Author(s): Caitlin Kennedy, Virginia Tedrow

Date: 2012-02-27

Question: Should oral emtricitabine (FTC) and/or tenofovir (TDF) be used in heterosexual serodiscordant couples?

Bibliography: Baeten et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. NEJM. In Press

Quality assessmentSummary of findingsImportance
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsoral emtricitabine (FTC) and/or tenofovir (TDF)controlRelative (95% CI)Absolute
HIV infection (TDF vs. placebo) (follow-up median 23 months; modified intention to treat analysis)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionstrong association217/1579 (1.1%)52/1578 (3.3%)HR 0.33 (0.19 to 0.56)22 fewer per 1000 (from 14 fewer to 27 fewer)⊕⊕⊕⊕
HIGH
CRITICAL
HIV infection (FTC/TDF vs. placebo) (follow-up median 23 months; modified intention to treat analysis)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionstrong association313/1576 (0.82%)52/1578 (3.3%)HR 0.25 (0.13 to 0.45)25 fewer per 1000 (from 18 fewer to 29 fewer)⊕⊕⊕⊕
HIGH
CRITICAL
Any adverse events (TDF vs. placebo) (follow-up median 23 months; intention to treat analysis)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone1350/1584 (85.2%)1350/1584 (85.2%)RR 1.0 (0.9461 to 1.057)0 fewer per 1000 (from 46 fewer to 49 more)⊕⊕⊕⊕
HIGH
IMPORTANT
Any adverse events (FTC/TDF vs. placebo) (follow-up median 23 months; intention to treat analysis)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone1362/1579 (86.3%)1350/1584 (85.2%)RR 1.0065 (0.9524 to 1.0636)6 more per 1000 (from 41 fewer to 54 more)⊕⊕⊕⊕
HIGH
IMPORTANT
Any grade 3 adverse events (TDF vs. placebo) (follow-up median 32 months; intention to treat analysis)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone289/1584 (18.2%)268/1584 (16.9%)RR 1.0663 (0.9147 to 1.2429)11 more per 1000 (from 14 fewer to 41 more)⊕⊕⊕⊕
HIGH
IMPORTANT
Any grade 3 adverse events (FTC/TDF vs. placebo) (follow-up median 32 months; intention to treat analysis)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone293/1579 (18.6%)268/1584 (16.9%)RR 1.0816 (0.9284 to 1.26)14 more per 1000 (from 12 fewer to 44 more)⊕⊕⊕⊕
HIGH
IMPORTANT
Any grade 4 adverse events (TDF vs. placebo) (follow-up median 32 months; intention to treat analysis)
11Randomized trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone34/1584 (2.1%)39/1584 (2.5%)RR 0.8745 (0.555 to 1.3779)3 fewer per 1000 (from 11 fewer to 9 more)⊕⊕⊕⊕
HIGH
IMPORTANT
Any grade 4 adverse events (FTC/TDF vs. placebo) (follow-up median 32 months; intention to treat analysis)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone44/1579 (2.8%)39/1584 (2.5%)RR 1.1282 (0.7372 to 1.7266)3 more per 1000 (from 6 fewer to 18 more)⊕⊕⊕⊕
HIGH
IMPORTANT
Condom use (TDF vs. placebo) (follow-up median 32 months; sex without condoms with HIV-positive partner)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone27% at baseline
13% at 12 months
9% at 24 months
No difference across study arms (p=0.32)-⊕⊕⊕⊕
HIGH
IMPORTANT
Condom use (FTC/TDF vs. placebo) (follow-up median 32 months; sex without condoms with HIV-positive partner)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone27% at baseline
13% at 12 months
9% at 24 months
No difference across study arms (p=0.66)-⊕⊕⊕⊕
HIGH
IMPORTANT
Number of sexual partners (TDF vs. placebo) (follow-up median 32 months; Any report of an outside sexual partner)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone468/1584 (29.5%)459/1584 (29%)RR 1.0151 (0.9064 to 1.1369)4 more per 1000 (from 27 fewer to 40 more)⊕⊕⊕⊕
HIGH
IMPORTANT
Number of sexual partners (FTC/TDF vs. placebo) (follow-up median 32 months; Any report of an outside sexual partner)
11randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone469/1579 (29.7%)459/1584 (29%)RR 1.0193 (0.9102 to 1.1414)6 more per 1000 (from 26 fewer to 41 more)⊕⊕⊕⊕
HIGH
IMPORTANT
1

Baeten et al. 2012 - Partners PrEP

2

67% reduction in HIV-1 acquisition vs. placebo

3

75% reduction in HIV-1 acquisition vs. placebo

From: Annex 2, GRADE Table for systematic review of serodiscordant couples

Cover of Guidance on Pre-Exposure Oral Prophylaxis (PrEP) for Serodiscordant Couples, Men and Transgender Women Who Have Sex with Men at High Risk of HIV
Guidance on Pre-Exposure Oral Prophylaxis (PrEP) for Serodiscordant Couples, Men and Transgender Women Who Have Sex with Men at High Risk of HIV: Recommendations for Use in the Context of Demonstration Projects.
Geneva: World Health Organization; 2012 Jul.
Copyright © 2012, World Health Organization.

All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: tni.ohw@sredrokoob).

Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_form/en/index.html).

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.