Table 1 Overview of included studies examining the efficacy, effectiveness, and adherence of oral PrEP
Characteristics | Number of incident HIV infections | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Year | Study name | Geographical location | Population | Sample size | Total follow-up time (person-years) | Design | Regimen | Drug | Study drug | Placebo/ comparator | Total |
2010 | iPrEx [6] | Global | MSM/TGW | 2499 | 3324 | RDBPCT | Daily | TDF-FTC | 36 | 64 | 100 |
2012 | Partners study [7] | Kenya and Uganda | Heterosexual HIV-discordant couples | 4758 | 7820 | RDBPCT | Daily | TDF-FTC | 13 | 52 | 82 |
TDF | 17 | ||||||||||
2012 | TDF2 [8] | Botswana | Heterosexual | 1219 | 1563 | RDBPCT | Daily | TDF-FTC | 9 | 24 | 33 |
2012 | FEM-PrEP [13] | Kenya, Tanzania and South Africa | Heterosexual females | 2120 | – | RDBPCT | Daily | TDF-FTC | 33 | 35 | 68 |
2012 | Kenya safety and adherence study [38] | Kenya | MSM and Female sex workers | 72 | – | RDBPCT | Daily | TDF-FTC | 0 | 1 | 1 |
Time-driven | 0 | ||||||||||
2013 | Partners adherence substudy [17] | Kenya and Uganda | Heterosexual HIV-discordant couples | 1147 | 807 | Convenience sub-cohort of a RDBPCT | Daily | TDF-FTC | 0 | 14 | 14 |
TDF | 0 | ||||||||||
2013 | Bangkok tenofovir study [31] | Bangkok | PWID | 2413 | 9665 | RDBPCT | Daily | TDF | 17 | 33 | 50 |
2013 | Uganda safety and adherence study [35] | Uganda | Heterosexual HIV-discordant couples | 72 | – | RDBPCT | Daily | TDF-FTC | 0 | 0 | 0 |
Time-driven | 0 | 0 | |||||||||
2013 | ATN 082 (Project PrEPARE) [54] | United States | Young MSM | 58 | – | RBPCT | Daily | TDF-FTC | 0 | 0 | 0 |
No pill | 0 | ||||||||||
2014 | iPrEx extension [15] | Global | MSM/TGW | 1603 (1225 received) | – | Open Label | Daily | TDF-FTC | 28 | 13 | 41 |
2015 | VOICE [14] | South Africa, Uganda, Zimbabwe | Heterosexual females | 3019 | 4253 | RCT | Daily | TDF-FTC | 61 | 60 | 173 |
TDF | 52 | ||||||||||
2015 | HPTN 067/ADAPTa [36] | South Africa | Heterosexual females | 191 | – | RCT with different regimens as comparators | Daily | TDF-FTC | 1 | N/A | 5 |
Time-driven | 2 | ||||||||||
Event-driven | 2 | ||||||||||
2015 | Generating adherence Philadelphia [50] | United States | Young MSM of colour | 23 | 7.5 | Observational | Daily | TDF-FTC | 0 | N/A | 0 |
2015 | PROUD [9] | United Kingdom | MSM | 544 | 465 | RCT with a 1 year deferred group as comparator | Daily | TDF-FTC | 3 | 20 | 23 |
2015 | IPERGAY [10] | France and Canada | MSM/TGW | 400 | 431 | RDBPCT | Event-driven | TDF-FTC | 2 | 14 | 16 |
2016 | Bangkok MSMa [55] | Thailand | MSM /TGW | 168 | – | Observational | Daily | TDF-FTC | 0 | N/A | 0 |
2016 | Permanente Cohort [24] | USA | At-risk | 972 | 850 | Open label | Daily | TDF-FTC | 0 | 2 Off-PrEP | 2 |
2016 | The Demo Project [23] | USA | MSM/TGW | 557 | 481 | Open label | Daily | TDF-FTC | 1 | 1 Off-PrEP | 2 |
2017 | SPARKa [57] | United States | MSM | 301 | – | Open Label | Daily | TDF-FTC | – | – | – |
2017 | IPERGAY extension [22] | France/Canada | MSM/TGW | 361 | 518 | Open label | Event-driven | TDF-FTC | 0 | 1 Off-PrEP | 1 |
2017 | Short term PrEP Mozambiquea [25] | Mozambique | Heterosexual females | 74 | 7.4 | Open label | Daily | TDF-FTC | 0 | N/A | 1 |
2017 | Parisian MSMa [26] | France | MSM | 785 | 215 | Open label | Daily & Event-driven | TDF-FTC | 3 | N/A | 3 |
2017 | Australia | Gay/bisexual males | 317 | 381 | Open label | Daily | TDF-FTC | 0 | N/A | 0 | |
2017 | PROUD adherencea [29] | UK | MSM | 544 enrolled (481 initiated) | 1253 | Open label | Daily | TDF-FTC | 10 | N/A | 10 |
2017 | Pluspillsa [30] | South Africa | Adolescents | 148 | 131 | Open label | Daily | TDF-FTC | 0 | 1 Off-PrEP | 1 |
2017 | Brazil Demoa [65] | Brasil | MSM/TGW | 450 | 389 | Open label | Daily | TDF-FTC | 0 | 2 Off-PrEP | 2 |