Peterson et al (2007)
22
  • Peterson L.
  • Taylor D
  • Roddy R.
  • et al.
Tenofovir disoproxil fumarate for the prevention of HIV infection in women: a phase 2, double-blind, randomized, placebo-controlled trial.

West Africa Security Study Ghana, Cameroon

Data from Nigeria were not included in the kidney function analyses.

cisgender women Tenofovir disoproxil fumarate (oral) June 2004 to March 2006 859 Registration; and months 1, 3, 6, 9 and 12 Any Grant et al (2010);
23
  • Grant RM
  • Llama JR
  • Anderson PL
  • et al.
Pre-exposure chemoprophylaxis for HIV prevention in men who have sex with men.

Solomon et al (2014)

5
  • Solomon MM
  • Llama JR
  • Glidden DV
  • et al.
Changes in renal function associated with oral use of emtricitabine/tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis.

iPrEx South Africa, Brazil, Ecuador, Peru, Thailand, United States Cisgender men who have sex with transgender men and women Tenofovir disoproxil fumarate (oral) plus emtricitabine (oral) July 2007 to December 2009 2499

The sample size for Solomon et al (2014) analysis for the iPrEx study was 1137.

Registration; weeks 4, 8, 12, 16 and 24; and every 12 weeks thereafter Cockcroft–Gault equation Mutua et al (2012)
24
  • Mutua G
  • E-sanders
  • Mugo P
  • et al.
Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 among African men who have sex with men and female sex workers.

IAVI-Kenya Kenya Cisgender men who have sex with men and female sex workers Tenofovir disoproxil fumarate (oral) plus emtricitabine (oral) October to December 2009 36 Monthly Cockcroft–Gault equation Baeten et al (2012);
25
  • Baeten JM
  • Donnel D
  • Ndase P
  • et al.
Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.

Mugwanya et al (2015);

3
  • Mugwanya KK
  • Wyatt C.
  • Celum C
  • et al.
Changes in glomerular renal function in HIV-1 uninfected men and women receiving emtricitabine fumarate-tenofovir disoproxil pre-exposure prophylaxis: a randomized clinical trial.

Mugwanya et al (2016)

26
  • Mugwanya K.
  • Baeten J.
  • Celum C
  • et al.
Low risk of proximal tubular dysfunction associated with emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis in men and women.

PrEP Partners Kenya, Uganda Serodisferous couples Tenofovir disoproxil fumarate (oral); and tenofovir disoproxil fumarate (oral) plus emtricitabine (oral) July 2008 to November 2010 4640 Baseline; month 1; and every 3 months thereafter Cockcroft-Gault equation, CKD-EPI and markers of proximal tubular dysfunction Thigpen et al (2012)
27
  • Thigpen MC
  • Kebaabetswe PM
  • Paxton LA
  • et al.
Pre-exposure antiretroviral prophylaxis for heterosexual transmission of HIV in Botswana.

TDF2 Botswana Cisgender men who have sex with cisgender men and women Tenofovir disoproxil fumarate (oral) plus emtricitabine (oral) March 2007 to October 2009 1219 Monthly Any Van Damme et al (2012);
28
  • Van Damme L
  • Corneli A.
  • Ahmad K.
  • et al.
Pre-exposure prophylaxis for HIV infection in African women.

Mandala et al (2014)

29
  • Mandala J
  • Nanda K
  • Wang M
  • et al.
Hepatic and renal safety of tenofovir disoproxil fumarate in combination with emtricitabine in African women in a pre-exposure prophylaxis trial.

FEM-PrEP Kenya, South Africa, Tanzania cisgender women Tenofovir disoproxil fumarate (oral) plus emtricitabine (oral) June 2009 to April 2011 2058 Registration; weeks 4, 12, 24, 36, 52 and 56; and when clinically indicated Any Choopanya et al (2013);
15
  • Choopanya K
  • Martin M.
  • Suntarasamai P
  • et al.
Antiretroviral prophylaxis of HIV infection among injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir study): a randomized, double-blind, placebo-controlled phase 3 trial.

Martin et al (2014)

16
  • Martin M.
  • Vanichseni S
  • Suntarasamai P
  • et al.
Kidney function of participants in the Bangkok-Thailand tenofovir study, 2005-2012.

Tenofovir from Bangkok Thailand People who inject drugs Tenofovir disoproxil fumarate (oral) June 2005 to July 2010 2413 Registration; months 1, 2 and 3; and every 3 months thereafter Cockcroft-Gault equation, MDRD and CKD-EPI Grohskopf et al (2013)
17
  • Grohskopf LA
  • Chillag KL
  • Gvetadze R
  • et al.
Randomized trial of the clinical safety of daily oral tenofovir disoproxil fumarate in HIV-uninfected men who have sex with men in the United States.

Security in the United States United States Cisgender men who have sex with men Tenofovir disoproxil fumarate (oral) January 2005 to July 2007 400 Registration; and months 1, 3, 6, 9, 12, 15, 18, 21 and 24 Any Kibengo et al (2013)
18
  • Kibengo FM
  • Ruzagira E
  • Katende D
  • et al.
Safety, compliance, and acceptability of intermittent tenofovir/emtricitabine as HIV pre-exposure prophylaxis (PrEP) in HIV-uninfected Ugandan volunteers living in serodiscordant relationships: a randomized clinical trial.

IAVI-Uganda Uganda Serodisferous couples Tenofovir disoproxil fumarate (oral) plus emtricitabine (oral) October 2009 to March 2010 36 Registration and monthly visits Cockcroft–Gault equation Marrazzo et al (2015)
19
  • Marrazzo J.M.
  • Ramjee G
  • Richardson BA
  • et al.
Tenofovir-based pre-exposure prophylaxis for HIV infection in African women.

VOICE trial (MTN-003) South Africa, Uganda, Zimbabwe cisgender women Tenofovir disoproxil fumarate (oral) and tenofovir disoproxil fumarate plus emtricitabine (oral and vaginal gel
§

Only data from oral PrEP participants were included in the meta-analysis.

)

September 2009 to June 2011 5029 Monthly Any Molina et al (2015);
20
  • Molina JM
  • Captain C
  • Arrow B
  • et al.
On-demand pre-exposure prophylaxis in men at high risk of HIV-1 infection.

Liègeon et al (2020)

21
  • Cork G
  • Antoni G.
  • Pialoux G.
  • et al.
Changes in kidney function in men who have sex with men starting on-demand tenofovir disoproxil fumarate – emtricitabine for HIV pre-exposure prophylaxis.

ANRS-IPERGAY Canada, France Cisgender men who have sex with transgender men and women Tenofovir disoproxil fumarate (oral) plus emtricitabine (oral) February 2012 to January 2015; on demand PrEP 2014–15 400 Registration; week 4; and every 8 weeks thereafter Cockcroft-Gault equation and CKD-EPI