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Genital secretion HIV RNA shedding in HIV-positive patients on ritonavir-boosted protease inhibitor monotherapy or standard combination ART: a cross-sectional sub-study from the PIVOT Trial

Arenas-Pinto, A; Stöhr, W; Khoo, S; Clarke, A; Beeching, N; Warwick, Z; Lee, V; ... Protease Inhibitor monotherapy Versus Ongoing Triple therapy (PI; + view all (2020) Genital secretion HIV RNA shedding in HIV-positive patients on ritonavir-boosted protease inhibitor monotherapy or standard combination ART: a cross-sectional sub-study from the PIVOT Trial. Antiviral Therapy 10.3851/IMP3340. (In press). Green open access

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Abstract

BACKGROUND: Protease inhibitors (PI) have relatively low penetration into the genital tract, raising concerns about the potential for genital HIV-RNA shedding in patients taking PI-based regimens, particularly PI monotherapy (PImono). METHODS: We measured HIV-RNA and PI drug concentrations in samples of semen; cervico-vaginal and rectal mucosa secretions; and plasma in patients after 48-96 weeks on PImono or standard triple therapy. RESULTS: A total of 85 participants were recruited. Of the 43 participants on PImono (70% on Darunavir (DRV)/ritonavir (r)), 3 had detectable virus in semen or vaginal secretions (all below quantification limit), and none in rectal mucosa or plasma. Among those taking triple therapy, 5 had detectable virus in semen or vaginal secretions (HIV-RNA >50 copies/ml in one), none in rectal mucosa, and one in plasma. The median (IQR) concentration of darunavir and atazanavir in semen (659.7 (339 - 1089) and 128.8 (63 - 368) ng/mL respectively) and cervico-vaginal samples (2768 (312 - 7879) and 1836 (359 - 3314) ng/mL respectively) exceeded their protein adjusted median inhibition concentration (MIC50). Darunavir (DRV) concentration in rectal secretions showed higher variability compared to concentration in the other sites, with particularly high rectal secretion/blood ratios (median 8.4; IQR 2.6 - 68.7:1). CONCLUSIONS: We found no substantive evidence of HIV shedding in patients taking PI monotherapy, suggesting that protease inhibitors provide adequate control of virus in the genital compartment and are unlikely to lead to ongoing sexual transmission.

Type: Article
Title: Genital secretion HIV RNA shedding in HIV-positive patients on ritonavir-boosted protease inhibitor monotherapy or standard combination ART: a cross-sectional sub-study from the PIVOT Trial
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.3851/IMP3340
Publisher version: https://doi.org/10.3851/IMP3340
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health > Infection and Population Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Infection, Immunity and Inflammation Dept
URI: https://discovery.ucl.ac.uk/id/eprint/10094616
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