Table 1.
Double-Blind Placebo-Controlled Randomized Trials that Included HIV Uninfected Heterosexual Women to Assess the Efficacy of Daily Oral Tenofovir Disoproxil Fumarate (TDF)-Based Pre-Exposure Prophylaxis (PrEP) for HIV Prevention
| Study Characteristics | Benefit of PrEP (95% CI) | ||||||
|---|---|---|---|---|---|---|---|
| Name | Study Population | Sample Size | Oral PrEP Agent | Plasma TDF in a Random Sample of Participants | Overall Efficacy | Female Subgroup Efficacy | Additional Analyses among Women |
| Partners PrEP Study Baeten et al. (9, 14, 15) |
Heterosexual HIV-1 uninfected persons in HIV-1 serodiscordant relationships: Kenya, Uganda | 4,747 serodiscordant couples (including 1,785 in which the HIV uninfected partner was female) | TDF-FTC | 81% | 75% (55, 87%) | 66% (28, 84%) | Tenofovir > 40 ng/mL: 94% (−17, 100%) Age < 30 years: 72% (25, 90%) Partner viral load > 50,000 copies/mL: 72% (13, 91%) |
| TDF | 83% | 67% (44, 81%) | 71% (37, 87%) | Tenofovir > 40 ng/mL: 85% (−90, 99%) Age < 30 years: 77% (29, 92%) Partner viral load > 50,000 copies/mL: 84% (29, 96%) |
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| TDF2 Thigpen et al. (11) |
Heterosexual men and women: Botswana | 1,219 (557 women) | TDF-FTC | 79% | 62% (22, 83%) | 49% (−22, 81%) | With censoring after self-reported discontinuation of study medication: 75% (24, 94%) |
| Bangkok Tenofovir Study Choopanya et al. (13) |
Male and female injection drug users: Thailand | 2,413 (489 women) | TDF | 67% | 49% (10, 72%) | 79% (17, 97%) | |
| FEM-PrEP Van Damme et al. (12) |
Heterosexual women: Kenya, Tanzania, and South Africa | 2,120 women | TDF-FTC | 24% | 6% (−52, 41%) | NA | |
| VOICE Marrazzo et al. (10) |
Heterosexual women: South Africa, Uganda, Zimbabwe | 3,019 women (an additional 2,010 women were assigned to tenofovir gel) | TDF-FTC | 29% | −4% (−49, 27%) | NA | |
| TDF | 30% | −49% (−129, 3%) | NA | ||||