Abstract
BackgroundA major concern with using antiretroviral (ARV)-based products for HIV prevention is the potential spread of drug resistance, particularly from individuals who are HIV-infected but unaware of their status. Limited data exist on the prevalence of HIV infection or drug resistance among potential users of ARV-based prevention products.MethodsA cross-sectional study of reproductive-aged women who presented to screen for an HIV prevention trial was conducted at 7 clinical sites in Durban, South Africa. CD4+T cell counts, HIV-1 RNA levels and population sequencing of the protease and reverse transcriptase genes were performed for all women with 2 positive HIV rapid tests. Resistance mutations were identified using the Stanford Calibrated Population Resistance Tool.ResultsOf the 1073 evaluable women, 400(37%) were confirmed as HIV-infected. Of those, plasma HIV-1 RNA was detectable in 365/400(91%) and undetectable(<40 copies/ml) in 35/400(9%) women. 156 women(39%) were eligible for antiretroviral therapy (CD4+T cell counts<350 cells/mm3) and 50(13%) met criteria for AIDS(CD4<200 cells/mm3). Of 352 plasma samples(>200 copies/ml) analyzed for drug resistance, 26(7.4%) had nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) drug resistance mutations. Among those with resistance, 18/26 participants(62%) had single-class NNRTI resistance and 5/26(19%) had dual-class NRTI/NNRTI. Major mutations in reverse transcriptase included K65R(n = 1), L74I(n = 1), K103N(n = 19), V106M(n = 4), Y181C(n = 2), M184V(n = 4), and K219E/R(n = 2). Major PI-resistance mutations were rare: M46L(n = 1) and I85V(n = 1). All participants were infected with subtype C virus, except one infected with subtype A.ConclusionsIn women from Durban, South Africa screening for an HIV prevention trial, the HIV prevalence was high (37%) and HIV drug resistance prevalence was above 5%. This study highlights the potential challenges faced when implementing an ARV-based prevention product that overlaps with first-line antiretroviral therapy. Effective screening to exclude HIV infection among women interested in uptake of ARV-based HIV prevention will be essential in limiting the spread of ARV resistance.
Highlights
Women are disproportionately burdened by human immunodeficiency virus (HIV) infection, in sub-Saharan Africa, where approximately three-quarters of new HIV-1 infections are in young women aged 15–24 years [1,2]
The 5 cases of resistance that have occurred in a total of 172 seroconverters from the use of tenofovir-based pre-exposure prophylaxis (PrEP) have been from participants on active antiretroviral (ARV) arms who enrolled during the acute phase of infection: 0/35 in the TFV gel arm in CAPRISA-004 [7]; 2/36 in the oral tenofovir disoproxil fumarate (TDF)-FTC arm in iPrEX [8], 1/9 in the TDF2 study [9], and 2/92 from the Partners in PrEP serodiscordant couple study, where 1 case occurred in the TDF arm, and 1 case occurred in the TDF-FTC arm [10]
MTN-009 is the first study to evaluate the prevalence of HIV infection and the proportion of drug-resistant infection in a population of women screening for participation in an ARV-based HIV prevention trial
Summary
Women are disproportionately burdened by human immunodeficiency virus (HIV) infection, in sub-Saharan Africa, where approximately three-quarters of new HIV-1 infections are in young women aged 15–24 years [1,2]. Some women who present to the clinic intending to participate in an HIV-prevention trial discover they are HIV positive or already have knowledge of their status but still seek HIV prevention products or trial participation for other reasons [4] This group of women is critical to understand both from a virologic and behavioral perspective because the future success and large scale implementation of an ARV product for HIV prevention largely depends on targeting the appropriate population for its use. A major concern with using antiretroviral (ARV)-based products for HIV prevention is the potential spread of drug resistance, from individuals who are HIV-infected but unaware of their status. Limited data exist on the prevalence of HIV infection or drug resistance among potential users of ARV-based prevention products
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