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. 2017 May 31;9:391–401. doi: 10.2147/IJWH.S113675

Table 1.

Efficacy data for HIV PrEP in women

Study Year Location No of women enrolled Regimen(s) tested* Efficacy for women Adherence
TDF24 2012 Botswana 557 Daily oral TDF/FTC 49% (95% CI −22% to 81%) Detectable plasma tenofovir levels in 80% of women who did not acquire HIV vs 50% of women who acquired HIV
Partners PrEP3 2012 Kenya, Uganda 4,758 couples, 1,164 with women as HIV-uninfected partner assigned to use PrEP (598 assigned to use TDF, 566 assigned to use TDF/FTC) Daily oral TDF or TDF/FTC TDF: 71% (95% CI 37% to 87%) TDF/FTC: 66% (95% CI 28% to 84%) Detectable plasma tenofovir levels in 83% of women who did not acquire HIV vs 31% of women who acquired HIV
FEM-PrEP12 2012 Kenya, South Africa 2,120 Daily oral TDF/FTC 6% (95% CI −52% to 41%) Detectable plasma levels tenofovir in <40% of women
VOICE13 2015 South Africa, Uganda, Zimbabwe 5,029 Daily oral TDF or TDF/FTC, or daily intravaginal 1% tenofovir gel TDF: −49% (95% CI −129% to 3%) TDF/FTC: −4% (95% CI -50% to 27%) Tenofovir gel: 15% (95% CI −21% to 39%) Detectable plasma levels in 30% of women assigned to oral TDF and 29% of women assigned to oral TDF/FTC. 41% of women assigned to tenofovir gel had no tenofovir detected in any vaginal samples
CAPRISA-00477 2010 South Africa 889 Pericoital intravaginal 1% tenofovir gel 39% (95% CI 6% to 60%) 54% efficacy when adherence >80%; 38% efficacy when adherence 50%–80%; 28% efficacy when adherence <50%
FACTS-00178 2015 South Africa 2,029 Pericoital intravaginal 1% tenofovir gel 0% (95% CI -40% to 30%) 13% of women with consistent use of gel (≥80% of sex acts). 22% of women with tenofovir detected in cervicovaginal samples at all quarterly visits; detectable levels of tenofovir associated with 52% efficacy
ASPIRE79 2016 Malawi, South Africa, Uganda, Zimbabwe 2,629 Monthly intravaginal ring (DPV) 27% (95% CI 1% to 46%) (56% risk reduction among women >21 years) Drug levels in 82% of plasma samples and 84% of returned rings consistent with use of intravaginal rings. Lowest levels of adherence and no efficacy demonstrated among women <21 years old
The Ring Study80 2016 South Africa, Uganda 1,959 Monthly intravaginal ring (DPV) 31% (95% CI 1% to 51%) Drug levels in 83% of plasma samples and 84% of returned rings consistent with use of intravaginal rings. 38% efficacy among women >21 years old; no efficacy among women ≤21 years old. 65% efficacy when ≤20 mg residual dapivirine in ring
Bangkok Tenofovir Study6 2013 Thailand 489 Daily oral TDF 79% (95% CI 17% to 97%) 66% of women with detectable plasma TDF

Notes:

*

All studies represent placebo-controlled efficacy trials.

The small number of study endpoints among women participants limited the statistical power to detect significant effect sizes for women.

Abbreviations: TDF, tenofovir disoproxil fumarate; FTC, emtricitabine; DPV, dapivirine; PrEP, pre-exposure prophylaxis; CI, confidence interval.