 0.90, 95% CI: 0.84, 0.97, p = 0.0039), no education (AOR = 2.25, (95% CI: 1.37, 3.70, p = 0.0004), nondisclosure to partner (AOR = 1.97, 95% CI: 1.21, 3.21, p = 0.0063) and side effects (AOR = 2.63, 95% CI: 1.72, 4.03, p<0.0001). ARV drug resistance mutations were detected in all of the eleven women on ART > 36 months with genotyping available. Most women were receiving ART at first antenatal visit, with relatively high viral suppression rates. Shorter ART duration was associated with higher VL, with a concerning increasing trend for higher viremia and drug resistance among women on ART for >3 years.

Highlights

In April 2012, the Rwandan government initiated a policy of lifelong antiretroviral therapy (ART) for all HIV-infected pregnant women for prevention of mother-to-child transmission (PMTCT) regardless of CD4 count or clinical status
This study allows for an assessment of the extent of viral suppression during pregnancy in women who received ART prior to or during pregnancy, with many women already receiving ART at their first antenatal care (ANC) visit. We present these results from women at the time of study enrollment, with an examination of factors associated with detectable maternal viral load (VL) in late pregnancy or early postpartum
Detectable VL was associated with a shorter duration of ART

Summary

Introduction

In April 2012, the Rwandan government initiated a policy of lifelong antiretroviral therapy (ART) for all HIV-infected pregnant women for prevention of mother-to-child transmission (PMTCT) regardless of CD4 count or clinical status ( known as Option B+). In 2013, the World Health Organization consolidated antiretroviral (ARV) guidelines endorsed this approach, in HIV-endemic resource-limited settings [1] These guidelines promoted the use of viral load (VL) testing as the preferred approach to monitoring ART and identifying treatment failure, recommending testing six months after starting ART and every 12 months thereafter. Per Rwandan national guidelines, pregnant women entering the PMTCT program have a VL test performed every 12 months [2] Studies in both resource-rich and resource-limited countries have demonstrated a link between duration of ART and risk of infant transmission in HIV-infected pregnant women [3,4,5], with the lowest rates of transmission observed among women starting ART preconception or early in the first trimester and having undetectable VL at delivery [5,6,7]. Factors associated with detectable VL at delivery included higher VL levels at ART initiation,

Methods

Results

Conclusion