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Zivich, Paul N.; Cole, Stephen R.; Edwards, Jessie K.; Glidden, David V.; Das, Moupali; Shook-Sa, Bonnie E.; Shao, Yongwu; Mehrotra, Megha L.; Adimora, Adaora A.; & Eron, Joseph J. (Online ahead of print). HIV Prevention among Men who Have Sex with Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis versus Placebo. Journal of Infectious Diseases.


BACKGROUND: While non-inferiority of tenofovir alafenamide and emtricitabine (TAF/FTC) as pre-exposure prophylaxis (PrEP) for the prevention of HIV has been shown, interest remains in its efficacy relative to placebo. We estimate the efficacy of TAF/FTC PrEP versus placebo for the prevention of HIV infection.
METHODS: We used data from the DISCOVER and iPrEx trials to compare TAF/FTC to placebo. DISCOVER was a non-inferiority trial conducted from 2016 to 2017. iPrEx was a placebo-controlled trial conducted from 2007 to 2009. Inverse probability weights were used to standardize the iPrEx participants to the distribution of demographics and risk factors in the DISCOVER trial. To check the comparison, we evaluated whether risk of HIV infection in the shared tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) arms was similar.
RESULTS: Notable differences in demographics and risk factors occurred between trials. After standardization, the difference in risk of HIV infection between the TDF/FTC arms was near zero. The risk of HIV with TAF/FTC was 5.8 percentage points lower than (95% confidence interval: -2.0%, -9.6%) or 12.5-fold lower (95% confidence interval: 0.02, 0.31) than placebo standardized to the DISCOVER population.
CONCLUSION: There was a reduction in HIV infection with TAF/FTC versus placebo across 96-weeks of follow-up.


Reference Type

Journal Article

Year Published

Online ahead of print

Journal Title

Journal of Infectious Diseases


Zivich, Paul N.
Cole, Stephen R.
Edwards, Jessie K.
Glidden, David V.
Das, Moupali
Shook-Sa, Bonnie E.
Shao, Yongwu
Mehrotra, Megha L.
Adimora, Adaora A.
Eron, Joseph J.

Article Type


Data Set/Study





Edwards, J -0000-0002-1741-335X