Table 1.
Summary table of included studies for effectiveness of oral HIV preexposure prophylaxis for all populations (adapted from Fonner et al)
| Study | Study design | Location | PrEP regimen | PrEP dosing and comparison | Primary mode of HIV acquisition | Study population | Number of participants | Overall effectiveness of PrEP (95% CI) by MITT* |
|---|---|---|---|---|---|---|---|---|
| iPrEx(27) | RCTa | Peru, Ecquador, S Africa, Brazil, Thailand, USA | FTC/TDFb | Daily PrEP to placebo | Rectal | MSMc and transgender women | 2499 | 44% (15-63%) |
| iPrEx OLEd(32) | Cohort | Peru, Ecquador, S Africa, Brazil, Thailand, USA | FTC/TDF | Daily PrEP to no PrEP use | Rectal | MSM and transgender women | 1603 | 49% (-0.1-74%) |
| PROUD(18) | RCT | England | FTC/TDF | Immediate to delayed PrEP | Rectal | MSM | 545 | 86% (64-96%)e |
| Project PrEPare(30) | RCT | USA | FTC/TDF | Daily PrEP to placebo and to ‘no pill’ | Rectal | Young MSM | 58 | No seroconversions |
| IPERGAY(28) | RCT | France, Canada | FTC/TDF | Intermittent PrEP to placebo | Rectal | MSM | 400 | 86% (40-99%) |
| IPERGAY OLE(20) | Cohort | France, Canada | FTC/TDF | Intermittent PrEP to placebo | Rectal | MSM | 362 | 97% (81-100%) |
| IAVI Kenya(31) | RCT | Kenya | FTC/TDF | Daily/intermittent PrEP to daily/intermittent placebo | Rectal | MSM and FSW | 72 | 1 seroconversion placebo group |
| CDC Safety Study(26) | RCT | USA | TDF | Immediate/delayed PrEP to immediate/delayed placebo | Rectal | MSM | 400 | 7 seroconversions (4 placebo, 3 delayed, 0 TDF) |
| ADAPT HPTN 067(45) | RCT | S Africa, Thailand, USA | FTC/TDF | Daily, time and event driven PrEP | Rectal Vaginal/Penile | MSM Women | 500 | 12 infections, distributed across the arms |
| Bangkok Tenofovir Study(42) | RCT | Thailand | TDF | Daily PrEP to placebo | Vaginal/penile | People who inject drugs | 2413 | 48.9% (9.6-72.2%) |
| Bangkok Tenofovir Study OLE(46) | Cohort | Thailand | TDF | Daily PrEP to placebo | Vaginal/penile | People who inject drugs | 787 | All: 48.9% (9.6-72.2) Females: 78.6 (16.8-96.7) |
| Partners PrEP(38) | RCT | Kenya, Uganda | FTC/TDF and TDF (2 active arms) | Daily PrEP to placebo | Vaginal/penile | Sero-discordant couples | 4747 couples | All: TDF/FTC: 75% (55-87%) TDF: 67% (44-81%) Women: TDF/FTC: 66% (28-84%) TDF: 71% (37-87%) Men: TDF/FTC: 84% (54-94%) TDF: 63% (20-83%) |
| Partners PrEP Demonstration Project (39) | RCT | Kenya, Uganda | FTC/TDF and FTC | Daily FTC/TDF to TDF | Vaginal/penile | Sero-discordant couples | 4410 couples | 33% (-17-41%) (i.e. no difference between TDF/FTC and TDF) |
| TDF-2(40) | RCT | Botswana | FTC/TDF | Daily PrEP to placebo | Vaginal/penile | Heteroseuxal men and women | 1219 | 61.7% (15.9-82.6%) |
| IAVI Uganda(47) | RCT | Uganda | FTC/TDF | Daily/intermittent PrEP to daily/intermittent placebo | Vaginal/penile | Sero-discordant couples | 72 | Not reported |
| FEM-PrEP(36) | RCT | Tanzania, S Africa, Kenya | FTC/TDF | Daily PrEP to placebo | Vaginal/penile | Women | 2056 | 6% (-52-41%) |
| VOICE(37) | RCT | S Africa, Uganda, Zimbabwe | FTC/TDF and TDF (2 active arms) | Daily PrEP to placebo | Vaginal/penile | Women | 4969 | TDF/FTC: -4.4% (-50-27%) TDF: -49% (-130-3%) |
| West African Safety Study(48) | RCT | Nigeria, Cameroon, Ghana | TDF | Daily PrEP to placbeo | Vaginal/penile | Women | 936 | 65% (-93-97%) |
a
RCT: Randomized controlled trial
b
FTC: Emtricitabine; TDF: tenofovir disoproxil fumarate
c
MSM: men who have sex with men
d
OLE: open label extension
e
90% confidence interval from the PROUD study
*
Not adjusted for adherence