MTN-009—Prevalence of HIV-1 Drug Resistance among Women Screening for HIV Prevention Trials: KwaZulu-Natal, South Africa
Urvi Parikh*1, P Kiepiela2, S Ganesh2, K Gomez Feliciano3, S Horn3, K Eskay1, C Kelly4, L Soto-Torres5, G Ramjee2, J Mellors1, on behalf of the MTN-009 Protocol Team
1Univ of Pittsburgh, PA, US; 2South African MRC, Durban; 3FHI 360, Durham, NC, US; 4Statistical Ctr for HIV/AIDS Res & Prevention, Seattle, WA, US; and 5NIAID, NIH, Bethesda, MD, US
Background: A major concern of using 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 drug resistance among such individuals who are potential users of ARV-based prevention products. We therefore evaluated the prevalence of HIV drug resistance among women who screened for HIV prevention trials.
Methods: Cross-sectional study of reproductive-aged women who presented to screen for an HIV prevention trial at 7 clinical sites in Durban, South Africa. CD4+ T cell counts, HIV-1 RNA levels (Abbott M2000), and population sequencing of the protease and reverse transcriptase genes (ViroSeq, Abbott) were performed for all women with 2 positive HIV rapid tests after enrollment into MTN-009.
Results: Of the 1074 women enrolled in MTN-009, 401 (37%) had 2 positive rapid tests for HIV infection. HIV infection was confirmed by EIA or Western blot. Plasma HIV-1 RNA was detectable (>40 copies/mL) in 363 of 401 (91%) and undetectable in 38 of 401 (9%). Of the 390 women with CD4+ T cell counts, 149 women (38%) were eligible for ART (CD4 <350 cells/mm3) and 50 (13%) met criteria for AIDS (CD4<200 copies/mm3 or <14%). Of 299 plasma samples genotyped, 54 (18%) had NRTI, NNRTI, or protease inhibitor (PI) drug resistance mutations. Samples with mutations in RT included K65R (n = 1), L74I (1), A98G (1), K101E/Q (3), K103N (19)/R (6), V106M (3), V108I (3), V179D/E (2), Y181C (2), M184V (4), G190A (1), and K219E/R (2). Samples with PI mutations included L10F/I/V (13), E35G (3), M46L (1), A71T (6), and L89V (1). All participants were infected with subtype C virus.
Conclusions: In women interested in participating in HIV prevention trials, the prevalence of both HIV infection and HIV drug resistance was higher than previous estimates in South Africa. Effective screening to exclude HIV infection and drug resistance among women interested in HIV prevention will be essential in limiting the spread of HIV drug resistance from rollout of ARV-based prevention programs.