The quality of evidence is downgraded by imprecise results (few outcome events).
A Cochrane review [Abstract] 1 included 6 studies with a total of 9 849 subjects. The trials evaluated the following: daily oral tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) versus placebo; TDF versus placebo; and daily TDF-FTC versus intermittent TDF-FTC. One of the trials had three study arms: TDF, TDF-FTC and placebo arm. The studies were carried out amongst different risk groups, including HIV-uninfected men who have sex with men, serodiscordant couples and other high risk men and women.
The use of oral TDF alone or a combination of TDF and FTC reduced the risk of acquiring HIV in high risk individuals (Table T1). There were no significant differences in the risk of adverse events across all the studies that reported on adverse events. Also, adherence and sexual behaviours were similar in both the intervention and control groups.
| Outcome | Number of participants (studies) | Assumed risk (placebo) | Corresponding risk (PrEP*, 95% CI) | Relative risk (95% CI) |
|---|---|---|---|---|
| Tenofovir (TDF) + Emtricitabine (FTC) compared to placebo | ||||
| HIV infection | 8 813 (4) | 37 per 1000 | 19 per 1000 (11 to 32) | 0.51 (0.3 to 0.86) |
| Serious adverse events | 6 862 (3) | 65 per 1000 | 65 per 1000 (54 to 77) | 1 (0.83 to 1.19) |
| TDF compared to placebo | ||||
| HIV infection | 4 027 (2) | 26 per 1000 | 10 per 1000 (6 to 17) | 0.38 (0.23 to 0.63) |
| Serious adverse events | 3 168 (1) | 66 per 1000 | 68 per 1000 (52 to 88) | 1.03 (0.79 to 1.33) |
| *PrEP = antiretroviral pre-exposure prophylaxis | ||||
The use of antiretroviral pre-exposure prophylaxis (PrEP) with other existing HIV prevention strategies will provide the greatest protection to individuals at risk. Further studies are need to evaluate the method of administration (daily versus intermittent dosing), long-term safety and cost effectiveness of PrEP in different risk groups and settings.
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