TY - JOUR
T1 - Differences in Cumulative Exposure and Adherence to Tenofovir in the VOICE, iPrEx OLE, and PrEP Demo Studies as Determined via Hair Concentrations
AU - on behalf of the MTN-003 Protocol Team
AU - Koss, Catherine A.
AU - Bacchetti, Peter
AU - Hillier, Sharon L.
AU - Livant, Edward
AU - Horng, Howard
AU - Mgodi, Nyaradzo
AU - Mirembe, Brenda G.
AU - Feliciano, Kailazarid Gomez
AU - Horn, Stephanie
AU - Liu, Albert Y.
AU - Glidden, David V.
AU - Grant, Robert M.
AU - Benet, Leslie Z.
AU - Louie, Alexander
AU - Van Der Straten, Ariane
AU - Chirenje, Z. Mike
AU - Marrazzo, Jeanne M.
AU - Gandhi, Monica
AU - Ganesh, Shayhana
AU - Gappoo, Sharika
AU - Jenneker, Marwah
AU - Kadwa, Shahnaaz
AU - Naicker, Vilma
AU - Naidoo, Sarita
AU - Ramjee, Gita
AU - Sookrajh, Yuki
AU - Zako, Linda
AU - Magure, Tsitsi
AU - Mhlanga, Felix
AU - Mngadi, Kathy
AU - Nair, Gonasagrie
AU - Nakabiito, Clemensia
AU - Palanee, Thesla
AU - Mkhize, Baningi
AU - Barnabas, Nomampondo
AU - Gondwe, Daniel K.
AU - Mafumane, Oupa
AU - Nakyanzi, Teopista
AU - Black, Roberta
AU - Sharma, Usha
AU - Estep, Scharla
AU - Soto-Torres, Lydia E.
AU - Forsyth, Andrew D.
AU - Turpin, Jim
AU - Piper, Jeanna
AU - Watts, Heather
AU - Gabelnick, Henry L.
AU - Rooney, James
AU - Bunge, Katherine
AU - Hendrix, Craig
N1 - Publisher Copyright:
© 2017 Mary Ann Liebert, Inc.
PY - 2017/8
Y1 - 2017/8
N2 - Pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) prevented HIV acquisition among men and women in several trials and is broadly recommended. In the VOICE and FEM-PrEP trials, however, TDF/FTC-based PrEP did not prevent HIV acquisition among women in eastern and southern Africa. Tenofovir was detected in plasma, reflecting exposure and adherence in recent days, in fewer than one-third of participants. Drug concentrations in hair, which represent cumulative exposure and adherence over weeks to months, have never previously been examined among women on PrEP. We compared tenofovir hair concentrations among women assigned to oral TDF/FTC in the VOICE trial to those among men and transgender women enrolled in 2 open-label PrEP studies, the iPrEx open-label extension (OLE) study and the U.S. PrEP Demonstration Project (PrEP Demo). Tenofovir hair concentrations were detectable in 55% of person-visits in VOICE, 75% of person-visits in iPrEx OLE (p = .006), and 98% of person-visits in PrEP Demo (p < .001). Median tenofovir hair concentrations corresponded to an estimated 0.2, 2.9, and 6.0 TDF/FTC doses taken per week in the three studies, respectively. In VOICE, combining tenofovir concentration data from plasma and hair suggested inconsistent, low-level product use. Incorporation of both short- and long-term adherence measures may allow for an improved understanding of patterns of drug-taking among women during global PrEP roll-out.
AB - Pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) prevented HIV acquisition among men and women in several trials and is broadly recommended. In the VOICE and FEM-PrEP trials, however, TDF/FTC-based PrEP did not prevent HIV acquisition among women in eastern and southern Africa. Tenofovir was detected in plasma, reflecting exposure and adherence in recent days, in fewer than one-third of participants. Drug concentrations in hair, which represent cumulative exposure and adherence over weeks to months, have never previously been examined among women on PrEP. We compared tenofovir hair concentrations among women assigned to oral TDF/FTC in the VOICE trial to those among men and transgender women enrolled in 2 open-label PrEP studies, the iPrEx open-label extension (OLE) study and the U.S. PrEP Demonstration Project (PrEP Demo). Tenofovir hair concentrations were detectable in 55% of person-visits in VOICE, 75% of person-visits in iPrEx OLE (p = .006), and 98% of person-visits in PrEP Demo (p < .001). Median tenofovir hair concentrations corresponded to an estimated 0.2, 2.9, and 6.0 TDF/FTC doses taken per week in the three studies, respectively. In VOICE, combining tenofovir concentration data from plasma and hair suggested inconsistent, low-level product use. Incorporation of both short- and long-term adherence measures may allow for an improved understanding of patterns of drug-taking among women during global PrEP roll-out.
KW - HIV and women
KW - HIV prevention
KW - adherence monitoring
KW - hair concentrations
KW - plasma concentrations
KW - pre-exposure prophylaxis
UR - http://www.scopus.com/inward/record.url?scp=85026883112&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85026883112&partnerID=8YFLogxK
U2 - 10.1089/aid.2016.0202
DO - 10.1089/aid.2016.0202
M3 - Article
C2 - 28253024
AN - SCOPUS:85026883112
SN - 0889-2229
VL - 33
SP - 778
EP - 783
JO - AIDS research and human retroviruses
JF - AIDS research and human retroviruses
IS - 8
ER -