TY - JOUR
T1 - Tenofovir gel for prevention of herpes simplex virus type 2 acquisition
T2 - Findings from the VOICE trial
AU - for the VOICE Study Team
AU - Marrazzo, Jeanne M.
AU - Rabe, Lorna
AU - Kelly, Cliff
AU - Richardson, Barbra
AU - Deal, Carolyn
AU - Schwartz, Jill L.
AU - Chirenje, Z. M.
AU - Piper, Jeanna
AU - Morrow, Rhoda Ashley
AU - Hendrix, Craig W.
AU - Marzinke, Mark A.
AU - Hillier, Sharon L.
N1 - Publisher Copyright:
© 2019 The Author(s).
PY - 2019/6/1
Y1 - 2019/6/1
N2 - Background. Genital infection with herpes simplex virus type 2 (HSV-2) is common and increases risk of human immunodeficiency virus (HIV) transmission and acquisition. Pericoital use of tenofovir (TFV) gel provided protection from HSV-2 acquisition in the CAPRISA 004 study. Methods. We measured estimate of effect of vaginal TFV 1% gel in preventing HSV-2 acquisition among women in VOICE, randomized, double-blinded, placebo-controlled trial assessing daily use of oral and vaginal TFV for HIV-1 preexposure prophylaxis. The TFV level in plasma at the first quarterly visit was used as a measure of gel use. Results. Of 566 participants at risk for HSV-2 acquisition, 532 (94%) had first-quarter plasma TFV and end-of-study HSV-2 serologic data available. Over a follow-up period of 501 person-years, 92 incident cases of HSV-2 acquisition occurred: 77 were in women with no TFV detected in plasma, and 15 occurred in women with TFV detected in plasma (incidence, 20.6 cases/100 personyears [95% confidence interval [CI], 16.2-25.7] vs 11.9 cases/100 person-years [95% CI, 6.6-19.6], respectively). TFV detection in plasma was associated with a trend toward a reduced risk of HSV-2 seroconversion, with an unadjusted hazard ratio (HR) of 0.59 (95% CI,.34-1.02; P =.060) and a HR adjusted for site, age, having ≥2 male sex partners in the past 3 months, use of hormonal contraception, having anal sex in the past 3 months, and HIV status of 0.60 (95% CI,.33-1.08; P =.086). Conclusions. Detection of TFV in plasma among TFV gel users was associated with a trend toward a reduced risk of HSV-2 acquisition, after controlling for sexual behavior and HIV-1 acquisition.
AB - Background. Genital infection with herpes simplex virus type 2 (HSV-2) is common and increases risk of human immunodeficiency virus (HIV) transmission and acquisition. Pericoital use of tenofovir (TFV) gel provided protection from HSV-2 acquisition in the CAPRISA 004 study. Methods. We measured estimate of effect of vaginal TFV 1% gel in preventing HSV-2 acquisition among women in VOICE, randomized, double-blinded, placebo-controlled trial assessing daily use of oral and vaginal TFV for HIV-1 preexposure prophylaxis. The TFV level in plasma at the first quarterly visit was used as a measure of gel use. Results. Of 566 participants at risk for HSV-2 acquisition, 532 (94%) had first-quarter plasma TFV and end-of-study HSV-2 serologic data available. Over a follow-up period of 501 person-years, 92 incident cases of HSV-2 acquisition occurred: 77 were in women with no TFV detected in plasma, and 15 occurred in women with TFV detected in plasma (incidence, 20.6 cases/100 personyears [95% confidence interval [CI], 16.2-25.7] vs 11.9 cases/100 person-years [95% CI, 6.6-19.6], respectively). TFV detection in plasma was associated with a trend toward a reduced risk of HSV-2 seroconversion, with an unadjusted hazard ratio (HR) of 0.59 (95% CI,.34-1.02; P =.060) and a HR adjusted for site, age, having ≥2 male sex partners in the past 3 months, use of hormonal contraception, having anal sex in the past 3 months, and HIV status of 0.60 (95% CI,.33-1.08; P =.086). Conclusions. Detection of TFV in plasma among TFV gel users was associated with a trend toward a reduced risk of HSV-2 acquisition, after controlling for sexual behavior and HIV-1 acquisition.
KW - Genital herpes
KW - HIV-1
KW - Herpes simplex virus
KW - Preexposure prophylaxis
KW - Tenofovir
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U2 - 10.1093/infdis/jiz045
DO - 10.1093/infdis/jiz045
M3 - Article
C2 - 30753642
AN - SCOPUS:85066925796
SN - 0022-1899
VL - 219
SP - 1940
EP - 1947
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 12
ER -